First post-contrAst SubtracTed (FAST) MRI, an abbreviated breast MRI scan, has high sensitivity for sub-centimetre aggressive breast cancer and short acquisition and interpretation times. These attributes promise effective supplemental screening. Until now, FAST MRI research has focused on women above population-risk of breast cancer (high mammographic density or personal history). DYAMOND aims to define the population within the population-risk NHS Breast Screening Programme (NHSBSP) likely to benefit from FAST MRI. The study population is the 40% of screening clients aged 50–52 who have average mammographic density (BI-RADS (Breast Imaging Reporting and Data System) B) on their first screening mammogram. DYAMOND will answer whether sufficient numbers of breast cancers, missed by mammography, can be detected by FAST MRI to justify the inclusion of this group in a future randomised controlled trial.

Prospective, multicentre, diagnostic yield, single-arm study with an embedded qualitative sub-study: all recruited participants undergo a FAST MRI. An internal pilot will assess the willingness of sites and screening clients to participate in the study. Screening clients aged 50–52, with a clear first NHSBSP mammogram and BI-RADS B mammographic density (by automated measurement) will be invited to participate (recruitment target: 1000). The primary outcome is the number of additional cancers detected by FAST MRI (missed by screening mammography). A Fleming’s two-stage design will be used as this allows for early stopping after stage 1, to save participants, funding costs and time continuing to the end of the study if the question can be answered earlier.

The NHSBSP Research and Innovation Development Advisory Committee and the Yorkshire and Humber–Sheffield Research Ethics Committee (23/YH/0268, study ID (IRAS): 330059) approved this research protocol. Participation involves a two-stage informed consent process, enabling screening for eligibility through automated mammographic density measurement. Patients with breast cancer helped shape the study design and co-produced participant-facing documents. They will disseminate the results to the public in a clear and meaningful way. Results will be published with open access in international peer-reviewed scientific journals.

ISRCTN74193022

To assess the feasibility of delivering the swallowing prehabilitation intervention known as Swallowing Intervention Package: Self-Monitoring, Assessment and Rehabilitation Training (SIP SMART) within the National Health Service (NHS) head and neck cancer care pathway.

Two-arm cluster-randomised pilot trial: SIP SMART2 trial.

Adults newly diagnosed with stage II–IV head and neck cancer receiving curative treatment within a multidisciplinary team who agree to participate.

Six hospitals were randomised. Trained clinicians at the intervention sites delivered the manualised SIP SMART intervention, while standard care was provided at care as usual (CAU) sites. The intervention included two 45-minute consultations incorporating an X-ray swallow assessment, tailored exercises/advice and specific behaviour change strategies while CAU involved a single consultation of information giving and provision of a generic exercise sheet.

Study outcomes related to feasibility of the cluster-randomised design, recruitment of both sites and patients and completeness of clinical and health economic data collected at baseline, 4 weeks, 12 weeks and 24 weeks after treatment.

12 hospitals expressed interest and six were randomised (50%) and provided data to the point of study completion. Patient recruitment across all sites (n=76) reached the target, although two sites fell short of their individual targets. The proportion of people with HNC recruited versus those eligible for each arm was 39% (95% CI 29 to 49) for SIP SMART group and 55% (95% CI 43 to 66) for CAU. The end point data at 24 weeks were completed for 50% (95% CI 33 to 67) for SIP SMART and 78% (95% CI 62 to 89) for CAU. Adherence to the intervention was above 50% at all time points. No harms related to the intervention were reported.

It is feasible to deliver the SIP SMART intervention embedded within the NHS cancer care pathway using a cluster-randomised design. A future trial will be optimised for efficiency in set-up and follow-up data collection based on these findings and learnings from the accompanying process evaluation study.

ISRCTN12377415.

Ebola virus disease remains a significant public health concern. For protection from Ebola virus, the main target populations are epidemiologically identified and often include healthcare workers and refugees. These target populations are also routinely offered vaccines for other vaccine-preventable diseases. However, concomitant use of rVSVG-ZEBOV-GP with other vaccines is not recommended, given the absence of data regarding its reactogenicity and antigen-specific immunogenicity profile when co-administered. The EbolaCov trial aims to inform whether rVSVG-ZEBOV-GP can be administered concurrent to a Pfizer–BioNTech COVID-19 booster dose without an unacceptable increase in reactogenicity and/or loss of humoral immunogenicity to Ebola vaccine antigen.

