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JMIR Research Protocols

JMIR Publications Inc.

Preprints posted in the last 7 days, ranked by how well they match JMIR Research Protocols's content profile, based on 18 papers previously published here. The average preprint has a 0.05% match score for this journal, so anything above that is already an above-average fit.

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Chinese Herbal Medicine as a complementary therapy for the management of Colorectal Cancer: Study protocol for a Delphi Expert Consensus survey

Ng, C. Y.; Liu, M.; Ai, D.; Yao, L.; Yang, M.; Zhong, L. L.

2026-04-22 oncology 10.64898/2026.04.21.26350990 medRxiv
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IntroductionColorectal cancer (CRC) remains a leading cause of cancer-related morbidity and mortality worldwide, despite advances in conventional oncological therapies. In recent years, various studies have made advances in integrative oncology, such as investigating the use of Chinese Herbal Medicine (CHM) as a complementary therapy alongside conventional oncological therapies to alleviate treatment-related adverse effects, improve quality of life, and potentially enhance therapeutic outcomes. Despite this, clinical practice in this area remains highly heterogeneous, with limited standardized guidelines on key areas of concern such as (1) optimal intervention, (2) recommended stage and duration of intervention, (3) safety considerations, and (4) possible herb-drug interactions. Hence, this study aims to establish expert consensus on the usage of CHM as a complementary therapy in the management of CRC, to support safe, consistent, and evidence-informed clinical practice. Methods and AnalysisWe will employ a modified Delphi technique to achieve consensus amongst a panel of international experts in various fields related to integrative oncology. Prior to the study, a list of questionnaire items was developed based on a systematic review of existing clinical practice guidelines on CRC. An international panel will be invited based on established international profile in integrative oncology research and clinical practice, and by peer referral. Two rounds of Delphi will be conducted using anonymous online questionnaires. Consensus will be considered reached if at least 50% of the panel strongly agree/disagree that an item should be included or excluded while strong consensus will be set at 76%. Items which achieve strong consensus after Round 1 will be removed, before being sent out for Round 2 with a summary of Round 1 responses for a final consensus. Ethics and DisseminationEthics approval has been obtained from the Institutional Review Board of Nanyang Technological University (IRB-2025-1222). Our findings will be disseminated through peer-reviewed publications and conference presentations. Strengths and limitations of this studyO_LIThis study will develop an expert consensus which aims to guide future integration of Chinese Herbal Medicine (CHM) as a complementary therapy into colorectal cancer (CRC) management. C_LIO_LIKey concerns in areas such as determining the (1) optimal intervention, (2) recommended stage and duration of intervention, (3) safety considerations, and (4) possible herb-drug interactions, thereby laying the groundwork for potential future incorporation of CHM into CRC treatment protocols alongside conventional oncology approaches has been identified, thus limiting implementation in clinical practice. C_LIO_LIDesigning a study e-guide, followed by the consensus rounds study online will facilitate participants responses and the dissemination of information from previous rounds. C_LI

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Digital Therapeutic for Hwa-byung Based on Acceptance and Commitment Therapy: A Pilot Feasibility Trial

Kwon, C.-Y.; Lee, B.; Kim, M.; Mun, J.-h.; Seo, M.-G.; Yoon, D.

2026-04-22 psychiatry and clinical psychology 10.64898/2026.04.19.26351203 medRxiv
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BackgroundHwa-byung (HB) is a Korean culture-bound syndrome characterised by prolonged suppression of anger and somatic complaints. No evidence-based digital therapeutic (DTx) has been developed for HB. We evaluated the feasibility, user experience (UX), and preliminary clinical effect of an acceptance and commitment therapy (ACT)-based DTx application, Hwa-free, for HB. MethodsAdults aged 19-80 years diagnosed with HB were enrolled in a four-week app-based intervention with assessment at baseline (Week 0), Week 2, Week 4, and Week 8 follow-up. The primary outcome was UX assessed via a 22-item survey at Week 4. Secondary outcomes included HB-related symptom and personality scales, depression, anxiety, anger expression, psychological flexibility, health-related quality of life, and heart rate variability. ResultsOf 45 screened, 30 were enrolled and 28 constituted the modified intention-to-treat population. Mean app use was 19.9 {+/-} 7.9 days (71.2% adherence over 28 days). Adverse events were infrequent and unrelated to the intervention. Positive response rates exceeded 80% for video content (items 2-4: 82.8-89.7%), HB self-assessment (86.2%), meditation therapy (86.2%), and in-app guidance (85.7%). Pre-post improvements from baseline to Week 4 were observed in 11 of 18 clinical scales, including HB Symptom Scale ({Delta} = -9.8, Cohens d = -0.92), Beck Depression Inventory-II ({Delta} = -13.3, d = -1.11), and state anger ({Delta} = -7.8, d = -0.96). The HB screening-positive rate declined from 100% at baseline to 55.6% at Week 8. ConclusionsHwa-free demonstrated adequate feasibility, acceptable UX, and preliminary evidence of clinically meaningful improvement in HB-related symptoms. Future randomised controlled trial is warranted. Trial registrationCRIS, KCT0011105

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Understanding the Intersection between Midwives Culture, Educational Background and Community Practice in Neonatal Jaundice Care in Ghana: A Qualitative Inquiry

Asamoah, G.; Ani-Amponsah, M.; Badzi, C. D.

