Abstract
BackgroundRandomised controlled trials are generally regarded as the ‘gold standard’ experimental design to determine the effectiveness of an intervention. Unfortunately, many trials either fail to recruit sufficient numbers of participants, or recruitment takes longer than anticipated. The current embedded trial evaluates the effectiveness of optimised patient information sheets on recruitment of participants in a falls prevention trial.MethodsA three-arm, embedded randomised methodology trial was conducted within the National Institute for Health Research-funded REducing Falls with ORthoses and a Multifaceted podiatry intervention (REFORM) cohort randomised controlled trial. Routine National Health Service podiatry patients over the age of 65 were randomised to receive either the control patient information sheet (PIS) for the host trial or one of two optimised versions, a bespoke user-tested PIS or a template-developed PIS. The primary outcome was the proportion of patients in each group who went on to be randomised to the host trial.ResultsSix thousand and nine hundred patients were randomised 1:1:1 into the embedded trial. A total of 193 (2.8%) went on to be randomised into the main REFORM trial (control n = 62, template-developed n = 68; bespoke user-tested n = 63). Information sheet allocation did not improve recruitment to the trial (odds ratios for the three pairwise comparisons: template vs control 1.10 (95% CI 0.77–1.56, p = 0.60); user-tested vs control 1.01 (95% CI 0.71–1.45, p = 0.94); and user-tested vs template 0.92 (95% CI 0.65–1.31, p = 0.65)).ConclusionsThis embedded methodology trial has demonstrated limited evidence as to the benefit of using optimised information materials on recruitment and retention rates in the REFORM study.Trial registrationInternational Standard Randomised Controlled Trials Number registry, ISRCTN68240461. Registered on 01 July 2011.
Highlights
A total of 6900 recruitment packs were sent to potential REFORM study participants across five centres between March 2013 and May 2014: Harrogate (n = 500, 7.3%), Scarborough (n = 1000, 14.5%), Selby (n = 1000, 14.5%), Sheffield (n = 1600, 23.2%) and Leeds (n = 2800, 40.6%) (Fig. 1)
The difference in percentages and their 95% Confidence interval (CI) are as follows: for template-developed vs controls there was a 0.3 percentage point difference; bespoke user-tested vs control 0.0; and bespoke user-tested vs templatedeveloped −0.2
The odds ratios for the three pairwise comparisons were: template-developed vs control 1.10; bespoke user-tested vs control 1.01; and bespoke usertested vs template-developed 0.92
Summary
Background and objectives 2aStructured summary of trial design, methods, results and conclusions (for specific guidance see CONSORT for abstracts)Scientific background and explanation of rationale2b Methods Trial design 3a. Randomised controlled trials are generally regarded as the ‘gold standard’ experimental design to determine the effectiveness of an intervention. Randomised controlled trials (RCTs) are generally regarded as the ‘gold standard’ experimental design to determine the effectiveness of an intervention. Many trials either fail to recruit sufficient numbers of participants, or recruitment takes longer than anticipated [1]. There is, limited evidence as to the effectiveness of recruitment strategies in healthcare settings [2], and as a result, the UK Medical Research Council funded the Systematic Techniques for Assisting Recruitment to Trials (MRC START) research programme [3]. The initial focus was on testing optimised patient information sheets and multimedia resources
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