Prehabilitation in elective patients undergoing cardiac surgery: a randomised control trial (THE PrEPS TRIAL) - a study protocol

\ua9 Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. INTRODUCTION: Prehabilitation prior to surgery has been shown to reduce postoperative complications, reduce length of hospital stay and improve quality of life after cancer and limb reconstruction surgery. However, there are minimal data on the impact of prehabilitation in patients undergoing cardiac surgery, despite the fact these patients are generally older and have more comorbidities and frailty. This trial will assess the feasibility and impact of a prehabilitation intervention consisting of exercise and inspiratory muscle training on preoperative functional exercise capacity in adult patients awaiting elective cardiac surgery, and determine any impact on clinical outcomes after surgery. METHODS AND ANALYSIS: PrEPS is a randomised controlled single-centre trial recruiting 180 participants undergoing elective cardiac surgery. Participants will be randomised in a 1:1 ratio to standard presurgical care or standard care plus a prehabilitation intervention. The primary outcome will be change in functional exercise capacity measured as change in the 6 min walk test distance from baseline. Secondary outcomes will evaluate the impact of prehabilitation on preoperative and postoperative outcomes including; respiratory function, health-related quality of life, anxiety and depression, frailty, and postoperative complications and resource use. This trial will evaluate if a prehabilitation intervention can improve preoperative physical function, inspiratory muscle function, frailty and quality of life prior to surgery in elective patients awaiting cardiac surgery, and impact postoperative outcomes. ETHICS AND DISSEMINATION: A favourable opinion was given by the Sheffield Research Ethics Committee in 2019. Trial findings will be disseminated to patients, clinicians, commissioning groups and through peer-reviewed publication. TRIAL REGISTRATION NUMBER: ISRCTN13860094

Accelerometer-Measured Physical Activity After Mitral Valve Surgery: An Analysis of the UK Mini Mitral Randomized Controlled Trial

\ua9 2025 The Authors. Circulation is published on behalf of the American Heart Association, Inc., by Wolters Kluwer Health, Inc.BACKGROUND: Wearable accelerometer devices measure free-living physical activity and sleep without relying on self-reports. Their utility to measure and compare recovery of physical function after cardiac surgery procedures has not been previously studied in the setting of a randomized controlled trial. METHODS: Data were collected during the UK (United Kingdom) Mini Mitral trial, in which patients were randomized to undergo either a sternotomy or a minimally invasive thoracoscopically guided right minithoracotomy procedure (Mini) for mitral valve repair. This is a secondary analysis of the trial data using a different primary end point. Patients wore a wrist-worn triaxial accelerometer on their nondominant wrist for 24 hours over a 7-day period before surgery and at 6, 12, 18, 24, 38, and 52 weeks after surgery. Accelerometer outcomes included the change from baseline to 52 weeks in total activity counts and time spent in moderate-to-vigorous physical activity, light physical activity, and sedentary time. Time spent asleep and sleep efficiency were also captured. Accelerometry data were processed and analyzed by researchers blinded to the surgical approach. RESULTS: A total of 230 patients (115 in each trial arm) provided valid accelerometry data. There were significant differences between arms in total activity counts; the mean difference was 26744 (95% CI, 9085–44403; P=0.003) at 6 weeks and 26060 (95% CI, 6971–45149; P=0.008) at 18 weeks, both favoring Mini. Time spent in moderate-to-vigorous physical activity also favored the Mini arm at 6 and 18 weeks, with mean differences of 15 (95% CI, 5.7–24; P=0.001) and 9.9 (95% CI, 0.31–20; P=0.043) minutes per day, respectively. Those in the Mini arm also had significantly lower sedentary time (at 12, 18, and 24 weeks) and spent more time in light physical activity (at 18 weeks) than those in the sternotomy arm. There were no differences in sleep duration between arms at any time point, although those in the Mini arm had higher sleep efficiency than those in the sternotomy arm at 12 weeks. CONCLUSIONS: This analysis from the UK Mini Mitral trial suggests that wearable accelerometer devices can be used to compare recovery after surgical procedures. The data support an overall decline from baseline activity to 52 weeks in patients undergoing a sternotomy and an earlier recovery of physical activity after a minimally invasive thoracoscopically guided right minithoracotomy approach

