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Use of clips to prevent delayed post-polypectomy bleeding in non-pedunculated colorectal lesions: protocol for a systematic review and meta-analysis

Por: Wei · Y. · Zhang · S. · Mabenga · H. S. · Ngowi · B. J. · Jin · Z.
Introduction

Delayed post-polypectomy bleeding (DPPB) remains a significant complication of endoscopic resection, contributing to morbidity and increased healthcare costs. Although prophylactic clipping is widely practised to mitigate this risk, evidence from recent randomised controlled trials (RCTs) regarding its efficacy is inconsistent. This protocol outlines a systematic review and meta-analysis to evaluate the effectiveness of prophylactic clips following thermal resection.

Methods and analysis

We will conduct a comprehensive search of MEDLINE, EMBASE and the Cochrane Library from inception to 10 February 2026, to identify RCTs comparing prophylactic clips vs no clips in patients undergoing thermal endoscopic resection of non-pedunculated polyps. The primary outcome is DPPB within 30 days, defined as overt bleeding requiring medical intervention or a haemoglobin decrease ≥2 g/dL. Secondary outcomes include DPPB in proximal large (≥20 mm) lesions, perforation, post-polypectomy syndrome and procedure time. Data synthesis will use a random-effects model. Methodological quality will be assessed using the Cochrane Risk of Bias 2 tool. Publication bias will be visualised using funnel plots. We will quantify the effect of potential effect modifiers by meta-regression if appropriate. The quality of evidence will be evaluated according to the Grading of Recommendations Assessment, Development and Evaluation framework.

Ethics and dissemination

This study will not use primary data, and therefore formal ethical approval is not required. The findings will be disseminated through peer-reviewed journals and committee conferences.

PROSPERO registration number

CRD420251246840.

Spatial variation in HIV test non-uptake among antenatal care-attending pregnant women in sub-Saharan Africa: a cross-sectional study using demographic and health survey data

Por: Alemu · E. A. · Endalamew · S. G. · Alemaw · H. B. · Kebede · H. A. · Assefa · S. K. · Andarge · E. M. · Taye · E. A. · Asgedom · D. K. · Kebede · S. A. · Zegeye · A. T. · Abate · B. J.
Objectives

This study assessed the spatial distribution of HIV test non-uptake among pregnant women who attended antenatal care (ANC) in sub-Saharan Africa.

Design

Cross-sectional study design.

Setting

Sub-Saharan Africa (SSA) region. 24 SSA countries were included in this study.

Data source

Demographic and Health Survey (DHS), 2016–2024.

Participants

82 397 women who were pregnant in the last 2 years preceding the survey.

Outcome measure

HIV test non-uptake, which is a legacy indicator of HIV test among pregnant women.

Result

The HIV test non-uptake among ANC attending pregnant women was 39.6% (95% CI 39.27% to 39.93%). The spatial autocorrelation test revealed that HIV testing non-uptake among pregnant women was clustered. The global Moran’s I value was 0.48 with a p value

Conclusion

There was a significant geographical variation in HIV test non-uptake among pregnant women attending antenatal care (ANC) in sub-Saharan Africa. Prioritising hotspot areas with high rates of HIV test non-uptake for spatially targeted interventions is essential. Policymakers, health professionals, and other stakeholders should focus on improving women’s formal education, expanding health insurance coverage, and increasing ANC contacts to ensure that each visit includes HIV screening. Moreover, special attention should be given to younger women to enhance HIV testing uptake among those attending ANC in sub-Saharan Africa.

Effect of iron dose in maternal multiple micronutrient supplement on perceived side effects, adherence, acceptability and preferences: protocol for a randomised crossover trial

Por: Sudfeld · C. R. · Muhihi · A. · Sylvetsky · A. C. · Metta · E. · Brownlee · V. S. · Oakley · E. M. · Bakari · M. · Fawzi · W. W. · Kinyogoli · S. · Kuiper · J. R. · Mugusi · S. · Pan · Q. · Sando · M. M. · Wylie · B. J. · Masanja · H. · Smith · E. R. · Pembe · A. B.
Introduction

Iron-folic acid (IFA) supplementation in pregnancy is recommended by the WHO, with a dose of 60 mg of iron in contexts where anaemia remains a severe public health problem. Iron-containing supplements may cause side effects that affect acceptability and adherence in a dose-response manner. Maternal multiple micronutrient supplements (MMS), which include iron and folic acid plus additional micronutrients, are also recommended in the context of rigorous research, and programmes are considering transitioning from IFA to MMS containing 30 mg of iron. We will evaluate the effect of iron dose in MMS on maternal acceptability, side effects, adherence and preferences.

