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

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          Abstract

          Are written informed consent documents for cancer radiotherapy used in US academic medical centers at appropriate readability levels to ensure patient comprehension? 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. 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. This survey study assesses the readability grade levels of patient informed consent forms used by 89 academic radiation oncology departments across the United States. 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. 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. 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. 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. 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. 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.

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          Most cited references24

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          Response rates and nonresponse errors in surveys.

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            A systematic review of readability and comprehension instruments used for print and web-based cancer information.

            Adequate functional literacy skills positively influence individuals' ability to take control of their health. Print and Web-based cancer information is often written at difficult reading levels. This systematic review evaluates readability instruments (FRE, F-K, Fog, SMOG, Fry) used to assess print and Web-based cancer information and word recognition and comprehension tests (Cloze, REALM, TOFHLA, WRAT) that measure people's health literacy. Articles on readability and comprehension instruments explicitly used for cancer information were assembled by searching MEDLINE and Psyc INFO from 1993 to 2003. In all, 23 studies were included; 16 on readability, 6 on comprehension, and 1 on readability and comprehension. Of the readability investigations, 14 focused on print materials, and 2 assessed Internet information. Comprehension and word recognition measures were not applied to Web-based information. None of the formulas were designed to determine the effects of visuals or design factors that could influence readability and comprehension of cancer education information.
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              Interventions to improve patient comprehension in informed consent for medical and surgical procedures: a systematic review.

              Patient understanding in clinical informed consent is often poor. Little is known about the effectiveness of interventions to improve comprehension or the extent to which such interventions address different elements of understanding in informed consent. . To systematically review communication interventions to improve patient comprehension in informed consent for medical and surgical procedures. Data Sources. A systematic literature search of English-language articles in MEDLINE (1949-2008) and EMBASE (1974-2008) was performed. In addition, a published bibliography of empirical research on informed consent and the reference lists of all eligible studies were reviewed. Study Selection. Randomized controlled trials and controlled trials with nonrandom allocation were included if they compared comprehension in informed consent for a medical or surgical procedure. Only studies that used a quantitative, objective measure of understanding were included. All studies addressed informed consent for a needed or recommended procedure in actual patients. Data Extraction. Reviewers independently extracted data using a standardized form. All results were compared, and disagreements were resolved by consensus. Data Synthesis. Forty-four studies were eligible. Intervention categories included written information, audiovisual/multimedia, extended discussions, and test/feedback techniques. The majority of studies assessed patient understanding of procedural risks; other elements included benefits, alternatives, and general knowledge about the procedure. Only 6 of 44 studies assessed all 4 elements of understanding. Interventions were generally effective in improving patient comprehension, especially regarding risks and general knowledge. Limitations. Many studies failed to include adequate description of the study population, and outcome measures varied widely. . A wide range of communication interventions improve comprehension in clinical informed consent. Decisions to enhance informed consent should consider the importance of different elements of understanding, beyond procedural risks, as well as feasibility and acceptability of the intervention to clinicians and patients. Conceptual clarity regarding the key elements of informed consent knowledge will help to focus improvements and standardize evaluations.
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                Author and article information

                Journal
                JAMA Oncology
                JAMA Oncol
                American Medical Association (AMA)
                2374-2437
                May 02 2019
                : e190260
                Affiliations
                [1 ]Vagelos College of Physicians and Surgeons, Columbia University, New York, New York
                [2 ]Harvard Radiation Oncology Program, Boston, Massachusetts
                [3 ]College of Medicine, University of Illinois at Chicago, Chicago
                [4 ]Department of Radiation Oncology and Herbert Irving Comprehensive Cancer Center, Columbia University Irving Medical Center and New York-Presbyterian Hospital, New York, New York
                [5 ]Department of Radiation and Cellular Oncology, University of Chicago, Chicago, Illinois
                [6 ]Division of Cardiology, Department of Medicine, Columbia University Irving Medical Center and New York-Presbyterian Hospital, New York, New York
                [7 ]Department of Radiology and Herbert Irving Comprehensive Cancer Center, Columbia University Irving Medical Center and New York-Presbyterian Hospital, New York, New York
                [8 ]Department of Radiation Oncology and Center for Bioethics and Social Sciences in Medicine, University of Michigan, Ann Arbor
                Article
                10.1001/jamaoncol.2019.0260
                6499131
                31046122
                ea3e0a28-8058-453d-8a94-101d41852ad3
                © 2019

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