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

Abstract

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.

Keywords: Cervical cancer; Clinical trial enrollment; Endometrial cancer; Gynecologic cancer; Literacy; Ovarian cancer; Readability.

Fig. 1

(A) Comparison of Readability Scores as depicted by grade level on the xaxis across all disease types using five readability metrics. (B) Differences between actual readability and target readability when compared to the recommended reading level of 8th grade (here represented by 0).

Fig. 2

(A) Comparison of Readability Scores as depicted by grade level on the xaxis across all clinical trial sponsors using five readability metrics. (B) Differences between actual readability and target readability when compared to the recommended reading level of 8th grade (here represented by 0). Any data that lies to the left of the set zero point would represent consent written at a reading level lower than eighth grade and any data that lies to the right correlates to a higher reading level than the target of eighth grade.

Fig. 3

(A) Fry Readability Graph for disease types. (B) Fry Readability Graph for sponsor type. Allows for grade reading level to be approximated by plotting the average number of sentences (y-axis) and syllables (x-axis) per hundred words.