@Article{info:doi/10.2196/69960, author="Kroumpouzos, George and Silikovich, Fernando", title="Exploring Nonresponse to Botulinum Toxin in Aesthetics: Narrative Review of Key Trigger Factors and Effective Management Strategies", journal="JMIR Dermatol", year="2025", month="Apr", day="24", volume="8", pages="e69960", keywords="botulinum toxin", keywords="onabotulinumtoxinA", keywords="abobotulinumtoxinA", keywords="incobotulinumtoxinA", keywords="daxibotulinumtoxinA", keywords="aesthetic", keywords="cosmetic", keywords="trigger factor", keywords="neutralizing antibody", keywords="nonresponse", keywords="resistance", keywords="immune response", keywords="prevention", keywords="treatment", keywords="management", abstract="Background: Nonresponse to botulinum toxin type A (BoNT-A) has been reported in both medical and aesthetic applications. Secondary nonresponse (SNR) occurs when BoNT-A is initially effective before failure commences at a later point. Most reported cases involve SNR in aesthetics. Several aspects of this complication remain elusive or controversial. Objective: We aimed to address unanswered questions regarding the prevalence and etiology of SNR. Additionally, we investigated the immunogenicity of BoNT-A formulations, mainly focusing on the development of neutralizing antibodies that hinder the toxin's pharmacologic effects. Furthermore, we sought to examine the management strategies for SNR. Methods: The PubMed and Google Scholar databases were searched from inception for articles on nonresponse to BoNT-A therapy. Articles were evaluated based on their contribution to the field. Expert opinions and panel recommendations regarding management and data gaps were also included in the review. Results: There are limited data on SNR prevalence in aesthetic applications compared to therapeutic uses. Trigger factors of SNR include improper handling of BoNT-A; incorrect injection practices; and impurities present in the formulation, such as clostridial complexing proteins that may increase immunogenicity. Other contributing factors include infection; patient characteristics; and treatment parameters that encompass an increased frequency of BoNT-A injections (ie, <3 months apart), higher cumulative dosages, elevated treatment dosages, and booster injections (retreatment within 3 weeks of the initial injection). Neutralizing antibodies developed with first-generation formulations, such as onabotulinumtoxinA and abobotulinumtoxinA that contain clostridial proteins, but not with second-generation BoNT-As, such as incobotulinumtoxinA and daxibotulinumtoxinA, which lack these proteins. Among patients who developed SNR after using first-generation BoNT-A for aesthetic purposes, switching to incobotulinumtoxinA therapy did not result in the development of immune responses. Switching to a protein-free BoNT-A formulation such as incobotulinumtoxinA upon development of SNR has been advocated. To effectively manage SNR, it is crucial to minimize the identified trigger factors. Conclusions: Nonresponse to BoNT-A is gaining importance in aesthetic treatments. Considering the potential for immunogenicity is essential when selecting a BoNT-A formulation. Preventing SNR is crucial, given the lack of solid data on effective treatments. ", doi="10.2196/69960", url="https://derma.jmir.org/2025/1/e69960" } @Article{info:doi/10.2196/60854, author="Rudin, S. Robert and Santacroce, M. Leah and Ganguli, Ishani and Solomon, H. Daniel", title="Tailoring Rheumatoid Arthritis Visit Timing Based on mHealth App Data: Mixed Methods Assessment of Implementation and Usability", journal="JMIR Form Res", year="2025", month="Apr", day="21", volume="9", pages="e60854", keywords="mobile health", keywords="patient-reported outcomes", keywords="visit timing", keywords="visit frequency", keywords="rheumatoid arthritis", keywords="rheumatology", abstract="Background: Visits to medical subspecialists are common, with follow-up timing often based on heuristics rather than evidence. Unnecessary visits contribute to long wait times for new patients. Specialists could enhance visit timing and reduce frequency by systematically monitoring patients' symptoms between visits, especially for symptom-driven conditions like rheumatoid arthritis (RA). We previously designed an intervention using a mobile health (mHealth) app to collect patient-reported outcomes (PRO). One of several aims of the app was to assist rheumatologists in determining visit timing for patients with RA. The intervention did not reduce visit frequency. Objective: To explore possible reasons for the lack of association between the intervention and visit frequency, we describe app usage, assess usability, and identify barriers and facilitators for using between-visit PRO data to reduce visits when patients' symptoms are stable. Methods: We analyzed patients' use of the app by reporting adherence (percent of PRO questionnaires completed during the 12-month study) and retention (use in the last month of the study). To examine rheumatologists' experiences, we summarized views of the electronic health record (EHR)--embedded PRO dashboard and EHR inbox messages suggesting early or deferred visits. We assessed app usability using the interactive mHealth App Usability Questionnaire for Ease of Use and Usefulness for patients and the System Usability Scale for rheumatologists. We assessed rheumatologist-level effects of intervention usage using Kruskal-Wallis rank sum and equality of proportion tests. We identified barriers and facilitators through interviews and surveys. Results: The analysis included 150 patients with RA and their 11 rheumatologists. Patients answered a median of 53.3\% (IQR 34.1\%-69.2\%) of PRO questionnaires; this proportion varied by rheumatologist (range 40.7\%?67\%). Over half of the patients used the app during the final month of the study (56\%, range 51\%?65\%, by rheumatologists); the median number of months of use was 12 (IQR 9-12). Rheumatologists viewed the dashboard 78 times (17.6\% of 443 visits) with significant differences in viewing rates by rheumatologist (range 10\%?66\%; P<.01). There were 108 generated messages sent to rheumatologists suggesting a deferred visit (24.4\% of 443 visits) with significant differences in message counts received per visit by rheumatologist (range 10.8\%?22.6\%; P=.03). Rheumatologists' reported barriers to offering visit deferrals included already scheduling as far out as they were comfortable and rescheduling complexities for staff. Based on 39 patient interviews and 44 surveys, patients reported 2 main barriers to app usage: questionnaire frequency not being tailored to them and reduced motivation after not discussing PRO data with their rheumatologist. A total of 5 interviewed patients received the option to defer their visits, of which 3 elected to defer the appointment and 2 chose to keep it. Conclusions: While an mHealth app for reporting RA PROs was used frequently by patients, using these data to reduce the frequency of unneeded visits was not straightforward. Better engagement of clinicians may improve the use of PRO data. ", doi="10.2196/60854", url="https://formative.jmir.org/2025/1/e60854" } @Article{info:doi/10.2196/63933, author="Cai, Zijie and Meng, ChunXue and Wang, Fei and Tang, ChunZhi and Zhang, Jing and Zhang, Qian and Guo, Bin", title="Efficacy And Safety of Acupoint Catgut Embedding for Perennial Allergic Rhinitis: Protocol for a Randomized Clinical Trial", journal="JMIR Res Protoc", year="2025", month="Apr", day="21", volume="14", pages="e63933", keywords="acupoint thread embedding", keywords="catgut embedding", keywords="allergic rhinitis", keywords="loratadine", abstract="Background: Allergic rhinitis (AR) is a noninfectious chronic inflammatory disease of the nasal mucosa characterized mainly by itching, sneezing, nasal congestion, and rhinorrhea. It is mediated by immunoglobulin E (IgE). AR is one of the most common allergic diseases globally, affecting 10\% to 20\% of the population worldwide, with some regions even reaching rates as high as 50\%, posing a global health issue. The prevalence of AR has been increasing since the 1960s, with a significant increase in recent years. At present, modern medicine---including desensitization therapy, the use of antiallergic drugs, antihistamines, hormones, and other treatments---can improve symptoms or regulate the immune system. However, both short- and long-term efficacy remain limited, as symptoms often recur after treatment cessation, and long-term drug use is associated with toxicity and side effects. Objective: Acupoint catgut embedding (ACE) therapy is widely used to treat AR in China. ACE therapy has been reported to be effective in managing the symptoms of AR, but the evidence faces methodological limitations. Therefore, we designed a parallel-arm, randomized controlled, multicentered, placebo-controlled, and single-blinded trial to evaluate the efficacy and safety of ACE therapy for AR. Methods: This study will be a parallel-group, patient-blind, placebo-controlled randomized controlled trial conducted in the Third Affiliated Hospital of Sun Yat-sen University, Ningxia Chinese Medicine Research Center, and the Affiliated Hospital of Shanxi University of Traditional Chinese Medicine. The trial consists of a 4-week treatment period, along with a 3-month follow-up. After providing written informed consent, eligible participants will be randomized at a ratio of 1: 1 into one of 2 groups: the ACE group receiving treatment and the sham ACE group. Both groups will receive conventional loratadine treatment. Results: The funding began in January 2022. The study was initiated on February 1, 2025, and will end in February 2026. Patient recruitment has already started, and the study results will be released in March 2026. Conclusions: We expect that this research will provide important insights into the efficacy of ACE treatment for AR and generate robust data for the foundation of future research in this field. Trial Registration: Chinese Clinical Trial Registry ChiCTR2500095634; https://www.chictr.org.cn/historyversionpubEN.html?regno=ChiCTR2500095634 International Registered Report Identifier (IRRID): PRR1-10.2196/63933 ", doi="10.2196/63933", url="https://www.researchprotocols.org/2025/1/e63933" } @Article{info:doi/10.2196/58095, author="Benavent, Diego and Iniesta-Chamorro, M. Jose and Novella-Navarro, Marta and P{\'e}rez-Mart{\'i}nez, Miguel and Mart{\'i}nez-S{\'a}nchez, Nuria and Kaffati, M{\'o}nica and Ju{\'a}rez-Garc{\'i}a, Manuel and Molinari-P{\'e}rez, Marina and Gonz{\'a}lez-Torbay, Andrea and Guti{\'e}rrez, Mariana and L{\'o}pez-Juanes, Natalia and Navarro-Comp{\'a}n, Victoria and Monjo-Henry, Irene and Rodr{\'i}guez-Rosales, Germ{\'a}n and Bachiller, Javier and Calvo-Aranda, Enrique and Michelena, Xabier and Berbel-Arcob{\'e}, Laura and Balsa, Alejandro and and G{\'o}mez, J. Enrique and Plasencia-Rodr{\'i}guez, Chamaida", title="Digital Health Intervention for Patient Monitoring in Immune-Mediated Inflammatory Diseases: Cocreation and Feasibility Study of the IMIDoc Platform", journal="JMIR Hum Factors", year="2025", month="Apr", day="21", volume="12", pages="e58095", keywords="immune-mediated inflammatory diseases", keywords="cocreation", keywords="health care provider", keywords="digital health solution", keywords="inflammatory", keywords="inflammatory disease", keywords="monitoring", keywords="care model", keywords="patient care", keywords="development", keywords="app", keywords="user centered", keywords="patient monitoring", keywords="decision-making", keywords="user needs", abstract="Background: Immune-mediated inflammatory diseases, such as rheumatoid arthritis and spondyloarthritis, pose challenges due to recurrent flares and gaps in patient monitoring. Traditional health care models often fail to capture disease progression effectively. Objective: This study aimed to describes the structured cocreation of the IMIDoc platform, an interdisciplinary initiative aimed at improving patient monitoring, education, and health care provider decision-making. Methods: IMIDoc was cocreated through an interdisciplinary team involving clinical experts, biomedical engineers, and technical developers, using user-centered design principles. The development process included the identification of unmet clinical needs, user-centered app design, implementation of medication management features, patient data recording capabilities, and educational content. A 3-month feasibility and functionality testing was performed to evaluate the usability and technical performance of the apption. Results: During the feasibility testing, 111 entries were logged for the patient mobile app, comprising 76 errors identified and corrected, 16 improvements addressing functionality, usability, and performance, and 10 evolutionary suggestions. The professional interface received 45 entries, identifying 40 errors and 5 evolutionary suggestions. Ten iterative updates significantly enhanced the user interface intuitiveness and medication reminder functionality, aligning the solution closely with clinical workflows and user needs. Conclusions: The IMIDoc platform, developed by a multidisciplinary cocreation methodology, shows potential to improve the management of immune-mediated inflammatory diseases ithrough enhanced communication and monitoring. A multicenter clinical study with 360 patients across 5 Spanish hospitals will further evaluate its impact. Trial Registration: ClinicalTrials.gov NCT06273306; https://tinyurl.com/4t6ubcsf ", doi="10.2196/58095", url="https://humanfactors.jmir.org/2025/1/e58095" } @Article{info:doi/10.2196/67883, author="Wei, Bin and Yao, Lili and Hu, Xin and Hu, Yuxiang and Rao, Jie and Ji, Yu and Dong, Zhuoer and Duan, Yichong and Wu, Xiaorong", title="Evaluating the Effectiveness of Large Language Models in Providing Patient Education for Chinese Patients With Ocular Myasthenia Gravis: Mixed Methods Study", journal="J Med Internet Res", year="2025", month="Apr", day="10", volume="27", pages="e67883", keywords="LLM", keywords="large language models", keywords="ocular myasthenia gravis", keywords="patient education", keywords="China", keywords="effectiveness", keywords="deep learning", keywords="artificial intelligence", keywords="health care", keywords="accuracy", keywords="applicability", keywords="neuromuscular disorder", keywords="extraocular muscles", keywords="ptosis", keywords="diplopia", keywords="ophthalmology", keywords="ChatGPT", keywords="clinical practice", keywords="digital health", abstract="Background: Ocular myasthenia gravis (OMG) is a neuromuscular disorder primarily affecting the extraocular muscles, leading to ptosis and diplopia. Effective patient education is crucial for disease management; however, in China, limited health care resources often restrict patients' access to personalized medical guidance. Large language models (LLMs) have emerged as potential tools to bridge this gap by providing instant, AI-driven health information. However, their accuracy and readability in educating patients with OMG remain uncertain. Objective: The purpose of this study was to systematically evaluate the effectiveness of multiple LLMs in the education of Chinese patients with OMG. Specifically, the validity of these models in answering patients with OMG-related questions was assessed through accuracy, completeness, readability, usefulness, and safety, and patients' ratings of their usability and readability were analyzed. Methods: The study was conducted in two phases: 130 choice ophthalmology examination questions were input into 5 different LLMs. Their performance was compared with that of undergraduates, master's students, and ophthalmology residents. In addition, 23 common patients with OMG-related patient questions were posed to 4 LLMs, and their responses were evaluated by ophthalmologists across 5 domains. In the second phase, 20 patients with OMG interacted with the 2 LLMs from the first phase, each asking 3 questions. Patients assessed the responses for satisfaction and readability, while ophthalmologists evaluated the responses again using the 5 domains. Results: ChatGPT o1-preview achieved the highest accuracy rate of 73\% on 130 ophthalmology examination questions, outperforming other LLMs and professional groups like undergraduates and master's students. For 23 common patients with OMG-related questions, ChatGPT o1-preview scored highest in correctness (4.44), completeness (4.44), helpfulness (4.47), and safety (4.6). GEMINI (Google DeepMind) provided the easiest-to-understand responses in readability assessments, while GPT-4o had the most complex responses, suitable for readers with higher education levels. In the second phase with 20 patients with OMG, ChatGPT o1-preview received higher satisfaction scores than Ernie 3.5 (Baidu; 4.40 vs 3.89, P=.002), although Ernie 3.5's responses were slightly more readable (4.31 vs 4.03, P=.01). Conclusions: LLMs such as ChatGPT o1-preview may have the potential to enhance patient education. Addressing challenges such as misinformation risk, readability issues, and ethical considerations is crucial for their effective and safe integration into clinical practice. ", doi="10.2196/67883", url="https://www.jmir.org/2025/1/e67883" } @Article{info:doi/10.2196/68704, author="Remaki, Adam and Ung, Jacques and Pages, Pierre and Wajsburt, Perceval and Liu, Elise and Faure, Guillaume and Petit-Jean, Thomas and Tannier, Xavier and G{\'e}rardin, Christel", title="Improving Phenotyping of Patients With Immune-Mediated Inflammatory Diseases Through Automated Processing of Discharge Summaries: Multicenter Cohort Study", journal="JMIR Med Inform", year="2025", month="Apr", day="9", volume="13", pages="e68704", keywords="secondary use of clinical data for research and surveillance", keywords="clinical informatics", keywords="clinical data warehouse", keywords="electronic health record", keywords="data science", keywords="artificial intelligence", keywords="AI", keywords="natural language processing", keywords="ontologies", keywords="classifications", keywords="coding", keywords="tools", keywords="programs and algorithms", keywords="immune-mediated inflammatory diseases", abstract="Background: Valuable insights gathered by clinicians during their inquiries and documented in textual reports are often unavailable in the structured data recorded in electronic health records (EHRs). Objective: This study aimed to highlight that mining unstructured textual data with natural language processing techniques complements the available structured data and enables more comprehensive patient phenotyping. A proof-of-concept for patients diagnosed with specific autoimmune diseases is presented, in which the extraction of information on laboratory tests and drug treatments is performed. Methods: We collected EHRs available in the clinical data warehouse of the Greater Paris University Hospitals from 2012 to 2021 for patients hospitalized and diagnosed with 1 of 4 immune-mediated inflammatory diseases: systemic lupus erythematosus, systemic sclerosis, antiphospholipid syndrome, and Takayasu arteritis. Then, we built, trained, and validated natural language processing algorithms on 103 discharge summaries selected from the cohort and annotated by a clinician. Finally, all discharge summaries in the cohort were processed with the algorithms, and the extracted data on laboratory tests and drug treatments were compared with the structured data. Results: Named entity recognition followed by normalization yielded F1-scores of 71.1 (95\% CI 63.6-77.8) for the laboratory tests and 89.3 (95\% CI 85.9-91.6) for the drugs. Application of the algorithms to 18,604 EHRs increased the detection of antibody results and drug treatments. For instance, among patients in the systemic lupus erythematosus cohort with positive antinuclear antibodies, the rate increased from 18.34\% (752/4102) to 71.87\% (2949/4102), making the results more consistent with the literature. Conclusions: While challenges remain in standardizing laboratory tests, particularly with abbreviations, this work, based on secondary use of clinical data, demonstrates that automated processing of discharge summaries enriched the information available in structured data and facilitated more comprehensive patient profiling. ", doi="10.2196/68704", url="https://medinform.jmir.org/2025/1/e68704" } @Article{info:doi/10.2196/66003, author="Nian, Hui and Bai, Yu and Yu, Hua", title="Assessing the Causal Association Between COVID-19 and Graves Disease: Mendelian Randomization Study", journal="JMIR Form Res", year="2025", month="Apr", day="8", volume="9", pages="e66003", keywords="Graves disease", keywords="COVID-19", keywords="Mendelian randomization", keywords="causal relationship", keywords="autoimmune disease", abstract="Background: Graves disease (GD) is an autoimmune thyroid disorder characterized by hyperthyroidism and autoantibodies. The COVID-19 pandemic has raised questions about its potential relationship with autoimmune diseases like GD. Objective: This study aims to investigate the causal association between COVID-19 and GD through Mendelian randomization (MR) analysis and assess the impact of COVID-19 on GD. Methods: We conducted an MR study using extensive genome-wide association study data for GD and COVID-19 susceptibility and its severity. We used stringent single nucleotide polymorphism selection criteria and various MR methodologies, including inverse-variance weighting, MR-Egger, and weighted median analyses, to assess causal relationships. We also conducted tests for directional pleiotropy and heterogeneity, as well as sensitivity analyses. Results: The MR analysis, based on the largest available dataset to date, did not provide evidence supporting a causal relationship between COVID-19 susceptibility (odds ratio [OR] 0.989, 95\% CI 0.405?2.851; P=.93), COVID-19 hospitalization (OR 0.974, 95\% CI 0.852?1.113; P=.70), COVID-19 severity (OR 0.979, 95\% CI 0.890?1.077; P=.66), and GD. Tests for directional pleiotropy and heterogeneity, as well as sensitivity analyses, supported these findings. Conclusions: This comprehensive MR study does not provide sufficient evidence to support a causal relationship between COVID-19 and the onset or exacerbation of GD. These results contribute to a better understanding of the potential association between COVID-19 and autoimmune diseases, alleviating concerns about a surge in autoimmune thyroid diseases due to the pandemic. Further research is warranted to explore this complex relationship thoroughly. ", doi="10.2196/66003", url="https://formative.jmir.org/2025/1/e66003" } @Article{info:doi/10.2196/72466, author="Plavoukou, Theodora and Iosifidis, Michail and Papagiannis, Georgios and Stasinopoulos, Dimitrios and Georgoudis, Georgios", title="The Effectiveness of Telerehabilitation in Managing Pain, Strength, and Balance in Adult Patients With Knee Osteoarthritis: Systematic Review", journal="JMIR Rehabil Assist Technol", year="2025", month="Apr", day="8", volume="12", pages="e72466", keywords="telerehabilitation", keywords="knee osteoarthritis", keywords="pain management", keywords="remote physiotherapy", keywords="digital health", keywords="remote therapy", keywords="physiotherapy", keywords="strength", keywords="balance", keywords="functional mobility", keywords="rehabilitation technology", abstract="Background: Knee osteoarthritis (KOA) is a chronic, degenerative joint disease characterized by pain, stiffness, and functional impairment, significantly affecting mobility and quality of life. Traditional rehabilitation, mainly through in-person physiotherapy, is widely recommended for KOA management. However, access to these services is often limited due to geographic, financial, and mobility constraints. Telerehabilitation has emerged as an alternative, providing remote rehabilitation through digital platforms. Despite its increasing adoption, its effectiveness in improving key functional parameters such as pain, strength, and balance remains uncertain. While previous studies have focused primarily on pain relief and overall functional improvement, a broader assessment of its impact on mobility and fall prevention is needed. Objective: This systematic review examines the effectiveness of telerehabilitation in improving pain, strength, and balance in adults with KOA compared with traditional rehabilitation or no intervention. In addition, it evaluates the impact of different telerehabilitation models, such as therapist-guided versus self-managed programs, and explores the feasibility of integrating telerehabilitation as an alternative in KOA management. Methods: A systematic search of 4 databases (PubMed, PEDro, Cochrane, and Scopus) was conducted to identify randomized controlled trials (RCTs) published from May 2004 to May 2024. Inclusion criteria consisted of adults with KOA, evaluation of telerehabilitation either as a stand-alone intervention or in comparison to traditional rehabilitation or no intervention, and measurement of at least one primary outcome (pain, strength, or balance). A total of 2 independent reviewers assessed the risk of bias using validated tools. Due to variations in intervention programs and assessment methods, a narrative synthesis was performed instead of a meta-analysis. The review followed established guidelines, and data extraction was conducted using appropriate software. Results: A total of 6 RCTs (N=581 participants) met the inclusion criteria. The results indicate that telerehabilitation effectively reduces pain and improves strength and balance, although the extent of benefits varies. Some studies reported similar pain reductions between telerehabilitation and traditional rehabilitation, while others highlighted greater functional improvements in telerehabilitation groups. Therapist-guided telerehabilitation was associated with higher adherence rates and better functional outcomes compared with self-managed programs. The risk of bias assessment showed that most studies were of moderate to good quality, though common issues included selection bias, performance bias, and participant attrition. Conclusions: Telerehabilitation is a promising alternative for KOA management, especially for individuals facing barriers to in-person therapy. It is effective in reducing pain and improving strength and balance, though its success depends on patient engagement, intervention delivery, and rehabilitation protocols. Therapist-guided programs yield better outcomes than self-managed approaches. Further research is needed to standardize intervention protocols, integrate emerging technologies, and evaluate cost-effectiveness to guide clinical practice and health care policies. Trial Registration: PROSPERO CRD42024564141; https://tinyurl.com/25ykvy7d ", doi="10.2196/72466", url="https://rehab.jmir.org/2025/1/e72466", url="http://www.ncbi.nlm.nih.gov/pubmed/40198917" } @Article{info:doi/10.2196/63569, author="Hestevik, Hillestad Christine and Varsi, Cecilie and {\O}ster{\aa}s, Nina and Tveter, Therese Anne and Skandsen, Jon and Eik, Hedda", title="Perspectives on and Experiences With Remote Monitoring and Patient-Initiated Care Among Norwegian Patients With Axial Spondyloarthritis: Qualitative Study", journal="J Med Internet Res", year="2025", month="Mar", day="28", volume="27", pages="e63569", keywords="remote monitoring", keywords="patient-initiated care", keywords="patient-reported outcome measures", keywords="chronic disease", keywords="rheumatology", keywords="axial spondyloarthritis", keywords="joint disease", keywords="spine", keywords="medication", keywords="therapy", keywords="rheumatic", keywords="patient care", keywords="randomized controlled trial", keywords="interventions", keywords="decision-making", abstract="Background: Axial spondyloarthritis (axSpA) is a chronic inflammatory joint disease affecting the spine and sacroiliac joints, requiring frequent, lifelong monitoring and treatment. This involves regular symptom monitoring, assessing medication tolerance and side effects, and prompt therapy adjustments. Typically, patients with axSpA attend prescheduled hospital visits, but once stable disease has been attained, these seldom align with periods of high disease activity. Remote monitoring and patient-initiated care offer flexible, need-based, follow-up options. However, knowledge about how patients with axSpA perceive and experience these approaches is limited. To effectively implement these strategies in clinical practice, understanding patient perspectives is crucial. Objective: This study aims to explore how patients with axSpA perceive and experience remote monitoring and patient-initiated care. Methods: Our qualitative study was embedded in a randomized controlled trial. Participants were allocated to either usual care, remote monitoring, or patient-initiated care. The 2 intervention groups had no prescheduled visits and used a remote monitoring app, but only the remote monitoring group received monitoring by health care professionals. Semistructured interviews were conducted with 18 participants from the intervention groups to explore their experiences. The interviews were audio recorded, transcribed, anonymized, and analyzed using thematic analysis. Participants provided informed consent. Results: Eighteen patients (11 men and 7 women, aged 26-65 years) participated, 10 from the remote monitoring group and 8 from the patient-initiated care group. Transcripts were analyzed into four key themes: (1) ``I don't need to go to the hospital just to report I'm doing well.'' When patients felt well, they perceived in-person consultations as less important. They acknowledged health care resource challenges and were willing to adapt but expressed concerns about rapid technological advancement, fearing it could exclude vulnerable groups. They emphasized the need for shared decision-making in determining follow-up strategies; (2) ``It feels safer to meet healthcare personnel in person'' highlighted participants' preference for in-person interactions as a safety net for detecting changes or signs of disease. They felt more secure when communicating face-to-face with health care professionals; (3) Remote monitoring can promote a sense of freedom and self-efficacy. The app provided autonomy, enabling patients to monitor their health without disrupting daily routines and promoting their health competency; and (4) Practical challenges and limitations of technology affect sense of security. Concerns about app deactivation, digital privacy, and lack of personalized settings negatively affected confidence in technology and sense of security. Conclusions: Remote monitoring and patient-initiated care can adequately meet the needs of patients with axSpA with low disease activity, reducing unnecessary visits and enhancing self-efficacy. However, these approaches should not be one-size-fits-all. Care must adapt to evolving disease activity, circumstances, and preferences. Human interaction and support remain crucial, and future technological developments must address practical challenges to ensure user-friendly and reliable interfaces. ", doi="10.2196/63569", url="https://www.jmir.org/2025/1/e63569" } @Article{info:doi/10.2196/69001, author="Razmjou, Helen and Denis, Suzanne and Robarts, Susan and Wainwright, Amy and Dickson, Patricia and Murnaghan, John", title="Convergent and Known-Groups Validity and Sensitivity to Change of the Virtual Performance Measure in Patients With Hip and Knee Osteoarthritis: Longitudinal Study", journal="JMIR Form Res", year="2025", month="Mar", day="28", volume="9", pages="e69001", keywords="virtual", keywords="video-based outcome", keywords="longitudinal validity", keywords="sensitivity to change", keywords="osteoarthritis", abstract="Background: Subsequent to the COVID-19 pandemic in 2020, a different approach to health care utilization was required to improve safety and efficiency. In the postpandemic era, virtual care and remote assessment of musculoskeletal conditions has become more common, and examining the accuracy of these remote encounters remains vital. In 2023, an innovative, video-based tool---the Virtual Performance Measure (VPM)---was introduced to assess the functional difficulties of patients with osteoarthritis of the knee joint. Further validation of this tool is warranted to expand its application longitudinally and in more diverse populations. Objective: This study examined the longitudinal validity of the VPM, a digitally based outcome tool, in patients with osteoarthritis of the hip and knee joints who had undergone arthroplasty. Methods: Patients completed a web-based survey after watching 40 videos that demonstrated 10 functional tasks with increasing difficulty, prior to and at approximately 3-5 months following surgery. The Lower Extremity Functional Scale (LEFS) was used as the reference measure. Longitudinal convergent and known-groups validity as well as sensitivity to change were assessed. Results: The data of 120 patients (n=80, 67\% female; mean age 67, SD 9 years; n=58, 48\% with hip osteoarthritis and n=62, 52\% with knee osteoarthritis) were examined. There was a statistically significant improvement in both LEFS (t119=16.04, P<.001) and VPM total scores (t119=13.92, P<.001) over time. The correlation between the postoperative LEFS and VPM scores was higher (r=0.66; P<.001) than the correlation between the change scores of these measures (r=0.51; P<.001). The area under the curve value for the VPM's ability to differentiate between urgent and nonurgent candidates for surgery was 0.71 (95\% CI 0.57-0.84). Sensitivity to change as measured by the standardized response mean was 1.27 (95\% CI 1.09-1.45), indicating good ability to detect change over time. Conclusions: The VPM demonstrated sufficient longitudinal convergent and known-groups validity as well as sensitivity to change in patients with hip and knee osteoarthritis following arthroplasty. This tool has a potential to improve the delivery of care by increasing access, reducing the frequency of in-person visits, and improving the overall efficiency of the health care system following a major surgery. ", doi="10.2196/69001", url="https://formative.jmir.org/2025/1/e69001" } @Article{info:doi/10.2196/58393, author="Mbada, E. Chidozie and Awosika, Akintunji Henry and Sonuga, Ademola Oluwatobi and Akande, Micheal and Gebrye, Tadesse and Woolf, Richard and Fatoye, Francis", title="Effect of Clinic-Based and Asynchronous Video-Based Exercise on Clinic and Psychosocial Outcomes in Patients With Knee Osteoarthritis: Quasi-Experimental Study", journal="J Med Internet Res", year="2025", month="Mar", day="26", volume="27", pages="e58393", keywords="knee osteoarthritis", keywords="video", keywords="physiotherapy", keywords="exercise", keywords="mobile phone", keywords="telehealth", keywords="telemedicine", keywords="randomized", keywords="controlled trial", keywords="asynchronous", keywords="rehabilitation", keywords="knees", keywords="joints", keywords="osteoarthritis", keywords="musculoskeletal", keywords="rheumatology", keywords="physical therapy", abstract="Background: Telerehabilitation is promising for improving knee osteoarthritis, but the effect of different telerehabilitation strategies on knee osteoarthritis is unclear. Objective: This study aimed to examine the effect of a clinic-based strengthening exercise (CbSE) and asynchronous video-based strengthening exercise (AVbSE) on pain, range of motion, muscle strength, quality of life, and physical function among patients with knee osteoarthritis. Methods: A total of 52 consenting patients participated in this 8-week experimental study; they were assigned to the CbSE or AVbSE group at 2 different study sites. CbSE is a circuit exercise module comprising knee flexion and extension warm-up in sitting, quadriceps isometric setting, quadriceps strengthening exercise, hamstring clenches, wall squat, and a cooldown of knee flexion and extension. The AVbSE is an asynchronous video-based version of the CbSE. Results: This study spanned from March 31, 2021, to November 26, 2021. Eight out of 62 participants discontinued participation. Data collection and analysis have been completed. Significant differences were only observed in the mental health (t50=--3, P=.004), pain (t39.4=--3.6, P<.001), social support (t50=--2.7, P=.009), and social activities (t50=2.2, P=.03) domains of the Osteoarthritis Knee and Hip Quality of Life (OAKHQoL) questionnaire with higher scores in the AVbSE group at the end of week 4. At the end of week 8, significant differences were observed in mental health (t50=--2.1, P=.04) and pain (t37.3=--2.8, P=.008) measures with higher scores in AVbSE; however, a significantly higher score was observed in the CbSE group for the Quadruple Visual Analog Scale. No significant main effect of time was observed in this study, except in the muscle strength (F2100=1.5, P=.24), social support (F2100=2.5, P=.09), and social activity (F2100=0.7, P=.48) domains of the OAKHQoL questionnaire and activity limitation (F2100=0.1, P=.90), and performance restriction (F2100=1.3, P=.27) domains of the Ibadan Knee and Hip Osteoarthritis Outcome Measure (IKHOAM) questionnaire. There was no significant difference between groups in all OAKHQoL domains except social activities (mean 17.6, SD 1.2 vs 22.8, SD 1.2; P=.003) and average pain (2.8, SD 1.6 vs 2.3, SD 1.6; P=.03) with higher AVbSE mean scores. However, a higher score was observed for the CbSE group in the Quadruple Visual Analog Scale's least pain domain (1.2, SD 0.2 vs 0.7, SD 0.2; P=.04). Also, interaction effects showed that AVbSE scores were significantly higher for the OAKHQoL questionnaire's physical activity and mental health domains at all time points. However, the CbSE score was higher for the physical performance domain of the IKHOAM questionnaire in the eighth week. Conclusions: CbSE circuit training and its AVbSE variant effectively improve treatment outcomes and increase the quality of life of patients. While AVbSE was associated with higher improvement in most health-related quality of life domains, CbSE led to higher improvement in average pain. Trial Registration: Pan African Clinical Trial Registry PACTR202208515182119, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=23943 ", doi="10.2196/58393", url="https://www.jmir.org/2025/1/e58393" } @Article{info:doi/10.2196/65826, author="Ren, Zihan and Chen, Yawen and Li, Yufeng and Fan, Panyu and Liu, Zhao and Shen, Biyu", title="Digital Interventions for Patients With Juvenile Idiopathic Arthritis: Systematic Review and Meta-Analysis", journal="JMIR Pediatr Parent", year="2025", month="Mar", day="21", volume="8", pages="e65826", keywords="juvenile idiopathic arthritis", keywords="digital intervention", keywords="application", keywords="children health care", keywords="pediatrics", abstract="Background: Juvenile idiopathic arthritis (JIA) is a chronic rheumatic condition requiring long-term, multidisciplinary treatment, which consumes significant health care resources and family energy. This study aims to analyze the effectiveness of digital interventions on patient outcomes in individuals with JIA. Objective: This meta-analysis aimed to evaluate the impact of digital interventions on alleviating symptoms and improving overall well-being in children and adolescents with JIA. Methods: A systematic search of 5 databases identified randomized controlled trials assessing the impact of digital interventions on physiological and psychological outcomes in adolescents and children (average age ?19 y). Outcomes included pain, physical activity, health-related quality of life, self-efficacy, and disease-related issues. A total of 2 reviewers independently screened papers and extracted data on intervention functionalities and outcomes, assessing the risk of bias. A meta-analysis using a random-effects model synthesized the results. Results: The review included 11 studies involving 885 patients with JIA. Digital interventions included educational (eg, self-management training), therapeutic (eg, pain management), and behavioral (eg, promoting physical activity) approaches. These were delivered through websites, telephone consultations, video conferences, apps, and interactive games, with durations ranging from 8 to 24 weeks and no clear link observed between intervention length and outcomes. Compared with conventional control groups, digital interventions were significantly effective in alleviating pain (standardized mean difference [SMD] ?0.19, 95\% CI ?0.35 to ?0.04) and enhancing physical activity levels (SMD 0.37, 95\% CI 0.06-0.69). Marginal improvements in health-related quality of life, self-efficacy, and disease-related issues were observed, but these did not reach statistical significance (SMD ?0.04, 95\% CI ?0.19 to 0.11; SMD 0.05, 95\% CI ?0.11 to 0.20; and SMD 0.09, 95\% CI ?0.11 to 0.29, respectively). The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach rated the quality of evidence for pain, health-related quality of life, self-efficacy, and disease-related issues as moderate, while the evidence quality for physical activity was assessed as low. Conclusions: Digital interventions can alleviate pain and enhance physical activity in patients with JIA. However, given the limited sample size and high risk of bias in some studies, further high-quality research is needed to improve the treatment and management of JIA. Trial Registration: PROSPERO CRD42023471223; https://www.crd.york.ac.uk/PROSPERO/view/CRD42023471223 ", doi="10.2196/65826", url="https://pediatrics.jmir.org/2025/1/e65826" } @Article{info:doi/10.2196/57697, author="Haegens, L. Lex and Huiskes, B. Victor J. and van den Bemt, F. Bart J. and Bekker, L. Charlotte", title="Factors Influencing the Intentions of Patients With Inflammatory Rheumatic Diseases to Use a Digital Human for Medication Information: Qualitative Study", journal="J Med Internet Res", year="2025", month="Mar", day="13", volume="27", pages="e57697", keywords="digital human", keywords="information provision", keywords="intention to use", keywords="qualitative study", keywords="focus groups", keywords="drug-related problems", keywords="medication safety", keywords="safety information", keywords="information seeking", keywords="Netherlands", keywords="Pharmacotherapy", keywords="medication", keywords="telehealth", keywords="communication technologies", keywords="medication information", keywords="rheumatic diseases", keywords="rheumatology", abstract="Background: Introduction: Patients with inflammatory rheumatic diseases (IRDs) frequently experience drug-related problems (DRPs). DRPs can have negative health consequences and should be addressed promptly to prevent complications. A digital human, which is an embodied conversational agent, could provide medication-related information in a time- and place-independent manner to support patients in preventing and decreasing DRPs. Objective: This study aims to identify factors that influence the intention of patients with IRDs to use a digital human to retrieve medication-related information. Methods: A qualitative study with 3 in-person focus groups was conducted among adult patients diagnosed with an IRD in the Netherlands. The prototype of a digital human is an innovative tool that provides spoken answers to medication-related questions and provides information linked to the topic, such as (instructional) videos, drug leaflets, and other relevant sources. Before the focus group, participants completed a preparatory exercise at home to become familiar with the digital human. A semistructured interview guide based on the Proctor framework for implementation determinants was used to interview participants about the acceptability, adoption, appropriateness, costs, feasibility, fidelity, penetration, and sustainability of the digital human. Focus groups were recorded, transcribed, and analyzed thematically. Results: The participants included 22 patients, with a median age of 68 (IQR 52-75) years, of whom 64\% (n=22) were female. In total, 6 themes describing factors influencing patients' intention to use a digital human were identified: (1) the degree to which individual needs for medication-related information are met; (2) confidence in one's ability to use the digital human; (3) the degree to which using the digital human resembles interacting with a human; (4) technical functioning of the digital human; (5) privacy and security; and (6) expected benefit of using the digital human. Conclusions: The intention of patients with IRDs to use a novel digital human to retrieve medication-related information was influenced by factors related to each patient's information