2026-04-22 nursing 10.64898/2026.04.18.26350907 medRxiv
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Culture plays a crucial role in health; family, community, culture, and social conventions all have a significant impact on how an infant with jaundice is treated. Written or unwritten rules govern what parents and the community are allowed to do, which may have a detrimental effect on the neonates care. ObjectivesThe study explored how social expectations affect midwives management of neonatal jaundice at the St Patricks hospital in Maase-Offinso, in the Ashanti region of Ghana. MethodA total of seventeen midwives were sampled purposively using an exploratory descriptive design. Participants were engaged in interviews and focus group discussion after ethical approval was obtained. A semi-structured focus group discussion guide and interview guide was used to collect data. ResultsThe study discovered that the treatment of neonatal jaundice was adversely affected by social pressures, misconceptions, maternal choices, and spiritual views. Mothers and midwives socially approved sunbathing, and there were indications that grandmothers disapproved hospital care for their grandchildren. ConclusionCulture, family and social norms cannot be separated from health especially for the neonate whose means of identification is to belong to a family. Consequently, it is essential to respond to social influences, cultural conventions, and the various cultures of families with a culturally sensitive approach.

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Feasibility and acceptability of contextually adapted AVATAR therapy for distressing voices in Ethiopia and India: a study protocol for the AVATAR3 study

Ward, T.; Alem, A.; Craig, T. K. J.; Sinha Deb, K.; Devi, S.; Fekadu, A.; Gumley, A.; Hanlon, C.; Kelly, R.; Manyazewal, T.; Misganaw, E.; Murcutt, I.; Oshodi, E.; Patil, V.; Sharan, P.; Tesfaye, Y.; Verma, R.; Ul-Haq, S.; Rus-Calafell, M.; Choudhary, R.; Getachew, M.; Hardy, A.; Wondiye, M.; Mihretu, A.; Sood, M.

2026-04-21 public and global health 10.64898/2026.04.21.26348779 medRxiv
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IntroductionIn many Low- and Middle-Income countries (LMIC), access to psychological therapies for psychosis remains extremely limited, contributing to significant treatment gaps and persistent inequalities in care. Novel interventions that are effective, scalable, and culturally acceptable across diverse settings are urgently needed. AVATAR therapy is an innovative digital intervention for distressing voices in psychosis, developed in the UK. The therapy enables voice-hearers to engage in a series of facilitated dialogues with a customized computer-based representation of their main distressing voice. AVATAR3 represents the first initiative to contextually adapt AVATAR therapy and evaluate its acceptability in two LMIC settings (Ethiopia and India). Methods and analysisWe will establish Innovation and Implementation Hubs in Addis Ababa, Ethiopia (Centre for Innovative Drug Development and Therapeutic Trials for Africa (CDT-Africa) at Addis Ababa University (AAU) and Mental Health Service Users Association (MHSUA), Ethiopia) and New Delhi, India (All India Institute of Medical Sciences). Phase 1 employs formative work and diverse stakeholder engagement to inform context-specific adaptations. Reflexive thematic analysis will be used, with data synthesis informed by the Cultural Adaptation of Scalable Psychological Interventions (CASPI) framework and Ecological Validity Model (EVM). Phase 2 tests adapted AVATAR therapy through a parallel case series (n=15 per site, targeting 70% completion rate) measuring feasibility, acceptability, and safety indicators at baseline, 12-weeks, and 24-weeks. Qualitative research will explore the experiences of participants (n=10) and therapists (n=8) at each site. Ethics and disseminationEthical approval has been obtained from Addis Ababa University College of Health Science Institutional Review Board, All India Institute of Medical Sciences (AIIMS) Institutional Review Board and the Kings College London (study sponsor) Research Ethics Committee. Findings will be disseminated to inform the implementation of AVATAR therapy across diverse international settings. Strengths and limitations of this studyO_LIInterdisciplinary and participatory approach C_LIO_LIContextual adaptation of a digital innovation C_LIO_LIExpert by experience leadership and involvement from the conception of the study C_LIO_LIThe study will develop tools and share learning to support future digital mental health innovation across diverse international settings C_LIO_LIThe case-series at each site will not have a control group C_LI

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Practical alcohol risk-reduction advice plus a brief commitment declaration in a social drinking laboratory: a pilot cluster randomized trial

Yoshimoto, H.; Hadano, T.; Shimada, K.; Gosho, M.; Fukuda, T.; Komano, Y.; Umeda, K.; Iwase, M.; Kusano, Y.; Kawabata, T.

2026-04-21 public and global health 10.64898/2026.04.19.26351067 medRxiv
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BackgroundPractical alcohol risk-reduction strategies are widely recommended in public-facing alcohol guidance, but randomized evidence from socially interactive drinking episodes remains limited. We conducted a pilot cluster randomized trial to evaluate the feasibility and preliminary effects of a package intervention comprising practical drinking-strategy information, participant self-selection of same-day strategies, and a brief commitment declaration in a social drinking laboratory. MethodsThis single-center, parallel-group pilot trial was conducted in Japan. Pre-existing social groups participated. One or two groups scheduled in the same session slot were combined into a time-slot allocation unit, which was randomized 1:1 either to the package intervention or to alcohol-related knowledge only. The primary outcome was total pure alcohol intake during the first 120 min. Session satisfaction on a Visual Analog Scale (VAS) was a prespecified secondary participant-experience outcome. ResultsOf 83 interested individuals, 63 were randomized and 59 participants in 17 social groups and 12 allocation units were included in the modified intention-to-treat analysis. The mean paired intervention-control difference for 120-min alcohol intake was-8.84 g (95% confidence interval [CI]-27.92 to 10.23; exact sign-flip p = 0.281). The corresponding exploratory 0-30 min difference was-4.90 g (95% CI-10.48 to 0.68; exact sign-flip p = 0.094). In a genotype-adjusted participant-level sensitivity analysis, the intervention coefficient for 120-min intake was-16.0 g (95% CI-30.9 to-1.1; p = 0.036). Session satisfaction was high in both arms with no clear between-arm difference. Next-day follow-up was 100%, and no adverse-event-related discontinuations occurred. ConclusionsThe intervention was feasible to deliver in a socially interactive drinking setting, and session satisfaction was high in both arms. Primary allocation-unit estimates favored lower alcohol intake but were imprecise. Larger trials are needed to estimate effects more precisely, while considering the potential influence of genotype imbalance on effect estimation in East Asian samples. Trial registrationUniversity Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) UMIN000060685. Registered 17 February 2026.