This is a single-centre, randomised, single-blinded, vaccine safety and immunogenicity study in healthy adults living in Rwanda. Seventy-two participants will be randomised in a 1:1 ratio to two study groups, the first receiving rVSVG-ZEBOV-GP with a placebo, the second group receiving rVSVG-ZEBOV-GP concurrently with a Pfizer–BioNTech COVID-19 booster dose. The primary outcome measures are quantitative serum anti-glycoprotein (GP) antibody responses, as measured by ELISA, 28 days after vaccination, and frequency and severity of adverse events in the 7 days following vaccination. Secondary outcome measures include day 28 and day 180 serum anti-GP and serum SARS-CoV-2 anti-spike protein-specific geometric mean antibody titres.

This trial was approved by the Rwanda National Ethics Committee (reference 442/2024) and the University of Birmingham (reference ERN_2661-Jun2024). All participants were required to provide written informed consent in accordance with good clinical practice. Dissemination of results will be through conference presentations and peer-reviewed publications.

Pan African Clinical Trials Registry (PACTR202407764378004) and ClinicalTrials.gov (NCT06587503)

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.

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.

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.

NCT06849245.

Relational continuity of care (RCC) refers to the sustained therapeutic relationship between a patient and a clinician, which fosters trust, enhances communication and facilitates the accumulation of knowledge about the patient. RCC is associated with enhanced patient outcomes, reduced hospital admissions, lower mortality rates, decreased healthcare costs and improved patient experience. Despite these benefits, reorganisations within the NHS and workforce challenges have led to an increased reliance on multidisciplinary and part-time working, resulting in fragmented care and a decline in RCC. Our study aims to explore who needs RCC, under what circumstances, to what extent and why, with the goal of informing optimal implementation strategies.

We will conduct a realist review to develop an evidence-based programme theory explaining the mechanisms underlying RCC, the populations that benefit most, the contextual factors influencing RCC and effective care models. Following Pawson’s five iterative stages, we will: (1) Locate existing theories, (2) Search for relevant evidence, (3) Select appropriate articles, (4) Extract and organise data and (5) Synthesise findings to draw conclusions. A stakeholder advisory group, comprising policymakers, healthcare professionals, public contributors and patients, will be engaged throughout the process. We will adhere to Realist And Meta-narrative Evidence Synthesis: Evolving Standards (RAMESES) for realist reviews to ensure methodological rigor.

Our findings will inform practical, evidence-based recommendations for optimising RCC within general practice. Outputs will include peer-reviewed publications, conference presentations, plain English summaries, social media infographics, a short video and end-of-study events. Collaborations with stakeholders and public involvement will ensure both accessibility and impact. Ethical approval is not required for this review.

Difficulty with walking can lead to reduced quality of life for people with Parkinson’s disease (pwPD); improving walking is considered a treatment priority. Drug therapies can control PD symptoms; however, pwPD often still experience mobility problems.

Functional electrical stimulation (FES) induces movement in weak muscles via external electrical stimulation. FES is used in stroke and multiple sclerosis patients to correct dropped foot by stimulating the common peroneal nerve and is associated with improved quality of life and mobility. The randomised feasibility study preceding this definitive study showed that daily FES can produce a clinically meaningful improvement in walking speed in pwPD; this was sustained 4 weeks after FES was withdrawn. STEPS II is the first definitive randomised controlled trial, with blinded outcome assessment, aiming to determine the efficacy of FES in pwPD.

STEPS II is a two-group, parallel, assessor-blinded, superiority randomised controlled trial with an internal pilot, designed to compare FES plus usual care versus usual care alone. 234 participants will be randomised across eight UK sites. Telephone pre-screening and face-to-face screening will determine eligibility. The intervention group will attend four unblinded FES visits to receive the device and assess walking with and without FES. All participants have blinded assessments at baseline and weeks 2, 6, 18 and 22. The primary objective is to compare whole body bradykinesia at 18 weeks post-baseline via changes in 10m walking speed. Secondary objectives will assess the wider effects of FES on Parkinsonian gait and quality of life. An embedded qualitative component will explore wider experiences of FES.

This study received ethical approval from the Yorkshire and The Humber-Sheffield Research Ethics Committee (reference 23/YH/0193). A Data Monitoring Committee and Trial Steering Committee will provide independent oversight. Dissemination will be via publications, conferences and social media. FES intervention and training materials will be made open access.

