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☐ ☆ ✇ Journal of Advanced Nursing

Recovery After Critical Illness: A Meta‐Ethnography of Patient, Family and Staff Perspectives

Por: Elizabeth King · Owen Gustafson · Annabel Williams · Francine Toye · Mark Williams · Sarah Vollam — Octubre 2nd 2025 at 11:59

ABSTRACT

Aim

To synthesise primary qualitative studies reporting experiences of post-hospital recovery for critical care survivors, their family and the healthcare professionals supporting them with a particular focus on physical impairment.

Design

The review was conducted through a meta-ethnography using the seven stages of Noblit and Hare.

Methods

Qualitative studies or mixed-method studies which included qualitative research were included if they were based on the phenomenon of interest. Study quality was assessed using the Critical Appraisal Skills Programme checklist and confidence in the findings with the GRADE CERQual framework.

Data Sources

Five electronic databases (PubMed, EMBASE, CINAHL, AMED and PEDro) were searched from inception to February 2022 and updated in November 2024. Grey literature for primary qualitative studies was also searched.

Results

A total of 26,249 studies were initially screened, and 38 eligible studies were analysed. Four themes were distilled describing the experiences of critical care survivors, their family members and staff involved in their care: ‘I survived, but I didn't thrive’, ‘Healthcare was there to save my life, but not for my long-term recovery’, ‘I am a burden on my family, and they feel the weight of carrying me’ and ‘My body still doesn't work like it used to’.

Conclusion

This meta-ethnography is unique in bringing together the experiences of patients recovering from critical illness, their families, and the staff who support them after hospital discharge. Ongoing diverse physical impairments prevented patients from thriving, significantly impacting family members. All groups clearly identified unmet rehabilitation needs following critical illness.

☐ ☆ ✇ BMJ Open

Model-based pharmacoeconomic analysis of anti-VEGF strategies for neovascular age-related macular degeneration: a value-based comparison of real-world administration approaches

Por: Gismero Moreno · S. M. · Jodar Sanchez · F. · Garcia-Agua Soler · N. · Rivas Ruiz · F. · Garcia-Ruiz · A. J. — Octubre 8th 2025 at 05:59
Objectives

To evaluate the cost-effectiveness of anti-vascular endothelial growth factor (VEGF) treatments for neovascular age-related macular degeneration (nAMD) using a value-based model that considers drug durability, dosing regimens and real-world administration strategies, including safe vial fractionation.

Design and setting

Model-based pharmacoeconomic analysis using data from randomised clinical trials and network meta-analyses. Analysis conducted from the payer perspective using cost data from the Spanish National Health System.

Methods

A model-based analysis compared five anti-VEGF agents—innovator and biosimilar ranibizumab, aflibercept 2 mg, brolucizumab and faricimab—across three dosing regimens: fixed, Pro Re Nata and Treat-and-Extend (TAE). Administration formats included single-use vials, prefilled syringes and vial fractionation (VF), with or without dead-space-free (DSF) syringes to minimise waste. The primary outcome was cost per optimal responder, defined as a patient gaining ≥15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, with and without adverse events. Cost-effectiveness was evaluated using Number Needed to Treat (NNT), Net Efficacy Adjusted for Risk-NNT (adjusted for safety) and incremental cost-effectiveness ratios. Secondary outcomes included the number of treated patients and optimal responders achievable within a fixed 1 000 000 budget.

Results

The most cost-effective strategy was aflibercept 2 mg under a TAE regimen using DSF VF, with a total cost of 6214 per patient and a cost per optimal responder of 27 155. Under a fixed budget of 1 000 000, this approach allowed treatment of 160 patients, yielding 36 optimal responders. Faricimab with DSF VF ranked second, with a total cost of 5847 and a cost per optimal responder of 28 652, treating 171 patients and achieving 34 responders. In contrast, single-use vials without VF led to substantially higher total costs (eg, 11 305 for aflibercept TAE) and lower treatment capacity (eg, 88 patients treated).

Conclusions

This model demonstrates that combining durable agents, extended dosing intervals and optimised delivery strategies (eg, prefilled syringes and DSF VF) can substantially improve the cost-effectiveness and sustainability of anti-VEGF therapy in public health systems.

☐ ☆ ✇ BMJ Open

Assessing the clinical and cost-effectiveness of endovascular vs open revascularisation in severe occlusive aorto-iliac disease (EVOCC trial): study protocol for a randomised controlled trial

Por: Saratzis · A. · Davies · A. · Diamantopoulos · A. · Davies · R. S. M. · Epstein · D. · Jepson · M. · Perez · D. · Apergi · D. · Harris · K. J. · Zayed · H. · Brookes · C. · Barber · S. · Suazo Di Paola · A. · Ingram · L. · Richardson · C. · Patel · A. — Octubre 8th 2025 at 05:59
Introduction

Severe aorto-iliac steno-occlusive atherosclerotic disease is a major cause of morbidity and amputation in patients with peripheral arterial disease. While both open surgical and endovascular revascularisation are standard treatments in this patient group, there is no high-quality randomised evidence to determine which approach offers superior clinical and cost-effectiveness, leading to uncertainty and poor outcomes after intervention.

