%0 Journal Article %@ 2291-5222 %I JMIR Publications %V 13 %N %P e59228 %T Efficacy of a Digital Postoperative Rehabilitation Intervention in Patients With Primary Liver Cancer: Randomized Controlled Trial %A Yu,Kaitao %A Yin,Baobing %A Zhu,Ying %A Meng,Hongdao %A Zhu,Wenwei %A Lu,Lu %A Wang,Junqiao %A Chen,Shugeng %A Ni,Jun %A Lin,Yifang %A Jia,Jie %K digital health %K surgery %K exercise rehabilitation %K randomized controlled trial %K primary liver cancer %D 2025 %7 7.4.2025 %9 %J JMIR Mhealth Uhealth %G English %X Background: Rehabilitation is considered a fundamental component of cancer treatment, especially for patients undergoing cancer surgery. In contrast to conventional rehabilitation education, digital rehabilitation has the potential to improve patients’ access to postoperative rehabilitation programs. While digital health has rapidly emerged to aid patients with various diseases, their clinical efficacy in the recovery of patients with primary liver cancer (PLC) undergoing hepatectomy remains inadequately investigated. Objective: This study aims to evaluate whether a digital postoperative rehabilitation intervention is efficient in improving physical fitness, enhancing exercise adherence, and alleviating fatigue among patients with PLC after hepatectomy. Methods: A randomized controlled trial was undertaken across 2 university-affiliated hospitals in Eastern China. A total of 100 participants were enrolled in this study and were allocated randomly to either the digital health (intervention group, n=50) or the rehabilitation manual-based group (control group, n=50) at a 1:1 ratio. Patients were unblinded and prospectively followed for the intervention of 3 weeks. Outcome measures included physical fitness, exercise adherence, and status of fatigue. Results: Overall, 91 out of 100 patients completed the research and were evaluated after 3 weeks of intervention. The digital health group showed better cardiopulmonary endurance than the control group. The mean difference in the change of 6-minute walk test distance from baseline between the groups was 70.21 (95% CI 0.730-82.869) m (P=.05). No statistically significant effects were found for grip strength, 5-repetition-sit-to-stand test time, and fatigue. The exercise adherence in the digital health group was higher than that in the control group (χ22=15.871, P<.001). Conclusions: The findings suggested that the implementation of digital health had a positive impact on recovery in exercise capacity after hepatectomy. In addition, rehabilitation exercise mode based on digital health has the potential to improve the exercise adherence of patients with PLC compared to conventional manual-based rehabilitation guidance. Trial Registration: Chinese Clinical Trial Registry ChiCTR2100052911; https://www.chictr.org.cn/showproj.html?proj=135351 %R 10.2196/59228 %U https://mhealth.jmir.org/2025/1/e59228 %U https://doi.org/10.2196/59228 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e66350 %T Epidemiological Characteristics of Intestinal Protozoal Infections and Their Risk Factors in Malaysia: Systematic Review and Meta-Analysis Protocol %A Mizan,Nor Shazlina %A Al-Talib,Hassanain %A Wang,Seok Mui %+ Department of Medical Microbiology and Parasitology, Faculty of Medicine, Universiti Teknologi MARA, Jalan Hospital, Sungai Buloh, 47000, Malaysia, 60 179131562, hassanain@uitm.edu.my %K intestinal protozoa %K infection %K gastroenteritis %K epidemiology %K parasite %K risk factor %K Malaysia %K contamination %K diarrhea %K outbreak %K socioeconomic %K sanitation %K systematic review %K meta-analysis %K protocol %K observational %K PRISMA %D 2025 %7 4.4.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Intestinal protozoal infections caused by Entamoeba histolytica, Giardia lamblia, and Cryptosporidium parvum are prevalent in Malaysia. They cause severe diarrheal diseases with symptoms such as bloody stools, abdominal pain, stomach discomfort, and bloating. These infection outbreaks have been reported in diverse socioeconomic backgrounds and geographical regions usually during the rainy season or in areas with poor sanitation. Despite the importance of these infections, data on its overall prevalence, risk factors, and diagnostic methods remain limited. Objective: The aim of this study is to systematically review and synthesize evidence on the risk factors, prevalence, and detection methods for intestinal protozoal infections in Malaysia, offering insights that are applicable to other tropical and low-income regions. Methods: Studies on intestinal protozoal infections among Malaysian patients published after January 2010 up to November 2024 will be eligible for inclusion. The eligibility criteria include studies investigating infections caused by E. histolytica, G. lamblia, and C. parvum using validated diagnostic methods such as microscopy, molecular techniques, or immunoassays. Case reports, reviews, and studies without original data will be excluded. Comprehensive database searches will be conducted in PubMed/MEDLINE, Scopus, ProQuest, Web of Science, Google Scholar, and the Cochrane Library. The reference lists of selected papers are also checked. A standardized data extraction form will be used to record study characteristics, outcomes, and associated variables. Risk of bias will be assessed using the Joanna Briggs Institute tools and Newcastle-Ottawa Scale approach. Data synthesis will utilize a random effects model to estimate pooled prevalence and identify risk factors associated with these infections. Subgroup analyses will examine variations by geographic region and diagnostic method. Statistical heterogeneity will be assessed using I2 statistic and meta-regression. Publication bias will be assessed using Egger and Begg funnel plot test. The results are reported in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Results: This systematic review was funded in June 2024. Database searches were started in July 2024, and we identified 1652 papers as of December 2024 for screening. Completion of study screening is anticipated by May 2025, with data extraction and analysis expected to conclude by December 2025. Conclusions: Our study will address critical knowledge gaps in the epidemiology and risk factors of intestinal protozoal infections in Malaysia. Study limitations include potential bias in study selection, heterogeneity in diagnostic methods, and differences in the reporting quality of the included studies. Our findings will provide valuable insights into the prevalence of these infections, the associated risk factors, and the diagnostic techniques employed, which should strengthen public health measures, improve diagnostic procedures, and guide future research to reduce the prevalence of intestinal protozoal infections in Malaysia. Trial Registration: PROSPERO (International Prospective Registry of Systematic Reviews) registration CRD42023456199; https://www.crd.york.ac.uk/PROSPERO/view/CRD42023456199 International Registered Report Identifier (IRRID): DERR1-10.2196/66350 %M 40184188 %R 10.2196/66350 %U https://www.researchprotocols.org/2025/1/e66350 %U https://doi.org/10.2196/66350 %U http://www.ncbi.nlm.nih.gov/pubmed/40184188 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e60019 %T Application of Internet Hospitals in the Disease Management of Patients With Ulcerative Colitis: Retrospective Study %A Yu,Tianzhi %A Li,Wanyu %A Liu,Yingchun %A Jin,Chunjie %A Wang,Zimin %A Cao,Hailong %+ Department of Gastroenterology, National Key Clinical Specialty, Tianjin Medical University General Hospital, 154 Anshan Road in Heping District, Tianjin, 300052, China, 86 +86 022 6036155, caohailong@tmu.edu.cn %K inflammatory bowel disease %K ulcerative colitis %K intelligent diagnosis and treatment service %K internet hospital %K chronic disease management %D 2025 %7 18.3.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Ulcerative colitis (UC) is a chronic disease characterized by frequent relapses, requiring long-term management and consuming substantial medical and social resources. Effective management of UC remains challenging due to the need for sustainable remission strategies, continuity of care, and access to medical services. Intelligent diagnosis refers to the use of artificial intelligence–driven algorithms to analyze patient-reported symptoms, generate diagnostic probabilities, and provide treatment recommendations through interactive tools. This approach could potentially function as a method for UC management. Objective: This study aimed to analyze the diagnosis and treatment data of UC from both physical hospitals and internet hospitals, highlighting the potential benefits of the intelligent diagnosis and treatment service model offered by internet hospitals. Methods: We collected data on the visits of patients with UC to the Department of Gastroenterology at Tianjin Medical University General Hospital. A total of 852 patients with UC were included between July 1, 2020, and June 31, 2023. Statistical methods, including chi-square tests for categorical variables, t tests for continuous variables, and rank-sum tests for visit numbers, were used to evaluate the medical preferences and expenses of patients with UC. Results: We found that internet hospitals and physical hospitals presented different medical service models due to the different distribution of medical needs and patient groups. Patients who chose internet hospitals focused on disease consultation and prescription medication (3295/3528, 93.40%). Patients’ medical preferences gradually shifted to web-based services provided by internet hospitals. Over time, 58.57% (270/461) of patients chose either web-based services or a combination of web-based and offline services for UC diagnosis and treatment. The number of visits in the combination of web-based and offline service modes was the highest (mean 13.83, SD 11.07), and younger patients were inclined to visit internet hospitals (49.66%>34.71%). In addition, compared with physical hospitals, there was no difference in testing fees and examination fees for patients with UC in internet hospitals, but medicine fees were lower. Conclusions: The intelligent diagnosis and treatment model provided by internet hospitals demonstrates the potential benefits in managing UC, including feasibility, accessibility, convenience, and economics. %M 40101745 %R 10.2196/60019 %U https://www.jmir.org/2025/1/e60019 %U https://doi.org/10.2196/60019 %U http://www.ncbi.nlm.nih.gov/pubmed/40101745 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 27 %N %P e58855 %T The Reliability and Quality of Videos as Guidance for Gastrointestinal Endoscopy: Cross-Sectional Study %A Liu,Jinpei %A Qiu,Yifan %A Liu,Yilong %A Xu,Wenping %A Ning,Weichen %A Shi,Peimei %A Yuan,Zongli %A Wang,Fang %A Shi,Yihai %+ Department of Gastroenterology, Gongli Hospital of Shanghai Pudong New Area, Pudong New Area 219 Miaopu Road, Shanghai, 200135, China, 86 5885873, syh01206@163.com %K gastrointestinal endoscopy %K YouTube %K patient education %K social media gastrointestinal %K large language model %K LLM %K reliability %K quality %K video %K cross-sectional study %K endoscopy-related videos %K health information %K endoscopy %K gastroscopy %K colonoscopy %D 2025 %7 11.3.2025 %9 Original Paper %J J Med Internet Res %G English %X Background: Gastrointestinal endoscopy represents a useful tool for the diagnosis and treatment of gastrointestinal diseases. Video platforms for spreading endoscopy-related knowledge may help patients understand the pros and cons of endoscopy on the premise of ensuring accuracy. However, videos with misinformation may lead to adverse consequences. Objective: This study aims to evaluate the quality of gastrointestinal endoscopy-related videos on YouTube and to assess whether large language models (LLMs) can help patients obtain information from videos more efficiently. Methods: We collected information from YouTube videos about 3 commonly used gastrointestinal endoscopes (gastroscopy, colonoscopy, and capsule endoscopy) and assessed their quality (rated by the modified DISCERN Tool, mDISCERN), reliability (rated by the Journal of the American Medical Association), and recommendation (rated by the Global Quality Score). We tasked LLM with summarizing the video content and assessed it from 3 perspectives: accuracy, completeness, and readability. Results: A total of 167 videos were included. According to the indicated scoring, the quality, reliability, and recommendation of the 3 gastrointestinal endoscopy-related videos on YouTube were overall unsatisfactory, and the quality of the videos released by patients was particularly poor. Capsule endoscopy yielded a significantly lower Global Quality Score than did gastroscopy and colonoscopy. LLM-based summaries yielded accuracy scores of 4 (IQR 4-5), completeness scores of 4 (IQR 4-5), and readability scores of 2 (IQR 1-2). Conclusions: The quality of gastrointestinal endoscope-related videos currently on YouTube is poor. Moreover, additional regulatory and improvement strategies are needed in the future. LLM may be helpful in generalizing video-related information, but there is still room for improvement in its ability. %M 40068165 %R 10.2196/58855 %U https://www.jmir.org/2025/1/e58855 %U https://doi.org/10.2196/58855 %U http://www.ncbi.nlm.nih.gov/pubmed/40068165 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e66184 %T Antibiotic Use In Utero and Early Life and Risk of Chronic Childhood Conditions in New Zealand: Protocol for a Data Linkage Retrospective Cohort Study %A Ram,Sharan %A Corbin,Marine %A 't Mannetje,Andrea %A Eng,Amanda %A Kvalsvig,Amanda %A Baker,Michael G %A Douwes,Jeroen %+ Centre for Public Health Research, Massey University, Block 3 Level D 63 Wallace Street, Wellington, 6021, New Zealand, 64 04 979 3094, s.ram@massey.ac.nz %K early childhood %K chronic childhood conditions %K antibiotics %K data linkage %K study protocol %K routine data %D 2025 %7 28.2.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: The incidence of many common chronic childhood conditions has increased globally in the past few decades, which has been suggested to be potentially attributed to antibiotic overuse leading to dysbiosis in the gut microbiome. Objective: This linkage study will assess the role of antibiotic use in utero and in early life in the development of type 1 diabetes (T1D), attention-deficit/hyperactive disorder (ADHD), and inflammatory bowel disease. Methods: The study design involves several retrospective cohort studies using linked administrative health and social data from Statistics New Zealand’s Integrated Data Infrastructure. It uses data from all children who were born in New Zealand between October 2005 and December 2010 (N=334,204) and their mothers. Children’s antibiotic use is identified for 4 time periods (at pregnancy, at ≤1 year, at ≤2 years, and at ≤5 years), and the development of T1D, ADHD, and inflammatory bowel disease is measured from the end of the antibiotic use periods until death, emigration, or the end of the follow-up period (2021), whichever came first. Children who emigrated or died before the end of the antibiotic use period are excluded. Cox proportional hazards regression models are used while adjusting for a range of potential confounders. Results: As of September 2024, data linkage has been completed, involving the integration of antibiotic exposure and outcome variables for 315,789 children. Preliminary analyses show that both prenatal and early life antibiotic consumption is associated with T1D. Full analyses for all 3 outcomes will be completed by the end of 2025. Conclusions: This series of linked cohort studies using detailed, complete, and systematically collected antibiotic prescription data will provide critical new knowledge regarding the role of antibiotics in the development of common chronic childhood conditions. Thus, this study has the potential to contribute to the development of primary prevention strategies through, for example, targeted changes in antibiotic use. International Registered Report Identifier (IRRID): DERR1-10.2196/66184 %M 40053783 %R 10.2196/66184 %U https://www.researchprotocols.org/2025/1/e66184 %U https://doi.org/10.2196/66184 %U http://www.ncbi.nlm.nih.gov/pubmed/40053783 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 12 %N %P e43618 %T The Effects of Digital eHealth Versus Onsite 2-Day Group-Based Education in 255 Patients With Irritable Bowel Syndrome: Cohort Study %A Berentsen,Birgitte %A Thuen,Camilla %A Hillestad,Eline Margrete Randulff %A Steinsvik,Elisabeth Kjelsvik %A Hausken,Trygve %A Hatlebakk,Jan Gunnar %K irritable bowel syndrome %K IBS %K eHealth %K internet-guided %K patient education %K self-management %K self-reported %K patient behavior %K quality of life %K QOL %K anxiety %K depression %K gastrointestinal %K physiotherapist %K kinesiology %K cognitive behavioural therapy %K CBT %K Hospital Anxiety and Depression Scale %K HADS %K client satisfaction questionnaire %K CSQ %K Mann-Whitney U test %K nonparametric %K Wilcoxon test %K neurogastroenterology %D 2025 %7 3.2.2025 %9 %J JMIR Hum Factors %G English %X Background: Irritable bowel syndrome (IBS) has a high worldwide prevalence and there are few effective treatment options. Patient education can influence patient behavior that subsequently may lead to changes in attitudes and skills necessary for maintenance or improvement in management of symptom severity and quality of life. However, as postdiagnostic patient education can be resource demanding, assessment of digital approaches and verification of their effectiveness is warranted. Objective: This cohort study aimed to investigate the effects of a digital web-based multidisciplinary eHealth program on the domains of symptom severity (Irritable Bowel Syndrome Symptom Severity Scale [IBS-SSS]), quality of life (irritable bowel syndrome quality of life [IBS-QOL]), anxiety and depression (Hospital Anxiety and Depression Scale), and a measure of general client satisfaction (client satisfaction questionnaire), compared with an onsite multidisciplinary 2-day group-based education program (“IBS-school”), in 2 cohorts of 255 patients with IBS. Methods: Patients diagnosed with IBS, aged 15-70 years, were enrolled after referral to the Section of Gastroenterology at Haukeland University Hospital, Norway. In total, 132 patients were recruited to the eHealth program and 123 to the IBS-school group for comparison. Data were self-reported and collected digitally at enrollment and after 3 months, between 2017 and 2019. Furthermore, 71 attending the eHealth program and 49 attending the IBS-school completed the questionnaires at 3 months. Intervention response was defined as a reduction of ≥50 points on the IBS-SSS. Results: Patients attending the eHealth program reported a significant reduction in IBS symptom severity 3 months after treatment (n=71), compared with patients attending the IBS-school (n=50). Overall, patients categorized as intervention responders in both programs showed a significant reduction in symptom severity at 3 months. Here, 41% (29/71) of patients attending the eHealth program reported a mean IBS-SSS reduction of 103 (SD 72.0) points (P<.001). In addition, these patients reported reduced anxiety (P>.001) and depression (P=.002) and enhanced quality of life (P=.03), especially the degrees of dysphoria, body image, food avoidance, health worry, interference with activity, relations, and social relations. Patients responding to the IBS-school intervention (18/50, 36%) reported a mean IBS-SSS reduction of 119 (SD 86.2) points (P<.001), and reduced depression scores (P=.046), but no difference in overall quality of life. Both groups reported the respective interventions as “good” quality health care programs, scoring them 23.5 (SD 4)—the eHealth program 23.5 (SD 4), and the IBS-school 24.2 (SD 4)—on the client satisfaction questionnaire. Conclusions: We conclude that the digital multidisciplinary eHealth program has a significant effect on IBS symptom severity in a portion of patients; it is useful as a tool in disease self-management and does not result in worse symptom scores than an onsite multidisciplinary 2-day group-based education program after 3 months. We believe these results indicate that a digital eHealth approach is preferable to an onsite multidisciplinary 2-day group-based education program covering the same topics. %R 10.2196/43618 %U https://humanfactors.jmir.org/2025/1/e43618 %U https://doi.org/10.2196/43618 %0 Journal Article %@ 2369-2960 %I JMIR Publications %V 10 %N %P e55376 %T Using Laboratory Test Results for Surveillance During a New Outbreak of Acute Hepatitis in 3-Week- to 5-Year-Old Children in the United Kingdom, the Netherlands, Ireland, and Curaçao: Observational Cohort Study %A Swets,Maaike C %A Kerr,Steven R %A MacKenna,Brian %A Fisher,Louis %A van Wijnen,Merel %A Brandwagt,Diederik %A Schenk,Paul W %A Fraaij,Pieter %A Visser,Leonardus G %A Bacon,Sebastian %A Mehrkar,Amir %A Nichol,Alistair %A Twomey,Patrick %A Matthews,Philippa C %A , %A Semple,Malcolm G %A Groeneveld,Geert H %A Goldacre,Ben %A Jones,Iain %A Baillie,J Kenneth %K pediatric hepatitis %K disease surveillance %K outbreak detection %K pandemic preparedness %K acute hepatitis %K children %K data analytics %K hospital %K laboratory %K all age groups %K pre-pandemic %K United Kingdom %K Netherlands %K Ireland Curacao %K single center %K federated analytics %K pandemic surveillance %K outbreaks %K public health %D 2024 %7 23.12.2024 %9 %J JMIR Public Health Surveill %G English %X Background: In March 2022, a concerning rise in cases of unexplained pediatric hepatitis was reported in multiple countries. Cases were defined as acute hepatitis with serum transaminases >500 U/L (aspartate transaminase [AST] or alanine transaminase [ALT]) in children aged 16 years or younger. We explored a simple federated data analytics method to search for evidence of unreported cases using routinely held data. We conducted a pragmatic survey to analyze changes in the proportion of hospitalized children with elevated AST or ALT over time. In addition, we studied the feasibility of using routinely collected clinical laboratory results to detect or follow-up the outbreak of an infectious disease. Objective: We explored a simple federated data analytics method to search for evidence of unreported cases using routinely held data. Methods: We provided hospitals with a simple computational tool to enable laboratories to share nondisclosive summary-level data. Summary statistics for AST and ALT measurements were collected from the last 10 years across all age groups. Measurements were considered elevated if ALT or AST was >200 U/L. The rate of elevated AST or ALT test for 3-week- to 5-year-olds was compared between a period of interest in which cases of hepatitis were reported (December 1, 2021, to August 31, 2022) and a prepandemic baseline period (January 1, 2012, to December 31, 2019). We calculated a z score, which measures the extent to which the rate for elevated ALT or AST was higher or lower in the period of interest compared to a baseline period, for the 3-week- to 5-year-olds. Results: Our approach of sharing a simple software tool for local use enabled rapid, federated data analysis. A total of 34 hospitals in the United Kingdom, the Netherlands, Ireland, and Curaçao were asked to contribute summary data, and 30 (88%) submitted their data. For all locations combined, the rate of elevated AST or ALT measurements in the period of interest was not elevated (z score=−0.46; P=.64). Results from individual regions were discordant, with a higher rate of elevated AST or ALT values in the Netherlands (z score=4.48; P<.001), driven by results from a single center in Utrecht. We did not observe any clear indication of changes in primary care activity or test results in the same period. Conclusions: Hospital laboratories collect large amounts of data on a daily basis that can potentially be of use for disease surveillance, but these are currently not optimally used. Federated analytics using nondisclosive, summary-level laboratory data sharing was successful, safe, and efficient. The approach holds potential as a tool for pandemic surveillance in future outbreaks. Our findings do not indicate the presence of a broader outbreak of mild hepatitis cases among young children, although there was an increase in elevated AST or ALT values locally in the Netherlands. %R 10.2196/55376 %U https://publichealth.jmir.org/2024/1/e55376 %U https://doi.org/10.2196/55376 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e66648 %T Large Language Models in Gastroenterology: Systematic Review %A Gong,Eun Jeong %A Bang,Chang Seok %A Lee,Jae Jun %A Park,Jonghyung %A Kim,Eunsil %A Kim,Subeen %A Kimm,Minjae %A Choi,Seoung-Ho %+ Department of Internal Medicine, Hallym University College of Medicine, sakjuro, 77, Chuncheon, Republic of Korea, 82 332405000, csbang@hallym.ac.kr %K large language model %K LLM %K deep learning %K artificial intelligence %K AI %K endoscopy %K gastroenterology %K clinical practice %K systematic review %K diagnostic %K accuracy %K patient engagement %K emotional support %K data privacy %K diagnosis %K clinical reasoning %D 2024 %7 20.12.2024 %9 Review %J J Med Internet Res %G English %X Background: As health care continues to evolve with technological advancements, the integration of artificial intelligence into clinical practices has shown promising potential to enhance patient care and operational efficiency. Among the forefront of these innovations are large language models (LLMs), a subset of artificial intelligence designed to understand, generate, and interact with human language at an unprecedented scale. Objective: This systematic review describes the role of LLMs in improving diagnostic accuracy, automating documentation, and advancing specialist education and patient engagement within the field of gastroenterology and gastrointestinal endoscopy. Methods: Core databases including MEDLINE through PubMed, Embase, and Cochrane Central registry were searched using keywords related to LLMs (from inception to April 2024). Studies were included if they satisfied the following criteria: (1) any type of studies that investigated the potential role of LLMs in the field of gastrointestinal endoscopy or gastroenterology, (2) studies published in English, and (3) studies in full-text format. The exclusion criteria were as follows: (1) studies that did not report the potential role of LLMs in the field of gastrointestinal endoscopy or gastroenterology, (2) case reports and review papers, (3) ineligible research objects (eg, animals or basic research), and (4) insufficient data regarding the potential role of LLMs. Risk of Bias in Non-Randomized Studies—of Interventions was used to evaluate the quality of the identified studies. Results: Overall, 21 studies on the potential role of LLMs in gastrointestinal disorders were included in the systematic review, and narrative synthesis was done because of heterogeneity in the specified aims and methodology in each included study. The overall risk of bias was low in 5 studies and moderate in 16 studies. The ability of LLMs to spread general medical information, offer advice for consultations, generate procedure reports automatically, or draw conclusions about the presumptive diagnosis of complex medical illnesses was demonstrated by the systematic review. Despite promising benefits, such as increased efficiency and improved patient outcomes, challenges related to data privacy, accuracy, and interdisciplinary collaboration remain. Conclusions: We highlight the importance of navigating these challenges to fully leverage LLMs in transforming gastrointestinal endoscopy practices. Trial Registration: PROSPERO 581772; https://www.crd.york.ac.uk/prospero/ %M 39705703 %R 10.2196/66648 %U https://www.jmir.org/2024/1/e66648 %U https://doi.org/10.2196/66648 %U http://www.ncbi.nlm.nih.gov/pubmed/39705703 %0 Journal Article %@ 2369-1999 %I JMIR Publications %V 10 %N %P e53229 %T Examining Racial Disparities in Colorectal Cancer Screening and the Role of Online Medical Record Use: Findings From a Cross-Sectional Study of a National Survey %A Ewing,Aldenise P %A Tounkara,Fode %A Marshall,Daniel %A Henry,Abhishek V %A Abdel-Rasoul,Mahmoud %A McElwain,Skylar %A Clark,Justice %A Hefner,Jennifer L %A Zaire,Portia J %A Nolan,Timiya S %A Tarver,Willi L %A Doubeni,Chyke A %K colorectal cancer %K cancer screening %K early detection %K Health Information National Trends Survey %K cancer disparities %K online medical records %K secondary data analysis %D 2024 %7 4.12.2024 %9 %J JMIR Cancer %G English %X Background: Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the United States. Early detection via routine CRC screening can significantly lower risks for CRC-specific morbidity and mortality. Public health initiatives between 2000 and 2015 nearly doubled CRC screening rates for some US adults. However, screening rates remain lowest for adults aged 45‐49 years (20%), patients of safety net health care facilities (42%), adults without insurance (44%), and other subgroups compared with national averages (72%). Given the evolving landscape of digital health care and trends in web-based health information–seeking behaviors, leveraging online medical record (OMR) systems may be an underutilized resource to promote CRC screening utilization. Recognizing trends in OMR usage and patient demographics may enhance digital inclusion—a key social determinant of health—and support equitable web-based interventions aimed at boosting CRC screening across diverse populations. Objective: This study examined the association of accessing an OMR with CRC screening utilization and corresponding sociodemographic characteristics of US adults. Methods: In 2023, we conducted a secondary data analysis using a pooled, weighted sample from Health Information National Trends Survey (HINTS) 5 cycles, 2, 3, and 4 (2018‐2020), a nationally representative survey assessing how US adults access and use health-related information. We analyzed the association between sociodemographic characteristics, medical conditions, OMR access, and CRC screening behaviors via logistic regression. Results: The sample included adults aged 45‐75 years (N=5143). The mean age was 59 (SD 8) years for those who reported CRC screening and 52 (SD 6) years for those never screened. Nearly 70% (4029/5143) of participants reported CRC screening and 52% (2707/5143) reported OMR access in the past year. Adjusted odds of CRC screening were higher among non-Hispanic African American or Black adults than among non-Hispanic White adults (odds ratio [OR] 1.76, 95% CI 1.22‐2.53), adults who accessed an OMR (OR 1.89, 95% CI 1.45‐2.46), older individuals (OR 1.18, 95% CI 1.16‐1.21), the insured (OR 3.69, 95% CI 2.34‐5.82), and those with a professional or graduate degree versus those with a high school diploma or less (OR 2.65, 95% CI 1.28‐5.47). Individuals aged 65‐75 years were significantly more likely (P<.001) to be screened (1687/1831, 91%) than those aged 45‐49 years (190/610, 29%). Conclusions: Promoting OMR access, especially among the most disadvantaged Americans, may assist in reaching national screening goals. Emphasis should be placed on the mutability of OMR use compared with most other statistically significant associations with CRC screening behaviors. OMR access provides an intervenable means of promoting CRC education and screening, especially among those facing structural barriers to cancer diagnoses and care. Future research should focus on tailored and accessible interventions that expand OMR access, particularly for younger populations. %R 10.2196/53229 %U https://cancer.jmir.org/2024/1/e53229 %U https://doi.org/10.2196/53229 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e60289 %T Understanding the Occurrence and Fate of Atmospheric Microplastics and Their Potential Risks to Human Health: Protocol for a Cross-Sectional Analysis %A Hasan,Shaikh Sharif %A Salam,Abdus %A Moniruzzaman,Mohammad %A Bari,Md Aynul %A Aich,Nirupam %A Jahan,Farjana %A Rahman,Mahbubur %A Islam,Zubayer %A Kabir,Md Humayun %A Shaikh,Md Aftab Ali %A Raqib,Rubhana %A Parvez,Sarker Masud %+ Children’s Health and Environment Program, Child Health Research Centre, The University of Queensland, St Lucia, Brisbane Queensland 4072, Brisbane, 4072, Australia, 61 480365175, s.parvez@uq.edu.au %K plastic exposure %K microplastic %K bisphenol %K phthalate %K heavy metals %K health consequences %K potential risk %K cross-sectional analysis %K pollution %K nanoplastics %K additives %K plastic additives %K health consequence %K exposure %K human exposure %K plastic recycling %K recycling activities %D 2024 %7 29.11.