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

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.

Any progress in informed consenting for cancer treatment? Results from a cross sectional analysis at a comprehensive cancer center

“…Finally, with increasing demographic aging, informed consent forms need to be adapted in terms of readability. An optimized, age-adapted version should have a larger font size and stronger contrasts, as well as simpler and more concise language (Spellecy et al 2018 ; Glaser et al 2020 )—not only for elderly patients. The impact of these features on patients’ satisfaction and understanding of the informed consent process have to be evaluated in future trials.…”

Struggling With Extensive Informed Consent Procedures for Cancer Trails – Is There Even a Benefit for the Patients?

“…A larger font size and stronger contrasts as well as a concise and simpler language may help to improve the readability. [20,21] Multimodal approaches to optimize the quality of the informed consent process -not only in the setting of cancer therapy -have shown promising results, e.g., the use of touch-screen tablets, animated videos, slideshows with voice-over or comics [22,23] or feedback interventions [20]. However, none of these attempts have yet been implemented into the real-world scenario of patient education, even though we have been aware of these shortcomings for years.…”

Study protocol for a randomised controlled trial of enhanced informed consent compared to standard informed consent to improve patient understanding of early phase oncology clinical trials (CONSENT)

“…We have also observed the statistical analysis for three other trials using the QuIC-A as a primary endpoint to test the effectiveness of an intervention to improve patient understanding of clinical trials. Tattersall et al 20 aimed to detect a difference of 5 points with the addition of a question prompt list, Hoffner et al 21 aimed to detect a difference of 5 points with an educational video about clinical trials and Spellecy et al 22 aimed to detect a difference of 4 points using an easy to read informed consent sheet.…”