Veronica L Richards, Ashlea Braun, Michael R Sladek, Junru Zhao, Thad Leffingwell, Sydney Newell Chesebro, Julie M Croff
Background: Alcohol-induced blackouts (AIBs) are a serious consequence of alcohol use that are strongly associated with experiencing excess alcohol-related harms. AIBs are common and recurrent among young adults who drink. The risk factors for AIBs include dynamics of alcohol use (quantity, speed, duration), alcohol-related behaviors (eg, playing drinking games, not using protective behavioral strategies), and factors related to the subjective experience of alcohol intoxication (eg, expectancies, motivations).
Objective: This study seeks to examine 2 modifiable behaviors that have been shown to impact both alcohol consumption and subjective experiences of intoxication and may therefore be associated with AIB risk: (1) other substance use and (2) sleep.
Methods: Approximately 50 participants will be recruited to participate in this study. Interested individuals will complete an online screening assessment, and those who are eligible (young adults who report recent heavy episodic drinking and AIBs) will be invited to an in-person baseline visit. At the baseline visit, participants will complete a baseline assessment, be fitted with a wrist-worn alcohol sensor (BACtrack Skyn) and a sleep or activity ring sensor (Oura ring), and receive training on the study protocol. Participants will complete a 14-day intensive data collection period consisting of twice daily scheduled mobile surveys and participant-initiated drinking surveys with hourly follow-ups. Participants will also wear the alcohol and sleep or activity sensors continuously during this 14-day period. After the intensive data collection period ends, participants will complete an in-person return visit to return their sensors, complete a follow-up survey, and receive compensation. The data will be processed and cleaned, and analyses will include multi-level structural equation models.
Results: This study was funded in July 2025. Data collection is projected to span January 2026 through June 2026.
Conclusions: This study seeks to understand 2 key modifiable behaviors that may be associated with increased AIB risk by leveraging multiple forms of innovative measurement. The integration of ecological momentary assessments with 2 sensors to capture alcohol use and sleep also supports potential applications in future digital interventions. This study will further enhance our preliminary data on the feasibility and acceptability of these methods, providing opportunities for conducting future research on a larger scale.
{"title":"Using Alcohol and Sleep Sensors to Understand Blackout Risk in Young Adults' Natural Settings (The Lights Out Study): Protocol for an Intensive Longitudinal Pilot Study.","authors":"Veronica L Richards, Ashlea Braun, Michael R Sladek, Junru Zhao, Thad Leffingwell, Sydney Newell Chesebro, Julie M Croff","doi":"10.2196/83980","DOIUrl":"10.2196/83980","url":null,"abstract":"<p><strong>Background: </strong>Alcohol-induced blackouts (AIBs) are a serious consequence of alcohol use that are strongly associated with experiencing excess alcohol-related harms. AIBs are common and recurrent among young adults who drink. The risk factors for AIBs include dynamics of alcohol use (quantity, speed, duration), alcohol-related behaviors (eg, playing drinking games, not using protective behavioral strategies), and factors related to the subjective experience of alcohol intoxication (eg, expectancies, motivations).</p><p><strong>Objective: </strong>This study seeks to examine 2 modifiable behaviors that have been shown to impact both alcohol consumption and subjective experiences of intoxication and may therefore be associated with AIB risk: (1) other substance use and (2) sleep.</p><p><strong>Methods: </strong>Approximately 50 participants will be recruited to participate in this study. Interested individuals will complete an online screening assessment, and those who are eligible (young adults who report recent heavy episodic drinking and AIBs) will be invited to an in-person baseline visit. At the baseline visit, participants will complete a baseline assessment, be fitted with a wrist-worn alcohol sensor (BACtrack Skyn) and a sleep or activity ring sensor (Oura ring), and receive training on the study protocol. Participants will complete a 14-day intensive data collection period consisting of twice daily scheduled mobile surveys and participant-initiated drinking surveys with hourly follow-ups. Participants will also wear the alcohol and sleep or activity sensors continuously during this 14-day period. After the intensive data collection period ends, participants will complete an in-person return visit to return their sensors, complete a follow-up survey, and receive compensation. The data will be processed and cleaned, and analyses will include multi-level structural equation models.</p><p><strong>Results: </strong>This study was funded in July 2025. Data collection is projected to span January 2026 through June 2026.</p><p><strong>Conclusions: </strong>This study seeks to understand 2 key modifiable behaviors that may be associated with increased AIB risk by leveraging multiple forms of innovative measurement. The integration of ecological momentary assessments with 2 sensors to capture alcohol use and sleep also supports potential applications in future digital interventions. This study will further enhance our preliminary data on the feasibility and acceptability of these methods, providing opportunities for conducting future research on a larger scale.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e83980"},"PeriodicalIF":1.5,"publicationDate":"2026-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12822870/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146018476","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: More than 20 million individuals worldwide, especially in the Vidarbha region of India, are affected by sickle cell anemia (SCA), a hereditary condition that results in aberrant hemoglobin S and red blood cell distortion. The condition leads to anemia, organ complications, and recurrent pain crises, making region-specific data necessary for efficient therapy and public health initiatives.
Objective: The goal of the study is to examine the clinical characteristics and unusual manifestations of SCA in the Vidarbha region, with an emphasis on dietary practices, clinical presentations, demographic distribution, and lifestyle factors such as alcohol consumption and smoking.
Methods: This observational cross-sectional study with random sampling will be conducted at Acharya Vinoba Bhave Rural Hospital in Wardha for 3 months. We will recruit 131 individuals aged 18 to 50 years with dominant hemoglobin S and a positive sickling test. A standardized questionnaire addressing clinical symptoms, nutrition, substance use, inheritance patterns, and demographic information will be used to gather data. SPSS (version 17; IBM Corp) will be used for statistical analysis. Data will be summarized using descriptive statistics. Group differences will be evaluated using inferential tests such as 1-way ANOVA, independent 2-tailed t tests, and chi-square tests. Associations between symptoms and lifestyle variables will be investigated by correlation analysis. Statistical significance is defined as a 2-tailed P value <.05.
Results: The anticipated findings may support the need for targeted regional public health initiatives and underscore the importance of comprehensive screening, detailed patient history, and tailored care strategies for individuals with SCA. As of January 2026, this observational study has not received external funding. Participant recruitment and data collection commenced in January 2026 and are currently ongoing. Data analysis will be undertaken following completion of data collection, and the final results are expected to be submitted for publication in April 2026.
Conclusions: The findings will support the need for focused regional public health initiatives and emphasize the need for thorough screening, patient history, and customized care techniques for SCA.
