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Original Investigation
May 2, 2019

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

Author Affiliations
  • 1Vagelos College of Physicians and Surgeons, Columbia University, New York, New York
  • 2Harvard Radiation Oncology Program, Boston, Massachusetts
  • 3College of Medicine, University of Illinois at Chicago, Chicago
  • 4Department of Radiation Oncology and Herbert Irving Comprehensive Cancer Center, Columbia University Irving Medical Center and New York-Presbyterian Hospital, New York, New York
  • 5Department of Radiation and Cellular Oncology, University of Chicago, Chicago, Illinois
  • 6Division of Cardiology, Department of Medicine, Columbia University Irving Medical Center and New York-Presbyterian Hospital, New York, New York
  • 7Department of Radiology and Herbert Irving Comprehensive Cancer Center, Columbia University Irving Medical Center and New York-Presbyterian Hospital, New York, New York
  • 8Department of Radiation Oncology and Center for Bioethics and Social Sciences in Medicine, University of Michigan, Ann Arbor
JAMA Oncol. 2019;5(8):e190260. doi:10.1001/jamaoncol.2019.0260
Key Points

Question  Are written informed consent documents for cancer radiotherapy used in US academic medical centers at appropriate readability levels to ensure patient comprehension?

Findings  In this nationwide survey study and readability analysis, only 9 (8%) of 113 cancer radiotherapy clinical consent forms met the most permissive national recommendation (eighth grade level) for patient materials. Moreover, consent forms contained an average of 7.2 common difficult words.

Meaning  High readability grade levels and common use of difficult words in radiotherapy consent forms may make it difficult for patients to give truly informed consent; therefore, reevaluation and modification of radiotherapy consent forms on a national scale is warranted.


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.