Experiences of randomization: interviews with patients and clinicians in the SPCG-IV trial.
OBJECTIVE
Recruitment of both patients and clinicians to randomized trials is difficult. Low participation carries the risk of terminating studies early and making them invalid owing to insufficient statistical power. This study investigated patients' and clinicians' experiences of randomization with the aim of facilitating trial participation in the future.


METHODS
This was a qualitative study using content analysis. Patients offered to participate in a randomized trial and randomizing clinicians were interviewed. Five participants, four non-participants and five randomizing clinicians were interviewed, 2-8 years from randomization.


RESULTS
Clinicians used strategies in interaction with the patients to facilitate decision making. Patients' attitudes differed and experiences of relatives or friends were often stated as reasons for treatment preferences. Patients described that letting chance decide treatment was a difficult barrier to overcome for randomization. The clinicians used a number of different strategies perceived to make randomization more acceptable to their patients. The clinicians' own motivation for randomizing patients for trials depended on the medical relevance of the study question and the clinicians' major obstacle was to maintain equipoise over time. Regular meetings with the study group helped to maintain equipoise and motivation.


CONCLUSIONS
To establish a good platform for randomization the clinician needs to know about the patient's treatment preferences and the patient's attitude concerning the role of the clinician to facilitate decision making. The strategies used by the clinicians were perceived as helpful and could be tested in an intervention study.
Bill-Axelson
Anna
A
Department of Urology, Uppsala University Hospital, Uppsala, Sweden. anna.bill.axelson@akademiska.se
Christensson
Anna
A
Carlsson
Marianne
M
Norlén
Bo Johan
BJ
Holmberg
Lars
L
D001294:Attitude to Health; D003657:Decision Making; D005387:Finland; D006801:Humans; D007055:Iceland; D007407:Interviews as Topic; D008297:Male; D010358:Patient Participation / Q000523:psychology*; D017060:Patient Satisfaction; D018579:Patient Selection; D010361:Patients / Q000523:psychology; D010817:Physician-Patient Relations; D010820:Physicians / Q000523:psychology; D011471:Prostatic Neoplasms / Q000628:therapy*; D016032:Randomized Controlled Trials as Topic / Q000523:psychology*; D013548:Sweden