Methods and analysis

The EVOCC trial is a national, multicentre, parallel-group, superiority randomised controlled trial comparing open surgery to endovascular revascularisation in patients with symptomatic severe aorto-iliac occlusive disease. A total of 628 participants across 30 NHS sites in the UK will be randomised 1:1 to receive either open surgery or endovascular (minimally invasive) intervention. The primary outcome is amputation-free survival, defined as time to first event (major lower limb amputation or death). Secondary outcomes include mortality, cardiovascular events, hospital readmissions, re-interventions and quality-of-life measures. An internal pilot phase (10 sites, 6-month duration) will assess recruitment feasibility. A QuinteT Recruitment Intervention is integrated into the trial to optimise recruitment.

Ethics and dissemination

The trial has received ethical approval from a UK Research Ethics Committee (REC reference: 23/SW/0065; trial registration reference: ISRCTN14591444). Informed consent will be obtained from all participants.

The EVOCC trial is the first RCT assessing the clinical and cost-effectiveness of open vs endovascular revascularisation for severe aorto-iliac disease worldwide. The results will provide robust evidence to inform clinical practice and healthcare policies globally. Results will be disseminated via patient groups, online lay summaries, a trial website, social media, presentations in conferences, a formal scientific publication in a medical journal and direct communications with policymakers across borders.

Trial registration number

ISRCTN14591444.

☐ ☆ ✇ BMJ Open

Advancing HIV pre-exposure prophylaxis (PrEP) implementation in Canada: a scoping review protocol of programmes, practices and policies

Por: Chakraborty · D. · Djiadeu · P. · Ziegler · C. · Chabikuli · A. · Ifeanacho · E. · Awoliyi · M. · Zuta · H. · Djuidje De Pandja · G. · Ajiboye · O. · Ajiboye · O. · Nelson · L. E. · Rourke · S. B. · Ajiboye · W. — Octubre 8th 2025 at 05:59
Introduction

HIV pre-exposure prophylaxis (PrEP) is an effective HIV prevention tool, reducing infection risk by up to 99% when used as prescribed. Despite its proven efficacy, PrEP uptake remains suboptimal, particularly among high-risk populations in Canada. Barriers to access and uptake, including stigma, financial constraints and healthcare accessibility, persist, highlighting the need for targeted interventions. The objective of this scoping review is to identify and map the extent and types of interventions, programmes, practices and policies aimed at increasing the acceptance, access, uptake and sustained use of HIV PrEP in Canada.

Methods and analysis

This review will use the Joanna Briggs Institute (JBI) Scoping Review methodology. Databases to be searched are MEDLINE, Embase, PsycINFO, Cochrane Library, CINAHL, Scopus and Web of Science from 2016 onwards. Two independent reviewers will screen studies, based on the inclusion criteria. The search results will be presented in a Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram. Data will be extracted from relevant studies by two independent reviewers and summarised to inform future research and policy development. This review will include studies focusing on individuals in Canada who are eligible for or using PrEP for HIV prevention. The interventions considered will address the awareness, acceptance, access, uptake and sustained use of PrEP. Studies must be set within the Canadian context, considering geographic, cultural and systemic factors. Exclusions include studies conducted outside Canada or those not addressing HIV prevention interventions.

Ethics and dissemination

This research will rely exclusively on previously published data and will not include human participants. Therefore, ethics approval is not required. For further clarification, please contact Stephen Hwang, Director, MAP Centre for Urban Health Solutions, Unity Health Toronto, at Stephen.Hwang@unityhealth.to. The findings of this research will be shared through peer-reviewed journal articles, conference presentations and may be relevant to governmental health agencies and local HIV/AIDS service organisations.

Registration

The protocol has been registered with Open Science Framework at https://doi.org/10.17605/OSF.IO/C7S4Z.

☐ ☆ ✇ BMJ Open

Sepsis-related myocardial injury: the role of bacterial pathogens and toxins--a scoping review protocol

Por: Lörstad · S. · Widaeus · J. · Gille-Johnson · P. · Persson · J. — Octubre 8th 2025 at 05:59
Introduction

Sepsis-related myocardial injury is common in sepsis patients and has been repeatedly associated with poor patient outcomes. While experimental animal studies suggest that direct and indirect myocardial damage occurs via a wide range of inflammatory mediators, including bacterial toxins, the extent of bacterial-driven myocardial injury in human sepsis remains unclear. This scoping review aims to map existing evidence, identify knowledge gaps and guide future research priorities.