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Plastic pollution has reached an alarming magnitude, defining the contemporary era as the “Plastic Age.” Uncontrolled plastic production and inadequate recycling processes have led to widespread contamination of the environment with micro and nanoplastics. Objective: The study aims to assess the environmental and human health consequences of exposure to microplastic particles (MPs) and their additives among plastic recycling workers in Dhaka. Specifically, it focuses on mapping the management pathways of plastic waste from collection to disposal, analyzing the types of MPs in the environment, and assessing the potential health impacts on plastic recycling workers. Methods: A cross-sectional exploratory study design was used, consisting of exposed and nonexposed groups in plastic recycling sites in Dhaka, Bangladesh. The study will establish possible associations between different health consequences and microplastic particle exposure with a systematic approach involving plastic recycling hot spot detection, management pathway mapping, and detecting the presence of environmental MP. MPs and heavy metals will be detected from environmental samples using fluorescence microscopy, Fourier-transform infrared spectroscopy, and inductively coupled plasma mass spectrometry. Human exposure will be assessed by detecting the metabolites of bisphenol and phthalates from urine samples using liquid chromatography–tandem mass spectrometry and thoroughly evaluating endocrine, reproductive, respiratory, and renal functions. The sample size was derived from the mean concentrations of urinary bisphenol and phthalates metabolites, requiring the participation of 168 respondents. A 1:1 exposure to nonexposed stratification would be sufficient to meet our study objectives, considering the conventional level of power and confidence interval. This study protocol (PR#22111) has received approval from the Research Review Committee and Ethical Review Committee of the icddr,b. Results: The project was funded in August 2022. We started collecting environmental samples in January 2023 and completed participant enrollment, exposure survey, and biological sample collection by December 2023. We enrolled 84 adult plastic recycling workers with at least 5 years of exposure history and 84 nonexposed participants who were not involved with plastic recycling activities. Data analysis is currently underway, and the first results are expected to be submitted for publication in November 2024. Conclusions: The findings would provide valuable insights into the adverse impacts of microplastic pollution on both the environment and human health, aiding in better understanding the extent of the issue. International Registered Report Identifier (IRRID): DERR1-10.2196/60289 %M 39612491 %R 10.2196/60289 %U https://www.researchprotocols.org/2024/1/e60289 %U https://doi.org/10.2196/60289 %U http://www.ncbi.nlm.nih.gov/pubmed/39612491 %0 Journal Article %@ 2563-3570 %I JMIR Publications %V 5 %N %P e62747 %T Eco-Evolutionary Drivers of Vibrio parahaemolyticus Sequence Type 3 Expansion: Retrospective Machine Learning Approach %A Campbell,Amy Marie %A Hauton,Chris %A van Aerle,Ronny %A Martinez-Urtaza,Jaime %+ Department of Genetics and Microbiology, Autonomous University of Barcelona, Facultat de Biociènces, oficina C3/109, Campus de la UAB, Bellaterra, Barcelona, 08193, Spain, 34 93 581 2729, jaime.martinez.urtaza@uab.cat %K pathogen expansion %K climate change %K machine learning %K ecology %K evolution %K vibrio parahaemolyticus %K sequencing %K sequence type 3 %K VpST3 %K genomics %D 2024 %7 28.11.2024 %9 Original Paper %J JMIR Bioinform Biotech %G English %X Background: Environmentally sensitive pathogens exhibit ecological and evolutionary responses to climate change that result in the emergence and global expansion of well-adapted variants. It is imperative to understand the mechanisms that facilitate pathogen emergence and expansion, as well as the drivers behind the mechanisms, to understand and prepare for future pandemic expansions. Objective: The unique, rapid, global expansion of a clonal complex of Vibrio parahaemolyticus (a marine bacterium causing gastroenteritis infections) named Vibrio parahaemolyticus sequence type 3 (VpST3) provides an opportunity to explore the eco-evolutionary drivers of pathogen expansion. Methods: The global expansion of VpST3 was reconstructed using VpST3 genomes, which were then classified into metrics characterizing the stages of this expansion process, indicative of the stages of emergence and establishment. We used machine learning, specifically a random forest classifier, to test a range of ecological and evolutionary drivers for their potential in predicting VpST3 expansion dynamics. Results: We identified a range of evolutionary features, including mutations in the core genome and accessory gene presence, associated with expansion dynamics. A range of random forest classifier approaches were tested to predict expansion classification metrics for each genome. The highest predictive accuracies (ranging from 0.722 to 0.967) were achieved for models using a combined eco-evolutionary approach. While population structure and the difference between introduced and established isolates could be predicted to a high accuracy, our model reported multiple false positives when predicting the success of an introduced isolate, suggesting potential limiting factors not represented in our eco-evolutionary features. Regional models produced for 2 countries reporting the most VpST3 genomes had varying success, reflecting the impacts of class imbalance. Conclusions: These novel insights into evolutionary features and ecological conditions related to the stages of VpST3 expansion showcase the potential of machine learning models using genomic data and will contribute to the future understanding of the eco-evolutionary pathways of climate-sensitive pathogens. %M 39607996 %R 10.2196/62747 %U https://bioinform.jmir.org/2024/1/e62747 %U https://doi.org/10.2196/62747 %U http://www.ncbi.nlm.nih.gov/pubmed/39607996 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e63376 %T Community Versus Facility-Based Services to Improve the Screening of Active Hepatitis C Virus Infection in Cambodia: The ANRS 12384 CAM-C Cluster Randomized Controlled Trial—Protocol for a Mixed Methods Study %A Mosnier,Emilie %A Ségéral,Olivier %A Neth,Sansothy %A Sagaon-Teyssier,Luis %A Khuon,Dyna %A Phoeung,Chan Leakhena %A Mam,Sovatha %A Chhay,Chhingsrean %A Heang,Kimeang %A Duclos-Vallée,Jean Charles %A Saphonn,Vonthanak %+ Aix Marseille Université, Institut national de la santé et de la recherche médicale (INSERM), Institut de recherche pour le développementIRD, Sciences Economiques & Sociales de la Santé & Traitement de l’Information Médicale (SESSTIM) Aix Marseille Univ,, Aix Marseille Institute of Public Health (ISSPAM), Faculté de Médecine 27 Bd Jean Moulin, Marseille, 13385, France, 33 491324600, emilie.mosnier@gmail.com %K hepatitis C virus %K HCV %K community-based intervention %K cluster randomized controlled trial %K Cambodia %K cost-effectiveness analysis %K qualitative analysis %D 2024 %7 20.11.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: In Cambodia, hepatitis C constitutes a significant public health challenge, particularly among older adults (>45 years) for whom prevalence is estimated to be 5%. To facilitate the elimination of hepatitis C among the general population, enhancing access to screening and treatment is imperative. In this regard, the evaluation of community-based screening programs emerges as a crucial step toward improving health care accessibility. Objective: This study aims to assess the comparative efficacy of a community-based versus a facility-based approach in enhancing the uptake of hepatitis C antibody testing among the general population older than 40 years of age in Cambodia. Methods: The CAM-C (Community Versus Facility-Based Services to Improve the Screening of Active Hepatitis C Virus Infection in Cambodia) study uses a cluster-randomized controlled trial design across two Cambodian provinces to compare community-based and facility-based hepatitis testing interventions. Sampling involves a multistage cluster approach, targeting individuals older than 40 years of age due to their higher prevalence and risk of chronic hepatitis complications. This study incorporates a qualitative analysis of acceptability and a cost-effectiveness comparison. Interventions include facility-based testing with subsequent referral and community-based testing with direct in-home assessments. Follow-up for positive cases involves comprehensive management and potential direct-acting antiviral treatment. This study aims to identify a significant increase in testing uptake, requiring the screening of 6000 individuals older than 40 years of age, facilitated by a structured sampling and intervention approach to minimize contamination risks. Results: The final protocol including the quantitative, qualitative, and cost-effectiveness part of the study was registered and was approved in 2019 by the National Ethical Cambodian for Health Research. Inclusions were completed by mid-2024, with analyses starting in May 2024. Conclusions: Using a mixed methods approach that combines a robust methodology (cluster-randomized controlled trial) with a cost-effectiveness analysis and qualitative research, such a study should provide invaluable information to guide the Ministry of Health in its hepatitis C virus screening strategy and move toward elimination. Trial Registration: ClinicalTrials.gov NCT03992313; https://clinicaltrials.gov/study/NCT03992313 International Registered Report Identifier (IRRID): DERR1-10.2196/63376 %M 39566053 %R 10.2196/63376 %U https://www.researchprotocols.org/2024/1/e63376 %U https://doi.org/10.2196/63376 %U http://www.ncbi.nlm.nih.gov/pubmed/39566053 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e60575 %T A Video-Based Communication Intervention for Fecal Ostomy Surgery (CI-oSurg): Protocol for Open Pilot Testing to Improve Intervention Acceptability and Feasibility %A Cauley,Christy Elaine %A Rubio,Atziri %A Brindle,Mary %A Cooper,Zara %A Vranceanu,Ana-Maria %A Ritchie,Christine S %+ Department of Surgery, Massachusetts General Hospital, Harvard Medical School, 55 Fruit St., Boston, MA, 02114, United States, 1 6177268129, ccauley@mgh.harvard.edu %K fecal ostomy %K distress %K open pilot %K fecal ostomy surgeryl CI-oSurg %K intervention acceptability %K biopsychosocial outcomes %K psychosocial support %K ostomy care %D 2024 %7 15.11.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Approximately 100,000 patients undergo fecal ostomy operations annually across the United States. This patient population experiences high surgical complication rates and poor biopsychosocial outcomes. Surgical teams are not trained to address the psychosocial needs that often arise during recovery after fecal ostomy surgery. Objective: This study aims to refine and establish the acceptability and usability of the Communication Intervention for fecal ostomy Surgery (CI-oSurg), a web-based communication intervention aimed at reducing distress among patients recovering from ostomy surgery. Methods: We describe the proposed study design, methodology, and training protocol. We will conduct an open pilot (n=24 patients and n=8 clinicians) of video-based training to first identify the level and types of distress patients are experiencing. Next, patients will view web videos that address frequent challenges faced by ostomy patients, considering practical management and emotional and adaptation concerns. Qualitative one-to-one semistructured interviews will be conducted with participants to explore the acceptability and feasibility of the program and refine the intervention and study procedures. Results: This study has been approved by the Mass General Brigham Institutional Review Board. Study funding has been obtained, and recruitment is planned for the fall of 2024. Conclusions: Through this study, we will refine CI-oSurg, a web-based communication intervention focused on reducing distress after ostomy surgery, to improve intervention acceptability and usability. These improvements will allow us to establish the usability and acceptability of the intervention before efficacy testing to determine the ability of this intervention to reduce distress after fecal ostomy surgery. Trial Registration: ClinicalTrials.gov NCT06320002; https://clinicaltrials.gov/study/NCT06320002 International Registered Report Identifier (IRRID): PRR1-10.2196/60575 %M 39546348 %R 10.2196/60575 %U https://www.researchprotocols.org/2024/1/e60575 %U https://doi.org/10.2196/60575 %U http://www.ncbi.nlm.nih.gov/pubmed/39546348 %0 Journal Article %@ 2369-2960 %I JMIR Publications %V 10 %N %P e57168 %T Association Between Fatty Liver Index and Incidence of Cataract Surgery in Individuals Aged 50 Years and Older Based on the Korean National Health Insurance Service-Health Screening Cohort (NHIS-HEALS) Data: Longitudinal Retrospective Cohort Study %A Kim,Yonghwan %A Kim,Jeongsook %A Seo,Eoi Jong %A Kim,Kyung Tae %A Lee,Jae-woo %A Kim,Joungyoun %A Kang,Hee-Taik %K fatty liver index %K nonalcoholic fatty liver disease %K all-cataract %K senile-cataract %K surgery %K NAFLD %K Korean National Health Insurance Service %K Health Screening Cohort %K NHIS-HEALS %D 2024 %7 14.11.2024 %9 %J JMIR Public Health Surveill %G English %X Background: Cataract is a leading cause of vision impairment. Obesity-related risk factors, including insulin resistance, increase the risk of cataract. The fatty liver index (FLI) is a biomarker for noninvasive fat layer prediction of nonalcoholic fatty liver disease. The FLI has been used to evaluate the metabolic contribution in other organs besides the eye. However, no study exists on the FLI and eye disease. Objective: This retrospective cohort study for the association between the FLI and incidence of cataract surgery in individuals older than 50 years was designed to show that a higher FLI is associated with an increased incidence of cataract surgery in individuals aged 50 years and older. Methods: This study was retrospectively designed based on the Korean National Health Insurance Service-Health Screening Cohort (NHIS-HEALS) cohort (median follow-up of 9.8 years). Participants were assigned to 1 of 3 groups based on the FLI: low (FLI<30), intermediate (FLI 30-59), or high (FLI≥60). Kaplan-Meier survival analysis was performed on the cumulative incidence of all-cataract and senile-cataract surgery. Multivariable Cox proportional hazards regression models were used to study the association between the FLI group and cataract surgery after adjusting for potential confounders. Results: Of the 138,347 included participants, the incidence of cataract surgery was 12.49% (4779/38,274), 13.95% (6680/47,875), and 14.16% (7496/52,930) in the low, intermediate, and high FLI groups, respectively. After adjusting for all confounding factors, hazard ratios (HRs; 95% CIs) in the high FLI group for all-cataract surgery were 1.111 (1.028‐1.199) and 1.184 (1.101‐1.274) in men and women, respectively, when compared with the low FLI group. HRs (95% CIs) in the high FLI group for senile-cataract surgery were 1.106 (1.022‐1.197) and 1.147 (1.065‐1.237) in men and women, respectively, when compared with the low FLI group. The project was conducted between August 2023 and February 2024 without donations from external bodies. Conclusions: Individuals with a higher FLI had a higher risk of all-cataract surgery. This association was maintained even after limiting the analyses to senile-cataract surgery. %R 10.2196/57168 %U https://publichealth.jmir.org/2024/1/e57168 %U https://doi.org/10.2196/57168 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e50023 %T True Mitotic Count Prediction in Gastrointestinal Stromal Tumors: Bayesian Network Model and PROMETheus (Preoperative Mitosis Estimator Tool) Application Development %A Renne,Salvatore Lorenzo %A Cammelli,Manuela %A Santori,Ilaria %A Tassan-Mangina,Marta %A Samà,Laura %A Ruspi,Laura %A Sicoli,Federico %A Colombo,Piergiuseppe %A Terracciano,Luigi Maria %A Quagliuolo,Vittorio %A Cananzi,Ferdinando Carlo Maria %+ Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, Pieve Emanuele, Milan, 20072, Italy, 39 0282247743, salvatore.renne@hunimed.eu %K GIST mitosis %K risk classification %K mHealth %K mobile health %K neoadjuvant therapy %K patient stratification %K Gastrointestinal Stroma %K preoperative risk %D 2024 %7 22.10.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Gastrointestinal stromal tumors (GISTs) present a complex clinical landscape, where precise preoperative risk assessment plays a pivotal role in guiding therapeutic decisions. Conventional methods for evaluating mitotic count, such as biopsy-based assessments, encounter challenges stemming from tumor heterogeneity and sampling biases, thereby underscoring the urgent need for innovative approaches to enhance prognostic accuracy. Objective: The primary objective of this study was to develop a robust and reliable computational tool, PROMETheus (Preoperative Mitosis Estimator Tool), aimed at refining patient stratification through the precise estimation of mitotic count in GISTs. Methods: Using advanced Bayesian network methodologies, we constructed a directed acyclic graph (DAG) integrating pertinent clinicopathological variables essential for accurate mitotic count prediction on the surgical specimen. Key parameters identified and incorporated into the model encompassed tumor size, location, mitotic count from biopsy specimens, surface area evaluated during biopsy, and tumor response to therapy, when applicable. Rigorous testing procedures, including prior predictive simulations, validation utilizing synthetic data sets were employed. Finally, the model was trained on a comprehensive cohort of real-world GIST cases (n=80), drawn from the repository of the Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Humanitas Research Hospital, with a total of 160 cases analyzed. Results: Our computational model exhibited excellent diagnostic performance on synthetic data. Different model architecture were selected based on lower deviance and robust out-of-sample predictive capabilities. Posterior predictive checks (retrodiction) further corroborated the model’s accuracy. Subsequently, PROMETheus was developed. This is an intuitive tool that dynamically computes predicted mitotic count and risk assessment on surgical specimens based on tumor-specific attributes, including size, location, surface area, and biopsy-derived mitotic count, using posterior probabilities derived from the model. Conclusions: The deployment of PROMETheus represents a potential advancement in preoperative risk stratification for GISTs, offering clinicians a precise and reliable means to anticipate mitotic counts on surgical specimens and a solid base to stratify patients for clinical studies. By facilitating tailored therapeutic strategies, this innovative tool is poised to revolutionize clinical decision-making paradigms, ultimately translating into improved patient outcomes and enhanced prognostic precision in the management of GISTs. %M 39437385 %R 10.2196/50023 %U https://www.jmir.org/2024/1/e50023 %U https://doi.org/10.2196/50023 %U http://www.ncbi.nlm.nih.gov/pubmed/39437385 %0 Journal Article %@ 2369-2960 %I JMIR Publications %V 10 %N %P e62864 %T Effectiveness of Risk-Adapted Upper Gastrointestinal Cancer Screening in China: Prospective Cohort Study %A Wang,Youqing %A Zhu,Juan %A Li,Huizhang %A Wang,Le %A Zhu,Chen %A Li,Xue %A Wang,Shi %A Du,Lingbin %K upper gastrointestinal cancer %K screening %K endoscopy %K effectiveness, incidence, mortality, all-cause mortality %D 2024 %7 10.10.2024 %9 %J JMIR Public Health Surveill %G English %X Background: Previous studies have proved the effectiveness of endoscopic screening in rural areas; however, long-term, high-quality evidence regarding the effectiveness of risk-adapted upper gastrointestinal cancer (UGC) sequential screening strategies in resource-rich regions is currently lacking. Objective: The objectives were to validate the effectiveness of risk-adapted sequential screening strategies in UGC prevention and control and assess the potential of sequential screening to lower mortality rates. Methods: Based on the Cancer Screening Program in Urban China, a prospective, large-scale cohort study based on population was conducted to recruit individuals from 4 cities in China from 2013‐2019. Those identified as having a high risk of UGC according to a validated risk-score model were advised to undergo endoscopy tests. Follow-up outcomes were tracked until June 2021. Incidence of UGC, UGC-related mortality, and all-cause mortality were evaluated between the screened and nonscreened cohorts. Results: The study included 153,079 participants at baseline. In total, 113,916 (74.42%) of the participants were designated as low risk of UGC. The remaining 39,163 (25.68%) participants were deemed to be at high risk of UGC and were offered gastroscopy tests. Among the high-risk participants, 9627 (compliance rate 24.6%) adhered to the gastroscopy tests. Over a median follow-up of 6.05 (IQR 3.06‐7.06) years, 622 UGC cases, 180 UGC deaths, and 1958 all-cause death cases were traced. The screened cohort exhibited the highest cumulative incidence of UGC (119.2 per 100,000 person-years), followed by the nonscreened and low-risk cohorts. Obvious reductions in both all-cause mortality and UGC mortality were observed between those who undertook screening (153.7 and 4.7 per 100,000 person-years, respectively) and the nonscreened group (245.3 and 27 per 100,000 person-years, respectively). The screening population showed a significant 36% and 82% reduction in both all-cause mortality (hazard ratio [HR] 0.64, 95% CI 0.49‐0.83, P<.001) and UGC mortality (HR 0.18, 95% CI 0.04‐0.74, P=.02), respectively, compared to the nonscreened group. Reductions of 35% in all-cause mortality (HR 0.65, 95% CI 0.49‐0.86, P=.003) and 81% in UGC mortality (HR 0.19, 95% CI 0.05‐0.80, P=.02) were observed in participants aged older than 55 years in the screened group compared to the nonscreened group. The reductions in all-cause mortality and UGC mortality were statistically significant in males (all-cause mortality: HR 0.64, 95% CI 0.47‐0.88, P=.005; UGC mortality: HR 0.10, 95% CI 0.01‐0.72, P=.02), but significant reductions were not observed in females (all P values were >.05). Conclusions: Our study suggests the significance of one-off risk-adapted UGC screening in reducing both all-cause mortality and UGC mortality, particularly among high-risk individuals, indicating its effectiveness in UGC prevention and management. %R 10.2196/62864 %U https://publichealth.jmir.org/2024/1/e62864 %U https://doi.org/10.2196/62864 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e50028 %T Increasing Colorectal Cancer Screening Among Black Men in Virginia: Development of an mHealth Intervention %A Thomson,Maria D %A Shahab,Guleer H %A Cooper-McGill,Chelsey A %A Sheppard,Vanessa B %A Hill,Sherrick S %A Preston,Michael %A Keen II,Larry %+ Department of Social and Behavioral Sciences, Virginia Commonwealth University, 830 E Main Street, Richmond, VA, 23219, United States, 1 8044844910, mthomson2@vcu.edu %K colorectal cancer %K cancer screening %K mHealth %K screening %K Black men %K early detection %K health disparities %K design thinking %D 2024 %7 10.10.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: In the United States, colorectal cancer (CRC) is the third leading cause of cancer death among Black men. Compared to men of all other races or ethnicities, Black men have the lowest rates of CRC screening participation, which contributes to later-stage diagnoses and greater mortality. Despite CRC screening being a critical component of early detection and increased survival, few interventions have been tailored for Black men. Objective: This study aims to report on the multistep process used to translate formative research including prior experiences implementing a national CRC education program, community advisory, and preliminary survey results into a culturally tailored mobile health (mHealth) intervention. Methods: A theoretically and empirically informed translational science public health intervention was developed using the Behavioral Design Thinking approach. Data to inform how content should be tailored were collected from the empirical literature and a community advisory board of Black men (n=7) and reinforced by the preliminary results of 98 survey respondents. Results: A community advisory board identified changes for delivery that were private, self-paced, and easily accessible and content that addressed medical mistrust, access delays for referrals and appointments, lack of local information, misinformation, and the role of families. Empirical literature and survey results identified the need for local health clinic involvement as critical to screening uptake, leading to a partnership with local Federally Qualified Health Centers to connect participants directly to clinical care. Men surveyed (n=98) who live or work in the study area were an average of 59 (SD 7.9) years old and held high levels of mistrust of health care institutions. In the last 12 months, 25% (24/98) of them did not see a doctor and 16.3% (16/98) of them did not have a regular doctor. Regarding CRC, 27% (26/98) and 38% (37/98) of them had never had a colonoscopy or blood stool test, respectively. Conclusions: Working with a third-party developer, a prototype mHealth app that is downloadable, optimized for iPhone and Android users, and uses familiar sharing, video, and text messaging modalities was created. Guided by our results, we created 4 short videos (1:30-2 min) including a survivor vignette, animated videos about CRC and the type of screening tests, and a message from a community clinic partner. Men also receive tailored feedback and direct navigation to local Federally Qualified Health Center partners including via school-based family clinics. These content and delivery elements of the mHealth intervention were the direct result of the multipronged, theoretically informed approach to translate an existing but generalized CRC knowledge–based intervention into a digital, self-paced, tailored intervention with links to local community clinics. Trial Registration: ClinicalTrials.gov NCT05980182; https://clinicaltrials.gov/study/NCT05980182 %M 39388688 %R 10.2196/50028 %U https://formative.jmir.org/2024/1/e50028 %U https://doi.org/10.2196/50028 %U http://www.ncbi.nlm.nih.gov/pubmed/39388688 %0 Journal Article %@ 1929-073X %I JMIR Publications %V 13 %N %P e50585 %T Temperature Measurement Timings and the Fever Detection Rate After Gastrointestinal Surgery: Retrospective Cross-Sectional Study %A Wang,Shiqi %A Ji,Gang %A Feng,Xiangying %A Huang,Luguang %A Luo,Jialin %A Yu,Pengfei %A Zheng,Jiyang %A Yang,Bin %A Wang,Xiangjie %A Zhao,Qingchuan %+ Xijing Hospital of Digestive Diseases, Xijing Hospital, Fourth Military Medical University, 127 Changlexi Street, Xi'an, 710032, China, 86 2984771533, wsqfmmu@126.com %K fever %K gastrointestinal surgery %K temperature measurement %K temperature %K detection %K gastrointestinal %K cross-sectional study %D 2024 %7 9.10.2024 %9 Original Paper %J Interact J Med Res %G English %X Background: Postoperative fever frequently indicates surgical complications and is commonly used to evaluate the efficacy of interventions against surgical stress. However, the presence of circadian rhythms in body temperature may compromise the accurate detection of fever. Objective: This study aimed to investigate the detection rate of fever under intermittent measurement. Methods: We retrospectively reviewed the clinical records of patients who underwent nonemergency gastrointestinal surgery between November 2020 and April 2021. Patients’ temperature data were continuously collected every 4 seconds using a wireless axillary thermometer, and fever was defined as a temperature exceeding 38 °C within a day. To simulate intermittent measurement in clinical practice, the body temperature at each hour was selected from the continuously collected temperature dataset. Considering that temperatures are measured multiple times per day, all possible measurement plans using intermittent measurement were composed by combining 1-24 time points from the 24-hour daily cycle. Fever was clinically diagnosed based on the temperature readings at the selected time points per day. The fever detection rates for each plan, with varying measurement times, were listed and ranked. Results: Based on the temperature data continuously collected by the thermometer, fever occurred in 60 (40.8%) of the 147 included patients within 3 days after surgery. Of the measurement plans that included 1-24 measurements daily, the fever detection rates ranged from 3.3% (2/60) to 85% (51/60). The highest detection rates and corresponding timings for measurement plans with 1, 2, 3, and 4 measurements daily were 38.3% (23/60; at 8 PM), 56.7% (34/60; at 3 AM and 7 or 8 PM), 65% (39/60; at 3 AM, 8 PM, and 10 or 11 PM), and 70% (42/60; at 12 AM, 3 AM, 8 PM, and 11 PM), respectively; and the lowest detection rates were 3.3% (2/60), 6.7% (4/60), 6.7% (4/60), and 8.3% (5/60), respectively. Although fever within 3 days after surgery was not correlated with an increased incidence of postoperative complications (5/60, 8.3% vs 6/87, 6.9%; P=.76), it was correlated with a longer hospital stay (median 7, IQR 6-9 days vs median 6, IQR 5-7 days; P<.001). Conclusions: The fever detection rate of the intermittent approach is determined by the timing and frequency of measurement. Measuring at randomly selected time points can miss many fever events after gastrointestinal surgery. However, we can improve the fever detection rate by optimizing the timing and frequency of measurement. %M 39383527 %R 10.2196/50585 %U https://www.i-jmr.org/2024/1/e50585 %U https://doi.org/10.2196/50585 %U http://www.ncbi.nlm.nih.gov/pubmed/39383527 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e56851 %T Development and Validation of a Computed Tomography–Based Model for Noninvasive Prediction of the T Stage in Gastric Cancer: Multicenter Retrospective Study %A Tao,Jin %A Liu,Dan %A Hu,Fu-Bi %A Zhang,Xiao %A Yin,Hongkun %A Zhang,Huiling %A Zhang,Kai %A Huang,Zixing %A Yang,Kun %+ Department of General Surgery and Laboratory of Gastric Cancer, State Key Laboratory of Biotherapy/Collaborative Innovation Center of Biotherapy and Cancer Center, West China Hospital, Sichuan University, Guo Xue street, Chengdu, 610041, China, 86 18980606729, yangkun068@163.com %K gastric cancer %K computed tomography %K radiomics %K T stage %K deep learning %K cancer %K multicenter study %K accuracy %K binary classification %K tumor %K hybrid model %K performance %K pathological stage %D 2024 %7 9.10.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: As part of the TNM (tumor-node-metastasis) staging system, T staging based on tumor depth is crucial for developing treatment plans. Previous studies have constructed a deep learning model based on computed tomographic (CT) radiomic signatures to predict the number of lymph node metastases and survival in patients with resected gastric cancer (GC). However, few studies have reported the combination of deep learning and radiomics in predicting T staging in GC. Objective: This study aimed to develop a CT-based model for automatic prediction of the T stage of GC via radiomics and deep learning. Methods: A total of 771 GC patients from 3 centers were retrospectively enrolled and divided into training, validation, and testing cohorts. Patients with GC were classified into mild (stage T1 and T2), moderate (stage T3), and severe (stage T4) groups. Three predictive models based on the labeled CT images were constructed using the radiomics features (radiomics model), deep features (deep learning model), and a combination of both (hybrid model). Results: The overall classification accuracy of the radiomics model was 64.3% in the internal testing data set. The deep learning model and hybrid model showed better performance than the radiomics model, with overall classification accuracies of 75.7% (P=.04) and 81.4% (P=.001), respectively. On the subtasks of binary classification of tumor severity, the areas under the curve of the radiomics, deep learning, and hybrid models were 0.875, 0.866, and 0.886 in the internal testing data set and 0.820, 0.818, and 0.972 in the external testing data set, respectively, for differentiating mild (stage T1~T2) from nonmild (stage T3~T4) patients, and were 0.815, 0.892, and 0.894 in the internal testing data set and 0.685, 0.808, and 0.897 in the external testing data set, respectively, for differentiating nonsevere (stage T1~T3) from severe (stage T4) patients. Conclusions: The hybrid model integrating radiomics features and deep features showed favorable performance in diagnosing the pathological stage of GC. %M 39382960 %R 10.2196/56851 %U https://www.jmir.org/2024/1/e56851 %U https://doi.org/10.2196/56851 %U http://www.ncbi.nlm.nih.gov/pubmed/39382960 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e48020 %T mHealth Physical Activity and Patient-Reported Outcomes in Patients With Inflammatory Bowel Diseases: Cluster Analysis %A Griffin,Ashley C %A Mentch,Lucas %A Lin,Feng-Chang %A Chung,Arlene E %+ VA Palo Alto Health Care System, 795 Willow Road, Palo Alto, CA, 94025, United States, 1 6504935000, griffina@stanford.edu %K inflammatory bowel diseases %K patient-reported outcome measures %K cluster analysis %K wearable electronic devices %K medical informatics %K mHealth %K mobile health %K physical activity %K bowel disease %K psychosocial %K smartphone %K wearables %K mobile phone %D 2024 %7 24.9.