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Family Constellations for All Clinical Conditions: A Systematic Review and Meta-analysis Showing a Lack of Supporting Evidence

Souza, F. L.; Cabral Souza, N.; Mendes, J. A. d. A.

2026-04-21 psychiatry and clinical psychology 10.64898/2026.04.19.26351231 medRxiv
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IntroductionFamily Constellation Therapy (FCT) has been widely disseminated in clinical, public health, and judicial settings despite persistent concerns regarding its theoretical basis, safety, and the limited availability of rigorous randomised evidence supporting its clinical use. ObjectiveThe aim of this systematic review is to assess the effects of FCT across all clinical conditions, explicitly considering both benefits and harms; and summarise the characteristics of studies and intervention settings used in randomised controlled trials of FCT. MethodsFollowing a prospectively registered protocol (CRD420251136190), we conducted a systematic search of seven databases (PubMed, EMBASE, APA PsycInfo, CENTRAL, BVS, Web of Science, and CINAHL) and grey literature (ICTRP and ProQuest database) without language or date restrictions to identify published and unpublished randomised controlled trials of FCT. Study selection, data extraction, risk of bias (RoB 2), and certainty of evidence (GRADE) were performed in duplicate. Statistical analyses followed a prospectively registered analysis plan with prespecified criteria for data pooling and for handling analytical limitations. ResultsNo reliable evidence was found to support the use of FCT for any condition across both clinical and non-clinical samples. All trials included were judged to be at high risk of bias and all comparisons were rated as very low-certainty evidence. Concerns regarding potential adverse effects were identified, and the available data was insufficient to establish the effectiveness of the intervention, precluding any clinical recommendation. ConclusionClinicians, policymakers, and consumers should reconsider adopting FCT while reliable evidence is not available.

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Patient perspectives on living with hypertension: Social media listening analysis across predominantly high-income countries

Di Somma, S.; Gervais, R.; Bains, M.; Carter-Williams, S.; Messner, S.; Onsongo, N.

2026-04-23 cardiovascular medicine 10.64898/2026.04.22.26351483 medRxiv
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Background: Chronic conditions such as hypertension can significantly disrupt daily life and emotional wellbeing. The interaction between patients' perceptions, adherence to antihypertensive medication and quality of life (QoL) remains underexplored outside structured clinical settings. Objectives: To capture unprompted patient perspectives and assess whether hypertension affects QoL and to investigate if patient reported experiences are associated with self-reported antihypertensive medication adherence. Methods: Social media listening (SML) study analyzing 86,368 anonymized posts from individuals with hypertension in 12 countries, collected between January 2022 and May 2024. Posts from 11 countries (n=81,368) were analyzed using artificial intelligence-enabled natural language processing. Posts from China (n=5,000) were analyzed separately using a harmonized framework. Quantitative and qualitative methods assessed variations by country, age, and gender, and associations between emotional expression and antihypertensive medication adherence. Results: Across the 11-country core sample, 45% of posts mentioned at least one QoL impact, most commonly worry/anxiety (11%). Impacts varied across countries. Among 8,096 posts with age identified, individuals <40 years reported emotional balance impacts in 28% of posts versus 22% among those aged 40+. Work/Education impacts were mentioned in 17% of posts by those <40 years vs 12% in 40+. Among 7968 posts explicitly referencing adherence, expressed worry was associated with stricter adherence (62% association score), as were structured routines (79% score), home monitoring (77%), dietary changes (77%), and exercise (71%). In contrast, sadness/depression was associated with inconsistent adherence (71%), as were forgetfulness (79%), side effects (73%), and cost/insurance concerns (65%). Conclusions: These results emphasize the importance of the psychological and emotional impact of hypertension, including on adherence to medication regimens, reinforcing the value of a holistic approach to patient care.

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International Adaptation of a brief Problem-Solving Skills (the IAPPS trial) training for people in custody with severe mental illness in Poland: an open multicentred, parallel group, feasibility randomised controlled trial.

Perry, A. E.; Zawadzka, M.; Rychlik, J.; Hewitt, C.

