scholarly journals A randomised controlled trial to determine the clinical and cost effectiveness of thulium laser transurethral vaporesection of the prostate (ThuVARP) versus transurethral resection of the prostate (TURP) in the National Health Service (NHS) – the UNBLOCS trial: a study protocol for a randomised controlled trial

Trials ◽  
2017 ◽  
Vol 18 (1) ◽  
Author(s):  
Jo Worthington ◽  
Hilary Taylor ◽  
Paul Abrams ◽  
Sara T. Brookes ◽  
Nikki Cotterill ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
National Health Service ◽  
Randomised Controlled Trial ◽  
Health Service ◽  
Study Protocol ◽  
National Health ◽  
Transurethral Resection ◽  
Controlled Trial ◽  
Thulium Laser ◽  
Randomised Controlled

scholarly journals The HARMONIC trial: Study protocol for a randomised controlled feasibility trial of Shaping Healthy Minds – a modular transdiagnostic intervention for mood, stress and anxiety disorders in adults

2018 ◽  
Author(s):  
Melissa Black ◽  
Caitlin Hitchcock ◽  
Anna Bevan ◽  
Cliodhna O Leary ◽  
James Clarke ◽  
...  
Keyword(s):  
National Health Service ◽  
Randomised Controlled Trial ◽  
Health Service ◽  
National Health ◽  
Controlled Trial ◽  
Self Report ◽  
Feasibility Trial ◽  
Randomised Controlled ◽  
Later Phase ◽  
Phase Trial

Introduction: Anxiety, mood and trauma-related disorders are common, affecting up to 20% of adults. Many of these individuals will experience symptoms of more than one disorder as diagnostically defined. However, most psychological treatments focus on individual disorders and are less effective for those who experience comorbid disorders. The HARMONIC trial introduces a novel transdiagnostic intervention (Shaping Healthy Minds), which synthesises several evidence-based treatment techniques to address the gap in effective interventions for people with complex and comorbid difficulties. This early-phase trial aims to estimate the efficacy and feasibility of the transdiagnostic intervention in preparation for a later-phase randomised controlled trial, and to explore mechanisms of change.Methods/Analysis: We outline a patient-level two-arm randomised controlled trial (HARMONIC) that compares Shaping Healthy Minds to treatment-as-usual (TAU) for individuals aged >18 years (N=50) with co-morbid mood, anxiety, obsessive-compulsive or trauma/stressor disorder diagnoses, recruited from outpatient psychological services within the UK National Health Service. The co-primary outcomes will be 3-month follow-up scores on self-report measures of depressive symptoms, anxiety symptoms, and disability and functional impairment. Secondary outcomes include changes in symptoms linked to individual disorders. We will assess the feasibility and acceptability of Shaping Healthy Minds, the utility of proposed outcome measures, and refine the treatment manuals in preparation for a later-phase trial. Ethics and dissemination: This trial protocol has been approved by the Health Research Authority of the National Health Service of the United Kingdom (East of England, Reference: 16/EE/0095). We anticipate that trial findings will inform future revisions of clinical guidelines for numerous forms of mood, anxiety, and stressor-related disorders. Findings will be disseminated broadly via peer-reviewed empirical journal articles, conference presentations, clinical workshops, and a trial website.

scholarly journals Slip-resistant footwear reduces slips among National Health Service workers in England: a randomised controlled trial

2021 ◽  
pp. oemed-2020-106914 ◽  
Author(s):  
Sarah Cockayne ◽  
Caroline Fairhurst ◽  
Gillian Frost ◽  
Mark Liddle ◽  
Rachel Cunningham-Burley ◽  
...  
Keyword(s):  
National Health Service ◽  
Randomised Controlled Trial ◽  
Health Service ◽  
Incidence Rate ◽  
National Health ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Randomised Controlled

