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
Louise HowardJenny Donovan

Abstract

Under-recruitment to randomised controlled trials (RCTs) is often problematic and there may be particular difficulties in recruiting patients with severe mental illness. To evaluate reasons for under-recruitment in an RCT of patients with severe mental illness 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. 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. 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.

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Citations

May 21, 2011·BMC Medical Research Methodology·Sue PattersonRohan Borschmann
May 4, 2010·The British Journal of Psychiatry : the Journal of Mental Science·Louise M HowardGraham Thornicroft
Jan 22, 2013·European Archives of Oto-rhino-laryngology : Official Journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : Affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery·D W HamiltonM Birchall
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Jul 1, 2014·Journal of Investigative Medicine : the Official Publication of the American Federation for Clinical Research·Jessica K HolzerMaria W Merritt
Feb 24, 2016·Journal of Clinical Epidemiology·Alba RealpeJenny L Donovan
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Oct 30, 2016·Journal of the National Cancer Institute·Janice L KriegerMelanie A Sarge
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Sep 16, 2017·The Australian & New Zealand Journal of Obstetrics & Gynaecology·Subashini GnanendranCaroline de Costa
Jan 21, 2018·Trials·Emily PeckhamUNKNOWN SCIMITAR+ collaborative

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