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☐ ☆ ✇ BMJ Open

Cross-cultural adaptation and psychometric testing of the Evidence-Based Practice Mentoring Scale in Chinese nurses

Por: Wang · M. · Sun · S. · Guo · M. · Qian · J. · Sun · Y. · Chen · M. · Yu · X. — Febrero 22nd 2026 at 18:08
Objectives

Mentoring has been identified as a promising strategy for implementing and sustaining evidence-based practice (EBP) in healthcare organisation. However, no appropriate tools were specifically developed or cross-culturally adapted into Chinese context to assess nurse’s perceived EBP mentoring, impeding comprehensive evaluation of the effects of mentoring intervention studies. This study aimed to cross-cultural adapt the Evidence-Based Practice Mentoring (EBPM) scale into Mainland China and evaluate its psychometric properties, including validity and reliability.

Design

A comprehensive translation and adaptation process was adopted to achieve the Chinese version of the EBPM (C-EBPM) scale. It consists of four steps: (1) trilateral translation procedure, (2) cognitive interview, (3) psychometric testing and (4) cross-time confirmatory factor analysis (CFA).

Setting

This study was conducted in four 3A-level hospitals located in Shaanxi and Zhejiang provinces, China, during two different data collection periods.

Participants

A total of 598 registered nurses participated in this study.

Results

After two rounds of the trilateral translation procedure, a 9-item version of the C-EBPM scale was generated. Ten registered nurses participated in cognitive interview understood the meaning of all items but the response options. All items had significant critical ratio values (t=15.866~20.584, p²/df=65.681/27 0.950, Tucker-Lewis Index=0.966 > 0.950, and standardised root mean square residual=0.026 0.70) and average variance extracted was 0.60 (>0.50).

Conclusions

The 9-item C-EBPM scale demonstrated robust reliability and validity and is suitable for assessing EBP mentoring among nurses.

☐ ☆ ✇ BMJ Open

Evidence-based team intervention to reduce diagnostic errors in anaemia and CKD diagnoses in primary care: protocol for a stepped-wedge cluster RCT

Por: Novikov · Z. · Mehra · N. · Li · X. · Wells · R. · Ottosen · M. · Hwang · K. · Avritscher · E. B. C. · Green · C. · Lee · K. H. · Oguin · X. · Janecka · M. · Espinoza · M. · Adebowale · B. · Araya · A. · Wahed · A. · Thomas · E. — Febrero 5th 2026 at 13:02
Introduction

Diagnostic errors in primary care are common, particularly in the interpretation and follow-up of abnormal haemoglobin (Hgb) and estimated glomerular filtration rate (eGFR) results. These errors frequently result in missed or delayed diagnoses of serious conditions such as anaemia and chronic kidney disease. This protocol describes a stepped-wedge cluster randomised controlled trial designed to evaluate a novel, evidence-based, team-based intervention aimed at improving diagnostic safety and efficiency.

Methods and analysis

The study will be conducted across 12 University of Texas Physicians (UTPs) primary care clinics in Houston, Texas, USA. Adult patients (≥18 years) with newly identified abnormal Hgb or eGFR results will be eligible for inclusion. The intervention integrates automated tracking of abnormal laboratory results, nurse navigators to support patient follow-up and engagement, and clinical pathologists to provide diagnostic guidance to primary care providers. The primary outcome is diagnostic safety, defined as the proportion of patients who receive a correct diagnosis within 6 months. Secondary outcomes include diagnostic efficiency, appropriate test utilisation, cost-effectiveness, patient activation and implementation metrics such as acceptability, fidelity and sustainability. The study will also explore barriers and facilitators to successful implementation using mixed-methods evaluation.

Ethics and dissemination

This trial has been approved by the Institutional Review Board at The University of Texas Health Science Center at Houston. Study results will be disseminated through peer-reviewed publications and conference presentations, and findings will be reported to UTP leadership to inform potential system-wide implementation.

Trial registration number

NCT05735314.

☐ ☆ ✇ BMJ Open

Critical appraisal and comparison of clinical practice guideline recommendations for the treatment of anaemia in chronic kidney disease: a systematic review protocol

Por: Agnelli · J. C. M. · Costa · W. R. d. · Iwami · R. S. · Franques · R. T. · Lopes · L. C. · Barberato-Filho · S. · Bergamaschi · C. d. C. — Enero 7th 2026 at 04:50
Introduction

In chronic kidney disease (CKD), anaemia develops and evolves as kidney dysfunction progresses. The treatment of anaemia is described in clinical practice guidelines (CPGs), which are designed to report the most relevant evidence for clinical practice in disease management. This study will analyse CPGs for transparency, methodological quality and quality of recommendations for their implementation over time, and also compare recommendations for the treatment of anaemia outlined in these documents.

Methods and analysis

CPGs will be identified by conducting a systematic search of the data sources CINAHL, Embase, MEDLINE, Scielo, Scopus, ProQuest, Trip Database, Virtual Health Library, Web of Science, and guidelines on websites, published between January 2009 and December 2025. Three reviewers will, independently, evaluate the methodological quality of the guidelines using the Appraisal of Guidelines for REsearch and Evaluation II (AGREE-II) tool and the quality of recommendations using the AGREE – Recommendations Excellence tool. The treatment recommendations for anaemia in CKD will be summarised and compared. Results will be presented in tables and descriptive statistics will be compiled for all domains of the tools.

