BACKGROUND: Informed consent forms are universally used by hospitals throughout the United States before surgery or invasive procedures. This survey was undertaken to determine the content of these forms and their ability to be understood by individuals with differing reading comprehension levels. METHODS: Ten percent of all U.S. hospitals were requested to forward a copy of their current surgical/procedural informed consent form. The forms received were digitized and computer assessed for readability. In addition, each form was evaluated for a variety of items with respect to content. RESULTS: Of the 2194 requests mailed, 681 responses were received including 616 with surgical/procedural consent forms. The mean grade level required to understand these consent forms was 12.6 (+/- 3.1). There was no variability in readability scores on the basis of hospital bed size. Of the 616 consent forms reviewed, 29, 146, 347, and 461 forms could be understood by individuals reading at a grade level of less than 8 and at least 8, 10, and 12 years of education, respectively. Although most required the name of the patient, physician, and procedure, the majority did not describe or provide a full-in blank for the specific benefits, risks, and alternatives to the procedure. CONCLUSIONS: The majority of surgical/procedural informed consent forms currently used by U.S. hospitals are complex and are not easily understood by the average patient. In addition, the majority of reviewed consent forms do not list specific benefits or potential complications of the planned surgery/procedure.
BACKGROUND: Informed consent forms are universally used by hospitals throughout the United States before surgery or invasive procedures. This survey was undertaken to determine the content of these forms and their ability to be understood by individuals with differing reading comprehension levels. METHODS: Ten percent of all U.S. hospitals were requested to forward a copy of their current surgical/procedural informed consent form. The forms received were digitized and computer assessed for readability. In addition, each form was evaluated for a variety of items with respect to content. RESULTS: Of the 2194 requests mailed, 681 responses were received including 616 with surgical/procedural consent forms. The mean grade level required to understand these consent forms was 12.6 (+/- 3.1). There was no variability in readability scores on the basis of hospital bed size. Of the 616 consent forms reviewed, 29, 146, 347, and 461 forms could be understood by individuals reading at a grade level of less than 8 and at least 8, 10, and 12 years of education, respectively. Although most required the name of the patient, physician, and procedure, the majority did not describe or provide a full-in blank for the specific benefits, risks, and alternatives to the procedure. CONCLUSIONS: The majority of surgical/procedural informed consent forms currently used by U.S. hospitals are complex and are not easily understood by the average patient. In addition, the majority of reviewed consent forms do not list specific benefits or potential complications of the planned surgery/procedure.
Entities:
Keywords:
Empirical Approach; Professional Patient Relationship
Authors: Wouter K G Leclercq; Bram J Keulers; Marc R M Scheltinga; Paul H M Spauwen; Gert-Jan van der Wilt Journal: World J Surg Date: 2010-07 Impact factor: 3.352