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Efficacy and moderators of cognitive behavioural therapy versus interpersonal psychotherapy for adult depression: study protocol of a systematic review and individual participant data meta-analysis

Por: Lin · T. · Cohen · Z. D. · Stefan · S. · Soflau · R. · Fodor · L. A. · Georgescu · R. · Bruijniks · S. J. E. · Lemmens · L. · Bagby · M. · Quilty · L. · Ekeblad · A. · Holmqvist · R. · Evans · J. · OMahen · H. A. · Johnson · J. E. · Zlotnick · C. · Hilpert · P. · Carter · J. · McBride · C.
Introduction

Cognitive behavioural therapy (CBT) and interpersonal psychotherapy (IPT) are both efficacious treatments for depression, but it is less clear how both compare on outcome domains other than depression and in the longer term. Moreover, it is unclear which of these two psychotherapies works better for whom. This article describes the protocol for a systematic review and individual participant data (IPD) meta-analysis that aims to compare the efficacy of CBT and IPT for adults with depression on a range of outcomes in both the short and long term, and to explore moderators of the treatment effect. This study can enhance our understanding of treatments for depression and inform treatment personalisation.

Methods and analysis

Systematic literature searches will be conducted in PubMed, PsycINFO, EMBASE and the Cochrane Library from inception to 1 January 2026, to identify randomised clinical trials (RCTs) comparing CBT and IPT for adult depression. Researchers of eligible studies will be invited to contribute their participant-level data. One-stage IPD meta-analyses will be conducted with mixed-effects models to examine (a) treatment efficacy on all outcome measures that are assessed at post-treatment or follow-up in at least two studies, and (b) various baseline participant characteristics as potential moderators of depressive symptom level at treatment completion.

Ethics and dissemination

Ethical approval is not required for this study since it will be based on anonymised data from RCTs that have already been completed. The findings of the present study will be disseminated through a peer-reviewed journal or conference presentation.

Development and validation of a postoperative risk calculator (POP-score) for patients undergoing cardiac surgery: a retrospective cohort study

Por: Pölzl · L. · Sutter · C. · Lohmann · R. · Eder · J. · Ioannou-Nikolaidou · M. · Engler · C. · Graber · M. · Naegele · F. · Hirsch · J. · Maier · S. · Ulmer · H. · Mathis · S. · Reinstadler · S. J. · Grimm · M. · Bonaros · N. · Holfeld · J. · Gollmann-Tepeköylü · C.
Objectives

This study aimed to identify intraoperative and perioperative factors influencing 30-day mortality after cardiac surgery and to develop a risk score (POP-score) for its prediction.

Design

Retrospective cohort study with multivariable regression analysis.

Setting

A tertiary care cardiac surgery centre in Austria; data from consecutive patients undergoing cardiac surgery between 2010 and 2020 were analysed.

Participants

A total of 8072 patients were included. The cohort was randomly divided into a derivation cohort (75%) and a validation cohort (25%).

Outcome measures

The primary outcome measure was 30-day mortality. We analysed associations between intraoperative and perioperative variables and 30-day mortality, assessed via multivariable regression analysis.

Results

Several factors were significantly associated with 30-day mortality, including intraoperative RBC transfusion (OR 3.407 (95% CI 2.124–5.464)), postoperative high-sensitive cardiac troponin T cut-off levels (OR 2.856 (95% CI 1.958 to 4.165)), need for dialysis/haemofiltration (OR 2.958 (95% CI 2.013 to 4.348)) and temporary extracorporeal membrane oxygenation support (OR 5.218 (95% CI 3.329 to 8.179)) (p

Conclusions

The validated POP-score provides an improved tool for predicting 30-day mortality after cardiac surgery by incorporating intraoperative and perioperative factors alongside the EuroSCORE II. Although model performance was evaluated using 7-day peak troponin data, the score can be calculated within the first 72 hours postoperatively in most patients, supporting its clinical applicability for early decision-making, resource allocation and patient counselling. Further research is warranted to assess its clinical utility in diverse populations.

How do musculoskeletal disorders impact on quality of life in Tanzania? Results from a community-based survey

Por: Grieve · E. · Deidda · M. · Krauth · S. J. · Biswaro · S. M. · Halliday · J. E. B. · Hsieh · P.-H. · Kelly · C. · Kilonzo · K. · Kiula · K. P. · Kolimba · R. · Msoka · E. F. · Siebert · S. · Walker · R. · Yongolo · N. M. · Mmbaga · B. · McIntosh · E. · NIHR Global Health Group · Biswaro
Objectives

There are little available data on the prevalence, economic and quality of life impacts of musculoskeletal disorders in sub-Saharan Africa. This lack of evidence is wholly disproportionate to the significant disability burden of musculoskeletal disorders as reported in high-income countries. Our research aimed to undertake an adequately powered study to identify, measure and value the health impact of musculoskeletal conditions in the Kilimanjaro region, Tanzania.

Design

A community-based cross-sectional survey was undertaken between January 2021 and September 2021. A two-stage cluster sampling with replacement and probability proportional to size was used to select a representative sample of the population.

Setting

The survey was conducted in 15 villages in the Hai District, Kilimanjaro region, Tanzania.

