JMIR Research Protocols

Background: Maternal mental health problems are common after prenatal diagnosis of congenital heart disease (CHD), with long-term implications for child and family wellbeing. HEARTPrep is a prenatal psychosocial intervention with three self-paced modules and corresponding telehealth sessions, delivered during pregnancy via mobile app to improve mental health and wellbeing for mothers expecting a baby with CHD. This proof-of-concept study evaluated the feasibility of HEARTPrep and examined maternal mental health and psychosocial functioning throughout participation. Methods: Participants were mothers receiving care for a fetal CHD diagnosis within one health system. Feasibility was assessed via rates of enrollment and completion. Mothers completed 4-item PROMIS questionnaires assessing anxiety, depression, and social isolation and reported self-efficacy and hope on a weekly basis throughout HEARTPrep. Results: Of 34 recruited mothers, 29 (85%) enrolled and two were subsequently not eligible (delivery prior to participation, change in fetal diagnosis), resulting in a final sample of 27 mothers. The majority (n = 22, 81%) completed all three telehealth sessions and Modules 1 (n = 22, 81%) and 2 (n = 19, 70%), with just over half (n = 14, 52%) completing Module 3 prior to delivery. Mean PROMIS depression T-scores decreased from 57.5 to 52.9, and 48% of mothers had a decrease in depression scores exceeding the meaningful change threshold (half standard deviation). The percentage of mothers reporting high self-efficacy increased from 19% to 48%. Conclusions: HEARTPrep is feasible and corresponds with reduced maternal depression and increased self-efficacy, supporting proof-of-concept. A randomized controlled trial is needed to determine whether HEARTPrep improves outcomes compared to a control group.

Background: Two-thirds of Dutch cardiovascular risk management (CVRM) for patients at risk of cardiovascular disease is delivered in primary care practices. While individual risk scores are increasingly used during consultation, a population-level structure for risk-based patient outreach is not currently available. We therefore developed the PROSPERA programme, a multilevel intervention comprising population-level risk stratification and individual-level support tools. Aim: To assess anticipated and experienced barriers and facilitators among healthcare professionals (HCPs) to inform implementation in primary care. Methods: We conducted four focus groups and six interviews with nine primary care HCPs to explore anticipated and experienced barriers and facilitators. Inductive codes were thematically analysed and assigned to corresponding domains of the Theoretical Domains Framework (TDF) and the related Capability, Opportunity, Motivation model of Behaviour. Results: Barriers and facilitators were identified in 11 TDF domains. Population-level barriers included altered professional roles and limitations in technological infrastructure. Individual-level barriers were limited skills in interpreting risk calculations and difficulty integrating tools into clinical routine. Facilitators were related to beliefs on the importance of providing proactive care (population level), the use of U-Prevent for risk communication (individual level) and positive patient responses to the Lifestylecheck questionnaire (individual level). Conclusion: Addressing barriers and facilitators identified at both the population and individual levels can support implementation of the PROSPERA programme. Opportunities exist in education and training of HCPs in risk communication, as well as support in restructuring the physical and digital environment.

Despite the global prevalence of postpartum depression (PPD), current referral uptake rates are far from satisfactory. While some qualitative studies have investigated factors affecting PPD referrals, a gap in quantitative analysis remains. Addressing this, our study utilized a discrete choice experiment (DCE) to understand the procedural elements influencing PPD referral uptake among diagnosed women. The DCE was conducted via home visits by healthcare providers and a comprehensive mobile app questionnaire. We constructed seven distinct referral attributes to explore participants' preferences, analyzed using mixed logit models and latent class analysis. This analysis identified key determinants and revealed the heterogeneities in referral preferences. A total of 698 individuals completed the DCE questionnaire. All assessed attributes, except for Accompaniment (going to clinic with a family member), were important determinants of preference. Participants generally preferred referrals to psychiatric clinics, face-to-face consultations, lower costs, and shorter waiting times. Significantly, participants' personal and socio-demographic characteristics also played a critical role in their referral preferences. Latent class analysis categorized participants into four distinct groups based on their preferences, with treatment cost and waiting times being the most decisive factors. In conclusion, the preference for PPD referrals is predominantly driven by convenience and access to specialist care. To enhance referral uptake, developing flexible and personalized referral programs that cater to these preferences is crucial.

