International Registered Report Identifier Research Articles

Traumatic Brain Injury Intensive Evaluation and Treatment Program: Protocol for a Partnered Evaluation Initiative Mixed Methods Study.

The traumatic brain injury (TBI) Intensive Evaluation and Treatment Program (IETP) is an innovative modality for delivering evidence-based treatments in a residential, inpatient format to special operational forces service members and veterans with mild TBI. IETPs provide bundled evidence-based assessment, treatment, referral, and case management in concordance with the existing guidelines for mild TBI and commonly co-occurring comorbidities. To date, there has been no formal characterization or evaluation of the IETP to understand the determinants of implementation across the system of care. The goal of our partnered evaluation initiative (PEI) with an operational partner, the Physical Medicine and Rehabilitation National Program Office, is to facilitate the full implementation of the IETP across all 5 Veterans Health Administration TBI-Centers of Excellence (TBI-COE) and to inform minimum standards while supporting the unique characteristics of each site. This IETP partnered evaluation will describe each of the 5 TBI-COE IETP services and state of implementation to identify opportunities for adaptation and scale, characterize the relationship between patient characteristics and clinical services received, evaluate the outcomes for participants in the IETP, and inform ongoing implementation and knowledge translation efforts to support IETP expansion. In alignment with the goals of the protocol, ineffective treatment components will be targeted for deimplementation. A 3-year concurrent mixed methods evaluation using a participatory approach in collaboration with the operational partner and TBI-COE site leadership will be conducted. Qualitative observations, semistructured focus groups, and interviewing methods will be used to describe IETP, stakeholder experiences and needs, and suggestions for IETP implementation. Quantitative methods will include primary data collection from patients in the IETP at each site to characterize long-term outcomes and patient satisfaction with treatment and secondary data collection to quantitatively characterize patient-level and care system-level data. Finally, data sets will be triangulated to share data findings with partners to inform ongoing implementation efforts. Data collection began in December 2021 and is currently ongoing. The results and deliverables will inform IETP characterization, evaluation, implementation, and knowledge translation. The results of this evaluation seek to provide an understanding of the determinants affecting the implementation of IETPs. Service member, staff, and stakeholder insights will inform the state of implementation at each site, and quantitative measures will provide options for standardized outcome measures. This evaluation is expected to inform national Physical Medicine and Rehabilitation Office policies and processes and knowledge translation efforts to improve and expand the IETP. Future work may include cost evaluations and rigorous research, such as randomized controlled trials. DERR1-10.2196/44776.

Upper Airway Assessment in Cone-Beam Computed Tomography for Screening of Obstructive Sleep Apnea Syndrome: Development of an Evaluation Protocol in Dentistry

The upper airways are formed by the nasal cavities, pharynx, and larynx. There are several radiographic methods that allow evaluation of the craniofacial structure. Upper airway analysis in cone-beam computed tomography (CBCT) may be useful in diagnosing some pathologies such as obstructive sleep apnea syndrome (OSAS). OSAS prevalence has increased significantly in recent decades, justified by increased obesity and average life expectancy. It can be associated with cardiovascular, respiratory, and neurovascular diseases, diabetes, and hypertension. In some individuals with OSAS, the upper airway is compromised and narrowed. Nowadays, CBCT is widely used in dentistry by clinicians. Its use for upper airway assessment would be an advantage for screening some abnormalities related to an increased risk of pathologies such as OSAS. CBCT helps to calculate the total volume of the airways and their area in different anatomical planes (sagittal, coronal, and transverse). It also helps identify regions with the highest anteroposterior and laterolateral constriction of the airways. Despite its undoubted advantages, airway assessment is not routinely performed in dentistry. There is no protocol that allows comparisons between studies, which makes it difficult to obtain scientific evidence in this area. Hence, there is an urgent need to standardize the protocol for upper airway measurement to help clinicians identify at-risk patients. Our main aim is to develop a standard protocol for upper airway evaluation in CBCT for OSAS screening in dentistry. To measure and evaluate the upper airways, data are obtained using Planmeca ProMax 3D (Planmeca). Patient orientation is performed in accordance with the manufacturer's indications at the time of image acquisition. The exposure corresponds to 90 kV, 8 mA, and 13,713 seconds. The software used for upper airway analysis is Romexis (version 5.1.O.R; Planmeca). The images are exhibited in accordance with the field of view of 20.1×17.4 cm, size of 502×502×436 mm, and voxel size of 400 μm. The protocol described and illustrated here allows for automatic calculation of the total volume of the pharyngeal airspace, its area of greatest narrowing, its location, and the smallest anteroposterior and laterolateral dimensions of the pharynx. These measurements are carried out automatically by the imaging software whose reliability is proven by the existing literature. Thus, we could reduce the possible bias of manual measurement, aiming at data collection. The use of this protocol by dentists will allow for standardization of the measurements and constitutes a valuable screening tool for OSAS. This protocol may also be suitable for other imaging software. The anatomical points used as reference are most relevant for standardizing studies in this field. RR1-10.2196/41049.