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Regular physical activity is associated with improved quality of life in patients with inflammatory bowel diseases (IBDs), although much of the existing research is based on self-reported data. Wearable devices provide objective data on many rich physical activity dimensions including steps, duration, distance, and intensity. Little is known about how patients with IBDs engage in these varying dimensions of exercise and how it may influence their symptom and disease-specific patient-reported outcomes (PROs). Objective: This study aims to (1) cluster physical activity patterns from consumer-grade wearable devices and (2) assess the relationship between the clusters and PROs in patients with IBDs. Methods: We conducted a cross-sectional and longitudinal cohort study among adults with IBDs in the Crohn’s and Colitis Foundation IBD Partners cohort. Participants contribute physical activity data through smartphone apps or wearable devices in a bring-your-own-device model. Participants also complete biannual PRO questionnaires from the Patient-Reported Outcomes Measurement Information System short forms and IBD-specific questionnaires. K-means cluster analysis was used to generate physical activity clusters based on 3 key features: number of steps, duration of moderate to vigorous activity (minutes), and distance of activity (miles). Based on the clusters, we conducted a cross-sectional analysis to examine differences in mean questionnaire scores and participant characteristics using one-way ANOVA and chi-square tests. We also conducted a longitudinal analysis to examine individual cluster transitions among participants who completed multiple questionnaires, and mean differences in questionnaire scores were compared using 2-tailed paired sample t tests across 6-month periods. Results: Among 430 participants comprising 1255 six-week physical activity periods, we identified clusters of low (33.7%, n=423), moderate (46%, n=577), and high (20.3%, n=255) physical activity. Scores varied across clusters for depression (P=.004), pain interference (P<.001), fatigue (P<.001), sleep disturbance (P<.001), social satisfaction (P<.001), and short Crohn Disease Activity Index (P<.001), with those in the low activity cluster having the worst scores. Sociodemographic characteristics also differed, and those with low physical activity were older (P=.002), had higher BMIs (P<.001), and had longer disease durations (P=.02) compared to other clusters. Among 246 participants who completed at least 2 consecutive questionnaires consisting of 726 questionnaire periods, 67.8% (n=492) remained in the same cluster, and only 1.2% (n=9) moved to or from the furthest clusters of low and high activity across 6-month periods. Conclusions: For patients with IBDs, there were positive associations between physical activity and PROs related to disease activity and psychosocial domains. Physical activity patterns mostly did not fluctuate over time, suggesting little variation in exercise levels in the absence of an intervention. The use of real-world data to identify subgroups with similar lifestyle behaviors could be leveraged to develop targeted interventions that provide support for psychosocial symptoms and physical activity for personalized IBD care. %M 39316795 %R 10.2196/48020 %U https://www.jmir.org/2024/1/e48020 %U https://doi.org/10.2196/48020 %U http://www.ncbi.nlm.nih.gov/pubmed/39316795 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e59928 %T Prevention of Recurrent Spontaneous Preterm Delivery Using Probiotics (Clostridium butyricum, Enterococcus faecium, and Bacillus subtilis; PPP Trial): Protocol for a Prospective, Single-Arm, Nonblinded, Multicenter Trial %A Yoneda,Satoshi %A Kobayashi,Tohru %A Kikuchi,Kayoko %A Iwamoto,Shintaro %A Teramoto,Tsuyoshi %A Chujo,Daisuke %A Otsuki,Katsufumi %A Nakai,Akihito %A Saito,Shigeru %+ University of Toyama, 3190 Gofuku, Toyama-shi, Toyama, 930-8555, Japan, 81 076 445 6000, s30saito@med.u-toyama.ac.jp %K clostridium %K multicenter open label trial %K preterm delivery %K probiotics %K recurrent spontaneous preterm delivery %K prospective single-arm %K spontaneous preterm delivery %K infection %K oral probiotics %K pregnant women %K pregnant %K pregnancy %K neonates %K preterm births %K systematic review %K meta-analysis %D 2024 %7 9.9.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: The rate of recurrent spontaneous preterm delivery (sPTD) ranges between 27% and 34% and is 22.3% in Japan. Although it currently remains unclear whether probiotics prevent sPTD, retrospective studies recently reported a reduction in the rate of recurrent sPTD with the administration of probiotics including Clostridium spp., which induce regulatory T cells that play an important role in maintaining pregnancy. Objective: The objective of this trial is to evaluate the preventative effects of available oral probiotics, including Clostridium butyricum, on recurrent sPTD. Methods: This is a prospective, single-arm, nonblinded, multicenter trial in Japan. The sample size required for this trial is 345 pregnant women with a history of sPTD, considering a clinically significant reduction in the relative risk of 30% (risk ratio=0.7). The primary endpoint is the rate of recurrent sPTD at <37 weeks of gestation. The secondary endpoints are the rate of sPTD at <34 weeks of gestation, the rate of recurrent sPTD at <28 weeks of gestation, the ratio of intestinal Clostridium spp. (detected by next-generation sequencing), and bacterial vaginosis (using the Nugent score). Results: The trial procedures were approved by the Clinical Research Review Board of Toyama University Hospital (SCR2020008) on March 31, 2021. The trial was registered on the Japan Registry of Clinical Trial website on April 28, 2021. Recruitment began on May 1, 2021, and the trial is estimated to finish on March 31, 2025. Conclusions: The findings will clarify the rate of recurrent sPTD following probiotic administration including Clostridium butyricum. Outcomes from this trial will inform clinical practice and guide future randomized controlled trials. Trial Registration: Japan Registry of Clinical Trials jRCTs041210014; https://jrct.niph.go.jp/latest-detail/jRCTs041210014 International Registered Report Identifier (IRRID): DERR1-10.2196/59928 %M 39250784 %R 10.2196/59928 %U https://www.researchprotocols.org/2024/1/e59928 %U https://doi.org/10.2196/59928 %U http://www.ncbi.nlm.nih.gov/pubmed/39250784 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e53512 %T Investigating Patient Perspectives on Using eHealth Technologies for the Self-Management of Inflammatory Bowel Disease: Mixed Methods Study %A Hermsen,Sander %A Tump,Danielle %A Wentink,Eva %A Duijvestein,Marjolijn %+ OnePlanet Research Centre, Precision Health and Nutrition Group, Bronland 10, Wageningen, 6708 WH, Netherlands, 31 317 791 009, sander.hermsen@imec.nl %K information and communication technology %K ICT %K self-management %K inflammatory bowel disease %K IBD %K smart toilet seat %K mobile phone %D 2024 %7 6.9.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: Inflammatory bowel disease (IBD) poses significant challenges for patients, requiring continuous monitoring and self-management to improve quality of life. Objective: This study aims to investigate the viewpoints of individuals living with IBD on the use of information and communication technology (ICT) for the self-management of their condition, with a particular focus on the concept of a “smart” toilet seat as an example of ICT for IBD self-management. Methods: We conducted an analysis of questionnaire responses obtained from 724 participants. They were encouraged to share their use cases and identify any perceived barriers associated with ICT adoption for managing their condition. To assess their responses, we used descriptive quantitative analysis, summative content analysis, and thematic qualitative analysis. We combined these results in an epistemic network analysis to look for meaningful patterns in the responses. Results: Of the 724 participants, more than half (n=405, 55.9%) were already using various forms of ICT for IBD self-management. The primary factor influencing their use of ICT was their affinity for interacting with technology. Distinct differences emerged between individuals who were using ICT and those who were not, particularly regarding their perceived use cases and concerns. Conclusions: This study provides valuable insights into the perspectives of individuals with IBD on the use of ICT for self-management. To facilitate wider adoption, addressing privacy concerns, ensuring data security, and establishing reliable ICT integration will be critical. %M 39240663 %R 10.2196/53512 %U https://www.jmir.org/2024/1/e53512 %U https://doi.org/10.2196/53512 %U http://www.ncbi.nlm.nih.gov/pubmed/39240663 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e59952 %T Decision Aid for Colectomy in Recurrent Diverticulitis: Development and Usability Study %A Hawkins,Alexander T %A Fa,Andrea %A Younan,Samuel A %A Ivatury,Srinivas Joga %A Bonnet,Kemberlee %A Schlundt,David %A Gordon,Elisa J %A Cavanaugh,Kerri L %+ Division of General Surgery, Section of Colon & Rectal Surgery, Vanderbilt University Medical Center, 1161 21st Ave South, Room D5248 MCN, Nashville, TN, 37232, United States, 1 615 343 4612, alex.hawkins@vumc.org %K design sprint %K diverticulitis %K decision aid %K shared decision-making %K colectomy %K diverticulitis %K decision-making %K diverticular diseases %K gastrointestinal diagnosis %K American %K America %K tools %K tool %K effectiveness %K surgeon %K patients %K patient %K communication %K synopsis %D 2024 %7 3.9.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Diverticular disease is a common gastrointestinal diagnosis with over 2.7 million clinic visits yearly. National guidelines from the American Society of Colon and Rectal Surgeons state that “the decision to recommend elective sigmoid colectomy after recovery from uncomplicated acute diverticulitis should be individualized.” However, tools to individualize this decision are lacking. Objective: This study aimed to develop an online educational decision aid (DA) to facilitate effective surgeon and patient communication about treatment options for recurrent left-sided diverticulitis. Methods: We used a modified design sprint methodology to create a prototype DA. We engaged a multidisciplinary team and adapted elements from the Ottawa Personal Decision Guide. We then iteratively refined the prototype by conducting a mixed methods assessment of content and usability testing, involving cognitive interviews with patients and surgeons. The findings informed the refinement of the DA. Further testing included an in-clinic feasibility review. Results: Over a 4-day in-person rapid design sprint, including patients, surgeons, and health communication experts, we developed a prototype of a diverticulitis DA, comprising an interactive website and handout with 3 discrete sections. The first section contains education about diverticulitis and treatment options. The second section clarifies the potential risks and benefits of both clinical treatment options (medical management vs colectomy). The third section invites patients to participate in a value clarification exercise. After navigating the DA, the patient prints a synopsis that they bring to their clinic appointment, which serves as a guide for shared decision-making. Conclusions: Design sprint methodology, emphasizing stakeholder co-design and complemented by extensive user testing, is an effective and efficient strategy to create a DA for patients living with recurrent diverticulitis facing critical treatment decisions. %M 39226090 %R 10.2196/59952 %U https://formative.jmir.org/2024/1/e59952 %U https://doi.org/10.2196/59952 %U http://www.ncbi.nlm.nih.gov/pubmed/39226090 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e59227 %T Effects of Defatted Rice Bran–Fortified Bread on the Gut Microbiota Composition of Healthy Adults With Low Dietary Fiber Intake: Protocol for a Crossover Randomized Controlled Trial %A Ng,Hwei Min %A Maggo,Jasjot %A Wall,Catherine Louisa %A Bayer,Simone Brigit %A McNabb,Warren C %A Mullaney,Jane Adair %A Foster,Meika %A Cabrera,Diana L %A Fraser,Karl %A Cooney,Janine %A Trower,Tania %A Günther,Catrin S %A Frampton,Chris %A Gearry,Richard Blair %A Roy,Nicole Clemence %+ Department of Human Nutrition, University of Otago, 362 Leith Street, Dunedin North, Dunedin, 9016, New Zealand, 64 4797000, nicole.roy@otago.ac.nz %K dietary fiber %K defatted rice bran %K bread %K healthy adults %K gut microbiota %K metabolites %K gut physiome %K randomized controlled trial %K mobile phone %D 2024 %7 29.8.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Inadequate dietary fiber (DF) intake is associated with several human diseases. Bread is commonly consumed, and its DF content can be increased by incorporating defatted rice bran (DRB). Objective: This first human study on DRB-fortified bread primarily aims to assess the effect of DRB-fortified bread on the relative abundance of a composite of key microbial genera and species in fecal samples. Secondary outcomes include clinical (cardiovascular risk profile), patient-reported (daily bread consumption and bowel movement, gut comfort, general well-being, and total DF intake), biological (fecal microbiota gene abundances, and fecal and plasma metabolites), and physiome (whole-gut and regional transit time and gas fermentation profiles) outcomes in healthy adults with low DF intake. Methods: This is a 2-armed, placebo-controlled, double-blinded, crossover randomized controlled trial. The study duration is 14 weeks: 2 weeks of lead-in, 4 weeks of intervention per phase, 2 weeks of washout, and 2 weeks of follow-up. Overall, 60 healthy adults with low DF intake (<18 g [female individuals] or <22 g [male individuals] per day) were recruited in Christchurch, New Zealand, between June and December 2022. Randomly assigned participants consumed 3 (female individuals) or 4 (male individuals) slices of DRB-fortified bread per day and then placebo bread, and vice versa. The DRB-fortified bread provided 8 g (female individuals) or 10.6 g (male individuals) of total DF, whereas the placebo (a matched commercial white toast bread) provided 2.7 g (female individuals) or 3.6 g (male individuals) of total DF. Before and after each intervention phase, participants provided fecal and blood samples to assess biological responses; completed a 3-day food diary to assess usual intakes and web-based questionnaires to assess gut comfort, general and mental well-being, daily bread intake, and bowel movement via an app; underwent anthropometry and blood pressure measurements; and drank blue food dye to assess whole-gut transit time. Additionally, 25% (15/60) of the participants ingested Atmo gas-sensing capsules to assess colonic gas fermentation profile and whole-gut and regional transit time. Mean differences from baseline will be compared between the DRB and placebo groups, as well as within groups (after the intervention vs baseline). For metabolome analyses, comparisons will be made within and between groups using postintervention values. Results: Preliminary analysis included 56 participants (n=33, 59% female; n=23, 41% male). Due to the large dataset, data analysis was planned to be fully completed by the last quarter of 2024, with full results expected to be published in peer-reviewed journals by the end of 2024. Conclusions: This first human study offers insights into the prospect of consuming DRB-fortified bread to effectively modulate health-promoting gut microbes, their metabolism, and DF intake in healthy adults with low DF intake. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12622000884707; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=383814 International Registered Report Identifier (IRRID): DERR1-10.2196/59227 %M 39207833 %R 10.2196/59227 %U https://www.researchprotocols.org/2024/1/e59227 %U https://doi.org/10.2196/59227 %U http://www.ncbi.nlm.nih.gov/pubmed/39207833 %0 Journal Article %@ 1929-073X %I JMIR Publications %V 13 %N %P e56035 %T Establishment and Evaluation of a Noninvasive Metabolism-Related Fatty Liver Screening and Dynamic Monitoring Model: Cross-Sectional Study %A Ni,Jiali %A Huang,Yong %A Xiang,Qiangqiang %A Zheng,Qi %A Xu,Xiang %A Qin,Zhiwen %A Sheng,Guoping %A Li,Lanjuan %+ State Key Laboratory for Diagnosis and Treatment of Infectious Disease, The First Affiliated Hospital, Zhejiang University School of Medicine, 79 Qingchun Rd, Hangzhou, 310058, China, 86 571 87236458, ljli@zju.edu.cn %K metabolic-associated fatty liver disease %K nonalcoholic fatty liver disease %K nonalcoholic steatohepatitis %K body fat mass %K waist-height ratio %K basal metabolic rate %K liver %D 2024 %7 22.8.2024 %9 Original Paper %J Interact J Med Res %G English %X Background: Metabolically associated fatty liver disease (MAFLD) insidiously affects people's health, and many models have been proposed for the evaluation of liver fibrosis. However, there is still a lack of noninvasive and sensitive models to screen MAFLD in high-risk populations. Objective: The purpose of this study was to explore a new method for early screening of the public and establish a home-based tool for regular self-assessment and monitoring of MAFLD. Methods: In this cross-sectional study, there were 1758 eligible participants in the training set and 200 eligible participants in the testing set. Routine blood, blood biochemistry, and FibroScan tests were performed, and body composition was analyzed using a body composition instrument. Additionally, we recorded multiple factors including disease-related risk factors, the Forns index score, the hepatic steatosis index (HSI), the triglyceride glucose index, total body water (TBW), body fat mass (BFM), visceral fat area, waist-height ratio (WHtR), and basal metabolic rate. Binary logistic regression analysis was performed to explore the potential anthropometric indicators that have a predictive ability to screen for MAFLD. A new model, named the MAFLD Screening Index (MFSI), was established using binary logistic regression analysis, and BFM, WHtR, and TBW were included. A simple rating table, named the MAFLD Rating Table (MRT), was also established using these indicators. Results: The performance of the HSI (area under the curve [AUC]=0.873, specificity=76.8%, sensitivity=81.4%), WHtR (AUC=0.866, specificity=79.8%, sensitivity=80.8%), and BFM (AUC=0.842, specificity=76.9%, sensitivity=76.2%) in discriminating between the MAFLD group and non-fatty liver group was evaluated (P<.001). The AUC of the combined model including WHtR, HSI, and BFM values was 0.900 (specificity=81.8%, sensitivity=85.6%; P<.001). The MFSI was established based on better performance at screening MAFLD patients in the training set (AUC=0.896, specificity=83.8%, sensitivity=82.1%) and was confirmed in the testing set (AUC=0.917, specificity=89.8%, sensitivity=84.4%; P<.001). Conclusions: The novel MFSI model was built using WHtR, BFM, and TBW to screen for early MAFLD. These body parameters can be easily obtained using a body fat scale at home, and the mobile device software can record specific values and perform calculations. MFSI had better performance than other models for early MAFLD screening. The new model showed strong power and stability and shows promise in the area of MAFLD detection and self-assessment. The MRT was a practical tool to assess disease alterations in real time. %M 39172506 %R 10.2196/56035 %U https://www.i-jmr.org/2024/1/e56035 %U https://doi.org/10.2196/56035 %U http://www.ncbi.nlm.nih.gov/pubmed/39172506 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e57344 %T Acceptability, Perceptions, and Experiences Regarding Electronic Patient-Reported Outcomes After Laparoscopic Cholecystectomy: Protocol for a Mixed Methods Feasibility Study %A Choucair,Kareem %A Corrigan,Mark %A O'Sullivan,Adrian %A Barber,Sean %A Stankiewicz,Lucja %A Henn,Patrick %A Dennehy,Oscar %A Kayyal,Mohd Yasser %A Tan,Yong Yu %A Fadahunsi,Kayode Philip %A O'Donoghue,John %+ Department of Primary Care and Public Health, School of Public Health, Imperial College London, Exhibition Rd, South Kensington, London, SW7 2BX, United Kingdom, 44 2075895111, k.fadahunsi14@imperial.ac.uk %K patient-reported outcomes %K digital technology %K hepatobiliary surgery %K surgery %K laparoscopic cholecystectomy %K electronic patient %K general surgeon %K mixed methods %K prospective study %K quantitative %K qualitative %K Qualtrics %K interview %K Microsoft Teams %K data collection %K patient care %K patient-centric %K patient-doctor communication %K eHealth %D 2024 %7 19.8.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Patient-reported outcomes (PROs) can be defined as any report of a patient’s health taken directly from the patient. Routine collection of PRO data has been shown to offer potential benefits to patient-doctor communication. Electronic forms of PRO measures (PROMs) could be more beneficial in comparison to traditional PROMs in obtaining PROs from patients. However, it is currently unclear whether the routine collection of electronic PRO data could result in better outcomes for patients undergoing laparoscopic cholecystectomy (LC). Objective: This study aims to explore the perspectives of patients and surgeons on the use of electronic PROMs. Based on prior research, technical skill and experience level of the surgeon, long-term quality of life, patient involvement in decision-making, communication skills of the surgeon, cleanliness of the ward environment, and standards of nursing care are identified to be the most important factors for the patients. Methods: This is a mixed methods prospective study that will collect both quantitative (survey) and qualitative (interview) data. The study has two components. The first involves the distribution of an electronic presurvey to patients who received elective LC within 48 hours of their surgery (n=80). This survey will explore the perspective of patients regarding the procedure, hospital experience, long-term outcomes, and the perceived value of using PROMs. These patients will then be followed up after 1 year and given another survey. The second component involves the distribution of the same survey and the completion of structured interviews with general surgeons (n=10). The survey will ascertain what PROs from the participants are most useful for the surgeons and the interviews will focus on how the surgeons view routine PRO collection. A convenience sampling approach will be used. Surveys will be distributed through Qualtrics and interviews will be completed on Microsoft Teams. Results: Data collection began on February 14, 2023. As of February 12, 2024, 71 of 80 recruited patients have been given the presurvey. The follow-up with the patients and the general surgeon components of the study have not begun. The expected completion date of this study is in April 2025. Conclusions: Overall, this study will investigate the potential of electronic PRO collection to offer value for patients and general surgeons. This approach will ensure that patient care is investigated in a multifaceted way, offering patient-centric guidance to surgeons in their approach to care. International Registered Report Identifier (IRRID): DERR1-10.2196/57344 %M 39159444 %R 10.2196/57344 %U https://www.researchprotocols.org/2024/1/e57344 %U https://doi.org/10.2196/57344 %U http://www.ncbi.nlm.nih.gov/pubmed/39159444 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e53909 %T Effect of a Mobile Health–Based Remote Interaction Management Intervention on the Quality of Life and Self-Management Behavior of Patients With Low Anterior Resection Syndrome: Randomized Controlled Trial %A Zhou,Peng %A Li,Hui %A Pang,Xueying %A Wang,Ting %A Wang,Yan %A He,Hongye %A Zhuang,Dongmei %A Zhu,Furong %A Zhu,Rui %A Hu,Shaohua %+ Department of Nursing, the First Affiliated Hospital of Anhui Medical University, 218 Jixi Road, Hefei, 230009, China, 86 62922005, hushaohua1003@126.com %K mHealth %K low anterior resection syndrome %K quality of life %K sphincter-preserving surgery %K randomized controlled trial %K mobile health %K mobile phone %D 2024 %7 13.8.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: People who undergo sphincter-preserving surgery have high rates of anorectal functional disturbances, known as low anterior resection syndrome (LARS). LARS negatively affects patients’ quality of life (QoL) and increases their need for self-management behaviors. Therefore, approaches to enhance self-management behavior and QoL are vital. Objective: This study aims to assess the effectiveness of a remote digital management intervention designed to enhance the QoL and self-management behavior of patients with LARS. Methods: From July 2022 to May 2023, we conducted a single-blinded randomized controlled trial and recruited 120 patients with LARS in a tertiary hospital in Hefei, China. All patients were randomly assigned to the intervention group (using the “e-bowel safety” applet and monthly motivational interviewing) or the control group (usual care and an information booklet). Our team provided a 3-month intervention and followed up with all patients for an additional 3 months. The primary outcome was patient QoL measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30. The secondary outcomes were evaluated using the Bowel Symptoms Self-Management Behaviors Questionnaire, LARS score, and Perceived Social Support Scale. Data collection occurred at study enrollment, the end of the 3-month intervention, and the 3-month follow-up. Generalized estimating equations were used to analyze changes in all outcome variables. Results: In the end, 111 patients completed the study. In the intervention group, 5 patients withdrew; 4 patients withdrew in the control group. Patients in the intervention group had significantly larger improvements in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 total score (mean difference 11.51; 95% CI 10.68-12.35; Cohen d=1.73) and Bowel Symptoms Self-Management Behaviors Questionnaire total score (mean difference 8.80; 95% CI 8.28-9.32; Cohen d=1.94) than those in the control group. This improvement effect remained stable at 3-month follow-up (mean difference 14.47; 95% CI 13.65-15.30; Cohen d=1.58 and mean difference 8.85; 95% CI 8.25-9.42; Cohen d=2.23). The LARS score total score had significantly larger decreases after intervention (mean difference –3.28; 95% CI –4.03 to –2.54; Cohen d=–0.39) and at 3-month follow-up (mean difference –6.69; 95% CI –7.45 to –5.93; Cohen d=–0.69). The Perceived Social Support Scale total score had significantly larger improvements after intervention (mean difference 0.47; 95% CI 0.22-0.71; Cohen d=1.81). Conclusions: Our preliminary findings suggest that the mobile health–based remote interaction management intervention significantly enhanced the self-management behaviors and QoL of patients with LARS, and the effect was sustained. Mobile health–based remote interventions become an effective method to improve health outcomes for many patients with LARS. Trial Registration: Chinese Clinical Trial Registry ChiCTR2200061317; https://tinyurl.com/tmmvpq3 %M 39137413 %R 10.2196/53909 %U https://www.jmir.org/2024/1/e53909 %U https://doi.org/10.2196/53909 %U http://www.ncbi.nlm.nih.gov/pubmed/39137413 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e58497 %T Development and Validation of a Mobile-Centered Digital Health Readiness Scale (mDiHERS): Health Literacy and Equity Scale %A Kim,Hana %A Schnall,Rebecca %A Yoon,Nagyeom %A Koh,Seong-Joon %A Lee,Jisan %A Cheon,Jae Hee %+ Department of Nursing, Gangneung-Wonju National University, Department of Nursing, Gangneung-Wonju National University, Wonju, 26403, Republic of Korea, 82 337608646, saan2mari@gmail.com %K digital health %K health literacy %K health equity %K inflammatory bowel diseases %K telemedicine %K patient participation %K validation %K validate %K IBD %K bowel %K inflammatory %K inflammation %K gastrointestinal %K GI %K internal medicine %K gastroenterology %K scale %K readiness %K adoption %K measure %K measures %K measurement %K measurements %K assessment %K assessments %K scales %K eHealth %K e-health %K literacy %K mHealth %K mobile health %K chronic %K mobile phone %D 2024 %7 13.8.2024 %9 Original Paper %J J Med Internet Res %G English %X Background: There has been a rapid expansion of digital health care services, making the need for measuring and improving digital health readiness a priority. In response, our study team developed the Mobile-Centered Digital Health Readiness: Health Literacy and Equity Scale (mDiHERS) to measure digital health readiness. Objective: We aim to develop and validate a scale that assesses digital health readiness, encompassing literacy and equity, and to ensure the effective use of mobile-centered digital health services. Methods: This study was conducted from October 2021 to October 2022 to develop and validate the mDiHERS. Participants included patients with inflammatory bowel disease, which is a chronic condition requiring continuous management, and experts in medical and nursing informatics. The scale development involved a literature review, focus group interviews, and content validity evaluations. A total of 440 patients with inflammatory bowel disease were recruited for the validation phase, with 403 completing the survey. The scale’s validity and reliability were assessed through exploratory factor analysis and Cronbach α. The scale was translated into English by translators and bilingual and native researchers, ensuring its applicability in diverse settings. Results: The mDiHERS consists of 36 items across 6 domains, with a 5-point Likert scale for responses. The validation process confirmed the scale’s construct validity, with 4 factors explaining 65.05% of the total variance. The scale’s reliability was established with Cronbach α values ranging from 0.84 to 0.91. The scale’s development considered the technical proficiency necessary for engaging with health mobile apps and devices, reflecting the importance of subjective confidence and objective skills in digital health literacy. Conclusions: The mDiHERS is a validated tool for measuring patients’ readiness and ability to use digital health services. The mDiHERS assesses user characteristics, digital accessibility, literacy, and equity to contribute to the effective use of digital health services and improve accessibility. The development and validation of the mDiHERS emphasize the importance of confidence and competence in managing health digitally. Continuous improvements are necessary to ensure that all patients can benefit from digital health care. %M 39137409 %R 10.2196/58497 %U https://www.jmir.org/2024/1/e58497 %U https://doi.org/10.2196/58497 %U http://www.ncbi.nlm.nih.gov/pubmed/39137409 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 26 %N %P e56664 %T Self-Management Using eHealth Technologies for Liver Transplant Recipients: Scoping Review %A Kim,Soo Hyun %A Kim,Kyoung-A %A Chu,Sang Hui %A Kim,Hyunji %A Joo,Dong Jin %A Lee,Jae Geun %A Choi,JiYeon %+ College of Nursing, Mo-Im Kim Nursing Research Institute, Institute for Innovation in Digital Healthcare, Yonsei University, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Republic of Korea, 82 2 2228 3301, jychoi610@yuhs.ac %K liver transplantation %K self-management %K transplant management %K eHealth %K eHealth technology %K digital health %K review %K mobile phone %K liver transplant %K liver disease %K scoping review %D 2024 %7 4.7.2024 %9 Review %J J Med Internet Res %G English %X Background: Liver transplantation has become increasingly common as a last-resort treatment for end-stage liver diseases and liver cancer, with continually improving success rates and long-term survival rates. Nevertheless, liver transplant recipients face lifelong challenges in self-management, including immunosuppressant therapy, lifestyle adjustments, and navigating complex health care systems. eHealth technologies hold the potential to aid and optimize self-management outcomes, but their adoption has been slow in this population due to the complexity of post–liver transplant management. Objective: This study aims to examine the use of eHealth technologies in supporting self-management for liver transplant recipients and identify their benefits and challenges to suggest areas for further research. Methods: Following the Arksey and O’Malley methodology for scoping reviews, we conducted a systematic search of 5 electronic databases: PubMed, CINAHL, Embase, PsycINFO, and Web of Science. We included studies that (1) examined or implemented eHealth-based self-management, (2) included liver transplant recipients aged ≥18 years, and (3) were published in a peer-reviewed journal. We excluded studies that (1) were case reports, conference abstracts, editorials, or letters; (2) did not focus on the posttransplantation phase; (3) did not focus on self-management; and (4) did not incorporate the concept of eHealth or used technology solely for data collection. The quality of the selected eHealth interventions was evaluated using (1) the Template for Intervention Description and Replication guidelines and checklist and (2) the 5 core self-management skills identified by Lorig and Holman. Results: Of 1461 articles, 15 (1.03%) studies were included in the final analysis. Our findings indicate that eHealth-based self-management strategies for adult liver transplant recipients primarily address lifestyle management, medication adherence, and remote monitoring, highlighting a notable gap in alcohol relapse interventions. The studies used diverse technologies, including mobile apps, videoconferencing, and telehealth platforms, but showed limited integration of decision-making or resource use skills essential for comprehensive self-management. The reviewed studies highlighted the potential of eHealth in enhancing individualized health care, but only a few included collaborative features such as 2-way communication or tailored goal setting. While adherence and feasibility were generally high in many interventions, their effectiveness varied due to diverse methodologies and outcome measures. Conclusions: This scoping review maps the current literature on eHealth-based self-management support for liver transplant recipients, assessing its potential and challenges. Future studies should focus on developing predictive models and personalized eHealth interventions rooted in patient-generated data, incorporating digital human-to-human interactions to effectively address the complex needs of liver transplant recipients. This review emphasizes the need for future eHealth self-management research to address the digital divide, especially with the aging liver transplant recipient population, and ensure more inclusive studies across diverse ethnicities and regions. %M 38963937 %R 10.2196/56664 %U https://www.jmir.org/2024/1/e56664 %U https://doi.org/10.2196/56664 %U http://www.ncbi.nlm.nih.gov/pubmed/38963937 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e53550 %T Integrating Virtual Mindfulness-Based Stress Reduction Into Inflammatory Bowel Disease Care: Mixed Methods Feasibility Trial %A Chappell,Kaitlyn Delaney %A Meakins,Diana %A Marsh-Joyal,Melanie %A Bihari,Allison %A Goodman,Karen J %A Le Melledo,Jean-Michel %A Lim,Allen %A Peerani,Farhad %A Kroeker,Karen Ivy %+ Division of Gastroenterology, Department of Medicine, University of Alberta, 130 University Campus NW, Edmonton, AB, T6G 2X8, Canada, 1 780 492 4873, karen.kroeker@ualberta.ca %K inflammatory bowel disease %K psychosocial care %K multidisciplinary care %K quality of care %K quality of life %K mental health %K adult %K adults %K anxiety %K depression %K IBD %K virtual mindfulness %K feasibility trial %K clinic %K health facility %K Canada %K semistructured interview %K psychiatrist %K psychiatrists %K videoconferencing %K effectiveness %K v-MBSR %K coping %K coping strategy %D 2024 %7 6.5.