ISRCTN13120555.

An increasing number of teenagers and young adults (TYA) with chronic conditions and complex needs are transitioning from paediatric to adult services, including admission to intensive care units (ICUs). As these services are often ill-equipped to care for TYA, there is a risk of compromised care. Despite recent guidelines from the UK Paediatric Critical Care and Intensive Care Societies highlighting the importance and urgency of improving ICU transition, current recommendations are not evidence-based and established pathways for ICU transition remain limited.

This mixed-methods research study aims to generate evidence to underpin national policy on transition from paediatric to adult ICUs that will improve clinical care and patient experience. To do this, we will: (1) link and analyse UK national data (years 2017–2024) on paediatric and adult ICU admissions, hospital inpatient, outpatient and emergency care visits and survival status, to determine the clinical characteristics and healthcare resource utilisation from teenage years to early adulthood of people admitted to an ICU as a young person (admission aged 14 and 15), and how these relate to ICU admissions after age 16; (2) conduct semistructured interviews, online forums and surveys with TYA patients, carers and health professionals to understand their experience of transition in ICU services; and (3) synthesise these strands of evidence and use a structured process of stakeholder engagement to propose potential targeted improvements as appropriate.

This study was approved by the East of England - Cambridge South Research Ethics Committee on 1 August 2024 (research ethics committee number 24/EE/0108), and the Health Research Authority Confidentiality Advisory Group (CAG) on 7 October 2024 (CAG number 24/CAG/0068). Study results will be actively disseminated through peer-reviewed journals, conference presentations and accessible lay texts and graphic summaries for the use of charities and patients including those with learning disabilities and neurodevelopmental disorders.

Elevated left ventricular end-diastolic pressure (LVEDP) in ST-segment elevation myocardial infarction (STEMI) has been studied in patients who received thrombolysis or who were treated early in the primary percutaneous coronary intervention (PCI) era; LVEDP was found to be a predictor of adverse outcomes in these retrospective post hoc analyses. The aim of the current analysis is to assess the prognostic value of the elevated LVEDP in STEMI patients undergoing primary PCI in current contemporary practice.

Prospective, single-centre study.

Our study enrolled STEMI patients with elevated LVEDP undergoing primary PCI at John Hunter Hospital, Newcastle, Australia.

The primary endpoint was the combination of 12-month all-cause mortality and heart failure admissions, comparing different quartiles of LVEDP.

A total of 997 patients underwent primary PCI at our hospital during the 5-year study period (age: 64±13 years, males: 73%; n=728) from 1 January 2015 to 31 December 2019. The median LVEDP for the whole cohort was 27 mm Hg (IQR: 22–31 mm Hg). The median LVEDP was 17 mm Hg (IQR: 13–18 mm Hg) and 33 mm Hg (IQR: 30–36 mm Hg) for 1st and 4th quartiles respectively (p

LVEDP is an independent predictor of adverse outcomes in STEMI patients, despite a relatively normal LVEF. Further prospective studies are needed to assess the effects of early reduction in LVEDP on the prognosis.

In qualitative research, there are different approaches to defining and engaging with social reality. Epistemology, as the study of knowledge and knowledge creation, influences the methodologies and theories used by researchers. A growing literature questions the universality of Western-centric and Global North research methodologies and theories and highlights their Western epistemological roots. While Western frameworks are appropriate for Western contexts, it is a fallacy to assume that they represent global realities, thereby marginalising Global South knowledge systems. Thus, the aim of this scoping review is to analyse the underlying epistemologies, methodologies or theories that are evident in qualitative research conducted by researchers from the Global North in their research on, for or with people from the Global South.

The review will be conducted using the Joanna Briggs Institute framework for scoping reviews. A search strategy will be developed to identify published and unpublished literature in CINAHL, Embase, Google Scholar, MEDLINE, ProQuest, PsycINFO and Web of Science. All potential papers will be exported to the reference manager Zotero, and the results will be uploaded to Rayyan. Studies are selected using a three-step process and documented using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses flowchart. The abstracted studies will then be collated using the PAGER framework to identify the patterns, advances, gaps, evidence and recommendations that help to understand the review question.

As this is a secondary analysis, our research does not require ethical approval, but we will scrutinise all included studies for inclusion of an ethical approval statement. We intend to share our findings through peer-reviewed international journals and presentations at conferences, as well as collaborating with colleagues in related fields.