背景:全世界有超过2000万人患有镰状细胞性贫血(SCA),特别是在印度的Vidarbha地区,这是一种导致血红蛋白S异常和红细胞畸变的遗传性疾病。这种疾病会导致贫血、器官并发症和复发性疼痛危机,因此需要针对特定区域的数据来进行有效治疗和采取公共卫生行动。目的:本研究的目的是检查维达巴地区SCA的临床特征和异常表现,重点是饮食习惯、临床表现、人口分布和生活方式因素,如饮酒和吸烟。方法:本观察性横断面随机抽样研究将在瓦尔达Acharya Vinoba Bhave农村医院进行为期3个月的研究。我们将招募年龄在18至50岁之间的131名显性血红蛋白S和镰状细胞试验阳性的个体。收集数据将使用一份涉及临床症状、营养、物质使用、遗传模式和人口统计信息的标准化问卷。将使用SPSS (version 17; IBM Corp)进行统计分析。数据将使用描述性统计进行汇总。采用单因素方差分析、独立双尾t检验和卡方检验等推理检验评估组间差异。将通过相关分析调查症状与生活方式变量之间的关系。结果:预期的研究结果可能支持有针对性的区域公共卫生倡议的必要性,并强调了对SCA患者进行全面筛查、详细病史和量身定制护理策略的重要性。截至2026年1月,该观察性研究尚未获得外部资助。参与者招募和数据收集于2026年1月开始,目前正在进行中。数据收集完成后将进行数据分析,预计最终结果将于2026年4月提交发表。结论:研究结果将支持有重点的区域公共卫生倡议的必要性,并强调对SCA进行彻底筛查、患者病史和定制护理技术的必要性。
{"title":"Sickle Cell Disease at a Tertiary Care Center in the Vidarbha Region of India: Protocol for a Clinical and Observational Study.","authors":"Tanushree Budhbaware, Jaishriram Rathored","doi":"10.2196/80483","DOIUrl":"10.2196/80483","url":null,"abstract":"<p><strong>Background: </strong>More than 20 million individuals worldwide, especially in the Vidarbha region of India, are affected by sickle cell anemia (SCA), a hereditary condition that results in aberrant hemoglobin S and red blood cell distortion. The condition leads to anemia, organ complications, and recurrent pain crises, making region-specific data necessary for efficient therapy and public health initiatives.</p><p><strong>Objective: </strong>The goal of the study is to examine the clinical characteristics and unusual manifestations of SCA in the Vidarbha region, with an emphasis on dietary practices, clinical presentations, demographic distribution, and lifestyle factors such as alcohol consumption and smoking.</p><p><strong>Methods: </strong>This observational cross-sectional study with random sampling will be conducted at Acharya Vinoba Bhave Rural Hospital in Wardha for 3 months. We will recruit 131 individuals aged 18 to 50 years with dominant hemoglobin S and a positive sickling test. A standardized questionnaire addressing clinical symptoms, nutrition, substance use, inheritance patterns, and demographic information will be used to gather data. SPSS (version 17; IBM Corp) will be used for statistical analysis. Data will be summarized using descriptive statistics. Group differences will be evaluated using inferential tests such as 1-way ANOVA, independent 2-tailed t tests, and chi-square tests. Associations between symptoms and lifestyle variables will be investigated by correlation analysis. Statistical significance is defined as a 2-tailed P value <.05.</p><p><strong>Results: </strong>The anticipated findings may support the need for targeted regional public health initiatives and underscore the importance of comprehensive screening, detailed patient history, and tailored care strategies for individuals with SCA. As of January 2026, this observational study has not received external funding. Participant recruitment and data collection commenced in January 2026 and are currently ongoing. Data analysis will be undertaken following completion of data collection, and the final results are expected to be submitted for publication in April 2026.</p><p><strong>Conclusions: </strong>The findings will support the need for focused regional public health initiatives and emphasize the need for thorough screening, patient history, and customized care techniques for SCA.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e80483"},"PeriodicalIF":1.5,"publicationDate":"2026-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12823013/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146018444","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Luqman Lawal, Christopher Paton, Mike English, Bruno Holthof, Tabitha Preston
<p><strong>Background: </strong>Artificial intelligence (AI)-powered analysis of electrocardiograms (ECGs) is reshaping cardiac diagnostics, offering faster and often more accurate detection of conditions such as arrhythmias and heart failure. However, growing evidence suggests that algorithmic bias, defined as performance disparities across patient subgroups, may undermine diagnostic equity. These biases can emerge at any stage of the AI life cycle, including data collection, model development, evaluation, deployment, and clinical use. If unaddressed, they risk exacerbating health disparities, particularly in underrepresented populations and low-resource settings. Early identification and mitigation of such bias are essential to ensuring diagnostic equity.</p><p><strong>Objective: </strong>This scoping review protocol outlines a structured approach to mapping the evidence on algorithmic bias in AI-enabled ECG interpretation. Following the population-concept-context framework and PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidance, the planned review will systematically identify and categorize reported sources and types of bias, examine their effects on diagnostic performance across demographic and geographic subgroups, and document mitigation strategies applied throughout the AI life cycle. By synthesizing how bias and fairness considerations are handled in this field, this review aims to clarify existing evidence, highlight key gaps, and inform future efforts toward equitable and clinically trustworthy application of AI in cardiology.</p><p><strong>Methods: </strong>We will conduct a comprehensive literature search across 5 electronic databases (PubMed, Embase, Cochrane CENTRAL, CINAHL, and IEEE Xplore) and gray literature sources. Eligible studies will include original research (2015-2025) evaluating the performance of AI-based ECG models across different subgroups or reporting on bias mitigation strategies. Two reviewers will independently screen studies, extract data using a standardized form, and resolve disagreements through consensus. This review will follow the PRISMA-ScR reporting framework.</p><p><strong>Results: </strong>At the time of submission, study identification and screening has been completed. Database searches conducted in August and September 2025 yielded 430 records, with an additional 18 records identified through other sources. After duplicates removal, 398 unique records remained. Title and abstract screening led to the exclusion of 250 records, and 148 articles proceeded to full-text review. Following full-text assessment, 110 articles were evaluated for eligibility, of which 38 studies met the inclusion criteria and were included in the qualitative synthesis. The study selection process is summarized in a PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) flow diagram. Data extraction was conducted between November and December
{"title":"Mapping Algorithmic Bias in AI-Powered Electrocardiogram Interpretation Across the AI Life Cycle: Protocol for a Scoping Review.","authors":"Luqman Lawal, Christopher Paton, Mike English, Bruno Holthof, Tabitha Preston","doi":"10.2196/82486","DOIUrl":"10.2196/82486","url":null,"abstract":"<p><strong>Background: </strong>Artificial intelligence (AI)-powered analysis of electrocardiograms (ECGs) is reshaping cardiac diagnostics, offering faster and often more accurate detection of conditions such as arrhythmias and heart failure. However, growing evidence suggests that algorithmic bias, defined as performance disparities across patient subgroups, may undermine diagnostic equity. These biases can emerge at any stage of the AI life cycle, including data collection, model development, evaluation, deployment, and clinical use. If unaddressed, they risk exacerbating health disparities, particularly in underrepresented populations and low-resource settings. Early identification and mitigation of such bias are essential to ensuring diagnostic equity.