Methods and analysis

The Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial is an individually randomised, quadruple-blind, non-inferiority crossover trial of daily antenatal MMS supplementation formulations that contain 60 mg, 45 mg and 30 mg elemental iron among pregnant women in Dar es Salaam, Tanzania. A total of 156 pregnant participants will be randomised to a sequence in which they receive each of the three MMS formulations for 1 month. Participants, investigators, outcome assessors and data analysts will be blinded to the treatment sequence. The primary trial outcome is participant-reported acceptability of each MMS formulation, measured on a Likert scale. Secondary and tertiary outcomes include preferred and least preferred formulation, identification of MMS formulation, reported side effects and adherence assessed by pill count. Regression analyses will be used to assess differences between formulations and will account for sequence and period effects of the crossover trial design. Qualitative in-depth interviews from a subsample of participants will be conducted to understand women’s perceptions and experiences taking the different MMS formulations.

Ethics and dissemination

The trial protocol was approved by Harvard T. H. Chan School of Public Health Institutional Review Board (IRB), the Ifakara Health Institute IRB, the Muhimbili University of Health and Allied Sciences IRB, the National Health Research Ethics Sub-Committee and the Tanzania Medicine and Medical Device Authority. Results will be shared through publications and presentations at the local, regional and international levels.

Trial registration number

ClinicalTrials.gov Identifier: NCT06069869.

Short-term intravenous fluids for prevention of post-ERCP pancreatitis (the STRIPE study): protocol for a five-arm randomised controlled trial

Por: Forbes · N. · Guo · H. · Kruk · A. · Ficaccio · S. · Cartwright · S. · Howarth · M. · Malik · G. · Nietert · P. J. · Smith · Z. L. · Li · S. · Chen · Y.-I. · Causada Calo · N. · Tse · F. · Telford · J. J. · Cook · D. J. · Hill · M. D. · Elmunzer · B. J.
Introduction

Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is a significant procedural adverse event (AE), occurring in 5–15% of cases and leading to substantial morbidity and mortality. Aggressive prolonged intravenous (IV) fluid regimens have demonstrated efficacy in reducing PEP in clinical trials. However, these regimens typically involve continuous infusion of IV fluids over 8–24 hours following ERCP, making them impractical for outpatient settings. Data on shorter hydration protocols are lacking. The STRIPE study aims to address this gap by evaluating short-term peri-procedural IV fluid regimens as a practical alternative for mitigating PEP.

Methods and analysis

This proof-of-concept, parallel-arm, randomised controlled trial will evaluate the impact of various short-term IV fluid regimens on post-ERCP serum amylase levels, a surrogate marker for PEP. Participants undergoing ERCP will be randomised into five groups, receiving 500 mL, 1000 mL, 1500 mL, 2000 mL or 2500 mL of IV Ringer’s lactate during the peri-procedural period. Patients, endoscopists and outcome assessors will be blinded to treatment allocation during the peri-procedural period. The primary outcome is the serum amylase level 24 hours post-ERCP. Secondary outcomes include PEP, 30-day AEs and unplanned healthcare encounters including those related to volume overload or cardiovascular AEs, duration of hospitalisation (for inpatients), death within 30 days and other relevant laboratory markers at 24 hours. A total of 505 participants (101 in each arm) will be enrolled to ensure adequate power after accounting for attrition and/or sample loss.

Ethics and dissemination

This trial was registered on clinicaltrials.gov on 7 February 2024. The study was approved by the University of Calgary Conjoint Health Research Ethics Board (REB23-0625). On study completion, data will be made available on reasonable request to the corresponding author after completion of the study. Study dissemination and knowledge translation is planned via presentations at scholarly meetings, publications in peer-reviewed journals and, ideally, via adoption of results into clinical practice guidelines.

Trial registration number

NCT06260878.

Type 3 hybrid effectiveness-implementation study implementing and evaluating the Comprehensive High-dose Aphasia Treatment (CHAT) programme in Australian rehabilitation services: a protocol

Por: McSween · M.-P. · Dignam · J. K. · Shrubsole · K. · Levine · R. · Power · E. · Lannin · N. A. · Wallace · S. J. · Cadilhac · D. A. · Kilkenny · M. F. · Hill · A. J. · Ryan · B. J. · Copland · D. A.
Introduction

The Comprehensive High-dose Aphasia Treatment (CHAT) programme is an intensive comprehensive aphasia programme, which aims to address evidence-practice gaps in aphasia rehabilitation where there are known barriers to service delivery requiring implementation strategies. The aims of this study are to (1) evaluate the clinical implementation of the CHAT programme, (2) assess the clinical effectiveness of CHAT compared with usual care in rehabilitation services and (3) determine whether the real-world implementation of CHAT compared with usual care is cost-effective.

