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Hoy — Diciembre 16th 2025Tus fuentes RSS

How can qualitative research enhance and strengthen randomised controlled trials undertaken with children and young people?

Por: Thompson · J. · Smith · J. · Evans · J.

Health research aims to improve people’s health by understanding the best ways to diagnose and treat conditions, and understand people’s responses to health problems and health promotion initiatives. Quantitative research, and more specifically randomised controlled trials (RCTs), aims to establish if an intervention works, for example testing the effectiveness of a new drug, using statistical analysis. In contrast, qualitative research focuses on understanding a situation, for example people’s experiences, perspectives and behaviours. Qualitative research can enhance RCTs by ensuring a more complete understanding of the factors that influence the acceptability of a new intervention and how it might be implemented in practice. A previous article in this series outlined how process evaluation embedded within RCTs can help understand how and why an intervention works.1 While process evaluation is important, we will outline the reasons qualitative research can enhance the design and procedures associated with RCTs, and the...

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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.

Generational mutation patterns in a honey bee Deformed wing virus via infectious clones

by Anthony Nearman, Alriana Buller-Jarrett, Dawn Boncristiani, Eugene Ryabov, Yanping Chen, Jay D. Evans

Efforts to improve honey bee colony health continue due to persistent high loss rates. A major focus in this area is Deformed wing virus (DWV), a key driver of colony loss. The application of modern molecular techniques has characterized the DWV genome and its high mutational rate that enables the formation of diverse quasi-species populations capable of evading host immune responses, while other work has led to the development of DWV clones suitable for sequence-specific tracking of viral dynamics. In this work we combine knowledge of these efforts to track the mutational progression in a DWV clone surrounding an area of low nucleotide diversity and compare it to its wild-type source. We achieve this through amplicon sequencing of the structural viral protein, VP2, after incubation across three generations and multiple host genetic sources. Inocula were injected into pupae, allowed to replicate, then extracted for a further two generations of injections. For the final injection generation, recipient pupae were injected with preparations from either the same genetic source or cross-fostered from other colonies. Overall, we compared the mean number and type of mutations, their proportional abundance in the read pool, and specific locations across strains. Sequencing results indicate a limited number of mutational hotspots, which were driven by silent mutations in the final injection generation of the wild-type strains. No significant differences were found among other mutation types, cross-fostering status, or interactions with host genetics. This work is an initial attempt at examining viral dynamics in a cloned system across multiple generations and treatment groups. The results provide valuable insights, which may further enhance our understanding of viral dynamics and potentially improve future honey bee therapeutics.

Online randomised e-hypnotherapy for chronic pelvic pain study (REST): comparing e-hypnotherapy with relaxation and waitlist to improve pain, cost-effectiveness and biopsychosocial outcomes

Por: Evans · S. · Naude · C. · Coitinho Biurra · Y. · Bowring · J. · Knowles · S. · Brooks · T. · Skvarc · D. · Esterman · A. · Fuller-Tyszkiewicz · M. · Klas · A. · Van Niekerk · L. · McCaffrey · N. · Stanley · K. · Druitt · M. · Andrews · J. · Vancaillie · T. · Cheah · S. · Ciccia · D. · Blak
Background

Chronic pelvic pain, defined as persistent pain in the structures of the pelvis, is a condition that significantly impacts the health-related quality of life (HRQoL) of up to one-third of people worldwide, with substantial associated costs to both the individual and healthcare system/s. The present trial aims to establish the efficacy of e-hypnotherapy over relaxation and waitlist controls on pain, HRQoL and biopsychosocial outcomes, and evaluate cost-effectiveness.

Methods

A parallel-group, investigator-blinded, randomised controlled trial will be conducted. Eligible participants will be randomly allocated to either a 7-week online personalised e-hypnotherapy programme (n=44), a 7-week online personalised relaxation control (n=44) or waitlist control (n=44). The primary outcome will be self-reported pain level, and secondary outcomes will include psychological distress, QoL, pain catastrophising, self-efficacy, central sensitisation, somatic symptoms, fatigue and sleep. Cost-effectiveness will also be examined. Longitudinal qualitative interviews will be conducted with participants in the e-hypnotherapy (n=20) and relaxation (n=20) groups to understand meaningful change and barriers/facilitators for ongoing use.

