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☐ ☆ ✇ 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

Continuous physiological monitoring for the detection of postoperative deterioration: a protocol for a multistage, multicentre, international, prospective cohort study

Por: Jiwa · A. · Cameron · M. M. · Ademuyiwa · A. O. · Adisa · A. · Aguilera Arevalo · M. L. · Bahrami Hessari · M. · Bhangu · A. · Brennan · P. M. · Clark · N. · Cresswell · K. · Czerwinska · I. · DAdderio · L. · Gunn · E. · Haque · P. D. · Ikegwuonu · T. · Lawani · I. · Morton · D. · Nganwa — Octubre 7th 2025 at 08:15
Introduction

Intermittent physiological monitoring and early warning scores (EWS) are limited in their ability to detect deteriorating patients in a timely manner. Wearable physiological sensors allow continuous remote monitoring and may be more timely and accurate in the identification of those at risk, compared with manual collection. This study aims to determine if wearable physiological sensors can be used for the early detection of postoperative deterioration, while being acceptable to patients and healthcare staff.

Methods and analysis

This is a prospective observational cohort study that will recruit adults undergoing major surgery in Benin, India, Ghana, Guatemala, Mexico, Nigeria, Rwanda and the UK. Participants will wear wearable physiological chest and limb sensors before, during and after surgery for up to 10 days or until discharge. In this ‘shadow-mode’ study, continuous physiological observations collected using the devices will not be made available to clinical teams. No changes in participant care will result. Standard of care clinical data will be collected contemporaneously. Continuous sensor data will be used to design algorithms to predict deterioration and specific complications in this population. Usability and feasibility testing, through focus groups, interviews and questionnaires, will be undertaken with healthcare professionals and people undergoing surgery.

Ethics and dissemination

Our stakeholder panel are directly involved in all aspects of this study, which will be conducted in accordance with the principles of the International Conference on Harmonisation Tripartite Guideline for Good Clinical Practice (ICH GCP) in addition to the principles of the ethics committee(s)/Institutional Review Boards (IRBs) who have reviewed and approved this study. Artificial intelligence (AI) prediction models will be reported in accordance with the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis+Artificial Intelligence (TRIPOD+AI) and Developmental and Exploratory Clinical Investigations of DEcision support systems driven by Artificial Intelligence (DECIDE-AI) reporting guidelines frameworks.

Trial registration number

NCT06565559.

☐ ☆ ✇ BMJ Open

Combining virtual reality and hypnosis to alleviate chronic pain in elderly with hand arthritis: protocol for a randomised phase II clinical trial

Por: Fournier · V. · Simard · M.-F. · Yuen · S. Y. · Guine · J. · Rousseaux · F. · Lebeau · J. · Jerbi · K. · Richebe · P. · Landry · M. · Rainville · P. · Ogez · D. — Octubre 6th 2025 at 02:14
Introduction

Chronic pain is a common health condition that significantly impacts the quality of life of those affected, affecting one in five people in Canada. The prevalence of this condition tends to increase with age, making it a major health issue given the ageing population. However, its management remains inadequate and requires significant mobilisation of healthcare professionals as well as the development of multiple therapeutic solutions. Among these, non-pharmacological interventions such as hypnosis and virtual reality have proven effective. Nevertheless, while the existing literature seems promising, it presents methodological limitations. Therefore, this study aims to assess the effectiveness of an intervention combining virtual reality and hypnosis in an ageing population suffering from a widespread chronic pain condition, that is, hand arthritis.

Methods and analysis

This study will be a single-centre randomised clinical trial. Participants will be randomly assigned to one of two conditions: one receiving an intervention combining virtual reality and hypnosis, and the other receiving only virtual reality. The effectiveness of the intervention on current perceived pain before and after the intervention (primary outcome) will be evaluated. Secondary outcomes will include anxiety and depressive symptoms, quality of life, relaxation and fatigue. Exploratory analyses will also be conducted to contribute to the emerging literature by examining physiological variables such as heart rate variability, respiratory rate and electrodermal activity during the intervention, and their relationship with primary and secondary outcomes.

Ethics and dissemination

The project was approved by the Research Ethical Committee of the Hospital Maisonneuve-Rosemont (Project no 2024-3539). Participants will be asked to provide written consent for their participation. Results from this study will be shared through peer-reviewed publications, as well as oral and poster presentations at scientific events. The protocol for this study was preregistered on Open Science Framework and raw anonymised data will be available on this platform (https://osf.io/vbh72/?view_only=1d17c5708f894faab6669d85e1fde75d).

Trial registration number

NCT06833905.

☐ ☆ ✇ BMJ Open

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

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

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

Methods and analysis

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

Ethics and dissemination

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

Trial registration number

NCT04897516.

☐ ☆ ✇ BMJ Open

Patient-reported outcome measured by EQ-5D and influencing factors among patients of systemic lupus erythematosus in China: a multicentre cross-sectional study from CSTAR Registry

Por: Li · L. · Bai · W. · Yu · B. · Zou · K. · Wang · Y. · Zuo · K. · Wang · L. · Wu · C.-Y. · Zhao · J. · Zeng · X. · Wang · Y. · Li · M. — Septiembre 29th 2025 at 07:52
Objectives

Until now, there has still been a lack of sufficient evidence on patient-reported outcomes (PROs) measured by the EuroQol-5 Dimension (EQ-5D) in patients with systemic lupus erythematosus (SLE) in China. This study aims to comprehensively assess EQ-5D outcomes and influencing factors in Chinese patients with SLE.

