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Protocol for a multimethods study evaluating a transition pathway between hospital settings and postsecondary institutions: the NavigateCAMPUS study

Por: Cleverley · K. · Brennenstuhl · S. · Davies · J. · Ewing · L. · Sainsbury · K. · Salman · S. · Levinson · A. · Chiasson · C.-A. · Nasir · S. · Bartha · C. · Ma · C. · de Oliveira · C. · Mason · J. · Barbic · S. P. · Dimitropoulos · G. · Freeland · A. · Halladay · J. · Hamza · C. A. · Lam
Introduction

The surge in postsecondary students reporting mental health concerns, coupled with increased utilisation of on-campus and hospital-based mental healthcare, highlights a need to understand effective service navigation. To address this system gap, the University of Toronto and the Centre for Addiction and Mental Health (CAMH) leveraged their unique expertise and resources to develop the University of Toronto Navigation (UTN) service. UTN introduces care navigators to facilitate postsecondary student transitions from acute mental health services to community or campus mental healthcare. There has been limited implementation and evaluation of navigator models specific to the postsecondary context to date, which hinders scalability. This paper describes the study protocol of Navigation to Enhance Post-Secondary Students’ Acute Mental Health Care Transitions, a study that aims to collaborate with students, navigators and clinicians to evaluate the UTN service.

Methods and analysis

A one-stage, single-arm multimethods study design will be used to evaluate the UTN service. We will recruit 103 students following their UTN intake appointment. Students will complete quantitative measures assessing health outcomes, experiences of care and service utilisation at baseline and at three subsequent time points across a 6-month follow-up period. The quantitative data will be linked to administrative healthcare data. The primary evaluation outcome will be defined as attending an appointment with an appropriate care provider (in person or virtually) within 30 days of discharge from the hospital. We will conduct interviews with students and referring clinicians to gather perspectives regarding their experiences and satisfaction with the UTN service in greater depth.

Ethics and dissemination

Research ethics board approvals have been obtained from the University of Toronto and CAMH. Results will be disseminated through publications and presentations, and a toolkit will be cocreated to support implementation and adaptation of hospital-based navigator interventions in postsecondary contexts.

Complications and costs to the UK National Health Service due to outward medical tourism for elective surgery: a rapid review

Por: England · C. · Bromham · N. · Needham-Taylor · A. · Hounsome · J. · Gillen · E. · Ingram · B.-J. · Davies · J. · Edwards · A. · Lewis · R.
Objectives

Outward medical tourism is when people seek medical treatment in a different country to the one they live in. We aimed to identify all studies that describe the impact on the UK National Health Service (NHS) of patients who require treatment due to outward medical tourism for elective surgery and report on complications, costs and benefits.

Design

A rapid literature review. Medical and grey literature databases were searched, limited to literature published between 2012 and 2024.

Selection criteria

Studies published in the English language, conducted in any NHS setting, describing complications, costs or benefits due to outward medical tourism for elective surgery were included. We excluded emergency and semi-urgent surgery, dental and transplant surgery, cancer treatment and fertility treatment.

Outcome measures

Primary outcomes were costs and savings to the NHS. Secondary outcomes were type and frequency, demographics, procedures, complications, treatment, follow-up care and use of NHS resources. Results were summarised narratively. Study quality was assessed using JBI critical appraisal tools and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used for certainty of evidence for costs.

Results

Some 35 case series and case reports and two surveys of NHS plastic surgeons were identified. Case studies described 655 patients treated in specific NHS hospitals between 2006 and 2024 for postoperative complications due to metabolic/bariatric surgery (n=385), cosmetic (n=265) and ophthalmic (n=5) surgery tourism. No cases relating to other surgical specialities were identified in the literature. Most patients were women (90%), with an average age of 38 (range 14–69) years. The most common destination for surgery was Turkey (61%). Complications were not well described for metabolic/bariatric surgery tourism; but for cosmetic surgery tourism, infection and wound dehiscence were most commonly reported. There was evidence that some patients needed complex treatment involving long hospital stays and multiple surgical interventions. Very low certainty evidence indicated that costs to the NHS from outward medical tourism for elective surgery ranged from £1058 to £19 549 per patient in 2024 prices. We found no studies that reported on the benefits of outward medical tourism.