The protocol for this scoping review has been registered with the Open Science Framework (https://doi.org/10.17605/OSF.IO/5BUZX).

The aim of this study was to explore the features of high-quality rural health student placements from the perspective of university staff involved in designing, delivering and evaluating these programmes.

A sequential explanatory mixed methods design was employed, integrating quantitative survey data with qualitative interview findings to provide a comprehensive understanding of the research question.

The study was conducted online and sampled staff from universities across Australia, focusing on rural health student placements. The study involved 121 university staff members who participated in the survey, with 10 of these participants also taking part in follow-up qualitative interviews.

Quantitative data were collected using an online survey distributed to university staff involved in designing, delivering and evaluating rural health student placements. The survey included Likert scale, open-ended and demographic questions, and a preliminary analysis was used to write the interview questions. Qualitative data were gathered through semi-structured interviews, which were transcribed and analysed using the Framework approach. The quantitative and qualitative results were integrated to produce a narrative summary of findings.

Key features identified as essential for high-quality rural health placements included safe and affordable accommodation, financial support and personal safety. High-quality supervision, cultural awareness training and opportunities for interprofessional education were also highlighted. The qualitative findings provided depth to the quantitative data, emphasising the importance of structuring learning within a continuum of education and fostering connections through co-location and community engagement.

This study identifies fundamental features of high-quality rural health placements in Australia, including accommodation, student safety, supervision and cultural responsiveness training. These findings can inform the design, delivery and evaluation of rural health student placements, contributing to the quality of these programmes as an efficacious learning experience.

Diabetes is one of the most common long-term health conditions worldwide, placing a huge economic burden on health services. Diabetes self-management education and support programmes can support people with diabetes to manage their condition; however, uptake of face-to-face services remains low. Digital self-management tools are becoming increasingly available. MyWay Diabetes is a digital platform that offers a comprehensive self-management and education programme accessible through a mobile app and website and allows patients to access their personal healthcare records. Following successful implementation in Scotland, MyWay Diabetes is now being rolled out in three geographical areas in England. We plan to undertake three qualitative studies, as part of a larger mixed-methods research programme, to assess whether MyWay Diabetes is acceptable across diverse patient groups and healthcare professionals and gather views of patients who do not currently use the digital service.

We will conduct three online focus group studies. (1) One focus group with healthcare professionals (n=6–10) to understand their perceptions of implementing MyWay Diabetes in their local regions. (2) Up to four focus groups with existing users of MyWay Diabetes (n=24–40) across the three geographical areas in England to explore their acceptability of the platform. (3) Up to three focus groups with people living with diabetes who do not currently use MyWay Diabetes (n=18–30). Data will be collected using online videoconferencing and analysed thematically using template analysis.

Ethical approval was granted by South Central – Berkshire Research Ethics Committee (ref: 25/SC/0125) and The University of Manchester Proportionate Research Ethics Committee (ref: 2025-23064-42006). Study results will be disseminated through peer-reviewed journals, conference presentations, MyWay Digital Health platforms and national bodies. The evidence from this broader mixed-methods evaluation will inform decisions for platform improvement and regional and national commissioning across the National Health Service in England.

To quantify the carbon footprint of a sample of clinical trials for neurological disorders.

Cross-sectional study.

Two clinical trial registries were searched on 29 December 2022 for phase 2–4 randomised controlled trials led from and recruiting in the UK, enrolling people with any of the 15 neurological disorders with the highest global burden, that had started recruitment or been registered in the preceding 5 years. Eligible trials were invited to share data to estimate emissions in each of the 10 modules of the Low Carbon Clinical Trials footprinting guidance. The primary outcome measure was kg of carbon dioxide equivalent (CO₂e).

318 randomised controlled trials were found, nine were eligible and six shared data (three completed and three ongoing). The module with the highest estimated CO₂e for each trial was the Clinical Trial Unit staff emissions (median 24 126 kg CO2e, IQR 10 395–78,867; range 45–79% of overall emissions of each trial); commuting accounted for >50% of CO₂e in this module. The second and third highest modules were trial-specific participant assessments (median 11 497 kg CO2e, IQR 825–15,682) and trial supplies and equipment (median 1161 kg CO₂e, IQR 226–6632). The total carbon footprint of these six trials involving 2248 participants at 239 sites was 2 63 215 kg CO₂e.