A Mobile Self-control Training App to Improve Self-control and Physical Activity in People With Severe Mental Illness: Protocol for 2 Single-Case Experimental Designs

Lack of physical activity is a common issue with detrimental consequences for the health of people with severe mental illness (SMI). Existing physical activity interventions show suboptimal effects as they require substantial cognitive skills, including goal setting and writing, whereas cognitive deficits are common in this population. To bolster the effectiveness of physical activity interventions, self-control training (SCT), in which users practice the ability to override unwanted thoughts and behaviors, can be used in addition. Recent research has demonstrated the initial effectiveness of a mobile SCT app, but this has not been studied in psychiatric clinical practice. This study aims to evaluate to what extent adding a mobile SCT app designed for and with people with SMI to a mobile lifestyle intervention aimed at increasing physical activity increases physical activity and self-control levels. A mixed methods approach incorporating 2 single-case experimental designs (SCEDs) and qualitative interviews was used to evaluate and optimize SCT. Overall, 12 participants with SMI will be recruited from 2 organizations offering outpatient and inpatient care to people with SMI. Each experiment will include 6 patients. SCED I is a concurrent multiple-baseline design across participants that explores initial effectiveness and optimal intervention duration. Using accelerometry and experience sampling questionnaires, participants' physical activity and self-control will be monitored for ≥5 days from baseline, followed by the sequential introduction of Google Fit, the physical activity intervention, for 7 days and the addition of SCIPP: Self-Control Intervention App for 28 days. SCED II is an introduction/withdrawal design in which optimized SCT will be introduced and withdrawn to validate the findings from SCED I. In both experiments, the daily average of total activity counts per hour and the state level of self-control will serve as the primary and secondary outcome measures. Data will be analyzed using visual analysis and piecewise linear regression models. The study was designated as not subject to the Dutch Medical Research Involving Human Subjects Act by the Medical Research Ethical Committee Oost-Nederland and approved by the Ethics Committee/domain Humanities and Social Sciences of the Faculty of Behavioural, Management, and Social Sciences at the University of Twente. Participant recruitment started in January 2022, and we expect to publish the results in early 2023. The mobile SCT app is expected to be feasible and effective. It is self-paced and scalable and can increase patient motivation, making it a suitable intervention for people with SMI. SCED is a relatively novel yet promising method for gaining insights into whether and how mobile apps work that can handle heterogeneous samples and makes it possible to involve a diverse population with SMI without having to include a large number of participants. PRR1-10.2196/37727.

Exploring the Efficacy of a Set of Smart Devices for Postural Awareness for Workers in an Industrial Context: Protocol for a Single-Subject Experimental Design.

In manufacturing industries, tasks requiring poor posture, high repetition, and long duration commonly induce fatigue and lead to an increased risk of work-related musculoskeletal disorders. Smart devices assessing biomechanics and providing feedback to the worker for correction may be a successful way to increase postural awareness, reducing fatigue, and work-related musculoskeletal disorders. However, evidence in industrial settings is lacking. This study protocol aims to explore the efficacy of a set of smart devices to detect malposture and increase postural awareness, reducing fatigue, and musculoskeletal disorders. A longitudinal single-subject experimental design following the ABAB sequence will be developed in a manufacturing industry real context with 5 workers. A repetitive task of screw tightening of 5 screws in a standing position into a piece placed horizontally was selected. Workers will be assessed in 4 moments per shift (10 minutes after the beginning of the shift, 10 minutes before and after the break, and 10 minutes before the end of the shift) in 5 nonconsecutive days. The primary outcomes are fatigue, assessed by electromyography, and musculoskeletal symptoms assessed by the Nordic Musculoskeletal Questionnaire. Secondary outcomes include perceived effort (Borg perceived exertion scale); range of motion of the main joints in the upper body, speed, acceleration, and deceleration assessed by motion analysis; risk stratification of range of motion; and cycle duration in minutes. Structured visual analysis techniques will be conducted to observe the effects of the intervention. Results for each variable of interest will be compared among the different time points of the work shift and longitudinally considering each assessment day as a time point. Enrollment for the study will start in April 2023. Results are expected to be available still in the first semester of 2023. It is expected that the use of the smart system will reduce malposture, fatigue, and consequently, work-related musculoskeletal pain and disorders. This proposed study will explore a strategy to increase postural awareness in industrial manufacturing workers who do repetitive tasks, using smart wearables that provide real-time feedback about biomechanics. Results would showcase a novel approach for improving self-awareness of risk for work-related musculoskeletal disorders for these workers providing an evidence base support for the use of such devices. PRR1-10.2196/43637.

Combining intensive rehabilitation with a non-functional isokinetic strengthening program in adolescents with cerebral palsy: a study protocol for a randomized controlled trial.

Cerebral palsy (CP) is the most common brain injury in the pediatric population. CP patients present different affectations such as decreased muscle strength, gait deviations, impaired proprioception, and spasticity. Isokinetic strengthening programs combined with an intensive rehabilitation may improve muscle strength and therefore gait efficiency. Clinical Trials: The protocol has been accepted by the French National Ethics Committee (IDRCB: 2022-A00431-42). The primary aim of this randomized controlled trial is to compare the effect of an intensive rehabilitation combined with a non-functional isokinetic progressive strengthening program to an intensive rehabilitation alone on gait parameters and muscle strength in CP patients. Another goal of the current study is to determine whether adding an isokinetic program to an intensive rehabilitation is more effective than an intensive reha-bilitation alone on decreasing spasticity and improving joint position sense in CP patients. Thirty adolescents with spastic diplegia CP (GMFCS level I to III) will be randomized, by an independent researcher, into a 3-week intensive rehabilitation and isokinetic pro-gressive strengthening group or an intensive rehabilitation control group. Gait param-eters, muscle strength, spasticity and knee joint position sense will be assessed. These variables will be evaluated at baseline (T0) and at the end of the intervention (T1). The intensive rehabilitation will consist of physiotherapy sessions twice a day and hydro-therapy and virtual reality gait training once a day. The isokinetic training group will have a total of 9 supervised isokinetic strength training focusing on knee flexors and extensors with different execution speeds. The protocol has been accepted by the French National Ethics Committee in October 2022. Inclusion of patients will start in November 2022. The combination of an intensive rehabilitation with an isokinetic program on knee flexors and extensors have not been studied yet. The findings of this study may determine if an isokinetic strength training program of knee flexors and extensors is benefic to improve gait parameters, muscle strength, spasticity, and joint position sense in adolescents with spastic diplegia. The protocol has been accepted by the French National Ethics Committee (IDRCB: 2022-A00431-42).

