Multicentre, randomised controlled feasibility study to compare a 10-week physiotherapy programme using an interactive exercise training device to improve walking and balance, to usual care of children with cerebral palsy aged 4-18 years: the ACCEPT study protocol.

INTRODUCTION: Children with cerebral palsy (CP) frequently undertake physiotherapy programmes to improve walking and balance. They often require adult support to exercise in a functional position. A novel interactive exercise trainer has been devised to enable children to exercise with against resistance in a functional position, but its efficacy has yet to be proved. A novel protocol has been developed to determine whether a randomised controlled trial (RCT) is feasible. AIM: To establish whether it is feasible to conduct an RCT to assess the effectiveness of a 10-week physiotherapy intervention using an interactive trainer in children with CP. METHODS AND ANALYSIS: This study is multicentre randomised controlled feasibility trial with an embedded qualitative study. Forty children with CP, Gross Motor Function Classification System (GMFCS) I-III will be recruited from community paediatric physiotherapy caseloads. Participants will be randomised to 10 weeks of training with the interactive training device or to usual physiotherapy care. The mediolateral motion of the centre of mass estimate and Paediatric Balance Scale will be explored as potential primary outcomes measures, tested at baseline, 10 weeks and follow-up at 20 weeks. The views of child participants, their parents and physiotherapists will be gained through e-diaries and qualitative interviews.Feasibility will be determined by examining recruitment and retention rates, completeness of, adherence to the intervention, appropriateness of outcome measures and effectiveness of blinding. Results will be reported in accordance to Consolidated Standards of Reporting Trials (CONSORT) guidelines. ETHICS AND DISSEMINATION: Physiotherapists, children and parents have informed trial design and information leaflets. Results will be disseminated via publications, conferences and to families. This study has approval from North of Scotland Research Ethics Committee (20/NS/0018). TRIAL REGISTRATION NUMBER: ISRCTN80878394.

Need for recovery amongst emergency physicians in the UK and Ireland: a cross-sectional survey.

OBJECTIVES: To determine the need for recovery (NFR) among emergency physicians and to identify demographic and occupational characteristics associated with higher NFR scores. DESIGN: Cross-sectional electronic survey. SETTING: Emergency departments (EDs) (n=112) in the UK and Ireland. PARTICIPANTS: Emergency physicians, defined as any registered physician working principally within the ED, responding between June and July 2019. MAIN OUTCOME MEASURE: NFR Scale, an 11-item self-administered questionnaire that assesses how work demands affect intershift recovery. RESULTS: The median NFR Score for all 4247 eligible, consented participants with a valid NFR Score was 70.0 (95% CI: 65.5 to 74.5), with an IQR of 45.5-90.0. A linear regression model indicated statistically significant associations between gender, health conditions, type of ED, clinical grade, access to annual and study leave, and time spent working out-of-hours. Groups including male physicians, consultants, general practitioners (GPs) within the ED, those working in paediatric EDs and those with no long-term health condition or disability had a lower NFR Score. After adjusting for these characteristics, the NFR Score increased by 3.7 (95% CI: 0.3 to 7.1) and 6.43 (95% CI: 2.0 to 10.8) for those with difficulty accessing annual and study leave, respectively. Increased percentage of out-of-hours work increased NFR Score almost linearly: 26%-50% out-of-hours work=5.7 (95% CI: 3.1 to 8.4); 51%-75% out-of-hours work=10.3 (95% CI: 7.6 to 13.0); 76%-100% out-of-hours work=14.5 (95% CI: 11.0 to 17.9). CONCLUSION: Higher NFR scores were observed among emergency physicians than reported in any other profession or population to date. While out-of-hours working is unavoidable, the linear relationship observed suggests that any reduction may result in NFR improvement. Evidence-based strategies to improve well-being such as proportional out-of-hours working and improved access to annual and study leave should be carefully considered and implemented where feasible.

Simvastatin as a neuroprotective treatment for Parkinson's disease (PD STAT): protocol for a double-blind, randomised, placebo-controlled futility study.

INTRODUCTION: Parkinson's disease (PD) is a progressive neurodegenerative condition affecting approximately 185,000 people in the UK. No drug has been proven to slow disease progression. Epidemiological and pre-clinical data support simvastatin, a widely used cholesterol-lowering drug with a well-established safety profile, having neuroprotective properties. The aim of this study (Simvastatin as a neuroprotective treatment for PD (PD STAT)) is to determine whether simvastatin has the potential to slow PD progression. The study is part of the International Linked Clinical Trials initiative coordinated by The Cure Parkinson's Trust. This paper describes the protocol for the PD STAT study. METHODS AND ANALYSIS: PD STAT is a double-blind, randomised, placebo-controlled, multi-centre, parallel group, futility trial in patients with PD of mild-moderate severity. 235 participants have been recruited and randomly allocated in a 1:1 ratio to receive either oral simvastatin or matched placebo. Treatment involves a 1-month low-dose phase (40 mg daily), followed by a 23-month high-dose phase (80 mg daily) and ends with a 2-month washout period. Participants are reviewed at clinic visits at 1 month, 6, 12, 18, 24 and 26 months post-baseline, with interim telephone follow-up to monitor for adverse events.The primary outcome is the change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale part III motor subscale score in the practically defined OFF medication state (OFF state) between baseline and 24 months. Primary analysis will be on a modified intention to treat basis and will include only those participants who progress to the high-dose phase of the study. ETHICS AND DISSEMINATION: The protocol has been approved by the North East-Newcastle and North Tyneside 2 Research Ethics Committee. The results will be disseminated via research articles in peer-reviewed journals and presentations at local, national and international scientific meetings, as well as disseminated via patient groups, websites and networks. A summary of the study findings will be posted to participants at the end of the study. TRIAL REGISTRATION: ISRCTN16108482 (prospectively registered); EudraCT 2015-000148-40; ClinicalTrials.gov NCT02787590; Pre-results.