Design

A multicentre, cross-sectional study based on the Chinese Systemic Lupus Erythematosus Treatment and Research Group registry.

Setting

101 hospitals across 27 provinces of China.

Participants

1336 patients with SLE.

Outcome measures

The information on EQ-5D was collected via an online questionnaire. Medical records were obtained from the Chinese Rheumatology Data Centre (CRDC). Clinical influencing factors related to the reported health problems were identified using multivariate logistic regression. Then, each health state was converted into a health utility score based on the Chinese 2014 tariff. Given the ceiling effects, Tobit regression models were used to analyse the factors influencing health utility scores.

Results

A total of 1336 patients with SLE were included. Of them, 626 patients (46.9%) reported health problems using EQ-5D. The proportions of patients reporting problems in mobility, self-care, usual activities, pain/discomfort and anxiety/depression were 12.80%, 5.24%, 14.90%, 27.47% and 30.46%, respectively. The mean utility score was 0.89 (SD: 0.15), and the mean Visual Analogue Scale (VAS) score was 76.80 (SD: 16.54). There was a statistically significant correlation (r=0.503, p

Conclusions

EQ-5D may be a useful, preference-based PRO measure for SLE and could potentially be integrated into routine clinical monitoring of patients with SLE and applied in economic evaluations in the future.

☐ ☆ ✇ BMJ Open

"Should be a dynamic tool": Aboriginal and Torres Strait Islander primary health care service staff perspectives on an effective patient reported experience measure (PREM) in Australia - a qualitative study

Por: Chakraborty · A. · Walke · E. · Laycock · A. F. · Piccoli · T. · Matthews · V. · Walpole · R. · Bailie · R. · Burgess · P. · Langham · E. · Larkins · S. · Bainbridge · R. · Brown · B. · Silver · B. · Swaminathan · G. · Smorgon · S. · Turner · N. · Passey · M. — Septiembre 25th 2025 at 11:09
Objectives

The Validating Outcomes by Including Consumer Experience (VOICE) project is developing patient reported experience measure (PREM) tools to collect consumer feedback for Indigenous primary healthcare (IPHC) services’ accreditation and quality improvement processes. This study aimed to explore the views of health service staff about: (1) optimising the feasibility of collection, analysis and interpretation of findings; and (2) resourcing requirements for implementation of the PREM.

Design

A participatory action research qualitative study design, guided by an Indigenous advisory group. Our team of Indigenous and non-Indigenous researchers conducted semistructured focus groups and individual interviews with IPHC staff. Focus groups and interviews were recorded, transcribed and thematically analysed. Multiple sense-making meetings were conducted with the Indigenous advisory group.

Setting

Eight partner IPHC services across four Australian states and territories.

Participants

All staff were eligible and invited to participate in the study via purposive and snowball sampling. Administrative staff (eg, receptionist, programme facilitator), clinicians/practitioners (eg, general practitioner, nurse, Aboriginal and Torres Strait Islander health workers and practitioners) and service managers (eg, CEO, practice manager) from partner health services participated.

Results

63 staff participated; 44 attended across 13 focus groups, with the remainder participating in individual interviews. The majority of participants were between 35 years and 55 years old (52%), female (66%) and working in frontline IPHC service delivery roles (56%). Equal numbers identified as Indigenous (50%) and non-Indigenous (50%). Many had worked in the Indigenous health and well-being sector for over 10 years (40%). ‘Culturally safe care’ and ‘accountability’ were identified as primary themes and key reasons for gathering consumer feedback. Subthemes identified were ‘Relationships’, ‘trust and respect’, ‘communication about consumer feedback’, ‘timing and frequency of requesting consumer feedback’, ‘health service systems’, ‘health service and staff capacity’, ‘staff skills’ and ‘structure and administration of the PREM’. All themes and subthemes need to be considered for the successful design and implementation of PREMs in IPHC settings.

Conclusion

Many of the issues identified are not currently considered in the process of collecting PREM data for accreditation yet, if addressed, would likely improve the quality and relevance of data collected. The findings from this study will inform the co-design and validation of Indigenous-specific PREM tools to collect consumer feedback. Critically, service and community input will ensure the PREM tools meet service needs for continuous quality improvement and accreditation and reflect the priorities and values of Indigenous peoples.

☐ ☆ ✇ BMJ Open

Leading practices in the development and delivery of case-based learning programmes for health and social care provider education: a scoping review protocol

Por: Saari · M. E. · Hudani · A. · Cardozo · V. · Giosa · J. L. — Septiembre 25th 2025 at 11:09
Introduction

As care needs increase in complexity, a shift to people-centred, integrated care is required to meet the full range of health and social care needs of clients. However, limited opportunities exist for care providers to develop interprofessional competencies as part of pre-licensing and/or continuing education. New learning models, such as case-based learning (CBL), that facilitate the development of interprofessional competencies and are aligned with practice realities of providers are needed. This scoping review will collate and codify leading practices and knowledge gaps in the development and delivery of CBL programmes in pre-licensing and continuing education for health and social care providers.

Methods and analysis

A scoping review will be conducted in accordance with the Joanna Briggs Institute methodology for scoping reviews and reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. MEDLINE, CINAHL Plus, Scopus, ERIC Institute of Education Sciences, PsycINFO and Education Source will be searched for peer-reviewed literature; Google Scholar, ProQuest Dissertations and Web of Science will be searched for grey literature. Reference lists of full-text scholarly sources, key journals and authors will be searched manually. Study selection and extraction will be conducted by two independent reviewers. English sources published between 2014 and 2024 that discuss CBL epistemologies, characteristics, delivery mechanisms, programme limitations and/or programme evaluation in health and social care pre-licensing and/or professional training will be included. Data will be analysed using directed content analysis and synthesised as a narrative summary.