Methods and analysis

This scoping review will follow the Joanna Briggs Institute methodology for scoping reviews. The review is anticipated to start on 12 December 2024 and be completed by 31 October 2025. A comprehensive search will be conducted in MEDLINE (PubMed), Web of Science and EMBASE. Two independent reviewers will screen titles and abstracts, followed by a full-text review of potentially eligible studies. Studies focusing on the role of bacteria and/or their toxins in myocardial injury in adult patients with sepsis will be included. Data will be independently extracted using predefined forms, and findings will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analysis extension for Scoping Reviews guidelines.

Ethics and dissemination

Ethical approval is not required for this scoping review. On completion, findings will be submitted for publication in a peer-reviewed medical journal and presented at scientific conferences. The results will help identify and analyse knowledge gaps, providing valuable insights to inform future research in patients with sepsis.

Registration details

Registered on Open Science Framework 3 March 2025.

☐ ☆ ✇ BMJ Open

Models, frameworks, and strategies used to implement digital interventions targeted to youth mental health: a scoping review protocol

Por: Moss · S. J. · Zuniga Chacon · C. · Hekmati · F. B. · Siddiqui · S. A. · Stelfox · M. · Ahmed · S. B. · Birnie · K. · Halperin · D. · Halperin · S. A. · Tutelman · P. R. · Stelfox · H. T. · Fiest · K. M. · Parsons Leigh · J. — Octubre 7th 2025 at 08:15
Introduction

The use of digitally enabled technology is considered a promising platform to prevent morbidity and enhance youth mental health as youth are growing up in the digital world and accessing the Internet at increasingly younger age. This scoping review will identify, describe and categorise the models, frameworks and strategies that have been used to study the implementation of digital mental health interventions targeted at youth aged 15–34 years.

Methods and analysis

We will conduct a scoping review following the Arksey-O’Malley five-stage scoping review method and the Scoping Review Methods Manual by the Joanna Briggs Institute. Implementation methods will be operationalised according to pre-established aims: (1) process models that describe or guide the implementation process; (2) evaluation frameworks evaluating or measuring the success of implementation; and (3) implementation strategies used in isolation or combination in implementation research and practice. Primary research studies in all languages will be identified in CINAHL, Cochrane Central Register of Controlled Trials, Embase, ERIC, Education Research Complete, MEDLINE and APA PsycINFO on 6 January 2025. Two reviewers will calibrate screening criteria and the data charting form and will independently screen records and abstract data. We will use the Evidence Standards Framework for Digital Health Technologies by the National Institute for Health and Care Excellence to classify digital interventions based on functions, and a pre-established working taxonomy to synthesise conceptually distinct implementation outcomes. Convergent integrated data synthesis will be performed.

Ethics and dissemination

Ethical approval is not applicable as this scoping review will be conducted only on data presented in the published literature. Findings will be published and directly infused into our multidisciplinary team of academic researchers, youth partners, health professionals and knowledge users (healthcare and non-governmental organisation decision makers) to co-design and pilot test a digital psychoeducational health intervention to engage, educate and empower youth to be informed stewards of their mental health.

☐ ☆ ✇ BMJ Open

Shared decision-making using a decision aid for patients with breast cancer considering breast reconstruction: study protocol for a cluster-randomised controlled trial in Japan

Por: Sowa · Y. · Osaka · W. · Tsuge · I. · Komiya · T. · Saiga · M. · Taminato · M. · Nagura · N. · Shiraishi · T. · Seki · H. · Otsuki · Y. · Matsuoka · Y. · Tomita · S. · Akita · S. · Fujimoto · H. · Otani · K. · Yoshimura · K. — Octubre 7th 2025 at 08:15
Introduction

Shared decision-making (SDM) requires that individuals are correctly and smoothly supported to make decisions. However, in Japan, development of decision aids (DAs) to support implementation of SDM is lagging behind Western countries, and there are few reports focused on breast reconstruction. Thus, it is unclear if SDM using a DA in the context of the unique national character and medical culture in Japan is useful in decision-making for breast reconstruction, including whether or not to undergo reconstruction. The aim of this multicentre collaborative study is to investigate the clinical effectiveness of SDM using a DA for patients with breast cancer considering reconstruction, from the perspectives of decisional conflict and postoperative quality of life.

Methods and analysis

A multisite trial will be conducted at 12 facilities certified by the Japanese Society of Breast Oncoplastic Surgery. A cluster-randomised controlled trial is planned at centres that have implemented SDM with DAs and those that have not implemented SDM, but use a conventional surgical explanation and informed consent to make decisions about reconstruction methods. The study participants will be female patients aged ≥20 years with newly diagnosed stage 0–III breast cancer who are interested in breast reconstruction. Data collection includes baseline and follow-up patient surveys and medical record review. The effectiveness of the DA at reducing conflict and regret in decision-making (primary outcome) will be evaluated using the decision conflict scale.