Participants

Economic and health-related quality of life (HRQOL) questionnaires were administered to a sample of residents (aged over 5 years old) in selected households (N=1050). There were a total of 594 respondents, of whom 153 had a confirmed musculoskeletal disorder and 441 matched controls. Almost three-quarters of those identified as having a musculoskeletal disorder were female and had an average age of 66 years.

Primary and secondary outcome measures

Questions on healthcare resource use, expenditure and quality of life were administered to all participants, with additional more detailed economic and quality of life questions administered to those who screened positive, indicating probable arthritis.

Results

There is a statistically significant reduction in HRQOL, on average 25% from a utility score of 0.862 (0.837, 0.886) to 0.636 (0.580, 0.692) for those identified as having a musculoskeletal disorder compared with those without. The attributes ‘pain’ and ‘discomfort’ were the major contributors to this reduction in HRQOL.

Conclusions

This research has revealed a significant impact of musculoskeletal conditions on HRQOL in the Hai district in Tanzania. The evidence will be used to guide clinical health practices, interventions design, service provisions and health promotion and awareness activities at institutional, regional and national levels.

Which way? Group-based smoking and vaping cessation support for Aboriginal and Torres Strait Islander women: protocol for a non-randomised type 1 hybrid implementation study

Por: Booth · K. · Bryant · J. · Maddox · R. · Ridgeway · T. · Maidment · S. · Martiniuk · A. L. · Chamberlain · C. · Eades · S. J. · Burchill · L. J. · Belfrage · M. · Bennett · J. · Doran · C. · Collis · F. · Mills · Z. · Foster · J. · Mersha · A. G. · Roberts-Barker · K. · Oldmeadow · C. · Lo
Introduction

Tobacco use is the most significant modifiable risk factor for adverse health outcomes, and early research indicates there are also significant harms associated with vaping. National targets aim to reduce smoking and vaping during pregnancy for Aboriginal and Torres Strait Islander people. While most Aboriginal and Torres Strait Islander people want to quit, cessation is frequently attempted without support, increasing the chance of relapse. Group-based smoking cessation programmes increase quit success by 50%–130% in the general population; however, they have never been evaluated in Aboriginal and/or Torres Strait Islander communities.

Methods and analysis

The Gulibaa study is an Indigenous-led and community-embedded project that will co-design, implement and evaluate a group-based model of care to support Aboriginal and Torres Strait Islander women to be smoke- and vape-free. Staff of Health Services in New South Wales, Australia, will receive training to deliver a face-to-face group-based smoking and vaping cessation intervention. Aboriginal and/or Torres Strait Islander people who identify as a woman or non-binary, are pregnant or of reproductive age (16 to 49 years), currently smoke or vape at least once per day and are willing to attend the programme are eligible to participate. Up to 500 participants will be recruited. A mixed method evaluation approach will be implemented guided by the RE-AIM framework. Outcomes will include intervention reach, intervention effectiveness (determined primarily by self-reported 7-day point prevalence abstinence at 6 months follow-up), acceptability and feasibility of the intervention, programme fidelity and maintenance and cost effectiveness.

Ethics and dissemination

Embedding culturally safe support to quit during pregnancy can result in improved outcomes for both mother and child and immediately improve intergenerational health and well-being. Ethics approval has been provided by the Aboriginal Health and Medical Research Council and the University of Newcastle. Study findings will be disseminated to Aboriginal and Torres Strait Islander communities in ways that are meaningful to them, as well as through Aboriginal health services, key national bodies, relevant state and federal government departments.

Trial registration number

ACTRN12625001050448.

Association between glucosamine use and albuminuria in the UK: a cohort and Mendelian randomisation study

Por: Hayward · S. J. · Constantinescu · A. · Hazelwood · E. · Butler · M. J. · Vincent · E. E. · Satchell · S. C.
Background

Glucosamine is a commonly used ‘over the counter’ dietary supplement. Previous research has identified an association between glucosamine use and several positive health outcomes. However, a plausible biological mechanism for these associations has not yet been identified, meaning the causality of these relationships remains unclear. A protective effect of glucosamine on the vascular endothelium has been suggested as one such possible mechanism. Albuminuria is an early marker of endothelial dysfunction within the kidney and is associated with progression of kidney disease and adverse cardiovascular outcomes. In order to provide insights into the potential biological mechanisms underlying a protective association of glucosamine use with health outcomes, we evaluated evidence for an association between glucosamine use and albuminuria in UK Biobank (N=436 200).

Methods

Univariable and multivariable ordinal logistic regression were performed to evaluate evidence for an association between self-reported glucosamine use and albuminuria (measured as urine albumin creatinine ratio (uACR) categories). As a secondary analysis, we performed Mendelian randomisation (MR) to demonstrate the difficulties in inferring causality in this relationship using currently available data, using summary genetic data from UK Biobank and CDKGen (N=67 452).

Results

We found that people who used glucosamine were more likely to be in a lower uACR group (OR 0.81, 95% CI 0.80 to 0.83, px10–16). This association was robust to sensitivity analyses and was maintained after adjustment for age, sex and measures of obesity. In our MR analysis, we found little evidence for an association of genetically proxied glucosamine use on albuminuria (change in log uACR (mg/g) per SD change in genetic liability=1.11, 95% CI –3.01 to 5.23, p=0.60).