Ethics and dissemination

This scoping review protocol was reviewed by the Southlake Health Research Ethics Board and received ethics exemption. Findings will be disseminated through peer-reviewed publication, conferences, professional networks and social media, and used to inform the development of an evidence-based training programme for health and social care providers.

Registration details

Open Science Framework https://doi.org/10.17605/OSF.IO/6YXHN

☐ ☆ ✇ BMJ Open

Multimorbidity before, during and after pregnancy among women in low-income and middle-income countries: protocol for a scoping review

Por: Ramokolo · V. · Roomaney · R. A. · Maqungo · M. · Nyirenda · M. · Puri · P. · Yakubu · K. · Gummidi · B. · Zembe-Mkabile · W. · Xu · X. · McCauley · M. — Septiembre 24th 2025 at 03:32
Introduction

The co-occurrence of multiple long-term conditions, that is, multimorbidity, is increasing globally and is associated with lower quality of life and increased risk of death. The risk and prevalence of multimorbidity are higher among women compared with men, but currently, evidence focusing on women’s multiple long-term conditions during the perinatal period is limited. Existing evidence needs to be examined to determine the extent to which maternal multimorbidity or women’s multiple health needs related to pregnancy have been addressed, especially for women living in low-income and middle-income countries (LMICs) where this burden of disease is the highest. The objective of this scoping review is to map existing evidence in LMICs on (a) Study designs and data sources, (b) Context-relevant definitions and descriptions, (c) Associated risk and protective factors, (d) Relevant maternal and infant health outcomes and (e) Treatments and interventions used to manage multiple long-term conditions before, during and after pregnancy.

Methods and analysis

This scoping review will be conducted using Joanna Briggs Institute methodology and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement extension for scoping reviews. This review will include observational, experimental or quasi-experimental studies, as well as systematic or umbrella reviews, on multimorbidity in women of reproductive age (15–49 years) in prepregnancy, pregnancy or up to 6 weeks after childbirth in LMICs. The studies will focus on definitions, risk and protective factors and management strategies for multiple long-term conditions before, during and after pregnancy. Studies of morbidity in women with a single index condition or conditions that are not related to pregnancy or childbirth will be excluded. A search strategy will be developed using thesaurus (including MeSH) and free-text terms for ‘maternal morbidity’ or ‘multiple long-term conditions’ and associated keywords such as multimorbidity, co-morbidity and unmet health needs related to pregnancy and/or childbirth for women living in LMICs. Electronic (EBSCOhost (CINAHL Ultimate, STM Source, Medline Ultimate), Cochrane Library, Web of Science or Scopus and Google Scholar) and grey literature databases will be searched from database inception. Reference lists and bibliographies of key topic articles will also be searched, and any additional papers that meet the inclusion criteria will be obtained. There will be no limitations on dates or languages. Records will be independently screened, selected and extracted by two researchers. Data will be presented in tables and narrative summaries.

Ethics and dissemination

Ethics approval is not required as this scoping review will summarise previously published data. Findings from the review will be disseminated through various platforms, including peer-reviewed journals, conferences and community meetings.

Study registration

Open Science Framework (https://doi.org/10.17605/OSF.IO/FYCR8).

☐ ☆ ✇ PLOS ONE Medicine&Health

Human papillomavirus, sexually transmitted infections, and antimicrobial resistance in West Africa: Estimating population burden and understanding exposures to accelerate vaccine impact and drive new interventions: The PHASE survey protocol

by Adedapo Olufemi Bashorun, Larry Kotei, Abdoulie F. Jallow, Ousubie Jawla, Emmanuel U. Richard-Ugwuadu, Muhammed Jagana, Lamin Bah, Amadou Tijan Bah, Karamo Conteh, Mamadou S.K. Jallow, Mehrab Karim, Bai Lamin Dondeh, Anne Segonds-Pichon, Gary M. Clifford, Iacopo Baussano, Bruno Pichon, David Jeffries, Ed Clarke