Addressing the Shortage of Health Professionals in Official Language Minority Communities to Strengthen Retention Strategies for the Benefit of New Brunswick Francophone and Acadian Communities: Protocol for a Mixed Methods Design

COVID-19 has highlighted already existing human resource gaps in health care systems. New Brunswick health care services are significantly weakened by a shortage of nurses and physicians, affecting regions where Official Language Minority Communities (OLMCs) reside. Since 2008, Vitalité Health Network (the "Network"), whose work language is French (with services delivered in both official languages, English and French), has provided health care to OLMCs in New Brunswick. The Network currently needs to fill hundreds of vacant physician and nurse positions. It is imperative to strengthen the network's retention strategies to ensure its viability and maintain adequate health care services for OLMCs. The study is a collaborative effort between the Network (our partner) and the research team to identify and implement organizational and structural strategies to upscale retention. The aim of this study is to support one of New Brunswick health networks in identifying and implementing strategies to promote physician and registered nurse retention. More precisely, it wishes to make 4 important contributions to identify (and enhance our understanding of) the factors related to the retention of physicians and nurses within the Network; determine, based on the "Magnet Hospital" model and the "Making it Work" framework, on which aspects of the Network's environment (internal or external) it should focus for its retention strategy; define clear and actionable practices to help the Network replenish its strength and vitality; and improve the quality of health care services to OLMCs. The sequential methodology combines quantitative and qualitative approaches based on a mixed methods design. For the quantitative part, data collected through the years by the Network will be used to take stock of vacant positions and examine turnover rates. These data will also help determine which areas have the most critical challenges and which ones have more successful approaches regarding retention. Recruitment will be made in those areas for the qualitative part of the study to conduct interviews and focus groups with different respondents, either currently employed or who have left it in the last 5 years. This study was funded in February 2022. Active enrollment and data collection started in the spring of 2022. A total of 56 semistructured interviews were conducted with physicians and nurses. As of manuscript submission, qualitative data analysis is in progress and quantitative data collection is intended to end by February 2023. Summer and fall 2023 is the anticipated period to disseminate the results. Applying the "Magnet Hospital" model and the "Making it Work" framework outside urban settings will offer a novel outlook to the knowledge of professional resource shortages within OLMCs. Furthermore, this study will generate recommendations that could contribute to a more robust retention plan for physicians and registered nurses. DERR1-10.2196/41485.

The Impact of Secure Messaging in the Treatment of Patients With Diabetes Within a Primary Care Setting: Protocol for a Scoping Review

Diabetes-a high-burden chronic disease-requires lifetime active management involving the use of different tools and health care resources to improve patient health outcomes. Recent studies have demonstrated promising results regarding the impact of the use of virtual care technology on the treatment of chronic diseases, such as diabetes. However, it is unclear whether the use of technologies, such as secure messaging, improves the quality of care and reduces diabetes-related costs to the health care system. The purpose of our scoping review is to explore what is known about the use of secure messaging in the treatment of diabetes within the primary care setting and how its impact has been assessed from the patient and health system perspectives. Our review aims to understand to what extent secure messaging improves the quality of diabetes care. Our scoping review will follow the 6-step Arksey and O'Malley methodological framework, as well as the Joanna Briggs Institute methodology for scoping reviews and their recommended tools. The tools to guide the development and reporting of the review in a structured way will include the Population, Concept, and Context framework and the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidelines and checklist. The search strategy was developed iteratively in collaboration with a professional information specialist. Furthermore, a peer review of electronic search strategies was also conducted by an independent, third-party, professional information specialist. A systematic literature search will be conducted against databases, including Ovid MEDLINE ALL, Embase, APA PsycINFO, Cochrane Library on Wiley, CINAHL on EBSCO, and PubMed. Grey literature sources will also be searched for relevant literature. Literature on the use of secure messaging in the treatment of diabetes (types 1 and 2) within a primary care setting will be included. Two reviewers will review the literature based on the inclusion criteria in the following two steps: (1) title and abstract review and (2) full-text review. Discrepancies will be discussed to reach consensus where possible; otherwise, a third reviewer will resolve the dispute. The results and a final report are expected to be completed and submitted to a peer-reviewed journal in 6 months. The review will examine existing literature to identify the impact of secure messaging in diabetes treatment within primary care settings. Research gaps will also be identified to determine if there is a need for further studies. DERR1-10.2196/42339.

