Assessment of Use, Specificity, and Readability of Written Clinical Informed Consent Forms for Patients With Cancer Undergoing Radiotherapy

Abstract

IMPORTANCE Appropriate informed consent processes are crucial to preservation of patient autonomy and shared decision making. Although half of patients with cancer receive radiotherapy, it is unknown whether current consent practices are comprehensible for patients. OBJECTIVE To characterize use, specificity, and readability of clinical informed consent forms for radiotherapy, hypothesizing that forms would be higher than the recommended sixth-to eighth-grade readability level. DESIGN, SETTING, AND PARTICIPANTS This nationwide cross-sectional survey study and readability analysis was conducted from 2016 to 2018 and included 89 academic radiation oncology departments that were part of the 2016 Electronic Residency Application Service. Department leaders (clinical directors, chairs, and personal contacts of study authors) at academic radiation oncology departments were contacted via email. MAIN OUTCOMES AND MEASURES Readability levels were measured by 7 validated readability indices, including the Ford, Caylor, Sticht (FORCAST) index for nonnarrative texts. Difficult words were identified using The Living Word Vocabulary, which describes the readability grade levels of 40 000 common words. RESULTS Of 89 departments, 67 (75%) responded to questions and 57 (64%) provided 113 forms for analysis. Departments providing forms did not differ substantially from others in terms of region, residency size, research output, rural vs urban location, or public vs private institution status. All departments obtained patient written informed consent before radiotherapy; 38 (57%) used body site-specific forms. Using the most conservative (low-score) estimate, mean form readability ranged from grade level 10.6 to 14.2. By 7 distinct indices, only 9 (8%) of 113 forms met the recommended eighth-grade readability level, and 4 (4%) forms met a sixth-grade level. Not a single form met either recommendation based on the FORCAST index. Forms used an average of 7.2 difficult words. Body site-specific forms had considerably better readability than general consent forms. CONCLUSIONS AND RELEVANCE This nationwide study of informed consent practices for cancer treatment with radiotherapy demonstrates that while all US academic radiotherapy departments use written consent forms, it is rare for templates to meet the recommended readability levels for patient materials. These data suggest the need for reevaluation and modification of the approach to radiotherapy consent, ideally with guidance and templates designed by national professional organizations.

Evaluation of the Informational Content and Readability of US Lung Cancer Screening Program Websites

“…In our comprehensive analysis of the LCS program websites, we found inconsistencies, incompleteness, and a reading level Reading levels were assessed as the mean of 5 validated readability scores (Flesch-Kincaid score, 22 Gunning-Fog index, 23 Coleman-Liau formula, 24 above that of the average US adult (grade 8 level). 9 Unlike other studies 11,28 investigating the reading level of online LCS information, the present study evaluated the content of LCS program websites, which may serve as a primary source of information for many LCS-eligible persons. The LCS program websites offer an opportunity for comprehensive coverage of enrollment criteria, logistics, costs, benefits, and risks of screening.…”

“…27 An additional 41 websites were written at or below the grade 7 to grade 8 level recommended by the National Institutes of Health, for a total of 45 websites meeting this less stringent guideline. 9 The word count ranged from 73 to 4410 (median, 571; IQR, 328-909) Other 18 (7) Lack of signs or symptoms of cancer 120 (47)…”

“…Several prior studies 9,11,18,28 have assessed the readability of health care information for patients, a handful of which evaluated LCS patient information available on the internet. 11,28 However, these studies were limited to a smaller subset of patient educational materials rather than 2).…”

“…8 Prior evidence has shown that medical information for patients is typically written at a reading level higher than the grade 8 level of the average US adult. 9 Many current and prior smokers may have cognitive and health literacy challenges, underscoring the need for accurate information written at an accessible level. 10,11 Shared decision-making, in which clinicians discuss eligibility, benefits, and risks of LCS with patients as mandated by the CMS, is intended to address questions and concerns, but many health care professionals have found it difficult to cover LCS optimally within the time constraints of a patient visit.…”

“…Evaluation of Informational Content and Readability of US Lung Cancer Screening Program WebsitesLCS program websites and did not evaluate information content. The most commonly used website readability scores are the Automated Readability Index 26 (which was designed for health education materials), the Coleman-Liau Index,24 the SMOG,25 the Gunning-Fog index,23 and the Flesch-Kincaid score22 (which is found in the Microsoft Word grammar checker9 ). Similar to our findings, Hansberry et al28 found a mean (SD) grade 12.6 (2.7) reading level among 80 online LCS patient education articles.…”