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Background: In Great Britain, 100,000 injuries due to slips, trips and falls on the level (as opposed to falls from a height, e.g. a ladder) occur in the workplace each year. They are the most common cause of non-fatal injury in the workplace, accounting for 30% of all those injuries reported to the Health and Safety Executive. Nearly 1 million working days are lost because of slips, trips and falls each year. Objectives: To assess the clinical effectiveness and cost-effectiveness of 5-star, GRIP-rated, slip-resistant footwear in preventing slips in the workplace compared with usual footwear. Design: A two-arm, multicentre, randomised controlled trial with an economic evaluation and qualitative study. Setting: Seven NHS trusts in England. Participants: NHS staff aged ≥ 18 years, working at least 22.5 hours per week in clinical, general or catering areas who owned a mobile phone. Staff required to wear protective footwear were excluded. Interventions: Intervention participants were offered 5-star, GRIP-rated, slip-resistant footwear. The waiting list control group were asked to wear their usual work shoes for the duration of the study and were offered the trial footwear at the end of their participation. Main outcome measures: The primary outcome was the incidence rate of self-reported slips in the workplace over 14 weeks. Secondary outcomes included the incidence rate of falls either resulting from a slip or not resulting from a slip, proportion of participants reporting a slip, fall or fracture, time to first slip and fall, health-related quality of life and cost-effectiveness. Results: A total of 4553 eligible NHS staff were randomised (2275 to the intervention arm and 2278 to the control arm). In total, 6743 slips were reported [2633 in the intervention group (mean 1.16 per participant, range 0–36 per participant) and 4110 in the control group (mean 1.80 per participant, range 0–83 per participant)]. There was a statistically significant reduction in the slip rate in the intervention group relative to the control group (incidence rate ratio 0.63, 95% confidence interval 0.57 to 0.70; p

Introduction The BRIGhTMIND study aims to determine the clinical effectiveness, cost-effectiveness and mechanism of action of connectivity guided intermittent theta burst stimulation (cgiTBS) versus standard repetitive transcranial magnetic stimulation (rTMS) in adults with moderate to severe treatment resistant depression.Methods and analysis The study is a randomised double-blind controlled trial with 1:1 allocation to either 20 sessions of (1) cgiTBS or (2) neuronavigated rTMS not using connectivity guidance. A total of 368 eligible participants with a diagnosis of current unipolar major depressive disorder that is both treatment resistant (defined as scoring 2 or more on the Massachusetts General Hospital Staging Score) and moderate to severe (scoring >16 on the 17-item Hamilton Depression Rating Scale (HDRS-17)), will be recruited from primary and secondary care settings at four treatment centres in the UK. The primary outcome is depression response at 16 weeks (50% or greater reduction in HDRS-17 score from baseline). Secondary outcomes include assessments of self-rated depression, anxiety, psychosocial functioning, cognition and quality of life at 8, 16 and 26 weeks postrandomisation. Cost-effectiveness, patient acceptability, safety, mechanism of action and predictors of response will also be examined.Ethics and dissemination Ethical approval was granted by East Midlands Leicester Central Research Ethics Committee (ref: 18/EM/0232) on 30 August 2018. The results of the study will be published in relevant peer-reviewed journals, and then through professional and public conferences and media. Further publications will explore patient experience, moderators and mediators of outcome and mechanism of action.Trial registration number ISRCTN19674644