Ethics and dissemination

This is a literature-based study and, therefore, no ethical approval will be required. Results of the study can be submitted for publication in high-impact, peer-reviewed scientific journals, and also presented at national and international conferences.

Prospero registration number

CRD42024629656.

☐ ☆ ✇ BMJ Open

Implementation strategies by leaders and health professionals to improve the safety climate in the operating room: a scoping review

Por: Alves Ferreira · R. · Santos · E. J. F. · Ribeiro · O. M. P. L. · Henrique · D. M. · Camerini · F. G. · Bueno · A. A. B. · de Abreu Pereira · S. C. · Schutz · V. · Rosa Lima · M. V. · Fassarella · C. S. — Enero 7th 2026 at 04:50
Objectives

This scoping review aims to map evidence or literature on improvement strategies used by health leaders and professionals to strengthen the safety climate in the operating room.

Design

A scoping review was performed on the basis of the method proposed by the Joanna Briggs Institute and applied to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews (PRISMA-ScR) extension.

Data sources

16 academic and grey literature data sources were searched using search terms on 17 January 2025, namely, Medical Literature Analysis and Retrieval System Online via Pubmed, Latin American and Caribbean Literature on Health Sciences via the Virtual Health Library, Cumulative Index to Nursing and Allied Health Literature, Scopus, Web of Science, Embase, PsycINFO, Cochrane Library, WorldCat, Digital Library of Theses and Dissertations, Brazilian Association of Surgical Center Nurses, Center for Material and Sterilization and Anesthetic Recovery, Association of Portuguese Operating Room Nurses, Association of PeriOperative Registered Nurses, Institute for Healthcare Improvement, WHO and Agency for Healthcare Research and Quality.

Eligibility

Study selection, data extraction and synthesis were based on the following eligibility criteria based on the acronym PCC (participants, concept, context): participants (health leaders and professionals), concept (strategies to improve the safety climate) and context (operating room). This scoping review considered studies published from 2009 onwards.

Data extraction

Information on the objective, method and findings addressing improvement strategies employed to strengthen the safety climate in the surgical centre was retrieved. The findings are presented in tables and in a qualitative thematic summary.

Results

A total of 26 studies were analysed, published between 2009 and 2024, with the USA as the country of origin of the publications with the highest number (11 studies). As for the methodological approach, intervention and quasi-experimental studies stand out. When the studies in this review were mapped, strategies that strengthened the safety climate in the operating room were identified and grouped into two main axes that are interrelated: communication tools and training programmes.

Conclusion

It is evident that the implementation of tools that promote communication and training programmes enhances safe surgical care, as they contribute substantially to the domains of the safety culture. The use of communication protocols in the operating room is recommended as a perioperative safety tool.

Trial registration number

This scoping review adhered to a protocol previously published in this journal and that is registered on the Open Science Framework website (https://osf.io/zg8nu/).

☐ ☆ ✇ BMJ Open

From international guidelines to practice: a multimethod evaluation of BMJ Rapid Recommendations focusing on suitability for adaptation and implementation

Por: Seterelv · S. S. · Gupta · S. · Kouri · A. · Florez · I. D. · Agoritsas · T. · Vandvik · P. O. · Van de Velde · S. — Diciembre 31st 2025 at 11:30
Objectives

We aimed to assess usage and explore factors influencing the suitability of British Medical Journal (BMJ) Rapid Recommendations—a set of international guidelines meeting standards of trustworthiness—for adaptation and implementation, further defined as implementability.

Design

Qualitative descriptive study with a multimethod approach.

Participants

We used citation screening and a survey to identify groups that had used any of a sample of 14 BMJ Rapid Recommendations in adoption, adaptation, de novo guideline development or implementation.

Setting

12 participants from a range of country income levels were interviewed, using semistructured interviews.

Methods

Interviews were analysed using thematic analysis to identify themes related to implementability of the guidelines. We compared these findings with those from a critical appraisal conducted using three different appraisal tools.

Results

BMJ Rapid Recommendations are used in high-income, middle-income and low-income countries. We identified 33 instances of use. Our thematic analysis of the interviews uncovered 14 challenges to implementability, categorised under perceived trustworthiness, comprehensibility and practical relevance. The critical appraisals gave the BMJ Rapid Recommendations high scores on validity, but low scores on implementability and measurability. The challenges found in the interviews were generally corroborated by the appraisals, but the comparison also exposed tensions such as the complex interaction between methodological rigour and perceived credibility, the balance between novelty and compatibility with current practice, and the difficulty of offering globally applicable yet locally practical guidance.

Conclusion

Implementability challenges may limit effective use of international guidelines globally. Recognising and reflecting on tensions between rigour, credibility and contextual feasibility may help improve their uptake and value. The next phase of this research will explore strategies to enhance guideline implementability during their development.

