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Background: Improving outcome data collection rates is an essential part of managing clinical trials and ensures statistical power and generalisability of results are maintained. Studies within a trial (SWATs) provide a robust methodology to investigate the most efficient methods to maximise outcome follow-up.Methods: LoTS2Care, a feasibility cluster Randomised Controlled Trial, recruited 269 stroke survivors across 10 services, and incorporated a SWAT to evaluate the effect of questionnaire booklet format (one booklet or two) on follow-up rates for self-reported postal outcomes at 6 and 9 months post-recruitment. Available participants were individually randomised (1 : 1) by the Clinical Trials Research Unit and follow-up rates in the two groups were compared.Results: At 6 months post-recruitment, 254 participants were randomised: 126 to receive (125 posted) the single booklet; 128 to receive two booklets. By 9 months post-recruitment, 116 and 123 participants were still available in each group, respectively. For participants randomised to two booklets, return of at least one of the booklets was considered as ‘followed-up’. At 6 months, 114/125 (91.2%) participants sent the single booklet returned it, compared to 108/128 (84.4%) sent two (odds ratio (OR) 1.92, 95% confidence interval (CI) 0.88 to 4.19). By 9 months, 108/116 (93.1%) participants returned the single booklet, compared to 105/123 (85.4%) sent two (OR 2.31, 95% CI 0.97 to 5.55).Conclusions: The SWAT was an inexpensive, straightforward way to test how booklet format affected follow-up rates. Larger participant numbers would be required for conclusive results. These initial findings, however, suggest that including all outcome measures in a single booklet may maximise return rates, especially in trials with similar populations, such as those living with brain injury, cognitive or speech impairment or older people.

Background A study within a trial (SWAT) is a self-contained research study embedded within one or more host trials to evaluate or explore alternative ways of delivering or organising a particular trial process. There is limited evidence of SWATs evaluating trial processes other than recruitment and retention.Purpose Embedding a SWAT into a host trial provides a potential method of evaluating an aspect of intervention implementation, such as engagement or compliance with the intervention.Research Design This paper presents two case studies of SWATs which aim to test the use of video animations to improve intervention implementation, with particular focus on enhancing understanding, engagement and compliance. These are important aspects of intervention implementation as they are directly linked to intervention effectiveness and therefore, important to study.Results In this paper, we present the potential benefits of conducting SWATs of intervention implementation processes as well as discussing the methodological considerations for embedding a SWAT of this nature within a host trial. Benefits include the opportunity to test minor refinements to intervention implementation within trials through robust randomised SWATs, and the possibility of increasing trial efficiency by maximising the quality or quantity of intervention implementation. Methodological considerations surrounding the design and conduct of the SWAT as well as statistical and health economics considerations are discussed in this paper.Conclusions This paper presents a novel application of SWAT methodology in investigating intervention implementation processes within trial conduct.