Patient advocacy and patient centredness in participant recruitment to randomized-controlled trials: implications for informed consent

Abstract

Context: With the routinization of evidence-based medicine and of the randomized-controlled trial (RCT), more patients are becoming 'sites of evidence production' yet, little is known about how they are recruited as participants; there is some evidence that 'substantively valid consent' is difficult to achieve.

Objective: To explore the views and experiences of nurses recruiting patients to randomized-controlled trials and to examine the extent to which their recruitment practices were patient-centred and patient empowering.

Design: Semi-structured in-depth interviews; audio recording of recruitment appointments; thematic interactional analysis (drawing on discourse and conversation analysis).

Setting and participants: Nurses recruiting patients to five publicly funded RCTs and patients consenting to the recording of their recruitment sessions.

Main outcome measures: The views of recruiting nurses about their recruitment role; the extent to which nurse-patient interactions were patient-centred; the nature of the nurses' interactional strategies and the nature and extent of patient participation in the discussion.

Results: The nurses had a keen sense of themselves as clinicians and patient advocates and their perceptions of the trial and its interventions were inextricably linked to those of the patients. However, many of their recruitment practices made it difficult for patients to play an active and informed part in the discussion about trial participation, raising questions over the quality of consent decisions.

Conclusion: Nurses working in patient recruitment to RCTs need to reconcile two different worlds with different demands and ethics. Evidence production, a central task in evidence-based medicine, poses a challenge to patient-centred practice and more research and relevant training are needed.

Keywords: informed consent; patient advocacy; patient recruitment; professional-patient; randomized controlled trial; relations; shared decision-making.