2026-04-25 forensic medicine 10.64898/2026.04.24.26351654 medRxiv
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Objectives: The primary aim of this study was to assess the feasibility of delivering an adapted problem-solving skills (PSS) intervention by quantifying the recruitment, follow-up and completion rates using a brief problem-solving intervention for people with a mental health diagnosis in two Polish prisons. Design: IAPPS is an open, multi-centred, parallel group feasibility randomised controlled trial (RCT). Setting: Two prisons in Poland. Participants: Men in custody aged 18 years and older, having a mental illness and living within the prison therapeutic unit. Interventions: The intervention consisted of an adapted PSS skills intervention plus care as usual (CAU) or care as usual only. Delivered in groups of up to five people in 1.5-hour sessions over the course of two weeks. Main outcome measures: Primary outcomes - rate of recruitment, follow-up, and feasibility to deliver the intervention. Secondary outcomes included measures of depression, general mental health, and coping strategies. Results: 129 male prisoners were screened, 64 were randomly allocated, with a mean age of 53.5 years (SD 14, range 23-84). 59 (95%) prisoners were of Polish origin. Our recruitment rate was 48%. There was differential follow up with those in the intervention group less likely to complete the post-test battery versus those who received care as usual. Outcome measures were successfully collected at both time points. Conclusions We were able to recruit, retain and deliver the intervention within the prison setting; some logistical challenges limited our assessment of intervention engagement. Our data helps to demonstrate how use of the RCT study design can be implemented and delivered within the complex prison environment. Trial registration number ISRCTN 70138247, protocol registration date May 2021

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Effects of Glucagon-Like Peptide-1 (GLP-1) Agonists on Surgical Wound Healing: A Single Institution Pilot Study

Adams, J. C.; Pullmann, D.; Belostotsky, H.; Mestvirishvili, T.; Chiu, E.; Oh, C.; Rabbani, P. S.

2026-04-22 surgery 10.64898/2026.04.21.26351321 medRxiv
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ObjectiveThis study evaluates the impact of systemic GLP-1 receptor agonist (GLP-1RA) use on surgical wound healing in high-risk surgical populations, including patients with diabetes, and implications for perioperative planning and healing outcomes. ApproachThis pilot retrospective cohort study compared adult surgery patients with non-healing postoperative wounds by their GLP-1RA use. Outcomes included healing status, time to wound closure, and number of surgical interventions. ResultsThe cohort included 35 non-GLP-1RA users and 16 GLP-1RA users with comparable baseline characteristics, except for significant higher prevalence of venous insufficiency among users. Though median time to closure was similar for all patients, users required fewer surgical interventions and their wounds reached closure in significant difference from non-users. Among patients with diabetes, all GLP-1RA users healed significantly compared to non-users. InnovationThe impact of GLP-1RA therapy on wound healing in high-risk reconstructive and soft-tissue surgery remains poorly defined. This pilot cohort addresses that gap, offering an early signal that GLP-1RA use is associated with improved wound healing and fewer postoperative interventions. These findings may inform perioperative practice by identifying a systemic pharmacologic factor that optimizes surgical outcomes in high-risk populations. ConclusionGLP-1RA use was associated with higher healing rates and fewer interventions, particularly among patients with diabetes. These findings support a beneficial role in surgical wound healing and warrant larger multi-site studies.

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Exploring provider preferences in the design of HIV treatment packages integrating long-acting injectable antiretroviral therapy in New York Ryan White Part A medical case management programs

Zimba, R.; Kelvin, E. A.; Kulkarni, S.; Carmona, J.; Avoundjian, T.; Emmert, C.; Peterson, M.; Irvine, M.; Nash, D.

2026-04-23 hiv aids 10.64898/2026.04.22.26351494 medRxiv
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Introduction Understanding provider preferences for the design of HIV treatment packages could enhance the implementation of programs to support the adoption of long-acting injectable antiretroviral therapy (LAI ART) by people living with HIV who are interested in initiating this treatment modality. Methods We recruited providers from New York City (NYC), Rockland, Putman, and Westchester County Ryan White Part A Medical Case Management (MCM) programs to complete a discrete choice experiment (DCE) containing twelve tasks with two alternatives and an opt-out option, with additional survey questions about implementation readiness and choice motivations. The alternatives included four attributes--Type of ART Medication (monthly or bimonthly LAI ART), Service Location and Mode, Support for Clients, and Rewards for Clients--with 2-4 levels each. We ran latent class multinomial logit analyses (LCA) with 1-5 classes to estimate preferences and explore hypothesis-free preference heterogeneity. We estimated attribute influence using relative importances and preferences using zero-centered part-worth utilities for each level. Results One hundred seventy-seven providers completed the survey (July 2022-January 2023). About half (52%) were 40-59 years old, 72% identified as women, and the plurality (41%) identified as Latino/a. We chose the two-group LCA solution. Bimonthly LAI ART was preferred over monthly LAI ART overall and in both groups. Group 1 (n=45) preferred more traditional adherence supports (e.g., injections at the clinic by appointment, injection appointment reminders) whereas Group 2 (n=132) preferred more client-centered supports (e.g., injections at home by appointment, free transportation to injection appointments if at a clinic). Both groups preferred higher monetary value gift cards for clients for every on-time injection. The top-ranking motivations indicated that participants prioritized patient convenience over job satisfaction and administrative or financial feasibility for the agency. The scores for all implementation measures indicate readiness to implement LAI ART in both groups. Conclusions Our implementation science-focused study suggests that providers of MCM services in NYC and surrounding counties are motivated to offer services to support clients' access and adherence to LAI ART. More work is needed to understand how programs have, in fact, integrated supports for LAI ART into their services.

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A fully remote randomized controlled trial of an ultra-brief digital meditation intervention reduces internalizing symptoms

Glick, C. C.; Pirzada, S. T.; Quah, S. K.; Feldman, S.; Enabulele, I.; Madsen, S.; Billimoria, N.; Feldman, S.; Bhatia, R.; Spiegel, D.; Saggar, M.

