COMMENTARY

Getting Better Informed Consent Before Surgery

William W. Culbertson, MD

Disclosures

February 15, 2012

Informed Consent for Cataract Surgery: Patient Understanding of Verbal, Written, and Videotaped Information

Shukla AN, Daly MK, Legutko P
J Cataract Refract Surg. 2012;38:80-84

Study Summary

Modern-day ethical and medicolegal requirements dictate that patients are provided with a reasonable description of the risks and benefits of a recommended surgical procedure before it is performed. Thus, "informed consent" is not simply a patient's signature on a consent form, but rather the patient's acknowledgment that appropriate, understandable education on the procedure has been given ("informed") and that, on the basis of this information, the patient assents to having the procedure performed ("consent").

However, studies have demonstrated that patients' comprehension and recollection of the information provided are variable and inconsistent, yet they still consent to the procedure.[1,2] When complications occur or the outcome of surgery is not as expected, patients may feel that they were not made aware of these possibilities preoperatively. Because it is difficult to prove to a jury that a complication or suboptimal outcome was unavoidable, medicolegal action often centers on whether adequate informed consent was given before surgery, usually with the patient claiming ignorance about possible adverse surgical consequences.[3]

This study by Shukla and colleagues examined 4 options for providing patients with the most understandable and memorable "informed consent" preoperatively. The study group consisted of 100 patients scheduled for cataract surgery who were randomly assigned to 1 of 4 standardized preoperative educational protocols:

  • Group 1 received only conventional verbal information;

  • Group 2 patients were given conventional verbal information, plus a brochure written at a second-grade level;

  • Group 3 received the same conventional verbal information and a brochure written at an eighth-grade reading level; and

  • Group 4 watched the American Academy of Ophthalmology DVD "Understanding Cataract Surgery Featuring an Aid to Informed Consent" and also were administered the same verbal information as the other 3 groups.

After the informed consent process, patients in each group were administered a 12-question survey about the surgical procedure, its benefits, its foreseeable and unforeseeable risks, and the alternatives to cataract surgery. Scores in each group were calculated as the number of correct responses out of 12 questions. The patients in groups 2 and 4 (mean correct responses, 10.8 and 10.6, respectively) scored significantly higher than patients in groups 1 and 3 (mean correct responses, 7.9 and 9.1, respectively). The patient's educational level or history of previous cataract surgery did not statistically influence the results.

Viewpoint

This study illustrates that the more plainly an informative brochure is written, the more widely it will be understood by any patient population. Especially for the population with cataracts (average age, 72 years), in which cognitive and memory difficulties may be present, printed material needs to be made more useful and memorable.

One lesson that this study underscores is that the more basic the level of language, the more likely that almost everyone will comprehend the material. A well-composed video, in which the information may seem "dumbed down" to improve comprehension, apparently adds to general understanding of the issues involved with cataract surgery.

Given that even the groups that performed best on the survey (ie, groups 2 and 4) averaged less-than-perfect scores in understanding and memory, it could be argued that patients should be reeducated on points that were answered incorrectly before proceeding with surgery. Ideally, such organizations as the American Academy of Ophthalmology and the American Society of Cataract and Refractive Surgery could develop a core patient information curriculum and posteducation questionnaire/test that could be readily customized for individual patients. Ongoing upgrades to the document and video would update and refine the necessary information.

This report emphasizes the importance of optimizing the informed consent process so that the possibility of either the surgeon or patient misestimating the risks of cataract surgery is minimized.

Abstract

processing....