Background: Lower limb amputation rates are increasing owing to aging and vascular diseases. However, no standardized rehabilitation protocol has been established for regaining walking ability. Conventional rehabilitation delays prosthetic gait training until 6-8 weeks post amputation, prolonging recovery and increasing medical expenses. Objective: This study aims to evaluate the impact of neurorehabilitation using the Hybrid Assistive Limb (HAL) for Medical Use Lower Limb Type, developed by Japan's Tsukuba University and the robotics company Cyberdyne, on gait acquisition, improvement in activities of daily living (ADL), and enhancement of quality of life (QOL) in patients with lower limb amputation, and assess the effectiveness of early HAL-assisted gait training before and after amputation. Methods: This single-arm trial will include 20 patients undergoing unilateral transfemoral or transtibial amputations. HAL-assisted gait training will be performed 5 days per week (30 minutes per session) until postoperative week 8. The primary outcome is a 2-minute walking distance, while secondary outcomes include muscle strength, balance, gait parameters, and ADL/QOL measures. Statistical analyses will be conducted using SPSS (IBM Corp), and results obtained at the following time points will be compared: preoperative, postintervention, and 6-month follow-up. Results: The planned sample size is 20 patients, calculated using JMP version 12 (SAS Institute) based on an expected 1.5-fold improvement in 6-minute walk distance (effect size 0.8, α=.05, power=0.8). Analyses will be performed using SPSS version 15.0 (IBM Corp). The 2-minute walk test (primary outcome) and secondary outcomes will be compared at baseline, post intervention, and 6-month follow-up using 1-way analysis of variance or Kruskal-Wallis test, and P values <.05 and 95% CIs will be reported. Conclusions: This is the first study to apply HAL-assisted neurorehabilitation to patients with lower limb amputations. Early gait training may increase prosthetic gait acquisition rates, shorten rehabilitation and hospitalization periods, and reduce medical costs. If effective, this study may contribute to the development of a Japan-originated rehabilitation program and provide clinical evidence supporting broader HAL implementation for patients with lower limb amputations. Clinical Trial: Japan Registry of Clinical Trials jRCTs062200031; https://jrct.mhlw.go.jp/latest-detail/jRCTs062200031

Background: Self-reported dietary intake data are crucial in nutrition and health research; however, their accuracy is compromised by challenges such as portion size estimations, food identification, memory-related bias, social desirability bias, and reactivity bias. Dietary assessment in adolescents is particularly challenging due to irregular eating habits, meal skipping, and parent or peer influences, potentially resulting in misreporting. Leveraging adolescents’ receptiveness to technology, we investigated the use of an innovative smartphone app (Traqq) that facilitates dietary assessment using repeated short recalls instead of traditional 24-hour recalls. Evaluation studies of the Traqq app in Dutch adults have shown successful results, but its suitability for other target populations, such as adolescents, requires further investigation. Objective: We designed a comprehensive, 3-phase study to evaluate the Traqq app’s accuracy using repeated short recalls, usability, and user perspectives among Dutch adolescents aged 12 to 18 years. This manuscript details the study setup, research methods, and basic characteristics in phases 1 and 2. Methods: In phase 1, adolescents (aged 12-18 years) downloaded the Traqq app and completed a demographic questionnaire. It was used on 4 random school days over 4 weeks, using 2-hour recalls on 2 days and 4-hour recalls on 2 days. A food frequency questionnaire and 2 interviewer-administered 24-hour recalls served as dietary reference methods to assess the Traqq app’s accuracy. In addition, usability was evaluated using the System Usability Scale and an experience questionnaire. In phase 2, user experiences were further explored through semistructured interviews within a subsample of 24 adolescents. These first 2 phases of this mixed methods study are now finalized for data collection. Phase 3 will focus on collecting user insights to inform app customization through cocreation sessions. Results: Recruitment concluded in September 2022 with 102 adolescents; 98 (96%) provided dietary data via the Traqq app, and 79 (78%) completed the evaluation questionnaire. Adolescents had a mean age of 15 (SD 2) years. The mean BMI was 19.9 (SD 3) kg/m2. A total of 64 (63%) participants were girls, 81 (84%) attended high school, and 88 (92%) were born in the Netherlands. Interviews were held with 6 (25%) boys and 18 (75%) girls. Cocreation sessions will be planned after all data have been analyzed. Conclusions: In this holistic study, we combine quantitative and qualitative methods to evaluate the dietary assessment performance among adolescents of the Traqq app, which was initially designed for adults. Specifically, next to quantitative comparisons of the Traqq app’s dietary assessment methods, we conducted semistructured interviews, and we will carry out cocreation sessions. With this user-centered, synergistic approach, we aim to establish a list of requirements for a dietary assessment app for adolescents, resulting in more efficient assessments, improved compliance, and enhanced overall accuracy in this population. Clinical Trial: ISRCTN Registry ISRCTN46230386; https://www.isrctn.com/ISRCTN46230386

Background: Transgender, nonbinary, and gender diverse (TGD) young adults face a disproportionately high mental health burden, including 2- to 4-fold increased risk of suicidality and depressive distress compared to their cisgender peers. Family and community support are protective factors that may mitigate these adverse outcomes, representing key targets for mental health interventions. Objective: This randomized controlled trial (RCT) evaluates the effectiveness of TransHealthGUIDE, a novel digital, app-based education and support intervention aimed at reducing past 3-month suicidal ideation and past 2-week depressive distress among TGD young adults. Participants are randomized 1:1 to an immediate intervention arm or a 6-month deferred intervention arm (waitlist control). Methods: From 2021 to 2024, a multidisciplinary team of academic and community partners conducted formative research and codeveloped a digital app containing 33 self-paced modules, communication, and interactive resources. The content is grounded in the Social Ecological Suicide Prevention Model and the Gender Minority Stress and Resilience Framework, designed to enhance family support and community connection for TGD young adults and their families. TGD young adults (ages 18-24 years) and their caregivers are prospectively enrolled and randomized in 10 US states (California, Connecticut, Illinois, Maryland, Massachusetts, New Jersey, New York, Oregon, Vermont, and Washington, DC). Participants complete self-reported surveys at baseline, 6 months, and 12 months, assessing sociodemographics, family support, community connection, suicidal ideation, depressive distress, and intervention acceptability. App usage and engagement are tracked via metadata. The target sample size is 500 TGD young adults, with 50% (n=250) identifying as people of color and 125 TGD young adult-caregiver dyads. Results: TGD young adult and caregiver communities, including our community advisory board (CAB), have guided all aspects of the project: study design (eg, waitlist control), survey development (eg, self-reported rather than clinician-administered suicidality measures and inclusion of social justice activism as a form of support), intervention content (eg, text, infographics, interviews with TGD people and caregivers, and simulations), and digital app safety features (eg, a quick-exit button for privacy). Recruitment and study screening began on January 21, 2025. As of May 2, 2025, a total of 149 individuals completed a study screener, with 132 (88.6%) of 149 found eligible. Enrollment visits began on April 23, 2025. As of May 2, 2025, five TGD young adults have been enrolled. Ongoing engagement with the CAB will inform iterative improvements throughout the trial. Conclusions: Scalable, app-based interventions tailored to meet the needs of TGD young people hold promise for population-level mental health impact. This RCT—targeting suicidality and depressive distress via education and support for both TGD young adults and their caregivers—addresses a critical gap in mental health interventions for this underserved population. Trial Registration: ClinicalTrials.gov NCT06177600; https://clinicaltrials.gov/study/NCT06177600

Background: Substance use is a high-impact biopsychosocial problem in Chile, where 21% of adults have experienced a severe alcohol use episode. In the past year, the prevalence rates were 12.5% for marijuana, 0.8% for cocaine, and 0.4% for cocaine base paste. Cannabis prevalence in Chile is higher than the global (4.2%) and South American (3.58%) averages. Cocaine prevalence in Chile is lower than in South America (1.62%) but higher than the global average (0.42%). No international reports are available for cocaine base paste. Mental health and substance use programs in Chilean primary care involve psychologists and social workers. Solution-focused brief interventions (SFBIs) are based on solution-focused brief therapy, a strengths-based and person-centered approach in which practitioners adopt a stance of “not being the expert,” respecting clients’ needs and perspectives. Objective: This study aims to determine whether the SFBI implemented by psychosocial teams (psychologists and social workers) for individuals with alcohol and other drug use in primary health care centers leads to better outcomes than usual care. Methods: We will conduct a randomized controlled clinical trial (ClinicalTrials.gov registration pending) comparing a 3-session SFBI (experimental group) with a single session of brief counselling as usual care (control group) in primary care. Interventions will be delivered in person by a psychologist or social worker. A total of 320 participants are expected to be recruited during preventive routine checkups using the Alcohol, Smoking, and Substance Involvement Screening Test. Participants reporting intermediate- to high-risk substance use on this screening tool will be randomly assigned to each group. Research assistants will administer instruments at baseline and at 3-, 6-, and 9-month follow-ups and will be blinded to the assigned treatments. The primary outcome assessed will be substance use patterns, while secondary outcomes include background information, depressive symptoms, anxiety symptoms, and motivation for treatment. Statistical analyses, including t tests, ANOVA, and Fisher exact tests will be conducted depending on variable type and normality. A qualitative component to assess acceptability and pertinence will include focus groups with participants and practitioners, followed by a content analysis. Results: Funding for this study started in April 2024. As of the submission date of this protocol, 55 practitioners from 9 primary health care centers have been trained in SFBIs. Recruitment began in February 2025, with 73 participants enrolled and 23 who dropped out. Recruitment will continue until December 2026. No analyses have been conducted to date. Findings are expected to be published during the second half of 2028. Conclusions: This study strengthens primary care by integrating targeted psychosocial interventions for substance use into existing programs, thereby enhancing real-world applicability. If effective, the intervention could be adopted into routine care and inform public policy on mental health and substance use. Trial Registration:

Background: Information and communication technology (ICT) has made remarkable progress in recent years and is being increasingly applied to medical research. This technology has the potential to facilitate the active involvement of research participants. Digital platforms that enable participants to be involved in the research process are called participant-centric initiatives (PCIs). Several PCIs have been reported in the literature, but no scoping reviews have been carried out. Moreover, detailed methods and features to aid in developing a clear definition of PCIs have not been sufficiently elucidated to date. Objective: The objective of this scoping review is to describe the recent trends in, and features of, PCIs across the United States, the United Kingdom, and Japan. Methods: We applied a methodology suggested by Levac et al to conduct this scoping review. We searched electronic databases—MEDLINE (Medical Literature Analysis and Retrieval System Online), Embase (Excerpta Medica Database), CINAHL (Cumulative Index of Nursing and Allied Health Literature), PsycINFO, and Ichushi-Web—and sources of grey literature, as well as internet search engines—Google and Bing. We hand-searched through key journals and reference lists of the relevant articles. Medical research using ICT was eligible for inclusion if there was a description of the active involvement of the participants. Results: Ultimately, 21 PCIs were identified that have implemented practical methods and modes of various communication activities, such as patient forums and use of social media, in the field of medical research. Various methods of decision making that enable participants to become involved in setting the agenda were also evident. Conclusions: This scoping review is the first study to analyze the detailed features of PCIs and how they are being implemented. By clarifying the modes and methods of various forms of communication and decision making with patients, this review contributes to a better understanding of patient-centric involvement, which can be facilitated by PCIs.