Ethics and dissemination

This protocol has received ethics approval in Australia from the Deakin University Research Ethics Committee (DUREC ref. 2024-080). Findings will be disseminated through peer-reviewed publications and presentations at national and international conferences related to chronic pelvic pain and mind–body interventions.

Trial registration number

Australian New Zealand Clinical Trials Registry ACTRN12623000368639p.

What is known about flexible assertive community treatment across populations and contexts? A scoping review protocol

Por: Tang · F. · Evans · C. · Bogdan · A. · Bullock · H. · Westen · K. · Kroon · H. · Delespaul · P.
Introduction

The objective of this scoping review is to elucidate contexts in which Flexible Assertive Community Treatment (FACT) has been utilised, which populations it has served, how it has been adapted and what outcomes it has achieved. FACT is a model of mental healthcare where patients are transitioned along a continuum of high-intensity outreach-based treatment and lower-intensity case management, according to need. Despite being adopted globally, a review of the evidence on the FACT model has not been conducted since 2014.

Methods and analysis

This study will follow the Joanna Briggs Institute’s (JBI) methodology for scoping reviews and the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews. A structured search of several electronic databases (MedLine, CINAHL, PsycINFO, Psychology & Behavioural Sciences, Embase, Scopus, Sociological Abstracts and ASSIA Social Sciences Index Abstracts) will be conducted to locate relevant studies addressing models of care that adhere to the core components of the FACT model and that were published in English or Dutch from 2003 (model conception date) to the present day. To explore the range of populations served by FACT, we will not limit participant populations by age or diagnosis. With respect to FACT adaptations, we will include articles that explore modifications to the structure of FACT such as staffing complement, caseloads or interface with other health and social services. Articles identified from our structured searches will be screened independently by two reviewers. Data from included articles will be extracted, analysed and presented on tables and visual graphs, and summarised in a narrative report.

Ethics and dissemination

Our scoping review does not require ethics approval as it does not involve human subjects and will draw evidence from published peer-reviewed articles. Our findings will be disseminated through journal publication, presentations at relevant conferences and distribution across our networks and those of our partners, including healthcare providers, researchers and other key stakeholders.

Morphine for chronic breathlessness (MABEL) in the UK: a health economic evaluation of a multisite, parallel-group, dose titration, double-blind, randomised, placebo-controlled trial

Por: Atter · M. J. · Hall · P. · Evans · R. A. · Norrie · J. · Cohen · J. · Williams · B. · Chaudhuri · N. · Bajwah · S. · Higginson · I. · Pearson · M. · Currow · D. · Stewart · G. · Fallon · M. · Johnson · M.
Objectives

To compare costs and health consequences and to assess the cost-effectiveness of using low-dose oral long-acting morphine in people with chronic breathlessness.

Design

Within-trial planned cost-consequences and cost-effectiveness analysis of data from a multisite, parallel-group, double-blind, randomised, placebo-controlled trial of low-dose, long-acting morphine.

Setting

11 hospital outpatients across the UK.

Participants

Consenting adults with chronic breathlessness due to long-term cardiorespiratory conditions.

Intervention

5–10 mg two times a day oral long-acting morphine with a blinded laxative for 56 days.

Primary outcome measures

Mean and SD of healthcare resource use (HRU) by trial arm; mean differences and 95% CI of costs between trial arms.

Secondary outcome measures

Mean differences in 28- and 56-day quality-adjusted life years (QALYs based on EuroQol five-dimension five-level score), Short Form-six dimensional scores and ICEpop CAPability-Supportive Care Measure scores; cost-utility of long-acting morphine for chronic breathlessness.

Results

143 participants (75 morphine and 67 placebo) were randomised; 140 (90% power, males 66%, mean age 70.5 (SD 9.4)) formed the modified intention-to-treat population (participants receiving at least one dose of study medication). There were more inpatient and fewer outpatient services used by the morphine group versus the placebo. In the base-case analysis at 56 days, long-acting morphine was associated with similar mean per-patient costs and QALYs. There was an increase of £24 (95% CI –£395 to £552) and 0.002 (95% CI –0.004 to 0.008) QALYs. Hospitalisations were the main driver of cost differences. The corresponding incremental cost-effectiveness ratio was £12 000/QALY, with a probability of cost-effectiveness of 54% at a £20 000 willingness-to-pay threshold. In the scenario analysis that excluded costs of adverse events considered unrelated to long-acting morphine by site investigators and researchers, the probability of cost-effectiveness increased to 73%.