Ethics and dissemination

This protocol has been approved by the Kyoto University Central Institutional Review Board, and permission for performance of the study has been obtained from the Ethics Review Board at each participating centre. We plan to disseminate the findings through journal publications and national meetings, including a presentation of the research results at the Japanese Society of Breast Oncoplastic Surgery. Our findings will advance the science of medical decision-making and have the potential to reduce socioeconomic health disparities.

Trial registration number

UMIN000052161.

☐ ☆ ✇ BMJ Open

Reference standard for the prevention and management of hospital falls: a multidisciplinary Delphi consensus study

Por: Morris · M. E. · Said · C. M. · Haines · T. · Heng · H. W. F. · Batchelor · F. · Hutchinson · A. M. · McKercher · J. P. · Semciw · A. I. · Hill · A.-M. · Peterson · S. · Kane · R. · Fowler-Davis · S. · Campbell · S. · Sherrington · C. · Gilmartin-Thomas · J. · Phan · U. · Thwaites · C. — Octubre 7th 2025 at 08:15
Background

Hospital falls persist as a major threat to patient safety. This study aimed to develop an interprofessional reference standard to prevent, manage and report hospital falls.

Methods

A Delphi consensus methodology, informed by the Conducting and Reporting Delphi Studies guideline, was used to design the reference standard. An interprofessional expert panel (n=47) of health professionals, researchers, policymakers and consumers participated in three Delphi rounds. Following the review of clinical guidelines, an e-Delphi survey was developed and piloted to derive 60 initial items for the standard. Two iterative rounds of e-Delphi surveys were distributed via Research Electronic Data Capture and included free-text questions and 9-point Likert scales. An online consensus meeting followed, to ratify the final standard.

Results

In the first Delphi round, there was over 80% agreement for 44/60 items to be included in the reference standard. This increased to 48/60 items in Round 2. At the final consensus meeting, 12 items still did not reach consensus for inclusion and one was added, yielding 49 items. Items that replicated text according to falls with injury/without injury were combined, resulting in 42 items in the final reference standard. Agreed items included: (1) brief screening of falls risk on hospital admission; (2) comprehensive falls assessment for inpatients who are older, frailer or have complex conditions; (3) single interventions (such as environmental adaptations and exercise); (4) multifactorial interventions; (5) education of patients, families and staff; (6) optimising local falls hospital policies, procedures and leadership capability; (7) optimising documentation and reporting; (8) improving accreditation processes; (9) workforce redesign to augment falls education. Items that did not reach agreement (n=12) pertained to alarms, bed rails, grip socks, artificial intelligence, volunteers and care bundles.

Conclusion

This new reference standard provides a checklist for staff, patients, managers and policymakers to reduce unwanted variations in prevention, management and reporting of hospital falls.

Trial registration number

ANZCTR 386960

☐ ☆ ✇ BMJ Open

Upfront surgery versus induction chemotherapy followed by surgery in oral cavity squamous cell cancers with advanced nodal disease (SurVIC Trial): a phase 3 multicentre randomised controlled trial

Por: Poonia · D. R. · Sehrawat · A. · Vishnoi · J. R. · Sharma · N. · Kumar · P. · Devnani · B. · Warriere · A. · Solanki · A. · Pareek · P. · Aggarwal · D. · Yadav · T. · Sharma · P. P. · Gadwal · A. · Goyal · A. · Elhence · P. · Khera · P. · Jakhetiya · A. · Swaim · P. · Muduly · D. · Mahajan — Octubre 7th 2025 at 08:15
Introduction

Most oral cancers in India present in advanced stages and tend to have poor oncological outcomes. Chemotherapy has been associated with improved oncological outcomes in various cancers, but its role in oral cancer is still not well-defined in curative settings beyond radiosensitisation. Despite an excellent response rate, neoadjuvant chemotherapy trials have failed to show an oncological advantage. Earlier studies were limited by their heterogeneous patient population, including all head and neck subsites, and included both inoperable cancer and early-stage operable cases. Due to such patient selection, the intended results were never met. Patients with biologically aggressive diseases (advanced nodal disease) may derive greater benefit from induction chemotherapy (ICT). Therefore, we aim to determine the oncological advantage of adding ICT to oral squamous cell cancer with advanced nodal disease (N2–N3).

