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☐ ☆ ✇ BMJ Open

Cross-sectional study of womens representation in leadership positions in Turkish medical schools, academic departments, specialty boards, conferences and journals in 2023

Por: Eroglu · F. S. · Koyuncu · S. B. · Erkan · B. · Kıyak · Y. S. — Octubre 13th 2025 at 16:51
Objectives

Ensuring gender equity in leadership is crucial for fair representation and diversity in academic medicine. This study aims to investigate the representation of women in leadership positions in Turkish academic medicine, including medical schools, specialty boards, conferences and medical journals.

Design and setting

A cross-sectional study was conducted between August and December 2023. The study analysed data from members of medical faculties, specialty boards, medical conferences and medical journals across Turkey. The source of information was publicly accessible websites.

Participants

The study included data from 17 939 members of 113 medical faculties, 112 specialty boards, 73 medical conferences and 246 medical journals in Turkey.

Interventions

This study has no interventions.

Results

Women made up 40.4% of all medical-school faculty but only 22.5% of deans (95% CI 15.5 to 31.6; p

Conclusions

Turkey’s academic medicine pipeline contains substantial numbers of women, yet marked gaps persist in senior positions. Bridging these gaps will require targeted policies that look beyond overall workforce proportions to the specific decision-making roles where shortfalls remain.

☐ ☆ ✇ BMJ Open

Integrative exploration of bio-psycho-social determinants of DSM-5 severity levels of opioid use disorder: the BEBOP cohort study protocol

Por: Lalanne · L. · Lutz · P.-E. · Caparros-Roissard · A. · Ruppert · E. · Waeckerle · G. · Scherer · C. · Oster · F. · Brand · C. · Henck · S. · Soavelo · H. · Ramousset · C. · Lebreton · M. · Audran · M. · Lazic · J. · Detrez · V. · Avril · E. · Merah · I. · Chappuy · M. · Meyer · N. · Jauffret — Octubre 13th 2025 at 16:51
Introduction

Opioid use disorder (OUD) is a chronic and severe psychiatric condition defined by a level of opioid use which significantly impairs interpersonal and social functioning. In the biopsychosocial model of addiction, research has shown that psychiatric, sociological and neurobiological factors individually affect OUD severity. However, how these factors interact in the determination of OUD severity remains poorly understood.

Method and analysis

The Epigenetic Bonds of Opioid Use Profiles are a multidisciplinary project whose primary objective is to characterise psychiatric and social factors of OUD in a large cohort of patients. The secondary objectives are, first, to correlate psychosocial severity with blood-derived epigenetic biomarkers to provide a deeper understanding of determinants of OUD and, second, to examine over a 2 year follow-up the correlation between the evolution of OUD and psychosocial severity with epigenetic biomarkers at inclusion. An additional objective is to analyse the impact of drug consumption rooms on access to care for most severely affected patients with OUD. In total, 300 opioid users will be recruited at supervised injection sites in Strasbourg and Paris and at addiction care centres in Strasbourg and Lyon to explore four psychiatric (substance use disorders beyond opioids, depression, anxiety, post-traumatic stress disorder) and five social (social support and status, traumatic experiences, housing, imprisonment, access to care) factors. Opioid users will be followed for 24 months and reassessed for psychosocial factors at 3, 6, 12, 18 and 24 months. Opioid consumption will be measured in all subjects using questionnaires, complemented by toxicological screenings (mass spectrometry). Finally, DNA methylation and gene expression will be characterised in capillary blood using next-generation sequencing. Mixed models will be used to model the primary and secondary outcomes.

Ethics and dissemination

This ongoing study was approved by the French Ethics Committee ‘Sud Méditerranée III’ of University Hospital of Nîmes (approval 2023–2024, protocol IDRCB number 2022-A02477-36) and authorised by the French Data Protection Authority (authorisation decision DR-2023–277 in December 2023). Results will be presented in international and national conferences and published in peer-reviewed international journals.

Trial registration number

NCT06021548.

☐ ☆ ✇ BMJ Open

Symptom tracking for endometriosis: a systematic review protocol for mobile applications focused on content, inclusivity and features

Por: Ortoleva Bucher · C. · Martin · L. A. · De Santo · A. · Pluchino · N. · Rio · L. — Octubre 10th 2025 at 11:24
Background

Endometriosis is a chronic gynaecological condition affecting 2%–10% of women worldwide, often leading to severe pain, organ dysfunction and infertility. Despite its prevalence, diagnosis is frequently delayed, and treatment options remain limited. Mobile health (mHealth) applications have gained popularity as tools for symptom tracking, yet concerns about their accessibility, evidence-based content and inclusivity persist. Ensuring that these digital tools are culturally relevant, user-friendly and available to diverse populations is crucial for improving patient care and engagement. This study aims to systematically review mobile applications designed for tracking endometriosis symptoms, with a focus on content quality, inclusivity and functionality. The objective is to identify gaps in existing apps and provide recommendations for developing more inclusive digital health solutions.

Method

This study follows a systematic review methodology proposed by Gasteiger et al. The research process consists of seven steps, including defining research questions, identifying relevant applications, determining eligibility criteria, selecting and analysing apps and synthesising results. The apps will be sourced from the Apple App Store and Google Play Store via predefined search strategies. The evaluation criteria include content accuracy, usability, inclusivity, privacy protection and adherence to evidence-based medical guidelines. Data extraction focuses on app characteristics, including language availability, user accessibility, evidence-based symptom tracking and adherence to health equity principles. The Mobile App Rating Scale will be used to assess usability, functionality, aesthetics and information quality. The findings will be systematically compared to identify strengths, limitations and areas for improvement in existing applications.