Conclusion

Oral morphine for chronic breathlessness is likely to be a cost-effective intervention provided adverse events are minimised, but the effect on outcome is small and cautious interpretation is warranted.

Trial registration number

ISRCTN87329095.

Portable devices for the diagnosis of glaucoma: a scoping review

Por: Garba · F. · Kyari · F. · Burton · M. J. · Adler · S. H. · Khan · Z. · Bello · M. · Evans · J. · Gordon · I. · Hu · V. H. · Nolan · W.
Background

Glaucoma is a leading cause of irreversible blindness worldwide. Early detection and continuous monitoring are essential to preventing vision loss, yet traditional diagnostic tools remain largely inaccessible in low-resource settings.

Purpose

This scoping review aimed to map the existing evidence on the use of portable devices for the detection, diagnosis and monitoring of glaucoma.

Methods

We conducted a scoping review in accordance with the Joanna Briggs Institute Manual and Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. A comprehensive search was performed across major databases to identify studies that evaluated handheld tonometers, portable fundus cameras and visual field testing devices. Data were extracted on study design, population characteristics, devices used, comparators and reported outcomes.

Results

A total of 216 studies published between 1975 and 2024 were included. Most studies (90.3%) were method agreement studies, primarily focused on intraocular pressure (IOP) devices. Only two studies evaluated all three glaucoma assessment domains (IOP, visual fields and fundus imaging). Most studies were conducted in high-income countries, with a smaller number from low- and middle-income countries. Despite variability in performance, many devices demonstrated acceptable agreement with gold standard methods and were assessed in a range of clinical and community settings.

Conclusion

This review highlights the range and characteristics of portable glaucoma devices and their potential for enhancing access to diagnosis and monitoring, particularly in underserved settings. However, the predominance of method agreement studies and the limited integration of multimodal assessments point to gaps in the literature. Future research should focus on comprehensive diagnostic pathways using multiple portable tools and on expanding evaluations in low-resource settings to inform policy and service planning.

Evaluating home-based personalised virtual reality physiotherapy rehabilitation compared with usual care in the treatment of pain for people with knee osteoarthritis: protocol for a randomised feasibility study

Por: Al-Amri · M. · Bird · S. · Nistor · D.-T. · White · J. · Button · K. · Warner · M. · Walsh · D. · Shorten · D. · Evans · R.
Introduction

Home-based physiotherapy is a current approach to manage knee osteoarthritis (OA). However, adherence to physiotherapy is poor. Non-immersive virtual reality (VR) has shown promise in improving self-efficacy and adherence in other clinical conditions. A non-immersive VR-based home physiotherapy system named Sensor-based Physiotherapy Intervention with Virtual Reality (SPIN-VR) for knee OA has been developed, integrating physiotherapy exercises into engaging games that adjust in difficulty based on real-time performance. This approach aims to enhance exercise adherence by making physiotherapy more enjoyable and personalised. To evaluate the feasibility of this intervention, a randomised controlled trial is being conducted.

Method and analysis

This single-centre, open-label, randomised controlled feasibility trial will evaluate the SPIN-VR system over 12 weeks compared with usual care physiotherapy for knee OA. 50 participants will be randomly assigned to either the SPIN-VR or usual care group, with follow-ups at 12 and 24 weeks post randomisation. The primary outcomes will be a description of feasibility of recruitment, patient willingness to be randomised, the completeness of outcome measures and patient adherence to the intervention. Secondary outcomes include evaluations of muscle strength, endurance, aerobic capacity, exercise technique, central pain processing and self-reported pain mechanisms and moderators. Participants in the intervention arm will be interviewed after 12 weeks to capture their experience in using the VR system.

Ethics and dissemination

This protocol was approved by the Wales Research Ethics Committee 3. Research findings will be disseminated in open-access peer-reviewed journals, to researchers and health professionals through conference presentations, to patients and the public by organising webinars and a seminar.

Trial registration number

NCT06639867.