The question of whether and, if so, how creativity and unethical behavior such as dishonesty are related to each other has been addressed in multiple studies, with mixed results overall. The aim of this Registered Report is to shed further light on this issue. We first present a meta-analysis on the relation between creativity and dishonesty comprising the samples from a pre-registered multi-lab study (on a different topic), which indicated no relation between the constructs in question (k = 19, N = 2,154, rp = .02). Next, we examined the relation between creativity and dishonesty in a study (N = 1,152), in which we addressed several limitations of previous research. Specifically, we examined relations between comprehensively assessed creativity and dishonesty using subjective and objective indicators for both constructs. We found mixed results concerning the relation between creativity and dishonesty. In the majority of the confirmatory statistical tests, subjective creativity was positively related, whereas objective creativity was negatively related to dishonesty in the mind game. However, in exploratory analyses, we found that neither subjective nor objective creativity was related to dishonesty in the second dishonesty measure, the sender–receiver game.

A critical step before data-sharing of human neuroimaging is removing facial features to protect individuals’ privacy. However, not only does this process redact identifiable information about individuals, but it also removes non-identifiable information. This introduces undesired variability into downstream analysis and interpretation. This registered report investigated the degree to which the so-called defacing altered the quality assessment of T1-weighted images of the human brain from the openly available “IXI dataset”. The effect of defacing on manual quality assessment was investigated on a single-site subset of the dataset (N = 185). By comparing two linear mixed-effects models, we determined that four trained human raters’ perception of quality was significantly influenced by defacing by modeling their ratings on the same set of images in two conditions: “nondefaced” (i.e., preserving facial features) and “defaced”. In addition, we investigated these biases on automated quality assessments by applying repeated-measures, multivariate ANOVA (rm-MANOVA) on the image quality metrics extracted with MRIQC on the full IXI dataset (N = 581; three acquisition sites). This study found that defacing altered the quality assessments by humans and showed that MRIQC’s quality metrics were mostly insensitive to defacing.

Background: Negative symptoms of schizophrenia, such as lack of motivation, pleasure, social interest, and expression, are key contributors to functional impairments in people with schizophrenia. While psychosocial interventions have demonstrated efficacy, no Food and Drug Administration–approved pharmacotherapies exist specifically to target these symptoms. Evidence-based digital therapeutics (DTx) may offer novel, scalable treatment options to augment existing treatments. Objective: This article describes the study design and methods of a phase 3, multicenter, double-blind, randomized controlled study (CONVOKE). It aims to evaluate the effectiveness and safety of CT-155/BI 3972080 (CT-155), a smartphone-based DTx, as an adjunct to standard-of-care antipsychotic medication in adults with experiential negative symptoms of schizophrenia. Methods: Eligible participants were 18 years or older with a primary diagnosis of schizophrenia receiving stable antipsychotic medication for ≥12 weeks, scored ≥2 on average in at least 2 Clinical Assessment Interview for Negative Symptoms Motivation and Pleasure subscale (CAINS-MAP) domains, and were smartphone owners. Participants were randomized 1:1 to CT-155 (intervention arm) or a digital control app (control arm). CT-155 integrates aspects of multiple evidence-based psychosocial therapeutic techniques, incorporating principles of in-person psychotherapy aimed at targeting negative symptoms. Development of CT-155 was informed by patients during early clinical learning studies using earlier versions of the app. The digital control included elements of the disease educational components of CT-155 and daily digital check-ins. Participants were blinded to their assigned intervention. A blind-to-hypothesis was used so participants appropriately engaged with both apps. Accordingly, participants were informed that they would receive one of 2 interventions under investigation. Investigators, designated site personnel, and central raters were blinded throughout the study. The study comprised a 2-week screening period, 16-week active period, and a 4-week follow-up period. Change in experiential negative symptoms from baseline to Week 16 (primary end point) was assessed using CAINS-MAP (centrally rated). Other study end points included Clinical Assessment Interview for Negative Symptoms Expressivity, Positive and Negative Syndrome Scale, Personal and Social Performance Scale, Dysfunctional Attitudes Scale, Clinical Global Impressions-Severity, and Patient Global Impression of Improvement Scale. Frequency and severity of adverse events were also assessed, as well as engagement and adherence to either app. Results: Study enrollment began in March 2023 and was completed in January 2025. Overall, 457 participants were enrolled across 66 clinical study sites in the United States. Conclusions: We summarize an innovative trial design for CONVOKE, a phase 3 randomized controlled study aimed at assessing the effectiveness, engagement, and safety of CT-155 as an adjunct to standard-of-care for people with negative symptoms of schizophrenia. CONVOKE is the largest-to-date and most robust clinical trial evaluating the effectiveness and safety of a DTx in schizophrenia. The study protocol included a centrally rated primary end point (CAINS-MAP), blind-to-hypothesis, with an appropriately designed digital control. Clinical Trial: ClinicalTrials.gov NCT05838625; https://www.clinicaltrials.gov/study/NCT05838625

Background: Hypercholesterolemia is a significant risk factor for cardiovascular diseases, necessitating effective management strategies. Herbal interventions have gained attention as potential alternative or complementary therapies to conventional lipid-lowering medications. Objective: This systematic review aims to evaluate the effectiveness of various herbal interventions in managing hypercholesterolemia. Methods: A comprehensive literature search will be conducted across multiple databases, including PubMed, MEDLINE, EMBASE, EBSCO, Cochrane Library, DHARA, AYUSH research portal, WHO portal, Shodhganga, and Google scholar as well as dissertations and thesis work available in the public domain and unpublished works from university websites for studies published from January 2020 onward. Randomized controlled trials investigating the impact of herbal interventions on cholesterol levels will be included. The primary outcome is the change in low-density lipoprotein cholesterol and high-density lipoprotein cholesterol levels. Data extraction and quality assessment will be performed independently by 3 reviewers, and discrepancies will be resolved by a fourth reviewer. All statistical analyses will be conducted using the Cochrane Collaboration software program, RevMan Web. Results: Following an initial screening, 96 studies were identified. After removing duplicates, 7 studies were excluded, leaving 89 studies ready for data extraction. The results of these studies will be synthesized and analyzed upon completion. Conclusions: This review aims to synthesize evidence on the potential benefits of herbal interventions in managing hypercholesterolemia. Preliminary findings suggest that specific herbal interventions may contribute to lower cholesterol levels, potentially complementing standard hypercholesterolemia management strategies. The findings will be systematically analyzed and presented upon completion of the review, providing insights into the effectiveness of integrating these interventions into current treatment protocols.

Abstract A seminal study by Triplett provided initial evidence for the social facilitation effect, and over the last century, research has demonstrated this effect across a range of settings. However, despite the importance attributed to Triplett’s study, no research has replicated the original study paradigm. Furthermore, in the context of research advances and methodological rigour, some elements of the original study weaken the validity of the observed findings. We address these critical limitations and replicate the original study, employing a standardized study protocol to minimize potential confounds, such as practice effects. This research reports on 445 school-aged children ( M age = 10.8, SD  = 1.3) who completed the study. As pre-registered in our Stage 1 submission, using a purpose-built apparatus, participants turned a crank to move a marker along a string course between two pulleys. Pairs of participants completed this task four times, twice alone and twice together. Trial order was standardized and balanced to control for possible order/practice effects. In line with Triplett’s original study, we show that participants completed the task faster in the together condition than in the alone condition. We also show interesting variability depending on age and gender, as well as demonstrating “carryover” effects. Thus, we replicate and extend this classic finding, adding to the literature on social facilitation/competitive coaction. In addition, the materials and methods developed here provide a template for future studies to further examine this phenomenon. Protocol registration The Stage 1 protocol for this Registered Report is available at https://osf.io/vsgpq , and appears as accepted in principle by the journal on 10th August 2022.

