All Outputs (140)

Monitoring performance of sites within multicentre randomised trials: a systematic review of performance metrics (2018)
Journal Article

© 2018 The Author(s). Background: Large multicentre trials are complex and expensive projects. A key factor for their successful planning and delivery is how well sites meet their targets in recruiting and retaining participants, and in collecting hi... Read More about Monitoring performance of sites within multicentre randomised trials: a systematic review of performance metrics.

Follow-on RifAximin for the prevention of recurrence following standard treatment of infection with Clostridium difficile (RAPID): a randomised placebo controlled trial (2018)
Journal Article

Background Clostridium difficile infection (CDI) recurs after initial treatment in approximately one in four patients. A single-centre pilot study suggested that this could be reduced using ‘follow-on’ rifaximin treatment. We aimed to assess the effi... Read More about Follow-on RifAximin for the prevention of recurrence following standard treatment of infection with Clostridium difficile (RAPID): a randomised placebo controlled trial.

Triple versus guideline antiplatelet therapy to prevent recurrence after acute ischaemic stroke or transient ischaemic attack: The TARDIS RCT (2018)
Journal Article

© Queen’s Printer and Controller of HMSO 2018. Background: Two antiplatelet agents are better than one for preventing recurrent stroke after acute ischaemic stroke or transient ischaemic attack (TIA). Therefore, intensive treatment with three agents... Read More about Triple versus guideline antiplatelet therapy to prevent recurrence after acute ischaemic stroke or transient ischaemic attack: The TARDIS RCT.

Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2): safety and efficacy of transdermal glyceryl trinitrate, a nitric oxide donor, and of the feasibility of a multicentre ambulance-based stroke trial (2018)
Conference Proceeding

Lamotrigine for people with borderline personality disorder: a RCT (2018)
Journal Article

Background: No drug treatments are currently licensed for the treatment of borderline personality disorder (BPD). Despite this, people with this condition are frequently prescribed psychotropic medications and often with considerable polypharmacy. Pr... Read More about Lamotrigine for people with borderline personality disorder: a RCT.

The clinical effectiveness and cost effectiveness of lamotrigine for people with borderline personality disorder: a randomized, placebo-controlled trial (2018)
Journal Article

Objectives: To examine whether lamotrigine is a clinically effective and cost-effective treatment for people with borderline personality disorder. Method: Multicentre, double-blind, placebo-controlled randomized trial. Between July 2013 to Novembe... Read More about The clinical effectiveness and cost effectiveness of lamotrigine for people with borderline personality disorder: a randomized, placebo-controlled trial.

NHS health checks: a cross- sectional observational study on equity of uptake and outcomes (2018)
Journal Article

Background The National Health Checks programme aims to reduce the incidence of cardiovascular diseases and health inequalities in England. We assessed equity of uptake and outcomes from NHS Health Checks in general practices in Bristol, UK. Me... Read More about NHS health checks: a cross- sectional observational study on equity of uptake and outcomes.

Home interventions and light therapy for treatment of vitiligo (HI-Light Vitiligo Trial): study protocol for a randomized controlled trial (2018)
Journal Article

Vitiligo is a condition resulting in white patches on the skin. People with vitiligo can suffer from low self-esteem, psychological disturbance and diminished quality of life. Vitiligo is often poorly managed, partly due to lack of high quality evide... Read More about Home interventions and light therapy for treatment of vitiligo (HI-Light Vitiligo Trial): study protocol for a randomized controlled trial.

Statistical analysis plan for the ‘Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2)’ (2018)
Journal Article

Rationale: Glyceryl trinitrate, a nitric oxide donor, is a candidate treatment for acute stroke; it lowers blood pressure, does not alter cerebral blood flow or platelet function and is neuroprotective in experimental stroke. The ongoing rapid interv... Read More about Statistical analysis plan for the ‘Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2)’.

Psychoeducation and Problem Solving (PEPS) Therapy for Adults With Personality Disorder: A Pragmatic Randomized-Controlled Trial (2017)
Journal Article

Antiplatelet therapy with aspirin, clopidogrel, and dipyridamole versus clopidogrel alone or aspirin and dipyridamole in patients with acute cerebral ischaemia (TARDIS): a randomised, open-label, phase 3 superiority trial (2017)
Journal Article

Background: Intensive antiplatelet therapy with three agents might be more effective than guideline treatment for preventing recurrent events in patients with acute cerebral ischaemia. We aimed to compare the safety and efficacy of intensive antiplat... Read More about Antiplatelet therapy with aspirin, clopidogrel, and dipyridamole versus clopidogrel alone or aspirin and dipyridamole in patients with acute cerebral ischaemia (TARDIS): a randomised, open-label, phase 3 superiority trial.

