A. Chakrabarty1, E. Kaplan1, L. Wood1, I. Marques1, K. Kichler1, S. J. Baker1, J. W. Toh3, E. M. Muller2, G. D. Kennedy1, M. S. Morris1, J. S. Richman1, D. I. Chu1 1University Of Alabama at Birmingham,Birmingham, Alabama, USA 2University of Cape Town,General Surgery,Cape Town, WESTERN CAPE, South Africa 3University Of Sydney,Sydney, NSW, Australia
Introduction:
The American Medical Association (AMA) and the National Institutes of Health (NIH) recommend that education materials given to patients should not exceed a sixth-grade reading level. Consent forms are legal documents that patients are expected to read, understand and sign before any surgical procedure. It is unclear, however, how readable contemporary consent forms are and whether these levels vary internationally. We hypothesized that the readability of consent forms would be poor and exceed the recommended sixth grade reading level.
Methods:
Major surgery English-consent forms were collected from four tertiary-care referral-centers across three countries: USA, Australia, and South Africa. Consent forms were analyzed to assess readability using four instruments: Flesch-Kincaid Grade Level (FKGL) instrument, SMOG (Simple Measure of Gobbledygook), PEMAT (Patient Education Materials Assessment Tool), and PCR (Print Communication Rating). Three independent observers analyzed each form to assess readability.
Results:
Seven consent forms were analyzed from three countries. None of the materials were under sixth-grade reading level when analyzed with FKGL and SMOG with average grade-level scores of 12.0 ± 2.4 SD and 15.2 ± 2.0 SD, respectively. The range for FKGL was 9 to 15 while the range for SMOG was 13.5 to 17 where the higher scores indicate a higher reading level. While no significant differences existed between FKGL and SMOG scores by institutions, Australia had the best FKGL and SMOG scores, at 9 and 13.5 respectively. The average PEMAT scores were 70.8% ± 13.8 SD for understandability and 30.5% ± 25.8 SD for actionability, with scores closer to 100% being ideal. No significant differences in PEMAT scores were observed by institutions, but Australia had the highest PEMAT scores for both understandability and actionability, at 85.2% and 40%, respectively. The average PCR score was 40.1 ± 4.6 SD and all consent forms scored in the 24-47 score range, for which “augmented efforts to eliminate literacy-related barriers” are recommended. While no significant differences in PCR scores were observed by institution, Australia again had the highest score, at 43 ± 5.2 SD.
Conclusion:
The readability of major surgery consent forms from three countries varied but was overall poor and failed to meet the AMA/NIH recommended sixth-grade reading level. While consent forms are legal documents, considerations should be made to make consent forms more readable and understandable.