Background: The European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines on nutrition for cancer patients provides evidence based dietary recommendations that is routinely deployed by dieticians in oncology settings. Although these can be culturally adapted, they do not adequately address inter individual variability in treatment related gastrointestinal symptoms and appetite, issues that increase malnutrition risk in cancer patients. Ayurveda, on the other hand, lacks nutrient based guidelines but offers a well grounded dietary framework to assess digestive function and personalise diets. This study investigated the feasibility of combining the two approaches in a clinical setting. Methods: Consenting adult cancer patients diagnosed with any type and stage of cancer were recruited. At baseline, digestive strength, dietary intake, quality and frequency and Patient Generated Subjective Global Assessment (PGSGA) score were recorded. Based on this, personalised meal plans (MPs) that combine nutrient guidelines from ESPEN and traditional food concepts to support digestive strength were provided to participants. Follow ups ranged from 4 weeks to 6 months, at which digestive strength and PGSGA was noted. To evaluate against a benchmark, meal plans were theoretically constructed using Ayurveda concepts (traditional MP) or ESPEN guidelines (Standard MP) alone. Results: Data is presented for 33 participants, of which 52% had weak digestive strength. Baseline intake averaged 879 kcal/day, well below the recommended 1400 to 1600 kcal/ day level. Traditional MPs improved energy intake but were protein insufficient, aspects that were addressed in the standard MPs. Diet quantity (1417 kcal/day), quality and frequency improved on the integrated MP, with 3 patients achieving optimal digestive strength. Personalised counselling reduced malnutrition risk, as reported by PGSGA score. Conclusion: Customising dietary advice by overlaying nutrient guidelines with Ayurveda dietary concepts is feasible. The evaluation of digestive strength holds promise for personalising nutrition therapy. Trial Registration: CTRI/2023/07/055657

Background: Medical and doctoral students in health sciences represent a strategic public health lever as future professionals who will have a lasting influence on healthcare practices and the overall quality of health systems. Impaired quality of life and mental health issues among these students, coupled with scarce prevention programmes, led us to develop PROMESS-Group, an innovative multimodal programme designed to promote healthier lifestyle habits among university students. Methods: We will conduct a 2-arm randomised, controlled, superiority monocentric trial to assess the effect of this programme on medical and doctoral students compared to a control group. The intervention will consist of six sessions covering stress, sleep and physical activity domains. Each session will include group and individual meetings led by trained peer experts, focusing on needs assessment, self-care education, and personalised goals setting. Students' quality of life, academic self-efficacy, and broader health outcomes will be assessed using validated questionnaires and objective tools at baseline, during, and post-intervention. Data will be analysed according to the intention-to-treat principle and presented in accordance with CONSORT guidelines. Ethical approval was obtained from the institutional review board (IRB2025021802). All procedures will be performed in adherence to the Helsinki Declaration. Discussion: This study will enable the generation of high-quality evidence to evaluate the programme's effects on students' quality of life and related psychosocial outcomes, and may inform evidence-based health promotion strategies in university settings. Trial registration: ClinicalTrials.gov: NCT07030751 (https://clinicaltrials.gov/study/NCT07030751?locStr=Lyon,%20France&country=FR&state=Auvergne-Rh%C3%B4ne-Alpes&city=Lyon&cond=promess%20group&rank=1), 06.12.2025 - retrospectively registered. This protocol study follows the SPIRIT guidelines (Appendix 1). Keywords: Doctoral student, health behaviour, medical student, quality of life, physical activity, sleep, stress