Introduction Uric acid (UA) is considered as a potential risk factor for coronary heart disease (CHD) and other cardiovascular diseases (CVDs). However, the association between hyperuricemia and the risk of CHD and other cardiovascular outcomes has not been fully clarified. This systematic review and dose-response meta-analysis was conducted to comprehensively the association between hyperuricemia and the risk of CHD or other cardiovascular outcomes in the general population. Methods We systematically searched Medline, Cochrane Library, Embase, and two clinical trial registration databases from inception to June 30, 2025, without restrictions on language or publication status. Only cohort and case-control studies enrolling participants without CHD, other CVDs, or gout at baseline were included. The primary outcome was the association between hyperuricemia and the risk of CHD, and secondary outcomes were the association between hyperuricemia and the risk of fatal and nonfatal CVDs, included CHD death, CVD, CVD death, and myocardial infarction (MI). Risk of bias was assessed using the Risk Of Bias In Non-randomized Studies-of Exposure (ROBINS-E) tool. All statistical analyses were performed using R 4.4.2. We conducted meta-analyses, heterogeneity assessments, publication bias tests, trim-and-fill analyses, subgroup and sensitivity analyses, meta-regressions, and dose-response meta-analyses. The GRADE recommendation was used to evaluate the quality of evidence. Results A total of 42 articles representing 39 individual studies and 1,082,880 participants were included. Among these, 2 articles were assess as “very high risk of bias”, eight as “high risk of bias”, and two as “some concerns”. Hyperuricemia was significantly associated with an increased risk of CHD [HR 1.21 (95%CI 1.14–1.28), p < 0.001, I2 = 34.34%], CHD death [1.20 (1.05–1.36), p = 0.005, I2 = 41.28%], CVD death [1.75 (1.12–2.74), p = 0.014, I2 = 49.48%], and MI [1.23 (1.03–1.47), p = 0.025, I2 = 56.96%]. No significant association was observed for overall CVD risk [1.09 (0.94–1.27), p = 0.245, I2 = 0%]. For each unit increase in serum UA, the risk of CHD, CHD death, CVD, CVD death, and MI increased by 16%, 13%, 12%, 11%, and 7%, respectively. No factors with a significant impact on the results were identified through subgroup analyses or meta-regression. Sex may have a potential influence, but the results were not robust. Further dose-response meta-analysis revealed a linear relationship between higher serum UA and CVD risk, and a U-shaped association between serum UA and CVD mortality in men. The quality of evidence was rated as low for CHD and very low for the other cardiovascular outcomes. Conclusion This systematic review and dose-response meta-analysis provides low- to very-low-quality evidence suggesting that hyperuricemia may be associated with an increased risk of CHD and other fatal or nonfatal CVDs. Trial registration This study was registered in PROSPERO CRD42024538553.

Background: The benefits of physical activity are well established in people with multiple sclerosis (MS); yet, most people with MS are insufficiently active. Although many apps and devices are available to promote physical activity, these are not connected to electronic health records (EHRs), making it difficult for health care providers to prescribe and monitor their patients’ physical activity. The ExerciseRx platform is an innovative cloud-based, Health Insurance Portability and Accountability Act–compliant software platform (app+provider dashboard) that was developed to bridge the gap between consumer activity tracking devices, such as personal smartphones, and the EHR. The ExerciseRx app tracks a patient’s physical activity using their existing personal smartphone and provides a personalized graded progression in step count goals to increase step count gradually and safely over time. The ExerciseRx app also translates the activity data into actionable metrics on a provider dashboard within the EHR that the provider can use to make activity recommendations and monitor patients’ progress; they can also support patients by providing semiautomated weekly feedback and encouragement in meeting physical activity goals.

Background: Abnormal cell growth that can multiply and transfer to other bodily parts is referred to as cancer. Chemotherapy is a standard treatment for cancer patients. During or after treatment, patients may have varying degrees of cognitive impairment caused by the drug, which can negatively impact their quality of life. Cognitive impairment brought on by chemotherapy is one of the most frequent side effects that occur both during and after chemotherapy. Cognitive effects after and during chemotherapy have not been addressed in patients. Objective: To evaluate the effectiveness of cognitive rehabilitation on cognition and quality of life in chemotherapy-induced cognitive impairment. Methods: In this Randomized Control Trial (RCT), 60 subjects with chemotherapy-induced cognitive impairments secondary to any cancer will be randomised into 2 groups by the sequentially numbered opaque sealed envelope approach. The cognitive functions will be measured as the outcome measures, which include all the recall strategies, executive function tasks, information processing speed, and attention. Both groups will receive intervention every day for 4 weeks. Wilcoxon signed the rank test for data analysis, and students paired the “t” test, which will be used to study within-group effects. Mann-Whitney U Test and students Unpaired “t” Test will be used to compare groups at pre-treatment and post-treatment. Results: As of November 2024, we will enrol 60 participants, and the data collection process will start from November 2024November 2025. The expected results of the effect of cognitive rehabilitation on cognition and quality of life in chemotherapy-induced cognitive impairment in cancer patients will be significant, and the expected results will be published at the end week of November 2025. Conclusions: The study design is a framework to plan and test the feasibility of the intervention. The cognitive therapy will improve the cognition in chemotherapy-induced cognitive impairment patients. Trial Registration: Clinical Trials Registry India CTRI/2024/04/065805; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTAyNTE1&Enc=&userName= International Registered Report Identifier (IRRID): DERR1-10.2196/66011

This trial and its outcomes were registered with clinicaltrials.gov on Feb. 7, 2023 under the identifier NCT05718973. The stage 1 protocol for this Registered Report was accepted in principle on 18/09/23. The protocol, as accepted by the journal, can be found at: 10.6084/m9.figshare.24246511.

Background: Chronic pain is one of the most common and debilitating health conditions. Treatments for chronic low back pain typically focus on biomedical treatment approaches. While psychosocial treatments exist, multiple barriers prevent broad access. There is a significant unmet need for integrative, easily accessible, non-opioid solutions for chronic pain. Virtual reality (VR) is an immersive technology allowing innovation in the delivery of behavioral pain treatments. Behavioral skills-based VR is effective at facilitating pain management and reducing pain-related concerns. Continued research on these emerging approaches is needed. Objective: In this randomized controlled trial, we seek to test the efficacy of a self-administered behavioral skills-based VR program as a nonpharmacological home-based pain management treatment for people with chronic low back pain (cLBP). Methods: We will randomize 180 individuals with cLBP to 1 of 2 VR programs: (1) EaseVRx (8-week skills-based VR program); or (2) Sham VR (control condition). All participants will receive a VR headset to minimize any biases related to the technology’s novelty. The Sham VR group had 2D neutral content in a 3D theater-like environment. Our primary outcome is average pain intensity and pain-related interference with activity, stress, mood, and sleep. Our secondary outcomes include patient-reported physical function, sleep disturbance, pain self-efficacy, pain catastrophizing, pain acceptance, health utilization, medication use, and user satisfaction. We hypothesize superiority for the skills-based VR program in all of these measures compared to the control condition. Team statisticians blinded to treatment assignment will assess outcomes up to 6 months posttreatment using an approach suitable for the longitudinal nature of the data. Results: The study was approved by the Western Institutional Review Board on July 2, 2020. The protocol (NCT04415177) was registered on May 27, 2020. Recruitment for this study was completed in July 2020, and data collection will remain active until March 2021. In total, 186 participants were recruited. Multiple manuscripts will be generated from this study. The primary manuscript will be submitted for publication in the winter of 2020. Conclusions: Effectively delivering behavioral treatments in VR could overcome barriers to care and provide scalable solutions to chronic pain’s societal burden. Our study could help shape future research and development of these innovative approaches.

Background: Chronic neuropathic pain affects 69% of adults with spinal cord injury (SCI). Medication, as a primary treatment, has insufficient benefits and significant risks for addiction and adverse effects. Of the available mind and body approaches, Qigong is the most accessible for adults with SCI, with evidence for effectiveness in reducing pain. Still, there is insufficient evidence to make recommendations for adults with SCI. Thus, the feasibility of Qigong in SCI needs to be established. We previously demonstrated feasibility in a pilot study, in which 18 non-Hispanic White adults with SCI completed a 12-week remote Qigong program. However, three additional key elements need to be addressed before performing a larger effectiveness study: (1) feasibility and acceptability of Qigong in adults with SCI with health disparities, (2) feasibility of a study design with a control group, and (3) objective outcome measures.

Background: Sexuality is multidimensional and complex, and involves identity development, attraction, and behavior. Heterosexual-identified men who have sex with men (H-MSM) experience sexual identity and behavior discordance, yet it is unknown how H-MSM compare to concordant heterosexual men and gay, bisexual, and queer (GBQ+) men in terms of sexuality constructs. Objective: This study aims to survey adult cisgender men in Canada, the United States, and the United Kingdom to gain greater insights into how demographics, identity development, attraction, behavior, technology use, relationship negotiation and communication skills, and pre-exposure prophylaxis and life satisfaction relate to each other, and then to interview H-MSM for an in-depth follow-up on survey concepts. Methods: Purposive sampling will be used to recruit men via online and offline venues. Data collection will be multifaceted and include an online questionnaire for adult cisgender men and a subsequent interview for H-MSM. The survey will be available in English, French, and Spanish. Structural equation modeling, underpinned by hegemonic masculinity and sexual script theories, will be performed to test the relationships among survey variables. Interpretive phenomenology will be employed on the qualitative data to consider how unique sociocultural factors influence the sexuality and experiences of H-MSM, allowing for similarities and differences across participants to be identified and explored. Results: Data collection began on November 26, 2024, and as of February 2025, data collection remains ongoing. We expect to conclude data collection and data cleaning by mid-summer 2025. Data analysis will begin in fall 2025. Our findings will provide a more nuanced understanding of the identity development, attraction, behavior, relationship negotiation, and technology use of H-MSM in comparison with GBQ+ men and concordant heterosexual men. Conclusions: This research aims to broaden the scope of existing literature and support advancements in interventions and knowledge to support the overall health and well-being of H-MSM. An examination of potential differences among H-MSM, concordant heterosexual men, and GBQ+ men aims to improve the understanding of H-MSM as a distinct population, without dismissing them as closeted GBQ+ men. This study aims to provide key insights into avenues for research and practice with men whose sexuality and sexual behaviors may be outside of commonly accepted norms.

