CONSENT TO TREAT FORMS FALL SHORT OF PROVIDING INFORMATION TO GUIDE DECISION MAKING

Purpose: There is surprisingly little published on how to incorporate patient preferences and suggestions to improve the informed consent process. Given that consent forms are intended to be read by patients, their opinions on formatting, style and information content should be solicited and incorporated into consent forms. This study examines patient understanding of information presented in current clinical consent forms and elicits their input on alterations to the consent process that would empower patients to take more active role in shared decision making for health care procedures. 

Method: We assessed readability of 5 common informed consent documents using the SMOG Readability Test and the Fry Readability Scale. We then presented the documents to 60 patients and family members, soliciting suggestions for improving the form. Prior to this, we measured patient numeracy and health literacy.  After participants read the documents, but prior to providing suggestions for improvement, participants completed short assessments of their comprehension of the documents.

Result: All included consent documents are written at a college level of reading comprehension were written at the college level with complex blocks of complicated text deterring patients from more than skimming the documents before signing. No forms contained numeric information. With reference back to the form, 48% of patients correctly answered three quiz questions. While one third of participants felt that the forms were easy to read, almost half of these patients missed one or more of the comprehension questions. There were four reoccurring recommendations for improving the informed consent process: specific formatting changes, additional sources of information, mixed attitudes towards inclusion of risk information, and the desire for more information, both in the form of illustrated pamphlets (50%) and through a more extended, interactive physician-patient conversation (44% of high school or higher education and 36% of patients with less education).

Conclusion: Altering the format or type of information that patients receive is a good first step in improving the informed consent process. However, the entire informed consent process needs to be improved. Conducting interviews with physicians, hospital wide education on how to properly engage patients of all literacy levels and utilizing decision aids will likely benefit the consent and decision making process improving both quality of care and patient satisfaction.