Conclusions

A systematic approach is needed to collecting information on the number of people who travel abroad for elective surgery and the frequency and impact on the UK NHS of treating complications. Without these data, we cannot fully understand the risk of seeking surgery abroad.

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

Access to quality trauma care after injury in Pakistan: a systematic review and narrative synthesis

Por: Atiq · H. · Rahim · K. A. · Shiekh · S. A. · Afzal · B. · Wajidali · Z. · Chand · Z. B. · Latif · A. · Ignatowicz · A. · Ghalichi · L. · Chu · K. · Razzak · J. A. · Davies · J.
Objectives

To conduct a systematic review and narrative synthesis to identify barriers, facilitators and pre-existing interventions and describe the current status of initiatives/interventions aimed at improving access to quality trauma healthcare after injury in Pakistan.

Design

Systematic review and narrative synthesis

Data sources

MEDLINE (Ovid), Embase (Ovid), Web of Science (Clarivate Analytics), Cochrane (Wiley), Scopus and ProQuest, as well as grey literature.

Eligibility criteria

Full-text peer-reviewed publications, including cross-sectional studies, cohort studies, case-control studies, randomised controlled trials and qualitative studies published in English from January 2013 to December 2023.

Data extraction and synthesis

Two independent reviewers used a standardised tool to extract data variables to Excel. The quality of the included studies was evaluated using the CASP checklist. The barriers, facilitators and pre-existing interventions were mapped using the four delays framework, the Institute of Medicine (IOM) quality domains and the WHO health systems building blocks. The data were synthesised narratively to improve access to quality trauma care in Pakistan. This review was reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guidelines.

Results

The review included 20 studies. 19 studies reported 58 barriers to access to quality care. Six studies reported 20 facilitators, and eight studies described initiatives or interventions aimed at improving access to quality trauma healthcare after injury. According to the four delays framework, the receiving care stage of access to care was primarily studied in 16 studies, which identified 37 barriers and 13 facilitators across 5 studies. Regarding the quality of care according to IOM domains, the effectiveness of quality trauma care after an injury was studied in 15 studies, which identified 19 barriers and 10 facilitators across four studies. According to the WHO health system building blocks, most studies (n=15) described challenges in healthcare service delivery, with these 15 studies identifying 23 barriers and 3 studies identifying 4 facilitators.

Conclusion

Our findings highlighted the scarcity of available literature, identified barriers and facilitators and pre-existing interventions, which informed the need to develop feasible, sustainable and contextually relevant interventions to improve access to quality trauma care after injury in Pakistan.

PROSPERO registration number

CRD42024545786

Assessments, diagnostic criteria and outcome measures for growing pains and persistent pain in the presence of restless leg syndrome in children: a scoping review

Por: Smith · M. · Pacey · V. · Davies · L. M. · Coventry · J. · Ilhan · E. · Williams · C. M.
Objective

To identify the assessments, diagnostic criteria and outcome measures reported in peer-reviewed literature for children with growing pains and persistent lower limb pain in the presence of restless leg syndrome (RLS).

Study design

Scoping review completed in line with Joanna Briggs Institute methodological guidance

Data sources

Five online databases were searched—MEDLINE, Embase, CINAHL, PsycINFO and AMED—for records up to 14 October 2024.

Eligibility criteria

Records reporting on the use of assessments, diagnostic criteria or outcome measures in children (aged 0–18 years) with growing pains or persistent lower limb pain in the presence of RLS. Articles were required to have a sample size of ≥10 and be available in English language.

Data extraction and synthesis

Data were extracted by two independent reviewers and analysed using descriptive statistics.

Results

Following review of 19 806 records, 61 unique records were included. Most were observational cross-sectional or case–control designs. Assessments were varied and primarily focused on body functions and pain characteristics rather than activities and participation. There were 15 unique diagnostic criteria reported for growing pains with limited consistency and sometimes conflict between included items. Outcomes measures were only reported in eight records and typically measured pain presence and intensity.