Free school meals, diet quality and food insecurity in secondary school students: protocol for a multiple-methods study - the CANTEEN study

Por: Alving-Jessep · E. · Pallan · M. · Ansell · E. · Hamill · L. · McConnell · C. · McIlwee · D. · McKinley · M. C. · Moore · S. E. · Murphy · M. · Neville · C. · ONeill · C. · Sevel · E. · Adab · P. · Bryant · M. · Chambers · S. · Cardwell · C. R. · Ensaff · H. · Evans · C. · Reid · S. · Holfor
Introduction

Food insecurity is increasing in the UK, impacting choice and diet quality. The current means-tested free school meals (FSM) policy was put in place to address dietary inequalities and food insecurity in school children. In secondary schools, approximately 20% of students who are eligible and registered do not take their FSM. Working across a range of schools that have variable levels of FSM uptake, this study aims to evaluate the effectiveness and cost-effectiveness of the current means-tested FSM policy in UK secondary schools on diet and food insecurity outcomes, understand what factors are associated with uptake and test the potential impact of any proposed policy change.

Secondary schools (n=32) in both Northern Ireland and the Midlands region of the UK are being recruited into the study. Data will be collected from school staff, governors, students and parents via questionnaires, as well as observational data of school eating environments. Qualitative data will be collected in selected case study schools (n=6–8). Multilevel modelling will be undertaken to evaluate the association between FSM uptake and fruit and vegetable intake, overall diet quality and food insecurity in all students. Economic evaluation will be conducted using a cost–utility approach. The effect of policy change will be modelled and school factors associated with FSM uptake explored using multiple methods.

Ethics and dissemination

Ethical approval has been obtained from Queen’s University Belfast Faculty of Medicine, Health and Life Sciences Research Ethical Committee (MHLS 23_55). Findings will be disseminated to key national and local agencies, to schools through reports and presentations, and to the public through media and open access publications.

Feasibility and acceptability of safer gambling interventions (social norms and goal setting) delivered via text message for those at low-to-moderate risk of gambling harm: a four-arm randomised controlled feasibility study

Por: Arden-Close · E. · Thomas · S. · Bush-Evans · R. · Hamson-Ford · A. · Bolat · E. · Hodge · S. · Phalp · K. · Wang · R. · McAlaney · J.
Objectives

To assess the feasibility and acceptability of three SMS-delivered safer gambling interventions (goal setting (GS), descriptive norms (DN), injunctive norms (IN)) aimed at reducing the transition from low or moderate risk of gambling harm to problematic gambling, and the feasibility of a full-scale randomised controlled trial evaluating their effectiveness and cost-effectiveness.

Design

Four-arm, parallel-group, pragmatic, randomised controlled feasibility study with a nested qualitative study.

Setting

The study was conducted in the UK. Participants were recruited online via UK-licensed gambling operators’ websites.

Participants

Adults aged ≥18 years, gambling online at least weekly, with low-to-moderate gambling risk levels.

Interventions

Participants were block randomised in equal proportions to a delayed intervention control group or one of three 6-week text message interventions delivered via the secure messaging app WIRE: (1) GS: weekly prompts to set gambling-related goals with personalised feedback; (2) DN: weekly messages challenging misperceptions about peer gambling behaviours and (3) IN: weekly messages addressing misperceptions about peer attitudes towards gambling.

Outcome measures

Feasibility was assessed through recruitment and retention rates, intervention adherence, data completeness and feasibility and acceptability of the interventions and study procedures. Secondary outcomes included gambling risk behaviours and cognitions, anxiety, depression, quality of life, healthcare use and productivity, measured at baseline, 7-weeks, and 3- and 6-months post-randomisation.

Results

Recruitment took place between April 2021 and August 2022 with final follow-up in February 2023. 167 participants (mean age 51.5; 36% male) were randomised (GS=43; DN=41; IN=42; Control=41). Retention at 6-months was 95.2%, with >95% completion for all outcome measures. Intervention adherence was high, with >95% of DN and IN participants responding to ≥4 messages and 93% of GS participants setting ≥4 goals. Qualitative findings indicated broad acceptability of the interventions and study procedures.

Conclusions

The study was feasible to conduct, interventions and study procedures acceptable to participants, and predefined progression criteria met. Findings support proceeding to a full-scale randomised controlled trial of effectiveness and cost-effectiveness, focusing on the social norms interventions.