Conclusions

We found that detectable albuminuria was common in UK Biobank participants and we are the first to show that use of glucosamine supplements was associated with lower levels. Though this fits with a plausible biological role of the vascular endothelium in a potential protective effect of glucosamine use on many health outcomes, whether this relationship is causal or confounded remains unclear. We further discuss the inherent difficulties in using genetic instruments to proxy supplement use in MR analyses and highlight the need for a genome-wide association study of measured circulating glucosamine levels.

Testing psychosocial work adversities as a necessary condition for work-related emotional exhaustion in young workers: a cross-sectional necessary condition analysis on a national general working population-based survey

Por: Schelvis · R. M. C. · van Veen · M. · Tamminga · S. J. · Oude Hengel · K. M. · Nieuwenhuijsen · K. · Boot · C. R. L. · Dul · J.
Objectives

Being exposed to adverse psychosocial working conditions contributes to poor mental health in young workers. This study explores whether psychosocial work adversities are a necessary condition for work-related emotional exhaustion in young workers.

Design

Data from the ‘Netherlands Working Condition Survey 2021’ was used. By applying a novel method called Necessary Condition Analysis, we tested two psychosocial work adversities as necessary conditions for high work-related emotional exhaustion in young workers: (1) a composite score of high job demands and low job resources and (2) a composite score of high job demands. Additionally, we tested whether the threshold for job demands as a necessary condition for high work-related emotional exhaustion differed for young workers with low versus high resources.

Setting

Secondary data analysis on a national working population-based survey.

Participants

The sample included 5791 young workers in the Netherlands (aged

Primary outcome measure

Work-related emotional exhaustion.

Results

A high level of the composite on job demands and job resources is necessary for a high level of work-related emotional exhaustion in young workers (effect size=0.11, p

Conclusions

Both psychosocial work adversities were necessary conditions for high work-related emotional exhaustion in young workers. The necessity threshold for job demands was higher for young workers with high job resources, compared with the group with low resources. This indicates that removing psychosocial work adversities and ensuring the presence of job resources might contribute to the prevention of high work-related emotional exhaustion in young workers.

Do opportunities exist to improve the use of the WHO Surgical Safety Checklist in cardiology and cardiothoracic surgery? Perspectives of patients and staff in a multimethod study in New Zealand

Por: Jowsey · T. · Ward · K. · Baradi · A. · Gargiulo · D. · Henderson · K. · Mitchell · S. J. · Moore · M. · Somaratne · J. · Merry · A. F.
Objectives

The WHO Surgical Safety Checklist (SSC) can improve patient outcomes through checks and enhancing the safety climate, provided the team engage. Patients are central to that team and may be awake during part or all of many procedures. Their greater inclusion in the SSC process could enhance its checking objectives by using patient knowledge of details relevant to proposed procedures, and its objective of improving culture by emphasising patient identity, seeing patients as individuals rather than items on a production line. We aimed to evaluate SSC use, including clinicians’ and patients’ perspectives, in cardiothoracic operating rooms (CTORs) and cardiac catheterisation laboratories (CCLs), and to identify opportunities to refine its use in these spaces.

Design

We undertook a multimethod study based on positivism and interpretivism, with evaluation of SSC administration and interviews. We evaluated SSC administration during 20 Sign Ins, 20 Time Outs and 20 Sign Outs in CTORs and 20 Time Outs in CCLs (11 coronary angiography and 9 electrophysiology cases) using the WHO Behaviourally Anchored Rating Scale (WHOBARS, 1–7, where higher scores indicate better practice). We additionally interviewed 10 clinicians and 17 patients about their experiences and perceptions of safety and SSC use. We undertook thematic analysis of interview data.

Setting

CTORs and CCLs in an Auckland public hospital.

Participants

We observed 171 clinicians during 20 cases. We interviewed 10 clinicians (Pakeha/New Zealand/European n=6; male n=5; doctor n=5). We interviewed 17 patients (Pakeha/New Zealand/European n=12; male n=10; age range 45–81 years).

Results

In CTORs, the SSC was used in full: median (IQR) WHOBARS score was 5.9 (5.2, 6.5). In CCLs, its use differed between electrophysiology and angiography CCLs: median (IQR) WHOBARS score was 4.50 (3.2, 5.6). In both CTORs and CCLs, high levels of carefulness and respect between team members were observed. Clinicians described the SSC as valuable and identified context-related reasons for variations in its use. Patients wanted to feel cared for and respected (including culturally). The SSC contributed positively to this. Clinicians expressed reservations about increasing patients’ involvement with the SSC. However, patients’ comments supported their increased engagement in the SSC process (including establishing their preferred names).

Conclusions

The SSC is used at Auckland City Hospital with some variation between services and with high levels of carefulness and respect. The SSC increased patients’ sense of being cared for. With modification (eg, by verifying their preferred name during the Sign In phase), the SSC could enhance patients’ perception of being seen as individuals, their cultural safety and the safety climate in operating and procedure rooms, and hence potentially improve patient outcomes. Our findings reinforce the value of regular evaluation and context-relevant modification of SSC for its effective use.

