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- New
- Research Article
- 10.1111/papr.70160
- Jun 1, 2026
- Pain practice : the official journal of World Institute of Pain
- Marissa Catalanotto + 2 more
Despite increasing representation of women in medicine overall, significant gender disparities persist in procedural specialties such as interventional pain medicine. Women remain underrepresented as speakers at national pain conferences and in leadership roles. Additionally, a pay gap between female and male pain physicians remains. This study aims to objectively demonstrate the above-mentioned inequities. National conference faculty were analyzed across five major pain societies (ASRA, NANS, AAPM, ASIPP, ASPN) from 2020 to 2024 annual conference agendas. Gender was assigned based on publicly available information. Leadership roles were assessed by identifying the gender of pain fellowship program directors and pain medicine department chairs. Lastly, using the Association of American Medical Colleges (AAMC) Faculty Salary Report (2021-2024), we examined the compensation gap and difference in salary growth rates between genders. Across national conferences, only 25% of speakers were female, with ASRA demonstrating the most consistent female representation. Of the pain medicine fellowship programs studied, there were 36 (32.7%) female program directors and 25 (23.8%) female department chairs. Programs led by female program directors had significantly higher proportions of female faculty (OR = 1.97, CI [1.45, 2.68], p < 0.0001). Salary data revealed that at every academic rank, women in pain medicine faculty earned less than their male counterparts. Additionally, there is a statistically significant difference between the salary growth rates of male and female associate professors between 2021 and 2024 (F = 12.25, p < 0.05). Substantial gender disparities remain in visibility at national conferences, academic leadership, and compensation in pain medicine. Female-led academic programs demonstrate more gender-diverse faculties, highlighting the importance of representation in leadership. Focused efforts are needed to promote mentorship, equitable hiring, and transparency in pay and speaking opportunities to foster a more inclusive field.
- New
- Research Article
- 10.1308/rcsann.2026.0039
- May 19, 2026
- Annals of the Royal College of Surgeons of England
- J M Wohlgemut + 10 more
Emergency general surgery (EGS) is an essential part of general surgery. However, the service configuration for EGS in the United Kingdom (UK) and Ireland varies significantly. This study aims to clarify current and desired future roles of EGS surgeons in the UK and Ireland, particularly regarding operative procedures. An e-survey, designed by the Association of Surgeons of Great Britain and Ireland (ASGBI) Moynihan Academy, was distributed to ASGBI members at two national conferences in 2023. Data collection included the operative roles of EGS surgeons and factors influencing the appeal of a dedicated EGS career. The study was conducted and reported according to the Checklist for Reporting Results of Internet E-Surveys (CHERRIES). There were 132 of 347 (response rate 38.0%) complete responses analysed. Respondents identified a core set of procedures that could be safely performed by EGS surgeons, regardless of dedicated EGS service configuration. A minority of respondents stated that EGS surgeons - rather than a surgeon with a specialist interest - should operate on specific conditions: emergency colonic resection for cancer (65 of 132 [49.2%]) or for inflammatory bowel disease (49 of 132 [37.1%]), laparoscopic cholecystectomy plus intraoperative cholangiogram with or without common bile duct exploration (45 of 132 [34.1%]), operations for gastric volvulus (45 of 132 [34.1%), operations for Boerhaave's (37 of 132 [28.0%]) and operations for bariatric complications (34 of 132 [25.8%]). Factors that might improve future EGS careers included pragmatic job planning, minimally invasive elective surgical opportunities and dedicated continuing professional development. This study outlines the operative role of EGS surgeons within the broader general surgical profession and highlights controversies regarding whether EGS surgeons should perform specific complex operations.
- New
- Research Article
- 10.1136/bmjopen-2025-109839
- May 19, 2026
- BMJ open
- Guangwen Liu + 6 more
Hearing loss (HL) imposes a substantial burden on families and society and is the largest modifiable risk factor for dementia. As a practical and non-invasive approach to managing HL, hearing aid use has been associated with a reduced risk of incident dementia and global cognitive decline. However, high-level evidence on the cognitive benefits of hearing aids among those at high dementia risk is scarce and adherence to hearing aid use remains challenging. Our study aims to explore whether a family-supported hearing aid use behaviour intervention, guided by the integrated framework of self-determination theory, technology acceptance model and family social support theory, can improve cognitive function in Chinese older adults with both HL and mild cognitive impairment (MCI). This study is a two-arm, single-blinded, randomised controlled trial. A total of 150 participants with HL and MCI will be randomly assigned in a 1:1 ratio to either an intervention group (hearing aid use and family intervention) or a control group (hearing aid use and regular health education). All interventions will last for 4 months. Hearing aid use will be delivered by professional audiologists, while family caregivers will deliver the behavioural intervention at home after receiving standardised training from researchers and guidance through structured manuals. Furthermore, family caregivers will be guided through a WeChat group to address unresolved issues related to hearing aid maintenance and intervention skills. The primary outcome is cognitive function measured by the Montreal Cognitive Assessment-Hearing Impairment at baseline and follow-up. Secondary outcomes include adherence score to hearing aid use measured by daily duration and weekly frequency, hearing aid use skills, motivation, activities of daily life, quality of life, depressive symptoms, subjective cognitive decline, social support, self-efficacy, healthcare utilisation, autonomy support and caregiver burden. The study was approved by the Institutional Review Board of Peking University. Research findings will be published in peer-reviewed journals and at national and international conferences. ChiCTR2400091791.