Blood Pressure and Self-management in Black Women With Hypertension: Protocol Revisions to the Brain Relationships Among Information, Neuroprocessing, and Self-Management Study Due to the COVID-19 Pandemic

The COVID-19 pandemic and the halt to in-person research activities beginning in March 2020 brought new challenges to protocol development and implementation. Due to the pandemic, we had to revise our protocol for the Brain Relationships Among Information, Neuroprocessing, and Self-Management (BRAINS) study, which was designed to examine health information behavior, brain activity, diabetes status, and self-management behavior among Black women with hypertension. This report outlines 7 steps describing how our research team (1) revised the BRAINS study protocol, (2) implemented a remote method of data collection, and (3) mitigated the challenges we faced. Prior to March 2020, Black women with hypertension were invited to participate in the BRAINS study to undergo a functional magnetic resonance imaging scan, complete surveys, have their blood pressure measured, and have their blood drawn. After these measures were collected, participants would receive phone calls from a dietician to complete two 24-hour dietary recalls using the Nutrition Data System for Research. Our revised protocol relied on a web-based, interactive approach. Participants received a study kit that included an Omron automatic home blood pressure monitor and a hemoglobin A1c kit from the DTIL laboratory. In a Zoom meeting with each participant, our team played an introductory video, administered surveys (via Qualtrics), and guided participants through measuring their blood pressure and performing a finger stick to collect a blood sample for hemoglobin A1c testing. We examined cognitive function using the TestMyBrain Digital Neuropsychology Toolkit, as we were unable to access the functional magnetic resonance imaging laboratory to assess brain activity. The 7 steps in revising our protocol were as follows: conceptualizing the move from in-person to remote study activities (step 1); contacting the funders (step 2); submitting changes for Institutional Review Board approval (step 3); preparing to implement the revised protocol (step 4); implementing the study changes (step 5); mitigating challenges (step 6); and evaluating protocol implementation (step 7). Approximately 1700 individuals responded to web-based advertisements about the BRAINS study. A total of 131 individuals completed our eligibility screener. We conducted our first Zoom appointment in July 2020 and our last Zoom appointment in September 2020. Using our revised strategies, a total of 99 participants completed all study measures within a 3-month period. In this report, we discuss successes and challenges in revising our protocol and reaching our population of interest remotely, safely, and effectively. The information we have outlined can help researchers create similar protocols to reach and conduct research remotely with diverse populations, such as individuals who are unable to participate in studies in person. DERR1-10.2196/43849.

A Visual Analytic Tool (VIADS) to Assist the Hypothesis Generation Process in Clinical Research: Mixed Methods Usability Study

Visualization can be a powerful tool to comprehend data sets, especially when they can be represented via hierarchical structures. Enhanced comprehension can facilitate the development of scientific hypotheses. However, the inclusion of excessive data can make visualizations overwhelming. We developed a visual interactive analytic tool for filtering and summarizing large health data sets coded with hierarchical terminologies (VIADS). In this study, we evaluated the usability of VIADS for visualizing data sets of patient diagnoses and procedures coded in the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM). We used mixed methods in the study. A group of 12 clinical researchers participated in the generation of data-driven hypotheses using the same data sets and time frame (a 1-hour training session and a 2-hour study session) utilizing VIADS via the think-aloud protocol. The audio and screen activities were recorded remotely. A modified version of the System Usability Scale (SUS) survey and a brief survey with open-ended questions were administered after the study to assess the usability of VIADS and verify their intense usage experience with VIADS. The range of SUS scores was 37.5 to 87.5. The mean SUS score for VIADS was 71.88 (out of a possible 100, SD 14.62), and the median SUS was 75. The participants unanimously agreed that VIADS offers new perspectives on data sets (12/12, 100%), while 75% (8/12) agreed that VIADS facilitates understanding, presentation, and interpretation of underlying data sets. The comments on the utility of VIADS were positive and aligned well with the design objectives of VIADS. The answers to the open-ended questions in the modified SUS provided specific suggestions regarding potential improvements for VIADS, and the identified problems with usability were used to update the tool. This usability study demonstrates that VIADS is a usable tool for analyzing secondary data sets with good average usability, good SUS score, and favorable utility. Currently, VIADS accepts data sets with hierarchical codes and their corresponding frequencies. Consequently, only specific types of use cases are supported by the analytical results. Participants agreed, however, that VIADS provides new perspectives on data sets and is relatively easy to use. The VIADS functionalities most appreciated by participants were the ability to filter, summarize, compare, and visualize data. RR2-10.2196/39414.

A Computational Platform to Support the Detection, Follow-up, and Epidemiological Surveillance of Mental Health and Substance Use Disorders: Protocol for a Development and Evaluation Study.

According to the World Health Organization, approximately 15% of the global population is affected by mental health or substance use disorders. These conditions contribute significantly to the global disease burden, which has worsened because of the direct and indirect effects of COVID-19. In Mexico, a quarter of the population between the ages of 18 and 65 years who reside in urban areas present a mental health condition. The presence of a mental or substance abuse disorder is behind a significant percentage of suicidal behaviors in Mexico, where only 1 in 5 of those who have these disorders receive any treatment. This study aims to develop, deploy, and evaluate a computational platform to support the early detection and intervention of mental and substance use disorders in secondary and high schools as well as primary care units. The platform also aims to facilitate monitoring, treatment, and epidemiological surveillance ultimately helping specialized health units at the secondary level of care. The development and evaluation of the proposed computational platform will run during 3 stages. In stage 1, the identification of the functional and user requirements and the implementation of the modules to support the screening, follow-up, treatment, and epidemiological surveillance will be performed. In stage 2, the initial deployment of the screening module will be carried out in a set of secondary and high schools, as well as the deployment of the modules to support the follow-up, treatment, and epidemiological surveillance processes in primary and secondary care health units. In parallel, during stage 2, patient applications to support early interventions and continuous monitoring will also be developed. Finally, during stage 3, the deployment of the complete platform will be performed jointly with a quantitative and qualitative evaluation. The screening process has started, and 6 schools have been currently enrolled. As of February 2023, a total of 1501 students have undergone screening, and the referral of those students presenting a risk in mental health or substance use to primary care units has also started. The development, deployment, and evaluation of all the modules of the proposed platform are expected to be completed by late 2024. The expected results of this study are to impact a better integration between the different levels of health care, from early detection to follow-up and epidemiological surveillance of mental and substance use disorders contributing to reducing the gap in the attention to these problems in the community. DERR1-10.2196/44607.