☐ ☆ ✇ BMJ Open

Exercise-focused wellness interventions for middle-aged adults: a scoping review

Por: Park · J. · Lee · H. · Lee · S. · Kim · Y. — Diciembre 12th 2025 at 18:11
Objectives

Middle-aged adults face multifaceted physical and psychosocial challenges that impact their overall wellness. Exercise has become a key component of wellness interventions due to its positive impacts on physical and psychosocial health. However, the understanding of exercise-focused wellness interventions for this age group remains limited. Therefore, this scoping review aimed to identify and map the existing literature on exercise-focused wellness interventions for middle-aged adults and to summarise their characteristics and reported outcomes.

Design

Scoping review.

Data sources

Six databases, including PubMed, EMBASE, CINAHL, Cochrane Library, Web of Science and PsycInfo, were initially searched on 29 July 2024, and the search was updated on 12 October 2025, with no restrictions on publication date. The reference lists of articles selected in the database search were also screened for further relevant studies.

Eligibility criteria

We included interventional studies, specifically randomised controlled trials (RCTs) and quasi-experimental designs, that examined exercise-focused wellness interventions for middle-aged adults.

Data extraction and synthesis

Two independent reviewers extracted data on study characteristics and intervention details and outcomes, and assessed the risk of bias. Any discrepancies were resolved by a third reviewer.

Results

A total of 15 studies were included in the review, of which 9 were RCTs and 6 were quasi-experimental studies. Most interventions targeted middle-aged women and were implemented in community settings. Exercise was often combined with diet and stress management. The majority of the interventions lasted for 3 months with weekly sessions. Additionally, various delivery modes were employed, including face-to-face, online, individual and group-based approaches. Outcome variables were categorised into exercise and physical activity, dietary intake, anthropometry and body composition, cardiovascular health, biochemical markers, menopausal symptoms, psychosocial health and wellness. Only one study assessed wellness as an outcome of the intervention. Across the included studies, improvements were commonly reported for physical and psychosocial health, whereas changes in biochemical markers were limited.

Conclusions

Exercise-focused wellness interventions for middle-aged adults encompass varied content and outcome variables, contributing to improvements in physical, psychological and social dimensions of health. Delivery modes are diverse, demonstrating flexibility and adaptability for tailored interventions. There is a need to develop a validated, midlife-specific measurement tool that reflects the multidimensional nature of wellness. Moreover, exercise-focused interventions tailored for middle-aged men, particularly in workplace settings, should be developed.

☐ ☆ ✇ BMJ Open

Development of implementation strategies for perineal warm compresses in the second stage of labour based on the PEDALs model: protocol for an implementation study

Por: Guo · Y. · First author · Huang · J. · Co-first author · Cheng · Y. · Third author · Yang · Z. · Joint corresponding author · Zang · Y. · Corresponding author — Noviembre 20th 2025 at 07:42
Introduction

Perineal warm compresses in the second stage of labour have been demonstrated by clinical guidelines as an effective intervention for improving perineal outcomes and mothers’ psychological well-being, yet their adoption in clinical practice remains suboptimal. Therefore, this study aims to bridge the evidence-practice gap through the application of implementation science models and frameworks to facilitate clinical adoption. The investigation will systematically explore the barriers and facilitators to the application of perineal warm compresses in the second stage of labour and subsequently develop a corresponding implementation strategy addressing identified barriers.

Methods and analysis

This study was guided by the PEDALs model. Using a scoping review and a parallel mixed-methods study to systematically investigate the barriers and facilitators to the application of perineal warm compresses in the second stage of labour. The identified barriers and facilitators were mapped to the domains of the Consolidated Framework for Implementation Research (CFIR). Then we will use a modified nominal group technique to determine seven priority barriers that need to be addressed. These barriers will be input into the CFIR-ERIC implementation strategy matching tool to obtain expert-recommended implementation strategies. Finally, the Delphi method will be employed to select and refine the implementation strategies into a clear and actionable implementation strategy bundle.

Ethics and dissemination

This study has been approved by the Ethics Committee of Hebei Medical University, with approval number 2024043. Written informed consent will be obtained from all participants. Study findings will be disseminated through articles in scientific, peer-reviewed journals, and at national and international conferences. This study will begin in August 2025 and be completed in June 2026.

☐ ☆ ✇ BMJ Open

Study protocol for developing the evaluation instrument of guideline adherence to GRADE approach (GRADE-Check)

Por: Jin · Y. · Yan · S. · Yao · X. · Dahm · P. · Alonso-Coello · P. · Brignardello-Petersen · R. · Keitz · S. · Rylance · J. · Cheung · M. · Agoritsas · T. · Kunkle · R. · Murad · M. H. · Guyatt · G. — Noviembre 10th 2025 at 05:24
Introduction

Many clinical practice guidelines (CPGs) claim to use Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, but its implementation varies. This suggests that CPG developers, methodologists and users would benefit from an instrument to evaluate the extent to which CPGs adhere to GRADE approach. Such a structured instrument is currently unavailable. Accordingly, this study will develop an evaluation instrument for assessing guideline adherence to the GRADE approach, which we have named ‘GRADE-Check’. The goal is to target items to which CPGs fail to adhere and that potentially have serious consequences resulting in inaccuracies in certainty of evidence and inappropriate direction or strength of recommendations, thereby discriminating across CPGs in issues of importance.

