With the rapidly changing landscape of rectal cancer treatment, it is becoming increasingly challenging for clinicians to interpret and synthesise the vast amount of high-quality evidence being generated. A core outcome set (COS) for clinical trials in rectal cancer would help address issues surrounding outcome selection and reporting. The purpose of this research project is to develop a COS to be used in research comparing different treatment paradigms in the management of rectal cancer.

This will be a mixed-methods project, including a systematic review, semi-structured interviews and a Delphi consensus process. The project was designed in accordance with the COMET (Core Outcome Measures in Effectiveness Trials) Handbook, which provides a framework for COS development based on existing evidence. A multidisciplinary Study Advisory Group, composed of rectal cancer providers, methodologists and patients, will oversee the project. A systematic review will be performed to identify an inclusive list of outcomes reported by researchers in previous rectal cancer trials. Outcomes will be collapsed into various core areas and domains according to the OMERACT Filter V.2.0. Semi-structured interviews with rectal cancer survivors and their partners/caregivers will help identify additional patient-centric outcomes not captured in the systematic review. Finally, after a final list of outcomes is generated, patients and healthcare professionals will be invited to participate in a Delphi process to develop the final COS.

The study has received full approval with the Research Ethics Committee at the Integrated Health and Social Services Network for West-Central Montreal (health network responsible for the Jewish General Hospital) (REC: 2025-4377) and the Institutional Review Board of the Mount Sinai School of Medicine (IRB: STUDY-25-00515). The results of this study will be presented at national and international meetings and a manuscript will be submitted for publication in a high-impact surgery and/or oncology peer-reviewed journal.

The study was registered in the COMET database in December 2023 (https://www.comet-initiative.org/Studies/Details/2941). The full systematic review protocol, along with the search strategy and inclusion/exclusion criteria, was registered online in September 2023 (researchregistry.com; reviewregistry1705).

Bilateral deep brain stimulation (DBS) of the subthalamic nucleus (STN) is a well-accepted treatment for advanced Parkinson’s disease (PD). Currently, programming of the DBS is done in a trial-and-error manner and it can take up to 12 months to reach optimal stimulation parameters. Technological advances in electrode design and implantable pulse generator capabilities lead to an almost infinite number of stimulation options. To explore the potential benefit of all these technological advances, a conventional trial-and-error approach is no longer sufficient. Consequently, there is a clear need for a more computational approach to programming DBS systems. This pilot study is a prospective trial to prove the feasibility of programming bilateral STN-DBS for PD in a computational fashion based on patient anatomy, electrode position and brain connectivity. In this study, we aim to assess the safety, practical feasibility and technical feasibility of a computational approach for programming newly implanted STN-DBS patients with PD. This computational approach will be based on a patient-specific DBS setting regarding sweet spots and structural connectivity of the STN. The results of this pilot study will be used to develop a computational approach for DBS programming to use in a future randomised clinical trial.

The iDBS trial will be a prospective randomised feasibility study carried out at the Radboud university medical center. A total of 24 patients with PD eligible for bilateral STN-DBS surgery implanted with Boston Scientific Cartesia leads will be included. Patients will be randomised to receive either (1) computational DBS programming (n=12) or (2) conventional DBS programming based on monopolar review (n=12). The primary endpoints are safety (occurrence of stimulation-induced side effects, duration of induced side effects (temporary or permanent), severity of the stimulation-induced side effects) and technical feasibility (time from surgery to DBS initiation, time from surgery to reaching optimal DBS stimulation settings) of the computational workflow.

Ethical approval for this study has been granted by the Medical Ethical Committee region Arnhem-Nijmegen, the Netherlands (2024–17453). This study will be conducted in accordance with the Declaration of Helsinki and all applicable European and Dutch law. All participants will have to provide written informed consent. Results of the study will be submitted for publication in peer-reviewed journals and conferences.

The study is registered in the OMON-registry (NL87334.091.24, NL-OMON57446).

The purpose of this study was to investigate the factors influencing life satisfaction in patients with chronic kidney disease and to explore any sex differences. Thus, this provides a theoretical basis for improving the life satisfaction status of middle-aged and elderly patients with chronic kidney disease, as well as formulating prevention, treatment and intervention strategies.

Based on the health ecology model, 22 potential influencing factors were identified at five levels. Subsequent analyses examined whether they impacted the life satisfaction of patients with chronic kidney disease and had varying effects on different sexes.

A total of 1422 patients with chronic kidney disease were included from the 2018 China Health and Retirement Longitudinal Study.

The ² test and multivariate logistic regression model were used to analyse the influencing factors of life satisfaction in patients with chronic kidney disease and their sex differences. Sensitivity analyses additionally supported the robustness of the results.

