JMIR Research Protocols最新文献

Background: Amyotrophic lateral sclerosis (ALS) leads to rapid physiological and functional decline before causing untimely death. Current best-practice approaches to interdisciplinary care are unable to provide adequate monitoring of patients' health. Passive in-home sensor systems enable 24×7 health monitoring. Combining sensor data with outcomes extracted from the electronic health record (EHR) through a supervised machine learning algorithm may enable health care providers to predict and ultimately slow decline among people living with ALS.

Objective: This study aims to describe a federated approach to assimilating sensor and EHR data in a machine learning algorithm to predict decline among people living with ALS.

Methods: Sensor systems have been continuously deployed in the homes of 4 participants for up to 330 days. Sensors include bed, gait, and motion sensors. Sensor data are subjected to a multidimensional streaming clustering algorithm to detect changes in health status. Specific health outcomes are identified in the EHR and extracted via the REDCap (Research Electronic Data Capture; Vanderbilt University) Fast Healthcare Interoperability Resource directly into a secure database.

Results: As of this writing (fall 2024), machine learning algorithms are currently in development to predict those health outcomes from sensor-detected changes in health status. This methodology paper presents preliminary results from one participant as a proof of concept. The participant experienced several notable changes in activity, fluctuations in heart rate and respiration rate, and reductions in gait speed. Data collection will continue through 2025 with a growing sample.

Conclusions: The system described in this paper enables tracking the health status of people living with ALS at unprecedented levels of granularity. Combined with tightly integrated EHR data, we anticipate building predictive models that can identify opportunities for health care services before adverse events occur. We anticipate that this system will improve and extend the lives of people living with ALS.

International registered report identifier (irrid): DERR1-10.2196/60437.

Background: Breast cancer is the second most common cancer in women worldwide. Treatments for this disease often result in side effects such as pain, fatigue, loss of muscle mass, and reduced quality of life. Physical exercise has been shown to effectively mitigate these side effects and improve the quality of life in patients with breast cancer.

Objective: This randomized clinical trial aims to evaluate the efficacy of a 12-week supervised exercise program on pain, physical function, and quality of life in female patients with cancer.

Methods: This randomized, double-blind clinical trial will recruit 325 participants, divided into an intervention group receiving the exercise program and a control group receiving standard care recommendations. Outcome measures, including pain (assessed via the Brief Pain Inventory), physical function (Disability of the Arm, Shoulder, and Hand Questionnaire), and quality of life (European Organization for Research and Treatment of Cancer QLQ-C30 and European Organization for Research and Treatment of Cancer QLQ-BR23), will be evaluated at baseline, immediately post intervention, and 12 weeks post intervention. Statistical analysis will involve repeated measures of ANOVA and MANOVA to determine the significance of the intervention's effects across time points.

Results: Recruitment and data collection will commence in February of 2025, and data analysis is scheduled for completion at the end of 2025. No results are currently available.

Conclusions: Physical exercise is anticipated to play a significant role in alleviating pain, enhancing physical function, and improving the quality of life in female patients with cancer. This study will provide robust evidence to support the integration of supervised exercise into standard care protocols for this population.

Trial registration: ClinicalTrials.gov NCT06618690; https://clinicaltrials.gov/ct2/show/NCT06618690.

International registered report identifier (irrid): PRR1-10.2196/63891.

Background: Indigenous people do not necessarily view disability in the same way as do other groups. Indigenous concepts of disability are connected to their ancestral history, cultural customs, and environmental context. Some Indigenous languages do not contain a word equivalent to disability. Western approaches to disability seldom reflect the voices of Indigenous people.

Objective: The objective of this scoping review is to collate the perspectives, concepts, and understandings of disability in Indigenous communities in Canada and to map the factors that influence social approaches to disability from an Indigenous perspective.

Methods: Following the methodological framework for scoping reviews of Arksey and O'Malley, we will search electronic databases, including PubMed, Scopus, Web of Science, EBSCOhost ProQuest, Autochtonia, and APA PsycINFO. We will search gray literature through the Google search engine, conference abstracts, dissertation databases, government documents, and Indigenous organization websites. We will include quantitative, qualitative, and mixed methods studies in English and French. The included studies will describe Indigenous approaches to disability, as they are understood based on personal, cultural, and historical contexts. Two reviewers will use Covidence software (Cochrane) to remove duplicates, screen articles, record the step-by-step selection process, and extract data from the included articles. We will follow the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews) guidelines. We will present the findings in tables, charts, narrative summaries, and through fuzzy cognitive mapping. We will contextualize the literature's findings by comparing them with the stakeholders in Quebec and provide a discussion to explore potential solutions for the identified factors.