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Individuals with inflammatory bowel disease (IBD) experience cycles of aggressive physical symptoms including abdominal pain, diarrhea, and fatigue. These acute symptoms regress and return, and chronic symptoms and complications often linger. The nature of the disease can also cause individuals to experience psychological distress including symptoms of anxiety and depression; however, unlike the physical symptoms of IBD, these psychological symptoms often remain untreated. Objective: This study aims to evaluate the feasibility, acceptability, and effectiveness of virtual mindfulness-based stress reduction (v-MBSR) for adults with IBD. Methods: IBD patients with self-reported anxiety or depression were recruited from clinics in Alberta, Canada to participate in an 8-week v-MSBR intervention. Eligible patients participated in v-MBSR delivered by psychiatrists using a videoconferencing platform. Primary feasibility outcomes included trial uptake, adherence, attendance, and attrition rates. Secondary effectiveness outcomes included measures of anxiety, depression, quality of life (QoL), and mindfulness. Effectiveness data were collected at 3 time points: baseline, at intervention completion, and 6 months after completion. To further assess feasibility and acceptability, participants were invited to participate in a semistructured interview after completing v-MBSR. Results: A total of 16 of the 64 (25%) referred patients agreed to participate in v-MBSR with the most common reason for decline being a lack of time while 7 of the 16 (43.8%) participants completed the program and experienced encouraging effects including decreased anxiety and depression symptoms and increased health-related QoL with both improvements persisting at 6-month follow-up. Participants described improved coping strategies and disease management techniques as benefits of v-MBSR. Conclusions: Patients with IBD were interested in a psychiatrist-led virtual anxiety management intervention, but results demonstrate v-MBSR may be too time intensive for some patients with IBD patients. v-MBSR was acceptable to those who completed the intervention, and improvements to anxiety, depression, and QoL were promising and sustainable. Future studies should attempt to characterize the patients with IBD who may benefit most from interventions like v-MBSR. %M 38709548 %R 10.2196/53550 %U https://formative.jmir.org/2024/1/e53550 %U https://doi.org/10.2196/53550 %U http://www.ncbi.nlm.nih.gov/pubmed/38709548 %0 Journal Article %@ 2561-1011 %I JMIR Publications %V 8 %N %P e53421 %T A Multidisciplinary Assessment of ChatGPT’s Knowledge of Amyloidosis: Observational Study %A King,Ryan C %A Samaan,Jamil S %A Yeo,Yee Hui %A Peng,Yuxin %A Kunkel,David C %A Habib,Ali A %A Ghashghaei,Roxana %+ Division of Cardiology, Department of Medicine, University of California, Irvine Medical Center, 101 The City Drive South, Orange, CA, 92868, United States, 1 714 456 7890, kingrc@hs.uci.edu %K amyloidosis %K ChatGPT %K large language models %K cardiology %K gastroenterology %K neurology %K artificial intelligence %K multidisciplinary care %K assessment %K patient education %K large language model %K accuracy %K reliability %K accessibility %K educational resources %K dissemination %K gastroenterologist %K cardiologist %K medical society %K institution %K institutions %K Facebook %K neurologist %K reproducibility %K amyloidosis-related %D 2024 %7 19.4.2024 %9 Original Paper %J JMIR Cardio %G English %X Background: Amyloidosis, a rare multisystem condition, often requires complex, multidisciplinary care. Its low prevalence underscores the importance of efforts to ensure the availability of high-quality patient education materials for better outcomes. ChatGPT (OpenAI) is a large language model powered by artificial intelligence that offers a potential avenue for disseminating accurate, reliable, and accessible educational resources for both patients and providers. Its user-friendly interface, engaging conversational responses, and the capability for users to ask follow-up questions make it a promising future tool in delivering accurate and tailored information to patients. Objective: We performed a multidisciplinary assessment of the accuracy, reproducibility, and readability of ChatGPT in answering questions related to amyloidosis. Methods: In total, 98 amyloidosis questions related to cardiology, gastroenterology, and neurology were curated from medical societies, institutions, and amyloidosis Facebook support groups and inputted into ChatGPT-3.5 and ChatGPT-4. Cardiology- and gastroenterology-related responses were independently graded by a board-certified cardiologist and gastroenterologist, respectively, who specialize in amyloidosis. These 2 reviewers (RG and DCK) also graded general questions for which disagreements were resolved with discussion. Neurology-related responses were graded by a board-certified neurologist (AAH) who specializes in amyloidosis. Reviewers used the following grading scale: (1) comprehensive, (2) correct but inadequate, (3) some correct and some incorrect, and (4) completely incorrect. Questions were stratified by categories for further analysis. Reproducibility was assessed by inputting each question twice into each model. The readability of ChatGPT-4 responses was also evaluated using the Textstat library in Python (Python Software Foundation) and the Textstat readability package in R software (R Foundation for Statistical Computing). Results: ChatGPT-4 (n=98) provided 93 (95%) responses with accurate information, and 82 (84%) were comprehensive. ChatGPT-3.5 (n=83) provided 74 (89%) responses with accurate information, and 66 (79%) were comprehensive. When examined by question category, ChatGTP-4 and ChatGPT-3.5 provided 53 (95%) and 48 (86%) comprehensive responses, respectively, to “general questions” (n=56). When examined by subject, ChatGPT-4 and ChatGPT-3.5 performed best in response to cardiology questions (n=12) with both models producing 10 (83%) comprehensive responses. For gastroenterology (n=15), ChatGPT-4 received comprehensive grades for 9 (60%) responses, and ChatGPT-3.5 provided 8 (53%) responses. Overall, 96 of 98 (98%) responses for ChatGPT-4 and 73 of 83 (88%) for ChatGPT-3.5 were reproducible. The readability of ChatGPT-4’s responses ranged from 10th to beyond graduate US grade levels with an average of 15.5 (SD 1.9). Conclusions: Large language models are a promising tool for accurate and reliable health information for patients living with amyloidosis. However, ChatGPT’s responses exceeded the American Medical Association’s recommended fifth- to sixth-grade reading level. Future studies focusing on improving response accuracy and readability are warranted. Prior to widespread implementation, the technology’s limitations and ethical implications must be further explored to ensure patient safety and equitable implementation. %M 38640472 %R 10.2196/53421 %U https://cardio.jmir.org/2024/1/e53421 %U https://doi.org/10.2196/53421 %U http://www.ncbi.nlm.nih.gov/pubmed/38640472 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e50513 %T Safety, Tolerability, and Dose-Limiting Toxicity of Lacosamide in Patients With Painful Chronic Pancreatitis: Protocol for a Phase 1 Clinical Trial to Determine Safety and Identify Side Effects %A Fogel,Evan L %A Easler,Jeffrey J %A Yuan,Ying %A Yadav,Dhiraj %A Conwell,Darwin L %A Vege,Santhi Swaroop %A Han,Samuel Y %A Park,Walter %A Patrick,Vanessa %A White,Fletcher A %+ Department of Medicine, School of Medicine, Indiana University, Suite 1602, 550 N. University Blvd, Indianapolis, IN, 46202, United States, 1 317 274 8157, efogel@iu.edu %K abdominal pain %K opioid-induced hyperalgesia %K pain %K abdomen %K protocol %K toxicity %K toxic %K lacosamide %K pancreas %K pancreatitis %K opioid %D 2024 %7 7.3.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chronic abdominal pain is the hallmark symptom of chronic pancreatitis (CP), with 50% to 80% of patients seeking medical attention for pain control. Although several management options are available, outcomes are often disappointing, and opioids remain a mainstay of therapy. Opioid-induced hyperalgesia is a phenomenon resulting in dose escalation, which may occur partly because of the effects of opioids on voltage-gated sodium channels associated with pain. Preclinical observations demonstrate that the combination of an opioid and the antiseizure drug lacosamide diminishes opioid-induced hyperalgesia and improves pain control. Objective: In this phase 1 trial, we aim to determine the safety, tolerability, and dose-limiting toxicity of adding lacosamide to opioids for the treatment of painful CP and assess the feasibility of performance of a pilot study of adding lacosamide to opioid therapy in patients with CP. As an exploratory aim, we will assess the efficacy of adding lacosamide to opioid therapy in patients with painful CP. Methods: Using the Bayesian optimal interval design, we will conduct a dose-escalation trial of adding lacosamide to opioid therapy in patients with painful CP enrolled in cohorts of size 3. The initial dose will be 50 mg taken orally twice a day, followed by incremental increases to a maximum dose of 400 mg/day, with lacosamide administered for 7 days at each dose level. Adverse events will be documented according to Common Terminology Criteria for Adverse Events (version 5.0). Results: As of December 2023, we have currently enrolled 6 participants. The minimum number of participants to be enrolled is 12 with a maximum of 24. We expect to publish the results by March 2025. Conclusions: This trial will test the feasibility of the study design and provide reassurance regarding the tolerability and safety of opioids in treating painful CP. It is anticipated that lacosamide will prove to be safe and well tolerated, supporting a subsequent phase 2 trial assessing the efficacy of lacosamide+opioid therapy in patients with painful CP, and that lacosamide combined with opiates will lower the opioid dose necessary for pain relief and improve the safety profile of opioid use in treating painful CP. Trial Registration: Clinicaltrials.gov NCT05603702; https://clinicaltrials.gov/study/NCT05603702 International Registered Report Identifier (IRRID): PRR1-10.2196/50513 %M 38451604 %R 10.2196/50513 %U https://www.researchprotocols.org/2024/1/e50513 %U https://doi.org/10.2196/50513 %U http://www.ncbi.nlm.nih.gov/pubmed/38451604 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e53347 %T Effects of the Prolong Life With Nine Turn-Method Qigong on Fatigue, Insomnia, Anxiety, and Gastrointestinal Disorders in Patients With Chronic Fatigue Syndrome: Protocol for a Randomized Controlled Trial %A Xie,Fangfang %A You,Yanli %A Gu,Yuanjia %A Xu,Jiatuo %A Yao,Fei %+ Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, 200071, No.274, Middle Zhijiang Road, Shanghai, 200071, China, 86 13585975106, doctoryaofei@shutcm.edu.cn %K chronic fatigue syndrome %K prolong life with nine turn method Qigong %K fMRI %K gut microbiota %K gastrointestinal %K fatigue %K insomnia %K CFS %K study protocol %K Qigong %K efficacy %K safety %K cognitive behavioral therapy %K CBT %K randomized trial %D 2024 %7 26.2.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chronic fatigue syndrome (CFS) is a debilitating multisystem disorder that can lead to various pathophysiological abnormalities and symptoms, including insomnia, gastrointestinal disorders, and anxiety. Due to the side effects of currently available drugs, there is a growing need for safe and effective nondrug therapies. The Prolong Life With Nine Turn (PLWNT) Qigong method is a system of mind-body exercise with restorative benefits that can alleviate the clinical symptoms of CFS and impart a significant inhibitory effect. Various studies have proven the treatment efficacy of PLWNT; however, the impact on insomnia, gastrointestinal disorders, and anxiety in patients with CFS has not yet been investigated. Objective: This study aims to evaluate the efficacy and safety of the PLWNT method in terms of its effects on fatigue, insomnia, anxiety, and gastrointestinal symptoms in patients with CFS. Methods: We will conduct a randomized, analyst-blinded, parallel-controlled trial with a 12-week intervention and 8-week follow-up. A total of 208 patients of age 20-60 years will be recruited. The patients will be randomly divided into a PLWNT Qigong exercise group (PLWNT Group) and a control group treated with cognitive behavioral therapy at a ratio of 1:1. Participants from the treatment groups will be taught by a highly qualified professor at the Shanghai University of Traditional Chinese Medicine once a week and will be supervised via web during the remaining 6 days at home, over 12 consecutive weeks. The primary outcome will be the Multidimensional Fatigue Inventory 20, while the secondary outcomes include the Pittsburgh Sleep Quality Index, Gastrointestinal Symptom Rating Scale, Hospital Anxiety and Depression Scale, functional magnetic resonance imaging, gut microbiota, and peripheral blood. Results: The study was approved by the ethics committee of Shanghai Municipal Hospital of Traditional Chinese Medicine in March 2022 (Ethics Approval Number 2022SHL-KY-05). Recruitment started in July 2022. The intervention is scheduled to be completed in December 2024, and data collection will be completed by the end of January 2025. Over the 3-year recruitment period, 208 participants will be recruited. Data management is still in progress; therefore, data analysis has yet to be performed. Conclusions: This randomized trial will evaluate the effectiveness of the PLWNT method in relieving fatigue, insomnia, anxiety, and gastrointestinal symptoms in patients with CFS. If proven effective, it will provide a promising alternative intervention for patients with CFS. Trial Registration: China Clinical Trials Registry ChiCTR2200061229; https://www.chictr.org.cn/showproj.html?proj=162803 International Registered Report Identifier (IRRID): PRR1-10.2196/53347 %M 38407950 %R 10.2196/53347 %U https://www.researchprotocols.org/2024/1/e53347 %U https://doi.org/10.2196/53347 %U http://www.ncbi.nlm.nih.gov/pubmed/38407950 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 8 %N %P e43286 %T Formative Evaluation of a Comprehensive Self-Management Intervention for Irritable Bowel Syndrome, Comorbid Anxiety, and Depression: Mixed Methods Study %A Kamp,Kendra %A Yang,Pei-Lin %A Friedman,Emily %A Lopez,Alejandra %A Iribarren,Sarah %A Barney,Pamela %A Munson,Sean %A Heitkemper,Margaret %A Levy,Rona %+ Department of Biobehavioral Nursing and Health Informatics, School of Nursing, University of Washington, 1410 NE Campus Parkway, Seattle, WA, 98195, United States, 1 206 221 4617, kamp@uw.edu %K acceptability %K anxiety %K depression %K design %K effectiveness %K feasibility %K implementation %K intervention %K irritable bowel syndrome %K management %K mixed methods %K patient %K self-management %K support %K usability %D 2024 %7 31.1.2024 %9 Original Paper %J JMIR Form Res %G English %X Background: Irritable bowel syndrome (IBS) is a disorder of the gut-brain interaction that is associated with abdominal pain, altered bowel patterns, and reduced quality of life. Up to 50% of patients with IBS also report anxiety or depressive symptoms. Although effective self-management interventions exist for individuals with IBS, few have been effectively implemented, and most do not consider the unique needs of patients with comorbid IBS and anxiety or depression. Objective: This study aimed to determine the anticipated acceptability, appropriateness, feasibility, and usability of a comprehensive self-management intervention using an implementation science and human-centered design approach among individuals with comorbid IBS and anxiety or depression and health care providers. Methods: A convergent mixed methods design was used to elicit feedback on the comprehensive self-management intervention outline and content to identify refinement needs before testing. Patients with IBS and moderate to severe anxiety or depression and health care providers were purposefully sampled from primary care and gastroenterology settings. Participants completed semistructured interviews and surveys on anticipated acceptability, appropriateness, feasibility, and usability. Results: Patient participants (n=12) were on average 36.8 (SD 12.2) years of age, and 42% (5/12) were currently receiving psychological therapy. Health care providers (n=14) were from primary care (n=7) and gastroenterology (n=7) settings. The mean usability scores (out of 100) were 52.5 (SD 14.5) for patients and 45.6 (SD 11.6) for providers. For patients and providers, qualitative data expanded the quantitative findings for acceptability and appropriateness. Acceptability findings were the comprehensive nature of the intervention and discussion of the gut-brain interaction. For appropriateness, participants reported that the intervention provided structure, accountability, and support. Feasibility was confirmed for patients, but there was a divergence of findings between quantitative and qualitative measures for providers. Patients focused on intervention feasibility, while providers focused on implementation feasibility in the clinic. Identified usability issues to address before implementation included the intervention delivery format, length, and lack of integration into health care settings that, if not addressed, may limit the reach of the intervention. Conclusions: Patients and health care providers found the intervention acceptable and appropriate. Several feasibility and usability issues were identified, including intervention delivery methods, length of intervention, and the best methods to implement in the clinic setting. The next steps are to refine the intervention to address the identified issues and test in a pilot study whether addressing usability issues leads to the anticipated improvements in implementation and uptake. %M 38294871 %R 10.2196/43286 %U https://formative.jmir.org/2024/1/e43286 %U https://doi.org/10.2196/43286 %U http://www.ncbi.nlm.nih.gov/pubmed/38294871 %0 Journal Article %@ 2369-2960 %I JMIR Publications %V 10 %N %P e45818 %T CD4/CD8 Ratio Recovered as a Predictor of Decreased Liver Damage in Adults Infected With HIV: 16-Year Observational Cohort Study %A Liang,Bingyu %A Sun,Rujing %A Liao,Yanyan %A Nong,Aidan %A He,Jinfeng %A Qin,Fengxiang %A Ou,Yanyun %A Che,Jianhua %A Wu,Zhenxian %A Yang,Yuan %A Qin,Jiao %A Cai,Jie %A Bao,Lijuan %A Ye,Li %A Liang,Hao %+ Biosafety III Laboratory, Life Science Institute, Guangxi Medical University, 22 Shuangyong Road, Nanning, 530021, China, 86 13737089380, lianghao@gxmu.edu.cn %K AIDS %K antiretroviral therapy %K CD4/CD8 %K efavirenz %K HIV %K liver damage %K lopinavir %K nevirapine %D 2024 %7 9.1.2024 %9 Original Paper %J JMIR Public Health Surveill %G English %X Background: As the life expectancy of individuals infected with HIV continues to increase, vigilant monitoring of non–AIDS-related events becomes imperative, particularly those pertaining to liver diseases. In comparison to the general population, patients infected with HIV experience a higher frequency of liver-related deaths. The CD4/CD8 ratio is emerging as a potential biomarker for non–AIDS-related events. However, few existing studies have been specially designed to explore the relationship between the CD4/CD8 ratio and specific types of non–AIDS-related events, notably liver damage. Objective: This study aimed to investigate the potential association between the CD4/CD8 ratio and the development of liver damage in a sizable cohort of patients infected with HIV receiving antiretroviral treatment (ART). Additionally, the study sought to assess the effectiveness of 3 antiretroviral drugs in recovering the CD4/CD8 ratio and reducing the occurrence of liver damage in this population. Methods: We conducted an observational cohort study among adults infected with HIV receiving ART from 2004 to 2020 in Guangxi, China. Propensity score matching, multivariable Cox proportional hazard, and Fine-Gray competing risk regression models were used to determine the relationship between the CD4/CD8 ratio recovered and liver damage. Results: The incidence of liver damage was 20.12% among 2440 eligible individuals during a median follow-up period of 4 person-years. Patients whose CD4/CD8 ratio did not recover to 1.0 exhibited a higher incidence of liver damage compared to patients with a CD4/CD8 ratio recovered (adjusted hazard ratio 7.90, 95% CI 4.39-14.21; P<.001; subdistribution hazard ratio 6.80, 95% CI 3.83-12.11; P<.001), findings consistent with the propensity score matching analysis (adjusted hazard ratio 6.94, 95% CI 3.41-14.12; P<.001; subdistribution hazard ratio 5.67, 95% CI 2.74-11.73; P<.001). The Efavirenz-based regimen exhibited the shortest time for CD4/CD8 ratio recovery (median 71, IQR 49-88 months) and demonstrated a lower prevalence of liver damage (4.18/100 person-years). Conclusions: Recovery of the CD4/CD8 ratio was associated with a decreased risk of liver damage in patients infected with HIV receiving ART, adding evidence for considering the CD4/CD8 ratio as a potential marker for identifying individuals at risk of non–AIDS-related diseases. An efavirenz-based regimen emerged as a recommended choice for recovering the CD4/CD8 ratio and mitigating the risk of liver damage. %M 37846087 %R 10.2196/45818 %U https://publichealth.jmir.org/2024/1/e45818 %U https://doi.org/10.2196/45818 %U http://www.ncbi.nlm.nih.gov/pubmed/37846087 %0 Journal Article %@ 2369-2960 %I JMIR Publications %V 9 %N %P e39472 %T Hepatitis C Knowledge and Self-Reported Testing Behavior in the General Population in China: Online Cross-Sectional Survey %A Liu,Yin %A Su,Juan %A Wang,Xiaoyang %A Xu,Huifang %A Wang,Hong %A Kang,Ruihua %A Zheng,Liyang %A Wang,Yixian %A Liu,Chunya %A Jing,Yiping %A Zhang,Shaokai %+ Department of Cancer Epidemiology, The Affiliated Cancer Hospital of Zhengzhou University (Henan Cancer Hospital), 127 Dongming Road, Zhengzhou, 450008, China, 86 65587361, shaokaizhang@126.com %K HCV %K hepatitis C virus %K knowledge %K testing behaviors %K general population %K cross-sectional %K online survey %K testing %K screening %K patient education %K China %K Chinese %K patient education %K health education %K hepatitis %K viral disease %K viral infection %K communicable disease %K liver %D 2023 %7 11.12.2023 %9 Original Paper %J JMIR Public Health Surveill %G English %X Background: The World Health Organization has proposed a worldwide target of eliminating hepatitis C virus (HCV) by 2030. A better understanding of HCV, testing behaviors, and associated factors in the general population is essential. Objective: This study aimed to assess HCV knowledge, self-reported HCV testing behavior, and willingness to undergo HCV screening in the general Chinese population. Methods: A cross-sectional online survey of the general Chinese population aged ≥15 years was conducted from November 2021 to May 2023. Participant characteristics were assessed based on their knowledge level and uptake of HCV testing. Participants ever having heard of HCV were recognized as being aware of HCV and asked additional HCV knowledge questions using a brief, validated 9-item scale. Participants with 0-3 points and who were unaware of HCV were categorized as having poor knowledge, and those with 4-6 points and ≥7 points were categorized as having fair and good knowledge, respectively. Participant uptake of HCV testing, testing results, reasons for undergoing or not undergoing HCV testing, and willingness to undergo HCV screening were collected through self-reports. Ordinal and binary logistic regression analyses were used to assess factors associated with the HCV knowledge level and the uptake of HCV testing, respectively. Results: A total of 1491 valid participants’ questionnaires were included. Of these, 714 (47.6%) participants were aware of HCV. The proportion of participants with poor, fair, and good HCV knowledge was 63.4% (945/1491), 9.3% (139/1491), and 27.3% (407/1491), respectively. A total of 465 (31.2%) participants reported ever undergoing HCV testing, and 4 (0.9%) were anti-HCV antibody positive. Most participants were tested for HCV following blood donation (353/465, 75.9%). The most common reasons for not undergoing HCV screening were a lack of HCV awareness (665/1026, 64.8%), followed by a low self-perceived risk of infection (176/1026, 17.2%). Of 1026 participants who had never undergone HCV testing, 937 (91.3%) were willing to undergo HCV screening if universal screening was provided at no cost. The HCV knowledge level was positively associated with the HCV testing rate. Participants who were less educated, lived in rural areas, resided in West China, and were currently alcohol drinkers had lower HCV knowledge and reduced odds of having undergone HCV testing. In contrast, participants with a blood donation history and a family history of hepatitis B virus or HCV infection had higher HCV knowledge and increased odds of prior testing. Participants aged ≥60 years had lower knowledge, and women had reduced odds of having undergone previous HCV testing. Conclusions: The general population of China has low HCV knowledge and testing rate. There is an urgent need for enhanced HCV awareness and scaled-up HCV screening and treatment. Individuals who are less well educated, reside in less-developed areas, currently drink alcohol, and are female should be prioritized for health education and interventions. %M 38079213 %R 10.2196/39472 %U https://publichealth.jmir.org/2023/1/e39472 %U https://doi.org/10.2196/39472 %U http://www.ncbi.nlm.nih.gov/pubmed/38079213 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e49513 %T Resistance Training in Patients After Metabolic and Bariatric Surgery: Protocol for a Systematic Review %A Elks,Whitney %A Rooks,Adam %A Schulte,Spencer %A Batra,Kavita %A Burke,Jocelyn %A Jain,Varun %+ Department of Medical Education, Kirk Kerkorian School of Medicine at University of Nevada, Las Vegas, Las Vegas, NV, United States, 1 702 671 2273, whitney.elks@unlv.edu %K bariatric surgery %K bariatric %K body composition %K exercise %K meta-analyses %K meta-analysis %K muscle %K muscular %K physical activity %K physiotherapy %K post-metabolic %K resistance training %K resistance %K review methodology %K review methods %K systematic %K weight lifting %K weight %D 2023 %7 23.11.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Resistance training has been consistently shown to have multiple health benefits, especially for patients who have undergone bariatric surgery. Patients who have undergone bariatric surgery are recommended to participate in resistance exercise; however, protocols and guidelines for resistance training remain poorly implemented. Objective: This is a protocol for a systematic review and possibly a meta-analysis that will synthesize evidence of the effects of resistance exercise on changes in body composition, muscular strength, overall weight loss or maintenance of weight loss, and quality of life in patients after metabolic and bariatric surgery (MBS). The findings of this study may provide practice recommendations for resistance training among patients who have undergone MBS. Methods: We registered this systematic review on PROSPERO (CRD42023464928) on September 18, 2023. A systematic search of electronic databases (Embase, PubMed, Scopus, Web of Science, and CINAHL) was conducted on studies published from January 1, 1991, to May 15, 2023, to identify English-language human studies on adult patients who have undergone MBS that include a resistance training intervention and describe outcome measurements of body composition or strength. Screening will be performed using PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, and relevant data elements will be extracted. Results: Searches and screenings commenced in May 2023. Data extraction and analyses will be completed by the end of December 2023, after which findings will be synthesized and reported by the end of March 2024. Conclusions: This systematic review will summarize the evidence regarding resistance training in patients after MBS. The findings from this systematic review and possible meta-analysis may provide practice recommendations for resistance training protocols in this patient population and identify characteristics of protocols with the best adherence and outcomes. With these results, we anticipate that we will gain a deeper understanding of the role of resistance training after MBS. Trial Registration: PROSPERO CRD42023464928; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=464928 International Registered Report Identifier (IRRID): PRR1-10.2196/49513 %M 37995123 %R 10.2196/49513 %U https://www.researchprotocols.org/2023/1/e49513 %U https://doi.org/10.2196/49513 %U http://www.ncbi.nlm.nih.gov/pubmed/37995123 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 25 %N %P e50448 %T Clinical Decision Support System for All Stages of Gastric Carcinogenesis in Real-Time Endoscopy: Model Establishment and Validation Study %A Gong,Eun Jeong %A Bang,Chang Seok %A Lee,Jae Jun %A Jeong,Hae Min %A Baik,Gwang Ho %A Jeong,Jae Hoon %A Dick,Sigmund %A Lee,Gi Hun %+ Department of Internal Medicine, Hallym University College of Medicine, Sakju-ro 77, Chuncheon, 24253, Republic of Korea, 82 1052657810, csbang@hallym.ac.kr %K atrophy %K intestinal metaplasia %K metaplasia %K deep learning %K endoscopy %K gastric neoplasms %K neoplasm %K neoplasms %K internal medicine %K cancer %K oncology %K decision support %K real time %K gastrointestinal %K gastric %K intestinal %K machine learning %K clinical decision support system %K CDSS %K computer aided %K diagnosis %K diagnostic %K carcinogenesis %D 2023 %7 30.10.2023 %9 Original Paper %J J Med Internet Res %G English %X Background: Our research group previously established a deep-learning–based clinical decision support system (CDSS) for real-time endoscopy-based detection and classification of gastric neoplasms. However, preneoplastic conditions, such as atrophy and intestinal metaplasia (IM) were not taken into account, and there is no established model that classifies all stages of gastric carcinogenesis. Objective: This study aims to build and validate a CDSS for real-time endoscopy for all stages of gastric carcinogenesis, including atrophy and IM. Methods: A total of 11,868 endoscopic images were used for training and internal testing. The primary outcomes were lesion classification accuracy (6 classes: advanced gastric cancer, early gastric cancer, dysplasia, atrophy, IM, and normal) and atrophy and IM lesion segmentation rates for the segmentation model. The following tests were carried out to validate the performance of lesion classification accuracy: (1) external testing using 1282 images from another institution and (2) evaluation of the classification accuracy of atrophy and IM in real-world procedures in a prospective manner. To estimate the clinical utility, 2 experienced endoscopists were invited to perform a blind test with the same data set. A CDSS was constructed by combining the established 6-class lesion classification model and the preneoplastic lesion segmentation model with the previously established lesion detection model. Results: The overall lesion classification accuracy (95% CI) was 90.3% (89%-91.6%) in the internal test. For the performance validation, the CDSS achieved 85.3% (83.4%-97.2%) overall accuracy. The per-class external test accuracies for atrophy and IM were 95.3% (92.6%-98%) and 89.3% (85.4%-93.2%), respectively. CDSS-assisted endoscopy showed an accuracy of 92.1% (88.8%-95.4%) for atrophy and 95.5% (92%-99%) for IM in the real-world application of 522 consecutive screening endoscopies. There was no significant difference in the overall accuracy between the invited endoscopists and established CDSS in the prospective real-clinic evaluation (P=.23). The CDSS demonstrated a segmentation rate of 93.4% (95% CI 92.4%-94.4%) for atrophy or IM lesion segmentation in the internal testing. Conclusions: The CDSS achieved high performance in terms of computer-aided diagnosis of all stages of gastric carcinogenesis and demonstrated real-world application potential. %M 37902818 %R 10.2196/50448 %U https://www.jmir.org/2023/1/e50448 %U https://doi.org/10.2196/50448 %U http://www.ncbi.nlm.nih.gov/pubmed/37902818 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e46375 %T Pediatric Tui Na for Feeding Intolerance in Premature Infants: Protocol for a Systematic Review and Meta-Analysis %A Bai,Zirong %A Lyu,Xiaoxiao %A Tang,Yichuan %A Wang,Meng %+ Department of Rehabilitation, College of Acupuncture and Moxibustion and Massage Health Preservation and Rehabilitation, Nanjing University of Chinese Medicine, 138 Xianlin Avenue, Qixia District, Jiangsu Province, Nanjing, 210023, China, 86 15077855256, wm4212576@163.com %K feeding intolerance %K pediatric tui na %K premature infants %K protocol %K systematic review %D 2023 %7 16.10.