@Article{info:doi/10.2196/35910, author="de la Cruz Herrera, Mercedes and Fuster-Casanovas, A{\"i}na and Mir{\'o} Catalina, Queralt and Cigarr{\'a}n Mensa, Mireia and Alc{\'a}ntara Pinillos, Pablo and Vilanova Guitart, Isabel and Grau Carri{\'o}n, Sergi and Vidal-Alaball, Josep", title="Use of Virtual Reality in the Reduction of Pain After the Administration of Vaccines Among Children in Primary Care Centers: Protocol for a Randomized Clinical Trial", journal="JMIR Res Protoc", year="2022", month="Apr", day="7", volume="11", number="4", pages="e35910", keywords="children", keywords="virtual reality", keywords="pain", keywords="pain perception", keywords="anxiety", keywords="vaccination", keywords="immunization schedule", abstract="Background: Pain and anxiety caused by vaccination and other medical procedures in childhood can result in discomfort for both patients and their parents. Virtual reality (VR) is a technology that is capable of entertaining and distracting the user. Among its many applications, we find the improvement of pain management and the reduction of anxiety in patients undergoing medical interventions. Objective: We aim to publish the protocol of a clinical trial for the reduction of pain and anxiety after the administration of 2 vaccines in children aged 3 to 6 years. Methods: We will conduct a randomized, parallel, controlled clinical trial with 2 assigned groups. The intervention group will wear VR goggles during the administration of 2 vaccines, while the control group will receive standard care from a primary care center for the procedure. Randomization will be carried out by using the RandomizedR computer system---a randomization tool of the R Studio program. This trial will be an open or unblinded trial; both the subjects and the investigators will know the assigned treatment groups. Due to the nature of the VR intervention, it will be impossible to blind the patients, caregivers, or observers. However, a blind third-party assessment will be carried out. The study population will include children aged 3 to 6 years who are included in the patient registry and cared for in a primary care center of the region of Central Catalonia. They will receive the following vaccines during the Well-Child checkup: the triple viral+varicella vaccine at 3 years of age and the hepatitis A+diphtheria-tetanus-pertussis vaccine at 6 years of age. Results: The study is scheduled to begin in January 2022 and is scheduled to end in January 2023, which is when the statistical analysis will begin. As of March 2022, a total of 23 children have been recruited, of which 13 have used VR during the vaccination process. In addition, all of the guardians have found that VR helps to reduce pain during vaccination. Conclusions: VR can be a useful tool in pediatric procedures that generate pain and anxiety. International Registered Report Identifier (IRRID): PRR1-10.2196/35910 ", doi="10.2196/35910", url="https://www.researchprotocols.org/2022/4/e35910", url="http://www.ncbi.nlm.nih.gov/pubmed/35388793" } @Article{info:doi/10.2196/29726, author="Ritvo, Paul and Gratzer, David and Knyahnytska, Yuliya and Ortiz, Abigail and Walters, Clarice and Katz, Joel and Laposa, Judith and Baldissera, Christopher and Wayne, Noah and Pfefer-Litman, Donna and Tomlinson, George and Daskalakis, Zafiris", title="Comparing Online and On-Site Cognitive Behavior Therapy in Major Depressive Disorder: Protocol for a Noninferiority Randomized Controlled Trial", journal="JMIR Res Protoc", year="2022", month="Apr", day="8", volume="11", number="4", pages="e29726", keywords="online intervention", keywords="randomized controlled trial", keywords="major depressive disorder", abstract="Background: The incidence of mental health disorders in Canada is increasing with costs of CAD \$51 billion (US \$40 billion) per year. Depression is the most prevalent cause of disability while cognitive behavioral therapy (CBT) is the best validated behavioral depression treatment. CBT, when combined with mindfulness meditation (CBT-M), has strong evidence for increased efficacy. While randomized controlled trials (RCTs) have demonstrated online CBT-M efficacy, comparisons with in-office delivery are lacking. Objective: The aim of this research is to assess whether online group CBT-M (with standard psychiatric care) is non-inferior in efficacy and more cost-effective than office-based, on-site group CBT-M at post-intervention and 6-months follow-up in major depressive disorder. The study will also assess whether digitally recorded data (ie, online workbooks completed, Fitbit step count, and online text messages) predict depression symptom reduction in online participants. Methods: This single-center, two-arm, noninferiority RCT employs assessor-blinded and self-report outcomes and economic evaluation. The research site is the Centre for Addiction and Mental Health (Toronto), a research-based psychiatry institution where participants will be identified from service wait lists and through contacts with other Toronto clinics. Inclusion criteria are as follows: (1) aged 18-60 years, any ethnicity; (2) Beck Depression Inventory-II (BDI-II) of mild severity (score ?14) with no upper severity limit; (3) Mini-International Neuropsychiatric Interview-confirmed, psychiatric major depressive disorder diagnosis; (4) fluent in English. All patients are diagnosed by staff psychiatrists. Exclusion criteria are as follows: (1) receipt of weekly structured psychotherapy; (2) observation of Diagnostic and Statistical Manual of Mental Disorders (5th Edition) criteria for severe alcohol or substance use disorder (in past 3 months), borderline personality disorder, schizophrenia (or other primary psychotic disorder), bipolar disorder, or obsessive-compulsive disorder; (3) clinically significant suicidal ideation (imminent intent or attempted suicide in the past 6 months); and (4) treatment-resistant depression. All participants receive standard psychiatric care, experimental participants receive online group CBT-M, and controls receive standard care in-office group CBT-M. The online group program (in collaboration with NexJ Health, Inc) combines smartphone and computer-accessed workbooks with mental health phone counselling (16 hours in 16 weeks) that coordinates software interactions (eg, secure text messaging and Fitbit-tracked walking). The primary outcome is BDI-II, and secondary outcomes are anxiety (Beck Anxiety Inventory), depression (ie, Quick Inventory of Depressive Symptomatology and 17-item Hamilton Depression Rating Scale), mindfulness (Five-Facet Mindfulness Questionnaire), quality of life (European Quality of Life Five Dimension), and pain (Brief Pain Inventory). Results: Based on prior studies with the BDI-II and 80\% power to reject an inferiority hypothesis with a 1-sided type I error rate of 5\%, a sample of 78 per group is adequate to detect small-to-medium--effect sizes. Conclusions: This study assesses online CBT-M efficacy and noninferiority in relation to in-person CBT, and the cost-effectiveness of both interventions. Trial Registration: ClinicalTrials.gov NCT04825535; https://www.clinicaltrials.gov/ct2/show/NCT04825535 International Registered Report Identifier (IRRID): DERR1-10.2196/29726 ", doi="10.2196/29726", url="https://www.researchprotocols.org/2022/4/e29726", url="http://www.ncbi.nlm.nih.gov/pubmed/35393942" } @Article{info:doi/10.2196/34470, author="Laranjo, Liliana and Shaw, Tim and Trivedi, Ritu and Thomas, Stuart and Charlston, Emma and Klimis, Harry and Thiagalingam, Aravinda and Kumar, Saurabh and Tan, C. Timothy and Nguyen, N. Tu and Marschner, Simone and Chow, Clara", title="Coordinating Health Care With Artificial Intelligence--Supported Technology for Patients With Atrial Fibrillation: Protocol for a Randomized Controlled Trial", journal="JMIR Res Protoc", year="2022", month="Apr", day="13", volume="11", number="4", pages="e34470", keywords="atrial fibrillation", keywords="interactive voice response", keywords="artificial intelligence", keywords="conversational agent", keywords="mobile phone", abstract="Background: Atrial fibrillation (AF) is an increasingly common chronic health condition for which integrated care that is multidisciplinary and patient-centric is recommended yet challenging to implement. Objective: The aim of Coordinating Health Care With Artificial Intelligence--Supported Technology in AF is to evaluate the feasibility and potential efficacy of a digital intervention (AF-Support) comprising preprogrammed automated telephone calls (artificial intelligence conversational technology), SMS text messages, and emails, as well as an educational website, to support patients with AF in self-managing their condition and coordinate primary and secondary care follow-up. Methods: Coordinating Health Care With Artificial Intelligence--Supported Technology in AF is a 6-month randomized controlled trial of adult patients with AF (n=385), who will be allocated in a ratio of 4:1 to AF-Support or usual care, with postintervention semistructured interviews. The primary outcome is AF-related quality of life, and the secondary outcomes include cardiovascular risk factors, outcomes, and health care use. The 4:1 allocation design enables a detailed examination of the feasibility, uptake, and process of the implementation of AF-Support. Participants with new or ongoing AF will be recruited from hospitals and specialist-led clinics in Sydney, New South Wales, Australia. AF-Support has been co-designed with clinicians, researchers, information technologists, and patients. Automated telephone calls will occur 7 times, with the first call triggered to commence 24 to 48 hours after enrollment. Calls follow a standard flow but are customized to vary depending on patients' responses. Calls assess AF symptoms, and participants' responses will trigger different system responses based on prespecified protocols, including the identification of red flags requiring escalation. Randomization will be performed electronically, and allocation concealment will be ensured. Because of the nature of this trial, only outcome assessors and data analysts will be blinded. For the primary outcome, groups will be compared using an analysis of covariance adjusted for corresponding baseline values. Randomized trial data analysis will be performed according to the intention-to-treat principle, and qualitative data will be thematically analyzed. Results: Ethics approval was granted by the Western Sydney Local Health District Human Ethics Research Committee, and recruitment started in December 2020. As of December 2021, a total of 103 patients had been recruited. Conclusions: This study will address the gap in knowledge with respect to the role of postdischarge digital care models for supporting patients with AF. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12621000174886; https://www.australianclinicaltrials.gov.au/anzctr/trial/ACTRN12621000174886 International Registered Report Identifier (IRRID): DERR1-10.2196/34470 ", doi="10.2196/34470", url="https://www.researchprotocols.org/2022/4/e34470", url="http://www.ncbi.nlm.nih.gov/pubmed/35416784" } @Article{info:doi/10.2196/35196, author="Ramos, Giovanni and Aguilera, Adrian and Montoya, Amanda and Lau, Anna and Wen, Yin Chu and Cruz Torres, Victor and Chavira, Denise", title="App-Based Mindfulness Meditation for People of Color Who Experience Race-Related Stress: Protocol for a Randomized Controlled Trial", journal="JMIR Res Protoc", year="2022", month="Apr", day="14", volume="11", number="4", pages="e35196", keywords="race-related stress", keywords="discrimination", keywords="mindfulness", keywords="meditation", keywords="mental health", keywords="app", keywords="digital mental health intervention", keywords="racial and ethnic minority", keywords="people of color", keywords="BIPOC", abstract="Background: People of color (POC) who experience race-related stress are at risk of developing mental health problems, including high levels of stress, anxiety, and depression. Mindfulness meditation may be especially well suited to help POC cope, given its emphasis on gaining awareness and acceptance of emotions associated with discriminatory treatment. However, mindfulness meditation rarely reaches POC, and digital approaches could reduce this treatment gap by addressing traditional barriers to care. Objective: This study will test the effectiveness of a self-directed app-based mindfulness meditation program among POC who experience elevated levels of race-related stress. Implementation outcomes such as treatment acceptability, adherence, and satisfaction will be examined. Methods: Participants (n=80) will be recruited online by posting recruitment materials on social media and sending emails to relevant groups. In-person recruitment will consist of posting flyers in communities with significant POC representation. Eligible participants will be block randomized to either the intervention group (n=40) that will complete a self-directed 4-week mindfulness meditation program or a wait-list control condition (n=40) that will receive access to the app after study completion. All participants will complete measures at baseline, midtreatment, and posttreatment. Primary outcomes include changes in stress, anxiety, and depression, and secondary outcomes constitute changes in mindfulness, self-compassion, rumination, emotion suppression, and experiential avoidance. Exploratory analyses will examine whether changes in the secondary outcomes mediate changes in primary outcomes. Finally, treatment acceptability, adherence, and satisfaction will be examined descriptively. Results: Recruitment began in October 2021. Data will be analyzed using multilevel modeling, a statistical methodology that accounts for the dependence among repeated observations. Considering attrition issues in self-directed digital interventions and their potential effects on statistical significance and treatment effect sizes, we will examine data using both intention-to-treat and per-protocol analyses. Conclusions: To our knowledge, this will be the first study to provide data on the effectiveness of a self-directed app-based mindfulness meditation program for POC recruited based on elevated race-related stress, a high-risk population. Similarly, meaningful clinical targets for POC affected by stressors related to race will be examined. Findings will provide important information regarding whether this type of intervention is an acceptable treatment among these marginalized groups. Trial Registration: ClinicalTrials.gov NCT05027113; https://clinicaltrials.gov/ct2/show/NCT05027113 International Registered Report Identifier (IRRID): DERR1-10.2196/35196 ", doi="10.2196/35196", url="https://www.researchprotocols.org/2022/4/e35196", url="http://www.ncbi.nlm.nih.gov/pubmed/35436228" } @Article{info:doi/10.2196/34005, author="Egan, A. Luke and Mulcahy, Mary and Tuqiri, Karen and Gatt, M. Justine", title="A Web-Based Well-being Program for Health Care Workers (Thrive): Protocol for a Randomized Controlled Trial", journal="JMIR Res Protoc", year="2022", month="Apr", day="21", volume="11", number="4", pages="e34005", keywords="well-being", keywords="Composure, Own-worth, Mastery, Positivity, Achievement, and Satisfaction for Wellbeing", keywords="COMPAS-W", keywords="mental health", keywords="resilience", keywords="health care", keywords="hospital", keywords="brain", keywords="neuroscience", keywords="online", keywords="randomized controlled trial", keywords="RCT", abstract="Background: Mental health has come to be understood as not merely the absence of mental illness but also the presence of mental well-being, and recent interventions have sought to increase well-being in various populations. A population that deserves particular attention is that of health care workers, whose occupations entail high levels of stress, especially given the ongoing COVID-19 pandemic. A neuroscience-based web-based well-being program for health care workers---the Thrive program---has been newly developed to promote habits and activities that contribute to brain health and overall mental well-being. Objective: This paper describes the protocol for a randomized controlled trial whose objective is to evaluate the Thrive program in comparison with an active control condition to measure whether the program is effective at increasing well-being and decreasing symptoms of psychological distress in health care workers at a designated Australian hospital. Methods: The trial will comprise two groups (intervention vs active control) and 4 measurement occasions over a 12-week period. A survey will be administered in each of weeks 0, 4, 8, and 12, and the well-being program will be delivered in weeks 1-7 (via web-based video presentations or digital pamphlets). Each of the 4 surveys will comprise a range of questionnaires to measure well-being, psychological distress, and other key variables. The planned analyses will estimate group-by-time interaction effects to test the hypothesis that mental health will increase over time in the intervention condition relative to the active control condition. Results: The Thrive program was delivered to a small number of wards at the hospital between February 2021 and July 2021, and it will be delivered to the remaining wards from October 2021 to December 2021. A power calculation has recommended a sample size of at least 200 participants in total. A linear mixed model will be used to estimate the interaction effects. Conclusions: This trial seeks to evaluate a new web-based well-being program for health care workers at a major public hospital. It will contribute to the growing body of research on mental well-being and ways to promote it. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12621000027819; https://tinyurl.com/58wwjut9 International Registered Report Identifier (IRRID): DERR1-10.2196/34005 ", doi="10.2196/34005", url="https://www.researchprotocols.org/2022/4/e34005", url="http://www.ncbi.nlm.nih.gov/pubmed/35451973" } @Article{info:doi/10.2196/34832, author="Nozawa, Kyosuke and Ishii, Ayaka and Asaoka, Hiroki and Iwanaga, Mai and Kumakura, Yousuke and Oyabu, Yuri and Shinozaki, Tomohiro and Imamura, Kotaro and Kawakami, Norito and Miyamoto, Yuki", title="Effectiveness of an Online Peer Gatekeeper Training Program for Postsecondary Students on Suicide Prevention in Japan: Protocol for a Randomized Controlled Trial", journal="JMIR Res Protoc", year="2022", month="Apr", day="26", volume="11", number="4", pages="e34832", keywords="gatekeeper", keywords="suicide prevention", keywords="mental health", keywords="youth", keywords="school", keywords="student", keywords="peer support", keywords="depression", keywords="self-efficacy", keywords="suicide", keywords="prevention", keywords="online training", keywords="online program", keywords="protocol", keywords="RCT", keywords="control trial", abstract="Background: Postsecondary student suicide is one of Japan's most severe public health problems. Gatekeeper training (GKT) programs are a generally recommended suicide prevention intervention in Japan. For suicide countermeasures, an online program tailored to students may enhance self-efficacy as a gatekeeper. Objective: This study aims to describe a research protocol to investigate the effect of a newly developed internet-delivered online peer GKT program to improve postsecondary student self-efficacy as gatekeepers for suicide countermeasures in Japan. Methods: This study is a 2-arm, parallel, randomized controlled trial with a 1:1 (intervention: waiting list) allocation. Participants (n=320) will be recruited, and those who meet the inclusion criteria will be randomly allocated to the intervention or waiting list control group. An approximately 85-minute, 6-section, internet-based gatekeeper program for postsecondary students has been developed that includes videos to help participants acquire skills as gatekeepers. The intervention group will complete the program within 10 days. The primary outcome, self-efficacy as a gatekeeper, is measured using the Gatekeeper Self-Efficacy Scale at baseline, immediately after taking the program, and 2 months after the survey after completing the program follow-up. To compare the primary outcomes, a t test, where the significance level is 5\% (2-sided), will be used to test the intervention effect on an intention-to-treat basis. Results: The study was at the stage of data collection at the time of submission. We recruited participants for this study during August and September 2021, and data collection will continue until December 2021. The data analysis related to the primary outcome will start in December 2021, and we hope to publish the results in 2022 or 2023. Conclusions: This is the first study to investigate the effectiveness of an online GKT program for postsecondary students to improve self-efficacy as a gatekeeper using a randomized controlled trial design. The study will explore the potential of an online peer gatekeeper program for postsecondary students that can be disseminated online to a large number of students with minimal cost. Trial Registration: University Hospital Medical Information Network Clinical Trials Registry UMIN000045325; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr\_view.cgi?recptno=R000051685 International Registered Report Identifier (IRRID): DERR1-10.2196/34832 ", doi="10.2196/34832", url="https://www.researchprotocols.org/2022/4/e34832", url="http://www.ncbi.nlm.nih.gov/pubmed/35471412" } @Article{info:doi/10.2196/26827, author="Patel, I. Darpan