Purpose: This study was performed to test the hypotheses that current consent methods may not convey the data that we imagine that they do, and that many patients may not want the data that we believe that we ought to provide. We also argue that excessive and unthinking emphasis on informed consent documentation may ignore real and important issues.
Methods: Fifty-nine male patients consecutively scheduled for screening sigmoidoscopy were interviewed before and after the procedure in a tertiary care academic health center. Chi-squared analysis was used to determine if the three independent variables of ethnicity, educational level, and previous sigmoidoscopy experience were able to discriminate various components of the informed consent process.
Results: Thirty-nine percent of patients could describe no indication other than doctor recommendation for the procedure. Although 86 percent of patients had heard of the word "polyp," 16 percent could not define it. Fifteen percent of patients could not pick out from a list subsequent steps to be taken in case of an abnormal examination. Although most patients could describe discomforts associated with the procedure, only 19 percent of patients mentioned bleeding and perforation as possible complications. Only 5 percent of patients knew any alternatives to sigmoidoscopy. No patient could explain risks and benefits of alternatives. Eighty-eight percent of patients could not identify their endoscopist, but this only bothered 13 percent. Ninety-three percent of patients were given an opportunity to ask questions, but only 22 percent actually did so. All patients signed the consent form, but only 14 percent of patients actually read all of it. Most patients, 97 percent, thought that they had enough information to proceed with the endoscopy.
Conclusions: By traditional and classic standards, the patients in this study did not give informed consent. Yet, surprisingly, despite this lack of informed consent, most of the patients failed to ask further questions of their physicians and claimed that they had sufficient information to proceed with the procedure. This was the case across the three independent variables of ethnicity, educational level, and previous sigmoidoscopy experience.