Readability of patient information and consent documents in rheumatological studies

Abstract

BackgroundBefore participation in medical research an informed consent must be obtained. This study investigates whether the readability of patient information and consent documents (PICDs) corresponds to the average educational level of participants in rheumatological studies in the Netherlands, Denmark, and Norway.Methods24 PICDs from studies were collected and readability was assessed independently using the Gunning’s Fog Index (FOG) and Simple Measure of Gobbledygook (SMOG) grading.ResultsThe mean score for the FOG and SMOG grades were 14.2 (9.0–19.0) and 14.2 (12–17) respectively. The mean FOG and SMOG grades were 12.7 and 13.3 in the Dutch studies, 15.0 and 14.9 in the Danish studies, and 14.6 and 14.3 in the Norwegian studies, respectively. Out of the 2865 participants, more than 57 % had a lower educational level than the highest readability score calculated in the individual study.ConclusionsAs the readability level of the PICDs did not match the participants’ educational level, consent may not have been valid, as the participants may have had a limited understanding of what they agreed to participate in. There should be more focus on the readability of PICDs. National guidelines for how to write clear and unambiguous PICDs in simple and easily understandable language could increase the focus on the readability of PICD.Electronic supplementary materialThe online version of this article (doi:10.1186/s12910-016-0126-0) contains supplementary material, which is available to authorized users.

Beyond the EULA: Improving Consent for Data Mining

“…Some of these weaknesses have been examined in the literature. Hamnes et al find that consent documents in rheumatological studies are not sufficiently readable for the majority of the population [15], a finding which is supported by Vučemilo and Borovečki who also find that medical consent forms often exclude important information [53]. Donovan-Kicken et al examine the sources of confusion when reviewing such documents [8], which include insufficient discussion of risk and lengthy or overly complex language.…”

Implementation of Common Rule Changes to the Informed Consent Form: A Research Staff and Institutional Review Board Collaboration

“…12,13 Potential participants may have difficulty understanding the information needed to make informed decisions. 12,14 Ideally, language should be written at an 8th grade reading level or below, 15,16 but this goal is not always achieved in practice. 14,15 In a review published in the New England Journal of Medicine, the average reading level of consent forms was grade 10.6, 16 and reading levels above the 8th grade level have been corroborated in other reports.…”

“…12,14 Ideally, language should be written at an 8th grade reading level or below, 15,16 but this goal is not always achieved in practice. 14,15 In a review published in the New England Journal of Medicine, the average reading level of consent forms was grade 10.6, 16 and reading levels above the 8th grade level have been corroborated in other reports. 15 One revision to the Common Rule is designed to improve participants' comprehension of a proposed study, as important information has often been buried in the long, complex forms.…”

Bed bath with soap and water or disposable wet wipes: Patients’ experiences and preferences

“…Next, the first author offered potential participants oral and written information about the study. The readability of the written patient information and consent documents was assessed using the Gunning fog index to ensure that the readability level matched the average educational level (Hamnes, van Eijk-Hustings, & Primdahl, 2016).…”