Random allocation or allocation at random? Patients' perspectives of participation in a randomised controlled trial

BMJ 1998;317:1177-1180 ( 31 October )

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Random allocation or allocation at random? Patients' perspectives of participation in a randomised controlled trial

Katie Featherstone, MRC PhD student, Jenny L Donovan, senior lecturer in health and health care.

Department of Social Medicine, University of Bristol, Bristol BS8 2PR

Correspondence to: Dr Donovan jenny.donovan{at}bris.ac.uk

Objectives To explore trial participants' understandings ofrandomisation.
Design In this exploratory study, which used qualitative research methods, in-depth, semistructured interviews werecarried out with 20 participants from the CLasP randomised controlledtrial. Interviews were recorded on audio tape and fully transcribed.Data were analysed by comparing transcripts and describing emergentthemes, using a grounded theoryapproach.
Setting The CLasP study comprises three linked multicentre, pragmatic randomised controlled trials evaluating the effectivenessand cost effectiveness of laser therapy, standard surgery, andconservative management for men with lower urinary tract symptomsor urinary retention, or both, related to benign prostatic disease.
Subjects 20 participants in the CLasP study were interviewed. Sampling was purposeful: men were included from eachof the treatment arms, the two major centres, and at differentpoints in thetrial.
Interventions and outcome measures Interviews used a checklist of topics to encourage participants to describe theirexperiences. Narratives concerning randomisation were comparedto identify common themes, retaining the context of the discussionto allow detailedinterpretation.
Results Most participants recalled and described aspects of randomisation, such as the involvement of chance, comparison,and concealed allocation. Many found the concept of randomisationdifficult, however, and developed alternative lay explanationsto make sense of their experiences. Inaccurate patient informationand lay interpretations of common trial terms caused confusion.
Conclusions The provision of clear and accurate patient information is important, but this alone will not ensure consistentinterpretation of concepts such as randomisation. Patients mayneed to discuss the purposes of randomisation in order to understandthem fully enough to give truly informedconsent.

Key messages

Most trial participants were able to recall and describe various aspects of randomisation, including the involvement of chance, comparison, and concealed allocation
The majority found the concept of randomisation difficult to accept and developed other accounts to make sense of their experiences
The use of terms which have different meanings to lay and professional audiences (such as trial and random) can cause confusion among participants
Providing clear and accurate patient information is crucial, but to give truly informed consent patients may also need time to discuss the purposes of clinical trials and concepts such as randomisation

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