Why is recruitment to trials difficult? An investigation into recruitment difficulties in an RCT of supported employment in patients with severe mental illness.
BACKGROUND
Under-recruitment to randomised controlled trials (RCTs) is often problematic and there may be particular difficulties in recruiting patients with severe mental illness.


OBJECTIVE
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.


CONCLUSIONS
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.
Howard
Louise
L
Health Service and Population Research Department, PO29 Institute of Psychiatry, King's College London, De Crespigny Park, London, UK. l.howard@iop.kcl.ac.uk
de Salis
Isabel
I
Tomlin
Zelda
Z
Thornicroft
Graham
G
Donovan
Jenny
J
D000293:Adolescent; D000328:Adult; D000368:Aged; D003625:Data Collection; D005260:Female; D006801:Humans; D008297:Male; D001523:Mental Disorders; D008875:Middle Aged; D026706:Paternalism; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D055815:Young Adult