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Feeding intolerance (FI), frequently resulting from gastrointestinal immaturity, is prevalent among premature infants. Current practices are gradually prioritizing nonpharmacological treatments, such as massage or “Tui na,” considering the potential side effects of prolonged medication use. Pediatric Tui na, a specialized massage therapy based on traditional Chinese medicine, has been widely studied for treating FI in premature infants. However, to our knowledge, no systematic review specifically focusing on the effectiveness and safety of traditional Chinese medicine–based pediatric Tui na for FI in premature infants has been published yet. Objective: This study aims to develop a protocol for a systematic review and meta-analysis for evaluating the safety and efficacy of pediatric Tui na for premature infants with FI. Methods: We will perform a comprehensive search in the following databases: Springer, Cochrane Library, Embase, MEDLINE, Clarivate Analytics, Physiotherapy Evidence Database (PEDro), CINAHL, PubMed, Scopus, World Health Organization (WHO) International Clinical Trials Registry Platform, and Chinese biomedical databases (Wanfang database, the China National Knowledge Infrastructure, Chinese Scientific Journals Database, and Chinese Biomedical Literature Databases), limited to studies published in Chinese and English languages between January 2000 and January 2023. The search strategy will use MeSH (Medical Subject Headings) terms and database-specific keywords. A total of 2 independent reviewers will initially screen the studies based on titles and abstracts, followed by a full-text evaluation of the eligible studies. Studies will include any nonrandomized controlled trials, nonrandomized clinical studies, randomized controlled trials, and quasi-experimental studies wherein the treatment group involves premature infants with FI given pediatric Tui na. Primary outcomes will be necrotizing enterocolitis, gastric residual volume, emesis, and stool blood. Secondary outcomes will be abdominal distension weight gain, time to achieve full enteral feeding, any adverse effects associated with pediatric Tui na, and length of hospital stay. The Cochrane Collaboration Risk of Bias Tool will be used to assess the risk of bias and methodological quality. Funnel plots will be used for evaluating publication bias. Meta-analysis will be conducted using the Review Manager software (version 5.4; Cochrane Collaboration). Subgroup analyses will be considered according to treatment received, country or setting, sex, and birth weight of premature infants (if heterogeneity is high, I2≥50%). Results: This is a systematic review and meta-analysis protocol, so the results are not yet available. The protocol has been registered with PROSPERO (CRD42023390021). We are currently in the study selection phase. Results are expected to be completed by the end of 2023. Conclusions: Following this protocol, a comprehensive and rigorous literature synthesis will be developed to assess the impact of pediatric Tui na treatment on premature infants with FI, enabling the determination of its efficacy and safety. Trial Registration: PROSPERO CRD42023390021; https://tinyurl.com/bdf4kn23 International Registered Report Identifier (IRRID): PRR1-10.2196/46375 %M 37843917 %R 10.2196/46375 %U https://www.researchprotocols.org/2023/1/e46375 %U https://doi.org/10.2196/46375 %U http://www.ncbi.nlm.nih.gov/pubmed/37843917 %0 Journal Article %@ 2369-2960 %I JMIR Publications %V 9 %N %P e48449 %T Secular Trends in Gastric and Esophageal Cancer Attributable to Dietary Carcinogens From 1990 to 2019 and Projections Until 2044 in China: Population-Based Study %A Guo,Hui-Xiao %A Wang,Qi %A Wang,Can %A Yin,Qing Chen %A Huo,Hua Zhi %A Yin,Bing Hua %+ Handan Central Hospital, Num 59, Congtai Road, Congtai District, Handan, 056001, China, 86 03102118383, 553050711@qq.com %K esophageal cancer %K gastric cancer %K dietary carcinogens %K prediction %K temporal trends %K China %D 2023 %7 21.9.2023 %9 Original Paper %J JMIR Public Health Surveill %G English %X Background: Little is known about trends in or projections of the disease burden of dietary gastric and esophageal cancer (GEC) in China. Objective: We aim to report GEC deaths and disability-adjusted life years (DALYs) from 1990 to 2019, predict them through 2044, and decompose changes in terms of population growth, population aging, and epidemiological changes. Methods: We retrieved dietary GEC data from the Global Burden of Disease (GBD) online database and used joinpoint regression and age-period-cohort models to analyze trends in dietary GEC deaths and DALYs from 1990 to 2019 in China. We used a Bayesian age period cohort model of integrated nested Laplace approximations to predict the disease burden of GEC through 2044 and obtained the estimated population of China from 2020 to 2050 from the Global Health Data Exchange website. Finally, we applied a recently developed decomposition method to attribute changes between 2019 and 2044 to population growth, population aging, and epidemiological changes. Results: The summary exposure values and age-standardized rates decreased significantly from 1990 to 1999, with percentage changes of –0.06% (95% CI –0.11% to –0.02%) and –0.05% (95% CI –0.1% to –0.02%), respectively. From 1990 to 2019, for dietary esophageal cancer, the percentage change in age-standardized mortality rate (ASMR) was –0.79% (95% CI –0.93% to –0.58%) and the percentage change in age-standardized DALY rate (ASDR) was –0.81% (95% CI –0.94% to –0.61%); these were significant decreases. For dietary stomach cancer, significant decreases were also observed for the percentage change in ASMR (–0.43%, 95% CI –0.55% to –0.31%) and the percentage change in ASDR (–0.47%, 95% CI –0.58% to –0.35%). In addition, data from both the joinpoint regression and annual percentage change analyses demonstrated significantly decreasing trends for the annual percentage change in ASMR and ASDR for GEC attributable to dietary carcinogens. The overall annual percentage change (net drift) was –5.95% (95% CI –6.25% to –5.65%) for dietary esophageal cancer mortality and –1.97% (95% CI –2.11% to –1.83%) for dietary stomach cancer mortality. Lastly, in 2044, dietary esophageal cancer deaths and DALYs were predicted to increase by 192.62% and 170.28%, respectively, due to age structure (121.58% and 83.29%), mortality change (76.81% and 92.43%), and population size (–5.77% and –5.44%). In addition, dietary stomach cancer deaths and DALYs were predicted to increase by 118.1% and 54.08%, with age structure, mortality rate change, and population size accounting for 96.71% and 53.99%, 26.17% and 3.97%, and –4.78% and –3.88% of the change, respectively. Conclusions: Although the predicted age-standardized rates of mortality and DALYs due to dietary GEC show downward trends, the absolute numbers are still predicted to increase in the next 25 years due to rapid population aging in China. %M 37560940 %R 10.2196/48449 %U https://publichealth.jmir.org/2023/1/e48449 %U https://doi.org/10.2196/48449 %U http://www.ncbi.nlm.nih.gov/pubmed/37560940 %0 Journal Article %@ 2152-7202 %I JMIR Publications %V 15 %N %P e47395 %T Coproduction of Low-Barrier Hepatitis C Virus and HIV Care for People Who Use Drugs in a Rural Community: Brief Qualitative Report %A Bardach,Shoshana H %A Perry,Amanda N %A Eccles,Elizabeth %A Carpenter-Song,Elizabeth A %A Fowler,Ryan %A Miers,Erin M %A Ovalle,Anais %A de Gijsel,David %+ The Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine at Dartmouth College, Williamson Translational Research Building, Room 563, Dartmouth-Hitchcock Medical Center, One Medical Center Dr, Lebanon, NH, 03756, United States, 1 603 646 5608, shani.bardach@dartmouth.edu %K hepatitis C %K HIV %K coproducing care %K testing %K people who use drugs %K HCV %K rural community %D 2023 %7 20.9.2023 %9 Original Paper %J J Particip Med %G English %X Background: People who inject drugs are experiencing syndemic conditions with increasing risk of infection with hepatitis C (HCV) and HIV. However, rates of accessing HCV and HIV testing and treatment among people who inject drugs are low for various reasons, including the criminalization of drug use, which leads to a focus on treating drug use rather than caring for drug users. For many people who inject drugs, health care becomes a form of structural violence, resulting in traumatic experiences, fear of police violence, unmet needs, and avoidance of medical care. There is a clear need for novel approaches to health care delivery for people who inject drugs. Objective: This study aimed to analyze the process of a multidisciplinary team—encompassing health care professionals, community representatives, researchers, and people with lived experience using drugs—that was formed to develop a deep understanding of the experiences of people who inject drugs and local ecosystem opportunities and constraints to inform the cocreation of low-barrier, innovative HCV or HIV care in a rural community. Given the need for innovative approaches to redesigning health care, we sought to identify challenges and tensions encountered in this process and strategies for overcoming these challenges. Methods: Analysis was based on an in-depth review of meeting notes from the project year, followed by member-checking with the project team to revise and expand upon the challenges encountered and strategies identified to navigate these challenges. Results: Challenges and tensions included: scoping the project, setting the pace and urgency of the work, adapting to web-based work, navigating ethics and practice of payment, defining success, and situating the project for sustainability. Strategies to navigate these challenges included: dedicated effort to building personal and meaningful connections, fostering mutual respect, identifying common ground to make shared decisions, and redefining successes. Conclusions: While cocreated care presents challenges, the resulting program is strengthened by challenging assumptions and carefully considering various perspectives to think creatively and productively about solutions. %M 37728975 %R 10.2196/47395 %U https://jopm.jmir.org/2023/1/e47395 %U https://doi.org/10.2196/47395 %U http://www.ncbi.nlm.nih.gov/pubmed/37728975 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e41399 %T The Efficacy of a Diet Low in Fermentable Oligo-, Di-, Monosaccharides, and Polyols in Irritable Bowel Syndrome Compared to Its “Real-world” Effectiveness: Protocol for a Systematic Review %A Jent,Sandra %A Bez,Natalie Sara %A Catalano,Loan %A Rogler,Gerhard %+ Department of Health Professions, Bern University of Applied Sciences, Murtenstrasse 10, Bern, 3008, Switzerland, 41 31 848 37 84, sandra.jent@bfh.ch %K FODMAP diet %K irritable bowel syndrome %K dietetics %K efficacy-effectiveness gap %K meta-analysis %K systematic review %D 2023 %7 12.6.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Irritable bowel syndrome (IBS) is associated with various gastrointestinal and nongastrointestinal symptoms and reduced quality of life. A diet low in fermentable oligo-, di-, monosaccharides, and polyols (FODMAPs) is one therapeutic option for IBS. Although the efficacy of the low FODMAP diet has been reported in several systematic reviews, the efficacy-effectiveness gap of the low FODMAP diet has not yet been assessed. Objective: This systematic review aims to compare the efficacy of the low FODMAP diet from efficacy randomized controlled trials (RCTs) with the effectiveness of studies conducted in “real-world” settings. Methods: RCTs, prospective and retrospective cohort studies, and retrospective audits assessing the low FODMAP diet in adults with IBS will be searched in 4 databases: Embase, MEDLINE, CENTRAL, and CINAHL. Two independent reviewers will perform study selection, data extraction, and risk of bias assessment and assess selected quality aspects from the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) protocol. Outcomes assessed are stool frequency, stool consistency, abdominal pain, overall symptom scores, adequate symptom relief, IBS-specific quality of life, and diet adherence. Data will be summarized with forest plots without summary statistics, tables, and narrative descriptions. Results: The search, title and abstract screening, and full-text screening were completed in March 2021, and an updated search was done in May 2022. As of May 2023, data analysis is almost finished, and manuscript writing is in progress. Submission of the manuscript is expected by July 2023. Conclusions: The findings of this systematic review will compare the efficacy of the low FODMAP diet for IBS found in RCTs to the diet’s real-world effectiveness. Trial Registration: PROSPERO CRD42021278952; https://tinyurl.com/32jk43ev International Registered Report Identifier (IRRID): DERR1-10.2196/41399 %M 37307063 %R 10.2196/41399 %U https://www.researchprotocols.org/2023/1/e41399 %U https://doi.org/10.2196/41399 %U http://www.ncbi.nlm.nih.gov/pubmed/37307063 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e46307 %T A Comprehensive Self-Management Intervention for Inflammatory Bowel Disease (CSM-IBD): Protocol for a Pilot Randomized Controlled Trial %A Kamp,Kendra %A Clark-Snustad,Kindra %A Yoo,Linda %A Winders,Samantha %A Cain,Kevin %A Levy,Rona L %A Dey,Neelendu %A Lee,Scott %A Keefer,Laurie %A Heitkemper,Margaret %+ Department of Biobehavioral Nursing and Health Informatics, School of Nursing, University of Washington, Box 357266, Seattle, WA, 98195, United States, 1 206 221 4617, kamp@uw.edu %K inflammatory bowel disease %K self-management %K symptom management %K pilot %K intervention %K randomized controlled trial %D 2023 %7 7.6.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Despite pharmacological treatment, individuals with inflammatory bowel disease (IBD) experience a variety of symptoms, including abdominal pain, fatigue, anxiety, and depression. Few nonmedical self-management interventions are available for people with IBD. A validated comprehensive self-management (CSM) intervention is effective for patients with irritable bowel syndrome who can have symptoms similar to those of individuals with IBD. We created a modified CSM intervention tailored to individuals with IBD (CSM-IBD). The CSM-IBD is an 8-session program delivered over 8-12 weeks with check-ins with a registered nurse. Objective: The primary objective of this pilot study is to determine the feasibility and acceptability of study procedures and the CSM-IBD intervention and to evaluate preliminary efficacy on quality of life and daily symptoms for a future randomized controlled trial. Additionally, we will examine the association of socioecological, clinical, and biological factors with symptoms at baseline and response to intervention. Methods: We are conducting a pilot randomized controlled trial of the CSM-IBD intervention. Participants aged 18-75 years who are experiencing at least 2 symptoms are eligible for inclusion. We plan to enroll 54 participants who will be randomized (2:1) into the CSM-IBD program or usual care. Patients in the CSM-IBD program will have 8 intervention sessions. Primary study outcomes include the feasibility of recruitment, randomization, and data or sample collection, as well as the acceptability of study procedures and interventions. Preliminary efficacy outcome variables include quality of life and symptoms. Outcomes data will be assessed at baseline, immediately post intervention, and 3 months post intervention. Participants in the usual care group will have access to the intervention after study participation. Results: This project is funded by the National Institutes of Nursing Research and reviewed by the University of Washington’s institutional review board. Recruitment began in February 2023. As of April 2023, we have enrolled 4 participants. We expect the study to be completed by March 2025. Conclusions: This pilot study will evaluate the feasibility and efficacy of a self-management intervention (a web-based program with weekly check-ins with a registered nurse) that aims to improve symptom management in individuals with IBD. In the long term, we aim to validate a self-management intervention to improve patient quality of life, reduce direct and indirect costs related to IBD, and be culturally appropriate and accessible, particularly in rural and underserved communities. Trial Registration: ClinicalTrials.gov NCT05651542; https://clinicaltrials.gov/ct2/show/NCT05651542 International Registered Report Identifier (IRRID): PRR1-10.2196/46307 %M 37285195 %R 10.2196/46307 %U https://www.researchprotocols.org/2023/1/e46307 %U https://doi.org/10.2196/46307 %U http://www.ncbi.nlm.nih.gov/pubmed/37285195 %0 Journal Article %@ 2369-2960 %I JMIR Publications %V 9 %N %P e45050 %T The Role of Metabolic Dysfunction–Associated Fatty Liver Disease in Developing Chronic Kidney Disease: Longitudinal Cohort Study %A Wei,Suosu %A Song,Jian %A Xie,Yujie %A Huang,Junzhang %A Yang,Jianrong %+ Institute of Health Management of Guangxi Academy of Medical Sciences, People’s Hospital of Guangxi Zhuang Autonomous Region, No 6 Taoyuan Road, Nanning, 530021, China, 86 13978630882, yjr@gxams.org.cn %K chronic kidney disease %K risk factor %K kidney %K renal %K cohort study %K metabolic dysfunction–associated fatty liver disease %K MAFLD %K incidence rate %K incidence %K liver %K chronic disease %K prevalence %K association %D 2023 %7 4.5.2023 %9 Original Paper %J JMIR Public Health Surveill %G English %X Background: The association between metabolic dysfunction–associated fatty liver disease (MAFLD) and chronic kidney disease (CKD) is unclear. Objective: This longitudinal cohort study aimed to test whether MAFLD plays an important role in the development of CKD. Methods: This cohort study included 41,246 participants who had undergone 3 or more health examinations from 2008 to 2015 at the People’s Hospital of Guangxi Zhuang Autonomous Region, China. Participants were categorized into 2 groups according to whether they presented with or without MAFLD. The occurrence of new-onset CKD was stated as either an estimated glomerular filtration rate of <60 mL/min per 1.73 m2 or a higher level of albuminuria during their follow-up appointment. The association between MAFLD and CKD was evaluated using a Cox regression method. Results: Of the 41,246 participants, 11,860 (28.8%) were diagnosed with MAFLD. Over the course of the 14-year follow-up (median 10.0 years), 5347 (13%) participants experienced a new incident of CKD (135.73 per 10,000 person-years). MAFLD was discovered as an important risk factor for new incidents of CKD (hazard ratio 1.18, 95% CI 1.11-1.26) by using the multivariable Cox proportional hazard regression model. When stratified by gender, the adjusted hazard ratio for the incidence of CKD in men and women with MAFLD were 1.16 (95% CI 1.07-1.26) and 1.32 (95% CI 1.18-1.48), respectively. According to the subgroup analysis results, after adjusting for confounding factors, the MAFLD-related CKD risk was greater in men aged <60 years (Pinteraction=.001) and in those with combined dyslipidemia (Pinteraction=.02), but this relationship was not found in women (all Pinteraction>.05). Conclusions: MAFLD plays an important role in the development of new incidents of CKD in the long run. Trial Registration: Chinese Clinical Trial Registry ChiCTR2200058543; https://www.chictr.org.cn/showproj.html?proj=153109 %M 37140958 %R 10.2196/45050 %U https://publichealth.jmir.org/2023/1/e45050 %U https://doi.org/10.2196/45050 %U http://www.ncbi.nlm.nih.gov/pubmed/37140958 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 8 %P e29186 %T Identifying Patients With Inflammatory Bowel Disease on Twitter and Learning From Their Personal Experience: Retrospective Cohort Study %A Stemmer,Maya %A Parmet,Yisrael %A Ravid,Gilad %+ Department of Industrial Engineering and Management, Ben-Gurion University of the Negev, POB 653, Beer-Sheva, 84105, Israel, 972 8 6461434, mayast@post.bgu.ac.il %K patient identification %K inflammatory bowel disease %K IBD %K user classification %K Twitter %K natural language processing %K NLP %K sentiment analysis %D 2022 %7 2.8.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Patients use social media as an alternative information source, where they share information and provide social support. Although large amounts of health-related data are posted on Twitter and other social networking platforms each day, research using social media data to understand chronic conditions and patients’ lifestyles is limited. Objective: In this study, we contributed to closing this gap by providing a framework for identifying patients with inflammatory bowel disease (IBD) on Twitter and learning from their personal experiences. We enabled the analysis of patients’ tweets by building a classifier of Twitter users that distinguishes patients from other entities. This study aimed to uncover the potential of using Twitter data to promote the well-being of patients with IBD by relying on the wisdom of the crowd to identify healthy lifestyles. We sought to leverage posts describing patients’ daily activities and their influence on their well-being to characterize lifestyle-related treatments. Methods: In the first stage of the study, a machine learning method combining social network analysis and natural language processing was used to automatically classify users as patients or not. We considered 3 types of features: the user’s behavior on Twitter, the content of the user’s tweets, and the social structure of the user’s network. We compared the performances of several classification algorithms within 2 classification approaches. One classified each tweet and deduced the user’s class from their tweet-level classification. The other aggregated tweet-level features to user-level features and classified the users themselves. Different classification algorithms were examined and compared using 4 measures: precision, recall, F1 score, and the area under the receiver operating characteristic curve. In the second stage, a classifier from the first stage was used to collect patients' tweets describing the different lifestyles patients adopt to deal with their disease. Using IBM Watson Service for entity sentiment analysis, we calculated the average sentiment of 420 lifestyle-related words that patients with IBD use when describing their daily routine. Results: Both classification approaches showed promising results. Although the precision rates were slightly higher for the tweet-level approach, the recall and area under the receiver operating characteristic curve of the user-level approach were significantly better. Sentiment analysis of tweets written by patients with IBD identified frequently mentioned lifestyles and their influence on patients’ well-being. The findings reinforced what is known about suitable nutrition for IBD as several foods known to cause inflammation were pointed out in negative sentiment, whereas relaxing activities and anti-inflammatory foods surfaced in a positive context. Conclusions: This study suggests a pipeline for identifying patients with IBD on Twitter and collecting their tweets to analyze the experimental knowledge they share. These methods can be adapted to other diseases and enhance medical research on chronic conditions. %M 35917151 %R 10.2196/29186 %U https://www.jmir.org/2022/8/e29186 %U https://doi.org/10.2196/29186 %U http://www.ncbi.nlm.nih.gov/pubmed/35917151 %0 Journal Article %@ 2291-9694 %I JMIR Publications %V 10 %N 6 %P e36997 %T Noninvasive Diagnosis of Nonalcoholic Steatohepatitis and Advanced Liver Fibrosis Using Machine Learning Methods: Comparative Study With Existing Quantitative Risk Scores %A Wu,Yonghui %A Yang,Xi %A Morris,Heather L %A Gurka,Matthew J %A Shenkman,Elizabeth A %A Cusi,Kenneth %A Bril,Fernando %A Donahoo,William T %+ Department of Medicine, College of Medicine, University of Florida, 1600 SW Archer Rd, Gainesville, FL, 32610, United States, 1 (352) 273 8655, Troy.Donahoo@medicine.ufl.edu %K machine learning %K nonalcoholic fatty liver disease %K nonalcoholic steatohepatitis %K fatty liver %K liver fibrosis %D 2022 %7 6.6.2022 %9 Original Paper %J JMIR Med Inform %G English %X Background: Nonalcoholic steatohepatitis (NASH), advanced fibrosis, and subsequent cirrhosis and hepatocellular carcinoma are becoming the most common etiology for liver failure and liver transplantation; however, they can only be diagnosed at these potentially reversible stages with a liver biopsy, which is associated with various complications and high expenses. Knowing the difference between the more benign isolated steatosis and the more severe NASH and cirrhosis informs the physician regarding the need for more aggressive management. Objective: We intend to explore the feasibility of using machine learning methods for noninvasive diagnosis of NASH and advanced liver fibrosis and compare machine learning methods with existing quantitative risk scores. Methods: We conducted a retrospective analysis of clinical data from a cohort of 492 patients with biopsy-proven nonalcoholic fatty liver disease (NAFLD), NASH, or advanced fibrosis. We systematically compared 5 widely used machine learning algorithms for the prediction of NAFLD, NASH, and fibrosis using 2 variable encoding strategies. Then, we compared the machine learning methods with 3 existing quantitative scores and identified the important features for prediction using the SHapley Additive exPlanations method. Results: The best machine learning method, gradient boosting (GB), achieved the best area under the curve scores of 0.9043, 0.8166, and 0.8360 for NAFLD, NASH, and advanced fibrosis, respectively. GB also outperformed 3 existing risk scores for fibrosis. Among the variables, alanine aminotransferase (ALT), triglyceride (TG), and BMI were the important risk factors for the prediction of NAFLD, whereas aspartate transaminase (AST), ALT, and TG were the important variables for the prediction of NASH, and AST, hyperglycemia (A1c), and high-density lipoprotein were the important variables for predicting advanced fibrosis. Conclusions: It is feasible to use machine learning methods for predicting NAFLD, NASH, and advanced fibrosis using routine clinical data, which potentially can be used to better identify patients who still need liver biopsy. Additionally, understanding the relative importance and differences in predictors could lead to improved understanding of the disease process as well as support for identifying novel treatment options. %M 35666557 %R 10.2196/36997 %U https://medinform.jmir.org/2022/6/e36997 %U https://doi.org/10.2196/36997 %U http://www.ncbi.nlm.nih.gov/pubmed/35666557 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 5 %P e27694 %T The Accuracy of Artificial Intelligence in the Endoscopic Diagnosis of Early Gastric Cancer: Pooled Analysis Study %A Chen,Pei-Chin %A Lu,Yun-Ru %A Kang,Yi-No %A Chang,Chun-Chao %+ Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taipei Medical University Hospital, No 252, Wuxing St, Taipei, 110, Taiwan, 886 227372181, chunchao@tmu.edu.tw %K artificial intelligence %K early gastric cancer %K endoscopy %D 2022 %7 16.5.2022 %9 Original Paper %J J Med Internet Res %G English %X Background: Artificial intelligence (AI) for gastric cancer diagnosis has been discussed in recent years. The role of AI in early gastric cancer is more important than in advanced gastric cancer since early gastric cancer is not easily identified in clinical practice. However, to our knowledge, past syntheses appear to have limited focus on the populations with early gastric cancer. Objective: The purpose of this study is to evaluate the diagnostic accuracy of AI in the diagnosis of early gastric cancer from endoscopic images. Methods: We conducted a systematic review from database inception to June 2020 of all studies assessing the performance of AI in the endoscopic diagnosis of early gastric cancer. Studies not concerning early gastric cancer were excluded. The outcome of interest was the diagnostic accuracy (comprising sensitivity, specificity, and accuracy) of AI systems. Study quality was assessed on the basis of the revised Quality Assessment of Diagnostic Accuracy Studies. Meta-analysis was primarily based on a bivariate mixed-effects model. A summary receiver operating curve and a hierarchical summary receiver operating curve were constructed, and the area under the curve was computed. Results: We analyzed 12 retrospective case control studies (n=11,685) in which AI identified early gastric cancer from endoscopic images. The pooled sensitivity and specificity of AI for early gastric cancer diagnosis were 0.86 (95% CI 0.75-0.92) and 0.90 (95% CI 0.84-0.93), respectively. The area under the curve was 0.94. Sensitivity analysis of studies using support vector machines and narrow-band imaging demonstrated more consistent results. Conclusions: For early gastric cancer, to our knowledge, this was the first synthesis study on the use of endoscopic images in AI in diagnosis. AI may support the diagnosis of early gastric cancer. However, the collocation of imaging techniques and optimal algorithms remain unclear. Competing models of AI for the diagnosis of early gastric cancer are worthy of future investigation. Trial Registration: PROSPERO CRD42020193223; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=193223 %M 35576561 %R 10.2196/27694 %U https://www.jmir.org/2022/5/e27694 %U https://doi.org/10.2196/27694 %U http://www.ncbi.nlm.nih.gov/pubmed/35576561 %0 Journal Article %@ 2562-7600 %I JMIR Publications %V 5 %N 1 %P e36654 %T Nurses’ Experiences Using an Interactive System to Assess and Manage Treatment-Related Symptoms of Patients With Pancreatic Cancer: Interview Study %A Mangsbacka,Maria %A Gustavell,Tina %+ Department of Upper Abdominal Diseases, Cancer Theme, Karolinska University Hospital (Huddinge), Hälsovägen, Flemingsberg (Main entrance), C1:77, Stockholm, 14186, Sweden, 46 724682250, tina.gustavell@ki.se %K app %K health care professionals %K mobile health %K mHealth %K nurses %K pancreatic cancer %K person-centered care %K symptom-management %K qualitative interview %K nursing %K interview %D 2022 %7 16.5.2022 %9 Original Paper %J JMIR Nursing %G English %X Background: Treatment for pancreatic cancer entails symptom distress and a high burden of self-care. Patient-reported outcomes, collected with the support of mobile health (mHealth), have shown positive effects on symptom management, patient satisfaction, and quality of life for patients with cancer. For mHealth tools to become an integral part of clinical routine, experiences from health care professionals are needed. Objective: The aim of this paper is to describe nurses’ experiences of integrating an interactive system (Interaktor) for symptom assessment and management into daily practice, when caring for patients following pancreaticoduodenectomy and during chemotherapy treatment due to pancreatic cancer. Methods: Patients reported symptoms via the Interaktor app daily for 6 months. In the event of alarming symptoms, an alert was triggered to the patient’s nurse who then called the patient to offer advice and support. All nurses (n=8) who assessed patients were interviewed either individually or in a group. Transcribed interviews were analyzed using qualitative thematic analysis. Results: mHealth can facilitate person-centered care by offering nurses a way to gain knowledge about patients and to build relationships. Further, obstacles to implementation could be seen due to a lack of structural prerequisites and uncertainty about multiple ways to interact with patients. Conclusions: The Interaktor system can provide person-centered care. However, to implement mHealth tools as a clinical routine, focus needs to be placed on creating the necessary organizational conditions. %M 35576577 %R 10.2196/36654 %U https://nursing.jmir.org/2022/1/e36654 %U https://doi.org/10.2196/36654 %U http://www.ncbi.nlm.nih.gov/pubmed/35576577 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 4 %P e31003 %T Buccal Mucosal Grafts as a Novel Treatment for the Repair of Rectovaginal Fistulas: Protocol for an Upcoming Prospective Single-Surgeon Case Series %A Cahill,Caitlin %A Kruger,Natalia %A Heine,John %+ Cumming School of Medicine, University of Calgary, 1403 29 Street NW, Calgary, AB, T2N 2T9, Canada, 1 403 880 1775, natalia.kruger@ucalgary.ca %K surgical protocol %K colorectal surgery, rectovaginal fistulas %K fistula %K surgery %K gynecology %K grafts %K perioperative medicine %D 2022 %7 29.4.2022 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Rectovaginal fistulas (RVFs) are abnormal communications between the rectum/anus and the vagina. They are most frequently formed a result of obstetric injury and have deleterious effects on patients’ quality of life. Despite several treatment modalities, RVFs remain difficult problems to manage, and many patients fail multiple attempts at surgical repair. Buccal mucosal grafts (BMGs) may be a solution to this problem. A BMG is an oral mucosal tissue