and Gonzalez, Angela and Moon, Crisann and Serra, Monica and Bridges, Blake Preston and Hughes, Daniel and Clarke, Geoffrey and Kilpela, Lisa and Jiwani, Rozmin and Musi, Nicolas", title="Exercise and Creatine Supplementation to Augment the Adaptation of Exercise Training Among Breast Cancer Survivors Completing Chemotherapy: Protocol for an Open-label Randomized Controlled Trial (the THRIVE Study)", journal="JMIR Res Protoc", year="2022", month="Apr", day="1", volume="11", number="4", pages="e26827", keywords="rehabilitation", keywords="supplements", keywords="resistant exercise", keywords="oncology", keywords="quality of life", keywords="doxorubicin", abstract="Background: In breast cancer survivors, chemotherapy-induced muscle loss has been shown to be attenuated with structured resistance exercise. Creatine supplementation can increase bioenergetics in skeletal muscle, which helps to improve overall strength and endurance and reduce muscular fatigue. Therefore, we hypothesize that adding creatinine supplementation to exercise training will accelerate improvements in strength, endurance, and bioenergetics in breast cancer survivors. Objective: The primary objective is to determine the effects of combining creatine supplementation with exercise on modulating strength and physical function in breast cancer survivors by comparing these effects to those of exercise alone. The secondary objectives are to determine if creatine supplementation and exercise can increase the intramuscular storage of creatine and improve body composition by comparing this intervention to exercise alone. Methods: We aim to test our hypothesis by conducting an open-label randomized controlled trial of 30 breast cancer survivors who have completed chemotherapy within 6 months of enrollment. Eligible participants will be equally randomized (1:1) to either a creatine and exercise group or an exercise-only group for this 12-week intervention. Individuals who are randomized to receive creatine will be initially dosed at 20 g per day for 7 days to boost the availability of creatine systemically. Thereafter, the dose will be reduced to 5 g per day for maintenance throughout the duration of the 12-week protocol. All participants will engage in 3 center-based exercise sessions, which will involve completing 3 sets of 8 to 12 repetitions on chest press, leg press, seated row, shoulder press, leg extension, and leg curl machines. The primary outcomes will include changes in strength, body composition, and physical function in breast cancer survivors. The secondary outcomes will be intramuscular concentrations of creatine and adenosine triphosphate in the vastus lateralis, midthigh cross-sectional area, and quality of life. Results: As of October 2021, a total of 9 patients have been enrolled into the study. No unexpected adverse events have been reported. Conclusions: Creatine is being studied as a potential agent for improving strength, endurance, and bioenergetics in breast cancer survivors following chemotherapy. The findings from our trial may have future implications for supporting breast cancer survivors in reversing the muscle loss experienced during chemotherapy and improving their physical function and quality of life. Trial Registration: ClinicalTrials.gov NCT04207359; https://clinicaltrials.gov/ct2/show/NCT04207359 International Registered Report Identifier (IRRID): PRR1-10.2196/26827 ", doi="10.2196/26827", url="https://www.researchprotocols.org/2022/4/e26827", url="http://www.ncbi.nlm.nih.gov/pubmed/35363152" } @Article{info:doi/10.2196/35543, author="van Veenendaal, Haske and Peters, J. Loes and Ubbink, T. Dirk and Stubenrouch, E. Fabienne and Stiggelbout, M. Anne and Brand, LP Paul and Vreugdenhil, Gerard and Hilders, GJM Carina", title="Effectiveness of Individual Feedback and Coaching on Shared Decision-making Consultations in Oncology Care: Protocol for a Randomized Clinical Trial", journal="JMIR Res Protoc", year="2022", month="Apr", day="6", volume="11", number="4", pages="e35543", keywords="decision-making", keywords="shared", keywords="education", keywords="professional", keywords="feedback learning", keywords="coaching", keywords="medical consultation", keywords="medical oncology", keywords="palliative care", abstract="Background: Shared decision-making (SDM) is particularly important in oncology as many treatments involve serious side effects, and treatment decisions involve a trade-off between benefits and risks. However, the implementation of SDM in oncology care is challenging, and clinicians state that it is difficult to apply SDM in their actual workplace. Training clinicians is known to be an effective means of improving SDM but is considered time consuming. Objective: This study aims to address the effectiveness of an individual SDM training program using the concept of deliberate practice. Methods: This multicenter, single-blinded randomized clinical trial will be performed at 12 Dutch hospitals. Clinicians involved in decisions with oncology patients will be invited to participate in the study and allocated to the control or intervention group. All clinicians will record 3 decision-making processes with 3 different oncology patients. Clinicians in the intervention group will receive the following SDM intervention: completing e-learning, reflecting on feedback reports, performing a self-assessment and defining 1 to 3 personal learning questions, and participating in face-to-face coaching. Clinicians in the control group will not receive the SDM intervention until the end of the study. The primary outcome will be the extent to which clinicians involve their patients in the decision-making process, as scored using the Observing Patient Involvement--5 instrument. As secondary outcomes, patients will rate their perceived involvement in decision-making, and the duration of the consultations will be registered. All participating clinicians and their patients will receive information about the study and complete an informed consent form beforehand. Results: This trial was retrospectively registered on August 03, 2021. Approval for the study was obtained from the ethical review board (medical research ethics committee Delft and Leiden, the Netherlands [N20.170]). Recruitment and data collection procedures are ongoing and are expected to be completed by July 2022; we plan to complete data analyses by December 2022. As of February 2022, a total of 12 hospitals have been recruited to participate in the study, and 30 clinicians have started the SDM training program. Conclusions: This theory-based and blended approach will increase our knowledge of effective and feasible training methods for clinicians in the field of SDM. The intervention will be tailored to the context of individual clinicians and will target the knowledge, attitude, and skills of clinicians. The patients will also be involved in the design and implementation of the study. Trial Registration: Netherlands Trial Registry NL9647; https://www.trialregister.nl/trial/9647 International Registered Report Identifier (IRRID): DERR1-10.2196/35543 ", doi="10.2196/35543", url="https://www.researchprotocols.org/2022/4/e35543", url="http://www.ncbi.nlm.nih.gov/pubmed/35383572" } @Article{info:doi/10.2196/36166, author="H{\"o}per, Christina Anje and Terjesen, Lilja Christoffer and Fleten, Nils", title="Comparing the New Interdisciplinary Health in Work Intervention With Conventional Monodisciplinary Welfare Interventions at Norwegian Workplaces: Protocol for a Pragmatic Cluster Randomized Trial", journal="JMIR Res Protoc", year="2022", month="Apr", day="7", volume="11", number="4", pages="e36166", keywords="sickness absence", keywords="work environment", keywords="work environment intervention", keywords="health related quality of life", keywords="cluster randomized trial", keywords="cost-effectiveness-analysis", keywords="cost-benefit-analysis", keywords="health in work", abstract="Background: Musculoskeletal and mental health complaints are the dominant diagnostic categories in long-term sick leave and disability pensions in Norway. Continuing to work despite health complaints is often beneficial, and a good work environment can improve work inclusion for people affected. In 2001, the Norwegian Labour and Welfare Administration began to offer inclusive work measures to improve the psychosocial work environment and work inclusion of people with health complaints. In 2018, the Norwegian Labour and Welfare Administration and specialist health services started offering the new collaborative Health in work program. Its workplace intervention presents health and welfare information that may improve employees' coping ability regarding common health complaints. It encourages understanding of coworkers' health complaints and appropriate work adjustments to increase work participation. Objective: This protocol presents an ongoing, 2-arm, pragmatic cluster-randomized trial. Its aim is to compare the effect of monodisciplinary inclusive work measures (treatment as usual) and interdisciplinary Health in work in terms of changes in overall sickness absence, health care use, health-related quality of life, and costs. The secondary objectives are to compare changes in individual sickness absence, psychosocial work environment, job and life satisfaction, health, and health anxiety at both the individual and group levels. Methods: Data will be collected from national registers, trial-specific registrations, and questionnaires. Effects will be explored using difference-in-difference analysis and regression modeling. Multilevel analysis will visualize any cluster effects using intraclass correlation coefficients. Results: Inclusion was completed in July 2021 with 97 workplaces and 1383 individual consents. Data collection will be completed with the last questionnaires to be sent out in July 2023. Conclusions: This trial will contribute to filling knowledge gaps regarding the effectiveness and costs of workplace interventions, thereby benefiting health and welfare services, political decision makers, and the public and business sectors. The findings will be disseminated in reports, peer-reviewed journals, and conferences. Trial Registration: ClinicalTrials.gov NCT04000035; https://clinicaltrials.gov/ct2/show/NCT04000035 International Registered Report Identifier (IRRID): DERR1-10.2196/36166 ", doi="10.2196/36166", url="https://www.researchprotocols.org/2022/4/e36166", url="http://www.ncbi.nlm.nih.gov/pubmed/35388792" } @Article{info:doi/10.2196/34576, author="Garcia-Rueda, Fernanda Maria and Bohorquez-Penaranda, Patricia Adriana and Gil-Laverde, Armando Jacky Fabian and Aguilar-Sierra, Javier Francisco and Mendoza-Pulido, Camilo", title="Casting Without Reduction Versus Closed Reduction With or Without Fixation in the Treatment of Distal Radius Fractures in Children: Protocol for a Randomized Noninferiority Trial", journal="JMIR Res Protoc", year="2022", month="Apr", day="14", volume="11", number="4", pages="e34576", keywords="radius fractures", keywords="distal radius", keywords="pediatric", keywords="remodeling", keywords="surgical reduction", keywords="cast immobilization", keywords="outcome measure", abstract="Background: Acute treatment for distal radius fractures, the most frequent fractures in the pediatric population, represents a challenge to the orthopedic surgeon. Deciding on surgical restoration of the alignment or cast immobilization without reducing the fracture is a complex concern given the remodeling potential of bones in children. In addition, the lack of evidence-based safe boundaries of shortening and angulation, that will not jeopardize upper-extremity functionality in the future, further complicates this decision. Objective: The authors aim to measure functional outcomes, assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Physical Function v2.0 instrument. The authors hypothesize that outcomes will not be worse in children treated with cast immobilization in situ compared with those treated with closed reduction with or without percutaneous fixation. The authors also aim to compare the following as secondary outcomes: ulnar variance and fracture alignment in the sagittal and coronal planes, range of motion, pressure ulcers, pain control, radius osteotomy due to deformity, pseudoarthrosis cure, and remanipulation. Methods: This is the protocol of a randomized noninferiority trial comparing upper-extremity functionality in children aged 5 to 10 years, after sustaining a distal radius fracture, treated with either cast immobilization in situ or closed reduction with or without fixation in a single orthopedic hospital. Functional follow-up is projected at 6 months, while clinical and radiographic follow-up will occur at 2 weeks, 3 months, and 9 months. Results: Recruitment commenced in July 2021. As of January 2022, 23 children have been randomized. Authors expect an average of 5 patients to be recruited monthly; therefore, recruitment and analysis should be complete by October 2024. Conclusions: This experimental design that addresses upper-extremity functionality after cast immobilization in situ in children who have sustained a distal fracture of the radius may yield compelling information that could aid the clinician in deciding on the most suitable orthopedic treatment. Trial Registration: ClinicalTrials.gov NCT05008029; https://clinicaltrials.gov/ct2/show/NCT05008029 International Registered Report Identifier (IRRID): DERR1-10.2196/34576 ", doi="10.2196/34576", url="https://www.researchprotocols.org/2022/4/e34576", url="http://www.ncbi.nlm.nih.gov/pubmed/35436224" } @Article{info:doi/10.2196/32693, author="Shimabukuro, Shizuka and Daley, David and Endo, Takahiro and Harada, Satoshi and Tomoda, Akemi and Yamashita, Yushiro and Oshio, Takashi and Guo, Boliang and Ishii, Atsuko and Izumi, Mio and Nakahara, Yukiko and Yamamoto, Kazushi and Yao, Akiko and Tripp, Gail", title="The Effectiveness and Cost-effectiveness of Well Parent Japan for Japanese Mothers of Children With ADHD: Protocol for a Randomized Controlled Trial", journal="JMIR Res Protoc", year="2022", month="Apr", day="19", volume="11", number="4", pages="e32693", keywords="ADHD", keywords="parent training", keywords="Japan", keywords="New Forest Parent Programme", keywords="parent stress management", abstract="Background: Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental disorder associated with numerous functional deficits and poor long-term outcomes. Internationally, behavioral interventions are recommended as part of a multimodal treatment approach for children with ADHD. Currently, in Japan, there are limited interventions available to target ADHD. Well Parent Japan (WPJ), a new hybrid parent-training program, provides a culturally acceptable and effective way to help support Japanese children with ADHD and their parents. Objective: This pragmatic multicenter randomized controlled trial aims to provide preliminary evidence about the effectiveness and cost-effectiveness of WPJ evaluated against treatment as usual (TAU) within routine Japanese mental health services. Methods: Mothers of children (aged 6-12 years) diagnosed with ADHD were recruited from child and adolescent mental health care services at three hospital sites across Japan (Fukui, Fukuoka, and Okinawa). The mothers were randomized to receive immediate treatment or TAU. The effectiveness and cost-effectiveness of WPJ over TAU at the end of the intervention and at 3-month follow-up will be evaluated. The primary outcome is maternal parent domain stress in the parenting role. The following secondary outcomes will be explored: child behavior, including severity of ADHD symptoms; parenting practices; emotional well-being; and the parent-child relationship and maternal child domain parenting stress. Data analysis will follow intention-to-treat principles with treatment effects quantified through analysis of covariance using multilevel modeling. An incremental cost-effectiveness ratio will be used to analyze the cost-effectiveness of the WPJ intervention. Results: Study funding was secured through a proof-of-concept grant in July 2018. Approval by the institutional review board for the data collection sites was obtained between 2017 and 2019. Data collection began in August 2019 and was completed in April 2022. Participant recruitment (N=124) was completed in May 2021. Effectiveness and cost-effectiveness analyses are expected to be completed by July 2022 and December 2022, respectively. These timelines are subject to change owing to the COVID-19 pandemic. Conclusions: This is the first multisite pragmatic trial of WPJ based on the recruitment of children referred directly to routine clinical services in Japan. This multisite randomized trial tests the effectiveness of WPJ in children and families by comparing WPJ directly with the usual clinical care offered for children diagnosed with ADHD in Japan. We also seek to assess and compare the cost-effectiveness of WPJ with TAU in Japan. Trial Registration: International Standard Randomised Controlled Trial Number ISRCTN66978270; https://www.isrctn.com/ISRCTN66978270 International Registered Report Identifier (IRRID): DERR1-10.2196/32693 ", doi="10.2196/32693", url="https://www.researchprotocols.org/2022/4/e32693", url="http://www.ncbi.nlm.nih.gov/pubmed/35438647" } @Article{info:doi/10.2196/31887, author="Borgonovo, Giulia and Vettus, Elen and Greco, Alessandra and Leo, Anna Laura and Faletra, Fulvio Francesco and Klersy, Catherine and Curti, Moreno and Valli, Mariacarla", title="Early Detection of Cardiotoxicity From Systemic and Radiation Therapy in Patients With Breast Cancer: Protocol for a Multi-Institutional Prospective Study", journal="JMIR Res Protoc", year="2022", month="Apr", day="21", volume="11", number="4", pages="e31887", keywords="breast cancer", keywords="cardiotoxicity", keywords="cardiac diagnostic imaging", keywords="radiotherapy", keywords="chemotherapy", abstract="Background: The incidence of breast cancer is rising worldwide. Recent advances in systemic and local treatments have significantly improved survival rates of patients having early breast cancer. In the last decade, great attention has been paid to the prevention and early detection of cardiotoxicity induced by breast cancer treatments. Systemic therapy-related cardiac toxicities have been extensively studied. Radiotherapy, an essential component of breast cancer treatment, can also increase the risk of heart diseases. Consequently, it is important to balance the expected benefits of cancer treatment with cardiovascular risk and to identify strategies to prevent cardiotoxicity and improve long-term outcomes and quality of life for these patients. Objective: This CardioTox Breast study aims to investigate the use of cardiac imaging, based on cardiac magnetic resonance and echocardiography, and to identify associated circulating biomarkers to assess early tissue changes in chemo-induced and radiation-induced cardiotoxicity in the time window of 12 months after the end of radiotherapy in patients with breast cancer. Methods: The CardioTox Breast trial is a multicenter observational prospective longitudinal study. We aim to enroll 150 women with stage I-III unilateral breast cancer, treated with breast conserving surgery, who planned to receive radiotherapy with or without systemic therapy. Baseline and follow-up data include cardiac measurements based on cardiac magnetic resonance imaging, echocardiography, and circulating biomarkers of cardiac toxicity. Results: This study details the protocol of the CardioTox Breast trial. Recruitment started in September 2020. The results of this study will not be published until data are mature for the final analysis of the primary study end point. Conclusions: The CardioTox Breast study is designed to investigate the effects of systemic and radiation therapy on myocardial function and structure, thus providing additional evidence on whether cardiac magnetic resonance is the optimal screening imaging for cardiotoxicity. Trial Registration: ClinicalTrials.gov NCT04790266; https://clinicaltrials.gov/ct2/show/NCT04790266 International Registered Report Identifier (IRRID): DERR1-10.2196/31887 ", doi="10.2196/31887", url="https://www.researchprotocols.org/2022/4/e31887", url="http://www.ncbi.nlm.nih.gov/pubmed/35451989" } @Article{info:doi/10.2196/31464, author="Lauffenburger, C. Julie and DiFrancesco, F. Matthew and Barlev, A. Renee and Robertson, Ted and Kim, Erin and Coll, D. Maxwell and Haff, Nancy and Fontanet, P. Constance and Hanken, Kaitlin and Oran, Rebecca and Avorn, Jerry and Choudhry, K. Niteesh", title="Overcoming Decisional Gaps in High-Risk Prescribing by Junior Physicians Using Simulation-Based Training: Protocol for a Randomized Controlled Trial", journal="JMIR Res Protoc", year="2022", month="Apr", day="27", volume="11", number="4", pages="e31464", keywords="pragmatic trial", keywords="behavioral science", keywords="prescribing", keywords="benzodiazepines", keywords="antipsychotics", keywords="impact evaluation", abstract="Background: Gaps between rational thought and actual decisions are increasingly recognized as a reason why people make suboptimal choices in states of heightened emotion, such as stress. These observations may help explain why high-risk medications continue to be prescribed to acutely ill hospitalized older adults despite widely accepted recommendations against these practices. Role playing and other efforts, such