Readability of Informed Consent Forms for Medical and Surgical Clinical Procedures: A Systematic Review.

Abstract

Background/Objectives: The wording of informed consent forms for medical or surgical clinical procedures can be difficult to read and comprehend, making it difficult for patients to make decisions. The objective of this study was to analyze the readability of informed consent forms for medical or surgical clinical procedures. Methods: A systematic review was performed according to the PRISMA statement using PubMed, Embase, and Google Scholar databases. Primary studies analyzing the readability of informed consent forms using mathematical formulas published in any country or language during the last 10 years were selected. The results were synthesized according to the degree of reading difficulty to allow for the comparison of the studies. Study selection was performed independently by the reviewers to avoid the risk of selection bias. Results: Of the 664 studies identified, 26 studies were selected that analyzed the legibility of 13,940 forms. Of these forms, 76.3% had poor readability. Of the six languages analyzed, only English, Spanish, and Turkish had adapted readability indexes. Flesch Reading Ease was the most widely used readability index, although it would be more reliable to use language-specific indices. Conclusions: Most of the analyzed informed consent forms had poor readability, which made them difficult for a large percentage of patients to read and comprehend. It is necessary to modify these forms to make them easier to read and comprehend, to adapt them to each specific language, and to carry out qualitative studies to find out the real legibility of each specific population.