</p><p><strong>Objective: </strong>This scoping review protocol outlines a structured approach to mapping the evidence on algorithmic bias in AI-enabled ECG interpretation. Following the population-concept-context framework and PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidance, the planned review will systematically identify and categorize reported sources and types of bias, examine their effects on diagnostic performance across demographic and geographic subgroups, and document mitigation strategies applied throughout the AI life cycle. By synthesizing how bias and fairness considerations are handled in this field, this review aims to clarify existing evidence, highlight key gaps, and inform future efforts toward equitable and clinically trustworthy application of AI in cardiology.</p><p><strong>Methods: </strong>We will conduct a comprehensive literature search across 5 electronic databases (PubMed, Embase, Cochrane CENTRAL, CINAHL, and IEEE Xplore) and gray literature sources. Eligible studies will include original research (2015-2025) evaluating the performance of AI-based ECG models across different subgroups or reporting on bias mitigation strategies. Two reviewers will independently screen studies, extract data using a standardized form, and resolve disagreements through consensus. This review will follow the PRISMA-ScR reporting framework.</p><p><strong>Results: </strong>At the time of submission, study identification and screening has been completed. Database searches conducted in August and September 2025 yielded 430 records, with an additional 18 records identified through other sources. After duplicates removal, 398 unique records remained. Title and abstract screening led to the exclusion of 250 records, and 148 articles proceeded to full-text review. Following full-text assessment, 110 articles were evaluated for eligibility, of which 38 studies met the inclusion criteria and were included in the qualitative synthesis. The study selection process is summarized in a PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) flow diagram. Data extraction was conducted between November and December ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e82486"},"PeriodicalIF":1.5,"publicationDate":"2026-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12869145/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146010537","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sylvie Arnoux, Mia Gisselbaek, Georges Louis Savoldelli, Nadia Masood Bajwa
Background: Several factors come into consideration when medical students choose their future specialty. Among these factors, the desire to start a family and planning the best timing for pregnancy may interfere with career advancement in certain specialties.
Objective: To the best of our knowledge, this is the first scoping review aimed at understanding medical students' career choice and parental expectations without restriction of the specialty chosen. This protocol describes a scoping review aiming to understand how representations regarding specialties and parenthood influence medical students' career choice., This protocol describes a scoping review aiming to understand how representations regarding specialties and parenthood influence medical students' career choice.
Methods: We will search PubMed, Embase, Web of Science, ERIC, and PsycInfo for literature. Additionally, the reference lists of included articles will be screened for further inclusion. Rayyan and Endnote will be used to organize data screening and extraction. The database selection will allow us to extract and analyze data from various disciplines. This diversity will increase our understanding of medical students' career and personal life decisions. This protocol and the upcoming scoping review have been designed following the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines to ensure the quality of the searching process, the data screening, and the data extraction.
Results: This study will conduct a thematic synthesis of how the concepts of representations and perceptions of parenthood are used by medical students in the selected literature, comparing them to theoretical frameworks to clarify their meanings. We also plan to identify key themes related to parenthood and medical specialty choice when planning a career. As of December 2025, we proceeded to data screening. We anticipate publishing our results in the second quarter of 2026.
Conclusions: This scoping review aims to better understand medical students' representations of medical specialties and parenthood, and how these perceptions influence their specialty preferences and career choices. By mapping existing evidence across various disciplines, the review will identify research gaps and provide a foundation for future studies. The findings will offer valuable insights into the challenges of balancing career aspirations and family life, particularly in the context of physician shortages and the growing feminization of the medical profession.
背景:医学生在选择未来专业时要考虑几个因素。在这些因素中,想要建立家庭和计划最佳怀孕时间的愿望可能会影响某些专业的职业发展。目的:据我们所知,这是第一次旨在了解医学生的职业选择和父母的期望,而不受所选专业的限制。本协议描述了一项范围审查,旨在了解关于专业和父母身份的陈述如何影响医学生的职业选择。本协议描述了一项范围审查,旨在了解关于专业和父母身份的陈述如何影响医学生的职业选择。方法:检索PubMed、Embase、Web of Science、ERIC、PsycInfo等文献。此外,将筛选纳入文章的参考文献列表以进一步纳入。Rayyan和Endnote将用于组织数据筛选和提取。数据库选择将允许我们提取和分析来自不同学科的数据。这种多样性将增加我们对医学生的职业和个人生活决定的理解。本方案和即将进行的范围审查是按照PRISMA-ScR(范围审查的系统审查和元分析扩展首选报告项目)指南设计的,以确保搜索过程、数据筛选和数据提取的质量。结果:本研究将对医学生在选定的文献中如何使用父母身份的表征和感知概念进行专题综合,并将其与理论框架进行比较,以澄清其含义。我们还计划在规划职业生涯时确定与父母和医学专业选择相关的关键主题。从2025年12月起,我们开始进行数据筛选。我们预计在2026年第二季度公布我们的业绩。结论:本综述旨在更好地了解医学生对医学专业和为人父母的看法,以及这些看法如何影响他们的专业偏好和职业选择。通过绘制不同学科的现有证据,该综述将确定研究差距,并为未来的研究提供基础。这些发现将为平衡职业抱负和家庭生活的挑战提供有价值的见解,特别是在医生短缺和医疗行业女性化日益增加的背景下。
{"title":"Exploring Medical Students' Representations of Future Specialties and Parenthood: Protocol for a Scoping Review.","authors":"Sylvie Arnoux, Mia Gisselbaek, Georges Louis Savoldelli, Nadia Masood Bajwa","doi":"10.2196/78133","DOIUrl":"10.2196/78133","url":null,"abstract":"<p><strong>Background: </strong>Several factors come into consideration when medical students choose their future specialty. Among these factors, the desire to start a family and planning the best timing for pregnancy may interfere with career advancement in certain specialties.</p><p><strong>Objective: </strong>To the best of our knowledge, this is the first scoping review aimed at understanding medical students' career choice and parental expectations without restriction of the specialty chosen. This protocol describes a scoping review aiming to understand how representations regarding specialties and parenthood influence medical students' career choice., This protocol describes a scoping review aiming to understand how representations regarding specialties and parenthood influence medical students' career choice.</p><p><strong>Methods: </strong>We will search PubMed, Embase, Web of Science, ERIC, and PsycInfo for literature. Additionally, the reference lists of included articles will be screened for further inclusion. Rayyan and Endnote will be used to organize data screening and extraction. The database selection will allow us to extract and analyze data from various disciplines. This diversity will increase our understanding of medical students' career and personal life decisions. This protocol and the upcoming scoping review have been designed following the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines to ensure the quality of the searching process, the data screening, and the data extraction.</p><p><strong>Results: </strong>This study will conduct a thematic synthesis of how the concepts of representations and perceptions of parenthood are used by medical students in the selected literature, comparing them to theoretical frameworks to clarify their meanings. We also plan to identify key themes related to parenthood and medical specialty choice when planning a career. As of December 2025, we proceeded to data screening. We anticipate publishing our results in the second quarter of 2026.</p><p><strong>Conclusions: </strong>This scoping review aims to better understand medical students' representations of medical specialties and parenthood, and how these perceptions influence their specialty preferences and career choices. By mapping existing evidence across various disciplines, the review will identify research gaps and provide a foundation for future studies. The findings will offer valuable insights into the challenges of balancing career aspirations and family life, particularly in the context of physician shortages and the growing feminization of the medical profession.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e78133"},"PeriodicalIF":1.5,"publicationDate":"2026-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12818495/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146010598","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Yunqing Xun, Tung Leong Fong, Guang Chen, Yibin Feng, Linda Chan, Ning Wang
