Uy Hoang, Utkarsh Agrawal, José Manuel Ordóñez-Mena, Zachary Marcum, Jennifer Radin, Andre Araujo, Catherine A Panozzo, Orsolya Balogh, Mihir Desai, Ahreej Eltayeb, Tianyi Lu, Catia Nicodemo, Xinchun Gu, Rosalind Goudie, Xuejuan Fan, Elizabeth Button, Jessica Smylie, Mark Joy, Gavin Jamie, William Elson, Rachel Byford, Joan Madia, Sneha Anand, Filipa Ferreira, Stavros Petrou, David Martin, Simon de Lusignan
Background: There are gaps in our understanding of the clinical characteristics and disease burden of the respiratory syncytial virus (RSV) among community-dwelling adults. This is in part due to a lack of routine testing at the point of care. More data would enhance our assessment of the need for an RSV vaccination program for adults in the United Kingdom.
Objective: This study aimed to implement point-of-care-testing (POCT) in primary care to describe the incidence, clinical presentation, risk factors, and economic burden of RSV among adults presenting with acute respiratory infection.
Methods: We are recruiting up to 3600 patients from at least 21 practices across England to participate in the Royal College of General Practitioners Research Surveillance Centre. Practices are selected if they undertake reference virology sampling for the Royal College of General Practitioners Research Surveillance Centre and had previous experience with respiratory illness studies. Any adult, ≥40 years old, presenting with acute respiratory infection with onset ≤10 days, but without RSV within the past 28 days, will be eligible to participate. We will estimate the incidence proportion of RSV, describe the clinical features, and risk factors of patients with RSV infection, and measure the economic burden of RSV infection.
Results: A total of 25 practices across different English health administrative regions expressed interest and were recruited to participate. We have created and tested an educational program to deploy POCT for RSV in primary care. In addition to using the POCT device, we provide suggestions about how to integrate POCT into primary care workflow and templates for high-quality data recording of diagnosis, symptoms, and signs. In the 2023-2024 winter RSV detection in the sentinel network grew between October and late November. According to data from the UK Health Security Agency, the peak RSV swab positivity was in International Standards Organization week 48, 2023. Data collection remains ongoing, and results from the subset of practices participating in this study are not yet available.
Conclusions: This study will provide data on the RSV incidence in the community as well as rapid information to inform sentinel surveillance and vaccination programs. This information could potentially improve clinical decision-making.
International registered report identifier (irrid): DERR1-10.2196/60669.
{"title":"Clinical Characteristics of Virologically Confirmed Respiratory Syncytial Virus in English Primary Care: Protocol for an Observational Study of Acute Respiratory Infection.","authors":"Uy Hoang, Utkarsh Agrawal, José Manuel Ordóñez-Mena, Zachary Marcum, Jennifer Radin, Andre Araujo, Catherine A Panozzo, Orsolya Balogh, Mihir Desai, Ahreej Eltayeb, Tianyi Lu, Catia Nicodemo, Xinchun Gu, Rosalind Goudie, Xuejuan Fan, Elizabeth Button, Jessica Smylie, Mark Joy, Gavin Jamie, William Elson, Rachel Byford, Joan Madia, Sneha Anand, Filipa Ferreira, Stavros Petrou, David Martin, Simon de Lusignan","doi":"10.2196/60669","DOIUrl":"10.2196/60669","url":null,"abstract":"<p><strong>Background: </strong>There are gaps in our understanding of the clinical characteristics and disease burden of the respiratory syncytial virus (RSV) among community-dwelling adults. This is in part due to a lack of routine testing at the point of care. More data would enhance our assessment of the need for an RSV vaccination program for adults in the United Kingdom.</p><p><strong>Objective: </strong>This study aimed to implement point-of-care-testing (POCT) in primary care to describe the incidence, clinical presentation, risk factors, and economic burden of RSV among adults presenting with acute respiratory infection.</p><p><strong>Methods: </strong>We are recruiting up to 3600 patients from at least 21 practices across England to participate in the Royal College of General Practitioners Research Surveillance Centre. Practices are selected if they undertake reference virology sampling for the Royal College of General Practitioners Research Surveillance Centre and had previous experience with respiratory illness studies. Any adult, ≥40 years old, presenting with acute respiratory infection with onset ≤10 days, but without RSV within the past 28 days, will be eligible to participate. We will estimate the incidence proportion of RSV, describe the clinical features, and risk factors of patients with RSV infection, and measure the economic burden of RSV infection.</p><p><strong>Results: </strong>A total of 25 practices across different English health administrative regions expressed interest and were recruited to participate. We have created and tested an educational program to deploy POCT for RSV in primary care. In addition to using the POCT device, we provide suggestions about how to integrate POCT into primary care workflow and templates for high-quality data recording of diagnosis, symptoms, and signs. In the 2023-2024 winter RSV detection in the sentinel network grew between October and late November. According to data from the UK Health Security Agency, the peak RSV swab positivity was in International Standards Organization week 48, 2023. Data collection remains ongoing, and results from the subset of practices participating in this study are not yet available.</p><p><strong>Conclusions: </strong>This study will provide data on the RSV incidence in the community as well as rapid information to inform sentinel surveillance and vaccination programs. This information could potentially improve clinical decision-making.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/60669.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e60669"},"PeriodicalIF":1.4,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11799813/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143005726","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}
Jillian A Johnson, Matthew J Zawadzki, Martin J Sliwinski, David M Almeida, Orfeu M Buxton, David E Conroy, David Marcusson-Clavertz, Jinhyuk Kim, Robert S Stawski, Stacey B Scott, Christopher N Sciamanna, Paige A Green, Emily M Repka, Meynard John L Toledo, Nicole L Sturges, Joshua M Smyth