- New
- Research Article
- 10.1302/2633-1462.75.bjo-2025-0324.r1
- May 19, 2026
- Bone & joint open
- Sai Pendyala + 7 more
This study aims to develop and internally validate an AI approach based on a deep learning (DL) algorithm to classify wound photographs as either 'healing well' or 'requiring review' after a total knee arthroplasty (TKA). A prospective cohort study will be conducted at a single, high-volume Elective Orthopaedic Centre. Adult patients who have undergone primary TKAs will be recruited either upon re-attendance at a wound review clinic or if they have a wound concern. Within the first two weeks postoperatively, an orthopaedic research fellow will obtain two standardized photographs of the wound, and the participant will complete a six-item symptom survey. Two blinded consultant orthopaedic surgeons will independently label each case (with the photographic and survey knowledge only) as 'healing well' or 'requires review'. The dataset of wound images will be split into an 80:20 ratio and a pre-trained DL algorithm will be fine-tuned using 80% of the data with five-fold cross-validation being employed. The folds will be generated using stratification not only by outcome labels but also by demographic variables in order to maintain similar distributions across folds. The remaining 20% will be the test set allowing for internal validation and assessment of the efficacy of the developed algorithm. Ethical approval has been granted by the NHS REC/HRA (IRAS 340642). This study will generate one of the first prospectively validated DL tools for orthopaedic wound triage. Embedding objective imaging and symptom data into a DL algorithm will allow for early detection of complications, timely intervention, streamlined follow-up, and support NHS digital-first pathways. This study's design directly mirrors NHS post-TKA pathways, supporting translatability into the current postoperative workflow for patients. The development of an early-detection system further enables patients to communicate concerns and receive timely assessment and treatment of any postoperative wound issues. The findings of this study will be disseminated through peer-reviewed publications and presentations at national and international conferences.
- New
- Research Article
- 10.1136/bmjopen-2026-119075
- May 14, 2026
- BMJ Open
- Jeremy Howick + 7 more
IntroductionRemote consultations (video, telephone, text) have become integral to the delivery of primary care and are promoted by government initiatives. While many find these more convenient, they may also discriminate against those with lower digital literacy and present a barrier to empathy by removing some non-verbal communication. The aim of this realist review is to understand how therapeutic empathy can be effectively expressed during remote consultations in general practice across different situations and for different people.Methods and analysisThis realist review will follow the methodological framework proposed by Pawson and colleagues, which includes the following five steps: (1) identify existing theories to develop an initial programme theory; (2) systematically search bibliographic databases to identify relevant literature; (3) select, extract and organise data; (4) synthesise evidence to develop context-mechanism-outcome configurations; (5) refine and finalise programme theory. This iterative process will be guided by a Content Expert Group consisting of patients, carers, clinical staff working in general practice and representatives from national stakeholder groups. The final programme theory will inform the development of evidence-based recommendations to help clinical staff working in general practice express empathy during remote consultations.Ethics and disseminationThis review does not require ethics approval. Findings will be disseminated through peer-reviewed journals, national and international conferences and through relevant professional associations and primary care networks in the UK.PROSPERO registration numberCRD420261306014.