needs and confidence in their ability to use the digital human, features of the digital human, and the expected benefits of using the digital human. These identified themes should be considered during the further development of the digital human and during implementation to increase intention to use and future adoption. Thereafter, the effect of applying a digital human as an instrument to improve patients' self-management regarding DRPs could be researched. ", doi="10.2196/57697", url="https://www.jmir.org/2025/1/e57697" } @Article{info:doi/10.2196/57918, author="Makhija, Deepa and Mata, Sunita and Sharma, Abha and Kachare, Kalpana and Manathottathil, Aparna and Jain, Seema and Jameela, Sophia and Rao, Chandrasekhara Bhogavalli and Rana, Rakesh and Tripathi, Arunabh and Rana, Kiran and Joshi, Vandana and Singh, Anukampa and Srikanth, Narayanam and Acharya, Rabinarayan", title="Effectiveness of Composite Ayurveda Regimen in a Black Box Design for the Management of Rheumatoid Arthritis: Protocol of a Single Arm, Community-Based Study", journal="JMIR Res Protoc", year="2025", month="Feb", day="18", volume="14", pages="e57918", keywords="rheumatoid arthritis", keywords="Amavata", keywords="Ayush-SG (coded drug)", keywords="Rasnasaptak Kashaya", abstract="Background: Rheumatoid arthritis (RA) is an autoimmune disease that affects joints and can have extra-articular manifestations. RA usually tends to be progressive and leads to substantial health care burdens, both in terms of disability and economic costs. Despite the various treatment modalities available, there is still an urgent need for safe and effective medicine based on the pattern of disease presentation. The increasing interest in complementary and alternative medicine has created a demand for extensive research in this area. Objective: This clinical study is designed to evaluate the effectiveness and tolerability of a composite Ayurveda regimen in RA. Methods: The study is a single-arm (pre-post design), community-based interventional study with a black box design being conducted at 6 study centers. A total of 240 participants aged between 18 and 65 years, diagnosed with RA as per the 2010 American College of Rheumatology and the European League Against Rheumatism criteria are recruited as per the selection criteria. All the participants received Ayush-SG and Rasnasaptak Kashaya for 84 days along with customized treatment as per the disease presentation and associated complaints. The outcome measures include the change in disease activity score (DAS)-28 with erythrocyte sedimentation rate, disease-specific biochemical and inflammatory markers, Disability Index score, change in the participant's assessment of pain and frequency of use of conventional analgesics or nonsteroidal anti-inflammatory drugs from baseline. The tolerability of interventions is assessed through the occurrence of adverse events. Categorical variables will be analyzed with McNemar chi-square test, and continuous variables will be assessed using the paired t test or Wilcoxon test for pre-post assessment. The level of significance will be 5\%. Results: The recruitment of participants was initiated in December 2023. The participant recruitment was completed in March 2024 and out of 240 participants enrolled, 222 (92.5\%) completed the study up to the last follow-up. Data verification, compilation, and analysis are under process. After data analysis, the study's findings will be published in a peer-reviewed journal. Conclusions: This interventional study that incorporates the black box approach may provide a strong framework for managing RA. This design is a more reliable method for evaluating the effectiveness and tolerability of the composite Ayurveda regimen in RA. Trial Registration: Clinical Trial Registry-India CTRI/2023/06/054203; https://tinyurl.com/4prvwr6z International Registered Report Identifier (IRRID): DERR1-10.2196/57918 ", doi="10.2196/57918", url="https://www.researchprotocols.org/2025/1/e57918" } @Article{info:doi/10.2196/52601, author="May, Susann and Darkow, Robert and Knitza, Johannes and Boy, Katharina and Klemm, Philipp and Heinze, Martin and Vuillerme, Nicolas and Petit, Pascal and Steffens-Korbanka, Patricia and Kladny, Heike and Hornig, Johannes and Aries, Peer and Welcker, Martin and Muehlensiepen, Felix", title="Digital Transformation of Rheumatology Care in Germany: Cross-Sectional National Survey", journal="J Med Internet Res", year="2025", month="Jan", day="6", volume="27", pages="e52601", keywords="telemedicine", keywords="digital health technologies", keywords="rheumatology", keywords="COVID-19", keywords="questionnaire", keywords="telehealth", keywords="eHealth", keywords="digital health", keywords="survey", keywords="rheumatism", keywords="Germany", keywords="Europe", keywords="national", keywords="use", keywords="experience", keywords="attitude", keywords="opinion", keywords="perception", keywords="perspective", keywords="acceptance", keywords="preference", keywords="correlation", abstract="Background: In recent years, health care has undergone a rapid and unprecedented digital transformation. In many fields of specialty care, such as rheumatology, this shift is driven by the growing number of patients and limited resources, leading to increased use of digital health technologies (DHTs) to maintain high-quality clinical care. Previous studies examined user acceptance of individual DHTs in rheumatology, such as telemedicine, video consultations, and mHealth. However, it is essential to conduct cross-technology and continuous analyses of user acceptance and DHT use to maximize the benefits for all relevant stakeholders. Objective: This study aimed to explore the current acceptance, use, and preferences regarding DHTs among patients in rheumatology care in Germany. Methods: Rheumatology patients from 3 clinics in Germany were surveyed to understand their perspectives on DHTs. The survey included main themes, including acceptance, preferences, COVID-19's impact, potential, and barriers related to DHTs. The data were analyzed using descriptive statistics and correlation analysis. Results: Out of 337 participants, 53\% (179/337) reported using DHTs. Specific technologies included wearables (72/337, 21\%), mHealth apps (71/337, 21\%), digital therapeutics (32/337, 9\%), electronic prescriptions (30/337, 9\%), video consultations (15/337, 4\%), and at-home blood self-sampling (3/337, 1\%). Nearly two-thirds (220/337, 65\%) found DHTs useful, and 69\% (233/337) held a generally positive attitude toward DHTs. Attitudes shifted positively during the COVID-19 pandemic for 40\% (135/337) of participants. Higher education was more prevalent among DHT users (114/179, 63.7\%) compared with nonusers (42/151, 27.8\%; P=.02). The main potential benefits identified were location-independent use (244/337, 72\%) and time-independent use (216/337, 64\%). Key barriers included insufficient user knowledge (165/337, 49\%) and limited information on DHTs (134/337, 40\%). Conclusions: Patient acceptance and use of DHTs in rheumatology is increasing in Germany. A prospective, standardized monitoring of digital transformation in rheumatology care is highly needed. ", doi="10.2196/52601", url="https://www.jmir.org/2025/1/e52601" } @Article{info:doi/10.2196/60731, author="Nagino, Ken and Sung, Jaemyoung and Midorikawa-Inomata, Akie and Akasaki, Yasutsugu and Adachi, Takeya and Ebihara, Nobuyuki and Fukuda, Ken and Fukushima, Atsuki and Fujio, Kenta and Okumura, Yuichi and Eguchi, Atsuko and Fujimoto, Keiichi and Shokirova, Hurramhon and Yee, Alan and Morooka, Yuki and Huang, Tianxiang and Hirosawa, Kunihiko and Nakao, Shintaro and Kobayashi, Hiroyuki and Inomata, Takenori", title="Minimal Clinically Important Differences With the Outcomes of the App-Based Japanese Allergic Conjunctival Diseases Quality of Life Questionnaire: Cross-Sectional Observational Study", journal="JMIR Form Res", year="2024", month="Nov", day="26", volume="8", pages="e60731", keywords="allergic conjunctivitis", keywords="hay fever", keywords="Japanese Allergic Conjunctival Disease Quality of Life Questionnaire", keywords="minimal clinically important difference", keywords="pollinosis", keywords="telemedicine", keywords="mobile phone", abstract="Background: Assessing changes in quality of life in patients with hay fever--related allergic conjunctivitis requires validated and clinically meaningful metrics. A minimal clinically important difference (MCID) that can be applied to assess Domain II of the Japanese Allergic Conjunctival Disease Quality of Life Questionnaire (JACQLQ) in a smartphone app setting has yet to be determined. Objective: This cross-sectional observational study aimed to determine MCIDs for the app-based JACQLQ in assessing hay fever--related allergic conjunctivitis. Methods: This study used data from a crowdsourced, cross-sectional, observational study conducted via the smartphone app ``AllerSearch'' between February 1, 2018, and May 1, 2020. Participants were recruited through digital media and social networking platforms and voluntarily provided electronic informed consent. Participants completed the JACQLQ, which includes items on daily activity and psychological well-being, as well as a visual analog scale to measure stress levels related to hay fever. Data were collected through the app, ensuring comprehensive user input. MCIDs were determined using both anchor- and distribution-based methods. The face scale of the JACQLQ Domain III and stress level scale for hay fever were used as anchors to estimate the MCID; ranges were derived from these MCID estimates. In the distribution-based method, MCIDs were calculated using half the SD and SE of the JACQLQ Domain II scores. SEs were derived from the intraclass correlation coefficient of an app-based JACQLQ test-retest reliability metric. Results: A total of 17,597 individuals were identified, of which 15,749 individuals provided electronic consent. After excluding those with incomplete data, 7590 participants with hay fever were included in the study (mean age 35.3, SD 13.9 years; n=4331, 57.1\% of women). MCID ranges calculated using the anchor-based method were 1.0-6.9, 1.2-5.6, and 2.1-12.6 for daily activity, psychological well-being, and total JACQLQ Domain II scores, respectively. Using the distribution-based method, the intraclass correlation coefficients were odds ratio (OR) 0.813 (95\% CI 0.769-0.849) for daily activity, OR 0.791 (95\% CI 0.743-0.832) for psychological well-being, and OR 0.841 (95\% CI 0.791-0.864) for total JACQLQ Domain II scores. In addition, the distribution-based method resulted in 2 MCIDs based on half the SD and SE of measurement for daily activity (4.8 and 4.2), psychological well-being (3.4 and 3.1), and total JACQLQ Domain II (7.8 and 6.4) scores. The final suggested MCID ranges for daily activity, psychological well-being, and total JACQLQ Domain II scores were 4.2-6.0, 3.1-4.7, and 6.4-10.5, respectively. Conclusions: MCID ranges for the JACQLQ estimation could help to standardize the app-based quality of life assessment for patients with hay fever--related allergic conjunctivitis. These MCIDs enhanced the precision of remote symptom monitoring and facilitated timely, data-driven interventions, ultimately improving the overall management and outcomes of allergic conjunctivitis through mobile health platforms. ", doi="10.2196/60731", url="https://formative.jmir.org/2024/1/e60731" } @Article{info:doi/10.2196/60942, author="Chun, Elizabeth and Joseph, Richard and Pojednic, Rachele", title="Whole-Body Cryotherapy Reduces Systemic Inflammation in Healthy Adults: Pilot Cohort Study", journal="Interact J Med Res", year="2024", month="Nov", day="22", volume="13", pages="e60942", keywords="cold therapy", keywords="C-reactive protein", keywords="fasting glucose", keywords="HbA1c", keywords="inflammation", keywords="lipid metabolism", keywords="whole-body cryotherapy", keywords="cryotherapy", keywords="retrospective", keywords="reactive protein", keywords="biomarker", keywords="adult", keywords="systemic inflammation", abstract="Background: Chronically elevated inflammation is implicated in many conditions, including obesity, metabolic syndrome, and cardiovascular disease, and has been associated with increased mortality risk. Whole-body cryotherapy (W-BC) is a promising modality to treat inflammation with demonstrated benefits for clinical subpopulations including those with arthritis, obesity, and type 2 diabetes. However, it is unclear whether the benefit from W-BC extends to healthy individuals prior to chronic disease--related inflammation. In addition, the long-term durability of W-BC effect is unknown. Objective: This study investigates the inflammatory response to W-BC in healthy adults with a biomarker of inflammation, high-sensitivity C-reactive protein (hsCRP), and clinical biomarkers of metabolism including fasting glucose, hemoglobin A1c (HbA1c), low-density lipoprotein (LDL) and high-density lipoprotein (HDL), and triglycerides. Methods: Fifteen individuals (n=9 female) participated in frequent recreational W-BC (3 minutes of cold exposure at --110 {\textcelcius}) over approximately 9 months and had blood draws at baseline plus follow-up visits. Biomarkers were modeled as linear functions of W-BC sessions received in the month prior to blood draw. Results: The mean amount of W-BC received was 6.78 (SD 4.26) times per month with the cumulative total ranging from 13 to 157 W-BC sessions over the course of the study. On average, participants completed 1-2 sessions per week throughout the intervention. The number of W-BC sessions were associated with decreased hsCRP (--0.14 mg/L in hsCRP per W-BC session; P<.01) and with durability of up to 9 months. Increased W-BC was also associated with a downward trend in fasting glucose. This trend failed to reach significance at 1 month (--0.73 mg/dL in fasting glucose per W-BC session; P<.10) but was significant for 2- and 3-month windows (P<.05). HbA1c was increased significantly after 9 months (P<.01); however, the change occurred within normal ranges (difference=0.13\% and <5.7\%) and was not clinically significant. There was no association between W-BC and LDL cholesterol, HDL cholesterol, or triglycerides (P>.10), although LDL trended lower over the time period examined (P=.07). Conclusions: These results suggest that W-BC beneficially impacts systemic inflammation by lowering hsCRP levels in healthy individuals and may also have some modulating effect on fasting glucose. ", doi="10.2196/60942", url="https://www.i-jmr.org/2024/1/e60942", url="http://www.ncbi.nlm.nih.gov/pubmed/39576692" } @Article{info:doi/10.2196/62877, author="Shim, Jinjoo and Muraru, Sinziana and Dobrota, Rucsandra and Fleisch, Elgar and Distler, Oliver and Barata, Filipe", title="Noninvasive, Multimodal Inflammatory Biomarker Discovery for Systemic Inflammation (NOVA Study): Protocol for a Cross-Sectional Study", journal="JMIR Res Protoc", year="2024", month="Nov", day="5", volume="13", pages="e62877", keywords="systemic inflammation", keywords="chronic inflammation", keywords="inflammatory biomarkers", keywords="biofluids", keywords="serum", keywords="urine", keywords="sweat", keywords="saliva", keywords="exhaled breath", keywords="stool", keywords="C-reactive protein", keywords="interleukin", keywords="IL-1$\beta$", keywords="IL-6", keywords="IL-8", keywords="IL-10", keywords="tumor necrosis factor", keywords="TNF-$\alpha$", keywords="fractional exhaled nitric oxide", keywords="calprotectin", keywords="core body temperature", keywords="noninvasive biomarker", keywords="multimodal biomarker", keywords="remote monitoring", keywords="surrogate biomarker", keywords="rheumatology", keywords="chronic inflammatory disease", abstract="Background: Prolonged systemic inflammation is recognized as a major contributor to the development of various chronic inflammatory diseases. Daily measurements of inflammatory biomarkers can significantly improve disease monitoring of systemic inflammation, thus contributing to reducing the burden on patients and the health care system. There exists, however, no scalable, cost-efficient, and noninvasive biomarker for remote assessment of systemic inflammation. To this end, we propose a novel, multimodal, and noninvasive approach for measuring inflammatory biomarkers. Objective: This study aimed to evaluate the relationship between the levels of inflammatory biomarkers in serum (gold standard) and those measured noninvasively in urine, sweat, saliva, exhaled breath, stool, and core body temperature in patients with systemic inflammation. Methods: This study is a single-center, cross-sectional study and includes a total of 20 participants (10 patients with systemic inflammation and 10 control patients). Eligible participants provide serum, urine, sweat, saliva, exhaled breath, and stool samples for biomarker analyses. Core body temperature is measured using a sensor. The primary end point is the level of C-reactive protein (CRP). The secondary end points are interleukin (IL)--1$\beta$, IL-6, IL-8, IL-10, and tumor necrosis factor-$\alpha$ levels. The tertiary end points are fractional exhaled nitric oxide, calprotectin, and core body temperature. Samples will be collected in 2 batches, enabling preliminary analysis of the first batch (patients 1-5 from each group). The full analysis will include both batches. CRP and cytokine levels will be measured using enzyme-linked immunosorbent assay and electrochemiluminescence immunoassay. For statistical analysis, the Shapiro-Wilk test will be used to evaluate the normality of the distribution in each variable. We will perform the 2-tailed t test or Wilcoxon rank sum test to compare the levels of inflammatory biomarkers between patients with systemic inflammations and control patients. Pearson and Spearman correlation coefficients will assess the relationship between inflammatory biomarkers from noninvasive methods and serum biomarkers. Using all-subset regression analysis, we will determine the combination of noninvasive methods yielding the highest predictive accuracy for serum CRP levels. Participants' preferences for sampling methods will be assessed through a questionnaire. Results: The study received ethics approval from the independent research ethics committee of Canton Zurich on October 28, 2022. A total of 20 participants participated in the study measurements. Data collection started on February 22, 2023, and was completed on September 22, 2023. Participants were on average 52.8 (SD 14.4; range 24-82) years of age, and 70\% (14/20) of them were women. The analysis results reporting findings are expected to be published in 2025. Conclusions: This study aims to evaluate the feasibility of noninvasive, multimodal assessment of inflammatory biomarkers in patients with systemic inflammation. Promising results could lead to the creation of noninvasive and potentially digital biomarkers for systemic inflammation, enabling continuous monitoring and early diagnosis of inflammatory activity in a remote setting. International Registered Report Identifier (IRRID): DERR1-10.2196/62877 ", doi="10.2196/62877", url="https://www.researchprotocols.org/2024/1/e62877" } @Article{info:doi/10.2196/58048, author="Lin, Yu-Chih and Wu, Chen-Ching and Sung, Wan-Yu and Yen, Jeng-Hsien and Lin, Yi-Ching", title="Home Transcutaneous Electrical Stimulation Rehabilitation Program for Patients With Ankylosing Spondylitis: Crossover Trial", journal="JMIR Form Res", year="2024", month="Oct", day="28", volume="8", pages="e58048", keywords="ankylosing spondylitis", keywords="galvanic response", keywords="home medical device", keywords="rehabilitation", keywords="transcutaneous electrical stimulation", abstract="Background: Maintaining physical function and preserving spinal flexibility have been challenging in managing ankylosing spondylitis (AS). Most rehabilitation programs, including manual therapy, massage, hydrotherapy, and acupuncture, cannot be performed at home. The effect of transcutaneous electrical nerve stimulation (TENS) was validated in treating AS, but no home TENS system has explored its efficacy to date. Objective: This study aims to evaluate the efficacy of a home TENS system with a novel treatment program for patients with AS. Methods: The modified WeHeal TS-200 TENS and galvanic response system provided home-based TENS treatment for patients with AS. Patients were divided into a 2-month course group and a 1-month course group. After the first treatment course, patients went through a washout period for the same duration of their treatment course. Participants could decide whether to accept the second course of treatment. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Schober test, finger-to-floor flexion test, enthesis score, cytokines, chemokines, inflammatory factors, and immunoglobulins were measured to evaluate its efficacy. The clinical trial protocol (1096607481) received approval from the Ministry of Health and Welfare in Taiwan. Results: A total of 9 patients (5 in a 2-month course group and 4 in a 1-month course group) completed the first treatment course, and 5 patients (4 in a 2-month course group and 1 in a 1-month course group) completed the sequential treatment course. The weighted results showed that patients reported an improving BASFI score (mean difference --0.9, SD 1.7; P=.03) after treatment. Looking into the trajectories, declined BASFI and BASDAI scores were noticed during treatments; this score increased during the washout period. There were improving trends in the Schober test (mean difference 1.9, SD 4.9; P=.11) and finger-to-floor flexion test (mean difference --0.6, SD 9.5; P=.79), but the results were not statistically significant. The response of cytokines, chemokines, inflammatory factors, and immunoglobulins before and after treatment did not show a consistent trend, and all results were not statistically significant (all P>.05). Conclusions: The home TENS device demonstrated a potential role in AS management. It may improve accessibility and adherence for patients with AS and provide remote monitoring for clinicians. Further research can compare the effectiveness of electrotherapy at home or in a medical setting and focus on integrating the home TENS system and exercise program to enhance patients' physical functions and spinal flexibility. ", doi="10.2196/58048", url="https://formative.jmir.org/2024/1/e58048" } @Article{info:doi/10.2196/55715, author="Al-Attar, Mariam and Assawamartbunlue, Kesmanee and Gandrup, Julie and van der Veer, N. Sabine and Dixon, G. William", title="Exploring the Potential of Electronic Patient-Generated Health Data for Evaluating Treatment Response to Intramuscular Steroids in Rheumatoid Arthritis: Case Series", journal="JMIR Form Res", year="2024", month="Oct", day="28", volume="8", pages="e55715", keywords="patient-reported outcome measures", keywords="remote monitoring", keywords="patient-generated health data", keywords="mobile health", keywords="intramuscular steroid injections", keywords="rheumatoid arthritis", keywords="app", keywords="case series", keywords="symptom tracking", keywords="pain score", abstract="Background: Mobile health devices are increasingly available, presenting exciting opportunities to remotely collect high-frequency, electronic patient-generated health data (ePGHD). This novel data type may provide detailed insights into disease activity outside usual clinical settings. Assessing treatment responses, which can be hampered by the infrequency of appointments and recall bias, is a promising, novel application of ePGHD. Drugs with short treatment effects, such as intramuscular steroid injections, illustrate the challenge, as patients are unlikely to accurately recall treatment responses at follow-ups, which often occur several months later. Retrospective assessment means that responses may be over- or underestimated. High-frequency ePGHD, such as daily, app-collected, patient-reported symptoms between clinic appointments, may bridge this gap. However, the potential of ePGHD remains untapped due to the absence of established definitions for treatment response using ePGHD or established methodological approaches for analyzing this type of data. Objective: This study aims to explore the feasibility of evaluating treatment responses to intramuscular steroid therapy in a case series of patients with rheumatoid arthritis tracking daily symptoms using a smartphone app. Methods: We report a case series of patients who collected ePGHD through the REmote Monitoring Of Rheumatoid Arthritis (REMORA) smartphone app for daily remote symptom tracking. Symptoms were tracked on a 0-10 scale. We described the patients' longitudinal pain scores before and after intramuscular steroid injections. The baseline pain score was calculated as the mean pain score in the 10 days prior to the injection. This was compared to the pain scores in the days following the injection. ``Response'' was defined as any improvement from the baseline score on the first day following the injection. The response end time was defined as the first date when the pain score exceeded the pre-steroid baseline. Results: We included 6 patients who, between them, received 9 steroid injections. Average pre-injection pain scores ranged from 3.3 to 9.3. Using our definitions, 7 injections demonstrated a response. Among the responders, the duration of response ranged from 1 to 54 days (median 9, IQR 7-41), average pain score improvement ranged from 0.1 to 5.3 (median 3.3, IQR 2.2-4.0), and maximum pain score improvement ranged from 0.1 to 7.0 (median 4.3, IQR 1.7 to 6.0). Conclusions: This case series demonstrates the feasibility of using ePGHD to evaluate treatment response and is an important exploratory step toward developing more robust methodological approaches for analysis of this novel data type. Issues highlighted by our analysis include the importance of accounting for one-off data points, varying response start times, and confounders such as other medications. Future analysis of ePGHD across a larger population is required to address issues highlighted by our analysis and to develop meaningful consensus definitions for treatment response in time-series data. ", doi="10.2196/55715", url="https://formative.jmir.org/2024/1/e55715" } @Article{info:doi/10.2196/58309, author="P{\'e}rez-P{\'e}rez, Mart{\'i}n and Fernandez Gonzalez, Mar{\'i}a and Rodriguez-Rajo, Javier Francisco and Fdez-Riverola, Florentino", title="Tracking the Spread of Pollen on Social Media Using Pollen-Related Messages From Twitter: Retrospective Analysis", journal="J Med Internet Res", year="2024", month="Oct", day="21", volume="26", pages="e58309", keywords="pollen", keywords="respiratory allergies", keywords="Twitter", keywords="large language model", keywords="LLM", keywords="knowledge reconstruction", keywords="text mining", abstract="Background: Allergy disorders caused by biological particles, such as the proteins in some airborne pollen grains, are currently considered one of the most common chronic diseases, and European Academy of Allergy and Clinical Immunology forecasts indicate that within 15 years 50\% of Europeans will have some kind of allergy as a consequence of urbanization, industrialization, pollution, and climate change. Objective: The aim of this study was to monitor and analyze the dissemination of information about pollen symptoms from December 2006 to January 2022. By conducting a comprehensive evaluation of public comments and trends on Twitter, the research sought to provide valuable insights into the impact of pollen on sensitive individuals, ultimately enhancing our understanding of how pollen-related information spreads and its implications for public health awareness. Methods: Using a blend of large language models, dimensionality reduction, unsupervised clustering, and term frequency--inverse document frequency, alongside visual representations such as word clouds and semantic interaction graphs, our study analyzed Twitter data to uncover insights on respiratory allergies. This concise methodology enabled the extraction of significant themes and patterns, offering a deep dive into public knowledge and discussions surrounding respiratory allergies on Twitter. Results: The months between March and August had the highest volume of messages. The percentage of patient tweets appeared to increase notably during the later years, and there was also a potential increase in the prevalence of symptoms, mainly in the morning hours, indicating a potential rise in pollen allergies and related discussions on social media. While pollen allergy is a global issue, specific sociocultural, political, and economic contexts mean that patients experience symptomatology at a localized level, needing appropriate localized responses. Conclusions: The interpretation of tweet information represents a valuable tool to take preventive measures to mitigate the impact of pollen allergy on sensitive patients to achieve equity in living conditions and enhance access to health information and services. ", doi="10.2196/58309", url="https://www.jmir.org/2024/1/e58309", url="http://www.ncbi.nlm.nih.gov/pubmed/39432897" } @Article{info:doi/10.2196/50846, author="Qin, Rundong and Feng, Yan and Zhang, Huanping and Zhao, Beibei and Lei, Wei and Sun, Hongying and Zhi, Lili and Zheng, Zhongsheng and Wang, Siqin and Yu, Yafeng and Jiang, Shengxue and Liu, Changshan and Ma, Xingkai and Ma, Hui and Wang, Huiying and Lin, Hang and He, Qiaojie and Wu, Lingying and Zhai, Yingying and Lu, Honglue and Chen, Shi and Ma, Yan and Jin, Xiaohong and Deng, Shan and Zhong, Nanshan and Chen, Ruchong and Li, Jing", title="Protective Effect of Allergen Immunotherapy in Patients With Allergic Rhinitis and Asthma Against COVID-19 Infection: Observational, Nationwide, and Multicenter Study", journal="JMIR Public Health Surveill", year="2024", month="Oct", day="16", volume="10", pages="e50846", keywords="allergen immunotherapy", keywords="COVID-19", keywords="antiviral effect", keywords="allergic rhinitis", keywords="asthma", keywords="viral infection", keywords="allergic disease", keywords="trajectory", keywords="questionnaire-based survey", keywords="clinical evidence", abstract="Background: Allergic diseases are associated with an increased susceptibility to respiratory tract infections. Although allergen immunotherapy (AIT) alters the course of allergies, there is limited evidence from clinical practice demonstrating its ability to enhance the host defense against pathogens. Objective: The aim of this study was to investigate the protective effect of AIT against viral infection in patients with allergic rhinitis (AR) and allergic asthma (AS) based on clinical evidence. Methods: A multicenter, questionnaire-based survey was conducted during a tremendous surge in COVID-19 cases between February 10, 2023, and March 15, 2023, in 81 centers across China recruiting healthy volunteers and patients with AR and AS to investigate the clinical outcomes of COVID-19 infection. Results: Of 10,151 participants recruited in the survey, 3654 patients and 2192 healthy volunteers who tested positive for COVID-19 were included in this analysis after screening. Overall, no significant differences in COVID-19 outcomes were observed between patients and healthy volunteers. An additional 451 patients were excluded due to their use of biologics as the sole add-on treatment, leaving 3203 patients in the further analysis. Of them, 1752 were undergoing routine medication treatment (RMT; the RMT group), whereas 1057 and 394 were receiving AIT and a combination of AIT and omalizumab (OMA) as adjunct therapies to RMT, respectively (AIT+RMT and AIT+OMA+RMT groups). The AIT group showed milder COVID-19 symptoms, shorter recovery periods, and a lower likelihood of hospitalization or emergency department visits than the RMT group (all P<.05). After adjusting for confounding factors, including demographic characteristics and COVID-19 vaccination, AIT remained a significant protective factor associated with shorter recovery time (adjusted odds ratio [OR] 0.62, 95\% CI 0.52?0.75; adjusted P<.001) and a lower incidence of hospitalization or emergency department visits (adjusted OR 0.73, 95\% CI 0.54?0.98; adjusted P=.03). Furthermore, the AIT+OMA+RMT group showed greater protection with a shorter recovery time (adjusted OR 0.51, 95\% CI 0.34?0.74; adjusted P<.001) than the AIT+RMT group. Conclusions: Our multicenter observational study provides valuable clinical evidence supporting the protective effect of AIT against COVID-19 infection in patients with AR and AS. ", doi="10.2196/50846", url="https://publichealth.jmir.org/2024/1/e50846" } @Article{info:doi/10.2196/48629, author="Rawat, Kumar Sumit and Asati, Anand Ajit and Mishra, Nitu and Jain, Ashish and Ratho, Kanta Radha", title="Identification of COVID-19--Associated Hepatitis in Children as an Emerging Complication in the Wake of SARS-CoV-2 Infections: Ambispective Observational Study", journal="JMIRx Med", year="2024", month="Oct", day="11", volume="5", pages="e48629", keywords="COVID-19", keywords="coronavirus", keywords="SARS-CoV-2", keywords="liver", keywords="hepatic", keywords="hepatitis", keywords="child", keywords="children", keywords="pediatric", keywords="pediatrics", keywords="retrospective", keywords="observational", keywords="jaundice", keywords="youth", keywords="inflammatory", keywords="inflammation", abstract="Background: Although the pediatric population has largely remained free of severe COVID-19 symptoms, in some cases, SARS-CoV-2 infection has been associated with complications such as multiple inflammatory syndrome in children (MIS-C). We identified another a unique form of hepatitis occurring subsequent to asymptomatic SARS-CoV-2 infection, designated by us as COVID-19--associated hepatitis in children (CAH-C), in a subset of children who presented with hepatitis. Objective: Our study describes the clinical presentations, temporal association, and viral parameters of the CAH-C cases and compares them to those of MIS-C cases or other known forms of hepatitis in children. Methods: In an ambispective (retrospective and follow-up) observational study, records from April to July 2021 were reviewed for all children aged ?14 years who were previously healthy and presented with a sudden onset of hepatitis, elevated transaminases, and nonobstructive jaundice. After performing all routine tests, those lacking marked inflammatory responses and without evidence of (1) other known causes of acute hepatitis or previous underlying liver disease and (2) multisystem involvement were classified as having CAH-C. Their characteristics were compared to those of children with MIS-C or other known forms of hepatitis. Results: Among the 5539 children tested for SARS-CoV-2, a total of 475 (8.6\%) tested positive and 47 (0.8\%) presented with hepatitis. Among the 47 children with hepatitis, 37 (79\%) had features of CAH-C: having symptoms of hepatitis only, without protracted illness (mean length of stay 5 d), and an uneventful recovery following supportive treatment. In contrast, the remaining 10 (21\%) had features of MIS-C--associated hepatitis: multiple system involvement; protracted illness (mean length of stay 8 d); and requiring admission to critical care, with a mortality rate of 30\% (3/10). Conclusions: Our data suggest that CAH-C might be one of the new clinical complications associated with the emergence of newer variants of concern of SARS-CoV-2, which often result in changing presentations. Our findings should facilitate its early identification and thorough workup and aid its differentiation from other emerging syndromes in children, which would help initiate appropriate measures, enable better resource prioritization, and thus limit adversities. ", doi="10.2196/48629", url="https://xmed.jmir.org/2024/1/e48629" } @Article{info:doi/10.2196/56063, author="Mata, Shweta and Rajput, Shivshankar and Tuli, Preet Isha and Mundada, Pallavi and Gupta, Bharti and Srikanth, Narayanam and Acharya, Rabinarayanan", title="Ayurveda Management of Allergic Rhinitis: Protocol for a Randomized Controlled Trial", journal="JMIR Res Protoc", year="2024", month="Sep", day="25", volume="13", pages="e56063", keywords="allergic rhinitis", keywords="AR", keywords="Anu Taila Nasya", keywords="fluticasone propionate nasal spray", keywords="Naradiya Laxmivilas Rasa", keywords="randomized controlled trial", keywords="Shrishadi Kwath", abstract="Background: Allergic rhinitis (AR) is the inflammation of the membranes lining the nose due to allergen exposure and is characterized by sneezing, nasal congestion, itching of the nose, or postnasal discharge. The prevalence varies worldwide, perhaps due to the geographic and aeroallergen differences, with 10\% to 30\% of the world's population experiencing AR. In this study, Anu Taila Nasya, Naradiya Laxmivilas Rasa, and Shirishadi Kwath will be compared to a fluticasone nasal spray. Objective: The primary aim is to assess the efficacy of Ayurvedic management for AR (or vataja pratishyaya) by comparing it to a conventional control group. The secondary aims are to determine the mean change in the nasal endoscopy index and the mean change in the laboratory tests. Methods: This ongoing study is an open-label randomized controlled interventional trial, with a sample size of 90 both in the trial and standard control group (including dropouts, 20\%), and will be carried out for 24 months. Participants in the trial group will receive Ayurvedic treatment, that is, Anu Taila Nasya (6 drops in each nostril for 7 days for 3 consecutive weeks), Naradiya Laxmivilas Rasa (250 mg twice per day), and Shirishadi Kwath (40 ml twice per day for 45 days). The participants in the control group will receive a fluticasone propionate nasal spray (2 sprays once per day for 45 days). The primary outcome will include the mean change in the Control of Allergic Rhinitis and Asthma Test score, and the secondary outcomes will include the mean change in the nasal endoscopy index (assessment of nasal membrane color, pale or hyperemia; rhinorrhea, watery or yellow; and inferior turbinate swelling, hypertrophy) and the mean change in the laboratory tests. Results: As of May 2024, 72 patients have been enrolled in both groups. Data analysis should be completed by February 2025. The study will be reported following standard guidelines for reporting randomized controlled trials. Clinical results will be disseminated through conferences and peer-reviewed publication in a relevant journal. Conclusions: The Ayurvedic approach could be an evidence-based therapeutic tactic for the management of AR. Trial Registration: Clinical Trials Registry India CTRI/2023/06/053395; https://tinyurl.com/564d2zz8 International Registered Report Identifier (IRRID): DERR1-10.2196/56063 ", doi="10.2196/56063", url="https://www.researchprotocols.org/2024/1/e56063" } @Article{info:doi/10.2196/57185, author="Grube, Lara and Petit, Pascal and Vuillerme, Nicolas and Nitschke, Marlies and Nwosu, Bertrand Obioma and Knitza, Johannes and Krusche, Martin and Seifer, Ann-Kristin and Eskofier, M. Bjoern and Schett, Georg and Morf, Harriet", title="Complementary App-Based Yoga Home Exercise Therapy for Patients With Axial Spondyloarthritis: Usability Study", journal="JMIR Form Res", year="2024", month="Sep", day="19", volume="8", pages="e57185", keywords="DTx", keywords="DHA", keywords="usability", keywords="Yoga", keywords="YogiTherapy", keywords="ankylosing spondylitis", keywords="axial spondylarthritis", keywords="digital health application", keywords="eHealth", keywords="self-assessment", keywords="physical exercise", keywords="patient acceptance", keywords="therapy", keywords="home exercise", keywords="exercise", keywords="patients", keywords="patient", keywords="spondyloarthritis", keywords="usability study", keywords="app", keywords="apps", keywords="rheumatic disease", keywords="chronic", keywords="spine", keywords="adjacent joints", keywords="joints", keywords="joint", keywords="correlation analysis", keywords="digital therapeutics", abstract="Background: Axial spondyloarthritis (AS) is a chronic inflammatory rheumatic disease characterized by potentially disabling inflammation of the spine and adjacent joints. Regular exercise is a cornerstone of treatment. However, patients with AS currently have little support. YogiTherapy (MaD Lab) is an app developed to support patients with AS by providing instructions for yoga-based home exercise therapy. Objective: This study aimed to evaluate the usability and acceptance of the newly designed YogiTherapy app for patients with AS. Methods: Patients completed the User Version of the Mobile Application Rating Scale (uMARS) and net promoter score (NPS) questionnaires after the app introduction. Wilcoxon Mann-Whitney rank sum test, chi-square test for count data, and correlation analysis were conducted to examine the usability of the app, acceptance, and patient characteristics. Results: A total of 65 patients with AS (33, 51\% female; age: mean 43.3, SD 13.6 years) were included in the study from May 2022 to June 2023. Subsequently, the data were analyzed. Usability was rated moderate, with a mean uMARS of 3.35 (SD 0.47) points on a scale from 0 to 5. The highest-rated uMARS dimension was information (mean 3.88, SD 0.63), followed by functionality (mean 3.84, SD 0.87). Females reported a significantly higher uMARS total score than males (mean 3.47, SD 0.48 vs mean 3.23, SD 0.45; P=.03, Vargha and Delaney A [VDA] 0.66, 95\% CI 0.53-0.77). The mean average of the NPS was 6.23 (SD 2.64) points (on a scale from 0 to 10), based on 43\% (26/65 nonpromoters, 42\% (25/65) indifferent, and 15\% (9/65) promoters. A total of 7\% (5/65) of those surveyed did not answer the question. When applying the NPS formula, the result is --26\%. The NPS showed a positive correlation with the usage of mobile apps (r=0.39; P=.02). uMARS functionality was significantly higher rated by patients younger than 41 years (mean 4.17, SD 0.55 vs mean 3.54, SD 1; P<.001; VDA 0.69, 95\% CI 0.56-0.80). Patients considering mobile apps as useful reported higher uMARS (r=0.38, P=.02). The uMARS app quality mean score was correlated with the frequency of using apps (r=--0.21, P<.001). Conclusions: The results revealed moderate acceptance and usability ratings, prompting further app improvement. Significant differences were observed between age and gender. Our results emphasize the need for further improvements in YogiTherapy. ", doi="10.2196/57185", url="https://formative.jmir.org/2024/1/e57185" } @Article{info:doi/10.2196/57340, author="Jimenez-Garcia, Rodrigo and Lopez-de-Andres, Ana and Hernandez-Barrera, Valentin and Zamorano-Leon, J. Jose and Cuadrado-Corrales, Natividad and de Miguel-Diez, Javier and del-Barrio, L. Jose and Jimenez-Sierra, Ana and Carabantes-Alarcon, David", title="Hospitalizations for Food-Induced Anaphylaxis Between 2016 and 2021: Population-Based Epidemiologic Study", journal="JMIR Public Health Surveill", year="2024", month="Aug", day="27", volume="10", pages="e57340", keywords="food-induced anaphylaxis", keywords="epidemiology", keywords="hospitalizations", keywords="in-hospital mortality", abstract="Background: Food-induced anaphylaxis (FIA) is a major public health problem resulting in serious clinical complications, emergency department visits, hospitalization, and death. Objective: This study aims to assess the epidemiology and the trends in hospitalizations because of FIA in Spain between 2016 and 2021. Methods: An observational descriptive study was conducted using data from the Spanish National Hospital discharge database. Information was coded based on the International Classification of Diseases, Tenth Revision. The study population was analyzed by gender and age group and according to food triggers, clinical characteristics, admission to the intensive care unit, severity, and in-hospital mortality. The annual incidence of hospitalizations because of FIA per 100,000 person-years was estimated and analyzed using Poisson regression models. Multivariable logistic regression models were constructed to identify which variables were associated with severe FIA. Results: A total of 2161 hospital admissions for FIA were recorded in Spain from 2016 to 2021. The overall incidence rate was 0.77 cases per 100,000 person-years. The highest incidence was found in those aged <15 years (3.68), with lower figures among those aged 15 to 59 years (0.25) and ?60 years (0.29). Poisson regression showed a significant increase in incidence from 2016 to 2021 only among children (3.78 per 100,000 person-years vs 5.02 per 100,000 person-years; P=.04). The most frequent food triggers were ``milk and dairy products'' (419/2161, 19.39\% of cases) and ``peanuts or tree nuts and seeds'' (409/2161, 18.93\%). Of the 2161 patients, 256 (11.85\%) were hospitalized because FIA required admission to the intensive care unit, and 11 (0.51\%) patients died in the hospital. Among children, the most severe cases of FIA appeared in patients aged 0 to 4 years (40/99, 40\%). Among adults, 69.4\% (111/160) of cases occurred in those aged 15 to 59 years. Multivariable logistic regression showed the variables associated with severe FIA to be age 15 to 59 years (odds ratio 5.1, 95\% CI 3.11-8.36), age ?60 years (odds ratio 3.87, 95\% CI 1.99-7.53), and asthma (odds ratio 1.71,95\% CI 1.12-2.58). Conclusions: In Spain, the incidence of hospitalization because of FIA increased slightly, although the only significant increase (P=.04) was among children. Even if in-hospital mortality remains low and stable, the proportion of severe cases is high and has not improved from 2016 to 2021, with older age and asthma being risk factors for severity. Surveillance must be improved, and preventive strategies must be implemented to reduce the burden of FIA. ", doi="10.2196/57340", url="https://publichealth.jmir.org/2024/1/e57340", url="http://www.ncbi.nlm.nih.gov/pubmed/38940759" } @Article{info:doi/10.2196/47733, author="Muehlensiepen, Felix and Petit, Pascal and Knitza, Johannes and Welcker, Martin and Vuillerme, Nicolas", title="Identification of Motivational Determinants for Telemedicine Use Among Patients With Rheumatoid Arthritis in Germany: Secondary Analysis of Data From a Nationwide Cross-Sectional Survey Study", journal="J Med Internet Res", year="2024", month="Aug", day="19", volume="26", pages="e47733", keywords="telemedicine", keywords="rheumatoid arthritis", keywords="rheumatology", keywords="primary care", keywords="health services research", keywords="eHealth", keywords="data analysis", keywords="survey", keywords="Germany", keywords="tool", keywords="care", keywords="willingness", keywords="sociodemographic", keywords="age", keywords="telehealth", keywords="digital transition", abstract="Background: Previous studies have demonstrated telemedicine to be an effective tool to complement rheumatology care and address workforce shortage. With the COVID-19 outbreak, telemedicine experienced a massive upswing. An earlier analysis revealed that the motivation of patients with rheumatic and musculoskeletal diseases to use telemedicine is closely connected to their disease. It remains unclear which factors are associated with patients' motivation to use telemedicine in certain rheumatic and musculoskeletal diseases groups, such as rheumatoid arthritis (RA). Objective: This study aims to identify factors that determine the willingness to try telemedicine among patients diagnosed with RA. Methods: We conducted a secondary analysis of data from a German nationwide cross-sectional survey among patients with RA. Bayesian univariate logistic regression analysis was applied to the data to determine which factors were associated with willingness to try telemedicine. Predictor variables (covariates) studied individually included sociodemographic factors (eg, age, sex) and health characteristics (eg, health status). All the variables positively and negatively associated with willingness to try telemedicine in the univariate analyses were then considered for Bayesian model averaging analysis after a selection based on the variance inflation factor (? 