Methods and analysis

Four participant groups will be recruited across six hospital and health services Australia-wide to participate in a type 3 hybrid effectiveness-implementation study: (1) people with aphasia, (2) support persons, (3) treating clinicians and students and (4) clinical stakeholders (eg, managers). This before-and-after study will include three time periods: (1) ‘usual care’ where people with aphasia will receive their usual care aphasia therapy, (2) ‘implementation transition’ where clinicians will be trained to deliver CHAT and (3) ‘intervention implementation’ where people with aphasia will receive the CHAT programme (ie, 50 hours of evidence-based aphasia therapy over 8 weeks). Evidence-based implementation strategies will be used to facilitate implementation within participating rehabilitation services. The primary outcome is delivery of evidence-based aphasia treatment (ie, CHAT) as measured by a composite score of quality indicators. Clinical effectiveness outcomes, measuring change in language impairment, communication effectiveness, confidence and quality of life, and implementation outcomes will also be examined. We will also conduct an embedded mixed-methods process evaluation and economic evaluation.

Ethics and dissemination

This study has been approved by the Royal Brisbane and Women’s Hospital Human Research Ethics Committee (HREC/2021/QRBW/72154). Outputs will include conference presentations, publications and a training package to optimise implementation of aphasia treatment in rehabilitation service contexts.

Registration details

Australian New Zealand Clinical Trials Registry (ANZCTR) prospective registration ACTRN12621001765819. Trial registered 23 December 2021. https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=381365&isReview=true.

Seroprevalence of COVID-19 among healthcare workers in Hong Kong during the first 2 years of the COVID-19 pandemic (2020-2021): a longitudinal cohort study

Por: Lim · W. W. · Mak · L. · Ho · F. · Ng · T. W. Y. · Yau · E. M. · Ko · R. L. W. · Chen · D. · Xiao · J. · Seto · W. H. · Cheng · S. M. S. · Perera · R. A. P. M. · Ip · D. K. M. · Peiris · M. · Cowling · B. J.
Background

In the first 2 years of the COVID-19 pandemic, Hong Kong adopted strict public health and social measures to stop community transmission of SARS-CoV-2. These include border screening and control, isolation of cases and quarantine of their contacts and universal masking. During this period, attack rates in Hong Kong were among the lowest globally.

Objectives

To estimate the seroprevalence of COVID-19 among healthcare workers (HCWs) in Hong Kong in 2020 and 2021.

Methods

We reviewed contact tracing data from the Hong Kong Department of Health to identify COVID-19 cases reported among HCWs. Between June 2020 and December 2021, we conducted a longitudinal cohort study to estimate the seroprevalence of COVID-19 among HCWs working in hospitals and clinics in Hong Kong during the first 2 years of the COVID-19 pandemic.

Results

Overall seropositivity of COVID-19 by plaque reduction neutralisation test during the first (May–October 2020) and second round (November 2020–April 2021) of the study was 0% (95% CI 0.00% to 0.49%) and 0.52% (95% CI 0.14% to 1.33%). After COVID-19 vaccines were offered to HCWs in February 2021, seroprevalence by surrogate virus neutralisation assay among cohort participants who provided biannual blood samples rose to 68.7% (95% CI 65.9%, 71.3%) and 80.2% (95% CI 76.8%, 83.2%) in round 3 (May–October 2021) and the first 2 months of round 4 (November–December 2021).

Conclusions

Seroprevalence in Hong Kong HCWs in our study was low despite considerable exposure to confirmed COVID-19 cases in some study participants. However, the low rate of community transmission may have also contributed to the observed low seroprevalence among HCWs in our cohort.

Exploring collaboration preferences of health care professionals and patients regarding treatment decision making in severe asthma: a qualitative study in The Netherlands

Por: Achterbosch · M. · van der Werf · H. M. · Mortelmans · L. · Dilles · T. · Dierick · B. J. H. · van Dijk · L. · van Boven · J. F. M.
Background

Shared decision making (SDM) is advocated as an approach for patient-centred asthma care. However, this approach may not always be feasible or preferred by patients and/or healthcare professionals (HCPs). Knowledge and insights into whether and how the preferred collaboration style in medical decision making is discussed and managed during consultations for severe asthma are limited.

Objectives

To investigate how HCPs’ and patients’ preferred collaboration styles in treatment decision making are experienced, discussed and managed during consultations.

Methods

Qualitative research using semi-structured interviews with HCPs specialised in severe asthma and a focus group with severe asthma patients in The Netherlands. Inductive thematic analysis was used, with results reported according to the COREQ checklist.

Results

Four themes concerning HCPs’ and patients’ experiences were identified: (1) overall preference for SDM, yet (2) ambiguity of SDM’s content, (3) variation in application of SDM and (4) friction between medical focus and patient autonomy in SDM. A fifth theme concerned the discussion and management of collaboration style preferences: limited metacommunication. HCPs and patients seem unable to identify each other’s preferences in collaboration styles. Overall, a lack of communication regarding how to collaborate in making treatment decisions was found. Varying views on meaning and content of collaboration styles, especially SDM, and HCPs’ medical focus seemed to contribute to the lack of communication.

Conclusion

With the lack of communication regarding preferences in collaborating, HCPs and patients are likely to miss out on effective collaboration. Future studies should explore how views and preferences regarding HCP-patient collaboration can be bridged.