From obstruction to ischaemia: a systematic review and meta-analysis on the diagnostic accuracy of CT scans in identifying small and large bowel obstruction, underlying causes and predicting critical complications in adults

Por: Ahmad · S. J. S. · Drvaric · I. · Ahmed · A. R. · Jakob · D. · Kyriazidis · I. P. · Pouwels · S. · Hajibandeh · S. · Tang · A. · Cripps · P. · Yang · W. · Parmar · C. · Kermansaravi · M. · Abdelwahed · A. · Gelber · E. · Lala · A. · Whiteley · G. · Wilkinson · D. · Agarwal · A. · Pritchard
Objectives

To evaluate the diagnostic accuracy of CT in identifying small and large bowel obstruction and associated complications, including ischaemia and perforation, in adult patients.

Design

Systematic review and meta-analysis reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses of Diagnostic Test Accuracy reporting guidelines.

Data sources

Ovid MEDLINE and Embase were searched from 1946 to 20 February 2025.

Eligibility criteria

The study included randomised controlled trials, cohort studies and case–control studies evaluating the diagnostic accuracy of CT for bowel obstruction in adults (aged ≥18 years). Only studies published in English were included. Conversely, case reports, editorials, conference abstracts without full data and studies focusing exclusively on paediatric populations or animal models were excluded.

Data extraction and synthesis

Three reviewers independently extracted data on study characteristics, CT modality, diagnostic accuracy metrics (sensitivity, specificity and predictive values) and complications. Risk of bias was assessed using the QUADAS-2 tool. A random-effects meta-analysis was conducted. Heterogeneity was assessed using I² and Tau² statistics.

Results

Sixty-five studies with 9418 patients were included. The pooled sensitivity and specificity of CT for bowel obstruction were 90% (95% CI 78 to 96; I²=56%, Tau²=0.36) and 88.8% (95% CI 78.0 to 94.8; I²=65%, Tau²=0.35), respectively. For bowel ischaemia, CT showed a pooled sensitivity of 47.0% (95% CI 32.4 to 59.9; I²=0%, Tau²=0.00) and specificity of 85.3% (95% CI 77.9 to 89.5; I²=1%, Tau²=0.45). Multidetector CT (MDCT) outperformed older modalities across all endpoints. Ischaemia was present in 22.05% of all cases, with higher rates in small bowel obstruction. Perforation and mortality rates were 3.98% and 4.40%, respectively. No significant publication bias was detected, and the certainty of evidence was graded as moderate for most diagnostic accuracy outcomes.

Conclusions

CT, particularly MDCT, offers high diagnostic accuracy for bowel obstruction and is a critical tool for detecting serious complications such as ischaemia and perforation. However, sensitivity for ischaemia remains modest. Standardised protocols and prospective studies are needed to enhance early identification and optimise care pathways.

Multicancer early detection in a cohort of patients with confirmed and suspected cancer by measuring plasma amino acid cross sections with the Enlighten test: MODERNISED protocol

Por: Wilding · S. · Goss · V. · Sukdao · W. · Hamady · Z. · Lord · J. · Coleman · A. · Pointer · C. · Walters · J. · Herbert · W. · Mclaughlin · K. · Waugh · R. · Irvine · N. · Oliver · T. · Soulsby · I. · Hooper · J. · Crabb · S. J. · Griffiths · G. · Yates · E. · Davies · A.
Introduction

Detecting cancer earlier improves treatment options and long-term survival. A multicancer early detection test that reliably picks up early-stage cancer would potentially save lives and reduce the cost of treating cancer. One promising candidate is the Enlighten test, which applies machine learning to plasma amino acid concentrations to detect cancer. In a cohort of 77 patients recently diagnosed with breast, colorectal, pancreatic or prostate cancer, 60 (78%) were detected by the test (sensitivity), with no false positives in 20 healthy controls. The MODERNISED study will further develop the Enlighten test to detect 10 different cancers by adding bladder, lung, melanoma, oesophageal, ovarian and renal cancer to the test.

Methods and analysis

MODERNISED (ISRCTN17299125) is a multicentre prospective, non-interventional, case–control study. We aim to recruit 1000 adult participants with a recent cancer diagnosis, 250 adult participants with symptoms of cancer where a cancer diagnosis was ruled out by the National Health Service (NHS) standard of care and 100 healthy adult volunteers. Cancer tissue of origin (ToO) will include bladder, breast, colorectal, lung, melanoma, oesophageal, ovarian, pancreatic, prostate and renal. Participants in the two non-cancer cohorts who are later diagnosed with cancer will be moved to the cancer cases cohort. The primary aim is to train and validate a machine learning algorithm to detect cancer, which will be evaluated by AUROC. Secondary aims include training and validating an algorithm to predict ToO and stage of cancer, exploring differences in performance by demographics and estimating how sensitivity varies across specificity cut-offs of 95%, 99% and 99.9%. These results will provide a statistically powered estimate of how well the Enlighten test can discriminate between individuals with and without cancer, which can then be validated for clinical use in further research.

Ethics and dissemination

This study is sponsored by University Hospital Southampton NHS Foundation Trust and has been approved by the Health Research Authority and Health and Care Research West Midlands (24/WM/0234). Results will be presented at scientific meetings and published in international peer-reviewed journals. Lay summaries of study progress and findings will be published on the Southampton Clinical Trial Unit’s website.

