JMIR Research Protocols最新文献

{"title":"Problematic Social Media Use Among Italian Midadolescents: Protocol and Rationale of the SMART Project.","authors":"Valeria Donisi, Laura Salerno, Elisa Delvecchio, Agostino Brugnera","doi":"10.2196/58739","DOIUrl":"https://doi.org/10.2196/58739","url":null,"abstract":"<p><strong>Background: </strong>Social media (SM) use constitutes a large portion of midadolescents' daily lives as a way of peer interaction. A significant percentage of adolescents experience intense or problematic social media use (PSMU), an etiologically complex behavior potentially associated with psychological distress. To date, studies longitudinally testing for risk or protective factors of PSMU, and collecting qualitative data are still scarce among midadolescents. Self-help interventions specifically targeting PSMU in this population and involving midadolescents in co-creation are needed.</p><p><strong>Objective: </strong>The 2-year SMART multicenter project aims to (1) advance knowledge on PSMU; (2) co-design an unguided self-help app for promoting awareness and functional SM use; and (3) test feasibility and provide preliminary findings on its effectiveness to further improve and adapt the app.</p><p><strong>Methods: </strong>The SMART project is organized in 3 phases: phase 1 will focus on knowledge advancement on PSMU and its risk and protective factors using a longitudinal design; phase 2 will explore adolescents perspectives using qualitative approach and will co-design an unguided self-help app for reducing PSMU, which will be evaluated and adapted in phase 3. Around 1500 midadolescents (aged 14-18 years) will be recruited in northern, central, and southern Italy to investigate the potential intra- and interpersonal psychological risk and protective factors for PSMU and define specific PSMU profiles and test for its association with psychological distress. Subjective (self-report) PSMU's psychosocial risk or protective factors will be assessed at 3 different time points and Ecological Momentary Assessment (EMA) will be used. Moreover, focus groups will be performed in a subsample of midadolescents to collect the adolescents' unique point of view on PSMU and experiences with SM. Those previous results will inform the self-help app, which will be co-designed through working groups with adolescents. Subsequently, the SMART app will be deployed and adapted, after testing its feasibility and potential effectiveness in a pilot study.</p><p><strong>Results: </strong>The project is funded by the Italian Ministry of University and Research as part of a national grant (PRIN, \"Progetti di Rilevante Interesse Nazionale\"). The research team received an official notice of research funding approval in July 2023 (Project Code 2022LC4FT7). The project was preregistered on Open Science Framework, while the ethics approval was obtained in November 2023. We started the enrollments in December 2023, with the final follow-up data to be collected within May 2025.</p><p><strong>Conclusions: </strong>The innovative aspects of the SMART project will deepen the conceptualization of PSMU and of its biopsychosocial antecedents among midadolescents, with relevant scientific, technological, and socioeconomic impacts. The advancement of knowledge and the develo","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142154135","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Establishing Priorities for Improving Data Collection and Measurement of Mental Health and Well-Being of Adolescents With Special Educational Needs Within Nonmainstream Schools: Protocol for a Delphi Study.","authors":"Mairi C Jeffery, Jessica Deighton, Suzet Tanya Lereya","doi":"10.2196/58610","DOIUrl":"https://doi.org/10.2196/58610","url":null,"abstract":"<p><strong>Background: </strong>There are more than 1.5 million children and young people in England with special educational needs (SEN), with over 160,000 young people in the United Kingdom attending a special school or alternative provision (AP) setting. Young people with SEN have been found to be at risk for poorer mental health and well-being than non-SEN peers. However, there is a range of both school-related and research challenges associated with identifying difficulties in a timely manner.</p><p><strong>Objective: </strong>This Delphi study aims to determine a list of stakeholder priorities for improving school-based measurement of mental health and well-being among young people with SEN, at an aggregated level, within secondary special school or AP settings. A secondary objective is to inform the implementation of school-based well-being surveys, improve engagement in special schools or AP settings, and improve survey response rates among children and young people with SEN.</p><p><strong>Methods: </strong>A mixed methods Delphi study will be conducted, including a scoping review and preliminary focus groups with school staff members and researchers to establish key issues. This will be followed by a 2-round Delphi survey to determine a list of stakeholder priorities for improving the measurement of mental health and well-being at an aggregate level within special schools and AP settings. A final stakeholder workshop will be held to discuss the findings. A list of recommendations will be drafted as a report for special schools and AP settings.