Methods and analysis

The study is an open-label, multicentre, randomised controlled trial, with an allocation ratio of 1:1, being conducted at seven leading cancer centres in India. The primary objective is to compare survival outcomes with and without ICT before surgery in patients with oral squamous cell carcinoma (OSCC) and advanced nodal disease, specifically focusing on 2-year disease-free survival (DFS). Secondary objectives include assessing overall survival (OS), clinical and pathological response rates, treatment compliance, treatment completion rates, adverse events, treatment-related toxicity (using Common Terminology Criteria for Adverse Events, V.5.0), quality of life (measured with Functional Assessment of Cancer Therapy-General and Functional Assessment of Cancer Therapy-Head and Neck) and postoperative complications (using the modified Clavien-Dindo classification).

The study population consists of patients with operable OSCC and advanced nodal disease (N2–N3), adequate organ function, aged 18–65 years and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0–2. The treatment arms are the standard arm Surgery arm (SURG), which involves surgery followed by adjuvant radiotherapy with or without concurrent chemotherapy, and the experimental arm (ICT), in which patients will receive two cycles of ICT using either cisplatin, docetaxel and 5-fluorouracil or cisplatin, docetaxel and capecitabine, followed by surgery and adjuvant radiotherapy with or without concurrent chemotherapy. The sample size was calculated to detect an HR of 0.67 with 80% power. A total of 184 events are required, and with an accrual rate of 15 patients per month, 300 patients will be recruited. DFS analysis will occur 32 months after the trial begins, and follow-up will continue for 5 years. OS analysis will be conducted when 184 deaths are observed. Taking 10% of the withdrawal of consent, a total of 346 patients need to be included.

Ethics and dissemination

This trial aims to establish the potential superiority of ICT or definitively determine its futility in OSCC with advanced nodal disease. A positive outcome could provide practice-changing data, particularly for Indian patients, whereas negative results could halt the use of ICT in this setting, directing research efforts towards more effective treatment strategies.

Trial registration number

CTRI/2024/03/064586; NCT06737822; Institutional Ethics Committee (IEC) number: AIIMS/IEC/2023/4622 (lead site).

☐ ☆ ✇ BMJ Open

Study protocol for an open-label, single-arm, mixed methods feasibility study of the MWIQ AI-powered decision support tool for diabetes management in GP practices

Por: Dickson · J. · Cunningham · S. G. · Sainsbury · C. · Rutter · M. K. · Kanumilli · N. · Pearson · E. · Brodie · D. · Stevens · M. · Wake · D. J. · Conway · N. — Octubre 6th 2025 at 02:14
Introduction

Diabetes affects ~10% of the world’s population and is rising. Treatment costs in the UK are ~15% of the NHS budget. Diabetes-related complications can be lowered through better evidence-based clinician management and patient self-management. MyWay intelligence quotient (MWIQ) is an electronic platform that will provide clinical decision support around the diagnosis and treatment of patients with diabetes. This study evaluates the safety and clinical performance (clinical appropriateness/applicability, clinical impact and clinical usability) of MWIQ.

Methods and analysis

The system will be implemented in real time in four to seven general practitioner (GP) practices. Clinicians with diabetes expertise will be recruited as validators, who will inspect records to ensure system robustness before use, and up to 14 healthcare professionals will use and evaluate the system.

Quantitative and qualitative analyses will be triangulated to assess the MWIQ system. Assessment of clinical outcomes will be made using pseudonymised routinely collected clinical data, including adherence to quality performance indicators, diabetes diagnosis, diabetes investigations (eg, genetic testing), HbA1c, blood pressure, body mass index, cholesterol and foot risk score for the diabetes population concerned. Clinical and validator participants will also submit a weekly questionnaire, and these, along with interviews, which are scheduled during the testing process, will be analysed to provide data on the utility, safety and usability of the system.

Ethics and dissemination

This study was approved, 08/01/2024, by the North of Scotland Research Ethics Committee (REC), IRAS project ID: 305267, REC, reference 23/NS/0134. The study has gained confidentiality advisory group (CAG) support (reference: 24/CAG/0002), medicines and healthcare products regulatory agency (MHRA) and health research authority (27/08/2024) approvals.

Findings will be reported to (1) The funding body, (2) The participating GP practices, (3) The study PPIE group, (4) The MHRA to support a submission for recognition as a class 2 CE/UKCA marked device, (5) Presented at local, national and international conferences and (6) Disseminated by peer-reviewed publications.

Trial registration number

ISRCTN17422256.

☐ ☆ ✇ BMJ Open

Barriers to treatment adherence among patients with tuberculosis: a qualitative study of Pakistani nationals and Afghan refugees

Por: Sanauddin · N. · Ahmad · F. · Rahim · M. · Paracha · M. A. · Khan · Z. · Qazi · F. K. · Rasool · S. · Butt · M. · Naeem · F. · Khan · M. F. · Sheikh · S. · Kibria · Z. · Fonseka · N. · Ul-Haq · M. · Farooq · S. — Octubre 6th 2025 at 02:14
Objectives

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

Design

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

Settings

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

Participants

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

Results

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

Conclusion

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

Trial registration number

ISRCTN10761003.

