This cross-sectional survey study evaluates the influence of international observerships organised by the coalition of healthcare professionals from academic institutions—the Ukrainian Alliance for Medical Exchange and Development (UA-MED)—on the professional development, knowledge transfer and clinical practice improvement of Ukrainian healthcare professionals during the war.

A total of 263 international observerships were facilitated for 204 Ukrainian medical professionals across the institutions in the USA, Canada, Europe and Australia during 2022–2024. To assess the impact of these observerships, a survey was administered focusing on overall satisfaction, procedural knowledge gained and challenges faced when implementing new techniques on return. The primary outcome was the success score, defined as a composite score of implementing new procedures, initiating quality improvement projects and knowledge dissemination efforts.

A total of 128 medical professionals from 45 Ukrainian institutions who completed 138 observerships in 27 institutions abroad participated in the survey (response rate of 62.7%). Observers varied by profession: surgeons (32.8%), radiation oncologists (14.8%), medical oncologists (11.7%), anaesthesiologists (11.7%) and others. Observerships lasted a median of 4 weeks; 74.1% included conference attendance. The average success and satisfaction scores were 6.5/10 and 9.3/10, respectively.

The majority (92.7%) reported a shift in perception of how to practise medicine and 75.5% implemented new procedures on returning to Ukraine. Encouraged to disseminate knowledge, participants provided informal training to colleagues (67.3%), prepared presentations for their institutions (65.5%) and national conferences (32.7%), incorporated learnt materials into educational lectures (39.1%) and engaged in all the activities above (15.5%).

The international observerships played an important role in enhancing the reported skills and knowledge of Ukrainian healthcare professionals during the war. Improvements were reported in clinical practice, medical education and the implementation of new procedures. The success of these observerships underscores the potential for similar programmes in other low-income and middle-income countries/upper-middle-income countries.

Although multiple studies have offered self-collection for human papillomavirus (HPV)-based cervical screening in community settings, there are no randomised controlled trials (RCTs) that have compared implementation outcomes of programme approaches for self-collection. This trial will compare two such approaches in low-resource settings in the states of Tamil Nadu and Mizoram, India.

A cluster RCT will be conducted over a year, offering self-collection to 3000 women aged 30–49 from 28 clusters (average size 101) in selected districts. Clusters in tribal, rural and urban low-income settings will be randomised to two arms. The intervention arm, co-designed with multiple stakeholders, will involve campaigns to offer self-collection in the community. The comparison arm will be offered self-collection at the nearest health facilities.

HPV-based cervical screening will be performed at central laboratories using clinically validated screening assays that can identify the highest risk carcinogenic HPV types (Group 1a–c - HPV16/18/31/33/45/52/58, ±35). Ablative treatment will be based on positivity with this extended genotyping triage, while those with any of the lower carcinogenic HPV types (Group 1d - 39, 51, 56, 59, ±35, Groups 2a/b - 66, 68) will undergo further assessment with visual inspection with acetic acid. Outcomes will be evaluated quantitatively and qualitatively using RE-AIM and the Theoretical Framework of Acceptability.

The primary outcome will be percentage of women well-managed (screened and appropriately treated) in both arms, with secondary outcomes including proportion screened, proportion treated, acceptability (willingness to screen, rescreen, and/or recommend to others) to women, community and healthcare providers, adoption (by providers), implementation fidelity, costs, sustainability assessment and systematically identified implementation barriers and facilitators. The reach, effectiveness and acceptability of community-based self-collection and the use of extended genotyping for triage in resource-constrained, hard-to-reach populations will be assessed, with lessons that can inform future statewide and national programmes.

