Non-adherence to tuberculosis (TB) treatment remains a major challenge in high-burden regions. However, few studies have qualitatively examined the sociocultural and emotional barriers to adherence, particularly among Afghan refugees in Pakistan. This study explores the patient-related, sociocultural and treatment-related barriers to treatment adherence among patients with TB of Pakistani and Afghan origin living in Pakistan.

We conducted an exploratory qualitative study consisting of semistructured focus group discussions (FGDs) and in-depth interviews (IDIs) with purposively selected multisectoral stakeholders. The data were analysed thematically using a combination of inductive and deductive approaches.

We employed a qualitative study design in the TB DOTS (Directly Observed Treatment Short course) centres in the Haripur and Peshawar districts of Khyber Pakhtunkhwa province, Pakistan.

We conducted IDIs (n=29) and FGDs (n=11) with three categories of participants: TB healthcare providers, patients with TB and their carers.

We identified several contributors to lower treatment adherence. These included patient-related barriers (eg, lack of awareness about TB and its treatment), sociocultural barriers (eg, stigma, refugee status of Afghan patients, gender roles and reliance on traditional and spiritual healing) and treatment-related barriers (eg, demanding treatment regimen and TB-induced depression).

Several personal, sociocultural and treatment-related barriers contribute to lower treatment adherence in patients with TB. A significant contributing factor to treatment non-adherence in patients is the high prevalence of anxiety and depression related to TB and its treatment, for which there is no treatment or counselling available at the DOTS level in Pakistan, warranting the need for mental health interventions that could improve adherence and treatment outcomes for both TB and depression.

ISRCTN10761003.

Engaging patients in surgical safety is challenging and has not been thoroughly investigated. Although surgical checklists and other safety protocols have been introduced across various surgical fields, preventable adverse events still occur, highlighting the need for additional research. A Patient’s Safety Checklist (PASC) has been developed and validated for use by surgical patients. Its effect on patient safety and patient outcomes is currently being investigated in a Stepped Wedge Cluster Randomised Controlled Trial (NCT03105713). In connection with this trial, we have examined elective patients’ experiences with using the PASC.

An exploratory qualitative study was conducted based on individual in-depth telephone interviews with 31 elective surgical patients. The interviews were carried out across three Norwegian hospitals including seven surgical specialties. The patients interviewed were part of the trial’s intervention arm and had used PASC. The interviews were transcribed verbatim, and reflective thematic analysis was applied.

Three themes were identified in the data: patient awareness, patient actions and utility value. Patients perceived PASC to increase awareness around surgical information, preparations, what to speak up about and which information to seek and repeat. This awareness led to a series of actions, such as ensuring medication control, optimising their own health, contacting healthcare professionals, asking questions, and for some no actions were needed. Patients perceived PASC to have high utility value for their surgical preparation.

The PASC enhanced patients’ involvement in surgical care and safety by ensuring they received systematic, accurate, clear, and understandable information and instructions throughout the surgical pathway. It is one of the few existing interventions that specifically focuses on assisting patients in preparing for surgery and managing their recovery. Further research is needed on the implementation of PASC and its adaptation to other clinical settings.

NCT03105713.

To investigate whether gestational diabetes mellitus (GDM) was associated with survival without bronchopulmonary dysplasia (BPD) in very preterm infants (VPIs).

Retrospective multicentre cohort study.

A total of 79 neonatal intensive care units across China, January 2019 to December 2021.

A total of 23 752 VPIs (

The primary outcomes are survival without BPD at 36 weeks’ postmenstrual age (PMA) and its components.

Infants exposed to GDM were associated with a higher rate of survival without BPD (aOR 1.12, 95% CI 1.04 to 1.21) at 36 weeks PMA and lower mortality (aOR 0.75, 95% CI 0.64 to 0.84) before 36 weeks PMA than unexposed infants. However, no significant association was observed between GDM and BPD at 36 weeks PMA (aOR 0.94, 95% CI 0.87 to 1.02), respiratory distress syndrome, need for advanced resuscitation or mechanical ventilation. After propensity score matching, GDM-exposed VPIs maintained higher survival without BPD (aOR 1.13, 95% CI 1.02 to 1.26) and lower mortality (aOR 0.81, 95% CI 0.68 to 0.97). These associations were strongest in infants born before 28 weeks (aOR 1.32, 95% CI 1.11 to 1.57) and those small for gestational age (aOR 1.41, 95% CI 1.11 to 1.80).