Age, self-rated health, depressive symptoms, marital satisfaction, satisfaction with children, activities of daily living and pension were all significant influencing factors of life satisfaction in patients with chronic kidney disease (p

This study reveals that a combination of factors affects life satisfaction in patients with chronic kidney disease. Therefore, targeted prevention and intervention strategies should be carried out, with specific focus on females, individuals with poor self-rated health and those experiencing depressive symptoms from a multidimensional perspective.

The objective of this study was to investigate the utility of the days alive and out of hospital (DAOH) metric within a cohort of patients undergoing burr-hole drainage of a chronic subdural haematoma (CSDH). We evaluate the validity of the DAOH metric in a national CSDH cohort and examine how the DAOH metric compares to its constituent outcomes (mortality and hospital bed days) at an organisational level.

Retrospective cohort study using Hospital Episode Statistics data linked to the national death registry to identify patients who underwent burr-hole drainage of CSDH in English National Health Service neurosurgical units between 1 April 2013 and 31 March 2020. Construct validity was assessed by measuring the patterns of DAOH across categories of known perioperative risk factors. Variation between units in the risk-adjusted values for DAOH, postoperative mortality and days in hospital was explored using funnel plots. Linear regression and logistic regression were used to derive the risk-adjusted rates.

Overall, 16 450 patients who underwent at least one burr-hole drainage of CSDH were identified during the time period. The median 30-day DAOH was 16 (IQR, 0–24); the median for the 90-day DAOH was 74 (42–84), and was better at measuring the complete stay associated with the index admission. Worse 90-day DAOH values were associated with older age, increasing comorbidities and greater frailty. Risk-adjusted 90-day DAOH values for neurosurgical units varied more markedly than for its constituent outcomes.

The 90-day DAOH looks to be a valid outcome metric for patients undergoing burr-hole drainage for CSDH that is feasible to derive using national hospital data. Future work should explore how to estimate a minimally important clinical difference for DAOH and evaluate its utility as an outcome measure.

Multivitamins and minerals (MVMs) are readily available dietary supplements that help prevent nutritional deficiencies and boost energy. This study examined the prescribing and consultation practices of healthcare professionals (HCPs) related to MVM supplements in Pakistan.

This cross-sectional study used a web-based structured questionnaire to collect data from HCPs from February 2021 to January 2022. The study link, which included a consent form and questionnaire, was circulated on social media platforms, and all individuals who provided consent and completed the forms were included in the study.

A total of 524 HCPs participated in the study, with the majority being males, holding MBBS or Fellow of the College of Physicians and Surgeons qualifications, and working in urban settings. Findings revealed that HCPs prescribe MVMs for varied reasons. We assessed differences based on various factors like gender, education level, area of practice and specialty. Most of the differences observed were not statistically significant, except for a few related to area of practice and education level that were found significant. The primary conditions prompting MVM prescriptions included osteoporosis and bone pain (80% for vitamin D and calcium), fatigue and weakness (over 70% for iron) and numbness/tingling (more than half for folate and vitamin B₁₂). Regarding biospecimen analysis before prescribing MVMs, 46% of HCPs required laboratory investigations before prescribing vitamin D and calcium and 60% for iron prescriptions. Common formulations prescribed include cholecalciferol for vitamin D deficiency (62%) and ferrous sulfate for iron deficiency (76%).

Our study findings highlight that the prescribing practices of MVMs by HCPs are primarily in line with the known physiological roles of these supplements. However, a few identified gaps in practices highlight the need for standardised guidelines to ensure patients’ health and well-being.

Diabetes is a chronic disease characterised by elevated blood sugar levels, which can lead to damage across various body systems. Bangladesh has the second highest number of adults with diabetes in South Asia and faces a significant economic burden from this condition. The objective of this study was to investigate the economic burden of diabetes and its associated factors among patients with diabetes registered at a tertiary-level diabetes hospital in the Rajshahi region of Bangladesh.

This was a cross-sectional hospital-based study.

Primary data were collected from patients with diabetes at a tertiary-level diabetes hospital in Bangladesh.

The study recruited 400 patientswith diabetes, who were randomly selected. The economic burden was assessed using the Catastrophic Health Expenditure (CHE) threshold of ≥10% of household income. Descriptive statistics, 2 tests, t-tests, linear regression and binary logistic regression were employed for analysis, with statistical significance set at p

The proportion of diabetes-related burden among patients with diabetes was 50.7%. 95.8% of patients had type 2 diabetes, and over half (52.5%) were overweight or obese. Treatment costs were significantly associated with diabetes duration, insulin use and age (35–55 vs ≥56 years). The economic burden was strongly associated with lower income levels (poor income and middle income vs high income) and longer diabetes duration. Participants not adhering to a healthy diet had 43% lower odds of experiencing economic burden than those following a healthy diet.