2026-04-21 psychiatry and clinical psychology 10.64898/2026.04.19.26351219 medRxiv
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BackgroundScalable, low-burden behavioral interventions are needed to address rising subclinical mental health symptoms. However, few randomized controlled trials have evaluated ultra-brief, remotely delivered, meditation using multimodal outcome assessment under real-world conditions. MethodsWe conducted a fully remote randomized controlled trial (ClinicalTrials.gov: NCT06014281) evaluating a focused-attention meditation intervention delivered via brief instructor training and independent daily practice. A total of 299 meditation-naive adults were randomized to immediate intervention or waitlist control in a delayed-intervention design. Participants practiced [&ge;]10 minutes daily for 8 weeks within a 16-week study. Outcomes included validated self-report measures, web-based cognitive tasks, and wearable-derived physiological metrics. ResultsAcross randomized and within-participant replication phases, the intervention was associated with significant reductions in anxiety and mind wandering, with effects remaining stable during 8-week follow-up. Improvements were greatest among participants with higher baseline symptom burden. Sleep disturbance improved selectively among individuals with poorer baseline sleep. Secondary outcomes, including rumination, perceived stress, social connectedness, and quality of life, also improved. Cognitive performance showed modest improvements primarily among lower-performing participants. Resting heart rate exhibited nominal reductions. ConclusionsAn ultra-brief, fully remote meditation intervention requiring 10 minutes per day was associated with sustained improvements in psychological functioning and smaller, baseline-dependent effects on cognition in a non-clinical population. These findings support digital delivery of low-dose meditation as a scalable preventive mental health strategy.

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Effects of Mindfulness-Based Interventions on Executive Function in Children and Adolescents: A Systematic Review and Meta-Analysis

Li, N.

2026-04-20 psychiatry and clinical psychology 10.64898/2026.04.18.26351184 medRxiv
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BackgroundMindfulness-based interventions (MBIs) have been increasingly adopted in educational settings to support cognitive development in youth. Executive function (EF)--encompassing inhibitory control, working memory, and cognitive flexibility--is a plausible target of MBI given its reliance on attention regulation. However, prior reviews have yielded mixed conclusions, partly due to inconsistent construct definitions and the pooling of heterogeneous outcome measures. ObjectivesTo (1) estimate the pooled effect of MBI on EF in youth aged 3-18 years using only construct-validated, direct EF measures, (2) examine potential moderators including age group, EF domain, and risk of bias, and (3) test dose-response relationships via meta-regression on intervention duration. MethodsWe searched PubMed, PsycINFO, CINAHL, Scopus, and Web of Science from inception to March 2026, supplemented by reference-list searches from two existing systematic reviews and a scoping review. Only English-language publications were eligible. Eligible studies were randomised controlled trials (RCTs) or quasi-RCTs of MBI (excluding yoga-only interventions) in typically developing youth, with at least one direct behavioural or computerised EF outcome. Risk of bias was assessed using Cochrane RoB 2. Hedges g was computed for each study, and pooled using a DerSimonian-Laird random-effects model. Subgroup analyses by age group, EF domain, and risk of bias were conducted, alongside leave-one-out sensitivity analyses, Eggers regression test, trim-and-fill, and Knapp-Hartung-adjusted meta-regression on intervention duration. Evidence certainty was rated using GRADE. ResultsThirteen RCTs (nine school-age, four preschool; total N = 1,560) met inclusion criteria. The pooled effect was g = 0.365 (95% CI 0.264 to 0.465; p < .00001), with negligible heterogeneity (I2 = 0.0%; Q = 6.76, p = .87). Effects were consistent across age groups (school-age g = 0.389; preschool g = 0.318) and EF domains (inhibitory control, working memory, cognitive flexibility; pbetween = .60). Meta-regression on intervention duration (4-20 weeks) was non-significant (p = .79). The effect was robust in leave-one-out analyses, in the low risk-of-bias subgroup (g = 0.361; k = 8), and after trim-and-fill adjustment (g = 0.354). The 95% prediction interval (0.252 to 0.477) was entirely positive. GRADE certainty was rated MODERATE, downgraded once for risk of bias. ConclusionsMBIs appear to produce a small, statistically significant improvement in EF in youth aged 3-18 years, with moderate certainty of evidence per the GRADE framework. The effect is consistent across preschool and school-age samples and across EF domains, with no significant dose-response relationship within the 4-20 week range studied. Emerging mediation evidence suggests that EF improvement may serve as an important pathway through which MBI supports emotion regulation, though this requires replication. Further large-scale, pre-registered RCTs with active control conditions and longitudinal follow-up are warranted.

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Translation, Validation, and Application of Indonesian Genetic Literacy Questionnaires for Medical Students

Kemal, R. A.; Dhani, R.; Simanjuntak, A. M.; Rafles, A. I.; Triani, H. X.; Rahmi, T. M.; Akbar, V. A.; Firdaus, F.; Pratama, B. F.; Zulharman, Z.

