Rahel Pearson, Christopher G Beevers, Joseph Mignogna, Justin Benzer, Paul N Pfeiffer, Edward Post, Suzannah K Creech
Background: Depressive symptoms are common in veterans, and the presence of these symptoms increases disability as well as suicidal thoughts and behaviors. However, there is evidence that these symptoms often go untreated. Intervening before symptoms become severe and entrenched is related to better long-term outcomes, including improved functioning and less disease chronicity. Computer-delivered interventions may be especially appropriate for those veterans with mild to moderate depressive symptoms, because these interventions can require fewer resources and have lower barriers to access and thus have potential for wider reach. Despite this potential, there is a dearth of research examining computerized interventions for depressive symptoms in veteran samples.
Objective: The aim of this study is to evaluate the efficacy of Deprexis (GAIA AG), a computerized intervention for depressive symptoms and related functional impairment.
Methods: Veterans will be recruited through the US Department of Veterans Affairs electronic medical record and through primary care and specialty clinics. First, qualitative interviews will be completed with a small subset of veterans (n=16-20) to assess the acceptability of treatment procedures. Next, veterans (n=132) with mild to moderate depressive symptoms will be randomly assigned to the fully automated Deprexis intervention or a treatment-as-usual control group. The primary outcomes will be self-reported depressive symptoms and various dimensions of psychosocial functioning.
Results: This project was funded in May 2024, and data collection will be conducted between October 2024 and April 2029. Overall, 4 participants have been recruited as of the submission of the manuscript, and data analysis is expected in June 2029, with initial results expected in November 2029.
Conclusions: This study will provide initial evidence for the efficacy of self-guided, computerized interventions for depressive symptoms and functional impairment in veterans. If effective, these types of interventions could improve veteran access to low-resource psychosocial treatments.
{"title":"The Evaluation of a Web-Based Intervention (Deprexis) to Decrease Depression and Restore Functioning in Veterans: Protocol for a Randomized Controlled Trial.","authors":"Rahel Pearson, Christopher G Beevers, Joseph Mignogna, Justin Benzer, Paul N Pfeiffer, Edward Post, Suzannah K Creech","doi":"10.2196/59119","DOIUrl":"10.2196/59119","url":null,"abstract":"<p><strong>Background: </strong>Depressive symptoms are common in veterans, and the presence of these symptoms increases disability as well as suicidal thoughts and behaviors. However, there is evidence that these symptoms often go untreated. Intervening before symptoms become severe and entrenched is related to better long-term outcomes, including improved functioning and less disease chronicity. Computer-delivered interventions may be especially appropriate for those veterans with mild to moderate depressive symptoms, because these interventions can require fewer resources and have lower barriers to access and thus have potential for wider reach. Despite this potential, there is a dearth of research examining computerized interventions for depressive symptoms in veteran samples.</p><p><strong>Objective: </strong>The aim of this study is to evaluate the efficacy of Deprexis (GAIA AG), a computerized intervention for depressive symptoms and related functional impairment.</p><p><strong>Methods: </strong>Veterans will be recruited through the US Department of Veterans Affairs electronic medical record and through primary care and specialty clinics. First, qualitative interviews will be completed with a small subset of veterans (n=16-20) to assess the acceptability of treatment procedures. Next, veterans (n=132) with mild to moderate depressive symptoms will be randomly assigned to the fully automated Deprexis intervention or a treatment-as-usual control group. The primary outcomes will be self-reported depressive symptoms and various dimensions of psychosocial functioning.</p><p><strong>Results: </strong>This project was funded in May 2024, and data collection will be conducted between October 2024 and April 2029. Overall, 4 participants have been recruited as of the submission of the manuscript, and data analysis is expected in June 2029, with initial results expected in November 2029.</p><p><strong>Conclusions: </strong>This study will provide initial evidence for the efficacy of self-guided, computerized interventions for depressive symptoms and functional impairment in veterans. If effective, these types of interventions could improve veteran access to low-resource psychosocial treatments.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06217198; https://www.clinicaltrials.gov/study/NCT06217198.</p><p><strong>International registered report identifier (irrid): </strong>PRR1-10.2196/59119.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"13 ","pages":"e59119"},"PeriodicalIF":1.4,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11544330/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142500758","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}
Antoine Khati, Jeffrey A Wickersham, Kamal Gautam, Kiran Paudel, Panyaphon Phiphatkhunarnon, Sin How Lim, Kirthana Puniamurthy, Frederick L Altice, Nittaya Phanuphak, Iskandar Azwa, Roman Shrestha
<p><strong>Background: </strong>HIV continues to have a disproportionate impact on specific populations in Malaysia, particularly men who have sex with men (MSM). HIV self-testing (HIVST) is a strategy that has been shown to scale up HIV testing rates. However, it faces shortcomings because of concerns about self-efficacy, result interpretation, and lack of counseling and linkage to care. This underscores the need for an innovative approach that integrates HIVST with timely counseling, expert guidance, and referrals to enhance engagement in relevant HIV prevention or treatment.</p><p><strong>Objective: </strong>This study aims to describe the protocol used in developing and testing a web-based platform (ie, CINTAI) providing an HIVST kit and real-time e-counseling to support online-to-offline linkage to HIV care services for MSM in Malaysia.</p><p><strong>Methods: </strong>The methods are reported according to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 guidelines. In phase I, we will adapt existing HIVST web-based platforms to create a new online-to-offline HIVST and counseling platform called "CINTAI" for Malaysian MSM. In phase II, we will use a type 1 hybrid implementation trial design to determine the feasibility, acceptability, and preliminary efficacy of "CINTAI" compared with treatment as usual among Malaysian MSM, with assessments conducted over 6 months. Multilevel implementation factors will also be collected to guide future adoption and scale-up. We will enroll 78 MSM in the pilot randomized controlled trial. Baseline characteristics will be tested for homogeneity between groups using appropriate statistical tests. A generalized linear mixed model with random subject effects will account for within-subject correlation. Treatment assignment, time, interaction, and confounders will be included. The proportion of MSM tested for HIV over 6 months and other outcomes (pre-exposure prophylaxis for HIV or antiretroviral therapy linkage, HIV risk behaviors, and chemsex harm reduction) will be compared using linear contrasts.