<p><strong>Background: </strong>Personalized approaches to behavior change to improve mental and physical health outcomes are needed. Reducing the intensity, duration, and frequency of stress responses is a mechanism for interventions to improve health behaviors. We developed an ambulatory, dynamic stress measurement approach that can identify personalized stress responses in the moments and contexts in which they occur; we propose that intervening in these stress responses as they arise (ie, just in time; JIT) will result in positive impacts on health behaviors.</p><p><strong>Objective: </strong>This study aims to (1) use an experimental medicine approach to evaluate the impact of a smartphone-delivered JIT stress management intervention on the frequency and intensity of person-specific stress responses (ie, stress reactivity, nonrecovery, and pileup); (2) evaluate the impact of the JIT intervention on the enactment of health behaviors in everyday life (physical activity and sleep); and (3) explore whether changes in stress responses mediate the interventions' effects on health behaviors.</p><p><strong>Methods: </strong>In a 2-arm phase 2 clinical trial, we will enroll 210 adults in either a JIT stress management intervention or an active control condition. For 4 weeks, participants will complete 8 brief smartphone surveys each day and wear devices to assess sleep and physical activity. After a 1-week run-in period, participants will be randomized into the JIT intervention or an active control condition for 2 weeks. Participants in the JIT intervention will receive very brief stress management activities when reporting greater than typical stress responses, whereas control participants will receive no personalized stress management activities. Participants enrolled in both conditions will engage in self-monitoring for the entire study period and have access to a general stress management education module. Self-report outcomes will be assessed again 1 month after the intervention. We will use mixed-effects models to evaluate differences in person-specific stress responses between the intervention and control groups. We will conduct parallel analyses to evaluate whether the intervention is associated with improvement in health behavior enactment (ie, sleep and physical activity). The Pennsylvania State University Institutional Review Board approved all study procedures (STUDY00012740).</p><p><strong>Results: </strong>Initial participant recruitment for the trial was initiated on August 15, 2022, and enrollment was completed on June 9, 2023. A total of 213 participants were enrolled in this period. Data are currently being processed; analyses have not yet begun.</p><p><strong>Conclusions: </strong>We anticipate that this research will contribute to advancing stress measurement, thereby enhancing understanding of health behavior change mechanisms and, more broadly, providing a conceptual roadmap to advance JIT interventions aimed at improving stress
{"title":"Adaptive Just-in-Time Intervention to Reduce Everyday Stress Responses: Protocol for a Randomized Controlled Trial.","authors":"Jillian A Johnson, Matthew J Zawadzki, Martin J Sliwinski, David M Almeida, Orfeu M Buxton, David E Conroy, David Marcusson-Clavertz, Jinhyuk Kim, Robert S Stawski, Stacey B Scott, Christopher N Sciamanna, Paige A Green, Emily M Repka, Meynard John L Toledo, Nicole L Sturges, Joshua M Smyth","doi":"10.2196/58985","DOIUrl":"10.2196/58985","url":null,"abstract":"<p><strong>Background: </strong>Personalized approaches to behavior change to improve mental and physical health outcomes are needed. Reducing the intensity, duration, and frequency of stress responses is a mechanism for interventions to improve health behaviors. We developed an ambulatory, dynamic stress measurement approach that can identify personalized stress responses in the moments and contexts in which they occur; we propose that intervening in these stress responses as they arise (ie, just in time; JIT) will result in positive impacts on health behaviors.</p><p><strong>Objective: </strong>This study aims to (1) use an experimental medicine approach to evaluate the impact of a smartphone-delivered JIT stress management intervention on the frequency and intensity of person-specific stress responses (ie, stress reactivity, nonrecovery, and pileup); (2) evaluate the impact of the JIT intervention on the enactment of health behaviors in everyday life (physical activity and sleep); and (3) explore whether changes in stress responses mediate the interventions' effects on health behaviors.</p><p><strong>Methods: </strong>In a 2-arm phase 2 clinical trial, we will enroll 210 adults in either a JIT stress management intervention or an active control condition. For 4 weeks, participants will complete 8 brief smartphone surveys each day and wear devices to assess sleep and physical activity. After a 1-week run-in period, participants will be randomized into the JIT intervention or an active control condition for 2 weeks. Participants in the JIT intervention will receive very brief stress management activities when reporting greater than typical stress responses, whereas control participants will receive no personalized stress management activities. Participants enrolled in both conditions will engage in self-monitoring for the entire study period and have access to a general stress management education module. Self-report outcomes will be assessed again 1 month after the intervention. We will use mixed-effects models to evaluate differences in person-specific stress responses between the intervention and control groups. We will conduct parallel analyses to evaluate whether the intervention is associated with improvement in health behavior enactment (ie, sleep and physical activity). The Pennsylvania State University Institutional Review Board approved all study procedures (STUDY00012740).</p><p><strong>Results: </strong>Initial participant recruitment for the trial was initiated on August 15, 2022, and enrollment was completed on June 9, 2023. A total of 213 participants were enrolled in this period. Data are currently being processed; analyses have not yet begun.</p><p><strong>Conclusions: </strong>We anticipate that this research will contribute to advancing stress measurement, thereby enhancing understanding of health behavior change mechanisms and, more broadly, providing a conceptual roadmap to advance JIT interventions aimed at improving stress","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e58985"},"PeriodicalIF":1.4,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11799819/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143023435","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>In South Africa, there is no centralized HIV surveillance system where key populations (KPs) data, including gay men and other men who have sex with men, female sex workers, transgender persons, people who use drugs, and incarcerated persons, are stored in South Africa despite being on higher risk of HIV acquisition and transmission than the general population. Data on KPs are being collected on a smaller scale by numerous stakeholders and managed in silos. There exists an opportunity to harness a variety of data, such as empirical, contextual, observational, and programmatic data, for evaluating the potential impact of HIV responses among KPs in South Africa.</p><p><strong>Objective: </strong>This study aimed to leverage and harness big heterogeneous data on HIV among KPs and harmonize and analyze it to inform a targeted HIV response for greater impact in Sub-Saharan Africa.</p><p><strong>Methods: </strong>The Boloka data repository initiative has 5 stages. There will be engagement of a wide range of stakeholders to facilitate the acquisition of data (stage 1). Through these engagements, different data types will be collated (stage 2). The data will be filtered and screened to enable high-quality analyses (stage 3). The collated data will be stored in the Boloka data repository (stage 4). The Boloka data repository will be made accessible to stakeholders and authorized users (stage 5).