Discussion

This systematic review of applications offers an overview of available apps that can be downloaded in Switzerland. Furthermore, it will present a detailed analysis of those that are specifically geared towards symptom tracking and will evaluate the level of evidence-based content, inclusivity, data protection and quality. A key strength of this review is its multidisciplinary approach, which involves engaging experts in healthcare, digital technology, inclusivity and individuals with lived experiences with endometriosis.

Ethics and dissemination

Approval from an ethics committee is not required. Data and material will be available on request from the authors.

☐ ☆ ✇ BMJ Open

Liposomal bupivacaine versus ropivacaine perianal infiltration for postoperative analgesia of haemorrhoidectomy: a multicentre, randomised controlled trial

Por: Huang · H. · Wei · S. · Lan · Y. · Huang · Y. · Liang · S. · Wei · N. · Wei · X. · Wei · X. · Tan · X. · Liu · N. · Qin · X. · Lu · K. — Octubre 9th 2025 at 10:17
Objectives

To evaluate whether liposomal bupivacaine provides superior postoperative analgesia compared with ropivacaine following haemorrhoidectomy, reduces the need for rescue analgesics in patients with mixed haemorrhoids and maintains a comparable safety profile.

Design

Prospective, randomised controlled multicentre trial.

Setting

Three grade 3A general hospitals in Guangxi, China, conducted between September 2023 and July 2024.

Participants

Eligible patients were aged 18–75 years undergoing elective external dissection and internal ligation for mixed haemorrhoids (grade III and IV mixed haemorrhoids). Key exclusion criteria were severe systemic diseases, history of substance abuse or known allergies to local anaesthetics. A total of 264 patients (male, n=162; mean age, 43.1±12.2 years) were enrolled and completed the study, with 132 randomised to each group.

Interventions

Patients received either ropivacaine (100 mg in 20 mL) or liposomal bupivacaine (226 mg in 20 mL) through local infiltration at the end of surgery.

Primary and secondary outcome measures

The primary outcomes were the resting numerical rating scale (NRS) pain scores (0–10) at postoperative 1, 5, 7, 9, 11, 24, 36, 48 and 72 hours. The secondary outcomes included the following: (1) exercise NRS pain scores at the same time points; (2) time to first ambulation, ambulation NRS pain scores on postoperative days 1, 2 and 3 and the proportion of patients having ambulation NRS pain scores ≥4; (3) defecation NRS pain scores and the proportion of of patients having score ≥4; (4) the time to the first administration of rescue analgesics and proportion of patients requiring rescue analgesics; (5) proportion of pain-free patients (NRS pain scores ≤1) 0–24, 24–72 and 0–72 hour after surgery; (6) incision assessments on postoperative days 1, 3 and 7 and postoperative adverse events (AEs); and (7) patients’ and researchers’ satisfaction with pain management.

Results

Resting NRS pain scores were significantly lower in the liposomal bupivacaine group at all time points (median, 0–2.0 vs 2.0–4.0 for ropivacaine, p

Conclusions

Perianal infiltration of liposomal bupivacaine significantly alleviates postoperative resting and exercise pain in patients undergoing surgery for mixed haemorrhoids, enhances comfort during ambulation and defecation, reduces the need for additional analgesics and demonstrates a safety profile comparable to that of ropivacaine.

Trial registration

chictr.org.cn # ChiCTR2300075276.

☐ ☆ ✇ BMJ Open

Comparison of efficacy and safety of different types of electrical stimulation for shoulder subluxation after acute stroke: protocol for a systematic review and network meta-analysis of randomised controlled trials

Por: Kan · M. · Chen · Q. · Dan · Y. · Li · L. · Li · W. · Zhang · L. · Lu · Y. · Feng · Z. — Octubre 9th 2025 at 10:17
Introduction

Glenohumeral subluxation (GHS) is a common rehabilitation challenge in the hemiplegic upper limb following stroke, potentially leading to shoulder pain, secondary brachial plexus injury and various other complications. While electrical stimulation therapies, such as electromyography biofeedback, electroacupuncture and neuromuscular electrical stimulation, have shown promise in managing GHS, some controversy remains. Although clinical trials and meta-analyses have confirmed the efficacy of these therapies, healthcare professionals have yet to reach a consensus on which specific therapy is most effective for reducing shoulder subluxation (SS), alleviating pain and improving quality of life. This study will perform a network meta-analysis to compare the relative efficacy of different electrical stimulation therapies for treating GHS in patients following acute stroke.

Methods and analysis

We will systematically search the following databases: PubMed, MEDLINE, Embase, Cochrane Library, Web of Science, Chinese biomedical literature database (SinoMed), Wanfang databases (Wanfang), VIP Journal Integration Platform (VIP) and China National Knowledge Infrastructure (CNKI). Our search will cover the period from the inception of each database until 14 April 2025, and will be restricted to studies published in Chinese or English. The primary outcomes of interest will be the degree of improvement in SS, improvements in quality of life and reductions in pain. We will conduct pairwise meta-analyses using RevMan V.5.3 (The Cochrane Collaboration, Copenhagen, Denmark), and network meta-analyses using ADDIS V.1.16.6 (Drugis, Groningen, The Netherlands) and Stata V.16.0 (StataCorp, College Station, Texas, USA) to compare the relative efficacy of different electrical stimulation therapies. Screening, data extraction, risk of bias assessment and evaluation of the certainty of evidence will all be performed independently by two reviewers to ensure accuracy and reliability. The risk of bias within individual studies will be assessed using the Cochrane Risk of Bias 2 (ROB 2) tool, and the certainty of evidence will be evaluated using the Grading of Recommendations Assessment, and Evaluation (GRADE) and Confidence in Network Meta-Analysis (CINeMA) frameworks to ensure transparency and methodological rigour.