2.5) to identify determinants of willingness to try telemedicine. Results: Among 438 surveyed patients in the initial study, 210 were diagnosed with RA (47.9\%). Among them, 146 (69.5\%) answered either yes or no regarding willingness to try telemedicine and were included in the analysis. A total of 22 variables (22/55, 40\%) were associated with willingness to try telemedicine (region of practical equivalence \%?5). A total of 9 determinant factors were identified using Bayesian model averaging analysis. Positive determinants included desiring telemedicine services provided by a rheumatologist (odds ratio [OR] 13.7, 95\% CI 5.55-38.3), having prior knowledge of telemedicine (OR 2.91, 95\% CI 1.46-6.28), residing in a town (OR 2.91, 95\% CI 1.21-7.79) or city (OR 0.56, 95\% CI 0.23-1.27), and perceiving one's health status as moderate (OR 1.87, 95\% CI 0.94-3.63). Negative determinants included the lack of an electronic device (OR 0.1, 95\% CI 0.01-0.62), absence of home internet access (OR 0.1, 95\% CI 0.02-0.39), self-assessment of health status as bad (OR 0.44, 95\% CI 0.21-0.89) or very bad (OR 0.47, 95\% CI 0.06-2.06), and being aged between 60 and 69 years (OR 0.48, 95\% CI 0.22-1.04) or older than 70 years (OR 0.38, 95\% CI 0.16-0.85). Conclusions: The results suggest that some patients with RA will not have access to telemedicine without further support. Older patients, those not living in towns, those without adequate internet access, reporting a bad health status, and those not owning electronic devices might be excluded from the digital transformation in rheumatology and might not have access to adequate RA care. These patient groups certainly require support for the use of digital rheumatology care. ", doi="10.2196/47733", url="https://www.jmir.org/2024/1/e47733" } @Article{info:doi/10.2196/55542, author="Knitza, Johannes and Tascilar, Koray and Fuchs, Franziska and Mohn, Jacob and Kuhn, Sebastian and Bohr, Daniela and Muehlensiepen, Felix and Bergmann, Christina and Labinsky, Hannah and Morf, Harriet and Araujo, Elizabeth and Englbrecht, Matthias and Vorbr{\"u}ggen, Wolfgang and von der Decken, Cay-Benedict and Kleinert, Stefan and Ramming, Andreas and Distler, W. J{\"o}rg H. and Bartz-Bazzanella, Peter and Vuillerme, Nicolas and Schett, Georg and Welcker, Martin and Hueber, Axel", title="Diagnostic Accuracy of a Mobile AI-Based Symptom Checker and a Web-Based Self-Referral Tool in Rheumatology: Multicenter Randomized Controlled Trial", journal="J Med Internet Res", year="2024", month="Jul", day="23", volume="26", pages="e55542", keywords="symptom checker", keywords="artificial intelligence", keywords="eHealth", keywords="diagnostic decision support system", keywords="rheumatology", keywords="decision support", keywords="decision", keywords="diagnostic", keywords="tool", keywords="rheumatologists", keywords="symptom assessment", keywords="resources", keywords="randomized controlled trial", keywords="diagnosis", keywords="decision support system", keywords="support system", keywords="support", abstract="Background: The diagnosis of inflammatory rheumatic diseases (IRDs) is often delayed due to unspecific symptoms and a shortage of rheumatologists. Digital diagnostic decision support systems (DDSSs) have the potential to expedite diagnosis and help patients navigate the health care system more efficiently. Objective: The aim of this study was to assess the diagnostic accuracy of a mobile artificial intelligence (AI)--based symptom checker (Ada) and a web-based self-referral tool (Rheport) regarding IRDs. Methods: A prospective, multicenter, open-label, crossover randomized controlled trial was conducted with patients newly presenting to 3 rheumatology centers. Participants were randomly assigned to complete a symptom assessment using either Ada or Rheport. The primary outcome was the correct identification of IRDs by the DDSSs, defined as the presence of any IRD in the list of suggested diagnoses by Ada or achieving a prespecified threshold score with Rheport. The gold standard was the diagnosis made by rheumatologists. Results: A total of 600 patients were included, among whom 214 (35.7\%) were diagnosed with an IRD. Most frequent IRD was rheumatoid arthritis with 69 (11.5\%) patients. Rheport's disease suggestion and Ada's top 1 (D1) and top 5 (D5) disease suggestions demonstrated overall diagnostic accuracies of 52\%, 63\%, and 58\%, respectively, for IRDs. Rheport showed a sensitivity of 62\% and a specificity of 47\% for IRDs. Ada's D1 and D5 disease suggestions showed a sensitivity of 52\% and 66\%, respectively, and a specificity of 68\% and 54\%, respectively, concerning IRDs. Ada's diagnostic accuracy regarding individual diagnoses was heterogenous, and Ada performed considerably better in identifying rheumatoid arthritis in comparison to other diagnoses (D1: 42\%; D5: 64\%). The Cohen $\kappa$ statistic of Rheport for agreement on any rheumatic disease diagnosis with Ada D1 was 0.15 (95\% CI 0.08-0.18) and with Ada D5 was 0.08 (95\% CI 0.00-0.16), indicating poor agreement for the presence of any rheumatic disease between the 2 DDSSs. Conclusions: To our knowledge, this is the largest comparative DDSS trial with actual use of DDSSs by patients. The diagnostic accuracies of both DDSSs for IRDs were not promising in this high-prevalence patient population. DDSSs may lead to a misuse of scarce health care resources. Our results underscore the need for stringent regulation and drastic improvements to ensure the safety and efficacy of DDSSs. Trial Registration: German Register of Clinical Trials DRKS00017642; https://drks.de/search/en/trial/DRKS00017642 ", doi="10.2196/55542", url="https://www.jmir.org/2024/1/e55542" } @Article{info:doi/10.2196/55855, author="Schaffert, Daniel and Bibi, Igor and Blauth, Mara and Lull, Christian and von Ahnen, Alwin Jan and Gross, Georg and Schulze-Hagen, Theresa and Knitza, Johannes and Kuhn, Sebastian and Benecke, Johannes and Schmieder, Astrid and Leipe, Jan and Olsavszky, Victor", title="Using Automated Machine Learning to Predict Necessary Upcoming Therapy Changes in Patients With Psoriasis Vulgaris and Psoriatic Arthritis and Uncover New Influences on Disease Progression: Retrospective Study", journal="JMIR Form Res", year="2024", month="Jun", day="27", volume="8", pages="e55855", keywords="psoriasis vulgaris", keywords="psoriatic arthritis", keywords="automated machine learning", keywords="therapy change", keywords="Psoriasis Area and Severity Index", keywords="PASI score change", keywords="Bath Ankylosing Spondylitis Disease Activity Index", keywords="BASDAI classification", keywords="mobile phone", abstract="Background: Psoriasis vulgaris (PsV) and psoriatic arthritis (PsA) are complex, multifactorial diseases significantly impacting health and quality of life. Predicting treatment response and disease progression is crucial for optimizing therapeutic interventions, yet challenging. Automated machine learning (AutoML) technology shows promise for rapidly creating accurate predictive models based on patient features and treatment data. Objective: This study aims to develop highly accurate machine learning (ML) models using AutoML to address key clinical questions for PsV and PsA patients, including predicting therapy changes, identifying reasons for therapy changes, and factors influencing skin lesion progression or an abnormal Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score. Methods: Clinical study data from 309 PsV and PsA patients were extensively prepared and analyzed using AutoML to build and select the most accurate predictive models for each variable of interest. Results: Therapy change at 24 weeks follow-up was modeled using the extreme gradient boosted trees classifier with early stopping (area under the receiver operating characteristic curve [AUC] of 0.9078 and logarithmic loss [LogLoss] of 0.3955 for the holdout partition). Key influencing factors included the initial systemic therapeutic agent, the Classification Criteria for Psoriatic Arthritis score at baseline, and changes in quality of life. An average blender incorporating three models (gradient boosted trees classifier, ExtraTrees classifier, and Eureqa generalized additive model classifier) with an AUC of 0.8750 and LogLoss of 0.4603 was used to predict therapy changes for 2 hypothetical patients, highlighting the significance of these factors. Treatments such as methotrexate or specific biologicals showed a lower propensity for change. An average blender of a random forest classifier, an extreme gradient boosted trees classifier, and a Eureqa classifier (AUC of 0.9241 and LogLoss of 0.4498) was used to estimate PASI (Psoriasis Area and Severity Index) change after 24 weeks. Primary predictors included the initial PASI score, change in pruritus levels, and change in therapy. A lower initial PASI score and consistently low pruritus were associated with better outcomes. BASDAI classification at onset was analyzed using an average blender of a Eureqa generalized additive model classifier, an extreme gradient boosted trees classifier with early stopping, and a dropout additive regression trees classifier with an AUC of 0.8274 and LogLoss of 0.5037. Influential factors included initial pain, disease activity, and Hospital Anxiety and Depression Scale scores for depression and anxiety. Increased pain, disease activity, and psychological distress generally led to higher BASDAI scores. Conclusions: The practical implications of these models for clinical decision-making in PsV and PsA can guide early investigation and treatment, contributing to improved patient outcomes. ", doi="10.2196/55855", url="https://formative.jmir.org/2024/1/e55855", url="http://www.ncbi.nlm.nih.gov/pubmed/38738977" } @Article{info:doi/10.2196/47446, author="Hartvigsen, Benedikte and Jakobsen, Kronberg Kathrine and Benfield, Thomas and Gredal, Tobias Niels and Ersb{\o}ll, Kj{\ae}r Annette and Gr{\o}nlund, Waldemar Mathias and Bundgaard, Henning and Andersen, Porsborg Mikkel and Steenhard, Nina and von Buchwald, Christian and Todsen, Tobias", title="Molecular Detection of SARS-CoV-2 From Throat Swabs Performed With or Without Specimen Collection From the Tonsils: Protocol for a Multicenter Randomized Controlled Trial", journal="JMIR Res Protoc", year="2024", month="Jun", day="12", volume="13", pages="e47446", keywords="SARS-CoV-2", keywords="COVID-19", keywords="pandemic", keywords="oropharyngeal sampling", keywords="diagnostic accuracy", keywords="PCR", keywords="polymerase chain reaction", keywords="PCR analysis", keywords="swab", keywords="diagnostic", keywords="oropharyngeal", keywords="virology", keywords="testing", keywords="detection", keywords="molecular biology", keywords="microbiology", keywords="laboratory", keywords="palatine tonsil", keywords="COVID-19 detection", keywords="COVID-19 testing", keywords="tonsil", keywords="swabs", keywords="oropharyngeal swabs", keywords="oropharyngeal swab", keywords="nasal swab", keywords="nasal swabs", keywords="molecular detection", keywords="tool", keywords="diagnostic technique", keywords="diagnostic procedure", keywords="clinical laboratory techniques", abstract="Background: Testing for SARS-CoV-2 is essential to provide early COVID-19 treatment for people at high risk of severe illness and to limit the spread of infection in society. Proper upper respiratory specimen collection is the most critical step in the diagnosis of the SARS-CoV-2 virus in public settings, and throat swabs were the preferred specimens used for mass testing in many countries during the COVID-19 pandemic. However, there is still a discussion about whether throat swabs have a high enough sensitivity for SARS-CoV-2 diagnostic testing, as previous studies have reported a large variability in the sensitivity from 52\% to 100\%. Many previous studies exploring the diagnostic accuracy of throat swabs lack a detailed description of the sampling technique, which makes it difficult to compare the different diagnostic accuracy results. Some studies perform a throat swab by only collecting specimens from the posterior oropharyngeal wall, while others also include a swab of the palatine tonsils for SARS-CoV-2 testing. However, studies suggest that the palatine tonsils could have a tissue tropism for SARS-CoV-2 that may improve the SARS-CoV-2 detection during sampling. This may explain the variation of sensitivity reported, but no clinical studies have yet explored the differences in sensitivity and patient discomfort whether the palatine tonsils are included during the throat swab or not. Objective: The objective of this study is to examine the sensitivity and patient discomfort of a throat swab including the palatine tonsils compared to only swabbing the posterior oropharyngeal wall in molecular testing for SARS-CoV-2. Methods: We will conduct a randomized controlled study to compare the molecular detection rate of SARS-CoV-2 by a throat swab performed from the posterior oropharyngeal wall and the palatine tonsils (intervention group) or the posterior oropharyngeal wall only (control group). Participants will be randomized in a 1:1 ratio. All participants fill out a baseline questionnaire upon enrollment in the trial, examining their reason for being tested, symptoms, and previous tonsillectomy. A follow-up questionnaire will be sent to participants to explore the development of symptoms after testing. Results: A total of 2315 participants were enrolled in this study between November 10, 2022, and December 22, 2022. The results from the follow-up questionnaire are expected to be completed at the beginning of 2024. Conclusions: This randomized clinical trial will provide us with information about whether throat swabs including specimens from the palatine tonsils will improve the diagnostic sensitivity for SARS-CoV-2 molecular detection. These results can, therefore, be used to improve future testing recommendations and provide additional information about tissue tropism for SARS-CoV-2. Trial Registration: ClinicalTrials.gov NCT05611203; https://clinicaltrials.gov/study/NCT05611203 International Registered Report Identifier (IRRID): DERR1-10.2196/47446 ", doi="10.2196/47446", url="https://www.researchprotocols.org/2024/1/e47446", url="http://www.ncbi.nlm.nih.gov/pubmed/38865190" } @Article{info:doi/10.2196/50679, author="Gandrup, Julie and Selby, A. David and Dixon, G. William", title="Classifying Self-Reported Rheumatoid Arthritis Flares Using Daily Patient-Generated Data From a Smartphone App: Exploratory Analysis Applying Machine Learning Approaches", journal="JMIR Form Res", year="2024", month="May", day="14", volume="8", pages="e50679", keywords="rheumatoid arthritis", keywords="flare", keywords="patient-generated health data", keywords="smartphone", keywords="mobile health", keywords="machine learning", keywords="arthritis", keywords="rheumatic", keywords="rheumatism", keywords="joint", keywords="joints", keywords="arthritic", keywords="musculoskeletal", keywords="flares", keywords="classify", keywords="classification", keywords="symptom", keywords="symptoms", keywords="mobile phone", abstract="Background: The ability to predict rheumatoid arthritis (RA) flares between clinic visits based on real-time, longitudinal patient-generated data could potentially allow for timely interventions to avoid disease worsening. Objective: This exploratory study aims to investigate the feasibility of using machine learning methods to classify self-reported RA flares based on a small data set of daily symptom data collected on a smartphone app. Methods: Daily symptoms and weekly flares reported on the Remote Monitoring of Rheumatoid Arthritis (REMORA) smartphone app from 20 patients with RA over 3 months were used. Predictors were several summary features of the daily symptom scores (eg, pain and fatigue) collected in the week leading up to the flare question. We fitted 3 binary classifiers: logistic regression with and without elastic net regularization, a random forest, and naive Bayes. Performance was evaluated according to the area under the curve (AUC) of the receiver operating characteristic curve. For the best-performing model, we considered sensitivity and specificity for different thresholds in order to illustrate different ways in which the predictive model could behave in a clinical setting. Results: The data comprised an average of 60.6 daily reports and 10.5 weekly reports per participant. Participants reported a median of 2 (IQR 0.75-4.25) flares each over a median follow-up time of 81 (IQR 79-82) days. AUCs were broadly similar between models, but logistic regression with elastic net regularization had the highest AUC of 0.82. At a cutoff requiring specificity to be 0.80, the corresponding sensitivity to detect flares was 0.60 for this model. The positive predictive value (PPV) in this population was 53\%, and the negative predictive value (NPV) was 85\%. Given the prevalence of flares, the best PPV achieved meant only around 2 of every 3 positive predictions were correct (PPV 0.65). By prioritizing a higher NPV, the model correctly predicted over 9 in every 10 non-flare weeks, but the accuracy of predicted flares fell to only 1 in 2 being correct (NPV and PPV of 0.92 and 0.51, respectively). Conclusions: Predicting self-reported flares based on daily symptom scorings in the preceding week using machine learning methods was feasible. The observed predictive accuracy might improve as we obtain more data, and these exploratory results need to be validated in an external cohort. In the future, analysis of frequently collected patient-generated data may allow us to predict flares before they unfold, opening opportunities for just-in-time adaptative interventions. Depending on the nature and implication of an intervention, different cutoff values for an intervention decision need to be considered, as well as the level of predictive certainty required. ", doi="10.2196/50679", url="https://formative.jmir.org/2024/1/e50679", url="http://www.ncbi.nlm.nih.gov/pubmed/38743480" } @Article{info:doi/10.2196/49928, author="Romeiser, L. Jamie and Jusko, Nicole and Williams, A. Augusta", title="Emerging Trends in Information-Seeking Behavior for Alpha-Gal Syndrome: Infodemiology Study Using Time Series and Content Analysis", journal="J Med Internet Res", year="2024", month="May", day="8", volume="26", pages="e49928", keywords="alpha-gal", keywords="alpha gal", keywords="alpha-gal syndrome", keywords="lone star tick", keywords="infodemiology", keywords="time series", keywords="content analysis", keywords="Google Trends", keywords="allergy", keywords="allergic", keywords="immune", keywords="immunology", keywords="immunological", keywords="information behavior", keywords="information behaviour", keywords="information seeking", keywords="geographic", abstract="Background: Alpha-gal syndrome is an emerging allergy characterized by an immune reaction to the carbohydrate molecule alpha-gal found in red meat. This unique food allergy is likely triggered by a tick bite. Cases of the allergy are on the rise, but prevalence estimates do not currently exist. Furthermore, varying symptoms and limited awareness of the allergy among health care providers contribute to delayed diagnosis, leading individuals to seek out their own information and potentially self-diagnose. Objective: The study aimed to (1) describe the volume and patterns of information-seeking related to alpha-gal, (2) explore correlations between alpha-gal and lone star ticks, and (3) identify specific areas of interest that individuals are searching for in relation to alpha-gal. Methods: Google Trends Supercharged-Glimpse, a new extension of Google Trends, provides estimates of the absolute volume of searches and related search queries. This extension was used to assess trends in searches for alpha-gal and lone star ticks (lone star tick, alpha gal, and meat allergy, as well as food allergy for comparison) in the United States. Time series analyses were used to examine search volume trends over time, and Spearman correlation matrices and choropleth maps were used to explore geographic and temporal correlations between alpha-gal and lone star tick searches. Content analysis was performed on related search queries to identify themes and subcategories that are of interest to information seekers. Results: Time series analysis revealed a rapidly increasing trend in search volumes for alpha-gal beginning in 2015. After adjusting for long-term trends, seasonal trends, and media coverage, from 2015 to 2022, the predicted adjusted average annual percent change in search volume for alpha-gal was 33.78\%. The estimated overall change in average search volume was 627\%. In comparison, the average annual percent change was 9.23\% for lone star tick, 7.34\% for meat allergy, and 2.45\% for food allergy during this time. Geographic analysis showed strong significant correlations between alpha-gal and lone star tick searches especially in recent years ($\rho$=0.80; P<.001), with primary overlap and highest search rates found in the southeastern region of the United States. Content analysis identified 10 themes of primary interest: diet, diagnosis or testing, treatment, medications or contraindications of medications, symptoms, tick related, specific sources of information and locations, general education information, alternative words for alpha-gal, and unrelated or other. Conclusions: The study provides insights into the changing information-seeking patterns for alpha-gal, indicating growing awareness and interest. Alpha-gal search volume is increasing at a rapid rate. Understanding specific questions and concerns can help health care providers and public health educators to tailor communication strategies. The Google Trends Supercharged-Glimpse tool offers enhanced features for analyzing information-seeking behavior and can be valuable for infodemiology research. Further research is needed to explore the evolving prevalence and impact of alpha-gal syndrome. ", doi="10.2196/49928", url="https://www.jmir.org/2024/1/e49928", url="http://www.ncbi.nlm.nih.gov/pubmed/38717813" } @Article{info:doi/10.2196/55829, author="Novella-Navarro, Marta and Iniesta-Chamorro, M. Jose and Benavent, Diego and Bachiller-Corral, Javier and Calvo-Aranda, Enrique and Borrell, Helena and Berbel-Arcob{\'e}, Laura and Navarro-Compan, Victoria and Michelena, Xabier and Lojo-Oliveira, Leticia and Arroyo-Palomo, Jaime and Diaz-Almiron, Mariana and Garc{\'i}a Garc{\'i}a, Ver{\'o}nica and Monjo-Henry, Irene and G{\'o}mez Gonz{\'a}lez, Mar{\'i}a Claudia and Gomez, J. Enrique and Balsa, Alejandro and Plasencia-Rodr{\'i}guez, Chamaida", title="Toward Telemonitoring in Immune-Mediated Inflammatory Diseases: Protocol for a Mixed Attention Model Study", journal="JMIR Res Protoc", year="2024", month="Apr", day="22", volume="13", pages="e55829", keywords="digital health", keywords="mHealth, telemonitoring, rheumatic musculoskeletal diseases", keywords="digital resources, mixed attention model", keywords="rheumatic disease", keywords="musculoskeletal diseases", keywords="chronic diseases", keywords="pain", keywords="inflammation", keywords="antirheumatic drugs", keywords="telemonitoring", keywords="rheumatology", keywords="hybrid care model", keywords="care model", keywords="MAM", keywords="implementation", keywords="clinical outcome", abstract="Background: Rheumatic and musculoskeletal diseases (RMDs) are chronic diseases that may alternate between asymptomatic periods and flares. These conditions require complex treatments and close monitoring by rheumatologists to mitigate their effects and improve the patient's quality of life. Often, delays in outpatient consultations or the patient's difficulties in keeping appointments make such close follow-up challenging. For this reason, it is very important to have open communication between patients and health professionals. In this context, implementing telemonitoring in the field of rheumatology has great potential, as it can facilitate the close monitoring of patients with RMDs. The use of these tools helps patients self-manage certain aspects of their disease. This could result in fewer visits to emergency departments and consultations, as well as enable better therapeutic compliance and identification of issues that would otherwise go unnoticed. Objective: The main objective of this study is to evaluate the implementation of a hybrid care model called the mixed attention model (MAM) in clinical practice and determine whether its implementation improves clinical outcomes compared to conventional follow-up. Methods: This is a multicenter prospective observational study involving 360 patients with rheumatoid arthritis (RA) and spondylarthritis (SpA) from 5 Spanish hospitals. The patients will be followed up by the MAM protocol, which is a care model that incorporates a digital tool consisting of a mobile app that patients can use at home and professionals can review asynchronously to detect incidents and follow patients' clinical evolution between face-to-face visits. Another group of patients, whose follow-up will be conducted in accordance with a traditional face-to-face care model, will be assessed as the control group. Sociodemographic characteristics, treatments, laboratory parameters, assessment of tender and swollen joints, visual analog scale for pain, and electronic patient-reported outcome (ePRO) reports will be collected for all participants. In the MAM group, these items will be self-assessed via both the mobile app and during face-to-face visits with the rheumatologist, who will do the same for patients included in the traditional care model. The patients will be able to report any incidence related to their disease or treatment through the mobile app. Results: Participant recruitment began in March 2024 and will continue until December 2024. The follow-up period will be extended by 12 months for all patients. Data collection and analysis are scheduled for completion in December 2025. Conclusions: This paper aims to provide a detailed description of the development and implementation of a digital solution, specifically an MAM. The goal is to achieve significant economic and psychosocial impact within our health care system by enhancing control over RMDs. Trial Registration: ClinicalTrials.gov NCT06273306; https://clinicaltrials.gov/ct2/show/NCT06273306 International Registered Report Identifier (IRRID): PRR1-10.2196/55829 ", doi="10.2196/55829", url="https://www.researchprotocols.org/2024/1/e55829", url="http://www.ncbi.nlm.nih.gov/pubmed/38501508" } @Article{info:doi/10.2196/51211, author="Wanberg, J. Lindsey and Pearson, R. David", title="Evaluating the Disease-Related Experiences of TikTok Users With Lupus Erythematosus: Qualitative and Content Analysis", journal="JMIR Infodemiology", year="2024", month="Apr", day="17", volume="4", pages="e51211", keywords="lupus", keywords="TikTok", keywords="autoimmune disease", keywords="qualitative research", keywords="quality of life", abstract="Background: Lupus erythematosus (LE) is an autoimmune condition that is associated with significant detriments to quality of life and daily functioning. TikTok, a popular social networking platform for sharing short videos, provides a unique opportunity to understand experiences with LE within a nonclinical sample, a population that is understudied in LE research. This is the first qualitative study that explores LE experiences using the TikTok platform. Objective: This study aims to evaluate the disease-related experiences of TikTok users with LE using qualitative and content analysis. Methods: TikTok videos were included if the hashtags included \#lupus, were downloadable, were in English, and involved the personal experience of an individual with LE. A codebook was developed using a standardized inductive approach of iterative coding until saturation was reached. NVivo (Lumivero), a qualitative analysis software platform, was used to code videos and perform content analysis. Inductive thematic analysis was used to derive themes from the data. Results: A total of 153 TikTok videos met the inclusion criteria. The most common codes were experiences with symptoms (106/153, 69.3\%), mucocutaneous symptoms (61/153, 39.9\%), and experiences with treatment (59/153, 38.6\%). Experiences with symptoms and mucocutaneous symptoms had the greatest cumulative views (25,381,074 and 14,879,109 views, respectively). Five thematic conclusions were derived from the data: (1) mucocutaneous symptoms had profound effects on the mental health and body image of TikTok users with LE; (2) TikTok users' negative experiences with health care workers were often derived from diagnostic delays and perceptions of ``medical gaslighting''; (3) TikTok users tended to portray pharmacologic and nonpharmacologic interventions, such as diet and naturopathic remedies, positively, whereas pharmacologic treatments were portrayed negatively or referred to as ``chemotherapy''; (4) LE symptoms, particularly musculoskeletal symptoms and fatigue, interfered with users' daily functioning; and (5) although TikTok users frequently had strong support systems, feelings of isolation were often attributed to battling an ``invisible illness.'' Conclusions: This study demonstrates that social media can provide important, clinically relevant information for health practitioners caring for patients with chronic conditions such as LE. As mucocutaneous symptoms were the predominant drivers of distress in our sample, the treatment of hair loss and rash is vital in this population. However, pharmacologic therapies were often depicted negatively, reinforcing the significance of discussions on the safety and effectiveness of these treatments. In addition, while TikTok users demonstrated robust support systems, feelings of having an ``invisible illness'' and ``medical gaslighting'' dominated negative interactions with others. This underscores the importance of providing validation in clinical interactions. ", doi="10.2196/51211", url="https://infodemiology.jmir.org/2024/1/e51211", url="http://www.ncbi.nlm.nih.gov/pubmed/38631030" } @Article{info:doi/10.2196/54172, author="McCallum, Claire and Campbell, Miglena and Vines, John and Rapley, Tim and Ellis, Jason and Deary, Vincent and Hackett, Katie", title="A Smartphone App to Support Self-Management for People Living With Sj{\"o}gren's Syndrome: Qualitative Co-Design Workshops", journal="JMIR Hum Factors", year="2024", month="Apr", day="17", volume="11", pages="e54172", keywords="self-management", keywords="mobile health", keywords="mHealth", keywords="eHealth", keywords="Sj{\"o}gren's syndrome", keywords="patient participation", keywords="patient involvement", keywords="fatigue", keywords="chronic disease", keywords="focus groups", keywords="complex intervention development", keywords="mobile phone", abstract="Background: Sj{\"o}gren's syndrome (SS) is the second most common autoimmune rheumatic disease, and the range of symptoms includes fatigue, dryness, sleep disturbances, and pain. Smartphone apps may help deliver a variety of cognitive and behavioral techniques to support self-management in SS. However, app-based interventions must be carefully designed to promote engagement and motivate behavior change. Objective: We aimed to explore self-management approaches and challenges experienced by people living with SS and produce a corresponding set of design recommendations that inform the design of an engaging, motivating, and evidence-based self-management app for those living with SS. Methods: We conducted a series of 8 co-design workshops and an additional 3 interviews with participants who were unable to attend a workshop. These were audio recorded, transcribed, and initially thematically analyzed using an inductive approach. Then, the themes were mapped to the Self-Determination Theory domains of competency, autonomy, and relatedness. Results: Participants experienced a considerable demand in the daily work required in self-managing their SS. The condition demanded unrelenting, fluctuating, and unpredictable mental, physical, and social efforts. Participants used a wide variety of techniques to self-manage their symptoms; however, their sense of competency was undermined by the complexity and interconnected nature of their symptoms and affected by interactions with others. The daily contexts in which this labor was occurring revealed ample opportunities to use digital health aids. The lived experience of participants showed that the constructs of competency, autonomy, and relatedness existed in a complex equilibrium with each other. Sometimes, they were disrupted by tensions, whereas on other occasions, they worked together harmoniously. Conclusions: An SS self-management app needs to recognize the complexity and overlap of symptoms and the complexities of managing the condition in daily life. Identifying techniques that target several symptoms simultaneously may prevent users from becoming overwhelmed. Including techniques that support assertiveness and communication with others about the condition, its symptoms, and users' limitations may support users in their interactions with others and improve engagement in symptom management strategies.?For digital health aids (such as self-management apps) to provide meaningful support, they should be designed according to human needs such as competence, autonomy, and relatedness. However, the complexities among the 3 Self-Determination Theory constructs should be carefully considered, as they present both design difficulties and opportunities. ", doi="10.2196/54172", url="https://humanfactors.jmir.org/2024/1/e54172", url="http://www.ncbi.nlm.nih.gov/pubmed/38630530" } @Article{info:doi/10.2196/57238, author="Livermore, Polly and Kupiec, Klaudia and Wedderburn, R. Lucy and Knight, Andrea and Solebo, L. Ameenat and Shafran, Roz and Robert, Glenn and Sebire, J. N. and Gibson, Faith and ", title="Designing, Developing, and Testing a Chatbot for Parents and Caregivers of Children and Young People With Rheumatological Conditions (the IMPACT Study): Protocol for a Co-Designed Proof-of-Concept Study", journal="JMIR Res Protoc", year="2024", month="Apr", day="3", volume="13", pages="e57238", keywords="caregivers", keywords="chatbot", keywords="paediatric rheumatology", keywords="parents and caregivers", keywords="parents/carers", keywords="pediatric", keywords="proof-of-concept", keywords="quality of life", keywords="rheumatology", abstract="Background: Pediatric rheumatology is a term that encompasses over 80 conditions affecting different organs and systems. Children and young people with rheumatological chronic conditions are known to have high levels of mental health problems and therefore are at risk of poor health outcomes. Clinical psychologists can help children and young people manage the daily difficulties of living with one of these conditions; however, there are insufficient pediatric psychologists in the United Kingdom. We urgently need to consider other ways of providing early, essential support to improve their current well-being. One way of doing this is to empower parents and caregivers to have more of the answers that their children and young people need to support them further between their hospital appointments. Objective: The objective of this co-designed proof-of-concept study is to design, develop, and test a chatbot intervention to support parents and caregivers of children and young people with rheumatological conditions. Methods: This study will explore the needs and views of children and young people with rheumatological conditions, their siblings, parents, and caregivers, as well as health care professionals working in pediatric rheumatology. We will ask approximately 100 participants in focus groups where they think the gaps are in current clinical care and what ideas they have for improving upon them. Creative experience-based co-design workshops will then decide upon top priorities to develop further while informing the appearance, functionality, and practical delivery of a chatbot intervention. Upon completion of a minimum viable product, approximately 100 parents and caregivers will user-test the chatbot intervention in an iterative sprint methodology to determine its worth as a mechanism for support for parents. Results: A total of 73 children, young people, parents, caregivers, and health care professionals have so far been enrolled in the study, which began in November 2023. The anticipated completion date of the study is April 2026. The data analysis is expected to be completed in January 2026, with the results being published in April 2026. Conclusions: This study will provide evidence on the accessibility, acceptability, and usability of a chatbot intervention for parents and caregivers of children and young people with rheumatological conditions. If proven useful, it could lead to a future efficacy trial of one of the first chatbot interventions to provide targeted and user-suggested support for parents and caregivers of children with chronic health conditions in health care services. This study is unique in that it will detail the needs and wants of children, young people, siblings, parents, and caregivers to improve the current support given to families living with pediatric rheumatological conditions. It will be conducted across the whole of the United Kingdom for all pediatric rheumatological conditions at all stages of the disease trajectory. International Registered Report Identifier (IRRID): DERR1-10.2196/57238 ", doi="10.2196/57238", url="https://www.researchprotocols.org/2024/1/e57238", url="http://www.ncbi.nlm.nih.gov/pubmed/38568725" } @Article{info:doi/10.2196/55327, author="Yang, Cheng-hao and Li, Xin-yu and Lv, Jia-jie and Hou, Meng-jie and Zhang, Ru-hong and Guo, Hong and Feng, Chu", title="Temporal Trends of Asthma Among Children in the Western Pacific Region From 1990 to 2045: Longitudinal Observational Study", journal="JMIR Public Health Surveill", year="2024", month="Mar", day="14", volume="10", pages="e55327", keywords="allergic disorders", keywords="global burden of disease", keywords="disability-adjusted life years", keywords="DALYs", keywords="incidence", keywords="prevalence", abstract="Background: Asthma has become one of the most common chronic conditions worldwide, especially among children. Recent findings show that the prevalence of childhood asthma has increased by 12.6\% over the past 30 years, with >262 million people currently affected globally. The reasons for the growing asthma epidemic remain complex and multifactorial. Objective: This study aims to provide an up-to-date analysis of the changing global and regional asthma prevalence, mortality, disability, and risk factors among children aged <20 years by leveraging the latest data from the Global Burden of Disease Study 2019. Findings from this study can help inform priority areas for intervention to alleviate the rising burden of childhood asthma globally. Methods: The study used data from the Global Burden of Disease Study 2019, concentrating on children aged 0 to 14 years with asthma. We conducted an in-depth analysis of asthma, including its age-standardized prevalence, incidence, mortality, and disability-adjusted life years (DALYs), across diverse demographics, such as region, age, sex, and sociodemographic index, spanning 1990 to 2019. We also projected the future burden of the disease. Results: Overall, in the Western Pacific Region, the age-standardized prevalence rate of asthma among children increased slightly, from 3898.4 cases per 100,000 people in 1990 to 3924 per 100,000 in 2019. The age-standardized incidence rate of asthma also increased slightly, from 979.2 to 994.9 per 100,000. In contrast, the age-standardized death rate of asthma decreased from 0.9 to 0.4 per 100,000 and the age-standardized DALY rate decreased from 234.9 to 189.7 per 100,000. At the country level, Japan experienced a considerable decrease in the age-standardized prevalence rate of asthma among children, from 6669.1 per 100,000 in 1990 to 5071.5 per 100,000 in 2019. Regarding DALYs, Japan exhibited a notable reduction, from 300.6 to 207.6 per 100,000. Malaysia also experienced a DALY rate reduction, from 188.4 to 163.3 per 100,000 between 1990 and 2019. We project that the burden of disease in countries other than Japan and the Philippines will remain relatively stable up to 2045. Conclusions: The study indicates an increase in the prevalence and incidence of pediatric asthma, coupled with a decrease in mortality and DALYs in the Western Pacific Region between 1990 and 2019. These intricate phenomena appear to result from a combination of lifestyle shifts, environmental influences, and barriers to health care access. The findings highlight that nations such as Japan have achieved notable success in managing asthma. Overall, the study identified areas of improvement in view of persistent disease burden, underscoring the need for comprehensive collaborative efforts to mitigate the impact of pediatric asthma throughout the region. ", doi="10.2196/55327", url="https://publichealth.jmir.org/2024/1/e55327", url="http://www.ncbi.nlm.nih.gov/pubmed/38483459" } @Article{info:doi/10.2196/48511, author="Li, Guanjian