</p><p><strong>Results: </strong>The protocol was funded by the South African Medical Research Council following external peer reviews (December 2022). The study received initial ethics approval (May 2022), renewal (June 2023), and amendment (July 2024) from the University of Johannesburg (UJ) Research Ethics Committee. The research team has been recruited, onboarded, and received non-web-based internet ethics training (January 2023). A list of current and potential data partners has been compiled (January 2023 to date). Data sharing or user agreements have been signed with several data partners (August 2023 to date). Survey and routine data have been and are being secured (January 5, 2023). In (September 2024) we received Ghana Men Study data. The data transfer agreement between the Pan African Centre for Epidemics Research and the Perinatal HIV Research Unit was finalized (October 2024), and we are anticipating receiving data by (December 2024). In total, 7 abstracts are underway, with 1 abstract completed the analysis and expected to submit the full article to the peer-reviewed journal in early January 2024. As of March 2025, we expect to submit the remaining 6 full articles.</p><p><strong>Conclusions: </strong>A truly "complete" data infrastructure that systematically and rigorously integrates diverse data for KPs will not only improve our understanding of local epidemics but will also improve HIV interventions and policies. Furthermore, it will inform future research directions and become an incredible institutional mechanism fo
{"title":"Harnessing Big Heterogeneous Data to Evaluate the Potential Impact of HIV Responses Among Key Populations in Sub-Saharan Africa: Protocol for the Boloka Data Repository Initiative.","authors":"Refilwe Nancy Phaswana Mafuya, Edith Phalane, Amrita Rao, Kalai Willis, Katherine Rucinski, K Alida Voet, Amal Abdulrahman, Claris Siyamayambo, Betty Sebati, Mohlago Seloka, Musa Jaiteh, Lerato Lucia Olifant, Katharine Journeay, Haley Sisel, Xiaoming Li, Bankole Olatosi, Neset Hikmet, Prashant Duhoon, Francois Wolmarans, Yegnanew A Shiferaw, Lifutso Motsieloa, Mashudu Rampilo, Stefan Baral","doi":"10.2196/63583","DOIUrl":"10.2196/63583","url":null,"abstract":"<p><strong>Background: </strong>In South Africa, there is no centralized HIV surveillance system where key populations (KPs) data, including gay men and other men who have sex with men, female sex workers, transgender persons, people who use drugs, and incarcerated persons, are stored in South Africa despite being on higher risk of HIV acquisition and transmission than the general population. Data on KPs are being collected on a smaller scale by numerous stakeholders and managed in silos. There exists an opportunity to harness a variety of data, such as empirical, contextual, observational, and programmatic data, for evaluating the potential impact of HIV responses among KPs in South Africa.</p><p><strong>Objective: </strong>This study aimed to leverage and harness big heterogeneous data on HIV among KPs and harmonize and analyze it to inform a targeted HIV response for greater impact in Sub-Saharan Africa.</p><p><strong>Methods: </strong>The Boloka data repository initiative has 5 stages. There will be engagement of a wide range of stakeholders to facilitate the acquisition of data (stage 1). Through these engagements, different data types will be collated (stage 2). The data will be filtered and screened to enable high-quality analyses (stage 3). The collated data will be stored in the Boloka data repository (stage 4). The Boloka data repository will be made accessible to stakeholders and authorized users (stage 5).</p><p><strong>Results: </strong>The protocol was funded by the South African Medical Research Council following external peer reviews (December 2022). The study received initial ethics approval (May 2022), renewal (June 2023), and amendment (July 2024) from the University of Johannesburg (UJ) Research Ethics Committee. The research team has been recruited, onboarded, and received non-web-based internet ethics training (January 2023). A list of current and potential data partners has been compiled (January 2023 to date). Data sharing or user agreements have been signed with several data partners (August 2023 to date). Survey and routine data have been and are being secured (January 5, 2023). In (September 2024) we received Ghana Men Study data. The data transfer agreement between the Pan African Centre for Epidemics Research and the Perinatal HIV Research Unit was finalized (October 2024), and we are anticipating receiving data by (December 2024). In total, 7 abstracts are underway, with 1 abstract completed the analysis and expected to submit the full article to the peer-reviewed journal in early January 2024. As of March 2025, we expect to submit the remaining 6 full articles.</p><p><strong>Conclusions: </strong>A truly \"complete\" data infrastructure that systematically and rigorously integrates diverse data for KPs will not only improve our understanding of local epidemics but will also improve HIV interventions and policies. Furthermore, it will inform future research directions and become an incredible institutional mechanism fo","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e63583"},"PeriodicalIF":1.4,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11799808/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143023517","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}
Francesca Mastorci, Maria Francesca Lodovica Lazzeri, Lamia Ait-Ali, Paolo Marcheschi, Paola Quadrelli, Massimiliano Mariani, Rafik Margaryan, Wanda Pennè, Marco Savino, Giuseppe Prencipe, Alina Sirbu, Paolo Ferragina, Corrado Priami, Alessandro Tommasi, Cesare Zavattari, Pierluigi Festa, Stefano Dalmiani, Alessandro Pingitore
<p><strong>Background: </strong>Among cardiovascular diseases, adult patients with congenital heart disease represent a population that has been continuously increasing, which is mainly due to improvement of the pathophysiological framing, including the development of surgical and reanimation techniques. However, approximately 20% of these patients will require surgery in adulthood and 40% of these cases will necessitate reintervention for residual defects or sequelae of childhood surgery. In this field, cardiac rehabilitation (CR) in the postsurgical phase has an important impact on the patient by improving psychophysical and clinical recovery in reducing fatigue and dyspnea to ultimately increase survival. In this context, compliance with the rehabilitation program is a key element for the therapeutic benefits of the program. The increase of mobile health care devices and software has greatly extended self-care capabilities across the spectrum of health care activities. Moreover, the possibility of telemonitoring the progress of this self-care provides elements of empowerment and awareness of one's state of health. As a branch of telehealth, CR can be optimized and facilitated using remote telemedicine devices.</p><p><strong>Objective: </strong>The principal goal of the Innovation in Postoperative Rehabilitation Training and Monitoring (IPOTERI) study is to design, realize, and test a composite and integrated system for postsurgical rehabilitation therapies at home specialized for cardiac surgery. The secondary aims are to implement the system in a "real-life" context of postcardiac surgical rehabilitation, and to create a data set and a data collection methodology to prototype data analytics algorithms and artificial intelligence techniques for customizing the rehabilitation pathway.</p><p><strong>Methods: </strong>The IPOTERI method consists of a telemonitoring platform that guarantees continuity of postoperative care, an intelligent home station based on an Android app for the patient with a user-friendly interface to record vital signals (electrocardiogram, blood pressure, oxygen saturation, and body weight) and access the planning of rehabilitation activities, and a decision support system that communicates with hospital medical records to transmit alerts and specific support information for the formulation and updating of the treatment and care plan.</p><p><strong>Results: </strong>The pilot test started in June 2023 (protocol number 20406/2021) including 50 patients who will be monitored for 12-14 weeks using the developed platform, as described in the Procedures subsection of the Methods section.</p><p><strong>Conclusions: </strong>The IPOTERI approach, based on the processing of data recorded during the monitoring of telemedicine devices used at home during the postsurgical rehabilitation of a cardiac patient, together with clinical data from the perioperative and postoperative periods could have positive effects on adherence to the re
