OBJECTIVES: To assess whether and how investigators of placebo controlled randomised trials inform participants of their treatment allocation at trial closure and to assess barriers to feedback. DESIGN: Postal survey with a semistructured questionnaire. PARTICIPANTS: All investigators who published a placebocontrolled randomised trial in 2000 in five leading medical journals, and a random sample of 120 trials listed in the national research register database. MAIN OUTCOME MEASURES: Number of investigators who informed participants of their treatment allocation at trial closure, methods for delivering the information, and barriers to unmasking treatment. RESULTS: 45% of investigators informed either all or most participants of their treatment allocation, and 55% did not inform any participant or only informed those who asked. The main reasons for not informing participants were that the investigators never considered this option (40%) or to avoid biasing results at study follow up (24%). CONCLUSION: Further research is required to examine sensitive ways to communicate treatment information to trial participants.
RCT Entities:
OBJECTIVES: To assess whether and how investigators of placebo controlled randomised trials inform participants of their treatment allocation at trial closure and to assess barriers to feedback. DESIGN: Postal survey with a semistructured questionnaire. PARTICIPANTS: All investigators who published a placebo controlled randomised trial in 2000 in five leading medical journals, and a random sample of 120 trials listed in the national research register database. MAIN OUTCOME MEASURES: Number of investigators who informed participants of their treatment allocation at trial closure, methods for delivering the information, and barriers to unmasking treatment. RESULTS: 45% of investigators informed either all or most participants of their treatment allocation, and 55% did not inform any participant or only informed those who asked. The main reasons for not informing participants were that the investigators never considered this option (40%) or to avoid biasing results at study follow up (24%). CONCLUSION: Further research is required to examine sensitive ways to communicate treatment information to trial participants.
Entities:
Keywords:
Biomedical and Behavioral Research; Empirical Approach
Authors: Ann H Partridge; Karen Sepucha; Anne O'Neill; Kathy D Miller; Christine Motley; Ramona F Swaby; Bryan P Schneider; Chau T Dang; Donald W Northfelt; George W Sledge Journal: JAMA Oncol Date: 2015-06 Impact factor: 31.777
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