- New
- Research Article
- 10.1136/bmjopen-2025-114901
- May 14, 2026
- BMJ Open
- Benson Droti + 4 more
IntroductionThe rising shift from paper-based to electronic health management information systems (EHMIS) among global health systems has shown promising strides over the past decade. Yet, most African health systems have continued to use paper records with attendant gaps and challenges. Most African governments have now started transitioning from paper to EHMIS but lack adequate guidance to support this shift. There is therefore a need for harmonised regional guidance to ensure that such transitions are carried out systematically and take into account country-specific contexts.ObjectiveThe objective of this study protocol is to conduct a scoping review to generate evidence that will inform the development of a comprehensive guide to support countries in the WHO African Region in transitioning from paper-based to EHMIS.Methods and analysisThe review will follow established methodological guidance for scoping reviews as outlined by Arksey and O’Malley and further refined by Levac et al and the Joanna Briggs Institute, with reporting guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. A search strategy will be developed to systematically identify relevant studies from both published and grey literature sources including PubMed, Cochrane Library, Scopus and African Index Medicus. Other sources will include Google Scholar, Emerald Journal, the WHO Regional Office for Africa Library and websites of WHO, ITU and Ministries of Health. Reference lists of the retrieved published articles will be manually searched to identify additional relevant studies. Descriptive qualitative content analysis will be undertaken using the policy analysis framework and key findings will be summarised and presented using tables, charts and maps.Ethics and disseminationThis study does not involve the collection of primary data; therefore, ethical approval will not be required. On completion of the study, findings will be submitted for publication in a peer-reviewed scientific journal and will also be presented at national, regional and international conferences to support knowledge sharing and policy engagement.
- New
- Research Article
- 10.1136/bmjopen-2025-112056
- May 14, 2026
- BMJ Open
- Carin Andrén Aronsson + 5 more
IntroductionType 1 diabetes is a chronic autoimmune disease, preceded by the presence of islet autoantibodies, a preclinical state defined as islet autoimmunity. Several environmental exposures have been associated with the initiation of islet autoimmunity but the triggers remain largely unknown. Rapid growth and weight gain during childhood are some of the exposures that have been proposed to promote islet autoimmunity. A high intake of protein and animal milks in early childhood is consistently associated with increased later obesity. Growth during early childhood is directly related to dietary intake and especially protein intake and this association has been linked to increased risk of islet autoimmunity and type 1 diabetes. The Intensive Dietary and Activity Counselling (IDAC) study aims to determine whether a healthy lifestyle counselling from age 3 months to age 2 years improves β-cell health in children with increased risk for islet autoimmunity.Methods and analysisThe IDAC study is a randomised trial (1:1 allocation) with two parallel groups, aiming to enrol 1244 children at increased genetic risk of type 1 diabetes before the age of 4 months. Participants will be randomised to either the control or intervention group based on the child’s current breastfeeding status (currently breastfeeding or no longer breastfeeding). The intervention group will receive regular dietary and physical activity counselling. The primary outcome is β-cell health at 36 months, assessed by fasting and stimulated proinsulin-to-C-peptide ratio. Secondary outcomes include accelerated growth during infancy, overweight at 36 months, and time to development of persistent confirmed islet autoantibodies or type 1 diabetes. Growth measures, blood samples for serological markers, stool samples, dietary intake (nutrients and food group data) and questionnaire data will be collected regularly throughout the study period. Regression models will be used to estimate the effects of the intervention on the primary outcome.Ethics and disseminationThe research protocol was approved by the Swedish Ethical Review Authority (dnr 2024-05217-01, 2024-08622-02, 2025-01759-02). Study findings will be presented at national and international conferences, submitted for publication in peer-reviewed journals, shared on social media and disseminated through patient-education materials.Trial registration numberNCT06670625.
- New
- Research Article
- 10.1136/bmjopen-2025-115344
- May 13, 2026
- BMJ Open
- Márton Papp + 6 more
IntroductionAppropriate antibiotic (AB) therapy remains a challenge in intensive care units (ICUs). Guidelines recommend against using procalcitonin (PCT) to guide the initiation of AB therapy, although with low certainty and a very low level of evidence. Recent studies suggest that changes in PCT levels may be more accurate than a single measurement; however, this has never been tested in a randomised trial.Methods and analysisIn this multicentre, randomised controlled trial (RCT), we aim to compare the efficacy and safety of two different PCT protocols for initiating AB therapy. Hemodynamically stable, critically ill adult patients with suspected new-onset infection at admission or during ICU stay will be randomised in a 1:1 ratio. In the treatment arm (Kinetics Group, KG), initiation of AB treatment is strongly recommended if PCT ≥0.5 ng/mL and increases by more than 100% compared with the previous day. In the control arm (Absolute Group, AG), the initiation of AB treatment is strongly recommended if PCT ≥0.5 ng/mL. The primary outcome will be the rate of unnecessary AB therapy: 72 hours after recruitment, an independent intensivist, microbiologist and infectologist will determine whether the therapy was necessary, using all relevant clinical, microbiological and radiographic results. If no consensus is reached, a decision will be made by secret vote. We plan to enrol 250 participants in the study, with 80% statistical power and a 5% alpha level.Ethics and disseminationEthics approval was obtained from the National Centre for Public Health and Pharmacy (BM/20019/2025). We plan to present our results at relevant national and international conferences and meetings and to submit them for publication in a peer-reviewed journal. Moreover, we plan to disseminate the results to important stakeholders in the Hungarian healthcare system.Trial registration numberThis is the first version of the trial protocol, prepared in accordance with the SPIRIT 2025 guideline (version 1.0, dated 30 September 2025). The trial has been registered on ClinicalTrials.gov (NCT07211620).
