Patients or research subjects? A qualitative study of participation in a randomised controlled trial of a complex intervention
Introduction
The randomised controlled clinical trial (RCT) is vital to the organisation and delivery of biomedical research and health technology assessment because it makes possible warrantable claims about the clinical and cost effectiveness of new treatments and ways of working [1]. In recent years, problems associated with recruiting and retaining trial participants has led to research that examines their understandings and attitudes to RCTs. Much of this literature has focused on participation in very specific contexts: for example, trials of interventions for unusual or life threatening conditions, participation by underrepresented populations, and involvement in pharmaceuticals-based Phase 1 trials [2], [3], [4]. This work has tended to be task-oriented, concentrating on topics such as informed consent, participants’ comprehension of trial methods and rationale, and ways of increasing their entry into RCTs [5], [6], [7], [8], [9]. The literature in this area implies a model of lay participation that is based primarily on the perspectives of trialists and statisticians. Variations in understandings of participation are assumed to relate to the level of comprehension of the participant [10]. What appears to be missing from this perspective is an awareness that participants may have their own coherent modes of understanding trial participation.
The need to explore how participants experience and understand involvement in RCTs (and other research) beyond issues of recruitment and retention, is identified by only a small number of studies [11], [12], [13], [14], [15]. Importantly, Featherstone and Donovan suggest that the ways in which participants understand their involvement may affect trial outcomes [16]. Currently there are many assumptions about the conceptual and behavioural basis of ‘lay’ participants in clinical, health technology assessment and health services research trials. However, there is little empirical research. What is required therefore is two-fold; firstly, research that explores the experiences of participants in common types of trial, and secondly, research that seeks to understand the processes of sense making and behaviour amongst participants. In this paper, we present results from a study which examined, in part, participants’ understandings regarding treatment decisions made within an efficacy randomised controlled trial of decision-support tools.
Section snippets
Context and methods
This paper reports results from an observational study, embedded within a randomised controlled trial. The observational study used multiple methods. In this paper, we draw on data collected via one of these methods (interviews) and focus on one of the study's aims. A description of the randomised controlled trial and the observational study is outlined below.
Results
The DARTSII trial was an efficacy study. It relied on the encounter between participants, a decision-support tool and the administering clinic doctor, to represent the optimum conditions under which such an intervention might be used. However, we discovered that participant understanding regarding the application of clinical evidence, and the broader process of decision-making, was shaped by the ways in which they made sense of their participation in the trial. Participants described many
Discussion
The randomised controlled trial at the centre of this study was an efficacy trial of decision aids for people with a chronic condition. Clinical encounters in the trial were designed to provide delivery of the computerised tools using a shared decision model under optimum conditions compared to doctor led guidelines-based practice. Participants within this setting were assumed to interact with the interventions in the manner of ‘patients’, yet because they were participants in a trial, were
Acknowledgements
We gratefully acknowledge the co-operation and candour of participating patients who must necessarily remain anonymous, and the general practitioners David Whitford, Jonathan Tose and Julian Hargreaves. We acknowledge the financial support of the Wellcome Trust for the DARTSII trial (HSR GR065131/2/01/Z and A) and observational study (grant HSR GR068380/2/02/Z). CM's contribution to this paper was partly supported by an ESRC personal research fellowship (RES 000270084). EFK's contribution was
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