GDM was not associated with worsened BPD in VPIs. The positive association with survival and survival without BPD warrants could reflect a selection bias.

This study aimed to examine how older adults form beliefs about their memory and how these beliefs are influenced by their level of concern about dementia. Inaccurate beliefs and excessive worrying, indicative of erroneous metacognition, are associated with negative health outcomes. This research can help identify mitigation for these harmful effects.

Qualitative focus groups; thematic analysis.

Focus group discussion with healthy older adults hosted at a university in central London.

35 healthy older individuals (women=29) without any psychiatric or neurological diagnoses, over the age of 65 years (mean 75.31, SD: 6.15). 13 participants were identified as having a high level of worry about dementia and 22 as having low worry. Groups were matched for cognitive performance on the Telephone Mini Addenbrooke’s cognitive assessment (Tele-MACE).

Participants were assigned to a focus group depending on their level of worry about dementia. During focus groups, a vignette prompted discussion around lifespan changes in memory and how this affected concerns around memory. This allowed investigation of the differences in beliefs about memory.

Thematic analysis revealed two key themes. First, older adults appear to base their definition of ‘normality’ of their own memory on comparisons. These comparisons were between themselves and others and between themselves now and their own past self. Despite similar strategies to define ‘normality’, those with high dementia worry had stricter definitions of what they determined as normal. The second theme described narratives around the ‘self’ and the ‘other’. There was a difference between those with high versus low worry; those with high worry had a strong focus on the ‘self’, while those with low dementia worry focused on ‘others’.

Comparison is a common metacognitive strategy used in forming beliefs about memory. Targeting the use of comparison is potentially valuable in interventions aiming to alleviate older adults’ memory concerns. Addressing self-focused thinking, for example, with cognitive behavioural therapy, could improve harmful levels of high worry.

There are substantial barriers to initiate advance care planning (ACP) for persons with chronic-progressive disease in primary care settings. Some challenges may be disease-specific, such as communicating in case of cognitive impairment. This study assessed and compared the initiation of ACP in primary care with persons with dementia, Parkinson’s disease, cancer, organ failure and stroke.

Longitudinal study linking data from a database of Dutch general practices’ electronic health records with national administrative databases managed by Statistics Netherlands.

Data from general practice records of 199 034 community-dwelling persons with chronic-progressive disease diagnosed between 2008 and 2016.

Incidence rate ratio (IRR) of recorded ACP planning conversations per 1000 person-years in persons with a diagnosis of dementia, Parkinson’s disease, organ failure, cancer or stroke, compared with persons without the particular diagnosis. Poisson regression and competing risk analysis were performed, adjusted for age, gender, migration background, living situation, frailty index and income, also for disease subsamples.

In adjusted analyses, the rate of first ACP conversation for persons with organ failure was the lowest (IRR 0.70 (95% CI 0.68 to 0.73)). Persons with cancer had the highest rate (IRR 1.75 (95% CI 1.68 to 1.83)). Within the subsample of persons with organ failure, the subsample of persons with dementia and the subsample of stroke, a comorbid diagnosis of cancer increased the probability of ACP. Further, for those with organ failure or cancer, comorbid dementia decreased the probability of ACP.

Considering the complexity of initiating ACP for persons with organ failure or dementia, general practitioners should prioritise offering it to them and their family caregivers. Policy initiatives should stimulate the implementation of ACP for people with chronic-progressive disease.

In Bangladesh, evidence on the long-term trajectory of adolescents' sexual and reproductive health (SRH) remains limited, largely due to the lack of longitudinal data to assess the changes over time. To address this gap, the Advancing Sexual and Reproductive Health and Rights (AdSEARCH) project of International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) set up an adolescent cohort study aimed at documenting changes in SRH knowledge, attitudes and practices, and identifying the factors affecting these changes. This article presents the baseline sociodemographic and SRH characteristics of this cohort as a pathway for future analyses.