Conclusions

Assessment and subsequent diagnosis of growing pains and persistent pain in the presence of RLS lack consistency. Outcome measures were seldom used as most records were not designed to measure change over time. Standardised practices for assessment and management of these conditions may benefit clinicians and optimise patient care.

PEER CONNECT: an embedded qualitative study of the experiences of a peer well-being coaching intervention for people living with a long-term health condition

Por: Dennett · R. · Elston · J. · Thompson · T. P. · Clyne · W. · Hosking · J. · Bones · K. · Davies-Cox · H. · Straukiene · A.
Introduction

Many people with long-term conditions such as pain and arthritis struggle with their health and well-being. To support better self-management, a new peer-delivered coaching intervention (Health Connect Coaching) was set up at a National Health Service integrated care organisation in Southwest England. Based on principles of personalised care and supported goal setting, the one-to-one coaching programme, targeting patients with low activation, delivered coaching sessions in a step-down approach over 6 months. A randomised controlled feasibility trial (fRCT) of Health Connect Coaching was conducted to inform the design of a definitive randomised controlled trial. This article reports the embedded qualitative component of the fRCT, describing the experiences of coaches, peers and staff of implementing and participating in the intervention and trial that ultimately struggled to recruit sufficient peers.

Methods

Semi-structured online interviews were conducted with coaches (n=16) and peers (n=6), and informal discussions held with staff (n=7). Interviews were recorded and transcribed verbatim, and summaries of informal discussions were made. Data were analysed using thematic framework analysis.

Results

Four themes were identified from the interview and discussion data: (1) motivation for participation, (2) balance, (3) flexibility and (4) connection and building relationships.

Conclusion

One-to-one peer coaching demonstrates potential as an intervention to enable people to better manage their chronic health condition. However, in people with low activation, programmes and effectiveness studies need to pay close attention in their design to the motivation of peers, flexible delivery models that enable connection but can accommodate fluctuating needs and facilitating links between coaching services and clinical teams.

Trial registration number

ISRCTN12623577.

Comparative effectiveness of educational interventions in neurological disease for healthcare workers and students: a systematic review

Por: Veremu · M. · Jiang · Z. · Gillespie · C. S. · Roman · E. · Cook · W. H. · Chauhan · R. V. · Rafati Fard · A. · Toumbas · G. · Baig · S. · Zipser · C. · Stacpoole · S. · Tetreault · L. · Deakin · N. · Bateman · A. · Davies · B. M.
Objectives

To assess the comparative effectiveness of educational interventions in neurological disease for healthcare workers and students.

Design

Systematic review.

Data sources

Medline, Embase and Cochrane through to 1 June 2025.

Eligibility criteria

Studies evaluating neurological disease educational interventions with a comparator group (observational cohort/randomised controlled trial (RCT)) were included.

Data extraction and synthesis

A Preferred Reporting Items for Systematic Reviews and Meta-Analyses-compliant systematic review was conducted (PROSPERO: CRD42023461838). Knowledge acquisition and educational methodologies were collected from each study. Study outcomes were classified using the Kirkpatrick and Kirkpatrick four-level model (learner reaction, knowledge acquisition, behavioural change, clinical outcome).1 Risk of bias was assessed using the Newcastle-Ottawa scale for non-randomised studies and the Cochrane Risk of Bias tool for RCTs.2 3

Results

A total of 67 studies involving 4728 participants were included. Of these, 36 were RCTs, and 31 were observational studies. Virtual interventions were the most common (67.2%, n=45 studies), primarily targeting either medical students (46.3%, n=31 studies) or specialists (40.3%, n=27 studies). Overall, 70.1% (n=47) of studies demonstrated outcomes in favour of the intervention. However, few studies used K&K level 3/4 outcomes, with two studies evaluating behaviour change (level 3) and three assessing clinical outcomes (level 4 combined with other levels). No study exclusively assessed level 4 outcomes. Meta-analysis of 22 RCTs with calculable standardised mean differences (SMDs) (n=1748) showed a significant benefit of interventions (SMD 0.75, 95% CI 0.22 to 1.27, p=0.0056).

