[In Process Citation]

Do patient information sheets for randomized controlled trial provide clear information? Aim. To assess whether patient information sheets (PIS) for randomized controlled trials (RCT) submitted during 2012 to a large Italian Ethics Committee provided clear information. Methods. One hundred and seven PIS for RCT involving adult subjects were obtained from the Ethics Committee Office. Using a five-point scale, two observers with education in nursing assessed the overall PIS comprehensibility and the clarity of information provided about the following items: rational of the study, aims, procedures, randomization, placebo, blindness, anticipated benefits, potential risks. Two further items focused on whether it was clear who promoted/sponsored the study and that the researcher/hospital would receive a fee/refund by the sponsor (clear/not clear). Results. At least 87% of PIS were rated as sufficiently clear regarding aims, procedures, placebo, potential risks, and who promoted/sponsored the study. Information about fee/refund to researcher/hospital, randomization, rational of the study, blindness, and anticipated benefits was rated as sufficiently clear in 61%, 60%, 53%, 50%, and 29% of PIS respectively. Overall comprehensibility was sufficient for 93% of PIS. Overall agreement between raters was on average 84%. Interobserver reliability was moderate or substantial for most items, and fair for randomization and blindness. Conclusions. Many PIS do not provide clear information about several issues important to allow informed consent, especially regarding anticipated benefits. Nurses may offer consistent opinion in PIS assessment.