Approximately half of the patients experienced catastrophic health expenditure due to diabetes, indicating a substantial economic burden in the Rajshahi region of Bangladesh. This burden was significantly higher among lower-income and middle-income groups and patients with longer disease duration, and treatment-related factors such as insulin use were associated with greater financial strain. These findings emphasise the need for targeted financial protection strategies, including subsidised care and preventive interventions.

Induction of labour (IOL) is a commonly performed obstetric intervention, particularly when delivery is deemed more beneficial than continuing the pregnancy due to maternal or fetal indications. When the cervix is unfavourable for delivery, cervical ripening is performed prior to IOL. A wide variety of mechanical, pharmacological and combination methods are used, but the optimal approach balancing efficacy, safety and patient experience remains uncertain. Conventional aggregate data (AD) meta-analyses lack individual-level data, limiting exploration of patient-level factors for personalised medicine and do not address concerns about the trustworthiness of data presented in peer-reviewed randomised controlled trials (RCTs). This protocol describes an individual participant data (IPD) network meta-analysis (NMA) designed to evaluate and rank cervical ripening methods for IOL using only high quality, trustworthy data.

We will identify eligible parallel-group RCTs enrolling pregnant women with a singleton, cephalic fetus at ≥34 weeks’ gestation requiring cervical ripening, through comprehensive searches of Ovid MEDLINE, Embase, Emcare, Scopus, Cochrane Pregnancy and Childbirth Register, WHO International Clinical Trials Registry Platform, clinicaltrials.gov and reference lists of prior reviews. The interventions we consider will be selected via Delphi consensus with international clinical experts. Eligible trial investigators will be invited to contribute de-identified IPD; AD will be used if IPD is unavailable. Trials will be assessed for trustworthiness using the Trustworthiness in RAndomised Clinical Trials checklist and the IPD Integrity Tool, with only eligible studies included in the primary analysis. All statistical analyses will follow a pre-specified statistical analysis plan (SAP) finalised before any analyses are conducted. A two-stage, contrast-based, frequentist IPD-NMA will compare cervical ripening methods for three co-primary outcomes: vaginal birth, composite adverse perinatal outcomes and composite adverse maternal outcomes. Subgroup analyses will assess effect modifiers (eg, parity, age and previous caesarean), with treatment rankings presented using the surface under the cumulative ranking curve and rank-heat plots. Sensitivity analyses will examine the impact of bias, missing data and population criteria.

This study has been approved by the Monash University Human Research Ethics Committee (No. 48189). IPD will be de-identified and securely transferred for storage on a Monash University-hosted shared network drive. Findings will be disseminated via peer-reviewed publications, conference abstracts and the Cervical Ripening for Induction of Labour Collaborative Evidence Network Meta-Analysis (CIRCLE-NMA) website (https://circlenma.com). Patient and public involvement will guide the communication and interpretation of results.

CRD420251077464.

Cognitive behavioural therapy (CBT) is recommended as a first-line treatment for depression and anxiety disorders, but its utilisation under Japan’s national health insurance remains poorly understood. This study aimed to describe CBT utilisation patterns, quantify regional disparities across prefectures and analyse temporal trends from fiscal year (FY)2015 to FY2023.

This was a nationwide repeated cross-sectional study.

Japan’s National Database of Health Insurance Claims and Specific Health Checkups Open Data (NDB Open Data), FY2015–2023.

All patients who received insurance-covered CBT in FY2023, with a longitudinal comparison across FY2015–2023.

The primary outcomes were annual CBT claims and patient counts. The secondary outcomes included prefecture-level distribution, population-adjusted utilisation rates per 100 000 population, distribution by sex and age, monthly trends and temporal changes over 9 years. Regional variation in physician-delivered CBT was assessed using the coefficient of variation (CV) and extremal quotient (EQ).

In FY2023, the total CBT claims numbered 38 045 with 8299 patients, representing only 0.14% of an estimated 6.03 million psychiatric patients. Physician-delivered CBT accounted for 99.6% (37 886 claims), whereas nurse-delivered CBT introduced in 2016 remained at 0.4% (159 claims). 13 of the 47 prefectures (27.7%) had zero or fewer than 10 claims. The population-adjusted physician-delivered CBT claims ranged from 370.96 per 100 000 in Okayama to 0.99 per 100 000 in Kumamoto, yielding an EQ of 375-fold. The CV among the 34 prefectures with measurable physician-delivered CBT was 174.8%. Despite indication expansions in 2016 and 2018, claims decreased by 9.9% from 42 216 in FY2015 to 38 045 in FY2023.

Insurance-covered CBT in Japan remains severely underused, with significant regional disparities. Incremental policy measures, including indication expansions and nurse-delivered CBT, have failed to improve access. Fundamental system reforms, potentially including dedicated psychological therapy services, are needed to ensure equitable access to evidence-based psychological treatments.