</p><p><strong>Results: </strong>We completed phase I of the proposed study in April 2024 and started phase II in May 2024, with 15 participants recruited (7 in the CINTAI and 8 in the treatment-as-usual groups). On the basis of a series of formative works completed during phase I, we developed a fully functional, web-based platform that provides a digital platform for MSM in Malaysia to order HIVST kits for free and to receive HIV counseling, followed by offline linkage to HIV prevention services (if HIV negative) or HIV treatment services (if HIV positive).</p><p><strong>Conclusions: </strong>Despite being at high risk for HIV transmission, MSM in Malaysia have alarmingly low testing and linkage to HIV care services, prompting the need for innovative approaches to support HIV prevention efforts. If found to be feasible and acceptable, CINTAI can be easily adapted for a range of hea
{"title":"Integrated Online-to-Offline Model of Care for HIV Prevention and Treatment Among Men Who Have Sex With Men in Malaysia: Protocol for an Intervention Development and a Multiphase Trial.","authors":"Antoine Khati, Jeffrey A Wickersham, Kamal Gautam, Kiran Paudel, Panyaphon Phiphatkhunarnon, Sin How Lim, Kirthana Puniamurthy, Frederick L Altice, Nittaya Phanuphak, Iskandar Azwa, Roman Shrestha","doi":"10.2196/60962","DOIUrl":"10.2196/60962","url":null,"abstract":"<p><strong>Background: </strong>HIV continues to have a disproportionate impact on specific populations in Malaysia, particularly men who have sex with men (MSM). HIV self-testing (HIVST) is a strategy that has been shown to scale up HIV testing rates. However, it faces shortcomings because of concerns about self-efficacy, result interpretation, and lack of counseling and linkage to care. This underscores the need for an innovative approach that integrates HIVST with timely counseling, expert guidance, and referrals to enhance engagement in relevant HIV prevention or treatment.</p><p><strong>Objective: </strong>This study aims to describe the protocol used in developing and testing a web-based platform (ie, CINTAI) providing an HIVST kit and real-time e-counseling to support online-to-offline linkage to HIV care services for MSM in Malaysia.</p><p><strong>Methods: </strong>The methods are reported according to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 guidelines. In phase I, we will adapt existing HIVST web-based platforms to create a new online-to-offline HIVST and counseling platform called \"CINTAI\" for Malaysian MSM. In phase II, we will use a type 1 hybrid implementation trial design to determine the feasibility, acceptability, and preliminary efficacy of \"CINTAI\" compared with treatment as usual among Malaysian MSM, with assessments conducted over 6 months. Multilevel implementation factors will also be collected to guide future adoption and scale-up. We will enroll 78 MSM in the pilot randomized controlled trial. Baseline characteristics will be tested for homogeneity between groups using appropriate statistical tests. A generalized linear mixed model with random subject effects will account for within-subject correlation. Treatment assignment, time, interaction, and confounders will be included. The proportion of MSM tested for HIV over 6 months and other outcomes (pre-exposure prophylaxis for HIV or antiretroviral therapy linkage, HIV risk behaviors, and chemsex harm reduction) will be compared using linear contrasts.</p><p><strong>Results: </strong>We completed phase I of the proposed study in April 2024 and started phase II in May 2024, with 15 participants recruited (7 in the CINTAI and 8 in the treatment-as-usual groups). On the basis of a series of formative works completed during phase I, we developed a fully functional, web-based platform that provides a digital platform for MSM in Malaysia to order HIVST kits for free and to receive HIV counseling, followed by offline linkage to HIV prevention services (if HIV negative) or HIV treatment services (if HIV positive).</p><p><strong>Conclusions: </strong>Despite being at high risk for HIV transmission, MSM in Malaysia have alarmingly low testing and linkage to HIV care services, prompting the need for innovative approaches to support HIV prevention efforts. If found to be feasible and acceptable, CINTAI can be easily adapted for a range of hea","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"13 ","pages":"e60962"},"PeriodicalIF":1.4,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11541154/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142500756","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}
Gede Rasben Dantes, Nice Maylani Asril, Andrian Liem, Ni Komang Arie Suwastini, Shian-Ling Keng, Ni Wayan Surya Mahayanti
<p><strong>Background: </strong>The COVID-19 pandemic has increased the level of anxiety among Indonesian senior high school teachers, who face challenges to treat their mental disorder symptoms that arise during their working hours, as mental health services in Indonesia are limited. Therefore, it is vital to equip schoolteachers in Indonesia with early interventions that are easily available, private, and affordable, and 1 feasible approach is to deploy a smartphone mobile app.</p><p><strong>Objective: </strong>The objectives of this study are (1) to evaluate the feasibility of a brief mindfulness-based mobile app (BM-MA) for Indonesian senior high school teachers experiencing anxiety and stress and (2) to examine the effects of using the BM-MA on anxiety, stress, life satisfaction, self-efficacy, trait mindfulness, self-compassion, and physical and social dysfunction among the participants.</p><p><strong>Methods: </strong>We followed the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 statement for this feasibility randomized controlled trial (RCT) protocol. A total of 60 Indonesian senior high school teachers were recruited for this study and randomly assigned to either the intervention group (BM-MA) or a wait-list control group (CG) in a 1:1 ratio. The BM-MA group was required to engage in mindfulness practices using the app for 10-20 minutes per day for 3 weeks. All participants were assessed with a battery of self-report measures at baseline, postintervention, and at 1-month follow-up. Validated scales used to measure the outcome variables of interest included the Satisfaction With Life Scale (SLS), the Teachers' Sense of Efficacy Scale (TSES), the Self-Compassion Scale-Short Form (SCS-SF), Generalized Anxiety Disorder-7 (GAD-7), General Health Questionnaire-12 (GHQ-12), and the Five Facet Mindfulness Questionnaire (FFMQ). The practicality and acceptability of the app will be evaluated using the Client Satisfaction Questionnaire-8 (CSQ-8) and structured qualitative interviews. Data from the interviews will be analyzed with the deductive thematic analysis framework as a process of qualitative inquiry. Repeated measures ANOVA with groups (intervention vs control) as a between-subject factor and time as a within-subject factor (baseline, postintervention, and 1-month follow-up) will be used to examine the effects of the BM-MA on the outcome variables. The data will be analyzed using an intent-to-treat approach and published in accordance with CONSORT (Consolidated Standards of Reporting Trials) recommendations.