Methods and analysis

The panel will include up to 25 individuals with specific knowledge and expertise, including experienced authors, educators and methodologists on CPGs methodology and GRADE approach from relevant organisations. The instrument will focus on the key elements of GRADE, aiming for clarity for GRADE experts and non-GRADE experts to apply. The development process for GRADE-Check will consist of the following five phases: (1) recruitment of a panel of GRADE experts; (2) development of objectives and scope for the development of GRADE-Check and criteria for item selection; (3) generation of candidate items through a literature review and panel consultation; (4) panellist discussion to construct the initial draft and extended explanation manual and (5) user testing.

Ethics and dissemination

This study has been approved by the Medical Ethics Committee of Zhongnan Hospital of Wuhan University (no. (2025047K)). Our research findings will be published in peer-reviewed journal articles and presented at academic conferences. Additionally, the dissemination plan will include considerations for the development of implementation manuals, a dedicated project website and training tools.

☐ ☆ ✇ BMJ Open

Comparing the accuracy of AI-assisted data extraction versus human double extraction in evidence synthesis: a randomised controlled trial protocol

Por: Peng · Z. · Fan · S. · Tian · Y. · Wang · Y. · Qin · Z. · Doi · S. · Xu · C. — Noviembre 6th 2025 at 06:00
Introduction

Traditional data extraction strategies, such as human double extraction, are both time consuming and labour-intensive. Artificial intelligence (AI) has emerged as a promising tool for facilitating data extraction. However, it is not yet suitable as a standalone solution. We will conduct a randomised controlled trial (RCT) to compare the efficiency and accuracy of the AI-human data extraction strategy with human double extraction.

Methods and analysis

This study is designed as a randomised, controlled, parallel trial. Participants will be randomly assigned to either the AI group or the non-AI group at a 1:2 allocation ratio. The AI group will use a hybrid approach that combines AI extraction followed by human verification by the same participant, while the non-AI group will use human double extraction. Data will be collected for two tasks: event count and group size. Ten RCTs will be selected from an established database that analysed data extraction errors in systematic reviews of sleep medicine. The primary outcome measure will be the percentage of correct extractions by both groups for each data extraction task.

Ethics and dissemination

The trial is approved by the Ethics Council of Anhui Medical University (No. 81250507). We plan to publish the main results as an academic publication in an international peer-reviewed journal in 2026.

Trial registration number

Chinese Clinical Trial Register (Identifier: ChiCTR2500100393).

☐ ☆ ✇ BMJ Open

Application of artificial intelligence in early childhood development: a scoping review protocol

Por: Yu · E. · Burns · S. · Wiebe · J. P. · Schmeichel · A. · Perlman · M. — Noviembre 4th 2025 at 13:13
Introduction

Early childhood—specifically, the period from 0 to 6 years of age—is a critical time in children’s lives with rapid growth in their cognitive, social and emotional development. This period has also been shown to be the most effective time for early interventions. The use of artificial Intelligence (AI) for supporting early child development is increasing alongside the rapid advancement of technology. AI can be used directly by children (eg, for implementing adaptive technologies), by individuals who interact with children (eg, educators, parents, nurses), and by individuals indirectly supporting early child development (eg, early childhood researchers or policy analysts). This scoping review will provide a roadmap for relevant stakeholders on how AI has been applied within and across different contexts to support infants and young children’s development, as well as the most predominant AI technologies used across various contexts.

Methods and analysis

The current study follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Review The search syntax will be applied in PsycINFO, ERIC, Education Source, CINHAL, MEDLINE, Embase and IEEE Xplore. The purpose of this study is to curate and synthesise academic papers to examine the application of AI for supporting the development of children between birth and age 6 years of age. Studies with children or individuals who work directly or indirectly with children will be included. Part of the abstract and full-text screening will be conducted by two researchers, with discrepancies being resolved by the lead authors. In addition, AI will be used to help with study screening and data extraction once confirmed to be reliable (Cohen’s kappa >0.80). Thematic and content analyses will be conducted to identify the types of AI products used and their applications in different contexts, the most predominant AI products used within and across each context, as well as how children’s developmental outcomes are impacted by the use of these AI products. Where applicable, visualisations such as tables, graphs and figures will be used to synthesise the data across contexts and AI products used to support early development of young children.

☐ ☆ ✇ BMJ Open

Validity of the International Classification of Diseases, 10th Revision codes for lithium toxicity in adult patients at hospital admission: a cohort study in Canada

Por: Ahmadi · F. · Muanda · F. T. · Ehiwario · J. · McArthur · E. · Jandoc · R. · Slater · J. · Vasudev · A. · Weir · M. A. · Clark · E. G. · Rej · S. · Herrmann · N. · Garg · A. X. — Noviembre 4th 2025 at 13:13
Objective

To assess the validity of the International Classification of Diseases, 10th Revision (ICD-10) healthcare database diagnosis codes for lithium toxicity at hospital admission in Ontario, Canada.

Design

Population-based retrospective validation study.

Setting

A total of 152 hospitals linked to a provincial laboratory database in Ontario, Canada, from 2007 to 2023.

Participants

Patients 50 years of age or older taking lithium with hospital-based serum lithium laboratory measurements during admission to the hospital (n=2804).