This cohort study included 2713 adolescents from the Baliakandi Health and Demographic Surveillance System run by icddr,b. The cohort covered three age groups from girls and boys, giving a total of five cohorts: girls aged 12, 14 and 16 years; and boys aged 14 and 16 years. A total of seven rounds of data had been collected at 4-month intervals over 2-years follow-up period.

The majority of adolescents were attending school (90%), and school dropouts were higher among boys. Around 17% of the respondents were involved in income-generating activities, which were mostly boys. Among girls, the mean age of menarche was 12.2 years. Overall, 6% of adolescents had major depressive disorder, with prevalence increasing with age. Gender differences were evident regarding knowledge about conception and contraception. Egalitarian attitudes towards social norms and gender roles were found higher among girls (52%) compared to boys (11%). The majority of adolescents reported experiencing social/verbal bullying (43%), followed by physical violence (38%) and cyberbullying (4%).

This article presents the baseline findings only. A series of papers is in the pipeline for submission to different peer-reviewed journals. The findings from this study will be used to support data-driven policy formulation for future adolescent health programmes.

Transvaginal and transabdominal cerclage procedures have become established interventions to prevent mid-trimester pregnancy loss and preterm birth. Transabdominal cerclage seems to be superior to transvaginal cerclage in women with a history of a failed transvaginal cerclage. However, with the availability of a less invasive laparoscopic procedure, there is limited evidence concerning which type of cerclage to recommend to many other risk groups. The objective of this trial is to compare laparoscopic abdominal cerclage and transvaginal cerclage in women at moderate to high risk of spontaneous preterm birth.

The trial is an open, multicentre, superiority, parallel arm randomised controlled investigator-initiated trial with an embedded internal pilot. Women in whom the clinician has clinical equipoise between laparoscopic and transvaginal cerclage are randomised to either laparoscopic abdominal or transvaginal cerclage in a ratio of 1:1. The trial extends from sites in Denmark, Finland and Norway. The primary outcome is birth

The Central Denmark Region Committee on Biomedical Research Ethics, Denmark, Helsinki University Hospital Ethics committee, Finland and the Regional Committees for Medical and Health Research Ethics, Norway approved the trial. This protocol is published prior to complete data collection and analysis. Important protocol changes will be made publicly available on ClinicalTrials.org, on the trial website and distributed electronically to all active sites. Positive, inconclusive as well as negative results from the trial will be published in peer-reviewed international scientific journals.

NCT06122506.

Incretin-based drugs, including glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) and dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 RAs, are increasingly used in the management of type 2 diabetes mellitus and obesity. While these agents have shown cardiovascular benefits, their effects on both cardiovascular outcomes and cardiac structure and function remain uncertain—particularly in patients with and without a history of heart failure (HF).

We will conduct a systematic review and search major medical databases (Cochrane Central Register of Controlled Trials (CENTRAL), Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica Database (EMBASE), Latin American and Caribbean Health Sciences Literature (LILACS), Science Citation Index Expanded (SCI-EXPANDED) and Conference Proceedings Citation Index-Science (CPCI-S)), as well as clinical trial registries from their inception and onwards to identify relevant randomised trials. The literature search is scheduled for July 2025. Two review authors will independently extract data and assess risk of bias. We will include randomised controlled trials assessing the effects of cagrilintide/semaglutide, liraglutide, semaglutide and tirzepatide in patients with and without a history of HF. The primary outcome will be cardiovascular mortality. Secondary outcomes will include HF hospitalisation, myocardial infarction, stroke, heart rate, systolic blood pressure, N-terminal pro B-type natriuretic peptide, left ventricular ejection fraction, left ventricular end-diastolic volume and left ventricular end-systolic volume. Data will be synthesised by aggregate data meta-analyses and trial sequential analysis. Risk of bias will be assessed with the Cochrane Risk of Bias tool, version 2, and the certainty of the evidence will be assessed by Grading of Recommendations, Assessment, Development and Evaluations (GRADE).