Emissions by Clinical Trials Unit staff were the top modifiable carbon hotspot in six randomised controlled trials for people with neurological disorders, which had a total carbon footprint equivalent to 1364 passengers’ return aeroplane journeys between London and Edinburgh.

Heart failure with preserved ejection fraction (HFpEF) is common and causes functional limitation, poor health-related quality of life (HRQoL) and impairs prognosis. Exercise-based cardiac rehabilitation is a promising intervention for HFpEF, but there is currently insufficient evidence to support its routine use. This trial will assess the clinical and cost-effectiveness of a 12-week health professional-facilitated, home-based rehabilitation intervention (REACH-HF), in people with HFpEF, for participants and their caregivers.

REACH-HFpEF is a parallel two group multicentre randomised controlled trial with 1:1 individual allocation to the REACH-HF intervention plus usual care (intervention group) or usual care alone (control group) with a target sample size of 372 participants with HFpEF and their caregivers recruited from secondary care centres in United Kingdom. Outcome assessment and statistical analysis will be performed blinded; outcomes will be assessed at baseline and 4-month and 12-month follow-up. The primary outcome measure will be patients’ disease-specific HRQoL, measured using the Minnesota Living with Heart Failure questionnaire, at 12 months. Secondary outcomes include patient's exercise capacity, psychological well-being, level of physical activity, generic HRQoL, self-management, frailty, blood biomarkers, mortality, hospitalisations, and serious adverse events, and caregiver's HRQoL and burden. A process evaluation and substudy will assess the fidelity of intervention delivery and adherence to the home-based exercise regime and explore potential mediators and moderators of changes in HRQoL with the intervention. Qualitative studies will describe facilitators’ experiences of delivery of the intervention. A cost-effectiveness analysis (CEA) of the REACH-HF intervention in participants with HFpEF will estimate incremental cost per quality-adjusted life year at 12 months. The CEA will be conducted from a UK NHS and Personal Social Services perspective and a wider societal perspective. The adequacy of trial recruitment in an initial 6-month internal pilot period will also be checked.

The study is approved by the West of Scotland Research Ethics Committee (ref 21/WS/0085). Results will be disseminated via peer-reviewed journal publication and conference presentations to researchers, service users and policymakers.

ISRCTN47894539.

To identify currently available functional vision tests and evaluate their use as clinical trial outcome measures in ophthalmology.

Scoping review using the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-analysis Extension for Scoping Reviews) guidelines.

A literature search was conducted in MEDLINE and Embase (via Ovid) for articles published between 1 January 2003 and 1 August 2024. Additional grey literature was sourced from institutional repositories, conference proceedings and a manual citation search. Article screening was conducted against a predefined inclusion criteria by two independent, masked reviewers, with a third reviewer acting as arbiter. The inclusion criteria were English language articles which feature a test assessing functional vision in patients with an ophthalmological disease. Details of source characteristics, test methodology and accessibility and evidence of test validation were collected.

Of 2665 articles returned by the search, 73 were included and 45 unique tests of functional vision were identified. Diseases affecting the peripheral retina were mainly affected, accounting for 77% (56 out of 73) of the diseases featured in all included studies. Overall, 82% (37 out of 45) functional vision tests reported evidence of statistical validation with varying robustness. Functional vision tests were mapped to domains of orientation and mobility, facial recognition, observer-rated task performance, visual search and driving. Obstacle courses assess vision-guided orientation and mobility, correlate highly with clinical measures of visual function in severe peripheral retinal disease and have been validated for use in clinical trials. Their requirement of physical space and time limits utility in multicentre trials; equivalent tests leveraging virtual reality and eye tracking technologies are in development. Early iterations of visual search tests to simulated realistic scenes have demonstrated discriminative ability, even in paediatric patients.

Functional vision tests can facilitate research into future novel ophthalmological treatments that prioritise patients in terms of how clinical benefit is defined. The principal barriers to the uptake of these tests are lack of accessibility, low quality validation and that many tests remain early in their development stage. This review captures the current landscape of functional vision tests and serves as a reference for investigators and regulatory bodies to evaluate the suitability of these tests for ophthalmic clinical trials.

This study aims to validate a high-fidelity three-dimensional (3D)-printed head and neck model for training emergency medicine (EM) physicians, primary care physicians and allied health professionals in managing 10 common ear, nose and throat (ENT) emergencies.