</p><p><strong>Results: </strong>Participants were recruited in December 2023, and this pilot RCT was conducted from January through March 2024. Data analysis was conducted from March through May 2024. The results of this study are expected to be published in December 2024. The trial registration of this protocol was submitted to the Chinese Clinical Trial Registry.</p><p><strong>Conclusions: </strong>Th
{"title":"Brief Mobile App-Based Mindfulness Intervention for Indonesian Senior High School Teachers: Protocol for a Pilot Randomized Controlled Trial.","authors":"Gede Rasben Dantes, Nice Maylani Asril, Andrian Liem, Ni Komang Arie Suwastini, Shian-Ling Keng, Ni Wayan Surya Mahayanti","doi":"10.2196/56693","DOIUrl":"10.2196/56693","url":null,"abstract":"<p><strong>Background: </strong>The COVID-19 pandemic has increased the level of anxiety among Indonesian senior high school teachers, who face challenges to treat their mental disorder symptoms that arise during their working hours, as mental health services in Indonesia are limited. Therefore, it is vital to equip schoolteachers in Indonesia with early interventions that are easily available, private, and affordable, and 1 feasible approach is to deploy a smartphone mobile app.</p><p><strong>Objective: </strong>The objectives of this study are (1) to evaluate the feasibility of a brief mindfulness-based mobile app (BM-MA) for Indonesian senior high school teachers experiencing anxiety and stress and (2) to examine the effects of using the BM-MA on anxiety, stress, life satisfaction, self-efficacy, trait mindfulness, self-compassion, and physical and social dysfunction among the participants.</p><p><strong>Methods: </strong>We followed the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 statement for this feasibility randomized controlled trial (RCT) protocol. A total of 60 Indonesian senior high school teachers were recruited for this study and randomly assigned to either the intervention group (BM-MA) or a wait-list control group (CG) in a 1:1 ratio. The BM-MA group was required to engage in mindfulness practices using the app for 10-20 minutes per day for 3 weeks. All participants were assessed with a battery of self-report measures at baseline, postintervention, and at 1-month follow-up. Validated scales used to measure the outcome variables of interest included the Satisfaction With Life Scale (SLS), the Teachers' Sense of Efficacy Scale (TSES), the Self-Compassion Scale-Short Form (SCS-SF), Generalized Anxiety Disorder-7 (GAD-7), General Health Questionnaire-12 (GHQ-12), and the Five Facet Mindfulness Questionnaire (FFMQ). The practicality and acceptability of the app will be evaluated using the Client Satisfaction Questionnaire-8 (CSQ-8) and structured qualitative interviews. Data from the interviews will be analyzed with the deductive thematic analysis framework as a process of qualitative inquiry. Repeated measures ANOVA with groups (intervention vs control) as a between-subject factor and time as a within-subject factor (baseline, postintervention, and 1-month follow-up) will be used to examine the effects of the BM-MA on the outcome variables. The data will be analyzed using an intent-to-treat approach and published in accordance with CONSORT (Consolidated Standards of Reporting Trials) recommendations.</p><p><strong>Results: </strong>Participants were recruited in December 2023, and this pilot RCT was conducted from January through March 2024. Data analysis was conducted from March through May 2024. The results of this study are expected to be published in December 2024. The trial registration of this protocol was submitted to the Chinese Clinical Trial Registry.</p><p><strong>Conclusions: </strong>Th","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"13 ","pages":"e56693"},"PeriodicalIF":16.4,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11541156/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142500753","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}
<p><strong>Background: </strong>Bedside ultrasonography, also known as point-of-care ultrasound (PoCUS), is a promising technological tool that enhances clinical assessment, enriching diagnostic capabilities and clinical reasoning. Its use in nursing spans various patient populations and health care settings, providing nurses with a valuable health assessment tool to improve care quality and patient safety. Despite its growing integration into clinical practice, PoCUS training has mainly focused on physicians, leaving a gap for trained nurses who demonstrate similar proficiency in conducting scans and interpreting images. Previous research highlights the value of digital tools in PoCUS training, showing their role in improving professionals' and students' knowledge, image interpretation skills, and clinical acumen.</p><p><strong>Objective: </strong>This study aimed to (1) establish an assessment instrument gauging nurses' competency milestones in PoCUS and evaluate its content and appearance validity, (2) develop a series of 5 educational videos focused on PoCUS and assess their content and appearance validity, and (3) construct an online learning environment tailored to nurses' PoCUS training needs and evaluate its content and appearance validity.</p><p><strong>Methods: </strong>We will conduct a methodological study of technological production guided by Rogers' diffusion of innovations theory. Subproject 1 will design and validate a comprehensive assessment tool for evaluating nurses' competency milestones in PoCUS use. For this purpose, a scoping review will be conducted. The review will be based on JBI Collaboration guidelines and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extended for Scoping Reviews (PRISMA-ScR) checklist. Subproject 2 involves an evaluation of content and appearance validity for a series of 5 educational videos on PoCUS, designed specifically for nurses about applying peripherally inserted central catheter lines, inserting nasogastric feeding tubes, assessing gastric residual volume, assessing pressure injuries and soft tissue conditions, and assessing muscle mass to monitor patient nutritional status. In subproject 3, a comprehensive online learning environment dedicated to PoCUS training for nurses will be developed and validated. The launch of an online learning environment represents a cornerstone of our dissemination strategy, scheduled to coincide with the inaugural Brazilian PoCUS symposium for nurses, an event organized by the project members. This platform will serve as a pivotal resource for continuous learning and professional development.</p><p><strong>Results: </strong>Subproject 1 will start in the second half of 2024 and is expected to be completed by mid-2025. Subproject 2 is currently ongoing and is expected to be completed in early 2026. Subproject 3 is set to begin in early 2025 and is planned to be completed by 2026.</p><p><strong>Conclusions: </strong>T