Outcome measures

Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) comparing an ICD-10 diagnostic coding algorithm for lithium toxicity to a serum lithium concentration of 1.5 mmol/L or more. The codes used in the algorithm were T568, T435, Y495, X41 and X49. Serum lithium values and changes in the concentration of serum lithium from baseline levels in patients with and without a diagnosis code for lithium toxicity (code-positive and code-negative, respectively).

Results

The sensitivity of the ICD-10 coding algorithm for identifying a serum lithium level≥1.5 mmol/L was 84% (95% CI 81% to 87%). The specificity and the NPV were over 88%, and the PPV was 63% (95% CI 60% to 66%). The median (IQR) serum lithium measurement in code-positive patients was 1.7 (1.2 to 2.2) mmol/L, and it was 0.6 (0.4 to 0.9) mmol/L in code-negative patients. The median (IQR) increase in serum lithium concentration compared with the most recent prehospital baseline values was 0.7 (0.2 to 1.3) mmol/L in code-positive patients and 0.0 (–0.2 to 0.2) mmol/L in code-negative patients.

Conclusion

In Ontario, the sensitivity of the ICD-10 coding algorithms was moderate for identifying a serum lithium level≥1.5 mmol/L at hospital admission. The presence or absence of the ICD-10 codes for lithium toxicity at hospital admission successfully differentiated two groups of patients with distinct serum lithium measurements.

☐ ☆ ✇ BMJ Open

Evaluating online information on temporomandibular disorders: readability, reliability, content and quality: a scoping review protocol

Por: Venda Nova · C. · Silva · J. · Faustino · N. · Cuenca-Zaldivar · J. N. · Cadeau Comte · N. · Sillevis · R. · Sanchez Romero · E. A. · Mariz de Almeida · A. — Octubre 24th 2025 at 08:07
Introduction

Temporomandibular disorders (TMDs) are a prevalent group of musculoskeletal conditions affecting the temporomandibular joint, associated structures and masticatory muscles. The internet has become a primary source of health information for many patients; however, the readability, reliability, content and quality of online information on TMDs vary widely. A comprehensive synthesis of the characteristics and evaluation methods of such content is currently lacking.

Methods and analysis

This scoping review will follow the Joanna Briggs Institute methodology and be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. Peer-reviewed primary and secondary studies assessing online information on TMDs will be included if they report on readability, reliability, content or quality. Eligible information sources include publicly available websites, videos and social media; discussion forums and printed materials will be excluded. No language, date or geographical restrictions will be applied. A three-step search strategy will be implemented across PubMed, Web of Science, Embase, PsycINFO and CINAHL, followed by citation tracking. Screening will be conducted independently by two reviewers using Rayyan. Data will be extracted with a pilot-tested charting tool and synthesised narratively and descriptively in tabular and graphical formats.

Ethics and dissemination

As this study will only use data from publicly available sources, ethical approval is not required. Findings will be disseminated through publication in a peer-reviewed journal, conference presentations and professional networks, with the aim of guiding the development of accessible and reliable digital resources for individuals seeking information on TMDs.

Registration

This protocol has been prospectively registered on the Open Science Framework (OSF): https://doi.org/10.17605/OSF.IO/TAH7K.

☐ ☆ ✇ BMJ Open

How clinical structures shape diagnostic practices in Swedish hard-to-heal ulcer care: a grounded theory study

Por: Roxenius · J. · Wickstrom · H. L. · Skär · L. · Oien · R. F. — Octubre 23rd 2025 at 09:28
Objective

The aim of this study was to explore why patients with hard-to-heal ulcers are treated without an aetiological diagnosis, using a grounded theory approach.

Design

The study employed a qualitative semistructured interview design to gain in-depth insights. Data were collected in 2024, and an explanatory model was formed in accordance with grounded theory analysis.

Setting

Interviews were conducted with healthcare staff across primary, community and specialist care units in Sweden, encompassing both public and private sectors and representing a wide geographical spread.

Participants

The study involved 23 healthcare professionals, including nurses (n=18), assistant nurses (n=2) and physicians (n=3), from 22 healthcare units that participated in a preceding national mapping study. Participants were selected purposively to represent various professional roles and healthcare levels.

Results

The analysis resulted in a theoretical model based on two categories: Healthcare traditions and clinical practices and Clinical governance. The lack of an aetiological diagnosis can be attributed to a traditional division of tasks, where ulcer care falls within the nurses’ domain. As a result, patients often receive treatment without a physician’s involvement, especially in home healthcare. Barriers and enablers for a diagnosis are present on different levels; issues close to the patient as well as structural matters. The results illustrate how healthcare units can be positioned along a scale, from traditional work distribution to evidence-based guidelines.

Conclusions

This study can be used to get a deeper understanding of the challenges of current wound management, where clinical governance can support or undermine the movement from a traditional work distribution towards an evidence-based clinical practice. Furthermore, this study can provide a basis for discussing quality improvement, to obtain good and equal care for patients with hard-to-heal ulcers.