- New
- Research Article
- 10.1136/bmjopen-2026-118108
- May 13, 2026
- BMJ Open
- Shinsuke Akita + 19 more
IntroductionSecondary lower extremity lymphoedema is a chronic progressive condition that frequently develops after cancer treatment and results in persistent swelling, recurrent cellulitis and impaired quality of life. Lymphaticovenous anastomosis (LVA) is an established physiological microsurgical treatment; however, postoperative outcomes vary and evidence-based adjunctive postoperative management remains limited. A novel pneumatic lymphatic drainage (PLD) system has been developed to deliver anatomically directed, pathway-aligned mechanical stimulation that mimics manual lymphatic drainage. Its clinical efficacy following LVA has not yet been evaluated in a randomised controlled trial.Methods and analysisThis multicentre, open-label, parallel-group randomised controlled trial will enrol adults (≥18 years) with unilateral secondary lower extremity lymphoedema (International Society of Lymphology stage I–II) undergoing LVA. Participants will be randomised 1:1 to receive PLD plus standard postoperative care or standard postoperative care alone. PLD will be initiated on the day of surgery and continue for 6 months (Day 183). The primary outcome is the rate of improvement in excess limb volume (EV) at Day 183 relative to baseline, calculated from circumferential measurements taken at 4 cm intervals using the truncated cone method, with the contralateral limb serving as an internal control. Secondary outcomes include longitudinal trajectories of EV, improvement in excess limb fluid volume assessed by bioimpedance, the Lymphedema Quality of Life Questionnaire, cellulitis incidence and safety outcomes. A total of 64 participants (32 per group) will provide 80% power (two-sided α=0.05) to detect a 15-percentage-point between-group difference in the rate of improvement in EV at 6 months, assuming a common SD of 20 percentage points and allowing for attrition. Primary analyses will follow the ITT principle using mixed-effects models for repeated measures.Ethics and disseminationThe study was approved by the Chiba University Certified Review Board (approval number: CRB0119-25; approval date: 15 December 2025) and was conducted in accordance with the Declaration of Helsinki and the Japanese Clinical Trials Act. Results will be disseminated through peer-reviewed publications and presentations at national and international scientific conferences, irrespective of study outcomes.Trial registrationjRCTs032250600.
- New
- Research Article
- 10.1097/sap.0000000000004773
- May 11, 2026
- Annals of plastic surgery
- Isaac Mordukhovich + 6 more
Conference presentations are a crucial instrument for disseminating research and measuring academic productivity in plastic surgery education. Much attention has been given to outcomes of abstracts presented at national conferences, but less so in regional settings. To better understand the validity and ultimate outcomes of abstracts presented at regional conferences, we evaluated their trends in abstract-to-peer-reviewed publication conversion. Regional plastic surgery conferences' publicly available oral abstract information for 2022 and 2023 was used to find corresponding full-length publications using keywords and author names. Abstract topic, study design, and author institutions/degrees were collected and evaluated for their influence on publication odds and lag time within 2.5 years of presentation. Southeast (SESPRS), Northeast (NESPS), New England (NESPRS), California (CSPS), Ohio Valley (OVSPS), and Mountain West (MWSPS) conferences were evaluated and compared with national conferences [Plastic Surgery Research Council (PSRC) and American Association of Plastic Surgeons (AAPS) annual meetings]. 2.5-year publication time ( P =0.050) and odds ( P <0.01) differed significantly across conferences, as did the composition of abstract topics and study designs ( P <0.01). The journals that published abstracts also differed significantly by conference ( P <0.01). CSPS, NESPS, and SESPRS had comparable publication conversion rates (66.7% to 68.4%) as national conferences (65.7% to 69.6%) and published in plastic surgery journals more often (87.3% to 92.3% vs. 56.5% to 80.0%). Notably, NESPS and OVSPS abstracts presented on medical education and reconstruction/microsurgery more often, respectively, and also published these topics with greater frequency. On multivariate analysis, abstract year strongly influenced the odds of an abstract converting to a full-length, peer-reviewed, published manuscript within 2.5 years (OR=0.67, P <0.01). Database, systematic review, and retrospective clinical studies increased 2.5-year conversion odds (OR≥3.04, P ≤0.036), whereas MWSPS and OVSPS conference abstracts had lower odds ( P ≤0.012). The only significant predictor of the time from presentation to publication was presentation of an abstract at PSRC (β=-2.73, P =0.021). Regional conferences contribute equally to research metrics, but differences in real-world impact and peer-reviewed outputs exist. However, these trends are not necessarily inferior to those of national conferences. Different regions also generate more abstracts on specific plastic surgery topics, although such specializations rarely persist into published full-length manuscripts.