{"title":"Advancing Digital Education Technologies by Empowering Nurses With Point-of-Care Ultrasound: Protocol for a Mixed Methods Study.","authors":"Fernanda Raphael Escobar Gimenes, Angelita Maria Stabile, Rodrigo Magri Bernardes, Vinicius Batista Santos, Mayra Gonçalves Menegueti, Patricia Rezende do Prado, Mauricio Serra Ribeiro, Flavia Giron Camerini, Soraia Assad Nasbine Rabeh","doi":"10.2196/58030","DOIUrl":"10.2196/58030","url":null,"abstract":"<p><strong>Background: </strong>Bedside ultrasonography, also known as point-of-care ultrasound (PoCUS), is a promising technological tool that enhances clinical assessment, enriching diagnostic capabilities and clinical reasoning. Its use in nursing spans various patient populations and health care settings, providing nurses with a valuable health assessment tool to improve care quality and patient safety. Despite its growing integration into clinical practice, PoCUS training has mainly focused on physicians, leaving a gap for trained nurses who demonstrate similar proficiency in conducting scans and interpreting images. Previous research highlights the value of digital tools in PoCUS training, showing their role in improving professionals' and students' knowledge, image interpretation skills, and clinical acumen.</p><p><strong>Objective: </strong>This study aimed to (1) establish an assessment instrument gauging nurses' competency milestones in PoCUS and evaluate its content and appearance validity, (2) develop a series of 5 educational videos focused on PoCUS and assess their content and appearance validity, and (3) construct an online learning environment tailored to nurses' PoCUS training needs and evaluate its content and appearance validity.</p><p><strong>Methods: </strong>We will conduct a methodological study of technological production guided by Rogers' diffusion of innovations theory. Subproject 1 will design and validate a comprehensive assessment tool for evaluating nurses' competency milestones in PoCUS use. For this purpose, a scoping review will be conducted. The review will be based on JBI Collaboration guidelines and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extended for Scoping Reviews (PRISMA-ScR) checklist. Subproject 2 involves an evaluation of content and appearance validity for a series of 5 educational videos on PoCUS, designed specifically for nurses about applying peripherally inserted central catheter lines, inserting nasogastric feeding tubes, assessing gastric residual volume, assessing pressure injuries and soft tissue conditions, and assessing muscle mass to monitor patient nutritional status. In subproject 3, a comprehensive online learning environment dedicated to PoCUS training for nurses will be developed and validated. The launch of an online learning environment represents a cornerstone of our dissemination strategy, scheduled to coincide with the inaugural Brazilian PoCUS symposium for nurses, an event organized by the project members. This platform will serve as a pivotal resource for continuous learning and professional development.</p><p><strong>Results: </strong>Subproject 1 will start in the second half of 2024 and is expected to be completed by mid-2025. Subproject 2 is currently ongoing and is expected to be completed in early 2026. Subproject 3 is set to begin in early 2025 and is planned to be completed by 2026.</p><p><strong>Conclusions: </strong>T","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"13 ","pages":"e58030"},"PeriodicalIF":1.4,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11541147/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142500752","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}
Eliana Fazuoli Chubaci, Carlos Dario da Silva Costa, Martins Fideles Dos Santos Neto, Emerson Roberto Dos Santos, Ana Maria Rita Pedroso Vilela Torres de Carvalho Engel, Ana Caroline Dos Santos Costa, Taisa Morete da Silva, Helena Landin Gonçalves Cristóvão, Alex Bertolazzo Quitério, Alba Regina de Abreu Lima, Vânia Maria Sabadoto Brienze, Fernando Nestor Fácio, Júlio César André
Background: Leadership is recognized as an essential competency in health care and science, being central for professionals to face health challenges. Few physicians feel prepared to serve as leaders in the health care environment, and few receive training in the leadership skills needed to be successful. Teaching leadership skills together with extensive, longitudinal, clinical education in an authentic and nurturing environment can effectively develop students for leadership in medicine. Studies on the subject still do not show the best way to implement it in medical education, and an updated review is necessary.
Objective: The aim of this study is to identify the types of available evidence on the teaching of leadership skills in undergraduate courses in the health area, analyze them, determine knowledge gaps, and disseminate the research results.
Methods: This is a scoping review that will consider studies on leadership skills in medical and health undergraduate courses. Primary studies published in English, Spanish, and Portuguese since 2019 will be considered. The search will be performed in 8 databases, and reference lists will be searched for additional studies. Duplicates will be removed, and 2 independent reviewers will examine the titles, abstracts, and full texts of the selected studies. Data extraction will be performed using a tool developed by the researchers.
Results: The scoping review is currently in progress. The preliminary database search has been completed, yielding a total of 1213 articles across multiple databases. The next stages, including deduplication, title and abstract screening, and full-text review, are scheduled to be completed by December 2024. Data extraction and analysis are expected to be finalized by March 2025, with the final report anticipated to be ready for submission by June 2025.
Conclusions: This scoping review on leadership in the medical curriculum can significantly contribute to the literature by organizing and synthesizing the available evidence on teaching leadership skills in undergraduate courses in the health area. Furthermore, by analyzing evidence and identifying knowledge gaps, the study can provide valuable insights to develop more efficient and comprehensive medical education programs, thus preparing students to take on leadership roles in the complex environment of health care.
Trial registration: Open Science Framework YEXKB; https://osf.io/yexkb.
International registered report identifier (irrid): PRR1-10.2196/62810.