Connection, confluence and convergence: a protocol for reviewing policies on antimicrobial resistance and plastic pollution

Por: Shah-Rohlfs · R. · Landicho · J. · Endoma · V. · Sornillo · B. J. · Treskova · M. · Rocklöv · J. · McMahon · S. A. · Renosa · M. D. C.
Introduction

Antimicrobial resistance (AMR) and plastic pollution are converging global crises that threaten both human health and environmental sustainability. Despite the growing recognition of these challenges, few legislative and policy frameworks acknowledge the complex interplay between antibiotic misuse and environmental plastic contamination. This protocol seeks to bridge that gap by critically examining policies in Europe and the Philippines, focusing on those that target antibiotic misuse and plastic pollution in human and animal health.

Methods and analysis

Document analysis will be employed to systematically review relevant legislative and policy frameworks. We will retrieve laws, regulations and policy documents from official databases, government websites and other sources using broad inclusion criteria. The extraction process and analysis will be guided by the READ (Ready, Extract, Analyse, Distill) approach which will ensure a thorough examination of how these documents address the dual challenges of AMR and plastic pollution. Particular attention will be paid to identifying policy gaps, overlaps and synergies that may affect the overall effectiveness and coherence of current governmental responses.

Ethics and dissemination

This policy review has been granted exemption from ethical review by the Research Institute for Tropical Medicine (RITM-IRB No. 2024-35), Philippines. The results are expected to provide a robust evidence base to inform the development of integrated policies at the nexus of global public health and environmental sustainability. Findings will be disseminated at academic conferences and peer-reviewed publications and to key stakeholders within European, Philippine, and international organisations.

Trial registration number

The detailed protocol is pre-registered and openly available on the Open Science Framework (https://osf.io/3tkn2/overview).

Strategies for assessing posthospitalisation outcomes in trauma survivors and their feasibility of implementation: a scoping review protocol

Por: Laberge Sevigny · M. · Moore · L. · Gabbe · B. J. · Haagsma · J. · Wake · E. · Haas · B. · Skaff · D. · Green · R. · Trevino · C. · Finstad · J. · Gagnon · M.-A. · Deziel · P.-L. · Berube · M.
Introduction

Each year, physical traumas affect over one billion people worldwide, generating a substantial burden in terms of mortality, disability and productivity loss. The period following hospital discharge, encompassing the transition to home, short-term stays in rehabilitation facilities, as well as outpatient and community-based follow-up care, represents a critical phase in the recovery process for trauma injury patients. Yet, this phase remains poorly documented. We aim to (1) Map data on assessment strategies for various outcomes among trauma survivors after hospital discharge, including the tools used and how they are administered, as well as the resources required, and the barriers and facilitators to their implementation, and (2) Compare the feasibility of implementing the assessment strategies while considering response rates, resource use, costs and sustainability.

Methods and analysis

We will conduct a scoping review using the Joanna Briggs Institute methodology. We will search MEDLINE, Embase, CINAHL, Scopus and PsycINFO for studies published since 1990 to reflect the evolution of contemporary follow-up practices, including the emergence of Patient-Reported Outcome Measures and digital tools. There will be no language restrictions. We will consider all studies involving trauma survivors, focusing on the evaluation of postdischarge health outcomes. Two independent reviewers will screen studies and extract data on population characteristics, assessment strategies and feasibility. Results will be analysed thematically and presented narratively. We will present counts and percentages for each assessment strategy, along with its characteristics and associated barriers and facilitators. Subgroup analyses will also be conducted based on clinical and social determinants and contextual factors.

Ethics and dissemination

Ethics approval is not required for this review. The results of this scoping review will be shared through publication in a peer-reviewed journal, conference presentations and our network of knowledge users.

Open science framework registration number

DOI 10.17605/OSF.IO/KZHS4

Association of diabetes severity with cognitive function in US adults: a cross-sectional analysis of the AI-READI multicentre cohort

Por: Um · K. M. · Kim · B. J. · Ying · G.-S.
Objectives

To evaluate whether type 2 diabetes mellitus (T2DM) presence and severity are associated with differences in global and domain-specific cognitive function among US adults, using standardised Montreal Cognitive Assessment (MoCA) testing.

Design

Cross-sectional study

Setting

Three U.S academic medical centres participating in the Artificial Intelligence–Ready and Equitable Atlas for Diabetes Insights (AI-READI) study.

Participants

Adults aged ≥40 years enrolled in the AI-READI cross-sectional study at three US academic medical centres were eligible. The study excluded individuals with type 1 diabetes, pregnancy or inability to speak, read and understand English. For this secondary analysis, 1067 participants from the first publicly released AI-READI data set who had MoCA data and assigned glycaemic status were included. Participants were classified into four prespecified glycaemic groups: controls without diabetes (n=371), pre-diabetes (n=239), medication-controlled type 2 diabetes (n=323), and insulin-dependent type 2 diabetes (n=129).