BackgroundEmergency obstetrics and newborn care training improves the knowledge and skills of healthcare professionals. However, there is limited evidence on training programs that had been informed by training needs analysis. The aim of the study was to determine training needs of registered midwives to inform a training program. MethodsA descriptive cross-sectional study design was used to collect data from N=202 midwives who worked at two comprehensive emergency obstetrics and neonatal care hospitals. Simple random sampling was used to select respondents. Ethics approval was obtained before conducting the study. Data were collected from November 2023 to January 2024 using an adapted self-administered Hennessy Hicks Training Needs Questionnaire. SPSS version 29 was used to analyze the data. Descriptive statistics, means and standard deviations were calculated. The differences between task importance and task performance were determined for each of the measured items. A paired sample t-test was used to establish the significance of the differences between each of the five category pairs with p=<.05. ResultsThe mean age of the 202 respondents was 38.06{+/-}6.9 years. The midwives predominantly fell into the age group 40-44 years (n=53, 22.2%), and they had an average of 5-9 years of work experience (n=75, 37.1%). Training needs were perceived for all the measured items. The research/ audit category emerged as the highest (M=2.23{+/-}1.05) training need, followed by clinical (1.94{+/-}0.55), administrative (1.70{+/-}1.03), communication (1.57{+/-}0.79) and supervisory tasks (1.14{+/-}0.76). Differences between each of the five category pairs were statistically significant with p=<.05. The highest specific training need was newborn resuscitation (n= 61, 30.2%). ConclusionThe study highlights the need for training on research and clinical tasks. RecommendationTailor training according to the identified needs for the effective management of emergency obstetrics and newborn complications.

Background The Precision rEsearCh pArticipatioN (PECAN) study aims to explore factors that influence perceptions of precision health research participation, focusing on diverse communities in South Carolina. The objective is to identify both positive and negative factors affecting participation, enabling the development of strategies to enhance understanding and reduce barriers, particularly within a population facing significant health disparities. Methods To ensure the effectiveness of the survey instrument for the PECAN study, researchers conducted a cognitive study through guided group discussions with community members. These discussions were designed to pinpoint survey questions that participants found difficult to understand, hard to answer, or unclear. The insights gained from this cognitive evaluation were used to refine and improve the survey, ensuring it is clear, uniform, and effective for gathering meaningful data. Results The cognitive interview study identified several survey items that participants found challenging or ambiguous, particularly due to complex wording, culturally irrelevant content, and questions requiring extensive recall. Participants emphasized the need for clearer language, reassurance about anonymity, and the use of biological terms, as well as greater cultural representation. Based on this feedback, researchers revised the survey to simplify language, provide contextual disclaimers about specimen collection, depersonalize genetic testing questions, and restructure redundant items. Conclusions The cognitive interview study was instrumental in enhancing the PECAN survey's clarity and effectiveness. By addressing participants' feedback, the researchers were able to create a more accessible survey instrument. These improvements are expected to facilitate better data collection, ultimately contributing to a deeper understanding of factors influencing precision health research participation among diverse populations. This methodology highlights the importance of participant feedback in developing research tools that are both inclusive and effective.