Results: An initial limited search was conducted in January 2024. The study will be conducted in 2025. Publication of the results is expected in late 2025.

Conclusions: We anticipate that the findings from the scoping review will be useful for professionals, researchers, policy makers, and Indigenous communities themselves interested in co-designing and implementing evidence-informed disability programs and services, which will prevent mismatches between the programs and the sociocultural context. We will disseminate the results of this review through workshops with the participating communities, direct engagement with relevant local stakeholders, and through conference presentations and publications in scientific journals.

Trial registration: OSF Registries osf.io/9rzkx; https://osf.io/9rzkx.

International registered report identifier (irrid): DERR1-10.2196/57590.

Background: Chronic heart failure has high morbidity and mortality, with approximately half of the patients dying within 5 years of diagnosis. Recent additions to the armamentarium of anti-heart failure therapies include angiotensin receptor-neprilysin inhibitors (ARNIs) and sodium/glucose cotransporter 2 inhibitors (SGLT2is). Both classes have demonstrated mortality and morbidity benefits. Although these new therapies have morbidity and mortality benefits, it is not known whether rapid initiation is beneficial when compared with the conventional, slower-stepped approach. Many clinicians have been taught that starting with low-dose therapies and gradually increasing the dose is a safe way of intensifying treatment regimens. Pharmacologically, it is rational to use a combination of drugs that target multiple pathological mechanisms, as there is potential synergism and better therapeutic outcomes. Theoretically, the quicker the right combinations are used, the more likely the beneficial effects will be experienced. However, rapid up-titration must be balanced with patient safety and tolerability.

Objective: This study aims to determine if early addition of ARNIs, SGLT2is, β-blockers, and mineralocorticoid receptor antagonists (within 4 weeks), when compared with the same therapies initiated slower (within 6 months), will reduce all-cause mortality and hospitalizations for heart failure in patients with stable heart failure with reduced ejection fraction.

Methods: This is a single-center, randomized controlled, double-arm, assessor-blinded, active control, and pragmatic clinical trial. Adults with stable heart failure with reduced ejection fraction and idiopathic dilated cardiomyopathy will be randomized to conventional sequencing (the control arm; over 6 months) of anti-heart failure therapies, and a second arm will receive rapid sequencing (over 4 weeks). Study participants will be followed for 5 years to assess the safety, efficacy, and tolerability of the 2 types of sequencing. Posttrial access and care will be provided to all study participants throughout their lifespan.

Results: We are currently in the process of obtaining ethical clearance and funding.

Conclusions: We envisage that this study will help support evidence-based medicine and inform clinical practice guidelines on the optimal rate of sequencing of anti-heart failure therapies. A third placebo arm was considered, but costs would be too much and not providing study participants with therapies with known morbidity and mortality benefits may be unethical, in our opinion. Given the post-COVID-19 economic downturn and posttrial access to interventions, a major challenge will be acquiring funding for this study.

International registered report identifier (irrid): PRR1-10.2196/44027.

Background: The synthesis of evidence in healthcare is essential for informed decision-making and policy development. This study aims to validate The Umbrella Collaboration® (TU®), an innovative, semi-automatic tertiary evidence synthesis methodology, by comparing it with Traditional Umbrella Reviews (TUR), which are currently the gold standard.

Objective: The primary objective of this study is to evaluate whether TU®, an AI-assisted, software-driven system for tertiary evidence synthesis, can achieve comparable effectiveness to TURs, while offering a more timely, efficient, and comprehensive approach. Additionally, as a secondary objective, the study aims to assess the accessibility and comprehensibility of TU®'s outputs to ensure its usability and practical applicability for healthcare professionals.

Methods: This protocol outlines a comparative study divided into two main parts. The first part involves a quantitative comparison of results obtained using TU® and TURs in geriatrics. We will evaluate the identification, size effect, direction, statistical significance, and certainty of outcomes, as well as the time and resources required for each methodology. Data for TURs will be sourced from Medline (via PubMed), while TU® will use AI-assisted informatics to replicate the research questions of the selected URTs. The second part of the study assesses the ease of use and comprehension of TU® through an online survey directed at health professionals, utilizing interactive features and detailed data access.