<p><strong>Background: </strong>Chronic fatigue syndrome, or myalgic encephalomyelitis, is characterized by persistent, unexplained exhaustion unalleviated by rest, with a pathophysiology distinct from underlying medical conditions. It is diagnostically complex due to symptoms that overlap with other disorders and the absence of definitive biomarkers, contributing to limited therapeutic options in current medicine. Lingzhi, a pharmacologically active basidiomycete mushroom, has been empirically used in traditional Chinese medicine for two millennia. This study has a dual focus: (1) systematically evaluating the efficacy and safety of lingzhi in managing chronic fatigue and post-COVID-19 fatigue syndrome and (2) elucidating its clinical associations with inflammatory, immune, and oxidative stress biomarkers to uncover potential therapeutic mechanisms.</p><p><strong>Objective: </strong>The primary objective is to investigate whether a 6-week intake of CP003, a lingzhi-containing supplement, can reduce physical and mental fatigue in patients with chronic fatigue syndrome (ie, myalgic encephalomyelitis) or post-COVID-19 fatigue. Secondary objectives include assessing its effects on sleep quality, anxiety, depression, and general health status and exploring associations with inflammatory, immune, and oxidative stress biomarkers.</p><p><strong>Methods: </strong>This randomized, waitlist-controlled trial will enroll 130 participants in Hong Kong, equally allocated (1:1) to either the CP003 intervention group or a waitlist control group. The intervention period spans 6 weeks, followed by a 6-week follow-up phase to assess the sustained effects. The trial data will be managed using REDCap (Research Electronic Data Capture) and analyzed via an intention-to-treat approach with inverse probability weighting for missing data, assessed through generalized linear regression (adjusted for covariates and interaction terms) at 6 and 12 weeks and supplemented by subgroup and sensitivity analyses in R, with results reported as mean differences (with 95% CIs) and P<.05 considered significant.</p><p><strong>Results: </strong>This study was funded in March 2024 (ITF/PRP/029/24FX). As of December 2025, all participants had been enrolled, but data entry had not yet commenced. Data analysis will commence after the completion of the 12-week follow-up for all participants. Results are expected to be submitted for publication in mid-2026. Safety outcomes will also be assessed and reported.</p><p><strong>Conclusions: </strong>This trial will evaluate the efficacy and safety of CP003 for chronic fatigue and post-COVID-19 fatigue syndrome and explore potential underlying mechanisms of action. The findings will provide experimental data to inform future clinical applications and research on traditional Chinese medicine-based interventions for fatigue-related disorders.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06739720; https://clinicaltrials.gov/study/NCT
{"title":"Effectiveness and Safety of a Supplement Containing a Pharmacologically Active Basidiomycete Mushroom for Chronic Fatigue and Post-COVID-19 Fatigue Syndrome: Protocol for a Randomized Controlled Trial.","authors":"Yunqing Xun, Tung Leong Fong, Guang Chen, Yibin Feng, Linda Chan, Ning Wang","doi":"10.2196/82633","DOIUrl":"10.2196/82633","url":null,"abstract":"<p><strong>Background: </strong>Chronic fatigue syndrome, or myalgic encephalomyelitis, is characterized by persistent, unexplained exhaustion unalleviated by rest, with a pathophysiology distinct from underlying medical conditions. It is diagnostically complex due to symptoms that overlap with other disorders and the absence of definitive biomarkers, contributing to limited therapeutic options in current medicine. Lingzhi, a pharmacologically active basidiomycete mushroom, has been empirically used in traditional Chinese medicine for two millennia. This study has a dual focus: (1) systematically evaluating the efficacy and safety of lingzhi in managing chronic fatigue and post-COVID-19 fatigue syndrome and (2) elucidating its clinical associations with inflammatory, immune, and oxidative stress biomarkers to uncover potential therapeutic mechanisms.</p><p><strong>Objective: </strong>The primary objective is to investigate whether a 6-week intake of CP003, a lingzhi-containing supplement, can reduce physical and mental fatigue in patients with chronic fatigue syndrome (ie, myalgic encephalomyelitis) or post-COVID-19 fatigue. Secondary objectives include assessing its effects on sleep quality, anxiety, depression, and general health status and exploring associations with inflammatory, immune, and oxidative stress biomarkers.</p><p><strong>Methods: </strong>This randomized, waitlist-controlled trial will enroll 130 participants in Hong Kong, equally allocated (1:1) to either the CP003 intervention group or a waitlist control group. The intervention period spans 6 weeks, followed by a 6-week follow-up phase to assess the sustained effects. The trial data will be managed using REDCap (Research Electronic Data Capture) and analyzed via an intention-to-treat approach with inverse probability weighting for missing data, assessed through generalized linear regression (adjusted for covariates and interaction terms) at 6 and 12 weeks and supplemented by subgroup and sensitivity analyses in R, with results reported as mean differences (with 95% CIs) and P<.05 considered significant.</p><p><strong>Results: </strong>This study was funded in March 2024 (ITF/PRP/029/24FX). As of December 2025, all participants had been enrolled, but data entry had not yet commenced. Data analysis will commence after the completion of the 12-week follow-up for all participants. Results are expected to be submitted for publication in mid-2026. Safety outcomes will also be assessed and reported.</p><p><strong>Conclusions: </strong>This trial will evaluate the efficacy and safety of CP003 for chronic fatigue and post-COVID-19 fatigue syndrome and explore potential underlying mechanisms of action. The findings will provide experimental data to inform future clinical applications and research on traditional Chinese medicine-based interventions for fatigue-related disorders.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06739720; https://clinicaltrials.gov/study/NCT","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e82633"},"PeriodicalIF":1.5,"publicationDate":"2026-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12869150/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146010605","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Shweta Premanandan, Sofia Ouhbi, Magdalena Ramstedt Stadin, Charlotte Blease, Åsa Cajander, Maria Hägglund
Background: Quality in use (QiU), a stakeholder-centered dimension of software quality encompassing effectiveness, efficiency, satisfaction, and freedom from risk, is essential in evaluating digital systems, particularly in health-related domains. Although QiU has been explored in various fields, its application within connected mental health (CMH) systems remains fragmented and understudied. Given the rapid rise in CMH technologies, ranging from mobile apps to teletherapy platforms, understanding how QiU is conceptualized, evaluated, and reported in this domain has become increasingly urgent.