☐ ☆ ✇ BMJ Open

Effects of photobiomodulation therapy combined with static magnetic field on pain and function in patients with lateral epicondylitis: a multicentre, randomised, placebo-controlled trial

Por: de Oliveira · M. F. D. · Leal-Junior · E. C. P. · Machado · C. d. S. M. · Ribeiro · N. F. · Dias · L. B. · Lino · M. M. A. · Araujo-Silva · O. M. · Casalechi · H. L. · Johnson · D. S. · Tomazoni · S. S. — Octubre 6th 2025 at 02:14
Introduction

Photobiomodulation therapy (PBMT), particularly when combined with a static magnetic field (PBMT-sMF), is a promising non-pharmacological approach for managing musculoskeletal disorders. However, high-quality evidence for its efficacy in lateral epicondylitis remains limited.

Objectives

The study aims to investigate the effectiveness of PBMT-sMF vs placebo in reducing pain, improving function and modulating inflammatory markers in individuals with lateral epicondylitis.

Design

Multicentre, randomised, triple-blinded, placebo-controlled trial.

Setting

Three outpatient physiotherapy clinics in Brazil.

Participants

50 adults (18–50 years) with unilateral lateral epicondylitis and baseline pain ≥50 on the visual analogue scale (VAS).

Interventions

Participants received either active PBMT-sMF (n=25) or placebo (n=25), 2 times per week for 3 weeks. PBMT-sMF involved multi-wavelength irradiation at 4 epicondyle sites (60 s; 27.1 J/site). The placebo group underwent the same procedure without active irradiation.

Primary and secondary outcome measures

The primary outcome was degree of pain rating (VAS). Secondary outcomes included forearm disability (Patient-Rated Tennis Elbow Evaluation, PRTEE), grip strength, serum tumour necrosis factor-alpha (TNF-α) levels and treatment satisfaction. Assessments were conducted at baseline, post-treatment (3 weeks) and at 4-week follow-up.

Results

PBMT-sMF yielded a higher responder rate (defined as the proportion of participants achieving at least a 30% reduction in pain intensity relative to baseline) than placebo (72% vs 40%, p=0.045), with a clinically and statistically significant between-group difference. Compared with placebo, the PBMT-sMF group showed significantly greater reductions in pain intensity both at the end of treatment (51.4±19.8 vs 36.9±22.6; p=0.0223) and at follow-up (37.4±24.1 vs 20.3±21.2; p=0.0049). TNF-α levels also decreased significantly in the PBMT-sMF group compared with placebo at both time points (p

Conclusions

PBMT-sMF significantly reduced pain intensity and TNF-α levels, suggesting an anti-inflammatory mechanism. Although functional outcomes were not improved, PBMT-sMF may be a valuable short-term, non-invasive option for lateral epicondylitis pain management.

Trial registration number

NCT04829734 on ClinicalTrials.gov

☐ ☆ ✇ BMJ Open

MaxiMoM InForM: individualised fortification of human milk for very low birthweight infants-- protocol of a three-arm randomised clinical trial

Por: Beggs · M. R. · Pichardo · D. · Chrzaniecki · A. · Kotsopoulos · K. · Bishara · R. · Ng · E. · Tomlinson · C. · Campbell · D. · Vaz · S. · Kiss · A. · Unger · S. · OConnor · D. L. — Octubre 6th 2025 at 02:14
Introduction

To meet the elevated nutritional requirements of very low birthweight (

Methods and analysis

This is a three-arm, pragmatic, multicentre, double-blind, randomised clinical trial of 615 human milk–fed infants born either (1) ≤1250 g or (2)

Ethics and dissemination

Ethical approval was obtained from Clinical Trials Ontario (CTO) and local research ethics boards that are not CTO members. Study findings will be disseminated to clinicians at seminars and conferences and in peer-reviewed publications.

Trial registration number

NCT05308134.

☐ ☆ ✇ BMJ Open

Effectiveness of vaccination in patients undergoing dialysis or patients with chronic kidney disease: a systematic review protocol

Por: Karim · M. · Milone · B. · Buh · A. · Wisener · N. · Benomar · C. · Mei Nsen · P. · Akbari · A. · Brown · P. A. · Hundemer · G. L. · Sood · M. — Octubre 6th 2025 at 02:14
Introduction

Vaccination has been an effective public health intervention for immunising individuals against many common communicable and non-communicable diseases. However, there is limited information on the efficacy of vaccination among patients undergoing dialysis or patients with chronic kidney disease (CKD). The objective of this review is to assess the effectiveness of vaccination within dialysis and CKD patient populations.