Background: The incidence of chronic diseases associated with physical inactivity is on the rise, being one of the leading risk-increasing factors for early death rates throughout the world. Often, physical activity interventions fail to deliver sustained adherence over time due to limiting tailoring to individual baseline characteristics, leaving out contextual changes over time. One solution for this issue may be the use of adaptive interventions relying on contextual multiarmed bandits, a type of reinforcement learning algorithm, that can use baseline and contextual individual data to personalize aspects of the intervention, such as developing personalized workout plans. Objective: The main objectives of this study are (1) to determine the effectiveness of contextual bandits for automated goal setting in the context of a web-based physical activity intervention, (2) to understand the role of user characteristics impacting ideal workout schedules based on adherence to predetermined goals, and (3) to explore the influence of user autonomy on recommendation effectiveness. Methods: We developed a protocol for a web-based adaptive intervention trial to investigate the effectiveness of goal recommendation (task difficulty) based on reinforcement learning. The web application (named Apptivate) creates workout routines with 3 different difficulty levels, changing the total workout duration as well as rest times between exercises. Physical activity professionals validated the routine design, ensuring that workouts match recommended guidelines for healthy adults. An initial pilot was conducted, aiming for 800 university students to test the web application for 1 week, to provide initial data to calibrate the algorithm as well as overall feedback for the web application. For the main study, a total of 500 university students will be recruited to participate for 40 days during early 2026. Participants will be divided into 3 groups: user choice (no recommendation), user choice with automated recommendations (contextual bandits), and automated plans without choice. Results: The pilot was conducted in September 2025. Data analysis for the pilot is undergoing, and the main study is planned for early 2026. Our main statistical analysis includes a direct comparison (paired tests) between success rates across intervention arms, as well as by difficulty level and individual characteristics. Conclusions: Physical activity maintenance is key to achieving long term health goals. Tailored digital interventions are promising strategies for physical activity adherence, but personalization often fails to consider dynamic contextual changes. The proposed protocol for a physical activity intervention using adaptive experimentation can provide robust causal inference on the role of choice versus autonomy when goal difficulty is tailored under an adaptive data-driven approach.

Background: Diabetic retinopathy (DR), a leading cause of preventable blindness among working-age adults, leads to worse health outcomes among Black, Latine, and individuals with lower income in comparison to other ethnic, racial, and socioeconomic groups in the United States. Objective: We aim to engage community members directly to identify barriers and facilitators of DR screening and co-design a digital health tool that is accessible, user-friendly, and community-responsive. Methods: We conducted focus groups with individuals from the Greater New Haven, Connecticut area, aged 18 years or older, and diagnosed with diabetes to (1) conduct a comprehensive disease-management needs assessment and (2) inform the development of a community-responsive digital health tool to optimize DR education and to increase access to DR screening in high-risk populations. We transcribed the focus group interviews, used rapid qualitative analysis to generate themes, and completed affinity mapping to identify content and features for a digital health tool for preventing blindness from DR. Results: We recruited and interviewed 19 individuals (13/19, 68% female; 9/19, 47% Black; 5/19, 26% Hispanic; 2/19, 11% Native American or Alaska Native) for 4 focus groups. Over 94% (18/19) had access to smart devices other than a computer. Participants self-reported mean hemoglobin A1c of 6.77 (SD 1.93). Approximately 58% (11/19) of the participants completed some college. Frequently occurring themes (&gt;30) obtained from coding contextual interviews were desired app attributes such as options for customization, covering topics such as, the mental impact of living with diabetes, informal support (eg, peer support), diabetes education, barriers to controlling blood sugar and maintenance of health, dietary guidance, and notifications. We created high-fidelity wireframes incorporating key features. Next, we will iteratively design a prototype with community feedback. Conclusions: We anticipate that this study will characterize the experiences of people living with diabetes. Using a community-led approach,we will continue to analyze the data that will generate insights regarding the key features, content, and benefits that are most important for the creation of a digital health tool for DR prevention.

Background: Almost a third of Australian adults are living with obesity, yet most cannot access medical nutrition therapy from dietitians, that is, the health professionals trained in dietary weight management services. Across the health system, primary care doctors readily identify people who may benefit from weight management services, but there are limited referral options in the community. Dietitians are trained to provide evidence-informed dietary treatment of overweight and obesity but are underutilized and underresourced. The chat2 (Connecting Health and Technology 2) trial will test combining new technologies for dietary assessment with behavior change techniques to improve outcomes for people living with obesity. Objective: This study aimed to compare the effectiveness of a 1-year digital dietary intervention, with standard care on body weight reduction and improved diet quality, in adults living with obesity delivered by dietitians in a primary care setting. Methods: This randomized controlled trial will compare a 1-year, digitally tailored, feedback dietary intervention with a control group in 430 adults living with obesity (BMI≥30 to ≤45 kg/m2). Participants will be recruited by letters sent to individuals randomly selected from the electoral roll and supplemented by hospital site posters, newsletters, and unaddressed mailbox delivery postcards sent to residential street points. The primary outcome is change in body weight, measured face-to-face at a baseline, 6 months, and 12 months. A 4-day, image-based dietary assessment tool (mobile Food Record) will be used to measure diet quality score. Secondary outcomes include diet quality score; dual-energy absorptiometry body composition; and total cholesterol, triglyceride, low-density lipoprotein, high-density lipoprotein, glycated hemoglobin, and fasting glucose levels. The intervention group will receive 8 video counseling sessions with a trained dietitian delivered over 12 months to support dietary behavior change and relapse prevention. The trial is unblinded. Both groups will receive feedback on their clinical chemistry and dual-energy absorptiometry scans at each time point. Results: Participant recruitment commenced in July 2023 and ended in August 2024. Data analysis will commence in 2025, with the anticipated publication of results in 2026. Conclusions: If found to be effective, the results of this randomized controlled trial will support the delivery of effective, evidence-based weight management advice using new technologies. Improving community access to high-quality dietetic services will ensure more effective use of the dietetic workforce to improve outcomes for people living with obesity. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12622000803796; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=383838

Background: Significant advances in digital technologies have meant that health care data can be collected, stored, transferred, and analyzed for research purposes more easily than ever before. Participant-centric initiatives (PCI) are defined as “tools, programs, and projects that empower participants to engage in the research process” using digital technologies and have the potential to provide a number of benefits to both participants and researchers, including the promotion of public trust in medical research, improved quality of research, increased recruitment and retention, and improved health care delivery. Objective: The main objective of this scoping review is to describe the extent and range of PCIs across the United Kingdom, United States, and Japan that are designed to facilitate medical research. Methods: The methodological framework described by Levac et al will be applied to this scoping review. We will search electronic databases (MEDLINE, EMBASE, PsychINFO, Cumulative Index to Nursing, and Allied Health Literature and CiNii), grey literature sources, Internet search engines (Google and Bing), and hand search key journals and reference lists of relevant articles. All digital tools and programs will be eligible for inclusion if there is a description of key features and functions that fall within the parameters of a PCI. Only those that play a role in medical research will be included. Results: Preliminary searches conducted in MEDLINE and EMBASE retrieved 1820 and 2322 results, respectively. The scoping review will be completed by January 2018. Conclusions: The scoping review will be the first to map the extent and range of PCIs currently available across the United Kingdom, United States, and Japan, and will be the first review to contribute to a better understanding of what PCIs patients may benefit from. Researchers and practitioners will be able to use information in this review as a guide for patients and also as a guide for the development of future tools and programs. The results will be disseminated through a peer-reviewed publication and conference presentations.

Stressors like test anxiety are known to decrease memory retrieval, whereas retrieval practice is the phenomenon that actively recalling information from memory enhances memory. Evidence suggests retrieval practice can protect memory against the negative effects of stress on memory (Agarwal et al., 2014; Smith &amp; Thomas, 2018), however the findings are mixed (Yang et al., 2020). Understanding whether retrieval practice maintains memory performance under stress could transform memory resilience and lead to new cognitive interventions. This raises the need for a meta-analytic summary of the literature to understand the effects of retrieval practice on memory in relation to stressors. In this registered report, we conducted a meta-analysis (k = 10, n = 908) on the impact of stress following learning with retrieval practice from 2006&ndash;2024 using databases and other information sources. We found a positive effect of retrieval practice in stress conditions, Hedges&rsquo; g = 0.45, 95% CI [0.17, 0.72] with a random-effects two-level model, suggesting retrieval practice is more beneficial than restudy during stress. Significant heterogeneity was observed along with a moderate risk of bias, yet little evidence for publication bias. We did not find significant moderators in this sample. Future studies should be conducted with sufficiently powered samples and using other types of control, or non-retrieval practice, strategies to better understand the protective effects of retrieval practice on memory following stress. We registered our meta-analysis, with datafile, code and supplementary here: https://osf.io/jwx4f/.

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

Background: Cardiovascular diseases (CVDs) are a leading cause of death and disability worldwide. For people living with CVD, clinical guidelines recommend ongoing self-care such as symptom monitoring, medication adherence, and lifestyle modifications. However, many people struggle to engage in this due to the complexity of disease management, limited understanding, and a lack of cultural support. Conversational agents (CAs) offer a solution by providing artificial intelligence–driven, voice-based support that enables human-like communication. While many CAs and digital interventions are good for people with CVDs, they are for mainstream populations and overlook culturally and linguistically diverse communities. Objective: This study outlines the protocol for pilot testing the feasibility and usability of Diaspora Engaged Self-Care Intervention and Heart (DESI-Heart) program, to support self-care management among Indian diaspora populations with CVDs in Australia over an 8-week intervention period. The formative development of DESI-Heart is also described. Methods: We integrated the Double Diamond Model and the ecological validity model to develop our DESI-Heart program. First, we co-designed the program with end users, who identified 4 key goals for engagement with self-care through culturally and linguistically appropriate approaches. Based on these priorities and ideas, we developed specific goals, including (1) medication reminders, (2) daily exercise guidance, (3) diet buddy, and (4) guided meditation. Participants will access the DESI-Heart program through a web-based CA, available on smartphones, laptops, or PCs. Based on their preferred timing, individuals will receive links to access specific components of the program corresponding to each goal. These links will be sent to participants via SMS or email, depending on their preference. A single-arm prepost pilot trial (N=28) will be conducted to evaluate the feasibility and usability of the DESI-Heart program among Indian adults living in Australia with CVDs. The primary outcome will assess feasibility indicators, including recruitment, engagement, and usability, while secondary outcomes will examine changes in self-care behaviors and quality of life. Results: The DESI-Heart program received ethics approval in July 2024. Recruitment for the pilot trial is scheduled to begin in June 2025 and conclude by September 2025, with participant follow-up expected to be completed by the end of December 2025. All 28 participants have been recruited, and data analysis will be conducted once follow-up is finalized. Conclusions: We have co-designed and developed the DESI-Heart program, a culturally and linguistically appropriate self-care intervention aimed at supporting Indian adults with CVD living in Australia. The next step is to conduct a pilot study to assess the feasibility and usability of DESI-Heart, which will inform the design of a larger evaluation trial. DESI-Heart has the potential to complement existing health services by helping individuals with CVD manage their condition within the community, while acknowledging their cultural backgrounds and language preferences.