{"title":"Development of Leadership Skills in Medical Education: Protocol for a Scoping Review.","authors":"Eliana Fazuoli Chubaci, Carlos Dario da Silva Costa, Martins Fideles Dos Santos Neto, Emerson Roberto Dos Santos, Ana Maria Rita Pedroso Vilela Torres de Carvalho Engel, Ana Caroline Dos Santos Costa, Taisa Morete da Silva, Helena Landin Gonçalves Cristóvão, Alex Bertolazzo Quitério, Alba Regina de Abreu Lima, Vânia Maria Sabadoto Brienze, Fernando Nestor Fácio, Júlio César André","doi":"10.2196/62810","DOIUrl":"10.2196/62810","url":null,"abstract":"<p><strong>Background: </strong>Leadership is recognized as an essential competency in health care and science, being central for professionals to face health challenges. Few physicians feel prepared to serve as leaders in the health care environment, and few receive training in the leadership skills needed to be successful. Teaching leadership skills together with extensive, longitudinal, clinical education in an authentic and nurturing environment can effectively develop students for leadership in medicine. Studies on the subject still do not show the best way to implement it in medical education, and an updated review is necessary.</p><p><strong>Objective: </strong>The aim of this study is to identify the types of available evidence on the teaching of leadership skills in undergraduate courses in the health area, analyze them, determine knowledge gaps, and disseminate the research results.</p><p><strong>Methods: </strong>This is a scoping review that will consider studies on leadership skills in medical and health undergraduate courses. Primary studies published in English, Spanish, and Portuguese since 2019 will be considered. The search will be performed in 8 databases, and reference lists will be searched for additional studies. Duplicates will be removed, and 2 independent reviewers will examine the titles, abstracts, and full texts of the selected studies. Data extraction will be performed using a tool developed by the researchers.</p><p><strong>Results: </strong>The scoping review is currently in progress. The preliminary database search has been completed, yielding a total of 1213 articles across multiple databases. The next stages, including deduplication, title and abstract screening, and full-text review, are scheduled to be completed by December 2024. Data extraction and analysis are expected to be finalized by March 2025, with the final report anticipated to be ready for submission by June 2025.</p><p><strong>Conclusions: </strong>This scoping review on leadership in the medical curriculum can significantly contribute to the literature by organizing and synthesizing the available evidence on teaching leadership skills in undergraduate courses in the health area. Furthermore, by analyzing evidence and identifying knowledge gaps, the study can provide valuable insights to develop more efficient and comprehensive medical education programs, thus preparing students to take on leadership roles in the complex environment of health care.</p><p><strong>Trial registration: </strong>Open Science Framework YEXKB; https://osf.io/yexkb.</p><p><strong>International registered report identifier (irrid): </strong>PRR1-10.2196/62810.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"13 ","pages":"e62810"},"PeriodicalIF":1.4,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11538880/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142465913","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}
Pierfilippo De Sanctis, Jeannette R Mahoney, Johanna Wagner, Helena M Blumen, Wenzhu Mowrey, Emmeline Ayers, Claudia Schneider, Natasha Orellana, Sophie Molholm, Joe Verghese
[This corrects the article DOI: 10.2196/56726.].
[此处更正了文章 DOI：10.2196/56726]。
{"title":"Correction: Linking Dementia Pathology and Alteration in Brain Activation to Complex Daily Functional Decline During the Preclinical Dementia Stages: Protocol for a Prospective Observational Cohort Study.","authors":"Pierfilippo De Sanctis, Jeannette R Mahoney, Johanna Wagner, Helena M Blumen, Wenzhu Mowrey, Emmeline Ayers, Claudia Schneider, Natasha Orellana, Sophie Molholm, Joe Verghese","doi":"10.2196/66438","DOIUrl":"10.2196/66438","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.2196/56726.].</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"13 ","pages":"e66438"},"PeriodicalIF":1.4,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11535779/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142465911","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}
Lauren T Berube, Archana Shrestha, Abha Shrestha, Jean-Francois Daneault, Prabin Raj Shakya, Meghnath Dhimal, Roman Shrestha, Shristi Rawal
<p><strong>Background: </strong>The prevalence of gestational diabetes mellitus (GDM) is increasing, particularly in low- and middle-income countries (LMICs) like Nepal. GDM self-management, including intensive dietary and lifestyle modifications and blood glucose monitoring, is critical to maintain glycemic control and prevent adverse outcomes. However, in resource-limited settings, several barriers hinder optimal self-management. Mobile health (mHealth) technology holds promise as a strategy to augment GDM treatment by promoting healthy behaviors and supporting self-management, but this approach has not yet been tested in any LMIC.</p><p><strong>Objective: </strong>This report describes the protocol to develop a culturally tailored mHealth app that supports self-management and treatment of GDM (GDM-Dhulikhel Hospital [GDM-DH] app, phase 1) and test its usability and preliminary efficacy (phase 2) among patients with GDM in a periurban hospital setting in Nepal.</p><p><strong>Methods: </strong>The study will be conducted at Dhulikhel Hospital in Dhulikhel, Nepal. In the development phase (phase 1), a prototype of the GDM-DH app will be developed based on expert reviews and a user-centered design approach. To understand facilitators and barriers to GDM self-management and to gather feedback on the prototype, focus groups and in-depth interviews will be conducted with patients with GDM (n=12), health care providers (n=5), and family members (n=3), with plans to recruit further if saturation is not achieved. Feedback will be used to build a minimum viable product, which will undergo user testing with 18 patients with GDM using a think-aloud protocol. The final GDM-DH app will be developed based on user feedback and following an iterative product design and user testing process. In the randomized controlled trial phase (phase 2), newly diagnosed patients with GDM (n=120) will be recruited and randomized to either standard care alone or standard care plus the GDM-DH app from 24-30 weeks gestation until delivery. In this proof-of-concept trial, feasibility outcomes will be app usage, self-monitoring adherence, and app usability and acceptability. Exploratory treatment outcomes will be maternal glycemic control at 6 weeks post partum, birth weight, and rates of labor induction and cesarean delivery. Qualitative data obtained from phase 1 will be analyzed using thematic analysis. In phase 2, independent 2-tailed t tests or chi-square analyses will examine differences in outcomes between the 2 treatment conditions.</p><p><strong>Results: </strong>As of July 2024, we have completed phase 1. Phase 2 is underway. The first participant was enrolled in October 2021, with 99 participants enrolled as of July 2024. We anticipate completing recruitment by December 2024 and disseminating findings by December 2025.</p><p><strong>Conclusions: </strong>App-based lifestyle interventions for GDM management are not common in LMICs, where GDM prevalence is rapidly increa