Ethics and dissemination

Ethical approval is not required for this study. The findings will be submitted to a peer-reviewed journal or conference.

PROSPERO registration number

CRD42024541228.

☐ ☆ ✇ BMJ Open

Intervention effects of optimised carbohydrate diet in patients with type 2 diabetes: study protocol for a randomised controlled crossover trial

Por: LU · Y. · Zhang · R. · Yang · J. · Liu · D. · Wu · Q. · Long · X. · Cheng · D. · Guo · J. · Li · Q. · Zhang · Y. · Kang · P. · Wang · Q. · Gao · X. · Zeng · R. · Zhang · M. · Fang · Q. · Jia · W. · Ni · Y. · Li · H. — Octubre 8th 2025 at 05:59
Introduction

Dietary intervention is fundamental for the management of type 2 diabetes (T2D), playing a crucial role in stabilising blood glucose levels and improving quality of life. As the major contributor to daily energy intake, the quality of carbohydrates can directly influence the glycaemic stability. Therefore, we aim to explore whether adjusting and optimising the composition of dietary carbohydrates, specifically starch, can provide multiple metabolic benefits for patients with T2D.

Methods and analysis

This multicentre randomised crossover clinical trial will include 150 participants with T2D. Participants will be assigned to either a conventional diet (CD) following the guidelines for T2D or an optimised carbohydrate diet (OCD) focused on increasing resistant starch intake to 40 g/day and decreasing rapidly digestible starch intake for 12 weeks. This will be followed by a 6-week wash-out period, after which participants will crossover to the alternate diet with equal energy and consistent energy proportion of the three macronutrients for another 12 weeks. The primary outcome is the difference in the change of postprandial glycaemia (changes in the average incremental area under the blood glucose curve (iAUC)) induced by OCD and CD interventions. Secondary outcomes include changes in other glucose and lipid metabolism-related parameters and cognitive function, as well as psychological, behavioural and physiological factors. Exploratory outcomes include changes in the iAUCs for each of the three meals, appetite-related hormone levels, degree of hepatic steatosis, serum cytokines, immune functions and multiomics parameters.

Ethics and dissemination

The protocol has received approval from the Ethics Committee of Shanghai Sixth People’s Hospital (Approval No. 2025–018; Protocol V.4.1, 20250112) and has been registered with the ClinicalTrials.gov Registry. The findings will be disseminated through peer-reviewed journal publications, conference presentations and media releases.

Trial registration number

NCT06936657.

☐ ☆ ✇ BMJ Open

Association of prior history of suicide attempt and disease severity and subsequent suicidal acts among patients with psychiatric disorders in North China: a multicentre prospective study protocol

Por: Wu · J. · Min · J. · Luo · Y. · Li · P. · Li · L. · Ge · Y. · Yun · Y. · Lei · C. · Wang · Q. · Zhou · F. · Yin · Y. · Tong · Y. — Octubre 8th 2025 at 05:59
Introduction

The suicide risk among discharged psychiatric patients is substantially higher than that among patients with physical diseases and the general population. In China, few cohort studies have investigated suicidal acts in patients discharged from psychiatric facilities, and the factors that convey the risk of post-discharge suicidal acts in this specific population remain unclear. Therefore, we are conducting a prospective multicentre cohort study to investigate the association between suicide attempt history and disease severity in patients with common psychiatric disorders with post-discharge suicidal acts.

Methods and analysis

This study will recruit 3000 inpatients with one of three common psychiatric disorders, namely schizophrenia, bipolar disorder and major depressive disorder, from three hospitals in North China: Beijing Huilongguan Hospital, Tianjin Anding Hospital and the First Hospital of Shanxi Medical University. Participants will include 1500 inpatients with schizophrenia, 900 inpatients with major depressive disorder and 600 inpatients with bipolar disorder. The baseline assessment includes determining whether each recruited patient meets the diagnostic criteria for schizophrenia, major depressive disorder or bipolar disorder using the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth edition (DSM-IV) and obtaining details on prior histories of suicide attempts and the severity of the diagnosed disorders using several questionnaires. A 2-year follow-up will be conducted after the recruited patients have been completely assessed. Follow-ups are scheduled at 3, 6, 12 and 24 months after discharge. The primary outcomes are suicidal acts, including suicide attempts and death, that occurred during the follow-up period. A survival analysis will be performed to test for the supposed associations.

Ethics and dissemination

This study was approved by the institutional review boards of Beijing Huilongguan Hospital (2022-67-Science), Tianjin Anding Hospital (2022-47) and First Hospital of Shanxi Medical University (2022-K155). All participants will be required to provide written informed consent before the baseline assessment. The recruitment methods will be explained to potential participants, and their confidentiality will be protected throughout the study. The findings of this study will be disseminated to peer-reviewed scientific journals and conference presentations.

Trial registration number

ChiCTR2200064610.

☐ ☆ ✇ BMJ Open

Surgical patients experiences with the Patients Safety Checklist (PASC): a qualitative interview study

Por: Harris · K. · Waehle · H. V. · Storesund · A. · Harthug · S. · Tangvik · R. J. · Monsen Lukcova · D. · Havik · W. · Humberset · A. · Stavang · E. · Hagerup · K. · Teigland Tepstad · A. · Sandsbakk Austarheim · A. K. · Healey · A. · Sevdalis · N. · Haugen · A. S. — Octubre 6th 2025 at 02:14
Background

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.

Methods

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.

Result

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.

Conclusions

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.

Trial registration number

NCT03105713.