2026-04-25 medical education 10.64898/2026.04.17.26350524 medRxiv
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Background: Increasing relevance of genetics and molecular biology in medicine necessitates greater genetic literacy among healthcare workers. To assess the literacy level, a validated genetic literacy questionnaire is needed. Therefore, a standardised Indonesian-language genetic literacy questionnaire is essential. Aims: We aimed to translate and validate three genetic literacy questionnaires (PUGGS, iGLAS, and UNC-GKS) for use among Indonesian medical students. We then evaluated genetic literacy levels using one of the validated questionnaires. Methods: The PUGGS, iGLAS, and UNC-GKS questionnaires were translated into Indonesian and then reviewed by an expert panel for translational accuracy and conceptual appropriateness. Back-translation was performed to confirm validity. Initial Indonesian versions of the questionnaires underwent cognitive pre-testing with 12 undergraduate medical students. After refinements, the questionnaires were validated among 34 first- to third-year medical students. The Indonesian version of UNC-GKS questionnaire was then used to assess genetic literacy of 486 medical students comprising 228 preclinical medical students, 187 clerkships, and 71 residents. Results: The Indonesian versions of PUGGS (Cronbach's = 0.819) and UNC-GKS ( = 0.809) demonstrated good reliability, while iGLAS showed poor reliability ( = 0.315). Among the 486 students tested, 56% demonstrated moderate overall genetic literacy, and only 15.2% demonstrated good overall literacy. Basic genetic concepts were relatively well-understood with 54.3% having good literacy. On the contrary, gene variant's effects on health were poorly understood with only 9.7% having good literacy. Inheritance concepts were moderately understood with 24.9% having good literacy. Conclusion: The Indonesian translations of PUGGS and UNC-GKS are reliable tools for assessing genetic literacy among medical students. Using UNC-GKS, we observed predominantly moderate genetic literacy levels. Curriculum improvement to better integrate genetics education is essential to support its clinical applications.

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Leveraging Predictive AI and LLM-Powered Trial Matching to Improve Clinical Trial Recruitment: A Usability Assessment of Trialshub

Blankson, P.-K.; Hussien, S.; Idris, F.; Trevillion, G.; Aslam, A.; Afani, A.; Dunlap, P.; Chepkorir, J.; Melgarejo, P.; Idris, M.

2026-04-20 health informatics 10.64898/2026.04.17.26351107 medRxiv
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BackgroundRecruitment remains a major barrier to timely clinical trial completion. Trialshub is an LLM-powered, chat-based platform intended to help users identify relevant trials and connect with coordinators to streamline recruitment workflows. ObjectiveTo evaluate the perceived usability and operational value of Trialshub, and identify implementation considerations for real-world deployment. MethodsA usability test was conducted at Morehouse School of Medicine for the Trialshub application. Purposively selected participants included clinical research coordinators and individuals with and without clinical trial search experience. Participants completed a pre-test survey assessing demographics, digital health information behaviors, and familiarity with AI tools, followed by a moderated usability session using a Trialshub prototype. Users completed scenario-based tasks (locating a breast cancer trial, reviewing results, and initiating coordinator contact) using a think-aloud protocol. Task ratings, screen recordings, and transcribed feedback were analyzed descriptively and thematically, and reported. ResultsParticipants reported high comfort with using digital tools and moderate-to-high familiarity with AI. Trialshubs chat-first design, guided prompts, and checklist-style eligibility display were perceived as intuitive and reduced cognitive load. Fast access to trials and the coordinator-contact workflow were viewed positively. Key usability issues included uncertainty at step transitions, insufficient cues for selecting results and next actions, and inconsistent system reliability (loading delays, errors, and broken trial detail pages). Participants also noted redundant questioning due to limited conversational memory, requested improved filtering/sorting, and clearer calls-to-action. All participants indicated that Trialshub has strong potential to meaningfully improve clinical trial processes. ConclusionsTrialshub shows promise for improving trial discovery and recruitment workflows, with identified design implications for real-world deployment.

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Predicting Depressive Symptoms Among Reproductive-Aged Women in Bangladesh Using Bagging Ensemble Machine Learning on Imbalanced Bangladesh Demographic and Health Survey 2022 Data

Mahmud, S.; Akter, M. S.; Ahamed, B.; Rahman, A. E.; El Arifeen, S.; Hossain, A. T.

2026-04-23 public and global health 10.64898/2026.04.22.26351445 medRxiv
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Background Depressive symptoms among reproductive-aged women represent a major public health concern in low- and middle-income countries, yet systematic screening remains limited. In most population survey datasets, the low prevalence of depression results in severe class imbalance, which challenges conventional machine learning models. Therefore, we develop and evaluate a bagging-based ensemble machine learning framework to predict depressive symptoms among reproductive-aged women using highly imbalanced Bangladesh demographic and health survey (BDHS) 2022 data. Methods The sample comprised women aged 15-49 years drawn from BDHS 2022 data. Depressive symptoms were defined using the Patient Health Questionnaire (PHQ-9 [&ge;]10). Candidate predictors were drawn from sociodemographic, reproductive, nutritional, psychosocial, healthcare access, and environmental domains. Feature selection was performed using Elastic Net (EN), Random Forest (RF), and XGBoost model. Five classifiers (EN, RF, Support Vector Machine (SVM), K-nearest neighbors (KNN), and Gradient Boosting Machine (GBM)) were trained using both oversampling-based approaches and the proposed ensemble framework. Model performance was evaluated on an independent test set using accuracy, sensitivity, specificity, F1-score, and the normalized Matthews correlation coefficient (normMCC). Results Approximately 4.8% of women were identified with depressive symptoms. The proposed bagging ensemble framework consistently achieved more balanced predictive performance than oversampling-based models. Average normMCC improved from 0.540 (oversampling) to 0.557 (ensemble). RF and GBM ensembles demonstrated notable improvements in identifying depressive cases, while the EN ensemble achieved the highest overall performance and sensitivity. Threshold optimization yielded stable normMCC across models, indicating robust trade-offs between sensitivity and specificity. Conclusions Bagging-based ensemble learning provides a more robust and balanced approach than synthetic oversampling for predicting depressive symptoms in highly imbalanced population survey data. This approach has important implications for improving early identification and population-level mental health surveillance in resource-constrained settings.