BackgroundLifestyle interventions incorporating medically-tailored meal delivery may support rapid behavior change among pregnant individuals with gestational diabetes (GDM). PurposeTo examine the feasibility and acceptability of a multicomponent lifestyle intervention for pregnant individuals with GDM. Primary outcomes included recruitment, retention, intervention receipt, and acceptability. MethodsWe conducted a pilot randomized feasibility trial among pregnant individuals with GDM recruited from maternal fetal medicine clinics in the Hartford, Connecticut area. Participants were randomized to usual GDM care or the Meals4Moms intervention plus usual care. The intervention included medically-tailored meal delivery, personalized physical activity support, and multimodal education with digital tools. Participants completed a survey and three 24-hour dietary recalls at baseline and post-intervention. Meals4Moms participants also completed a semi-structured interview at follow-up. Intervention receipt was tracked by study staff. ResultsOf 30 individuals approached, we screened 80% (n=24), of whom 75% (n=18/24) were eligible; we randomized 8 participants. Seventy-five percent (n=6/8) completed at least one component of the follow-up assessment (100%, n=4/4 Meals4Moms, 50%, n=2/4 Usual Care). One participant spent [&ge;]80% of her total food budget (n=1/4, 25%), and no participants completed [&ge;]80% of prescribed exercise sessions (range: 0-50%). All (n=4) Meals4Moms participants reported they would be very likely to participate in the program if they had GDM again, and 100% (n=4) would be very likely to recommend the program to a friend with GDM. ConclusionsWhile the Meals4Moms intervention was highly acceptable to participants, procedural refinements are needed prior to conducting a full-scale efficacy trial.

Background: Young women in Ghana (18-35 years) remain disproportionately affected by HIV due to intersecting structural and social challenges, including stigma, gendered power dynamics, and limited access to women-centered prevention services. Although HIV self-testing (HIVST) and pre-exposure prophylaxis (PrEP) are effective biomedical prevention strategies, uptake among young Ghanaian women remains low. Barriers include limited awareness, persistent stigma, and a lack of culturally relevant, youth-responsive prevention approaches. The WISE WOMAN study aims to address these gaps by developing and piloting a women-centered HIV prevention intervention co-created with young women in Ghana. Methods: This protocol describes a pilot implementation study of a women-centered HIV prevention intervention that will be delivered via WhatsApp. The intervention is informed by community-based participatory research and human-centered design approaches to enhance cultural relevance and responsiveness to young womens lived experiences. The study will enroll 50 young women aged 18-35 years who will participate in a four-week WhatsApp-based intervention designed to increase HIV prevention knowledge, reduce stigma, and support engagement with HIVST and PrEP. Implementation outcomes, including feasibility, acceptability, and appropriateness, will be assessed using mixed methods. Quantitative data will be collected through baseline and post-intervention surveys, including the PIERS-22 engagement scale, and will be analyzed using descriptive statistics and paired comparisons. Qualitative data from group interactions and post-intervention interviews will be analyzed using thematic analysis. The study has received ethical approval from the University at Buffalo Institutional Review Board (STUDY00009328) and the Ensign Global College Ethics Committee (IRB/EL/AF-02/2025) and is registered at ClinicalTrials.gov (NCT07003789). Discussion: This protocol outlines the design and methods for a digitally delivered, women-centered HIV prevention intervention grounded in participatory approaches. The planned pilot study will generate critical implementation evidence on the feasibility, acceptability, and appropriateness of a WhatsApp-based, co-designed intervention, informing future adaptation, scale-up, and integration of culturally grounded HIV prevention strategies for young women in Ghana and similar settings.

Background Depression and anxiety are prevalent among cardiovascular disease (CVD) patients and significantly worsen clinical outcomes, increasing complications, recurrent events, and healthcare costs. Evidence shows that psychological stress, depression, and anxiety elevate CVD risk, while post-discharge nurse-led telephone follow-up has demonstrated benefits in patient support and symptom management. Little is known about its impact on mental health. Objective The aim of this study was to evaluate the effects of implementing the "nurse telephone follow-up" project on depression, anxiety and stress levels among cardiovascular patients. Methods An experimental study was conducted with 60 randomly selected patients from the Coronary Care Unit (CCU) department of a hospital in Iran, who were divided into two groups: an intervention group and a control group. The educational intervention was administered within two weeks after discharge. Data were collected via the Depression Anxiety Stress Scale (DASS-21). Descriptive analysis, Mann?Whitney and Wilcoxon tests, Generalized Estimating Equations (GEE) regression, and Spearmans correlation were used for data analysis. Results The mean age of the patients was 57.43 {+/-} 15.33 years. While no significant difference was found between the intervention and control groups in terms of depression, anxiety, or stress (p>0.05), the depression score decreased by 1.53 points, and the anxiety score decreased by 1.18 points after the intervention. Furthermore, an increase in patients ejection fraction (EF) score was associated with a 0.1 decrease in both depression and anxiety levels. No significant relationship was found between stress and any variables. Conclusions The results of this study suggest that psychological and therapeutic interventions may help reduce depression and anxiety in patients with cardiovascular diseases. However, this requires further detailed evaluation and additional studies. The potential link between improved cardiac function and reduced psychological symptoms could be effective in designing more comprehensive treatments for these patients.