Objective: This study aims to systematically map and synthesize existing research on QiU in CMH applications. It seeks to identify current trends, research gaps, evaluation methods, and the range of technologies examined concerning QiU.
Methods: A systematic mapping methodology following the guidelines by Petersen et al will be used. The process includes defining mapping questions, developing a classification scheme, and systematically searching and analyzing peer-reviewed literature from databases-Scopus, PubMed, IEEE Xplore, and ACM Digital Library. Eight mapping questions will guide the analysis, focusing on publication trends, research types, empirical evaluations, QiU characteristics and subcharacteristics, and technologies studied.
Results: As this paper presents the protocol for an ongoing mapping study, results are not yet available. The literature search and data analysis are scheduled for completion in 2026. Preliminary screening suggests variability in how QiU is defined and evaluated across CMH technologies, highlighting the need for systematic synthesis.
Conclusions: This systematic mapping study will fill a critical gap by providing a comprehensive overview of QiU research in the context of CMH. By organizing and classifying the existing literature, the study will inform future research, support the development of more user-centered CMH tools, and contribute to establishing more consistent evaluation practices in this growing field.
International registered report identifier (irrid): DERR1-10.2196/79611.
{"title":"Quality in Use in Connected Mental Health: Protocol for a Systematic Mapping Study.","authors":"Shweta Premanandan, Sofia Ouhbi, Magdalena Ramstedt Stadin, Charlotte Blease, Åsa Cajander, Maria Hägglund","doi":"10.2196/79611","DOIUrl":"10.2196/79611","url":null,"abstract":"<p><strong>Background: </strong>Quality in use (QiU), a stakeholder-centered dimension of software quality encompassing effectiveness, efficiency, satisfaction, and freedom from risk, is essential in evaluating digital systems, particularly in health-related domains. Although QiU has been explored in various fields, its application within connected mental health (CMH) systems remains fragmented and understudied. Given the rapid rise in CMH technologies, ranging from mobile apps to teletherapy platforms, understanding how QiU is conceptualized, evaluated, and reported in this domain has become increasingly urgent.</p><p><strong>Objective: </strong>This study aims to systematically map and synthesize existing research on QiU in CMH applications. It seeks to identify current trends, research gaps, evaluation methods, and the range of technologies examined concerning QiU.</p><p><strong>Methods: </strong>A systematic mapping methodology following the guidelines by Petersen et al will be used. The process includes defining mapping questions, developing a classification scheme, and systematically searching and analyzing peer-reviewed literature from databases-Scopus, PubMed, IEEE Xplore, and ACM Digital Library. Eight mapping questions will guide the analysis, focusing on publication trends, research types, empirical evaluations, QiU characteristics and subcharacteristics, and technologies studied.</p><p><strong>Results: </strong>As this paper presents the protocol for an ongoing mapping study, results are not yet available. The literature search and data analysis are scheduled for completion in 2026. Preliminary screening suggests variability in how QiU is defined and evaluated across CMH technologies, highlighting the need for systematic synthesis.</p><p><strong>Conclusions: </strong>This systematic mapping study will fill a critical gap by providing a comprehensive overview of QiU research in the context of CMH. By organizing and classifying the existing literature, the study will inform future research, support the development of more user-centered CMH tools, and contribute to establishing more consistent evaluation practices in this growing field.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/79611.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e79611"},"PeriodicalIF":1.5,"publicationDate":"2026-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12869151/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146010556","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Katie Weatherson, Jessica E Bourne, Kaela Cranston, Kyra Braaten, Natalie Grieve, Joseph Kelly, Mary E Jung
<p><strong>Background: </strong>It is estimated that type 2 diabetes (T2D) impacts an estimated 5.3 million Canadians, despite the condition being largely preventable. Laboratory-based diabetes prevention programs (DPPs) have limited effectiveness when translated into community settings due to their low-quality delivery and inability to reach people in the community most in need. To date, no community-based DPPs have been implemented nationwide across Canada. Small Steps for Big Changes (SSBC) is a diet and physical activity counseling intervention that significantly reduces the risk of developing T2D and has been designed for feasible delivery by community-dwelling peers. To ensure maximum public health impact, SSBC must be optimally implemented, demonstrate effectiveness for diverse groups, and be sustainable over time.</p><p><strong>Objective: </strong>This project aims to adapt SSBC and evaluate the implementation, effectiveness, and sustainability of SSBC in diverse urban communities across Canada.</p><p><strong>Methods: </strong>A hybrid type 2 implementation-effectiveness study design using multiple and mixed methods will be used to evaluate the implementation and effectiveness of SSBC over 6 years in partnership with 11 regional Young Men's Christian Associations across 8 provinces in Canada. Beginning in 2024, we will (1) adapt and implement SSBC in diverse urban cities across Canada; (2) examine the implementation (including implementation strategies), effectiveness, and cost-effectiveness of SSBC (2024-2028); and (3) determine the sustainability of SSBC at each delivery location (2028-2029). Data will be collected from SSBC clients, coaches, site leads, and senior leadership municipality partners. The project will be overseen by an advisory group and 3 committees focused on sex, gender, and inclusivity; program evaluation; and diabetes prevention engagement. This study has received ethical approval from the University of British Columbia Clinical Research Ethics Board (H23-01930).</p><p><strong>Results: </strong>Funding for this project began in October 2022, and Institutional Review Board approval was obtained in October 2023. Program implementation within each region is occurring in a phased approach, with partners beginning program delivery in one site (2024-2025) before expanding to any additional locations (2025-2027). Program enrollment occurs continuously during the implementation phase across all sites. From 2024-2025, a total of 13 delivery sites began program delivery, 722 participants have enrolled in the program, and 406 have begun the program (153/342, 44.7% non-Western or Eastern European; 80/345, 23.2% men or 82/347, 23.6% male). An additional 13 sites have confirmed they will launch the program in 2026.</p><p><strong>Conclusions: </strong>This study will demonstrate that SSBC can be scaled up nationwide to effectively and equitably reduce the Canadian population-level risk of T2D. This work will determine best practice