Methods and analysis

This will be a systematic review of studies assessing the effectiveness of vaccination among CKD and dialysis patients. Relevant studies will be identified using MEDLINE, Embase, Scopus and Cochrane Library. All searches will be conducted from database inception to October 2025. Only observational studies such as cohort, prospective, retrospective and cross-sectional studies will be included. Data pertaining to patient outcomes and study design will be extracted. A narrative synthesis will be conducted as well as a meta-analysis if data permitting this analysis is extracted from included studies.

Ethics and dissemination

Since data collection will be conducted by examining existing studies, no ethical approval or consent will be required. The results of this review will be published in a peer-reviewed journal as well as presented at seminars, conferences and symposiums.

Trial registration number

This review protocol has been registered in International Prospective Register of Systematic Reviews (PROSPERO), registration number CRD42025648534.

☐ ☆ ✇ BMJ Open

Comparative efficacy and safety of high-dose rifamycin regimens for tuberculosis treatment: a Bayesian network meta-analysis

Por: Feng · Z. · Wu · H. · Li · Q. · Zhang · X. · He · Q. · Wang · H. · Yu · J. · Ge · S. · Song · L. · Zhang · Y. · Zhou · X. · Sun · F. · Zhang · J. · Li · Y. · Zhang · W. — Octubre 6th 2025 at 02:14
Objectives

High-dose rifamycin (HDR) regimens have demonstrated significant potential in tuberculosis (TB) treatment. This study aims to evaluate the efficacy and safety profile of different HDR regimens.

Design

Using a systematic review and Bayesian network meta-analysis (NMA).

Data sources

PubMed, Web of Science, Cochrane Library and Embase were searched up to 2 November 2024.

Eligibility criteria for selecting studies

Randomised controlled trials that compared the efficacy and safety of HDR regimens (rifampin 15–30 mg/kg/day and rifapentine 7.5–20 mg/kg/day) to standard-dose rifampin in patients with pulmonary drug-susceptible TB were included.

Data extraction and synthesis

The risk of bias was assessed using Cochrane tools. We conducted NMA with GEMTC in R. The simulation was performed using the Markov Chain Monte Carlo technique set on four parallel chains, with 20 000 burn-in iterations, 50 000 inference iterations and a thinning factor of n=2.5. To check for model convergence, Gelman and Rubin diagnostic plots and density plots were applied. We assessed heterogeneity using the I² test, evaluated transitivity by comparing effect modifiers across studies and examined consistency via node-splitting analysis. The confidence in network meta-analysis online tool and Cochrane Risk of Bias 2.0 Tool were used to assess evidence certainty and risk of bias, respectively. Higher surface area under the cumulative rank curve scores indicated a higher probability of top-ranking treatments.

Results

Out of 15 766 citations screened, 15 randomised controlled trials were included, encompassing 6456 subjects. The risk of bias was low in 14 studies, with some concerns in one. Patients receiving rifapentine 20 mg/kg/day (risk ratio, 1.09; 95% credible interval, 1.03 to 1.17) had higher culture conversion rates at 8 weeks in solid culture compared with the control. There was no significant difference in primary efficacy within all HDR regimens. Rifapentine 20 mg/kg/day was ranked as the most effective intervention for primary efficacy. No statistical difference in the incidence of serious adverse events was found between all regimens.

Conclusions

Rifapentine 20 mg/kg/day may be the most effective for achieving the strongest anti-TB activity. All HDR regimens demonstrated good safety.

PROSPERO registration number

CRD42024504575.

☐ ☆ ✇ BMJ Open

Integrating social drivers of health screening and management into prenatal care: protocol for a mixed-methods implementation evaluation

Por: Anderson · P. · Neustrom · V. · Hepting · S. · Menard · M. K. · Cash · K. · Gbozah · K. · Tang · J. — Octubre 6th 2025 at 02:14
Background

Social drivers of health (SDOH), such as housing stability, food security and access to transportation, profoundly influence both healthcare access and health outcomes. In pregnancy, screening positively for SDOH domains correlates with poorer perinatal outcomes. While the American college of Obstetricians and Gynaecologists recommends screening for SDOH at every routine prenatal visit, many prenatal practices struggle to systematically screen patients for SDOH. This study evaluates the implementation of a universal SDOH screening and management protocol in prenatal care and aims to bridge the gap between the recommendation for universal SDOH screening in prenatal care and its actual integration by evaluating implementation strategies that can serve as a guide for other prenatal care clinics.

Methods and analysis

This multi-site, prospective formative implementation evaluation will assess the integration of standardised SDOH screening and management into prenatal care workflows at four prenatal clinic sites within an academic Obstetrics and Gynaecology department. The study employs a concurrent triangulation mixed-methods approach integrating chart-abstracted patient data, staff surveys, and staff and patient semi-structured interviews, guided by established implementation science frameworks (exploration, preparation, implementation and sustainment, consolidated framework for implementation research and implementation outcomes framework). Key implementation strategies include workflow integration, electronic medical record optimisation, role clarification and comprehensive training. Implementation outcomes to be evaluated include feasibility, acceptability, appropriateness, adoption, fidelity and sustainability.