Background: With an aging population and increasing comorbidities, supporting people to remain at home for as long as possible is essential. A major challenge in home care is ensuring coordinated, interprofessional collaboration among all actors involved: patients and their close ones, health and social care professionals, and the broader health and social network. To address this challenge, a new organizational model promoting reinforced interprofessional collaboration, the "Reseau Interprofessionnel Ambulatoire de Proximite" (Local Interprofessional Outpatient Network; RIAP) has recently been developed in the canton of Geneva. The aim of this paper is to present the protocol for a research project evaluating both the effectiveness and implementation of this model. Methods: This is a type-2 hybrid effectiveness implementation study guided by the RE-AIM framework, aiming to evaluate the RIAP organizational model and its implementation, context, and outcomes. This multi-method study will examine the RIAP model under real-world conditions. Routinely collected data on patient outcomes and institutional processes will be used to compare the RIAP model with usual care. Questionnaires will assess patients' perceptions of continuity of care, professionals' perceptions of interprofessional collaboration, and stakeholders' views on the acceptability of the model. Open-ended questions will be included to explore experiences and insights in greater depth, complemented by qualitative data on barriers and facilitators to implementation. Financial indicators will also be analyzed to contextualize the model within the institutional setting. Results: The EFFI-RIAP project began in October 2025 and has a planned duration of 22 months. The project will primarily rely on the reuse of institutional routine data, complemented by questionnaires and interviews scheduled for September 2026. At the time of submission, study preparation and institutional data processing are ongoing. Discussion: This research will provide insights into the clinical, organizational, and implementation-related effects of the RIAP model compared with usual care. The natural deployment of new RIAP teams will enable investigation of the organizational model under real-world conditions. The combined evaluation of the effectiveness and implementation of RIAP will assess the model's added value, inform refinement, and identify potential barriers and facilitators relevant to implementation in other teams.

BackgroundMobile health programs (MHPs) provide essential preventive services to uninsured and underserved communities. Following the 2024 regulatory approval of human papillomavirus (HPV) self-collection for cervical cancer screening, MHPs represent an access point for healthcare-based self-collection. However, little is known about patient perceptions of this approach in MHP and other healthcare settings. MethodsFrom May - August 2025, we surveyed individuals aged 25-65 years with a cervix who attended MHPs in Southern Arizona. The survey assessed interest in HPV self-collection, preferred locations, instructional preferences, and facilitators to attend follow-up after a positive result. Descriptive statistics summarized demographic characteristics and survey responses. ResultsFifteen female participants completed the survey (mean age 36 years). Ten (67%) identified as Hispanic or Latino, nine (60%) preferred Spanish, and 14 (93%) were uninsured. Interest in HPV self-collection was high, with ten (67%) very or extremely interested. Among those interested, nine (69%) preferred home-based self-collection, and four (31%) preferred clinic or MHP-based self-collection. Most common concerns regarding self-collection on the MHP were ensuring privacy (n=7; 47%) and knowing how to perform the test correctly (n=5; 33%). Most participants (n=11; 73%) reported being very or extremely confident they would attend follow-up after a positive result; language-concordant support, reminder calls, and scheduling assistance were the most endorsed facilitators. ConclusionHPV self-collection was highly acceptable among MHP attendees, although home-based self-collection was most preferred. Addressing privacy concerns, providing multiple modes of instruction, and offering navigation support may improve implementation success and ensure timely follow-up care in MHP settings.