Human papillomavirus (HPV) infection is a primary cause of preventable deaths from cervical cancer, a condition of profound inequality with approximately 90% of deaths occurring in low- and middle-income countries, particularly in sub-Saharan Africa. In May 2018, the WHO Director-General declared a Joint Global Commitment to Cervical Cancer Elimination, highlighting the critical role of HPV vaccines in achieving this goal. However, there is a lack of systemically collected data on HPV prevalence in The Gambia, and impact data from high-income countries may not be reliably extrapolated to West African settings due to geographical variation in HPV types and distinct behavioural, biological, and sociodemographic exposures. The Gambia introduced a two-dose HPV vaccination schedule in 2019, but coverage has been very low, interrupted mainly by the COVID-19 pandemic. This presents a key opportunity to generate vital baseline data on HPV prevalence in the population before potential scale-up of vaccination efforts. The PHASE survey, a multi-stage cluster survey, aims to establish the baseline, population prevalence estimates of high-risk and low-risk, vaccine-type and non-vaccine-type HPV infection in 15- to 49-year-old females in The Gambia by measuring urinary HPV-DNA. The survey will also quantify the effects of various exposures on HPV prevalence, including sexual behaviour, the presence of other sexually-transmitted infections (STIs) - Neisseria gonorrhoea (NG), Chlamydia trachomatis (CT), Trichomonas vaginalis (TV), Mycoplasma genitalium (MG), syphilis, as well as blood borne viruses, human immunodeficiency virus (HIV), hepatitis B and hepatitis C; obstetric history, socio-demographic characteristics, and cervical cancer screening and/or treatment. Additionally, the study will provide important antimicrobial resistance (AMR) data for NG and MG in sub-Saharan Africa, a region poorly represented in global surveillance programs. This data is needed to guide regional treatment guidelines and advocate for new solutions, including gonococcal vaccines. The AMR data are expected to immediately influence recommendations regarding the appropriate choice of antibiotics for syndromic STI management in West Africa and hence to address an important driver of AMR in the sub-region. Leveraging on the Medical Research Council Unit The Gambia funded Health Demographic Surveillance system (HDSS) as its sampling frame, the survey will utilize validated diagnostic assays and culturally sensitive data collection methods, to ensure both scientific rigor and local relevance. Tools such as Audio Computer-Assisted Self-Interviewing (ACASI) technology, developed in consultation with local community advisory boards, are included to reduce social desirability bias in reporting sexual behaviour. This approach aims to maximize both the reliability and cultural appropriateness of the findings. This study directly addresses the critical need for baseline epidemiological data on HPV in a West African setting to accelerate vaccine impact and drive new interventions towards cervical cancer elimination. By understanding other factors that influence HPV (like other STIs, sexual behaviour, etc.), the study aims to ensure that, when the vaccine’s impact is measured later, changes in other confounding factors that may impact on HPV prevalence can be accounted for. The study will also establish the population prevalence of the measured STIs and their relationship to common symptoms and other adverse health outcomes related to STIs.
☐ ☆ ✇ BMJ Open

Cardiovascular effects of incretin-based drugs in patients with and without a history of heart failure: a protocol for a systematic review, meta-analysis and trial sequential analysis of randomised controlled trials

Por: El-Sheikh · M. · Sillassen · C. D. B. · Wisborg · F. D. · Hove · J. D. · Dirksen · C. · Lee · M. M. Y. · Jakobsen · J. C. · Grand · J. — Septiembre 22nd 2025 at 03:00
Background

Incretin-based drugs, including glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) and dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 RAs, are increasingly used in the management of type 2 diabetes mellitus and obesity. While these agents have shown cardiovascular benefits, their effects on both cardiovascular outcomes and cardiac structure and function remain uncertain—particularly in patients with and without a history of heart failure (HF).

Methods and analysis

We will conduct a systematic review and search major medical databases (Cochrane Central Register of Controlled Trials (CENTRAL), Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica Database (EMBASE), Latin American and Caribbean Health Sciences Literature (LILACS), Science Citation Index Expanded (SCI-EXPANDED) and Conference Proceedings Citation Index-Science (CPCI-S)), as well as clinical trial registries from their inception and onwards to identify relevant randomised trials. The literature search is scheduled for July 2025. Two review authors will independently extract data and assess risk of bias. We will include randomised controlled trials assessing the effects of cagrilintide/semaglutide, liraglutide, semaglutide and tirzepatide in patients with and without a history of HF. The primary outcome will be cardiovascular mortality. Secondary outcomes will include HF hospitalisation, myocardial infarction, stroke, heart rate, systolic blood pressure, N-terminal pro B-type natriuretic peptide, left ventricular ejection fraction, left ventricular end-diastolic volume and left ventricular end-systolic volume. Data will be synthesised by aggregate data meta-analyses and trial sequential analysis. Risk of bias will be assessed with the Cochrane Risk of Bias tool, version 2, and the certainty of the evidence will be assessed by Grading of Recommendations, Assessment, Development and Evaluations (GRADE).

Ethics and dissemination

As this study is a systematic review based on secondary analysis of published data, ethical approval is not required. Findings will be published in international peer-reviewed scientific journals.

PROSPERO registration number

CRD420251003374.

☐ ☆ ✇ BMJ Open

Development of methods to identify digitally excluded older people, and tailoring of interventions to meet their digital needs: a protocol for a mixed-methods study (the INCLUDE study)

Por: Brundle · C. · Johansson · J. F. · Best · K. · Clegg · A. · Forster · A. · Atkinson · T. · Foster · M. · Humphrey · S. · Iliff · A. · Inglis · J. · Walker · C. · Graham · L. — Septiembre 19th 2025 at 06:54
Introduction

Digital inclusion (which includes skills, accessibility and connectivity to the internet and digital devices) is a ‘super social determinant of health’ because it affects many aspects of life that influence health. Older people are especially vulnerable to digital exclusion. Existing digital inclusion interventions are commonly offered opportunistically to people who come into contact with services, or in specific locations. The lack of systematic identification of need unintentionally excludes older people who may be most in need of support, and that support is not addressing their needs.

Methods and analysis

This multi-method project includes six workstreams: (1) A survey of people aged 65+ to ask about digital use and engagement. Survey data will be used to develop a model that predicts digital exclusion from data available in primary care records. (2) Testing, via a further survey, the external validity of the model to identify those who are digitally excluded. (3) Interviews with community service providers to identify, understand and define the components of existing digital inclusion services for older people. Concurrently, a rapid review of the literature will identify evidence for interventions aimed at supporting digitally excluded adults aged 65+. (4) Interviews with people aged 65+ representing a range of digital use will explore factors from the COM-B model that influence digital behaviours—their capability (C), opportunity (O) and motivation (M) relating to digital engagement. Analysis outputs will identify the intersectional nature of barriers or facilitators to digital inclusion. (5) Co-production workshops with older people and community service providers will identify key components of interventions that are required to address digital exclusion. Components will be mapped against existing interventions, and the ‘best fit’ intervention(s) refined. An implementation plan will be developed in parallel. (6) Feasibility testing of the refined intervention(s) to assess acceptability and obtain feedback on content and delivery mechanisms.