as simulation training, have demonstrated benefits to help people avoid decisional gaps but have not been tested to reduce overprescribing of high-risk medications. Objective: This study aims to evaluate the impact of a simulation-based training program designed to address decisional gaps on prescribing of high-risk medications compared with control. Methods: In this 2-arm pragmatic trial, we are randomizing at least 36 first-year medical resident physicians (ie, interns) who provide care on inpatient general medicine services at a large academic medical center to either intervention (simulation-based training) or control (online educational training). The intervention comprises a 40-minute immersive individual simulation training consisting of a reality-based patient care scenario in a simulated environment at the beginning of their inpatient service rotation. The simulation focuses on 3 types of high-risk medications, including benzodiazepines, antipsychotics, and sedative hypnotics (Z-drugs), in older adults, and is specifically designed to help the physicians identify their reactions and prescribing decisions in stressful situations that are common in the inpatient setting. The simulation scenario is followed by a semistructured debriefing with an expert facilitator. The trial's primary outcome is the number of medication doses for any of the high-risk medications prescribed by the interns to patients aged 65 years or older who were not taking one of the medications upon admission. Secondary outcomes include prescribing by all providers on the care team, being discharged on 1 of the medications, and prescribing of related medications (eg, melatonin, trazodone), or the medications of interest for the control intervention. These outcomes will be measured using electronic health record data. Results: Recruitment of interns began on March 29, 2021. Recruitment for the trial ended in Q42021, with follow-up completed by Q12022. Conclusions: This trial will evaluate the impact of a simulation-based training program designed using behavioral science principles on prescribing of high-risk medications by junior physicians. If the intervention is shown to be effective, this approach could potentially be reproducible by others and for a broader set of behaviors. Trial Registration: ClinicalTrials.gov NCT04668248; https://clinicaltrials.gov/ct2/show/NCT04668248 International Registered Report Identifier (IRRID): PRR1-10.2196/31464 ", doi="10.2196/31464", url="https://www.researchprotocols.org/2022/4/e31464", url="http://www.ncbi.nlm.nih.gov/pubmed/35475982" } @Article{info:doi/10.2196/37282, author="Jacobson, Natasha and Lithgow, Brian and Jafari Jozani, Mohammad and Moussavi, Zahra", title="The Effect of Transcranial Alternating Current Stimulation With Cognitive Training on Executive Brain Function in Individuals With Dementia: Protocol for a Crossover Randomized Controlled Trial", journal="JMIR Res Protoc", year="2022", month="Apr", day="27", volume="11", number="4", pages="e37282", keywords="transcranial alternating current stimulation", keywords="Alzheimer disease", keywords="cognitive impairment", keywords="double blind", keywords="treatment", keywords="placebo-controlled", keywords="randomized", keywords="crossover", keywords="dementia", keywords="cognitive", abstract="Background: Although memory and cognitive declines are associated with normal brain aging, they may also be precursors to dementia. Objective: We aim to offer a novel approach to prevent or slow the progress of neurodegenerative dementia, or plausibly, improve the cognitive functions of individuals with dementia. Methods: We will recruit and enroll 75 participants (older than 50 years old with either mild cognitive impairment or probable early or moderate dementia) for this double-blind randomized controlled study to estimate the efficacy of active transcranial alternating current stimulation with cognitive treatment (in comparison with sham transcranial alternating current stimulation). This will be a crossover study; a cycle consists of sham or active treatment for a period of 4 weeks (5 days per week, in two 30-minute sessions with a half-hour break in between), and participants are randomized into 2 groups, with stratification by age, sex, and cognitive level (measured with the Montreal Cognitive Assessment). Outcomes will be assessed before and after each treatment cycle. The primary outcomes are changes in Wechsler Memory Scale Older Adult Battery and Alzheimer Disease Assessment Scale scores. Secondary outcomes are changes in performance on tests of frontal lobe functioning (verbal fluency), neuropsychiatric symptoms (Neuropsychiatric Inventory Questionnaire), mood changes (Montgomery-{\AA}sberg Depression Rating Scale), and short-term recall (visual 1-back task). Exploratory outcome measures will also be assessed: static and dynamic vestibular response using electrovestibulography, neuronal changes using functional near-infrared spectroscopy, and change in spatial orientation using virtual reality navigation. Results: As of February 10, 2022, the study is ongoing: 7 patients have been screened, and all were deemed eligible for and enrolled in the study; 4 participants have completed baseline assessments. Conclusions: We anticipate that transcranial alternating current stimulation will be a well-tolerated treatment, with no serious side effects and with considerable short- and long-term cognitive improvements. Trial Registration: Clinicaltrials.gov NCT05203523; https://clinicaltrials.gov/show/NCT05203523 International Registered Report Identifier (IRRID): DERR1-10.2196/37282 ", doi="10.2196/37282", url="https://www.researchprotocols.org/2022/4/e37282", url="http://www.ncbi.nlm.nih.gov/pubmed/35475789" } @Article{info:doi/10.2196/35945, author="Bas-Sarmiento, Pilar and Fern{\'a}ndez-Guti{\'e}rrez, Martina and Poza-M{\'e}ndez, Miriam and Mar{\'i}n-Paz, Jes{\'u}s Antonio and Paloma-Castro, Olga and Romero-S{\'a}nchez, Manuel Jos{\'e} and ", title="Development and Effectiveness of a Mobile Health Intervention in Improving Health Literacy and Self-management of Patients With Multimorbidity and Heart Failure: Protocol for a Randomized Controlled Trial", journal="JMIR Res Protoc", year="2022", month="Apr", day="29", volume="11", number="4", pages="e35945", keywords="complex health needs", keywords="health literacy", keywords="heart failure", keywords="mHealth", keywords="multimorbidity", abstract="Background: Patients with multimorbidity and complex health needs are defined as a priority by the World Health Organization (WHO) and the European Union. There is a need to develop appropriate strategies with effective measures to meet the challenge of chronicity, reorienting national health systems. The increasing expansion of mobile health (mHealth) interventions in patient communication, the reduction of health inequalities, improved access to health care resources, adherence to treatment, and self-care of chronic diseases all point to an optimistic outlook. However, only few mobile apps demonstrate their effectiveness in these patients, which is diminished when they are not based on evidence, or when they are not designed by and for users with different levels of health literacy (HL). Objective: This study aims to evaluate the efficacy of an mHealth intervention relative to routine clinical practice in improving HL and self-management in patients with multimorbidity with heart failure (HF) and complex health needs. Methods: This is a randomized, multicenter, blinded clinical trial evaluating 2 groups, namely, a control group (standard clinical practice) and an intervention group (standard clinical practice and an ad hoc designed mHealth intervention previously developed), for 12 months. Results: The contents of the mHealth intervention will address user-perceived needs based on the development of user stories regarding diet, physical exercise, cardiac rehabilitation, therapeutic adherence, warning signs and symptoms, and emotional management. These contents have been validated by expert consensus. The creation and development of the contents of the mHealth intervention (app) took 18 months and was completed during 2021. The mobile app is expected to be developed by the end of 2022, after which it will be applied to the experimental group as an adjunct to standard clinical care during 12 months. Conclusions: The trial will demonstrate whether the mobile app improves HL and self-management in patients with HF and complex health needs, improves therapeutic adherence, and reduces hospital admissions. This study can serve as a starting point for developing other mHealth tools in other pathologies and for their generalization to other contexts. Trial Registration: ClinicalTrials.gov NCT04725526; https://tinyurl.com/bd8va27w International Registered Report Identifier (IRRID): DERR1-10.2196/35945 ", doi="10.2196/35945", url="https://www.researchprotocols.org/2022/4/e35945", url="http://www.ncbi.nlm.nih.gov/pubmed/35486437" } @Article{info:doi/10.2196/37255, author="Campo, Reyes Andr{\'e}s and Pacichana-Quinay{\'a}z, Gabriela Sara and Bonilla-Escobar, Javier Francisco and Leiva-Pemberthy, Miriam Luz and Tovar-S{\'a}nchez, Ana Maria and Hern{\'a}ndez-Orobio, Marina Olga and Arango-Hoyos, Gloria-Patricia and Mujanovic, Adnan", title="Effectiveness of Hydrotherapy on Neuropathic Pain and Pain Catastrophization in Patients With Spinal Cord Injury: Protocol for a Pilot Trial Study", journal="JMIR Res Protoc", year="2022", month="Apr", day="29", volume="11", number="4", pages="e37255", keywords="spinal cord injury", keywords="neuropathic pain", keywords="quality of life", keywords="catastrophization", keywords="hydrotherapy", keywords="neurology", keywords="spinal cord", keywords="nonpharmacological", abstract="Background: Neuropathic pain (NP) is one of the most frequent spinal cord injury (SCI) complications. Pain, quality of life, and functionality are associated and can lead to pain catastrophization. Pharmacological management of patients with NP secondary to SCI is widely known and there is increasing evidence in the area. Nevertheless, nonpharmacological management is not fully elucidated since its efficacy is inconclusive. Objective: We hypothesize that (1) hydrotherapy is effective in reducing NP secondary to SCI. Additionally, our secondary hypotheses are that (2) hydrotherapy decreases the catastrophization of NP, and that (3) hydrotherapy improves life quality and minimizes the degree of disability, when compared to physical therapy. Methods: A sample of approximately 20 participants will be randomly assigned to either the intervention (hydrotherapy) or control group (standard physical therapy). Both interventions will be administered twice a week over a 9-week period (18 sessions in total). Primary outcomes are changes in neuropathic pain perception and pain catastrophization. Secondary outcomes are changes in disability and quality of life scores. They will be assessed at baseline and follow-up at 4 weeks after discharge. Validated Spanish language scales that will be used are the following: Numerical Pain Rating Scale, Pain Catastrophization, Health-related Quality of life, and the World Health Organization's Disability Assessment Schedule 2.0. Generalized mixed linear models will be used for comparing baseline and postintervention means of each group and their differences, together with 95\% CIs and P values. A P value of less than .05 will be considered significant. Results: Recruitment began in April 2019, and we recruited the last participants by December 2019, with 10 individuals assigned to hydrotherapy and 8 to physical therapy (control). Results from this study will be disseminated via scientific publication, in ClinicalTrials.gov, and in national and international conferences in the latter half of 2022. Conclusions: This trial will explore the effects of hydrotherapy on neuropathic pain, together with functionality and quality of life, in patients with SCI. Furthermore, this study aims to evaluate these therapeutic modalities, including perception variables, and mental processes, which may affect the clinical condition and rehabilitation outcomes in these patients. Hydrotherapy is likely to be a safe, efficient, and cost-effective alternative to the current standard of care for NP secondary to SCI, with comparable results between the two. Trial Registration: ClinicalTrials.gov NCT04164810; https://clinicaltrials.gov/ct2/show/NCT04164810 International Registered Report Identifier (IRRID): DERR1-10.2196/37255 ", doi="10.2196/37255", url="https://www.researchprotocols.org/2022/4/e37255", url="http://www.ncbi.nlm.nih.gov/pubmed/35486436" } @Article{info:doi/10.2196/33982, author="Budhwani, Henna and Sharma, Vinita and Long, Dustin and Simpson, Tina", title="Developing a Clinic-Based, Vaccine-Promoting Intervention for African American Youth in Rural Alabama: Protocol for a Pilot Cluster-Randomized Controlled Implementation Science Trial", journal="JMIR Res Protoc", year="2022", month="Apr", day="8", volume="11", number="4", pages="e33982", keywords="human papillomavirus", keywords="COVID-19", keywords="vaccine", keywords="adolescents", keywords="rural", keywords="African American", keywords="implementation science", abstract="Background: African American youth in rural Alabama are clinically underserved and have limited knowledge about the human papillomavirus and the novel coronavirus 2019 (COVID-19) vaccines, including knowledge about the risk for developing cervical or oropharyngeal cancers or COVID-19. Objective: In this 30-month study, we propose to develop an in-clinic, youth-tailored, vaccine-promoting intervention for vaccine hesitancy reduction that can be seamlessly integrated into the existing environments of pediatric and family practice settings in rural Alabama. Methods: This exploratory, sequential mixed methods study will be conducted in 3 phases. In the first phase, we will assess stakeholders' knowledge, sentiments, and beliefs related to vaccination in general, COVID-19 vaccination, and human papillomavirus vaccination. We will also assess stakeholders' perceptions of barriers to vaccination that exist in rural Alabama. This will be followed by a second phase wherein we will use the data collected in the first phase to inform the development and finalization of a noninvasive, modular, synchronous counseling intervention that targets the behaviors of 15- to 26-year-old adolescents. In the third phase, we will conduct a pilot hybrid type 1 effectiveness-implementation cluster-randomized controlled trial to assess intervention acceptability and feasibility (clinics: N=4; African American youth: N=120) while assessing a ``clinical signal'' of effectiveness. We will document implementation contexts to provide real-world insight and support dissemination and scale-up. Results: The study was funded at the end of December 2020. Approval from the University of Alabama at Birmingham Institutional Review Board was obtained in May 2021, and the qualitative data collection process outlined in the first phase of this project concluded in November 2021. The entire study is expected to be complete at the end of December 2023. Conclusions: The results of the trial will provide much needed information on vaccine hesitancy in rural Alabama, and if found efficacious, the intervention could notably increase rates of vaccinations in one of the most underserved parts of the United States. The results from the trial will provide information that is valuable to public health practitioners and providers in rural settings to inform their efforts in increasing vaccination rates among 15- to 26-year-old African American youth in rural southern United States. Trial Registration: ClinicalTrials.gov NCT04604743; https://clinicaltrials.gov/ct2/show/NCT04604743 International Registered Report Identifier (IRRID): DERR1-10.2196/33982 ", doi="10.2196/33982", url="https://www.researchprotocols.org/2022/4/e33982", url="http://www.ncbi.nlm.nih.gov/pubmed/35212640" } @Article{info:doi/10.2196/33145, author="Al-Zubaidy, Mohaimen and Hogg, Jeffry H. D. and Maniatopoulos, Gregory and Talks, James and Teare, Dawn Marion and Keane, A. Pearse and R Beyer, Fiona", title="Stakeholder Perspectives on Clinical Decision Support Tools to Inform Clinical Artificial Intelligence Implementation: Protocol for a Framework Synthesis for Qualitative Evidence", journal="JMIR Res Protoc", year="2022", month="Apr", day="1", volume="11", number="4", pages="e33145", keywords="artificial intelligence", keywords="clinical decision support tools", keywords="digital health", keywords="implementation", keywords="qualitative evidence synthesis", keywords="stakeholders", keywords="clinical decision", keywords="decision support", abstract="Background: Quantitative systematic reviews have identified clinical artificial intelligence (AI)-enabled tools with adequate performance for real-world implementation. To our knowledge, no published report or protocol synthesizes the full breadth of stakeholder perspectives. The absence of such a rigorous foundation perpetuates the ``AI chasm,'' which continues to delay patient benefit. Objective: The aim of this research is to synthesize stakeholder perspectives of computerized clinical decision support tools in any health care setting. Synthesized findings will inform future research and the implementation of AI into health care services. Methods: The search strategy will use MEDLINE (Ovid), Scopus, CINAHL (EBSCO), ACM Digital Library, and Science Citation Index (Web of Science). Following deduplication, title, abstract, and full text screening will be performed by 2 independent reviewers with a third topic expert arbitrating. The quality of included studies will be appraised to support interpretation. Best-fit framework synthesis will be performed, with line-by-line coding completed by 2 independent reviewers. Where appropriate, these findings will be assigned to 1 of 22 a priori themes defined by the Nonadoption, Abandonment, Scale-up, Spread, and Sustainability framework. New domains will be inductively generated for outlying findings. The placement of findings within themes will be reviewed iteratively by a study advisory group including patient and lay representatives. Results: Study registration was obtained from PROSPERO (CRD42021256005) in May 2021. Final searches were executed in April, and screening is ongoing at the time of writing. Full text data analysis is due to be completed in October 2021. We anticipate that the study will be submitted for open-access publication in late 2021. Conclusions: This paper describes the protocol for a qualitative evidence synthesis aiming to define barriers and facilitators to the implementation of computerized clinical decision support tools from all relevant stakeholders. The results of this study are intended to expedite the delivery of patient benefit from AI-enabled clinical tools. Trial Registration: PROSPERO CRD42021256005; https://tinyurl.com/r4x3thvp International Registered Report Identifier (IRRID): DERR1-10.2196/33145 ", doi="10.2196/33145", url="https://www.researchprotocols.org/2022/4/e33145", url="http://www.ncbi.nlm.nih.gov/pubmed/35363141" } @Article{info:doi/10.2196/28625, author="Main, Penelope and Anderson, Sarah", title="Evidence for Continuing Professional Development and Recency of Practice Standards for Regulated Health Professionals in Australia: Protocol for a Systematic Review", journal="JMIR Res Protoc", year="2022", month="Apr", day="13", volume="11", number="4", pages="e28625", keywords="protocol", keywords="systematic review", keywords="continuing professional development", keywords="continuing education", keywords="recency of practice", keywords="regulatory standards", keywords="health practitioners", abstract="Background: Continuing professional development (CPD) and recency of practice (ROP) standards are components of health practitioner regulation in Australia. The CPD and ROP standards are currently under review, and an evidence base to assist the development of consistent standards is required. Preliminary searching was unable to find a recent systematic review of the literature to provide an evidence base to underpin the standards review. Objective: This paper presents the protocol for a systematic review that aims to develop a current evidence base that will support the National Boards to develop more consistent, evidence-based, effective standards that are clear and easy to understand and operationalize. Methods: Research questions were developed to support the planned review of CPD and ROP registration standards. Major databases and relevant journals were searched for articles published in English between 2015 and 2021, using key search terms based on previous unpublished reviews of the CPD and ROP registration standards. The quality of the articles retrieved will be assessed using an instrument suitable for use in the development of public policy. The findings will be published in a peer-reviewed journal. Results: In September 2021, our search strategy identified 18,002 studies for the CPD-related research questions after removal of duplicates. Of these, 509 records were screened based on their title, and 66 full-text articles were assessed for eligibility based on their abstract, of which 31 met the inclusion criteria. A further 291 articles were identified as relevant to the ROP research questions. Of these, 87 records were screened based on their title, and 46 full-text