Primary and secondary outcome measures

The primary outcome was global cognitive function measured by the MoCA total score. Secondary outcomes included MoCA domain scores and the prevalence of cognitive impairment, defined as MoCA

Results

Significant differences in MoCA total scores were observed across glycaemic groups (p

Conclusions

Individuals with more advanced T2DM, particularly those on insulin, had significantly higher risk of cognitive impairment. These findings support routine cognitive screening in patients with T2DM, especially those on insulin therapy. Early identification of cognitive impairment may improve diabetes management and cognitive outcomes.

Advancing Strategies to Optimise the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) study: rationale and design for a sequential, repeated crossover trial

Por: Stallings · E. G. · Wanderer · J. P. · Balavage · M. · Henson · C. P. · Fowler · L. · Eden · S. · Shotwell · M. S. · Gruss · C. · Neuhafen · K. R. · Gelfand · B. J. · Kertai · M. D. · for the ASPIRE-PONV Investigators
Introduction

This project, in adult surgical patients, will evaluate whether the creation of a customised checklist, driven by a clinical decision support tool, is able to improve anaesthesia providers’ adherence to consensus guidelines and standardised practice recommendations for the prevention of postoperative nausea and vomiting (PONV).

Methods and analysis

The intervention will be evaluated using a sequential, repeated crossover design at the institutional level, with designated washout, control and intervention periods. The surgical case will serve as the unit of analysis. The primary outcome is adherence to appropriate PONV prophylaxis administration guidelines. Secondary outcomes include the incidence of PONV and length of stay in the postanaesthesia care unit (PACU).

Ethics and dissemination

This protocol and statistical analysis plan provide an outline of the study design, primary and secondary end points and analytic approach. The Advancing Strategies to Optimise the PerIopeRativE Management of PostOperative Nausea and Vomiting trial has received approval from the Vanderbilt University Institutional Review Board (IRB: 250773). The results will be disseminated through peer-reviewed publications and presentations at national conferences. Findings from this trial will inform best practices for timely antiemetic prophylaxis, with the goal of reducing PONV incidence and shortening PACU stay.

Trial registration number

NCT07152249.

Patterns in meperidine distribution and associations with income and obesity in the USA and Puerto Rico between 2019 and 2023: a retrospective study

Por: Gonzalez · B. · Healy · L. G. · Harrison · L. R. · Piper · B. J.
Objectives

Meperidine, once viewed as relatively safe, is now discouraged in clinical settings due to its associated risks. Previous studies have identified a significant decrease in meperidine distribution across the USA from 2000 to 2021. Regional disparities accompanied this decline. The goal of this study was to investigate if the decrease in meperidine distribution has continued in recent years, 2019–2023, and if regional variations persist. This investigation also aimed to identify correlates of meperidine distribution, including adult obesity prevalence and annual income, to provide insight into the regional variation.

Design

Retrospective observational study using data from the Automation of Reports and Consolidated Orders System Drug Retail Summary Reports by the Drug Enforcement Administration (DEA), the Centers for Disease Control and Prevention (CDC) and the US Census Bureau.

Setting

USA, including Puerto Rico.

Participants

US population.

Primary and secondary outcome measures

The primary outcome was the meperidine distribution across the US between 2019 and 2023. Secondary outcomes included associations between meperidine distribution and adult obesity prevalence and median household income.

Results

Total meperidine distribution across the USA dropped by 57.8% from 2019 to 2023. A substantial geographic variation was found with southern states accounting for the second, third and fourth highest in meperidine use per capita in 2023, only behind Puerto Rico. In contrast, northeastern states accounted for four of the five lowest states. A significant relationship was found between annual income and meperidine distribution in 2022 (r(49) = –0.38, p

Conclusion

Our study revealed a continued decrease in meperidine distribution and sustained presence of geographical variation from 2019 to 2023. Furthermore, novel relationships were identified between meperidine distribution, annual income and adult obesity prevalence.

Agreement testing of AMSTAR-PF, a tool for quality appraisal of systematic reviews of prognostic factor studies

Por: Henry · M. L. · OConnell · N. E. · Riley · R. D. · Moons · K. G. M. · Shea · B. J. · Hooft · L. · Wallwork · S. B. · Damen · J. A. A. G. · Skoetz · N. · Appiah · R. P. · Berryman · C. · Crouch · S. M. · Ferencz · G. A. · Grant · A. R. · Henry · K. M. · Herman · A. M. · Karran · E. L. · K
Objectives

To test the agreement and usability of a novel quality appraisal tool: A MeaSurement Tool to Assess systematic Reviews of Prognostic Factor studies (AMSTAR-PF).

Design

Observational study.

Participants

14 appraisers of varied experience levels and backgrounds, including undergraduate, master’s and PhD students, postgraduate researchers, research fellows and clinicians.

Study procedure

Eight systematic reviews were rated by all reviewers using AMSTAR-PF.