Background: HIV/AIDS is an epidemic in 190 countries, with Indonesia having more than half a million people living with the virus. Risk factors include risky sexual activity and alternating needle usage. The majority of cases are young adults (18-30 years old). The Indonesian National HIV/AIDS strategy aims to reduce new cases to less than a thousand per year. Nowadays, effective prevention involves avoiding free sex and adopting healthier lifestyles. Objective: This research aims to explore young adults’ needs, perceptions, and cultural aspects of HIV/AIDS prevention, develop the intervention model, analyze its effectiveness, and examine its effect on HIV prevention behavior. Methods: We will conduct the study in three phases: qualitative research, model development, and quantitative research. In the first phase, we will use descriptive phenomenology and forum group discussion (FGD) to collect data from young adults and stakeholders in Batang and Pekalongan regencies. The second phase will develop a motivation model for HIV/AIDS prevention using culture-based communication (MK-U) through website media. We will design the model in consultation with an IT team and experts to ensure its suitability. The third phase will involve a pre-post-test with a control group quasi-experiment involving young adults aged 20–30 years old in Batang and Pekalongan districts. The intervention group will receive culture-based motivational interviewing, while the control group will receive standard counseling. We will analyze the data using a generalized linear model (GLM) and multivariate analysis of variance (MANOVA). Results: We expect to develop the MK-U model for HIV prevention behavior among young adults. In 2025, we will implement a community-based nursing research program for the MK-U model to prevent HIV/AIDS. Conclusions: In this research, we will compare the results with similar studies, which will benefit program implementers and policymakers in both regions and enhance the effectiveness of HIV prevention programs.

Background: Medical, psychiatric-psychosomatic facilities are confronted with a variety of daily challenges that affect working conditions, the mental health of employees and the quality of patient care. This project focuses on the work-related challenges faced by healthcare professionals in psychiatric-psychosomatic clinics in Germany. Objective: Therefore, the aim of the current research is to investigate the interactions between individuals and their social environment, identify psychological and organizational challenges and job demands to use these findings to inform the development of a participatory, evidence-based intervention. Methods: This two-phase research is grounded in the job demands-resources model (JD-R). Study phase one (needs assessment) employs a cross-sectional online survey with healthcare professionals in German psychiatric-psychosomatic clinics to assess job demands, resources, and outcomes in a target sample of 600 participants (power analysis). Study phase two (co-design of a training) involves co-creatively designing an intervention based on survey findings through participatory workshops with at least 20 participants. Analyses include regression and moderation tests (SPSS), and qualitative data analysis to co-design training. Results: The recruitment of participants is planned to be finished by October 2025. The co-designing of workshops (phase two) will be started in February 2026. As this is a study protocol, results are not available yet. Conclusions: This current research examines the work-related challenges faced by healthcare professionals in psychiatric-psychosomatic clinics. It is expected that burnout, engagement, and psychological safety will likely emerge as central mediating and moderating variables. As the findings of phase one serve as a basis for the development of an intervention this research seeks to improve the well-being of healthcare professionals in psychiatric-psychosomatic institutions sustainably. Clinical Trial: ClinicalTrials.gov NCT06867601; https://clinicaltrials.gov/study/NCT06867601

Background: The COVID-19 pandemic impacted trust in public health, medical care, scientific, and governmental institutions; this influenced health, health-seeking behaviors, and adherence to public health measures. Understanding how trust evolves is necessary for informing future public health crisis management and strategies. Rebuilding public trust is key to pandemic preparedness worldwide. This research protocol examines these trust dynamics, their determinants, and their implications. Objective: This study aimed to investigate the evolution of public trust in scientists, public health and medical care institutions, governments, and social and personal networks during the COVID-19 pandemic. It sought to identify key factors contributing to trust maintenance or erosion, particularly in marginalized and minority communities, and understand the impact of trust level on public health adherence. Methods: A sequential, explanatory mixed methods approach was implemented, consisting of an initial quantitative survey followed by qualitative interviews. The nationwide representative survey included 5607 Canadian residents as of May 2024. The questionnaire assessed trust in 6 key trust sources before and during the pandemic: provincial and federal governments, public health authorities, medical care providers, health scientists, and social and personal networks. To complement, 41 qualitative interviews were conducted to understand participants’ lived experiences, perceptions, and how trust played into both. Data have been analyzed using quantitative statistical techniques and qualitative phenomenological analysis, and the results have been integrated to derive comprehensive insights. All phases of data collection and analysis were finalized by early 2025. The project then advanced to paper preparation, dissemination at national conferences, and knowledge-translation activities, including the report development and public-facing outputs, scheduled for completion in end-2025. Results: This Canadian survey included participants from all 10 provinces and 2 territories; the provinces and territories’ samples matched the proportions of each in the overall Canadian population. Age and sex or gender were well distributed across the sample. Additionally, 18.6% (1040/5607) identified as an ethnic minority, 12.7% (710/5607) identified as Indigenous, including 7.2% (403/5607) First Nations, 4.8% (270/5607) Métis, and 0.4% (25/5607) Inuit. Fifty-five percent (3094/5607, 55.2%) had received at least 1 dose and planned to stay up to date with booster recommendations, while 36.6% (2052/5607) were vaccinated but did not intend to receive additional doses. A small percentage, 0.7% (39/5607), had not yet been vaccinated but were open to it, whereas 6.4% (359/5607) had not received a vaccine and did not plan to take a vaccine. Conclusions: The COVID-19 pandemic has underscored the critical role of trust in public health behavior and crisis response. This study explores how consistent, transparent communication and equity-driven policies may contribute to maintaining public trust, particularly among marginalized communities. By examining trust dynamics and identifying potential disparities, this study aims to inform evidence-based public health strategies and improve preparedness for future health emergencies. Trial Registration:

Background: The COVID-19 pandemic challenged families, youth, and frontline workers, including childcare providers. Studying lived experiences before, during, and near the pandemic’s end from multiple perspectives provides a more holistic and deeper understanding of its effects and impacts. Objective: This study investigated how parental, childcare provider, and youth stress, mental health, and role overload relate to individual coping and family functioning, as well as vaccine attitudes and uptake patterns among youth, parents, and childcare providers. Information learned from this investigation will inform policy and messaging for future public health crises. Methods: This study is an explanatory sequential mixed methods study designed to capture the voices of parents of children younger than 18 years of age, childcare providers, and youth aged 12-17 years through surveys and interviews. This retrospective cross-sectional study began with a web-based survey that included demographic questions and validated scales to assess personal well-being, household and family dynamics, behavioral problems, and vaccination-related perceptions, attitudes, and behaviors. Open-ended responses about pandemic experiences for themselves and their families were included. A subsample of parents, youth, and childcare providers was selected for in-depth interviews about their pandemic-related experiences. Descriptive statistics were used to summarize demographic characteristics, and internal consistency was assessed for all survey measures using Cronbach α. Future studies will use inferential statistical techniques to analyze survey measures, thematic analysis for open-ended survey responses and interview data, and mixed methods data integration to synthesize quantitative and qualitative findings. Results: Data collection for the study began in August 2022 and finished in August 2023. Data analysis is currently in progress to address research questions, and study preparation and dissemination efforts are underway. A total of 506 adults and 93 youths answered a study survey, and 45 adults and 21 youths completed in-depth interviews. Among the 506 adults, 166 were childcare providers. The adult sample had a mean age of 42.8 (SD 9.15) years and was predominantly female (467/506, 92.3%), with 9.7% (49/506) identifying as Black, 4.7% (24/506) as Hispanic, and 81.2% (411/506) being parents of children aged 17 years or younger. The youth sample had a mean age of 14.5 (SD 1.63) years, and 55.9% (52/93) were female, 6.4% (6/93) were Black, and 17.2% (16/93) were Hispanic. Several dyads and triads participated. The sample included 42 parent-child dyads, 3 parent-parent dyads, 2 parent-parent-child triads, and 21 parent-child-child triads. Conclusions: These data will be used to understand the diverse experiences of families, youth, and childcare providers during and after the COVID-19 pandemic. This includes successful and unsuccessful adaptations, responses to policies and mandates, and the unmet needs for health messaging, programs, policies, and services. This research aims to guide the development of effective policies and public health communication, fostering scalable and sustainable messaging resources.

Background: Driving performance involves multiple underlying components of psychomotor functioning, such as attention, executive functions, and vehicle control. While the effects of acute medical marijuana and prescription opioid intoxication are known, how long-term use of medical marijuana under real-world conditions affects driving performance is unknown. Additionally, there are numerous ongoing physical and cognitive changes that affect driving performance with age. Given the proliferation of medical marijuana and prescription opioid use in adults aged 50 years and older, the prevalence of polypharmacy, and declining functional abilities, it is imperative to understand the long-term effects of daily medical marijuana use. Further, we need to understand how co-occurring use of medical marijuana and prescription opioids, in the presence of comorbidities such as chronic pain, affects real-world driving outcomes. Objective: This study aims to document the observational trial protocol. The primary goal of this study is to identify the effects of daily long-term (ie, use for &gt;12 months daily or most days of the week) medical marijuana use on driving performance outcomes using an open-road driving performance task under real-world conditions in adults aged 50 years and older who endorse chronic or severe nonmalignant pain and to examine the combined effect of daily long-term medical marijuana use and prescription opioid use on driving outcomes. A secondary goal is to qualitatively explore self-regulation of medical marijuana and prescription opioid use in this population. Methods: We plan to test medical marijuana use as the exposure variable in adults aged 50 years and older on an open-road driving task performance as the primary outcome. The study will detail tetrahydrocannabinol exposure through ecological momentary assessment and urinalysis and will compare performance with a race-sex–matched group of non–marijuana users. Results: This study is funded by a grant from the National Institute on Drug Abuse (5R01DA057965). Recruitment began on May 19, 2025. As of November 2025, a total of 30 participants had been enrolled. Recruitment is anticipated to be completed by 2029. Publication of the complete results and data from this study is expected by 2030. Conclusions: Data from this study will identify the effects of long-term medical marijuana use and the combined effect of that use with prescription opioids to develop risk screening protocols and intervention targets for this population. The development and dissemination of screening and intervention guidelines will be the next step in this work. Trial Registration: ClinicalTrials.gov NCT06995937; https://www.clinicaltrials.gov/study/NCT06995937