☐ ☆ ✇ BMJ Open

Effect of no reduction versus closed reduction on distal radius fractures in adults aged 65 years and older: a protocol for the DISCLOSE randomised equivalence trial

Por: Kärnä · L. · Ponkilainen · V. · Reito · A. · Ostergaard · H. · Brorson · S. · Tootsi · K. · Paasikallio · K. · Senholt · T. · Li · Y. · Heikkinen · J. · Kukkonen · J. · Ryhänen · J. · Christensen · R. · Mattila · V. M. · Launonen · A. P. — Octubre 16th 2025 at 09:34
Introduction

Distal radius fractures (DRFs) are common injuries, especially in older adults due to age-related frailty. Most DRFs in patients aged 60 and older are treated non-operatively since surgery offers no clinically important benefits. Although anatomical alignment has traditionally been the goal of the treatment, evidence suggests that in older populations, radiographic outcomes do not reliably correlate with functional outcomes. Current evidence, including one randomised trial, shows no functional benefit of closed reduction compared with casting alone, calling into question the routine use of the procedure in older patients. The primary objective is to evaluate whether no reduction is equivalent to closed reduction in patients aged 65 years or older with a displaced DRF, based on wrist-related pain and disability measured by the Patient-Rated Wrist Evaluation (PRWE) score at 12 months.

Methods and analysis

This is a multi-centre, randomised controlled, equivalence trial conducted in hospitals in Finland, Denmark, Sweden and Estonia. We aim to enrol 532 patients aged ≥65 years with a displaced DRF (AO/OTA 23A/23C). Participants will be randomised (1:1) to receive either a dorsal cast without reduction (experimental intervention) or closed reduction followed by casting (control comparator). The primary endpoint is the difference between groups assessed using the PRWE outcome score at 12 months. The equivalence margin will be set at 6 PRWE points. Key secondary endpoints will include the Numeric Rating Scale for pain, patient satisfaction, quality of life (EQ-5D-5L Index) and serious adverse events at 3 months and 12 months and cosmesis at 3 months. Our main analyses will follow an intention-to-treat principle, analysed using repeated measures mixed model.

Ethics and dissemination

Ethical approval has been granted by the Ethics Committee of Tampere University Hospital (R25001). Results of the trial will be disseminated through peer-reviewed journals.

Protocol version

6 July 2025, v1.0.

Trial registration number

NCT07042139.

☐ ☆ ✇ BMJ Open

Incidence and drivers of medication returned to health facilities by patients in low- and middle-income countries: a scoping review protocol

Por: Kutina · C. · Dugle · G. · Bawontuo · V. — Octubre 1st 2025 at 08:29
Introduction

Medication returned by patients to healthcare facilities is a critical aspect of reverse logistics, intersecting healthcare delivery, patient safety and environmental sustainability, especially in low- and middle-income countries (LMICs) where systemic inefficiencies and socio-cultural factors may exacerbate the issue. While emerging medication return programmes are recognised for their potential to enhance resource efficiency and prevent misuse, they also signal inefficiencies in medical supply chains, prescribing practices and patient-provider interactions. This scoping review aims to systematically map the incidence and drivers of medication returned to health facilities by patients in LMICs.

Methods and analysis

This review follows Arksey and O'Malley’s scoping review framework and the PRISMA-ScR reporting guidelines. Searches will be conducted in Google Scholar, PubMed, CINAHL, Embase, Web of Science and Scopus, supplemented by grey literature sources and reference list screening. Searches will include studies from January 2005 to December 2025 and English-language publications, reflecting both the relevance of recent evidence and practical considerations for screening and analysis. Eligible studies must address the incidence or drivers of medication returned in LMICs and meet predefined inclusion criteria based on the Population, Concept, Context framework. Data will be extracted using a standardised charting form and analysed using narrative synthesis, supported by descriptive statistics and thematic analysis.

Ethics and dissemination

No ethical approval is required as this scoping review will analyse publicly available literature. Findings will be disseminated through peer-reviewed publications, academic conferences and healthcare organisations, with all data and search strategies made openly accessible through Springer Nature’s protocols.io preprint repository to support transparency and future research.

Registration

Springer Nature’s protocols.io dx.doi.org/10.17504/protocols.io.3byl4wd5ovo5/v1.

☐ ☆ ✇ BMJ Open

Protocol for development of SPIRIT and CONSORT extensions for reporting climate and environmental outcomes in randomised trials (SPIRIT-ICE and CONSORT-ICE)

Por: Petersen · J. J. · Hemberg · L. · Thabane · L. · Hopewell · S. · Chan · A.-W. · Hrobjartsson · A. · Mathiesen · O. · Kandasamy · S. · Siegfried · N. · Williamson · P. R. · Fox · L. · Kamp · C. B. · Hoffmann · J.-M. · Brorson · S. · Boutron · I. · McGain · F. · McAlister · S. · Mutengu · L — Septiembre 22nd 2025 at 03:00
Introduction

The WHO has declared climate change the defining public health challenge of the 21st century. Incorporating climate and environmental outcomes in randomised trials is essential for enhancing healthcare treatments’ sustainability and safeguarding global health. To implement such outcomes, it is necessary to establish a framework for unbiased and transparent planning and reporting. We aim to develop extensions to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT 2025) and Consolidated Standards of Reporting Trials (CONSORT 2025) statements by introducing guidelines for reporting climate and environmental outcomes.

