Informed Consent: How Much Information Is Enough?

Abstract

Background: Recent judicial decisions involving informed consent have led to some medical practitioners altering the way they obtain consent. The aim of this study was to determine the degree to which patients understood the risks associated with a surgical procedure after giving routine consent and whether providing additional detailed verbal and/or written information improved their understanding. It was further determined whether the provision of more extensive information Altered patients' anxiety levels. Methods: Patients undergoing femoral popliteal bypass or carotid surgery were randomized to obtain either routine consent only or routine consent with verbal or written or verbal and written consent. Patients undertook a pre-operative risk and complication questionnaire, a pre-and postoperative anxiety and depression evaluation and a follow-up questionnaire 6 weeks after discharge. Results: Thirty-two patients were included in the trial. The comprehension questionnaire resulted in a correct percentage response of 48% for the routine information only, 59% with added verbal information, 59% with added written information and 55% with added written and verbal information. Twenty-five per cent of patients stated that they had a poor understanding of the risks and complications of the procedure. Conclusions: Additional written or verbal information did not improve a patient's understanding of risks and complications of the procedure. It also did not improve patients' perceived understanding of the operation or its complications. Patients' anxiety levels were unaltered by the increase in the information they were given. The information provided to patients should be simple, easy to understand and list any possible major complications to enable the patient to determine whether to undergo or decline a procedure.

The effect of video-based education on patient anxiety in men undergoing transrectal prostate biopsy

“…Similarly, Stanle and colleagues found that additional written or verbal information did not improve a patient's understanding of the risks and complications of the procedure. 17 Although we found a significant decrease of post-information STAI-S scores in Group 1, the proportion of patients scoring low, moderate and high levels of anxiety was essentially the same in both groups. When we compared the pre and post information STAI-S scores of Group 1 patients, it would appear that the most striking difference was observed in those who score high at the onset for situational anxiety.…”

Length and Complexity of US and International HIV Consent Forms from Federal HIV Network Trials

“…16,17 Data suggest consent forms are becoming longer over time, 17,18 of potential concern even if using non-technical language. 17,[19][20][21] One study showed mean length of consent forms tripled over a 20-year period, with significant additional text related to "juridicial and financial matters, insurance, and data safety and storage." 5 This increase in length is relevant, ethically, as evidence exists that shorter forms are associated with better understanding.…”

Communicating new policy on antibiotic prophylaxis with patients: a randomised controlled trial

“…5 Mixed results have been shown by studies investigating the effectiveness of evidence-based leaflets as a communication tool to improve information to patients. 6,7 Many patients do not read such forms and of those who do, many do not fully comprehend the information provided. Written information requires at least basic literacy as well as the motivation to read the material provided.…”