Background: For many years, clinicians have been seeking for objective pain assessment solutions via neuroimaging techniques, focusing on the brain to detect human pain. Unfortunately, most of those techniques are not applicable in the clinical environment or lack accuracy. Objective: This study aimed to test the feasibility of a mobile neuroimaging-based clinical augmented reality (AR) and artificial intelligence (AI) framework, CLARAi, for objective pain detection and also localization direct from the patient’s brain in real time. Methods: Clinical dental pain was triggered in 21 patients by hypersensitive tooth stimulation with 20 consecutive descending cold stimulations (32°C-0°C). We used a portable optical neuroimaging technology, functional near-infrared spectroscopy, to gauge their cortical activity during evoked acute clinical pain. The data were decoded using a neural network (NN)–based AI algorithm to classify hemodynamic response data into pain and no-pain brain states in real time. We tested the performance of several networks (NN with 7 layers, 6 layers, 5 layers, 3 layers, recurrent NN, and long short-term memory network) upon reorganized data features on pain diction and localization in a simulated real-time environment. In addition, we also tested the feasibility of transmitting the neuroimaging data to an AR device, HoloLens, in the same simulated environment, allowing visualization of the ongoing cortical activity on a 3-dimensional brain template virtually plotted on the patients’ head during clinical consult. Results: The artificial neutral network (3-layer NN) achieved an optimal classification accuracy at 80.37% (126,000/156,680) for pain and no pain discrimination, with positive likelihood ratio (PLR) at 2.35. We further explored a 3-class localization task of left/right side pain and no-pain states, and convolutional NN-6 (6-layer NN) achieved highest classification accuracy at 74.23% (1040/1401) with PLR at 2.02. Conclusions: Additional studies are needed to optimize and validate our prototype CLARAi framework for other pains and neurologic disorders. However, we presented an innovative and feasible neuroimaging-based AR/AI concept that can potentially transform the human brain into an objective target to visualize and precisely measure and localize pain in real time where it is most needed: in the doctor’s office. International Registered Report Identifier (IRRID): RR1-10.2196/13594

Background: Background: The Symptom iNput Clinical (SYNC) system was developed to enhance the timely reporting of Head and Neck Cancer (HNC) symptoms and to ensure that high-risk patients receive faster diagnoses. A key feature of the system is a digital questionnaire co-designed with patient representatives to accommodate varying levels of digital literacy. The system integrates a validated algorithm that assigns risk scores to categorise cases as low or high risk, and a dashboard that supports clinicians by providing them with patient reports. However, the development process encountered challenges that necessitates a systematic evaluation of the process, roles, and experiences of team members. Objective: Objective: This study aims to identify challenges faced during development, how these challenges were addressed, and the implications for future digital health innovations. Methods: Methods: A qualitative single-case study approach will be employed, focusing on individuals involved in the SYNC system’s development. Participants will be selected using a combination of purposive and snowball sampling to ensure diverse perspectives, using meeting minutes and recommendations from key stakeholders. A total of 8 to 12 participants will be interviewed, representing clinical, research, and IT roles. Data collection will involve semi-structured interviews which will be conducted through Microsoft Teams. The interviews are expected to last between 40–60 minutes each. These interviews will be audio-recorded, transcribed, and analysed using framework analysis in Dedoose. Actor-Network Theory (ANT) will guide the analysis by mapping interactions between human and non-human actors, such as developers, clinicians, and technological tools, to understand how they influenced the project’s outcomes. Participant confidentiality will be maintained through data encryption, de-identification, and secure storage. Results: Expected Results: The study anticipates identifying key barriers and facilitators in the SYNC system’s development, including technical, organisational, and collaboration-related challenges. The findings are expected to provide a detailed account of the challenges encountered, such as delays, security concerns, and coordination issues, an insight into how these challenges were mitigated and lessons learned and recommendations for improving digital health technology development, including best practices for co-design, technical integration, and stakeholder engagement. Conclusions: Conclusion: This case study will provide valuable insights into the complexities of developing digital health technologies, particularly in collaborative, multi-stakeholder environments. Documenting the challenges encountered in the SYNC system’s development will contribute to best practices in digital health innovation.

Background: Spondyloarthritis is divided into axial and peripheral subtypes. The axial subtype is further divided into ankylosing spondylitis (AS) or radiographic axial spondyloarthritis and nonradiographic axial spondyloarthritis (nr-axSpA). Although AS and nr-axSpA share some common features, nr-axSpA lacks X-ray–based sacroiliitis as defined by the modified New York criteria, that is, the presence of either bilateral grade 2 sacroiliitis or unilateral grade 3 sacroiliitis, which is present in AS. Disease activity in either of them is measured via C-reactive protein (CRP) levels or magnetic resonance imaging (MRI) of the pelvis showing sacroiliitis due to the presence of bone marrow edema. A person with active disease can have normal CRP and MRI findings, especially in nr-axSpA. Immune system activation during inflammation has been shown to alter platelet maturation and morphology, as reflected by platelet indices. These platelet indices have been studied in the past in various autoimmune diseases, such as psoriatic arthritis, AS, and rheumatoid arthritis, and have been correlated with disease activity. Particularly, in spondyloarthritis, platelet indices are more central to the pathology of sacroiliitis, and CRP, which is currently used, is a generalized marker of inflammation. Therefore, platelet indices can provide a better understanding of inflammation, particularly in patients with sacroiliitis. Objective: This study aims to investigate whether platelet indices can be better markers of inflammation in patients with nr-axSpA. We will determine whether platelet indices are reliable biomarkers for measuring disease activity in patients with nr-axSpA. Methods: All patients who are classified as having axial spondyloarthritis as per the Assessment of Spondylarthritis International Society criteria will be included in this study. Patients will be divided into 2 case groups: group A (patients without radiographic sacroiliitis [nr-axSpA]) and group B (patients with radiographic sacroiliitis [AS]). Healthy individuals will be enrolled as controls to compare and correlate platelet indices such as platelet count, plateletcrit, mean platelet volume, and platelet distribution width with CRP, erythrocyte sedimentation rate, and MRI findings in patients with AS and nr-axSpA. Results: This is a nonfunded study. The data collection started on February 1, 2025, and we expect to complete the study by December 2027. As of July 2025, 7 individuals had been enrolled in groups A and B, respectively, and 5 individuals had been included in the control group. At the end of the study, we will be able to correlate whether platelet indices are trustworthy biomarkers of active disease in patients with nr-axSpA. Conclusions: If platelet indices prove to be better markers of active disease in patients with nr-AxSpA, then these markers should be included in the routine evaluation of these patients.

This pre-registered study tries to explore whether female loan officers maintain their advantage in credit quality in unsecured lending markets, as observed in secured lending markets. The study addresses three key research questions: (1) Whether female loan officers exhibit higher or lower loan performance compared to their male colleagues in unsecured lending; (2) The underlying factors driving the performance gap between male and female loan officers in this market; and (3) How digital lending models influence the credit quality of loans underwritten by female officers. This research provides empirical evidence on the performance differentials of female loan officers across secured and unsecured lending markets. The findings offer valuable insights for commercial banks seeking to optimize the credit assessment efficiency of loan officers and inform their digital transformation strategies.

Background: Cardiovascular disease (CVD) is a leading cause of mortality and morbidity in the United States, with risk factors such as hypertension and elevated low-density lipoprotein (LDL) cholesterol originating in childhood. While statins and blood pressure–lowering medications can mitigate these risks, adherence is often poor, particularly among youth. Innovative solutions, such as monetary incentives via smartphone apps, may enhance adherence, but evidence in youth is lacking. Objective: This study aims to evaluate the efficacy of a smartphone app (Wellth) offering financial incentives to improve adherence to statins and blood pressure–lowering medications among youth aged 12 to 19 years at risk for cardiovascular disease. Methods: We initially designed a randomized controlled trial to compare the efficacy of 2 different incentive structures in youth treated with a statin for familial hypercholesterolemia with inadequate adherence. After facing recruitment challenges, the study protocol was changed to evaluating a single incentive in a pre-post design. The primary outcome was the change in adherence rate over the 60-day incentive period compared to the adherence rate during the 14-day run-in period. The secondary outcome was a change in LDL cholesterol level. Adjustments to the protocol were made in response to recruitment challenges during the COVID-19 pandemic, simplifying the incentive structure and expanding eligibility criteria. Results: The study is currently undergoing recruitment and collection of data from the first participants. The study has faced recruitment challenges exacerbated by the COVID-19 pandemic, necessitating protocol modifications. Detailed analysis of adherence rates and LDL cholesterol changes is ongoing. Conclusions: This study explores the efficacy of monetary incentives delivered through a smartphone app to improve medication adherence in youth at risk for CVD. The findings will be used to build upon the existing literature in an effort to improve medication adherence throughout the life course and ultimately reduce CVD. Trial Registration: ClinicalTrials.gov NCT04458766; https://clinicaltrials.gov/study/NCT04458766

Background: Post–critical illness dysphagia occurs in about 10% to 62% of patients in the intensive care unit (ICU). Studies focusing on risk factors for dysphagia following endotracheal intubation are scarce and provide conflicting results. More research is required to determine the true prevalence of dysphagia, possible mechanisms, and risk factors. Objective: The aims of the study are to determine (1) risk factors associated with post–critical illness dysphagia, (2) the prevalence of post–critical illness dysphagia, (3) outcomes of patients with post–critical illness dysphagia, and (4) the diagnostic accuracy of the water sip test compared to fiber-optic endoscopic evaluation of swallowing (FEES). Methods: We plan to undertake a single-center prospective cohort study of patients with post–critical illness dysphagia admitted to the ICU at Prince Sultan Military Medical City, Saudi Arabia. Our inclusion criteria are as follows: (1) being an adult (age 18 years and older), (2) having undergone invasive mechanical ventilation for &gt;24 hours, (3) having been extubated for &gt;24 hours, (4) being able to participate in a FEES, and (5) being hemodynamically stable. Each day, the research coordinator will screen all patients in the ICU for enrollment in the study. The research coordinator will collect daily data on the use of advanced life support, the need for mechanical ventilation, and outcomes (mortality, duration of mechanical ventilation, ICU length of stay, and hospital length of stay). Enrolled patients will undergo a water sip test in the ICU and FEES performed by a certified speech-language pathologist. Patients will then be followed during a hospital stay truncated for analysis at 30 days as two cohorts: (1) patients that have dysphagia, that is, abnormal FEES results; and (2) patients who have normal FEES results. Logistic regression will identify dysphagia risk factors (eg, age, Acute Physiology and Chronic Health Evaluation II score, and ventilation duration), while sensitivity and specificity tests will be used to compare the results of the water sip test to the FEES. Survival analysis will be used to evaluate 30-day outcomes. Results: The study anticipates enrolling 200 patients over 18 months. Key outcomes include dysphagia prevalence and risk factors. Final results will be analyzed and reported upon completion of the 30-day follow-up for all participants. As of July 13, 2025, a total of 45 patients had been enrolled, with an average recruitment rate of 7.5 patients per month. Conclusions: The study findings will promote early intervention for patients with post–critical illness dysphagia, improve multidisciplinary care, and inform policymakers for better resource allocation. This study lays the groundwork for future research and clinical guidelines tailored to Saudi Arabia’s health care context.