{"title":"Scaling Up a Diabetes Prevention Program in Geographically and Ethnoculturally Diverse Urban Regions of Canada: Protocol for a Hybrid Type 2 Implementation-Effectiveness Study.","authors":"Katie Weatherson, Jessica E Bourne, Kaela Cranston, Kyra Braaten, Natalie Grieve, Joseph Kelly, Mary E Jung","doi":"10.2196/80276","DOIUrl":"10.2196/80276","url":null,"abstract":"<p><strong>Background: </strong>It is estimated that type 2 diabetes (T2D) impacts an estimated 5.3 million Canadians, despite the condition being largely preventable. Laboratory-based diabetes prevention programs (DPPs) have limited effectiveness when translated into community settings due to their low-quality delivery and inability to reach people in the community most in need. To date, no community-based DPPs have been implemented nationwide across Canada. Small Steps for Big Changes (SSBC) is a diet and physical activity counseling intervention that significantly reduces the risk of developing T2D and has been designed for feasible delivery by community-dwelling peers. To ensure maximum public health impact, SSBC must be optimally implemented, demonstrate effectiveness for diverse groups, and be sustainable over time.</p><p><strong>Objective: </strong>This project aims to adapt SSBC and evaluate the implementation, effectiveness, and sustainability of SSBC in diverse urban communities across Canada.</p><p><strong>Methods: </strong>A hybrid type 2 implementation-effectiveness study design using multiple and mixed methods will be used to evaluate the implementation and effectiveness of SSBC over 6 years in partnership with 11 regional Young Men's Christian Associations across 8 provinces in Canada. Beginning in 2024, we will (1) adapt and implement SSBC in diverse urban cities across Canada; (2) examine the implementation (including implementation strategies), effectiveness, and cost-effectiveness of SSBC (2024-2028); and (3) determine the sustainability of SSBC at each delivery location (2028-2029). Data will be collected from SSBC clients, coaches, site leads, and senior leadership municipality partners. The project will be overseen by an advisory group and 3 committees focused on sex, gender, and inclusivity; program evaluation; and diabetes prevention engagement. This study has received ethical approval from the University of British Columbia Clinical Research Ethics Board (H23-01930).</p><p><strong>Results: </strong>Funding for this project began in October 2022, and Institutional Review Board approval was obtained in October 2023. Program implementation within each region is occurring in a phased approach, with partners beginning program delivery in one site (2024-2025) before expanding to any additional locations (2025-2027). Program enrollment occurs continuously during the implementation phase across all sites. From 2024-2025, a total of 13 delivery sites began program delivery, 722 participants have enrolled in the program, and 406 have begun the program (153/342, 44.7% non-Western or Eastern European; 80/345, 23.2% men or 82/347, 23.6% male). An additional 13 sites have confirmed they will launch the program in 2026.</p><p><strong>Conclusions: </strong>This study will demonstrate that SSBC can be scaled up nationwide to effectively and equitably reduce the Canadian population-level risk of T2D. This work will determine best practice ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e80276"},"PeriodicalIF":1.5,"publicationDate":"2026-01-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12865348/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145998211","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Genevieve N Healy, Sjaan R Gomersall, David W Dunstan, Elisabeth A H Winkler, Katherine A Heseltine, Grace Q Sim, Fiona Mason, Denis Giguere, Michael Tsiamis, Mary E Jung, Ana D Goode
<p><strong>Background: </strong>With type 2 diabetes rates escalating worldwide, including in Australia, effective, acceptable, sustainable, and scalable diabetes prevention programs are needed. Small Steps for Big Changes (SSBC) is a Canadian-developed, community-delivered diet and exercise counseling intervention for individuals at risk of type 2 diabetes. The 3- to 6-week intervention can be delivered by trained non-health professionals, with all SSBC coaches receiving training in the delivery of the program, including motivational interviewing. However, the suitability and feasibility of the program in the Australian context are unknown. To address this gap, funding has been secured to adapt, implement, and evaluate SSBC in Australia (SSBC Australia), providing evidence on its effectiveness, acceptability, and implementation in this context.</p><p><strong>Objective: </strong>The aim of the study is to describe the protocol for the type 2 cluster nonrandomized single-arm hybrid effectiveness-implementation trial of SSBC Australia.</p><p><strong>Methods: </strong>SSBC Australia will be delivered and evaluated in 5 community-based sites across 2 organizations in South-East Queensland, Australia. One organization (1 site) will trial training students on clinical and project placements as coaches. The evaluation period is 4 years. For the first 2 years, sites receive funding for program delivery, after which, ongoing delivery will be self-funded. The recruitment target is 500 participants completing the 6-session intervention across the 5 sites within 2 years, with approximately 50 coaches trained. Data will be collected from the organization, site, coach, and client using a variety of methods (surveys, objective assessments, interviews, site audits, website analytics, meeting minutes, and project tracking). The integrated Practical, Robust, Implementation Sustainability Model and Reach, Effectiveness, Adoption, Implementation, Maintenance framework and the Affordability, Practicality, Effectiveness and Cost-Effectiveness, Acceptability, Side-Effects/Safety, and Equity criteria will guide implementation and evaluation and inform iterative adaptations as required. Data will be collected on the context for delivery; adoption and reach (number of coaches and clients and their characteristics); effectiveness of the coach training and the intervention (client pre- and post changes in measured clinical indicators [body composition, cardiorespiratory fitness, strength, and balance], self-reported health behaviors [movement behaviors, healthy eating, and program behaviors], psychosocial indicators [self-efficacy and social supports], quality of life, diabetes status, and health care use); implementation of the coach training and program delivery (fidelity and acceptability); and maintenance of program delivery (sites) and client outcomes at 3, 6, and 12 months post end-of-program.</p><p><strong>Results: </strong>Ethics approval and trial registration were