Anaemia is highly prevalent among the indigenous population globally. Several interventions have been used to prevent and manage nutritional anaemia, including dietary measures, health education, oral iron supplements, food fortification and intravenous iron therapy. This protocol describes a systematic review and meta-analysis to assess the effectiveness of interventions for the prevention and treatment of nutritional anaemia in indigenous populations worldwide.

The review will include randomised controlled trials, quasi-experimental studies and observational studies evaluating interventions, including but not limited to iron and folic acid supplementation, dietary modifications, food fortification, deworming and health education. A robust search strategy will be developed, and six electronic bibliographic databases and Google Scholar will be searched from 2000 to 2025. Two reviewers will independently screen the identified studies, extract data, conduct a critical appraisal and evaluate quality using the Joanna Briggs Institute tool. Based on the level of heterogeneity, a meta-analysis will be conducted using either a fixed-effect or random-effects model, with pooled estimates, and 95% CIs. The I² statistic will be used to evaluate heterogeneity. When meta-analysis is not feasible, narrative synthesis will be conducted. The impact of the intervention type and delivery model will be investigated using subgroup analysis.

This systematic review has been registered with PROSPERO. Ethical approval is not required as the study does not collect primary data from participants. The findings will be communicated via peer-reviewed journal articles and presentations at national and international conferences.

CRD420251120554.

All physicians will experience challenging history taking encounters, where communication is impaired and negatively impacts the diagnostic process. The aims of this systematic review were to (1) undertake a meta-analysis of the frequency of challenging encounters; (2) collate adverse outcomes of challenging encounters; (3) identify underlying causes of challenging encounters; (4) identify strategies to deal with different challenges; and (5) align these strategies with our published phenomenological framework of history taking challenges.

This was a systematic review and meta-analysis of prevalence data adhering to the Preferred Reporting Items for Systematic reviews and Meta-Analyses and the Meta-analyses of Observational Studies in Epidemiology guidelines.

A literature search in MEDLINE, Embase and Cochrane databases was performed on 12 July 2020, and updated on 4 August 2025, focusing on challenging history taking encounters in any clinical setting.

Articles reporting on the frequency, adverse outcomes, causative factors or strategies used to address challenges in the history taking process in any clinical area of medicine.

Factors associated with challenging history encounters (causative or consequential) were categorised using inductive coding and referenced to a phenomenological framework. Meta-analysis was used to estimate the prevalence of history taking encounters using a restricted maximum likelihood model with ² and I² as tests for heterogeneity and funnel plot with Egger’s test for publication bias.

73 articles were included in the analysis. The overall prevalence of challenging history taking encounters was 19.5% (95% CI 14.2% to 24.7%). Adverse outcomes of patient dissatisfaction (level 1 evidence) and diagnostic uncertainty (level 3 evidence) were identified. Factors associated with (n=22) and strategies to mitigate challenging encounters (n=13) were categorised. Correlation of factors and strategies with a phenomenological approach created a framework to assist novice history takers in approaching such circumstances.

Challenging history taking encounters are common. Little is known of the relative importance of factors associated with challenging history taking encounters or the impact of suggested strategies. Many of the suggested strategies to facilitate meaningful communication in these situations involve a departure from standard history taking. More research is required to better define the nature of challenges encountered in history taking with a view to develop better educational models for trainee physicians.

The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) was the first to show that multidomain lifestyle interventions can enhance brain health and reduce cognitive decline. However, the clinical effectiveness and delivery of the FINGER model within primary care settings remain unexplored. This paper presents the protocol for the STRONGER 60+trial, which aims to evaluate both the clinical effectiveness and real-world delivery of an adapted FINGER-based intervention in primary care.

This 6-month randomised controlled clinical effectiveness trial will be conducted in primary care and will include adults aged 60 and older with vascular or lifestyle-related risk factors for dementia. A total of 80 participants will be randomised to either a structured, supervised multidomain lifestyle intervention or a self-guided version of the same programme. The intervention includes nutritional guidance, physical exercise, cognitive training, social engagement and management of vascular and metabolic risk factors. Data will be collected at baseline, 6 months (primary endpoint) and 12 months post-randomisation. The primary outcome is the change in a composite healthy lifestyle score at 6 months. In addition, the study will explore delivery processes and stakeholder (participant and healthcare professional) perspectives using both qualitative and quantitative methods.

The study has been approved by the Swedish Ethical Review Authority (approval numbers: 2020–05785, 2021–06413-02, 2022–05454-02) and will follow the principles of the Declaration of Helsinki. Ethical procedures for informed consent, confidentiality and data management will be strictly observed. Results will be disseminated through scientific publications, conferences and targeted outreach to healthcare professionals and the general public.

NCT07117916.