Why is recruitment to trials difficult? An investigation into recruitment difficulties in an RCT of supported employment in patients with severe mental illness

Howard, Louise, de Salis, Isabel, Tomlin, Zelda, Thornicroft, Graham and Donovan, Jenny 2009. Why is recruitment to trials difficult? An investigation into recruitment difficulties in an RCT of supported employment in patients with severe mental illness. Contemporary Clinical Trials 30 (1) , pp. 40-46. 10.1016/j.cct.2008.07.007

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Abstract

Background Under-recruitment to randomised controlled trials (RCTs) is often problematic and there may be particular difficulties in recruiting patients with severe mental illness. Aim To evaluate reasons for under-recruitment in an RCT of patients with severe mental illness Methods Qualitative study during the recruitment phase of an RCT of supported employment. Trial staff and recruiting clinicians were interviewed. Data were analyzed thematically using constant comparative techniques. Results Recruitment rates were low. Five main reasons for recruitment difficulties were found. These included: (i) misconceptions about trials, (ii) lack of equipoise, (iii) misunderstanding of the trial arms, (iv) variable interpretations of eligibility criteria, (v) paternalism. Conclusion Reasons for recruitment difficulties in trials involving patients with severe mental illness include issues that occur in trials in general, but others are more specific to these patients. Clinician and patient involvement in the study design may improve recruitment in future similar trials.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine
Subjects:	R Medicine > R Medicine (General)
Uncontrolled Keywords:	randomized controlled trials, mental disorders, qualitative research, clinical trials as topic, patient participation
Publisher:	Elsevier
ISSN:	1551-7144
Last Modified:	19 Mar 2016 22:41
URI:	https://orca.cardiff.ac.uk/id/eprint/24238

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