☐ ☆ ✇ BMJ Open

Evaluation of an intervention to increase topical sunscreen use in German outdoor workers: study protocol for the non-randomised controlled intervention study ProtExSun

Por: Dick · A. · Rocholl · M. · Ludewig · M. · Skudlik · C. · Jakasa · I. · Kezic · S. · de Boer · F. · van der Molen · H. F. · John · S. M. — Octubre 6th 2025 at 02:14
Introduction

Squamous cell carcinoma and multiple actinic keratoses caused by solar ultraviolet radiation (UVR) are among the most frequently recognised occupational diseases in Germany. Employees who regularly work outdoors, for example, in the construction industry, agriculture, forestry and gardening, are at a higher risk of developing occupational skin cancer. However, sun-safety behaviour in outdoor workers is currently insufficient. Therefore, this study aims to investigate the effectiveness of an intervention to increase sunscreen use among outdoor workers.

Methods and analysis

In this non-randomised, controlled intervention study, 234 outdoor workers from different companies in industries with outdoor working activities based in Germany will be included. The study population, aged 18 years and above, has to be intensively exposed to solar UVR of regularly 1 hour or more per day. The intervention group will receive a sunscreen package as well as health education. The control group follows the practice in their companies (‘treatment-as-usual’). At the beginning of the study, after 3 months and at the end of the study (after 6 months), both groups filled in different questionnaires. In addition, stratum corneum (SC) samples will be collected at the beginning and after 3 months. The primary outcome—increase in the frequency of sunscreen use during work and in leisure time—will be assessed from data on self-reported sunscreen use. The secondary outcomes include sun protection behaviour, knowledge about sun protection and skin cancer, and acceptance of the provided sunscreens. Further secondary outcomes include internal UV dose and UV-related immune response, determined by the levels of SC biomarkers. Data will be analysed using both descriptive and inferential methods.

Ethics and dissemination

The study protocol followed the principles of the Declaration of Helsinki (2013) and was approved by the Ethics Committee of Osnabrück University, Germany (reference Ethik-37/2024). Study results will be disseminated through peer-reviewed publications and conference presentations.

Trial registration number

DRKS00035178.

☐ ☆ ✇ BMJ Open

Identification of gestational diabetes mellitus in European electronic healthcare databases: insights from the ConcePTION project

Por: Molgaard-Nielsen · D. · Mitter · V. · Lupattelli · A. · Hoxhaj · V. · Andaur Navarro · C. L. · Hayati · S. · Lopez-Leon · S. · Morris · J. K. · Geldof · A. · Jordan · S. · Leinonen · M. K. · Martikainen · V. · Manfrini · M. · Cammarota · L. · Neville · A. · Barrachina-Bonet · L. · Cave — Octubre 6th 2025 at 02:14
Objective

To develop and compare algorithms for identifying gestational diabetes mellitus (GDM) across European electronic healthcare databases and evaluate their impact on the estimated prevalence.

Design

Multi-national cohort study using routinely collected electronic healthcare data

Setting

National and regional databases in five European countries (Norway, Finland, Italy, Spain and France), in primary and/or secondary care.

Participants

Pregnancy cohorts resulting in stillbirths or live births between 2009 and 2020, comprising 602 897 pregnancies in Norway, 507 904 in Finland, 374 009 in Italy, 193 495 in Spain and 116 762 in France.

Primary and secondary outcomes

The primary outcome was the prevalence of GDM identified using six algorithms: (1) Only diagnosis; (2) Diagnosis or prescription; (3) Two diagnoses or prescriptions (2DxRx); (4) Diagnosis including unspecified diabetes in pregnancy or prescription (DxRx broad); (5) Diagnosis excluding pre-existing diabetes in pregnancy or prescription; (6) Registration of GDM in a birth registry (BR).

Results

The strictest algorithm (2DxRx) resulted in the lowest GDM prevalence, while the broadest (DxRx broad) resulted in the highest, except in France where it was BR. In the Nordic countries, GDM prevalence varied only slightly by algorithm; greater variations were observed in other countries. The prevalence ranged from 3.5% (95% CI: 3.5% to 3.5%) to 4.6% (95% CI: 4.5% to 4.7%) in Norway; 12.1% (95% CI: 12.0% to 12.2%) to 15.8% (95% CI: 15.7% to 15.9%) in Finland, where prevalence was much higher than elsewhere. The prevalence ranged from 1.3% (95% CI: 1.3% to 1.3%) to 5.4% (95% CI: 5.3% to 5.5%) in Italy; 1.6% (95% CI: 1.5% to 1.7%) to 6.2% (95% CI: 6.1% to 6.3%) in Spain; and 1.7% (95% CI: 1.6% to 1.8%) to 5.8% (95% CI: 5.7% to 5.9%) in France.

Conclusions

In this multinational study, GDM prevalence ranged from 1.3% to 15.8% depending on the algorithm and database. Nordic countries showed smaller differences in prevalence between algorithms, while the other countries showed larger variations, likely due to differences in coding practices, healthcare systems and database coverage.

☐ ☆ ✇ BMJ Open

General surgery nurses views on preoperative spiritual care: a qualitative descriptive study

Por: Koroglu · S. · Durat · G. — Octubre 3rd 2025 at 06:32
Objective

Spiritual care has been shown to assist patients in managing anxiety, fear of death and existential concerns commonly encountered during the preoperative period. Nevertheless, surgical clinics often fail to prioritise this dimension of care. Accordingly, it is essential to gain a thorough understanding of how surgical nurses perceive and implement spiritual care. This study aims to describe the views of nurses working in surgical units regarding the provision of spiritual care in the preoperative phase, the challenges they encounter and the factors that influence this process.

Design

A qualitative descriptive study using an inductive thematic analysis approach.

Setting

The study was conducted in the general surgery units of a tertiary-level hospital providing healthcare services to a diverse patient population, with the aim of enhancing nurses’ views related to spiritual care.

Participants

18 nurses with a minimum of 6 months of experience in surgical units were selected using purposive sampling. Head nurses and those on leave during the data collection period were excluded from participation.

