An interview study of the reasons patients have to consent in a randomised controlled study (INTER-EFFECTS)

BACKGROUND 

Many randomised controlled trials (RCT) fail meeting their recruitment goals within time. One possible explanation for the recruitment problem is that people do not want to be part of a study. However little is known about the reason for individual’s acceptance or denials to participate in RCT.
EFFECTS (www.effects.se; NCT02683213) is a Swedish academic-initiated, multicentre, randomised, placebo-controlled trial of fluoxetine for stroke recovery. The trial will investigate whether routine administration of fluoxetine (20 mg daily), 6 months after an acute stroke improves patient’s functional outcome. EFFECTS collaborate with two other studies, FOCUS (UK) and AFFINITY (Australia/New Zealand,Vietnam). Each trial is funded independently and intend to report its own results.
We will use EFFECTS as a host study, and do a Trial within a Study (TWIST) called INTER-EFFECTS, an interview study, the aim is to identify and describe factors contributing to acceptance or denial to participation in a randomised controlled trial.
METHOD/DESIGN 
A qualitative descriptive study with individual interviews with patients who agreed or choose not to participate in EFFECTS
 
RESULTS 
The result could be useful in clinical settings outside the field of stroke, the results could be applicable to a wide range of RCT studies. The study will add knowledge about the management of RCT.
CONCLUSION
Research about management of clinical trials and how to enhance recruitment to clinical trials is very important and this study can help identify barriers and find solutions to why patients say no to participate in RCT.
 
TRIAL REGISTRATION 
Ethical approval 9 August, 2017, 2017/1286-31/1
The protocol is registered at the Northern Ireland Hub for trials methodology research.


KEYWORDS: RCT, consent, qualitative, interview, recruitment

AN INTERVIEW STUDY OF THE REASONS PATIENTS HAVE TO CONSENT IN A RANDOMISED CONTROLLED STUDY (INTER-EFFECTS)