Introduction: Menstrual cycle phase has been proposed as a source of intra-individual variability in resting energy expenditure and the thermic effect of food in premenopausal females, yet studies examining the thermic effect of food across menstrual cycle phases report conflicting findings. Methods: This protocol describes a secondary analysis of prespecified outcomes from a non-randomized, two-period crossover trial primarily designed to assess postprandial plasma triglyceride concentrations across menstrual cycle phases (ClinicalTrials.gov: NCT07459465) in 12 premenopausal females aged 18-30 years, free of chronic disease and hormonal contraceptive use, recruited in Ottawa, Canada. Participants complete two experimental sessions: one in the early follicular phase and one in the mid-luteal phase, each involving consumption of a high-fat meal. Eleven secondary outcomes will be reported: fasting resting energy expenditure, thermic effect of food, respiratory exchange ratio, carbohydrate oxidation rate, lipid oxidation rate, desire to eat, hunger, fullness, prospective food consumption, serum beta-estradiol, and serum progesterone. Masked outcome analyses are performed using linear mixed-effects models. Results: Recruitment began on 26 March 2026; results will be reported in the Stage 2 manuscript. Discussion: Findings from this trial may help clarify whether menstrual cycle phase constitutes a meaningful source of intra-individual variability in energy metabolism, with implications for the design of metabolic research in premenopausal females.

Background: Pre-exposure prophylaxis (PrEP) has demonstrated a significant reduction in HIV infections among men who have sex with men (MSM), however, low medication adherence hinders its preventative effectiveness. Traditional approaches, such as health education and face-to-face inquiry (HEF), have demonstrated certain efficacy in improving PrEP adherence. However, these methods are resource-intensive and often plagued by delays, rendering timely and precise interventions challenging. This randomized controlled trial aims to assess the effectiveness of an intervention comprising AI-chatbot for PrEP (PrEP-bot) and Smart pillbox (SPB) (PrEP-bot-SPB) strategy to improve PrEP adherence among MSM compared to HEF.Methods and analysis: A three-arm, multicenter, open-lable RCT will be conducted with Chinese MSM [&ge;]18 years. A total of 300 participants will be recruited through three sources, including hospitals, community-based organizations (CBOs) and peer referral in five cities: Shenzhen, Beijing, Qingdao, Hangzhou and Zhengzhou. After completing baseline survey, participants will be randomized evenly into interventions or control groups: the PrEP-bot group, the PrEP-bot-SPB group, and the HEF control group. Participants in the PrEP-bot group will be granted access to an AI-chatbot agent through WeChat. This agent will: 1) generate personalized PrEP medication plans; 2) provide medication reminders and PrEP-related health check-ups notifications; 3) inquire about missed doses to deliver tailored interventions; 4) answer participant questions about PrEP using guideline-based knowledge. Participants in the PrEP-bot-SPB group will receive both the SPB and the PrEP-bot interventions. SPB could delivers medication reminders. Participants in HEF group will receive a health education pamphlet introducing PrEP and knowledge related to PrEP medication adherence at baseline and face-to-face inquiry every three months. Outcomes will be assessed for both short-term and medium-to-long-term effects. The primary objective is the effectiveness in improving PrEP adherence measured by self-report, Eight-Item Morisky medication adherence scale (MMAS-8) and concentration of Tenofovir in dried blood spots (DBS) (PrEP adherence [&ge;]90%) at 3 months follow-up. Secondary outcomes include: 1) effectiveness in preventing HIV infection measured by HIV-self test (HIVST); 2) effectiveness of PrEP-related health check-ups; 3) the effectiveness, feasibility, acceptability, and user satisfaction with the PrEP-bot; 4) effectiveness in improving PrEP adherence at 6-month, 9-month and 12-month follow-up periods. All participants will receive quarterly follow-up visits during the 12-month study period. Intention-to-treat analysis and per protocol set (PPS) analysis will be used.Results: Recruitment and enrollment of participants began in January 2026 and is currently ongoing.Discussion: This study is expected to establish a novel AI-based intervention model for PrEP, providing innovative strategies for HIV control among MSM populations. If the PrEP-bot is proven non-inferior to HEF, it could offer users real-time, precise, and personalized interventions while simultaneously addressing PrEP-related inquiries and health check-ups reminders. Importantly, this approach would achieve significant reductions in resource requirements for implementation and maintenance and be more cost-effective. With the ongoing advancement of AI technologies, PrEP-bot holds substantial promise for widespread implementation in PrEP adherence, potentially revolutionizing HIV prevention for MSM in China through this innovative intervention modality.Trial registration: ChiCTR2500111280 (Chinese Clinical Trial Registry). Date of registration: 29 October 2025.