Trial registration number

ISRCTN17299125.

Characterisation of the bacterial and archaeal microbiota in fresh colostrum collected from a single, spring-calving dairy herd

by Sabine Scully, Bernadette Earley, Paul E. Smith, Matthew S. J. Finnie, Catherine McAloon, Frank Buckley, David A. Kenny, Sinéad M. Waters

There is increasing evidence to support the existence of a naturally occurring colostral microbiome, which may influence the development of the gastrointestinal microbiota and immune function of the calf. The objective of this study was to characterize the prokaryotic community of colostrum collected fresh (within 2h parturition) from primi- and multiparous Holstein-Friesian (n = 17) and Jersey (n = 10) cows. Extracted microbial DNA underwent qPCR and Illumina amplicon sequencing of the V4 region of the 16S rRNA gene. High throughput amplicon sequencing data was analysed using a variety of R packages. Taxonomy was assigned using the SILVA database (v. 138.1). No effect of breed or parity was observed on alpha (α; Shannon) diversity and community composition. The mean Shannon score was 3.33 (SE 0.14), indicating a diverse community within sample. A total of 681 genus-level amplicon sequence variant (ASV) groups were identified prior to filtering for relative abundance (RA) of >0.05%. Nineteen bacterial genera were identified as core. The predominant bacterial phyla observed were Bacillota, Pseudomonadota, and Actinomycetota. Community membership consisted of common gut commensals, with many members exhibiting diverse metabolic functions. Within the archaeal community, Methanobrevibacter had the highest RA, accounting for 85.99%. No observed differences between breeds suggests that farm origin may be more influential than breed on microbiota composition. The presence of archaea and strict anaerobes highlights the need to investigate the existence of an entero-mammary pathway in cattle. This is the first study jointly characterising bacteria and archaea in colostrum from different breeds from the same dairy herd under pasture-based conditions. The diverse bacterial community observed warrants further investigation into its role in calf health in early life. Specific microbes, like Lachnospiraceae, should be investigated for their potential in the development of probiotics and preventative practices for better calf health.

Emerging concepts and practices in health disparities implementation science in the United States: a scoping review protocol

Por: Earland · D. E. · Andreae · L. J. · Austin · J. D. · Gollust · S. E. · Japuntich · S. J. · Theis-Mahon · N. · Reardon · E. · Abdikeir · K. · Crusan · A. · Overcash · F. · Allen · M. L.
Introduction

Implementation science research increases the uptake of evidence-based interventions, which may improve health equity among racial and ethnic minorities. However, it is unclear how anti-racism and anti-colonialism practices have been integrated into implementation science research. The objectives of this scoping review are to describe the current conceptualisations of racism and colonialism within the USA, examine racism or colonialism-conscious approaches and analyse gaps in the operationalisation of anti-racism or anti-colonialism within implementation science studies.

Methods and analysis

This scoping review will be conducted following the Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for scoping reviews guidelines. The Center for Chronic Disease Reduction and Equity Promotion Across Minnesota conceptual framework and an implementation science anti-racism lens will guide the study design and analysis. To determine study eligibility for the scoping review, articles will undergo abstract and full-text screening by two independent reviewers and discrepancies will be settled together. Data charting will be extracted from included articles by eight independent reviewers. The search strategy will use controlled vocabulary and natural language keywords related to health equity, health disparities and anti-racism/colonialism on six databases. The scoping review will include studies that applied implementation science theories, models or frameworks among US-based populations. Additionally, included studies will report any of the following implementation activities: implementation strategies, implementation outcomes, adaptations to evidence-based interventions, or evaluations of pre-implementation or implementation context.

Ethics and dissemination

No ethical approval was required for the scoping review. Dissemination will be through publication in a peer-reviewed journal and conference presentations.

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

Por: Moss · S. J. · Zuniga Chacon · C. · Hekmati · F. B. · Siddiqui · S. A. · Stelfox · M. · Ahmed · S. B. · Birnie · K. · Halperin · D. · Halperin · S. A. · Tutelman · P. R. · Stelfox · H. T. · Fiest · K. M. · Parsons Leigh · J.
Introduction

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

Methods and analysis

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

Ethics and dissemination

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

Bridging the gap: development of a methodology for retrieving and harmonising body mass index (BMI) from population-level linked electronic health records

Por: Childs · M. J. · Aldridge · S. J. · Daniels · H. · Davies · G. I. · Best · V. · Abbasizanjani · H. · Lyons · R. · Akbari · A. · Torabi · F.
Objective

This study aims to develop a methodology to retrieve, harmonise and evaluate the completeness of national body mass index (BMI) data from linked electronic health record (EHR) sources to build a longitudinal research-ready data asset (RRDA).

Design

A longitudinal study of BMI records spanning 23 years (1 January 2000 to 31 December 2022) from four data sources.

Setting

The national BMI RRDA is created within the Secure Anonymised Information Linkage (Databank), encompassing the entire population of Wales, UK.

