Assessment of readability of informed consent forms of gynecologic cancer clinical trials: A (Potential) barrier to enrollment?

OBJECTIVE

Limited English language proficiency (LEP) is associated with decreased clinical trial enrollment. Notably, the AMA and the NIH recommend that patient materials have a readability level commensurate to a sixth- through eighth-grade reading level. This study evaluated the readability of informed consent forms for gynecologic oncology clinical trials.

METHODS

This was an IRB-exempt, retrospective, quantitative analysis of for gynecologic oncology clinical trials opened at Ohio State University, a National Cancer Institute (NCI)-designated institution, from 1/1/2017 through 12/31/2022. We analyzed patient informed consent documents from gynecologic oncology clinical trials. The researchers assessed the readability of these consent forms using standardized readability tests to determine their complexity and readability levels. Readability was assessed using Readability Studio Professional Edition software for five metrics.

RESULTS

A total of 103 informed consent forms were reviewed, capturing trials for ovarian (n = 41, 39.8 %), endometrial (n = 21, 20.4 %), cervical (n = 14, 13.6 %), vulvar/vaginal cancers (n = 3, 2.9 %), as well as multi-disease site/basket trials (n = 24, 23.3 %). Most informed consent forms were from industry-sponsored studies (n = 45, 43.7 %) and NCI, NRG Oncology, and GOG Foundation (GOG) sponsored studies (n = 42, 40.8 %). The mean reading grade-level for all analyses was 13th grade, specifically 13 for ovarian cancer, 12.02 for endometrial, 12.9 for cervical, 12.8 for vulva/vaginal, and 13.0 for others (p = 0.26). There was no difference (p = 0.21) between NCI/NRG/GOG studies (13.3) and industry-sponsored trials (13.6).

CONCLUSIONS

In this study, we found that current informed consent forms do not meet current recommended readability standards for medical literature regardless of disease site or sponsor. This is an opportunity to reduce disparities and improve patient understanding and involvement in clinical trials.