- New
- Research Article
- 10.1002/ajmg.a.70200
- May 11, 2026
- American journal of medical genetics. Part A
- Sarah Elsaim + 8 more
Congenital heart disease (CHD) and dermatologic conditions such as lymphedema and acquired melanocytic nevi (AMN) are common in Turner Syndrome (TS). We hypothesized that abnormalities of cranial neural crest cell derivatives drive the skin and heart manifestations of TS. We conducted joint cardiac and skin examinations of volunteers at a 2023 national TS conference. Electrocardiographic abnormalities were classified according to the Minnesota Codes. Aortic diameters and cardiac anatomy were assessed using a standardized echocardiographic protocol. The primary outcome was the association between ECG abnormalities and thoracic aortic aneurysms (TAA) or CHD. The secondary outcome was the association between AMN counts and CHD, TAA, or the corrected QT interval (QTc). Among 118 participants (median age 33 years; CHD 39%; TAA ~25%), 35% had major ECG abnormalities, most commonly T-wave inversions and ST depressions; QTc prolongation occurred in 7%. Major ECG abnormalities were associated with larger aortic diameter and were more frequent in CHD, with a trend toward increased TAA (OR 2.8). Notably, 17% without known CHD had ECG abnormalities, and > 25% of these had previously unrecognized TAA. Only 45,X karyotype independently predicted ECG abnormalities. AMN burden was markedly elevated and increased stepwise with combined CHD + TAA (adjusted OR per level 13.1) but was not associated with QTc. ECG abnormalities and AMN burden track with cardiovascular disease severity in TS and may identify individuals with unrecognized aortopathy. These preliminary findings support integrated multimodal screening for CHD in TS, pending validation in larger cohorts.
- Research Article
- 10.1136/bmjopen-2026-117431
- May 7, 2026
- BMJ open
- Ebaa Al Ozairi + 7 more
Medication for the disease of obesity has improved, and clinical trials based on natural gut hormones such as tirzepatide, showed only mild side effects and ~22% weight loss maintenance. However, patients with type 2 diabetes only lose 15% bodyweight with tirzepatide while tolerating the medications very well, but little is known in patients with the disease of obesity who also have type 1 diabetes, especially regarding safety of the medications. Tirzepatide's licence in the Gulf countries and Europe for obesity does not exclude patients with obesity and type 1 diabetes, unlike the USA. In Kuwait, more than a quarter of patients with type 1 diabetes also have the disease of obesity. Tirzepatide is not approved for glycaemic control in patients with type 1 diabetes, because it is unlikely to make a difference. Because tirzepatide is approved for the treatment of obesity in patients who also have type 1 diabetes we can now test how effective treatments for obesity such as tirzepatide are for patients with obesity and type 1 diabetes. Concerns regarding the safety of the medication in type 1 diabetes can also be addressed thus addressing an important knowledge gap. This will be a randomised double blind controlled trial of 60 patients with obesity and type 1 diabetes to test usual care with or without maximum tolerable dose of tirzepatide to achieve weight loss. We will investigate the safety of the medications in patients with obesity and type 1 diabetes to address important knowledge gap which can change clinical practice. The study has received ethical approval from the Dasman Diabetes Institute Ethical Review Committee (HR-RA-2025-03) and is registered at ClinicalTrials.gov (NCT07096908). Written informed consent will be obtained from all participants, with no financial compensation provided. Data will be reported in accordance with Consolidated Standards of Reporting Trials guidelines, ensuring participant anonymity. Findings will be disseminated through peer-reviewed publications and presentations at national and international conferences. NCT07096908.
- Research Article
- 10.1136/bmjopen-2025-107582
- May 7, 2026
- BMJ open
- Lara Schürmann + 8 more
The shortage of general practitioners in many countries remains a persistent issue and is likely to become more severe in the future. Multiple factors influencing the attitude of medical students towards general practice have been identified. The aim of this scoping review is to describe the scope of the evidence on the influence of teaching general practice in medical school (eg, lectures, seminars, internships) on medical students' attitude towards this discipline and to identify knowledge gaps. We will apply a mixed studies scoping review design. Quantitative, qualitative and mixed-methods studies exploring the influence of general practice education in medical school (exposure) on the attitudes (outcome) of medical students (population) will be included. The outcome will be any measured or reported change in medical students' attitude towards general practice as a discipline. A systematic search in MEDLINE through PubMed, Cochrane, Embase, the Education Resources Information Centre and PsycInfo, as well as forward and backward citation tracking, will be conducted starting from 2015, published in English or German. Titles, abstracts and full texts will be screened and data will be extracted independently by two reviewers. Results will be tabulated and summarised narratively and interpreted according to the framework of the affective domain. By identifying and linking educational formats with levels of the affective domain, this approach may help educators understand how medical training can influence the attitude towards and interest in primary care and improve the development of professional identity formation and general practice focused curricula. This scoping review does not require ethical approval. The results will be disseminated through publications in peer-reviewed journals and presentations at national and international conferences. The protocol of this scoping review has been registered on OSF (DOI: 10.17605/OSF.IO/UFJCR).