Procedure and participants

We built a methodology that provides a reproducible framework for extracting and harmonising BMI data from four major linked EHRs across two age groups: children and young people (CYP; 2–18 years old) and adults (19 years and older). The methodology is adaptable across different trusted research environments. We evaluated the completeness and retention of records over 1-, 5- and 23-year periods by calculating the proportion of missing data relative to each year’s population.

Results

We retrieved 53.4 million records for 3.2 million individuals across Wales from 1st January 2000 to 31 December 2022. Among these, 3% of CYP and 34% of adults had repeat BMI measurements recorded over periods ranging from 5 to 23 years. Throughout the entire population of Wales during this period, 49% of CYP and 26% of adults had at least one BMI reading recorded, resulting in a missingness rate of 51% for CYP and 74% for adults. Preserving BMI information by retaining the most recently recorded BMI over 1-, 5- and 23-year intervals from 2022 showed coverage rates of 10%, 33% and 68%, respectively, for CYP, and 25%, 51% and 73%, respectively, for adults.

Conclusions

Our findings highlight substantial variations in BMI data availability and retention across CYP and adults, as well as time periods within EHR in Wales. Wider adoption of this approach can enhance standardised approaches in using accessible measures like BMI to assess disease risk in population-based studies, strengthening public health initiatives and research efforts.

Improving reproducibility of data analysis and code in medical research: 5 recommendations to get started

Por: Streiber · A. M. · Hoepel · S. J. W. · Blok · E. · van Rooij · F. J. A. · Neitzel · J. · Labrecque · J. · Ikram · M. K. · Bos · D.

Due to the growing use of high-dimensional data and methodological advances in medical research, reproducibility of research is increasingly dependent on the availability of reproducible code. However, code is rarely made available and too often only partly reproducible. Here, we aim to provide practical and easily implementable recommendations for medical researchers to improve the reproducibility of their code. We reviewed current coding practices in the population-based Rotterdam Study cohort. Based on this review, we formulated the following five recommendations to improve the reproducibility of code used in data analysis: (1) make reproducibility a priority and allocate time and resources; (2) implement systematic code review by peers, as it further strengthens reproducibility. We provide a code review checklist, which serves as a practical tool to facilitate structured code review; (3) write comprehensible code that is well-structured; (4) report decisions transparently, for instance by providing the annotated workflow code for data cleaning, formatting and sample selection; and (5) focus on accessibility of code and data and share both, when possible, via an open repository to foster accessibility. Ideally, this repository should be managed by the institution and should be accessible to everyone. Based on these five recommendations, medical researchers can take actionable steps to improve the reproducibility of their research. Importantly, these recommendations are thought to provide a practical starting point for enhancing reproducibility rather than mandatory guidelines.

Challenges of using and managing medication: a meta-ethnography of the experiences and perceptions of people with intellectual disability and people who support them

Por: Ghosh · I. · Adams · D. · Auguste · P. · Brown · A. · Chaplin · E. · Flynn · S. · Gauly · J. · Gill · P. · Langdon · P. E. · Mahon · D. · Martin · K. · Patterson · S. · Sutherland · D. · Tromans · S. J. · Chen · Y.-F. · Seers · K. · Supporting Medication use In people with a LEarning d
Objective

To explore the challenges experienced by people with intellectual disability, their carers and health and social care professionals when using and managing medication.

Design

A synthesis of qualitative research using meta-ethnography.

Data source

We searched seven databases: MEDLINE, Embase, CINAHL, Science, Social Science and Conference Proceedings Citation Indices (Web of Science), Cochrane Library, PsycINFO and Proquest Dissertations and Theses from inception to September 2022 (updated in July 2023).

Eligibility criteria for selecting studies

We included studies exploring the challenges and perceptions of people with intellectual disability, their carers and health and social care professionals regarding medication management and use.

Results

We reviewed 7593 abstracts and 475 full texts, resulting in 45 included papers. Four major themes were identified: (1) Medication-related issues, (2) navigating autonomy and relationships, (3) knowledge and training needs and (4) inequalities in the healthcare system. We formulated a conceptual framework centred around people with intellectual disability and described the interconnectedness between them, their carers and health and social care professionals in the process of managing and using medication. We identified challenges that could be associated with the person, the medication and/or the context, along with a lack of understanding of these challenges and a lack of capability or resources to tackle them. We developed an overarching concept of ‘collective collaboration’ as a potential solution to prevent or mitigate problems related to medication use in people with intellectual disability.

Conclusions

The effective management of medication for people with intellectual disability requires a collaborative and holistic approach. By fostering person-centred care and shared decision-making, providing educational and practical support, and nurturing strong relationships between all partners involved to form a collective collaboration surrounding people with intellectual disability, improved medication adherence and optimised therapeutic outcomes can be achieved.

PROSPERO registration number

CRD42022362903.

The clinical application of shared decision-making in emergency surgery: a scoping review protocol

Por: Bisset · C. N. · Keane · C. · McKee · T. · John-Charles · R. · Wells · C. I. · Moug · S. J.
Introduction

Shared decision-making (SDM) between clinicians and patients is considered ‘best practice’. There is limited evidence regarding SDM in surgery, particularly in the emergency setting. Emergency SDM may be particularly challenging due to: time pressures, the patient’s underlying condition and the nature of the patient-surgeon interaction. However, emergency surgery arguably has a greater need for SDM due to the likelihood of disparate outcomes from intervention, which is dependent on the various treatment options available. This is necessary for patients to make informed decisions regarding their treatment of surgical pathology. The primary objective of this scoping review is to understand the extent and type of evidence in relation to SDM in emergency surgery to determine methods for improving SDM.