Toward Enhanced Clinical Decision Support for Patients Undergoing a Hip or Knee Replacement: Focus Group and Interview Study With Surgeons

The current assessment of recovery after total hip or knee replacement is largely based on the measurement of health outcomes through self-report and clinical observations at follow-up appointments in clinical settings. Home activity-based monitoring may improve assessment of recovery by enabling the collection of more holistic information on a continuous basis. This study aimed to introduce orthopedic surgeons to time-series analyses of patient activity data generated from a platform of sensors deployed in the homes of patients who have undergone primary total hip or knee replacement and understand the potential role of these data in postoperative clinical decision-making. Orthopedic surgeons and registrars were recruited through a combination of convenience and snowball sampling. Inclusion criteria were a minimum required experience in total joint replacement surgery specific to the hip or knee or familiarity with postoperative recovery assessment. Exclusion criteria included a lack of specific experience in the field. Of the 9 approached participants, 6 (67%) orthopedic surgeons and 3 (33%) registrars took part in either 1 of 3 focus groups or 1 of 2 interviews. Data were collected using an action-based approach in which stimulus materials (mock data visualizations) provided imaginative and creative interactions with the data. The data were analyzed using a thematic analysis approach. Each data visualization was presented sequentially followed by a discussion of key illustrative commentary from participants, ending with a summary of key themes emerging across the focus group and interview data set. The limitations of the evidence are as follows. The data presented are from 1 English hospital. However, all data reflect the views of surgeons following standard national approaches and training. Although convenience sampling was used, participants' background, skills, and experience were considered heterogeneous. Passively collected home monitoring data offered a real opportunity to more objectively characterize patients' recovery from surgery. However, orthopedic surgeons highlighted the considerable difficulty in navigating large amounts of complex data within short medical consultations with patients. Orthopedic surgeons thought that a proposed dashboard presenting information and decision support alerts would fit best with existing clinical workflows. From this, the following guidelines for system design were developed: minimize the risk of misinterpreting data, express a level of confidence in the data, support clinicians in developing relevant skills as time-series data are often unfamiliar, and consider the impact of patient engagement with data in the future. RR2-10.1136/bmjopen-2018-021862.

The Development of a UK Culturally Adapted and Modified Version of the Person Attuned Musical Interactions Manual: Protocol for a 2-Phase Mixed Methods Study

Previous research has suggested that care home interactions need significant improvements, especially those between staff and residents with dementia. Reasons for the lack of interactions are staff time pressures and residents' language impairments. Although residents may experience reduced language abilities, they can continue to communicate through other forms, including nonverbal communication and music. Person Attuned Musical Interactions (PAMI) is a staff training tool that provides staff with music therapy skill-sharing to promote high-quality interactions between staff and residents using nonverbal communication and music. The tool was originally developed in Denmark. To ensure that the tool is appropriate for UK care homes, a team of researchers in the United Kingdom have modified and culturally adapted the tool. This study aims to investigate the appropriateness of the adapted and modified manual for UK care homes and to explore the impact of PAMI on residents with dementia and care staff. The project consists of 2 phases, a qualitative field-testing study and a mixed methods evaluation study, which have been developed following the Medical Research Council's guidelines for complex interventions. Care staff and residents with dementia will be recruited from care homes in Lincolnshire, where the care staff will be trained in the PAMI intervention before implementing the intervention in their daily routines. Fortnightly reflective sessions will be provided throughout the phases to provide supervision and monitoring. The qualitative methods include interviews, reflective session transcripts, diary entries, and resident experience questionnaires. The quantitative outcome measures are residents' music engagement, staff's dementia competence, residents' quality of life, and staff burden. The resident's music engagement will be administered at 9 fortnightly time points. Staff's dementia competence, resident's quality of life, and staff burden will be administered at preintervention and postintervention time points. The study has been funded by The Music Therapy Charity as part of a PhD studentship. The study began recruiting in September 2021. The research team aims to publish the results of the first phase in July to September 2023 and those of the second phase in October to December 2023. This study will be the first to investigate the modified version of PAMI. Therefore, it will provide feedback on the appropriateness of the manual for UK care homes. The PAMI intervention has the potential to offer high-quality music intervention training to a larger population of care homes who may currently be restricted by finances, the availability of time, and a lack of training opportunities. DERR1-10.2196/43408.

Identification of Key Factors for Optimized Health Care Services: Protocol for a Multiphase Study of the Dubai Vaccination Campaign.

Mass vaccination of the global population against the novel COVID-19 outbreak posed multiple challenges, including effectively administering millions of doses in a short period of time while ensuring public safety and accessibility. The government of Dubai launched a mass campaign in December 2020 to vaccinate all its citizens and residents, targeting the population aged >18 years against COVID-19. The vaccination campaign involved a transformation of multiple commercial spaces into mass vaccination centers across the city of Dubai, the largest of which was the Dubai One Central (DOC) vaccination center. It was operational between January 17, 2021, and 27 January 27, 2022. The multiphase research study aims to empirically explore the opinions of multiple health care stakeholders, elicit the key success factors that can influence the effective delivery of emergency health care services such as a COVID-19 mass vaccination center, and explore how these factors relate to one another. To understand more about the operations of the DOC vaccination center, the study follows a multiphase design divided into 2 phases. The study is being conducted by the Institute for Excellence in Health Professions Education at Mohammed Bin Rashid University of Medicine and Health Sciences between December 2021 and January 2023. To elicit the key success factors that contributed to the vaccination campaign administered at DOC, the research team conducted 30 semistructured interviews (SSIs) with a sample of staff and volunteers who worked at the DOC vaccination center. Stratified random sampling was used to select the participants, and the interview cohort included representatives from the management team, team leaders, the administration and registration team, vaccinators, and volunteers. A total of 103 people were invited to take part in the research study, and 30 agreed to participate in the SSIs. To validate the participation of various stakeholders, phase 2 will analytically investigate one's subjectivity through Q-methodology and empirically investigate the opinions obtained from the research participants during phase 1. As of July 2022, 30 SSIs were conducted with the research participants. The study will provide a comprehensive 2-phase approach to obtaining the key success factors that can influence the delivery of high-quality health care services such as emergency services launched during a global pandemic. The study's findings will be translated into key factors that could support designing future health care services utilizing evidence-based practice. In line with future plans, a study will use data, collected through the DOC vaccination center, to develop a simulation model outlining the process of the customer journey and center workflow. DERR1-10.2196/42278.