and Zhang, Rongqiu and Song, Bing and Wang, Chao and Shen, Qunshan and He, Xiaojin and Cao, Yunxia", title="Effects of SARS-CoV-2 Vaccines on Sperm Quality: Systematic Review", journal="JMIR Public Health Surveill", year="2023", month="Dec", day="6", volume="9", pages="e48511", keywords="COVID-19 vaccine", keywords="SARS-CoV-2", keywords="reproductive system", keywords="fertility", keywords="sperm quality", abstract="Background: The COVID-19 pandemic, caused by SARS-CoV-2, has triggered a global public health crisis of unprecedented proportions. SARS-CoV-2 vaccination is a highly effective strategy for preventing infections and severe COVID-19 outcomes. Although several studies have concluded that COVID-19 vaccines are unlikely to affect fertility, concerns have arisen regarding adverse events, including the potential impact on fertility; these concerns are plagued by limited and inconsistent evidence. Objective: This review aims to provide a recent assessment of the literature on the impact of COVID-19 vaccines on male sperm quality. The possible impact of COVID-19 vaccines on fertility potential was also examined to draw a clearer picture and to evaluate the effects of COVID-19 on male reproductive health. Methods: PubMed, Scopus, Web of Science, Embase, and Cochrane databases were searched from their inception to October 2023. Eligible studies included articles reporting SARS-CoV-2 vaccination and human semen quality and fertility, as well as the impact of vaccination on assisted reproductive technology treatment outcomes. The quality of cohort studies was assessed using the Newcastle-Ottawa Scale, and the quality of cross-sectional studies was assessed using the quality evaluation criteria recommended by the Agency for Healthcare Research and Quality. The systematic review followed PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Results: The initial literature search yielded 4691 records by searching 5 peer-reviewed databases (PubMed, Scopus, Web of Science, Embase, and Cochrane). Finally, 24 relevant studies were selected for our study. There were evident research inequalities at the regional level, with the United States and Western European countries contributing 38\% (9/24) of the studies, Middle Eastern countries contributing 38\% (9/24), China accounting for 21\% (5/24), and Africa and South America accounting for none. Nonetheless, the overall quality of the included studies was generally good. Our results demonstrated that serious side effects of the COVID-19 vaccine are extremely rare, and men experience few problems with sperm parameters or reproductive potential after vaccination. Conclusions: On the basis of the studies published so far, the COVID-19 vaccine is safe for male reproductive health. Obviously, vaccination is a wise option rather than experience serious adverse symptoms of viral infections. These instances of evidence may help reduce vaccine hesitancy and increase vaccination coverage, particularly among reproductive-age couples. As new controlled trials and prospective cohort studies with larger sample sizes emerge, the possibility of a negative effect of the COVID-19 vaccine on sperm quality must be further clarified. ", doi="10.2196/48511", url="https://publichealth.jmir.org/2023/1/e48511", url="http://www.ncbi.nlm.nih.gov/pubmed/37976132" } @Article{info:doi/10.2196/44034, author="Nowell, B. William and Curtis, R. Jeffrey and Zhao, Hong and Xie, Fenglong and Stradford, Laura and Curtis, David and Gavigan, Kelly and Boles, Jessica and Clinton, Cassie and Lipkovich, Ilya and Venkatachalam, Shilpa and Calvin, Amy and Hayes, S. Virginia", title="Participant Engagement and Adherence to Providing Smartwatch and Patient-Reported Outcome Data: Digital Tracking of Rheumatoid Arthritis Longitudinally (DIGITAL) Real-World Study", journal="JMIR Hum Factors", year="2023", month="Nov", day="7", volume="10", pages="e44034", keywords="real-world evidence", keywords="real-world data", keywords="patients", keywords="rheumatoid arthritis", keywords="patient-reported outcomes", keywords="patient-generated health data", keywords="mobile technology", keywords="wearable digital technology", keywords="mobile phone", abstract="Background: Digital health studies using electronic patient-reported outcomes (ePROs) and wearables bring new challenges, including the need for participants to consistently provide trial data. Objective: This study aims to characterize the engagement, protocol adherence, and data completeness among participants with rheumatoid arthritis enrolled in the Digital Tracking of Arthritis Longitudinally (DIGITAL) study. Methods: Participants were invited to participate in this app-based study, which included a 14-day run-in and an 84-day main study. In the run-in period, data were collected via the ArthritisPower mobile app to increase app familiarity and identify the individuals who were motivated to participate. Successful completers of the run-in period were mailed a wearable smartwatch, and automated and manual prompts were sent to participants, reminding them to complete app input or regularly wear and synchronize devices, respectively, during the main study. Study coordinators monitored participant data and contacted participants via email, SMS text messaging, and phone to resolve adherence issues per a priori rules, in which consecutive spans of missing data triggered participant contact. Adherence to data collection during the main study period was defined as providing requested data for >70\% of 84 days (daily ePRO, ?80\% daily smartwatch data) or at least 9 of 12 weeks (weekly ePRO). Results: Of the 470 participants expressing initial interest, 278 (59.1\%) completed the run-in period and qualified for the main study. Over the 12-week main study period, 87.4\% (243/278) of participants met the definition of adherence to protocol-specified data collection for weekly ePRO, and 57.2\% (159/278) did so for daily ePRO. For smartwatch data, 81.7\% (227/278) of the participants adhered to the protocol-specified data collection. In total, 52.9\% (147/278) of the participants met composite adherence. Conclusions: Compared with other digital health rheumatoid arthritis studies, a short run-in period appears useful for identifying participants likely to engage in a study that collects data via a mobile app and wearables and gives participants time to acclimate to study requirements. Automated or manual prompts (ie, ``It's time to sync your smartwatch'') may be necessary to optimize adherence. Adherence varies by data collection type (eg, ePRO vs smartwatch data). International Registered Report Identifier (IRRID): RR2-10.2196/14665 ", doi="10.2196/44034", url="https://humanfactors.jmir.org/2023/1/e44034", url="http://www.ncbi.nlm.nih.gov/pubmed/37934559" } @Article{info:doi/10.2196/48479, author="Suhana, Azis Panaparambil and Kusum, Lata and Shruti, Vij Jain and Sreekanth, Pillai Gopinathan and Bijukumar, Damodaran and Shaji Kumar, T. R. and Muraleedharan, C. K. and Kaushik, Subhash", title="Immunological Responses of Arsenicum album 30CH to Combat COVID-19: Protocol for a Double-Blind, Randomized, Placebo-Controlled Clinical Trial in the Pathanamthitta District of Kerala", journal="JMIR Res Protoc", year="2023", month="Oct", day="16", volume="12", pages="e48479", keywords="COVID-19", keywords="Arsenicum album 30CH", keywords="randomized controlled trial", keywords="Pathanamthitta", keywords="immunology", abstract="Background: COVID-19 is a recent major public health concern caused by the SARS-CoV-2 virus, with approximately 44.6 million COVID-19--positive cases and 530,000 deaths in India (as of February 1, 2023). The COVID-19 vaccination drive in India was initiated in January 2021; however, an effective preventive strategy with high efficacy and immunological safety remains elusive. Objective: The aim of this study is to assess the immunogenic responses of Arsenicum album 30CH (AA30CH) as COVID-19 prophylaxis, including assessment of immunological markers, innate and acquired immune responses, COVID-19 symptoms, and its associated antibody responses. Methods: This randomized controlled clinical trial (RCT) will include two parallel comparator groups of AA30CH and placebo with an allocation ratio of 1:1 conducted in the Pathanamthitta district of Kerala, India. The placebo or AA30CH will be administered in three intervention schedules and blood samples will be collected before and after each of the intervention schedules. Based on the inclusion and exclusion criteria, 112 participants per arm (with an expected dropout of 20\%) will be screened. Immunogenic responses will be evaluated by determining the antigen density and modulation in immunological markers and lymphocyte subsets CD3, CD4, CD8, CD24, CD27, CD38, CD4 interferon-$\gamma$, CD4 CD17, CD4 CD25 (activated T lymphocytes), T cells, B cells, dendritic cells (mature and immature), and natural killer cells on days 1, 5, 23,27, 45, 49, and 66. The innate and acquired immune responses will also be evaluated by a real-time reverse-transcriptase polymerase chain reaction (RT-PCR) array profiler (84-gene set) before and after the study interventions. The toxicity status of AA30CH in study participants will be evaluated through hepatic, renal, and hematological parameters and peripheral smears on days 1, 5, 23, 27, 45, 49, and 66. The number of participants developing COVID-19--like symptoms per National Centre for Disease Control guidelines and the number of participants testing positive for COVID-19 in RT-PCR during follow-ups in any of the three intervention schedules will be identified. Moreover, a subgroup analysis will be used to assess the COVID-19 antibody responses between vaccinated and unvaccinated participants. Results: This RCT protocol has been approved by various committees and funded by the Central Council for Research in Homoeopathy, Ministry of Ayush, Government of India. The project has been implemented in collaboration with the Department of Homoeopathy, Government of Kerala. The RCT was rolled out on January 25, 2023, and enrollment was completed April 3, 2023. The immunological assays will be conducted at the Department of Biotechnology-Translational Health Science and Technology Institute, Faridabad, India. Conclusions: This study will represent the first evaluation of the immunological efficacy and safety of AA30CH in an RCT, which may significantly impact the use of homeopathy as an evidence-based medicine approach. Trial Registration: Clinical Trials Registry-India CTRI/2022/08/045089; https://tinyurl.com/mryrpkvk International Registered Report Identifier (IRRID): DERR1-10.2196/48479 ", doi="10.2196/48479", url="https://www.researchprotocols.org/2023/1/e48479", url="http://www.ncbi.nlm.nih.gov/pubmed/37843912" } @Article{info:doi/10.2196/46955, author="Yano, Rina and Terada-Hirashima, Junko and Uemura, Yukari and Tomita, Noriko and Shimizu, Yosuke and Iwasaki, Haruka and Okumura, Nobumasa and Suzuki, Tetsuya and Saito, Sho and Ujiie, Mugen and Sugiura, Wataru and Ohmagari, Norio", title="Efficacy and Safety of the Smallpox Vaccine for Postexposure Prophylaxis in Monkeypox: Protocol for an Open-Labeled, Single-Armed Study", journal="JMIR Res Protoc", year="2023", month="Aug", day="25", volume="12", pages="e46955", keywords="monkeypox", keywords="post-exposure prophylaxis", keywords="smallpox vaccine", keywords="vaccinia virus", keywords="LC16", keywords="poxvirus", keywords="smallpox", keywords="vaccination", keywords="smallpox virus", keywords="orthopoxvirus", keywords="immunity", keywords="epidemiology", keywords="zoonosis", keywords="virus", keywords="vaccine", keywords="Disease Control and Prevention", keywords="inoculation", keywords="injection site", keywords="body temperature", keywords="headache", keywords="rash", keywords="lymphadenopathy", keywords="infectious disease", keywords="endpoint analysis", abstract="Background: In May 2022, a case of monkeypox (currently known as ``mpox'') with no history of overseas travel was reported in the United Kingdom, followed by reports of infections reported in Europe, the United States, and other countries worldwide. Due to the significant overlap in immune responses among viruses of the genus Orthopoxvirus (including smallpox virus, mpox virus, and vaccinia virus), it is believed that cross-immunity can be achieved by administering the smallpox virus vaccine. In Japan, a smallpox vaccine (LC16m8 strain vaccine) has been approved; however, there was no regulatory approval for the mpox vaccine during the design of this study. Although it is believed that individuals exposed to the mpox virus may receive smallpox vaccination as mpox prophylaxis, the existing evidence is not clear. Objective: The primary objective was to evaluate the efficacy of the LC16m8 strain vaccine, approved for smallpox in Japan, for postexposure prophylaxis against mpox when administered to close contacts of individuals with mpox. The secondary objective was to investigate the safety of the vaccine for postexposure prophylaxis against mpox. Methods: The study aimed to enroll 100 vaccinated participants who had been identified as close contacts of individuals with mpox. Consent was obtained, and the participants are inoculated with the vaccine. Daily recordings of symptoms (body temperature, headache, rash, and side effects) were made until day 21 and then again on day 28. Furthermore, additional evaluations of adverse events were performed by the investigators on days 7, 14, 21, and 28. Considering that the maximum incubation period for mpox is 21 days, the primary end point is the presence or absence of the disease 21 days after close contact. The primary analysis focused on cases within 4 days of intense contact as it has been reported that vaccination within this timeframe can reduce the incidence of the disease. Results: The first trial participant was enrolled on July 28, 2022, and the research period concluded in March 2023. The study results will be published in a peer-reviewed scientific journal. Conclusions: This study allowed us to investigate the efficacy and safety of the LC16m8 strain vaccine in postexposure prophylaxis against mpox. Trial Registration: Japan Registry of Clinical Trials jRCTs031220137; https://jrct.niph.go.jp/en-latest-detail/jRCTs031220137 International Registered Report Identifier (IRRID): DERR1-10.2196/46955 ", doi="10.2196/46955", url="https://www.researchprotocols.org/2023/1/e46955", url="http://www.ncbi.nlm.nih.gov/pubmed/37624623" } @Article{info:doi/10.2196/48790, author="H{\"o}per, Christina Anje and Kirkeleit, Jorunn and Thomassen, Renate Marte and Irgens-Hansen, Kaja and Hollund, Eli Bj{\o}rg and Fagern{\ae}s, Fredrik Carl and Svedahl, Rabben Sindre and Eriksen, Eirik Thor and Grgic, Miriam and Bang, Elisabeth Berit", title="Effects of Interventions to Prevent Work-Related Asthma, Allergy, and Other Hypersensitivity Reactions in Norwegian Salmon Industry Workers (SHInE): Protocol for a Pragmatic Allocated Intervention Trial and Related Substudies", journal="JMIR Res Protoc", year="2023", month="Jul", day="19", volume="12", pages="e48790", keywords="allergy", keywords="bioaerosols", keywords="exposure-response", keywords="health promotion", keywords="hypersensitivity", keywords="occupational asthma", keywords="occupational skin disease", keywords="psychosocial work environment", keywords="salmon processing industry", abstract="Background: Workers in the salmon processing industry have an increased risk of developing respiratory diseases and other hypersensitivity responses due to occupational exposure to bioaerosols containing fish proteins and microorganisms, and related allergens. Little is known about effective measures to reduce bioaerosol exposure and about the extent of skin complaints among workers. In addition, while identification of risk factors is a core activity in disease prevention strategies, there is increasing interest in health-promoting factors, which is an understudied area in the salmon processing industry. Objective: The overall aim of this ongoing study is to generate knowledge that can be used in tailored prevention of development or chronification of respiratory diseases, skin reactions, protein contact dermatitis, and allergy among salmon processing workers. The main objective is to identify effective methods to reduce bioaerosol exposure. Further objectives are to identify and characterize clinically relevant exposure agents, identify determinants of exposure, measure prevalence of work-related symptoms and disease, and identify health-promoting factors of the psychosocial work environment. Methods: Data are collected during field studies in 9 salmon processing plants along the Norwegian coastline. Data collection comprises exposure measurements, health examinations, and questionnaires. A wide range of laboratory analyses will be used for further analysis and characterization of exposure agents. Suitable statistical analysis will be applied to the various outcomes of this comprehensive study. Results: Data collection started in September 2021 and was anticipated to be completed by March 2023, but was delayed due to the COVID-19 pandemic. Baseline data from all 9 plants included 673 participants for the health examinations and a total of 869 personal exposure measurements. A total of 740 workers answered the study's main questionnaire on demographics, job characteristics, lifestyle, health, and health-promoting factors. Follow-up data collection is not completed yet. Conclusions: This study will contribute to filling knowledge gaps concerning salmon workers' work environment. This includes effective workplace measures for bioaerosol exposure reduction, increased knowledge on hypersensitivity, allergy, respiratory and dermal health, as well as health-promoting workplace factors. Together this will give a basis for improving the work environment, preventing occupational health-related diseases, and developing occupational exposure limits, which in turn will benefit employees, employers, occupational health services, researchers, clinicians, decision makers, and other stakeholders. Trial Registration: ClinicalTrials.gov NCT05039229; https://www.clinicaltrials.gov/study/NCT05039229 International Registered Report Identifier (IRRID): DERR1-10.2196/48790 ", doi="10.2196/48790", url="https://www.researchprotocols.org/2023/1/e48790", url="http://www.ncbi.nlm.nih.gov/pubmed/37467018" } @Article{info:doi/10.2196/46816, author="Abang Abdullah, Fadhilah Aisha and Muhamad, Asiah Nor and Ab Ghani, Melati Rimah and Maamor, Hasnah Nur and Leman, Norhasny Fatin and Too, Lai Chun and Ismail, Hakimah Intan and Mohd Zulkefli, Afiah Nor and Mohd Nazan, Nashriq Ahmad Iqmer and Md Said, Salmiah", title="The Effectiveness of Early Food Introduction in Preventing Childhood Allergic Diseases: Protocol for a Systematic Review and Meta-Analysis", journal="JMIR Res Protoc", year="2023", month="Jun", day="26", volume="12", pages="e46816", keywords="protocol", keywords="systematic review", keywords="childhood allergic disease", keywords="weaning", keywords="early food introduction", keywords="food allergy", keywords="allergy", keywords="anaphylaxis", keywords="randomized controlled trial", keywords="pediatric", keywords="infant", keywords="childhood", abstract="Background: Allergic diseases affect around 40\% of the pediatric population worldwide. The coexistence of asthma, allergic rhinitis, eczema, and food allergy renders allergy treatment and prevention challenging. Infant feeding strategies recommend avoiding allergenic foods to prevent allergy development and anaphylaxis. However, recent evidence suggests that early consumption of food allergens during weaning in infants aged 4-6 months could result in food tolerance, thus reducing the risk of developing allergies. Objective: The aim of this study is to systematically review and carry out a meta-analysis of evidence on the outcome of early food introduction for preventing childhood allergic diseases. Methods: We will conduct a systematic review of interventions through a comprehensive search of various databases including PubMed, Embase, Scopus, CENTRAL, PsycINFO, CINAHL, and Google Scholar to identify potential studies. The search will be performed for any eligible articles from the earliest published articles up to the latest available studies in 2023. We will include randomized controlled trials (RCTs), cluster RCTs, non-RCTs, and other observational studies that assess the effect of early food introduction to prevent childhood allergic diseases. Results: Primary outcomes will include measures related to the effect of childhood allergic diseases (ie, asthma, allergic rhinitis, eczema, and food allergy). PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines will be followed for study selection. All data will be extracted using a standardized data extraction form and the quality of the studies will be assessed using the Cochrane Risk of Bias tool. A summary of findings table will be generated for the following outcomes: (1) total number of allergic diseases, (2) rate of sensitization, (3) total number of adverse events, (4) improvement of health-related quality of life, and (5) all-cause mortality. Descriptive and meta-analyses will be performed using a random-effects model in Review Manager (Cochrane). Heterogeneity among selected studies will be assessed using the I2 statistic and explored through meta-regression and subgroup analyses. Data collection is expected to start in June 2023. Conclusions: The results acquired from this study will contribute to the existing literature and harmonize recommendations for infant feeding with regard to the prevention of childhood allergic diseases. Trial Registration: PROSPERO CRD42021256776; https://tinyurl.com/4j272y8a International Registered Report Identifier (IRRID): PRR1-10.2196/46816 ", doi="10.2196/46816", url="https://www.researchprotocols.org/2023/1/e46816", url="http://www.ncbi.nlm.nih.gov/pubmed/37358892" } @Article{info:doi/10.2196/46741, author="Howell, Imran and Mahdi, Mahdi and Bafadhel, Mona and Hinks, C. Timothy S. and Ramakrishnan, Sanjay and Melhorn, James and Jabeen, Maisha and Pavord, D. Ian", title="Recovery of Breakthrough Asthma Attacks Treated With Oral Steroids While on Monoclonal Antibody Therapy: Protocol for a Prospective Observational Study (BOOST)", journal="JMIR Res Protoc", year="2023", month="Jun", day="23", volume="12", pages="e46741", keywords="asthma", keywords="monoclonal antibodies", keywords="steroids", keywords="monoclonal antibody", keywords="oral steroid", keywords="asthma attack", keywords="quality of life", keywords="adult", keywords="inflammatory response", keywords="prednisolone treatment", keywords="treatment", abstract="Background: Asthma attacks are a common and important problem. Someone experiences an asthma attack in the United Kingdom every 10 seconds. Asthma attacks cause coughing, wheezing, breathlessness, and chest tightness and are highly stressful for patients. They result in reduced quality of life, with days lost from work or school. Asthma attacks are treated with oral corticosteroids (OCSs), but these have many short- and long-term side effects. Asthma monoclonal antibodies (mAbs) have revolutionized the treatment of severe asthma by reducing asthma attacks and OCS burden by over 50\%, but some people still experience attacks while on mAbs. The MEX study showed that residual asthma attacks are broadly eosinophilic (high fractional exhaled nitric oxide [FeNO]) or noneosinophilic (low FeNO), but it did not measure response to OCS treatment. There is an evidence gap in understanding the clinical and inflammatory responses that occur when using OCSs to treat residual asthma attacks in patients taking asthma mAbs. Objective: The primary objective is to compare the clinical recovery between high-FeNO and low-FeNO attacks after acute treatment with oral prednisolone among people established on long-term asthma mAb treatment. The exploratory objective is to compare the inflammatory response to acute treatment with oral prednisolone between high-FeNO and low-FeNO attacks. Methods: BOOST (Breakthrough Asthma Attacks Treated With Oral Steroids) is a single-center, prospective observational study of 60 adults established on long-term asthma mAb treatment who receive acute treatment with oral prednisolone (usual care) for an asthma attack. The primary outcome will be the proportion of treatment failure (the need to start oral prednisolone or antibiotics or an unscheduled health care visit for asthma, following an attack) at day 28. The secondary outcomes will be the change in forced expiratory volume in 1 second and the change in visual analogue scale symptom score between the stable state, attack, day 7, and day 28 visits. The exploratory outcomes include the changes in sputum, nasal, and blood inflammometry between the stable state, attack, day 7, and day 28 visits. Results: The last asthma attack visit is anticipated to occur in December 2023. Data analysis and publication will take place in 2024. Conclusions: We will test the hypothesis that there is a difference in the rate of recovery of clinical and inflammatory measures between high-FeNO and low-FeNO asthma attacks that occur in patients on mAb therapy. The study data will help power a future randomized placebo-controlled trial of prednisolone treatment for nonsevere attacks in patients treated with asthma mAbs and will provide important information on whether corticosteroid treatment should be FeNO-directed. International Registered Report Identifier (IRRID): DERR1-10.2196/46741 ", doi="10.2196/46741", url="https://www.researchprotocols.org/2023/1/e46741", url="http://www.ncbi.nlm.nih.gov/pubmed/37351918" } @Article{info:doi/10.2196/43344, author="Arguni, Eggi and Chamida, Murni Fatia and Indrawanti, Ratni and Rusmawatiningtyas, Desy and Dewi, Puspa Yunika and Laksanawati, Safitri Ida", title="The Kinetics of Anti--SARS-CoV-2 Antibodies in Pediatric Patients and the Characterization of Post--COVID-19 Condition at 6 Months After Infection: Protocol for a Longitudinal Observational Study", journal="JMIR Res Protoc", year="2023", month="Jun", day="6", volume="12", pages="e43344", keywords="kinetics", keywords="anti--SARS-CoV-2 antibodies", keywords="post--COVID-19 condition", keywords="long COVID", keywords="pediatric patient", keywords="antibodies", keywords="COVID-19", abstract="Background: Data regarding the kinetics of anti--SARS-CoV-2 antibodies and information about post--COVID-19 condition (colloquially known as ``long COVID'') in children are scarce, especially in low-income countries. Even though cases of COVID-19 in children are less prevalent than adults, post--COVID-19 condition cases in children are high and have a burden that may impact their growth and development. There are other features of antibody kinetics in connection with SARS-CoV-2 infection that are yet unknown as of this writing, especially in children following infection. Furthermore, the long-term results, risk factors, and underlying pathophysiology are still uncertain. To better understand post--COVID-19 condition in children, it is necessary to further investigate the impact of clinically significant factors such multisystem inflammatory syndrome and disease severity among hospitalized survivors through their SARS-CoV-2 antibody response. Objective: We aim to analyze anti--receptor-binding domain SARS-CoV-2 immunoglobulin G antibodies over time and characterize the signs and symptoms of post--COVID-19 condition in pediatric patients at the time of diagnosis and at 2 weeks and 1, 3, and 6 months following infection. Methods: This is a longitudinal observational study in Indonesia. Pediatric patients diagnosed with COVID-19 by positive molecular assay using nasopharyngeal swab will be tested for anti--SARS-CoV-2 antibodies using the Roche Elecsys Anti-SARS-CoV-2 S assay at the time of diagnosis and at 2 weeks and 1, 3, and 6 months following infection. Antibody titer data will be reported as means and SDs. The respondents' signs and symptoms will be observed up to 6 months after the onset of infection, including the vaccination event, reinfection, rehospitalization, and mortality. The clinical features will be reported as frequencies and percentages. Results: Participant enrollment began in February 2022. As of September 30, 2022, a total of 58 patients were enrolled. After data collection, results are expected to be analyzed in August 2023. Conclusions: This study will allow us to know the kinetics of anti--receptor-binding domain SARS-CoV-2 immunoglobulin G antibodies and data regarding post--COVID-19 condition up to 6 months following infection in the Indonesian pediatric population. Furthermore, this study has the potential to serve as a foundation for government decisions about vaccination programs and prevention measures. International Registered Report Identifier (IRRID): DERR1-10.2196/43344 ", doi="10.2196/43344", url="https://www.researchprotocols.org/2023/1/e43344", url="http://www.ncbi.nlm.nih.gov/pubmed/37246961" } @Article{info:doi/10.2196/39024, author="Heiberger, Andrea and Dresch, Carolin and Schulz, Alexandra Anja and Wirtz, Antonius Markus", title="Health Literate Internet-Based Information-Seeking Processes: Theory-Based Development of a Conceptual Model", journal="J Med Internet Res", year="2023", month="Mar", day="23", volume="25", pages="e39024", keywords="health literacy", keywords="internet-based search", keywords="model development", keywords="parents", keywords="health information", keywords="internet", keywords="childhood", keywords="allergy", keywords="prevention", keywords="pediatric", keywords="online", keywords="content", keywords="information", doi="10.2196/39024", url="https://www.jmir.org/2023/1/e39024", url="http://www.ncbi.nlm.nih.gov/pubmed/36951897" } @Article{info:doi/10.2196/41436, author="H{\"o}rold, Madlen and Apfelbacher, Christian and Gerhardinger, Katharina and Rohr, Magdalena and Schimmelpfennig, Maria and Weigt, Julia and Brandstetter, Susanne", title="Parents' and Health Care Professionals' Perspectives on Prevention and Prediction of Food Allergies in Children: Protocol for a Qualitative Study", journal="JMIR Res Protoc", year="2023", month="Mar", day="22", volume="12", pages="e41436", keywords="parents", keywords="health care professionals", keywords="content analysis", keywords="grounded theory", keywords="food allergy", keywords="children", keywords="allergic reaction", keywords="information needs", keywords="information seeking", keywords="prevention", keywords="prediction", keywords="risk factors", abstract="Background: Food allergy in children is increasing in prevalence in the western world and appears to become an important health problem. Parents of children at risk of food allergy live with the fear of allergic reaction, especially when the children are very young. The paradigm shift in allergy prevention in the last decade---away from allergen avoidance toward a tolerance induction approach---challenges both parents and health care professionals, as they have to deal with changing information and new evidence that often contradicts previous assumptions. Yet, research on health information--seeking behavior and needs of parents on primary prevention of food allergy in children as well as on prediction and prevention strategies of German health care professionals is lacking. Objective: The aim of the study is to explore and understand parents' and health care professionals' perspectives on the prediction and prevention of food allergies. We are particularly interested in information needs, information seeking, and health care usage and place a special focus on families' experiences when their child is at risk or diagnosed with food allergies. Furthermore, food allergy prediction and prevention strategies of health care professionals will be explored. Methods: This study is part of the NAMIBIO (food allergy biomarker) app consortium, which aims to identify early predictors for the development of food allergy in children and develop apps to guide health care professionals and parents of children with a high risk of food allergy toward prevention and timely tolerance induction. The study uses a qualitative approach with topic-guided interviews and focus groups with parents of children (0-3 years) and health care professionals. Data collection will continue until theoretical saturation is reached. The qualitative content analysis will be used according to Kuckartz to identify overarching themes toward information needs and seeking behavior as well as usage of health care and health care professionals' predictive and preventive strategies. In addition, a constructivist grounded theory approach will be used to explore and understand parents' experiences, interactions, and social processes in families in daily life. Results: Recruitment and data collection started in February 2022 and is still ongoing. Conclusions: The qualitative study will provide insight into parents' information-seeking behavior and needs regarding the prevention of food allergy in children, parents' use of pediatric primary care, and health care professionals strategies for the prediction and prevention of food allergies in children. We assume that our results will highlight the challenges associated with the paradigm shift in allergy prevention for both parents and health care professionals. The results will be used to make practical recommendations from the user's perspective and inform the development of the NAMIBIO apps. International Registered Report Identifier (IRRID): DERR1-10.2196/41436 ", doi="10.2196/41436", url="https://www.researchprotocols.org/2023/1/e41436", url="http://www.ncbi.nlm.nih.gov/pubmed/36947117" } @Article{info:doi/10.2196/37790, author="Pickering, Gis{\`e}le and Mezouar, Linda and Kechemir, Hayet and Ebel-Bitoun, Caty", title="Paracetamol Use in Patients With Osteoarthritis and Lower Back Pain: Infodemiology Study and Observational Analysis of Electronic Medical Record Data", journal="JMIR Public Health Surveill", year="2022", month="Oct", day="27", volume="8", number="10", pages="e37790", keywords="osteoarthritis", keywords="lower back pain", keywords="general practice", keywords="rheumatology", keywords="paracetamol", keywords="real-world evidence", abstract="Background: Lower back pain (LBP) and osteoarthritis (OA) are common musculoskeletal disorders and account for around 17.0\% of years lived with disability worldwide; however, there is a lack of real-world data on these conditions. Paracetamol brands are frequently prescribed in France for musculoskeletal pain and include Doliprane, Dafalgan, and Ixprim (tramadol-paracetamol). Objective: The objective of this retrospective study was to understand the journey of patients with LBP or OA when treated with paracetamol. Methods: Three studies were undertaken. Two studies analyzed electronic medical records from general practitioners (GPs) and rheumatologists of patients with OA or LBP, who had received at least one paracetamol prescription between 2013 and 2018 in France. Data were extracted, anonymized, and stratified by gender, age, and provider specialty. The third study, an infodemiology study, analyzed associations between terms used on public medical forums and Twitter in France and the United States for OA only. Results: In the first 2 studies, among patients with LBP (98,998), most (n=92,068, 93.0\%) saw a GP, and Doliprane was a first-line therapy for 87.0\% (n=86,128) of patients (71.0\% [n=61,151] in combination with nonsteroidal anti-inflammatory drugs [NSAIDs] or opioids). Among patients with OA (99,997), most (n=84,997, 85.0\%) saw a GP, and Doliprane was a first-line therapy for 83.0\% (n=82,998) of patients (62.0\% [n=51,459] in combination). Overall, paracetamol monotherapy prescriptions decreased as episodes increased. In the third study, in line with available literature, the data confirmed that the prevalence of OA increases with age (91.5\% [212,875/232,650] above 41 years), OA is more predominant in females (46,530/232,650, 20.0\%), and paracetamol use varies between GPs and rheumatologists. Conclusions: This health surveillance analysis provides a better understanding of the journey for patients with LBP or OA. These data confirmed that although paracetamol remains the most common first-line analgesic for patients with LBP and OA, usage varies among patients and health care specialists, and there are concerns over efficacy. ", doi="10.2196/37790", url="https://publichealth.jmir.org/2022/10/e37790", url="http://www.ncbi.nlm.nih.gov/pubmed/36301591" } @Article{info:doi/10.2196/35300, author="McCombe, Geoff and Swan, Davina and Lambert, S. John and O'Connor, Eileen and Ward, Zoe and Vickerman, Peter and Avramovic, Gordana and Crowley, Des and Tinago, Willard and Mafirakureva, Nyashadzaishe and Cullen, Walter", title="Integrating Hepatitis C Care for Opioid Substitution Treatment Patients Attending General Practice: Feasibility, Clinical, and Cost-Effectiveness Analysis", journal="Interact J Med Res", year="2022", month="Aug", day="23", volume="11", number="2", pages="e35300", keywords="hepatitis C", keywords="integrated HCV care", keywords="people who inject drugs", keywords="primary health care", abstract="Background: Hepatitis C virus (HCV) infection is common among people who inject drugs, yet well-described barriers mean that only a minority have accessed HCV treatment. Recent developments in HCV diagnosis and treatment facilitate innovative approaches to HCV care that improve access to, and uptake of, care by people who inject drugs. Objective: This study aims to examine feasibility, acceptability, likely clinical effectiveness, and cost-effectiveness of an integrated model of HCV care for patients receiving opioid substitution treatment in general practice. Methods: A pre- and postintervention design with an embedded economic analysis was used to establish the feasibility, acceptability, and clinical and cost-effectiveness of a complex intervention to optimize HCV identification and linkage to HCV treatment among patients prescribed methadone in primary care. The ``complex intervention'' comprised general practitioner (GP)/practice staff education, nurse-led clinical support, and enhanced community-based HCV assessment of patients. General practices in North Dublin were recruited from the professional networks of the research team and from GPs who attended educational sessions. Results: A total of 135 patients from 14 practices participated. Follow-up data were collected 6 months after intervention from 131 (97.0\%) patients. With regard to likely clinical effectiveness, among patients with HCV antibody positivity, there was a significant increase in the proportions of patients who had a liver FibroScan (17/101, 16.8\% vs 52/100, 52.0\%; P<.001), had attended hepatology/infectious diseases services (51/101, 50.5\% vs 61/100 61.0\%; P=.002), and initiated treatment (20/101, 19.8\% vs 30/100, 30.0\%; P=.004). The mean incremental cost-effectiveness ratio of the intervention was {\texteuro}13,255 (US \$13,965.14) per quality-adjusted life-year gained at current full drug list price ({\texteuro}39,729 [US \$41,857.48] per course), which would be cost saving if these costs are reduced by 88\%. Conclusions: The complex intervention involving clinical support, access to assessment, and practitioner education has the potential to enhance patient care, improving access to assessment and treatment in a cost-effective manner. ", doi="10.2196/35300", url="https://www.i-jmr.org/2022/2/e35300", url="http://www.ncbi.nlm.nih.gov/pubmed/35998029" } @Article{info:doi/10.2196/29787, author="Mulligan, Kathleen and Hirani, P. Shashivadan and Harris, Sally and Taylor, Jo and Wedderburn, R. Lucy and Newman, Stanton and ", title="The Effects of a Web-Based Tool for Parents of Children With Juvenile Idiopathic Arthritis: Randomized Controlled Trial", journal="J Med Internet Res", year="2022", month="May", day="12", volume="24", number="5", pages="e29787", keywords="parenting stress", keywords="juvenile idiopathic arthritis", keywords="web-based intervention", keywords="randomized controlled trial", keywords="parenting", keywords="pediatrics", keywords="arthritis", keywords="RCT", keywords="rheumatology", keywords="children", keywords="youth", keywords="web-based tool", keywords="mobile phone", abstract="Background: Juvenile idiopathic arthritis (JIA) is a group of autoinflammatory diseases that cause pain and disability if not controlled by treatment. Parenting a child with JIA is stressful for parents, who express concerns about their child's treatment and may experience anxiety and powerlessness concerning their child's illness. Parenting stress is greater in parents of children with chronic illness than in those with healthy children and is related to poorer psychological adjustment in both parents and children. It is therefore important to develop interventions to support parents. This paper reports the evaluation of a web-based tool that provides information and practical skills to help increase parents' confidence in managing their child's illness and reduce parenting stress. Objective: The aim of this study is to evaluate the benefits of a web-based tool (WebParC) for parents of children with recently diagnosed JIA. Methods: A multicentered randomized controlled trial was conducted at pediatric rheumatology centers in England. We recruited parents of children aged ?12 years who had been diagnosed with JIA within the previous 6 months. They were randomized to the intervention (WebParC access plus standard care) or the control (standard care alone) and followed up 4 months and 12 months after randomization. Where both parents participated, they were randomized by household to the same trial arm. The WebParC intervention consists of information about JIA and its treatment plus a toolkit, based on cognitive behavioral therapy, to help parents develop skills to manage JIA-related issues. The primary outcome was the self-report Pediatric Inventory for Parents measure of illness-related parenting stress. The secondary outcomes were parental mood, self-efficacy, coping, effectiveness of participation in their child's health care, satisfaction with health care, and child's health-related quality of life. Results: A total of 203 households comprising 220 parents were randomized to the intervention (100/203, 49.3\%) or control (103/203, 50.7\%) arm. Follow-up assessments were completed by 65.5\% (133/203) of the households at 4 months (intervention 60/100, 60\%, and control 73/103, 70.9\%) and 61.1\% (124/203) of the households at 12 months (intervention 58/100, 58\%, and control 66/103, 64.1\%). A main effect of the trial arm was found on the Pediatric Inventory for Parents: the intervention participants reported less frequency (subscales communication F1,120627=5.37; P=.02, and role function F1,27203=5.40; P=.02) and difficulty (subscales communication F1,2237=7.43; P=.006, medical care F1,2907=4.04; P=.04, and role function F1,821=4.37, P=.04) regarding illness-related stressful events than the control participants. Conclusions: The WebParC website for parents of children with JIA reduced illness-related parenting stress. This web-based intervention offers a feasible preventive approach for parents of children with JIA and potentially could be adapted and evaluated for parents of children with other chronic illnesses. