Informed Patient Consent

To obtain informed consent, the physician must have disclosed adequately all facts about the nature of the treatment, the risks involved, the available alternatives and risks,

These investigators found that the greatest percentage of claims arose from the categories of inpatient, adult, and surgical procedures, and that endourological procedures resulted in the greatest incidence of surgical claims. This was in contrast to an earlier report in 1977, which had shown vasectomy to be the most common claim generating procedure.

Crucial factors are: foreseability of harm, magnitude of the risk imposed, the practicality of taking precautions, and reasonableness of the urologist's actions.

When appropriate, the surgeon must disclose and document the experience with the procedure and the results the surgeon has achieved. It is not acceptable for a urologist simply to advise the patient of the general results in the field and imply that his outcomes will be similar.

There are three key elements of consent. The patient must be competent to give consent, the patient must be informed, and consent must be voluntary.

An honest estimate from personal experience is preferable to simply reporting results from the literature.

and reasonable expectations for the outcome of the proposed treatment (12,13). In this manner, the patient may come to understand the available treatment options for approaching the patient's medical condition.

There are three key elements of consent. The patient must be competent to give consent, the patient must be informed, and consent must be voluntary (14).

The actual consent form documents that risks and alternatives were discussed with the patient, but a signed piece of paper sufficient to show that the requirements for informed consent have been met needs to be obtained. Consent entails disclosure, which is the information shared with the patient. It is recommended that such discussion occur on more than one occasion for elective procedures, and that family members or other individuals close to the patient be present during these discussions. Documentation that such discussions occurred, the nature of these discussions, the specific treatments, and risks all need to be in the patient record. The importance of documentation is emphasized when a patient alleges that if the risks associated with a given procedure would have been known, then the patient would not have agreed to undergo treatment (15).

Reasonable guidelines regarding disclosure can be found in a report from the Australian Law Reform Commission (16). In that report, it is recommended that the physician discuss the magnitude of possible harm by addressing specific serious adverse events. The greater the likelihood of risk, the greater is the obligation to discuss the more frequent adverse events.

An honest estimate from personal experience is preferable to simply reporting results from the literature. As simple as this may seem, there may be a lack of consensus among surgeons regarding given risks of a particular procedure and their importance, and hence the informed consent will vary in practice among patients and physicians. This was illustrated by McManus and Wheatley (16) in studying the frequency of disclosure of certain risks prior to laparoscopic cholecystectomy in England. Two-hundred surgeons were asked to comment on the frequency with which they instructed their patients preoperatively about the risk of nine specific potential complications. The average number of laparoscopic cholecystectomies performed by the group annually was 72. Forty-four percent provided written information to patients preoperatively. For the nine potential risks (e.g., bile duct injury, retained calculi, port site hernia, shoulder tip pain, open conversion, wound infection, respiratory complications, thromboembolic complications, and death), only three of the nine were mentioned more than 50% of the time. Surprisingly, 25% never discussed bile duct injury, 22% mentioned it rarely, 27% always mentioned it, and 17% usually did. Quality-standardized written information may serve to be useful as an adjunct to oral discussions between physician and patient. Investigators in Belgium have evaluated patient opinion on the addition of a clear written explanation of risk to a preoperative information packet prior to laparoscopic surgery (17). These investigators propose that such written information would serve to better inform the patient compared to reliance on oral instruction only, and that such practice may lead to reduction in physician liability. In 100 consecutive patients undergoing laparo-scopic surgery who received this information preoperatively, the majority of patients reported being pleased to receive information regarding the surgical technique (91%) and associated risks (97%). Although 41% reported feeling worried by the explanation of risk, none cancelled surgery, and the majority (95%) of patients agreed with such an approach to informed consent (18).

The concept of informed consent is very critical to the medicolegal issues surrounding laparoscopic surgery.

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