Trial registration number

ISRCTN37874344.

Does blended learning have a place in nurse education?

Por: Evans · D.

Commentary on: Wang R, Raman A. Systematic literature review on the effects of blended learning in nursing education. Nurse Educ Pract. 2024 Dec 16; 82:1 04 238–8.

Implications for practice and research

  • The authors report in their systematic literature review that many studies demonstrated how blended learning (BL) positively influenced nursing students, while some other studies did not.

  • They have developed a model to illustrate the multifaceted aspects of BL in nursing education.

  • They largely support the use of BL in nurse education but advocate more randomised controlled trials, especially in relation to its effects on mental health and in relation to optimal BL conditions for nurse education.

  • Context

    Blended learning (BL) in nurse education appears to be used more since COVID-19 and in countries whose governments’ policies support and promote the application of BL. The authors, educators in universities in China and Malaysia,...

    Getting recovery right after neck dissection for head and neck cancer (GRRAND): trial protocol for a multicentre, pragmatic randomised controlled trial with health economic evaluation and process evaluation

    Por: Evans · C. · Greene · L. · Hossain · A. · Klear · P. · Ratna · M. · Bradley · H. · Lall · R. · Mistry · H. · Naghdi · S. · Reategui · M. · Stevens · T. · Bruce · J. · Price · R. · Schache · A. · Dean · S. G. · Lamb · S. E. · Smith · T. · Winter · S. C.
    Introduction

    Head and neck cancer (HNC) affects the mouth, throat, salivary glands, voice box, nose or sinuses. Every year, over 12 000 people in the UK are diagnosed with HNC. Neck dissection is a key, surgical component of patient care. However, many people experience postoperative restriction in shoulder and neck movements, pain, fatigue and low mood, with only half ever returning to work.

    Methods and analysis

    Getting Recovery Right After Neck Dissection (GRRAND) is a two-arm, multicentre, pragmatic randomised controlled trial. The trial aims to compare clinical and cost-effectiveness of a personalised physiotherapy programme (GRRAND programme) versus usual practice, National Health Service (NHS), postdischarge care.

    The planned sample size is 390 participants. Participants will be recruited from across UK sites and followed up for 12 months. The primary outcome is the shoulder pain and disability index at 12 months. Economic evaluation will be conducted from a healthcare system and personal social services perspective. Secondary outcome data, including pain, function, health-related quality of life, mental well-being, health resource use and adverse events, will be collected at 6 weeks, 3, 6 and 12 months, with exercise adherence at 6 weeks. A process evaluation will determine how GRRAND is implemented, delivered and received across clinical settings, exploring what works, for whom and under what conditions. Analysis will be on an intention-to-treat basis and reported inline with the Consolidated Standards of Reporting Trials statement.

    Ethics and dissemination

    The trial was approved by the London-Brent Research Ethics Committee (ref: 24/LO/0722) on 15 October 2024. Trial results will be disseminated via peer-reviewed publications, presentations at national and international conferences, in lay summaries and social media. This protocol adheres to the recommended Standard Protocol Items: Recommendations for Interventional Trials checklist.

    Trial registration number

    ISRCTN13855775.

    Personalised Exercise Rehabilitation FOR people with Multiple long-term conditions (PERFORM): findings from a process evaluation of a randomised feasibility study

    Por: Brown · S. E. · Simpson · S. A. A. · Greaves · C. · Daw · P. · Dean · S. G. · Evans · R. A. · Withers · T. M. · Ahmed · Z. · Barber · S. · Barwell · G. · Doherty · P. J. · Gardiner · N. · Ibbotson · T. · Jani · B. · Jolly · K. · Mair · F. · Manifield · J. R. · McIntosh · E. · Miller · D. · O
    Objective

    The number of people living with multiple long-term conditions (MLTCs or ‘multimorbidity’) is growing. Evidence indicates that exercise-based rehabilitation can improve health-related quality of life and reduce hospital admissions for a number of single long-term conditions. However, it is increasingly recognised that such condition-focused rehabilitation programmes do not meet the needs of people living with MLTCs. The aims for this study were to (1) evaluate the acceptability and feasibility of the newly developed Personalised Exercise Rehabilitation FOR people with Multiple long-term conditions (PERFORM) intervention; (2) assess the feasibility of study methods to inform progression to a definitive randomised controlled trial (RCT) and (3) refine our intervention programme theory.