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN) 13159730; http://www.isrctn.com/ISRCTN13159730 ", doi="10.2196/29787", url="https://www.jmir.org/2022/5/e29787", url="http://www.ncbi.nlm.nih.gov/pubmed/35551065" } @Article{info:doi/10.2196/34735, author="Taxter, Alysha and Johnson, Lisa and Tabussi, Doreen and Kimura, Yukiko and Donaldson, Brittany and Lawson, Erica and Del Gaizo, Vincent and Vitelli, Daniela and Pinter, Corinne and Van Citters, Aricca and Nelson, Eugene and Lee, Tzielan", title="Co-design of an Electronic Dashboard to Support the Coproduction of Care in Pediatric Rheumatic Disease: Human-Centered Design and Usability Testing", journal="J Particip Med", year="2022", month="Apr", day="22", volume="14", number="1", pages="e34735", keywords="human-centered design", keywords="coproduction", keywords="dashboard", keywords="pediatric rheumatology", keywords="juvenile idiopathic arthritis", keywords="JIA", keywords="juvenile arthritis", keywords="patient centered", keywords="patient-reported outcomes", keywords="patient communication", keywords="patient education", keywords="family education", abstract="Background: The coproduction of care involves patients and families partnering with their clinicians and care teams, with the premise that each brings their own perspective, knowledge, and expertise, as well as their own values, goals, and preferences, to the partnership. Dashboards can display meaningful patient and clinical data to assess how a patient is doing and inform shared decision-making. Increasing communication between patients and care teams is particularly important for children with chronic conditions. Juvenile idiopathic arthritis (JIA), the most common chronic pediatric rheumatic condition, is associated with increased pain, decreased function, and decreased quality of life. Objective: The aim of this study is to design a dashboard prototype for use in coproducing care in patients with JIA. We evaluated the use and needs of end users, obtained a consensus on the necessary dashboard data elements, and constructed display prototypes to inform meaningful discussions for coproduction. Methods: A human-centered design approach involving parents, patients, clinicians, and care team members was used to develop a dashboard to support the coproduction of care in 4 ambulatory pediatric rheumatology clinics. We engaged a multidisciplinary team (n=18) of patients, parents, clinicians, nurses, and staff during an in-person kick-off meeting followed by biweekly meetings. We also leveraged advisory panels. Teams mapped workflows and patient journeys, created personas, and developed dashboard sketches. The final dashboard components were determined via Delphi consensus voting. Low-tech dashboard testing was completed during clinic visits, and visual display prototypes were iterated by using the Plan-Do-Study-Act methodology. Patients and clinicians were surveyed regarding their experiences. Results: Teams achieved consensus on what data mattered most at the point of care to support patients with JIA, families, and clinicians collaborating to make the best possible health care decisions. Notable themes included the right data in the right place at the right time, data in once for multiple purposes, patient and family self-management components, and the opportunity for education and increased transparency. A final set of 11 dashboard data elements was identified, including patient-reported outcomes, clinical data, and medications. Important design considerations featured the incorporation of real-time data, clearly labeled graphs, and vertical orientation to facilitate review and discussion. Prototype paper-testing with 36 patients and families yielded positive feedback, with 89\% (8/9) to 100\% (9/9) of parents (n=9) and 80\% (8/10) to 90\% (9/10) of clinicians (n=10) strongly agreeing or agreeing that the dashboard was useful during clinic discussions, helped to talk about what mattered most, and informed health care decision-making. Conclusions: We developed a dashboard prototype that displays patient-reported and clinical data over time, along with medications that can be used during a clinic visit to support meaningful conversations and shared decision-making among patients with JIA, their families, and their clinicians and care teams. ", doi="10.2196/34735", url="https://jopm.jmir.org/2022/1/e34735", url="http://www.ncbi.nlm.nih.gov/pubmed/35133283" } @Article{info:doi/10.2196/32825, author="McBeth, John and Dixon, G. William and Moore, Mary Susan and Hellman, Bruce and James, Ben and Kyle, D. Simon and Lunt, Mark and Cordingley, Lis and Yimer, Birlie Belay and Druce, L. Katie", title="Sleep Disturbance and Quality of Life in Rheumatoid Arthritis: Prospective mHealth Study", journal="J Med Internet Res", year="2022", month="Apr", day="22", volume="24", number="4", pages="e32825", keywords="mobile health", keywords="sleep", keywords="rheumatoid arthritis", keywords="pain", keywords="fatigue", keywords="mood", keywords="sleep disturbance", keywords="HRQoL", keywords="quality of life", keywords="health-related quality of life", keywords="QoL", keywords="sleep efficiency", keywords="WHOQoL-BREF", keywords="mobile phone", abstract="Background: Sleep disturbances and poor health-related quality of life (HRQoL) are common in people with rheumatoid arthritis (RA). Sleep disturbances, such as less total sleep time, more waking periods after sleep onset, and higher levels of nonrestorative sleep, may be a driver of HRQoL. However, understanding whether these sleep disturbances reduce HRQoL has, to date, been challenging because of the need to collect complex time-varying data at high resolution. Such data collection is now made possible by the widespread availability and use of mobile health (mHealth) technologies. Objective: This mHealth study aimed to test whether sleep disturbance (both absolute values and variability) causes poor HRQoL. Methods: The quality of life, sleep, and RA study was a prospective mHealth study of adults with RA. Participants completed a baseline questionnaire, wore a triaxial accelerometer for 30 days to objectively assess sleep, and provided daily reports via a smartphone app that assessed sleep (Consensus Sleep Diary), pain, fatigue, mood, and other symptoms. Participants completed the World Health Organization Quality of Life-Brief (WHOQoL-BREF) questionnaire every 10 days. Multilevel modeling tested the relationship between sleep variables and the WHOQoL-BREF domains (physical, psychological, environmental, and social). Results: Of the 268 recruited participants, 254 were included in the analysis. Across all WHOQoL-BREF domains, participants' scores were lower than the population average. Consensus Sleep Diary sleep parameters predicted the WHOQoL-BREF domain scores. For example, for each hour increase in the total time asleep physical domain scores increased by 1.11 points ($\beta$=1.11, 95\% CI 0.07-2.15) and social domain scores increased by 1.65 points. These associations were not explained by sociodemographic and lifestyle factors, disease activity, medication use, anxiety levels, sleep quality, or clinical sleep disorders. However, these changes were attenuated and no longer significant when pain, fatigue, and mood were included in the model. Increased variability in total time asleep was associated with poorer physical and psychological domain scores, independent of all covariates. There was no association between actigraphy-measured sleep and WHOQoL-BREF. Conclusions: Optimizing total sleep time, increasing sleep efficiency, decreasing sleep onset latency, and reducing variability in total sleep time could improve HRQoL in people with RA. ", doi="10.2196/32825", url="https://www.jmir.org/2022/4/e32825", url="http://www.ncbi.nlm.nih.gov/pubmed/35451978" } @Article{info:doi/10.2196/16430, author="Nugent, Lisa and Anthony Kouyate, Robin and Jackson, Shawna and Smith, Y. Meredith", title="Development of a Digital Health Intervention for Rheumatoid Arthritis Symptom Management in a Biotechnology Industry Context: Protocol for the Application of a Human-Centered Design Framework", journal="JMIR Res Protoc", year="2022", month="Mar", day="22", volume="11", number="3", pages="e16430", keywords="human-centered design", keywords="patient-reported outcomes", keywords="rheumatoid arthritis", keywords="digital journal", keywords="patient diaries", keywords="data visualization", keywords="mobile phone", abstract="Background: Involving chronically ill patients in the management of their health is widely recognized as a vital component of high-quality health care. However, to assume the role of informed participants, patients need both access to their health information and assistance in interpreting such data. Smartphone technology with SMS text messaging functionality offers a convenient and minimally demanding mechanism for providing such dual capabilities to patients. To date, a number of similar digital tools have been developed for use in various chronic and progressive disease conditions, including rheumatoid arthritis. Objective: This paper aims to describe the development of a research protocol that applies a human-centered design (HCD) approach to develop a mobile health (mHealth) intervention to support symptom management and treatment adherence for rheumatoid arthritis. Methods: To guide the development of the mHealth intervention for use within a commercial biotechnology context, we selected and applied an HCD framework consisting of three phases: understanding, ideation, and implementation. Results: Leveraging the framework, we mapped the key objectives and research questions to each phase and identified the HCD techniques and methods most suitable for addressing them. In addition, we identified the need to include a fourth phase, one that referred to postimplementation assessment, which would enable evaluation of patient engagement and intervention impact on symptom self-management. Conclusions: This paper presents a research protocol that applied an HCD framework to guide the development of an mHealth intervention within a commercial biotechnology context. This type of guidance is salient because commercial entities are becoming one of the leading producers of this type of intervention. However, the methodologies used and challenges faced from a research and development perspective are not well-represented in the published research literature to date. Our application of the HCD framework yielded important findings. Each phase of the HCD framework provided important guidance for increasing the likelihood that the final product would be understandable, acceptable, feasible, and engaging to use. Consistent with other researchers in the field of mHealth interventions, we identified the need to add a fourth phase to the HCD framework, one that focused on a postimplementation assessment to guide further improvements to support adoption in real-world settings. International Registered Report Identifier (IRRID): RR1-10.2196/16430 ", doi="10.2196/16430", url="https://www.researchprotocols.org/2022/3/e16430", url="http://www.ncbi.nlm.nih.gov/pubmed/35315784" } @Article{info:doi/10.2196/30829, author="Rothmann, Juel Mette and Mouritsen, Drotner Julie and Ladefoged, Skov Nanna and Jeppesen, Nedergaard Marie and Lillevang, Sofie Anna and Laustrup, Helle and Ellingsen, Torkell", title="The Use of Telehealth for Psychological Counselling of Vulnerable Adult Patients With Rheumatic Diseases or Diabetes: Explorative Study Inspired by Participatory Design", journal="JMIR Hum Factors", year="2022", month="Mar", day="21", volume="9", number="1", pages="e30829", keywords="telehealth", keywords="videoconferencing", keywords="app", keywords="co-production", keywords="co-creation", keywords="psychologist", keywords="psychology", keywords="rheumatic diseases", keywords="diabetes", keywords="mobile phone", abstract="Background: Video consultation is increasingly used in different health care settings to reach patients. However, little is known about telehealth in psychological counselling for vulnerable patients with somatic and chronic conditions such as rheumatoid arthritis and diabetes. Objective: This study aimed to develop and pilot test a telepsychology module for inclusion in the app My Hospital (Mit Sygehus) to provide remote psychological counselling to vulnerable adults with either rheumatic diseases or diabetes. Methods: With inspiration from participatory design, the content of the telepsychology module was developed through user involvement and evaluated by individual interviews with patients and psychologists as well as questionnaires. Results: We developed a module with our patient partners that targeted patients with rheumatic diseases and diabetes in relation to the psychological challenges of living with chronic diseases. The module included information, tools, exercises, and videoconferencing. In total, 16 patients and 3 psychologists participated in the pilot test. Psychological counselling was described by 4 themes: ``The good relation despite physical distance,'' ``The comfort of being at home,'' ``The pros of saving time on transport and energy,'' and ``A therapeutic alliance at a distance.'' Conclusions: Psychological counselling in relation to somatic care can be provided by videoconferencing supported by web-based or mobile delivery of tailored information, tools, and exercises without compromising on the quality of care. To ensure a good alliance between the patient and psychologist, a first face-to-face meeting is important. The home location provided patients with a safe environment and increased accessibility and reduced travel time to the hospital. ", doi="10.2196/30829", url="https://humanfactors.jmir.org/2022/1/e30829", url="http://www.ncbi.nlm.nih.gov/pubmed/35311690" } @Article{info:doi/10.2196/31016, author="Romero-Jimenez, Rosa and Escudero-Vilaplana, Vicente and Chamorro-De-Vega, Esther and Ais-Larisgoitia, Arantza and Lobato Matilla, Elena Maria and Herranz-Alonso, Ana and Sanjurjo, Maria", title="The Characteristics and Functionalities of Mobile Apps Aimed at Patients Diagnosed With Immune-Mediated Inflammatory Diseases: Systematic App Search", journal="J Med Internet Res", year="2022", month="Mar", day="4", volume="24", number="3", pages="e31016", keywords="immune-mediated inflammatory disease", keywords="mobile app", keywords="mHealth", keywords="mobile health", keywords="chronic disease", keywords="disease management", keywords="outcomes", keywords="functionality", keywords="quality", keywords="patient education", keywords="health outcomes", keywords="reliability", abstract="Background: Immune-mediated inflammatory diseases (IMIDs) are systemic conditions associated with a high social and health impact. New treatments have changed the prognosis of IMIDs and have increased patient autonomy in disease management. Mobile apps have enormous potential to improve health outcomes in patients with IMIDs. Although a large number of IMID apps are available, the app market is not regulated, and functionality and reliability remain uncertain. Objective: Our aims are to review available apps for patients with IMIDs or caregivers and to describe the main characteristics and functionalities of these apps. Methods: We performed an observational, cross-sectional, descriptive study of all apps for patients with IMIDs. Between April 5 and 14, 2021, we conducted a search of the App Store (iOS) and Play Store (Android) platforms. We used the names of the different IMIDs as search terms. The inclusion criteria were as follows: content related to IMIDs, English or Spanish language, and user population consisting of patients and health care consumers, including family and caregivers. The variables analyzed were as follows: app name, type of IMID, platform (Android or iOS), country of origin, language, category of the app, cost, date of the last update, size, downloads, author affiliation, and functionalities. Results: We identified 713 apps in the initial search, and 243 apps met the criteria and were analyzed. Of these, 37\% (n=90) were on Android, 27.2\% (n=66) on iOS, and 35.8\% (n=87) on both platforms. The most frequent categories were health and well-being/fitness apps (n=188, 48.5\%) and medicine (n=82, 37.9\%). A total of 211 (82.3\%) apps were free. The mean time between the date of the analysis and the date of the most recent update was 18.5 (SD 19.3) months. Health care professionals were involved in the development of 100 (41.1\%) apps. We found differences between Android and iOS in the mean time since the last update (16.2, SD 14.7 months vs 30.3, SD 25.7 months) and free apps (85.6\% vs 75.8\%; respectively). The functionalities were as follows: general information about lifestyles, nutrition, or exercises (n=135, 55.6\%); specific information about the disease or treatment (n=102, 42\%); recording of symptoms or adverse events (n=51, 21\%); agenda/calendar (n=44, 18.1\%); reminder medication (n=41, 16.9\%); and recording of patient-reported outcomes (n=41, 16.9\%). A total of 147 (60.5\%) apps had more than one functionality. Conclusions: IMID-related apps are heterogeneous in terms of functionality and reliability. Apps may be a useful complement to IMID care, especially inpatient education (their most frequent functionality). However, more than half of the IMID apps had not been developed by health care professionals or updated in the last year. ", doi="10.2196/31016", url="https://www.jmir.org/2022/3/e31016", url="http://www.ncbi.nlm.nih.gov/pubmed/35254286" } @Article{info:doi/10.2196/33941, author="Wakamiya, Shoko and Morimoto, Osamu and Omichi, Katsuhiro and Hara, Hideyuki and Kawase, Ichiro and Koshiba, Ryuji and Aramaki, Eiji", title="Exploring Relationships Between Tweet Numbers and Over-the-counter Drug Sales for Allergic Rhinitis: Retrospective Analysis", journal="JMIR Form Res", year="2022", month="Feb", day="2", volume="6", number="2", pages="e33941", keywords="infoveillance", keywords="social media", keywords="Twitter", keywords="over-the-counter drugs", keywords="allergic rhinitis", keywords="hay fever", keywords="drug", keywords="treatment", keywords="allergy", keywords="immunology", keywords="surveillance", keywords="monitoring", keywords="prevalence", keywords="motivation", keywords="Japan", keywords="symptom", abstract="Background: Health-related social media data are increasingly being used in disease surveillance studies. In particular, surveillance of infectious diseases such as influenza has demonstrated high correlations between the number of social media posts mentioning the disease and the number of patients who went to the hospital and were diagnosed with the disease. However, the prevalence of some diseases, such as allergic rhinitis, cannot be estimated based on the number of patients alone. Specifically, individuals with allergic rhinitis typically self-medicate by taking over-the-counter (OTC) medications without going to the hospital. Although allergic rhinitis is not a life-threatening disease, it represents a major social problem because it reduces people's quality of life, making it essential to understand its prevalence and people's motives for self-medication behavior. Objective: This study aims to explore the relationship between the number of social media posts mentioning the main symptoms of allergic rhinitis and the sales volume of OTC rhinitis medications in Japan. Methods: We collected tweets over 4 years (from 2017 to 2020) that included keywords corresponding to the main nasal symptoms of allergic rhinitis: ``sneezing,'' ``runny nose,'' and ``stuffy nose.'' We also obtained the sales volume of OTC drugs, including oral medications and nasal sprays, for the same period. We then calculated the Pearson correlation coefficient between time series data on the number of tweets per week and time series data on the sales volume of OTC drugs per week. Results: The results showed a much higher correlation (r=0.8432) between the time series data on the number of tweets mentioning ``stuffy nose'' and the time series data on the sales volume of nasal sprays than for the other two symptoms. There was also a high correlation (r=0.9317) between the seasonal components of these time series data. Conclusions: We investigated the relationships between social media data and behavioral patterns, such as OTC drug sales volume. Exploring these relationships can help us understand the prevalence of allergic rhinitis and the motives for self-care treatment using social media data, which would be useful as a marketing indicator to reduce the number of out-of-stocks in stores, provide (sell) rhinitis medicines to consumers in a stable manner, and reduce the loss of sales opportunities. In the future, in-depth investigations are required to estimate sales volume using social media data, and future research could investigate other diseases and countries. ", doi="10.2196/33941", url="https://formative.jmir.org/2022/2/e33941", url="http://www.ncbi.nlm.nih.gov/pubmed/35107434" } @Article{info:doi/10.2196/29892, author="Ietto, Giuseppe and Mortara, Lorenzo and Dalla Gasperina, Daniela and Iovino, Domenico and Azzi, Lorenzo and Baj, Andreina and Ageno, Walter and Genoni, Paolo Angelo and Acquati, Francesco and Gallazzi, Matteo and Spina, Giorgia and Coco, Grace and Pierin, Federica and Noonan, Douglas and Vigezzi, Andrea and Monti, Elisa and Iori, Valentina and Masci, Federica and Franchi, Caterina and Di Saverio, Salomone and Carcano, Giulio", title="Immune-Mediated Mechanisms in Patients Testing Positive for SARS-CoV-2: Protocol for a Multianalysis Study", journal="JMIR Res Protoc", year="2022", month="Jan", day="25", volume="11", number="1", pages="e29892", keywords="SARS-CoV-2", keywords="COVID-19", keywords="immunomodulation", keywords="severe acute respiratory syndrome", keywords="mechanism", keywords="phenotype", keywords="immunology", keywords="white blood cell", keywords="immune system", keywords="monocyte", keywords="natural killer cell", keywords="blood", keywords="infectious disease", keywords="immune response", keywords="antigen", keywords="vaccine", keywords="immunity", keywords="protection", keywords="genetics", keywords="epidemiology", abstract="Background: The novel coronavirus has a high mortality rate (over 1\% for patients older than 50 years). This can only be partially ascribed to other comorbidities. A possible explanation is a factor that assures a prompt response to SARS-CoV-2 in younger people, independent from the novelty of the virus itself. A factor is believed to stimulate the immune system and provide immunity against more antigens. The only external stimulation received by healthy people is vaccination (eg, the diphtheria, tetanus, and pertussis [DTP] vaccine). One hypothesis is that vaccination helps develop specific immunity but generates sprouting immunity against antigens in transit. The underlying immunological phenomena are the ``bystander effect'' and ``trained immunity.'' The developed immunity gives protection for years until it naturally fades out. After the fifth decade of life, the immune system is almost incompetent when a viral infection occurs, and thus, at this stage, the novel coronavirus can enter the body and cause acute respiratory distress syndrome. Objective: The initial aim is to demonstrate that blood monocytes and natural killer cells show overpowering hyperactivity, while CD4+ and CD8+ T cells experience impediments to their defensive functions in patients with severe SARS-CoV-2 infection. The secondary objectives are to correlate clinical data and vaccination history with laboratory immune patterns in order to identify protective factors. Subsequently, we are also interested in characterizing the phenotypes and state of the degree of activation of peripheral blood mononuclear cells, including monocytes, natural killer cells, and CD4+ and CD8+ T cells, in healthy subjects vaccinated with the Pfizer vaccine. Methods: Data will be collected using the following 3 approaches: (1) an experimental analysis to study the innate immune response and to identify genetic profiles; (2) an epidemiological analysis to identify the patients' vaccination history; and (3) a clinical analysis to detect the immunological profile. Results: The protocol was approved by the Ethics Committee on April 16, 2020, and the study started on April 27, 2020. As of February 2021, enrollment has been completed. Immunological analysis is ongoing, and we expect to complete this analysis by December 2022. Conclusions: We will recognize different populations of patients, each one with a specific immunological pattern in terms of cytokines, soluble factor serum levels, and immune cell activity. Anamnestic data, such as preceding vaccinations and comorbidities, biochemical findings like lymphocyte immunophenotyping, and pre-existing persistent cytomegalovirus infection, allow depicting the risk profile of severe COVID-19. Proof of the roles of these immunological phenomena in the development of COVID-19 can be the basis for the implementation of therapeutic immunomodulatory treatments. Trial Registration: ClinicalTrials.gov NCT04375176; https://clinicaltrials.gov/ct2/show/NCT04375176 International Registered Report Identifier (IRRID): DERR1-10.2196/29892 ", doi="10.2196/29892", url="https://www.researchprotocols.org/2022/1/e29892", url="http://www.ncbi.nlm.nih.gov/pubmed/34854818" } @Article{info:doi/10.2196/29703, author="Wang, Yiwen and Liu, Xingkang and Wang, Weimin and Shi, Yanyun and Ji, Xiaojian and Hu, Lidong and Wang, Lei and Yin, Yiquan and Xie, Siyuan and Zhu, Jian and Zhang, Jianglin and Jiao, Wei and Huang, Feng", title="Adherence, Efficacy, and Safety of Wearable Technology--Assisted Combined Home-Based Exercise in Chinese Patients With Ankylosing Spondylitis: Randomized Pilot Controlled Clinical Trial", journal="J Med Internet Res", year="2022", month="Jan", day="18", volume="24", number="1", pages="e29703", keywords="ankylosing spondylitis", keywords="wearable technology", keywords="home-based exercise", keywords="combined exercise", keywords="randomized controlled trial", keywords="RCT", keywords="exercise", keywords="wearable", keywords="photoplethysmography", keywords="spondyloarthritis", abstract="Background: Clinical practice guidelines recommend that exercise is essential in the self-management of ankylosing spondylitis (AS). Attending supervised interventions requiring periodic medical center visits can be difficult and patients may decline participation, whereas effective home-based exercise interventions that do not require regular medical center visits are likely to be more accessible for AS patients. Objective: The goal of the research was to investigate the adherence, efficacy, and safety of a wearable technology--assisted combined home-based exercise program in AS. Methods: This was a 16-week investigator-initiated, assessor-blinded, randomized, pilot controlled trial conducted at Chinese People's Liberation Army General Hospital. We enrolled patients with AS who had no regular exercise habits and had been stable in drug treatment for the preceding month. Patients were randomly assigned (1:1) using a computer algorithm. An exercise program consisting of moderate-intensity aerobic exercise and functional exercise was given to the patients in the intervention group. The exercise intensity was controlled by a Mio FUSE Heart Rate Monitor wristband, which uses photoplethysmography to measure heart rate. Patients in the control group received usual care. The primary outcome was the difference in the Ankylosing Spondylitis Disease Activity Score (ASDAS). The secondary outcomes were patient global assessment (PGA), physician global assessment (PhGA), total pain, nocturnal pain, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), BAS Functional Index (BASFI), BAS Metrology Index (BASMI), Spondyloarthritis International Society Health Index (ASAS HI), 36-item Short Form Survey (SF-36), maximal oxygen uptake (VO2) max, body composition, range of motion of joints, and muscle endurance tests. Retention rate, adherence rate, barriers to being active, and adverse events were also assessed. Results: A total of 77 patients were screened, of whom 55 (71\%) patients were enrolled; 2\% (1/55) withdrew without treatment after randomization. Patients were assigned to the intervention (n=26) or control group (n=28). The median adherence rate of the prescribed exercise protocol was 84.2\% (IQR 48.7\%-97.9\%). For the primary outcome, between-group difference of ASDAS was significant, favoring the intervention (--0.2, 95\% CI --0.4 to 0.02, P=.03). For the secondary outcomes, significant between-group differences at 16 weeks were detected in PGA, PhGA, total pain, BASDAI, BASDAI-fatigue, BASDAI--spinal pain, BASDAI--morning stiffness intensity, BASFI, and BASMI. Moreover, the frequency of difficulty in ASAS HI-motivation at 16 weeks was less in the intervention group (P=.03). Between-group difference for change from baseline were also detected in VO2 max, SF-36, back extensor endurance test, and the range of motion of cervical lateral flexion at 16 weeks. Lack of time, energy, and willpower were the most distinct barriers to being active. Incidences of adverse events were similar between groups (P=.11). Conclusions: Our pilot study suggests that this technology-assisted combined home-based exercise program can improve the clinical outcomes of patients with AS who have no exercise habit, with good adherence and safety profile. Trial Registration: Chinese Clinical Trial Registry ChiCTR1900024244; http://www.chictr.org.cn/showproj.aspx?proj=40176 ", doi="10.2196/29703", url="https://www.jmir.org/2022/1/e29703", url="http://www.ncbi.nlm.nih.gov/pubmed/35040798" } @Article{info:doi/10.2196/22122, author="Mart{\'i}nez Silvagnoli, Leia and Shepherd, Caroline and Pritchett, James and Gardner, Jason", title="Optimizing Readability and Format of Plain Language Summaries for Medical Research Articles: Cross-sectional Survey Study", journal="J Med Internet Res", year="2022", month="Jan", day="11", volume="24", number="1", pages="e22122", keywords="biomedical research", keywords="health literacy", keywords="multiple sclerosis", keywords="plain language summary", keywords="psoriasis", keywords="rheumatoid arthritis", abstract="Background: Plain language summaries (PLSs) are intended to provide readers with a clear, nontechnical, and easily understandable overview of medical and scientific literature; however, audience preferences for specific PLS formats have yet to be fully explored. Objective: This study aims to evaluate the preferred readability level and format for PLSs of medical research articles of different disease states via a web-based survey of audiences of different age groups. Methods: Articles describing phase III clinical trials published in top-level, peer-reviewed journals between May 2016 and May 2018 were identified for 3 chronic disease states representing a range of adult patient age groups: (1) psoriasis, a skin disease representative of younger patients; (2) multiple sclerosis (MS), a neurological disease representative of middle-aged patients; and (3) rheumatoid arthritis (RA), a painful joint disease representative of older patients. Four PLSs were developed for each research article, of which 3 were text-only summaries (written with high, medium, and low complexity) and 1 was an infographic. To evaluate each of the 4 PLS formats, a 20-question open survey (specific to one of the 3 diseases) was sent to a representative sample selected via UK-based patient association websites, Twitter, and Facebook patient groups. A weighted-average calculation was applied to respondents' ranked preferences for each PLS format. Results: For all 3 articles, the weighted-average preference scores showed that infographic (psoriasis 2.91, MS 2.71, and RA 2.78) and medium-complexity text-based PLS (reading age 14-17 years, US Grade 9-11; psoriasis 2.90; MS 2.47; RA 2.77) were the two most preferred PLS formats. Conclusions: Audience preferences should be accounted for when preparing PLSs to accompany peer-reviewed original research articles. Oversimplified text can be viewed negatively, and graphical summaries or medium-complexity text-based summaries appear to be the most popular. Plain Language Summary: Patients and caregivers should have the chance to read about medical research in a format they can understand. However, we do not know much about the formats that people with different illnesses or ages prefer. Researchers wanted to find out more about this. They selected 3 medical articles about illnesses that affect different age groups: psoriasis (younger patients), multiple sclerosis (middle-aged patients), and rheumatoid arthritis (older patients). They created 4 summaries of each article. One was a graphical summary, and the other 3 were words-only summaries of high, medium, and low complexity. Then, the researchers posted surveys on UK patient group websites and Facebook patient groups to ask people what they thought of the summaries. The surveys were taken by 167 people. These people were patients with psoriasis, multiple sclerosis, or rheumatoid arthritis, or their caregivers. Most were women, and about half had a university degree. For each illness, most people preferred the graphical summary. Among the word-only summaries, most people preferred the medium-complexity wording written for a reading age of 14 to 17 years. People felt that the graphical and medium-complexity summaries were clear and concise, while the others used jargon or were too simple. Authors of medical articles should remember these results when writing summaries for patients. More research is needed about the preferences of other people, such as those with other illnesses. (See Multimedia Appendix 1 for the graphical summary of the plain language summary.) ", doi="10.2196/22122", url="https://www.jmir.org/2022/1/e22122", url="http://www.ncbi.nlm.nih.gov/pubmed/35014966" } @Article{info:doi/10.2196/24931, author="Lairez, Olivier and Blanchard, Virginie and Balardy, Laurent and Vardon-Bounes, Fanny and Cazalbou, St{\'e}phanie and Ruiz, St{\'e}phanie and Collot, Samia and Houard, Val{\'e}rie and Rolland, Yves and Conil, Jean-Marie and Minville, Vincent", title="COCARDE Study--Cardiac Imaging Phenotype in Patients With COVID-19: Protocol for a Prospective Observational Study", journal="JMIR Res Protoc", year="2022", month="Jan", day="6", volume="11", number="1", pages="e24931", keywords="COVID-19", keywords="SARS-CoV-2", keywords="cardiac imaging", keywords="echocardiography", keywords="cardiac MRI", keywords="hyperinflammation", keywords="inflammation", abstract="Background: The effects of SARS-CoV-2 (COVID-19) on the myocardium and their role in the clinical course of infected patients are still unknown. The severity of SARS-CoV-2 is driven by hyperinflammation, and the effects of SARS-CoV-2 on the myocardium may be significant. This study proposes to use bedside observations and biomarkers to characterize the association of COVID-19 with myocardial injury. Objective: The aim of the study is to describe the myocardial function and its evolution over time in patients infected with SARS-CoV-2 and to investigate the link between inflammation and cardiac injury. Methods: This prospective, monocentric, observational study enrolled 150 patients with suspected or confirmed SARS-CoV-2 infection at Toulouse University Hospital, Toulouse, France. Patients admitted to the intensive care unit (ICU), regular cardiologic ward, and geriatric ward of our tertiary university hospital were included during the pandemic period. Blood sampling, electrocardiography, echocardiography, and morphometric and demographic data were prospectively collected. Results: A total of 100 patients were included. The final enrolment day was March 31, 2020, with first report of results at the end of the first quarter of 2021. The first echocardiographic results at admission of 31 patients of the COCARDE-ICU substudy population show that biological myocardial injury in COVID-19 has low functional impact on left ventricular systolic function. Conclusions: A better understanding of the effects of COVID-19 on myocardial function and its link with inflammation would improve patient follow-up and care. Trial Registration: Clinicaltrials.gov NCT04358952; https://clinicaltrials.gov/ct2/show/NCT04358952 International Registered Report Identifier (IRRID): DERR1-10.2196/24931 ", doi="10.2196/24931", url="https://www.researchprotocols.org/2022/1/e24931", url="http://www.ncbi.nlm.nih.gov/pubmed/34751159" } @Article{info:doi/10.2196/32635, author="Kumar, Bharat and Zetumer, Samuel and Swee, Melissa and Endelman, Keyser Ellen L. and Suneja, Manish and Davis, Benjamin", title="Reducing Delays in Diagnosing Primary Immunodeficiency Through the Development and Implementation of a Clinical Decision Support Tool: Protocol for a Quality Improvement Project", journal="JMIR Res Protoc", year="2022", month="Jan", day="4", volume="11", number="1", pages="e32635", keywords="immunology", keywords="clinical decision support", keywords="diagnostic decision-making", abstract="Background: Primary immunodeficiencies (PIs) are a set of heterogeneous chronic disorders characterized by immune dysfunction. They are diagnostically challenging because of their clinical heterogeneity, knowledge gaps among primary care physicians, and continuing shortages of clinically trained immunologists. As a result, patients with undiagnosed PIs are at increased risk for recurrent infections, cancers, and autoimmune diseases. Objective: The aim of this research is to develop and implement a clinical decision support (CDS) tool for the identification of underlying PIs. Methods: We will develop and implement a CDS tool for the identification of underlying PIs among patients who receive primary care through a health care provider at the University of Iowa Hospitals and Clinics. The CDS tool will function through an algorithm that is based on the Immune Deficiency Foundation's 10 Warning Signs for Primary Immunodeficiency. Over the course of a year, we will use Lean Six Sigma principles and the Define, Measure, Analyze, Improve, and Control (DMAIC) framework to guide the project. The primary measure is the number of newly diagnosed PI patients per month. Secondary measures include the following: (1) the number of new patients identified by the CDS as being at high risk for PI, (2) the number of new PI cases in which immunoglobulin replacement or rotating antibiotics are started, (3) the cost of evaluation of each patient identified by the CDS tool as being at high risk for PIs, (4) the number of new consults not diagnosed with a PI, and (5) patient satisfaction with the process of referral to the Immunology Clinic. Results: This study was determined to not be Human Subjects Research by the Institutional Review Board at the University of Iowa. Data collection will begin in August 2021. Conclusions: The development and implementation of a CDS tool is a promising approach to identifying patients with underlying PI. This protocol assesses whether such an approach will be able to achieve its objective of reducing diagnostic delays. The disciplined approach, using Lean Six Sigma and the DMAIC framework, will guide implementation to maximize opportunities for a successful intervention that meets the study's goals and objectives as well as to allow for replication and adaptation of these methods at other sites. International Registered Report Identifier (IRRID): PRR1-10.2196/32635 ", doi="10.2196/32635", url="https://www.researchprotocols.org/2022/1/e32635", url="http://www.ncbi.nlm.nih.gov/pubmed/34587114" } @Article{info:doi/10.2196/23359, author="Carlin, Thomas and Soulard, Julie and Aubourg, Timoth{\'e}e and Knitza, Johannes and Vuillerme, Nicolas", title="Objective Measurements of Physical Activity and Sedentary Behavior Using Wearable Devices in Patients With Axial Spondyloarthritis: Protocol for a Systematic Review", journal="JMIR Res Protoc", year="2021", month="Nov", day="25", volume="10", number="11", pages="e23359", keywords="axial spondyloarthritis", keywords="rheumatology", keywords="physical activity", keywords="sedentary behavior", keywords="objective measures", keywords="wearable", keywords="systematic review", abstract="Background: Axial spondyloarthritis (axSpA) is a subgroup of inflammatory rheumatic diseases. Practicing regular exercise is critical to manage pain and stiffness, reduce disease activity, and improve physical functioning, spinal mobility, and cardiorespiratory function. Accordingly, monitoring physical activity and sedentary behavior in patients with axSpA is relevant for clinical outcomes and disease management. Objective: This review aims to determine which wearable devices, assessment methods, and associated metrics are commonly used to quantify physical activity or sedentary behavior in patients with axSpA. Methods: The PubMed, Physiotherapy Evidence Database (PEDro), and Cochrane electronic databases will be searched, with no limit on publication date, to identify all the studies matching the inclusion criteria. Only original English-language articles published in a peer-reviewed journal will be included. The search strategy will include a combination of keywords related to the study population, wearable devices, physical activity, and sedentary behavior. We will use the Boolean operators ``AND'' and ``OR'' to combine keywords as well as Medical Subject Headings terms. Results: Search strategy was completed in June 2020 with 23 records obtained. Data extraction and synthesis are currently ongoing. Dissemination of study results in peer-reviewed journals is expected at the end of 2021. Conclusions: This review will provide a comprehensive and detailed synthesis of published studies that examine the use of wearable devices for objective assessment of physical activity and sedentary behavior in patients with axSpA. Trial Registration: PROSPERO CRD42020182398; https://www.crd.york.ac.uk/prospero/display\_record.php?RecordID=182398 International Registered Report Identifier (IRRID): PRR1-10.2196/23359 ", doi="10.2196/23359", url="https://www.researchprotocols.org/2021/11/e23359", url="http://www.ncbi.nlm.nih.gov/pubmed/34842559" } @Article{info:doi/10.2196/32285, author="Polosa, Riccardo and Tomaselli, Venera and Ferrara, Pietro and Romeo, Corina Alba and Rust, Sonja and Saitta, Daniela and Caraci, Filippo and Romano, Corrado and Thangaraju, Murugesan and Zuccarello, Pietro and Rose, Jed and Cantone, Giacomo Giulio and Ferrante, Margherita and Belsey, Jonathan and Cibella, Fabio and Interlandi, Elisa and Ferri, Raffaele", title="Seroepidemiological Survey on the Impact of Smoking on SARS-CoV-2 Infection and COVID-19 Outcomes: Protocol for the Troina Study", journal="JMIR Res Protoc", year="2021", month="Nov", day="22", volume="10", number="11", pages="e32285", keywords="antibody persistence", keywords="cotinine", keywords="COVID-19", keywords="SARS-CoV-2", keywords="seroprevalence", keywords="smoking impact", keywords="smoking status", abstract="Background: After the global spread of SARS-CoV-2, research has highlighted several aspects of the pandemic, focusing on clinical features and risk factors associated with infection and disease severity. However, emerging results on the role of smoking in SARS-CoV-2 infection susceptibility or COVID-19 outcomes are conflicting, and their robustness remains uncertain. Objective: In this context, this study aims at quantifying the proportion of SARS-CoV-2 antibody seroprevalence, studying the changes in antibody levels over time, and analyzing the association between the biochemically verified smoking status and SARS-CoV-2 infection. Methods: The research design involves a 6-month prospective cohort study with a serial sampling of the same individuals. Each participant will be surveyed about their demographics and COVID-19--related information, and blood sampling will be collected upon recruitment and at specified follow-up time points (ie, after 8 and 24 weeks). Blood samples will be screened for the presence of SARS-CoV-2--specific antibodies and serum cotinine, being the latter of the principal metabolite of nicotine, which will be used to assess participants' smoking status. Results: The study is ongoing. It aims to find a higher antibody prevalence in individuals at high risk for viral exposure (ie, health care personnel) and to refine current estimates on the association between smoking status and SARS-CoV-2/COVID-19. Conclusions: The added value of this research is that the current smoking status of the population to be studied will be biochemically verified to avoid the bias associated with self-reported smoking status. As such, the results from this survey may provide an actionable metric to study the role of smoking in SARS-CoV-2 infection and COVID-19 outcomes, and therefore to implement the most appropriate public health measures to control the pandemic. Results may also serve as a reference for future clinical research, and the methodology could be exploited in public health sectors and policies. International Registered Report Identifier (IRRID): DERR1-10.2196/32285 ", doi="10.2196/32285", url="https://www.researchprotocols.org/2021/11/e32285", url="http://www.ncbi.nlm.nih.gov/pubmed/34678752" } @Article{info:doi/10.2196/30079, author="Wang, Huan and Wu, Wei and Han, Chunxia and Zheng, Jiaqi and Cai, Xinyu and Chang, Shimin and Shi, Junlong and Xu, Nan and Ai, Zisheng", title="Prediction Model of Osteonecrosis of the Femoral Head After Femoral Neck Fracture: Machine Learning--Based Development and Validation Study", journal="JMIR Med Inform", year="2021", month="Nov", day="19", volume="9", number="11", pages="e30079", keywords="femoral neck fracture", keywords="osteonecrosis of the femoral head", keywords="machine