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Racioethnic Disparities in Risk of Cardiometabolic Risk Factors and Cardiovascular Disease among Women Treated for Breast Cancer: The Pathways Heart Study

Yao, S.; Zimbalist, A.; Sheng, H.; Fiorica, P.; Cheng, R.; Medicino, L.; Omilian, A.; Zhu, Q.; Roh, J.; Laurent, C.; Lee, V.; Ergas, I.; Iribarren, C.; Rana, J.; Nguyen-Huynh, M.; Rillamas-Sun, E.; Hershman, D.; Ambrosone, C.; Kushi, L.; Greenlee, H.; Kwan, M.

2026-04-24 epidemiology 10.64898/2026.04.23.26351612 medRxiv
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Background: Few studies have examined racioethnic disparities in cardiovascular disease (CVD) in women after breast cancer treatment, who are at higher risk due to cardiotoxic cancer treatment. Methods: Based on the Pathways Heart Study of women with a history of breast cancer, this analysis examines the association between cardiometabolic risk factors (hypertension, diabetes, and dyslipidemia) and CVD events with self-reported race and ethnicity, as well as genetic similarity. Multivariable logistic and Cox proportional hazards regression models were used to test race and ethnicity and genetic similarity with prevalent and incident cardiometabolic risk factors and CVD events. Results: Of the 4,071 patients in this analysis, non-Hispanic Black (NHB), Asian, and Hispanic women were more likely to have prevalent and incident diabetes than non-Hispanic White (NHW) women. Analysis of genetic similarity revealed results consistent with self-reported race and ethnicity. For CVD risk, NHB women were more likely to develop heart failure and cardiomyopathy than NHW women. In contrast, Hispanic women were at lower risk of any incident CVD, serious CVD, arrhythmia, heart failure or cardiomyopathy, and ischemic heart disease, which was consistent with the associations found with Native American ancestry. Conclusions: This is the largest multi-ethnic study of disparities in CVD health in breast cancer survivors, demonstrating corroborating findings between self-reported race and ethnicity and genetic similarity. The results highlight disparities in cardiometabolic risk factors and CVD among breast cancer survivors that warrant more research and clinical attention in these distinct, high-risk populations.

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Why Patients Choose Spiritual Healers, Alternative Medicine, and Unqualified Practitioners Before Formal Medical Care: An Exploratory Mixed Methods Study in Peri-Urban and Rural Faisalabad, Pakistan

Hamid, S.; Muneez, M.; Saleem, S.

2026-04-24 health systems and quality improvement 10.64898/2026.04.23.26351601 medRxiv
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ABSTRACT Background Before obtaining professional medical care, many people in peri-urban and rural Pakistan contact herbalists, spiritual healers, and unlicensed caregivers. This study examined the social, economic, and cultural factors influencing the use of informal care by analysing the health-seeking behaviours of individuals in the Faisalabad District. Methods An exploratory mixed-methods study was conducted in Makkuana and the surrounding villages of Faisalabad District, Punjab. The quantitative component involved a cross-sectional survey of 69 adults using a structured questionnaire adapted from the I-CAM-Q. The qualitative component comprised twelve in-depth interviews and two focus group discussions. Descriptive statistics and chi-square analysis were used for quantitative data. Thematic analysis, guided by the Health Belief Model and Andersen's Behavioural Model, was applied to qualitative data. Results The mean age of participants was 40.4 years; 62.3% were female, and 79.7% had monthly household incomes below PKR 60,000. Of the 69 participants, 68 (98.6%) sought care from an informal provider first, most commonly an unqualified practitioner (50.7%), herbal practitioner (29.0%), or homeopath (17.4%). Trust was the leading reason for provider choice (43.5%), followed by proximity (24.6%) and low cost (15.9%). Complications were reported by 21.7% of participants, and 39.1% later required formal care for the same illness. Eight qualitative themes emerged: structural and economic barriers to formal care; proximity and convenience as determinants of informal care; trust, familiarity, and social networks; cultural and religious normalisation of traditional practices; poor doctor-patient communication in formal settings; perceived safety and naturalness of alternative remedies; awareness deficits about provider qualifications; and treatment-related harm and delayed escalation to formal care. Conclusion Informal health care seeking is nearly universal in this community, driven by intersecting economic, structural, cultural, and interpersonal factors. Enhancing primary care affordability, accessibility, and the quality of provider-patient communication together with culturally sensitive health literacy programs, is essential to redirect care seeking toward qualified providers.

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When Data Meets Practice: A Qualitative Study of Clinician Perspectives on Streaming Data in Mental Health

Tian, J.; Kurkova, V.; Wu, Y.; Adu, M.; Hayward, J.; Greenshaw, A. J.; Cao, B.