Background: Deep neck abscesses are a disease in the field of otorhinolaryngology-head and neck surgery that causes significant morbidity, death, and expenditures. Treatment length, whether inpatient or outpatient, is also prolonged. Deep neck abscesses are managed with incision and drainage, abscess exploration, systemic broad-spectrum antibiotic treatment, comorbidity control, and postoperative wound care through recovery. Standard dressings for wound treatment have proven time-consuming and expensive. Honey is one type of dressing that has long been used in wound treatment for a number of body areas and disorders. Objective: The purpose of this study is to investigate the use of honey as a potential substitute for standard dressings for deep neck abscesses. Methods: This is a single-blind randomized controlled trial. Randomization will be done through simple random sampling. The population and sample of the study include all patients with deep neck abscesses treated at Dr Sardjito General Hospital, which is equipped with board-certified otorhinolaryngologists. Patients with deep neck abscesses who were given ethical clearance and meet the inclusion criteria were recruited as study participants until the sample size was reached. There are 18 participants in each group. Participants in the intervention group received standard dressings in addition to honey dressings, whereas those in the control group received standard dressings alone. Proinflammatory cytokines and growth factors, wound size, Bates-Jensen Wound Assessment Tools scoring, and quantitative bacterial colony identification will be all evaluated and assessed. The gathered data will be documented and subjected to statistical analysis. Results: This manuscript presents a study protocol for a randomized controlled trial investigating honey as a wound care modality in patients with deep neck space abscesses. Ethical approval and partial funding for the study were obtained in May 2024. Recruitment and data collection commenced in June 2024 and were successfully completed as of June 2025. Conclusions: We hypothesize that honey may serve as a safe, effective, and affordable alternative wound dressing for the management of deep neck abscesses, with potential benefits in both clinical and health care system outcomes. Trial Registration: ClinicalTrials.gov NCT06562257; https://clinicaltrials.gov/study/NCT06562257.

Background: Pediatric to adult health service (AHS) transition is an inevitable but challenging time for many adolescents and young adults (AYAs) with a chronic illness. As the responsibility of illness management begins to shift from parents to the AYA themselves, many AYAs fail to transition in a timely manner which has important health consequences. Mobile apps have the potential to assist AYAs in self-managing their condition during this vulnerable time, but empirical data on app uptake as well as efficacy with respect to transition outcomes and illness control are lacking. Objective: This pragmatic, single arm pilot trial aimed to evaluate AYA usage of a mobile app called ‘TransitionMate’ (TMApp) which was purpose-built to support chronic illness self-management for youth undergoing transition. Secondary aims were to assess AHS attendance and changes in illness control over the first 12 months post-transition. Upon demonstration of TMApp feasibility (≥70% of participants using TMApp at least once a month), a randomized controlled trial was planned to test efficacy of the app in relation to transition and illness control outcomes. Methods: AYAs aged 16-19 years who were transitioning out of two major pediatric hospitals in Sydney, Australia were recruited. Just prior to transition, participants’ demographic and clinical details were collected and TMApp was installed on their mobile devices. Participants were contacted by telephone at six and 12 months for information on self-reported usage, app usefulness and other feedback. Quantitative cohort-level usage data, including the number of times specific app features were accessed, was tracked via mobile analytics. At 12 months, electronic medical records (eMR) from participants’ designated AHS were accessed for data on AHS attendances, measures of illness control and unplanned hospitalizations. Results: 73 AYAs (30 male; median age 18 years) were recruited, with one withdrawing participation in the first month. Participants were primarily from three chronic illness subgroups: diabetes mellitus (n=23); inflammatory bowel disease (n=19); and cystic fibrosis (n=9). 50% of participants reported using TMApp at one month post-transition. Self-reported usage rates subsequently fell to 25% and 11% at six and 12 months, respectively. Mobile analytics data broadly corroborated self-reported usage. Eight participants who continued to use TMApp until 12 months gave a median usefulness rating of 8/10. Over two-thirds (68%) of participants successfully transitioned to their designated AHS by 12 months. Among the successful transitioners who had illness control data available on eMR, over 80% maintained a stable/improved illness status at six and 12 months. Conclusions: Results showed that TMApp was not used regularly enough by AYAs to demonstrate feasibility and justify progression to a randomized controlled trial. Despite low app uptake, over two-thirds of participants successfully transitioned suggesting that TMApp had minimal influence on transition outcomes. Clinical Trial: Australian New Zealand Clinical Trials Registry ACTRN12620000074998; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377349&isReview=true.

Background: Care for mild to moderate chronic kidney disease (CKD) entails self-management from patients and clinical support from primary care and nephrology. In response to a gap in resources for this population, My Kidneys My Health was co-developed to support self-management of CKD. Health care providers play a critical role in the implementation of patient resources, yet there is a gap in understanding providers’ perspectives in this role. Objective: This study develops and evaluates strategies to implement My Kidneys My Health into routine primary care and general nephrology clinical care. Methods: Health care providers working in Alberta, Canada who support patients with CKD were invited to participate in our multi-step study, guided by the Quality Implementation Framework. Step 1: we followed qualitative descriptive methodology to identify barriers and enablers to implementation using a directed content analysis and a deductive coding approach. Participants were invited to complete semi-structured interviews from October 2021 to May 2022. Step 2: we identified, prioritized, co-developed, and launched implementation strategies based on Step 1 results using behaviour change theory. Participants were invited to use the materials during the implementation period (May to October 2022). Utilization was tracked through Google Analytics and document distribution tracking. Step 3: we conducted follow-up interviews with participants (October to December 2022) to evaluate implementation based on the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework, following the same qualitative approach as Step 1. Effectiveness was out of scope of this study. Results: 14 health care providers participated in Step 1 qualitative interviews (42.9% from nephrology clinics, 35.7% from primary care). Participants shared an individual-level readiness and interest in sharing My Kidneys My Health with their patients. The key barriers to implementation included awareness, memory, time, motivation, and innovation accessibility. Implementation strategies were co-designed and implemented by Step 1 participants (i.e., educational sessions and materials, reminders, implementation coaching). 9 health care providers participated in Step 3 qualitative interviews. Participants shared their approach to tailoring implementation based on their patients and integrating the resource into their current practices. The resources developed were highly utilized by participants, with positive feedback on their usability and accessibility. Participants expressed motivation to continue sharing My Kidneys My Health; however, awareness and accessibility require further adaptations can improve sustainability of implementation. Our rigorous approach allowed us to address behaviour change and sustainability of implementation of My Kidneys My Health, as well as identifying appropriate and tailored implementation strategies. Conclusions: There is a readiness to implement self-management supports for patients with early-stage CKD. A theory-informed approach and strategic implementation strategies can support sustainability.

Background: Low back pain (LBP) is a leading cause of work absence globally. Digital interventions have the potential to increase access to self-management support for individuals with persistent LBP. Objective: To evaluate the feasibility, usability and acceptability of an online educational programme (MyRelief) designed to support self-management strategies for people with persistent LBP Methods: A prospective uncontrolled feasibility study was conducted across four countries Italy, Portugal, Sweden and the United Kingdom between 2020 and 2021. Adults in employment with non-specific persistent low-back pain (>3months) with access to the internet were eligible to participate. Participants were given access to MyRelief, an eight unit evidence based educational self-management programme. Feasibility of the MyRelief programme was assessed using recruitment rates, a priori success threshold of >70% of the target sample (50 participants), retention <35% drop-out rate. Pre and post intervention measures of functional disability were assessed using the Oswestry Disability Index (ODI), and health related quality of life using the EQ-5D-5L. Additional post intervention measures included the Patient enablement instrument (PEI) the System Usability Scale (SUS). Quantitative data were analysed descriptively, and qualitative feedback was analysed using a reflexive analytical approach. Results: The recruitment feasibility threshold was met (80%), forty participants (21 women,19 men) mean age of 57 years, mean pain duration 11.5 years enrolled in the study. 17 participants (11 male, 6 female) completed both the baseline and 12 week follow-up questionnaires. This represented a retention rate of 42.5% (n=17/40) and a dropout rate of 57.5% , which did not meet a priori criteria of < 35% dropouts. Approximately half of the participants presented with low baseline disability scores (mean ODI 24.0; 95%CI:18-31) with no significant change at follow-up (mean ODI 23.9; 95%CI:16- 31). EQ-5D-5L scores improved from 0.68 (95%CI: 0.608-0.76) to 0.72 (95%CI: 0.66-0.79) indicating a clinically significant change. PEI scores post intervention were high (mean 5.31) indicating good perceived enablement. The mean SUS score was 72.4 (95%CI: 67.5-73.3) indicating an good level of perceived ease-of-use. Over all the quality of outcome measure completion was high (100%). Qualitative feedback indicated areas for improvement relating to challenges around access and navigation within the website. Conclusions: The MyRelief study demonstrated feasibility in terms of recruitment but not retention. However low baseline disability levels are not representative of the wider persistent LBP population. Future studies should broaden recruitment strategies, in particular recruiting from healthcare settings to improve representativeness. Although usability met industry standards, qualitative feedback suggests that navigation and accessibility require further optimisation to better align with end-user preferences for online digital health interventions. Clinical Trial: ClinicalTrial.gov, NCT04673773; https://clinicaltrials.gov/ct2/show/NCT04673773

Low back pain (LBP) is the main cause of activity limitation and work absence across the world, leading to a high social and economic burden for individuals, families, the labour market and society. The overall aim of this multicentre study is to test the usability, acceptability and feasibility of an evidence-based, digital education programme for people living and working with persistent LBP who are in sedentary or physically demanding jobs and need advice on ergonomics, self-management of pain and healthy behavioural strategies.