Methods and analysis

This is a protocol for SPIRIT and CONSORT extensions on reporting climate and environmental outcomes in randomised trials termed SPIRIT-Implementing Climate and Environmental (ICE) and CONSORT-ICE. The development of the extensions will consist of five phases: phase 1—project launch, phase 2—review of the literature, phase 3—Delphi survey, phase 4—consensus meeting and phase 5—dissemination and implementation. The phases are expected to overlap. The SPIRIT-ICE and CONSORT-ICE extensions will be developed in parallel. The extensions will guide researchers on how and what to report when assessing climate and environmental outcomes.

Ethics and dissemination

The protocol was submitted to the Danish Research Ethics Committees, Denmark in June 2025. Ethics approval is expected in September 2025. The SPIRIT and CONSORT extensions will be published in international peer-reviewed journals.

☐ ☆ ✇ BMJ Open

Clinical practice guidelines for the care of people experiencing chronic primary pain: protocol for a systematic review with interpretation against an established chronic pain care priority framework

Por: Briggs · A. M. · Siegfried · N. · Waller · R. · OConnell · N. E. · Romero · L. · Klem · N.-R. · Ampiah · P. K. · Belton · J. L. · Blyth · F. M. · De Morgan · S. · Lord · S. M. · Nicholas · M. · OSullivan · P. B. · Shakya · A. · Smith · A. J. · Slater · H. — Septiembre 19th 2025 at 06:54
Introduction

Most clinical practice guidelines (CPGs) for assessing and managing people’s chronic pain focus on specific pain conditions, body sites or life course stages. This creates complexity for clinicians making care choices in the absence of a diagnosis and/or where a person experiences more than one pain condition. Specific to this context is the ICD-11 classification of chronic primary pain where an experience of pain cannot be better accounted for by another condition. CPGs for chronic primary pain, agnostic to condition or body part, may support clinicians towards best pain care since many of the principles of person-centred chronic pain care are transdiagnostic. The two aims of this systematic review are to (1) identify and appraise CPGs for chronic primary pain, relevant across the life course and (2) map the CPG content against a pain care priority framework to evaluate the extent to which the CPG content aligns with the priorities of people with lived chronic pain experience.

Methods and analysis

We will systematically search nine scholarly databases, the Epistemonikos database and international and national guidelines clearinghouses. CPGs published within 2015–2025, in any language, that offer recommendations about assessment and/or management of chronic primary pain for people of any age, excluding hospitalised inpatients or institutionalised populations, will be included. Pairs of reviewers will independently screen citations for eligibility and appraise CPG quality and implementation potential using the Appraisal of Guidelines for Research and Evaluation (AGREE)-II and the AGREE-Recommendations Excellence tools, respectively. Data extraction will include the citation and scope characteristics of each CPG, methods used to develop recommendations, verbatim recommendations, guiding principles or practice information and narrative excerpts related to the GRADE Evidence-to-Decision (EtD) considerations (or equivalent). We will use the PROGRESS-PLUS framework as a checklist to identify whether determinants of health equity were considered by guideline developers. CPG recommendations will be organised according to common topics and categorised in a matrix according to strength and direction. Qualitative content analysis will be used to synthesise excerpts relating to GRADE EtD considerations (or equivalent), and we will map extracted data against an established chronic pain care priority framework to determine the extent to which the CPGs align with values and preferences of people with lived experience. Interpretation will be informed by an interdisciplinary Advisory Group, including lived experience partners.

Ethics and dissemination

Ethical approval is not required for this systematic review. Results will be disseminated through publication in an open-access peer-reviewed journal, through professional societies, and integrated into education curricula and public-facing resources. Reporting will be consistent with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement.

PROSPERO registration number

CRD420251000482.

☐ ☆ ✇ BMJ Open

Does online information about hormone replacement therapy (or menopause hormone therapy) reflect indications from the British National Formulary and guidance from the National Institute for Health and Care Excellence: a cross-sectional study of UK media

Por: McCartney · M. · Morgan-Young · R. · Sullivan · F. · Murphy · D. J. · Albulushi · J. · Larkin · J. — Septiembre 4th 2025 at 15:50
Objectives

To describe: (1) the most visible information (from individuals or organisations) on UK social media regarding hormone replacement therapy (HRT)/menopause hormone treatment for menopause; (2) claims made by these sources for HRT and testosterone outwith the indications specified by the British National Formulary (BNF) and the National Institute of Health and Care Excellence (NICE) (ie, vasomotor instability, vaginal dryness, low mood associated with the menopause and, for testosterone, low libido after treatment with HRT) and for use for the prevention of future ill health and (3) conflicts of interest of commentators.

Design

Cross-sectional study.

Setting

Online references to HRT, for use in menopause, in UK online media, comprising Facebook, Google, Instagram, TikTok and YouTube, 30 top ranked hits between 1 January 2022 and 1 June 2023 and Twitter (X) up to 1 May 2024.

Methods

Identification of the most visible information was performed via online searching with the term ‘HRT’ using incognito searches within each modality. Statements making claims were identified and analysed as to whether they were congruent with BNF and NICE advice on indications for use. Declarations of interest were extracted from the source or searched for if not apparent using a standardised search strategy. Data were entered into an Excel spreadsheet. Summary and descriptive statistics were used to summarise the results, including description of origin and types of claims, percentage of claims in agreement with NICE/BNF indications, relationship to financial interests and readership data, where available.