2026-04-25 psychiatry and clinical psychology 10.64898/2026.04.23.26351640 medRxiv
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Patient-generated streaming data from wearable and digital technologies is increasingly promoted as a means of supporting mental health monitoring and clinical decision-making. While patient acceptance of these technologies has been reported, clinician perspectives remain underexplored despite their central role in determining whether streaming data are meaningfully integrated into routine care. This study explored clinicians experiences, as well as perceived facilitators and barriers, related to integrating patient-generated streaming data into routine mental health practice. A qualitative, exploratory interview study was conducted to examine clinicians experiences and perspectives on integrating patient-generated streaming data into mental health care. Semi-structured interviews were conducted with 33 clinicians, including family physicians (n=11), psychiatrists (n=12), and psychologists (n=10). Data were analyzed using reflexive thematic analysis guided by Braun and Clarkes six-step approach. Six themes were identified. Clinicians described variable use of digital and streaming technologies, ranging from routine engagement to deliberate non-use. Streaming data were viewed as clinically valuable when they provided longitudinal and objective insights, identified physiological and behavioural pattern changes, and supported patient engagement. However, clinicians emphasized that clinical usefulness was contingent on interpretability, contextual information, and relevance to decision-making. Major barriers included poor integration with electronic medical records, time constraints, data volume, limited organizational support, and uncertainty regarding data reliability and validity. Clinicians also expressed persistent concerns about privacy, governance, and regulatory oversight, highlighting the need for clear safeguards and accountability structures. Clinicians view patient-generated streaming data as a promising adjunct to mental health care, particularly for capturing longitudinal change between visits. However, meaningful clinical integration remains constrained by usability, workflow, organizational, and regulatory challenges, as well as limited confidence in data interpretation. Addressing these barriers through improved system integration, interpretive support, validation, and governance will be essential for translating the potential of streaming data into routine clinical practice.

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Assessing the efficacy of behaviourally informed invitation messaging in increasing attendance at the NHS Targeted Lung Health Check: A randomised experimental study

Tan, X.; Danka, M. N.; Urbanski, S.; Kitsawat, P.; McElvaney, T. J.; Jundi, S.; Porter, L.; Gericke, C.

2026-04-24 public and global health 10.64898/2026.04.12.26350693 medRxiv
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Background: Lung cancer screening can reduce lung cancer mortality through early detection, but uptake of the NHS Targeted Lung Health Check (TLHC) programme remains low. Behaviourally informed invitation messages have been proposed as a low-cost approach to increase attendance, but evidence of their effectiveness in lung cancer screening is mixed. Few intervention studies used evidence-based behaviour change frameworks, and rarely tailored invitation strategies to empirically identified barriers and enablers. Methods: In an online experiment, 3,274 adults aged 55-74 years and with a history of smoking were randomised to see one of four behaviourally informed invitation messages or a control message. Participants then rated their intention to attend a TLHC appointment, and selected barriers and enablers to attending from a pre-defined list, which were classified according to the Theoretical Domains Framework. Invitation messages were mapped to Behaviour Change Techniques using the Theory and Techniques Tool. Message conditions were compared on intention to attend TLHC using bootstrapped ANOVA followed by pairwise comparisons. Exploratory counterfactual mediation analyses examined the role of fear in intention to attend. Results: Behaviourally informed invitation messages did not meaningfully increase intention to attend TLHC compared with the control message. While a GP-endorsed message showed a small potential benefit relative to the other conditions, this finding was not robust after adjustment for multiple comparisons. Participants most frequently reported barriers related to Emotion (particularly fear), Social Influence, and Knowledge, while Beliefs about Consequences emerged as the primary enabler of attendance. Only around half of reported barriers and enablers were addressed by the invitation messages. Exploratory analyses found that fear was associated with lower intention to attend a TLHC appointment, yet none of the behaviourally informed messages appeared to reduce fear compared to the control message. Conclusions: Improving lung cancer screening uptake will likely require invitation messages that directly address emotional concerns, particularly fear, alongside credible recommendations. These findings highlight the importance of systematically aligning invitation message content with empirically identified behavioural influences when designing scalable interventions to improve lung cancer screening uptake.

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Stakeholder perspectives on the use of enhanced mobile phone capabilities for public health surveillance for non-communicable disease risk factors: A qualitative study

Mwaka, E. S.; Nabukenya, S.; Kasiita, V.; Bagenda, G.; Rutebemberwa, E.; Ali, J.; Gibson, D.

2026-04-23 health informatics 10.64898/2026.04.22.26351443 medRxiv
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Background: Mobile phone-based tools are increasingly used to collect data on non-communicable disease (NCD) risk factors, particularly in low-resource settings where traditional data collection systems face operational and infrastructural constraints. This study examined stakeholder perspectives on the use of enhanced mobile phone-based capabilities to support the collection of public health surveillance data on NCD risk factors in low-resource settings. Methods: An exploratory qualitative study was conducted between November 2022 and July 2023. Twenty in-depth interviews were conducted with public health specialists, ethicists, NCD researchers, health informaticians, and policy makers in Uganda. Thematic analysis was used to interpret the results. Results: Four themes emerged from the data, including benefits of using mobile phone capabilities for NCD risk factor data collection; ethical, legal, and social implications; perceived challenges of using such mobile phone capabilities; and proposed solutions to improve the utility of phone-based capabilities in data collection on NCD risk factors. Participants recognized the potential of mobile technologies to improve data collection efficiency and expand access to hard-to-reach populations. However, concerns emerged regarding inadequate informed consent, risks to privacy and confidentiality, unclear data ownership, and vulnerabilities created by inconsistent enforcement of data protection laws. Social concerns included low digital literacy, unequal access to mobile devices, and fear of stigmatization. Participants emphasized the need for transparent communication, robust data governance, and community engagement. Conclusion: Mobile phone-based systems can strengthen the collection of NCD risk factor data in low-resource settings; however, their benefits depend on addressing key ethical, legal, and social challenges. To ensure responsible deployment, digital health initiatives must prioritize participant autonomy, data protection, equity, and trust building. Integrating contextualized ethical, legal, and social considerations into design and policy frameworks will be essential to leveraging mobile technologies in ways that support inclusive and effective NCD prevention and control.