Obtaining informed consent at office lowers indemnity risk

Documenting the informed-consent process in operative or office notes may also decrease the risk of indemnity payments.

The location where orthopedic surgeons obtain informed consent before performing elective surgery can significantly influence the risk of making a malpractice indemnity payment, a new study shows.

Timothy Bhattacharyya, MD, and colleagues at Massachusetts General Hospital and at Brigham and Women’s Hospital in Boston, found that obtaining informed consent at a location other than the operating surgeon’s office, such as a hospital ward or preoperative holding area, significantly increased indemnity risk (P<.004).

The researchers reviewed a database of closed malpractice claims covering a 24-year period. All claims came from two large malpractice insurers that represent 494 orthopedic surgeons in a single state annually. They identified 26 cases involving allegations of inadequate informed consent against orthopedic surgeons, although they had gotten written informed consent.

In 13 cases, surgeons obtained the consent at a location other than their office, and nine of these cases resulted in an indemnity payment. In contrast, the informed consent in the other 13 cases was obtained at the operating surgeon’s office, and only one case resulted in a payment (P<.004), according to the study.

“This finding is likely due to the effect of communication on malpractice claims,” the authors said in the study.

“It seems logical that the physician/patient communication that occurs in the office is more interactive and substantive than discussions that occur on the hospital floor or in the preoperative holding area,” they added.

Overall, Bhattacharyya and colleagues identified 1810 closed claims involving orthopedic surgeons. Of these, a total of 28 cases alleged inadequate informed consent (including two without written consent), and all involved patients undergoing elective surgical procedures. Specific allegations included the following:

did not adequately describe the underlying orthopedic condition, 15 cases;
did not discuss the natural history of the condition without intervention, five cases;
experienced a complication not described preoperatively, 13 cases;
did not describe all of the risks of the procedure, 20 cases; and
patient claimed he was incapable of giving informed consent, one case.

These patients had an average age of 46 years. On average, malpractice claims were filed 3.1 years after surgery and were resolved 3.1 years after being filed.

All orthopedic surgeons involved in the malpractice cases had been in practice for at least three years and 64% had board certification.

Of the 28 claims, courts dismissed 15, ruled in favor of the defendant in three and a jury ruled in favor of the plaintiff in one. The remaining nine cases were settled with an indemnity payment, according to the study.

The authors noted that 26 of the 28 cases also alleged negligence and a failure to adhere to the standard of care. “In general, the allegation of a lack of informed consent was part of a number of allegations constituting negligence,” they said.

In 18 of the 26 cases with written consent, the surgeon had also documented that some form of informed consent discussion had occured. Sixteen of these 18 cases resulted in no indemnity payment, according to the study.

In the two cases without written consent, the surgeons had documented in their notes that a discussion had occurred, and neither case resulted in an indemnity payment, the authors noted.

“Documentation of the informed-consent process in the notes was associated with a significantly decreased indemnity risk (P<.005),” they said in the study. “Dictating even a brief description of the informed consent process — whether as part of the operative notes or the office notes — provides strong evidence should a malpractice claim arise.”

For more information:
Bhattacharyya T, Yeon H, Harris MB. The medical-legal aspects of informed consent in orthopaedic surgery. J Bone Joint Surg Am. 2005;87-A:2395-2400.