</p><p><strong>Results: </strong>The study has received ethical approval from the University College London Research Ethics Committee. The stage 1 scoping review has commenced. Recruitment for focus groups will begin in Autumn 2024. The first round of the Delphi survey will commence in early 2025, and the second round of the Delphi survey in the spring of 2025. The final workshop will commence in mid-2025 with final results expected in late 2025.</p><p><strong>Conclusions: </strong>There is a need for clear recommendations for special schools and AP settings on priorities for improving the measurement of mental health and well-being problems among young people with SEN. There is also a need for recommendations to researchers implementing school-based well-being surveys, including the #BeeWell program, to enable them to improve their engagement in special schools and AP settings and ensure surveys are accessible.</p><p><strong>International registered report identifier (irrid): </strong>PRR1-10.2196/58610.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142154134","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Feuerstein Instrumental Enrichment Program for People With Schizophrenia After the First Episode of Psychosis: Protocol for an Open-Label Intervention Study.","authors":"Ana Olivia Fonseca, July Silveira Gomes, Rafael Angulo Condoretti Barros Novaes, Cíntia Lopes Dias, Maria Eva de Miranda Alves Rodrigues, Ary Gadelha, Cristiano Noto","doi":"10.2196/57031","DOIUrl":"10.2196/57031","url":null,"abstract":"<p><strong>Background: </strong>Schizophrenia is a disorder associated with neurocognitive deficits that adversely affect daily functioning and impose an economic burden. Cognitive rehabilitation interventions, particularly during the early phases of illness, have been shown to improve cognition, functionality, and quality of life. The Feuerstein Instrumental Enrichment (FIE) program, based on the Mediated Learning Experience and the Structural Cognitive Modifiability theory, has been applied in various disorders, but its applicability in schizophrenia has not yet been clarified.</p><p><strong>Objective: </strong>This study aims to investigate the effects of the FIE program on the functionality of patients with first-episode schizophrenia.</p><p><strong>Methods: </strong>In total, 17 patients will be recruited for an open-label intervention consisting of twice-weekly sessions for 10 weeks. The primary outcome measure will be changes in the Goal Achievement Scale score. Maze task performance from the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) battery will serve as a secondary outcome measure. At the same time, changes in Positive and Negative Syndrome Scale scores and other MATRICS domains will be analyzed as exploratory outcomes. Assessments will be administered before and after the intervention, with a follow-up period of 6 months.</p><p><strong>Results: </strong>This trial was preregistered in The Brazilian Registry of Clinical Trials (RBR-4gzhy4s). By February 2024, 11 participants were enrolled in the training. Recruitment is expected to be completed by May 2024. Data analysis will be conducted between May and September 2024. The results are expected to be published in January 2025.</p><p><strong>Conclusions: </strong>This study may establish a protocol for the FIE program that uses mediation techniques for individuals in the early stages of schizophrenia. The results will add to the knowledge about strategies to promote cognitive skills and functional impairment in daily life.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/57031.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142140148","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Piloting the Inclusion of the Key Populations Unique Identifier Code in the South African Routine Health Information Management System: Protocol for a Multiphased Study.","authors":"Mashudu Rampilo, Edith Phalane, Refilwe Nancy Phaswana-Mafuya","doi":"10.2196/55092","DOIUrl":"10.2196/55092","url":null,"abstract":"<p><strong>Background: </strong>The global community has set an ambitious goal to end HIV/AIDS as a public health threat by 2030. Significant progress has been achieved in pursuing these objectives; however, concerns remain regarding the lack of disaggregated routine data for key populations (KPs) for a targeted HIV response. KPs include female sex workers, transgender populations, gay men and other men who have sex with men, people who are incarcerated, and people who use drugs. From an epidemiological perspective, KPs play a fundamental role in shaping the dynamics of HIV transmission due to specific behaviors. In South Africa, routine health information management systems (RHIMS) do not include a unique identifier code (UIC) for KPs. The purpose of this protocol is to develop the framework for improved HIV monitoring and programming through piloting the inclusion of KPs UIC in the South African RHIMS.</p><p><strong>Objective: </strong>This paper aims to describe the protocol for a multiphased study to pilot the inclusion of KPs UIC in RHIMS.</p><p><strong>Methods: </strong>We will conduct a multiphased study to pilot the framework for the inclusion of KPs UIC in the RHIMS. The study has attained the University of Johannesburg Research Ethics Committee approval (REC-2518-2023). This study has four objectives, including a systematic review, according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines (objective 1). Second, policy document review and in-depth stakeholder interviews using semistructured questionnaires (objective 2). Third, exploratory data analysis of deidentified HIV data sets (objective 3), and finally, piloting the framework to assess the feasibility of incorporating KPs UIC in RHIMS using findings from objectives 1, 2, and 3 (objective 4). Qualitative and quantitative data will be analyzed using ATLAS.ti (version 6; ATLAS.ti Scientific Software Development GmbH) and Python (version 3.8; Python Software Foundation) programming language, respectively.