The study was conducted at an ENT Emergencies course in London.

Prospective validation study.

All delegates (n=90) were healthcare professionals. Among them, 60% (n=54) were EM residents/trainees, 28% (n=25) were primary care residents/trainees, 4% (n=4) were ENT residents/trainees, 4% (n=4) were emergency nurse practitioners, 2% (n=2) were primary care attending physicians and 1% (n=1) was an EM attending/consultant. All faculty were consultant ENT surgeons (n=11).

The 3D models, produced using proprietary 3D printing technology (Fuesetec), were used in a 1-day ENT emergencies course for validating training and confidence of delegates in performing 10 common ENT emergencies.

A total of 86% (n=77) of delegates found the models extremely or very helpful in learning ENT emergencies. Delegates rated the resemblance to real patients as excellent or very good in both haptic feedback (n=58, 64%) and tissue texture (n=67, 74%). Additionally, 74%–96% of delegates felt confident in performing the 10 ENT procedures after using the models.

The 3D models enhanced participant confidence in performing 10 common ENT emergency procedures, demonstrating good face, content and indirect criterion validity. These models could support emergency ENT skill development in local emergency departments.

Sodium-glucose co-transporter inhibitors have potential glycaemic and non-glycaemic benefits in people with type 1 diabetes (T1D). However, the increased risk of diabetic ketoacidosis (DKA) limits their widespread use. We hypothesise that dapagliflozin 10 mg daily, combined with the use of continuous ketone monitoring (CKM) and education strategies to mitigate progression to DKA, will demonstrate improved glycaemic control without increasing DKA events.

PARTNER is a multisite 6-month randomised crossover double-masked study involving Australian adults with T1D who have a Haemoglobin A1c (HbA1c)

The study has received ethical approval from the St Vincent’s Hospital Melbourne Human Research Ethics Committee (HREC reference 302/23). The results will be published in peer-reviewed journals and presented at national and international diabetes conferences.

ACTRN12624000448549.

Evidence that smoking cessation benefits physical and mental health has led to recommendations to support quitting. Unsuccessful quit attempts are common and associated with guilt and frustration; however, their impact on mental health is unclear. This review investigated the association between the success/failure of smoking cessation attempts and changes in symptoms of depression and anxiety.

Systematic review and meta-analysis, following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines.

Inclusion and exclusion lists of two previous reviews, plus update searches of Embase, Medline and PsycINFO (January 2020–January 2025).

Trials and longitudinal observational studies measuring symptoms of anxiety or depression before and after a smoking cessation attempt, beyond the withdrawal period (6 weeks), in adults who successfully quit and made an unsuccessful attempt.

Standardised methods were used for screening and data extraction. Two independent reviewers screened a minimum of 25% and extracted data for 100% of studies. Meta-analyses were conducted using random effects models, and narrative synthesis was used when necessary. Study quality, heterogeneity and publication bias were assessed using the adapted Newcastle-Ottawa Scale, I² and funnel plots, respectively.

62 studies were included, representing 36 150 participants. Most featured behavioural smoking cessation interventions and defined successful cessation attempts by self-reported or biologically verified abstinence. Follow-up ranged from 6 weeks to 4 years. Overall, successfully quitting smoking was associated with reduced symptoms of depression (standardised mean difference (SMD)=–0.21, 95% CI –0.27 to –0.16) and anxiety (SMD=–0.22, 95% CI –0.33 to –0.12) compared with unsuccessful quit attempts. Heterogeneity was substantial (I²=50-69%).

Most studies indicated a positive trend in alleviating symptoms of anxiety and depression during a quit attempt. Successful quitters experienced more substantial reductions in these symptoms compared with those who were unsuccessful. Importantly, those who made an unsuccessful quit attempt did not experience worse mental health.

CRD42022314728.

The majority of studies in our review indicated a positive trend in alleviating symptoms of anxiety and depression when individuals attempt to quit smoking. Successful quitters experienced more substantial reductions in these symptoms compared with those who were unsuccessful. Importantly, those who attempted to quit but failed did not experience worse mental health. These findings are relevant to people who smoke tobacco and the health professionals who support them as they may hold some apprehensions about quitting smoking or the anticipated emotional consequences of failing to quit. The current review contributes to clinical practice by adding to the information on which risk-benefit decisions are made regarding smoking cessation.