Ethics and dissemination

This study was approved by the Yorkshire & The Humber - Bradford Leeds Research Ethics Committee on 23 October 2023 (ref. 23/YH/0234). Findings will be disseminated in academic journals and shared at webinars, seminars, conferences and events arranged by organisations operating across the digital inclusion and older people fields.

Trial registration

https://www.isrctn.com/ISRCTN18306736

☐ ☆ ✇ BMJ Open

What features should an effective system for declaring and managing conflicts of interest in healthcare have? An adapted Delphi study of key stakeholders in the UK

Por: McCartney · M. · Metsis · K. · Orr · K. · Millum · J. · Wilkes · A. · Sullivan · F. — Septiembre 19th 2025 at 06:54
Objective

To identify views and establish agreements of key stakeholders on the features of an effective system for declaring and managing conflicts of interest in healthcare.

Design

A modified Delphi study consisting of two surveys and semi-structured interviews. Surveys included closed and free-text questions.

Setting and participants

UK, purposefully and generally invited participants including academics, researchers, healthcare professionals, regulators, patients and citizens from 10 countries, during 25 August 2024 and 20 January 2025.

Main outcome measures

Quantitative and qualitative analysis of two surveys and 21 interviews. Descriptive statistics were used to describe the sample and analyse closed survey questions. Thematic analysis was used to analyse free-text survey responses and interview data. Results were synthesised to describe the perceived importance and purposes of declaration of interest systems.

Results

In the first survey round, 616 invitations were sent, along with social media advertisements. 237 questionnaires were returned and 200 full responses were analysable. 129 respondents consented to recontact on the online form. In the interview round, 37 invitations were sent and 21 interviews completed (response rate 59.5%). Invitations for the second survey were sent to all 129 participants who consented to recontact. 91 responses were received and 89 questionnaires were analysable (response rate 82%). Features of ideal systems to declare and manage the interests of healthcare professionals identified by participants were categorised under seven themes: regulatory issues, the healthcare environment, human vices, professional virtues, the use of judgement, features of a better system and patients and public. There was broad agreement on the need for transparency and clarity in declaration systems. The most agreed features were: clarity on what information was needed; it should be a centralised ‘deposit’ for all declarations; it should be publicly accessible, educating and informing people accessing and using the register. Having a lifelong personal identifier, some flexibility in declarations and some privacy features were also rated highly. Respondents were less concerned about scrutiny or a loss of trust. Small numbers of participants raised concerns about serious adverse effects, including loss of privacy, personal safety and the potential of information to contribute to conspiracy theories. There were also major disagreements between participants concerning whether or not healthcare professionals should work with industry, and whether conflicts of interest from working with industry can be safely managed. Individuals with each perspective felt they were acting ethically.

Conclusions

While many agreements were identified, disagreements were also found. If improved declaration systems are to be accepted by professionals and useful to regulators, patients and citizens, the potential for benefit and harm from new declaration systems must be addressed.

Registration details

Prepublished, Open Science Framework https://osf.io/fbj5n.

☐ ☆ ✇ BMJ Open

Bringing diagnostic home: models, challenges and enablers of home-based examinations imaging/graph services - a scoping review

Por: Costa · G. F. · Lorenzi · L. J. · Raymundo · T. M. · Kort · H. · Castro · P. C. — Septiembre 18th 2025 at 03:51
Background

Mobile diagnostic imaging services provided at home increase accessibility and convenience, particularly for older adults, people with disabilities and other vulnerable groups. These services can reduce the need for patient travel and support the routine monitoring of chronic conditions. However, current guidelines often overlook user acceptance and environmental considerations within the home setting.

Objectives

To map studies that identify the models, barriers and facilitators for performing home-based diagnostic imaging/graph according to end users.

Design

A scoping review was conducted following the methodological framework of the Joanna Briggs Institute and reported according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews checklist.

Eligibility criteria

Studies that addressed mobile or portable diagnostic imaging or graph examinations conducted in the home for individuals of any age or health status were included. Studies were eligible if they reported on barriers, facilitators or user experiences. Studies that focused on wearable technologies were excluded.

Sources of evidence

The search strategy was developed using terms related to home-based diagnostic imaging/graph, portability, home setting and user perceptions. Searches were conducted in PubMed, Web of Science, Scopus, Embase, The ACM Guide to Computing Literature and LILACS, without restrictions on publication date or language. Additional grey literature was identified through Google Scholar.

Data extraction and synthesis

Two reviewers independently extracted data using a standardised form that captured study characteristics, types of procedures, target populations and reported barriers and facilitators. Quantitative data were summarised using absolute and relative frequencies. Qualitative findings were synthesised through basic content analysis to identify and categorise recurring themes.

Charting methods

Data were charted in tables to organise and visually map study contexts, methodological features and thematic patterns related to implementation and user experience.

Results

Twenty-six studies published between 1998 and 2023 across 15 countries were included. The diagnostic examinations included mostly polysomnography, X-ray imaging and ultrasonography. Seven categories of barriers were identified, such as physical discomfort, equipment-related challenges and procedural limitations. Seven facilitators were also reported, including perceived comfort, patient satisfaction and equipment usability.