Ethics and dissemination

This study was approved by the University of North Carolina at Chapel Hill’s Institutional Review Board (IRB #24-3104). Verbal informed consent will be obtained from all interview participants, and consent will be embedded in staff surveys. Results will be disseminated through peer-reviewed publications, conference presentations, stakeholder meetings and directly to participating clinical sites.

☐ ☆ ✇ BMJ Open

More is more? The role of surgeon in the volume-outcome relationship: an Italian population-based cohort study

Por: Soldati · S. · Colais · P. · Davoli · M. · Michelozzi · P. · Pinnarelli · L. — Octubre 6th 2025 at 02:14
Introduction

The relationship between surgical volume and clinical outcomes is complex and varies considerably across surgical specialties. While the role of hospital volume is well-established, the specific contribution of surgeon-level volume and the interaction between these two factors are less clear.

Objectives

This study investigates the association between surgeon volume and clinical outcomes for surgeons performing breast-conserving surgery for malignant breast cancer, laparoscopic cholecystectomy and surgery for malignant colon cancer.

Methods

Data from the Lazio Region’s health information systems (2020–2023) were analysed. Primary outcomes included 120-day reinterventions after breast-conserving surgery for breast cancer, 30-day complications after laparoscopic cholecystectomy and 30-day mortality after colon cancer surgery. The association between surgeon volume and outcomes was examined for all surgeons performing at least five procedures annually in Lazio hospitals. A stratified analysis was conducted to assess the impact of hospital volume on the surgeon-volume-outcome relationship, comparing outcomes between surgeons in low-volume and high-volume hospitals. Fractional polynomial and segmented regression models were employed to identify non-linear relationships and potential breakpoints in the surgeon volume-outcome association.

Results

Higher-volume surgeons demonstrated significantly improved outcomes across all three procedures, including lower reintervention rates, fewer complications and reduced mortality. This positive association was further amplified for surgeons practising in high-volume hospitals. Graphical analysis, which involved stratifying the volume-outcome relationship for individual surgeons by hospital volume (high vs low), strongly suggested a synergistic effect between surgeon and hospital volume, clearly illustrating how the benefits of higher surgeon volume were further amplified in high-volume settings.

Conclusions

These findings underscore the critical role of both surgeon-level and hospital-level factors in determining surgical outcomes. Optimising patient care requires a comprehensive approach that considers both individual surgeon performance and the overall quality of the healthcare system. Future research should focus on elucidating the underlying mechanisms driving these associations to inform the development of strategies for improving surgical care delivery.

☐ ☆ ✇ Evidence-Based Nursing

Clinical-academic positions that promote research activity and adoption of findings are dependent on clinical leadership support

Por: Henderson · A. — Octubre 3rd 2025 at 17:49

Commentary on: Aspinall C, Slark J, Parr J, et al. The role of healthcare leaders in implementing equitable clinical academic pathways for nurses: An integrative review. J Adv Nurs. 2024: 1-15. doi: 10.1111/jan.16043

Implications for practice and research

  • All levels of leadership need to engage with and support ‘clinical-academic positions’ to realise the potential these positions offer clinical practice improvement.

  • It is imperative that clinical-academic nurses develop leadership skills to engage with policy and influence executive decisions relevant to advancing clinical practice.

  • Context

    Clinical-academic positions have been developed to advance the nursing profession. The intent of these positions is to lead the continuous generation and adoption of strong evidence into clinical practice that improves healthcare provision; and thereby, strengthening professional credibility. These positions bridge the clinical academic space through drawing on their expertise, research and understanding of implementation science to foster partnership and...

    ☐ ☆ ✇ Evidence-Based Nursing

    A hard act to follow for the new editor-in-chief of Evidence-Based Nursing

    Por: Parkinson · B. — Octubre 3rd 2025 at 17:49

    In the last edition (July, Vol. 28-3) of Evidence-Based Nursing (EBN), Alison Twycross bid farewell to the journal after 15 years of service as the editor-in-chief.1 In those 15 years, Alison made a huge contribution to EBN through editorial leadership and impactful journal content and supported the next generation of editors. Alison shaped EBN into what it is today and helped it transition from a paper-based journal into a modern digital and paper journal with a strong online platform and active social media presence. Alison’s impact on EBN and nursing in general is truly remarkable and reflects her commitment to evidence-based practice and nursing. At EBN, we are immensely grateful for Alison’s leadership, and undoubtedly, her legacy with EBN will continue to have a significant impact on nursing for years to come.

    With Alison stepping down as the Editor-in-Chief of EBN, the journal begins a...

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