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

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

ObjectiveTo explore the interpretation of unexpected results from a randomized controlled trial (RCT). Study Design and SettingAdjunctive frequentist (power and type{square}M error) and Bayesian analyses were performed on a recently published RCT reporting a statistically significant relative risk reduction (p <0.01) for caffeinated coffee drinkers compared with abstinence on atrial fibrillation (AF) recurrence. Individual patient data for the Bayesian survival models were reconstructed from the RCT published material and priors informed by the RCT power calculations. ResultsThe original RCT design had limited power for realistic effect sizes, increasing susceptibility to type{square}M (magnitude) error. Bayesian analyses also tempered the benefit for caffeinated coffee implied by standard statistical analysis resulting in only modest probabilities of clinically meaningful risk reductions (e.g., hazard ratio < 0.9 of 88% or a risk difference > 2% of 82%). ConclusionsSupplemental frequentist and Bayesian approaches can provide robustness checks for unexpected RCT findings, providing contextualization, clarifying distinctions between statistical and clinical significance, and guiding replication needs. HighlightsO_LIRandomized controlled trial (RCT) results may be unexpected and challenge prior beliefs C_LIO_LISupplemental frequentist and Bayesian analyses can clarify interpretation of surprising findings C_LIO_LIPower and type{square}M error assessments help evaluate design adequacy for realistic effects C_LIO_LIBayesian posterior probabilities provide additional nuanced insights into contextulaization and clinical significance C_LI

Background: Obesity is globally recognized as a complex, multifactorial chronic disease, with biological, psychological, environmental and behavioural factors involved in both disease pathogenesis and maintenance. Although previous group-based studies demonstrated involvement of each of these factors, there is large inter-individual variability in the factors contributing to disease development as well as intervention outcomes, causing limited translatability to the individual level. This heterogeneity in treatment effectiveness might be due to differential causal and maintenance factors of obesity. To enable the transition from a one-size-fits-all approach to a more personalized approach for individuals with overweight or obesity, this study aims to investigate if and how the degree of weight loss and changes in daily life behaviour after a combined lifestyle intervention depend on individual baseline profiles comprising of person characteristics, biological, psychological, environmental and behavioural factors. Methods: This study will include 600 individuals varying in BMI, 200 participants with a healthy BMI (18.5-24.9kg/m2), 200 with overweight (BMI 25.0-29.9kg/m2), and 200 with obesity (BMI [&ge;]30.0kg/m2). For all participants, a comprehensive individual baseline profile is created, including person characteristics, biological, psychological, environmental and behavioural factors. A clustering method is applied to identify clusters of participants with similar characteristics. Next, we examine if and how these clusters are linked to bodyweight indicators measured at baseline, and how they relate to daily lifestyle behaviour, as measured by ecological momentary assessment (EMA) using a smartphone app and sensor technology (3-week measurements). Individuals with overweight or obesity will be randomized to the intensive lifestyle intervention or a lifestyle information condition, to determine if treatment response can be predicted based on cluster characteristics, how daily lifestyle behaviour changes after an intervention, and how changes in daily lifestyle behaviour relate to treatment response. Discussion: The End of Average study aims to characterize a large set of individuals varying in body weight to predict intervention effectiveness measured as changes in body weight indicators and in daily lifestyle behaviours. If reliable predictors of treatment success can be identified, these can be applied in personalized lifestyle interventions to improve lifestyle behaviour, body weight management and overall health.