Conclusions

This review identifies key factors affecting the delivery and user experience of mobile diagnostic imaging at home, including logistical, technical and environmental aspects. It reveals gaps in the literature and provides a basis for future research to inform more inclusive and effective public health policies and service design.

Trial registration number

Open Science Framework (DOI 10.17605/OSF.IO/7UV5D).

☐ ☆ ✇ BMJ Open

Impact of fibrinogen-to-erythrocyte suspension ratio on mortality and functional outcomes in major perioperative bleeding (Approximate Dose-Equivalent of Fibrinogen-to-Erythrocyte Suspension (ADEFES) study): protocol for a prospective observational study

Por: Demir · Z. A. · Kavak Akelma · F. · Akca · O. · Koltka · K. · Dincer · B. · Kocyigit · M. · Tuna · A. T. · Sayın · J. · Yıldırım Ar · A. · Kuvaki · B. · Aykut · A. · Sahin · A. S. · Aydın Güzey · N. · ADEFES Investigators · Yigit · Akyol · Akel · Argun · Aydın · Saracoglu · Canb — Septiembre 17th 2025 at 06:57
Introduction

Early and balanced replacement of blood products appears to be the key factor in improving outcomes of major bleeding patients including acute trauma, cardiac, obstetric and transplant surgery patients. Definitive clinical guidance regarding the optimal ratio of blood products, including those containing fibrinogen, is still lacking. Therefore, we tested the hypothesis that increasing the fibrinogen content to erythrocyte suspension ratio improves the mortality and functional outcomes of patients undergoing surgeries with expected major bleeding.

Methods and analysis

The Approximate Dose-Equivalent of Fibrinogen-to-Erythrocyte Suspension (ADEFES) ratio is a multicentre, prospective, observational, cohort study of patients undergoing major surgical procedures with expected major perioperative bleeding (ie, requiring packed red blood cells (PRBC)>4U/24 hours). For 5U of cryoprecipitate and 1.5 U of fresh frozen plasma (FFP), the approximate dose-equivalent for fibrinogen is considered as 1 gram of fibrinogen. Association of the ADEFES ratio at 24 hours will be assessed on the primary objective, which will consist of the composite of 30-day all-cause mortality, 30-day bleeding-specific mortality and the ‘highly-dependent scores’ of Katz index of independence in activities of daily living.

Ethics and dissemination

The study protocol was approved by the Ethics Committee of Ankara Bilkent City Hospital (approval no. E2-23-4265, dated 07 June 2023; Chair: Prof. Dr. F.E. Canpolat) and by the institutional review boards of all participating centres. The study will be conducted in accordance with the principles of the Declaration of Helsinki and the Strengthening the Reporting of Observational Studies in Epidemiology guidelines, as well as in compliance with national regulations on data protection and Good Clinical Practice standards. Written informed consent will be obtained from all participants prior to inclusion in the study.

The results of this study will be disseminated through peer-reviewed scientific journals, presentations at national and international conferences, and communication with relevant stakeholders including clinical practitioners and healthcare institutions. If applicable, study outcomes will also be shared via institutional newsletters and digital platforms to reach a broader audience in the medical community.

Trial registration number

NCT06021184.

☐ ☆ ✇ BMJ Open

Picture perfect: study protocol for assessing the accuracy, feasibility and acceptability of intraoral photographs captured by parents for remote dental screening in children - an observational mixed-methods study

Por: Al-Yaseen · W. · Haghi Ashtiani · G. · Pattinson · R. · Pritchard · M. F. · Pickles · T. · Galloway · J. · Innes · N. — Septiembre 17th 2025 at 06:57
Background

Children with limited access to dental care can be negatively impacted by reduced frequency of oral health monitoring, delays in diagnosis of dental disease and increased waits for dental care, resulting in them experiencing more disease (extent and amount). Smartphone-based intraoral photography has been cited as having the potential to improve oral health monitoring for children through screening; however, it has not been well evaluated, and its limitations are unclear. The picture-perfect study aims to assess diagnostic accuracy, feasibility and acceptability to determine whether remote photographic monitoring can be effectively integrated into pathways of dental care for children aged 6-16 years.

Methods

Observational, cross-sectional, mixed-methods study with three workflows: Workflow 1: development of user-friendly, comprehensive guidance to help parent/carers (parents) take high-quality intraoral photographs of their children’s mouths. The guidance will be codesigned with parents and healthcare professionals. Workflow 2: diagnostic accuracy using intraoral photographs taken by a parent of their children will be evaluated by comparing clinicians' diagnoses from the photographs to gold-standard clinical visual-tactile examinations. Parent–child dyads (n=110) will be recruited to capture intraoral photographs using positioning aids, guidance and smartphones provided by the research team. The diagnoses will focus on plaque accumulation, gingival health, restoration status and dental caries. Diagnostic accuracy will be assessed using sensitivity, specificity, positive predictive value, negative predictive value and area under the curve. Workflow 3: assessment of feasibility and acceptability will be through task completion rates, photograph quality and participant feedback. Qualitative interviews and an online survey will capture parents’ and children’s experiences. Observational data will provide insights into practical challenges.

Ethics and dissemination

This study, approved by the National Health Service (NHS) Research Ethics Committee (Integrated Research Application System [IRAS]: 24/EE0137), will be conducted in adherence to the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines. Written informed consent will be obtained from all participating parents, with age-appropriate assent from children prior to enrolment. Participants have the right to withdraw at any time without explanation, and their data will be anonymised to ensure privacy and confidentiality. Study findings will be disseminated through peer-reviewed journals, conference presentations and reports to relevant stakeholders.