Outcome measures

Planned measures included intrapair and inter-pair agreement using Cohen’s and Fleiss’ kappa, time of use and time to reach consensus. Interrater agreement was an added measure, and Gwet’s agreement coefficient was calculated and presented due to its greater stability across agreement levels. The percentage of intrapair agreements identical or one category apart was also presented.

Results

Interrater agreement averaged 0.59 (range 0.21–0.90), inter-pair agreement 0.61 (range 0.24–0.91) and intrapair agreement 0.75 (range 0.45–0.95) across the domains, with agreement for the overall rating 0.46 (95% CI 0.30 to 0.62) for interrater agreement, 0.46 (95% CI 0.17 to 0.74) for inter-pair agreement and 0.68 (range of averages 0.22–1.00) for intrapair agreement. The majority (60.7%) of intrapair ratings were identical, with 94.6% of final ratings either identical or only one category different for the overall appraisal. The time taken to appraise a study with AMSTAR-PF improved with use and averaged around 34 min after the first two appraisals.

Conclusions

Despite some variance in agreement for different domains and between different appraisers, the testing results suggest that AMSTAR-PF has clear utility for appraising the quality of systematic reviews of prognostic factor studies.

Addressing Commercial Health determinants: Indigenous Empowerment and Voices for Equity (ACHIEVE)--protocol for a multiphase study

Por: Cubillo (Larrakia/Wadjigan) · B. J. · Browne · J. · Sherriff · S. · Walker (Yorta Yorta) · T. · Hill · K. · Crocetti · A. · Mitchell · F. · Backholer · K. · Maddox · R. · Brown · A. · Allender · S. · Wright · C. J. C. · Lacy-Nichols · J. · Chamberlain · C. · Ropitini (Ngati Kahungu
Introduction

The commercial determinants of health (CDoH) are a rapidly growing field of research and global health priority. Despite being disproportionately affected, Indigenous Peoples’ voices and perspectives are conspicuously absent from CDoH research and policy. This article outlines the protocol for Addressing Commercial Health determinants: Indigenous Empowerment and Voices for Equity (ACHIEVE), an Aboriginal and Torres Strait Islander-led project in Australia.

Methods and analysis

ACHIEVE integrates four research streams, using a novel combination of methods. The first three streams will (i) conceptualise the CDoH using Indigenous yarning methodology, (ii) evaluate the effectiveness and cost-effectiveness of policies to reduce exposure to harmful marketing and (iii) assess the impacts of specific commercial entities on Aboriginal and Torres Strait Islander health using case studies. The final stream will consolidate findings from streams 1–3 and work with Aboriginal Community Controlled Health Organisations (ACCHOs) to co-create strategies for addressing the commercial determinants of Aboriginal and Torres Strait Islander health.

Ethics and dissemination

Ethical approval for streams 1–3 has been granted by Deakin University Human Research Ethics Committee. ACHIEVE is guided by a governance model that prioritises Indigenous data sovereignty, community and ACCHO partnerships, capacity building and knowledge translation. Findings will be shared with participants, ACCHOs and policymakers to maximise research impact.

Impact of vitamin D non-reimbursement policy on therapy discontinuation in the general and rheumatic population in the Netherlands: a cross-sectional study

Por: Singh · A. · Huiskes · V. J. B. · van den Bemt · B. J. F. · van Ameijden · H. · Nurmohamed · M. T. · Spijkers · K. M. · Vervloet · M. · Brabers · A. E. M.
Objective

To assess the impact of the non-reimbursement policy on vitamin D therapy discontinuation in patients from the general and rheumatic populations.

Design

A cross-sectional study.

Setting

Research institute specialised in health research and two outpatient pharmacies in the Netherlands.

Participants

Patients from the general and rheumatic population with an active prescription for vitamin D supplementation therapy were included.

Data collection and analysis

Data were collected between April and May 2023 through self-reported questionnaires. Descriptive statistics and logistic regression were performed using STATA V. 17. P value

Primary and secondary outcome measures

The primary outcome was the proportion of patients who discontinued vitamin D supplementation therapy following the implementation of the non-reimbursement policy. Secondary outcomes included patient-reported reasons for therapy discontinuation and the association between patient-related characteristics and the risk of therapy discontinuation. In addition, the proportion of patients who switched to an alternative supplement and whether this switch had been made in consultation with a healthcare provider was examined.

