“Why don’t they just tell me straight, why allocate it?” The struggle to make sense of participating in a randomised controlled trial
Section snippets
Background
The demand for evidence about the effectiveness of treatments has led to the increasing dominance in funded health services research of the randomised controlled trial (RCT). Historically, the literature examining RCTs has tended to focus on the methodological issues that should be taken into account during design and implementation, such as blinding and placebos, ethical issues and informed consent (Pocock, 1983). Rather less research effort has concentrated on investigating the patient's
The main trial
Both authors worked in a department where a range of randomised controlled trials were being undertaken. The trial chosen for this study was one that was being led by one of the authors (JD) to facilitate access to patients and study information. The trial, known as CLasP (the acronym relating to the treatments involved), aimed to compare the effectiveness of laser therapy (a new technology), standard surgery (transurethral resection of the prostate—TURP), and conservative management
Results
Thirty-three men potentially eligible for the CLasP trials were finally interviewed—22 participants and 11 non-participants. Men with a range of ages, from each of the clinical centres and in each of the arms of the trial were interviewed. Seven participants were interviewed within three months of being randomised, five within five months, and eight after at least six months, by which time they had completed their treatment and had been followed up. The majority of the non-participants attended
Recall of trial design
Participants had greater overall recall than non-participants about the design issues in the trial. About half or more of the participants recalled that the study involved experimentation, the comparison of treatments and allocation by concealment, usually by envelopes. While non-participants had lower levels of recall of most design aspects, almost all recalled the experimental nature of the trial and emphasised this aspect consistently more often than the participants. Only one participant
Participants: the struggle to make sense of participation
Whilst the majority of participants had a good or partial recall of the major aspects of trial design and methods, many indicated in their interviews that they had difficulties understanding the terminology and coming to terms with the concepts inherent in the trial design. The case studies of each man showed that all were involved in what was, essentially, a struggle to make sense of their participation. Table 1 outlines the major explanations given by the men to describe their understanding
Non-participants: pathways to refusal
Although reasons for refusal were written by recruiting clinicians in the patients’ notes, it quickly became apparent in the interviews that patients often gave very different explanations of their ‘refusal’. In the interviews, five were able to cite clear and particular reasons for non-participation. However, there was less clarity among the remaining ‘refusers’, with three indicating that they had treatment preferences but thought they were participants in the trial, and three who could not
Discussion
This study shows that it is possible to engage trial participants and non-participants in discussions about their attitudes towards a trial, their allocated treatment, and the method of allocation. Previous studies have suggested that trial participants are confused about randomisation and give distorted accounts (Snowdon et al., 1997; Appelbaum et al., 1987). The men in this study acknowledged that randomisation was confusing and difficult, and many formed alternative accounts to explain the
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