articles were assessed for eligibility based on their abstract, of which 8 studies met our inclusion criteria. Conclusions: This protocol outlines the scope and methodology that will be used to conduct a systematic review of evidence for CPD and ROP and inform a review of the standards for regulated health professionals in Australia. Previous research has shown that while CPD improves practitioner knowledge, the link to public safety is unclear. While there has been a greater focus on maintenance of certification and other quality assurance activities over the past 10 years, there remains great variability in CPD requirements across both professions and jurisdictions. ROP was found to be a poorly researched area with most research concentrating on medical practitioners, nurses, and midwives and no clear consensus about the optimal time period after which retraining or an assessment of competence should be introduced. As the CPD and ROP standards are currently under review, it is timely that a review of current evidence be undertaken. International Registered Report Identifier (IRRID): DERR1-10.2196/28625 ", doi="10.2196/28625", url="https://www.researchprotocols.org/2022/4/e28625", url="http://www.ncbi.nlm.nih.gov/pubmed/35416788" } @Article{info:doi/10.2196/34987, author="Silva, Wnurinham and Virtanen, Eeva and Kajantie, Eero and Sebert, Sylvain", title="Cognitive Function, Mental Health, and Quality of Life in Siblings of Preterm Born Children: Protocol for a Systematic Review", journal="JMIR Res Protoc", year="2022", month="Apr", day="14", volume="11", number="4", pages="e34987", keywords="preterm birth", keywords="birth weight", keywords="siblings", keywords="cognitive", keywords="mental health", keywords="quality of life", keywords="family", abstract="Background: Children and adults born preterm are at increased risk of cognitive impairments, mental health disorders, and poorer quality of life. Epidemiological studies have shown that the impact of preterm birth extends to the immediate family members; however, existing research have focused on parents, and little attention has been given to siblings. Objective: The aim of the systematic review described in this protocol is to synthesize currently available evidence on the impact of exposure to preterm birth (ie, having a sibling born preterm) on cognition, mental health, and quality of life of term born siblings (index child) of preterm born children, and to critically appraise the evidence. Methods: This protocol outlines a systematic review designed in accordance with the PRISMA-P (Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols) checklist. We will include all studies that assess outcomes in siblings of children born preterm. Quantitative and qualitative studies will be eligible for the systematic review, and only studies in English will be included. Firstly, search will be conducted electronically on PubMed, Scopus, Embase, Mednar, and opengrey.eu databases and, secondly, manually in Google Scholar and reference lists. The search strategy will include keywords and synonyms, Boolean operators, and text words (ie, within title and abstract). The team of reviewers will screen the search results, extract data from eligible studies, and critically appraise the studies. Analysis will involve both descriptive and quantitative approaches. Meta-analysis will be conducted if appropriate. Results: This systematic review was registered on PROSPERO (International Prospective Register of Systematic Reviews) on December 18, 2020, and it is currently in progress. The findings will be synthesized to determine the effect of preterm birth on full-term siblings and the quality of the available evidence. Conclusions: The evidence derived from this study will shed light on gaps and limitations in the field of preterm birth, more specifically, the effect of preterm birth on full-term siblings. In addition, we hope that understanding the impact of preterm birth on family members will inform targeted interventions and policies for those identified at high risk and how to mitigate health risks. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42021222887; https://www.crd.york.ac.uk/prospero/display\_record.php?ID=CRD42021222887 International Registered Report Identifier (IRRID): DERR1-10.2196/34987 ", doi="10.2196/34987", url="https://www.researchprotocols.org/2022/4/e34987", url="http://www.ncbi.nlm.nih.gov/pubmed/35436229" } @Article{info:doi/10.2196/28338, author="Wang, Duanyang and Yin, Pengbin and Li, Yi and Chen, Ming and Cui, Xiang and Cheng, Shi and Lin, Yuan and Yan, Jinglong and Zhang, Licheng and Tang, Peifu", title="Frailty Factors and Outcomes in Patients Undergoing Orthopedic Surgery: Protocol for a Systematic Review and Meta-analysis", journal="JMIR Res Protoc", year="2022", month="Apr", day="15", volume="11", number="4", pages="e28338", keywords="frailty", keywords="orthopedic surgery", keywords="systemic review", keywords="meta-analysis", keywords="older adults", keywords="elderly", keywords="surgery", keywords="orthopedics", abstract="Background: Frailty is an aggregate expression of susceptibility to adverse health outcomes because of age- and disease-related deficits that accumulate across multiple domains. Previous studies have found the presence of preoperative frailty is associated with an increased risk of adverse outcomes. The number of older adults undergoing orthopedic surgery is rapidly increasing. However, there has been no evidence-based study on the relationship between frailty and outcomes in patients undergoing orthopedic surgery. Objective: The aims of this study are to investigate the association between frailty and outcomes in patients who underwent orthopedic surgery as well as patient factors associated with frailty. Methods: The methods to be used for this systematic review are reported according to the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-analysis Protocols) 2015 checklist. An extensive search will be conducted in PubMed, Embase, the Cochrane Library, and other mainstream databases. Any study where patients undergoing orthopedic surgery were assessed using a defined or validated measure of frailty and the association of frailty with patient factors and/or outcomes was reported will be included. A total of 2 researchers will independently screen articles for inclusion, with disagreements resolved by a third reviewer. We will perform a narrative synthesis of the factors associated with frailty, prevalence of frailty, effect of frailty on patient outcomes, and interventions for patients who are frail. A meta-analysis focusing on individual factors associated with frailty and the effect of frailty on patient outcomes will be performed, if applicable. The risk of bias will be evaluated. A subgroup analysis and sensitivity analysis will be performed. Results: Literature searches were conducted in September 2021 and the review is anticipated to be completed by the end of July 2022. Conclusions: This systematic review and meta-analysis will provide an overview of frailty and investigate the relationship between frailty and patient outcomes as well as the relationship between patient factors and frailty in patients undergoing orthopedic surgery. This study could potentially increase patients' awareness of the outcomes associated with frailty, compel clinical specialties to further acknowledge the concept of frailty, and enhance the development of assessment instruments and tools for frailty. Trial Registration: PROSPERO CRD42020181846; https://www.crd.york.ac.uk/prospero/display\_record.php?RecordID=181846 International Registered Report Identifier (IRRID): DERR1-10.2196/28338 ", doi="10.2196/28338", url="https://www.researchprotocols.org/2022/4/e28338", url="http://www.ncbi.nlm.nih.gov/pubmed/35436222" } @Article{info:doi/10.2196/35243, author="Ronellenfitsch, Ulrich and Mathis, Nika and Friedrichs, Juliane and Kleeff, J{\"o}rg", title="Lymph Node Yield in Gastrointestinal Cancer Surgery With or Without Prior Neoadjuvant Therapy: Protocol for a Systematic Review and Meta-analysis", journal="JMIR Res Protoc", year="2022", month="Apr", day="28", volume="11", number="4", pages="e35243", keywords="lymph node yield", keywords="lymph node harvest", keywords="neoadjuvant therapy", keywords="neoadjuvant chemotherapy", keywords="neoadjuvant radiotherapy", keywords="surgery", keywords="resection", keywords="gastrointestinal cancer", keywords="chemotherapy", keywords="cancer", abstract="Background: Lymph node yield is the number of lymph nodes retrieved during oncological resection and histopathologically identified in the resection specimen. It is an important surrogate parameter for assessing the oncological radicality of the resection of gastrointestinal carcinomas, as well as a prognostic factor in these diseases. It remains unclear if and to what extent neoadjuvant chemotherapy, radiotherapy, or chemoradiotherapy, which have become established treatments for carcinoma of the esophagus, stomach, and rectum and are increasingly used in pancreatic carcinoma, affect the lymph node yield. Objective: This systematic review with meta-analysis is conducted with the aim of summarizing the available evidence regarding the lymph node yield, an oncological surrogate marker, in patients with gastrointestinal carcinomas undergoing surgery after neoadjuvant therapy compared to those undergoing surgery without neoadjuvant therapy. Methods: Randomized and nonrandomized studies comparing oncological resection of esophageal, stomach, pancreatic, and rectal carcinoma with and without prior neoadjuvant therapy are eligible for inclusion regardless of study design. Publications will be identified with a defined search strategy in 2 electronic databases: PubMed and Cochrane Library. The primary endpoint of the analysis is the number of lymph nodes identified in the resected specimen. Secondary endpoints include the number of harvested metastatic lymph nodes, operation time, postoperative complications, pathological TNM staging, and overall and recurrence-free survival time. Using suitable statistical methods, the endpoints between patients with and without neoadjuvant therapy, as well as in defined subgroups (neoadjuvant chemotherapy, radiotherapy, or chemoradiotherapy; and patients with esophageal, gastric, pancreatic, or rectal cancer), will be compared. Results: The literature search and data collection started in October 2021. Results are expected to be published in mid-2022. Conclusions: This meta-analysis will provide the most up-to-date and complete summary of the evidence on an association between neoadjuvant therapy and lymph node yield in gastrointestinal cancer surgery. The underlying hypothesis is that neoadjuvant therapy decreases the number and size of lymph nodes through lymphocyte depletion and radiation-induced fibrosis, thus leading to a lower possible lymph node yield. The findings of the meta-analysis will show if this hypothesis is supported by evidence. Trial Registration: PROSPERO CRD218459; https://www.crd.york.ac.uk/prospero/display\_record.php?ID=CRD42021218459 International Registered Report Identifier (IRRID): DERR1-10.2196/35243 ", doi="10.2196/35243", url="https://www.researchprotocols.org/2022/4/e35243", url="http://www.ncbi.nlm.nih.gov/pubmed/35482374" } @Article{info:doi/10.2196/36753, author="Garcia, K. Franshelis and Verkooijen, T. Kirsten and Veen, J. Esther and Mulder, C. Bob and Koelen, A. Maria and Hazebroek, J. Eric", title="Stigma Toward Bariatric Surgery in the Netherlands, France, and the United Kingdom: Protocol for a Cross-cultural Mixed Methods Study", journal="JMIR Res Protoc", year="2022", month="Apr", day="28", volume="11", number="4", pages="e36753", keywords="bariatric surgery", keywords="obesity surgery", keywords="weight loss surgery", keywords="stigma", keywords="cross-cultural study", keywords="France", keywords="the Netherlands", keywords="the United Kingdom", abstract="Background: Bariatric surgery is an effective procedure for the treatment of obesity. Despite this, only 0.1\% to 2\% of eligible individuals undergo surgery worldwide. The stigma surrounding surgery might be a reason for this. Thus far, no research has systematically studied the nature and implications of bariatric surgery stigma. The limited studies on bariatric surgery stigma are often conducted from the perspective of the public or health care professions and either use small and nonrepresentative samples or fail to capture the full essence and implications of the stigma altogether, including attitudes toward patients and perpetrators of the stigma. In addition, studies from patients' perspectives are limited and tend to address bariatric surgery stigma superficially or implicitly. Finally, the extent to which cultural factors shape and facilitate this stigma and the experiences of patients have not yet been researched. Objective: This study aimed to explore the perceptions, experiences, and consequences of bariatric surgery stigma from the perspective of the public, health care professionals, and patients before and after bariatric surgery. Furthermore, although the concept of stigma is universal, every society has specific cultural norms and values that define acceptable attributes and behaviors for its members. Therefore, this study also aimed to explore the extent to which cultural factors influence bariatric surgery stigma by comparing the Netherlands, France, and the United Kingdom. Methods: This paper describes the protocol for a multiphase mixed methods research design. In the first part, we will conduct a scoping review to determine the current knowledge on bariatric surgery stigma and identify knowledge gaps. In the second part, semistructured interviews among patients before and after bariatric surgery will be conducted to explore their experiences and consequences of bariatric surgery stigma. In the third part, surveys will be conducted among both the public and health care professionals to determine the prevalence, nature, and impact of bariatric surgery stigma. Surveys and interviews will be conducted in the Netherlands, France, and the United Kingdom. Finally, data integration will be conducted at the interpretation and reporting levels. Results: The study began in September 2020 and will continue through September 2025. With the results of the review, we will create an overview of the current knowledge regarding bariatric surgery stigma from patients' perspectives. Qualitative data will provide insights into patients' experiences with bariatric surgery stigma. Quantitative data will provide information related to the prevalence and nature of bariatric surgery stigma from the perspective of the public and health care professionals. Both qualitative and quantitative data will be compared for each country. Conclusions: The findings from this study will lead to new insights that can be used to develop strategies to reduce bariatric surgery stigma and improve access, use, and outcomes of bariatric surgery. International Registered Report Identifier (IRRID): PRR1-10.2196/36753 ", doi="10.2196/36753", url="https://www.researchprotocols.org/2022/4/e36753", url="http://www.ncbi.nlm.nih.gov/pubmed/35482364" } @Article{info:doi/10.2196/27207, author="Cullington, Helen and Kitterick, Padraig and Darnton, Philippa and Finch, Tracy and Greenwell, Kate and Riggs, Carol and Weal, Mark and Walker, Dawn-Marie and Sibley, Andrew", title="Telemedicine for Adults With Cochlear Implants in the United Kingdom (CHOICE): Protocol for a Prospective Interventional Multisite Study", journal="JMIR Res Protoc", year="2022", month="Apr", day="13", volume="11", number="4", pages="e27207", keywords="cochlear implants", keywords="hearing", keywords="deafness", keywords="telemedicine", keywords="patient-centered care", abstract="Background: Cochlear implants provide hearing to approximately 750,000 people with deafness worldwide; these patients require lifelong follow-up. Care for adults with implants in the United Kingdom occurs at one of 19 centers, which may be far from the patients' homes. In a previous randomized controlled trial, we successfully introduced person-centered care. We designed, implemented, and evaluated the following remote care pathway: a personalized web-based support tool, home hearing check, self--device adjustment, and upgrading of sound processors at home rather than in the clinic. The remote care group had a significant increase in empowerment after using the tools, and the patients and clinicians were keen to continue. We would now like to scale up these improvements as an option for >12,000 UK adults using implants; we are commissioning an independent evaluation of this intervention and rollout to establish if it achieves its aims of more empowered and confident patients; more accessible and equitable care; stable hearing; more efficient, person-centered, and scalable service; and more satisfied and engaged patients and clinicians. Objective: This study aims to evaluate the impact and rollout of a person-centered clinical care pathway via telemedicine for adults with cochlear implants in the United Kingdom, using both outcomes and process evaluation. Methods: This project will scale up and evaluate a person-centered long-term follow-up pathway for adults using cochlear implants through a personalized website, including a home hearing check, uploading photos of cochlear implant site, listening in noise and music practice, ordering of spares, questionnaires, and other resources. Both quantitative and qualitative analyses will be conducted, and they will be both an outcome and process evaluation. Results: As of July 2021, the trial is closed, and all data collection is complete. The evaluation report is expected to be published in December 2021, and the research data have not yet been analyzed. Conclusions: This project will present the results of the first scaling up of a remote care pathway for adults with cochlear implants in the United Kingdom. Trial Registration: International Standard Randomized Controlled Trial Number ISRCTN51668922; https://www.isrctn.com/ISRCTN51668922 International Registered Report Identifier (IRRID): DERR1-10.2196/27207 ", doi="10.2196/27207", url="https://www.researchprotocols.org/2022/4/e27207", url="http://www.ncbi.nlm.nih.gov/pubmed/35416780" } @Article{info:doi/10.2196/30680, author="Obuobi-Donkor, Gloria and Eboreime, Ejemai and Bond, Jennifer and Phung, Natalie and Eyben, Scarlett and Hayward, Jake and Zhang, Yanbo and MacMaster, Frank and Clelland, Steven and Greiner, Russell and Jones, Chelsea and Cao, Bo and Br{\'e}mault-Phillips, Suzette and Wells, Kristopher and Li, Xin-Min and Hilario, Carla and Greenshaw, J. Andrew and Agyapong, Opoku Vincent Israel", title="An E--Mental Health Solution to Prevent and Manage Posttraumatic Stress Injuries Among First Responders in Alberta: Protocol for the Implementation and Evaluation of Text Messaging Services (Text4PTSI and Text4Wellbeing)", journal="JMIR Res Protoc", year="2022", month="Apr", day="25", volume="11", number="4", pages="e30680", keywords="posttraumatic stress injury", keywords="first responders", keywords="messaging", keywords="mobile phone", keywords="text-based intervention", keywords="Text4PTSI", keywords="Text4Wellbeing", abstract="Background: First responders are confronted with traumatic events in their work that has a substantial toll on their psychological health and may contribute to or result in posttraumatic stress injuries (PTSIs) for many responders. Persons with a PTSI usually seek management therapies. Evidence indicates that digital delivery of these therapies is an innovative, efficient, and effective way to improve PTSI symptoms as an adjunct to in-person delivery. Objective: This project aims to implement and provide accessible, convenient, and economical SMS text messaging services, known as Text4PTSI and Text4Wellbeing, to first responders in Alberta, Canada; to prevent and improve the symptoms of PTSI among first responders; and to improve their overall quality of life. We will evaluate posttraumatic symptoms and the impact of Text4PTSI and Text4Wellbeing on stress, anxiety, and depression in relation to the correspondents' demographic backgrounds. Methods: First responders who subscribe to Text4PTSI or Text4Wellbeing receive daily supportive and psychoeducational SMS text messages for 6 months. The SMS text messages are preprogrammed into an online software program that delivers messages to subscribers. Baseline and follow-up data are collected through online questionnaires using validated scales at enrollment, 6 weeks, 12 weeks, and 24 weeks (end point). In-depth interviews will be conducted to assess satisfaction with the text-based intervention. Results: We hypothesize that participants who enroll in this program will have improved PTSI symptoms; increased or improved quality of life; and significant reduction in associated stress, depression, and anxiety symptoms, among other psychological concerns. Improvement will be determined in comparison to established baseline parameters. Conclusions: This research will be beneficial for practitioners and will inform policy-making and decision-making regarding psychological interventions for PTSI. Lessons from this study will inform the scale-up of the intervention, a cost-effective, zero contact therapeutic option to manage PTSI. International Registered Report Identifier (IRRID): PRR1-10.2196/30680 ", doi="10.2196/30680", url="https://www.researchprotocols.org/2022/4/e30680", url="http://www.ncbi.nlm.nih.gov/pubmed/35468094" } @Article{info:doi/10.2196/37171, author="de Ruijter, Alexander Marinus and Yuan, Zhang Jian and Derksen, Jan Robert", title="The Clinical Outcomes of Operative Treatment Versus Conservative Treatment for Dancer's Fractures: Protocol for a Retrospective Cohort Study", journal="JMIR Res Protoc", year="2022", month="Apr", day="5", volume="11", number="4", pages="e37171", keywords="Dancer's fracture", keywords="fifth metatarsal fracture", keywords="outcomes", keywords="surgery", keywords="nonoperative treatment", abstract="Background: Fifth metatarsal fractures are one of the most common foot fractures, and 11\% to 25\% of such fractures are Dancer's fractures (distal spiral fractures). Conservative therapy while wearing a cast and operative treatment have been used as preferred modes of treatment in the limited literature available. However, we often see healing problems, such as delayed union and nonunion, when Dancer's fractures are treated nonoperatively, resulting in a need for secondary intervention. In our institution, treatment has changed over the years from predominantly conservative treatment to mostly operative treatment. To investigate whether our hypothesis holds true that primary surgical treatment is beneficial, a retrospective study was designed. Objective: The objective of the study is to compare differences between outcomes (delayed union and nonunion) of conservative and operative treatments for Dancer's fractures. Methods: A retrospective comparative cohort study will be conducted in a level II trauma center (Zaandam Medical Center). Patients who experienced a Dancer's fracture in the period of 2012 to 2021 will be included and divided into 2 cohorts---the conservative (2012-2015) and operative (2016-2021) treatment cohorts. The primary outcome will be the differences in percentages of delayed union and nonunion between the two groups. The secondary outcomes will be the percentage of primary conservative treatment failure, the need for secondary operative treatment, complications (infection and hardware failure), and functional outcomes. If 118 patients are included in each group, sufficient power is expected to be reached, depending on the age distribution of patients. The percentages of delayed union and nonunion among the two groups will be calculated and statistically compared via chi-square statistics. A logistic regression analysis will be used to investigate possible associations between patient characteristics and failed conservative treatment. A Mann-Whitney U test will be used to compare functional outcomes between groups. An independent, 2-tailed t test will be used to compare mean 12-Item Short Form Survey scores if they are normally distributed, and a Wilcoxon rank sum test will be used if they are nonnormally distributed. Results: In total, 2134 potentially relevant health insurance codes have been extracted from the hospital's register. We expect to find a total of 236 Dancer's fractures in this data set. Conclusions: Our study has limitations due to it being a single-center study and data collection being performed retrospectively. However, it covers a large time period and may provide the possibility to show treatment outcome differences (delayed union and nonunion, complications, and functional outcomes) in 2 reasonably large cohorts (conservative and operative treatment cohorts), which has not been done before in literature on Dancer's fractures. If our hypothesis that surgery is beneficial for Dancer's fractures is proven true by our study, we plan to further corroborate it by conducting a prospective randomized controlled trial. International Registered Report Identifier (IRRID): PRR1-10.2196/37171 ", doi="10.2196/37171", url="https://www.researchprotocols.org/2022/4/e37171", url="http://www.ncbi.nlm.nih.gov/pubmed/35380544" } @Article{info:doi/10.2196/33426, author="Breneol, Sydney and Curran, A. Janet and Macdonald, Marilyn and Montelpare, William and Stewart, A. Samuel and Martin-Misener, Ruth and Vine, Jocelyn", title="Children With Medical Complexity in the Canadian Maritimes: Protocol for a Mixed Methods Study", journal="JMIR Res Protoc", year="2022", month="Apr", day="6", volume="11", number="4", pages="e33426", keywords="pediatrics", keywords="complex care", keywords="health data", keywords="mixed methods", keywords="children", keywords="qualitative", keywords="health administration", keywords="health care resources", keywords="health resources", abstract="Background: Ongoing developments in the medical field have improved survival rates and long-term management of children with complex chronic health conditions. While the number of children with medical complexity is small, they use a significant amount of health resources across various health settings and sectors. Research to date exploring this pediatric population has relied primarily on quantitative or qualitative data alone, leaving significant gaps in our understanding of this population. Objective: The objective of this research is to use health administrative and family-reported data to gain an in-depth understanding of patterns of health resource use and health care needs of children with medical complexity and their families in the Canadian Maritimes. Methods: An explanatory sequential mixed methods design will be used to achieve our research objective. Phase 1 of this research will leverage the use of health administrative data to examine the prevalence and health service use of children with medical complexity. Phase 2 will use case study methods to collect multiple sources of family-reported data to generate a greater understanding of their experiences, health resource use, and health care needs. Two cases will be developed in each of the 3 provinces. Cases will be developed through semistructured interviews with families and their health care providers and health resource journaling. Findings will be triangulated from phase 1 and 2 using a joint display table to visually depict the convergence and divergence between the quantitative and qualitative findings. This triangulation will result in a comprehensive and in-depth understanding into the population of children with medical complexity. Results: This study will be completed in May 2022. Findings from each phase of the research and integration of the two will be reported in full in 2022. Conclusions: There is a current disconnect between the Canadian health care system and the needs of children with medical complexity and their families. By combining health administrative and family-reported data, this study will unveil critical information about children with medical complexity and their families to more efficiently and effectively meet their health care needs. Results from this research will be the first step in designing patient-oriented health policies and programs to improve the health care experiences, health system use, and health outcomes of children with medical complexity and their families. International Registered Report Identifier (IRRID): DERR1-10.2196/33426 ", doi="10.2196/33426", url="https://www.researchprotocols.org/2022/4/e33426", url="http://www.ncbi.nlm.nih.gov/pubmed/35383571" } @Article{info:doi/10.2196/33783, author="Moran, Orla and Doyle, Julie and Giggins, Oonagh and McHugh, Louise and Gould, Evelyn and Smith, Suzanne and Gavin, Shane and Sojan, Nisanth and Boyle, Gordon", title="Efficacy of a Digital Acceptance and Commitment Therapy Intervention for the Improvement of Self-management Behaviors and Psychological Flexibility in Adults With Cardiac Disease: Protocol for a Single Case Experimental Design", journal="JMIR Res Protoc", year="2022", month="Apr", day="1", volume="11", number="4", pages="e33783", keywords="cardiac disease", keywords="acceptance and commitment therapy", keywords="distress management", keywords="self-management", keywords="single case experimental design", keywords="digital health", abstract="Background: Research indicates that the management of distress levels in those with cardiac disease is not only important for improving quality of life and functioning but also critical for condition management; adherence to treatment; and, ultimately, disease prognosis and progression. Acceptance and commitment therapy (ACT) has consistently demonstrated positive long-term outcomes across a wide array of conditions, including chronic illness. However, most empirical investigations conducted to date have also involved in-person therapy, which can be difficult to access, particularly for those dealing with the demands of chronic disease. Objective: The objective of our research is to evaluate a digital ACT intervention for improving self-management behaviors and distress levels in those with cardiac conditions. Methods: The digital ACT intervention will be delivered via a digital health self-management platform over 6 sessions. This will involve a randomized, multiple baseline, single case experimental design with approximately 3 to 15 adults with cardiac disease. The independent variable for each participant will be the pre-post intervention phase. The dependent variables will be a daily self-report measure of psychological flexibility as well as objective measures of condition self-management (eg, blood pressure readings) and engagement with the app (eg, completing guided mindfulness). One-to-one qualitative interviews will also be conducted to further examine participants' experiences with using the intervention and what factors contribute to or impede successful outcomes. Results: Participant recruitment and data collection began in October 2021, and it is projected that the study findings will be available for dissemination by spring 2022. Conclusions: The findings will be discussed in terms of how a digital ACT intervention can best meet the needs of cardiac patients. International Registered Report Identifier (IRRID): PRR1-10.2196/33783 ", doi="10.2196/33783", url="https://www.researchprotocols.org/2022/4/e33783", url="http://www.ncbi.nlm.nih.gov/pubmed/35363156" } @Article{info:doi/10.2196/30638, author="Khetrapal, Pramit and Stafford, Ronnie and {\'O} Scanaill, P{\'a}draig and Kocadag, Huriye and Timinis, Constantinos and Chang, L. Angela H. and Hadjivasiliou, Adamos and Liu, Yansong and Gibbs, Olivia and Pickford, Eleanor and Walker, David and Baker, Hilary and Duncan, Jacqueline and Tan, Melanie and Williams, Norman and Catto, James and Drobnjak, Ivana and Kelly, John", title="Measuring Patient Compliance With Remote Monitoring Following Discharge From Hospital After Major Surgery (DREAMPath): Protocol for a Prospective Observational Study", journal="JMIR Res Protoc", year="2022", month="Apr", day="6", volume="11", number="4", pages="e30638", keywords="digital health", keywords="telemonitoring", keywords="remote monitoring", keywords="telehealth", keywords="surgery", keywords="hospital", keywords="compliance", keywords="patient monitoring", keywords="wearable technology", keywords="smart devices", abstract="Background: The incidence of major surgery is on the rise globally, and more than 20\% of patients are readmitted to hospital following discharge from hospital. During their hospital stay, patients are monitored for early detection of clinical deterioration, which includes regularly measuring physiological parameters such as blood pressure, heart rate, respiratory rate, temperature, and pulse oximetry. This monitoring ceases upon hospital discharge, as patients are deemed clinically stable. Monitoring after discharge is relevant to detect adverse events occurring in the home setting and can be made possible through the development of digital technologies and mobile networks. Smartwatches and other technological devices allow patients to self-measure physiological parameters in the home setting, and Bluetooth connectivity can facilitate the automatic collection and transfer of this data to a secure server with minimal input from the patient. Objective: This paper presents the protocol for the DREAMPath (Domiciliary Recovery After Medicalization Pathway) study, which aims to measure compliance with a multidevice remote monitoring kit after discharge from hospital following major surgery. Methods: DREAMPath is a single-center, prospective, observational, cohort study, comprising 30 patients undergoing major intracavity surgery. The primary outcome is to assess patient compliance with wearable and interactive smart technology in the first 30 days following discharge from hospital after major surgery. Secondary outcomes will explore the relation between unplanned health care events and physiological data collected in the study, as well as to explore a similar relationship with daily patient-reported outcome measures (Quality of Recovery--15 score). Secondary outcomes will be analyzed using appropriate regression methods. Cardiopulmonary exercise testing data will also be collected to assess correlations with wearable device data. Results: Recruitment was halted due to COVID-19 restrictions and will progress once research staff are back from redeployment. We expect that the study will be completed in the first quarter of 2022. Conclusions: Digital health solutions have been recently made possible due to technological advances, but urgency in rollout has been expedited due to COVID-19. The DREAMPath study will inform readers about the feasibility of remote monitoring for a patient group that is at an increased risk of acute deterioration. Trial Registration: ISRCTN Registry ISRCTN62293620; https://www.isrctn.com/ISRCTN62293620 International Registered Report Identifier (IRRID): DERR1-10.2196/30638 ", doi="10.2196/30638", url="https://www.researchprotocols.org/2022/4/e30638", url="http://www.ncbi.nlm.nih.gov/pubmed/35383570" } @Article{info:doi/10.2196/35971, author="Mathew, Mekha and van Vlymen, Jeremy and Meza-Torres, Bernardo and Hinton, William and Delanerolle, Gayathri and Yonova, Ivelina and Feher, Michael and Fan, Xuejuan and Liyanage, Harshana and Joy, Mark and Carinci, Fabrizio and de Lusignan, Simon", title="The Effect of the COVID-19 Pandemic on Glycemic Monitoring and Other Processes of Care for Type 2 Diabetes: Protocol for a Retrospective Cohort Study", journal="JMIR Res Protoc", year="2022", month="Apr", day="22", volume="11", number="4", pages="e35971", keywords="cohort studies", keywords="COVID-19", keywords="computerized medical record systems", keywords="primary health care", keywords="type 2 diabetes mellitus", keywords="diabetes", keywords="glycemic control", keywords="monitoring", abstract="Background: Social distancing and other nonpharmaceutical interventions to reduce the spread of COVID-19 infection in the United Kingdom have led to substantial changes in delivering ongoing care for patients with chronic conditions, including type 2 diabetes mellitus (T2DM). Clinical guidelines for the management and prevention of complications for people with T2DM delivered in primary care services advise routine annual reviews and were developed when face-to-face consultations were the norm. The shift in consultations from face-to-face to remote consultations caused a reduction in direct clinical contact and may impact the process of care for people with T2DM. Objective: The aim of this study is to explore the impact of the COVID-19 pandemic's first year on the monitoring of people with T2DM using routine annual reviews from a national primary care perspective in England. Methods: A retrospective cohort study of adults with T2DM will be performed using routinely collected primary care data from the Oxford-Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC). We will describe the change in the rate of monitoring of hemoglobin A1c (HbA1c) between the first year of the COVID-19 pandemic (2020) and the preceding year (2019). We will also report any change in the eight checks that make up the components of these reviews. The change in HbA1c monitoring rates will be determined using a multilevel logistic regression model, adjusting for patient and practice characteristics, and similarly, the change in a composite measure of the completeness of all eight checks will be modeled using ordinal regression. The models will be adjusted for the following patient-level variables: age, gender, socioeconomic status, ethnicity, COVID-19 shielding status, duration of diabetes, and comorbidities. The model will also be adjusted for the following practice-level variables: urban versus rural, practice size, Quality and Outcomes Framework achievement, the National Health Service region, and the proportion of face-to-face consultations. Ethical approval was provided by the University of Oxford Medical Sciences Interdivisional Research Ethics Committee (September 2, 2021, reference R77306/RE001). Results: The analysis of the data extract will include 3.96 million patients with T2DM across 700 practices, which is 6\% of the available Oxford-RCGP RSC adult population. The preliminary results will be submitted to a conference under the domain of primary care. The resulting publication will be submitted to a peer-reviewed journal on diabetes and endocrinology. Conclusions: The COVID-19 pandemic has impacted the delivery of care, but little is known about the process of caring for people with T2DM. This study will report the impact of the COVID-19 pandemic on these processes of care. International Registered Report Identifier (IRRID): DERR1-10.2196/35971 ", doi="10.2196/35971", url="https://www.researchprotocols.org/2022/4/e35971", url="http://www.ncbi.nlm.nih.gov/pubmed/35417404" } @Article{info:doi/10.2196/37009, author="Bilodeau, Karine and Gouin, Marie-Michelle and Lecours, Alexandra and Lederer, Val{\'e}rie and Durand, Marie-Jos{\'e} and Kilpatrick, Kelley and Lepage, David and Ladouceur-Deslauriers, Lauriane and Dorta, Tomas", title="Acceptability and Feasibility of a Return-to-Work Intervention for Posttreatment Breast Cancer Survivors: Protocol for a Co-design and Development Study", journal="JMIR Res Protoc", year="2022", month="Apr", day="22", volume="11", number="4", pages="e37009", keywords="co-design", keywords="breast cancer", keywords="intervention", keywords="return-to-work", keywords="primary care", keywords="qualitative", abstract="Background: The mortality rate from breast cancer has been declining for many years, and the population size of working-age survivors is steadily increasing. However, the recurrent side effects of cancer and its treatment can result in multiple disabilities and disruptions to day-to-day life, including work disruptions. Despite the existing knowledge of best practices regarding return to work (RTW) for breast cancer survivors, only a few interdisciplinary interventions have been developed to address the individualized needs and multiple challenges of breast cancer survivors, health care professionals, and employer and insurer representatives. Thus, it seems appropriate to develop RTW interventions collaboratively by using a co-design approach with these specific stakeholders. Objective: This paper presents a protocol for developing and testing an innovative, interdisciplinary pilot intervention based on a co-design approach to better support RTW and job retention after breast cancer treatment. Methods: First, a participatory research approach will be used to develop the intervention in a co-design workshop with 12 to 20 participants, including people affected by cancer, employer and insurer representatives, and health care professionals. Next, a pilot intervention will be tested in a primary care setting with 6 to 8 women affected by breast cancer. The acceptability and feasibility of the pilot intervention will be pretested through semistructured interviews with participants, health care professionals, and involved patient partners. The transcribed data will undergo an iterative content analysis. Results: The first phase of the project---the co-design workshop---was completed in June 2021. The pilot test of the intervention will begin in spring 2022. The results from the test will be available in late 2022. Conclusions: The project will offer novel data regarding the use of the co-design approach for the development of innovative, co-designed interventions. In addition, it will be possible to document the acceptability and feasibility of the pilot intervention with a primary care team. Depending on the results obtained, the intervention could be implemented on a larger scale. International Registered Report Identifier (IRRID): DERR1-10.2196/37009 ", doi="10.2196/37009", url="https://www.researchprotocols.org/2022/4/e37009", url="http://www.ncbi.nlm.nih.gov/pubmed/35451972" } @Article{info:doi/10.2196/37279, author="Fuchs-Neuhold, Bianca and Staubmann, Wolfgang and Peterseil, Marie and Rath, Anna and Schweighofer, Natascha and Kronberger, Anika and Riederer, Monika and van der Kleyn, Moenie and Martin, Jochen and H{\"o}rmann-Wallner, Marlies and Waldner, Irmgard and Konrad, Manuela and Aufschnaiter, Lena Anna and Siegmund, Barbara and Berghold, Andrea and Holasek, Sandra and Pail, Elisabeth", title="Investigating New Sensory Methods Related to Taste Sensitivity, Preferences, and Diet of Mother-Infant Pairs and Their Relationship With Body Composition and Biomarkers: Protocol for an Explorative Study", journal="JMIR Res Protoc", year="2022", month="Apr", day="27", volume="11", number="4", pages="e37279", keywords="taste", keywords="preferences", keywords="nutrition", keywords="biomarkers", keywords="body