Results

Of the 4800 patients, 302 (6.4%) patients discontinued their vitamin D therapy. The three most frequently reported reasons for therapy discontinuation were the inability to afford supplements without reimbursement, not willing to pay for supplements without reimbursement and being unaware of the alternative vitamin D supplements to switch to. Younger age, financial constraints and limited health literacy were significantly associated with vitamin D therapy discontinuation (p

Conclusion

The implementation of the non-reimbursement policy resulted in a small proportion of patients discontinuing their vitamin D therapy. Elevated discontinuation rates were associated with specific patient-related characteristics including patients aged

Online Remote Behavioural Intervention for Tics (ORBIT-UK): protocol of a single cohort usability study

Por: Hastings · O. · Brown · B. J. · Prentice · K.-M. · Babbage · C. M. · Davies · E. B. · Kilgariff · J. · Murphy · T. · McGarry · G. · Guo · B. · Greenhalgh · C. · Hollis · C. · Hall · C. L.
Introduction

Tourette syndrome is a common, disabling childhood-onset condition. Exposure and response prevention (ERP) is an effective treatment for tics, yet access remains limited due to a shortage of trained therapists and uneven geographical distribution of services. The ORBIT trial demonstrated that internet-delivered ERP is both clinically and cost-effective, but was developed on a university research platform, not suitable for widescale roll-out. To enable adoption by the National Health Service (NHS) in England, ORBIT has been redeveloped on an NHS compliant platform. This study will evaluate the usability, acceptability and preliminary outcomes of ORBIT on the new platform within an NHS tic disorder service.

Methods and analysis

This single-cohort usability study will recruit 20 children and young people (aged 9–17) with tics and their chosen supporters (parents/carers). Participants will receive a 10-week online ERP intervention supported by trained coaches. Outcomes include uptake, adherence, system usability, satisfaction and clinical measures such as the Yale Global Tic Severity Scale, Parent Tic Questionnaire and Goal-Based Outcomes. Qualitative feedback will be collected via semi-structured exit interviews. Usability metrics and adverse events will be monitored throughout.

Ethics and dissemination

The study has received ethical approval from North West Greater Manchester Research Ethics Committee (ref: 25/NW/0107). The findings from the study will inform future NHS adoption. The results will be submitted for publication in peer-reviewed journals.

Trial registration number

ISRCTN82718960. Registered 10 July 2025. https://doi.org/10.1186/ISRCTN82718960

Triple-drug therapy with Goreisan, tranexamic acid and carbazochrome sodium sulfonate hydrate to prevent recurrence after chronic subdural haematoma surgery: a multicentre, randomised, controlled trial protocol

Por: Negishi · H. · Hirata · K. · Aiyama · H. · Fujita · K. · Komatsu · Y. · Kato · N. · Shibata · Y. · Tsuda · K. · Yamazaki · T. · Sato · M. · Watanabe · S. · Sugii · N. · Konishi · T. · Mathis · B. J. · Ohigashi · T. · Endo · M. · Ishikawa · E. · Matsumaru · Y. · The Triple Study Investigato
Introduction

Chronic subdural haematoma (CSDH) is a common neurosurgical condition in older adults, with a recurrence rate of approximately 7.1–13% after burr-hole drainage. Although surgical adjuncts such as subdural drains and middle meningeal artery embolisation may reduce recurrence, these are not suitable for all patients. Pharmacological strategies, including tranexamic acid, Goreisan and carbazochrome sodium sulfonate hydrate, have shown potential, but high-level evidence remains lacking. A prior retrospective study suggested that a triple oral regimen combining these agents may reduce recurrence. This randomised controlled trial aims to evaluate its efficacy and safety.

Methods and analysis

This is a prospective, multicentre, open-label, randomised controlled trial conducted across six hospitals in Ibaraki, Japan. A total of 180 patients undergoing first-time burr-hole surgery for CSDH will be randomised 1:1 to receive either triple therapy (Goreisan 7.5 g/day, carbazochrome sodium sulfonate hydrate 90 mg/day and tranexamic acid 750 mg/day for up to 90 days) or standard postoperative care. The primary outcome is recurrence requiring reoperation within 90 days. Secondary outcomes include time to recurrence and haematoma volume reduction on serial CT imaging. All analyses will follow the intention-to-treat principle, using logistic regression, Cox proportional hazards models and mixed-effects models.

Ethics and dissemination

Written, informed consent will be obtained from all participants at each participating hospital by trained staff from that hospital. The trial protocol has been approved by the ethics committee of the University of Tsukuba Hospital (approval no. TCRB23-025) and the Institutional Review Boards of all participating centres. Study findings will be disseminated through presentations at scientific conferences and publications in peer-reviewed journals. A summary of the results will also be provided to participating institutions and made publicly available in accordance with the BMJ Open data sharing policy.

Trial registration number

jRCTs031240007.

Development of a practical guide for patient participation in value-based healthcare: an action research study

Objectives

Value-based healthcare (VBHC) strives to improve the healthcare system by focusing on value of care, that is, patient relevant outcomes relative to the costs for achieving these outcomes. Within VBHC, patient participation is crucial to identify patient relevant outcomes and value improvement potential. However, patient participation in VBHC initiatives remains limited. Therefore, we aimed to improve patient participation within VBHC teams with the ultimate aim to develop a practical guide for patient participation in VBHC.

Design

An action research study.

Setting

This study was conducted in seven collaborating Dutch hospitals from March 2023 to November 2024.