</p><p><strong>Results: </strong>The results will encompass a systematic review of literature, qualitative interviews, and document reviews, along with exploratory analysis of deidentified routine program data and findings from the pilot study. The systematic review has been registered in PROSPERO (International Prospective Register of Systematic Reviews; CRD42023440656). Data collection is planned to commence in September 2024 and expected results for all objectives will be published by December 2025.</p><p><strong>Conclusions: </strong>The study will produce a framework to be recommended for the inclusion of the KP UIC national rollout. The study results will contribute to the knowledge base around the inclusion of KPs UIC in RHIMS data.</p><p><strong>Trial registration: </strong>PROSPERO CRD42023440656; https://tinyurl.com/msnppany.</p><p><strong>International registered report identifier (irrid): </strong>PRR1-10.2196/55092.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142140149","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Smartphone App for Prehospital ECG Transmission in ST-Elevation Myocardial Infarction Activation: Protocol for a Mixed Methods Study.","authors":"Hassan Mir, Katelyn J Cullen, Karen Mosleh, Rafi Setrak, Sanjit Jolly, Michael Tsang, Gregory Rutledge, Quazi Ibrahim, Michelle Welsford, Mathew Mercuri, J D Schwalm, Madhu K Natarajan","doi":"10.2196/55506","DOIUrl":"https://doi.org/10.2196/55506","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Timely diagnosis and treatment for ST-elevation myocardial infarction (STEMI) requires a coordinated response from multiple providers. Rapid intervention is key to reducing mortality and morbidity. Activation of the cardiac catheterization laboratory may occur through verbal communication and may also involve the secure sharing of electrocardiographic images between frontline health care providers and interventional cardiologists. To improve this response, we developed a quick, easy-to-use, privacy-compliant smartphone app, that is SMART AMI-ACS (Strategic Management of Acute Reperfusion and Therapies in Acute Myocardial Infarction Acute Coronary Syndromes), for real-time verbal communication and sharing of electrocardiographic images among health care providers in Ontario, Canada. The app further provides information about diagnosis, management, and risk calculators for patients presenting with acute coronary syndrome.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to integrate the app into workflow processes to improve communication for STEMI activation, resulting in decreased treatment times, improved patient outcomes, and reduced unnecessary catheterization laboratory activation and transfer.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Implementation of the app will be guided by the Reach, Effectiveness, Acceptability, Implementation, and Maintenance (RE-AIM) framework to measure impact. The study will use quantitative registry data already being collected through the SMART AMI project (STEMI registry), the use of the SMART AMI app, and quantitative and qualitative survey data from physicians. Survey questions will be based on the Consolidated Framework for Implementation Research. Descriptive quantitative analysis and thematic qualitative analysis of survey results will be conducted. Continuous variables will be described using either mean and SD or median and IQR values at pre- and postintervention periods by the study sites. Categorical variables, such as false activation, will be described as frequencies (percentages). For each outcome, an interrupted time series regression model will be fitted to evaluate the impact of the app.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The primary outcomes of this study include the usability, acceptability, and functionality of the app for physicians. This will be measured using electronic surveys to identify barriers and facilitators to app use. Other key outcomes will measure the implementation of the app by reviewing the timing-of-care intervals, false \"avoidable\" catheterization laboratory activation rates, and uptake and use of the app by physicians. Prospective evaluation will be conducted between April 1, 2022, and March 31, 2023. However, for the timing- and accuracy-of-care outcomes, registry data will be compared from January 1, 2019, to March 31, 2023. Data analysis is expected to be completed in Fall 2024, with the completion of a paper for publication anticipated by the end of 2","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142140150","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Digitizing Survivorship Care Plans Through the POST-Treatment Health Outcomes of Cancer Survivors (POSTHOC) Mobile App: Protocol for a Phase II Randomized Controlled Trial.","authors":"Kaitlin H Chung, Shari M Youngblood, Carin L Clingan, Dana C Deighton, Virginia A Jump, Thushini Manuweera, Nicolette M McGeorge, Cynthia L Renn, Paula Y Rosenblatt, Aaron T Winder, Shijun Zhu, Ian R Kleckner, Amber S Kleckner","doi":"10.2196/59222","DOIUrl":"10.2196/59222","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Survivorship care plans (SCPs) are provided at the completion of cancer treatment to aid in the transition from active treatment to long-term survivorship. They describe the details of a patient's diagnosis and treatment and offer recommendations for follow-up appointments, referrals, and healthy behaviors. The plans are currently paper-based and become outdated as soon as a patient's health status changes. There is a need to digitize these plans to improve their accessibility, modifiability, and longevity. With current technology, SCPs can be linked to mobile devices and activity trackers so that patients can track health behaviors and compare them to their clinical goals, taking charge of their own health.