Ethics approval has been obtained from the Institutional Review Board (IRB) and Ethics Committee of the Christian Medical College Vellore, Tamil Nadu, India (IRB Min. No 14314; INTERVEN), the Alfred Hospital Ethics Committee (HREC Ref 80134, Local Reference: project 601/21), Melbourne, Australia, the IARC Ethics Committee (IEC 21-32), Lyon, France, the Salem Polyclinic Institutional Ethics Committee (SPCIEC/2022/June/01/02), Tamil Nadu, India and the Institutional Ethics Committee, Civil Hospital, Aizawl, Mizoram, India (No.B.12018/1/13-CHA(A)/IEC/115). The study is also approved by the State Scientific Advisory Committee, Directorate of Public Health and Preventive Medicine, Chennai, Tamil Nadu (R. No. 011575/HEB/A2/2023). The Alfred Hospital Approval, as an authorised Australian ethics committee for national mutual recognition, is recognised and registered with the University of Melbourne Human Research Ethics Committee (2024-25255-57650-1). Written informed consent will be obtained from participants. The results of the trial will be disseminated through a peer-reviewed medical journal, and also through workshops, reports and conferences.

The trial has been registered with the Clinical Trials Registry - India: CTRI/2022/04/042327.

To identify parent/caregiver perspectives prior to taking part in a transition care intervention involving group education sessions and peer support for parents/caregivers of adolescents with T1D.

Pre-intervention, semi-structured interviews were conducted with parents/caregivers of adolescents (14–16 years) with T1D followed in a tertiary care paediatric diabetes clinic and participating in a pilot, randomised controlled trial: The Group Education Trial to Improve Transition for Parents/Caregivers of Adolescents with T1D (ClinicalTrials.gov ID: NCT05445284). We conducted a reflexive thematic analysis to identify key aspects of the intervention that may help support parents/caregivers of adolescents with T1D during their transition to adult care.

Of the 17 parents/caregivers randomized to the intervention group, 13 completed pre-intervention interviews.

Four themes were generated from the parents/caregivers, including (1) Creating a Community of Learners (i.e., importance of fostering a bidirectional and supportive environment for parents/caregivers), (2) Psychological Perspectives of Parenting (i.e., acknowledgement of shifting parental/caregiver roles during adolescents’ transition), (3) Diabetes Management During Adolescence (i.e., identification of relevant diabetes education topics to be covered), and (4) Ideal Format and Delivery of the Program (i.e., practical recommendations for the logistics of the intervention).

The findings provide practical and pragmatic suggestions to refine the parent/caregiver-based transition of care intervention for a future, full-scale trial, including addressing parental/caregiver needs as they learn how to best support their adolescent with T1D during transition to adulthood. Future transition programmes for adolescents with T1D may also benefit by incorporating aspects of the current transition readiness program for parents/caregivers of adolescents with T1D.

Hospitalised patients nearing the end of life (EOL) often face complex treatment decisions, leading to potential conflicts among care teams, patients and families. Palliative care consultations may enhance decision-making processes, improve satisfaction and reduce unnecessary interventions. This systematic review will assess the impact of palliative care consultations on treatment decisions, family and patient satisfaction, and psychological outcomes in hospitalised adults.

We will include randomised controlled trials comparing palliative care consultations to standard care in hospitalised adults. The primary outcomes will include decisions to withhold or withdraw treatments, patient and family satisfaction with EOL decision-making, and psychological outcomes such as anxiety, depression and post-traumatic stress disorder. Secondary outcomes will include intensive care unit (ICU) and hospital length of stay, utilisation of potentially non-beneficial treatments, and the use of institutional policies or legal actions. Databases including MEDLINE, Embase, CINAHL, Cochrane CENTRAL and PsycINFO will be systematically searched from inception to September 2025. Two independent reviewers will screen studies and extract data using Covidence. Meta-analyses will use random-effects models to generate pooled estimates for primary and secondary outcomes. Risk of bias will be assessed using the Cochrane Risk of Bias 2 tool, and evidence certainty will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation approach. Subgroup analyses will explore variations by ICU versus non-ICU settings, cancer versus non-cancer diagnoses and default versus clinician-initiated consultations.