Conclusions

This review highlights a growing body of research particularly focusing on virtual techniques, specialist audiences and treatment-oriented content. Few studies assessed changes in practice or patient care. Non-specialists remain underrepresented. Future studies should prioritise assessing the clinical impact of educational interventions within non-specialist audiences.

Understanding preferences for self-sampling in a national cervical screening programme: a protocol for a discrete choice experiment

Por: Thapa · S. · Davies · J. C. · Crosbie · E. J. · Payne · K. · Wright · S.
Introduction

The National Health Service Cervical Screening Programme (NHSCSP) currently involves a healthcare professional collecting a cervical sample in a healthcare setting. This method of screening has barriers associated with access to screening appointments and the poor acceptability of the speculum examination. Primary screening through HPV testing has led to the development of self-sampling screening methods including vaginal and urine self-sampling, with many UK studies comparing these screening methods with the current NHSCSP. It is not known what features of self-sampling influence individuals’ preferences and cervical screening uptake. To understand these preferences, we plan to undertake a discrete choice experiment (DCE). This protocol aims to describe the steps taken to design the DCE and the proposed approach to fielding the DCE to identify preferences for different sampling approaches in cervical screening.

Methods and analysis

An online survey comprising a DCE was designed to understand preferences of individuals for self-sampling methods within the NHSCSP. Attributes and levels for the DCE were generated through an iterative process including a literature review of qualitative studies about self-sampling cervical screening methods, input from cervical screening clinical experts and a patient and public involvement group (n=6). A D-efficient design was used to create choice sets for the DCE survey. Regression-based analysis will be used to estimate the impact of each attribute and level on individual choices.

Ethics and dissemination

This study has been approved by The University of Manchester Proportionate Research Ethics Committee (2024-20767-37669). The results of the DCE will be submitted for publication in a relevant peer review journal and the results will be presented at national and international conferences.

Data statement

There are no data associated with this protocol. The data produced by this study and analysis scripts will be made available in a public repository following publication of the study.

Evaluating health system expenditure across the rural-urban spectrum in New Zealand: a study protocol

Por: Liepins · T. · Atkinson · J. · Davie · G. · Leung · W. · Crengle · S. · Keenan · R. · Whitehead · J. · Stokes · T. · Nixon · G.
Introduction

Inequities in health status exist in New Zealand across the rural–urban spectrum. In parallel, rural–urban differences in health service utilisation vary by service type. Despite the New Zealand public health system being based on principles of universal access, equity and fairness, levels of health expenditure on rural and urban populations are not well understood. The purpose of the study is to undertake a rural–urban analysis of public health system expenditure, based on individual-level service utilisation and national pricing of health service events.

Methods and analysis

Individual-level service utilisation and pricing will be collated from national collection databases for all eligible users of publicly funded services. The analysis will include calendar years 2017–2024. Descriptive analysis and a two-part generalised linear regression model will be used to identify if rural–urban differences in expenditure exist, and what the association of rurality is with expenditure (if any). The model will also be used to identify geographic regions with expenditure levels that vary from those predicted using regression model weights. As the specific statistical approach will be determined by data attributes, this protocol outlines the intended approach to construct the analytical model.

Ethics and consultation

Ethics approval was obtained from the University of Otago Human Research Ethics Committee (HD23/052). Māori consultation has been undertaken with the Ngāi Tahu Research Consultation Committee and will continue throughout the research process.

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.

Comparison of the effectiveness of fast-acting insulin aspart with rapid-acting insulin analogues on glycaemic control: a retrospective cohort study using patient data from primary care practices in England

Por: Davies · M. J. · Alibegovic · A. C. · Jensen · A. B. · Kelkar · P. · Nordsborg · R. B. · Thamattoor · U. K. · Braae · U. C.
Objectives

This study compared the effectiveness of first-time use of faster aspart with rapid-acting insulin analogues in patients with type 1 diabetes (T1D) or type 2 diabetes (T2D).