IntroductionAdolescents with mental health disorders represent a vulnerable group with complex care needs, yet their and their relatives experiences in acute inpatient mental health services remain poorly understood. While patient-reported experience measures (PREMs) are increasingly recognized as essential for improving healthcare quality, validated instruments for child and adolescent mental health inpatient settings are lacking--particularly from the perspective of relatives, who are often deeply involved in care. ObjectiveThis study aims to develop and psychometrically evaluate the Relatives Experience Questionnaire for Acute Inpatient Child and Adolescent Mental Health Services (REQ-AICAMHS), the first instrument designed to capture relatives experiences in Norwegian acute inpatient mental health units for adolescents. MethodsThe REQ-AICAMHS will be developed using the Norwegian Institute of Public Healths (NIPH) standard methodology, including a literature review, expert consultation, qualitative interviews, and cognitive testing with relatives. Data will be collected digitally from relatives of all adolescents admitted to 17 acute inpatient child and adolescent mental health units across Norway. Descriptive statistics, exploratory factor analysis (EFA), and Item Response Theory (IRT) using the Generalized Partial Credit Model (GPCM) will be applied to assess data quality, factor structure, construct validity, and internal consistency. Open-ended responses will be analysed using both qualitative and machine learning methods to identify key themes and subdomains of experience. ResultsPreliminary results will include descriptive statistics of respondents, item-level analysis (missing data, ceiling effects), factor loadings and reliability coefficients (Cronbachs alpha [&ge;]0.7), inter-item and scale correlations, construct validity testing, and IRT parameters (item discrimination and threshold estimates). Findings will inform the development of a shortened version of the questionnaire for broader implementation in quality improvement initiatives.

The ISBAR framework is used to standardize clinical handovers and enhance patient safety. Observational tools based on ISBAR have been developed to assess the completeness of information transfer. However, these instruments have primarily been developed in non-Chinese contexts, and validated Chinese-language observational tools suitable for clinical practice remain limited. In this study, a cross-cultural adaptation and psychometric validation of the ISBAR Structured Handover Observation Tool was conducted, examining its reliability and discriminant validity in Chinese clinical settings. The study was conducted in two phases: cross-cultural adaptation and psychometric evaluation in real-world clinical settings. Content validity was assessed using the Content Validity Index (CVI), and inter-rater reliability was evaluated using the Intraclass Correlation Coefficient (ICC) based on a two-way mixed-effects model with absolute agreement. Discriminant validity was examined using the Mann-Whitney U test to compare scores across nurses with varying levels of clinical experience. A total of 233 handover cases involving patient transfers from the intensive care unit (ICU) to general wards were collected, involving 84 nurses. The scale demonstrated good content validity, with item-level content validity indices (CVI) ranging from 0.88 to 1.00 and a scale-level CVI/Ave of 0.98. The inter-rater reliability, assessed using fifty randomly selected cases, was high, with an intraclass correlation coefficient (ICC) of 0.885 for single-rater assessments and 0.939 for average-rater assessments. Discriminant validity analysis showed that nurses with more clinical experience had significantly higher total scores than those with less experience (Z = -4.772, p < 0.001). The Chinese version of the ISBAR Structured Handover Observation Tool demonstrates good content validity, high inter-rater reliability, and acceptable discriminant validity. This tool provides a standardized and practical method for assessing the completeness of information transfer and is expected to support quality improvement in patient handover from the ICU to general wards in Chinese clinical settings.