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;A mobile app, POSTHOC (POST-Treatment Health Outcomes of Cancer Survivors), that digitizes the SCP was developed, with goals of integrating it with wearable technologies and electronic medical records. Herein, we are conducting a randomized controlled trial that evaluates the POSTHOC app versus the traditional SCP on total symptom burden in the early posttreatment period.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We will recruit 54 patients who have recently completed curative therapy for cancer (any type) in person and remotely. They will be randomized 2:1, POSTHOC:usual care (unblinded). Those randomized to the POSTHOC group will receive their SCP via the app and will choose to focus on nutrition or exercise for the duration of the study based on their individual plan and personal preferences. Those randomized to the control group will get a paper-based plan. At baseline, 6 weeks, and 12 weeks, we will evaluate patient-reported outcomes, including total symptom burden (web-based questionnaire), diet (24-hour Automated Self-Administered [ASA24]), and physical activity (Fitbit Charge 6 [Google LLC]). We will also collect quantitative and qualitative feedback on the usability of the app from those in the POSTHOC arm to improve the app for future implementation studies, with a specific focus on patient-provider communication. For feasibility, we will calculate the percentage of patients who used the POSTHOC app at least 3 times per week. We will use linear mixed models to evaluate the effects of the POSTHOC app versus those of usual care on other outcomes at weeks 6 and 12.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;This trial is open to accrual in the University of Maryland Medical System as of March 2024, and as of July 3, 2024, a total of 20 participants have consented.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This study is among the first to digitize the SCP in a mobile app and test the effects of a mobile health-delivered behavioral health intervention on symptom burden in cancer survivors. Our results will provide evidence about the effects of health self-management on symptoms. This knowledge will be integral to larger randomized controlled studies, integration with the electronic medical record, a","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142132728","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Challenges and Facilitation Approaches for the Participatory Design of AI-Based Clinical Decision Support Systems: Protocol for a Scoping Review.","authors":"Tabea Rambach, Patricia Gleim, Sekina Mandelartz, Carolin Heizmann, Christophe Kunze, Philipp Kellmeyer","doi":"10.2196/58185","DOIUrl":"10.2196/58185","url":null,"abstract":"<p><strong>Background: </strong>In the last few years, there has been an increasing interest in the development of artificial intelligence (AI)-based clinical decision support systems (CDSS). However, there are barriers to the successful implementation of such systems in practice, including the lack of acceptance of these systems. Participatory approaches aim to involve future users in designing applications such as CDSS to be more acceptable, feasible, and fundamentally more relevant for practice. The development of technologies based on AI, however, challenges the process of user involvement and related methods.</p><p><strong>Objective: </strong>The aim of this review is to summarize and present the main approaches, methods, practices, and specific challenges for participatory research and development of AI-based decision support systems involving clinicians.</p><p><strong>Methods: </strong>This scoping review will follow the Joanna Briggs Institute approach to scoping reviews. The search for eligible studies was conducted in the databases MEDLINE via PubMed; ACM Digital Library; Cumulative Index to Nursing and Allied Health; and PsycInfo. The following search filters, adapted to each database, were used: Period January 01, 2012, to October 31, 2023, English and German studies only, abstract available. The scoping review will include studies that involve the development, piloting, implementation, and evaluation of AI-based CDSS (hybrid and data-driven AI approaches). Clinical staff must be involved in a participatory manner. Data retrieval will be accompanied by a manual gray literature search. Potential publications will then be exported into reference management software, and duplicates will be removed. Afterward, the obtained set of papers will be transferred into a systematic review management tool. All publications will be screened, extracted, and analyzed: title and abstract screening will be carried out by 2 independent reviewers. Disagreements will be resolved by involving a third reviewer. Data will be extracted using a data extraction tool prepared for the study.