Design, setting

This retrospective cohort study used data from 1 January 2017 to 8 May 2021 captured in the Clinical Practice Research Datalink Aurum database in the UK.

Interventions

Patients with T1D or T2D either initiating faster aspart or another rapid-acting insulin analogue (‘new users’) or switching from a rapid-acting insulin analogue to faster aspart or to another rapid-acting insulin analogue (‘switchers’) were included. The index date was the date of first prescription of faster aspart or a rapid-acting insulin analogue, or of switching to a different rapid-acting analogue or to faster aspart.

Participants

A total of 9695 and 2170 patients were included in the new users (T1D, 1737; T2D, 7958) and switchers cohorts (T1D, 1764; T2D, 406), respectively.

Primary and secondary outcome measures

Glycated haemoglobin (HbA1c) change at 6 months, occurrence of hypoglycaemia from index to 12 months post-index and treatment persistency from index to discontinuation or censoring.

Results

Numerically greater reductions were observed with faster aspart than rapid-acting insulins in T1D switchers and new users in change in HbA1c at 6 months. Patients with T1D who switched to faster aspart experienced a significant reduction in rate of hypoglycaemia (p=0.0021). Treatment persistency was higher with faster aspart than with rapid-acting insulins among T1D switchers. No distinction in treatment persistency was observed between the treatment groups for T1D new users or T2D switchers.

Conclusions

Reductions in HbA1c were numerically larger with faster aspart in three of four subgroups. There was higher treatment persistency with faster aspart vs rapid-acting insulin analogues among T1D switchers.

Trial registration number

NN1218-4967.

Effects of deprescribing from inhaled corticosteroids in people with cystic fibrosis: protocol for a target trial emulation using the UK CF Registry

Por: McClenaghan · E. · Rouette · J. · Granger · E. · Davies · G. · Keogh · R. H. · Tazare · J.
Introduction

Observational data are increasingly used to study and draw causal inferences about the effects of treatments. Target trial emulation (TTE) is a framework for mitigating biases in causal investigations through specification of an observational study, targeting a specific causal research question, based on a real or hypothetical randomised controlled trial. Investigations into the effects of treatment discontinuation are of growing interest and particularly relevant in cystic fibrosis (CF), where treatment burden is high and new transformative therapies are becoming widespread. We aim to use the TTE framework to investigate the effect of discontinuation of inhaled corticosteroids (ICS) on clinical outcomes in people with CF. Our observational emulation will be based on the CF WISE (Withdrawal of Inhaled Steroids Evaluation) trial (PMID:16556691).

Methods and analysis

Two study designs proposed for investigating treatment effects using observational data are the prevalent new-user design and the sequential trials design. Each design uses different but related methods to address similar causal questions; however, the comparability between them remains uncertain. We will conduct a population-based cohort study using data from the UK CF Registry between January 2016 and June 2018 and apply these designs. We will specify the target trial protocol for each study design. Estimates for the causal effects of discontinuing ICS will be obtained and compared with those from the CF-WISE trial.

Ethics and dissemination

This study has received approval from the UK CF Registry Research Committee for both the research and access to data. Ethical approval has also been granted by the LSHTM Ethics Committee. The UK CF Registry has NHS Research Ethics Committee approval (REC reference: 24/EE/0012). The findings from this project will be submitted to peer-reviewed journals and presented at academic conferences.

Understanding internet-supported self-management for low back pain in primary care: a qualitative process evaluation of the SupportBack 2 randomised controlled trial

Por: Geraghty · A. W. A. · Hughes · S. · Roberts · L. · Hill · J. C. · Foster · N. E. · Hay · E. · Mansell · G. · White · M. · Davies · F. · Steele · M. · Little · P. · Yardley · L.
Objective

The SupportBack 2 randomised controlled trial (RCT) compared the clinical and cost-effectiveness of an internet intervention supporting self-management versus usual primary care in reducing low back pain (LBP)-related disability. In this study, we aimed to identify and understand key processes and potential mechanisms underlying the impact of the intervention.