{"title":"Development and Testing of a Mobile App for Management of Gestational Diabetes in Nepal: Protocol for a User-Centered Design Study and Exploratory Randomized Controlled Trial.","authors":"Lauren T Berube, Archana Shrestha, Abha Shrestha, Jean-Francois Daneault, Prabin Raj Shakya, Meghnath Dhimal, Roman Shrestha, Shristi Rawal","doi":"10.2196/59423","DOIUrl":"10.2196/59423","url":null,"abstract":"<p><strong>Background: </strong>The prevalence of gestational diabetes mellitus (GDM) is increasing, particularly in low- and middle-income countries (LMICs) like Nepal. GDM self-management, including intensive dietary and lifestyle modifications and blood glucose monitoring, is critical to maintain glycemic control and prevent adverse outcomes. However, in resource-limited settings, several barriers hinder optimal self-management. Mobile health (mHealth) technology holds promise as a strategy to augment GDM treatment by promoting healthy behaviors and supporting self-management, but this approach has not yet been tested in any LMIC.</p><p><strong>Objective: </strong>This report describes the protocol to develop a culturally tailored mHealth app that supports self-management and treatment of GDM (GDM-Dhulikhel Hospital [GDM-DH] app, phase 1) and test its usability and preliminary efficacy (phase 2) among patients with GDM in a periurban hospital setting in Nepal.</p><p><strong>Methods: </strong>The study will be conducted at Dhulikhel Hospital in Dhulikhel, Nepal. In the development phase (phase 1), a prototype of the GDM-DH app will be developed based on expert reviews and a user-centered design approach. To understand facilitators and barriers to GDM self-management and to gather feedback on the prototype, focus groups and in-depth interviews will be conducted with patients with GDM (n=12), health care providers (n=5), and family members (n=3), with plans to recruit further if saturation is not achieved. Feedback will be used to build a minimum viable product, which will undergo user testing with 18 patients with GDM using a think-aloud protocol. The final GDM-DH app will be developed based on user feedback and following an iterative product design and user testing process. In the randomized controlled trial phase (phase 2), newly diagnosed patients with GDM (n=120) will be recruited and randomized to either standard care alone or standard care plus the GDM-DH app from 24-30 weeks gestation until delivery. In this proof-of-concept trial, feasibility outcomes will be app usage, self-monitoring adherence, and app usability and acceptability. Exploratory treatment outcomes will be maternal glycemic control at 6 weeks post partum, birth weight, and rates of labor induction and cesarean delivery. Qualitative data obtained from phase 1 will be analyzed using thematic analysis. In phase 2, independent 2-tailed t tests or chi-square analyses will examine differences in outcomes between the 2 treatment conditions.</p><p><strong>Results: </strong>As of July 2024, we have completed phase 1. Phase 2 is underway. The first participant was enrolled in October 2021, with 99 participants enrolled as of July 2024. We anticipate completing recruitment by December 2024 and disseminating findings by December 2025.</p><p><strong>Conclusions: </strong>App-based lifestyle interventions for GDM management are not common in LMICs, where GDM prevalence is rapidly increa","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"13 ","pages":"e59423"},"PeriodicalIF":16.4,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11535795/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142465912","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}
<p><strong>Background: </strong>Food safety is a global concern, which is often underestimated owing to challenges in investigating foodborne diseases. These challenges arise from the increased globalization of the food trade, advancements in agricultural practices, and shifts in environmental factors. In North-East India, common diarrheal outbreaks from fermented foods pose significant health risks. Despite these challenges, systematic data on foodborne pathogens is lacking in India, highlighting a crucial gap in understanding food safety issues.</p><p><strong>Objective: </strong>The aim of this research protocol is to establish an integrated surveillance system to identify enteric pathogens circulating within humans, food animals, and the environment through a health approach in North-East India, and to conduct outbreak investigations.</p><p><strong>Methods: </strong>The Indian Council of Medical Research (ICMR) initiated a surveillance study across all 8 North-East states in India, employing a centralized digital database for data collation. The project aims to enhance the infrastructure for microbial culture, antibiotic sensitivity testing, and molecular epidemiological studies. The study involves laboratory-based surveillance of foodborne pathogens in market foods, hospitalized diarrheal patients, poultry and animal farms, slaughterhouses, butcher shops, and diarrheal outbreaks. A standardized case report form ensures consistent data collection of age, sex, signs, symptoms, and admission dates for diarrheal cases. Stool and rectal swabs will undergo testing for pathogen identification and antimicrobial resistance. Similarly, samples of market foods, food animals, and the environment will be collected. Outbreaks confirmed by the Integrated Disease Surveillance Project (IDSP) will be thoroughly investigated following standardized guidelines.</p><p><strong>Results: </strong>In phase I, 5 surveillance centers were established across 4 states (ie, Assam [Dibrugarh and Guwahati], Tripura, Sikkim, and Arunachal Pradesh) in 2020. Following an interim phase I data assessment and the successful establishment of a streamlined system for data procurement, investigation, recording, and analysis, along with the implementation of regular training and monitoring programs, phase II expansion was initiated in 2023-24. This includes the addition of 7 more centers (including 3 veterinary centers) in the remaining 4 states (ie, Manipur, Meghalaya, Mizoram, and Nagaland), eventually covering the entire North-Eastern Region of India.</p><p><strong>Conclusions: </strong>Food and waterborne diseases are a constant public health problem in many countries. Key challenges to the enhancement of food safety policy include the paucity of systematic data and awareness. With this background, ICMR's initiative is the first systematic surveillance study in the country to adopt a single health approach. Data obtained from this project will help to understand the risk of acquir
{"title":"Surveillance of Food and Waterborne Pathogens in North-East India: Protocol for a Laboratory-Based Sentinel Surveillance Study.","authors":"Venencia Albert, Thandavarayan Ramamurthy, Madhuchhanda Das, Samaresh Das, Anup Kumar Ojha, Pallab Sarmah, Dimpu Gogoi, Karma G Dolma, Tapan Majumdar, Indira Sarangthem, Tapan Dutta, Suranjana Chaliha Hazarika","doi":"10.2196/56469","DOIUrl":"10.2196/56469","url":null,"abstract":"<p><strong>Background: </strong>Food safety is a global concern, which is often underestimated owing to challenges in investigating foodborne diseases. These challenges arise from the increased globalization of the food trade, advancements in agricultural practices, and shifts in environmental factors. In North-East India, common diarrheal outbreaks from fermented foods pose significant health risks. Despite these challenges, systematic data on foodborne pathogens is lacking in India, highlighting a crucial gap in understanding food safety issues.</p><p><strong>Objective: </strong>The aim of this research protocol is to establish an integrated surveillance system to identify enteric pathogens circulating within humans, food animals, and the environment through a health approach in North-East India, and to conduct outbreak investigations.</p><p><strong>Methods: </strong>The Indian Council of Medical Research (ICMR) initiated a surveillance study across all 8 North-East states in India, employing a centralized digital database for data collation. The project aims to enhance the infrastructure for microbial culture, antibiotic sensitivity testing, and molecular epidemiological studies. The study involves laboratory-based surveillance of foodborne pathogens in market foods, hospitalized diarrheal patients, poultry and animal farms, slaughterhouses, butcher shops, and diarrheal outbreaks. A standardized case report form ensures consistent data collection of age, sex, signs, symptoms, and admission dates for diarrheal cases. Stool and rectal swabs will undergo testing for pathogen identification and antimicrobial resistance. Similarly, samples of market foods, food animals, and the environment will be collected. Outbreaks confirmed by the Integrated Disease Surveillance Project (IDSP) will be thoroughly investigated following standardized guidelines.</p><p><strong>Results: </strong>In phase I, 5 surveillance centers were established across 4 states (ie, Assam [Dibrugarh and Guwahati], Tripura, Sikkim, and Arunachal Pradesh) in 2020. Following an interim phase I data assessment and the successful establishment of a streamlined system for data procurement, investigation, recording, and analysis, along with the implementation of regular training and monitoring programs, phase II expansion was initiated in 2023-24. This includes the addition of 7 more centers (including 3 veterinary centers) in the remaining 4 states (ie, Manipur, Meghalaya, Mizoram, and Nagaland), eventually covering the entire North-Eastern Region of India.</p><p><strong>Conclusions: </strong>Food and waterborne diseases are a constant public health problem in many countries. Key challenges to the enhancement of food safety policy include the paucity of systematic data and awareness. With this background, ICMR's initiative is the first systematic surveillance study in the country to adopt a single health approach. Data obtained from this project will help to understand the risk of acquir","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"13 ","pages":"e56469"},"PeriodicalIF":1.4,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11535797/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142465839","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}