</p><p><strong>Results: </strong>This scoping review protocol was registered on March 11, 2023, at the Open Science Framework. The full-text screening had already started at that time. Of the 3,118 studies screened by title and abstract, 31 were included in the full-text screening. Data collection and analysis as well as manuscript preparation are planned for the second and third quarter of 2024. The manuscript should be submitted towards the end of 2024.</p><p><strong>Conclusions: </strong>This review will describe the current state of knowledge on participatory development of AI-based decision support systems. The aim is to identify knowledge gaps and provide research impetus. It also aims to provide relevant information for policy makers and practitioners.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/58185.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142132727","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dexmedetomidine Versus Midazolam for End-of-Life Sedation and Agitation: Protocol for a Randomized Controlled Trial (The DREAMS Trial).","authors":"Benjamin Thomas, Greg Barclay, Wing-Shan Angela Lo, Judy Mullan, Kylie Mansfield","doi":"10.2196/55129","DOIUrl":"10.2196/55129","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Sedation at the end of life is used to relieve distressing symptoms including agitation and delirium. Standard care may include infused benzodiazepines or antipsychotics. These agents often result in deep sedation with loss of interaction with loved ones, which may be distressing.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The DREAMS (Dexmedetomidine for the Reduction of End-of-life Agitation and for optiMised Sedation) trial aimed to compare the sedative and antidelirium effects of the alpha-2 agonist dexmedetomidine, a novel palliative care sedative, compared with midazolam, a benzodiazepine when administered by subcutaneous infusion at the end of life, with doses of both agents targeting lighter, or potentially interactive sedation.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Participants were recruited from adult inpatients admitted for end-of-life care under a palliative care team in regional New South Wales, Australia. Inclusion criteria included patients older than 18 years, with a preference for lighter sedation at the end of life. Exclusion criteria included severe cardiac dysfunction (contraindication to dexmedetomidine). Participants consented and were placed on a treatment-pending list. Upon experiencing terminal deterioration, patients were randomized to either arm 1 (dexmedetomidine) or arm 2 (midazolam) as their treatment arm. These treatments were administered by continuous subcutaneous infusion. The level of consciousness and agitation of the patients were measured by the Richmond Agitation-Sedation Scale-Palliative version and the Memorial Delirium Assessment Score. Richmond Agitation-Sedation Scale-Palliative version assessments were performed by both nursing and medical staff, while Memorial Delirium Assessment Score assessments were carried out by medical staff only. Families and patients were asked to complete, as able, a patient comfort assessment form, to gauge perceptions of distress. Data were collected and matched with the breakthrough medication doses administered, along with qualitative comments in the medical record. In addition, the study tracked symptoms and patient functional status that were recorded as part of the Palliative Care Outcomes Collaborative, a national tracking project for monitoring symptom outcomes in palliative care.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The DREAMS trial was funded in May 2020, approved by the ethics committee in November 2020, and started recruiting participants in May 2021. Data collection commenced in May 2021 and is anticipated to continue until December 2024. Publication of results is anticipated from 2024 to 2026.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The evidence base for sedative dosing in palliative care for distress and agitation is not robust, with standard care based primarily on clinical experience and not robust scientific evidence. This study is important because it will compare a standard and a novel sedative used in end-of-life treatment. By assessing the poten","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142125750","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Identifications of Similarity Metrics for Patients With Cancer: Protocol for a Scoping Review.","authors":"Iryna Manuilova, Jan Bossenz, Annemarie Bianka Weise, Dominik Boehm, Cosima Strantz, Philipp Unberath, Niklas Reimer, Patrick Metzger, Thomas Pauli, Silke D Werle, Susann Schulze, Sonja Hiemer, Arsenij Ustjanzew, Hans A Kestler, Hauke Busch, Benedikt Brors, Jan Christoph","doi":"10.2196/58705","DOIUrl":"10.2196/58705","url":null,"abstract":"<p><strong>Background: </strong>Understanding the similarities of patients with cancer is essential to advancing personalized medicine, improving patient outcomes, and developing more effective and individualized treatments. It enables researchers to discover important patterns, biomarkers, and treatment strategies that can have a significant impact on cancer research and oncology. In addition, the identification of previously successfully treated patients supports oncologists in making treatment decisions for a new patient who is clinically or molecularly similar to the previous patient.</p><p><strong>Objective: </strong>The planned review aims to systematically summarize, map, and describe existing evidence to understand how patient similarity is defined and used in cancer research and clinical care.