{"title":"Home-Based Intervention Tool for Cardiac Telerehabilitation: Protocol for a Controlled Trial.","authors":"Francesca Mastorci, Maria Francesca Lodovica Lazzeri, Lamia Ait-Ali, Paolo Marcheschi, Paola Quadrelli, Massimiliano Mariani, Rafik Margaryan, Wanda Pennè, Marco Savino, Giuseppe Prencipe, Alina Sirbu, Paolo Ferragina, Corrado Priami, Alessandro Tommasi, Cesare Zavattari, Pierluigi Festa, Stefano Dalmiani, Alessandro Pingitore","doi":"10.2196/47951","DOIUrl":"10.2196/47951","url":null,"abstract":"<p><strong>Background: </strong>Among cardiovascular diseases, adult patients with congenital heart disease represent a population that has been continuously increasing, which is mainly due to improvement of the pathophysiological framing, including the development of surgical and reanimation techniques. However, approximately 20% of these patients will require surgery in adulthood and 40% of these cases will necessitate reintervention for residual defects or sequelae of childhood surgery. In this field, cardiac rehabilitation (CR) in the postsurgical phase has an important impact on the patient by improving psychophysical and clinical recovery in reducing fatigue and dyspnea to ultimately increase survival. In this context, compliance with the rehabilitation program is a key element for the therapeutic benefits of the program. The increase of mobile health care devices and software has greatly extended self-care capabilities across the spectrum of health care activities. Moreover, the possibility of telemonitoring the progress of this self-care provides elements of empowerment and awareness of one's state of health. As a branch of telehealth, CR can be optimized and facilitated using remote telemedicine devices.</p><p><strong>Objective: </strong>The principal goal of the Innovation in Postoperative Rehabilitation Training and Monitoring (IPOTERI) study is to design, realize, and test a composite and integrated system for postsurgical rehabilitation therapies at home specialized for cardiac surgery. The secondary aims are to implement the system in a \"real-life\" context of postcardiac surgical rehabilitation, and to create a data set and a data collection methodology to prototype data analytics algorithms and artificial intelligence techniques for customizing the rehabilitation pathway.</p><p><strong>Methods: </strong>The IPOTERI method consists of a telemonitoring platform that guarantees continuity of postoperative care, an intelligent home station based on an Android app for the patient with a user-friendly interface to record vital signals (electrocardiogram, blood pressure, oxygen saturation, and body weight) and access the planning of rehabilitation activities, and a decision support system that communicates with hospital medical records to transmit alerts and specific support information for the formulation and updating of the treatment and care plan.</p><p><strong>Results: </strong>The pilot test started in June 2023 (protocol number 20406/2021) including 50 patients who will be monitored for 12-14 weeks using the developed platform, as described in the Procedures subsection of the Methods section.</p><p><strong>Conclusions: </strong>The IPOTERI approach, based on the processing of data recorded during the monitoring of telemedicine devices used at home during the postsurgical rehabilitation of a cardiac patient, together with clinical data from the perioperative and postoperative periods could have positive effects on adherence to the re","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e47951"},"PeriodicalIF":1.4,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11799807/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143005077","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}
Henriette Louise Möllmann, Eman Alhammadi, Soufian Boulghoudan, Julian Kuhlmann, Anica Mevissen, Philipp Olbrich, Louisa Rahm, Helmut Frohnhofen
Background: An aging population in combination with more gentle and less stressful surgical procedures leads to an increased number of operations on older patients. This collectively raises novel challenges due to higher age heavily impacting treatment. A major problem, emerging in up to 50% of cases, is perioperative delirium. It is thus vital to understand whether and which existing geriatric assessments are capable of reliably identifying risk factors, how high the incidence of delirium is, and whether the resulting management of these risk factors might lead to a reduced incidence of delirium.
Objective: This study aimed to determine the frequency and severity of geriatric medical problems in elective patients of the Clinics of Oral and Maxillofacial Surgery, Vascular Surgery, and Orthopedics, General Surgery, and Trauma Surgery, revealing associations with the incidence of perioperative delirium regarding potential risk factors, and recording the long-term effects of geriatric problems and any perioperative delirium that might have developed later the patient's life.
Methods: We performed both pre- and postoperative assessments in patients of 4 different surgical departments who are older than 70 years. Patient-validated screening instruments will be used to identify risk factors. A geriatric assessment with the content of basal and instrumental activities of daily living (basal activities of daily living [Katz index], instrumental activities of daily living [Lawton and Brody score], cognition [6-item screener and clock drawing test], mobility [de Morton Mobility Index and Sit-to-Stand test], sleep [Pittsburgh Sleep Quality Index and Insomnia Severity Index/STOP-BANG], drug therapy [polypharmacy and quality of medication, Fit For The Aged classification, and anticholinergic burden score], and pain assessment and delirium risk (Delirium Risk Assessment Tool) will be performed. Any medical problems detected will be treated according to current standards, and no intervention is planned as part of the study. In addition, a telephone follow-up will be performed 3, 6, and 12 months after discharge.
Results: Recruitment started in August 2022, with 421 patients already recruited at the time of submission. Initial analyses of the data are to be published at the end of 2024 or the beginning of 2025.
Conclusions: In the current study, we investigate whether the risk factors addressed in the assessment are associated with an increase in the delirium rate. The aim is then to reduce this comprehensive assessment to the central aspects to be able to conduct targeted and efficient risk screening.
Trial registration: German Clinical Trials Registry DRKS00028614; https://www.drks.de/search/de/trial/DRKS00028614.
International registered report identifier (irrid): DERR1-10.2196/59203.