Yann Thoma, Annie E Cathignol, Yuan J Pétermann, Margaretha L Sariko, Bibie Said, Chantal Csajka, Monia Guidi, Stellah G Mpagama
<p><strong>Background: </strong>The end tuberculosis (TB) strategy requires a novel patient treatment approach contrary to the one-size-fits-all model. It is well known that each patient's physiology is different and leads to various rates of drug elimination. Therapeutic drug monitoring (TDM) offers a way to manage drug dosage adaptation but requires trained pharmacologists, which is scarce in resource-limited settings.</p><p><strong>Objective: </strong>We will develop an automated clinical decision support system (CDSS) to help practitioners with the dosage adaptation of rifampicin, one of the essential medical drugs targeting TB, that is known for large pharmacokinetic variability and frequent suboptimal blood exposure. Such an advanced system will encourage the spread of a dosage-individualization culture, including among practitioners not specialized in pharmacology. Thus, the objectives of this project are to (1) develop the appropriate population pharmacokinetic (popPK) model for rifampicin for Tanzanian patients, (2) optimize the reporting of relevant information to practitioners for drug dosage adjustment, (3) automate the delivery of the report in line with the measurement of drug concentration, and (4) validate and implement the final system in the field.</p><p><strong>Methods: </strong>A total of 3 teams will combine their efforts to deliver the first automated TDM CDSS for TB. A cross-sectional study will be conducted to define the best way to display information to clinicians. In parallel, a rifampicin popPK model will be developed taking advantage of the published literature, complemented with data provided by existing literature data from the Pan-African Consortium for the Evaluation of Antituberculosis Antibiotics (panACEA), and samples collected within this project. A decision tree will be designed and implemented as a CDSS, and an automated report generation will be developed and validated through selected case studies. Expert pharmacologists will validate the CDSS, and finally, field implementation in Tanzania will occur, coupled with a prospective study to assess clinicians' adherence to the CDSS recommendations.</p><p><strong>Results: </strong>The TuberXpert project started in November 2022. In July 2024, the clinical study in Tanzania was completed with the enrollment of 50 patients to gather the required data to build a popPK model for rifampicin, together with a qualitative study defining the report design, as well as the CDSS general architecture definition.</p><p><strong>Conclusions: </strong>At the end of the TuberXpert project, Tanzania will possess a new tool to help the practitioners with the adaptation of drug dosage targeting complicated TB cases (TB or HIV, TB or diabetes mellitus, and TB or malnutrition). This automated system will be validated and used in the field and will be proposed to other countries affected by endemic TB. In addition, this approach will serve as proof of concept regarding the feasibility
{"title":"Toward a Clinical Decision Support System for Monitoring Therapeutic Antituberculosis Medical Drugs in Tanzania (Project TuberXpert): Protocol for an Algorithm' Development and Implementation.","authors":"Yann Thoma, Annie E Cathignol, Yuan J Pétermann, Margaretha L Sariko, Bibie Said, Chantal Csajka, Monia Guidi, Stellah G Mpagama","doi":"10.2196/58720","DOIUrl":"10.2196/58720","url":null,"abstract":"<p><strong>Background: </strong>The end tuberculosis (TB) strategy requires a novel patient treatment approach contrary to the one-size-fits-all model. It is well known that each patient's physiology is different and leads to various rates of drug elimination. Therapeutic drug monitoring (TDM) offers a way to manage drug dosage adaptation but requires trained pharmacologists, which is scarce in resource-limited settings.</p><p><strong>Objective: </strong>We will develop an automated clinical decision support system (CDSS) to help practitioners with the dosage adaptation of rifampicin, one of the essential medical drugs targeting TB, that is known for large pharmacokinetic variability and frequent suboptimal blood exposure. Such an advanced system will encourage the spread of a dosage-individualization culture, including among practitioners not specialized in pharmacology. Thus, the objectives of this project are to (1) develop the appropriate population pharmacokinetic (popPK) model for rifampicin for Tanzanian patients, (2) optimize the reporting of relevant information to practitioners for drug dosage adjustment, (3) automate the delivery of the report in line with the measurement of drug concentration, and (4) validate and implement the final system in the field.</p><p><strong>Methods: </strong>A total of 3 teams will combine their efforts to deliver the first automated TDM CDSS for TB. A cross-sectional study will be conducted to define the best way to display information to clinicians. In parallel, a rifampicin popPK model will be developed taking advantage of the published literature, complemented with data provided by existing literature data from the Pan-African Consortium for the Evaluation of Antituberculosis Antibiotics (panACEA), and samples collected within this project. A decision tree will be designed and implemented as a CDSS, and an automated report generation will be developed and validated through selected case studies. Expert pharmacologists will validate the CDSS, and finally, field implementation in Tanzania will occur, coupled with a prospective study to assess clinicians' adherence to the CDSS recommendations.</p><p><strong>Results: </strong>The TuberXpert project started in November 2022. In July 2024, the clinical study in Tanzania was completed with the enrollment of 50 patients to gather the required data to build a popPK model for rifampicin, together with a qualitative study defining the report design, as well as the CDSS general architecture definition.</p><p><strong>Conclusions: </strong>At the end of the TuberXpert project, Tanzania will possess a new tool to help the practitioners with the adaptation of drug dosage targeting complicated TB cases (TB or HIV, TB or diabetes mellitus, and TB or malnutrition). This automated system will be validated and used in the field and will be proposed to other countries affected by endemic TB. In addition, this approach will serve as proof of concept regarding the feasibility ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"13 ","pages":"e58720"},"PeriodicalIF":1.4,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11535787/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142465841","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: The prevalence of heart failure (HF) is increasing worldwide, with the associated mortality rates rising consistently. Preventing HF progression requires adherence to restricted sodium intake alongside sufficient and balanced nutritional consumption. For patients at home, preparing nutritionally balanced meals is essential, either self-assisted or with the aid of close individuals. Patients with HF frequently experience decreased exercise tolerance, depression, anxiety, and social isolation, which interfere with eating behaviors, leading to inadequate dietary habits. However, measures focusing on the determinants of eating behavior among patients with HF are currently lacking.