    Design

    Semi-structured qualitative interviews were conducted with patients receiving and healthcare practitioners delivering the PERFORM intervention, to seek their experiences of the intervention and taking part in the study. Interviews were analysed thematically, informed by Normalisation Process Theory and the programme theory.

    Setting

    Three UK sites (two acute hospital settings, one community-based healthcare setting).

    Participants

    18 of the 60 PERFORM participants and 6 healthcare professionals were interviewed.

    Intervention

    The intervention consisted of 8 weeks of supervised group-based exercise rehabilitation and structured self-care symptom-based support.

    Results

    All participants and staff interviewed found PERFORM useful for physical and mental well-being and noted positive impacts of participation, although some specific modifications to the intervention delivery and training and study methods were identified. Scheduling, staffing and space limitations were barriers that must be considered for future evaluation and implementation. Key intervention mechanisms identified were social support, patient education, building routines and habits, as well as support from healthcare professionals.

    Conclusions

    We found the PERFORM intervention to be acceptable and feasible, with the potential to improve the health and well-being of people with MLTCs. The findings of the process evaluation inform the future delivery of the PERFORM intervention and the design of our planned full RCT. A definitive trial is needed to assess the clinical and cost-effectiveness.

    Trial registration number

    ISRCTN68786622.

    Personalised exercise-rehabilitation for people with multiple long-term conditions (PERFORM): a randomised feasibility study

    Por: Evans · R. A. · Simpson · S. A. · Manifield · J. R. · Ahmed · Z. · Barber · S. · Barwell · G. · Brown · S. E. · Daw · P. · Dean · S. G. · Doherty · P. J. · Fraser · H. · Gardiner · N. · Greaves · C. · Ibbotson · T. · Jani · B. · Jolly · K. · Mair · F. · McIntosh · E. · Megaritis · D. · Mille
    Objective

    Existing exercise-based rehabilitation services, such as cardiac and pulmonary rehabilitation, are traditionally commissioned around single long-term conditions (LTCs) and therefore may not meet the complex needs of adults with multiple long-term conditions (MLTCs) or multimorbidity. The aim of this study was to assess the feasibility and acceptability of the newly developed personalised exercise-rehabilitation programme for people with multiple long-term conditions (PERFORM) and the trial methods.

    Design

    A parallel two-group mixed-methods feasibility randomised controlled trial (RCT) with embedded process and economic evaluation.

    Setting

    Three UK sites (two acute hospital settings, one community-based healthcare setting).

    Participants

    60 adults with MLTCs (defined as the presence of ≥2 LTCs) with at least one known to benefit from exercise therapy were randomised 2:1 to PERFORM intervention plus usual care (PERFORM group) or usual care alone (control group).

    Intervention

    The intervention consisted of 8 weeks of supervised group-based exercise rehabilitation and structured self-care symptom-based support.

    Primary and secondary outcome measures

    Primary feasibility outcomes included: trial recruitment (percentage of a target of 60 participants recruited within 4.5 months), retention (percentage of participants with complete EuroQol data at 3 months) and intervention adherence (percentage of intervention group attending ≥60% sessions). Other feasibility measures included completion of outcome measures at baseline (pre-randomisation), 3 months post-randomisation (including patient-reported outcomes, exercise capacity and collection of health and social care resource use) and intervention fidelity.

    Results

    Target recruitment (40 PERFORM group, 20 control group) was met within the timeframe. Participants were 57% women with a mean (SD) age of 62 (13) years, body mass index of 30.8 (8.0) kg/m2 and a median of 4 LTCs (most common: diabetes (41.7%), hypertension (38.3%), asthma (36.7%) and a painful condition (35.0%)). We achieved EuroQol outcome retention of 76.7% (95% CI: 65.9% to 87.1%; 46/60 participants) and intervention adherence of 72.5% (95% CI: 56.3% to 84.4%; 29/40 participants). Data completion for attendees was over 90% for 11/18 outcome measures.

    Conclusions

    Our findings support the feasibility and rationale for delivering the PERFORM comprehensive self-management and exercise-based rehabilitation intervention for people living with MLTCs and progression to a full multicentre RCT to formally assess clinical effectiveness and cost-effectiveness.