{"title":"Assessment of Geriatric Problems and Risk Factors for Delirium in Surgical Medicine: Protocol for Multidisciplinary Prospective Clinical Study.","authors":"Henriette Louise Möllmann, Eman Alhammadi, Soufian Boulghoudan, Julian Kuhlmann, Anica Mevissen, Philipp Olbrich, Louisa Rahm, Helmut Frohnhofen","doi":"10.2196/59203","DOIUrl":"10.2196/59203","url":null,"abstract":"<p><strong>Background: </strong>An aging population in combination with more gentle and less stressful surgical procedures leads to an increased number of operations on older patients. This collectively raises novel challenges due to higher age heavily impacting treatment. A major problem, emerging in up to 50% of cases, is perioperative delirium. It is thus vital to understand whether and which existing geriatric assessments are capable of reliably identifying risk factors, how high the incidence of delirium is, and whether the resulting management of these risk factors might lead to a reduced incidence of delirium.</p><p><strong>Objective: </strong>This study aimed to determine the frequency and severity of geriatric medical problems in elective patients of the Clinics of Oral and Maxillofacial Surgery, Vascular Surgery, and Orthopedics, General Surgery, and Trauma Surgery, revealing associations with the incidence of perioperative delirium regarding potential risk factors, and recording the long-term effects of geriatric problems and any perioperative delirium that might have developed later the patient's life.</p><p><strong>Methods: </strong>We performed both pre- and postoperative assessments in patients of 4 different surgical departments who are older than 70 years. Patient-validated screening instruments will be used to identify risk factors. A geriatric assessment with the content of basal and instrumental activities of daily living (basal activities of daily living [Katz index], instrumental activities of daily living [Lawton and Brody score], cognition [6-item screener and clock drawing test], mobility [de Morton Mobility Index and Sit-to-Stand test], sleep [Pittsburgh Sleep Quality Index and Insomnia Severity Index/STOP-BANG], drug therapy [polypharmacy and quality of medication, Fit For The Aged classification, and anticholinergic burden score], and pain assessment and delirium risk (Delirium Risk Assessment Tool) will be performed. Any medical problems detected will be treated according to current standards, and no intervention is planned as part of the study. In addition, a telephone follow-up will be performed 3, 6, and 12 months after discharge.</p><p><strong>Results: </strong>Recruitment started in August 2022, with 421 patients already recruited at the time of submission. Initial analyses of the data are to be published at the end of 2024 or the beginning of 2025.</p><p><strong>Conclusions: </strong>In the current study, we investigate whether the risk factors addressed in the assessment are associated with an increase in the delirium rate. The aim is then to reduce this comprehensive assessment to the central aspects to be able to conduct targeted and efficient risk screening.</p><p><strong>Trial registration: </strong>German Clinical Trials Registry DRKS00028614; https://www.drks.de/search/de/trial/DRKS00028614.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/59203.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e59203"},"PeriodicalIF":1.4,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11799817/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143005704","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: In recent years, the intersection of natural language processing (NLP) and public health has opened innovative pathways for investigating social determinants of health (SDOH) in textual datasets. Despite the promise of NLP in the SDOH domain, the literature is dispersed across various disciplines, and there is a need to consolidate existing knowledge, identify knowledge gaps in the literature, and inform future research directions in this emerging field.
Objective: This research protocol describes a systematic review to identify and highlight NLP techniques, including large language models, used for SDOH-related studies.
Methods: A search strategy will be executed across PubMed, Web of Science, IEEE Xplore, Scopus, PsycINFO, HealthSource: Academic Nursing, and ACL Anthology to find studies published in English between 2014 and 2024. Three reviewers (SR, ZZ, and YC) will independently screen the studies to avoid voting bias, and two (AS and YX) additional reviewers will resolve any conflicts during the screening process. We will further screen studies that cited the included studies (forward search). Following the title abstract and full-text screening, the characteristics and main findings of the included studies and resources will be tabulated, visualized, and summarized.
Results: The search strategy was formulated and run across the 7 databases in August 2024. We expect the results to be submitted for peer review publication in early 2025. As of December 2024, the title and abstract screening was underway.
Conclusions: This systematic review aims to provide a comprehensive study of existing research on the application of NLP for various SDOH tasks across multiple textual datasets. By rigorously evaluating the methodologies, tools, and outcomes of eligible studies, the review will identify gaps in current knowledge and suggest directions for future research in the form of specific research questions. The findings will be instrumental in developing more effective NLP models for SDOH, ultimately contributing to improved health outcomes and a better understanding of social determinants in diverse populations.
International registered report identifier (irrid): DERR1-10.2196/66094.
背景：近年来，自然语言处理（NLP）和公共卫生的交叉研究为在文本数据集中研究健康的社会决定因素（SDOH）开辟了创新途径。尽管NLP在SDOH领域的前景光明，但文献分散在各个学科中，需要巩固现有知识，识别文献中的知识空白，并为这一新兴领域的未来研究方向提供信息。目的：本研究方案描述了一项系统综述，以识别和突出用于sdoh相关研究的NLP技术，包括大型语言模型。方法：在PubMed、Web of Science、IEEE explore、Scopus、PsycINFO、HealthSource: Academic Nursing和ACL Anthology上执行搜索策略，查找2014年至2024年间发表的英文研究。三名审稿人（SR、ZZ和YC）将独立筛选研究以避免投票偏倚，另外两名审稿人（AS和YX）将解决筛选过程中的任何冲突。我们将进一步筛选引用纳入研究的研究（前向检索）。在标题摘要和全文筛选之后，将对纳入的研究和资源的特征和主要发现进行制表、可视化和总结。结果：制定了检索策略，并于2024年8月在7个数据库中运行。我们预计研究结果将于2025年初提交同行评议。截至2024年12月，片名和摘要放映正在进行中。结论：本系统综述旨在对NLP在不同文本数据集上应用于各种SDOH任务的现有研究进行全面研究。通过严格评估方法、工具和合格研究的结果，本综述将确定当前知识的差距，并以具体研究问题的形式为未来的研究提出方向。这些发现将有助于为SDOH开发更有效的NLP模型，最终有助于改善健康结果和更好地了解不同人群的社会决定因素。国际注册报告标识符（irrid）： DERR1-10.2196/66094。
{"title":"Applications of Natural Language Processing and Large Language Models for Social Determinants of Health: Protocol for a Systematic Review.","authors":"Swati Rajwal, Ziyuan Zhang, Yankai Chen, Hannah Rogers, Abeed Sarker, Yunyu Xiao","doi":"10.2196/66094","DOIUrl":"10.2196/66094","url":null,"abstract":"<p><strong>Background: </strong>In recent years, the intersection of natural language processing (NLP) and public health has opened innovative pathways for investigating social determinants of health (SDOH) in textual datasets. Despite the promise of NLP in the SDOH domain, the literature is dispersed across various disciplines, and there is a need to consolidate existing knowledge, identify knowledge gaps in the literature, and inform future research directions in this emerging field.</p><p><strong>Objective: </strong>This research protocol describes a systematic review to identify and highlight NLP techniques, including large language models, used for SDOH-related studies.</p><p><strong>Methods: </strong>A search strategy will be executed across PubMed, Web of Science, IEEE Xplore, Scopus, PsycINFO, HealthSource: Academic Nursing, and ACL Anthology to find studies published in English between 2014 and 2024. Three reviewers (SR, ZZ, and YC) will independently screen the studies to avoid voting bias, and two (AS and YX) additional reviewers will resolve any conflicts during the screening process. We will further screen studies that cited the included studies (forward search). Following the title abstract and full-text screening, the characteristics and main findings of the included studies and resources will be tabulated, visualized, and summarized.</p><p><strong>Results: </strong>The search strategy was formulated and run across the 7 databases in August 2024. We expect the results to be submitted for peer review publication in early 2025. As of December 2024, the title and abstract screening was underway.</p><p><strong>Conclusions: </strong>This systematic review aims to provide a comprehensive study of existing research on the application of NLP for various SDOH tasks across multiple textual datasets. By rigorously evaluating the methodologies, tools, and outcomes of eligible studies, the review will identify gaps in current knowledge and suggest directions for future research in the form of specific research questions. The findings will be instrumental in developing more effective NLP models for SDOH, ultimately contributing to improved health outcomes and a better understanding of social determinants in diverse populations.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/66094.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e66094"},"PeriodicalIF":1.4,"publicationDate":"2025-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11795155/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143005700","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: Gender is known to have a strong influence on human health and disease. Despite its relevance to treatment and outcome, gender is insufficiently considered in current health research. One hindering factor is the poor representation of gender information in clinical and health (meta) data.