Introduction Patients with frailty are at risk of adverse outcomes such as mortality, falls, deconditioning and hospital readmissions. With an increasingly ageing population and a greater likelihood of frailty, there is a significant need to ensure that patients are managed in the right place and at the right time. There has been a focus on offering hospital-level care at home as a way to meet this need, incorporating strategies to integrate care and use digital solutions. Digital twin (DT) technology is one advancement, offering a virtual replica of an object/environment, which has the potential to make use of real-time data personalised for an individual patient and/or setting to inform and support patient management decisions. We are yet to realise the full potential of this new way of integrated working and technological advancements. This scoping review aims to ascertain the current evidence for the components of the DT architecture to enable the monitoring and management of patients with frailty living at home. Methods This scoping review will follow the Joanna Briggs Institute methodology for scoping reviews and will be reported following the Preferred Reporting Items for Systematic Reviews Extension for Scoping Reviews guidelines. The following electronic databases will be searched: Medline, Embase, CINAHL, Cochrane CENTRAL, Web of Science and Scopus. Relevant websites will be searched for grey literature or case reports to capture the required information, as well as any documents provided by stakeholders. Primary studies, published in the English language from 2019 to the present day, which report on the monitoring or management of patients with long-term conditions and frailty within their home environment, will be included. Screening will be conducted by at least two independent reviewers against eligibility criteria, and a piloted data extraction form will be used to align with the research questions. Qualitative content analysis will be used. Data will be presented in tabular form, as well as descriptive and illustrative formats, to address the objectives of this review. Ethics and dissemination This scoping review does not require ethical approval. The findings of this review will be disseminated through peer-reviewed journals and conferences and will support the development of a conceptual model of a hospital-at-home DT for the management of patients with frailty.

Background: Increasing demand on healthcare systems requires innovative and transformative solutions to deliver efficient, high-quality care. One promising approach is Digital Twin (DT) technology, which leverages real time data to create dynamic virtual representations of a physical entity (individuals or space) to anticipate future scenarios and support care decisions. While DTs have been explored in various sectors, their application in Hospital at Home (HaH), which delivers acute level care in home environments, remains unexplored. Objective: This review bridges a critical knowledge gap and examines the existing evidence on DT-enabling tools for managing patients with frailty in home settings. This will identify the underpinning architectural components required to inform a HaH-DT system which can support clinical decision-making. Methods: Six electronic databases (Embase, MEDLINE, Cochrane CENTRAL, CINAHL, Web of Science and Scopus) were searched, along with grey literature, to identifying primary studies published in English, between January 2019 and September 2025. Included studies had to report on the monitoring or management of patients with frailty within their own home, and information was charted on a pre-defined data collection form to answer the research objectives. Review articles, protocols, and conference abstracts were excluded. Results: Sixty-nine reports were included, of which 54% (n=37) used quantitative approaches, and 36% (n=25) were pilot or feasibility studies. Reports were analysed for DT-enabling tools and systematically mapped across the proposed five-layered DT architecture: sensing, communication, storage, analytics, and visualisation. Taxonomies of DT layers, their interconnections, and the classifications of the types of data collected (e.g., about the patient, the home environment, the use of medical equipment) are presented. This evidence identifies DT-enabling tools used for a variety of functions and a range of sensing technologies that exist (e.g., passive sensing via wearables, active physiological sensors, ambient sensors to detect motion/environmental changes). The most prevalent modes of communication were wireless and network-based (n=36), with the majority using Bluetooth (n=12). This review highlights better understanding of data management, in particular secure storage, is required within local healthcare systems. The emerging potential of predictive and prescriptive analytics, which can enable clinicians to predict risk, support clinical decision-making, or activate alert-triggered health interventions were mapped. Existing evidence suggests analytics methods are currently largely descriptive with a lack of advanced methods such as prescriptive analytics to enable recommendations of an optimal course of action, and the absence of diagnostic analytics which can highlight why a situation has occurred. Reported DT-enabling tools demonstrate patient-centered benefits, including enhanced motivation, reassurance, and personalised care. However, concerns persist regarding device accuracy, user acceptability, and implications for carers and organisational workflows. Conclusions: This review is among the first to systematically map DT-enabling tools to inform a potential HaH-DT in patients with frailty and organised by a 5-layered conceptual model. Understanding these architectural layers provides the foundations to enable stakeholders advance research and development in areas where there are knowledge gaps and consider how a HaH DT can effectively operate within current healthcare systems. By leveraging technology-enabled care in complex home-based settings, there is great potential to deliver safer, personalised and timely care.

Background: Dental caries is a common chronic disease in children, yet large-scale surveillance is limited by the resource demands of clinical examinations. Digital tools like intraoral scanners may offer a scalable alternative for caries detection, enabling more efficient data collection for research and population-level oral health monitoring. Objective: To assess the diagnostic agreement between visual examination and on-screen assessment of 3D models generated by an intraoral scanner (IOS) in colour and supplemented with fluorescence for caries detection in primary teeth. Methods: Children participating in a clinical trial (n=216, mean age 5.6 years) underwent visual examination using the International Caries Detection and Assessment System (ICDAS) and intraoral scanning using the TRIOS 4 IOS (3Shape TRIOS A/S Denmark). Four trained registered dental practitioners independently assessed each participant’s 3D models in colour, then supplemented with fluorescence, using a previously validated ICDAS index modified for on-screen assessments of 3D models. All 3D models were assessed again four weeks later. The time taken for intraoral scanning and on-screen assessment was recorded. Multilevel logistic regression was used to estimate and compare the likelihood of detecting caries between methods, and Bland–Altman plots were used to visualise agreement. Analyses were performed at the initial (ICDAS>01), moderate (ICDAS>03), and extensive (ICDAS>05) dental caries thresholds. Intraclass Correlation Coefficient (ICC) estimated method agreement and examiner reliability. Results: 8,209 visible primary tooth coronal surfaces were analysed. The likelihood of detecting caries using colour assessment of 3D models was similar to visual examination at all disease thresholds: initial (odds ratio 1.1, 95% confidence interval (CI) 1.0–1.3), moderate (0.9, 0.7-1.1) and extensive (1.0, 0.7–1.3). When colour assessments were supplemented with fluorescence, the likelihood of detecting caries was 30% higher at the initial threshold relative to visual examination (1.3, 1.1-1.5) and similar at the moderate (0.9, 0.7-1.1) and extensive thresholds (0.9, 0.7-1.3). Bland-Altman plots showed a high level of agreement at both moderate and extensive thresholds. Examiner reliability using intraoral scans ranged from good to excellent. Conclusions: On-screen assessment of 3D models in colour shows greatest agreement with visual examination for caries detection at all disease thresholds. Clinical Trial: Australian New Zealand Clinical Trials Registry ACTRN12622001237774

A recommendation of: Emma L. Henderson, Ruth Abrams, Afrodita Marcu, Lou Atkins, Emily K. Farran Investigating the barriers and enablers to data sharing behaviours: A qualitative Registered Report https://osf.io/8yqbs

Background: The loss of a loved one is a common yet stressful event in later life. Internet- and mobile-based interventions have been proposed as an effective treatment approach for individuals with prolonged grief. Objective: The AgE-health study aimed to investigate the efficacy of an eHealth intervention, trauer@ktiv, in reducing prolonged grief symptoms in a sample of older adults. The trauer@ktiv intervention is an unguided, web-based self-management intervention based on cognitive behavioral therapy principles, addressing grief in later life. Methods: The AgE-health study was designed as a randomized controlled trial with an active control group (CG). Recruitment and data assessment took place between October 2020 and September 2022. A sample of 177 older adults (aged ≥60 years) with prolonged grief symptoms was randomly assigned to the intervention group (IG; access to the trauer@ktiv eHealth intervention) or the active CG (access to an information brochure on loss and grief). Participants were interviewed at 2 time points, before and after accessing the intervention, via postal questionnaires (baseline and follow-up 4 months after the intervention). The primary outcome was the reduction in prolonged grief symptoms assessed with the Prolonged Grief-13 scale. Adjusted mixed-effects regression models were used to test for changes in primary and secondary outcomes (eg, depression and self-efficacy) as part of an intention-to-treat (ITT) analysis. The study procedure was described in detail in the study protocol. Results: From baseline to 4 months after the intervention, 7 participants were lost to follow-up. Final analyses included a sample of 170 individuals (IG: n=81, 47.6%; CG: n=89, 52.4%). The study population had an average age of 67.3 (SD 6.4; range 60-95) years and consisted predominantly of female participants (129/170, 75.9%). While there was a pre-post-reduction in persistent grief symptoms, the ITT analysis showed no significant differences between IG and CG at follow-up (Prolonged Grief-13 scale, average marginal effect of 0.56, 95% CI –2.30 to 3.44, P=.70). Similarly, the ITT analysis showed no significant treatment effects for any of the secondary outcomes at follow-up. The trauer@ktiv intervention was rated high on satisfaction and usability. More than half of the IG (49/81, 61%) completed 5 or more of the 8 modules of the eHealth intervention. Conclusions: The tested eHealth intervention, trauer@ktiv, showed no superiority compared to an active CG in reducing prolonged grief symptoms in a sample of older bereaved individuals. Therefore, trauer@ktiv is not suitable as a stand-alone treatment. However, as the ease of use and satisfaction with the application were high, there may be potential for the intervention within a stepped and collaborative treatment approach. Trial Registration: German Clinical Trials Register DRKS00020595; https://drks.de/search/de/trial/DRKS00020595