The amount of information in consent forms for surgical and other procedures varies among hospitals, as does the process for presenting the form to patients scheduled for a procedure. The consent form may be presented to the patient by a physician, a nurse or even nonmedical personnel. The readability of consent forms also varies. Hopper and colleagues evaluated the quality, including the readability, of consent forms used in U.S. hospitals.
Letters requesting a copy of each institution's surgical and procedure consent form were sent to a random selection of 2,194 hospitals.A total of 681 responses were received, of which 616 provided a copy of the form used at the hospital. The consent forms were analyzed for readability by means of the RightWriter 4.0 computer software program. This program evaluates readability according to eight criteria: a readability index, a strength index, a descriptive index, a jargon index, sentence structure recommendations, words to review, a word frequency list and the number of words per sentence. To ensure accuracy, two investigators also separately evaluated the overall content of each form and looked for the inclusion of such information as the name of the patient, the name of the procedure and the physician who would be performing the procedure, the name of the person providing consent, the benefits and risks of the procedure, alternatives to the procedure, and contraindications to and complications of anesthesia.
Most of the consent forms required at least a high school education level to be understood. The mean grade level readability score was 12.6 years. Only 29 forms could be understood by persons reading below the eighth-grade level. The number of words in the forms varied from a low of 58 to a high of 4,217. The strength index of the forms was very low, averaging 0.2 for all states and regions (a well-written document would have a score of at least 0.5 out of 1.0).
While most of the forms included general descriptions of the procedure and its benefits, risks and alternatives, only a small number of them included specific details. For example, only 6.2 percent listed the benefits of the specific procedure, and only 5.4 percent listed alternatives. Most (87.4 percent) of the forms asked permission for anesthesia, but only 47.7 percent included mention of the additional risks of anesthesia. The specific risks of anesthesia were described in only 14.9 percent of the forms. Only 50.9 percent of the forms specifically stated that the patient understood the procedure, and only 27.1 percent stated that the patient's questions had been answered. The physician's signature was required on only 43.2 percent of the forms.
The authors draw several conclusions from their study. Significant variability exists in both readability and content of consent forms included in the study. Moreover, the majority of consent forms require at least a 12th-grade reading level and are too complex for the average person to fully understand. The authors attribute at least some of the complexity to medicolegal concerns. The authors hope the findings of their study will encourage hospitals to develop readable consent forms that are appropriate for most patients' reading levels.