Decolonization in Sexual and Reproductive Health Research Methods: Protocol for a Scoping Review

As researchers and implementors begin to acknowledge the repercussions of institutionalized colonialism on community and individual health, the need to decolonize research has become clear. Despite this, there is neither a singular definition of decolonizing methodologies nor an overview of the shared principles and characteristics of decolonized research needed to codify this work as common practice in global health. The review will identify papers that reference principles of decolonization and identify shared characteristics between them. The aim of this scoping review is to review decolonized research methodologies through the lens of sexual health as a step in creating a shared understanding of best practices. We will further examine the tools and methods used to collect and analyze data within the included studies. The protocol for this scoping review was developed using the framework from the Joanna Briggs Institute and the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews). The search strategy will comprise a search of electronic databases (JSTOR, Embase, EMCare, MEDLINE [Ovid], Global Health Database, Web of Science), gray literature sources, and key studies. Titles and abstracts will be reviewed by 2 or more independent reviewers against inclusion criteria. Bibliometric details, study design, methodology, community involvement, and other indicators will be collected using a data extraction tool developed for this review. Extracted data will be analyzed using descriptive statistics and qualitative analysis of content and themes to identify common practices in decolonized methodologies within sexual health. Narrative summaries will be used to describe results in relation to the research question, and identified gaps will be discussed. The initial title or abstract review of 4967 studies identified by the search strategy was completed in November 2022. In total, 1777 studies met initial inclusion criteria and were sent to a second round of title or abstract review, which was completed in January 2023. In total, 706 studies were downloaded for full-text inclusion, which is expected to be completed by April 2023. We aim to complete data extraction and analysis by May 2023 and expect to publish the findings by the end of July 2023. There remains a gap in the research on the meaning and application of decolonized research strategies, particularly within sexual and reproductive health. The findings of this study will contribute to a shared definition of decolonized methodologies and how they can be applied as a common practice in global health research. Applications include the development of decolonized frameworks, theoretical discourses, and methodologies. The study will inform the design and implementation of future decolonized research and evaluation strategies, particularly around sexual and reproductive health. DERR1-10.2196/45771.

Wearable Sensor and Mobile App–Based mHealth Approach for Investigating Substance Use and Related Factors in Daily Life: Protocol for an Ecological Momentary Assessment Study

Digital health technologies using mobile apps and wearable devices are a promising approach to the investigation of substance use in the real world and for the analysis of predictive factors or harms from substance use. Moreover, consecutive repeated data collection enables the development of predictive algorithms for substance use by machine learning methods. We developed a new self-monitoring mobile app to record daily substance use, triggers, and cravings. Additionally, a wearable activity tracker (Fitbit) was used to collect objective biological and behavioral data before, during, and after substance use. This study aims to describe a model using machine learning methods to determine substance use. This study is an ongoing observational study using a Fitbit and a self-monitoring app. Participants of this study were people with health risks due to alcohol or methamphetamine use. They were required to record their daily substance use and related factors on the self-monitoring app and to always wear a Fitbit for 8 weeks, which collected the following data: (1) heart rate per minute, (2) sleep duration per day, (3) sleep stages per day, (4) the number of steps per day, and (5) the amount of physical activity per day. Fitbit data will first be visualized for data analysis to confirm typical Fitbit data patterns for individual users. Next, machine learning and statistical analysis methods will be performed to create a detection model for substance use based on the combined Fitbit and self-monitoring data. The model will be tested based on 5-fold cross-validation, and further preprocessing and machine learning methods will be conducted based on the preliminary results. The usability and feasibility of this approach will also be evaluated. Enrollment for the trial began in September 2020, and the data collection finished in April 2021. In total, 13 people with methamphetamine use disorder and 36 with alcohol problems participated in this study. The severity of methamphetamine or alcohol use disorder assessed by the Drug Abuse Screening Test-10 or the Alcohol Use Disorders Identification Test-10 was moderate to severe. The anticipated results of this study include understanding the physiological and behavioral data before, during, and after alcohol or methamphetamine use and identifying individual patterns of behavior. Real-time data on daily life among people with substance use problems were collected in this study. This new approach to data collection might be helpful because of its high confidentiality and convenience. The findings of this study will provide data to support the development of interventions to reduce alcohol and methamphetamine use and associated negative consequences. DERR1-10.2196/44275.

Utilization of Research in Clinical Nursing and Midwifery Practice in Ghana: Protocol for a Mixed Methods Study.

