Abd-Elsayed-2012-Understanding of consenting copy

Background. Informed consent is the ethical basis for clinical research. !e physical appearance of the consent document may in$uence patients’ willingness to carefully read the consent document. We therefore tested the hypothesis that presentation of consent documents in an enhanced format improves patients’ attention, understanding and therefore willingness to consent for clinical research. Methods. Patients being asked to participate in three large clinical trials were randomly assigned to enhanced or routine presentation. !e enhanced document was printed on 20-pound, cream-colored bond paper and presented in a blue folio. In contrast, patients assigned to routine presentation were given an otherwise identical stapled set of photocopied pages. !e primary outcome was the e#ect of the enhanced format on the proportion of patients consenting; the major secondary outcome was patient’s understanding of the presented procedures and risks. Results. A total of 189 of 251 (75%) patients approached with standard format consenting documents consented for an underlying study, whereas 164 of 248 (66%) approached with enhanced format documents consented; the adjusted odds ratio (95% con"dence interval) for consenting (comparing enhanced to standard formats) was 0.64 (0.43, 0.95), P=0.03. About 90% of the patients in each group correctly identi"ed the major study intervention and major associated risk. Neither patients’ characteristics nor understanding a#ected the consenting rate for the presented clinical research. Conclusion. Consent forms in an enhanced format (i.e., printed on "ne paper and presented in a folio) did not improve patients’ understanding or willingness to consent to participate in clinical trials. (Minerva Anestesiol 2012;78:564-73)