Objective: We aim to conduct a scoping review of the literature describing gender scores. The review will provide insights into the current application of gender scores in clinical and health settings. The protocol describes how relevant literature will be identified and how gender scores will be evaluated concerning applicability and usability in scientific investigations.
Methods: Our scoping review follows the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. A title and abstract screening was conducted on PubMed, followed by a full-text screening. The inclusion and exclusion criteria were discussed by a team of 5 domain experts, and a data-charting form was developed. The charted data will be categorized, summarized, and analyzed based on the research questions during the scoping review.
Results: We will report our research results according to the PRISMA-ScR guidelines. The literature retrieval was carried out on June 13, 2024, and resulted in 1202 matches. As of July 2024, the scoping review is in the data extraction phase and we expect to complete and publish the results in the first quarter of 2025.
Conclusions: The scoping review lays the foundation for a retrospective gender assessment by identifying scores that can be applied to existing large-scale datasets. Moreover, it will help to formulate recommendations for standardized gender scores in future investigations.
International registered report identifier (irrid): DERR1-10.2196/57669.
{"title":"Applicability of Retrospective and Prospective Gender Scores for Clinical and Health Data: Protocol for a Scoping Review.","authors":"Lea Schindler, Hilke Beelich, Selina Röll, Elpiniki Katsari, Sylvia Stracke, Dagmar Waltemath","doi":"10.2196/57669","DOIUrl":"10.2196/57669","url":null,"abstract":"<p><strong>Background: </strong>Gender is known to have a strong influence on human health and disease. Despite its relevance to treatment and outcome, gender is insufficiently considered in current health research. One hindering factor is the poor representation of gender information in clinical and health (meta) data.</p><p><strong>Objective: </strong>We aim to conduct a scoping review of the literature describing gender scores. The review will provide insights into the current application of gender scores in clinical and health settings. The protocol describes how relevant literature will be identified and how gender scores will be evaluated concerning applicability and usability in scientific investigations.</p><p><strong>Methods: </strong>Our scoping review follows the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. A title and abstract screening was conducted on PubMed, followed by a full-text screening. The inclusion and exclusion criteria were discussed by a team of 5 domain experts, and a data-charting form was developed. The charted data will be categorized, summarized, and analyzed based on the research questions during the scoping review.</p><p><strong>Results: </strong>We will report our research results according to the PRISMA-ScR guidelines. The literature retrieval was carried out on June 13, 2024, and resulted in 1202 matches. As of July 2024, the scoping review is in the data extraction phase and we expect to complete and publish the results in the first quarter of 2025.</p><p><strong>Conclusions: </strong>The scoping review lays the foundation for a retrospective gender assessment by identifying scores that can be applied to existing large-scale datasets. Moreover, it will help to formulate recommendations for standardized gender scores in future investigations.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/57669.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e57669"},"PeriodicalIF":1.4,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11791438/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143005692","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}
Jing Zhao, Akitomo Yasunaga, Andrew T Kaczynski, Hyuntae Park, Yufeng Luo, Jiuling Li, Ai Shibata, Kaori Ishii, Shohei Yano, Koichiro Oka, Mohammad Javad Koohsari
Background: The worldwide rise in the prevalence of noncommunicable diseases has increased the recognition of the need to identify modifiable risk factors for preventing and managing these diseases. The office worker, as a representative group of physically inactive workers, is exposed to risk factors for metabolic syndrome, which is a primary driver of noncommunicable diseases. The use of virtual reality (VR) exergames may offer a potential solution to the problem of increasing noncommunicable disease prevalence, as it can help individuals increase their physical activity levels while providing a more immersive experience.
Objective: This exploratory study aims to examine the interventional efficacy of at-home immersive VR exergames on metabolic syndrome biomarkers among office workers. Additionally, it seeks to investigate the impacts of at-home immersive VR exergames on the active and sedentary behaviors of office workers.
Methods: A 3-arm, single-blinded pilot randomized controlled trial will be conducted to examine the therapeutic effects of at-home immersive VR exergames. A total of 120 Chinese office workers, engaging in less than 150 minutes per week of moderate to vigorous intensity physical activity, will be recruited via a convenience sampling method. The participants, who will be tested over a 12-week period, will be randomly assigned to one of three groups: (1) the VR exergame intervention group, (2) the regular physical activity control group, and (3) the nonexercise control group. Throughout the 12-week trial, three categories of variables will be collected across the three groups: clinical risk factors associated with metabolic syndrome, active and sedentary behaviors, and demographics. To analyze variance among the groups, a mixed linear model will be applied to assess the efficacy of each group. Differences in metabolic syndrome clinical risk factors among all groups will be used to evaluate the effects of at-home immersive VR exergames. Changes in active and sedentary behaviors will also be used to determine the impacts of VR exergames on metabolic syndrome.
Results: The ethics committee of Guangzhou University, China, approved this study on September 25, 2024. Participant recruitment will begin in early 2025 and continue for approximately 3 months. Data will be analyzed after the 12-week trial is completed, with full results expected to be presented in early 2026.
Conclusions: This study explores an emerging topic by applying an at-home immersive VR exergame intervention, potentially contributing to understanding the effects of an exergame program on metabolic syndrome risk among office workers.