{"title":"A Context-Adapted Diabetes Prevention Program (Small Steps for Big Changes) in Australia: Protocol for a Hybrid Implementation-Effectiveness Study.","authors":"Genevieve N Healy, Sjaan R Gomersall, David W Dunstan, Elisabeth A H Winkler, Katherine A Heseltine, Grace Q Sim, Fiona Mason, Denis Giguere, Michael Tsiamis, Mary E Jung, Ana D Goode","doi":"10.2196/81195","DOIUrl":"10.2196/81195","url":null,"abstract":"<p><strong>Background: </strong>With type 2 diabetes rates escalating worldwide, including in Australia, effective, acceptable, sustainable, and scalable diabetes prevention programs are needed. Small Steps for Big Changes (SSBC) is a Canadian-developed, community-delivered diet and exercise counseling intervention for individuals at risk of type 2 diabetes. The 3- to 6-week intervention can be delivered by trained non-health professionals, with all SSBC coaches receiving training in the delivery of the program, including motivational interviewing. However, the suitability and feasibility of the program in the Australian context are unknown. To address this gap, funding has been secured to adapt, implement, and evaluate SSBC in Australia (SSBC Australia), providing evidence on its effectiveness, acceptability, and implementation in this context.</p><p><strong>Objective: </strong>The aim of the study is to describe the protocol for the type 2 cluster nonrandomized single-arm hybrid effectiveness-implementation trial of SSBC Australia.</p><p><strong>Methods: </strong>SSBC Australia will be delivered and evaluated in 5 community-based sites across 2 organizations in South-East Queensland, Australia. One organization (1 site) will trial training students on clinical and project placements as coaches. The evaluation period is 4 years. For the first 2 years, sites receive funding for program delivery, after which, ongoing delivery will be self-funded. The recruitment target is 500 participants completing the 6-session intervention across the 5 sites within 2 years, with approximately 50 coaches trained. Data will be collected from the organization, site, coach, and client using a variety of methods (surveys, objective assessments, interviews, site audits, website analytics, meeting minutes, and project tracking). The integrated Practical, Robust, Implementation Sustainability Model and Reach, Effectiveness, Adoption, Implementation, Maintenance framework and the Affordability, Practicality, Effectiveness and Cost-Effectiveness, Acceptability, Side-Effects/Safety, and Equity criteria will guide implementation and evaluation and inform iterative adaptations as required. Data will be collected on the context for delivery; adoption and reach (number of coaches and clients and their characteristics); effectiveness of the coach training and the intervention (client pre- and post changes in measured clinical indicators [body composition, cardiorespiratory fitness, strength, and balance], self-reported health behaviors [movement behaviors, healthy eating, and program behaviors], psychosocial indicators [self-efficacy and social supports], quality of life, diabetes status, and health care use); implementation of the coach training and program delivery (fidelity and acceptability); and maintenance of program delivery (sites) and client outcomes at 3, 6, and 12 months post end-of-program.</p><p><strong>Results: </strong>Ethics approval and trial registration were","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e81195"},"PeriodicalIF":1.5,"publicationDate":"2026-01-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12865356/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146003674","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Holly B Schuh, Marieke Van der Zalm, Margaret Van Niekerk, Lise-Marie Laubscher, Abenathi Mcinziba, Steve Gomas, Sunaina Kapoor, Shubhada Hooli, Lario Viljoen, Andre Gie, Bareng A S Nonyane, Pierre Goussard, Anneke C Hesseling, Carina King, Eric D McCollum
Background: The burden of children with lower respiratory infections and low blood oxygen levels (hypoxemia) is high and outcomes are poor in low-and-middle-income countries (LMICs). Pulse oximeters non-invasively measure the capillary oxyhemoglobin saturation (SpO2) to identify hypoxemia, but high-quality devices designed for the unique needs of children are rarely available in primary healthcare clinics (PHCs) in LMICs where children initially access care.
Objective: To evaluate whether two pediatric pulse oximeters co-designed with healthcare workers (HCWs) in LMICs, compared to a standard pulse oximeter, improve the correct SpO2 management of children in PHCs.
Methods: We are conducting a pragmatic three-arm cluster randomized controlled trial in the Eastern Khayelitsha, Northern, and Tygerberg areas of Cape Town, South Africa, over 18 months between 2024-2026. We plan to enroll 1,200 <2-year-olds with an acute respiratory infection from 18 PHCs randomized to implement one of three pulse oximeters, either one standard of care device or two intervention devices. HCWs in selected PHCs will administer the intervention. Our primary outcome will be 'correct SpO2 management,' an intermediate clinical endpoint between device implementation and hypoxemia outcome, and is defined by the three elements necessary to reduce inappropriately treated hypoxemia, (1) device adoption: HCW use of the device as evidenced by a HCW documented SpO2 and pulse rate, (2) quality SpO2 measurement: SpO2 confirmed by reference device measurement within 2% SpO2 above or below the HCW SpO2, and (3) correct SpO2 decision-making: an appropriate referral recommendation by the HCW. A concurrent mixed methods process evaluation will explore how, why, for whom, and to what extent these devices impact the clinical management of hypoxemic children. The primary analysis will be intention to treat, and for all primary and secondary outcomes, we will conduct pairwise comparisons between the two intervention arms and the control arm.
Results: Data collection commenced in 2024. Results are expected in 2026-2027.
Conclusions: While there are notable challenges inherent to designing a trial to evaluate whether pulse oximeters improve HCW SpO2 management of children at PHCs, our protocol development process attempted to address all potential limitations and sources of bias to maximize the trial's future impact.