learning", keywords="interpretability", abstract="Background: The absolute number of femoral neck fractures (FNFs) is increasing; however, the prediction of traumatic femoral head necrosis remains difficult. Machine learning algorithms have the potential to be superior to traditional prediction methods for the prediction of traumatic femoral head necrosis. Objective: The aim of this study is to use machine learning to construct a model for the analysis of risk factors and prediction of osteonecrosis of the femoral head (ONFH) in patients with FNF after internal fixation. Methods: We retrospectively collected preoperative, intraoperative, and postoperative clinical data of patients with FNF in 4 hospitals in Shanghai and followed up the patients for more than 2.5 years. A total of 259 patients with 43 variables were included in the study. The data were randomly divided into a training set (181/259, 69.8\%) and a validation set (78/259, 30.1\%). External data (n=376) were obtained from a retrospective cohort study of patients with FNF in 3 other hospitals. Least absolute shrinkage and selection operator regression and the support vector machine algorithm were used for variable selection. Logistic regression, random forest, support vector machine, and eXtreme Gradient Boosting (XGBoost) were used to develop the model on the training set. The validation set was used to tune the model hyperparameters to determine the final prediction model, and the external data were used to compare and evaluate the model performance. We compared the accuracy, discrimination, and calibration of the models to identify the best machine learning algorithm for predicting ONFH. Shapley additive explanations and local interpretable model-agnostic explanations were used to determine the interpretability of the black box model. Results: A total of 11 variables were selected for the models. The XGBoost model performed best on the validation set and external data. The accuracy, sensitivity, and area under the receiver operating characteristic curve of the model on the validation set were 0.987, 0.929, and 0.992, respectively. The accuracy, sensitivity, specificity, and area under the receiver operating characteristic curve of the model on the external data were 0.907, 0.807, 0.935, and 0.933, respectively, and the log-loss was 0.279. The calibration curve demonstrated good agreement between the predicted probability and actual risk. The interpretability of the features and individual predictions were realized using the Shapley additive explanations and local interpretable model-agnostic explanations algorithms. In addition, the XGBoost model was translated into a self-made web-based risk calculator to estimate an individual's probability of ONFH. Conclusions: Machine learning performs well in predicting ONFH after internal fixation of FNF. The 6-variable XGBoost model predicted the risk of ONFH well and had good generalization ability on the external data, which can be used for the clinical prediction of ONFH after internal fixation of FNF. ", doi="10.2196/30079", url="https://medinform.jmir.org/2021/11/e30079", url="http://www.ncbi.nlm.nih.gov/pubmed/34806984" } @Article{info:doi/10.2196/31647, author="van Hal, W. Tamara and Van den Reek, MPA Juul and Groenewoud, MM Hans and Pasch, C. Marcel and Van den Hoogen, HJ Frank and Wenink, H. Mark and De Jong, MGJ Elke", title="Discovery of Arthritis in Psoriasis Patients for Early Rheumatological Referral (DAPPER): Protocol for a Longitudinal Observational Study", journal="JMIR Res Protoc", year="2021", month="Nov", day="16", volume="10", number="11", pages="e31647", keywords="psoriasis", keywords="psoriatic arthritis", keywords="screening", abstract="Background: One in three patients with psoriasis will develop psoriatic arthritis (PsA). If left untreated, this can lead to pain, impaired function, and irreversible joint damage. Timely recognition and referral to a rheumatologist are therefore key. However, current methods used to screen patients with psoriasis for those who might benefit from referral to a rheumatologist are not performing well enough. Objective: The Discovery of Arthritis in Psoriasis Patients for Early Rheumatological Referral (DAPPER) study is designed to determine the prevalence of PsA in a psoriasis population and to find parameters that can be used to develop a new or enhance an existing instrument for a rheumatological referral. Methods: DAPPER is a longitudinal observational study with a 1-year follow-up. Patients with psoriasis (N=300) who are treated at an outpatient dermatological clinic will be screened extensively for signs and symptoms of PsA by a trained rheumatologist. If there is clinical suspicion of PsA and the patient is not yet treated by a rheumatologist, referral to the Department of Rheumatology will follow for confirmation of the diagnosis and further care. After 1 year, data on changes in quality of life and PsA and psoriasis disease activity will be collected from the referred patients. The screening visit will be used to gather demographical and medical data, which can later be used to develop the aforementioned screening instrument. Results: Inclusion started in June 2019 and finished in June 2021. Follow-up with newly discovered patients with PsA is ongoing. Conclusions: The DAPPER study is specifically designed to improve the detection of existing PsA in a dermatologic outpatient setting. Although internal validity will be tested, external validity will have to be checked using a second validation cohort. To predict the development of PsA in the future, longitudinal/prospective data collection is required and will be performed in a follow-up study (DAPPER-i). Trial Registration: Dutch Trial Register NTR7604; https://www.trialregister.nl/trial/7397 International Registered Report Identifier (IRRID): DERR1-10.2196/31647 ", doi="10.2196/31647", url="https://www.researchprotocols.org/2021/11/e31647", url="http://www.ncbi.nlm.nih.gov/pubmed/34783659" } @Article{info:doi/10.2196/31186, author="Hammam, Nevin and Izadi, Zara and Li, Jing and Evans, Michael and Kay, Julia and Shiboski, Stephen and Schmajuk, Gabriela and Yazdany, Jinoos", title="The Relationship Between Electronic Health Record System and Performance on Quality Measures in the American College of Rheumatology's Rheumatology Informatics System for Effectiveness (RISE) Registry: Observational Study", journal="JMIR Med Inform", year="2021", month="Nov", day="12", volume="9", number="11", pages="e31186", keywords="rheumatoid arthritis", keywords="electronic health record", keywords="patient-reported outcomes", keywords="quality measures", keywords="disease activity", keywords="quality of care", keywords="performance reporting", keywords="medical informatics", keywords="clinical informatics", abstract="Background: Routine collection of disease activity (DA) and patient-reported outcomes (PROs) in rheumatoid arthritis (RA) are nationally endorsed quality measures and critical components of a treat-to-target approach. However, little is known about the role electronic health record (EHR) systems play in facilitating performance on these measures. Objective: Using the American College Rheumatology's (ACR's) RISE registry, we analyzed the relationship between EHR system and performance on DA and functional status (FS) quality measures. Methods: We analyzed data collected in 2018 from practices enrolled in RISE. We assessed practice-level performance on quality measures that require DA and FS documentation. Multivariable linear regression and zero-inflated negative binomial models were used to examine the independent effect of EHR system on practice-level quality measure performance, adjusting for practice characteristics and patient case-mix. Results: In total, 220 included practices cared for 314,793 patients with RA. NextGen was the most commonly used EHR system (34.1\%). We found wide variation in performance on DA and FS quality measures by EHR system (median 30.1, IQR 0-74.8, and median 9.0, IQR 0-74.2), respectively). Even after adjustment, NextGen practices performed significantly better than Allscripts on the DA measure (51.4\% vs 5.0\%; P<.05) and significantly better than eClinicalWorks and eMDs on the FS measure (49.3\% vs 29.0\% and 10.9\%; P<.05). Conclusions: Performance on national RA quality measures was associated with the EHR system, even after adjusting for practice and patient characteristics. These findings suggest that future efforts to improve quality of care in RA should focus not only on provider performance reporting but also on developing and implementing rheumatology-specific standards across EHRs. ", doi="10.2196/31186", url="https://medinform.jmir.org/2021/11/e31186", url="http://www.ncbi.nlm.nih.gov/pubmed/34766910" } @Article{info:doi/10.2196/30197, author="Anderson, Jarett and Sivesind, Torunn", title="From the Cochrane Library: Skin Care Interventions in Infants for Preventing Eczema and Food Allergy", journal="JMIR Dermatol", year="2021", month="Sep", day="2", volume="4", number="2", pages="e30197", keywords="eczema", keywords="atopic dermatitis", keywords="skin care", keywords="emollients", keywords="pediatrics", keywords="food allergy", keywords="allergy", keywords="dermatology", doi="10.2196/30197", url="https://derma.jmir.org/2021/2/e30197", url="http://www.ncbi.nlm.nih.gov/pubmed/37632815" } @Article{info:doi/10.2196/26823, author="Barata, Carolina and Rodrigues, Maria Ana and Canh{\~a}o, Helena and Vinga, Susana and Carvalho, M. Alexandra", title="Predicting Biologic Therapy Outcome of Patients With Spondyloarthritis: Joint Models for Longitudinal and Survival Analysis", journal="JMIR Med Inform", year="2021", month="Jul", day="30", volume="9", number="7", pages="e26823", keywords="data mining", keywords="survival analysis", keywords="joint models", keywords="spondyloarthritis", keywords="drug survival", keywords="rheumatic disease", keywords="electronic medical records", keywords="medical records", abstract="Background: Rheumatic diseases are one of the most common chronic diseases worldwide. Among them, spondyloarthritis (SpA) is a group of highly debilitating diseases, with an early onset age, which significantly impacts patients' quality of life, health care systems, and society in general. Recent treatment options consist of using biologic therapies, and establishing the most beneficial option according to the patients' characteristics is a challenge that needs to be overcome. Meanwhile, the emerging availability of electronic medical records has made necessary the development of methods that can extract insightful information while handling all the challenges of dealing with complex, real-world data. Objective: The aim of this study was to achieve a better understanding of SpA patients' therapy responses and identify the predictors that affect them, thereby enabling the prognosis of therapy success or failure. Methods: A data mining approach based on joint models for the survival analysis of the biologic therapy failure is proposed, which considers the information of both baseline and time-varying variables extracted from the electronic medical records of SpA patients from the database, Reuma.pt. Results: Our results show that being a male, starting biologic therapy at an older age, having a larger time interval between disease start and initiation of the first biologic drug, and being human leukocyte antigen (HLA)--B27 positive are indicators of a good prognosis for the biological drug survival; meanwhile, having disease onset or biologic therapy initiation occur in more recent years, a larger number of education years, and higher values of C-reactive protein or Bath Ankylosing Spondylitis Functional Index (BASFI) at baseline are all predictors of a greater risk of failure of the first biologic therapy. Conclusions: Among this Portuguese subpopulation of SpA patients, those who were male, HLA-B27 positive, and with a later biologic therapy starting date or a larger time interval between disease start and initiation of the first biologic therapy showed longer therapy adherence. Joint models proved to be a valuable tool for the analysis of electronic medical records in the field of rheumatic diseases and may allow for the identification of potential predictors of biologic therapy failure. ", doi="10.2196/26823", url="https://medinform.jmir.org/2021/7/e26823", url="http://www.ncbi.nlm.nih.gov/pubmed/34328435" } @Article{info:doi/10.2196/28624, author="Fong, Gavin Wei Chern and Grevatt, Susan and Potter, Stephen and Tidbury, Tracey and Kadalayil, Latha and Bennett, Kaisha and Larsson, Maria and Nicolas, Fr{\'e}d{\'e}ric and Kurukulaaratchy, Ramesh and Arshad, Hasan Syed", title="The Efficacy of the Dyson Air Purifier in Improving Asthma Control: Protocol for a Single-Center, Investigator-Led, Randomized, Double-Blind, Placebo-Controlled Trial", journal="JMIR Res Protoc", year="2021", month="Jul", day="27", volume="10", number="7", pages="e28624", keywords="air purifier", keywords="asthma", keywords="clinical trial", keywords="air pollution", keywords="allergens", keywords="respiratory function tests", keywords="bronchial provocation tests", abstract="Background: Indoor air quality has been shown to influence asthma control and outcomes. Air purifiers and high-efficiency particulate air filtration devices can improve indoor air quality by reducing the indoor levels of air pollution and allergens. However, the influence of this improved indoor air quality on asthma control remains unclear; hence, randomized controlled trials are needed to further elucidate this phenomenon. Objective: This study aims to investigate the effect of reducing the levels of allergens and pollutants in the bedroom and living room through the use of Dyson air purifiers (Dyson Pure Cool) on asthma control. Methods: This is an 18-month long, investigator-led, randomized, double-blinded, placebo-controlled, single-center trial. Subjects will be randomized in a 1:1 ratio to active or placebo Dyson filters. The primary outcome is the change in the scores of Asthma Control Questionnaire 6 and Asthma-specific Quality of Life Questionnaire from baseline. Secondary outcomes include changes in lung function (forced expiratory volume in one second, forced expiratory volume in one second/forced vital capacity ratio, and midexpiratory flows), peak expiratory flow measurements, airway hyperresponsiveness (assessed by methacholine bronchial challenge), fractional exhaled nitric oxide, and indoor air pollutant levels. The sample size will be 50 subjects, and all subjects will have a confirmed diagnosis of mild persistent to moderate persistent asthma along with an Asthma Control Questionnaire 6 score of >1.5. Results: This study was approved by the West Midlands Research Ethics Committee (18/WM/0277). The study results will be published in peer-reviewed scientific journals; presented at relevant scientific conferences; and shared in plain English with participants in our newsletters, in our clinics, and via the David Hide Asthma and Allergy Research Centre website. Our trial began in September 2019 and is expected to end in August 2021. Conclusions: This is a double-blinded, placebo-controlled, randomized, investigator-led study to investigate the efficacy of a novel air purifier in improving asthma control in adults. The trial period of 18 months will facilitate the collection of robust data and will therefore generate clear signals. However, this extended trial duration may lead to patient withdrawal. Furthermore, this trial is conducted at a single center and in a location with a homogenous cohort of people, which may affect translatability. Nonetheless, it is hoped that the findings of this trial may help further inform clinicians regarding the utility of this novel device as an adjunct in asthma care. Trial Registration: ClinicalTrials.gov NCT04729530; https://clinicaltrials.gov/ct2/show/NCT04729530 International Registered Report Identifier (IRRID): DERR1-10.2196/28624 ", doi="10.2196/28624", url="https://www.researchprotocols.org/2021/7/e28624", url="http://www.ncbi.nlm.nih.gov/pubmed/34313599" } @Article{info:doi/10.2196/28164, author="Kleinert, Stefan and Bartz-Bazzanella, Peter and von der Decken, Cay and Knitza, Johannes and Witte, Torsten and Fekete, P. S{\'a}ndor and Konitzny, Matthias and Zink, Alexander and Gauler, Georg and Wurth, Patrick and Aries, Peer and Karberg, Kirsten and Kuhn, Christoph and Schuch, Florian and Sp{\"a}thling-Mestekemper, Susanna and Vorbr{\"u}ggen, Wolfgang and Englbrecht, Matthias and Welcker, Martin and ", title="A Real-World Rheumatology Registry and Research Consortium: The German RheumaDatenRhePort (RHADAR) Registry", journal="J Med Internet Res", year="2021", month="May", day="20", volume="23", number="5", pages="e28164", keywords="registry", keywords="rheumatology", keywords="real-world data", keywords="symptom checker", keywords="patient-reported outcomes", doi="10.2196/28164", url="https://www.jmir.org/2021/5/e28164", url="http://www.ncbi.nlm.nih.gov/pubmed/34014170" } @Article{info:doi/10.2196/15716, author="Bunyan, Alden and Venuturupalli, Swamy and Reuter, Katja", title="Expressed Symptoms and Attitudes Toward Using Twitter for Health Care Engagement Among Patients With Lupus on Social Media: Protocol for a Mixed Methods Study", journal="JMIR Res Protoc", year="2021", month="May", day="6", volume="10", number="5", pages="e15716", keywords="health promotion", keywords="infodemiology", keywords="infoveillance", keywords="Internet", keywords="listening", keywords="lupus", keywords="systematic lupus erythematosus", keywords="surveillance", keywords="Twitter", keywords="survey", keywords="social media", keywords="social network", abstract="Background: Lupus is a complex autoimmune disease that is difficult to diagnose and treat. It is estimated that at least 5 million Americans have lupus, with more than 16,000 new cases of lupus being reported annually in the United States. Social media provides a platform for patients to find rheumatologists and peers and build awareness of the condition. Researchers have suggested that the social network Twitter may serve as a rich avenue for exploring how patients communicate about their health issues. However, there is a lack of research about the characteristics of lupus patients on Twitter and their attitudes toward using Twitter for engaging them with their health care. Objective: This study has two objectives: (1) to conduct a content analysis of Twitter data published by users (in English) in the United States between September 1, 2017 and October 31, 2018 to identify patients who publicly discuss their lupus condition and to assess their expressed health themes and (2) to conduct a cross-sectional survey among these lupus patients on Twitter to study their attitudes toward using Twitter for engaging them with their health care. Methods: This is a mixed methods study that analyzes retrospective Twitter data and conducts a cross-sectional survey among lupus patients on Twitter. We used Symplur Signals, a health care social media analytics platform, to access the Twitter data and analyze user-generated posts that include keywords related to lupus. We will use descriptive statistics to analyze the data and identify the most prevalent topics in the Twitter content among lupus patients. We will further conduct self-report surveys via Twitter by inviting all identified lupus patients who discuss their lupus condition on Twitter. The goal of the survey is to collect data about the characteristics of lupus patients (eg, gender, race/ethnicity, educational level) and their attitudes toward using Twitter for engaging them with their health care. Results: This study has been funded by the National Center for Advancing Translational Science through a Clinical and Translational Science Award. The institutional review board at the University of Southern California (HS-19-00048) approved the study. Data extraction and cleaning are complete. We obtained 47,715 Twitter posts containing terms related to ``lupus'' from users in the United States published in English between September 1, 2017 and October 31, 2018. We included 40,885 posts in the analysis. Data analysis was completed in Fall 2020. Conclusions: The data obtained in this pilot study will shed light on whether Twitter provides a promising data source for garnering health-related attitudes among lupus patients. The data will also help to determine whether Twitter might serve as a potential outreach platform for raising awareness of lupus among patients and implementing related health education interventions. International Registered Report Identifier (IRRID): DERR1-10.2196/15716 ", doi="10.2196/15716", url="https://www.researchprotocols.org/2021/5/e15716", url="http://www.ncbi.nlm.nih.gov/pubmed/33955845" } @Article{info:doi/10.2196/25500, author="Peng, T. Henry and Rhind, G. Shawn and Beckett, Andrew", title="Convalescent Plasma for the Prevention and Treatment of COVID-19: A Systematic Review and Quantitative Analysis", journal="JMIR Public Health Surveill", year="2021", month="Apr", day="7", volume="7", number="4", pages="e25500", keywords="COVID-19", keywords="SARS-CoV-2", keywords="antibodies", keywords="convalescent plasma", keywords="immunotherapy", keywords="prevention", keywords="treatment", keywords="review", keywords="quantitative", keywords="therapeutic", keywords="immunology", keywords="research", keywords="literature", keywords="knowledge", keywords="recommendation", abstract="Background: The COVID-19 pandemic, caused by a novel coronavirus termed SARS-CoV-2, has spread quickly worldwide. Convalescent plasma (CP) obtained from patients following recovery from COVID-19 infection and development of antibodies against the virus is an attractive option for either prophylactic or therapeutic treatment, since antibodies may have direct or indirect antiviral activities and immunotherapy has proven effective in principle and in many clinical reports. Objective: We seek to characterize the latest advances and evidence in the use of CP for COVID-19 through a systematic review and quantitative analysis, identify knowledge gaps in this setting, and offer recommendations and directives for future research. Methods: PubMed, Web of Science, and Embase were continuously searched for studies assessing the use of CP for COVID-19, including clinical studies, commentaries, reviews, guidelines or protocols, and in vitro testing of CP antibodies. The screening process and data extraction were performed according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Quality appraisal of all clinical studies was conducted using a universal tool independent of study designs. A meta-analysis of case-control and randomized controlled trials (RCTs) was conducted using a random-effects model. Results: Substantial literature has been published covering various aspects of CP therapy for COVID-19. Of the references included in this review, a total of 243 eligible studies including 64 clinical studies, 79 commentary articles, 46 reviews, 19 guidance and protocols, and 35 in vitro testing of CP antibodies matched the criteria. Positive results have been mostly observed so far when using CP for the treatment of COVID-19. There were remarkable heterogeneities in the CP therapy with respect to patient demographics, donor antibody titers, and time and dose of CP administration. The studies assessing the safety of CP treatment reported low incidence of adverse events. Most clinical studies, in particular case reports and case series, had poor quality. Only 1 RCT was of high quality. Randomized and nonrandomized data were found in 2 and 11 studies, respectively, and were included for meta-analysis, suggesting that CP could reduce mortality and increase viral clearance. Despite promising pilot studies, the benefits of CP treatment can only be clearly established through carefully designed RCTs. Conclusions: There is developing support for CP therapy, particularly for patients who are critically ill or mechanically ventilated and resistant to antivirals and supportive care. These studies provide important lessons that should inform the planning of well-designed RCTs to generate more robust knowledge for the efficacy of CP in patients with COVID-19. Future research is necessary to fill the knowledge gap regarding prevention and treatment for patients with COVID-19 with CP while other therapeutics are being developed. ", doi="10.2196/25500", url="https://publichealth.jmir.org/2021/4/e25500", url="http://www.ncbi.nlm.nih.gov/pubmed/33825689" } @Article{info:doi/10.2196/22473, author="White, M. Katie and Ivan, Alina and Williams, Ruth and Galloway, B. James and Norton, Sam and Matcham, Faith", title="Remote Measurement in Rheumatoid Arthritis: Qualitative Analysis of Patient Perspectives", journal="JMIR Form Res", year="2021", month="Mar", day="9", volume="5", number="3", pages="e22473", keywords="rheumatoid arthritis", keywords="remote measurement technologies", keywords="symptom assessment", keywords="disease management", keywords="smartphone", keywords="qualitative research", keywords="mobile phone", abstract="Background: Rheumatoid arthritis (RA) is characterized by recurrent fluctuations in symptoms such as joint pain, swelling, and stiffness. Remote measurement technologies (RMTs) offer the opportunity to track symptoms continuously and in real time; therefore, they may provide a more accurate picture of RA disease activity as a complement to prescheduled general practitioner appointments. Previous research has shown patient interest in remote symptom tracking in RA and has provided evidence for its clinical validity. However, there is a lack of co-design in the current development of systems, and the features of RMTs that best promote optimal engagement remain unclear. Objective: This study represents the first in a series of work that aims to develop a multiparametric RMT system for symptom tracking in RA. The objective of this study is to determine the important outcomes for disease management in patients with RA and how these can be best captured via remote measurement. Methods: A total of 9 patients (aged 23-77 years; mean 55.78, SD 17.54) with RA were recruited from King's College Hospital to participate in two semistructured focus groups. Both focus group discussions were conducted by a facilitator and a lived-experience researcher. The sessions were recorded, transcribed, independently coded, and analyzed for themes. Results: Thematic analysis identified a total of four overarching themes: important symptoms and outcomes in RA, management of RA symptoms, views on the current health care system, and views on the use of RMTs in RA. Mobility and pain were key symptoms to consider for symptom tracking as well as symptom triggers. There is a general consensus that the ability to track fluctuations and transmit such data to clinicians would aid in individual symptom management and the effectiveness of clinical care. Suggestions for visually capturing symptom fluctuations in an app were proposed. Conclusions: The findings support previous work on the acceptability of RMT with RA disease management and address key outcomes for integration into a remote monitoring system for RA self-management and clinical care. Clear recommendations for RMT design are proposed. Future work will aim to take these recommendations into a user testing phase. ", doi="10.2196/22473", url="https://formative.jmir.org/2021/3/e22473", url="http://www.ncbi.nlm.nih.gov/pubmed/33687333" } @Article{info:doi/10.2196/24211, author="Kurizky, Patricia and N{\'o}brega, T. Ot{\'a}vio and Soares, Munhoz Alexandre Anderson De Sousa and Aires, Barbosa Rodrigo and Albuquerque, De Cleandro Pires and Nicola, Moraes Andr{\'e} and Albuquerque, Patr{\'i}cia and Teixeira-Carvalho, Andr{\'e}a and Naves, Ansaneli Luciana and Fontes, Wagner and Luz, Souza Isabelle and Felicori, Liza and Gomides, Monteiro Ana Paulo and Mendon{\c{c}}a-Silva, Lane Dayde and Espindola, Salmen Laila and Martins-Filho, Assis Olindo and de Lima, Barbosa Sheila Maria and Mota, Henrique Licia Maria and Gomes, Martins Ciro", title="Molecular and Cellular Biomarkers of COVID-19 Prognosis: Protocol for the Prospective Cohort TARGET Study", journal="JMIR Res Protoc", year="2021", month="Mar", day="4", volume="10", number="3", pages="e24211", keywords="COVID-19", keywords="TARGET", keywords="cytokine profile", keywords="neutrophil function", keywords="thromboelastometry", keywords="neutralizing antibodies", keywords="metabolomics", keywords="proteomics", keywords="biomarker", keywords="prognosis", keywords="design", keywords="cohort", keywords="virus", keywords="immunology", keywords="immune system", keywords="genetics", abstract="Background: Since the beginning of the COVID-19 pandemic, the world's attention has been focused on better understanding the relation between the human host and the SARS-CoV-2 virus, as its action has led to hundreds of thousands of deaths. Objective: In this context, we decided to study certain consequences of the abundant cytokine release over the innate and adaptive immune systems, inflammation, and hemostasis, comparing mild and severe forms of COVID-19. Methods: To accomplish these aims, we will analyze demographic characteristics, biochemical tests, immune biomarkers, leukocyte phenotyping, immunoglobulin profile, hormonal release (cortisol and prolactin), gene expression, thromboelastometry, neutralizing antibodies, metabolic profile, and neutrophil function (reactive oxygen species production, neutrophil extracellular trap production, phagocytosis, migration, gene expression, and proteomics). A total of 200 reverse transcription polymerase chain reaction--confirmed patients will be enrolled and divided into two groups: mild/moderate or severe/critical forms of COVID-19. Blood samples will be collected at different times: at inclusion and after 9 and 18 days, with an additional 3-day sample for severe patients. We believe that this information will provide more knowledge for future studies that will provide more robust and useful clinical information that may allow for better decisions at the front lines of health care. Results: The recruitment began in June 2020 and is still in progress. It is expected to continue until February 2021. Data analysis is scheduled to start after all data have been collected. The coagulation study branch is complete and is already in the analysis phase. Conclusions: This study is original in terms of the different parameters analyzed in the same sample of patients with COVID-19. The project, which is currently in the data collection phase, was approved by the Brazilian Committee of Ethics in Human Research (CAAE 30846920.7.0000.0008). Trial Registration: Brazilian Registry of Clinical Trials RBR-62zdkk; https://ensaiosclinicos.gov.br/rg/RBR-62zdkk International Registered Report Identifier (IRRID): DERR1-10.2196/24211 ", doi="10.2196/24211", url="https://www.researchprotocols.org/2021/3/e24211", url="http://www.ncbi.nlm.nih.gov/pubmed/33661132" } @Article{info:doi/10.2196/25805, author="Broome, Brantlee and Madisetti, Mohan and Prentice, Margaret and Williams, Wong Kelli and Kelechi, Teresa", title="Food Allergy Symptom Self-Management With Technology (FASST) mHealth Intervention to Address Psychosocial Outcomes in Caregivers of Children With Newly Diagnosed Food Allergy: Protocol for a Pilot Randomized Controlled Trial", journal="JMIR Res Protoc", year="2021", month="Mar", day="3", volume="10", number="3", pages="e25805", keywords="caregiver well-being", keywords="food allergy", keywords="self-management", keywords="mhealth, randomizes mixed trial", keywords="caregiver", keywords="well-being", keywords="emergency room", keywords="smartphone app", keywords="smartphone", keywords="children", abstract="Background: Approximately 2.4 million children in the United States suffer from food-induced anaphylaxis, a condition that is annually responsible for over 200 deaths and 200,000 emergency room visits. As a result, caregivers of children newly diagnosed with severe and life-threatening food allergic reactions experience clinically significant symptoms of psychological distress, including fatigue, anxiety, depressed mood, social isolation, and substantially reduced quality of life. Despite this recognition, there is a lack of caregiver-centered self-management interventions to address these concerns. Objective: In this protocol, we propose to develop and conduct feasibility testing of a technology-enhanced, self-management, mobile health, smartphone app intervention called Food Allergy Symptom Self-Management with Technology for Caregivers (FASST) designed to meet the psychosocial health needs of caregivers of children with a new diagnosis of food allergy. Methods: This pilot study uses qualitative work (Phase I) to inform a 4-week longitudinal randomized controlled trial (Phase II). In Phase I, 10 caregivers of children (?18 years old) with established food allergy (?1 year from diagnosis) will participate in semistructured interviews to inform the development of the FASST app. In Phase II, 30 caregivers of children (?18 years old) with a newly diagnosed food allergy (?90 days from diagnosis) will be randomized 2:1 to receive the FASST intervention (n=20) or control condition (basic app with educational resources; n=10). Process measures include feasibility, caregiver acceptability, adherence, and satisfaction. Outcome measures include caregiver fatigue, anxiety, depression, sleep, self-efficacy, and quality of life measured at baseline, week 4, and 3 months post study completion. Results: Phase I study activities have been completed, and Phase II participant enrollment into the randomized controlled trial is expected to commence in 2021. Conclusions: With limited readily available resources at their disposal, the results from this study have the potential to provide caregivers of children with a newly diagnosed food allergy a tool to help them self-manage and mitigate negative psychosocial factors during a critical time period in the caregiving/condition trajectory. Trial Registration: ClinicalTrials.gov Identifier NCT04512924: https://clinicaltrials.gov/ct2/show/NCT04512924 International Registered Report Identifier (IRRID): DERR1-10.2196/25805 ", doi="10.2196/25805", url="https://www.researchprotocols.org/2021/3/e25805", url="http://www.ncbi.nlm.nih.gov/pubmed/33656448" } @Article{info:doi/10.2196/22222, author="Morrow, L. Ardythe and Staat, A. Mary and DeFranco, A. Emily and McNeal, M. Monica and Cline, R. Allison and Conrey, C. Shannon and Schlaudecker, P. Elizabeth and Piasecki, M. Alexandra and Burke, M. Rachel and Niu, Liang and Hall, J. Aron and Bowen, D. Michael and Gerber, I. Susan and Langley, E. Gayle and Thornburg, J. Natalie and Campbell, P. Angela and Vinj{\'e}, Jan and Parashar, D. Umesh and Payne, C. Daniel", title="Pediatric Respiratory and Enteric Virus Acquisition and Immunogenesis in US Mothers and Children Aged 0-2: PREVAIL Cohort Study", journal="JMIR Res Protoc", year="2021", month="Feb", day="12", volume="10", number="2", pages="e22222", keywords="birth cohort", keywords="RSV", keywords="influenza", keywords="rotavirus", keywords="norovirus", keywords="vaccines", keywords="vaccine effectiveness", keywords="immunology", keywords="pediatrics", abstract="Background: Acute gastroenteritis (AGE) and acute respiratory infections (ARIs) cause significant pediatric morbidity and mortality. Developing childhood vaccines against major enteric and respiratory pathogens should be guided by the natural history of infection and acquired immunity. The United States currently lacks contemporary birth cohort data to guide vaccine development. Objective: The PREVAIL (Pediatric Respiratory and Enteric Virus Acquisition and Immunogenesis Longitudinal) Cohort study was undertaken to define the natural history of infection and immune response to major pathogens causing AGE and ARI in US children. Methods: Mothers in Cincinnati, Ohio, were enrolled in their third trimester of pregnancy, with intensive child follow-up to 2 years. Blood samples were obtained from children at birth (cord), 6 weeks, and 6, 12, 18, and 24 months. Whole stool specimens and midturbinate nasal swabs were collected weekly and tested by multipathogen molecular assays. Saliva, meconium, maternal blood, and milk samples were also collected. AGE (?3 loose or watery stools or ?1 vomiting episode within 24 hours) and ARI (cough or fever) cases were documented by weekly cell phone surveys to mothers via automated SMS text messaging and review of medical records. Immunization records were obtained from registries and providers. follow-up ended in October 2020. Pathogen-specific infections are defined by a PCR-positive sample or rise in serum antibody. Results: Of the 245 enrolled mother--child pairs, 51.8\% (n=127) were White, 43.3\% (n=106) Black, 55.9\% (n=137) publicly insured, and 86.5\% (n=212) initiated breastfeeding. Blood collection was 100.0\% for mothers (n=245) and 85.7\% for umbilical cord (n=210). A total of 194/245 (79.2\%) mother--child pairs were compliant based on participation in at least 70\% (?71/102 study weeks) of child-weeks and providing 70\% or more of weekly samples during that time, or blood samples at 18 or 24 months. Compliant participants (n=194) had 71.0\% median nasal swab collection (IQR 30.0\%-90.5\%), with 98.5\% (191/194) providing either an 18- or 24-month blood sample; median response to weekly SMS text message surveys was 95.1\% (IQR 76.5\%-100\%). Compliant mothers reported 2.0 AGE and 4.5 ARI cases per child-year, of which 25.5\% (160/627) and 38.06\% (486/1277) of cases, respectively, were medically attended; 0.5\% of AGE (3/627) and 0.55\% of ARI (7/1277) cases were hospitalized. Conclusions: The PREVAIL Cohort demonstrates intensive follow-up to document the natural history of enteric and respiratory infections and immunity in children 0-2 years of age in the United States and will contribute unique data to guide vaccine recommendations. Testing for pathogens and antibodies is ongoing. International Registered Report Identifier (IRRID): RR1-10.2196/22222 ", doi="10.2196/22222", url="http://www.researchprotocols.org/2021/2/e22222/", url="http://www.ncbi.nlm.nih.gov/pubmed/33576746" } @Article{info:doi/10.2196/21734, author="Ateudjieu, J{\'e}r{\^o}me and Yakum, Martin Ndinakie and Goura, Pascal Andr{\'e} and Guenou, Etienne and Beyala, Bita'a Landry and Amada, Lapia and Ngoche, Isabelle and Kiadjieu, Forex Frank and Nangue, Charlette and Djosseu, Soukep Elvis Briand and Kenfack, Bruno", title="Tracking Demographic Movements and Immunization Status to Improve Children's Access to Immunization (TDM-IAI): Protocol for a Field-Based Randomized Controlled Trial", journal="JMIR Res Protoc", year="2021", month="Feb", day="8", volume="10", number="2", pages="e21734", keywords="immunization status", keywords="coverage: completeness", keywords="timeliness", keywords="EPI vaccines", keywords="children under five", keywords="Foumban", keywords="Cameroon", keywords="vaccines", keywords="infectious", keywords="immunization", abstract="Background: In Cameroon, the coverage, completeness, and timeliness of the Expanded Programme on Immunization (EPI) vaccines administration in children have remained heterogeneous and below the national and districts targets in several districts. In an effort to solve this problem, many interventions have been tested but none has shown significant improvement of the situation. Objective: This trial aims to test whether involving Community Volunteers to assess children vaccination status and demographic movements and using recorded data to plan catch-up immunization sessions can improve children vaccination timeliness, completeness and coverage. Methods: Communities of the Foumban Health district, West region of Cameroon will be selected and assigned to either intervention or control groups using a restricted randomization of 2. In the intervention group, one Community Volunteer per community will be trained to visit households and record EPI-targeted children in a register, record their demographic movements, and assess their immunization status monthly for a year. The information recorded will be snapped and sent to the competent health center immunization team through WhatsApp. These will be used to plan and implement monthly community catch up immunization sessions in collaboration with the community volunteer. In the control group, the routine immunization sessions will be conducted with health centers organizing either weekly vaccination sessions for communities situated not farther than 5 kilometers away from the health facility or monthly vaccination sessions in communities situated more than 5 kilometers away from the health center. Baseline, mid-term and end-line surveys will be conducted to assess and compare immunization coverage, timeliness, and completeness. Results: Funded in 2018, data collection started in 2018 and has been completed. Data analysis and reporting are ongoing. Conclusions: This trial is expecting to test an innovative approach to improving children's immunization timeliness, completeness and coverage of immunization by tracking EPI targeted population vaccination status and denominator at household level and building collaboration between the community and health facilities vaccination teams to organize monthly community-based response vaccination sessions. This intervention is expected to improve children sustainable access to EPI vaccination as it offers assessing and responding to their immunization needs at monthly basis using low cost local human resources. Trial Registration: Pan African Clinical Trials Registry ID PACTR201808527428720; tinyurl.com/u058qnse International Registered Report Identifier (IRRID): DERR1-10.2196/21734 ", doi="10.2196/21734", url="https://www.researchprotocols.org/2021/2/e21734", url="http://www.ncbi.nlm.nih.gov/pubmed/33555269" } @Article{info:doi/10.2196/25474, author="Lander, Jonas and Curbach, Janina and von Sommoggy, Julia and Bitzer, Maria Eva and Dierks, Marie-Luise", title="Awareness, Information-Seeking Behavior, and Information Preferences About Early Childhood Allergy Prevention Among Different Parent Groups: Protocol for a Mixed Methods Study", journal="JMIR Res Protoc", year="2021", month="Jan", day="20", volume="10", number="1", pages="e25474", keywords="health literacy", keywords="allergy prevention", keywords="children", keywords="health information", keywords="parents", abstract="Background: In early childhood allergy prevention (ECAP), parents act on behalf of their children. Parental health literacy and the availability of high-quality information, both online and offline, are crucial for effective ECAP. Recent research highlights three main points. First, parents need sufficient health literacy to discriminate between high-quality and low-quality information. Second, ECAP information behaviors may vary between phases of childhood development and according to individual circumstances. Third, to strengthen user-centeredness of available services, a better overview of parents' information practices and needs and how they handle uncertainties is required. Objective: This study aims to explore why, how, and when parents search for and apply ECAP-specific health information and which individual (eg, understanding of advice) and organizational challenges (eg, information services, information complexity, and changing recommendations) they perceive and how they handle them. This study also aims to assess the needs and preferences that parents express for future information formats and contents. The findings should inform the practical design of ECAP information as well as formats and channels specific to different parent groups. Methods: The above-named issues will be explored with parents in four German cities as one element in our efforts to cover the spectrum of perspectives. Based on a mixed methods design, including qualitative and quantitative assessments, the first year serves to prepare focus groups, a piloted focus group guide, a short standardized survey adapted from the European Health Literacy Project, recruitment channels, and the recruitment of participants. After conducting 20 focus groups in the second year, data will be analyzed via a constant comparison method in the third year. Based on this, practice implications on channels (ie, Where?), formats (ie, How?), and contents (ie, What?) of ECAP-specific information will be derived and discussed with parents and associated project partners before its dissemination to relevant ECAP actors (eg, childcare institutions and