- Research Article
- 10.1136/bmjopen-2025-112179
- May 6, 2026
- BMJ open
- Simiao Chen + 26 more
Tobacco use is a major contributor to the burden of chronic obstructive pulmonary disease (COPD) and other non-communicable diseases in China. People at high risk for COPD who smoke, particularly those with pre-existing chronic conditions, often remain underserved by conventional smoking cessation programmes. Population medicine offers a promising framework for proactively identifying high-burden diseases, managing multimorbidity and prioritising interventions for vulnerable populations. This protocol describes a stratified, two-arm cluster randomised controlled trial (Population Medicine Multimorbidity Intervention in Xishui County-Smoking) being conducted in Xishui County, a rural area of Guizhou Province, China. A total of 26 townships were stratified by population size and randomly assigned in a 1:1 ratio to receive either a multicomponent intervention or usual care. Eligible participants were individuals aged 35 years or older who smoked and were at high risk for COPD as identified by the COPD Screening Questionnaire. The intervention package integrates multiple components, including a digital smoking cessation programme, digital mental health support, community-based spirometry, tailored chronic disease management, health education and a performance-linked 'pay-for-population' scheme that aligns healthcare worker reimbursement with population health outcomes. Primary outcomes are smoking amount and nicotine dependence and secondary outcomes include COPD-related health outcomes, hypertension, diabetes, health risk behaviours, quality of life, healthcare utilisation and productivity loss. Follow-up occurs at 3, 6 and 12 months. Ethical approval has been granted by the Peking Union Medical College Ethics Committee (CAMS&PUMC-IEC-2024-042). Informed consent was obtained from all participants prior to enrolment. Results will be shared through peer-reviewed publication and (inter)national conference presentations. NCT06458205.
- Research Article
- 10.1136/bmjopen-2025-115741
- May 3, 2026
- BMJ open
- Jessica Dyck + 8 more
There are national calls for reducing physician administrative burden. While interest in digital scribes (DS) is growing, there is limited evidence evaluating their safety and effectiveness. In contrast, human scribes (HS) have demonstrated significant benefits in multiple controlled studies. To our knowledge, no prior study has compared the utility of HS versus DS in improving clinical efficiency in psychiatric clinical settings. We hypothesise that HS and DS will reduce administrative burden for psychiatrists compared with no scribes. Following institutional ethics board approvals, we will conduct a randomised controlled crossover study with 10 Manitoba psychiatrists. Study phases will include 1 month periods for baseline, HS and DS for a total of 3 months. Measures will include physician characteristics, practice patterns, administrative hours and patient satisfaction. Depending on distributional characteristics, data will be analysed using parametric or non-parametric tests to compare scribed and non-scribed periods as well as HS versus DS. Ethics approval has been obtained from the Committee for Harmonized Health Impact, Privacy, and Ethics Review (CHIPER) Health Research Ethics Board, which is the ethics board for medical research at the University of Manitoba (HS26944 (H2025:154)). The results of this trial will be disseminated through a peer-reviewed journal and provincial and national conference presentations. Integrated knowledge translation will be conducted throughout the duration of the research process with key stakeholders including medical organisations, such as the provincial health organisation. 1.2, 9 April 2026.