Methods

Semi-structured interviews were conducted via video conferencing or telephone between September and October 2023, each lasting between 45 and 60 min. Audio-recorded interviews were transcribed verbatim and analysed using Braun and Clarke’s six-step thematic analysis method. Data collection ceased at the point of thematic saturation.

Results

Three key themes emerged: (1) perceptions of spirituality—nurses viewed spirituality as abstract and subjective, yet recognised religious rituals as visible signs of patients’ emotional and spiritual needs. (2) Spiritual care in nursing—though seen as vital to holistic care, spiritual support was limited by privacy concerns and unclear professional boundaries. (3) Dynamics of spiritual care—delivery was shaped by institutional barriers, nurses’ personal traits and patients’ non-verbal communication of distress.

Conclusion

This study revealed the views of general surgical nurses regarding spiritual care. The findings indicate that while nurses acknowledge the importance of spiritual care, they encounter obstacles in its implementation. Consequently, the results suggest that nurses need to be culturally sensitive and receive institutional support—particularly in collectivist and high-context cultures such as Turkey—in order to better understand and meet spiritual needs. Future studies should explore spiritual care models adapted to different cultural contexts.

☐ ☆ ✇ BMJ Open

How do metacognitive beliefs about memory differ between older adults with low and high dementia worry? A focus group study

Por: Lund · A. E. · von Stein zu Nord- und Ostheim · A. F. · Ridley · H. · Bobyreva · K. · Foster · J. L. H. · Russell · C. — Octubre 3rd 2025 at 06:32
Objectives

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.

Design

Qualitative focus groups; thematic analysis.

Setting

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

Participants

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).

Outcome measures

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.

Results

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’.

Conclusion

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.

☐ ☆ ✇ BMJ Open

Development, validation and clinical utility of prognostic models for patients with traumatic brain injury in an Indian setting using machine learning and traditional approaches: a study protocol

Por: Kamal · V. K. · Agrawal · D. · Kumar · A. · Radhakrishnan · R. · Ponnaiah · M. · Ramaiya · D. · Thiruvalluvan · A. · Sivaram · A. — Octubre 3rd 2025 at 06:32
Introduction

Traumatic brain injury (TBI) remains a major public health concern in India, with high mortality and long-term disability. Existing prognostic models, mostly developed in high-income countries using traditional methods, lack generalisability to the Indian context and do not use the potential of machine learning or multicentric data. This study primarily aims to develop, compare and validate machine learning methods, including the traditional approach, to predict 30-day mortality and 6-month functional outcomes in patients with moderate or severe TBI. A secondary objective is to describe and compare admission characteristics and outcomes (at discharge, 3 months, 6 months and 1 year) in TBI patients in tertiary care settings using descriptive analyses.

Methods and analysis

Data from the neurotrauma registry at Jai Prakash Narayan Apex Trauma Centre, department of neurosurgery, All India Institute of Medical Sciences (AIIMS), New Delhi, including patients admitted between 23 March 2022 and 22 September 2024, will be used for model development and internal validation. For external validation, retrospectively collected data from the same centre (May 2010 to August 2013) and prospectively collected data from AIIMS Patna (1 June 2022 to 30 November 2024) and Rajiv Gandhi Government General Hospital, Madras Medical College (MMC), Chennai (1 May 2022 to 31 October 2024) will be included. Prediction models for 30-day mortality and 6-month functional outcomes will be developed using both machine learning and traditional statistical techniques. Model performance will be evaluated based on discrimination, calibration and clinical utility, with the latter assessed through decision curve analysis (DCA). An online risk calculator will be developed based on the best-performing model to estimate outcome probabilities along with 95% CIs.

Ethics and dissemination

The institutional Ethics Review Board of respective data collection centres, that is, AIIMS, New Delhi, AIIMS, Patna, and MMC, Chennai, approved the study. Findings will be published in peer-reviewed journals and disseminated at national and international conferences.

Discussion

This study will develop and validate prognostic models using traditional and machine learning methods tailored to the Indian TBI context. Multicentric, prospectively collected data will enhance generalisability, while clinical utility will be evaluated through DCA. Adherence to Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis + Artificial Intelligence (TRIPOD+AI) guidelines ensures methodological transparency. With external validation, these models may improve clinical decision-making, resource planning and patient-family communication in diverse Indian healthcare settings.

☐ ☆ ✇ BMJ Open

Climate seasonality and the health and well-being of older adults in rural Busia and Kilifi Counties, Kenya: SENIORS study - protocol for a qualitative study

Por: Shumba · C. S. · Dawson · A. Z. · Xu · W. · Muchanga · K. · Lusambili · A. — Octubre 3rd 2025 at 06:32
Introduction

Older adults are particularly vulnerable to climate-related stressors such as extreme heat, food and water insecurity and displacement, all of which can worsen existing health conditions. This is further compounded by age-related physiological changes, pre-existing health conditions and social factors like isolation and limited mobility. With a growing population of older adults in low-income and middle-income countries, their vulnerability to climate change becomes a critical global public health issue and yet is understudied and needs urgent and comprehensive action. This study aims to investigate how climate seasonality impacts the health, well-being and socioeconomic conditions of older adults in rural communities of Kenya.

Methods and analysis

This formative qualitative study will use a combination of 40 in-depth interviews with older adults and key informant interviews with 20 health workers and 12 policy-makers to provide a comprehensive understanding of the impacts of climate seasonality on the health, well-being and socioeconomic conditions of older adults in rural communities of Busia and Kilifi Counties in Kenya. These counties were selected for the study due to their history of significant flooding and heat stress events. Study participants will be purposively selected for the interviews. A thematic approach will be employed in data analysis using NVivo V.14 software.

