Subversion of allocation concealment in a randomised controlled trial: a historical case study.

Background: If the randomisation process within a trial is subverted, this can lead to selection bias that may invalidate the trial's result. To avoid this problem, it is recommended that some form of concealment should be put into place. Despite ongoing anecdotal concerns about their susceptibility to subversion, a surprising number of trials (over 10%) still use sealed opaque envelopes as the randomisation method of choice.

A randomised controlled trial of the clinical effectiveness and cost-effectiveness of different knee prostheses: the Knee Arthroplasty Trial (KAT).

Background: In the late 1990s, new developments in knee replacement were identified as a priority for research within the NHS. The newer forms of arthroplasty were more expensive and information was needed on their safety and cost-effectiveness.

Objectives: The Knee Arthroplasty Trial examined the clinical effectiveness and cost-effectiveness of four aspects of knee replacement surgery: patellar resurfacing, mobile bearings, all-polyethylene tibial components and unicompartmental replacement.

A framework for the evaluation of new interventional procedures.

Objectives: The introduction of new interventional procedures is less regulated than for other health technologies such as pharmaceuticals. Decisions are often taken on evidence of efficacy and short-term safety from small-scale usually observational studies. This reflects the particular challenges of evaluating interventional procedures - the extra facets of skill and training and the difficulty defining a 'new' technology.

Long-term follow-up for mortality and cancer in a randomized placebo-controlled trial of vitamin D(3) and/or calcium (RECORD trial).

Context: Vitamin D or calcium supplementation may have effects on vascular disease and cancer.

Objective: Our objective was to investigate whether vitamin D or calcium supplementation affects mortality, vascular disease, and cancer in older people.

Design And Setting: The study included long-term follow-up of participants in a two by two factorial, randomized controlled trial from 21 orthopedic centers in the United Kingdom.

Case study: a patient-clinician collaboration that identified and prioritized evidence gaps and stimulated research development.

Objective: To assess the effect of a research prioritization partnership that aimed to influence the research agenda relating to urinary incontinence (UI).

Study Design And Setting: Research often neglects important gaps in existing evidence so that decisions must be made about treatments without reliable evidence of their effectiveness. In 2007-2009, a United Kingdom partnership of eight patient and 13 clinician organizations identified and prioritized gaps in the evidence that affect everyday decisions about treatment of UI.

The introduction of new interventional procedures in the British National Health Service--a qualitative study.

Objectives: To investigate how interventional procedures (IPs) are introduced into the British National Health Services and identify areas for improvement in the current process.

Methods: Qualitative study using one to one semi-structured interviews. Using the framework approach, the data generated from 14 participants were analysed with coding of emergent themes.

Reaching a consensus and ranking research priorities in urinary incontinence.

Gaps in the evidence base in healthcare are common, and this is also the case for the management of urinary incontinence. The James Lind Alliance helped patients and clinicians to identify and then prioritise gaps in the evidence base for managing this condition, producing a list of 10 research priorities. This article outlines the process involved in reaching this consensus.

Medical versus surgical management for gastro-oesophageal reflux disease (GORD) in adults.

Background: Gastro-oesophageal reflux disease (GORD) is a common condition with up to 20% of patients from Westernised countries experiencing heartburn, reflux or both intermittently. It is unclear whether medical or surgical (laparoscopic fundoplication) management is the most clinically and cost-effective treatment for controlling GORD.

Objectives: To compare the effects of medical management versus laparoscopic fundoplication surgery on health-related and GORD-specific quality of life (QOL) in adults with GORD.

Prioritizing research: Patients, carers, and clinicians working together to identify and prioritize important clinical uncertainties in urinary incontinence.

Aims: Research often neglects important gaps in existing evidence. Throughout healthcare, clinicians and patients face avoidable "clinical uncertainties" daily, making decisions about treatments without reliable evidence about their effects. This partnership of patients and clinicians aimed to identify and prioritize "clinical uncertainties" relating to treatment of urinary incontinence (UI).

Minimal access surgery compared with medical management for chronic gastro-oesophageal reflux disease: UK collaborative randomised trial.

Objective: To determine the relative benefits and risks of laparoscopic fundoplication surgery as an alternative to long term drug treatment for chronic gastro-oesophageal reflux disease (GORD).

Design: Multicentre, pragmatic randomised trial (with parallel preference groups).

Setting: 21 hospitals in the United Kingdom.

Marketing and clinical trials: a case study.

Background: Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies.

Methods: Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials.

Financial considerations in the conduct of multi-centre randomised controlled trials: evidence from a qualitative study.

Background: Securing and managing finances for multicentre randomised controlled trials is a highly complex activity which is rarely considered in the research literature. This paper describes the process of financial negotiation and the impact of financial considerations in four UK multicentre trials. These trials had met, or were on schedule to meet, recruitment targets agreed with their public-sector funders.

What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies.

Background: A commonly reported problem with the conduct of multicentre randomised controlled trials (RCTs) is that recruitment is often slower or more difficult than expected, with many trials failing to reach their planned sample size within the timescale and funding originally envisaged. The aim of this study was to explore factors that may have been associated with good and poor recruitment in a cohort of multicentre trials funded by two public bodies: the UK Medical Research Council (MRC) and the Health Technology Assessment (HTA) Programme.

Methods: The cohort of trials was identified from the administrative databases held by the two funding bodies.

Persistent urinary incontinence and delivery mode history: a six-year longitudinal study.

Objective: To investigate the prevalence of persistent and long term postpartum urinary incontinence and associations with mode of first and subsequent delivery.

Design: Longitudinal study.

Setting: Maternity units in Aberdeen (Scotland), Birmingham (England) and Dunedin (New Zealand).

The effects of an open design on trial participant recruitment, compliance and retention--a randomized controlled trial comparison with a blinded, placebo-controlled design.

Background: In randomized trials there may be no overriding reason whether or not to have a placebo control.

Purpose: We assessed the effects of an open trial design (no placebo and people know what tablets they are given) compared with a blinded, placebo-controlled design on recruitment, compliance and retention within a randomized trial of secondary osteoporotic fracture prevention.

Methods: We undertook a randomized controlled comparison nested within a placebo-controlled trial of nutritional supplementation amongst people aged 70 years or over who had previously sustained a fracture, recruited in a UK teaching hospital.

Low back pain: influence of early MR imaging or CT on treatment and outcome--multicenter randomized trial.

Purpose: To establish whether early use of magnetic resonance (MR) imaging or computed tomography (CT) influences treatment and outcome of patients with low back pain (LBP) and whether it is cost-effective.

Materials And Methods: In a multicenter randomized study, two imaging policies for LBP were compared in 782 participants with symptomatic lumbar spine disorders who were referred to orthopedists or neurosurgeons. Participants were randomly allocated to early (393 participants; mean age, 43.

Assessing the learning curve effect in health technologies. Lessons from the nonclinical literature.

Introduction: Many health technologies exhibit some from of learning effect, and this represents a barrier to rigorous assessment. It has been shown that the statistical methods used are relatively crude. Methods to describe learning curves in fields outside medicine, for example, psychology and engineering, may be better.