Design

This was a nested qualitative process evaluation of the SupportBack 2 RCT (ISRCTN: 14736486 pre-results).

Setting

Primary care in the UK (England).

Participants

46 trial participants experiencing LBP without indicators of serious spinal pathologies (eg, fractures, infection) took part in telephone interviews at either 3 (n=15), 6 (n=14) or 12 months (n=17) post randomisation. Five physiotherapists who provided telephone support for the internet intervention also took part in telephone interviews.

Intervention

An internet intervention ‘SupportBack’ supporting self-management of LBP primarily through physical activity and exercise delivered in addition to usual care, with and without physiotherapist telephone support.

Analysis

Data were analysed thematically, applying a realist logic to develop context-mechanism-outcome configurations.

Results

Four explanatory themes were developed, with five context-mechanism-outcome configurations. Where benefit was reported, SupportBack appeared to work by facilitating a central associative process where participants linked increases in physical activity or exercise with improvements in LBP, then continued to use physical activity or exercise as key regulatory strategies. Participants who reported little or no benefit from the intervention appeared to experience several barriers to this associative process, including negative expectations, prohibitive beliefs about the cause of LBP or functional limitations preventing engagement. Physiotherapists appeared to provide accountability and validation for some; however, the remote telephone support that lacked physical assessment was viewed as limiting its potential value.

Conclusions

Digital interventions targeting physical activity and exercise to support LBP self-management may rely on mechanisms that are easily inhibited in complex, heterogeneous populations. Future research should focus on identifying and removing barriers that may limit the effectiveness of digital self-management support for LBP.

Prevalence and impact of comorbid PTSD, c-PTSD and EUPD on symptom severity in functional neurological disorder: protocol for a systematic review and meta-analysis

Por: Davies · S. · Rafi · D. · Rifkin-Zybutz · R. · Heyland · S. · Jadhakhan · F.
Introduction

Previous trauma and adverse life experiences have been hypothesised to be aetiological factors for functional neurological disorder (FND) leading to the hypothesis of a ‘trauma-subtype’ of FND. Individuals who have experienced prior abuse are more likely to develop FND than healthy controls. Post-traumatic stress disorder (PTSD) and personality disorders have been described to be comorbid with FND at varying prevalence rates. Complex PTSD (c-PTSD) and emotionally unstable personality disorder (EUPD) have clinical similarities with PTSD and trauma is a common aetiological factor in the development of all three conditions. There is some research exploring the resemblance of personality traits in populations diagnosed with FND and EUPD compared with controls. However, it remains unclear what the current prevalence rates are of PTSD, c-PTSD and EUPD in populations diagnosed with FND. Understanding the overlap between these trauma-based comorbid psychiatric diagnoses with FND will hopefully inform better and more comprehensive trauma-informed treatment strategies. The aims of the systematic review are therefore to (1) establish the prevalence of PTSD, c-PTSD and EUPD in adults diagnosed with FND and (2) compare core FND symptom severity between adults with FND alone and those with comorbid PTSD, c-PTSD and EUPD.

Methods and analysis

This systematic review will assess the prevalence of PTSD, c-PTSD and EUPD in FND patients aged over 18, diagnosed using standardised questionnaires or clinical interviews as per international diagnostic criteria. Studies will be identified through comprehensive searches of databases including PsycINFO, PsycARTICLES, CINAHL, MEDLINE, EMBASE, Web of Science and Scopus, from May 1990 to May 2025. The review aims to estimate the prevalence of these conditions in FND, with findings presented as a narrative description discussing contributing factors, and a meta-analysis considered if heterogeneity is suitable.

Ethics and dissemination

Ethical approval is not required since only data from existing studies will be used and no original data will be collected. Results will be disseminated at national and international academic conferences and in peer-reviewed publications. Any deviations from this protocol will be recorded and explained in the final report and updated on PROSPERO.

PROSPERO registration number

CRD42024599112.

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

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

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

Methods and analysis

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

Ethics and dissemination

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

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

Trial registration number

ISRCTN14591444.

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.