The International Council of Nurses' 2021 code of ethics mandates nurses to provide evidence-informed care to patients. Globally, using research evidence has led to improvement in nursing and midwifery practice, according to the World Health Organization. A study in Ghana found that 25.3% (n=40) of nurses and midwives use research in clinical care. Research utilization (RU) increases therapeutic effectiveness, improves health outcomes, and enhances the personal and professional development of clinicians. However, it is uncertain the extent to which nurses and midwives are prepared, skilled, and supported to utilize research in clinical care in Ghana. This study aims to develop a conceptual framework that can facilitate RU among clinical nurses and midwives in Ghanaian health facilities. This will be a cross-sectional study with a concurrent mixed methods approach. It will be conducted in 6 hospitals and 4 nursing educational institutions in Kumasi, Ghana. The study has 4 objectives which will be executed in 3 phases. Phase 1 follows a quantitative approach to describe the knowledge, attitudes, and practices of clinical nurses and midwives on the use of research in their practice. Using a web-based survey, 400 nurses and midwives working in 6 health facilities will be recruited. Data analysis will be conducted using SPSS, with statistical significance set at .05. Qualitative methodology, using focus group discussions with clinical nurses and midwives, will be conducted to identify the factors influencing their RU. In phase 2, focus group discussions will be used to examine and describe how nurse educators in 4 nursing and midwifery educational institutions prepare nurses and midwives for RU during their education. Views of nurse managers on the RU in Ghanaian health care facilities will be explored in the second section of this phase through one-on-one interviews. Inductive thematic analysis will be used to analyze the qualitative data, and Lincoln and Guba's principles of trustworthiness will be applied. In phase 3, the stages of model development proposed by Chinn and Kramer; and Walker and Avant will be used to triangulate findings from all objectives and formulate a conceptual framework. Data collection started in December 2022. Publication of the results will begin in April 2023. RU in clinical practice has become an acceptable practice in nursing and midwifery. It is critical that nursing and midwifery professionals in sub-Saharan Africa shift their practice to embrace the global movement. This proposed conceptual framework will empower nurses and midwives to improve their practice of RU. DERR1-10.2196/45067.

Platform-Based Patient-Clinician Digital Health Interventions for Care Transitions: Protocol for a Scoping Review

With the increased adoption of technology, the use of digital health interventions in health care settings has increased. Patient-clinician digital health interventions have the potential to improve patient care, especially during important transitions between hospital and home. Digital health interventions can provide support to patients during these transitions, thereby leading to better patient outcomes. This scoping review aims to explore the available literature, specifically (1) to examine the impact of platform-based digital health interventions focused on care transitions on patient outcomes, and (2) to identify the barriers to and enablers for the uptake and implementation of these digital health interventions. This protocol was developed based on Arksey and O'Malley's, Levac and colleagues', and JBI scoping review methodologies, and it has been reported according to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Statement for the Scoping Reviews) format. The search strategies were developed for 4 databases: MEDLINE, CINAHL, EMBASE, and the Cochrane Central Register of Controlled Trials by using key words such as "hospital to home transition" and "platform-based digital health." Studies involving patients 16 years or older that used a platform-based digital health intervention during their hospital to home transition will be included in this review. Two reviewers will independently screen articles for eligibility by using a 2-stage process (ie, title and abstract screening and full-text screening). We expect to refine the eligibility criteria during the title and abstract screening process as we anticipate retrieving a significant number of articles. In addition, we will also perform a targeted search of the grey literature, as well as data extraction. Data analysis will consist of a narrative and descriptive synthesis. The review is expected to identify research gaps that will inform the development of future patient-clinician digital health interventions. We have identified a total of 8333 articles. Screening began in September 2022, and data extraction is expected to commence in February 2023 and end by April 2023. Data analyses and final results will be submitted to a peer-reviewed journal in August 2023. We expect to find a wide variety of postcare interventions, some gaps in the quality of research evidence, as well as a lack of detailed information on digital health interventions. PRR1-10.2196/42056.

Identification of Patients With Elevated Urine Albumin-to-Creatinine Ratio Levels in a Type 2 Diabetes Mellitus Cohort Based on Data Submitted by Patients via a Smartphone App (SMART-Finder): Protocol for an Observational Study.

Despite effective treatment options, chronic kidney disease (CKD) has become a major cause of mortality worldwide due to the ever-increasing number of patients with type 2 diabetes mellitus (T2DM). Guideline-compliant, at least, annual screening of patients with T2DM is crucial to prevent renal disease progression. However, data on the prevalence of CKD in patients with T2DM and on screening frequency are limited. SMART-Finder is the first study to exclusively use data provided directly by patients via an adherence app to collect information on the prevalence of CKD, risk factors, disease management, and quality of life of patients with T2DM in Germany. The primary objective of this study is to determine the proportion of patients with T2DM and an elevated urine albumin-to-creatinine ratio (UACR; albumin-to-creatinine ratio stage A2 and A3) at baseline and after 12 (±3) months. Secondary objectives include the proportion of patients who remain in or switch to another albumin-to-creatinine ratio classification category after 12 months, information on quality of life, disease awareness, and adherence rates, as well as the proportion of patients without any UACR-screening data. Recruitment occurs via push notification among MyTherapy app users with T2DM. This is a single-arm, retrospective/prospective, observational, digital, patient-centered cohort study, with recruitment and data documentation via a health app. Required routine laboratory data are provided by treating physicians to their patients for data entry. The study population includes adult patients with T2DM documenting their data in the MyTherapy app using their own smartphone or tablet. Study participants are provided with a specifically developed electronic case report form containing questions on demographic and general data, quality of life, disease awareness, and laboratory values including estimated glomerular filtration rate, UACR, hemoglobin 1Ac, and blood pressure. Apart from demographic and general data, all data are collected at baseline and 12 months after the last UACR assessment. An automatically generated push notification reminds participants of the second data entry. The extracted and pseudonymized data are analyzed descriptively. The enrollment period for this study started in February 2023 and shall end after 12 months or after the enrollment of 5000 patients. An interim analysis is planned 3 months after the inclusion of the first patient and the final analysis after 12 months of follow-up. Overall, the study will contribute to minimizing the existing data gap on the prevalence of CKD in patients with T2DM in Germany, provide important insights into the current disease management of patients with T2DM in everyday clinical practice in Germany, and support guideline-based care for the participating patients. PRR1-10.2196/44996.

