Easy-to-Read Informed Consent Form for Hematopoietic Cell Transplantation Clinical Trials: Results from the Blood and Marrow Transplant Clinical Trials Network 1205 Study

• Published in: Biology of blood and marrow transplantation Vol. 24; no. 10; pp. 2145 - 2151
• Main Authors: Spellecy, Ryan, Tarima, Sergey, Denzen, Ellen, Moore, Heather, Abhyankar, Sunil, Dawson, Peter, Foley, Amy, Gersten, Iris, Horwitz, Mitchell, Idossa, Lensa, Joffe, Steven, Kamani, Naynesh, King, Roberta, Lazaryan, Aleksandr, Morris, Lawrence, Horowitz, Mary M., Majhail, Navneet S.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.10.2018
• Subjects: Aged; Blood and Marrow Transplant Clinical Trials Network: hematopoietic cell transplantation; Clinical trials; Comprehension; Consent Forms; Female; Hematopoietic Stem Cell Transplantation; Humans; Informed Consent; Male; Mental Competency; Middle Aged; Research subjects; Clinical trials; Research subjects; Informed consent; Blood and Marrow Transplant Clinical Trials Network: hematopoietic cell transplantation
• ISSN: 1083-8791; 1523-6536; 1523-6536
• DOI: 10.1016/j.bbmt.2018.04.014

•A 2-column easy-to-read informed consent form incorporating elements of health literacy and readability in participants was viewed favorably by clinical trial sites.•However, it did not alter comprehension of the trial among participants considering participation in Blood and Marrow Transplant Clinical Trials Network clinical trials. Because of the complexity of hematopoietic cell transplant trial treatments, informed consent forms are often long and difficult to read. We evaluated a 2-column easy-to-read informed consent (ETRIC) form that incorporates elements of health literacy and readability in participants and centers participating in Blood and Marrow Transplant Clinical Trials Network (BMT CTN) clinical trials. In a randomized study 198 adult patients from 25 centers potentially eligible to participate in 4 BMT CTN interventional trials were randomized to the ETRIC form or a standard consent form for that trial. Both forms were written at no more than an eighth-grade reading level. The primary endpoint was objective comprehension score on the Quality of Informed Consent, part A (QuIC-A) instrument. In a parallel evaluation study, 2 moderators conducted semistructured interviews of 49 investigators, research staff, and institutional review board (IRB) members at 9 BMT CTN trial sites. The mean QuIC-A scores were comparable in 152 patients (77%) assessable for the primary endpoint (ETRIC form, 80.5; standard form, 81.8; P = .37). In regression analysis there was no significant association between the consent type and QuIC-A score. In the evaluation study dominant themes identified on qualitative analyses included general comfort and willingness to use the ETRIC template and that its formatting and layout enhancements would offer additional value to research participants, investigators, and IRBs. IRB language preferences and requirements, length, and prior experience with alternative consent formats were perceived as barriers. Among patients considering participation in BMT CTN clinical trials, the formatting enhancements of the ETRIC form did not alter comprehension of the trial. Despite local challenges to implementation, trial sites generally viewed the ETRIC form favorably and expressed willingness to use it over standard consent form.