- Research Article
- 10.1136/bmjopen-2025-111477
- May 1, 2026
- BMJ open
- Weihai Shi + 5 more
Postoperative sleep disturbance (PSD) is a common complication following laparoscopic cholecystectomy (LC). It is associated with delirium, cognitive decline and delayed recovery. Effective preventive strategies are currently lacking. Dexmedetomidine, a highly selective α₂-adrenergic receptor agonist, offered in a nasal spray formulation with high bioavailability and convenient administration, may present a novel approach for PSD prevention. The primary objective is to evaluate the effect of evening dexmedetomidine nasal spray on the incidence of PSD on the first postoperative day in LC patients. Secondary objectives include assessing its impact on the quality of recovery, anxiety and depression and pain scores. This is a multicentre, prospective, randomised, double-blind, controlled trial. At least 260 patients will be enrolled and randomly allocated in a 1:1 ratio to receive either dexmedetomidine (50 µg nasal spray) or saline placebo the night before and the night of surgery (between 20:00 and 22:00). The primary outcome is the incidence of PSD on postoperative day 1 defined as an Numerical Rating Scale (NRS) >6 or Athens Insomnia Scale >6 score, which will be compared between groups using the χ2 or Fisher's exact test on the full analysis set. Secondary outcomes include quality of recovery (Quality of Recovery-15 scale, QoR-15), anxiety and depression (Hospital Anxiety and Depression Scale, HADS), pain (NRS), postoperative nausea and vomiting and adverse events, analysed using t-tests, rank-sum tests or repeated-measures mixed-effects models as appropriate. The study protocol has been approved by the Ethics Committee of the Affiliated Drum Tower Hospital of Nanjing University Medical School (Approval No.: 2025-0064-02) and registered with the Chinese Clinical Trial Registry. The findings of this study will be disseminated through various channels. Academic dissemination will include publication in peer-reviewed journals and presentations at national and international conferences. ChiCTR2500101205.
- Research Article
- 10.1136/bmjopen-2025-113204
- Apr 29, 2026
- BMJ open
- Laura Kinsey + 9 more
Weight gain in adulthood is a common potentially modifiable breast cancer risk factor. Intermittent 5:2 diets (two low-calorie days/week) have proven efficacy for weight loss among people with overweight or obesity and can promote sustained awareness and mindfulness of diet choice and help appetite control.This trial aims to test whether a less intensive 6:1 intermittent diet programme (one low-calorie day/week) is a feasible intervention to promote healthy eating and prevent weight gain in women at increased risk of breast cancer. Single arm prospective feasibility trial in 30 healthy weight women aged 18-40 years, at moderate or high risk of breast cancer (≥17% lifetime risk and/or ≥3% 10 year risk at 40 years), body mass index 20-25 kg/m2. Participants will be entered to a 16-week 6:1 diet programme involving 1 day consuming 1000 kcal and healthy eating for 6 days a week. Participants will also be advised to meet physical activity recommendations for health (≥150 min of moderate intensity physical activity/week and resistance exercise two times per week). The programme will be supported remotely by dietitian calls at baseline, week 1, 4, 8, 12 and 16. Participants will also be provided access to a trial-specific private monitored Facebook group which includes information and the opportunity for peer support.Co-primary outcomes are: (a) uptake to the trial, (b) retention rate, (c) adherence to the 6:1 diet and (d) participant feedback on acceptability of the programme. Secondary outcomes include characteristics of those recruited and completing the programme and a preliminary evaluation of benefits and harms. This includes changes in body weight and body composition (bioelectrical impedance), diet quality, physical activity, binge eating, sleep quality (Pittsburgh Sleep Quality Index), menstrual cycle length and potentially diet-related adverse events, that is, fatigue, constipation, dizziness, headache, indigestion. Exploratory outcomes include the impact of low-calorie days on dietary intake and physical activity across the week and any differences in adherence to the low calorie days across the menstrual cycle. This trial has been approved by South Central-Berkshire B Research Ethics committee (rec reference 24/SC/0321). Findings will be disseminated via peer-reviewed journals, national and international cancer prevention and obesity conferences and cancer prevention charitable bodies. ISRCTN14330469.
- Research Article
- 10.1136/bmjopen-2025-108674
- Apr 28, 2026
- BMJ open
- Rodrigo Antunes Lima + 31 more
This trial aims to evaluate the impact of the IMPROVA intervention programme in improving mental health, quality of life, and well-being in adolescents enrolled in secondary schools in four European countries. The IMPROVA intervention will be evaluated using a two-arm parallel group pragmatic cluster randomised controlled trial with an intervention and a wait-list control group. Secondary schools in France, Germany, Romania, and Spain were recruited. Originally, we estimated to enrol a total of 6000 students within 64 schools; that is, 16 schools per country. The IMPROVA programme is a multi-level intervention that provides tailored content for adolescents, families, and school staff. This content creates a unified and supportive framework that promotes mental health and social-emotional development among adolescents. A series of implementation strategies was planned to support the uptake of the programme into the education setting and among participants. Study outcomes were assessed at baseline, mid-term (during the intervention), postintervention (primary end point), and will be assessed at postintervention (secondary end-point; 6 months after postintervention). Overall mental health (Strengths and Difficulties Questionnaire) is the primary outcome. Secondary outcomes include: health-related quality of life, depression, anxiety, social isolation, and self-esteem. The trial will be evaluated regarding its effectiveness, cost-effectiveness, implementation, and social return on investment analysis. This study has received the approval of human research ethics committees in France (Comité de Protection des Personnes Ile-de-France VIII", No. 2024-A00201-46), Germany (Ulm University Ethics Committee, No. 186-24), Romania (The Research Ethics Subcommittee of the Babeș-Bolyai University of Cluj-Napoca, No. 14.146/23.09.2024), and Spain (CEIm Fundació Sant Joan de Déu, No. PIC-61-24). Results will be disseminated through peer-reviewed open-access publications and presentations at national and international conferences. Non-technical summaries will be shared with public health authorities, participants, and stakeholder organisations. All findings will be reported in aggregate form, ensuring no individual participant can be identified. NCT06556576.