Effects of a novel, brief psychological therapy (Managing Unusual Sensory Experiences) for hallucinations in first episode psychosis (MUSE FEP): Findings from an exploratory randomised controlled trial

\ua9 2024Hallucinations are a common feature of psychosis, yet access to effective psychological treatment is limited. The Managing Unusual Sensory Experiences for First-Episode-Psychosis (MUSE-FEP) trial aimed to establish the feasibility and acceptability of a brief, hallucination-specific, digitally provided treatment, delivered by a non-specialist workforce for people with psychosis. MUSE uses psychoeducation about the causal mechanisms of hallucinations and tailored interventions to help a person understand and manage their experiences. We undertook a two-site, single-blind (rater) Randomised Controlled Trial and recruited 82 participants who were allocated 1:1 to MUSE and treatment as usual (TAU) (n = 40) or TAU alone (n = 42). Participants completed assessments before and after treatment (2 months), and at follow up (3–4 months). Information on recruitment rates, adherence, and completion of outcome assessments was collected. Analyses focussed on feasibility outcomes and initial estimates of intervention effects to inform a future trial. The trial is registered with the ISRCTN registry 16793301. Criteria for the feasibility of trial methodology and intervention delivery were met. The trial exceeded the recruitment target, had high retention rates (87.8%) at end of treatment, and at follow up (86.6%), with good acceptability of treatment. There were 3 serious adverse events in the therapy group, and 5 in the TAU group. Improvements were evident in both groups at the end of treatment and follow up, with a particular benefit in perceived recovery in the MUSE group. We showed it was feasible to increase access to psychological intervention but a definitive trial requires further changes to the trial design or treatment

Feasibility and acceptability of autism adapted safety plans: an external pilot randomised controlled trial.

Autistic people are a high-risk group for self-harm and suicide. There are no evidence-based suicide prevention interventions developed specifically for autistic people. We undertook a pilot feasibility randomised controlled trial of autism adapted safety plans (AASP) to reduce self-harm and suicide for autistic people. This study took place in the United Kingdom and followed a randomised, two-arm, controlled design. Autistic adults (n=53, mean age=39, gender=49% female, 29% not male or female) were recruited via third sector organisations and self-referral between 11.8.21 and 19.10.22. Participants were randomised without stratification to usual care with or without AASP. The AASP was completed by the autistic adults together with someone trained to support them. Research staff who completed follow-up assessments were blind to participant allocation. Primary outcomes were feasibility and acceptability. Participants were assessed at baseline, 1 and 6 months. Primary data were analysed under the intention to treat principle. Study protocol is published. The trial is closed to new participants. This study is registered with the ISRCTN registry, ISRCTN70594445. 53 participants consented, 49 were randomised to either AASP with usual care (n=25) or usual care (n=24). 68% of participants in the AASP arm were satisfied with the AASP and 41% rated it as useable. Feedback on the AASP and research methods were positive with suggested adaptations to some outcome measures. Retention and completion of outcomes measures in both arms was excellent, as was fidelity of delivery of the AASP. Study progression criteria were met, suggesting that the parameters of a future definitive trial of clinical and cost effectiveness of AASP to reduce self-harm and suicide in autistic adults are achievable, with minor recommended adaptions to outcome measures and AASP. Future research should explore the use of AASP in routine clinical practice. This study is funded by the NIHR [Public Health Research Programme (NIHR129196)]. [Abstract copyright: © 2024 The Authors.