pediatricians). Results: The study began with preselection of recruitment channels, drafting of recruitment and study information for potential participants, and agreement on a first full version of the guideline. Then, a detailed contact list was compiled of health professionals, administrative and social institutions, and relevant social media channels (N=386) to be approached for assistance in contacting parents. The recruitment was postponed due to COVID-19 and will start in January 2021. Conclusions: ECAP is a relevant example for assessing how users (ie, parents) handle not only health information but the various and continuous changes, uncertainties, and controversies attached to it. So far, it is unclear how parents implement the respective scientific recommendations and expert advice, which is why this study aims to inform those who communicate with parents about ECAP information. International Registered Report Identifier (IRRID): PRR1-10.2196/25474 ", doi="10.2196/25474", url="http://www.researchprotocols.org/2021/1/e25474/", url="http://www.ncbi.nlm.nih.gov/pubmed/33470948" } @Article{info:doi/10.2196/23930, author="Maarseveen, D. Tjardo and Meinderink, Timo and Reinders, T. Marcel J. and Knitza, Johannes and Huizinga, J. Tom W. and Kleyer, Arnd and Simon, David and van den Akker, B. Erik and Knevel, Rachel", title="Machine Learning Electronic Health Record Identification of Patients with Rheumatoid Arthritis: Algorithm Pipeline Development and Validation Study", journal="JMIR Med Inform", year="2020", month="Nov", day="30", volume="8", number="11", pages="e23930", keywords="Supervised machine learning", keywords="Electronic Health Records", keywords="Natural Language Processing", keywords="Support Vector Machine", keywords="Gradient Boosting", keywords="Rheumatoid Arthritis", abstract="Background: Financial codes are often used to extract diagnoses from electronic health records. This approach is prone to false positives. Alternatively, queries are constructed, but these are highly center and language specific. A tantalizing alternative is the automatic identification of patients by employing machine learning on format-free text entries. Objective: The aim of this study was to develop an easily implementable workflow that builds a machine learning algorithm capable of accurately identifying patients with rheumatoid arthritis from format-free text fields in electronic health records. Methods: Two electronic health record data sets were employed: Leiden (n=3000) and Erlangen (n=4771). Using a portion of the Leiden data (n=2000), we compared 6 different machine learning methods and a na{\"i}ve word-matching algorithm using 10-fold cross-validation. Performances were compared using the area under the receiver operating characteristic curve (AUROC) and the area under the precision recall curve (AUPRC), and F1 score was used as the primary criterion for selecting the best method to build a classifying algorithm. We selected the optimal threshold of positive predictive value for case identification based on the output of the best method in the training data. This validation workflow was subsequently applied to a portion of the Erlangen data (n=4293). For testing, the best performing methods were applied to remaining data (Leiden n=1000; Erlangen n=478) for an unbiased evaluation. Results: For the Leiden data set, the word-matching algorithm demonstrated mixed performance (AUROC 0.90; AUPRC 0.33; F1 score 0.55), and 4 methods significantly outperformed word-matching, with support vector machines performing best (AUROC 0.98; AUPRC 0.88; F1 score 0.83). Applying this support vector machine classifier to the test data resulted in a similarly high performance (F1 score 0.81; positive predictive value [PPV] 0.94), and with this method, we could identify 2873 patients with rheumatoid arthritis in less than 7 seconds out of the complete collection of 23,300 patients in the Leiden electronic health record system. For the Erlangen data set, gradient boosting performed best (AUROC 0.94; AUPRC 0.85; F1 score 0.82) in the training set, and applied to the test data, resulted once again in good results (F1 score 0.67; PPV 0.97). Conclusions: We demonstrate that machine learning methods can extract the records of patients with rheumatoid arthritis from electronic health record data with high precision, allowing research on very large populations for limited costs. Our approach is language and center independent and could be applied to any type of diagnosis. We have developed our pipeline into a universally applicable and easy-to-implement workflow to equip centers with their own high-performing algorithm. This allows the creation of observational studies of unprecedented size covering different countries for low cost from already available data in electronic health record systems. ", doi="10.2196/23930", url="http://medinform.jmir.org/2020/11/e23930/", url="http://www.ncbi.nlm.nih.gov/pubmed/33252349" } @Article{info:doi/10.2196/22297, author="Zhang, Shouling and Henderson, S. Tiffany and Scalchunes, Christopher and Sullivan, E. Kathleen and Jongco III, M. Artemio", title="Persons Living With Primary Immunodeficiency Act as Citizen Scientists and Launch Prospective Cohort Body Temperature Study", journal="J Participat Med", year="2020", month="Nov", day="30", volume="12", number="4", pages="e22297", keywords="fever", keywords="temperature", keywords="primary immunodeficiency", abstract="Background: Although fever is considered a sign of infection, many individuals with primary immunodeficiency (PI) anecdotally report a lower-than-normal average body temperature on online forums sponsored by the Immune Deficiency Foundation (IDF). There is limited knowledge about the average body temperature and fever response in PI. Objective: This study aims to compare median body temperatures between adults with and without PI diagnoses living in the same household and to engage individuals living with PI throughout the research process. Methods: Patients with PI designed and launched a prospective cohort comparison study as citizen scientists. A multidisciplinary team designed and implemented a patient-informed study with continuous patient-driven input. Median body temperatures were compared between the 2 cohorts using the Mann-Whitney test with Bonferroni correction. The IDF conducted a post-study patient experience survey. Results: Data from 254 households were analyzed (254/350, 72.6\% participation rate). The PI population was predominantly female (218/254, 85.8\%), White (248/254, 97.6\%), and with a median age of 49 years. The non-PI population was largely male (170/254, 66.9\%), White (236/254, 92.9\%), and with a median age of 53 years. Common variable immunodeficiency was the most common PI diagnosis (190/254, 74.8\%). Of the 254 individuals with PI, 123 (48.4\%) reported a lower-than-normal nonsick body temperature, whereas 108 (42.5\%) reported a normal (between 97{\textdegree}F and 99{\textdegree}F) nonsick body temperature. Among individuals with PI, when infected, 67.7\% (172/254) reported the absence of fever, whereas 19.7\% (50/254) reported a normal fever response. The recorded median body temperature was minimally but statistically significantly higher for patients with PI in the morning. Although 22.4\% (57/254) of patients with PI self-reported illness, a fever of 100.4{\textdegree}F or higher was uncommon; 77.2\% (196/254) had a normal temperature (between 97{\textdegree}F and 99{\textdegree}F), and 16.2\% (41/254) had a lower-than-normal temperature (between 95.0{\textdegree}F and 96.9{\textdegree}F) when sick. For these sick patients with PI, the median body temperature was minimally but statistically significantly higher for patients in the morning and early evening. Overall, 90.9\% (231/254) of participants would be very likely to participate in future IDF studies, although 94.1\% (239/254) participants had never taken part in previous studies. Conclusions: To our knowledge, this is the first study to evaluate average body temperature in individuals with PI. Although there were small statistically significant differences in body temperatures between PI and non-PI subjects, the clinical significance is unclear and should be interpreted with caution, given the methodological issues associated with our small convenience sample and study design. As PIs are heterogeneous, more research is needed about how the fever response differs among diverse PIs compared with healthy controls. This study highlights that individuals with PI are knowledgeable about their health and can offer unique insights and direction to researchers and clinicians. ", doi="10.2196/22297", url="http://jopm.jmir.org/2020/4/e22297/", url="http://www.ncbi.nlm.nih.gov/pubmed/33252341" } @Article{info:doi/10.2196/19260, author="Seppen, F. Bart and den Boer, Pim and Wiegel, Jimmy and ter Wee, M. Marieke and van der Leeden, Marike and de Vries, Ralph and van der Esch, Martin and Bos, H. Wouter", title="Asynchronous mHealth Interventions in Rheumatoid Arthritis: Systematic Scoping Review", journal="JMIR Mhealth Uhealth", year="2020", month="Nov", day="5", volume="8", number="11", pages="e19260", keywords="mobile health", keywords="eHealth", keywords="digital health", keywords="telehealth", keywords="telerheumatology", keywords="mHealth", keywords="web app", keywords="smartphone app", keywords="activity tracker", keywords="rheumatoid arthritis", keywords="rheumatology", keywords="review", keywords="telemonitoring", abstract="Background: Mobile devices such as smartphones and tablets have surged in popularity in recent years, generating numerous possibilities for their use in health care as mobile health (mHealth) tools. One advantage of mHealth is that it can be provided asynchronously, signifying that health care providers and patients are not communicating in real time. The integration of asynchronous mHealth into daily clinical practice might therefore help to make health care more efficient for patients with rheumatoid arthritis (RA). The benefits have been reviewed in various medical conditions, such as diabetes and asthma, with promising results. However, to date, it is unclear what evidence exists for the use of asynchronous mHealth in the field of RA. Objective: The objective of this study was to map the different asynchronous mHealth interventions tested in clinical trials in patients with RA and to summarize the effects of the interventions. Methods: A systematic search of Pubmed, Scopus, Cochrane, and PsycINFO was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. Studies were initially screened and later assessed by two independent researchers. Disagreements on inclusion or exclusion of studies were resolved by discussion. Results: The literature search yielded 1752 abstracts. After deduplication and screening, 10 controlled intervention studies were included. All studies were assessed to be at risk for bias in at least one domain of the Cochrane risk-of-bias tool. In the 10 selected studies, 4 different types of mHealth interventions were used: SMS reminders (to increase medication adherence or physical activity; n=3), web apps (for disease monitoring and/or to provide medical information; n=5), smartphone apps (for disease monitoring; n=1), and pedometers (to increase and track steps; n=1). Measured outcomes varied widely between studies; improvements were seen in terms of medication compliance (SMS reminders), reaching rapid remission (web app), various domains of physical activity (pedometer, SMS reminders, and web apps), patient-physician interaction (web apps), and self-efficacy (smartphone app). Conclusions: SMS reminders, web apps, smartphone apps, and pedometers have been evaluated in intervention studies in patients with RA. These interventions have been used to monitor patients or to support them in their health behavior. The use of asynchronous mHealth led to desirable outcomes in nearly all studies. However, since all studies were at risk of bias and methods used were very heterogeneous, high-quality research is warranted to corroborate these promising results. ", doi="10.2196/19260", url="http://mhealth.jmir.org/2020/11/e19260/", url="http://www.ncbi.nlm.nih.gov/pubmed/33151161" } @Article{info:doi/10.2196/20165, author="Seppen, F. Bart and Wiegel, Jimmy and L'ami, J. Merel and Duarte dos Santos Rico, Sharon and Catarinella, S. Fabio and Turkstra, Franktien and Boers, Maarten and Bos, H. Wouter", title="Feasibility of Self-Monitoring Rheumatoid Arthritis With a Smartphone App: Results of Two Mixed-Methods Pilot Studies", journal="JMIR Form Res", year="2020", month="Sep", day="21", volume="4", number="9", pages="e20165", keywords="mHealth", keywords="eHealth", keywords="patient-reported outcome, smartphone app", keywords="rheumatoid arthritis", keywords="self-monitoring", keywords="telemonitoring", keywords="mobile phone", abstract="Background: Several mobile apps that monitor symptoms of rheumatoid arthritis (RA) exist, but a recent systematic review indicated that high-quality apps are lacking. When patients self-monitor their own disease with patient-reported outcomes (PROs) and self-initiate care at the right moment, it may be possible to reduce the frequency of their clinic visits, which would reduce health care burden and costs. We developed an app, that is, the MijnReuma Reade app, for this purpose and performed 2 pilot tests with weekly self-monitoring. Objective: The primary objective of this study was to design, develop, and evaluate the usability, satisfaction, and usage of the MijnReuma Reade app---an app that allows patients with RA to monitor their own disease. The secondary objective was to review the patients' perspectives on app usage and its intended purpose. Methods: This app was designed in collaboration with patients with RA, rheumatologists, and information technology experts. Two 1-month pilot studies were performed, after which satisfaction (0-10 scale), usability (system usability scale, 0-100), and usage (proportion of completed questionnaires) of this app were assessed. After the second pilot study, semistructured interviews were performed to determine patients' perspectives and the promoters and barriers of app usage. Results: In the first and second pilot study, 42 and 27 patients were included, respectively. Overall, the patients were satisfied (medians, 8 and 7) and found the app usable (mean system usability scores, 76 and 71) in pilot studies 1 and 2, respectively. App usage declined over time in both the pilot studies; 61\% (17/28) and 37\% (10/27) of the patients who disclosed their usage statistics completed the final weekly questionnaire in pilot study 1 and pilot study 2, respectively. Approximately 81\% (25/31) of the patients indicated they would like to skip hospital visits if the self-monitored disease activity is low. In the semistructured interviews, technical problems, internal resistance (respondent fatigue, the app reminded them of their disease), and a lack of symptoms were identified as barriers for usage. Patients reported that ``experiencing more grip on their disease'' and ``improved communication with their physician'' were promoters for usage. Patients reported that pain positively mediated usage, that is, more pain promoted and less pain discouraged app usage. Conclusions: This study illustrates the feasibility of the MijnReuma Reade app that enables self-monitoring of the disease activity in patients with RA with the overarching aim to allocate clinical consultations according to need. Satisfaction with the app and usability of the app were found to be high; however, app usage declined over time. Patients acknowledged the potential of the app to self-monitor their own disease and would like to be able to skip clinic visits if the monitored disease activity is low. To evaluate this strategy, a randomized controlled trial is underway. ", doi="10.2196/20165", url="http://formative.jmir.org/2020/9/e20165/", url="http://www.ncbi.nlm.nih.gov/pubmed/32955447" } @Article{info:doi/10.2196/18339, author="Mandracchia, Floriana and Llaurad{\'o}, Elisabet and Tarro, Lucia and Valls, Maria Rosa and Sol{\`a}, Rosa", title="Mobile Phone Apps for Food Allergies or Intolerances in App Stores: Systematic Search and Quality Assessment Using the Mobile App Rating Scale (MARS)", journal="JMIR Mhealth Uhealth", year="2020", month="Sep", day="16", volume="8", number="9", pages="e18339", keywords="food allergy", keywords="food hypersensitivity", keywords="food intolerance", keywords="allergens", keywords="mobile applications", keywords="mobile health", keywords="mHealth", keywords="eHealth.", abstract="Background: Food allergies and intolerances are increasing worldwide, and mobile phone apps could be a promising tool for self-management of these issues. Objective: This study aimed to systemically search and assess food allergy or intolerance apps in app stores using the multidimensional Mobile App Rating Scale (MARS) to rate the objective and subjective quality and to identify critical points for future improvements. Methods: This systematic search identified apps through the keywords ``food allergy,'' ``food intolerance,'' and ``allergens'' in English, Spanish, and Italian in the Apple App Store (iOS) and Google Play Store (Android). The inclusion criteria were a user star rating of ?3 (of 5 stars) to limit the selection to the most highly rated apps; ?1000 reviews as an indicator of reliability; and the most recent update performed up to 2017. Then, the apps were divided according to their purpose (searching for allergen-free ``food products,'' ``restaurants,'' or recipes in ``meal planners'') and evaluated on a scale of 1 to 5 points using the MARS in terms of (1) app classification category with a descriptive aim; (2) app subjective and objective quality categories comprised of engagement, functionality, esthetics, and information sections (Medline was searched for eligible apps to check whether they had been tested in trials); and (3) an optional app-specific section. Furthermore, the output and input features were evaluated. Differences between MARS sections and between app purposes and correlations among MARS sections, star ratings, and numbers of reviews were evaluated. Results: Of the 1376 apps identified, 14 were included: 12 related to food allergies and intolerances that detect 2-16 food allergens and 2 related only to gluten intolerance. The mean (SD) MARS scores (maximum 5 points) were 3.8 (SD 0.4) for objective quality, highlighting whether any app had been tested in trials; 3.5 (SD 0.6) for subjective quality; and 3.6 (SD 0.7) for the app-specific section. Therefore, a rating ?3 points indicated overall acceptable quality. From the between-section comparison, engagement (mean 3.5, SD 0.6) obtained significantly lower scores than functionality (mean 4.1, SD 0.6), esthetics (mean 4, SD 0.5), and information (mean 3.8, SD 0.4). However, when the apps were compared by purpose, critical points were identified: meal planner apps showed significantly higher engagement (mean 4.1, SD 0.4) than food product (mean 3.0, SD 0.6; P=.05) and restaurant (mean 3.2, SD 0.3; P=.02) apps. Conclusions: In this systematic search of food allergy or intolerance apps, acceptable MARS quality was identified, although the engagement section for food product and restaurant purpose apps should be improved and the included apps should be tested in trials. The critical points identified in this systematic search can help improve the innovativeness and applicability of future food allergy and intolerance apps. ", doi="10.2196/18339", url="http://mhealth.jmir.org/2020/9/e18339/", url="http://www.ncbi.nlm.nih.gov/pubmed/32936078" } @Article{info:doi/10.2196/19661, author="Knitza, Johannes and Simon, David and Lambrecht, Antonia and Raab, Christina and Tascilar, Koray and Hagen, Melanie and Kleyer, Arnd and Bayat, Sara and Derungs, Adrian and Amft, Oliver and Schett, Georg and Hueber, J. Axel", title="Mobile Health Usage, Preferences, Barriers, and eHealth Literacy in Rheumatology: Patient Survey Study", journal="JMIR Mhealth Uhealth", year="2020", month="Aug", day="12", volume="8", number="8", pages="e19661", keywords="mobile applications", keywords="eHealth", keywords="rheumatology", keywords="mHealth", keywords="eHEALS", keywords="telemedicine", abstract="Background: Mobile health (mHealth) defines the support and practice of health care using mobile devices and promises to improve the current treatment situation of patients with chronic diseases. Little is known about mHealth usage and digital preferences of patients with chronic rheumatic diseases. Objective: The aim of the study was to explore mHealth usage, preferences, barriers, and eHealth literacy reported by German patients with rheumatic diseases. Methods: Between December 2018 and January 2019, patients (recruited consecutively) with rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis were asked to complete a paper-based survey. The survey included questions on sociodemographics, health characteristics, mHealth usage, eHealth literacy using eHealth Literacy Scale (eHEALS), and communication and information preferences. Results: Of the patients (N=193) who completed the survey, 176 patients (91.2\%) regularly used a smartphone, and 89 patients (46.1\%) regularly used social media. Patients (132/193, 68.4\%) believed that using medical apps could be beneficial for their own health. Out of 193 patients, only 8 (4.1\%) were currently using medical apps, and only 22 patients (11.4\%) stated that they knew useful rheumatology websites/mobile apps. Nearly all patients (188/193, 97.4\%) would agree to share their mobile app data for research purposes. Out of 193 patients, 129 (66.8\%) would regularly enter data using an app, and 146 patients (75.6\%) would welcome official mobile app recommendations from the national rheumatology society. The preferred duration for data entry was not more than 15 minutes (110/193, 57.0\%), and the preferred frequency was weekly (59/193, 30.6\%). Medication information was the most desired app feature (150/193, 77.7\%). Internet was the most frequently utilized source of information (144/193, 74.6\%). The mean eHealth literacy was low (26.3/40) and was positively correlated with younger age, app use, belief in benefit of using medical apps, and current internet use to obtain health information. Conclusions: Patients with rheumatic diseases are very eager to use mHealth technologies to better understand their chronic diseases. This open-mindedness is counterbalanced by low mHealth usage and competency. Personalized mHealth solutions and clear implementation recommendations are needed to realize the full potential of mHealth in rheumatology. ", doi="10.2196/19661", url="http://mhealth.jmir.org/2020/8/e19661/", url="http://www.ncbi.nlm.nih.gov/pubmed/32678796" } @Article{info:doi/10.2196/16234, author="Stinson, N. Jennifer and Lalloo, Chitra and Hundert, S. Amos and Campillo, Sarah and Cellucci, Tania and Dancey, Paul and Duffy, Ciaran and Ellsworth, Janet and Feldman, M. Brian and Huber, M. Adam and Johnson, Nicole and Jong, Geert't and Oen, Kiem and Rosenberg, M. Alan and Shiff, J. Natalie and Spiegel, Lynn and Tse, L. Shirley M. and Tucker, Lori and Victor, Charles Joseph", title="Teens Taking Charge: A Randomized Controlled Trial of a Web-Based Self-Management Program With Telephone Support for Adolescents With Juvenile Idiopathic Arthritis", journal="J Med Internet Res", year="2020", month="Jul", day="29", volume="22", number="7", pages="e16234", keywords="eHealth", keywords="randomized controlled trial", keywords="adolescents", keywords="juvenile idiopathic arthritis", keywords="self-management", keywords="self-efficacy", keywords="technology", keywords="patient education", keywords="internet", keywords="pediatric pain", abstract="Background: Juvenile idiopathic arthritis (JIA) is a serious and potentially debilitating pediatric illness. Improved disease self-management may help to improve health outcomes. Objective: This study aimed to evaluate the effectiveness of the Teens Taking Charge Web-based self-management intervention in reducing symptoms and improving health-related quality of life (HRQL) in adolescents with JIA compared with a Web-based education control condition. Methods: Adolescents with JIA aged 12 to 18 years were recruited from 11 Canadian pediatric rheumatology centers. Caregivers were invited to participate along with their child. In addition to standard medical care, participants were randomized to receive either (1) the Teens Taking Charge self-management intervention or (2) a Web-based education control condition for a period of 12 weeks. Adolescents in the intervention group completed website modules addressing cognitive behavioral coping skills, stress management, and other self-management topics, while also receiving monthly telephone calls from a trained health coach. Adolescents in the education control group were instructed to view a series of preselected public JIA educational websites and received monthly calls from a coach who asked about their own best efforts at managing JIA. Caregivers in the intervention group completed website modules related to promoting independence and disease self-management in their child. Caregivers in the education control group were instructed to view a series of preselected public JIA educational websites. Outcome assessment occurred at baseline, 12 weeks (posttreatment), and at 6 and 12 months postrandomization. The primary outcomes were pain intensity, pain interference, and HRQL. Secondary outcomes were emotional symptoms, adherence, coping, knowledge, and self-efficacy. Results: In total, 333 adolescents and 306 caregivers were enrolled. Significant overall reductions in pain intensity (P=.02) and pain interference (P=.007) were observed for intervention group participants compared with those in the education control group, after adjusting for baseline levels. There was a significant overall improvement in HRQL related to problems with pain (P=.02) and problems with daily activities (P=.01). There was also a significant difference in the intervention group over time (P=.008) for HRQL related to treatment problems, with the intervention group participants demonstrating improved HRQL by 12 months compared with education control group participants. Both groups showed nonsignificant improvements compared with baseline in other primary outcomes. There were no significant differences between the groups in any secondary outcomes or caregiver-reported outcomes. Conclusions: The results of this randomized trial suggest that the Teens Taking Charge Web-based intervention is effective at reducing both pain intensity and pain interference, as well as improving HRQL in adolescents with JIA, compared with education control. These effects are sustained for up to 12 months following program completion. The Teens Taking Charge program is now publicly available at no cost. Trial Registration: ClinicalTrials.gov NCT01572896; https://clinicaltrials.gov/ct2/show/NCT01572896 ", doi="10.2196/16234", url="https://www.jmir.org/2020/7/e16234", url="http://www.ncbi.nlm.nih.gov/pubmed/32723728" } @Article{info:doi/10.2196/17373, author="Doma?ska, Barbara and Vansant, Stijn and Mountian, Irina", title="A Companion App to Support Rheumatology Patients Treated with Certolizumab Pegol: Results From a Usability Study", journal="JMIR Form Res", year="2020", month="Jul", day="27", volume="4", number="7", pages="e17373", keywords="rheumatology", keywords="internet", keywords="digital health", keywords="mobile health", keywords="mHealth", keywords="smartphone", keywords="mobile phone", keywords="validation human factors study", abstract="Background: Certolizumab pegol (CZP) is an anti-tumor necrosis factor drug approved for the treatment of multiple moderate to severe chronic inflammatory diseases. In the European Union, CZP is approved for administration by subcutaneous self-injection using a prefilled syringe, prefilled pen, or reusable electromechanical auto-injector (electronic device). CimplyMe is a companion app for use alongside CZP self-injection devices, designed to support CZP-treated patients self-managing their treatment and disease. Objective: This study aimed to validate the usability of the companion app by demonstrating that tasks required for use can be performed successfully by intended end users. Methods: We recruited 15 patients with moderate to severe rheumatoid arthritis, currently prescribed biologic treatment, and using apps on a smart phone. Patients were assessed on their ability to use the companion app in a setting designed to simulate a location where patients regularly administer biologic treatment. To assess the usability of the key features of the app, 8 critical and 3 noncritical tasks were designed. Patients' success on each task was recorded through observations or knowledge-based questions. Successes with difficulty and use errors were also recorded. If a patient made a use error at the first attempt, a second attempt was allowed. Second-attempt use errors were recorded as a task failure. Results: A total of 207 first attempts at the 14 components of the 8 critical tasks were evaluated (3 patients failed to complete one component); 178 (86.0\%) critical tasks were successfully completed at the first attempt. The remaining first attempts comprised 16 (7.7\%) successes with difficulty and 13 (6.3\%) use errors, which had to be repeated. One critical task was not re-attempted by one patient due to time constraints; however, there were no use errors in the 12 completed second attempts. A total of 107 first attempts at the 3 noncritical tasks were made, all of which (107/107, 100.0\%) were completed without use errors. Conclusions: In simulated testing, patients were able to successfully use the companion app without formal training. This study suggests the companion app is easy to use and could help patients prescribed CZP better manage their treatment and disease. ", doi="10.2196/17373", url="http://formative.jmir.org/2020/7/e17373/", url="http://www.ncbi.nlm.nih.gov/pubmed/32716310" } @Article{info:doi/10.2196/15815, author="Pincus, Theodore and Castrejon, Isabel and Riad, Mariam and Obreja, Elena and Lewis, Candice and Krogh, Steen Niels", title="Reliability, Feasibility, and Patient Acceptance of an Electronic Version of a Multidimensional Health Assessment Questionnaire for Routine Rheumatology Care: Validation and Patient Preference Study", journal="JMIR Form Res", year="2020", month="May", day="27", volume="4", number="5", pages="e15815", keywords="patient reported outcomes", keywords="health status measures", keywords="electronic version", keywords="rapid3", keywords="mdhaq", abstract="Background: A multidimensional health assessment questionnaire (MDHAQ) that was developed primarily for routine rheumatology care has advanced clinical research concerning disease burden, disability, and mortality in rheumatic diseases. Routine Assessment of Patient Index Data 3 (RAPID3), an index within the MDHAQ, is the most widely used index to assess rheumatoid arthritis (RA) in clinical care in the United States, and it recognizes clinical status changes in all studied rheumatic diseases. MDHAQ physical function scores are far more significant in the prognosis of premature RA mortality than laboratory or imaging data. However, electronic medical records (EMRs) generally do not include patient questionnaires. An electronic MDHAQ (eMDHAQ), linked by fast healthcare interoperability resources (FIHR) to an EMR, can facilitate clinical and research advances. Objective: This study analyzed the reliability, feasibility, and patient acceptance of an eMDHAQ. Methods: Since 2006, all Rush University Medical Center rheumatology patients with all diagnoses have been asked to complete a paper MDHAQ at each routine care encounter. In April 2019, patients were invited to complete an eMDHAQ at the conclusion of the encounter. Analyses were conducted to determine the reliability of eMDHAQ versus paper MDHAQ scores, arithmetically and by intraclass correlation coefficient (ICC). The feasibility of the eMDHAQ was analyzed based on the time for patient completion. The patient preference for the electronic or paper version was analyzed through a patient paper questionnaire. Results: The 98 study patients were a typical routine rheumatology patient group. Seven paper versus eMDHAQ scores were within 2\%, differences neither clinically nor statistically significant. ICCs of 0.86-0.98 also indicated good to excellent reliability. Mean eMDHAQ completion time was a feasible 8.2 minutes. The eMDHAQ was preferred by 72\% of patients; preferences were similar according to age and educational level. Conclusions: The results on a paper MDHAQ versus eMDHAQ were similar. Most patients preferred an eMDHAQ. ", doi="10.2196/15815", url="http://formative.jmir.org/2020/5/e15815/", url="http://www.ncbi.nlm.nih.gov/pubmed/32459182" } @Article{info:doi/10.2196/15158, author="Desai, Sonali and Stevens, Emma and Emani, Srinivas and Meyers, Peter and Iversen, Maura and Solomon, H. Daniel", title="Improving Quality of Care in Rheumatoid Arthritis Through Mobile Patient-Reported Outcome Measurement: Focus Group Study", journal="JMIR Form Res", year="2020", month="May", day="27", volume="4", number="3", pages="e15158", keywords="quality improvement", keywords="rheumatoid arthritis", abstract="Background: Patient-reported outcomes (PROs) for chronic disease management can be integrated into the routine workflow by leveraging mobile technology. Objective: The objective of our study was to describe the process of our quality improvement (QI) efforts using tablets for PRO collection in a busy, academic rheumatology practice to support a treat-to-target (TTT) approach for rheumatoid arthritis (RA) management. Methods: Our QI team designed a process for routine collection of PROs for RA patients at the Arthritis Center, employing information technology and an electronic medical record (EMR) system. Patients received a tablet at the clinic check-in desk to complete the Routine Assessment of Patient Index Data 3 (RAPID3) survey, a validated RA PRO. RAPID3 scores were uploaded to the EMR in real time and available for use in shared decision making during routine office visits. Weekly data were collected on RAPID3 completion rates and shared with front desk staff and medical assistants to drive improvement. Patients in our patient family advisory council and focus groups provided informal feedback on the process. Results: From May 1, 2017, to January 31, 2019, a total of 4233 RAPID3 surveys were completed by 1691 patients. The mean age of patients was 63 (SD 14) years; 84.00\% (1420/1691) of the patients were female, and 83.00\% (1403/1691) of the patients were white. The rates of RAPID3 completion increased from 14.3\% (58/405) in May 2017 to 68.00\% (254/376) in September 2017 and were sustained over time through January 2019. Informal feedback from patients was positive and negative, relating to the usability of the tablet and the way rheumatologists used and explained the RAPID3 data in shared decision making during the office visit. Conclusions: We designed a sustainable and reliable process for collecting PROs from patients with RA in the waiting room and integrated these data through the EMR during office visits. ", doi="10.2196/15158", url="http://formative.jmir.org/2020/3/e15158/", url="http://www.ncbi.nlm.nih.gov/pubmed/32459179" } @Article{info:doi/10.2196/17507, author="Knitza, Johannes and Knevel, Rachel and Raza, Karim and Bruce, Tor and Eimer, Ekaterina and Gehring, Isabel and Mathsson-Alm, Linda and Poorafshar, Maryam and Hueber, J. Axel and Schett, Georg and Johannesson, Martina and Catrina, Anca and Klareskog, Lars and ", title="Toward Earlier Diagnosis Using Combined eHealth Tools in Rheumatology: The Joint Pain Assessment Scoring Tool (JPAST) Project", journal="JMIR Mhealth Uhealth", year="2020", month="May", day="15", volume="8", number="5", pages="e17507", keywords="rheumatology", keywords="eHealth", keywords="mHealth", keywords="symptom-checkers", keywords="apps", doi="10.2196/17507", url="https://mhealth.jmir.org/2020/5/e17507", url="http://www.ncbi.nlm.nih.gov/pubmed/32348258" } @Article{info:doi/10.2196/16763, author="King, Catherine and Judge, Ciaran and Byrne, Aideen and Conlon, Niall", title="Googling Allergy in Ireland: Content Analysis", journal="J Med Internet Res", year="2020", month="May", day="13", volume="22", number="5", pages="e16763", keywords="allergy", keywords="food allergy", keywords="food intolerance", keywords="technology", keywords="Ireland", keywords="immunology", abstract="Background: Internet search engines are increasingly being utilized as the first port of call for medical information by the public. The prevalence of allergies in developed countries has risen steadily over time. There exists significant variability in the quality of health-related information available on the web. Inaccurately diagnosed and mismanaged allergic disease has major downstream effects on patients, general practitioners, and regional allergy services. Objective: This study aimed to verify whether Ireland has a relatively high rate of web-based allergy-related searches, to establish the proportion of medically accurate web pages encountered by the public, and to compare current search results localized to Dublin, Ireland with urban centers elsewhere. Methods: Google Trends was used to evaluate regional interest of allergy-related search terms over a 10-year period using terms ``allergy,'' ``allergy test,'' ``food allergy,'' and ``food intolerance.'' These terms were then inputted into Google search, localizing them to cities in Ireland, the United Kingdom, and the United States. Output for each search was reviewed by two independent clinicians and deemed rational or nonevidence based, as per current best practice guidelines. Searches localized to Dublin were initially completed in 2015 and repeated in 2019 to assess for changes in the quality of search results over time. Results: Ireland has a persistently high demand for web-based information relating to allergy and ranks first worldwide for ``allergy test,'' second for ``food allergy'' and ``food intolerance,'' and seventh for ``allergy'' over the specified 10-year timeframe. Results for each of the four subsearches in Dublin (2015) showed that over 60\% of websites promoted nonevidence-based diagnostics. A marginal improvement in scientifically robust information was seen in 2019, but results for ``allergy test'' and ``food intolerance'' continued to promote alternative testing 57\% (8/14) of the time. This strongly contrasted with results localized to Southampton and Rochester, where academic and hospital-affiliated web pages predominantly featured. Government-funded Department of Health websites did not feature in the top five results for Dublin searches ``allergy testing,'' ``food allergy,'' or ``food intolerance'' in either 2015 or 2019. Conclusions: The Irish public demonstrates a keen interest in seeking allergy-related information on the web. The proportion of evidence-based websites encountered by the Irish public is considerably lower than that encountered by patients in other urban centers. Factors contributing to this are the lack of a specialist register for allergy in Ireland, inadequate funding for allergy centers currently in operation, and insufficient promotion by the health service of their web-based health database, which contains useful patient-oriented information on allergy. Increased funding of clinical allergology services will more meaningfully impact the health of patients if there is a parallel investment by the health service in information and communication technology consultancy to amplify their presence on the web. ", doi="10.2196/16763", url="https://www.jmir.org/2020/5/e16763", url="http://www.ncbi.nlm.nih.gov/pubmed/32401220" } @Article{info:doi/10.2196/17863, author="Talwar, Deepak and Bendre, Salil", title="Health-Related Effects of Home Nebulization With Glycopyrronium on Difficult-to-Treat Asthma: Post-Hoc Analyses of an Observational Study", journal="Interact J Med Res", year="2020", month="Apr", day="29", volume="9", number="2", pages="e17863", keywords="difficult-to-treat asthma", keywords="exacerbation", keywords="glycopyrronium", keywords="home nebulization", keywords="uncontrolled asthma", keywords="vibrating mesh nebulizer", abstract="Background: Bronchial asthma remains a clinical enigma with poorly controlled symptoms or exacerbations despite regular use of inhaled corticosteroids. Home nebulization offers a simplified solution for the delivery of rescue and maintenance bronchodilators, which is especially true for patients with frequent exacerbations during management of uncontrolled or difficult-to-treat asthma. Objective: We aimed to assess the clinical impact and outcomes associated with home nebulization---delivered long-acting bronchodilators for uncontrolled or difficult-to-treat asthma. Methods: This observational, concurrent study was conducted with 60 patients at 2 centers during November 2018. Statistical analyses for prebronchodilator forced expiratory volume in one second (FEV1) and Global Initiative for Asthma (GINA) asthma control score in patients on long-acting bronchodilators and corticosteroids were conducted, with two-tailed P values <.05 considered statistically significant. Results: Per protocol analyses (53/60) for consecutive cases receiving home nebulization with long-acting bronchodilators and corticosteroids were conducted. The baseline demographics included a male-to-female ratio of 30:23 and mean values of the following: age, 60.3 years (SD 11.8 years); weight, 64 kg (SD 16.8 kg); FEV1, 43\% (SD 16\%); GINA asthma control score, 3.0 points (SD 0.8 points); serum eosinophil level, 4\% (SD 3\%); fractional exhaled nitric oxide (FeNO), 12.1 ppb (SD 6 ppb). Of the patients, 100\% (53/53) had uncontrolled symptoms, 69.8\% (37/53) had prior exacerbations, 100\% (53/53) used formoterol/budesonide, and 75.5\% (40/53) used glycopyrronium. The per protocol group (n=53) had significantly improved mean prebronchodilator FEV1 (23.7\%, SD 29.8\%; 0.46 L, SD 0.58 L; P<.001) and GINA asthma control score (2.1 points, SD 0.8 points, P<.001). At baseline, patients (n=40) receiving glycopyrronium/formoterol/budesonide (25/20/500 mcg) nebulization admixture had the following mean values: prebronchodilator FEV1, 38\% (SD 15\%); GINA asthma control score, 3.0 points (SD 0.8 points); reversibility, 12\% (SD 6\%); peripheral eosinophil level, 4\% (SD 3\%); FeNO, 12 ppb (SD 5.7 ppb). In the post hoc analyses, these patients had significantly improved mean prebronchodilator FEV1 of 27.7\% (SD 26.2\%; 0.54 L, SD 0.51 L; P<.001) at 8 weeks compared with baseline. At baseline, patients (n=13) receiving formoterol/budesonide (20/500 mcg) nebulization had the following mean values: FEV1, 55\% (SD 12\%); GINA asthma control score, 3.0 points (SD 1.2 points); reversibility, 14\% (SD 7\%); serum eosinophil level, 4\% (SD 3\%); FeNO, 13.3 ppb (SD 6.8 ppb). In the post hoc analyses, these patients showed a significant improvement in prebronchodilator FEV1 of 11.2\% (SD 13.1\%; 0.22 L, SD 0.25 L; P<.001) from baseline. Breathlessness of mild to moderate intensity was reported by 10 cases (10/53, 18.9\%), with no other treatment-emergent adverse events or serious adverse events. Conclusions: Home nebulization remains a viable option for symptomatic difficult-to-treat asthma cases with frequent use of rescue medications. Glycopyrronium as add-on therapy offers a synergistic response in patients on corticosteroids with difficult-to-treat asthma. Trial Registration: Clinical Trial Registry of India CTRI/2018/11/016319; https://tinyurl.com/y78cctm3 ", doi="10.2196/17863", url="http://www.i-jmr.org/2020/2/e17863/", url="http://www.ncbi.nlm.nih.gov/pubmed/32347812" } @Article{info:doi/10.2196/14351, author="Najm, Aurelie and Lempp, Heidi and Gossec, Laure and Berenbaum, Francis and Nikiphorou, Elena", title="Needs, Experiences, and Views of People With Rheumatic and Musculoskeletal Diseases on Self-Management Mobile Health Apps: Mixed Methods Study", journal="JMIR Mhealth Uhealth", year="2020", month="Apr", day="20", volume="8", number="4", pages="e14351", keywords="mHealth", keywords="mixed methods", keywords="mobile health apps", keywords="rheumatic and musculoskeletal disease", keywords="smartphone", keywords="apps", keywords="rheumatoid arthritis, digital health, mobile health", abstract="Background: Despite the growing interest and exponential popularity of mobile health (mHealth) apps for