Regional Assessment of Lower limb Amputations in sub-Saharan Africa (RAMPs): a prospective cohort study protocol

Por: Moody · N. · Sandford · B. · Bosanquet · D. C. · Chu · K. · Assefa · R. · Hall · J. · Stephen · T. · Popplewell · M. · Seyoum · N. · Davies · J.
Introduction

Major lower limb amputation, defined as an amputation above the level of the ankle joint, is a substantial cause of morbidity and mortality. Limited data exist on the burden, aetiology and outcomes of major lower limb amputations in sub-Saharan Africa (SSA). This is despite increasing rates of diabetes, peripheral arterial disease and trauma, with further projected increases in these conditions, which often precede major lower limb amputation. The Regional Assessment of Amputations in sub-Saharan Africa (RAMPs) study aims to address this knowledge gap by performing a multicentre, prospective study of major lower limb amputations across the region.

Methods

We describe a prospective, multicentre observational cohort study enrolling patients undergoing major lower limb amputation at hospitals in SSA over a consecutive 6-month period. Consecutive patients will be included, and data will be collected from medical records until discharge, death or 30 days postoperatively, whichever is sooner. The primary outcome is in-hospital or 30-day mortality. Secondary outcomes include the aetiology of amputations and in-hospital complications. We will also examine systems and processes using a facility survey of each participating centre. The study will collect system-level, patient-level and outcome-level data. Our sample size calculation suggests 904 patients need to be recruited.

Ethics and dissemination

The RAMPs study will provide a snapshot of the current outcomes and aetiology of major lower limb amputation in SSA. It will show if variation in outcomes and aetiology in patients in the region exists and provide information on the healthcare processes and systems in those who may be at risk of lower limb amputation. Ethical approval has been granted by the University of Birmingham (Science, Technology, Engineering and Mathematics Committee reference: ERN_2929-Jan2025) and the College of Surgeons of East, Central and Southern Africa (COSECSA Institutional review board reference COSECSA/REC/2025/07). Findings will be disseminated throughout the region at local, national and international conferences and through at least one peer-reviewed manuscript.

Impacts of Global School Feeding Programmes on Childrens Health and Wellbeing Outcomes: A Scoping Review

Por: Locke · A. · James · M. · Jones · H. · Davies · R. · Williams · F. · Brophy · S.
Objectives

School feeding programmes (SFPs) are widely implemented to address child poverty, food insecurity and malnutrition, yet evidence on their influence on children’s health outcomes is limited. With ongoing debate around universal versus targeted provision, this scoping review aims to map global literature on SFPs, identify which health and well-being outcomes are reported, and explore how these outcomes vary by programme type (targeted vs universal).

Design

Scoping review conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The protocol was pre-registered on the Open Science Framework.

Data sources

Four electronic databases—Medline, PubMed, Web of Science and Google Scholar—were searched in December 2023 and July 2025. Reference lists of included papers were also screened.

Eligibility criteria

Included studies examined the impact of SFPs on physical, emotional, psychological and social health outcomes in children aged 5–16. Only English-language studies published between 2009 and 2025 were included.

Data extraction and synthesis

Data were extracted using a structured template and reviewed by multiple authors. Due to the heterogeneity in study designs and reported outcomes, a narrative synthesis approach was used to group findings thematically, following established guidance for narrative synthesis in systematic reviews.

Results

A total of 44 papers were included in the final review, spanning 13 countries and published between 2009 and 2025. SFPs were associated with healthier weight status, improved dietary intake, better social engagement and reductions in stigma. Targeted programmes addressed food insecurity but were more often linked to stigma and poorer mental health outcomes.

Conclusions

Universal SFP were effective at improving children’s health outcomes such as healthy weight, improved behaviour and social support. Overall, both targeted and universal SFP positively impact children’s health outcomes and address health disparities.

