Abstract
Background: Studies within trials (SWATs) present an opportunity to examine design factors that may impact on the successful delivery of trials. One area in need of research is trial recruitment. Recruiting patients to trials is a major challenge facing trialists. Failure to meet recruitment targets can result in delays and underpowered studies. This SWAT evaluates the effectiveness of hand-held digital multimedia presentation of trial information and standard written patient information to potential participants on recruitment and retention to a host trial. Methods: This is the protocol for SWAT 15, a two-group, embedded parallel randomised controlled trial (RCT) (ISRCTN12838042) designed within a host trial - the SATIN trial (ISRCTN88111427), a RCT designed for implementation in the Irish primary care setting. The SWAT eligibility criteria was determined by the host trial. General practices who agree to participate in the host trial will provide women (participants) who are willing to consider participating in the host trial with either a multimedia digital information resource facilitated through a handheld tablet device, plus a written participant information leaflet (Intervention) or a written participant information leaflet (comparator). Outcomes are recruitment and retention to the host SATIN trial and participant's quality of decision-making. Discussion: Although designed to be implemented in a host trial, the host trial, was suspended and therefore this SWAT was not implemented. The protocol and the lessons learnt whilst developing it offer guidance to researchers who wish to answer similar research questions in the future in a similar context or setting. Trial registration: ISRCTN Registry ISRCTN12838042 (11/10/2017).
Highlights
Studies within trials (SWATs) present an opportunity to examine design factors that may impact on the successful delivery of trials
Of 114 trials funded by the UK Medical Research Council (MRC) and the Health Technology Assessment (HTA) Programme that recruited participants between 1994 and 2002, only 31% met their recruitment targets and over half (53%) were given an extension[5]
Exclusion criteria Exclusion criteria are as per the SATIN trial i.e., any signs of complicated infection or any condition that may lead to complications, current or recent antibiotic use, recent urinary tract infections (UTI), current intake of NSAIDs, pregnancy or breastfeeding, non-use of highly effective contraception, previous adverse reaction to any of the study drugs, current intake of drugs potentially interacting with the trial drugs, diabetes mellitus, chronic kidney disease or any other previous illness related to kidney or urinary tract, history of gastro-intestinal ulcers, Glucose 6 phosphate Dehydrogenase deficiency or any other medical condition that may put the participant at risk or influence the study results in the investigators’ opinion
Summary
Studies within trials (SWATs) present an opportunity to examine design factors that may impact on the successful delivery of trials. Failure to meet recruitment targets can result in delays and underpowered studies This SWAT evaluates the effectiveness of hand-held digital multimedia presentation of trial information and standard written patient information to potential participants on recruitment and retention to a host trial. Primary care trials often fail to achieve adequate sample size as demonstrated in a recent study of primary care trials in which only 23% recruited successfully compared to 62% of mental health trials[6]. These failures in meeting recruitment targets mean that overall trial findings are likely to be underpowered; with the studies delayed and falling short of answering their objectives[3,6]
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