As this study is a systematic review based on secondary analysis of published data, ethical approval is not required. Findings will be published in international peer-reviewed scientific journals.

CRD420251003374.

Treatment expectations are a key mechanism of placebo effects in clinical trials. In a previous study (PSY-HEART-I), preoperative expectation optimisation improved quality of life 6 months postcardiac surgery. However, barriers such as travel distance, staffing shortages and COVID-19 limited participation. This study evaluates the feasibility and acceptability of iEXPECT, a brief internet-based intervention designed to optimise expectations before heart surgery.

In this three-arm, multicentre randomised controlled trial, 160 patients undergoing elective coronary artery bypass graft surgery are randomised to: (a) standard of care (SOC); (b) SOC plus iEXPECT with phone-based guidance (iEXPECT enhanced) or (c) SOC plus iEXPECT with email-based guidance (iEXPECT limited). The intervention includes four 20 min online modules addressing surgical benefits, side effects and coping strategies. Modules are accompanied by personalised guidance provided through feedback on each module via email or telephone (three before surgery, three booster sessions at 6, 12 and 18 weeks postsurgery). Assessments occur at baseline (5–21 days before surgery), preoperatively (day before surgery), 7 days postsurgery and 6 months later. Primary feasibility outcomes include recruitment (≥1 participant/week/centre), retention (≥49% completing 6-month follow-up including biomarkers) and engagement (≥75% completing ≥1 presurgery module). Acceptability is measured by self-reported enjoyment, usefulness and impact, with acceptance defined as mean scores >3.4 (5-point Likert scale) and CSQ-I ratings. Secondary outcomes include psychological measures, inflammatory markers and heart rate variability.

Ethical approval was granted by the Ethics Committees of Philipps University Marburg (AZ 229/23 BO) and the University of Giessen (AZ 186/23). All participants provide written informed consent. Results will be shared via publications, conferences and public outreach with relevant consumer advocacy groups.

DRKS00033284.

In 2022, the WHO conditionally recommended the use of treatment decision algorithms (TDAs) for treatment decision-making in children

Within the Decide-TB project (PACT ID: PACTR202407866544155, 23 July 2024), we aim to generate an individual-participant dataset (IPD) from prospective TB diagnostic accuracy cohorts (RaPaed-TB, UMOYA and two cohorts from TB-Speed). Using the IPD, we aim to: (1) assess the diagnostic accuracy of published TDAs using a set of consensus case definitions produced by the National Institute of Health as reference standard (confirmed and unconfirmed vs unlikely TB); (2) evaluate the added value of novel tools (including biomarkers and artificial intelligence-interpreted radiology) in the existing TDAs; (3) generate an artificial population, modelling the target population of children eligible for WHO-endorsed TDAs presenting at primary and secondary healthcare levels and assess the diagnostic accuracy of published TDAs and (4) identify clinical predictors of radiological disease severity in children from the study population of children with presumptive TB.

This study will externally validate the first data-driven WHO TDAs in a large, well-characterised and diverse paediatric IPD derived from four large paediatric cohorts of children investigated for TB. The study has received ethical clearance for sharing secondary deidentified data from the ethics committees of the parent studies (RaPaed-TB, UMOYA and TB Speed) and as the aims of this study were part of the parent studies’ protocols, a separate approval was not necessary. Study findings will be published in peer-reviewed journals and disseminated at local, regional and international scientific meetings and conferences. This database will serve as a catalyst for the assessment of the inclusion of novel tools and the generation of an artificial population to simulate the impact of novel diagnostic pathways for TB in children at lower levels of healthcare. TDAs have the potential to close the diagnostic gap in childhood TB. Further finetuning of the currently available algorithms will facilitate this and improve access to care.