Trial registration

The study protocol has been registered on the Open Science Framework: https://doi.org/10.17605/OSF.IO/WX29D.

☐ ☆ ✇ BMJ Open

Seeing Isnt measuring: ICU staffs ability to estimate patient height and weight -- A cross-sectional study from Pakistans largest cardiac centre

Por: Ahmad · B. · Islam · F. · Ansari · M. I. · Taimoor · L. · Arif · M. S. · ur Rehman Memon · A. · Umair · M. · Abubaker · J. — Septiembre 16th 2025 at 03:21
Objective

In critical care, intensive care unit (ICU) staff and physicians often estimate patients' height and weight visually, impacting calculations for cardiac function, ventilation, medication, nutrition and renal function. However, accurate assessment is challenging in critically ill patients. This study evaluates the accuracy of visual estimations by ICU staff.

Design

Descriptive cross-sectional study.

Setting

National Institute of Cardiovascular Diseases, Karachi, Pakistan.

Participants

We included a convenient sample of adult (≥18 years) cardiac patients admitted to the critical care unit in this study. Patients who refused to give consent, trauma/surgery of lower limbs or patients with below-knee or above-knee amputation were excluded to avoid bias.

Outcome measure

A convenient sample of cardiac ICU patients was included. Measured weight (kg) and height (cm) were compared with visual estimations by senior ICU nurse, senior non-ICU nurse, ICU consultants, fellows and residents. Correlation and agreement were analysed using Bland–Altman plots and 95% agreement limits.

Results

A total of 356 patients were evaluated, of whom 204 (57.3%) were male, with a mean age of 55.2 ± 14.3 years. The median SOFA score was 3 [2–5], and 101 patients (28.4%) were on mechanical ventilation. The mean difference between measured and estimated weight by senior non-ICU nurse was 4.7±9.2 [–13.38–22.83] kg, senior ICU nurse was 7.8±9.9 [–11.56–27.12] kg, ICU consultants was 3.0±6.6 [–9.89–15.79] kg, ICU fellow was 3.0±7.1 [–10.88–16.92] kg and ICU resident was 8.0±9.6 [–10.83–26.79] kg. Similarly, the mean difference between measured and estimated height by senior non-ICU nurse was 2.0±7.3 [-12.36–16.34] cm, senior ICU nurse was 2.4±7.5 [–12.19–17.00] cm, ICU consultants was 1.5±5.6 [–9.51–12.48] cm, ICU fellow was 1.1±5.5 [–9.68–11.95] cm and ICU resident was 2.3±8.5 [–14.40–19.01] cm.

Conclusion

The findings indicate that healthcare professionals tend to overestimate both weight and height. The accuracy of these estimations varied among professional groups, underscoring the potential clinical consequences of such errors. This emphasises the need for objective measurements in clinical decision-making.

☐ ☆ ✇ BMJ Open

Global mapping of oral health plans, programmes and policies in countries with universal health coverage: a scoping review protocol

Por: Monteiro · D. L. A. · Laureano · I. C. C. · Menezes · C. C. T. · Sousa · M. G. d. P. · Santiago · B. M. · Faquim · J. P. d. S. · Cavalcanti · Y. W. — Septiembre 16th 2025 at 03:21
Introduction

This review aims to map oral health plans, programmes and policies worldwide in countries with universal health coverage.

Methods and analysis

This protocol describes a scoping review that will follow the Joanna Briggs Institute methodology and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Scoping Review checklist, guided by the PCC framework: Population—countries with universal health coverage (78 globally recognised); Concept—oral health plans, programmes and policies; Context—integration into health systems. Searches will be conducted in MEDLINE (PubMed), Scopus, Web of Science, Embase, Health System Evidence and Epistemonikos, with no restrictions on date, language or study type. Grey literature will be accessed through Google Scholar, OpenThesis and the Brazilian Digital Library of Theses and Dissertations. Official documents from ministries of health and international bodies, including the WHO and the International Monetary Fund, will also be reviewed. Two independent reviewers will screen titles and abstracts; a third will resolve disagreements. Eligible records will undergo full-text review. Data will be extracted into predefined categories reflecting health system components: population, structure, services, governance and oral health indicators. Results will be presented using tables, charts and figures to illustrate strategies and innovations.

Ethics and dissemination

This review does not involve primary data collection and does not require ethical approval. Results will be disseminated through a peer-reviewed publication and presentations at academic conferences and scientific events.

Study registration

Open Science Framework (DOI 10.17605/OSF.IO/RCP8N).

☐ ☆ ✇ BMJ Open

Development of a nurse-led clinical pathway to prevent delirium in older adults in general hospital wards: a realist review protocol

Por: Hoch · J. · Müller · M. · Unger · I. · Mitzkat · A. · Denninger · N.-E. — Septiembre 16th 2025 at 03:21
Introduction

Delirium is a critical and complex neuropsychiatric syndrome that significantly affects older adults in general hospital wards. Although multicomponent interventions have been shown to be effective in preventing delirium, the consistent implementation remains a challenge. Also, to manage the complex pathway of patients from admission to discharge in hospital, the involvement of the nursing staff is essential. Developing a nurse-led clinical pathway for delirium prevention could provide a structured approach to improving care quality. For intervention development taking account of the complexity of the clinical environment, the UK Medical Research Council framework is frequently used. A core element of this framework is mapping a programme theory that explains how, for whom and in what circumstances an intervention may work. The realist review methodology is well suited to uncovering the underlying mechanisms, contexts and outcomes of interventions, translating these into a programme theory.