composition", keywords="air displacement plethysmography", keywords="Baby Facial Actions Coding System", keywords="mother", keywords="infant", keywords="parenting", keywords="pediatrics", keywords="prenatal", keywords="postnatal", abstract="Background: Early experiences with different flavors play an important role in infant development, including food and taste acceptance. Flavors are already perceived in utero with the development of the taste and olfactory system and are passed on to the child through breast and bottle feeding. Therefore, the first 1000 days of life are considered a critical window for infant developmental programming. Objective: The objective of our study is to investigate, both in the prenatal and postnatal period, taste sensitivity, preferences, and dietary diversity of mother-infant pairs. The explorative study design will also report on the impact of these variables on body composition (BC) and biomarkers. In contrast to conventional methods, this study involves long-term follow-up data collection from mother-infant pairs; moreover, the integration of audiovisual tools for recording infants' expressions pertaining to taste stimuli is a novelty of this study. Considering these new methodological approaches, the study aims to assess taste-related data in conjunction with BC parameters like fat-free mass or fat mass, biomarkers, and nutritional intake in infants and children. Methods: Healthy pregnant women aged between 18 and 50 years (BMI?18.5 kg/m2 to ?30 kg/m2; <28 weeks of gestation) were recruited from January 2014 to October 2014. The explorative design implies 2 center visits during pregnancy (24-28 weeks of gestation and 32-34 weeks of gestation) and 2 center visits after delivery (6-8 weeks postpartum and 14-16 weeks postpartum) as well as follow-up visits at 1, 3-3.5, and 6 years after delivery. Data collection encompasses anthropometric and biochemical measurements as well as BC analyses with air displacement plethysmography, taste perception assessments, and multicomponent questionnaires on demographics, feeding practices, and nutritional and lifestyle behaviors. Audiovisual data from infants' reactions to sensory stimuli are collected and coded by trained staff using Baby Facial Action Coding and the Body Action Posture System. Birth outcomes and weight development are obtained from medical records, and additional qualitative data are gathered from 24 semistructured interviews. Results: Our cohort represents a homogenous group of healthy women with stringent exclusion criteria. A total of 54 women met the eligibility criteria, whereas 47 mother-child pairs completed data collection at 4 center visits during and after pregnancy. Follow-up phases, data analyses, and dissemination of the findings are scheduled for the end of 2023. The study was approved by the ethics committee of the Medical University of Graz (EC No 26--066 ex 13/14), and all participants provided informed consent. Conclusions: The results of this study could be useful for elucidating the connections between maternal and infant statuses regarding diet, taste, biomarkers, and prenatal and postnatal weight development. This study may also be relevant to the establishment of further diagnostic and interventional strategies targeting childhood obesity and early body fat development. International Registered Report Identifier (IRRID): DERR1-10.2196/37279 ", doi="10.2196/37279", url="https://www.researchprotocols.org/2022/4/e37279", url="http://www.ncbi.nlm.nih.gov/pubmed/35475790" } @Article{info:doi/10.2196/34200, author="Kottink, Roza Anke Ida and Nikamp, DM Corien and Bos, P. Foskea and van der Sluis, K. Corry and van den Broek, Marieke and Onneweer, Bram and Stolwijk-Sw{\"u}ste, M. Janneke and Brink, M. Sander and Voet, BM Nicoline and Buurke, B. Jacob and Rietman, S. Johannes and Prange-Lasonder, B. Gerdienke", title="Therapeutic Effect of a Soft Robotic Glove for Activities of Daily Living In People With Impaired Hand Strength: Protocol for a Multicenter Clinical Trial (iHand)", journal="JMIR Res Protoc", year="2022", month="Apr", day="5", volume="11", number="4", pages="e34200", keywords="upper extremity", keywords="hand function", keywords="hand strength", keywords="robotics", keywords="rehabilitation", keywords="assistive technology", keywords="activities of daily living", keywords="wearable devices", keywords="soft-robotic glove", keywords="wearable", keywords="hand", keywords="robot", keywords="assist", keywords="protocol", keywords="therapy", keywords="support", keywords="intervention", keywords="function", abstract="Background: Decline of hand function, especially reduced hand strength, is a common problem that can be caused by many disorders and results in difficulties performing activities of daily living. A wearable soft robotic glove may be a solution, enabling use of the affected arm and hand repeatedly during functional daily activities and providing intensive and task-specific training simultaneously with assistance of hand function. Objective: We aim to investigate the therapeutic effect of an assistive soft robotic glove (Carbonhand). Methods: This multicenter uncontrolled intervention study consists of 3 preassessments (T0, T1, and T2), a postassessment (T3), and a follow-up assessment (T4). Participants are patients who experience hand function limitations. For the intervention, participants will use the glove during activities of daily living at home for 6 weeks, with a recommended use of at least 180 minutes per week. The primary outcome measure is handgrip strength, and secondary outcome measures are related to functional arm and hand abilities, amount of glove use, and quality of life. Results: The first participant was included on June 25, 2019. Currently, the study has been extended due to the COVID-19 pandemic; data collection and analysis are expected to be completed in 2022. Conclusions: The Carbonhand system is a wearable assistive device, allowing performance of functional activities to be enhanced directly during functional daily activities. At the same time, active movement of the user is encouraged as much as possible, which has potential to provide highly intensive and task-specific training. As such, it is one of the first assistive devices to incorporate assist-as-needed principles. This is the first powered clinical trial that investigates the unique application of an assistive grip-supporting soft robotic glove outside of clinical settings with the aim to have a therapeutic effect. Trial Registration: Netherlands Trial Register NTR NL7561; https://www.trialregister.nl/trial/7561 International Registered Report Identifier (IRRID): DERR1-10.2196/34200 ", doi="10.2196/34200", url="https://www.researchprotocols.org/2022/4/e34200", url="http://www.ncbi.nlm.nih.gov/pubmed/35380115" } @Article{info:doi/10.2196/33517, author="Verwaaijen, Jacobine Emma and van Hulst, Annelienke and Fiocco, Marta and Hartman, Annelies and Grootenhuis, Martha and Pluijm, Saskia and Pieters, Rob and van den Akker, Erica and van den Heuvel-Eibrink, M. Marry", title="Dexamethasone-Induced Sarcopenia and Physical Frailty in Children With Acute Lymphoblastic Leukemia: Protocol for a Prospective Cohort Study", journal="JMIR Res Protoc", year="2022", month="Apr", day="11", volume="11", number="4", pages="e33517", keywords="acute lymphoblastic leukemia", keywords="sarcopenia", keywords="physical frailty", keywords="muscle atrophy", keywords="dexamethasone", keywords="fatigue", keywords="physical activity", keywords="glucocorticoid-induced atrophy", abstract="Background: During treatment for pediatric acute lymphoblastic leukemia (ALL), children receive high doses of dexamethasone for its apoptotic effect on leukemia cells; however, muscle atrophy is a well-known serious side effect. Muscle atrophy (loss of muscle mass) accompanied by a decreased muscle strength may lead to a generalized impaired skeletal muscle state called sarcopenia. Loss of muscle mass is also an indicator of physical frailty, which is defined as a state of increased vulnerability that is characterized by co-occurrence of low muscle mass, muscle weakness, fatigue, slow walking speed, and low physical activity. Both sarcopenia and physical frailty are related to an increased risk of infections, hospitalizations, and decreased survival in children with chronic diseases. Objective: This study aims to (1) estimate the occurrence of sarcopenia and physical frailty in children during ALL maintenance therapy, (2) evaluate the effect of administering dexamethasone, and (3) explore determinants associated with these outcomes. Methods: This prospective study is being pursued within the framework of the DexaDays-2 study: a randomized controlled trial on neurobehavioral side effects in pediatric patients with ALL. A total of 105 children (3-18 years) undergoing ALL maintenance treatment at the Princess M{\'a}xima Center for Pediatric Oncology are included in this study. Sarcopenia/frailty assessments are performed before and just after a 5-day dexamethasone course. A subset of 50 children participating in the DexaDays-2 trial because of severe dexamethasone-induced neurobehavioral problems were assessed at 3 additional timepoints. The sarcopenia/frailty assessment consists of bioimpedance analysis (skeletal muscle mass [SMM]), handheld dynamometry (handgrip strength), Pediatric Quality of Life Inventory Multidimensional Fatigue Scale (fatigue), Timed Up and Go Test (TUG; walking speed), and physical activity questionnaires. To evaluate potential change in sarcopenia/frailty components after a 5-day dexamethasone administration, a paired Student t test or Mann-Whitney U test will be used. Because of the presence of repeated measurements, generalized linear mixed models will be used to estimate the effect of dexamethasone on sarcopenia and frailty outcomes. Multivariable regression models will be estimated to investigate associations between the assessment scores and patient and treatment-related factors. Results: Patient accrual started in 2018 and was finalized in spring 2021. From autumn 2021 onward final data analyses will be performed. Conclusions: This first study combining parameters of sarcopenia and physical frailty is of importance because these conditions can seriously complicate continuation of ALL therapy, independence in physical functioning, reaching motor milestones, and participating in daily life activities. The results will provide knowledge about these complications, the association between dexamethasone treatment and muscle loss and other components of frailty, and therefore insights into the severity of this side effect. By exploring potential determinants that may be associated with sarcopenia and physical frailty, we may be able to identify children at risk at an earlier stage and provide timely interventions. International Registered Report Identifier (IRRID): DERR1-10.2196/33517 ", doi="10.2196/33517", url="https://www.researchprotocols.org/2022/4/e33517", url="http://www.ncbi.nlm.nih.gov/pubmed/35403603" } @Article{info:doi/10.2196/36357, author="Cameron, M. Cate and McCreanor, Victoria and Shibl, Rania and Smyth, Tanya and Proper, Melanie and Warren, Jacelle and Vallmuur, Kirsten and Bradford, Natalie and Carter, Hannah and Graves, Nicholas and Loveday, Bill", title="Community Opioid Dispensing After Injury (CODI): Protocol for a Population-Based Data Linkage Study", journal="JMIR Res Protoc", year="2022", month="Apr", day="12", volume="11", number="4", pages="e36357", keywords="opioids", keywords="injury", keywords="data linkage", keywords="cohort study", keywords="outcomes", keywords="epidemiology", keywords="population-based study", keywords="health records", abstract="Background: There is an urgent need to reduce preventable deaths and hospitalizations from prescription opioid harms and minimize the negative effect opioid misuse can have on injured individuals, families, and the wider community. Data linkage between administrative hospitalization records for injured patients and community opioid dispensing can improve our understanding of the health and surgical trajectories of injured persons and generate insights into corresponding opioid dispensing patterns. Objective: The Community Opioid Dispensing after Injury (CODI) study aims to link inpatient hospitalization data with opioid dispensing data to examine the distribution and predictive factors associated with high or prolonged community opioid dispensing among adults, for 2 years following an injury-related hospital admission. Methods: This is a retrospective population-based cohort study of adults aged 18 years or older hospitalized with an injury in Queensland, Australia. The study involves the linkage of statewide hospital admissions, opioid prescription dispensing, and mortality data collections. All adults hospitalized for an injury between January 1, 2014, and December 31, 2015, will be included in the cohort. Demographics and injury factors are recorded at the time of the injury admission. Opioid dispensing data will be linked and extracted for 3 months prior to the injury admission date to 2 years after the injury separation date (last date December 31, 2017). Deaths data will be extracted for the 2-year follow-up period. The primary outcome measure will be opioid dispensing (frequency and quantity) in the 2 years following the injury admission. Patterns and factors associated with community opioid dispensing will be examined for different injury types, mechanisms, and population subgroups. Appropriate descriptive statistics will be used to describe the cohort. Regression models will be used to examine factors predictive of levels and duration of opioid use. Nonparametric methods will be applied when the data are not normally distributed. Results: The project is funded by the Royal Brisbane and Women's Hospital Foundation. As of November 2021, all ethics and data custodian approvals have been granted. Data extraction and linkage has been completed. Data management and analysis is underway with results relating to an analysis for blunt chest trauma patients expected to be published in 2022. Conclusions: Little is currently known of the true prevalence or patterns of opioid dispensing following injury across Queensland. This study will provide new insights about factors associated with high and long-term opioid dispensing at a population level. This information is essential to inform targeted public policy and interventions to reduce the risk of prolonged opioid use and dependence for those injured. The novel work undertaken for this project will be vital to planning, delivering, monitoring, and evaluating health care services for those injured. The findings of this study will be used to inform key stakeholders as well as clinicians and pain management services. International Registered Report Identifier (IRRID): RR1-10.2196/36357 ", doi="10.2196/36357", url="https://www.researchprotocols.org/2022/4/e36357", url="http://www.ncbi.nlm.nih.gov/pubmed/35412468" } @Article{info:doi/10.2196/32784, author="Odom, J. Krista and Ottosson, Amanda and Draru, Joyce and Komujuni, Harriet and Karamagi Nkolo, Karungi Esther and Faramand, Harb Taroub", title="Improving Viral Load Suppression Among Men and Children Active in Care Through Community-Designed and Led Solutions: Protocol for Retrospective Closed Cohort Study in Eastern Uganda", journal="JMIR Res Protoc", year="2022", month="Apr", day="13", volume="11", number="4", pages="e32784", keywords="HIV/AIDS", keywords="viral load suppression", keywords="Uganda", keywords="people living with HIV", keywords="95-95-95", keywords="social and behavior change", keywords="USAID", keywords="gender, youth, and social inclusion", keywords="virus", keywords="HIV", keywords="AIDS", keywords="antiretroviral therapy", keywords="behavioral science", keywords="implementation science", keywords="behavior change", keywords="men", keywords="children", keywords="community design", keywords="methodology", abstract="Background: In collaboration with facilities, communities, district local government, and the United States Agency for International Development (USAID) implementing partners, the iDARE methodology was implemented at the community level to address root causes of low HIV antiretroviral therapy adherence among men and children actively enrolled in care, resulting in low viral load suppression (VLS) in two districts in the eastern region of Uganda. The methodology encourages the use of cocreated sustainable solutions addressing gender, youth, and social inclusion issues to reduce barriers to care and reach the 95-95-95 Joint United Nations Programme on HIV/AIDS target for HIV epidemic control. We aim to measure the impact of iDARE on VLS for men and children active in care and investigate the practical scale up of the solutions designed using the iDARE methodology. Objective: The primary objective of this study will be to measure the implementation impact of the iDARE methodology at the facility and community levels on VLS for people living with HIV. The secondary objective is to investigate the practical scale up of the iDARE methodology using evidence-based gender, youth, and social inclusion social behavior change packages to rapidly meet the Ugandan Ministry of Health targets for VLS. Methods: A retrospective cohort study design will be used to analyze program data that aims to increase the rates of VLS in men and children who are classified as active in care using community engagement and quality improvement techniques. We will examine 3 pilot health centers' data from a USAID-funded program aimed at social behavior change to increase health-seeking behavior in Uganda. Based on the iDARE process and results, change packages were developed to highlight lessons learned and best practices in order to share with subsequent implementation sites. Results: The USAID-funded Social and Behavior Change Activity began implementation of iDARE in September 2020, with baseline data collected in August 2020. Conclusions: Data on viral load suppression was collected from facilities on a monthly basis to record progress toward the 95-95-95 goal. The expected primary outcome is an increase in actively enrolled men and children reaching VLS in order to meet the Ugandan Ministry of Health target of 95\% VLS among those active in care. International Registered Report Identifier (IRRID): DERR1-10.2196/32784 ", doi="10.2196/32784", url="https://www.researchprotocols.org/2022/4/e32784", url="http://www.ncbi.nlm.nih.gov/pubmed/35416790" } @Article{info:doi/10.2196/35083, author="Ewais, Tatjana and Hunt, Georgia and Munro, Jonathan and Pun, Paul and Hogan, Christy and William, Leeroy and Teodorczuk, Andrew", title="Schwartz Rounds for Staff in an Australian Tertiary Hospital: Protocol for a Pilot Uncontrolled Trial", journal="JMIR Res Protoc", year="2022", month="Apr", day="27", volume="11", number="4", pages="e35083", keywords="Schwartz Rounds", keywords="compassionate care", keywords="health care staff well-being", abstract="Background: Schwartz Rounds are a unique, organization-wide interdisciplinary intervention aimed at enhancing staff well-being, compassionate care, teamwork, and organizational culture in health care settings. They provide a safe space wherein both clinical and nonclinical health staff can connect and share their experiences about the social and emotional aspects of health care. Objective: Although Schwartz Rounds have been assessed and widely implemented in the United States and United Kingdom, they are yet to be formally evaluated in Australian health care settings. The purpose of this study is to evaluate the feasibility and impact of Schwartz Rounds on staff well-being, compassionate care, and organizational culture, in a tertiary metropolitan hospital in Brisbane, Australia. Methods: This mixed methods repeated measures pilot study will recruit 24 participants in 2 groups from 2 departments, the intensive care unit and the gastroenterology department. Participants from each group will take part in 3 unit-based Schwartz Rounds. Primary outcomes will include the study and intervention feasibility measures, while secondary outcomes will include scores on the Maslach Burnout Inventory--Human Services Survey, the Schwartz Centre Compassionate Care Scale, and the Culture of Care Barometer. Primary and secondary outcomes will be collected at baseline, after the Rounds, and 3-month follow-up. Two focus groups will be held approximately 2 months after completion of the Schwartz Rounds. Descriptive statistics, paired t tests, chi-square tests, and analysis of variance will be used to compare quantitative data across time points and groups. Qualitative data from focus groups and free-text survey questions will be analyzed using an inductive thematic analysis approach. Results: The study was approved by the Mater Hospital Human Research Ethics Committee (reference number: HREC/MML/71868) and recruitment commenced in July 2021; study completion is anticipated by May 2022. Conclusions: The study will contribute to the assessment of feasibility and preliminary efficacy of the Schwartz Rounds in a tertiary Australian hospital during the COVID-19 pandemic. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12621001473853; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382769\&isReview=true International Registered Report Identifier (IRRID): DERR1-10.2196/35083 ", doi="10.2196/35083", url="https://www.researchprotocols.org/2022/4/e35083", url="http://www.ncbi.nlm.nih.gov/pubmed/35475785" } @Article{info:doi/10.2196/33552, author="El Tantawi, Maha and Folayan, O. Morenike and Bhayat, Ahmed", title="Oral Health Status and Practices, and Anthropometric Measurements of Preschool Children: Protocol for a Multi-African Country Survey", journal="JMIR Res Protoc", year="2022", month="Apr", day="27", volume="11", number="4", pages="e33552", keywords="oral health", keywords="early childhood caries", keywords="oral hygiene", keywords="dietary intake", keywords="Africa", keywords="preschool children", keywords="dentistry", keywords="oral disease", abstract="Background: Oral diseases are among the most prevalent conditions with significant impact on the growth and development of young children. Data are required to plan effectively for the management of early childhood caries (ECC) and other oral diseases in this age. There are currently very few African countries with updated and nationally representative data on ECC prevalence, and risk indicators and regional data on ECC and other oral diseases are scarce. Objective: We aim to determine the oral health status and practices, dietary intake, and anthropometric measurements of preschool children in several African countries. Methods: A cross-sectional study will be conducted in several African countries using a standardized questionnaire and clinical examination for data collection from healthy preschool children in kindergartens and primary health care facilities. The clinical examination will assess ECC using the decayed, missing due to caries, and filled teeth (dmft) index according to the World Health Organization (WHO) criteria, dental erosion (using the Basic Erosive Wear Examination Index), deciduous molar hypomineralization (using the European Association of Paediatric Dentistry criteria), dental fluorosis (using Dean's Index), oral hygiene status (using the Oral Hygiene Index Simplified), and oral mucosal lesions. Oral hygiene habits and dental visits will be assessed using the WHO child questionnaire, and dietary intake will be assessed using the Food and Agriculture Organization method. Anthropometric measurements will be obtained following the International Society for the Advancement of Kinanthropometry standard protocol, and the children's nutritional status will be assessed following the WHO child growth standards. To train and calibrate examiners, educational resources and electronic forms will be used to reach interexaminer and intraexaminer reliability with $\kappa$>0.6. Descriptive analysis will determine the prevalence of clinical conditions by age and sex. Bivariate analysis and multivariable regression will assess associations between the clinical conditions and sociodemographic factors, and oral health behaviors. Results: Data collection will begin after approvals and ethical clearance are obtained. The first stage will include 3 countries, namely Egypt, Nigeria, and South Africa, and collaborators from other African countries will join afterward. Conclusions: This study will lay down the foundations for using validated tools to collect data on the oral health of young children in Africa, allowing researchers from different countries across Africa to collect standardized data on ECC and other oral conditions. This will facilitate comparisons and analysis of risk factors that might be unique to the African continent. The results will provide baseline data on the prevalence of oral diseases and enable planning to address the treatment needs of young African children and design programs to prevent oral diseases in the African continent. International Registered Report Identifier (IRRID): PRR1-10.2196/33552 ", doi="10.2196/33552", url="https://www.researchprotocols.org/2022/4/e33552", url="http://www.ncbi.nlm.nih.gov/pubmed/35476047" } @Article{info:doi/10.2196/36928, author="Nour, Radwa and Powell, Leigh and Alnakhi, K. Wafa and Mamdouh, Heba and Zidoun, Youness and Hussain, Y. Hamid and Al Suwaidi, Hanan and Zary, Nabil", title="Adult Vaccine Hesitancy Scale in Arabic and French: Protocol for Translation and Validation in the World Health Organization Eastern Mediterranean Region", journal="JMIR Res Protoc", year="2022", month="Apr", day="12", volume="11", number="4", pages="e36928", keywords="scale", keywords="instrument", keywords="vaccine hesitancy", keywords="COVID-19", keywords="validation", keywords="translation", keywords="Arabic", keywords="French", keywords="EMRO", abstract="Background: The world as we know it changed during the COVID-19 pandemic. Hope has emerged with the development of new vaccines against the disease. However, many factors hinder vaccine uptake and lead to vaccine hesitancy. Understanding the factors affecting vaccine hesitancy and how to assess its prevalence have become imperative amid the COVID-19 pandemic. The vaccine hesitancy scale (VHS), developed by the World Health Organization (WHO) Strategic Advisory Group of Experts on Immunization, has been modified to the adult VHS (aVHS) and validated in English and Chinese. To our knowledge, no available aVHS has been designed or validated in Arabic or French. Objective: The aim of this research is to translate the aVHS from its original English language to Arabic and French and validate the translations in the WHO Eastern Mediterranean region. Methods: The study will follow a cross-sectional design divided into 5 phases. In phase 1, the original aVHS will be forward-translated to Arabic and French, followed by backward translation to English. An expert committee will review and rate all versions of the translations. Expert agreement will then be measured using the Cohen kappa coefficient (k). In phase 2, the translated aVHS will be pilot-tested with 2 samples of participants (n=100): a group that speaks both Arabic and English and another that speaks French and English. Participants' responses to the English version will also be collected. In phase 3, responses will then be compared. Descriptive statistics and paired t tests or one-way analyses of variance (ANOVA) and Pearson correlation coefficient will be used in the preliminary validation. In phase 4, prefinal versions (Arabic and French) will be tested with larger sample sizes of Arabic speakers (n=1000) and French speakers (n=1000). Sociodemographic information and vaccination status will be collected and used for further analysis. In phase 5, the scale's statistical reliability and internal consistency will be measured using Cronbach alpha. An exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) will be used to examine the model fit resulting from the EFA. ANOVA and regression models will be constructed to control for confounders. All data will be electronically collected. Results: As of January 2022, the scale had been translated to Arabic and French and was undergoing the process of back translation. All data collection tools have been prepared (ie, sociodemographics, vaccination status, and open-ended questions) and are ready to go into their electronic formats. We expect to reach the desired sample size in this phase by June 2022. Conclusions: This study will provide researchers with a validated tool to assess adult vaccine hesitancy within populations that speak Arabic and/or French and provide a road map to scale translation and ensure cross-cultural adaptation. International Registered Report Identifier (IRRID): PRR1-10.2196/36928 ", doi="10.2196/36928", url="https://www.researchprotocols.org/2022/4/e36928", url="http://www.ncbi.nlm.nih.gov/pubmed/35247043" } @Article{info:doi/10.2196/34297, author="Diepstraten, A. Franciscus and Meijer, JM Annelot and van Grotel, Martine and Plasschaert, LA Sabine and Hoetink, E. Alexander and Fiocco, Marta and Janssens, O. Geert and Stokroos, J. Robert and van den Heuvel-Eibrink, M. Marry", title="A Study on Prevalence and Determinants of Ototoxicity During Treatment of Childhood Cancer (SOUND): Protocol for a Prospective Study", journal="JMIR Res Protoc", year="2022", month="Apr", day="7", volume="11", number="4", pages="e34297", keywords="pediatrics", keywords="ototoxicity", keywords="audiometry", keywords="antibiotics", keywords="diuretics", keywords="radiotherapy", keywords="solid tumors", keywords="neuro-oncology", keywords="audiology", keywords="cancer", keywords="children", abstract="Background: Some children with central nervous system (CNS) and solid tumors are at risk to develop ototoxicity during treatment. Up to now, several risk factors have been identified that may contribute to ototoxicity, such as platinum derivates, cranial irradiation, and brain surgery. Comedication, like antibiotics and diuretics, is known to enhance ototoxicity, but their independent influence has not been investigated in childhood cancer patients. Recommendations for hearing loss screening are missing or vary highly across treatment protocols. Additionally, adherence to existing screening guidelines is not always optimal. Currently, knowledge is lacking on the prevalence of ototoxicity. Objective: The aim of the Study on Prevalence and Determinants of Ototoxicity During Treatment of Childhood Cancer (SOUND) is to determine the feasibility of audiological testing and to determine the prevalence and determinants of ototoxicity during treatment for childhood cancer in a national cohort of patients with solid and CNS tumors. Methods: The SOUND study is a prospective cohort study in the national childhood cancer center in the Netherlands. The study aims to include all children aged 0 to 19 years with a newly diagnosed CNS or solid tumor. Part of these patients will get audiological examination as part of their standard of care (stratum 1). Patients in which audiological examination is not the standard of care will be invited for inclusion in stratum 2. Age-dependent audiological assessments will be pursued before the start of treatment and within 3 months after the end of treatment. Apart from hearing loss, we will investigate the feasibility to screen patients for tinnitus and vertigo prevalence after cancer treatment. This study will also determine the independent contribution of antibiotics and diuretics on ototoxicity. Results: This study was approved by the Medical Research Ethics Committee Utrecht (Identifier 20-417/M). Currently, we are in the process of recruitment for this study. Conclusions: The SOUND study will raise awareness about the presence of ototoxicity during the treatment of children with CNS or solid tumors. It will give insight into the prevalence and independent clinical and cotreatment-related determinants of ototoxicity. This is important for the identification of future high-risk patients. Thereby, the study will provide a basis for the selection of patients who will benefit from innovative otoprotective intervention trials during childhood cancer treatment that are currently being prepared. Trial Registration: Netherlands Trial Register NL8881; https://www.trialregister.nl/trial/8881 International Registered Report Identifier (IRRID): DERR1-10.2196/34297 ", doi="10.2196/34297", url="https://www.researchprotocols.org/2022/4/e34297", url="http://www.ncbi.nlm.nih.gov/pubmed/35389352" } @Article{info:doi/10.2196/31003, author="Cahill, Caitlin and Kruger, Natalia and Heine, John", title="Buccal Mucosal Grafts as a Novel Treatment for the Repair of Rectovaginal Fistulas: Protocol for an Upcoming Prospective Single-Surgeon Case Series", journal="JMIR Res Protoc", year="2022", month="Apr", day="29", volume="11", number="4", pages="e31003", keywords="surgical protocol", keywords="colorectal surgery, rectovaginal fistulas", keywords="fistula", keywords="surgery", keywords="gynecology", keywords="grafts", keywords="perioperative medicine", abstract="Background: Rectovaginal fistulas (RVFs) are abnormal communications between the rectum/anus and the vagina. They are most frequently formed a result of obstetric injury and have deleterious effects on patients' quality of life. Despite several treatment modalities, RVFs remain difficult problems to manage, and many patients fail multiple attempts at surgical repair. Buccal mucosal grafts (BMGs) may be a solution to this problem. A BMG is an oral mucosal tissue harvested from the inner cheek. There are 2 case reports that describe the successful use of BMGs in the repair of RVFs. Objective: Our objective is to validate these findings with a prospective case series while also addressing the key issues of indication, technical details, procedure safety, and short-term outcomes. Methods: A prospective single-surgeon case series will be undertaken at a university-affiliated academic tertiary care hospital in Calgary, Alberta (Canada). The estimated recruitment is between 3 and 5 patients. Patients will undergo surgical repair of their RVFs with an autologous BMG. Data on patient characteristics, fistula characteristics, and surgical variables will be collected and analyzed prospectively. The primary outcome is fistula closure. This study has been approved by the Conjoint Health Research Ethics Board at the University of Calgary (REB20-1123). Results: Two previous case reports have described the successful use of BMGs in the repair of RVFs. We have received ethics approval to attempt to validate these findings through a prospective case series. Conclusions: RVFs cause significant patient morbidity and are difficult problems to manage. Bolstered by the successful use of BMGs in urologic surgery and the previously published case reports demonstrating success in RVFs, we believe that BMGs may be a solution to RVFs. International Registered Report Identifier (IRRID): PRR1-10.2196/31003 ", doi="10.2196/31003", url="https://www.researchprotocols.org/2022/4/e31003", url="http://www.ncbi.nlm.nih.gov/pubmed/35486431" } @Article{info:doi/10.2196/38720, author="Ritvo, Paul and Gratzer, David and Knyahnytska, Yuliya and Ortiz, Abigail and Walters, Clarice and Katz, Joel and Laposa, Judith and Baldissera, Christopher and Wayne, Noah and Pfefer-Litman, Donna and Tomlinson, George and Daskalakis, Zafiris", title="Correction: Comparing Online and On-Site Cognitive Behavior Therapy in Major Depressive Disorder: Protocol for a Noninferiority Randomized Controlled Trial", journal="JMIR Res Protoc", year="2022", month="Apr", day="21", volume="11", number="4", pages="e38720", doi="10.2196/38720", url="https://www.researchprotocols.org/2022/4/e38720", url="http://www.ncbi.nlm.nih.gov/pubmed/35451994" } @Article{info:doi/10.2196/36849, author="Dauber, Sarah and Beacham, Alexa and Hammond, Cori and West, Allison and Thrul, Johannes", title="Adaptive Text Messaging for Postpartum Risky Drinking: Conceptual Model and Protocol for an Ecological Momentary Assessment Study", journal="JMIR Res Protoc", year="2022", month="Apr", day="4", volume="11", number="4", pages="e36849", keywords="postpartum", keywords="alcohol use", keywords="risky drinking", keywords="mobile health", keywords="ecologic momentary assessment", keywords="mobile phone", abstract="Background: Risky drinking is prevalent among women of childbearing age. Although many women reduce their drinking during pregnancy, more than half return to prepregnancy levels during the early postpartum period. Risky drinking in new mothers may be associated with negative child and maternal health outcomes; however, new mothers are unlikely to seek treatment for risky drinking because of stigma and fear of child protective service involvement. SMS text messaging is a promising approach for reaching non--treatment-seeking new mothers at risk because of risky drinking. SMS text messaging interventions (TMIs) are empirically supported for alcohol use, but a tailored intervention for new mothers does not exist. This study aims to fill this gap by developing a just-in-time adaptive TMI for postpartum risky drinking. Objective: The objectives of this paper are to present a preliminary conceptual model of postpartum risky drinking and describe the protocol for conducting an ecological momentary assessment (EMA) study with new mothers to inform the refinement of the conceptual model and development of the TMI. Methods: This paper presents a preliminary conceptual model of postpartum risky drinking based on the motivational model of alcohol use, social cognitive theory, and temporal self-regulation theory. The model proposes three primary intervention targets: motivation, self-efficacy, and self-regulation. Theoretical and empirical literature in support of the conceptual model is described. The paper also describes procedures for a study that will collect EMA data from 30 participants recruited via social media and the perinatal Central Intake system of New Jersey. Following the baseline assessment, EMA surveys will be sent 5 times per day for 14 days. The assessment instruments and data analysis procedures are described. Results: Recruitment is scheduled to begin in January 2022 and is anticipated to conclude in March 2022. Study results are estimated to be published in July 2022. Conclusions: The study findings will enhance our understanding of daily and momentary fluctuations in risk and protective factors for risky drinking during the early postpartum period. The findings will be used to refine the conceptual model and inform the development of the TMI. The next steps for this work include the development of intervention components via an iterative participatory design process and testing of the resulting intervention in a pilot microrandomized trial. International Registered Report Identifier (IRRID): PRR1-10.2196/36849 ", doi="10.2196/36849", url="https://www.researchprotocols.org/2022/4/e36849", url="http://www.ncbi.nlm.nih.gov/pubmed/35373778" } @Article{info:doi/10.2196/37200, author="Cunha-Cruz, Joana and Ko, K. Linda and Mancl, Lloyd and Rothen, L. Marilynn and Harter, Catherine and Davis, Stephen and Koday, Mark", title="Home Delivery of Water for Caries Prevention in Latinx Children (``Sediento por una Sonrisa,'' Thirsty for a Smile): Protocol for a Single-Arm Feasibility Study", journal="JMIR Res Protoc", year="2022", month="Apr", day="15", volume="11", number="4", pages="e37200", keywords="dental caries", keywords="behavioral intervention", keywords="environmental restructuring", keywords="practice-based research", keywords="sugar consumption", keywords="feasibility", keywords="water consumption", keywords="nutrition", keywords="oral health", keywords="Latino (a) health", keywords="dental health", keywords="dentistry", keywords="dental", keywords="public health", abstract="Background: Dental caries has significant public health implications afflicting young children. In addition to low social economic status, the most prominent risk factor for early childhood caries is sugar in the diet, particularly sugar-sweetened beverages. Dental treatment for caries in young children is commonly performed under general anesthesia and a significant proportion of children require repeated treatment. Interventions to reduce sugar-sweetened beverage consumption could lead to reduced rates of retreatment for dental caries in young children. Objective: This protocol describes the rationale, design, and methods of the ``Thirsty for a Smile'' feasibility study. The aim of the study is to assess the feasibility, acceptability, and appropriateness of a dietary intervention promoting water consumption in lieu of sugar-sweetened beverages among young patients, mostly from Latino heritage. Methods: This protocol describes a single-arm feasibility study. Twenty-one dyads of children and their caregivers will be recruited. Children between 2 and 9 years old who recently had treatment under general anesthesia for early childhood dental caries will be eligible to participate. The intervention has two components: (1) environmental, in which bottled water is delivered to participants' homes; and (2) behavioral, in which caregivers will receive patient-centered counseling to increase children's water intake and reduce sugar-sweetened beverages consumption. Dental caries and anthropometric data will be collected at examination during baseline and final visits. The primary outcome is feasibility and secondary outcomes are acceptability and appropriateness of the intervention. Results: Funding has been obtained from the National Institute of Dental and Craniofacial Research and the University of Washington approved the study. The feasibility study was conducted from March to November 2019. Conclusions: This feasibility study will test the study processes prior to a two-arm randomized controlled trial to determine feasibility and acceptability of the intervention and study procedures. This study may provide useful information for other researchers attempting to test similar interventions. International Registered Report Identifier (IRRID): RR1-10.2196/37200 ", doi="10.2196/37200", url="https://www.researchprotocols.org/2022/4/e37200", url="http://www.ncbi.nlm.nih.gov/pubmed/35436235" } @Article{info:doi/10.2196/37106, author="Lewis, A. Melissa and Litt, M. Dana and Fairlie, M. Anne and Kilmer, R. Jason and Kannard, Emma and Resendiz, Raul and Walker, Travis", title="Investigating Why and How Young Adults Use Protective Behavioral Strategies for Alcohol and Marijuana Use: Protocol for Developing a Randomized Controlled Trial", journal="JMIR Res Protoc", year="2022", month="Apr", day="19", volume="11", number="4", pages="e37106", keywords="alcohol use", keywords="marijuana use", keywords="protective behavioral strategies", keywords="intervention development", keywords="young adults", abstract="Background: Young adulthood is associated with increased alcohol and marijuana use compared with other developmental periods. Alcohol and marijuana use place individuals at high risk for acute and long-term negative consequences. Despite the relatively large cross-sectional and longitudinal literature on protective behavioral strategies (PBS; behaviors that individuals can use to limit consequences and reduce substance use), little is known about why young adults choose to use PBS on specific occasions or why they might use PBS differently across occasions (ie, quality and consistency). There is significant room for improvement in the conceptualization, application, and understanding of PBS. Objective: This study aims to develop a novel, brief web-based and SMS text messaging intervention, with input from young adults who use alcohol and marijuana, which addresses the extent to which motivations for PBS use and nonuse (marijuana or alcohol) and the quality of PBS use (the degree of effectiveness or degree of implementation) differ when using alcohol alone versus concurrently or simultaneously with marijuana. Methods: This research will be conducted in 2 phases. Phase 1 will involve web-based focus groups (N=100) and cognitive interviews (N=10) to determine why young adults (aged 18-24 years) use or do not use specific PBS related to alcohol and marijuana use and elicit feedback on how motivations and the quality of PBS could be incorporated into a web-based and SMS text messaging PBS intervention as well as elicit feedback on developed intervention material. In phase 2, young adults (N=200; aged 18-24 years), who typically use alcohol and marijuana for at least 2 days per week, will be randomized to either the intervention or waitlist control group. The intervention will be brief, web-based, focusing on self-selected alcohol and marijuana PBS messages and motives for using alcohol- and marijuana-related PBS, and including intervention content delivered via SMS text messages 3 days a week (random day, Friday, and Saturday) over 8 consecutive weeks. All participants will report on PBS use, motivations for PBS use (and nonuse), quality of PBS use, and alcohol and marijuana use in morning surveys timed to occur the day after the intervention SMS text messages for those in the intervention group. Results: Recruitment and enrollment for phase 1 began in January 2022. Recruitment for phase 2 is anticipated to begin in January 2023. Upon completion of the phase 2 pilot, we will examine the feasibility, acceptability, and preliminary effect sizes of the newly developed brief web-based and SMS text messaging intervention. Conclusions: This study will provide an in-depth understanding of young adults' PBS use and has the potential to develop a more efficacious intervention for co-occurring or simultaneous alcohol and marijuana behaviors. Trial Registration: ClinicalTrials.gov NCT04978129; https://clinicaltrials.gov/ct2/show/NCT04978129 International Registered Report Identifier (IRRID): DERR1-10.2196/37106 ", doi="10.2196/37106", url="https://www.researchprotocols.org/2022/4/e37106", url="http://www.ncbi.nlm.nih.gov/pubmed/35438642" } @Article{info:doi/10.2196/38180, author="Sutton, Lynsey and Bell, Elliot and Every-Palmer, Susanna and Weatherall, Mark and Skirrow, Paul", title="Correction: Survivorship of Patients After Long Intensive Care Stay With Exploration and Experience in a New Zealand Cohort (SPLIT ENZ): Protocol for a Mixed Methods Study", journal="JMIR Res Protoc", year="2022", month="Apr", day="4", volume="11", number="4", pages="e38180", doi="10.2196/38180", url="https://www.researchprotocols.org/2022/4/e38180", url="http://www.ncbi.nlm.nih.gov/pubmed/35377851" } @Article{info:doi/10.2196/37925, author="Ranjit, S. Yerina and Krishnan, Archana and Ghosh, Debarchana and Cravero, Claire and Zhou, Xin and Altice, L. Frederick", title="Correction: mHealth Intervention to Improve Treatment Outcomes Among People With HIV Who Use Cocaine: Protocol for a Pilot Randomized Controlled Trial", journal="JMIR Res Protoc", year="2022", month="Apr", day="7", volume="11", number="4", pages="e37925", doi="10.2196/37925", url="https://www.researchprotocols.org/2022/4/e37925", url="http://www.ncbi.nlm.nih.gov/pubmed/35389873" } @Article{info:doi/10.2196/31189, author="Wagman, A. Jennifer and Amabile, Claire and Sumstine, Stephanie and Park, Eunhee and Boyce, Sabrina and Silverman, Jay and Fielding-Miller, Rebecca and Oaks, Laury and Swendeman, Dallas", title="Student, Staff, and Faculty Perspectives on Intimate Partner and Sexual Violence on 3 Public University Campuses: Protocol for the UC Speaks Up Study and Preliminary Results", journal="JMIR Res Protoc", year="2022", month="Apr", day="5", volume="11", number="4", pages="e31189", keywords="campus-based violence prevention", keywords="intimate partner violence", keywords="sexual violence", keywords="mixed methods research", keywords="public health approach", keywords="prevention", keywords="student-led", keywords="trauma-informed research", keywords="University of California", abstract="Background: Intimate partner and sexual violence are pervasive public health issues on college and university campuses in the United States. Research is recommended for creating and maintaining effective, relevant, and acceptable prevention programs and response services for student survivors. Objective: The University of California (UC) Speaks Up study aims to examine factors contributing to intimate partner and sexual violence on 3 UC campuses and use the findings to develop and test interventions and policies to prevent violence, promote health, and lay the groundwork for subsequent large-scale quantitative research. Methods: A mixed methods study was conducted at UC Los Angeles, UC San Diego, and UC Santa Barbara. Phase I (2017-2020) involved a resource audit; cultural consensus modeling of students' perceptions of sexual consent; in-depth interviews (IDIs) and focus group discussions with students to understand perceptions of campus environment related to experiences as well as prevention of and responses to violence; and IDIs with faculty, staff, and community stakeholders to investigate institutional and community arrangements influencing students' lives and experiences. Phase II (2020-ongoing) involves IDIs with student survivors to assess the use and perceptions of campus and community services. Qualitative content analysis is used to generate substantive codes and subthemes that emerge, using a thematic analysis approach. Results: In January 2019, we conducted 149 free-listing interviews and 214 web-based surveys with undergraduate and graduate and professional students for the cultural consensus modeling. Between February 2019 and June 2019, 179 IDIs were conducted with 86 (48\%) undergraduate students, 21 (11.7\%) graduate and professional students, 34 (19\%) staff members, 27 (15.1\%) faculty members, and 11 (6.1\%) community stakeholders, and 35 focus group discussions (27/35, 77\% with undergraduate students and 8/35, 23\% with graduate and professional students) were conducted with 201 participants. Since September 2020, 50\% (15/30) of the planned student survivor interviews have been conducted. This segment of data collection was disrupted by the COVID-19 pandemic. Recruitment is ongoing. Conclusions: Data analysis and phase II data collection are ongoing. The findings will be used to develop and test interventions for preventing violence, promoting health and well-being, and ensuring that survivor services are relevant and acceptable to and meet the needs of all individuals in the campus community, including those who are typically understudied. The findings will also be used to prepare for rigorous, UC--system-wide public health prevention research. International Registered Report Identifier (IRRID): DERR1-10.2196/31189 ", doi="10.2196/31189", url="https://www.researchprotocols.org/2022/4/e31189", url="http://www.ncbi.nlm.nih.gov/pubmed/35380114" } @Article{info:doi/10.2196/36725, author="Stenseth, Vistven Hege and Steindal, Alexander Simen and Solberg, Trygg Marianne and {\O}lnes, Alexandra Mia and Mohallem, Andrea and S{\o}rensen, Lene Anne and Strandell-Laine, Camilla and Olaussen, Camilla and Aure, Farsj{\o} Caroline and Riegel, Fernando and Pedersen, Ingunn and Zlamal, Jaroslav and Martini, Gue Jussara and Bresolin, Paula and Linnerud, Wang Silje Christin and Nes, Gon{\c{c}}alves Andr{\'e}a Aparecida", title="Simulation-Based Learning Supported by Technology to Enhance Critical Thinking in Nursing Students: Protocol for a Scoping Review", journal="JMIR Res Protoc", year="2022", month="Apr", day="4", volume="11", number="4", pages="e36725", keywords="simulation-based learning", keywords="technological supported simulation-based learning", keywords="critical thinking", keywords="nursing students", keywords="nursing education, educational approach", keywords="education", keywords="nursing", abstract="Background: Critical thinking is a crucial skill in the nursing profession, so teaching strategies and methodology must be carefully considered when training and preparing nursing students to think critically. Studies on simulation-based learning supported by technology are increasing in nursing education, but no scoping reviews have mapped the literature on simulation-based learning supported by technology to enhance critical thinking in nursing students. Objective: The proposed scoping review aims to systematically map research on the use of simulation-based learning supported by technology to enhance critical thinking in nursing students. Methods: The proposed scoping review will use the framework established by Arksey and O'Malley and will be reported according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) extension for scoping reviews. A systematic, comprehensive literature search was performed in the LILACS, ERIC, MEDLINE, EMBASE, PsycINFO, and Web of Science databases. Pairs of authors independently selected the articles by screening titles, abstracts, full-text papers, and extract data. The data will be analyzed and thematically categorized. Results: The development of a comprehensive and systematic search strategy was completed in June 2021. The database searches were performed in July 2021, and the screening of titles and abstracts was completed in September 2021. Charting the data began in February 2022. Analysis and synthesis will be performed sequentially, and the scoping review is expected to be complete by May 2023. Conclusions: The results of this proposed scoping review may identify gaps in the literature and provide an overview of research on the topic of simulation-based learning supported by technology to enhance critical thinking in nursing students. The research may identify nursing students' reported barriers and enablers for learning critical thinking skills through simulation-based learning supported by technology, and the results may help educators enhance their educational approach through knowledge of students' firsthand experiences and further development of successful teaching strategies in nursing education. International Registered Report Identifier (IRRID): DERR1-10.2196/36725 ", doi="10.2196/36725", url="https://www.researchprotocols.org/2022/4/e36725", url="http://www.ncbi.nlm.nih.gov/pubmed/35373777" } @Article{info:doi/10.2196/31923, author="Powell, Leigh and Nizam, Zayan Mohammed and Nour, Radwa and Zidoun, Youness and Sleibi, Randa and Kaladhara Warrier, Sreelekshmi and Al Suwaidi, Hanan and Zary, Nabil", title="Conversational Agents in Health Education: Protocol for a Scoping Review", journal="JMIR Res Protoc", year="2022", month="Apr", day="19", volume="11", number="4", pages="e31923", keywords="conversational agents", keywords="artificial intelligence chatbots", keywords="chatbots", keywords="health education", keywords="health promotion", keywords="classification", keywords="artificial intelligence assistants", keywords="conversational artificial intelligence", abstract="Background: Conversational agents have the ability to reach people through multiple mediums, including the online space, mobile phones, and hardware devices like Alexa and Google Home. Conversational agents provide an engaging method of interaction while making information easier to access. Their emergence into areas related to public health and health education is perhaps unsurprising. While the building of conversational agents is getting more simplified with time, there are still requirements of time and effort. There is also a lack of clarity and consistent terminology regarding what constitutes a conversational agent, how these agents are developed, and the kinds of resources that are needed to develop and sustain them. This lack of clarity creates a daunting task for those seeking to build conversational agents for health education initiatives. Objective: This scoping review aims to identify literature that reports on the design and implementation of conversational agents to promote and educate the public on matters related to health. We will categorize conversational agents in health education in alignment with current classifications and terminology emerging from the marketplace. We will clearly define the variety levels of conversational agents, categorize currently existing agents within these levels, and describe the development models, tools, and resources being used to build conversational agents for health care education purposes. Methods: This scoping review will be conducted by employing the Arksey and O'Malley framework. We will also be adhering to the enhancements and updates proposed by Levac et al and Peters et al. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) extension for scoping reviews will guide the reporting of this scoping review. A systematic search for published and grey literature will be undertaken from the following databases: (1) PubMed, (2) PsychINFO, (3) Embase, (4) Web of Science, (5) SCOPUS, (6) CINAHL, (7) ERIC, (8) MEDLINE, and (9) Google Scholar. Data charting will be done using a structured format. Results: Initial searches of the databases retrieved 1305 results. The results will be presented in the final scoping review in a narrative and illustrative manner. Conclusions: This scoping review will report on conversational agents being used in health education today, and will include categorization of the levels of the agents and report on the kinds of tools, resources, and design and development methods used. International Registered Report Identifier (IRRID): DERR1-10.2196/31923 ", doi="10.2196/31923", url="https://www.researchprotocols.org/2022/4/e31923", url="http://www.ncbi.nlm.nih.gov/pubmed/35258006" } @Article{info:doi/10.2196/32702, author="Giebel, Denk Godwin and Speckemeier, Christian and Abels, Carina and B{\"o}rchers, Kirstin and Wasem, J{\"u}rgen and Blase, Nikola and Neusser, Silke", title="Problems and Barriers Related to the Use of Digital Health Applications: Protocol for a Scoping Review", journal="JMIR Res Protoc", year="2022", month="Apr", day="21", volume="11", number="4", pages="e32702", keywords="digital health application", keywords="DHA", keywords="mHealth, problems, barriers, scoping review", keywords="mobile health", keywords="health insurance", keywords="electronic database", keywords="health database", keywords="mHealth app", abstract="Background: The use of mobile health (mHealth) apps is increasing rapidly worldwide. More and more institutions and organizations develop regulations and guidelines to enable an evidence-based and safe use. In Germany, mHealth apps fulfilling predefined criteria (Digitale Gesundheitsanwendungen [DiGA]) can be prescribed and are reimbursable by the German statutory health insurance scheme. Due to the increasing distribution of DiGA, problems and barriers should receive special attention. Objective: This study aims to identify the relevant problems and barriers related to the use of mHealth apps fulfilling the criteria of DiGA. Methods: This scoping review will follow published methodological frameworks and the PRISMA-Scr (Preferred Reporting Items for Systematic Reviews and Meta-analyses Extension for Scoping Reviews) criteria. Electronic databases (MEDLINE, EMBASE, PsycINFO, and JMIR), reference lists of relevant articles, and grey literature sources will be searched. Two reviewers will assess the eligibility of the articles by a two-stage (title and abstract as well as full text) screening process. Only problems and barriers related to mHealth apps fulfilling the criteria of DiGA are included for this research. The identified studies will be categorized and analyzed with MAXQDA. Results: This scoping review gives an overview of the available evidence and identifies research gaps regarding problems and barriers related to DiGA. The results are planned to be submitted to an indexed, peer-reviewed journal in the first quarter of 2022. Conclusions: This is the first review to identify the problems and barriers related to the use of mHealth apps fulfilling the German definition of DiGA. Nevertheless, the findings can be applied to other contexts and health care systems as well. International Registered Report Identifier (IRRID): DERR1-10.2196/32702 ", doi="10.2196/32702", url="https://www.researchprotocols.org/2022/4/e32702", url="http://www.ncbi.nlm.nih.gov/pubmed/35451979" } @Article{info:doi/10.2196/37748, author="Hodges, Jacqueline and Caldwell, Sylvia and Cohn, Wendy and Flickinger, Tabor and Waldman, Lena Ava and Dillingham, Rebecca and Castel, Amanda and Ingersoll, Karen", title="Evaluation of the Implementation and Effectiveness of a Mobile Health Intervention to Improve Outcomes for People With HIV in the Washington, DC Cohort: Study Protocol for a Cluster Randomized Controlled Trial", journal="JMIR Res Protoc", year="2022", month="Apr", day="22", volume="11", number="4", pages="e37748", keywords="human immunodeficiency virus", keywords="HIV", keywords="mobile health", keywords="mHealth", keywords="implementation science", keywords="cluster randomized controlled trial", keywords="smartphone", abstract="Background: Gaps remain in achieving retention in care and durable HIV viral load suppression for people with HIV in Washington, DC (hereafter DC). Although people with HIV seeking care in DC have access to a range of supportive services, innovative strategies are needed to enhance patient engagement in this setting. Mobile health (mHealth) interventions have shown promise in reaching previously underengaged groups and improving HIV-related outcomes in various settings. Objective: This study will evaluate the implementation and effectiveness of a clinic-deployed, multifeature mHealth intervention called PositiveLinks (PL) among people with HIV enrolled in the DC Cohort, a longitudinal cohort of people with HIV receiving care in DC. A cluster randomized controlled trial will be conducted using a hybrid effectiveness-implementation design and will compare HIV-related outcomes between clinics randomized to PL versus usual care. Methods: The study aims are threefold: (1) We will perform a formative evaluation of PL in the context of DC Cohort clinics to test the feasibility, acceptability, and usability of PL and tailor the platform for use in this context. (2) We will conduct a cluster randomized controlled trial with 12 DC Cohort clinics randomized to PL or usual care (n=6 [50\%] per arm) and measure the effectiveness of PL by the primary outcomes of patient visit constancy, retention in care, and HIV viral load suppression. We aim to enroll a total of 482 participants from DC Cohort clinic sites, specifically including people with HIV who show evidence of inconsistent retention in care or lack of viral suppression. (3) We will use the Consolidated Framework for Implementation Research (CFIR) and the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework to measure implementation success and identify site, patient, provider, and system factors associated with successful implementation. Evaluation activities will occur pre-, mid-, and postimplementation. Results: Formative data collection was completed between April 2021 and January 2022. Preliminary mHealth platform modifications have been performed, and the first round of user testing has been completed. A preimplementation evaluation was performed to identify relevant implementation outcomes and design a suite of instruments to guide data collection for evaluation of PL implementation throughout the trial period. Instruments include those already developed to support DC Cohort Study activities and PL implementation in other cohorts, which required modification for use in the study, as well as novel instruments designed to complete data collection, as guided by the CFIR and RE-AIM frameworks. Conclusions: Formative and preimplementation evaluations will be completed in spring 2022 when the trial is planned to launch. Specifically, comprehensive formative data analysis will be completed following data collection, coding, preliminary review, and synthesis. Corresponding platform modifications are ready for beta testing within the DC Cohort. Finalization of the platform for use in the trial will follow beta testing. Trial Registration: ClinicalTrials.gov NCT04998019; https://clinicaltrials.gov/ct2/show/NCT04998019 International Registered Report Identifier (IRRID): PRR1-10.2196/37748 ", doi="10.2196/37748", url="https://www.researchprotocols.org/2022/4/e37748", url="http://www.ncbi.nlm.nih.gov/pubmed/35349466" }