    Trial registration number

    ISRCTN68786622.

    Prioritising methodological research questions for scoping reviews, mapping reviews and evidence and gap maps for health research: a protocol for PROSPECT Delphi study

    Por: Pollock · D. · Hasanoff · S. · McBride · G. · Kanukula · R. · Tricco · A. C. · Khalil · H. · Campbell · F. · Jia · R. M. · Alexander · L. · Peters · M. · Vieira · A. M. · Aromataris · E. · Nunn · J. · Saran · A. · Evans · C. · Godfrey · C. · Pieper · D. · de Moraes · E. B. · Biesty · L. · Co
    Introduction

    Scoping reviews, mapping reviews and evidence and gap maps (collectively known as ‘big picture reviews’) in health continue to gain popularity within the evidence ecosystem. These big-picture reviews are beneficial for policy-makers, guideline developers and researchers within the field of health for understanding the available evidence, characteristics, concepts and research gaps, which are often needed to support the development of policies, guidelines and practice. However, these reviews often face criticism related to poor and inconsistent methodological conduct and reporting. There is a need to understand which areas of these reviews require further methodological clarification and exploration. The aim of this project is to develop a research agenda for scoping reviews, mapping reviews and evidence and gap maps in health by identifying and prioritising specific research questions related to methodological uncertainties.

    Methods and analysis

    A modified e-Delphi process will be adopted. Participants (anticipated N=100) will include patients, clinicians, the public, researchers and others invested in creating a strategic research agenda for these reviews. This Delphi will be completed in four consecutive stages, including a survey collecting the methodological uncertainties for each of the big picture reviews, the development of research questions based on that survey and two further surveys and four workshops to prioritise the research questions.

    Ethics and dissemination

    This study was approved by the University of Adelaide Human Research Ethics Committee (H-2024-188). The results will be communicated through open-access peer-reviewed publications and conferences. Videos and infographics will be developed and placed on the JBI (previously Joanna Briggs Institute) Scoping Review Network webpage.

    Evaluating the effectiveness of community health worker interventions on glycaemic control in type 2 diabetes mellitus: a systematic review and meta-analysis

    Por: Evans · J. · Ha · H. · White · P. T.
    Objective

    Community health worker (CHW) interventions in control of HbA1c levels in diabetes have shown varied effects in randomised controlled trials. In the systematic review reported here, we aimed to evaluate the independent effectiveness of CHW interventions on the control of HbA1c levels in adults with type 2 diabetes.

    Design

    Systematic review and meta-analysis.

    Participants

    1684 participants from 7 studies were included.

    Interventions

    Randomised controlled trials of adults with type 2 diabetes receiving CHW interventions of at least 12 months’ duration compared with usual care were eligible. Databases searched were Ovid MEDLINE, the Cochrane Central Register, CINAHL and Web of Science from 2000 to March 2025. Quality was assessed using the Cochrane RoB2 tool.

    Primary outcome measure

    Through meta-analysis, we calculated the mean weighted difference (MWD) of change in HbA1c level from baseline between groups using RevMan.

    Results

    Seven of 86 retrieved studies were eligible. Six studies were suitable for meta-analysis and included 1280 participants. An inverse variance weighted meta-analysis showed a significant improvement in pooled HbA1c level with an MWD of 0.50% (0.28%, 0.71%) in the CHW group (p2=21%), and the overall level of certainty was high.

    Conclusions

    CHW interventions in type 2 diabetes showed statistically significant and clinically important reductions in HbA1c levels in people from minority ethnic groups on low income.

    Women's information needs, decision-making and experiences of membrane sweeping to promote spontaneous labour

    UK policy currently recommends membrane sweeping to avoid prolonged pregnancy and reduce the need for formal induction. Guidance from the National Institute for Health and Care Excellence (NICE, 2008) on induction of labour recommends that at 40- and 41-week antenatal visits, nulliparous women should be offered membrane sweeping prior to formal induction and additional membrane sweeping may be offered if labour does not start spontaneously. Updates to the guideline are expected in July 2020. NICE Quality Standard [QS22] (NICE, 2016) for antenatal care additionally recommends that women having their second or later baby are offered membrane sweeping.
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