Ethics and dissemination

This study received ethical approval from the Medical College of Wisconsin Institutional Review Board, Institutional Scientific Ethics Review Committee at Africa International University and National Commission for Science, Technology and Innovation, Kenya. The study outputs will reflect the views and experiences of older adults, health workers and policy-makers. The findings will be disseminated to the scientific community through conferences and peer-reviewed publications and to the older adults, health workers, communities and policy-makers through videos and dissemination meetings, and policy briefs. The findings will deepen understanding of how climate seasonality is experienced by older people and shape strategies for resilience and adaptation.

☐ ☆ ✇ BMJ Open

Understanding structured medication reviews delivered by clinical pharmacists in primary care in England: a national cross-sectional survey

Por: Agwunobi · A. J. · Seeley · A. E. · Tucker · K. L. · Bateman · P. A. · Clark · C. E. · Clegg · A. · Ford · G. · Gadhia · S. · Hobbs · F. D. R. · Khunti · K. · Lip · G. Y. H. · de Lusignan · S. · Mant · J. · McCahon · D. · Payne · R. A. · Perera · R. · Seidu · S. · Sheppard · J. P. · Willia — Octubre 1st 2025 at 08:29
Objectives

This study explored how Structured Medication Reviews (SMRs) are being undertaken and the challenges to their successful implementation and sustainability.

Design

A cross-sectional mixed methods online survey.

Setting

Primary care in England.

Participants

120 clinical pharmacists with experience in conducting SMRs in primary care.

Results

Survey responses were received from clinical pharmacists working in 15 different regions. The majority were independent prescribers (62%, n=74), and most were employed by Primary Care Networks (65%, n=78), delivering SMRs for one or more general practices. 61% (n=73) had completed, or were currently enrolled in, the approved training pathway. Patient selection was largely driven by the primary care contract specification: care home residents, patients with polypharmacy, patients on medicines commonly associated with medication errors, patients with severe frailty and/or patients using potentially addictive pain management medication. Only 26% (n=36) of respondents reported providing patients with information in advance. The majority of SMRs were undertaken remotely by telephone and were 21–30 min in length. Much variation was reported in approaches to conducting SMRs, with SMRs in care homes being deemed the most challenging due to additional complexities involved. Challenges included not having sufficient time to prepare adequately, address complex polypharmacy and complete follow-up work generated by SMRs, issues relating to organisational support, competing national priorities and lack of ‘buy-in’ from some patients and General Practitioners.

Conclusions

These results offer insights into the role being played by the clinical pharmacy workforce in a new country-wide initiative to improve the quality and safety of care for patients taking multiple medicines. Better patient preparation and trust, alongside continuing professional development, more support and oversight for clinical pharmacists conducting SMRs, could lead to more efficient medication reviews. However, a formal evaluation of the potential of SMRs to optimise safe medicines use for patients in England is now warranted.

☐ ☆ ✇ BMJ Open

Co-designing, evaluating and implementing online supportive care for endometriosis in Australia: study protocol for the hybrid type 1 effectiveness, cost-effectiveness and implementation randomised controlled trial of the CodeEndo program

Por: Mikocka-Walus · A. · Naude · C. · Coitinho Biurra · Y. · Blake · L. · Bowring · J. · De Araugo · S. · Bassili · A. · Bennetts · S. K. · Hutchinson · A. M. · Ng · C. H. M. · Prasertsung · C. · Skvarc · D. · Aras · D. · Ciccia · D. · O · E. · Jacka · F. · Staudacher · H. M. · Varney · J. · A — Octubre 1st 2025 at 08:29
Introduction

Endometriosis is a chronic condition affecting up to 11% of people presumed female at birth by the age of 44 years, characterised by the growth of tissue similar to the lining of the uterus on other organs. Endometriosis significantly impacts health-related quality of life (HRQoL) and imposes a substantial burden on both individuals and the healthcare system. International guidelines recommend the interdisciplinary management of endometriosis due to its significant biopsychosocial burden; however, research aimed at exploring psychological approaches for endometriosis is limited. This trial aims to evaluate the effectiveness of CodeEndo, an online co-designed interdisciplinary supportive care program, compared with a waitlist control (WLC), on HRQoL and biopsychosocial outcomes in people with a diagnosis of endometriosis.

Methods and analysis

A hybrid type 1 effectiveness and implementation randomised controlled trial (RCT) will be conducted. Eligible participants will be randomly allocated to either the CodeEndo program (n=176) or WLC group (n=176) for 8 weeks. The primary outcome will be HRQoL, and secondary outcomes will include psychological symptoms (anxiety, depression, stress), self-efficacy, menstrual, bladder and gastrointestinal symptoms, pain, fatigue, sleep, exercise, diet, symptom bothersomeness and physical and psychological well-being, measured at 8 weeks post-randomisation (T2) and 6-month follow-up (T3). Cost-effectiveness will also be examined. Longitudinal qualitative individual interviews (up to n=40) will be conducted with participants who complete the CodeEndo program to explore benefits, barriers and facilitators of ongoing use. Additionally, the CodeEndo program will undergo evaluation by a group of endometriosis healthcare providers, who will assess potential barriers and facilitators to its real-world implementation. Various process evaluation strategies will also be measured to inform future implementation. Data analyses will incorporate mixed-effects regression models on an intention-to-treat basis, cost-consequences and cost-utility, dietary and qualitative thematic analysis.

Ethics and dissemination

This protocol received ethics approval from Deakin University Research Ethics Committee (DUREC Ref: 2024-157). Dissemination is expected to include peer-reviewed journal articles, reports, conference presentations as well as websites or social media platforms of relevant chronic pain organisations. Participants will be sent a summary of trial results.