Results: Expected results include the assessment of concordance in identifying outcomes, the size effect, direction and significance of these outcomes, and the certainty of evidence. Additionally, we will measure the operational efficiency of each methodology by evaluating the time taken to complete projects. User perceptions of the ease of use and comprehension of TU® will be gathered through detailed surveys. The implementation of new methodologies in evidence synthesis requires validation. This study will determine whether TU® can match the accuracy and comprehensiveness of TURs while offering benefits in terms of efficiency and user accessibility. The comparative study is designed to address the inherent challenges in validating a new methodology against established standards.

Conclusions: If TU® proves as effective as TURs but more time-efficient, accessible and easily updatable, it could significantly enhance the process of evidence synthesis, facilitating informed decision-making and improving healthcare. This study represents a step towards integrating innovative technologies into routine evidence synthesis practice, potentially transforming health research.

Clinicaltrial:

Background: Individuals with intellectual disabilities or autism spectrum disorder (ID/A) sometimes require supportive services from direct support professionals (DSPs). The supportive care provided to individuals with ID/A by DSPs can vary from assistance with daily living activities to navigating society. The COVID-19 pandemic not only exacerbated poor outcomes for individuals with ID/A but also for DSPs, who report experiencing burnout in the aftermath of the pandemic. DSPs are critical to providing much-needed support to individuals with ID/A.

Objective: The goal of this study is to evaluate the impact of the community resilience model on DSP burnout and neurodivergent client outcomes using the Project ECHO (Extension for Community Healthcare Outcomes) telementoring platform as a dissemination tool.

Methods: This protocol leverages community resilience theory and telementoring through the Project ECHO model to foster resilience in DSPs and their neurodiverse client population. ECHO participants' resilience behaviors will be evaluated via surveys including the Connor Davison Resilience Scale and the WHO-5 Well-Being Index. These surveys will be administered preprogram, at the end of the 8-week ECHO program, and 90 days after the ECHO program's completion. Pre-post relationships will be assessed using generalized estimating equations. The main outcomes will be self-reported changes in knowledge, self-efficacy, and resilience.

Results: All ECHO program cohorts and follow-up data collection have concluded, with 131 survey participants. The project team is currently analyzing and interpreting the data. We anticipate having all data analyzed and interpreted by February 2025.

Conclusions: DSPs provide critical services to individuals with ID/A. By providing skills in resiliency via the ECHO model, participants will be able to apply resiliency to their own professional lives while fostering resilience within their neurodiverse client base, leading to increased positive outcomes for both groups.

International registered report identifier (irrid): DERR1-10.2196/59913.

Background: The use of artificial intelligence (AI) technologies in radiography practice is increasing. As this advanced technology becomes more embedded in radiography systems and clinical practice, the role of radiographers will evolve. In the context of these anticipated changes, it may be reasonable to expect modifications to the competencies and educational requirements of current and future practitioners to ensure successful AI adoption.

Objective: The aim of this scoping review is to explore and synthesize the literature on the adjustments needed in the radiography curriculum to prepare radiography students for the demands of AI-assisted health care environments.

Methods: Using the Joanna Briggs Institute methodology, an initial search was run in Scopus to determine whether the search strategy that was developed with a library specialist would capture the relevant literature by screening the title and abstract of the first 50 articles. Additional search terms identified in the articles were added to the search strategy. Next, EBSCOhost, PubMed, and Web of Science databases were searched. In total, 2 reviewers will independently review the title, abstract, and full-text articles according to the predefined inclusion and exclusion criteria, with conflicts resolved by a third reviewer.

Results: The search results will be reported using the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) checklist. The final scoping review will present the data analysis as findings in tabular form and through narrative descriptions. The final database searches were completed in October 2024 and yielded 2224 records. Title and abstract screening of 1930 articles is underway after removing 294 duplicates. The scoping review is expected to be finalized by the end of March 2025.

Conclusions: A scoping review aims to systematically map the evidence on the adjustments needed in the radiography curriculum to prepare radiography students for the integration of AI technologies in the health care environment. It is relevant to map the evidence because increased integration of AI-based technologies in clinical practice has been noted and changes in practice must be underpinned by appropriate education and training. The findings in this study will provide a better understanding of how the radiography curriculum should adapt to meet the educational needs of current and future radiographers to ensure competent and safe practice in response to AI technologies.

Trial registration: Open Science Framework 3nx2a; https://osf.io/3nx2a.

International registered report identifier (irrid): PRR1-10.2196/60431.