Case-mix-adjusted mean number of polyps per 100 procedures: a new candidate gold standard colonoscopy key performance indicator

\ua9 Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.Objective Adenoma detection rate (ADR) has been criticised as a colonoscopy key performance indicator (KPI), for excluding serrated polyps, requiring histological data and fostering a ‘one-and-done’ attitude. We hypothesised that a case-mix-adjusted mean number of polyps (aMNP) would address these criticisms and provide a better measure of colonoscopy quality. We aimed to develop an aMNP using the National Endoscopy Database (NED) and assess its relationship with quality metrics. Methods We extracted colonoscopy data from NED for 1 January 2019–4 April 2019. Multiple negative binomial regression was undertaken to estimate effects of patient variables on MNP and generate aMNP. Associations between aMNP and polyp detection rate (PDR), proximal polypectomy rate (PPR), postcolonoscopy colorectal cancer (PCCRC) rate and Joint Advisory Group for GI endoscopy (JAG) Global Rating Scale (GRS) were explored. Results 92 892 colonoscopies were analysed. Patient age, sex and procedure indication were significantly associated with MNP and used to create aMNP. At endoscopist level, aMNP strongly correlated with PDR (Spearman rho=0.834, p<0.001) and PPR (rho=0.709, p<0.001). Median aMNP was significantly lower in Trusts with higher versus lower PCCRC rates (73.9 vs 67.0 polyps per 100 procedures, p=0.047) and higher in units with GRS A/B versus C/D (aMNP 63.5 vs 55.2, p<0.001). Conclusions We demonstrate a method to compute a novel case-mix-adjusted KPI, aMNP, which is significantly associated with PDR, PPR, PCCRC and JAG GRS. Histological data were unavailable. aMNP addresses many limitations of ADR, adjusts for warranted variation in detection, and hence may improve audit and feedback engagement. We propose it as a candidate gold standard KPI for reporting endoscopy quality

Erratum to: Methods for evaluating medical tests and biomarkers

[This corrects the article DOI: 10.1186/s41512-016-0001-y.]

Understanding Repetitive Behaviours: A clinical and cost-effectiveness, multi-site randomised controlled trial of a group for parents and carers of young autistic children

\ua9 The Author(s) 2025.Restricted and repetitive behaviours vary greatly between autistic people. Some are a source of pleasure or create opportunities for learning; others may be detrimental in day-to-day life or cause harm. We have developed, in close collaboration with parents/carers, the Understanding Repetitive Behaviours programme, designed for families of young autistic children, to help them recognise, understand and respond sensitively to their child’s impactful restricted and repetitive behaviours. This study is a clinical and cost-effectiveness, multi-site randomised controlled trial of the Understanding Repetitive Behaviours parent programme versus a psychoeducation programme (equivalent to current best practice), learning about autism. Participants were parents/carers, with an autistic child aged between 3–9 years and 11 months. The study was delivered across three sites in England and Scotland. Analyses were completed using intention-to-treat principles. Two hundred and twenty seven families were randomised (113 in LAA; 114 in Understanding Repetitive Behaviours arm). No differences were found between the arms on the primary outcome measure (The Clinical Global Impression – Improvement scale). Analysis of secondary outcomes indicated that children in the Understanding Repetitive Behaviours arm were more likely to be rated as responders in target impactful restricted and repetitive behaviours at 24 weeks but that this effect was not maintained at 52 weeks. Improvements in parent and family functioning were apparent, with no evidence of differences between the arms. The study reconfirms that it is important that clinicians consider both restricted and repetitive behaviours and social communication needs of autistic children with parents when planning appropriate support. Lay abstract: Autistic children, frequently repeat the same behaviours over and over, have specific interests or like things to stay the same. These behaviours and interests are often fun and helpful. However, sometimes they can impact negatively on day-to-day life or put the child at risk of harm. Working closely with parents of autistic children, we developed an 8-week programme (Understanding Repetitive Behaviours) to help them recognise and understand these behaviours. This study aimed to find out whether the understanding repetitive behaviour programme was helpful and good value for money. Two hundred and twenty seven families were allocated by chance to receive either Understanding Repetitive Behaviours or a learning about autism programme. When experts made judgements about whether children showed positive changes across various measures, and these were analysed, there were no differences between the programmes. However, parents who attended the Understanding Repetitive Behaviours programme reported improvement in one of their child’s specific repetitive behaviour (selected to be the main focus of the Understanding Repetitive Behaviours programme) at 24 weeks after the end of the programme. Parents who attended either programme reported more confidence, greater wellbeing and less stress up to 1 year after the end of the study