Trial registration number

ACTRN12623000598684p.

☐ ☆ ✇ BMJ Open

New regimens of benznidazole for the treatment of chronic Chagas disease in adult participants in indeterminate form or with mild cardiac progression (NuestroBen study): protocol for a phase III randomised, multicentre non-inferiority clinical trial

Por: Marques · T. · Forsyth · C. · Barreira · F. · Lombas · C. · Blum de Oliveira · B. · Laserna · M. · Molina · I. · Bangher · M. d. C. · Javier Fernandez · R. · Lloveras · S. · Fernandez · M. L. · Scapellato · P. · Patterson · P. · Garcia · W. · Ortiz · L. · Schijman · A. · Moreira · O. C. — Septiembre 30th 2025 at 09:49
Introduction

Chagas disease (CD) is one of the most neglected diseases in the world. In Latin America, CD is endemic in 21 countries, with an estimated 70 million people at risk of infection. Current treatments are limited to two nitroheterocyclic compounds: nifurtimox and benznidazole (BZN). Each has significant limitations, including long duration and safety concerns. However, data from recently completed studies suggest that reduced-duration regimens may be equally effective while enhancing safety.

Methods and analysis

NuestroBen is a phase III, randomised, multicentre clinical trial designed to assess whether shorter (2- and 4-week) regimens of BZN are non-inferior to the standard 8-week treatment. A total of 540 adult participants with no evidence of organ damage (the indeterminate form) or with mild cardiac progression (mild electrocardiographic alterations and without systolic dysfunction or symptoms), all in the chronic phase of CD, will be recruited at six study sites in Argentina and two study sites in Bolivia. Participants will be randomised to receive one of the two shortened regimens of BZN (300 mg per day for 2 or 4 weeks) or standard treatment (300 mg per day for 8 weeks). The primary endpoint is sustained elimination of parasitaemia from the end of treatment through 12 months of follow-up. Secondary endpoints will assess sustained clearance of parasitaemia at 1, 4, 6 and 8 months of follow-up from the end of treatment, drug tolerability and adherence to treatment. NuestroBen will also evaluate whether two shortened regimens of BZN improve drug tolerability and treatment adherence compared with the current standard treatment while maintaining efficacy in participants with the indeterminate form of CD or with mild cardiac involvement.

Ethics and dissemination

In Argentina, this study was approved by Fundación de Estudios Farmacológicos y Medicamentos ‘Luis M. Zieher’ for its conduct at the Instituto de Cardiología de Corrientes ‘Juana Francisca Cabral’ (reference: NuestroBen-2020/2021) and the Instituto Nacional de Parasitología ‘Dr. Mario Fatala Chaben’ (reference: NuestroBen-2020/2021) by Comité Institucional de Ética de Investigación en Salud for the Centro de Chagas y Patología Regional de Santiago del Estero (reference: NuestroBen-2020-088/2021), by Comité de Ética en Investigación for the Hospital de Infecciosas F.J. Muñiz (reference: NuestroBen-2020–4037) and the Hospital General de Agudos D.F. Santojanni (reference: NuestroBen-2020–4039) and by Comité de Bioética for the Fundación Huésped (reference: NuestroBen-2020/2021). In Bolivia, it was approved by Comité de Ética en Investigación en Salud from the Universidad Autónoma Juan Misael Saracho (reference: NuestroBen-2020/2025). All participants are asked to provide written informed consent to participate. Recruitment processes started in July 2023, and as of 15 June 2025, 140 participants have been recruited. Findings will be shared with Argentinian and Bolivian public health officials and with the Chagas and tropical medicine communities via international conferences. Findings will also be published in medical journals.

Trial registration number

NCT04897516.

☐ ☆ ✇ BMJ Open

The effects of oliceridine and sufentanil on postoperative nausea and vomiting in abdominal surgery (EOSPONVAS): protocol for a multicentre, two-arm, randomised controlled trial

Por: Luo · J. · Wang · L. · Jie · Z. · Li · Y. · Geng · C. · Li · P. · Wang · T. · Shi · Y. · Fan · X. · Zhang · L. · Xu · T. — Septiembre 30th 2025 at 09:49
Introduction

Oliceridine is a novel μ-opioid receptor selective agonist that provides analgesia while reducing μ-receptor-mediated adverse effects such as postoperative nausea and vomiting (PONV). Evidence in abdominal surgery remains limited. This study aims to determine whether oliceridine reduces PONV and improves recovery in abdominal surgery.

Methods and analysis

This is a prospective, multicentre, two-arm, randomised trial. Participants aged 18–65 years, with American Society of Anesthesiologists physical status I–III and a body mass index of 18.5–23.9 kg/m², undergoing elective major abdominal surgery, will be eligible for inclusion. Gynaecological surgeries are excluded. All patients must require postoperative intravenous patient-controlled analgesia (PCIA) and give written consent. 494 participants will be randomised to oliceridine group or sufentanil group. The primary outcome is the incidence of PONV within 48 hours postsurgery. Secondary outcomes include vomiting frequency, nausea severity score, use of rescue antiemetics, resting numerical rating scale (NRS) pain score, Quality of Recovery-15 (QoR-15) score, time to first postoperative flatus, intensive care unit (ICU) length of stay (LOS), hospital LOS and PCIA metrics (effective attempts and total volume used). Safety outcomes include other opioid-related adverse effects (ORAEs) (eg, respiratory depression, pruritus, dizziness, headache), complications related to PONV (eg, electrolyte disturbances, wound dehiscence) and other perioperative complications.

Ethics and dissemination

This protocol was approved (Version V3.0, 2025-01-14) by the Ethics Committee of Changhai Hospital (CHEC-2025–069), the Shanghai Public Health Clinical Centre (2025-S024-01) and the Wusong Central Hospital of Baoshan District, Shanghai (2025-17-01). It complies with the Declaration of Helsinki. Results will be shared via conferences and peer-reviewed journals.