harvested from the inner cheek. There are 2 case reports that describe the successful use of BMGs in the repair of RVFs. Objective: Our objective is to validate these findings with a prospective case series while also addressing the key issues of indication, technical details, procedure safety, and short-term outcomes. Methods: A prospective single-surgeon case series will be undertaken at a university-affiliated academic tertiary care hospital in Calgary, Alberta (Canada). The estimated recruitment is between 3 and 5 patients. Patients will undergo surgical repair of their RVFs with an autologous BMG. Data on patient characteristics, fistula characteristics, and surgical variables will be collected and analyzed prospectively. The primary outcome is fistula closure. This study has been approved by the Conjoint Health Research Ethics Board at the University of Calgary (REB20-1123). Results: Two previous case reports have described the successful use of BMGs in the repair of RVFs. We have received ethics approval to attempt to validate these findings through a prospective case series. Conclusions: RVFs cause significant patient morbidity and are difficult problems to manage. Bolstered by the successful use of BMGs in urologic surgery and the previously published case reports demonstrating success in RVFs, we believe that BMGs may be a solution to RVFs. International Registered Report Identifier (IRRID): PRR1-10.2196/31003 %M 35486431 %R 10.2196/31003 %U https://www.researchprotocols.org/2022/4/e31003 %U https://doi.org/10.2196/31003 %U http://www.ncbi.nlm.nih.gov/pubmed/35486431 %0 Journal Article %@ 2561-6722 %I JMIR Publications %V 5 %N 2 %P e34466 %T Contrasting Social Media Use Between Young Adults With Inflammatory Bowel Disease and Type 1 Diabetes: Cross-sectional Study %A Rajanala,Susruthi %A Wilson,Jennifer K %A Mitchell,Paul D %A Garvey,Katharine C %A Fishman,Laurie N %+ Division of Gastroenterology, Boston Children's Hospital, Harvard Medical School, Harvard University, 300 Longwood Avenue, Boston, MA, 02115, United States, 1 617 355 1836, laurie.fishman@childrens.harvard.edu %K social media %K inflammatory bowel disease %K type 1 diabetes %K internet %K young adult %K children %K Instagram %K Facebook %K type 1 %K diabetes %D 2022 %7 25.4.2022 %9 Original Paper %J JMIR Pediatr Parent %G English %X Background: Social media is used by young adult patients for social connection and self-identification. Objective: This study aims to compare the social media habits of young adults with inflammatory bowel disease (IBD) and type 1 diabetes (T1D). Methods: This is a cross-sectional study of subjects from Boston Children’s Hospital outpatient IBD and diabetes clinics. Patients above 18 years of age were invited to complete a brief anonymous survey, which asked about the various ways they use several social media platforms. Results: Responses were received from 108 patients (92.5% response rate), evenly split across disease type. We found that 83% of participants spent at least 30 minutes per day on social media, most commonly on Instagram and Facebook. Although the content varied based on the platform, patients with IBD posted or shared content related to their disease significantly less than those with T1D (23% vs 38%, P=.02). Among Instagram users, patients with IBD were less likely to engage with support groups (22% vs 56%, P=.04). Among Twitter users, patients with IBD were less likely to seek disease information (77% vs 29%, P=.005). Among Facebook users, patients with IBD were less likely to post about research and clinical trials (31% vs 65%, P=.04) or for information seeking (49% vs 87%, P=.003). Patients with IBD were also less likely to share their diagnosis with friends or family in person. Conclusions: Young adults with IBD were less willing to share their diagnosis and post about or explore the disease on social media compared to those with T1D. This could lead to a sense of isolation and should be further explored. %M 35139484 %R 10.2196/34466 %U https://pediatrics.jmir.org/2022/2/e34466 %U https://doi.org/10.2196/34466 %U http://www.ncbi.nlm.nih.gov/pubmed/35139484 %0 Journal Article %@ 2292-9495 %I JMIR Publications %V 9 %N 1 %P e33325 %T Designing a Novel Clinician Decision Support Tool for the Management of Acute Diarrhea in Bangladesh: Formative Qualitative Study %A Rosen,Rochelle K %A Garbern,Stephanie C %A Gainey,Monique %A Lantini,Ryan %A Nasrin,Sabiha %A Nelson,Eric J %A Elshabassi,Nour %A Alam,Nur H %A Sultana,Sufia %A Hasnin,Tahmida %A Qu,Kexin %A Schmid,Christopher H %A Levine,Adam C %+ Center for Behavioral and Preventive Medicine, The Miriam Hospital, 164 Summit St, Coro Building Suite 134, Providence, RI, 02906, United States, 1 401 793 8182, rrosen@lifespan.org %K clinical decision support tools %K diarrhea management %K focus group %K formative qualitative research %K low- and middle-income countries %K mobile phone %D 2022 %7 25.3.2022 %9 Original Paper %J JMIR Hum Factors %G English %X Background: The availability of mobile clinical decision support (CDS) tools has grown substantially with the increased prevalence of smartphone devices and apps. Although health care providers express interest in integrating mobile health (mHealth) technologies into their clinical settings, concerns have been raised, including perceived disagreements between information provided by mobile CDS tools and standard guidelines. Despite their potential to transform health care delivery, there remains limited literature on the provider’s perspective on the clinical utility of mobile CDS tools for improving patient outcomes, especially in low- and middle-income countries. Objective: This study aims to describe providers’ perceptions about the utility of a mobile CDS tool accessed via a smartphone app for diarrhea management in Bangladesh. In addition, feedback was collected on the preliminary components of the mobile CDS tool to address clinicians’ concerns and incorporate their preferences. Methods: From November to December 2020, qualitative data were gathered through 8 web-based focus group discussions with physicians and nurses from 3 Bangladeshi hospitals. Each discussion was conducted in the local language—Bangla—and audio recorded for transcription and translation by the local research team. Transcripts and codes were entered into NVivo (version 12; QSR International), and applied thematic analysis was used to identify themes that explore the clinical utility of an mHealth app for assessing dehydration severity in patients with acute diarrhea. Summaries of concepts and themes were generated from reviews of the aggregated coded data; thematic memos were written and used for the final analysis. Results: Of the 27 focus group participants, 14 (52%) were nurses and 13 (48%) were physicians; 15 (56%) worked at a diarrhea specialty hospital and 12 (44%) worked in government district or subdistrict hospitals. Participants’ experience in their current position ranged from 2 to 14 years, with an average of 10.3 (SD 9.0) years. Key themes from the qualitative data analysis included current experience with CDS, overall perception of the app’s utility and its potential role in clinical care, barriers to and facilitators of app use, considerations of overtreatment and undertreatment, and guidelines for the app’s clinical recommendations. Participants felt that the tool would initially take time to use, but once learned, it could be useful during epidemic cholera. Some felt that clinical experience remains an important part of treatment that can be supplemented, but not replaced, by a CDS tool. In addition, diagnostic information, including mid-upper arm circumference and blood pressure, might not be available to directly inform programming decisions. Conclusions: Participants were positive about the mHealth app and its potential to inform diarrhea management. They provided detailed feedback, which developers used to revise the mobile CDS tool. These formative qualitative data provided timely and relevant feedback to improve the utility of a CDS tool for diarrhea treatment in Bangladesh. %M 35333190 %R 10.2196/33325 %U https://humanfactors.jmir.org/2022/1/e33325 %U https://doi.org/10.2196/33325 %U http://www.ncbi.nlm.nih.gov/pubmed/35333190 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 24 %N 3 %P e28978 %T Role of Telemedicine in Inflammatory Bowel Disease: Systematic Review and Meta-analysis of Randomized Controlled Trials %A Pang,Lanlan %A Liu,Hengyu %A Liu,Zhidong %A Tan,Jinyu %A Zhou,Long-yuan %A Qiu,Yun %A Lin,Xiaoqing %A He,Jinshen %A Li,Xuehua %A Lin,Sinan %A Ghosh,Subrata %A Mao,Ren %A Chen,Minhu %+ Department of Gastroenterology, The First Affiliated Hospital of Sun Yat-sen University, 58 Zhongshan II Road, Guangzhou, 510080, China, 86 13286834857, maor5@mail.sysu.edu.cn %K telemedicine %K inflammatory bowel disease %K quality of life %K disease activity %K mobile phone %D 2022 %7 24.3.2022 %9 Review %J J Med Internet Res %G English %X Background: Telemedicine plays an important role in the management of inflammatory bowel disease (IBD), particularly during a pandemic such as COVID-19. However, the effectiveness and efficiency of telemedicine in managing IBD are unclear. Objective: This systematic review and meta-analysis aimed to compare the impact of telemedicine with that of standard care on the management of IBD. Methods: We systematically searched the PubMed, Cochrane Library, EMBASE, Web of Science, and Scopus databases on April 22, 2020. Randomized controlled trials comparing telemedicine with standard care in patients with IBD were included, while conference abstracts, letters, reviews, laboratory studies, and case reports were excluded. The IBD-specific quality of life (QoL), disease activity, and remission rate in patients with IBD were assessed as primary outcomes, and the number of in-person clinic visits per patient, patient satisfaction, psychological outcome, and medication adherence were assessed as secondary outcomes. Review Manage 5.3 and Stata 15.1 were used for data analysis. Results: A total of 17 randomized controlled trials (2571 participants) were included in this meta-analysis. The telemedicine group had higher IBD-specific QoL than the standard care group (standard mean difference 0.18, 95% CI 0.01 to 0.34; P.03). The number of clinic visits per patient in the telemedicine group was significantly lower than that in the standard care group (standard mean difference −0.71, 95% CI −1.07 to −0.36; P<.001). Subgroup analysis showed that adolescents in the telemedicine group had significantly higher IBD-specific QoL than those in the standard care group (standard mean difference 0.42, 95% CI 0.15 to 0.69; I2=0; P.002), but there was no significant difference between adults in the 2 groups. There were no significant differences in disease activity, remission rate, patient satisfaction, depression, self-efficacy, generic QoL, and medication adherence outcomes between the telemedicine and standard care groups. Conclusions: Telemedicine intervention showed a promising role in improving IBD-specific QoL among adolescents and decreased the number of clinic visits among patients with IBD. Further research is warranted to identify the group of patients with IBD who would most benefit from telemedicine. %M 35323120 %R 10.2196/28978 %U https://www.jmir.org/2022/3/e28978 %U https://doi.org/10.2196/28978 %U http://www.ncbi.nlm.nih.gov/pubmed/35323120 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 3 %P e35700 %T Feasibility of a Home-Based Exercise Program for Managing Posttransplant Metabolic Syndrome in Lung and Liver Transplant Recipients: Protocol for a Pilot Randomized Controlled Trial %A Rozenberg,Dmitry %A Santa Mina,Daniel %A Nourouzpour,Sahar %A Camacho Perez,Encarna %A Stewart,Brooke Lyn %A Wickerson,Lisa %A Tsien,Cynthia %A Selzner,Nazia %A Shore,Josh %A Aversa,Meghan %A Woo,Minna %A Holdsworth,Sandra %A Prevost,Karina %A Park,Jeff %A Azhie,Amirhossein %A Huszti,Ella %A McLeod,Elizabeth %A Dales,Sarah %A Bhat,Mamatha %+ Respirology and Lung Transplantation, Temerty Faculty of Medicine, Toronto General Hospital Research Institute, University Health Network, 200 Elizabeth Street, 13 EN-229, Toronto, ON, M5G 2C4, Canada, 1 416 340 4800 ext 7358, Dmitry.Rozenberg@uhn.ca %K lung transplant %K liver transplant %K posttransplant metabolic syndrome %K exercise training %K randomized controlled trial %K pilot study %D 2022 %7 23.3.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Posttransplant metabolic syndrome (PTMS) is a common contributor to morbidity and mortality among solid organ transplant recipients in the late posttransplant period (≥1 year). Patients diagnosed with PTMS are at a higher risk of cardiovascular disease and frequently experience decreased physical function and health-related quality of life (HRQL). Studies in the early posttransplant period (<1 year) have shown the benefits of facility-based exercise training on physical function and HRQL, but have not evaluated the effects on metabolic risk factors. It remains unclear whether home-based exercise programs are feasible and can be delivered at a sufficient exercise dose to have effects on PTMS. This protocol outlines the methodology of a randomized controlled trial of a partly supervised home-based exercise program in lung transplant (LTx) and orthotopic liver transplant (OLT) recipients. Objective: This study aims to evaluate the feasibility (ie, recruitment rate, program adherence, attrition, safety, and participant satisfaction) of a 12-week individualized, home-based aerobic and resistance training program in LTx and OLT recipients initiated 12 to 18 months after transplantation, and to assess estimates of intervention efficacy on metabolic risk factors, exercise self-efficacy, and HRQL. Methods: In total, 20 LTx and 20 OLT recipients with ≥2 cardiometabolic risk factors at 12 to 18 months after transplantation will be randomized to an intervention (home-based exercise training) or control group. The intervention group will receive an individualized exercise prescription comprising aerobic and resistance training, 3 to 5 times a week for 12 weeks. Participants will meet on a weekly basis (via videoconference) with a qualified exercise professional who will supervise exercise progression, provide support, and support exercise self-efficacy. Participants in both study groups will receive a counseling session on healthy eating with a dietitian at the beginning of the intervention. For the primary aim, feasibility will be assessed through recruitment rate, program adherence, satisfaction, attrition, and safety parameters. Secondary outcomes will be measured at baseline and 12 weeks, including assessments of metabolic risk factors (ie, insulin resistance, abdominal obesity, blood pressure, and cholesterol), HRQL, and exercise self-efficacy. Descriptive statistics will be used to summarize program feasibility and effect estimates (means and 95% CIs) for sample size calculations in future trials. Results: Enrollment started in July 2021. It is estimated that the study period will be 18 months, with data collection to be completed by December 2022. Conclusions: A partly supervised home-based, individually tailored exercise program that promotes aerobic and resistance training and exercise self-efficacy may be an important intervention for improving the metabolic profile of LTx and OLT recipients with cardiometabolic risk factors. Thus, characterizing the feasibility and effect estimates of home-based exercise constitutes the first step in developing future clinical trials designed to reduce the high morbidity associated with PTMS. Trial Registration: ClinicalTrials.gov NCT04965142; https://clinicaltrials.gov/ct2/show/NCT04965142 International Registered Report Identifier (IRRID): DERR1-10.2196/35700 %M 35319467 %R 10.2196/35700 %U https://www.researchprotocols.org/2022/3/e35700 %U https://doi.org/10.2196/35700 %U http://www.ncbi.nlm.nih.gov/pubmed/35319467 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 3 %P e20168 %T Nonalcoholic Fatty Liver Disease in Children and Adolescents Taking Atypical Antipsychotic Medications: Protocol for a Systematic Review and Meta-analysis %A Hatem,Reem %A Nawaz,Faisal A %A Al-Sharif,Ghadah A %A Almoosa,Mohammad %A Kattan,Wid %A Tzivinikos,Christos %A Amirali,E Lila %A Albanna,Ammar %+ Al Jalila Children's Specialty Hospital, Oud Metha Road, Al Jaddaf, Dubai, 007662, United Arab Emirates, 971 502030000, aalbanna@ajch.ae %K nonalcoholic fatty liver disease %K psychopharmacology %K antipsychotics %K children %K adolescents %K overprescribing %K pharmaceuticals %K antipsychotic medications %K medication %K pediatric psychopharmacology %K pharmacology %K child and adolescent psychiatry %D 2022 %7 21.3.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Atypical antipsychotics (AAP) are commonly prescribed to children and adolescents and are associated with important adverse effects including weight gain and metabolic syndrome. Nonalcoholic fatty liver disease (NAFLD) is not only the most common pediatric liver disease but is also associated with serious complications including liver cirrhosis. Objective: Given that NAFLD and AAP are associated with metabolic syndrome, we aim to comprehensively examine the association between AAP and NAFLD in children and adolescents. Methods: We will conduct a systematic review of studies exploring NAFLD in subjects younger than 18 years on AAP published in English between 1950 and 2020 following the PRISMA (Preferred Reporting items for Systematic Reviews and Meta-Analysis) guidelines. Results: A PRISMA flowchart will be used present the study results after comprehensively reviewing studies on NAFLD in children and adolescents taking AAP. The first and second systematic searches will be conducted during December 2021. The results are expected to be published in June 2022. Conclusions: This research project will serve as a foundation for future studies and assist in devising interventions and reforming clinical guidelines for using AAP to ensure improved patient safety. International Registered Report Identifier (IRRID): PRR1-10.2196/20168 %M 35311689 %R 10.2196/20168 %U https://www.researchprotocols.org/2022/3/e20168 %U https://doi.org/10.2196/20168 %U http://www.ncbi.nlm.nih.gov/pubmed/35311689 %0 Journal Article %@ 1929-073X %I JMIR Publications %V 11 %N 1 %P e32234 %T Microbial Ecosystem Therapeutic-2 Intervention in People With Major Depressive Disorder and Generalized Anxiety Disorder: Phase 1, Open-Label Study %A Chinna Meyyappan,Arthi %A Forth,Evan %A Milev,Roumen %+ Department of Psychiatry, Queen's University, 752 King St. West, Kingston, ON, K7L 4X3, Canada, 1 6135444900, 14acm@queensu.ca %K gut-brain axis %K microbiome %K Microbial Ecosystem Therapeutic %K depression %K anxiety %D 2022 %7 21.1.2022 %9 Original Paper %J Interact J Med Res %G English %X Background: Recent studies have investigated the potential of treatments that modify the gut microbiome, such as fecal microbiota transplantation and probiotics, in individuals with psychiatric illnesses. Objective: The aim of this study was to investigate the safety, tolerability, and efficacy of a novel gut microbiome therapeutic, Microbial Ecosystem Therapuetic-2 (MET-2), in people with depression and anxiety. Methods: In this phase 1, open-label trial, 12 adults diagnosed with major depressive disorder, generalized anxiety disorder, or both were recruited. Over 8 weeks, participants consumed three capsules per day, orally, of an encapsulated microbial therapeutic (MET-2), which contained 40 strains of bacteria that were purified and lab-grown from the stool of a single healthy donor. Participants were assessed biweekly using clinical scales and questionnaires in order to evaluate the safety, efficacy, and tolerability of the therapeutic. Results: The therapeutic was found to be generally safe and tolerable, with limited adverse events and side effects and no serious adverse events. Of the 12 individuals included in this study, 9 (75%) responded to treatment (50% improvement in Montgomery-Asberg Depression Rating Scale [MADRS] scores, 7-item Generalized Anxiety Disorder scale [GAD-7] scores, or both, from baseline to the week-8 visit). Over the course of 10 weeks, MET-2 significantly decreased mean MADRS and GAD-7 scores (MADRS: F2.731, 30.05=8.784, P<.001; GAD-7: F2.778, 30.55= 9.638, P<.001). Multiple comparisons with Bonferroni adjustments showed a significant reduction in MADRS scores from baseline (mean 19.00, SD 4.843) to week 6 (mean 11.25, SD 8.001; P=.009), week 8 (mean 8.667, SD 8.732; P=.002), and week 10 (mean 8.250, SD 9.304; P=.006). Multiple comparisons showed a significant reduction in GAD-7 scores from baseline (mean 13.58, SD 4.010) to week 4 (mean 9.167, SD 5.096; P=.03), week 6 (mean 7.667, SD 4.539; P=.004), week 8 (mean 7.333, SD 6.583; P=.03), and week 10 (mean 7.500, SD 6.448; P=.03). Conclusions: The findings from this study are the first to provide evidence for the role of microbial ecosystem therapy in treating depression and anxiety. However, a double-blind, randomized controlled trial with a larger sample size is needed for more conclusive results. Trial Registration: ClinicalTrials.gov NCT04052451; https://www.clinicaltrials.gov/ct2/show/NCT04052451 International Registered Report Identifier (IRRID): RR2-10.2196/17223 %M 35060914 %R 10.2196/32234 %U https://www.i-jmr.org/2022/1/e32234 %U https://doi.org/10.2196/32234 %U http://www.ncbi.nlm.nih.gov/pubmed/35060914 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 1 %P e30078 %T School Attendance Registers for the Syndromic Surveillance of Infectious Intestinal Disease in UK Children: Protocol for a Retrospective Analysis %A Donaldson,Anna L %A Harris,John P %A Vivancos,Roberto %A Hungerford,Daniel %A Hall,Ian %A O'Brien,Sarah J %+ NIHR Health Protection Research Unit in Gastrointestinal Infections, University of Liverpool, 2nd Floor, Block F, Waterhouse Buildings, 1-5 Brownlow Street, Liverpool, L69 3GL, United Kingdom, 44 151 795 8347, A.Donaldson2@liverpool.ac.uk %K syndromic surveillance %K schools %K children %K absenteeism %K infectious intestinal disease %K diarrhea and vomiting %K school attendance registers %D 2022 %7 20.1.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Infectious intestinal disease (IID) is common, and children are more likely than adults both to have IID and to transmit infection onto others. Before the introduction of the vaccine, rotavirus was the leading cause of severe childhood diarrhea, with norovirus and Campylobacter predominate pathogens. Public health surveillance of IID is primarily based on health care data, and as such, illness that is managed within the community will often go undetected. School attendance registers offer a novel data set that has the potential to identify community cases and outbreaks of IID that would otherwise be missed by current health surveillance systems. Although studies have explored the role of school attendance registers in the monitoring of influenza among children, no studies have been identified that consider this approach in the surveillance of IID. Objective: The aim of this study is to explore the role and utility of school attendance registers in the detection and surveillance of IID in children. The secondary aims are to estimate the burden of IID on school absenteeism and to assess the impact of the rotavirus vaccine on illness absence among school-aged children. Methods: This study is a retrospective analysis of school attendance registers to investigate whether school absences due to illness can be used to capture seasonal trends and outbreaks of infectious intestinal disease among school-aged children. School absences in Merseyside, United Kingdom will be compared and combined with routine health surveillance data from primary care, laboratories, and telehealth services. These data will be used to model spatial and temporal variations in the incidence of IID and to apportion likely causes to changes in school absenteeism trends. This will be used to assess the potential utility of school attendance data in the surveillance of IID and to estimate the burden of IID absenteeism in schools. It will also inform an analysis of the impact of the rotavirus vaccine on disease within this age group. Results: This study has received ethical approval from the University of Liverpool Research Ethics Committee (reference number 1819). Use of general practice data has been approved for the evaluation of rotavirus vaccination in Merseyside by NHS Research Ethics Committee, South Central-Berkshire REC Reference 14/SC/1140. Conclusions: This study is unique in considering whether school attendance registers could be used to enhance the surveillance of IID. Such data have multiple potential applications and could improve the identification of outbreaks within schools, allowing early intervention to reduce transmission both within and outside of school settings. These data have the potential to act as an early warning system, identifying infections circulating within the community before they enter health care settings. School attendance data could also inform the evaluation of vaccination programs, such as rotavirus and, in time, norovirus. International Registered Report Identifier (IRRID): DERR1-10.2196/30078 %M 35049509 %R 10.2196/30078 %U https://www.researchprotocols.org/2022/1/e30078 %U https://doi.org/10.2196/30078 %U http://www.ncbi.nlm.nih.gov/pubmed/35049509 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 1 %P e31413 %T The Role of Carbohydrates in Irritable Bowel Syndrome: Protocol for a Randomized Controlled Trial Comparing Three Different Treatment Options %A Nybacka,Sanna %A Törnblom,Hans %A Simren,Magnus %A Störsrud,Stine %+ Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Medicinaregatan 13, Gothenburg, 413 46, Sweden, 46 031 7860000, sanna.nybacka@gu.se %K irritable bowel syndrome %K low FODMAP %K LCHF %K pharmacological treatment %K diet %K NICE diet %D 2022 %7 17.1.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Although it is widely acknowledged that food intake can worsen symptoms in patients with irritable bowel syndrome (IBS), there is a lack of efficient treatments that can apply to all patients and subtypes of IBS. As IBS can manifest in different ways, it is likely that the most successful treatment option will differ among patients; therefore, this large, randomized controlled trial comparing 3 different treatment options for patients with IBS is highly warranted. Objective: This study aims to conduct a randomized controlled trial to evaluate the effectiveness of 3 different treatment options for patients with IBS. Methods: A total of 300 patients with IBS will be randomized (1:1:1) to receive one of the following three treatment options: a diet with low total carbohydrate content; a diet combining low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols and traditional dietary advice in IBS; and optimized medical treatment. The study will comprise a 10-day screening period, 28 days of intervention, and a 6-month follow-up for patients receiving dietary treatment. Questionnaires assessing both gastrointestinal and extraintestinal symptoms will be used as end points, as well as metabolomics, microbiota profiling, and immunological markers. Furthermore, qualitative methods will be used to evaluate the patients’ experiences regarding diet treatments. Results: Recruitment for this study began in January 2017. By May 2021, of the proposed 300 participants, 270 (90%) had been randomized, and 244 (81.3%) participants had finished the 4-week intervention. The study is still in progress, and the results are expected to be published in 2022. Conclusions: By collecting a wide range of data before, during, and after treatment in a large group of patients with IBS and diverse bowel habits, we will gain new insights into the predictors of response to treatment. That information can, in the future, be used to personalize treatment for the patient, based on the individual’s phenotype and IBS symptoms. In addition, the long-term effects of 2 different dietary treatments will be evaluated regarding their impact on gut microbiota and clinical laboratory tests and to ensure that they are safe, effective, and applicable for patients with IBS. Trial Registration: ClinicalTrials.gov NCT02970591; https://clinicaltrials.gov/ct2/show/NCT02970591 International Registered Report Identifier (IRRID): DERR1-10.2196/31413 %M 35037893 %R 10.2196/31413 %U https://www.researchprotocols.org/2022/1/e31413 %U https://doi.org/10.2196/31413 %U http://www.ncbi.nlm.nih.gov/pubmed/35037893 %0 Journal Article %@ 2291-9694 %I JMIR Publications %V 9 %N 12 %P e25328 %T Can Real-time Computer-Aided Detection Systems Diminish the Risk of Postcolonoscopy Colorectal Cancer? %A Madalinski,Mariusz %A Prudham,Roger %+ Northern Care Alliance, Royal Oldham Hospital, Rochdale Rd, Oldham, OL1 2JH, United Kingdom, 44 01616240420, mariusz.madalinski@googlemail.com %K artificial intelligence %K colonoscopy %K adenoma %K real-time computer-aided detection %K colonic polyp %D 2021 %7 24.12.2021 %9 Viewpoint %J JMIR Med Inform %G English %X The adenoma detection rate is the constant subject of research and the main marker of quality in bowel cancer screening. However, by improving the quality of endoscopy via artificial intelligence methods, all polyps, including those with the potential for malignancy, can be removed, thereby reducing interval colorectal cancer rates. As such, the removal of all polyps may become the best marker of endoscopy quality. Thus, we present a viewpoint on integrating the computer-aided detection (CADe) of polyps with high-accuracy, real-time colonoscopy to challenge quality improvements in the performance of colonoscopy. Colonoscopy for bowel cancer screening involving the integration of a deep learning methodology (ie, integrating artificial intelligence with CADe systems) has been assessed in an effort to increase the adenoma detection rate. In this viewpoint, a few studies are described, and their results show that CADe systems are able to increase screening sensitivity. The detection of adenomatous polyps, which are associated with a potential risk of progression to colorectal cancer, and their removal are expected to reduce cancer incidence and mortality rates. However, so far, artificial intelligence methods do not increase the detection of cancer or large adenomatous polyps but contribute to the detection of small precancerous polyps. %M 34571490 %R 10.2196/25328 %U https://medinform.jmir.org/2021/12/e25328 %U https://doi.org/10.2196/25328 %U http://www.ncbi.nlm.nih.gov/pubmed/34571490 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 12 %P e33267 %T Computer-Aided Diagnosis of Gastrointestinal Ulcer and Hemorrhage Using Wireless Capsule Endoscopy: Systematic Review and Diagnostic Test Accuracy Meta-analysis %A Bang,Chang Seok %A Lee,Jae Jun %A Baik,Gwang Ho %+ Department of Internal Medicine, Hallym University College of Medicine, 77 Sakju-ro, Chuncheon, 24253, Republic of Korea, 82 33 240 5821, csbang@hallym.ac.kr %K artificial intelligence %K computer-aided diagnosis %K capsule endoscopy %K ulcer %K hemorrhage %K gastrointestinal %K endoscopy %K review %K accuracy %K meta-analysis %K diagnostic %K performance %K machine learning %K prediction models %D 2021 %7 14.12.2021 %9 Review %J J Med Internet Res %G English %X Background: Interpretation of capsule endoscopy images or movies is operator-dependent and time-consuming. As a result, computer-aided diagnosis (CAD) has been applied to enhance the efficacy and accuracy of the review process. Two previous meta-analyses reported the diagnostic performance of CAD models for gastrointestinal ulcers or hemorrhage in capsule endoscopy. However, insufficient systematic reviews have been conducted, which cannot determine the real diagnostic validity of CAD models. Objective: To evaluate the diagnostic test accuracy of CAD models for gastrointestinal ulcers or hemorrhage using wireless capsule endoscopic images. Methods: We conducted core databases searching for studies based on CAD models for the diagnosis of ulcers or hemorrhage using capsule endoscopy and presenting data on diagnostic performance. Systematic review and diagnostic test accuracy meta-analysis were performed. Results: Overall, 39 studies were included. The pooled area under the curve, sensitivity, specificity, and diagnostic odds ratio of CAD models for the diagnosis of ulcers (or erosions) were .97 (95% confidence interval, .95–.98), .93 (.89–.95), .92 (.89–.94), and 138 (79–243), respectively. The pooled area under the curve, sensitivity, specificity, and diagnostic odds ratio of CAD models for the diagnosis of hemorrhage (or angioectasia) were .99 (.98–.99), .96 (.94–0.97), .97 (.95–.99), and 888 (343–2303), respectively. Subgroup analyses showed robust results. Meta-regression showed that published year, number of training images, and target disease (ulcers vs erosions, hemorrhage vs angioectasia) was found to be the source of heterogeneity. No publication bias was detected. Conclusions: CAD models showed high performance for the optical diagnosis of gastrointestinal ulcer and hemorrhage in wireless capsule endoscopy. %M 34904949 %R 10.2196/33267 %U https://www.jmir.org/2021/12/e33267 %U https://doi.org/10.2196/33267 %U http://www.ncbi.nlm.nih.gov/pubmed/34904949 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 11 %P e31678 %T Digital Instruments for Reporting of Gastrointestinal Symptoms in Clinical Trials: Comparison of End-of-Day Diaries Versus the Experience Sampling Method %A Beckers,Abraham B %A Snijkers,Johanna T W %A Weerts,Zsa Zsa R M %A Vork,Lisa %A Klaassen,Tim %A Smeets,Fabienne G M %A Masclee,Ad A M %A Keszthelyi,Daniel %+ Division of Gastroenterology-Hepatology, Department of Internal Medicine, Maastricht University Medical Center, Universiteitssingel 50, Maastricht, 6229 ER, Netherlands, 31 0433881844, ab.beckers@maastrichtuniversity.nl %K irritable bowel syndrome %K functional dyspepsia %K digital diary %K experience sampling method %K smartphone app %K mobile phone application %K mHealth %K eHealth %K compliance %K patient-reported outcome measures %D 2021 %7 24.11.