</p><p><strong>Methods: </strong>To systematically identify relevant studies and to ensure reproducibility and transparency of the review process, a comprehensive literature search will be conducted in several bibliographic databases, including Web of Science, PubMed, LIVIVIVO, and MEDLINE, covering the period from 1998 to February 2024. After the initial duplicate deletion phase, a study selection phase will be applied using Rayyan, which consists of 3 distinct steps: title and abstract screening, disagreement resolution, and full-text screening. To ensure the integrity and quality of the selection process, each of these steps is preceded by a pilot testing phase. This methodological process will culminate in the presentation of the final research results in a structured form according to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) flowchart. The protocol has been registered in the Journal of Medical Internet Research.</p><p><strong>Results: </strong>This protocol outlines the methodologies used in conducting the scoping review. A search of the specified electronic databases and after removing duplicates resulted in 1183 unique records. As of March 2024, the review process has moved to the full-text evaluation phase. At this stage, data extraction will be conducted using a pretested chart template.</p><p><strong>Conclusions: </strong>The scoping review protocol, centered on these main concepts, aims to systematically map the available evidence on patient similarity among patients with cancer. By defining the types of data sources, approaches, and methods used in the field, and aligning these with the research questions, the review will provide a foundation for future research and clinical application in personalized cancer care. This protocol will guide the literature search, data extraction, and synthesis of findings to achieve the review's objectives.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/58705.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142125751","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patterns of Use of e-Cigarettes and Their Respiratory Effects: Protocol for an Umbrella Review.","authors":"Giusy Rita Maria La Rosa, Riccardo Polosa, Renée O'Leary","doi":"10.2196/60325","DOIUrl":"10.2196/60325","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Electronic nicotine delivery systems (ENDS)-e-cigarettes or vapes-have been shown to substantially reduce or eliminate many toxins compared with cigarette smoke, but simultaneously ENDS use also produces their own unique toxins. Yet the patterns of use among people who use ENDS are not homogeneous. Some people who use ENDS also smoke cigarettes (dual use). Other people who formerly smoked cigarettes are completely substituting ENDS (exclusive use). A small number of people who have never smoked cigarettes are using ENDS (naïve use of nicotine). Each of these patterns of use results in different exposures to toxins. Unfortunately, epidemiological studies routinely group together any ENDS use regardless of other tobacco use.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This umbrella review primarily aims to present all the evidence available on the respiratory effects of ENDS use by adults based on their pattern of use: dual use, exclusive use, and naïve use. With each of these patterns of use, are there benefits, no changes, or harmful effects on respiratory functioning? Our objective is to provide clinicians with a detailed analysis of how different patterns of ENDS use impact respiratory functioning and to point to the best sources of evidence.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This umbrella review follows the Methods for Overviews of Reviews framework and the PRIOR (Preferred Reporting Items for Overviews of Reviews) statement. Systematic reviews published since 2019 will be searched across 4 databases and 3 gray literature sources. Additional searches will include citation chasing, references lists, and referrals from respiratory specialists. The quality of included reviews will be evaluated using the AMSTAR2 (A Measurement Tool to Assess Systematic Reviews) checklist. We will document biases in 3 areas: protocol deviations, biases from the Oxford Catalogue of Bias, and internal data discrepancies. Two reviewers will independently conduct the search and quality assessments. Our analysis will focus on reviews rated as moderate or high confidence by AMSTAR2. We will use the Vote Counting Direction of Effect method to manage expected data heterogeneity, assessing whether ENDS use is beneficial or detrimental, or has no effect on respiratory functions based on the pattern of use.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The review is expected to be completed by December 2024. The database search was concluded in April 2024, and data extraction and bias assessment were completed in June 2024. The analysis phase is planned to be completed by October 2024.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;A thorough and comprehensive assessment of the evidence will better inform the contentious debate over the respiratory effects of ENDS providing much needed clarity by linking their effects to specific usage patterns. This analysis is particularly crucial in understanding the risks associated with continued cigarette smoking.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registr","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142125752","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}