Ethical approval is not required for this review. Findings will be disseminated through peer-reviewed publications and conference presentations.

CRD420250624190.

Many researchers conduct a process evaluation alongside an effectiveness trial of a public health intervention to better understand mechanisms behind observed effects. Yet, there is no standardised, scientifically accepted guideline for reporting such process evaluations, which impedes interpretation and comparison of study results. The aim of this project was to develop a consensus-based and expert-based guideline for reporting process evaluations of public health interventions conducted alongside an effectiveness trial.

We conducted an e-Delphi study with a large panel of international experts.

Based on purposive sampling, we invited 137 international experts that had been involved in the design of process evaluations, researchers who published high-profile process evaluations or frameworks, editors of journals that publish process evaluations, and authors of other reporting guidelines.

Based on a literature search, a first draft of the reporting guideline included 32 items, which was proposed to panel members during the first round. Of the invited 137 invited international experts, 73 (53%) participated in at least one round of the e-Delphi study. Participants rated the inclusion and comprehensibility of the proposed items on a 5-point Likert scale and provided comments and suggestions for relevance and definitions of the items. Adjustments to the items and descriptions were proposed to the e-Delphi panel until consensus of ≥67% for each individual item was reached. In total, 64 (88% of 73) completed round 2, and 55 (76% of 73) completed round 3. This resulted in 19 items that are included in the consensus-based process evaluation reporting guideline for public health intervention studies (CONPHES) guideline. The items cover a detailed description of the intervention that is evaluated, the implementation strategies applied, and underlying causal pathways, and the role of the delivery and support team. The guideline also requires describing the evaluation framework and how evaluation outcomes were assessed. Lastly, the guideline includes items on providing a detailed description of applied analyses (both quantitative and qualitative) and measures for assuring quality. The guideline is accompanied by an Explanation and Elaboration document, with a more detailed explanation of each item.

We expect that the CONPHES reporting guideline for process evaluations of public health interventions can improve the reporting of process evaluations of interventions aimed at promoting public health. This can potentially facilitate more effective translation of public health research into practice and contribute to improving both individual and population health outcomes.

To assess the feasibility and preliminary effectiveness of ‘Partners for Patient Safety’ (P4PS) programme for strengthening competencies and patient engagement at the organisational level.

Prospective study with three measurement points (baseline, interim and follow-up) and an explanatory sequential mixed methods approach for formative and process evaluation.

Oncology-focused patient and family advisory councils (PFACs) integrated into healthcare organisations and networks in five German federal states.

Initially, 36 stakeholders of six PFACs were recruited. At follow-up, 27 participated in all intervention modules and completed all surveys. From those, 14 participated in follow-up interviews.

The P4PS programme consists of two sequentially implemented modules: (1) an e-learning module and (2) a 4-hour on-site workshop. The programme focuses on the following topics: patient safety (PS), communication strategies and PFAC engagement in respective care organisations.

Primary outcome measures were feasibility domains, assessed via standardised (acceptability, appropriateness, feasibility) and self-developed measures (relevance, acceptability and social validity, complexity and practicability, demand and implementation, and adaptability). Secondary outcome measure was preliminary effectiveness, measured via changes in self-assessed competencies in PS, communication and engagement.

Feasibility ratings were high across standardised and self-developed measures (median range: 4–5 of 5). Qualitative data showed P4PS programme’s practical relevance, need for organisational support and its adaptability across PFAC contexts. Effectiveness analyses showed significant improvements in PS competencies (adjusted pV) and selected domains of PFAC engagement (adjusted pd=–0.77 to –1.37). Participants expressed strong expectations for future improvements in competencies regarding PS, communication and PFAC engagement.

This P4PS programme showed high feasibility and effectiveness, it increased key competencies, clarified roles and promoted active PFAC engagement in PS. Future work needs to address organisational support and sustainable implementation with application to context as well as long-term evaluation across different care settings.

DRKS00034733; German Clinical Trials Register.