Trial registration number

Chinese Clinical Trial Registry (ID: ChiCTR2400089262).

☐ ☆ ✇ BMJ Open

Minimum effective dose of betamethasone for incisional local infiltration for the prevention of postoperative pain after spine surgery: study protocol for a randomised controlled trial

Por: Wang · Y. · Han · B. · Zhao · C. · Ren · H. · Jia · W. · Luo · F. — Septiembre 29th 2025 at 07:52
Introduction

Postoperative pain is particularly pronounced in spinal surgery. Inadequate management of acute postoperative pain not only reduces patient satisfaction and delays recovery but also increases the risk of developing chronic pain. Local infiltration analgesia (LIA) is a widely used technique for perioperative pain management. However, even with the use of long-acting local anaesthetics, such as ropivacaine, postoperative analgesia often remains insufficient. Preliminary evidence suggests that combining diprospan, a mixture of betamethasone disodium phosphate and betamethasone dipropionate, with ropivacaine can significantly reduce analgesic requirements in the immediate postoperative period. However, concerns about steroid-related complications, including hyperglycaemia and surgical site infections, highlight the need to identify the minimum diprospan concentration to achieve a balance between efficacy and safety. This randomised, controlled, evaluator-blinded trial aims to investigate the dose-response relationship of diprospan as an adjunct to ropivacaine for LIA in spinal surgery to determine the minimum effective dose for effective and safe pain management.

Methods and analysis

This is a single-centre, randomised, evaluator-blinded, controlled, dose-mapping study in which subjects will be randomised in a 1:1:1:1:1 ratio to the control group or to receive diprospan at concentrations of 0.003%, 0.006%, 0.009% or 0.012%. Patients will receive either 0.5% ropivacaine alone or a corresponding dose of diprospan combined with 0.5% ropivacaine for LIA. All participants will be followed for a duration of 3 months. The primary outcome measure will be cumulative sufentanil consumption within the first 48 hours postsurgery. Secondary outcomes will include additional assessments of analgesia, steroid-related adverse events and other complications within the 3-month follow-up period.

Ethics and dissemination

This study protocol was approved by the Institutional Review Board of Beijing Tiantan Hospital (KY2024-365-02-1). Written informed consent will be obtained from all participants. The results will be submitted for publication in a peer-reviewed journal.

Trial registration number

NCT06785350.

☐ ☆ ✇ BMJ Open

Association of type 2 diabetes with reoperation, adverse events and mortality after hip and knee replacement: a Swedish register-based study including 109 938 hip and 80 897 knee replacements

Por: Vinblad · J. · Bülow · E. · Nyberg · F. · Eeg-Olofsson · K. · W-Dahl · A. · Limbäck · G. · Englund · M. · Abbott · A. · DellIsola · A. · Rolfson · O. — Septiembre 29th 2025 at 07:52
Objective

Type 2 diabetes mellitus (T2DM) and osteoarthritis (OA) are globally prevalent chronic diseases that affect millions of individuals in ageing populations. Hip and knee replacements are well established and effective treatments in patients suffering from end-stage OA. Understanding how T2DM influences the outcomes of these surgeries is important for optimising patient care and improving surgical results. This study aimed to explore the association of T2DM with reoperation (regardless of the reason), adverse events (AEs) and mortality after primary hip and knee replacement surgery.

Design

Observational study based on prospectively collected registry data analysed retrospectively.

Setting and participants

Data from several Swedish national quality registers and health data registers were used to create a study database. 109 938 and 80 897 primary hip and knee replacements due to OA, performed between 2008 and 2019 (hip) and 2009 and 2018 (knee), were included in the study.

Outcome measures

The risk of complications, such as reoperation, AEs and mortality, was investigated by estimating HRs using Cox regression, and OR using logistic regression, unadjusted and adjusted for confounding factors, such as patient characteristics, socioeconomic status and comorbidities, and mediators, such as surgical factors.

Results

Adjusted multivariable Cox-regression analysis showed no T2DM-associated risk of reoperation after hip or knee replacement, adjusted HR 1.10 (95% CI 0.99 to 1.23) and 1.09 (95% CI 0.96 to 1.24), respectively, while T2DM was associated with increased risk of death after hip and knee replacement, adjusted HR 1.40 (95% CI 1.34 to 1.47) and 1.38 (95% CI 1.31 to 1.45). Adjusted logistic regression analysis showed T2DM-associated increase of reoperation within 90 days (OR 1.23 (95% CI 1.05 to 1.43)) and increased mortality within 90 days (OR 1.42 (95% CI 1.01 to 1.95)) following hip replacement; however, this was not the case after knee replacement, OR 1.08 (95% CI 0.85 to 1.36) for reoperation and OR 1.29 (95% CI 0.84 to 1.94) for mortality. Several factors closely linked with T2DM, such as body-mass index and comorbidities, were identified as important when assessing risk of reoperation and mortality. Regarding AEs within 30 and 90 days, very slight but not statistically significant T2DM-associated increases were seen after either hip replacement, OR 1.01 (95% CI 0.91 to 1.11) and 1.07 (95% CI 0.98 to 1.16) or after knee replacement, OR 1.05 (95% CI 0.93 to 1.17) and 1.08 (95% CI 0.98 to 1.19).

Conclusion

The observed risk of reoperation suggests that T2DM alone was not a strong justification to advise against hip or knee replacement in individuals with T2DM deemed eligible for joint replacement. The T2DM-associated increased mortality after hip and knee replacement is challenging to interpret, as T2DM itself without undergoing hip or knee replacement surgery is associated with increased mortality.

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