Guidelines for the Content of Statistical Analysis Plans in Clinical Trials (2017)
Journal Article

© 2017 American Medical Association. All rights reserved. IMPORTANCE While guidance on statistical principles for clinical trials exists, there is an absence of guidance covering the required content of statistical analysis plans (SAPs) to support tr... Read More about Guidelines for the Content of Statistical Analysis Plans in Clinical Trials.

A feasibility study investigating the acceptability and design of a multicentre randomised controlled trial of needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren's contractures of the fingers (HAND-1): Study protocol for a randomised controlled trial (2017)
Journal Article

© 2017 The Author(s). Background: Dupuytren's contractures are fibrous cords under the skin of the palm of the hand. The contractures are painless but cause one or more fingers to curl into the palm, resulting in loss of function. Standard treatment... Read More about A feasibility study investigating the acceptability and design of a multicentre randomised controlled trial of needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren's contractures of the fingers (HAND-1): Study protocol for a randomised controlled trial.

Effectiveness and cost effectiveness of daily all over body application of emollient during the first year of life for preventing atopic eczema in high risk children (The BEEP trial): protocol for a randomised controlled trial (2017)
Journal Article

Background: Atopic eczema (AE) is a common skin problem that impairs quality of life and is associated with the development of other atopic diseases including asthma, food allergy and allergic rhinitis. AE treatment is a significant cost burden for... Read More about Effectiveness and cost effectiveness of daily all over body application of emollient during the first year of life for preventing atopic eczema in high risk children (The BEEP trial): protocol for a randomised controlled trial.

Large multi-centre pilot randomized controlled trial testing a low-cost, tailored, self-help smoking cessation text message intervention for pregnant smokers (MiQuit): randomized controlled trial of MiQuit (2017)
Journal Article

Aims: To estimate the effectiveness of pregnancy smoking cessation support delivered by short message service (SMS) text message and key parameters needed to plan a definitive trial. Design: Multi‐centre, parallel‐group, single‐blinded, individual r... Read More about Large multi-centre pilot randomized controlled trial testing a low-cost, tailored, self-help smoking cessation text message intervention for pregnant smokers (MiQuit): randomized controlled trial of MiQuit.

Evaluation of the effectiveness and cost-effectiveness of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: a randomised controlled trial (2017)
Journal Article

Background Ulcers of the foot in people with diabetes mellitus are slow to heal and result in considerable cost and patient suffering. The prognosis is worst for ulcers of the heel. Objective To assess both the clinical effectiveness and the cost-... Read More about Evaluation of the effectiveness and cost-effectiveness of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: a randomised controlled trial.

Silk garments plus standard care compared with standard care for treating eczema in children: A randomised, controlled, observer-blind, pragmatic trial (CLOTHES Trial) (2017)
Journal Article

© 2017 Thomas et al. Background: The role of clothing in the management of eczema (also called atopic dermatitis or atopic eczema) is poorly understood. This trial evaluated the effectiveness and cost-effectiveness of silk garments (in addition to st... Read More about Silk garments plus standard care compared with standard care for treating eczema in children: A randomised, controlled, observer-blind, pragmatic trial (CLOTHES Trial).

Randomised controlled trial of silk therapeutic garments for the management of atopic eczema in children: the CLOTHES trial (2017)
Journal Article

Background: Atopic eczema (AE) is a chronic, itchy, inflammatory skin condition that affects the quality of life of children and their families. The role of specialist clothing in the management of AE is poorly understood. Objectives: To assess the... Read More about Randomised controlled trial of silk therapeutic garments for the management of atopic eczema in children: the CLOTHES trial.

Investigating the effect of independent blinded digital image assessment on the STOP GAP trial (2017)
Journal Article

Background Blinding is the process of keeping treatment assignment hidden and is used to minimise the possibility of bias. Trials at high risk of bias have been shown to report larger treatment effects than low risk studies. In dermatology, one popu... Read More about Investigating the effect of independent blinded digital image assessment on the STOP GAP trial.

Gentamicin versus ceftriaxone for the treatment of gonorrhoea (G-TOG trial): study protocol for a randomised trial (2016)
Journal Article

Background: Gonorrhoea is a common sexually transmitted infection which causes genital pain and discomfort; in women it can also lead to pelvic inflammatory disease and infertility, and in men to epididymo-orchitis. Current treatment is with ceftriax... Read More about Gentamicin versus ceftriaxone for the treatment of gonorrhoea (G-TOG trial): study protocol for a randomised trial.