Objective: This study aims to develop a self-administered scale to assess the eating behaviors of patients with HF living at home (Self-Administered Eating Behaviors Scale for Heart Failure [SEBS-HF]).
Methods: This study encompasses 3 phases. Phase 1 involves identifying factors influencing eating behaviors in patients with HF. First, a literature review will be conducted using PubMed and CINAHL databases. The specified literature will be analyzed qualitatively and inductively. Additionally, verbatim transcripts obtained from semistructured interviews of patients with HF and medical experts will be qualitatively analyzed. Based on the Phase 1 results, a preliminary scale will be constructed. In Phase 2, cognitive interviews will be conducted with patients with HF and experts; the preliminary scale will be used to qualitatively evaluate its content validity. After validation, the scale will be used in Phase 3 to conduct a cross-sectional study involving patients with HF. In Phase 3, data will be collected from clinical records and self-administered questionnaires or scales. After conducting a preliminary survey, the main survey will be conducted. The reliability and validity of the scale will be assessed using statistical methods.
Results: The first phase of this study commenced in September 2023, and by May 2, 2024, a total of 7 patients with HF and 6 expert professionals were enrolled as study participants. The draft creation of the scale will be completed in 2024, and the content validity evaluation of the draft scale is expected to be finished by early 2025. The third phase will begin its investigation in mid-2025 and is expected to be completed by late 2025, after which the SEBS-HF will be published.
Conclusions: The development and use of this scale will enable a more comprehensive evaluation of the factors influencing eating behaviors in patients with HF. Thus, medical and welfare professionals should provide appropriate support tailored to the specific needs of patients with HF.
International registered report identifier (irrid): DERR1-10.2196/60719.
{"title":"A Self-Administered Eating Behavior Scale for Patients With Heart Failure Living at Home: Protocol for a Mixed Methods Scale Development Study.","authors":"Daisaku Kashiwakura, Akiko Hiyama, Masumi Muramatsu, Atsuko Hinotsu, Michiko Takeda, Norio Suzuki, Sachie Akiyama, Sayuri Kurihara, Keisuke Kida","doi":"10.2196/60719","DOIUrl":"10.2196/60719","url":null,"abstract":"<p><strong>Background: </strong>The prevalence of heart failure (HF) is increasing worldwide, with the associated mortality rates rising consistently. Preventing HF progression requires adherence to restricted sodium intake alongside sufficient and balanced nutritional consumption. For patients at home, preparing nutritionally balanced meals is essential, either self-assisted or with the aid of close individuals. Patients with HF frequently experience decreased exercise tolerance, depression, anxiety, and social isolation, which interfere with eating behaviors, leading to inadequate dietary habits. However, measures focusing on the determinants of eating behavior among patients with HF are currently lacking.</p><p><strong>Objective: </strong>This study aims to develop a self-administered scale to assess the eating behaviors of patients with HF living at home (Self-Administered Eating Behaviors Scale for Heart Failure [SEBS-HF]).</p><p><strong>Methods: </strong>This study encompasses 3 phases. Phase 1 involves identifying factors influencing eating behaviors in patients with HF. First, a literature review will be conducted using PubMed and CINAHL databases. The specified literature will be analyzed qualitatively and inductively. Additionally, verbatim transcripts obtained from semistructured interviews of patients with HF and medical experts will be qualitatively analyzed. Based on the Phase 1 results, a preliminary scale will be constructed. In Phase 2, cognitive interviews will be conducted with patients with HF and experts; the preliminary scale will be used to qualitatively evaluate its content validity. After validation, the scale will be used in Phase 3 to conduct a cross-sectional study involving patients with HF. In Phase 3, data will be collected from clinical records and self-administered questionnaires or scales. After conducting a preliminary survey, the main survey will be conducted. The reliability and validity of the scale will be assessed using statistical methods.</p><p><strong>Results: </strong>The first phase of this study commenced in September 2023, and by May 2, 2024, a total of 7 patients with HF and 6 expert professionals were enrolled as study participants. The draft creation of the scale will be completed in 2024, and the content validity evaluation of the draft scale is expected to be finished by early 2025. The third phase will begin its investigation in mid-2025 and is expected to be completed by late 2025, after which the SEBS-HF will be published.</p><p><strong>Conclusions: </strong>The development and use of this scale will enable a more comprehensive evaluation of the factors influencing eating behaviors in patients with HF. Thus, medical and welfare professionals should provide appropriate support tailored to the specific needs of patients with HF.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/60719.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"13 ","pages":"e60719"},"PeriodicalIF":1.4,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11530741/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142465908","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}
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