Think about the last time you signed an informed consent form for yourself or a dependent, or if you’ve ever been with a family member during a visit involving an informed consent process. Were you provided all of the information about the risks, benefits, potential complications, and alternative treatments for a procedure or treatment?

The malpractice experience informs us of significant opportunities to improve how and what is communicated with patients during the informed consent process. Informed consent is more than a form. The intention of an informed consent process is to ensure that the patient not only understands the risks, benefits, and alternatives, but also has an appreciation of the anticipated outcomes, potential complications, and the trajectory for recovery.

Consider the following case: A 49-year-old male with a history of high BMI and hypertension underwent a total hip replacement. He signed an informed consent form during a preoperative evaluation, which listed nerve injury among the possible risks. The patient developed a foot drop post-operatively. The surgeon did not explicitly list developing a foot drop as a risk during the informed consent process. Consequently, the patient filed a malpractice claim as he did not have the risks of the procedure adequately explained to him.

In Candello’s database of approximately 500,000 MPL cases, inadequate informed consent for surgical/invasive procedures was a contributing factor in seven percent of all surgery malpractice cases; about half of these surgery MPL claims closed with an indemnity payment with an average amount of $415,000.

The Candello team conducted a multivariable analysis to help predict which contributing factors increase the odds of a malpractice case closing with payment. Of the results, a claim that listed “inadequate informed consent for procedures” as a contributing factor had 114 percent higher odds of closing with a payment compared to claims that did not have this factor. Additionally, claims that listed “inadequate informed consent for alternative treatments” as a contributing factor had 90 percent higher odds of closing with payment compared to claims without this factor.

Dr. Adam Schaffer, a hospitalist at Brigham and Women’s Hospital in Boston and a Sr. Clinical Analytic Specialist at CRICO, shared these insights at Candello’s annual community summit on September 12, 2023. Dr. Shaffer described how insufficient discussions with a patient about the risks and benefits of a procedure significantly increase the likelihood of a malpractice claim closing with payment. He also emphasized that providing the patient with non-operative alternatives before surgery and setting realistic expectations for a procedure can help prevent MPL claims. How else can we improve or even perfect the informed consent process?

Dr. Michael Barry, a primary care physician at Massachusetts General Hospital, and a Clinical Professor at Harvard Medical School, also joined the summit to share his answers to this question. As a prominent researcher in patient outcomes research, Dr. Barry presented a study evaluating whether receiving a decision aid prior to elective hip or knee replacement or spinal surgery influenced patient outcomes. The researchers asked patients about their level of trust in the operating surgeon as well as any decision regret six months after the study participant’s surgery. The results demonstrated that while there was not a significant difference in decision regret, patients who received a decision aid reported higher trust in their surgeons when asked six months after surgery.

These findings are important to consider as we develop interventions to reduce malpractice risks. Enhancing trust, engaging the patient in shared decision making, and ensuring that the informed consent processes are comprehensive and robust may be essential steps toward reducing malpractice claims.

Written By
Pat Folcarelli photo
Pat Folcarelli, RN, PhD
Vice President, Patient Safety, CRICO
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