Management of Pain and Cachexia in Pancreatic Cancer: Protocol for Two Systematic Reviews, Network Meta-Analysis, Surveys, and Focus Groups

Approximately 75% of people with pancreatic cancer experience pain, and >50% of them have cachexia (weakness and wasting of the body). However, there is considerable uncertainty regarding the management of these distressing symptoms. Our primary objectives are to compare the relative benefits and harms of different interventions for pain in people with unresectable pancreatic cancer and for prevention and treatment of cachexia due to pancreatic cancer, through systematic reviews and network meta-analysis. Our secondary objectives are to develop an evidence-based clinical care pathway to manage pain and prevent and treat cachexia in people with pancreatic cancer through surveys and focus groups involving patients, carers, and health care professionals. We will perform 2 systematic reviews of the literature related to pain and cachexia in people with pancreatic cancer using searches from Cochrane Library, MEDLINE, Embase, Science Citation Index, and trial registries. Two researchers will independently screen for eligibility and identify randomized controlled trials (no language or publication status restriction), comparing interventions for pain or cachexia based on full-texts for articles shortlisted during screening. We will assess risk of bias in the trials using the Cochrane risk of bias tool (version 2.0) and obtain data related to baseline prognostic characteristics, potential effect modifiers and outcome data related to overall survival, health-related quality of life, treatment-related complications, and resource utilisation. We aim to conduct network meta-analysis on outcomes with multiple treatment comparisons where possible, otherwise, meta-analysis with direct comparisons, or narrative synthesis. We will perform various subgroup and sensitivity analyses. Using information obtained from both systematic reviews, we will conduct 2 surveys: one directed to patients or carers to assess acceptability of interventions, and the other to health care professionals to assess feasibility of delivery in the National Health Service. Four mixed focus groups will be conducted to evaluate findings and foster consensus in the development of the care pathway. Funding was awarded from April 2022 (NIHR202727). Both systematic review protocols were prospectively registered on PROSPERO in May 2022. Formal searches began thereafter. Approval by the University College London Research Ethics Committee (23563/001) was received in December 2022. Data collection began in January 2023; data analysis will begin in May 2023 (completion expected by October 2023). This study will comprehensively encompass major interventions for management of pain in people with unresectable pancreatic cancer, and prevention and treatment of cachexia in people with pancreatic cancer. Key stakeholders will facilitate the development of an evidence-based care pathway, ensuring both acceptability and feasibility. The project ends in April 2024 and published results are expected within 12 months of completion. We aim to present the findings through patient group websites, conferences, and publications, irrespective of the findings, in a peer-reviewed journal. DERR1-10.2196/46335.

Value of Including the Children’s Experience for Improving Their Rights During Hospitalization: Protocol for the VoiCEs Project

Users' feedback is a key asset for organizations that want to improve their services. Studying how organizations are enabling their users to participate in evaluation activities is particularly important, especially when there are vulnerable or disadvantaged people, and the services to be evaluated can be life-changing. This is the case in the coassessment by pediatric patients experiencing hospital stay. The international literature reports a few attempts and several challenges in systematically collecting and using the pediatric patient experience with respect to hospitalization, to undertake quality improvement actions. This paper describes the research protocol of a European project intended to develop and implement a systematic pediatric patient-reported experience measures (PREMs) observatory that will be shared by 4 European children's hospitals in Finland, Italy, Latvia, and the Netherlands. The VoiCEs (Value of including the Children's Experience for improving their rightS during hospitalization) project uses a participatory action research approach, based on a mixture of qualitative and quantitative methods. It consists of 6 different phases, including a literature review, an analysis of the previous experiences of pediatric PREMs reported by project partners, a Delphi process, a cycle of focus groups or in-depth interviews with children and their caregivers, a series of workshops with interactive working groups, and a cross-sectional observational survey. The project guarantees the direct participation of children and adolescents in the development and implementation phases of the project. The expected results are (1) a deeper knowledge of published methodologies and tools on collecting and reporting pediatric patients' voice; (2) lessons learnt from the analysis of previous experiences of pediatric PREMs; a consensus reached through a participatory process (3) among experts, (4) pediatric patients and caregivers about a standard set of measures for the evaluation of hospitalization by patients; (5) the implementation of a European observatory on pediatric PREMs; and (6) the collection and comparative reporting of the pediatric patients' voice. In addition, the project is aimed at studying and proposing innovative methodologies and tools for capturing the pediatric patients' feedback directly, avoiding the intermediation of parents/guardians. Over the last decade, the collection and use of PREMs have gained importance as a research field. Children and adolescents' perspectives have also been increasingly taken into consideration. However, to date, there are limited experiences regarding the continuous and systematic collection and use of pediatric PREMs data for implementing timely improvement actions. In this perspective, the VoiCEs project provides room for innovation, by contributing to the creation of an international, continuous, and systematic pediatric PREMs observatory that can be joined by other children's hospitals or hospitals with pediatric patients, and foresees the return of usable and actionable data in benchmarking. DERR1-10.2196/42804.