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Questionnaires are necessary tools for assessing symptoms of disorders of the brain-gut interaction in clinical trials. We previously reported on the excellent adherence to a smartphone app used as symptom diary in a randomized clinical trial on irritable bowel syndrome (IBS). Other sampling methods, such as the experience sampling method (ESM), are better equipped to measure symptom variability over time and provide useful information regarding possible symptom triggers, and they are free of ecological and recall bias. The high frequency of measurements, however, could limit the feasibility of ESM in clinical trials. Objective: This study aimed to compare the adherence rates of a smartphone-based end-of-day diary and ESM for symptom assessment in IBS and functional dyspepsia (FD). Methods: Data from 4 separate studies were included. Patients with IBS participated in a randomized controlled trial, which involved a smartphone end-of-day diary for a 2+8-week (pretreatment + treatment) period, and an observational study in which patients completed ESM assessments using a smartphone app for 1 week. Patients with FD participated in a randomized controlled trial, which involved a smartphone end-of-day diary for a 2+12-week (pretreatment + treatment) period, and an observational study in which patients completed ESM assessments using a smartphone app for 1 week. Adherence rates were compared between these 2 symptom sampling methods. Results: In total, 25 patients with IBS and 15 patients with FD were included. Overall adherence rates for the end-of-day diaries were significantly higher than those for ESM (IBS: 92.7% vs 69.8%, FD: 90.1% vs 61.4%, respectively). Conclusions: This study demonstrates excellent adherence rates for smartphone app–based end-of-day diaries as used in 2 separate clinical trials. Overall adherence rates for ESM were significantly lower, rendering it more suitable for intermittent sampling periods rather than continuous sampling during longer clinical trials. %M 34821561 %R 10.2196/31678 %U https://formative.jmir.org/2021/11/e31678 %U https://doi.org/10.2196/31678 %U http://www.ncbi.nlm.nih.gov/pubmed/34821561 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 10 %P e30131 %T Modulation of Bone and Joint Biomarkers, Gut Microbiota, and Inflammation Status by Synbiotic Supplementation and Weight-Bearing Exercise: Human Study Protocol for a Randomized Controlled Trial %A Ilesanmi-Oyelere,Bolaji Lilian %A Roy,Nicole C %A Kruger,Marlena C %+ College of Health, Massey University, Private Bag 11222, Palmerston North, 4442, New Zealand, 64 2108522308, b.ilesanmi-oyelere@massey.ac.nz %K synbiotic (prebiotic+probiotic) %K weight-bearing exercise %K gut microbiota %K inflammation %K BMD %K cytokines %K bone and joint biomarkers %D 2021 %7 26.10.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: There is strong evidence suggesting that prebiotics and probiotics regulate gut microbiota, reducing inflammation and thereby potentially improving bone health status. Similarly, mechanistic evidence suggests that either low-impact or high-impact weight-bearing exercises improve body composition and consequently increase bone mineral density in individuals with osteoporosis and osteoarthritis. Objective: This study aims to investigate the effects of a synbiotic (probiotic+prebiotic) supplementation, an exercise intervention, or a combination of both on gut microbiota, inflammation, and bone biomarkers in postmenopausal women. Methods: A total of 160 postmenopausal women from New Zealand will be recruited and randomized to one of four interventions or treatments for 12 weeks: control, synbiotic supplementation, exercise intervention, or synbiotic supplementation and exercise. The primary outcome measure is the bone and joint biomarkers at baseline and week 12, whereas the gut microbiota profile and inflammatory cytokine measurements will serve as the secondary outcome measures at baseline and week 12. Baseline data and exercise history will be used to assess, allocate, and stratify participants into treatment measures. Results: Recruitment of participants will begin in September 2021, and the anticipated completion date is June 2022. Conclusions: To the best of our knowledge, this will be the first randomized controlled trial to analyze the effects of both a synbiotic supplement and an exercise intervention in postmenopausal women. On the basis of the results obtained, a combination of synbiotic supplements and exercise might serve as a noninvasive approach to manage and/or improve body composition and bone health in postmenopausal women. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12620000998943p; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380336&isClinicalTrial=False %M 34698648 %R 10.2196/30131 %U https://www.researchprotocols.org/2021/10/e30131 %U https://doi.org/10.2196/30131 %U http://www.ncbi.nlm.nih.gov/pubmed/34698648 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 10 %P e19915 %T Comparative Effectiveness of Enhanced Patient Instructions for Bowel Preparation Before Colonoscopy: Network Meta-analysis of 23 Randomized Controlled Trials %A Tian,Xu %A Yi,Li-Juan %A Han,Yang %A Chen,Hui %A Liu,Xiao-Ling %A Chen,Wei-Qing %A Jiménez-Herrera,Maria F %+ Nursing Department, Universitat Rovira i Virgili, Avinguda Catalunya, 35, Tarragona, 43002, Spain, 34 977299426, maria.jimenez@urv.cat %K colonoscopy %K bowel preparation %K patient instruction %K systematic review %K network meta-analysis %D 2021 %7 25.10.2021 %9 Review %J J Med Internet Res %G English %X Background: Various enhanced patient instructions (EPIs) have been used for bowel preparation (BP) and our previous meta-analysis also demonstrated the efficacy of EPIs in increasing the colonic polyp and adenoma detection rates; however, the optimal method for adequate BP has not yet been developed. Objective: We performed a network meta-analysis to determine the optimal instructions. Methods: We searched for randomized controlled trials (RCTs) comparing the effectiveness of EPIs with each other or standard patient instructions (SPIs) for BP. We performed direct and Bayesian network meta-analyses for all instructions and used the GRADE (Grading of Recommendations Assessment, Development and Evaluation) criteria to appraise the quality of evidence. Results: We included 23 RCTs (7969 patients) comparing 10 different instructions. In direct meta-analyses, most of the EPIs, except visual aids and mobile apps, increased the adequate preparation rate (APR). Network meta-analyses showed that additional explanations were superior to visual aids (odds ratio [OR] 0.35, 95% CI 0.19-0.59), telephone calls (OR 0.62, 95% CI 0.37-0.99), educational videos (OR 0.79, 95% CI 0.5-0.77), and mobile apps (OR 0.33, 95% CI 0.14-0.68) with low-to-high-quality evidence; newly designed booklets (OR 3.28, 95% CI 1.59-6.16), SMS text messaging (OR 2.33, 95% CI 1.28-3.91), telephone calls (OR 1.86, 95% CI 1.03-1.78), educational videos (OR 2.33, 95% CI 1.40-3.65), and social media applications (OR 2.42, 95% CI 1.4-3.93) were superior to visual aids and mobile apps with low-to-high-quality evidence. SMS text messaging, telephone calls, and social media applications increase adherence to and satisfaction with the BP regime. Social media applications reduce the risk of adverse events (AEs). Telephone calls and social media applications increase the polyp detection rate (PDR). Conclusions: Newly designed booklets, telephone calls, educational videos, and social media applications can improve the quality of BP. Telephone calls and social media applications improve adherence to and satisfaction with the BP regime, reduce the risk of AEs, and increase the PDR. Trial Registration: INPLASY (International Platform of Registered Systematic Review and Meta-analysis Protocols) INPLASY2020120103; https://inplasy.com/inplasy-2020-12-0103/ %M 34694227 %R 10.2196/19915 %U https://www.jmir.org/2021/10/e19915 %U https://doi.org/10.2196/19915 %U http://www.ncbi.nlm.nih.gov/pubmed/34694227 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 10 %P e33158 %T An Advanced Nursing Directive for Children With Suspected Appendicitis: Protocol for a Quality Improvement Feasibility Study %A Chaudhari,Hanu %A Schneeweiss,Michelle %A Rebinsky,Reid %A Rullo,Enrico %A Eltorki,Mohamed %+ Faculty of Health Sciences, McMaster University, 1200 Main St W, Hamilton, ON, L8N 3Z5, Canada, 1 416 985 4520, hanu.chaudhari@medportal.ca %K quality improvement %K pediatric %K nursing %K medical directive %K appendicitis %K emergency department flow %K nursing directive %D 2021 %7 20.10.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Pediatric appendicitis accounts for an estimated 7% to 10% of abdominal pain cases in the emergency department (ED). The diagnosis is time-consuming, and the investigative process depends on physician assessment, resulting in delays in diagnosis and therapeutic management. The utility of an advanced nursing directive (AND) to expedite this process is unclear and needs further exploration. Objective: This study aims to describe key components of ED flow in patients with suspected appendicitis seen at a pediatric ED and pilot a directive that allows ED nurses to perform an order set that includes blood work, urine tests, analgesics, fluids, and an abdominal-pelvis ultrasound prior to physician assessment. Methods: This study involves conducting a retrospective chart review alongside a quality improvement initiative to compare key ED flow metrics before and after AND implementation. Primary outcome measures include median time from ED triage assessment to ultrasound completion, analgesia administration, blood work results, and time to disposition (consult or discharge), alongside other key ED flow metrics for suspected appendicitis. Secondary outcomes will involve patient and caretaker satisfaction surveys. Descriptive statistics will be used to summarize the data. For differences in proportions, a chi-square test will be used. The Student t test will be used for continuous variables. A variable-controlled run chart will be performed to assess impact on ED flow metrics. Patient and family satisfaction surveys are administered immediately after the directive encounter and 7 days afterward. Results: There are currently 3900 patients who have been screened, 344 patients who have been enrolled, and 90 patients who have received the medical directive since implementation in June 2020. Interim results on reduction of time to diagnostic and therapeutic ED flow parameters and satisfaction surveys are expected to be published in February 2022. The final study endpoint will be in June 2022. Conclusions: This study proposes a novel protocol for improving the diagnosis and treatment of suspected pediatric appendicitis through implementation of an evidence-based AND. This model may provide a standardized, international pathway for management of common pediatric and adult emergencies. International Registered Report Identifier (IRRID): RR1-10.2196/33158 %M 34668867 %R 10.2196/33158 %U https://www.researchprotocols.org/2021/10/e33158 %U https://doi.org/10.2196/33158 %U http://www.ncbi.nlm.nih.gov/pubmed/34668867 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 10 %P e33009 %T Evaluation of a Digital Handheld Hydrogen Breath Monitor to Diagnose Lactose Malabsorption: Interventional Crossover Study %A Mathews,Simon C %A Templeton,Sandy %A Taylor,Stephanie K %A Harris,Sten %A Stewart,Margaret %A Raja,Shruti M %+ Johns Hopkins Medicine, 1800 Orleans St, Baltimore, MD, 21287, United States, 1 410 955 5000, smathe14@jhmi.edu %K digital health %K lactose intolerance %K digestive disease %K evaluation %K medical device %K detection %K diagnostic %K digestion %K testing %K performance %K gastrointestinal %K diagnosis %D 2021 %7 18.10.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: Lactose malabsorption is a common condition that affects a broad segment of the population. Clinical diagnosis based on symptom recall can be unreliable and conventional testing can be inconvenient, requiring expensive laboratory-based equipment and conduction of the testing in a clinical setting. Objective: The aim of this study is to assess the performance of a digital handheld hydrogen breath monitor (GIMate) in diagnosing lactose malabsorption compared to a US Food and Drug Administration (FDA)–cleared device (H2 Check) for the same indication. Methods: An interventional crossover study was performed in adult participants with a prior confirmed diagnosis of lactose malabsorption or a suspected history of lactose intolerance. Results: A total of 31 participants (mean age 33.9 years) were enrolled in the study. There was 100% positive percent agreement and 100% negative percent agreement between the GIMate monitor and the H2 Check. Correlation between gastrointestinal symptoms and hydrogen values was positive at 0.82 (P<.001). Conclusions: The digital handheld GIMate breath monitor achieved equivalent diagnostic performance to that of an FDA-cleared device in the diagnosis of lactose malabsorption. Trial Registration: ClinicalTrials.gov NCT04754724; https://clinicaltrials.gov/ct2/show/NCT04754724 %M 34544034 %R 10.2196/33009 %U https://formative.jmir.org/2021/10/e33009 %U https://doi.org/10.2196/33009 %U http://www.ncbi.nlm.nih.gov/pubmed/34544034 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 10 %P e29046 %T An Intervention With Michigan-Grown Wheat in Healthy Adult Humans to Determine Effect on Gut Microbiota: Protocol for a Crossover Trial %A Kinney,Gigi A %A Haddad,Eliot N %A Garrow,Linda S %A Ng,Perry K W %A Comstock,Sarah S %+ Department of Food Science & Human Nutrition, Michigan State University, 204 Trout Food Science Bldg, 469 Wilson Rd, East Lansing, MI, 48824, United States, 1 517 353 3415, comsto37@msu.edu %K fiber %K microbiota %K whole grain %K wheat %K butyrate %K calprotectin %K lipocalin-2 %D 2021 %7 6.10.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Daily fiber intake can increase the diversity of the human gut microbiota as well as the abundance of beneficial microbes and their metabolites. Whole-grain wheat is high in fiber. Objective: This manuscript presents a study protocol designed to understand the effects of different types of wheat on gastrointestinal tract microbes. Methods: Human adults will consume crackers made from three types of wheat flour (refined soft white wheat, whole-grain soft white wheat, and whole-grain soft red wheat). In this study, participants will alternate between crackers made from refined soft white wheat flour to those made from whole-grain soft white wheat and whole-grain soft red wheat flour. Survey and stool sample collection will occur after 7-day treatment periods. We will assess how wheat consumption affects gastrointestinal bacteria by sequencing the V4 region of 16S rRNA gene amplicons and the inflammatory state of participants’ intestines using enzyme-linked immunosorbent assays. The butyrate production capacity of the gut microbiota will be determined by targeted quantitative real-time polymerase chain reaction. Results: We will report the treatment effects on alpha and beta diversity of the microbiota and taxa-specific differences. Microbiota results will be analyzed using the vegan package in R. Butyrate production capacity and biomarkers of intestinal inflammation will be analyzed using parametric statistical methods such as analysis of variance or linear regression. We expect whole wheat intake to increase butyrate production capacity, bacterial alpha diversity, and abundance of bacterial taxa responsive to phenolic compounds. Soft red wheat is also expected to decrease the concentration of inflammatory biomarkers in the stool of participants. Conclusions: This protocol describes the methods to be used in a study on the impact of wheat types on the human gastrointestinal microbiota and biomarkers of intestinal inflammation. The analysis of intestinal responses to the consumption of two types of whole wheat will expand our understanding of how specific foods affect health-associated outcomes. International Registered Report Identifier (IRRID): DERR1-10.2196/29046 %M 34612840 %R 10.2196/29046 %U https://www.researchprotocols.org/2021/10/e29046 %U https://doi.org/10.2196/29046 %U http://www.ncbi.nlm.nih.gov/pubmed/34612840 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 9 %P e31439 %T The Safety and Efficacy of Microbial Ecosystem Therapeutic-2 in People With Major Depression: Protocol for a Phase 2, Double-Blind, Placebo-Controlled Study %A Chinna Meyyappan,Arthi %A Sgarbossa,Cassandra %A Vazquez,Gustavo %A Bond,David J %A Müller,Daniel J %A Milev,Roumen %+ Centre for Neuroscience Studies, Queen's University, 752 King St. West, Kingston, ON, K7L4X3, Canada, 1 6135444900, 14acm@queensu.ca %K gut-brain axis %K depression %K microbiome %K probiotics %K fecal transplant %K MET-2 %D 2021 %7 22.9.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: The gut-brain axis is a bidirectional signaling pathway between the gastrointestinal tract and the brain; it is being studied because of its potential influence in mediating mood, anxiety, and other neuropsychiatric symptoms. Previous research examining the effects of gut microbiota on neuropsychiatric disorders suggests that gut repopulation treatments such as probiotics, microbe therapy, and fecal microbiota transplantation show promising results in treating symptoms of anxiety and depression. This study explores the use of an alternative gut repopulation treatment to fecal microbiota transplantation, known as Microbial Ecosystem Therapeutic (MET)-2, as an intervention against symptoms of depression. MET-2 is a daily, orally administered capsule containing 40 bacterial strains purified from a single healthy donor. Objective: The primary aim of this study is to assess changes in mood in people with major depression that occur pre-, post-, and during the administration of MET-2. The secondary aims are to assess changes in anxiety symptoms, blood biomarker concentrations, and the level of repopulation of healthy gut bacteria as a response to treatment. Methods: In this study, we will recruit 60 adults aged between 18 and 45 years old with major depression and randomly assign them to treatment or placebo groups. Patients in the treatment group will receive MET-2 once a day for 6 weeks, whereas patients in the placebo group will receive a matching placebo for 6 weeks. Participants will complete biweekly visits during the treatment period and a follow-up visit at 2 weeks post treatment. As a primary outcome measure, participants’ mood will be assessed using the Montgomery-Asberg Depression Rating Scale. Secondary outcome measures include changes in mood, anxiety, early stress, gastrointestinal symptoms, and tolerability of MET-2 treatment using a series of clinical scales and changes in blood markers, particularly immunoglobulins (Igs; IgA, IgG, and IgM) and inflammatory markers (C-reactive protein, tumor necrosis factor-α, transforming growth factor-β, interleukin-6, and interleukin-10). Changes in the relative abundance, diversity, and level of engraftment in fecal samples will be assessed using 16S rRNA sequencing. All data will be integrated to identify biomarkers that could indicate disease state or predict improvement in depressive symptoms in response to MET-2 treatment. Results: Given the association between the gut microbiome and depression, we hypothesized that participants receiving MET-2 would experience greater improvement in depressive symptoms than those receiving placebo owing to the recolonization of the gut microbiome with healthy bacteria modulating the gut-brain axis connection. Conclusions: This study is the first of its kind to evaluate the safety and efficacy of a microbial therapy such as MET-2 in comparison with placebo for major depressive disorder. We hope that this study will also reveal the potential capabilities of microbial therapies to treat other psychiatric illnesses and mood disorders. Trial Registration: ClinicalTrials.gov NCT04602715; https://clinicaltrials.gov/ct2/show/NCT04602715 International Registered Report Identifier (IRRID): DERR1-10.2196/31439 %M 34550085 %R 10.2196/31439 %U https://www.researchprotocols.org/2021/9/e31439 %U https://doi.org/10.2196/31439 %U http://www.ncbi.nlm.nih.gov/pubmed/34550085 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 9 %P e19232 %T Remote Consultations Versus Standard Face-to-Face Appointments for Liver Transplant Patients in Routine Hospital Care: Feasibility Randomized Controlled Trial of myVideoClinic %A Damery,Sarah %A Jones,Janet %A O'Connell Francischetto,Elaine %A Jolly,Kate %A Lilford,Richard %A Ferguson,James %+ Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, B15 2TT, United Kingdom, 44 1214147661, j.e.jones@bham.ac.uk %K digital health %K remote consultation %K patient satisfaction %K feasibility %K VSQ-9 %K secondary care %K liver transplant patients %K mobile phone %D 2021 %7 17.9.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Using technology to reduce the pressure on the National Health Service (NHS) in England and Wales is a key government target, and the NHS Long-Term Plan outlines a strategy for digitally enabled outpatient care to become mainstream by 2024. In 2020, the COVID-19 response saw the widespread introduction of remote consultations for patient follow-up, regardless of individual preferences. Despite this rapid change, there may be enduring barriers to the effective implementation of remote appointments into routine practice once the unique drivers for change during the COVID-19 pandemic no longer apply, to which pre-COVID implementation studies can offer important insights. Objective: This study aims to evaluate the feasibility of using real-time remote consultations between patients and secondary care physicians for routine patient follow-up at a large hospital in the United Kingdom and to assess whether patient satisfaction differs between intervention and usual care patients. Methods: Clinically stable liver transplant patients were randomized to real-time remote consultations in which their hospital physician used secure videoconferencing software (intervention) or standard face-to-face appointments (usual care). Participants were asked to complete postappointment questionnaires over 12 months. Data were analyzed on an intention-to-treat basis. The primary outcome was the difference in scores between baseline and study end by patient group for the three domains of patient satisfaction (assessed using the Visit-Specific Satisfaction Instrument). An embedded qualitative process evaluation used interviews to assess patient and staff experiences. Results: Of the 54 patients who were randomized, 29 (54%) received remote consultations, and 25 (46%) received usual care (recruitment rate: 54/203, 26.6%). The crossover between study arms was high (13/29, 45%). A total of 129 appointments were completed, with 63.6% (82/129) of the questionnaires being returned. Patient satisfaction at 12 months increased in both the intervention (25 points) and usual care (14 points) groups. The within-group analysis showed that the increases were significant for both intervention (P<.001) and usual care (P=.02) patients; however, the between-group difference was not significant after controlling for baseline scores (P=.10). The qualitative process evaluation showed that—according to patients—remote consultations saved time and money, were less burdensome, and caused fewer negative impacts on health. Technical problems with the software were common, and only 17% (5/29) of patients received all appointments over video. Both consultants and patients saw remote consultations as positive and beneficial. Conclusions: Using technology to conduct routine follow-up appointments remotely may ease some of the resource and infrastructure challenges faced by the UK NHS and free up clinic space for patients who must be seen face-to-face. Our findings regarding the advantages and challenges of using remote consultations for routine follow-ups of liver transplant patients have important implications for service organization and delivery in the postpandemic NHS. Trial Registration: ISRCTN Registry 14093266; https://www.isrctn.com/ISRCTN14093266 International Registered Report Identifier (IRRID): RR2-10.1186/s13063-018-2953-4 %M 34533461 %R 10.2196/19232 %U https://www.jmir.org/2021/9/e19232 %U https://doi.org/10.2196/19232 %U http://www.ncbi.nlm.nih.gov/pubmed/34533461 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 8 %P e21656 %T Using Infodemiology Metrics to Assess Public Interest in Liver Transplantation: Google Trends Analysis %A Effenberger,Maria %A Kronbichler,Andreas %A Bettac,Erica %A Grabherr,Felix %A Grander,Christoph %A Adolph,Timon Erik %A Mayer,Gert %A Zoller,Heinz %A Perco,Paul %A Tilg,Herbert %+ Department of Internal Medicine I, Gastroenterology, Hepatology, Endocrinology and Metabolism, Medical University of Innsbruck, Anichstrasse 35, Innsbruck, 6020, Austria, 43 512 504 23539, herbert.tilg@i-med.ac.at %K digital medicine %K search trends %K public awareness %K infodemiology %K eHealth %D 2021 %7 17.8.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: Liver transplantation (LT) is the only curative treatment for end-stage liver disease. Less than 10% of global transplantation needs are met worldwide, and the need for LT is still increasing. The death rates on the waiting list remain too high. Objective: It is, therefore, critical to raise awareness among the public and health care providers and in turn increasingly acquire donors. Methods: We performed a Google Trends search using the search terms liver transplantation and liver transplant on October 15, 2020. On the basis of the resulting monthly data, the annual average Google Trends indices were calculated for the years 2004 to 2018. We not only investigated the trend worldwide but also used data from the United Network for Organ Sharing (UNOS), Spain, and Eurotransplant. Using pairwise Spearman correlations, Google Trends indices were examined over time and compared with the total number of liver transplants retrieved from the respective official websites of UNOS, the Organización Nacional de Trasplantes, and Eurotransplant. Results: From 2004 to 2018, there was a significant decrease in the worldwide Google Trends index from 78.2 in 2004 to 20.5 in 2018 (–71.2%). This trend was more evident in UNOS than in the Eurotransplant group. In the same period, the number of transplanted livers increased worldwide. The waiting list mortality rate was 31% for Eurotransplant and 29% for UNOS. However, in Spain, where there are excellent awareness programs, the Google Trends index remained stable over the years with comparable, increasing LT numbers but a significantly lower waiting list mortality (15%). Conclusions: Public awareness in LT has decreased significantly over the past two decades. Therefore, novel awareness programs should be initialized. %M 34402801 %R 10.2196/21656 %U https://www.jmir.org/2021/8/e21656 %U https://doi.org/10.2196/21656 %U http://www.ncbi.nlm.nih.gov/pubmed/34402801 %0 Journal Article %@ 2291-9694 %I JMIR Publications %V 9 %N 8 %P e26398 %T Current-Visit and Next-Visit Prediction for Fatty Liver Disease With a Large-Scale Dataset: Model Development and Performance Comparison %A Wu,Cheng-Tse %A Chu,Ta-Wei %A Jang,Jyh-Shing Roger %+ Department of Obstetrics and Gynecology, Tri-Service General Hospital, National Defense Medical Center, No. 325, Sec. 2, Chenggong Rd., Neihu Dist.,, Taipei, 114, Taiwan, 886 287923311 ext 88083, taweichu@gmail.com %K machine learning %K sequence forward selection %K one-pass ranking %K fatty liver diseases %K alcohol fatty liver disease %K nonalcoholic fatty liver disease %K long short-term memory %K current-visit prediction %K next-visit prediction %D 2021 %7 12.8.2021 %9 Original Paper %J JMIR Med Inform %G English %X Background: Fatty liver disease (FLD) arises from the accumulation of fat in the liver and may cause liver inflammation, which, if not well controlled, may develop into liver fibrosis, cirrhosis, or even hepatocellular carcinoma. Objective: We describe the construction of machine-learning models for current-visit prediction (CVP), which can help physicians obtain more information for accurate diagnosis, and next-visit prediction (NVP), which can help physicians provide potential high-risk patients with advice to effectively prevent FLD. Methods: The large-scale and high-dimensional dataset used in this study comes from Taipei MJ Health Research Foundation in Taiwan. We used one-pass ranking and sequential forward selection (SFS) for feature selection in FLD prediction. For CVP, we explored multiple models, including k-nearest-neighbor classifier (KNNC), Adaboost, support vector machine (SVM), logistic regression (LR), random forest (RF), Gaussian naïve Bayes (GNB), decision trees C4.5 (C4.5), and classification and regression trees (CART). For NVP, we used long short-term memory (LSTM) and several of its variants as sequence classifiers that use various input sets for prediction. Model performance was evaluated based on two criteria: the accuracy of the test set and the intersection over union/coverage between the features selected by one-pass ranking/SFS and by domain experts. The accuracy, precision, recall, F-measure, and area under the receiver operating characteristic curve were calculated for both CVP and NVP for males and females, respectively. Results: After data cleaning, the dataset included 34,856 and 31,394 unique visits respectively for males and females for the period 2009-2016. The test accuracy of CVP using KNNC, Adaboost, SVM, LR, RF, GNB, C4.5, and CART was respectively 84.28%, 83.84%, 82.22%, 82.21%, 76.03%, 75.78%, and 75.53%. The test accuracy of NVP using LSTM, bidirectional LSTM (biLSTM), Stack-LSTM, Stack-biLSTM, and Attention-LSTM was respectively 76.54%, 76.66%, 77.23%, 76.84%, and 77.31% for fixed-interval features, and was 79.29%, 79.12%, 79.32%, 79.29%, and 78.36%, respectively, for variable-interval features. Conclusions: This study explored a large-scale FLD dataset with high dimensionality. We developed FLD prediction models for CVP and NVP. We also implemented efficient feature selection schemes for current- and next-visit prediction to compare the automatically selected features with expert-selected features. In particular, NVP emerged as more valuable from the viewpoint of preventive medicine. For NVP, we propose use of feature set 2 (with variable intervals), which is more compact and flexible. We have also tested several variants of LSTM in combination with two feature sets to identify the best match for male and female FLD prediction. More specifically, the best model for males was Stack-LSTM using feature set 2 (with 79.32% accuracy), whereas the best model for females was LSTM using feature set 1 (with 81.90% accuracy). %M 34387552 %R 10.2196/26398 %U https://medinform.jmir.org/2021/8/e26398 %U https://doi.org/10.2196/26398 %U http://www.ncbi.nlm.nih.gov/pubmed/34387552 %0 Journal Article %@ 1929-073X %I JMIR Publications %V 10 %N 2 %P e27784 %T Relevance of Anthropometric Measurements in a Multiethnic Obesity Cohort: Observational Study %A Bhatti,Rahila %A Warshow,Usama %A Joumaa,Mona %A ElSaban,Mariam %A Nawaz,Faisal A %A Khamis,Amar Hassan %+ Mediclinic Parkview Hospital, Umm Suqeim Street, Dubai, PO Box 51122, United Arab Emirates, 971 505290575, rsbhatti91@hotmail.com %K anthropometrics %K body mass index %K cardiovascular health %K comorbidities %K liver disease %K obesity %K overweight %K type 2 diabetes mellitus %K visceral fat %K waist circumference %K weight loss %K weight management %D 2021 %7 13.5.2021 %9 Original Paper %J Interact J Med Res %G English %X Background: The prevalence of obesity is increasing worldwide, and the Middle East is not an exception to this increasing trend. Obesity increases the risk of multiple metabolic complications, such as diabetes mellitus. Measurement of obesity has primarily relied on the BMI to identify risk; however, both bedside and office-based anthropometric measures of obesity can provide more detailed information on risk. Objective: This study aimed to investigate the prevalence of obesity-related diseases in a multidisciplinary weight management population and to determine its relationship with obesity anthropometric indices. Methods: This cross-sectional study was conducted at Mediclinic Parkview Hospital (Dubai, the United Arab Emirates). In total, 308 patients have been evaluated from January to September 2019 as part of a multidisciplinary weight management program. Key demographics, anthropometrics, and clinical data were analyzed using SPSS (version 25, SPSS Inc). Results: Our cohort of 308 patients included 103 (33%) males and 205 (67%) females of 38 nationalities. The mean age of the cohort was 41 (SD 9.6) years, with a median BMI of 34.5 (IQR 6.7) and 33.7 (IQR 7.8) for males and females, respectively. The mean waist circumference (WC) was 113.4 (SD 23.3) cm and 103.5 (SD 16.2) cm, fat percentage was 33.7% (SD 11.6%) and 45% (SD 6.8%), fat mass was 41 (SD 15.2) kg and 41.1 (SD 14.1) kg, and visceral fat mass was 6.5 (SD 3.2) kg and 3.1 (SD 1.8) kg for males and females, respectively. There