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

TitleEasy-to-Read Informed Consent Form for Hematopoietic Cell Transplantation Clinical Trials: Results from the Blood and Marrow Transplant Clinical Trials Network 1205 Study.
Publication TypeJournal Article
Year of Publication2018
AuthorsSpellecy, R, Tarima, S, Denzen, E, Moore, H, Abhyankar, S, Dawson, P, Foley, A, Gersten, I, Horwitz, M, Idossa, L, Joffe, S, Kamani, N, King, R, Lazaryan, A, Morris, L, Horowitz, MM, Majhail, NS
JournalBiol Blood Marrow Transplant
Volume24
Issue10
Pagination2145-2151
Date Published2018 10
ISSN1523-6536
KeywordsAged, Comprehension, Consent Forms, Female, Hematopoietic Stem Cell Transplantation, Humans, Informed Consent, Male, Mental Competency, Middle Aged
Abstract

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.

DOI10.1016/j.bbmt.2018.04.014
Alternate JournalBiol Blood Marrow Transplant
PubMed ID29679770
PubMed Central IDPMC6193865
Grant ListU10 HL069294 / HL / NHLBI NIH HHS / United States
UG1 HL069290 / HL / NHLBI NIH HHS / United States
U24 CA076518 / CA / NCI NIH HHS / United States
U24 HL138660 / HL / NHLBI NIH HHS / United States
U01 HL069294 / HL / NHLBI NIH HHS / United States
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