Study protocol for a prospective diagnostic accuracy study to assess the feasibility and diagnostic accuracy of serial ankle handheld Doppler waveform assessment (Ankle HHD) for surveillance after lower-limb revascularisation: WAVE study

Por: Alodayni · H. M. · Smith · S. · Poushpas · S. · Swagell · K. · Mandic · D. · Johnson · N. A. · Jaffer · U. · Davies · A. · Normahani · P.
Introduction

Peripheral arterial disease (PAD) affects approximately one in five people over 60 in the UK. In severe cases, revascularisation, such as surgical bypass or endovascular methods, is often required to restore limb perfusion. Between 2000 and 2019, 527 131 revascularisation procedures were carried out in the UK. Postprocedural surveillance is essential to detect restenosis and maintain vessel patency. However, standard surveillance using duplex ultrasound (DUS) is resource intensive. Ankle Doppler waveform assessment is quick, inexpensive and accurate for PAD diagnosis, yet its role in postrevascularisation surveillance remains unexplored. This study aims to evaluate the diagnostic accuracy of ankle handheld Doppler waveform assessment (ankle HHD) for detecting restenosis after lower limb revascularisation, as compared with formal DUS.

Methods and analysis

This is a prospective diagnostic accuracy study (ClinicalTrials.gov Identifier NCT06619223). We aim to recruit 121 people with PAD undergoing planned lower limb revascularisation at Imperial College Healthcare NHS Trust. Follow-up assessments will take place at 3 months, 6 months and 12 months post revascularisation. At each visit, a vascular scientist will perform the index test (Ankle HHD) followed by DUS as the reference standard. A subset of participants will undergo repeat testing to assess interobserver and intraobserver reliability. Restenosis will be defined as one or more arterial lesions of ≥50% stenosis or tandem lesions with a combined value of ≥50%. The primary outcome is the sensitivity of ankle Doppler waveform assessment for detecting restenosis, compared with DUS.

Ethics and dissemination

The study has received approval from Health Research Authority (HRA) and Health and Care Research Wales (REC reference 24/LO/0462). Results will be disseminated through research presentations and papers.

Trial registration number

ClinicalTrials.gov, NCT06619223.

Health economic impact of early versus delayed treatment of herpes simplex virus encephalitis in the UK

Por: Defres · S. · Navvuga · P. · Moore · S. · Hardwick · H. · Easton · A. · Michael · B. D. · Kneen · R. · Griffiths · M. · ENCEPHUK Study Group · Medina-Lara · A. · Solomon · T. · Barlow · Beeching · Blanchard · Body · Boyd · Cebria-Prejan · Chadwick · Cooke · Crawford · Davies · Davies
Objective

Thanks to the introduction of recent national guidelines for treating herpes simplex virus (HSV) encephalitis, health outcomes have improved. This paper evaluates the health system costs and the health-related quality of life implications of these guidelines.

Design and setting

A sub-analysis of data from a prospective, multi-centre, observational cohort ENCEPH-UK study conducted across 29 hospitals in the UK from 2012 to 2015.

Study participants

Data for patients aged ≥16 years with a confirmed HSV encephalitis diagnosis admitted for treatment with aciclovir were collected at discharge, 3 and 12 months.

Primary and secondary outcome measures

Patient health outcomes were measured by the Glasgow outcome score (GOS), modified ranking score (mRS) and the EuroQoL; healthcare costs were estimated per patient at discharge from hospital and at 12 months follow-up. In addition, Quality Adjusted Life Years (QALYs) were calculated from the EQ-5D utility scores. Cost–utility analysis was performed using the NHS and Social Care perspective.

Results

A total of 49 patients were included; 35 were treated within 48 hours, ‘early’ (median (IQR) 8.25 [3.7–20.5]) and 14 were treated after 48 hours ‘delayed’ (median (IQR) 93.9 [66.7–100.1]). At discharge, 30 (86%) in the early treatment group had a good mRS outcome score (0–3) compared with 4 (29%) in the delayed group. According to GOS, 10 (29%) had a good recovery in the early treatment group, but only 1 (7%) in the delayed group. EQ-5D-3L utility value at discharge was significantly higher for early treatment (0.609 vs 0.221, p

Conclusions

This study suggests that early treatment may be associated with better health outcomes and reduced patient healthcare costs, with a potential for savings to the NHS with faster treatment.

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