Participants

Seven VBHC teams were selected to participate in the cyclical action research steps, that is, orientation, planning, implementation, and evaluation, in which patient participation was implemented or improved. These included the following patient groups: prostate cancer, vulnerable elderly, breast cancer, diabetes, maternity care, colorectal cancer and chronic kidney disease.

Outcomes

Both qualitative and quantitative data were collected. Qualitative data included observations and minutes of meetings with the intervention teams. Quantitative data included responses to the Public and Patient Engagement Evaluation Tool (PPEET) by multiple members of the intervention (n=7) and control teams (n=94) at three time points (T1=6 months, T2=12 months, T3=end of study). Qualitative data were thematically analysed and quantitative data were analysed descriptively. Finally, the data were triangulated to create an overview of lessons learnt in improving patient participation.

Results

Patient participation goals varied across teams, leading to diverse actions, such as establishing a diabetes patient panel and distributing questionnaires to patients with colorectal cancer. PPEET results show that 71% of intervention team members reported that patient participation had an impact on the team’s outcomes compared with 44% in control teams (T3). Furthermore, 80% of the intervention team members initially wanted training in patient participation (T1), which dropped to 29% at T3. Overall, 22 lessons in improving patient participation in multidisciplinary project teams were identified and compiled into a practical guide.

Conclusions

The action research process improved the process and impact of patient participation in the intervention teams. Furthermore, the results indicate that the action research process enhanced the team members’ knowledge and skills on patient participation. The practical guide developed in this study can be used to support implementation of patient participation in VBHC.

Undisclosed financial conflicts of interest among physician-authors in leading US psychiatry journals: a cross-sectional study

Por: Gesel · F. · Baraldi · J. · Goldhirsh · J. · Piper · B. J.
Objective

To assess the prevalence and magnitude of undisclosed financial conflicts of interest (COIs) among physician-authors in high-impact US-based psychiatry journals.

Design

Cross-sectional study comparing the author self-reported disclosures to the journal(s) with payments mandatorily reported in the Open Payments database.

Methods

We examined original research articles published between 1 January 2020 and 31 December 2022 in two prominent US-based psychiatry journals: the American Journal of Psychiatry (AJP) and Journal of the American Medical Association Psychiatry (JAMA-PSY). Of 2872 publications screened, 74 articles authored by 27 eligible US-based physician-authors met the inclusion criteria.

Outcome measures

Total payments received by authors within the 3 years prior to publication and the proportion of undisclosed payments. Additional analyses assessed payment types (research vs general), author demographics and study characteristics associated with undisclosed COIs.

Results

US$4.54 million was paid to authors in the two journals, of which US$645 135 (14.2%) were undisclosed. AJP authors received US$205 943 (7.5% of total payments) in undisclosed payments, while JAMA-PSY authors received US$439 192 (24.8%). Research payments constituted 82.3% of all undisclosed payments. Total undisclosed payments among the top 10 highest-earning authors accounted for 84.8% (AJP) and 99.6% (JAMA-PSY) of all undisclosed payments to journals. Nearly all undisclosed payments, 96.2%, were made to authors conducting randomised controlled trials.

Conclusions

Substantial undisclosed financial COIs were identified among the top 10 earners in high-impact psychiatry journals. These findings highlight potential risks to research transparency and integrity. Further research is needed to evaluate the effectiveness of disclosure policies and develop mechanisms to mitigate COIs in psychiatric research.

Prioritizing food systems interventions to reduce adolescents nutrition insecurity and malnutrition in low-income settings: protocol for the Dishi Fiti Ishi Fiti (Eat Well Live Well) mixed-methods study

Por: Lee · G. O. · McCormick · B. J. · Staromiejska · W. · Mutuku · V. · Fox · E. L. · Kimenju · S. · Mawa · P. A. · Asiki · G. · Downs · S.
Introduction

Adolescents in informal urban communities, defined as settlements that fall outside of formal governmental planning and regulatory frameworks, are at increasing risk of poor-quality diets and malnutrition in all its forms. The food environment is the interface of adolescent food choice and the broader food system, and food environment interventions have the potential to improve adolescent diets and nutritional outcomes.

Methods and analysis

We will conduct a mixed-methods study, integrating methods from participatory systems science and nutritional epidemiology to characterise linkages among adolescents’ neighbourhood and home food environments, and their food choices, diets and nutritional outcomes. We will recruit adolescents, caregivers, school staff and food system actors from five communities along a gradient of urban informality in Nairobi, Kenya, to participate in cognitive mapping, group-based modelling and a cohort study over one academic year to evaluate dietary choices and nutritional outcomes.

Ethics and dissemination

The study has been approved by the Research Ethics Committee of Rutgers University (Pro2024001981) and Amref Health Africa (P1831-2025). Adult participants will provide written informed consent, and adolescents will provide written informed assent to participate in the study. Findings will be disseminated through peer-reviewed journals, conference presentations and to participants through planned participatory interaction throughout the study.

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