The aim of this realist review is to develop a programme theory for a nurse-led clinical pathway to prevent delirium in older adults aged 65 years or older in general hospital wards and to identify strategies to support its effective implementation.

Methods and analysis

The realist review is based on the methodical framework developed by Pawson et al and further adapted by Rycroft-Malone et al and the reporting will follow the Realist And MEta-narrative Evidence Syntheses: Evolving Standards guidelines. The process comprises four steps: (1) defining the review scope; (2) systematically searching for and appraising the evidence; (3) extracting and synthesising findings and (4) developing a narrative synthesis. Interest holders, including clinical and academic experts, will be actively involved as an expert reference group to inform and refine the programme theory. The final programme theory will be presented in Context-Mechanism-Outcome configurations and the Implementation Research Logic Model.

Ethics and dissemination

Since no data are collected as part of the review, ethical approval is not required. Findings will be disseminated through academic conferences and publication in a peer-reviewed journal.

Registration

This protocol has been registered at Open Science Framework (https://doi.org/10.17605/OSF.IO/7EPTF).

☐ ☆ ✇ BMJ Open

Administration of levofloxacin combined with metronidazole suppositories prior to in vitro fertilisation in women with chronic endometritis: a protocol of a single-centre, randomised, controlled clinical trial

Por: Lin · M. · Wang · Y. · Lv · X. · Lin · Z. · Zeng · Z. · Mo · D. · Shan · H. · Li · R. — Septiembre 16th 2025 at 03:21
Introduction

Chronic endometritis (CE) is regarded as a potential factor contributing to infertility and embryo implantation failure. The cause of CE remains unclear at present, but it might be associated with intrauterine microbial infections. Empirical antibiotic treatment typically consists of a 2-week course of oral levofloxacin combined with oral metronidazole. Currently, there is no research comparing the efficacy of oral levofloxacin versus vaginal metronidazole suppositories in improving pregnancy outcomes for these patients. This study aims to evaluate the effectiveness of combining oral levofloxacin with metronidazole suppositories in the treatment of CE. The goal is to enhance clinical pregnancy rates and live birth rates among patients undergoing in vitro fertilisation (IVF), while concurrently mitigating the incidence of miscarriages.

Methods and analysis

The trial concerning the combination of levofloxacin and metronidazole suppositories for the treatment of CE is a single-centre, randomised controlled clinical trial. We plan to recruit female patients with CE who are planning to undergo IVF. Following informed consent, eligible participants will be randomly assigned in a 1:1 ratio to receive either daily oral levofloxacin combined with oral metronidazole or oral levofloxacin combined with a metronidazole suppository for 2 weeks until the human chorionic gonadotropin trigger day. All IVF procedures will be carried out routinely at this centre. The primary outcome is the live birth rate after embryo transfer, while the secondary pregnancy outcomes include clinical pregnancy rates and miscarriage rates.

Ethics and dissemination

This study has been approved by the Ethics Committee of Peking University Third Hospital on 28 June 2024 (Reference No. IRB00006761-M2023857). Written informed consent will be acquired from all participants prior to randomisation. The study findings will be submitted to scientific conferences and peer-reviewed journals.

Trial registration number

NCT06650540.

☐ ☆ ✇ BMJ Open

What is known about gambling in lesbian, gay, bisexual, trans and queer (LGBTQ+) communities? A scoping review

Por: Zeeman · L. · Sawyer · A. · Bailey · L. · Sherriff · N. · Smith · M. — Septiembre 15th 2025 at 05:56
Background

Gambling is of public health importance due to the potential impacts of gambling on individuals and their communities.

Objectives

This review draws on evidence to address: ‘What is known about gambling in lesbian, gay, bisexual, trans and queer+ (LGBTQ+) communities?’ including (i) the prevalence of gambling harm; (ii) the lived experience of gambling harms; (iii) the interventions and service barriers and (iv) the risk and protective factors against gambling harms.

Eligibility criteria

The identified peer-reviewed and grey literature papers were screened against inclusion and exclusion criteria by two reviewers prior to extracting data. Eligibility for inclusion was assessed via the Critical Appraisal Skills Programme (CASP) framework and a Weight of Evidence approach.

Sources of evidence

PubMed, Web of Science, ProQuest, Google Scholar and Cochrane were searched for peer reviewed and grey literature published from June 2000 to June 2023.

Charting methods

Data extraction tables were developed to include the characteristics, methods, sample and key findings for each study.

Results

19 papers were included, which showed mixed prevalence of problems with gambling among lesbian, gay and bisexual populations. There is more consistent evidence that trans and gender diverse people experience higher levels of problems with gambling compared with cisgender (not trans) people. Limited research focused on the lived experience or the wider impact of gambling harm among LGBTQ+communities. Risk factors for gambling harm included minority stress, societal stigma, discrimination and isolation. Protective factors against gambling harm included higher levels of support, positive social interaction and mainstream community connectedness. No studies were identified with gambling interventions specific to LGBTQ+people. General health service barriers included professionals’ use of pathologising language or a lack of cultural competency and education around LGBTQ+issues.

Conclusion

Research on LGBTQ+ gambling harm remains distinctly limited. Further, population-based surveys as well as in-depth qualitative research are needed to develop a comprehensive understanding of gambling in LGBTQ+communities. Research should be undertaken in collaboration with LGBTQ+peers. A better understanding of gambling could inform a whole systems approach with targeted interventions to protect against gambling harm and to promote greater health equity. Open Science Framework registration number (http://osf.io/jf85y/).

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