Elsevier

Social Science & Medicine

Volume 55, Issue 5, September 2002, Pages 709-719
Social Science & Medicine

“Why don’t they just tell me straight, why allocate it?” The struggle to make sense of participating in a randomised controlled trial

https://doi.org/10.1016/S0277-9536(01)00197-6Get rights and content

Abstract

Randomised controlled trials are the acknowledged ‘gold standard’ method of evaluating the effectiveness of treatments, but little is known about how and why patients decide to participate in trials nor how much they understand about trial design. In this study, in-depth, semi-structured interviews were carried out with 33 middle aged and older men with lower urinary tract symptoms related to benign prostatic disease, 22 of whom had consented to participate and 11 refused to take part in a randomised trial. The trial was evaluating the effectiveness of a new technology (laser therapy) compared with standard surgery (transurethral resection of the prostate) and conservative management (monitoring without active intervention) (the CLasP study). Purposive sampling was used to include participants from different centres, each treatment arm, and at different stages in participation, as well as those indicated to have refused participation. Interviews explored their recall and understanding of trial information, and their reasoning about how they were allocated to a treatment. Data were analysed thematically according to the methods of constant comparison, and by examining each participant's narrative of their experiences.

Most participants recalled major aspects of trial design, including the involvement of chance, but the case studies showed that most also held other co-existing (and sometimes contradictory) views about their treatment allocation. The key to understanding their experiences was their engagement in a struggle to understand the trial in the context of their own beliefs, their recall of the study information and their actual experiences of the trial. The outcome of the struggle was the placing of trust in clinicians or the development of distrust. Non-participants made sense of their experiences in similar ways, but gave different reasons for non-participation than indicated by recruiters.

This study shows that most eligible patients, whatever their level of knowledge, will struggle to make sense of their participation in randomised trials. The provision of clearer written information or time to discuss the trial with particular individuals might be beneficial, although greater public understanding of trials is also needed.

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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