- Research Article
- 10.1136/bmjopen-2025-114465
- Apr 28, 2026
- BMJ open
- Anna Seiterö + 13 more
Adolescence is a critical period marked by physiological and psychological changes that influence long-term health. Establishing healthy behaviours, particularly regular physical activity, is essential during this stage; however, around 80% of young people do not meet the WHO's physical activity recommendations. Digital technologies offer promising opportunities to promote health among youth, yet most physical activity mobile applications (apps) lack scientific validation and usability. Unlike psychology, which has validated repositories to guide users in selecting mental health apps, physical activity lacks validated repository platforms, especially for adolescents. The project has a twofold aim: (1) to co-design a website, named the TeenFit website, that facilitates the selection of physical activity apps tailored to each adolescent's individual needs and preferences and (2) to investigate the barriers and facilitators for the implementation of the TeenFit website in real-world settings. Adolescents and other stakeholders (ie, caregivers, educators, and health professionals) will be engaged in the development of the TeenFit website app finder through a participatory design approach that involves three workshops, encompassing both a development phase and an implementation phase. Approximately 10-12 participants per group will take part in smaller working groups to collaboratively contribute to the co-design of the TeenFit website. TeenFit will include physical activity apps available in the Spanish market, developed in both English and Spanish. These applications are currently being identified through two ongoing systematic reviews. In addition to qualitative data gathered during the audio- and video-recorded workshops, quantitative data will be collected on participants' co-design experiences and the acceptability of the TeenFit website. Data analysis will involve descriptive statistics, qualitative content analysis for describing participants' perspectives on what aspects (ie, content, features and layout) are important for the design of the website and reflexive thematic analysis to identify barriers and facilitators to implementation. The study was approved by the Research Ethics Committee in the province of Málaga (Spain) (REC ref: SICEIA-2024-003172). Research findings will be disseminated primarily via national and international conferences and publication in peer-reviewed journals. Patient and public involvement will inform further dissemination activities.
- Research Article
- 10.1136/bmjopen-2025-114320
- Apr 28, 2026
- BMJ open
- Siqi Hao + 5 more
Postoperative delirium (POD) is a common acute central nervous system syndrome in elderly patients following surgery. Due to pre-existing brain tissue damage, elderly patients with non-acute fragile brain function (NFBF) are at higher risk of developing POD, which can lead to long-term cognitive impairment, postoperative complications increasing and prolong hospitalisation. Transcutaneous auricular vagus nerve stimulation (taVNS) has been demonstrated to play a significant role in treating various neurological disorders, including epilepsy, depression and consciousness impairment. However, its efficacy in preventing POD in elderly NFBF patients remains unknown. Therefore, this study aims to investigate the effect of perioperative taVNS on the incidence of POD in elderly NFBF patients. A bi-centre, double-blind, randomised, controlled trial will be conducted at Beijing Friendship Hospital, Capital Medical University and Xiyuan Hospital of China Academy of Traditional Chinese Medical Sciences, China, from December 2025 to December 2026. A total of 148 elderly NFBF patients (≥60 years old) undergoing abdominal surgery will be enrolled and randomly allocated to two groups: the taVNS group (receiving transcutaneous auricular vagus nerve stimulation) and the tnVNS group (receiving transcutaneous non-vagus nerve stimulation). The primary outcome will be the incidence of POD within 5 days after surgery. Secondary outcomes include delirium severity, changes in biomarkers, postoperative delayed cognitive dysfunction, Numerical Rating Scale (NRS) scores, recovery of gastrointestinal function, anaesthesia-associated parameters, economic indicators, and the incidence of perioperative complications or other serious adverse events. This study was approved by the Ethics Committee of Beijing Friendship Hospital, Capital Medical University and adheres to the principles of the Declaration of Helsinki. The protocol was written in accordance with the 2013 Standard Protocol Items: Recommendations for Interventional Trials guidelines. The results of this study will be published in a peer-reviewed journal and presented at national or international conferences. ITMCTR2025002263.