Many patients receive oral anticoagulation for reduced stroke risk in atrial fibrillation or as treatment or prevention of venous thromboembolism. Oral factor Xa inhibitors (oral FXaI, eg, apixaban, edoxaban or rivaroxaban) are commonly prescribed for this indication. Dabigatran, an oral direct thrombin inhibitor, is similarly approved. In vitro and animal model evidence suggests that dabigatran also has direct effects on Staphylococcus aureus virulence and infection. Observational data have shown that dabigatran users are less likely to develop S. aureus bacteremia (SAB), and a small randomised controlled trial showed that dabigatran has anti-S. aureus effects when compared with low molecular weight heparins during bloodstream infection. We seek to answer whether dabigatran is superior to the oral FXaIs in achieving better SAB outcomes among patients who independently require oral anticoagulation. We report the intervention-specific protocol, embedded in an adaptive platform trial.

The S. aureus Network Adaptive Platform (SNAP) trial [NCT05137119] is a pragmatic, randomised, multicentre adaptive platform trial that compares different SAB therapies for 90-day mortality rates. For this intervention (‘Dabi-SNAP’), patients receiving therapy with an oral FXaI will be randomised to continue as usual or to change to dabigatran as of the next scheduled dose. All subjects will receive standard of care antibiotics and/or antibiotics allocated through other active domains in the platform. As the choice of anticoagulant may not demonstrate large differences in mortality, a ranked composite of death and adverse outcomes (Desirability of Outcome Ranking, or DOOR) was chosen as the primary outcome.

The study is conditionally approved by the research ethics board of the McGill University Health Centre: identifier 2025-10900. Trial results will be published open access in a peer-reviewed journal and presented at a global infectious disease conference. The trial is registered at clinicaltrials.gov with the identifier NCT06650501.

NCT0665050.

Cognitive behavioural therapy (CBT) and interpersonal psychotherapy (IPT) are both efficacious treatments for depression, but it is less clear how both compare on outcome domains other than depression and in the longer term. Moreover, it is unclear which of these two psychotherapies works better for whom. This article describes the protocol for a systematic review and individual participant data (IPD) meta-analysis that aims to compare the efficacy of CBT and IPT for adults with depression on a range of outcomes in both the short and long term, and to explore moderators of the treatment effect. This study can enhance our understanding of treatments for depression and inform treatment personalisation.

Systematic literature searches will be conducted in PubMed, PsycINFO, EMBASE and the Cochrane Library from inception to 1 January 2026, to identify randomised clinical trials (RCTs) comparing CBT and IPT for adult depression. Researchers of eligible studies will be invited to contribute their participant-level data. One-stage IPD meta-analyses will be conducted with mixed-effects models to examine (a) treatment efficacy on all outcome measures that are assessed at post-treatment or follow-up in at least two studies, and (b) various baseline participant characteristics as potential moderators of depressive symptom level at treatment completion.

Ethical approval is not required for this study since it will be based on anonymised data from RCTs that have already been completed. The findings of the present study will be disseminated through a peer-reviewed journal or conference presentation.

Anxiety disorders, obsessive–compulsive disorder (OCD) and post-traumatic stress disorder (PTSD) are common in children and adolescents and can lead to significant impairment. Cognitive behavioural therapy (CBT) with exposure is the first-line treatment, yet approximately half of treated youth do not achieve full remission. Dysfunctional cognitions—negative automatic thoughts, maladaptive beliefs and distorted interpretations—are considered key targets of CBT, but evidence in youth is mixed and underpowered. This study will examine whether change in dysfunctional cognitions mediates treatment outcome in anxiety, OCD and PTSD symptoms and whether this association varies across individual characteristics.

