Development of a model angiography informed consent form based on a multiinstitutional survey of current forms

PURPOSE: To develop an informative consent form for angiography that can be read and understood by a patient with an eighth-grade level of education. MATERIALS AND METHODS: Consent forms from 125 medical centers were evaluated with Right Writer 4.0 software, The readability index, a measure of educational grade level needed to understand a document, was determined for each form, Features of forms and discussion of complications were evaluated, A model consent form was developed. RESULTS: Analysis of 27 consent forms revealed a mean readability index of 14.2; to adequately understand the documents, an average of 2.2 years of college were required, Alternatives to the procedure were listed in 14 forms (52%). All consent forms listed potential complications, but only 15 (56%) identified specific numeric risks, and attempts to classify complications according to severity were made in only five (18%). CONCLUSION: An angiography consent form has been developed that can be understood with an eighth-grade level of education, It should allow patients to more easily understand the procedure and its risks, benefits, and alternatives, It remains the obligation of the physician to tailor the discussion for each procedure to meet the needs of each patient.