In the UK, approximately 5.4 million adults live with asthma, of whom one in five have an uncontrolled form. Uncontrolled asthma reduces quality of life and increases healthcare use. Engaging with peers through online health communities (OHCs) can empower patients to self-manage their long-term condition. While OHCs have been in existence for several years and growing numbers of patients access them, the role of primary care in signposting patients to them has been minimal and ad hoc. We have co-developed with patients and healthcare professionals (HCPs) an intervention for adult patients with asthma, consisting of an appointment with a primary care HCP to introduce online peer support and sign patients up to an established asthma OHC, followed by OHC engagement. Feasibility work found the intervention acceptable to patients and HCPs. This protocol outlines our plan to test the intervention’s effectiveness and cost-effectiveness.

An individual randomised controlled trial will be carried out. Eligible participants will be recruited via an online survey sent to adult patients on the asthma register in 50–70 general practices in several UK locations. Participants will be invited to attend a one-off, face-to-face appointment with a primary care HCP, during which they will be individually randomised to the intervention or usual care. An asthma control test (primary outcome) and other measures of clinical effectiveness will be collected at baseline and every 3 months over a 12-month follow-up period. Descriptive and inferential statistics will be used to compare outcome measures between study arms. Cost-effectiveness assessment of the intervention compared with current standard of asthma management in primary care will be reported. A sample of patients and HCPs will be interviewed at study exit and the data analysed thematically.

The study was approved by a National Health Service Research Ethics Committee (reference: 25/NE/0006). Written consent will be obtained from all participants. Findings will be disseminated through various means, including sharing with general practices, conference presentations and peer-reviewed publications.

NCT06849245.

Combined vascular endothelial growth factor/programmed death-ligand 1 blockade through atezolizumab/bevacizumab (A/B) is the current standard of care in advanced hepatocellular carcinoma (HCC). A/B substantially improved objective response rates compared with tyrosine kinase inhibitor sorafenib; however, a majority of patients will still not respond to A/B. Strong scientific rationale and emerging clinical data suggest that faecal microbiota transfer (FMT) may improve antitumour immune response on PD-(L)1 blockade. Early trials in melanoma with FMT and reinduction of immune checkpoint blockade (ICI) therapy in patients with anti-PD-1-refractory metastatic melanoma were reported in 2021 and demonstrated reinstatement of response to ICI therapy in many patients. Due to anatomical vicinity and the physiological relevance of the gut-liver axis, we hypothesise HCC to be a particularly attractive cancer entity to further assess a potential benefit of FMT in combination with ICI towards increased antitumour immunity. Additionally, HCC often occurs in patients with liver cirrhosis, where liver function is prognostically relevant. There is evidence that FMT may increase hepatic function and therefore could positively affect outcome in this patient population.

This prospective, multicentre, randomised, placebo-controlled, double-blind phase II clinical trial has been designed to assess immunogenicity and safety of FMT via INTESTIFIX 001 combined with A/B in advanced HCC in comparison to A/B with placebo. Primary endpoints are measured as tumour CD8+ T cell infiltration after 2 cycles of treatment with vancomycin, A/B+INTESTIFIX 001 in comparison to vancomycin-placebo, A/B+INTESTIFIX 001-placebo and safety of the therapeutic combination in advanced HCC. INTESTIFIX 001 is an encapsulated FMT preparation by healthy donors with a high alpha-diversity in their gut microbiome for oral administration, manufactured by the Cologne Microbiota Bank (CMB). Sample size was calculated to achieve a specific expected accuracy for the primary immunological endpoint. 48 subjects will be randomised to reach a goal of 42 usable measurements in the modified intention-to-treat set. Subjects will be randomised in a 2:1 ratio to A/B or placebo (28 A/B, 14 placebo).

The study was approved by ethics committee review and the German Federal Ministry of Drugs and Medical Devices. The trial is registered under EU CT no. 2023-506887-15-00. The outcome of the study will be disseminated via peer-reviewed publications and at international conferences.

NCT05690048.