ObjectivesAssess the effectiveness of 5* GRIP-rated slip-resistant footwear in preventing slips in the workplace compared to usual footwear (control group).MethodsA multicentre, randomised controlled trial; 4553 National Health Service (NHS) staff were randomised 1:1 to the intervention group (provided with 5* GRIP-rated slip-resistant footwear) or the control group. The primary outcome of incidence rate of self-reported slips in the workplace over 14 weeks was analysed using a mixed-effects negative binomial model. Secondary outcome measures included incidence rate of falls from a slip, falls not from a slip, proportion of participants reporting a slip, fall or fracture and time to first slip and fall.Results6743 slips were reported: 2633 in the intervention group (mean 1.16 per participant, range 0 to 36) and 4110 in the control group (mean 1.80 per participant, range 0 to 83). There was a statistically significant reduction in slip rate in the intervention group relative to the control group (incidence rate ratio (IRR) 0.63, 95% CI 0.57 to 0.70, p<0.001). Statistically significant differences, in favour of the intervention group, were observed in falls from a slip (IRR 0.51, 95% CI 0.28 to 0.92, p=0.03), the proportion of participants who reported a slip (OR 0.58, 95% CI 0.50 to 0.66, p<0.001) or fall (OR 0.73, 95% CI 0.54 to 0.99, p=0.04) and time to first slip (HR 0.73, 95% CI 0.67 to 0.80, p<0.001).ConclusionsThe offer and provision of 5* GRIP-rated footwear reduced slips in NHS staff in the workplace.Trial registration numberISRCTN33051393.

scholarly journals Cost-effectiveness of habit-based advice for weight control versus usual care in general practice in the Ten Top Tips (10TT) trial: economic evaluation based on a randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e017511 ◽  
Author(s):  
Nishma Patel ◽  
Rebecca J Beeken ◽  
Baptiste Leurent ◽  
Rumana Z Omar ◽  
Irwin Nazareth ◽  
...  
Keyword(s):  
General Practice ◽  
Economic Evaluation ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Health Service ◽  
Usual Care ◽  
Controlled Trial ◽  
Cost Effective ◽  
The Mean ◽  
Randomised Controlled

ObjectiveTen Top Tips (10TT) is a primary care-led behavioural intervention which aims to help adults reduce and manage their weight by following 10 weight loss tips. The intervention promotes habit formation to encourage long-term behavioural changes. The aim of this study was to estimate the cost-effectiveness of 10TT in general practice from the perspective of the UK National Health Service.DesignAn economic evaluation was conducted alongside an individually randomised controlled trial.Setting14 general practitioner practices in England.ParticipantsAll patients were aged ≥18 years, with body mass index ≥30 kg/m2. A total of 537 patients were recruited; 270 received the usual care offered by their practices and 267 received the 10TT intervention.Outcomes measuresHealth service use and quality-adjusted life years (QALYs) were measured over 2 years. Analysis was conducted in terms of incremental net monetary benefits (NMBs), using non-parametric bootstrapping and multiple imputation.ResultsOver a 2-year time horizon, the mean costs and QALYs per patient in the 10TT group were £1889 (95% CI £1522 to £2566) and 1.51 (95% CI 1.44 to 1.58). The mean costs and QALYs for usual care were £1925 (95% CI £1599 to £2251) and 1.51 (95% CI 1.45 to 1.57), respectively. This generated a mean cost difference of −£36 (95% CI −£512 to £441) and a mean QALY difference of 0.001 (95% CI −0.080 to 0.082). The incremental NMB for 10TT versus usual care was £49 (95% CI −£1709 to £1800) at a maximum willingness to pay for a QALY of £20 000. 10TT had a 52% probability of being cost-effective at this threshold.ConclusionsCosts and QALYs for 10TT were not significantly different from usual care and therefore 10TT is as cost-effective as usual care. There was no evidence to recommend nor advice against offering 10TT to obese patients in general practices based on cost-effectiveness considerations.Trial registration numberISRCTN16347068; Post-results.

Sign in / Sign up

Export Citation Format

Share Document