An individual participant data meta-analysis (IPDMA) of randomised controlled trials of CBT for youth aged 5–18 years with anxiety disorders, OCD or PTSD will be conducted. The search strategy includes the databases APA PsycINFO, MEDLINE and Web of Science Core Collection from inception to 8 September 2025. It is supplemented by screening reference lists, trial registries, grey literature and outreach to relevant research groups. Eligible trials must include at least one validated measure of dysfunctional cognitions administered at minimum pre- and post-treatment, and clinical outcomes assessed at post-treatment and follow-up. The two primary outcomes are (1) child-reported symptom severity and (2) clinician-rated clinical severity. Data will be harmonised for dysfunctional cognition scores, moderators (age, gender, socioeconomic status, comorbidity), and primary outcomes. One-stage Bayesian mixed-effects models will examine whether changes in dysfunctional cognitions predict improvements in primary outcomes and whether these effects are moderated by individual characteristics. Missing data will be addressed using multiple imputation within the Bayesian framework, and study-level heterogeneity will be modelled using random intercepts and slopes.

All datasets will be de-identified and managed under General Data Protection Regulation standards. Each included trial will have ethical approval permitting data sharing and reuse, and the secondary analysis of the shared datasets has been approved by the University of Amsterdam. Findings will be disseminated via a peer-reviewed publication, scientific conferences and open sharing of analysis scripts and harmonisation procedures.

CRD420251139130.

To contribute to the development of a people-centred global framework for collaborative action on tuberculosis (TB) and comorbidities, a rapid qualitative study on the perspectives of people with lived experience of TB and its associated comorbidities was undertaken.

From August to October 2021, TB survivors from high-burden countries, who encountered at least one comorbidity during TB treatment, were interviewed to explore their healthcare experiences and priorities. Thematic analysis drew on a healthcare acceptability model.

Participants (n=24, 13 women) were treated for drug-susceptible (n=13) or drug-resistant (n=11) TB between 2015 and 2021. They faced diverse comorbidities (mental health and substance use disorders, diabetes, Hepatitis C, lupus and HIV); half of whom reported more than one comorbidity, and all faced socioeconomic hardships. TB diagnosis and treatment exacerbated participants’ comorbidities and, in the absence of integrated support, precipitated mental health challenges. Four healthcare priorities for addressing TB-associated comorbidities were identified: (1) disclosure and early identification of comorbidities, (2) timely and affordable access to care for comorbidities, (3) tailored counselling and peer support and (4) coordinated and consolidated care for TB and comorbidities.

The syndemic manifestation of comorbidities in people affected by TB calls for a people-centred approach to care that facilitates building of trust with multiple care providers, timely linkages to non-TB programmes, access to integrated diagnosis and treatment, allaying intersecting stigmas and self-shame, and care coordination approaches that correspond to people’s needs and preferences. These healthcare priorities were included in the WHO’s Framework for collaborative action on TB and comorbidities.

Digital media practices have varied implications for the mental health of youth, notably as a function of sociocultural and environmental factors. However, there are limited tools available to guide the assessment of digital culture in clinical practice. This study will aim to design and pilot test an interview tool for the assessment of youth digital culture, as a companion to the Cultural Formulation Interview which broadly assesses cultural factors in mental healthcare.

We will recruit youth aged 16–35 years and receiving mental healthcare in Montreal, Canada, to codesign (n=10) and evaluate (n=20) the interview tool. We will also recruit clinician participants (n=10) to provide feedback on the interview. The tool will be developed with codesign participants using the nominal group technique and subsequently tested with the evaluation participants. We will provide the evaluation participants and clinicians with a written summary of the interview and will assess their perspectives on the feasibility, acceptability and utility of the interview method through surveys and debriefing interviews. We will conduct reflexive thematic analysis of the interview transcripts and descriptive quantitative analyses of the feasibility, acceptability and utility scores.

The study received ethical approval from the Research Ethics Board of the CIUSSS de l’Ouest-de-l’Île-de-Montréal (MP-18-2025-1164). The results will be interpreted in consultation with codesign participants and will be disseminated through peer-reviewed publications, workshops for clinicians and academic conferences.