Coronary artery bypass grafting (CABG) remains one of the most commonly performed cardiac surgeries worldwide. Despite surgical advancements, a significant proportion of patients experience psychological distress following surgery, with depression being particularly common. Current evidence regarding the effectiveness of preoperative psychological interventions in improving postoperative mental health outcomes remains inconclusive. There is a critical need for predictive models that can identify patients at risk of developing clinically significant depressive symptoms (CSDSs) and related psychological conditions after CABG. This multicentre observational study aims to develop and validate prognostic models for predicting CSDSs and other psychological outcomes, including anxiety, post-traumatic stress symptoms and quality of life, 6 weeks after elective CABG surgery.

The study will recruit 300 adult patients undergoing elective CABG (with or without valve intervention) across two Swiss hospitals. Data collected will include demographic, clinical, psychometric, inflammation-related and interoceptive variables. A training set (n=200) will be used to develop predictive models using machine learning, while a held-out test set (n=100) will be used for model validation. The primary outcome prediction will focus on CSDSs, assessed using the Patient Health Questionnaire-9 (PHQ-9), with analyses conducted both categorically (PHQ-9 total score ≥10) and continuously as complementary approaches. Secondary models will address anxiety, using the General Anxiety Disorder Scale-7, post-traumatic stress, using the post-traumatic stress disorder checklist for Diagnostic and Statistical Manual of Mental Disorders-5 and health-related quality of life, using the 12-item Short Form Survey. A simplified ‘light solution’ model with fewer predictors will also be developed for broader applicability. This study will address an important gap in perioperative mental healthcare by identifying key predictors of psychological morbidity following CABG, particularly CSDSs. The resulting models may inform future screening and preventive strategies and improve postsurgical outcomes through early identification and intervention in high-risk individuals.

The responsible ethics committee has reviewed and approved this project (Kantonale Ethikkommission Zürich, BASEC number: 2023-02040). The study minimises participant burden by integrating brief validated instruments and limiting psychiatric interviews to relevant outcomes, while ensuring ethical safeguards and respect for participant rights (including written consent). Results will be shared through peer-reviewed publications, conference presentations and stakeholder meetings involving clinicians and mental health professionals. Findings will also be communicated to participating centres and patient communities in accessible formats.

Over the past two decades, initiatives promoting research-policy engagement have increased broadly and in health. Numerous factors influencing the engagement of policymakers in research have been described primarily from the perspective of researchers. This scoping review aimed to identify the enablers and barriers to policymaker engagement across the research process from the perspective of policymakers.

Scoping review following the Joanna Briggs Institute Methods Manual for scoping reviews.

MEDLINE, Cochrane Library, Social Policy and Practice, Campbell Collaboration, Health Systems Evidence and World Bank e-Library, supplemented by grey literature from Google Scholar, WHO Global Index Medicus and VHL Regional Portal.

We included English language studies published after 2007 that involved policymakers at national or subnational levels who were actively engaged in research at any stage. We excluded studies which did not include policymakers, where engagement was passive, or perspectives were marginal or not clearly outlined.

After screening and full-text review, we extracted and coded data using MAXQDA Plus 24. We conducted thematic analysis, categorising findings as enablers or barriers into three levels: individual, organisational and contextual/system. Findings were iteratively reviewed and refined by the research team.

We screened 5384 titles and abstracts, reviewed 59 full-text documents and included 30 articles for analysis. Most studies were published after 2016 and were focused on policymaker engagement at the national level. Organisational factors were the most frequently reported influences on engagement of policymakers in research across different contexts. The most frequent enablers mentioned in the literature were (1) the institutionalisation of partnerships, initiatives and having formal agreements; (2) defining goals, roles, responsibilities and conflict resolution mechanisms; (3) researchers providing practical and expert advice to policymakers; (4) leveraging networks; and (5) having supportive institutions. The most frequent barriers were (1) the lack of regulations, infrastructure, funding and communication channels to support engagement; (2) the lack of skills of researchers to understand policymaking processes and work in collaboration with policymakers; and (3) the mismatch in priorities, values, perspectives and expectations.

Our study highlights the role of institutional support, widespread collaboration opportunities and the interconnected nature of these factors within the research-policy ecosystem.

Open Science Framework (https://osf.io/ynr78/).