{"title":"At-Home Immersive Virtual Reality Exergames to Reduce Cardiometabolic Risk Among Office Workers: Protocol for a Randomized Controlled Trial.","authors":"Jing Zhao, Akitomo Yasunaga, Andrew T Kaczynski, Hyuntae Park, Yufeng Luo, Jiuling Li, Ai Shibata, Kaori Ishii, Shohei Yano, Koichiro Oka, Mohammad Javad Koohsari","doi":"10.2196/64560","DOIUrl":"10.2196/64560","url":null,"abstract":"<p><strong>Background: </strong>The worldwide rise in the prevalence of noncommunicable diseases has increased the recognition of the need to identify modifiable risk factors for preventing and managing these diseases. The office worker, as a representative group of physically inactive workers, is exposed to risk factors for metabolic syndrome, which is a primary driver of noncommunicable diseases. The use of virtual reality (VR) exergames may offer a potential solution to the problem of increasing noncommunicable disease prevalence, as it can help individuals increase their physical activity levels while providing a more immersive experience.</p><p><strong>Objective: </strong>This exploratory study aims to examine the interventional efficacy of at-home immersive VR exergames on metabolic syndrome biomarkers among office workers. Additionally, it seeks to investigate the impacts of at-home immersive VR exergames on the active and sedentary behaviors of office workers.</p><p><strong>Methods: </strong>A 3-arm, single-blinded pilot randomized controlled trial will be conducted to examine the therapeutic effects of at-home immersive VR exergames. A total of 120 Chinese office workers, engaging in less than 150 minutes per week of moderate to vigorous intensity physical activity, will be recruited via a convenience sampling method. The participants, who will be tested over a 12-week period, will be randomly assigned to one of three groups: (1) the VR exergame intervention group, (2) the regular physical activity control group, and (3) the nonexercise control group. Throughout the 12-week trial, three categories of variables will be collected across the three groups: clinical risk factors associated with metabolic syndrome, active and sedentary behaviors, and demographics. To analyze variance among the groups, a mixed linear model will be applied to assess the efficacy of each group. Differences in metabolic syndrome clinical risk factors among all groups will be used to evaluate the effects of at-home immersive VR exergames. Changes in active and sedentary behaviors will also be used to determine the impacts of VR exergames on metabolic syndrome.</p><p><strong>Results: </strong>The ethics committee of Guangzhou University, China, approved this study on September 25, 2024. Participant recruitment will begin in early 2025 and continue for approximately 3 months. Data will be analyzed after the 12-week trial is completed, with full results expected to be presented in early 2026.</p><p><strong>Conclusions: </strong>This study explores an emerging topic by applying an at-home immersive VR exergame intervention, potentially contributing to understanding the effects of an exergame program on metabolic syndrome risk among office workers.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06556784; https://clinicaltrials.gov/study/NCT06556784.</p><p><strong>International registered report identifier (irrid): </strong>PRR1-10.2196/64560.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e64560"},"PeriodicalIF":1.4,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11791450/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143005714","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: Podcasts are an unconventional method of disseminating information through audio to the masses. They are an emerging portable technology and a valuable resource that provides unlimited access for promoting health among participants. Podcasts related to health care have been used as a source of medical education, but there is a dearth of studies on the use of podcasts as a source of health information. This study will provide new perspectives by implementing the SANGYAN podcast, which contains information about COVID-19 and other health conditions.
Objective: The study aims to determine the usefulness and effectiveness of the SANGYAN podcast as a digital health intervention to address misinformation related to COVID-19 and other health conditions among individuals in Chennai, Tamil Nadu, India.
Methods: An implementation and evaluation study will be conducted with 500 participants from the Panimalar Medical College Hospital & Research Institute (PMCHRI) and Rural Health Training Centre in Chennai. Among individuals aged 18 years and older, those residing in the selected urban and rural settings who visit the outpatient department of the PMCHRI and Rural Health Training Centre will be recruited. For participants who consent to the study, their sociodemographic details will be noted and their health literacy will be assessed using the Rapid Estimate of Adult Literacy in Medicine scale. Once the participants have listened to the podcast, the usability, acceptance, and user satisfaction of the podcast will be assessed. Descriptive analysis will be used for continuous variables, and frequency analysis will be used for categorical variables. Bivariate analysis will be conducted to understand the correlation of sociodemographic features in response to perception, usefulness, acceptance, and user satisfaction of the podcast. All analysis will be performed using SPSS (version 24), and the results will be reported with 95% CIs and P<.05.
Results: As of December 2024, the SANGYAN podcast has been launched for voluntary usage in the PMCHRI.
Conclusions: The finding from this research project will aid in the development and implementation of data-driven, evidence-based, and human-centered behavior change interventions using podcasts to address public health challenges among populations living in diverse settings. This would also help in enhancing the acceptability of podcasts as a source of health-related information.
International registered report identifier (irrid): DERR1-10.2196/41175.