Methods

Any studies reporting SDM in emergency surgery on adult patients (age >18 years) will be included. EMBASE, Medline, Cochrane, CINAHL and Scopus databases will be searched for articles with no language or date limits. Studies will be screened by two independent reviewers, with consensus met prior to data extraction. Data extracted to include study design, details of study population, tools used to measure SDM, prevalence of SDM and barriers and enablers for SDM.

A systematic narrative synthesis will be performed following JBI (Joanna Briggs Institute) guidance. These will summarise findings of included studies. The findings may inform future research into facilitating implementation of SDM in emergency surgery.

Ethics and dissemination

This study does not require ethical approval. Final findings will be submitted for peer-reviewed publication and presentation at surgical conferences.

Developing an approach to enhance recruitment for a cluster-randomised implementation trial: leveraging deliberative participation and credible messengers

Por: Vaughn · V. M. · Horowitz · J. · Gandhi · T. · Neetz · R. A. · Petty · L. · Hersh · A. · Lindenauer · P. · Bernstein · S. J. · Flanders · S. A. · Harrison · J. D. · Smith · J. D. · White · A. T. · Szymczak · J. E.
Objectives

To evaluate an innovative approach to recruit 40 hospitals to a cluster randomised controlled trial (RCT) to improve discharge antibiotic prescribing.

Design

This study describes the design, implementation and impact of a theory-informed recruitment approach for hospitals participating in the Reducing Overuse of Antibiotics at Discharge (ROAD) Home trial.

Setting

An inperson meeting of a quality improvement collaborative of acute care hospitals in the state of Michigan.

Participants

Representatives from acute care hospitals that are part of the Michigan Hospital Medicine Safety Consortium.

Interventions

Small group recruitment sessions that combined deliberative participation and credible messengers to recruit hospitals to participate in a cluster RCT on a single date (1 November 2023).

Primary and secondary outcomes

The primary outcome was the number of hospitals which agreed to participate in the trial. We also assessed participant feedback, effectiveness of recruitment methods and resources required for implementation of this approach.

Results

We recruited 51 (74%) of 69 eligible hospitals. Survey participants reported: sessions made clear the purpose of the trial (94%, 64/68) and time commitment required (87%, 59/68); agreed deliberative participation was helpful (82%, 56/68) and were ‘very satisfied’ with the session (82%, 56/68). Investigators largely reported credible messengers were a positive influence, though this varied across sessions. Hospital recruitment was time intensive, taking 179.5 total person hours. The recruitment process involved 3 months of preparation for the sessions and 2 months of follow-up prior to closing recruitment.

Conclusions

We demonstrated the feasibility and impact of a novel approach to recruit hospitals from an existing collaborative to a cluster RCT using the principles of deliberative participation and credible messengers. While the approach was time-consuming, we achieved success at over-recruiting hospitals in a relatively short period of time. Strategies presented here may assist future trial organisers in implementing hospital-based cluster RCTs.

Trial registration number

The ROAD Home trial is registered on Clinical.Trials.gov (NCT06106204).

Tirzepatide for the treatment of adults living with concurrent type 1 diabetes and overweight or obesity (TZP-T1D): a double-blind, placebo-matched randomised controlled trial protocol

Por: Purcell · A. R. · Rodrigo · N. · Longfield · M. S. G. · Glastras · S. J.
Introduction

The increasing prevalence of overweight and obesity among individuals with type 1 diabetes (T1D) complicates glycaemic management and escalates insulin resistance, necessitating innovative therapeutic strategies. Tirzepatide, a dual agonist for glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide receptors, shows promise in managing weight and glycaemic control in type 2 diabetes but is unexplored in the context of T1D. This double-blind, placebo-controlled randomised trial will evaluate the efficacy of tirzepatide in adults with T1D and overweight/obesity over 32 weeks.

Methods and analysis

60 participants (aged 18–70 years) with a body mass index ≥27 kg/m2 and HbA1c≤10% will be randomised 1:1 to receive either tirzepatide or a placebo, alongside standard insulin therapy. The primary outcome is the change in body weight (%). Secondary measures include change in HbA1c (%), proportion of body weight lost (>5%, >10%, >15% and >20%), changes in insulin dosage, time in range by continuous glucose monitoring (CGM) criteria and severity of comorbidities. Compliance, adverse events and medication interactions will be closely monitored, with adjustments made for tolerability. Patient-reported outcomes and experiences will be measured to capture the benefits of glycaemic management, weight management and quality of life. To compare the means of body weight reduction (%) between the tirzepatide and control groups, an independent samples t-test will be employed under the assumption that data are normally distributed. Secondary outcome measures will be analysed by Student’s t-test. All data will be reported as group means with confidence intervals, with default statistical significance assumed at p

Ethics and dissemination

Ethical approval has been obtained from the Northern Sydney Local Health District’s Human Research Ethics Committee (approval ID #2024/ETH00180).

