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

Ryan Spellecy, Sergey Tarima, Ellen Denzen, Heather Moore, Sunil Abhyankar, Peter Dawson, Amy Foley, Iris Gersten, Mitchell Horwitz, Lensa Idossa, Steven Joffe, Naynesh Kamani, Roberta King, Aleksandr Lazaryan, Lawrence Morris, Mary M. Horowitz, Navneet S. Majhail

Research output: Contribution to journalArticlepeer-review

2 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)2145-2151
Number of pages7
JournalBiology of Blood and Marrow Transplantation
Volume24
Issue number10
DOIs
StatePublished - Oct 2018

Bibliographical note

Funding Information:
Financial disclosure: Support for this study was provided to the BMT CTN from the National Heart, Lung, and Blood Institute (NHLBI) and the National Cancer Institute (grant no. U10HL069294) and from the NHLBI (grant no. U10HL069294-12S1). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Funding Information:
Financial disclosure: Support for this study was provided to the BMT CTN from the National Heart, Lung, and Blood Institute (NHLBI) and the National Cancer Institute (grant no. U10HL069294 ) and from the NHLBI (grant no. U10HL069294-12S1 ). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Publisher Copyright:
© 2018 The American Society for Blood and Marrow Transplantation

Keywords

  • Blood and Marrow Transplant Clinical Trials Network: hematopoietic cell transplantation
  • Clinical trials
  • Informed consent
  • Research subjects

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