{"title":"Digital Health Intervention (SANGYAN Podcast) to Enhance Knowledge Related to COVID-19 and Other Health Conditions: Protocol for an Implementation and Evaluation Study.","authors":"Ashish Joshi, Surapaneni Krishna Mohan, Apurva Kumar Pandya, Ashoo Grover, Sofia Rani Saggu, Saravanavel Kalpana Revathi, Shruti Sharma","doi":"10.2196/41175","DOIUrl":"10.2196/41175","url":null,"abstract":"<p><strong>Background: </strong>Podcasts are an unconventional method of disseminating information through audio to the masses. They are an emerging portable technology and a valuable resource that provides unlimited access for promoting health among participants. Podcasts related to health care have been used as a source of medical education, but there is a dearth of studies on the use of podcasts as a source of health information. This study will provide new perspectives by implementing the SANGYAN podcast, which contains information about COVID-19 and other health conditions.</p><p><strong>Objective: </strong>The study aims to determine the usefulness and effectiveness of the SANGYAN podcast as a digital health intervention to address misinformation related to COVID-19 and other health conditions among individuals in Chennai, Tamil Nadu, India.</p><p><strong>Methods: </strong>An implementation and evaluation study will be conducted with 500 participants from the Panimalar Medical College Hospital & Research Institute (PMCHRI) and Rural Health Training Centre in Chennai. Among individuals aged 18 years and older, those residing in the selected urban and rural settings who visit the outpatient department of the PMCHRI and Rural Health Training Centre will be recruited. For participants who consent to the study, their sociodemographic details will be noted and their health literacy will be assessed using the Rapid Estimate of Adult Literacy in Medicine scale. Once the participants have listened to the podcast, the usability, acceptance, and user satisfaction of the podcast will be assessed. Descriptive analysis will be used for continuous variables, and frequency analysis will be used for categorical variables. Bivariate analysis will be conducted to understand the correlation of sociodemographic features in response to perception, usefulness, acceptance, and user satisfaction of the podcast. All analysis will be performed using SPSS (version 24), and the results will be reported with 95% CIs and P<.05.</p><p><strong>Results: </strong>As of December 2024, the SANGYAN podcast has been launched for voluntary usage in the PMCHRI.</p><p><strong>Conclusions: </strong>The finding from this research project will aid in the development and implementation of data-driven, evidence-based, and human-centered behavior change interventions using podcasts to address public health challenges among populations living in diverse settings. This would also help in enhancing the acceptability of podcasts as a source of health-related information.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/41175.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":" ","pages":"e41175"},"PeriodicalIF":1.4,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11791439/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45236974","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}
Dominique Tremblay, Thomas Joly-Mischlich, Annick Dufour, Marie-Claude Battista, Djamal Berbiche, José Côté, Marco Décelles, Catherine Forget, Brigitte Guérin, Manon Larivière, Frédéric Lemay, Manon Lemonde, Éric Maillet, Nathalie Moreau, Michel Pavic, Sara Soldera, Catherine Wilhelmy
<p><strong>Background: </strong>Telehomecare monitoring (TM) in patients with cancer is a complex intervention. Research shows variations in the benefits and challenges TM brings to equitable access to care, the therapeutic relationship, self-management, and practice transformation. Further investigation into these variations factors will improve implementation processes and produce effective outcomes.</p><p><strong>Objective: </strong>This study aims to concurrently analyze implementation and evaluate the effectiveness of TM for patients receiving anticancer oral therapy. The objectives are to (1) contextualize how and why TM is implemented according to (a) site characteristics, (b) team characteristics, and (c) characteristics of patients receiving anticancer oral therapy; (2) assess TM effectiveness for recording electronic patient-reported outcome measures (ePROMs) and patient-reported experience measures (ePREMs) according to the site, implementation process, and patient characteristics; (3) describe the acceptability and feasibility of TM from the perspectives of the people directly or indirectly involved and provide evidence-based actionable guidance in anticipation of provincewide implementation.</p><p><strong>Methods: </strong>This type II hybrid effectiveness-implementation study uses a concurrent mixed methods design. Evaluability assessment is integrated into an emerging practice in 3 participating sites to enable the evaluation of implementation strategies on TM clinical outcomes. Quantitative data for ePROMs and ePREMs will be collected using validated oncology questionnaire. Descriptive statistics and repeated measures using multiple linear mixed models and generalized estimating equations analyses will be undertaken alongside interpretive descriptive coding of qualitative data. Qualitative data will be gathered from key informants guided by the RE-AIM (reach, efficacy, adoption, implementation, maintenance) framework and its extension, PRISM (practical robust implementation and sustainability model). The concurrent approach allows results at multiple stages of this study to be integrated iteratively. The methodological choice aims to provide real-world data that are rigorous, rapidly usable in practice, and transferable to other settings.</p><p><strong>Results: </strong>Questionnaires were pretested and the technological platform was codeveloped with members of the cancer care team and patients. Preparatory work was carried out to configure the TM platform and activate coordinating mechanisms between members of the cancer care team, patients, information technology experts, and the research team. A steering committee with 3 working groups was established to oversee the technological, clinical, and evaluation aspects of this study. Recruitment of patients for ePROMs started in February 2024, and data collection is expected to continue until March 2025. Interviews with members of the cancer care team began in November 2024. Full ana
{"title":"Telehomecare Monitoring for Patients Receiving Anticancer Oral Therapy: Protocol for a Mixed Methods Evaluability Study.","authors":"Dominique Tremblay, Thomas Joly-Mischlich, Annick Dufour, Marie-Claude Battista, Djamal Berbiche, José Côté, Marco Décelles, Catherine Forget, Brigitte Guérin, Manon Larivière, Frédéric Lemay, Manon Lemonde, Éric Maillet, Nathalie Moreau, Michel Pavic, Sara Soldera, Catherine Wilhelmy","doi":"10.2196/63099","DOIUrl":"10.2196/63099","url":null,"abstract":"<p><strong>Background: </strong>Telehomecare monitoring (TM) in patients with cancer is a complex intervention. Research shows variations in the benefits and challenges TM brings to equitable access to care, the therapeutic relationship, self-management, and practice transformation. Further investigation into these variations factors will improve implementation processes and produce effective outcomes.</p><p><strong>Objective: </strong>This study aims to concurrently analyze implementation and evaluate the effectiveness of TM for patients receiving anticancer oral therapy. The objectives are to (1) contextualize how and why TM is implemented according to (a) site characteristics, (b) team characteristics, and (c) characteristics of patients receiving anticancer oral therapy; (2) assess TM effectiveness for recording electronic patient-reported outcome measures (ePROMs) and patient-reported experience measures (ePREMs) according to the site, implementation process, and patient characteristics; (3) describe the acceptability and feasibility of TM from the perspectives of the people directly or indirectly involved and provide evidence-based actionable guidance in anticipation of provincewide implementation.</p><p><strong>Methods: </strong>This type II hybrid effectiveness-implementation study uses a concurrent mixed methods design. Evaluability assessment is integrated into an emerging practice in 3 participating sites to enable the evaluation of implementation strategies on TM clinical outcomes. Quantitative data for ePROMs and ePREMs will be collected using validated oncology questionnaire. Descriptive statistics and repeated measures using multiple linear mixed models and generalized estimating equations analyses will be undertaken alongside interpretive descriptive coding of qualitative data. Qualitative data will be gathered from key informants guided by the RE-AIM (reach, efficacy, adoption, implementation, maintenance) framework and its extension, PRISM (practical robust implementation and sustainability model). The concurrent approach allows results at multiple stages of this study to be integrated iteratively. The methodological choice aims to provide real-world data that are rigorous, rapidly usable in practice, and transferable to other settings.</p><p><strong>Results: </strong>Questionnaires were pretested and the technological platform was codeveloped with members of the cancer care team and patients. Preparatory work was carried out to configure the TM platform and activate coordinating mechanisms between members of the cancer care team, patients, information technology experts, and the research team. A steering committee with 3 working groups was established to oversee the technological, clinical, and evaluation aspects of this study. Recruitment of patients for ePROMs started in February 2024, and data collection is expected to continue until March 2025. Interviews with members of the cancer care team began in November 2024. Full ana","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e63099"},"PeriodicalIF":1.4,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11791446/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143005235","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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