{"title":"Clinical evaluation of pediatric pulse oximeters in South Africa: cluster randomized controlled trial protocol.","authors":"Holly B Schuh, Marieke Van der Zalm, Margaret Van Niekerk, Lise-Marie Laubscher, Abenathi Mcinziba, Steve Gomas, Sunaina Kapoor, Shubhada Hooli, Lario Viljoen, Andre Gie, Bareng A S Nonyane, Pierre Goussard, Anneke C Hesseling, Carina King, Eric D McCollum","doi":"10.2196/82888","DOIUrl":"https://doi.org/10.2196/82888","url":null,"abstract":"<p><strong>Background: </strong>The burden of children with lower respiratory infections and low blood oxygen levels (hypoxemia) is high and outcomes are poor in low-and-middle-income countries (LMICs). Pulse oximeters non-invasively measure the capillary oxyhemoglobin saturation (SpO2) to identify hypoxemia, but high-quality devices designed for the unique needs of children are rarely available in primary healthcare clinics (PHCs) in LMICs where children initially access care.</p><p><strong>Objective: </strong>To evaluate whether two pediatric pulse oximeters co-designed with healthcare workers (HCWs) in LMICs, compared to a standard pulse oximeter, improve the correct SpO2 management of children in PHCs.</p><p><strong>Methods: </strong>We are conducting a pragmatic three-arm cluster randomized controlled trial in the Eastern Khayelitsha, Northern, and Tygerberg areas of Cape Town, South Africa, over 18 months between 2024-2026. We plan to enroll 1,200 <2-year-olds with an acute respiratory infection from 18 PHCs randomized to implement one of three pulse oximeters, either one standard of care device or two intervention devices. HCWs in selected PHCs will administer the intervention. Our primary outcome will be 'correct SpO2 management,' an intermediate clinical endpoint between device implementation and hypoxemia outcome, and is defined by the three elements necessary to reduce inappropriately treated hypoxemia, (1) device adoption: HCW use of the device as evidenced by a HCW documented SpO2 and pulse rate, (2) quality SpO2 measurement: SpO2 confirmed by reference device measurement within 2% SpO2 above or below the HCW SpO2, and (3) correct SpO2 decision-making: an appropriate referral recommendation by the HCW. A concurrent mixed methods process evaluation will explore how, why, for whom, and to what extent these devices impact the clinical management of hypoxemic children. The primary analysis will be intention to treat, and for all primary and secondary outcomes, we will conduct pairwise comparisons between the two intervention arms and the control arm.</p><p><strong>Results: </strong>Data collection commenced in 2024. Results are expected in 2026-2027.</p><p><strong>Conclusions: </strong>While there are notable challenges inherent to designing a trial to evaluate whether pulse oximeters improve HCW SpO2 management of children at PHCs, our protocol development process attempted to address all potential limitations and sources of bias to maximize the trial's future impact.</p><p><strong>Clinicaltrial: </strong>Clinicaltrials.gov (NCT05914324).</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":" ","pages":""},"PeriodicalIF":1.5,"publicationDate":"2026-01-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146003270","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Nor Azwani Mohd Shukri, Sarah Muneera Karami, Wan Azdie Mohd Abu Bakar, Roselawati Mat Ya, Norhasmah Sulaiman
<p><strong>Background: </strong>Food insecurity involves the lack of physical and economic access to sufficient, safe, and nutritious food that meets an individual's dietary needs. Patients with end-stage renal disease (ESRD) undergoing hemodialysis have specific dietary needs, but food insecurity may hinder them from adhering to prescribed guidelines and preserving their nutritional status. However, no research has been conducted to elucidate food insecurity among patients undergoing hemodialysis in Malaysia.</p><p><strong>Objective: </strong>This study aimed to assess the prevalence of food insecurity, its determinants, and its association with nutritional status and explore the coping strategies used among patients undergoing hemodialysis in Pahang, Malaysia.</p><p><strong>Methods: </strong>This was a cross-sectional study that followed a mixed methods approach and was conducted with patients undergoing hemodialysis for ESRD at the Pahang Islamic Religious Council and Malay Customs (Majlis Ugama Islam dan Adat Resam Melayu Pahang [MUIP]) dialysis centers. The inclusion criteria were patients who were aged 18 years or older, were generally healthy, and had been undergoing hemodialysis regularly for at least 3 months. The food security status of the participants was determined using the Malay version of the Food Insecurity Experience Scale (M-FIES). The nutritional status included anthropometric measurements (height, weight, BMI, triceps skinfold [TSF] thickness, mid-upper arm circumference (MUAC), midarm muscle circumference (MAMC), and body fat percentage), biochemical parameters (serum urea, creatinine, albumin, phosphate, potassium, hemoglobin, and total iron-binding capacity [TIBC]), clinical assessments (Malnutrition Inflammation Score [MIS] and protein energy wasting [PEW]), and dietary intake (adherence to total calorie, protein, sodium, potassium, and phosphorus intake and diet monotony index [DMI]). The determinants were identified using logistic regression, while the association between food security status and nutritional status was analyzed using the chi-square or Fisher's exact test and the independent t test. Semistructured interviews involved participants who were categorized as mildly, moderately, or severely food insecure in order to explore the contributing factors of food insecurity and how they coped with it based on their lived experience. The interviews were carried out until the data reached saturation, and then the data were analyzed thematically.</p><p><strong>Results: </strong>The study was funded by the Ministry of Higher Education Malaysia under the Fundamental Research Grant Scheme (FRGS/1/2023/SS10/UIAM/02/1) starting in September 2023. Data collection was conducted from December 2023 until August 2024, involving 287 participants, and data analysis has also been completed. As of January 2026, quantitative findings are under review and qualitative findings are being prepared.</p><p><strong>Conclusions: </strong>The
背景:粮食不安全是指无法从物质和经济上获得满足个人饮食需求的充足、安全和有营养的食物。接受血液透析的终末期肾病(ESRD)患者有特定的饮食需求,但粮食不安全可能会阻碍他们遵守规定的指南并保持其营养状况。然而,没有研究进行了阐明在马来西亚接受血液透析患者的食物不安全。目的:本研究旨在评估食品不安全的患病率,其决定因素及其与营养状况的关系,并探讨在马来西亚彭亨市接受血液透析的患者中使用的应对策略。方法:这是一项采用混合方法的横断研究,在彭亨伊斯兰宗教委员会和马来海关(Majlis Ugama Islam dan Adat Resam Melayu Pahang [MUIP])透析中心接受ESRD血液透析的患者中进行。纳入标准为18岁或以上,总体健康,定期进行血液透析至少3个月的患者。参与者的粮食安全状况是用马来语版的粮食不安全体验量表(M-FIES)来确定的。营养状况包括人体测量(身高、体重、BMI、三头肌皮褶[TSF]厚度、上臂中围(MUAC)、上臂中肌围(MAMC)和体脂率)、生化参数(血清尿素、肌酐、白蛋白、磷酸盐、钾、血红蛋白和总铁结合能力[TIBC])、临床评估(营养不良炎症评分[MIS]和蛋白质能量浪费[PEW])和饮食摄入(坚持总热量、蛋白质、钠、钾、磷摄入量与饮食单调指数[DMI])。采用logistic回归确定影响因素,同时使用卡方检验或Fisher精确检验和独立t检验分析食品安全状况与营养状况之间的关系。半结构化访谈涉及轻度、中度或严重粮食不安全的参与者,以探讨粮食不安全的促成因素以及他们如何根据自己的生活经验应对粮食不安全。访谈一直进行到数据达到饱和,然后对数据进行主题分析。结果:该研究由马来西亚高等教育部根据基础研究资助计划(FRGS/1/2023/SS10/UIAM/02/1)资助,于2023年9月开始。数据收集时间为2023年12月至2024年8月,共287名参与者,并已完成数据分析。截至2026年1月,正在审查定量调查结果,并正在编制定性调查结果。结论:本研究方案的实施将为提高对该人群粮食不安全的认识提供新的证据。阐明其主要影响因素、应对策略以及与这一人群营养状况的潜在联系,有助于指导更明智的政策制定和有效的干预措施。国际注册报告标识符(irrid): RR1-10.2196/84575。
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