was a strong correlation between BMI and WC (r=0.65 and r=0.69 in males and females, respectively; P=.01) and visceral fat (r=0.78 and r=0.90 in males and females, respectively). Furthermore, visceral fat was significantly associated with WC in both sexes (r=0.73 and r=0.68 in females and males respectively; P=.01). Furthermore, WC was significantly associated with a risk of diabetes, hypertension, and nonalcoholic fatty liver disease. Conclusions: BMI and WC are the most representative measures of obesity in our population and correlate with abdominal adiposity– and obesity-related diseases. Further studies are required to assess the benefits of these measures during weight reduction interventions. %M 33983128 %R 10.2196/27784 %U https://www.i-jmr.org/2021/2/e27784 %U https://doi.org/10.2196/27784 %U http://www.ncbi.nlm.nih.gov/pubmed/33983128 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 5 %P e23599 %T Impact of an Online Gastrointestinal Symptom History Taker on Physician Documentation and Charting Time: Pragmatic Controlled Trial %A Hall,Natalie J %A Berry,Sameer K %A Aguilar,Jack %A Brier,Elizabeth %A Shah,Parth %A Cheng,Derek %A Herman,Jeremy %A Stein,Theodore %A Spiegel,Brennan M R %A Almario,Christopher V %+ Karsh Division of Gastroenterology and Hepatology, Cedars-Sinai Medical Center, 116 N Robertson Blvd, Suite 800, Los Angeles, CA, 90048, United States, 1 310 423 4462, Christopher.Almario@csmc.edu %K patient-provider portal %K computer-generated patient history %K patient-reported outcome %K gastrointestinal %K EHR %D 2021 %7 4.5.2021 %9 Original Paper %J JMIR Form Res %G English %X Background: A potential benefit of electronic health records (EHRs) is that they could potentially save clinician time and improve documentation by auto-generating the history of present illness (HPI) in partnership with patients prior to the clinic visit. We developed an online patient portal called AEGIS (Automated Evaluation of Gastrointestinal [GI] Symptoms) that systematically collects patient GI symptom information and then transforms the data into a narrative HPI that is available for physicians to review in the EHR prior to seeing the patient. Objective: This study aimed to compare whether use of an online GI symptom history taker called AEGIS improves physician-centric outcomes vs usual care. Methods: We conducted a pragmatic controlled trial among adults aged ≥18 years scheduled for a new patient visit at 4 GI clinics at an academic medical center. Patients who completed AEGIS were matched with controls in the intervention period who did not complete AEGIS as well as controls who underwent usual care in the pre-intervention period. Of note, the pre-intervention control group was formed as it was not subject to contamination bias, unlike for post-intervention controls. We then compared the following outcomes among groups: (1) documentation of alarm symptoms, (2) documentation of family history of GI malignancy, (3) number of follow-up visits in a 6-month period, (4) number of tests ordered in a 6-month period, and (5) charting time (difference between appointment time and time the encounter was closed). Multivariable regression models were used to adjust for potential confounding. Results: Of the 774 patients who were invited to complete AEGIS, 116 (15.0%) finished it prior to their visit. The 116 AEGIS patients were then matched with 343 and 102 controls in the pre- and post-intervention periods, respectively. There were no statistically significant differences among the groups for documentation of alarm symptoms and GI cancer family history, number of follow-up visits and ordered tests, or charting time (all P>.05). Conclusions: Use of a validated online HPI-generation portal did not improve physician documentation or reduce workload. Given universal adoption of EHRs, further research examining how to optimally leverage patient portals for improving outcomes are needed. %M 33944789 %R 10.2196/23599 %U https://formative.jmir.org/2021/5/e23599 %U https://doi.org/10.2196/23599 %U http://www.ncbi.nlm.nih.gov/pubmed/33944789 %0 Journal Article %@ 2561-326X %I JMIR Publications %V 5 %N 1 %P e13888 %T Identifying Health Economic Considerations to Include in the Research Protocol of a Randomized Controlled Trial (the REDUCE-RISK Trial): Systematic Literature Review and Assessment %A Neyt,Mattias %A Christiaens,Annick %A Aloi,Marina %A de Ridder,Lissy %A Croft,Nicholas M %A Koletzko,Sibylle %A Levine,Arie %A Turner,Dan %A Russell,Richard K %A Ruemmele,Frank M %A Veereman,Gigi %+ Medical Evaluation and Technology Assessment (ME-TA), Jan Burssensstraat 23, Merendree, 9850, Belgium, 32 477901317, mattias.neyt@me-ta.eu %K Crohn disease %K cost-benefit analysis %K adalimumab %K clinical trial %K protocol %K technology assessment, biomedical %D 2021 %7 25.1.2021 %9 Review %J JMIR Form Res %G English %X Background: The REDUCE-RISK trial was set up to compare the effectiveness of weekly subcutaneously administered methotrexate with daily oral azathioprine or 6-mercaptopurine in low-risk Crohn disease (CD) or subcutaneously administered adalimumab (ADA) in high-risk CD in a pediatric population (age 6-17 years). Objective: The aim of this study is to perform a systematic review to provide input into the research protocol to gather the necessary information to improve the performance of an evidence-based economic evaluation when the trial is finished. Methods: The Centre for Reviews and Dissemination (CRD) Health Technology Assessment (HTA) database, websites of HTA institutes, CRD’s National Health Service Economic Evaluation Database, MEDLINE (OVID), and Embase databases were consulted to retrieve (reviews of) relevant economic evaluations. Studies were eligible if they included a pediatric or adult population with inflammatory bowel diseases (CD and ulcerative colitis [UC]) treated with ADA (Humira). There were no restrictions on the comparator. Only economic evaluations expressing outcomes in life years gained or quality-adjusted life years gained were selected. Results: A total of 12 primary studies were identified. None of these studies included a pediatric population because of a lack of supporting trials. The economic evaluations identified in our systematic review indicate that ADA is an appropriate intervention for inclusion in such a trial. From a health economic point of view, it is important to make an incremental analysis comparing such an intervention with standard care and not immediately versus another (expensive) biological treatment. Information on the impact of children’s school attendance and parents’ productivity is currently lacking in economic evaluations, and none of the underlying trials measured quality of life (QoL) using a generic utility instrument. Conclusions: The review of the economic literature on ADA for the treatment of patients with CD supports the performance of a trial with biologicals in pediatric patients, including making a distinction according to disease severity. Conducting an economic literature review enabled us to decide which variables should be added to the research protocol from an economic point of view. Measurements for children’s and parents’ QoL (EuroQol 5-Dimension questionnaires), children’s school attendance, and parents’ productivity (WPAI-CD-CG questionnaire) were added to the research protocol. This will provide support for the calculation of the cost-effectiveness of the interventions evaluated in the REDUCE-RISK trial. Trial Registration: ClinicalTrials.gov NCT02852694; https://clinicaltrials.gov/ct2/show/NCT02852694 %M 33492239 %R 10.2196/13888 %U http://formative.jmir.org/2021/1/e13888/ %U https://doi.org/10.2196/13888 %U http://www.ncbi.nlm.nih.gov/pubmed/33492239 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 23 %N 1 %P e20629 %T Economic Burden and Health Care Access for Patients With Inflammatory Bowel Diseases in China: Web-Based Survey Study %A Yu,Qiao %A Zhu,Chunpeng %A Feng,Shuyi %A Xu,Liyi %A Hu,Shurong %A Chen,Hao %A Chen,Hanwen %A Yao,Sheng %A Wang,Xiaoying %A Chen,Yan %+ Department of Gastroenterology, the Second Affiliated Hospital, Zhejiang University School of Medicine, No 88, Jiefang Road, Hangzhou, 310000, China, 86 13757118653, chenyan72_72@zju.edu.cn %K inflammatory bowel disease %K Crohn disease %K ulcerative colitis %K primary care provider %K emergency room %K eHealth %K gastroenterology %K proctology %D 2021 %7 5.1.2021 %9 Original Paper %J J Med Internet Res %G English %X Background: The increasing incidence of inflammatory bowel disease (IBD) has imposed heavy financial burdens for Chinese patients; however, data about their financial status and access to health care are still lacking. This information is important for informing patients with IBD about disease treatment budgets and health care strategies. Objective: The aim of this study was to evaluate the economic status and medical care access of patients with IBD through the China Crohn’s & Colitis Foundation web-based platform in China. Methods: Our study was performed in 14 IBD centers in mainland China between 2018 and 2019 through WeChat. Participants were asked to complete a 64-item web-based questionnaire. Data were collected by the Wenjuanxing survey program. We mainly focused on income and insurance status, medical costs, and access to health care providers. Respondents were stratified by income and the associations of income with medical costs and emergency visit times were analyzed. Results: In this study, 3000 patients with IBD, that is, 1922 patients with Crohn disease, 973 patients with ulcerative colitis, and 105 patients with undetermined colitis were included. During the last 12 months, the mean (SD) direct and indirect costs for per patient with IBD were approximately US $11,668.68 ($7944.44) and US $74.90 ($253.60) in China. The average reimbursement ratios for most outpatient and inpatient costs were less than 50%. However, the income of 85.5% (2565/3000) of the patients was less than ¥10,000 (US $1445) per month. Approximately 96.5% (2894/3000) of the patients were covered by health insurance, but only 24.7% (741/3000) of the patients had private commercial insurance, which has higher imbursement ratios. Nearly 98.0% (2954/3000) of the patients worried about their financial situation. Thus, 79.7% (2392/3000) of the patients with IBD tried to save money for health care and even delayed their medical treatments. About half of the respondents (1282/3000, 42.7%) had no primary care provider, and 52.2% (1567/3000) of the patients had to visit the emergency room 1-4 times per year for the treatment of their IBD. Multivariate analysis revealed that lower income (P=.001) and higher transportation (P=.004) and accommodation costs (P=.001) were significantly associated with the increased number of emergency visits of the patients. Conclusions: Chinese patients with IBD have enormous financial burdens and difficulties in accessing health care, which have increased their financial anxiety and inevitably influenced their disease outcomes. Early purchase of private insurance, thereby increasing the reimbursement ratio for medical expenses, and developing the use of telemedicine would be effective strategies for saving on health care costs. %M 33399540 %R 10.2196/20629 %U https://www.jmir.org/2021/1/e20629 %U https://doi.org/10.2196/20629 %U http://www.ncbi.nlm.nih.gov/pubmed/33399540 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 11 %P e17247 %T Mapping and Modeling of Discussions Related to Gastrointestinal Discomfort in French-Speaking Online Forums: Results of a 15-Year Retrospective Infodemiology Study %A Schäfer,Florent %A Faviez,Carole %A Voillot,Paméla %A Foulquié,Pierre %A Najm,Matthieu %A Jeanne,Jean-François %A Fagherazzi,Guy %A Schück,Stéphane %A Le Nevé,Boris %+ Innovation Science and Nutrition, Danone Nutricia Research, RD 128 Avenue de la Vauve, Palaiseau, 91767, France, 33 1 69 35 70 00, florent.schafer@danone.com %K gastrointestinal discomfort %K disorders of gut-brain interactions %K social media %K infodemiology %K topic modeling %D 2020 %7 3.11.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: Gastrointestinal (GI) discomfort is prevalent and known to be associated with impaired quality of life. Real-world information on factors of GI discomfort and solutions used by people is, however, limited. Social media, including online forums, have been considered a new source of information to examine the health of populations in real-life settings. Objective: The aims of this retrospective infodemiology study are to identify discussion topics, characterize users, and identify perceived determinants of GI discomfort in web-based messages posted by users of French social media. Methods: Messages related to GI discomfort posted between January 2003 and August 2018 were extracted from 14 French-speaking general and specialized publicly available online forums. Extracted messages were cleaned and deidentified. Relevant medical concepts were determined on the basis of the Medical Dictionary for Regulatory Activities and vernacular terms. The identification of discussion topics was carried out by using a correlated topic model on the basis of the latent Dirichlet allocation. A nonsupervised clustering algorithm was applied to cluster forum users according to the reported symptoms of GI discomfort, discussion topics, and activity on online forums. Users’ age and gender were determined by linear regression and application of a support vector machine, respectively, to characterize the identified clusters according to demographic parameters. Perceived factors of GI discomfort were classified by a combined method on the basis of syntactic analysis to identify messages with causality terms and a second topic modeling in a relevant segment of phrases. Results: A total of 198,866 messages associated with GI discomfort were included in the analysis corpus after extraction and cleaning. These messages were posted by 36,989 separate web users, most of them being women younger than 40 years. Everyday life, diet, digestion, abdominal pain, impact on the quality of life, and tips to manage stress were among the most discussed topics. Segmentation of users identified 5 clusters corresponding to chronic and acute GI concerns. Diet topic was associated with each cluster, and stress was strongly associated with abdominal pain. Psychological factors, food, and allergens were perceived as the main causes of GI discomfort by web users. Conclusions: GI discomfort is actively discussed by web users. This study reveals a complex relationship between food, stress, and GI discomfort. Our approach has shown that identifying web-based discussion topics associated with GI discomfort and its perceived factors is feasible and can serve as a complementary source of real-world evidence for caregivers. %M 33141087 %R 10.2196/17247 %U https://www.jmir.org/2020/11/e17247 %U https://doi.org/10.2196/17247 %U http://www.ncbi.nlm.nih.gov/pubmed/33141087 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 22 %N 6 %P e17417 %T Evaluating Safety and Efficacy of Follow-up for Patients With Abdominal Pain Using Video Consultation (SAVED Study): Randomized Controlled Trial %A Gunasekeran,Dinesh Visva %A Liu,Zhenghong %A Tan,Win Jim %A Koh,Joshua %A Cheong,Chiu Peng %A Tan,Lay Hong %A Lau,Chee Siang %A Phuah,Gaik Kheng %A Manuel,Newsie Donnah A %A Chia,Che Chong %A Seng,Gek Siang %A Tong,Nancy %A Huin,May Hang %A Dulce,Suzette Villaluna %A Yap,Susan %A Ponampalam,Kishanti %A Ying,Hao %A Ong,Marcus Eng Hock %A Ponampalam,R %+ Department of Emergency Medicine, Singapore General Hospital, Singapore, Singapore, 65 6321 3497, ponampalam@singhealth.com.sg %K digital health %K teleconsultation %K video consultation %K telereview %K abdominal pain %K primary care %K emergency department %D 2020 %7 15.6.2020 %9 Original Paper %J J Med Internet Res %G English %X Background: The benefits of telemedicine include cost savings and decentralized care. Video consultation is one form that enables early detection of deteriorating patients and promotion of self-efficacy in patients who are well but anxious. Abdominal pain is a common symptom presented by patients in emergency departments. These patients could benefit from video consultation, as it enables remote follow-up of patients who do not require admission and facilitates early discharge of patients from overcrowded hospitals. Objective: The study aimed to evaluate the safety and efficacy of the use of digital telereview in patients presenting with undifferentiated acute abdominal pain. Methods: The SAVED study was a prospective randomized controlled trial in which follow-up using existing telephone-based telereview (control) was compared with digital telereview (intervention). Patients with undifferentiated acute abdominal pain discharged from the emergency department observation ward were studied based on intention-to-treat. The control arm received routine, provider-scheduled telereview with missed reviews actively coordinated and rescheduled by emergency department staff. The intervention arm received access to a platform for digital telereview (asynchronous and synchronous format) that enabled patient-led appointment rescheduling. Patients were followed-up for 2 weeks for outcomes of service utilization, efficacy (compliance with their disposition plan), and safety (re-presentation for the same condition). Results: A total of 70 patients participated, with patients randomly assigned to each arm (1:1 ratio). Patients were a mean age of 40.0 (SD 13.8; range 22-71) years, predominantly female (47/70, 67%), and predominantly of Chinese ethnicity (39/70, 56%). The telereview service was used by 32 patients in the control arm (32/35, 91%) and 18 patients in the intervention arm (18/35, 51%). Most patients in control (33/35, 94%; 95% CI 79.5%-99.0%) and intervention (34/35, 97%; 95% CI 83.4%-99.9%) arms were compliant with their final disposition. There was a low rate of re-presentation at 72 hours and 2 weeks for both control (72 hours: 2/35, 6%; 95% CI 1.0%-20.5%; 2 weeks: 2/35, 6%, 95% CI 1.0%-20.5%) and intervention (72 hours: 2/35, 6%; 95% CI 1.0%-20.5%; 2 weeks: 3/35, 9%, 95% CI 2.2%-24.2%) arms. There were no significant differences in safety (P>.99) and efficacy (P>.99) between the two groups. Conclusions: The application of digital telereview for the follow-up of patients with abdominal pain may be safe and effective. Future studies are needed to evaluate its cost-effectiveness and usefulness for broader clinical application. Trial Registration: ISRCTN Registry ISRCTN28468556; http://www.isrctn.com/ISRCTN28468556. %M 32459637 %R 10.2196/17417 %U https://www.jmir.org/2020/6/e17417 %U https://doi.org/10.2196/17417 %U http://www.ncbi.nlm.nih.gov/pubmed/32459637 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 9 %P e13345 %T Association Between Institutional Social Media Involvement and Gastroenterology Divisional Rankings: Cohort Study %A Chiang,Austin Lee %A Rabinowitz,Loren Galler %A Kumar,Akhil %A Chan,Walter Wai-Yip %+ Brigham and Women's Hospital, 75 Francis Street, Boston, MA, 02115, United States, 1 617 732 6389, wwchan@bwh.harvard.edu %K social media %K Twitter %K hospital ranking %D 2019 %7 06.09.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: Patients often look to social media as an important tool to gather information about institutions and professionals. Since 1990, United States News and World Report (USNWR) has published annual rankings of hospitals and subspecialty divisions. It remains unknown if social media presence is associated with the USNWR gastroenterology and gastrointestinal (GI) surgery divisional rankings, or how changes in online presence over time affects division ranking. Objective: The objective of this study was to determine if social media presence is associated with USNWR gastroenterology and GI surgery divisional rankings and to ascertain how changes in online presence over time affect division rankings. Methods: Social media presence among the top 30 institutions listed in the 2014 USNWR gastroenterology and GI surgery divisional rankings were assessed using Pearson’s correlation coefficients and multivariate analysis, controlling for covariates. Linear and logistic regression using data from 2014 and 2016 USNWR rankings were then used to assess the association between institutional ranking or reputation score with any potential changes in numbers of followers over time. Sensitivity analysis was performed by assessing the area under the receiver operating characteristic curve to determine the follower threshold associated with improved or maintained ranking, which was done by dichotomizing changes in followers at values between the 7000 and 12,000 follower mark. Results: Twitter follower count was an independent predictor of divisional ranking (β=.00004; P<.001) and reputation score (β=–.00002; P=.03) in 2014. Academic affiliation also independently predicted USNWR division ranking (β=5.3; P=.04) and reputation score (β=–7.3; P=.03). Between 2014 and 2016, Twitter followers remained significantly associated with improved or maintained rankings (OR 14.63; 95% CI 1.08-197.81; P=.04). On sensitivity analysis, an 8000 person increase in Twitter followers significantly predicted improved or maintained rankings compared to other cutoffs. Conclusions: Institutional social media presence is independently associated with USNWR divisional ranking and reputation score. Improvement in social media following was also independently associated with improved or maintained divisional ranking and reputation score, with a threshold of 8000 additional followers as the best predictor of improved or stable ranking. %M 31493321 %R 10.2196/13345 %U http://www.jmir.org/2019/9/e13345/ %U https://doi.org/10.2196/13345 %U http://www.ncbi.nlm.nih.gov/pubmed/31493321 %0 Journal Article %@ 1947-2579 %I JMIR Publications %V 11 %N 1 %P e9945 %T Roles of Health Literacy in Relation to Social Determinants of Health and Recommendations for Informatics-Based Interventions: Systematic Review %D 2019 %7 ..2019 %9 %J Online J Public Health Inform %G English %X ObjectiveUsing a large nationally representative dataset, we estimated the prevalence of self-reported hepatitis C testing among individuals who were recommended to be tested (i.e., baby boomer cohort born between 1945 and 1965) by the CDC and United States Preventive Services Task Force.IntroductionHepatitis C virus (HCV) infection is the most common blood-borne disease in the US and the leading cause of liver-related morbidity and mortality. Approximately 3.5 million individuals in the US were estimated to have been living with hepatitis C in 2010 and approximately half of them were unaware that they were infected. Among HCV infected individuals, those born between 1945 and 1965 (usually referred to as the baby boomer cohort) represents approximately 75% of current cases. Because of the substantial burden of disease among this age group, CDC expanded its existing hepatitis C risk-based testing recommendations to include a one-time HCV antibody test for all persons born between 1945 and 1965. The United States Preventive Services Task Force (USPSTF) subsequently made the same recommendation in June 2013.DescriptionMethodsThe following question \"Have you ever had a blood test for hepatitis C?\" has been administered annually from 2013 through 2017 on the National Health Interview Survey (NHIS). The NHIS is a nationally representative cross-sectional face-to-face household interview of civilian noninstitutionalized individuals in the U.S. The NHIS survey uses a complex multistage probability design that includes stratification, clustering, and oversampling. We estimated the prevalence of hepatitis C testing for adults in the US during the study period from 2013 to 2017. In addition, we carried out stratified analyses comparing those with private insurance to those who did not have private insurance. We reported weighted estimates taking into account the NHIS survey design. The R statistical software (R Core Team, 2018) was used to estimate weighted prevalence estimates for hepatitis C testing.ResultsDuring the study period from 2013-2017, there were 148,674 adults who responded to the ever tested for hepatitis C question. In addition, 33.56% of these individuals were born between 1945 and 1965; among all adults, the weighted percentage of individuals that responded yes they had received a hepatitis C screening test was 12.82% (95% CI: 12.54-13.10%) while for baby boomers the estimate was 13.93% (95% CI: 13.51-14.35%).Figure 1 presents the annual trend in the hepatitis C test prevalence over the study period by birth cohorts. For both cohorts, there were significant increases over time in hepatitis C testing prevalence. The two trend lines began to diverge in 2015 with the baby boomer cohort reporting higher rates of hepatitis C testing. For the baby boomer cohort, there was also a substantial increase in reported hepatitis C testing in 2017 relative to 2016. Similar trends were found for the samples when we restricted the sample to only those with private insurance. Compared to the people with private insurance, the baby boomers with ''Non-private’ insurance, including Medicaid, Medicare, or military- government sponsored insurances, reported higher rates of testing.ConclusionAcross the five-year period from 2013 through 2017, we found increasing rates of self-reported hepatitis C testing among non-institutionalized U.S. adults. For the baby boomer cohort, we saw a substantial increase in testing in 2017, which was likely due in part, to increased awareness among both physicians and patients of the CDC and USPSTF recommendation to have all baby boomers tested. Efforts to increase the awareness of these recommendations should continue. Additional targeted promotions among hard to reach populations should also be considered.How the Moderator Intends to Engage the Audience in Discussions on the TopicThis panel will discuss strengths and weaknesses for monitoring hepatitis C testing using alternative data sources including self-reported data, insurance claims data, and laboratory testing data. %R 10.5210/ojphi.v11i1.9945 %U %U https://doi.org/10.5210/ojphi.v11i1.9945 %0 Journal Article %@ 1438-8871 %I JMIR Publications %V 21 %N 3 %P e11761 %T Exploring the Challenges of Implementing a Web-Based Telemonitoring Strategy for Teenagers With Inflammatory Bowel Disease: Empirical Case Study %A Dijkstra,Alie %A Heida,Anke %A van Rheenen,Patrick Ferry %+ Department of Pediatric Gastroenterology, Hepatology and Nutrition, University of Groningen, University Medical Centre Groningen, Internal Code CA31, Hanzeplein 1, Groningen, 9713 GZ, Netherlands, 31 503614151, p.f.van.rheenen@umcg.nl %K eHealth %K inflammatory bowel disease %K health care improvement %K implementation science %K quality of care %D 2019 %7 29.03.2019 %9 Original Paper %J J Med Internet Res %G English %X Background: We designed a telemonitoring strategy for teenagers with inflammatory bowel disease to prevent an anticipated disease flare and avert unplanned office visits and day care procedures. The strategy was evaluated in a randomized controlled trial that involved 11 Dutch pediatric gastroenterology centers, each using repeated symptom scores and stool calprotectin measurements. In the telemonitoring arm of the trial, teenagers (n=84) as well as their health providers were alerted to out-of-range results, and suggestions for change in therapy were offered. We demonstrated that the technology was a safe and cost saving alternative to health checks by the specialist at fixed intervals. Objective: The aim of this study was to evaluate whether we could move our telemonitoring strategy from a demonstration project to one that is sustained within existing sites. Methods: In this empirical case study, we used the nonadoption, abandonment, scale-up, spread, and sustainability (NASSS) framework to explore the challenges to implementing our strategy. The framework distinguishes 7 domains: (1) the illness, (2) the technology, (3) the value proposition, (4) the adopter system, (5) the organization, (6) the societal system, and (7) the time dimension. We summarized the challenges across all 7 domains and classified them as simple (+++), complicated (++), or complex (+). Technologies in which multiple domains are complicated have proven difficult to implement, whereas those with multiple complex domains may not even become mainstreamed. Results: The technology that we used and the linked program (IBD-live) allowed us to select and target the teenagers who were most likely to benefit from a face-to-face encounter with their specialist (+++). The value proposition of the technology was clear, with a distinct benefit for patients and an affordable service model, but health providers had plausible personal reasons to resist (double data entry, ++). The organization was not yet ready for the innovation, as it requires a shift to new ways of working (+). We had no concerns about reimbursement, as Dutch health insurers agreed that screen-to-screen consultations will be reimbursed at a rate equivalent to face-to-face consultations (+++). Finally, the technology was considered easy to adapt and evolve over time to meet the needs of its users (+++). Conclusions: The challenges to be addressed are merely complicated (++) rather than complex (+), which means that our program may be difficult but not impossible to sustain within existing sites. After integrating the technology and its use with local workflows first, we believe that our telemonitoring strategy will be ready for sustained adoption. In contrast with what we did ourselves, we recommend others to use the NASSS framework prospectively and in real time to predict and explore the challenges to implementing new technologies. %M 30924785 %R 10.2196/11761 %U http://www.jmir.org/2019/3/e11761/ %U https://doi.org/10.2196/11761 %U http://www.ncbi.nlm.nih.gov/pubmed/30924785 %0 Journal Article %@ 1929-073X %I JMIR Publications %V 7 %N 2 %P e10313 %T Hepatitis C Prevalence and Management Among Patients Receiving Opioid Substitution Treatment in General Practice in Ireland: Baseline Data from a Feasibility Study %A Murtagh,Ross %A Swan,Davina %A O'Connor,Eileen %A McCombe,Geoff %A Lambert,John S %A Avramovic,Gordana %A Cullen,Walter %+ University College Dublin, Belfield, Dublin, D14 YH57, Ireland, 353 1 4730893, walter.cullen@ucd.ie %K hepatitis C %K integrated HCV care %K people who inject drugs %K primary care %D 2018 %7 19.12.2018 %9 Original Paper %J Interact J Med Res %G English %X Background: Hepatitis C virus (HCV) infection is a major cause of chronic liver disease and death. Injection drug use is now one of the main routes of transmission of HCV in Ireland and globally with an estimated 80% new infections occurring among people who inject drugs (PWID). Objective: We aimed to examine whether patients receiving opioid substitution therapy in primary care practices in Ireland were receiving guideline-adherent care regarding HCV screening. Ireland has developed a model of care for delivering opioid substitution treatment in the primary care setting. We conducted this study given the shift of providing care for PWID from secondary to primary care settings, in light of current guidelines aimed at scaling up interventions to reduce chronic HCV infection and associated mortality. Methods: We included baseline data from the Dublin site of the Heplink study, a feasibility study focusing on developing complex interventions to enhance community-based HCV treatment and improve the HCV care pathway between primary and secondary care. We recruited 14 opioid substitution treatment-prescribing general practices that employed the administration of opioid substitution therapy from the professional networks and databases of members of the research consortium. A standardized nonprobability sampling framework was used to identify 10 patients from each practice to participate in the study. Patients were eligible if aged ≥18 years, on opioid substitution treatment, and attending the practice for any reason during the recruitment period. The baseline data were collected from the clinical records of participating patients. We collected and analyzed data on demographic characteristics, care processes and outcomes regarding HCV and other blood-borne viruses, urinalysis test results, alcohol use disorders, chronic illness, and health service utilization. We examined whether patients received care concordant with guidelines related to HCV screening and care. Results: The baseline data were collected from clinical records of 134 patients; 72.2% (96/134) were males; (mean age 43, SD 7.6; range 27-71 years); 94.8% (127/134) of patients had been tested for anti-HCV antibody in their lifetime; of those, 77.9% (99/127) tested positive. Then, 83.6% (112/134) of patients had received an HIV antibody test in their lifetime; of those, 6.3% (7/112) tested HIV positive. Moreover, 66.4% (89/134) of patients had been tested for hepatitis B virus in their lifetime and 8% (7/89) of those were positive. In the 12 months before the study, 30.6% (41/134) of patients were asked about their alcohol use by their general practitioner, 6.0% (8/134) received a brief intervention, and 2.2% (3/134) were referred to a specialist addiction or alcohol treatment service. Conclusions: With general practice and primary care playing an increased role in HCV care, this study highlights the importance of prioritizing the development and evaluation of real-world clinical solutions that support patients from diagnosis to treatment completion. %M 30567692 %R 10.2196/10313 %U http://www.i-jmr.org/2018/2/e10313/ %U https://doi.org/10.2196/10313 %U http://www.ncbi.nlm.nih.gov/pubmed/30567692