Results

180 recommendations and/or claims for HRT were examined (30 from each of six platforms), made by professional individuals (53.4%), laypeople (41.7%) and patient, media and professional organisations (4.9%) completing the total. Overall, 67.2% of claims were outside of BNF/NICE recommendations. 139 (77.2%) were associated with a conflict of interest. In 117 cases, this was a conflict either directly or indirectly related to menopause, through provision of private practice, pharmaceutical industry funding or retail products marketed at the menopause.

Conclusions

Social media commonly contains claims for HRT outside BNF/NICE guidance. Conflicts of interest by commentators are also common, directly or indirectly related to menopause. Less than a quarter of media contained no commercial conflict. Policymakers should consider means to ensure that non-conflicted, evidence-based information is visible to professionals, patients and the public.

Trial registration number

Open Science Framework (https://osf.io/r7e5c/).

☐ ☆ ✇ BMJ Open

Prioritising methodological research questions for scoping reviews, mapping reviews and evidence and gap maps for health research: a protocol for PROSPECT Delphi study

Por: Pollock · D. · Hasanoff · S. · McBride · G. · Kanukula · R. · Tricco · A. C. · Khalil · H. · Campbell · F. · Jia · R. M. · Alexander · L. · Peters · M. · Vieira · A. M. · Aromataris · E. · Nunn · J. · Saran · A. · Evans · C. · Godfrey · C. · Pieper · D. · de Moraes · E. B. · Biesty · L. · Co — Agosto 4th 2025 at 18:58
Introduction

Scoping reviews, mapping reviews and evidence and gap maps (collectively known as ‘big picture reviews’) in health continue to gain popularity within the evidence ecosystem. These big-picture reviews are beneficial for policy-makers, guideline developers and researchers within the field of health for understanding the available evidence, characteristics, concepts and research gaps, which are often needed to support the development of policies, guidelines and practice. However, these reviews often face criticism related to poor and inconsistent methodological conduct and reporting. There is a need to understand which areas of these reviews require further methodological clarification and exploration. The aim of this project is to develop a research agenda for scoping reviews, mapping reviews and evidence and gap maps in health by identifying and prioritising specific research questions related to methodological uncertainties.

Methods and analysis

A modified e-Delphi process will be adopted. Participants (anticipated N=100) will include patients, clinicians, the public, researchers and others invested in creating a strategic research agenda for these reviews. This Delphi will be completed in four consecutive stages, including a survey collecting the methodological uncertainties for each of the big picture reviews, the development of research questions based on that survey and two further surveys and four workshops to prioritise the research questions.

Ethics and dissemination

This study was approved by the University of Adelaide Human Research Ethics Committee (H-2024-188). The results will be communicated through open-access peer-reviewed publications and conferences. Videos and infographics will be developed and placed on the JBI (previously Joanna Briggs Institute) Scoping Review Network webpage.

☐ ☆ ✇ BMJ Open

Developing a core outcome set for gender-affirming healthcare in transgender and gender diverse adults in Sweden using the Delphi approach: a study protocol

Por: Dahlen · L. · Pettersson · K. · Berglund · F. · Bodlund · O. · Dhejne · C. · Elfving · M. · Frisen · L. · Halldin-Stenlid · M. · Holmberg · J. · Holmberg · M. · Högström · J. · Indremo · M. · Karvonen · L. · Kratz · G. · Nygren · U. · Selvaggi · G. · Skalkidou · A. · Summanen · E. · So — Julio 9th 2025 at 03:44
Introduction

Despite an increasing amount of research related to gender-affirming treatment (GAT) outcomes among transgender and gender-diverse (TGD) people (ie, people who experience discomfort or distress in the misalignment between their gender and sex assigned at birth) in recent years, the evidence base for current recommendations is suboptimal. One contributing factor is the heterogeneity in the outcomes and outcome measures used. This study seeks to address this challenge by developing a foundational core outcome set (COS) to be used for TGD adults receiving GAT in Sweden.

Methods

Recommendations from the Core Outcome Measures in Effectiveness Trials initiative will be used to address this aim in four phases. Phase 1, an umbrella review of peer-reviewed literature and international guidelines in GAT will be conducted to identify relevant outcomes. In phase 2, we will solicit input from TGD individuals through the review of patient and interest organisations’ reports and an anonymous survey to identify outcomes of personal significance. In phase 3, using the Delphi method, 2–3 rounds of assessment will be conducted where researchers, healthcare professionals, policy-makers and TGD adults rate the identified outcomes by perceived importance. In phase 4, a consensus meeting will convene representatives from all stakeholder groups to finalise the COS.

Analysis

The results of this study will consist of a COS for GAT regarding TGD adults in Sweden. Participant survey responses will be evaluated using interpretive analysis to identify core outcomes. During each of the Delphi rounds, Likert-type scale ratings will be aggregated for outcomes to advance or be eliminated in each round.

Ethics and dissemination

The study has received ethical approval by the Swedish Ethical Review Authority (Umeå medicine department, Registration number: 2024-04672-01). The results of this study will be published open-access and disseminated through TGD interest organisations and a Swedish research network for gender dysphoria.

Trial registration number

COMET registration number 3223.

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