Trial registration number

NCT06180616.

Two years and counting: a prospective cohort study on the scope and severity of post-COVID symptoms across diverse patient groups in the Netherlands--insights from the CORFU study

Por: Klein · D. O. · Waardenburg · S. F. · Janssen · E. B. N. J. · Wintjens · M. S. J. N. · Imkamp · M. · Heemskerk · S. C. M. · Birnie · E. · Bonsel · G. J. · Warle · M. C. · Jacobs · L. M. C. · Hemmen · B. · Verbunt · J. · van Bussel · B. C. T. · van Santen · S. · Kietelaer · B. L. J.
Importance

Little research has been done on post-COVID symptoms at 24 months postinfection and on the association these may have on health-related quality of life (HRQOL).

Objective

We assessed the prevalence and severity of post-COVID symptoms and quantified EuroQol 5 Dimension 5 Level (EQ-5D-5L), self-perceived health question (EuroQol Visual Analogue Scale (EQ-VAS)) and health utility scores (HUS) up to 24 months follow-up.

Design

The longitudinal multiple cohort CORona Follow-Up (CORFU) study combines seven COVID-19 patient cohorts and a survey among the general public. The participants received questionnaires on several time points. Participants were stratified by: without a known SARS-CoV-2 infection (control group), proven SARS-CoV-2 infection but non-hospitalised, proven SARS-CoV-2 infection hospitalised to the ward, and proven SARS-CoV-2 infection hospitalised to the intensive care unit (ICU).

Setting

In this study, data of seven COVID-19 patient cohorts and a survey among the general public are included.

Participants

Former COVID-19 patients and controls participated in this cohort study.

Main outcomes and measures

Former COVID-19 patients and non-COVID-19 controls were sent questionnaires on symptoms associated with post-COVID condition. The CORFU questionnaire included 14 symptom questions on post-COVID condition using a five-level Likert-scale format. Furthermore, HRQOL was quantified using the EuroQol EQ-5D-5L questionnaire: EQ-VAS and the EQ-5D-5L utility score. The EQ-5D-5L questionnaire includes five domains that are scored on a five-point Likert scale: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

Results

A total of 901 participants (and 434 controls) responded at 24 months follow-up. In all former COVID-19 patients, the presence of post-COVID condition at 24 months was observed in 62 (42.5%, 95% CI 34.3% to 50.9%) of the non-hospitalised patients, 333 (65.0%, 95% CI 60.7% to 69.2%) of the hospitalised ward patients and 156 (63.2%, 95% CI 56.8% to 69.2%) of the ICU patients, respectively (p

Conclusions

Many former COVID-19 patients experience post-COVID symptoms at 24 months follow-up, with the highest prevalence in hospitalised participants. Also, former patients reported a lower HRQOL.

Trial registration number

The CORFU study was registered at clinicaltrials.gov (registration number NCT05240742).

Randomised controlled trial to measure effectiveness and cost-effectiveness of a digital social intervention promoted by primary care clinicians to adults with asthma to improve asthma control: protocol

Por: Karampatakis · G. D. · Wood · H. E. · Griffiths · C. J. · Taylor · S. J. · Toffolutti · V. · Bird · V. J. · Lea · N. C. · Ashcroft · R. · Coulson · N. S. · Panzarasa · P. · Li · X. · Sheikh · A. · Relton · C. · Sastry · N. · Watson · J. S. · Mant · J. · Marsh · V. · Day · B. · Mihaylova · B
Introduction

In the UK, approximately 5.4 million adults live with asthma, of whom one in five have an uncontrolled form. Uncontrolled asthma reduces quality of life and increases healthcare use. Engaging with peers through online health communities (OHCs) can empower patients to self-manage their long-term condition. While OHCs have been in existence for several years and growing numbers of patients access them, the role of primary care in signposting patients to them has been minimal and ad hoc. We have co-developed with patients and healthcare professionals (HCPs) an intervention for adult patients with asthma, consisting of an appointment with a primary care HCP to introduce online peer support and sign patients up to an established asthma OHC, followed by OHC engagement. Feasibility work found the intervention acceptable to patients and HCPs. This protocol outlines our plan to test the intervention’s effectiveness and cost-effectiveness.

Methods and analysis

An individual randomised controlled trial will be carried out. Eligible participants will be recruited via an online survey sent to adult patients on the asthma register in 50–70 general practices in several UK locations. Participants will be invited to attend a one-off, face-to-face appointment with a primary care HCP, during which they will be individually randomised to the intervention or usual care. An asthma control test (primary outcome) and other measures of clinical effectiveness will be collected at baseline and every 3 months over a 12-month follow-up period. Descriptive and inferential statistics will be used to compare outcome measures between study arms. Cost-effectiveness assessment of the intervention compared with current standard of asthma management in primary care will be reported. A sample of patients and HCPs will be interviewed at study exit and the data analysed thematically.

Ethics and dissemination

The study was approved by a National Health Service Research Ethics Committee (reference: 25/NE/0006). Written consent will be obtained from all participants. Findings will be disseminated through various means, including sharing with general practices, conference presentations and peer-reviewed publications.

Trial registration number

NCT06849245.

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