long-term conditions such as rheumatic and musculoskeletal diseases (RMDs) and their self-management, patients are rarely directly consulted and involved in the app development process. Objective: This study aims to explore the needs, experiences, and views of people diagnosed with RMDs on mHealth apps. Methods: The study used a mixed methods approach: (1) an initial qualitative phase via a patient focus group in the UK and (2) a survey disseminated through national organizations for patients with RMDs across European countries, the United States, Canada, and Australia. Results: The focus group included six patients with life-long musculoskeletal conditions. Half had used a self-management app at least once. The use of existing apps was reported as time-consuming due to a lack of functionality. The need for bespoke apps was voiced by all participants. Among 424 patients across European countries, the United States, Canada, and Australia, the main age group was 45 to 54 years (122/424, 28.7\%), and 86.8\% (368/424) were women. Half of the respondents were aware of the existence of apps to support self-management of their RMDs (188/355, 53\%), with 42\% (79/188) of them currently using such devices. Patients were mostly interested in an app to self-monitor their health parameters (259/346, 74.9\%) and disease activity (221/346, 63.9\%) or communicate directly with their health care provider (200/346, 57.8\%). Conclusions: Patients considered that using an app could help them to self-manage their RMD condition if it was tailored to their needs and co-developed with health professionals. The development of such apps will require standardization and regular quality control. ", doi="10.2196/14351", url="https://mhealth.jmir.org/2020/4/e14351", url="http://www.ncbi.nlm.nih.gov/pubmed/32310151" } @Article{info:doi/10.2196/13029, author="Volpicelli Leonard, Kathryn and Robertson, Courtney and Bhowmick, Amrita and Herbert, Beth Leslie", title="Perceived Treatment Satisfaction and Effectiveness Facilitators Among Patients With Chronic Health Conditions: A Self-Reported Survey", journal="Interact J Med Res", year="2020", month="Mar", day="6", volume="9", number="1", pages="e13029", keywords="treatment effectiveness", keywords="patient satisfaction", keywords="migraine", keywords="multiple sclerosis", keywords="rheumatoid arthritis", abstract="Background: Approximately 50\% of patients are nonadherent to prescribed medications. Patient perception regarding medication effectiveness has been linked to improved adherence. However, how patients perceive effectiveness is poorly understood. Objective: The aim of this study was to elucidate factors associated with perceived treatment satisfaction and effectiveness among patients with chronic health conditions. Methods: We conducted a descriptive study using a cross-sectional survey design. We administered a Web-based survey to participants with migraine, multiple sclerosis (MS), or rheumatoid arthritis (RA). Patients were recruited from established online communities of Health Union. Descriptive statistics, correlations, and comparison tests were used to examine outcomes. Results: Data were collected from 1820 patients: 567 with migraine, 717 with MS, and 536 with RA. The majority of participants were female (1644/1820, 90.33\%), >40 years old (1462/1820, 80.33\%), and diagnosed >5 years ago (1189/1820, 65.33\%). Treatment satisfaction and perceived medication effectiveness were highly correlated (r=0.90, P<.01). Overall, three temporal factors were positively correlated with satisfaction or perceived effectiveness: time on current medication (satisfaction rs=0.22, P<.01; effectiveness rs=0.25, P<.01), time since diagnosis (satisfaction rs=0.07, P<.01; effectiveness rs=0.09, P<.01), and time on treatment (effectiveness rs=0.08, P<.01). Conclusions: Findings validated the strong relationship between treatment satisfaction and perceived effectiveness. Understanding the (1) positive relationship between time and treatment satisfaction and effectiveness and (2) factors associated with determining medication effectiveness can help clinicians better understand the mindset of patients regarding treatment. Clinicians may be better prepared to elicit patient beliefs, which influence medication adherence, for people diagnosed with chronic health conditions. ", doi="10.2196/13029", url="http://www.i-jmr.org/2020/1/e13029/", url="http://www.ncbi.nlm.nih.gov/pubmed/32141836" } @Article{info:doi/10.2196/16767, author="Bastl, Katharina and Bastl, Maximilian and Bergmann, Karl-Christian and Berger, Markus and Berger, Uwe", title="Translating the Burden of Pollen Allergy Into Numbers Using Electronically Generated Symptom Data From the Patient's Hayfever Diary in Austria and Germany: 10-Year Observational Study", journal="J Med Internet Res", year="2020", month="Feb", day="21", volume="22", number="2", pages="e16767", keywords="symptom data", keywords="Patient's Hayfever Diary", keywords="pollen allergy", keywords="symptom score calculation", abstract="Background: Pollen allergies affect a significant proportion of the population globally. At present, Web-based tools such as pollen diaries and mobile apps allow for easy and fast documentation of allergic symptoms via the internet. Objective: This study aimed to characterize the users of the Patient's Hayfever Diary (PHD), a Web-based platform and mobile app, to apply different symptom score calculations for comparison, and to evaluate the contribution of organs and medications to the total score for the first time. Methods: The PHD users were filtered with regard to their location in Austria and Germany, significant positive correlation to the respective pollen type (birch/grass), and at least 15 entries in the respective season. Furthermore, 4 different symptom score calculation methods were applied to the datasets from 2009 until 2018, of which 2 were raw symptom scores and 2 were symptom load index (normalized) calculations. Pearson correlation coefficients were calculated pairwise for these 4 symptom score calculations. Results: Users were mostly male and belonged to the age groups of 21 to 40 years or >40 years. User numbers have increased in the last 5 years, especially when mobile apps were made available. The Pearson correlation coefficients showed a significant linear relationship above 0.9 among the 4 symptom score datasets and thus indicated no significant difference between the different methods of symptom score calculation. The nose contributed the most to the symptom score and determined about 40\% of the score. Conclusions: The exact method of calculation of the symptom score is not critical. All computation methods show the same behavior (increase/decrease during the season). Therefore, the symptom load index is a useful computation method in all fields exploring pollen allergy, and Web-based diaries are a globally applicable tool to monitor the effect of pollen on human health via electronically generated symptom data. ", doi="10.2196/16767", url="http://www.jmir.org/2020/2/e16767/", url="http://www.ncbi.nlm.nih.gov/pubmed/32130130" } @Article{info:doi/10.2196/15105, author="Seppen, F. Bart and L'ami, J. Merel and Duarte dos Santos Rico, Sharon and ter Wee, M. Marieke and Turkstra, Franktien and Roorda, D. Leo and Catarinella, S. Fabio and van Schaardenburg, Dirkjan and Nurmohamed, T. Michael and Boers, Maarten and Bos, H. Wouter", title="A Smartphone App for Self-Monitoring of Rheumatoid Arthritis Disease Activity to Assist Patient-Initiated Care: Protocol for a Randomized Controlled Trial", journal="JMIR Res Protoc", year="2020", month="Feb", day="19", volume="9", number="2", pages="e15105", keywords="smartphone app", keywords="telemonitoring", keywords="rheumatoid arthritis", abstract="Background: Telemedicine based on self-measurement of disease activity could be one of the key components to create the health care system of the future. Previous publications in various medical fields have shown that it is possible to safely telemonitor patients while reducing the number of outpatient clinic visits. For this purpose, we developed a mobile phone app for patients with rheumatoid arthritis (RA), which allows them to self-monitor their disease. Objective: The objective of this study is to assess the safety and efficacy of self-initiated care assisted by a smartphone app in patients with RA. Methods: This is a randomized controlled trial that will be performed for 1 year. A total of 176 patients with RA will be randomized to either self-initiated care with only one scheduled follow-up consultation assisted by our app or usual care. The coprimary outcome measures are the number of outpatient clinic consultations with a rheumatologist taking place during the trial period and the mean disease activity score as measured by the disease activity score 28 (DAS28) at 12 months. The secondary outcomes are patient satisfaction, adherence, patient empowerment, and cost evaluation of health care assisted by the app. Results: Recruitment started in May 2019, and up to 18 months will be required for completion of recruitment. Thus far, 78 patients have been randomized, and thus far, experiences with the app have been positive. The study results are expected to be published by the end of 2021. Conclusions: The completion of this study will provide important data regarding the following: (1) safety of self-initiated care supported by a smartphone app in terms of DAS28 and (2) efficacy of lowering health care usage with this new strategy of providing health care. Trial Registration: Netherlands Trial Register NL7715; https://www.trialregister.nl/trial/7715 International Registered Report Identifier (IRRID): DERR1-10.2196/15105 ", doi="10.2196/15105", url="http://www.researchprotocols.org/2020/2/e15105/", url="http://www.ncbi.nlm.nih.gov/pubmed/32130182" } @Article{info:doi/10.2196/15987, author="Plinsinga, Louise Melanie and Besomi, Manuela and Maclachlan, Liam and Melo, Luciano and Robbins, Sarah and Lawford, J. Belinda and Teo, Ling Pek and Mills, Kathryn and Setchell, Jenny and Egerton, Thorlene and Eyles, Jillian and Hall, Leanne and Mellor, Rebecca and Hunter, J. David and Hodges, Paul and Vicenzino, Bill and Bennell, Kim", title="Exploring the Characteristics and Preferences for Online Support Groups: Mixed Method Study", journal="J Med Internet Res", year="2019", month="Dec", day="3", volume="21", number="12", pages="e15987", keywords="osteoarthritis", keywords="self-help groups", keywords="self-management", keywords="surveys and questionnaires", abstract="Background: Osteoarthritis (OA) is a chronic, disabling, and prevalent disorder. As there is no cure for OA, long-term self-management is paramount. Support groups (SGs) can facilitate self-management among people living with OA. Understanding preferences in design and features of SGs, including online SGs (OSGs), among people with OA can inform future development of SG interventions for this condition. Objective: The objective of this study was to investigate health care-- and health information--seeking behavior, digital literacy, and preferences for the design of SGs in people with OA. The study also explored the perceived barriers and enablers to being involved in OSGs. Methods: An online survey study was conducted with a mixed method design (quantitative and qualitative). Individuals aged ?45 years with knee, hip, or back pain for ?3 months were recruited from an extant patient database of the Institute of Bone and Joint Research via email invitations. Quantitative elements of the survey included questions about sociodemographic background; health care-- and health information--seeking behavior; digital literacy; and previous participation in, and preferences for, SGs and OSGs. Respondents were classified into 2 groups (Yes-SG and No-SG) based on previous participation or interest in an SG. Group differences were assessed with Chi-square tests (significance level set at 5\%). Responses to free-text questions relating to preferences regarding OSG engagement were analyzed qualitatively using an inductive thematic analysis. Results: A total of 415 people with OA completed the survey (300/415, 72.3\% females; 252/415, 61.0\% lived in a major city). The Yes-SG group included 307 (307/415, 73.9\%) participants. Between the Yes-SG and No-SG groups, there were no differences in sociodemographic characteristics, health care-- and health information--seeking behavior, and digital literacy. An online format was preferred by 126/259 (48.7\%) of the Yes-SG group. Trained peer facilitators were preferred, and trustworthiness of advice and information were highly prioritized by the respondents. Qualitative analysis for OSG participation revealed 5 main themes. Lack of time and motivation were the main barriers identified. The main enablers were related to accessibility, enjoyment of the experience, and the content of the discussed information. Conclusions: These findings highlight the preferences in design features and content of SGs and OSGs and may assist in the further development of such groups. ", doi="10.2196/15987", url="https://www.jmir.org/2019/12/e15987", url="http://www.ncbi.nlm.nih.gov/pubmed/31793893" } @Article{info:doi/10.2196/14730, author="Najm, Aur{\'e}lie and Gossec, Laure and Weill, Catherine and Benoist, David and Berenbaum, Francis and Nikiphorou, Elena", title="Mobile Health Apps for Self-Management of Rheumatic and Musculoskeletal Diseases: Systematic Literature Review", journal="JMIR Mhealth Uhealth", year="2019", month="Nov", day="26", volume="7", number="11", pages="e14730", keywords="mobile health", keywords="self-management", keywords="arthritis", keywords="telemedicine", keywords="musculoskeletal diseases", abstract="Background: Although the increasing availability of mobile health (mHealth) apps may enable people with rheumatic and musculoskeletal diseases (RMDs) to better self-manage their health, there is a general lack of evidence on ways to ensure appropriate development and evaluation of apps. Objective: This study aimed to obtain an overview on existing mHealth apps for self-management in patients with RMDs, focusing on content and development methods. Methods: A search was performed up to December 2017 across 5 databases. For each publication relevant to an app for RMDs, information on the disease, purpose, content, and development strategies was extracted and qualitatively assessed. Results: Of 562 abstracts, 32 were included in the analysis. Of these 32 abstracts, 11 (34\%) referred to an app linked to a connected device. Most of the apps targeted rheumatoid arthritis (11/32, 34\%). The top three aspects addressed by the apps were pain (23/32, 71\%), fatigue (15/32, 47\%), and physical activity (15/32, 47\%). The development process of the apps was described in 84\% (27/32) of the articles and was of low to moderate quality in most of the cases. Despite most of the articles having been published within the past two years, only 5 apps were still commercially available at the time of our search. Moreover, only very few studies showed improvement of RMD outcome measures. Conclusions: The development process of most apps was of low or moderate quality in many studies. Owing to the increasing RMD patients' willingness to use mHealth apps for self-management, optimal standards and quality assurance of new apps are mandatory. ", doi="10.2196/14730", url="https://mhealth.jmir.org/2019/11/e14730", url="http://www.ncbi.nlm.nih.gov/pubmed/31769758" } @Article{info:doi/10.2196/12225, author="Lander, Jonas and Drixler, Karin and Dierks, Marie-Luise and Bitzer, Maria Eva", title="How Do Publicly Available Allergy-Specific Web-Based Training Programs Conform to the Established Criteria for the Reporting, Methods, and Content of Evidence-Based (Digital) Health Information and Education: Thematic Content Evaluation", journal="Interact J Med Res", year="2019", month="Oct", day="24", volume="8", number="4", pages="e12225", keywords="allergy", keywords="asthma", keywords="health communication", keywords="health education", keywords="health information systems", keywords="evidence-based practice", abstract="Background: Allergic diseases, such as allergic asthma, rhinitis, and atopic eczema, are widespread, and they are a considerable burden on the health care system. For patients and health care professionals, Web-based training programs may be helpful to foster self-management and provide allergy-specific information, given, for instance, their good accessibility. Objective: This study aimed to assess an exploratory sample of publicly available allergy-specific Web-based training programs---that is, interactive, feedback-oriented Web-based training platforms promoting health behavior change and improvement of personal skills---with regard to (1) general characteristics, aims, and target groups and (2) the extent to which these tools meet established criteria for the reporting, methods, and content of evidence-based (digital) health information and education. Methods: Web-based training programs were identified via an initial Google search and a search of English and German language websites of medical and public health services, such as the European Centre for Allergy Research Foundation (German), Asthma UK, and Anaphylaxis Canada. We developed a checklist from (1) established guidelines for Web-based health information (eg, the Journal of the American Medical Association benchmarks, DISCERN criteria, and Health On the Net code) and (2) a database search of related studies. The checklist contained 44 items covering 11 domains in 3 areas: (1) content (completeness, transparency, and evidence), (2) structure (data safety and qualification of trainers and authors), and (3) impact (effectiveness, user perspective, and integration into health care). We rated the Web-based training programs as completely, partly, or not satisfying each checklist item and calculated overall and domain-specific scores for each Web-based training program using SPSS 23.0 (SPSS Inc). Results: The 15 identified Web-based training programs covered an average of 37\% of the items (score 33 out of 88). A total of 7 Web-based training programs covered more than 40\% (35/88; maximum: 49\%; 43/88). A total of 5 covered 30\% (26/88) to 40\% (35/88) of all rated items and the rest covered fewer (n=3; lowest score 24\%; 21/88). Items relating to intervention (58\%; 10/18), content (49\%; 9/18), and data safety (60\%; 1/2) were more often considered, as opposed to user safety (10\%; 0.4/4), qualification of staff (10\%; 0.8/8), effectiveness (16\%; 0.4/2), and user perspective (45\%; 5/12). In addition, in 13 of 15 Web-based training programs, a minimum of 3 domains were not covered at all. Regarding evidence-based content, 46\% of all Web-based training programs (7/15) scored on use of scientific research, 53\% on regular information update (8/15), and 33\% on provision of references (5/15). None of 15 provided details on the quality of references or the strength of evidence. Conclusions: English and German language allergy-specific Web-based training programs, addressing lay audiences and health care professionals, conform only partly to established criteria for the reporting, methods, and content of evidence-based (digital) health information and education. Particularly, well-conducted studies on their effectiveness are missing. ", doi="10.2196/12225", url="http://www.i-jmr.org/2019/4/e12225/", url="http://www.ncbi.nlm.nih.gov/pubmed/31651401" } @Article{info:doi/10.2196/13414, author="Gaziel Yablowitz, Michal and D{\"o}lle, Sabine and Schwartz, G. David and Worm, Margitta", title="Proximity-Based Emergency Response Communities for Patients With Allergies Who Are at Risk of Anaphylaxis: Clustering Analysis and Scenario-Based Survey Study", journal="JMIR Mhealth Uhealth", year="2019", month="Aug", day="22", volume="7", number="8", pages="e13414", keywords="consumer health informatics", keywords="anaphylaxis", keywords="emergency responders", keywords="social networking", keywords="telemedicine", abstract="Background: Anaphylaxis is a potentially fatal allergic reaction. However, many patients at risk of anaphylaxis who should permanently carry a life-saving epinephrine auto injector (EAI) do not carry one at the moment of allergen exposure. The proximity-based emergency response communities (ERC) strategy suggests speeding EAI delivery by alerting patient-peers carrying EAI to respond and give their EAI to a nearby patient in need. Objectives: This study had two objectives: (1) to analyze 10,000 anaphylactic events from the European Anaphylaxis Registry (EAR) by elicitor and location in order to determine typical anaphylactic scenarios and (2) to identify patients' behavioral and spatial factors influencing their response to ERC emergency requests through a scenario-based survey. Methods: Data were collected and analyzed in two phases: (1) clustering 10,000 EAR records by elicitor and incident location and (2) conducting a two-center scenario-based survey of adults and parents of minors with severe allergy who were prescribed EAI, in Israel and Germany. Each group received a four-part survey that examined the effect of two behavioral constructs---shared identity and diffusion of responsibility---and two spatial factors---emergency time and emergency location---in addition to sociodemographic data. We performed descriptive, linear correlation, analysis of variance, and t tests to identify patients' decision factors in responding to ERC alerts. Results: A total of 53.1\% of EAR cases were triggered by food at patients' home, and 46.9\% of them were triggered by venom at parks. Further, 126 Israeli and 121 German participants completed the survey and met the inclusion criteria. Of the Israeli participants, 80\% were parents of minor patients with a risk of anaphylaxis due to food allergy; their mean age was 32 years, and 67\% were women. In addition, 20\% were adult patients with a mean age of 21 years, and 48\% were female. Among the German patients, 121 were adults, with an average age of 47 years, and 63\% were women. In addition, 21\% were allergic to food, 75\% were allergic to venom, and 2\% had drug allergies. The overall willingness to respond to ERC events was high. Shared identity and the willingness to respond were positively correlated (r=0.51, P<.001) in the parent group. Parents had a stronger sense of shared identity than adult patients (t243= --9.077, P<.001). The bystander effect decreased the willingness of all patients, except the parent group, to respond (F1,269=28.27, P<.001). An interaction between location and time of emergency (F1,473=77.304, P<.001) revealed lower levels of willingness to respond in strange locations during nighttime. Conclusions: An ERC allergy app has the potential to improve outcomes in case of anaphylactic events, but this is dependent on patient-peers' willingness to respond. Through a two-stage process, our study identified the behavioral and spatial factors that could influence the willingness to respond, providing a basis for future research of proximity-based mental health communities. ", doi="10.2196/13414", url="http://mhealth.jmir.org/2019/8/e13414/", url="http://www.ncbi.nlm.nih.gov/pubmed/31441432" } @Article{info:doi/10.2196/10812, author="Hamshaw, Thomas Richard James and Barnett, Julie and Gavin, Jeff and Lucas, S. Jane", title="Perceptions of Food Hypersensitivity Expertise on Social Media: Qualitative Study", journal="Interact J Med Res", year="2019", month="Jun", day="28", volume="8", number="2", pages="e10812", keywords="social media", keywords="food allergy", keywords="food hypersensitivity", keywords="celiac disease", keywords="food intolerance", keywords="interviews as topic", keywords="qualitative methods", abstract="Background: Seeking and sharing information are the primary uses of the internet and social media. It is therefore vital to understand the processes individuals go through when engaging with information on these diverse platforms, especially in areas such as health- and risk-related information. One important element of such engagement is evaluating and attributing expertise to others. Objective: This study aimed to explore how meanings around expertise in relation to food allergy and intolerance (food hypersensitivity) were constructed by 2 groups of social media users: (1) those who use platforms for reasons relating to food hypersensitivity and (2) those seen as experts by this community. Methods: Survey participants were asked open-ended questions to identify potential experts in food hypersensitivity issues on social media and to discuss their reasoning for their choices (n=143). Subsequently, 8 adult social media users with experience of managing food hypersensitivity and 5 participants designated as experts by those users took part in email interviews. Survey and interview data were analyzed thematically using Braun and Clarke's approach. Results: Judging expertise on social media is a complex and multifaceted process. Users might be judged as experts through their professional background or their experience living with food hypersensitivities. How users behave on social media and the traces of their Web-based activity can influence how others will see them. Such considerations are both measured and moderated through the social media community itself. Findings highlighted how social media often act as a supportive information tool following a diagnosis, but this also raised concerns regarding the scenario of patients not being able to access suitable vetted information. Conclusions: This work has implications for understanding how users perceive expertise on social media in relation to a health concern and how information assessments are made during the management of risks. Findings provide practical insights to both medical and organizational stakeholders involved in the support of those living with life-changing conditions, such as food hypersensitivities. ", doi="10.2196/10812", url="http://www.i-jmr.org/2019/2/e10812/", url="http://www.ncbi.nlm.nih.gov/pubmed/31254334" } @Article{info:doi/10.2196/13698, author="Liran, Omer and Dasher, Robert and Kaeochinda, Kevin", title="Using Virtual Reality to Improve Antiretroviral Therapy Adherence in the Treatment of HIV: Open-Label Repeated Measure Study", journal="Interact J Med Res", year="2019", month="Jun", day="20", volume="8", number="2", pages="e13698", keywords="HAART", keywords="technology", keywords="virtual reality", keywords="medication adherence", keywords="viral load", keywords="education", abstract="Background: Nonadherence to HIV medications is a serious unsolved problem and is a major cause of morbidity and mortality in the HIV-positive population. Although treatment efficacy is high if compliance is greater than 90\%, about 40\% of people with HIV do not meet this threshold. Objective: This study aimed to test a novel approach to improve medication adherence by using a low-cost virtual reality (VR) experience to educate people with HIV about their illness. We hypothesized that people with HIV would be more likely to be compliant with the treatment following the 7-minute experience and, therefore, should have decreasing viral load (VL), increasing cluster of differentiation 4+ (CD4+) cell counts, and improved self-reported adherence. Methods: We showed the VR experience to 107 participants with HIV at a county hospital in Los Angeles, California. Participants were asked to self-report how often they take their medications on a Likert-scale. The self-reported question (SRQ) was given before and at least 2 weeks after the VR experience. We also compared VL and CD4+ cell counts before and on average 101 days after the experience. VL and CD4+ were obtained per the clinic's standard care protocol. Two-tailed paired t tests were performed on the initial and follow-up SRQ scores, VL, and CD4+. We restricted the CD4+ analysis to participants who had a pre-CD4+ below normal (defined as 500 cells/mm3). To reduce the possibility that VL were trending down and CD4+ were trending up regardless of the VR experience, 2 serial VL and CD4+ obtained before the experience were also compared and analyzed. Immediately following the VR experience, participants were given a 4-question Likert-type postexperience questionnaire (PEQ) that assessed their opinions about the experience. Results: SRQ scores improved from pre to post experience with high significance (P<.001). VL decreased from pre to post experience by 0.38 log10 copies/mL (95\% CI 0.06-0.70; P=.02). In contrast, the 2 serial VL obtained before the experience showed no statistically significant changes. There was also a statistically significant increase in CD4+ (95\% CI --3.4 to --54.3 cells/mm3; P=.03). Analysis of the PEQ revealed that VR was comfortable for almost all of the participants and that most participants believed the experience to be educational and that it would improve their medication adherence. Conclusions: The findings suggest that the low-cost VR experience caused an increased rate of antiretroviral therapy adherence that resulted in a decrease of VL and an increase of CD4+. Further studies are required to explore the duration of this effect and whether these results are generalizable to other treatment settings and populations. ", doi="10.2196/13698", url="http://www.i-jmr.org/2019/2/e13698/", url="http://www.ncbi.nlm.nih.gov/pubmed/31223117" } @Article{info:doi/10.2196/12605, author="Van den Eynde, Jef and Crauwels, Alexander and Demaerel, Georg Philip and Van Eycken, Lisa and Bullens, Dominique and Schrijvers, Rik and Toelen, Jaan", title="YouTube Videos as a Source of Information About Immunology for Medical Students: Cross-Sectional Study", journal="JMIR Med Educ", year="2019", month="May", day="28", volume="5", number="1", pages="e12605", keywords="antigen presentation", keywords="education", keywords="immunoglobulins", keywords="immunology", keywords="learning", keywords="students", abstract="Background: The use of the internet as a source of information has grown exponentially in the last decade. YouTube is currently the second most visited website and a major Web-based educational resource for medical students. Objective: The aim of this study was to evaluate the quality, accuracy, and attractiveness of the information acquired from YouTube videos about 2 central concepts in immunology. Methods: YouTube videos posted before August 27, 2018 were searched using selected keywords related to either antigen presentation or immunoglobulin gene rearrangement. Video characteristics were recorded, and the Video Power Index (VPI) was calculated. Videos were assessed using 5 validated scoring systems: understandability and attractiveness, reliability, content and comprehensiveness, global quality score (GQS), and a subjective score. Videos were categorized by educational usefulness and by source. Results: A total of 82 videos about antigen presentation and 70 about immunoglobulin gene rearrangement were analyzed. Videos had a mean understandability and attractiveness score of 6.57/8 and 5.84/8, content and comprehensiveness score of 9.84/20 and 5.84/20, reliability score of 1.65/4 and 1.53/4, GQS of 3.38/5 and 2.76/5, and subjective score of 2.00/3 and 2.00/3, respectively. The organized channels group tended to have the highest VPI and GQS. Conclusions: YouTube can provide medical students with some useful information about immunology, although content wise it cannot substitute textbooks and academic courses. Students and teachers should be aware of the educational quality of available videos if they intend to use them in the context of blended learning. ", doi="10.2196/12605", url="http://mededu.jmir.org/2019/1/e12605/", url="http://www.ncbi.nlm.nih.gov/pubmed/31140440" } @Article{info:doi/10.2196/10450, author="Wakamiya, Shoko and Matsune, Shoji and Okubo, Kimihiro and Aramaki, Eiji", title="Causal Relationships Among Pollen Counts, Tweet Numbers, and Patient Numbers for Seasonal Allergic Rhinitis Surveillance: Retrospective Analysis", journal="J Med Internet Res", year="2019", month="Feb", day="20", volume="21", number="2", pages="e10450", keywords="seasonal allergic rhinitis", keywords="social media", keywords="Twitter", keywords="causal relationship", keywords="infoveillance", keywords="disease surveillance", abstract="Background: Health-related social media data are increasingly used in disease-surveillance studies, which have demonstrated moderately high correlations between the number of social media posts and the number of patients. However, there is a need to understand the causal relationship between the behavior of social media users and the actual number of patients in order to increase the credibility of disease surveillance based on social media data. Objective: This study aimed to clarify the causal relationships among pollen count, the posting behavior of social media users, and the number of patients with seasonal allergic rhinitis in the real world. Methods: This analysis was conducted using datasets of pollen counts, tweet numbers, and numbers of patients with seasonal allergic rhinitis from Kanagawa Prefecture, Japan. We examined daily pollen counts for Japanese cedar (the major cause of seasonal allergic rhinitis in Japan) and hinoki cypress (which commonly complicates seasonal allergic rhinitis) from February 1 to May 31, 2017. The daily numbers of tweets that included the keyword ``kafunsh?'' (or seasonal allergic rhinitis) were calculated between January 1 and May 31, 2017. Daily numbers of patients with seasonal allergic rhinitis from January 1 to May 31, 2017, were obtained from three healthcare institutes that participated in the study. The Granger causality test was used to examine the causal relationships among pollen count, tweet numbers, and the number of patients with seasonal allergic rhinitis from February to May 2017. To determine if time-variant factors affect these causal relationships, we analyzed the main seasonal allergic rhinitis phase (February to April) when Japanese cedar trees actively produce and release pollen. Results: Increases in pollen count were found to increase the number of tweets during the overall study period (P=.04), but not the main seasonal allergic rhinitis phase (P=.05). In contrast, increases in pollen count were found to increase patient numbers in both the study period (P=.04) and the main seasonal allergic rhinitis phase (P=.01). Increases in the number of tweets increased the patient numbers during the main seasonal allergic rhinitis phase (P=.02), but not the overall study period (P=.89). Patient numbers did not affect the number of tweets in both the overall study period (P=.24) and the main seasonal allergic rhinitis phase (P=.47). Conclusions: Understanding the causal relationships among pollen counts, tweet numbers, and numbers of patients with seasonal allergic rhinitis is an important step to increasing the credibility of surveillance systems that use social media data. Further in-depth studies are needed to identify the determinants of social media posts described in this exploratory analysis. ", doi="10.2196/10450", url="http://www.jmir.org/2019/2/e10450/", url="http://www.ncbi.nlm.nih.gov/pubmed/30785411" } @Article{info:doi/10.2196/ijmr.9625, author="Fogel, Rachel and Comerford, Megan and Chilukuri, Prianka and Orman, Eric and Chalasani, Naga and Lammert, Craig", title="Extrahepatic Autoimmune Diseases are Prevalent in Autoimmune Hepatitis Patients and Their First-Degree Relatives: Survey Study", journal="Interact J Med Res", year="2018", month="Dec", day="19", volume="7", number="2", pages="e18", keywords="autoimmune hepatitis", keywords="first-degree relatives", keywords="social media", abstract="Background: Concurrent autoimmune illnesses contribute to increased medical burden and reduced quality of life in patients with autoimmune hepatitis (AIH). The frequency of coexisting autoimmune conditions among North American patients with AIH and their families remains incomplete. Challenges associated with disease capture in the electronic medical record, high study costs, and geographic spread of patients are formidable barriers to understanding the extent of concurrent autoimmune conditions in these groups. Objective: This objective of this study was to examine the frequency of extrahepatic autoimmune diseases (EHAD) among AIH cases and healthy controls as well as their first-degree relatives using social networking sites (SNS). Methods: We developed a 53-question survey detailing the history of autoimmune diseases. A survey link was posted at routine intervals within specific Web-based cohorts on SNS. Healthy controls, without self-reported autoimmune liver disease, were recruited from Amazon's Mechanical Turk. Continuous variables were summarized using medians and P values obtained with the Wilcoxon rank-sum test. Categorical variables were compared using the chi-square test. Results: Compared with controls (n=1162), cases (n=306) were more likely to be older (median age: 49 vs 33 years), female (284/306, 92.81\% vs 955/1162, 82.18\%), and have an EHAD (128/306, 41.83\% vs 218/1162, 18.76\%; P=.001). The most frequent EHADs among cases were thyroid disease (49/306, 16.01\% ), Sj{\"o}gren syndrome (27/306, 8.82\%), Raynaud phenomenon (23/306, 7.52\%), and psoriasis (22/306, 7.19\%). Overall, 55.88\% (171/306) of cases and 35.71\% (1601/4484) of controls reported at least 1 first-degree relative (FDR) with a history of EHAD (P=.001). Cases had a significantly higher risk of EHAD than controls after the adjustment for age, sex, race, and body mass index: odds ratio 2.46 (95\% CI 1.8-3.3); P=.001. Conclusions: Patients with AIH report higher prevalence of coexistent EHAD than healthy controls, and their FDRs are also more likely to have autoimmune disorders. ", doi="10.2196/ijmr.9625", url="http://www.i-jmr.org/2018/2/e18/", url="http://www.ncbi.nlm.nih.gov/pubmed/30567687" } @Article{info:doi/10.2196/11354, author="de Lusignan, Simon and McGee, Christopher and Webb, Rebecca and Joy, Mark and Byford, Rachel and Yonova, Ivelina and Hriskova, Mariya and Matos Ferreira, Filipa and Elliot, J. Alex and Smith, Gillian and Rafi, Imran", title="Conurbation, Urban, and Rural Living as Determinants of Allergies and Infectious Diseases: Royal College of General Practitioners Research and Surveillance Centre Annual Report 2016-2017", journal="JMIR Public Health Surveill", year="2018", month="Nov", day="26", volume="4", number="4", pages="e11354", keywords="population surveillance", keywords="respiratory tract infections", keywords="conjunctivitis, allergic", keywords="asthma", keywords="urinary tract infections", keywords="gastroenteritis", keywords="healthcare disparities", keywords="socioeconomic factors", keywords="social determinants of health", keywords="medical records systems, computerized", keywords="data collection", keywords="records as topic", keywords="primary health care", keywords="general practice", keywords="infectious diseases", abstract="Background: Living in a conurbation, urban, or rural environment is an important determinant of health. For example, conurbation and rural living is associated with increased respiratory and allergic conditions, whereas a farm or rural upbringing has been shown to be a protective factor against this. Objective: The objective of the study was to assess differences in general practice presentations of allergic and infectious disease in those exposed to conurbation or urban living compared with rural environments. Methods: The population was a nationally representative sample of 175 English general practices covering a population of over 1.6 million patients registered with sentinel network general practices. General practice presentation rates per 100,000 population were reported for allergic rhinitis, asthma, and infectious conditions grouped into upper and lower respiratory tract infections, urinary tract infection, and acute gastroenteritis by the UK Office for National Statistics urban-rural category. We used multivariate logistic regression adjusting for age, sex, ethnicity, deprivation, comorbidities, and smoking status, reporting odds ratios (ORs) with 95\% CIs. Results: For allergic rhinitis, the OR was 1.13 (95\% CI 1.04-1.23; P=.003) for urban and 1.29 (95\% CI 1.19-1.41; P<.001) for conurbation compared with rural dwellers. Conurbation living was associated with a lower OR for both asthma (OR 0.70, 95\% CI 0.67-0.73; P<.001) and lower respiratory tract infections (OR 0.94, 95\% CI 0.90-0.98; P=.005). Compared with rural dwellers, the OR for upper respiratory tract infection was greater in urban (OR 1.06, 95\% CI 1.03-1.08; P<.001) but no different in conurbation dwellers (OR 1.00, 95\% CI 0.97-1.03; P=.93). Acute gastroenteritis followed the same pattern: the OR was 1.13 (95\% CI 1.01-1.25; P=.03) for urban dwellers and 1.04 (95\% CI 0.93-1.17; P=.46) for conurbation dwellers. The OR for urinary tract infection was lower for urban dwellers (OR 0.94, 95\% CI 0.89-0.99; P=.02) but higher in conurbation dwellers (OR 1.06, 95\% CI 1.00-1.13; P=.04). Conclusions: Those living in conurbations or urban areas were more likely to consult a general practice for allergic rhinitis and upper respiratory tract infection. Both conurbation and rural living were associated with an increased risk of urinary tract infection. Living in rural areas was associated with an increased risk of asthma and lower respiratory tract infections. The data suggest that living environment may affect rates of consultations for certain conditions. Longitudinal analyses of these data would be useful in providing insights into important determinants. ", doi="10.2196/11354", url="http://publichealth.jmir.org/2018/4/e11354/", url="http://www.ncbi.nlm.nih.gov/pubmed/30478022" } @Article{info:doi/10.2196/ijmr.7612, author="Gorczynski, Reginald and Hoffmann, Geoffrey", title="Toward a New Kind of Vaccine: A Logical Extension of the Symmetrical Immune Network Theory", journal="Interact J Med Res", year="2017", month="Jul", day="05", volume="6", number="2", pages="e8", keywords="immunity", keywords="anti-idiotype antibodies immune system concepts", keywords="information networks", abstract="Background: The symmetrical immune network theory, developed in 1975, is based on the existence of specific T cell factors and hypothesizes that normal IgG immune responses comprise the production of 2 kinds of antibodies, namely antigen-specific antibodies and anti-idiotypic antibodies. Objective: The aim of this study was to confirm the existence of specific T cells factors and to show that immunization of C3H mice with BL/6 skin or using nominal antigen for immunization (Tetanus Toxoid) induced production of antigen-specific (anti-BL/6 or antitetanus) antibodies plus anti-idiotypic antibodies (C3H anti-anti-C3H). Subsequently, we investigated the role of combinations of antigen-specific and anti-idiotype antibodies in a variety of animal models of clinical diseases. Methods: Antigen-specific antibodies were produced by conventional immunization of mice (eg, with tetanus toxoid or by skin allografting). Subsequent anti-idiotypic antibodies were derived by exhaustive absorption of antigen-specific antibody, with confirmation of anti-idiotypic specificity by binding to relevant target antigen-specific antibodies in an enzyme-linked immunosorbent assay (ELISA). Antigen-specific plus anti-idiotypic antibodies were then used to modulate skin allograft survival, dextran sulfate sodium?(DSS)-induced colitis, ovalbumin (OVA)-induced IgE production, and breast cancer growth in mice. Results: Infusions of anti-BL/6 antibodies together with BL/6 anti-anti-BL/6 antibodies specifically suppressed (>85\%) an immune response to BL/6 lymphocytes in C3H mice. The two kinds of antibodies with complementary specificity are hypothesized to stimulate 2 populations of T lymphocytes. Coselection of these 2 populations leads to a new stable steady state of the system with diminished reactivity to BL/6 tissue. A combination of anti-C3H and C3H?anti?anti-C3H IgG antibodies down-regulated inflammation in a mouse model of inflammatory bowel disease (>75\%) and attenuated anti-IgE production and sensitization to produce IL4 cytokines (>70\%) in an OVA-allergy model. Combination of C3H anti?BL/6 and BL/6 anti-anti-BL/6 antibodies decreased tumor growth and metastases (>705) in an EMT6 transplantable breast cancer model. Conclusions: Use of a combination of antigen-specific and anti-idiotypic antibodies has potential as a new class of vaccines. ", doi="10.2196/ijmr.7612", url="http://www.i-jmr.org/2017/2/e8/", url="http://www.ncbi.nlm.nih.gov/pubmed/28679488" }