Obtaining and documenting informed patient consent prior to surgery

May 3 2006

Obtaining and documenting informed patient consent prior to surgery is of vital importance, but both the process and documentation of consent can be inadequate.

At the annual meeting of the American Association of Neurological Surgeons in San Francisco, physicians from the University of Pittsburgh Medical Center reported on a study of a procedure-based consent form they have developed to enhance and improve this process.

"Appropriate physician conduct in medical/legal matters begins with the informed consent process. This leads to an understanding of the patient's diagnosis, the planned procedure, the therapeutic alternatives - both medical and surgical, and the inherent procedural risks," reported Douglas Kondziolka, M.D., Peter J. Jannetta Professor and vice-chairman of neurological surgery, and professor of radiation oncology at the University of Pittsburgh School of Medicine. "It has been argued that most surgeons do not devote appropriate importance to informed consent in their daily duties. The patient consent procedure we developed facilitates patient discussion and we validated this process by surveying our patients on various elements of the consent process."

In the study, 120 consecutive patients were evaluated prior to different neurological surgery procedures. Two consent forms were used by the surgeon; one was a standard hospital consent form, and the other was a specialized form created for the neurological surgery practice. This specialized consent form listed specific diagnoses, procedures, alternatives and risks. Each point discussed with the patient was checked off by the surgeon. The form then was signed by both the patient and the surgeon. Ten to twenty minutes later, the patient was questioned by a non-medical member of the office staff.

All of the 120 patients using the new form correctly recalled their diagnoses and the procedure they were going to receive. The diagnoses included brain tumor vascular malformation, brain lesion, trigeminal neuralgia, sphenopalatine neuralgia, or Parkinson's disease. Of 428 treatment alternatives discussed with patients before surgery, 420 or 98 percent, were subsequently recalled. Specifically, patients recalled the options of observation with periodic imaging (114/117), use of radiation therapy (73/75), and surgical resection (89/92). Of 1,207 risks discussed with patients before surgery, 1,176 or 97 percent, were later recalled.

When 20 randomly selected patients were reevaluated at a mean of 4.5 months later, all patients correctly recalled their procedure and diagnosis. Of 79 treatment alternatives discussed with these patients before surgery, 73 or 92 percent, were subsequently recalled.

By contrast Dr. Kondziolka reported that previous studies evaluating patient recall using traditional informed consent forms found considerably lower rates of retention. For example, in a cardiothoracic surgery study, patient retention of preoperative information was 29 percent during a four-to-six month follow up. Another study of 100 patients undergoing surgeries or procedures in the emergency room found a 35 percent retention rate at seven days. A study of 100 ophthalmology patients two-to-eleven days after surgery found a 59 percent overall retention rate.

"The practice-specific consent form we developed is modular and simple to use. Because it is written as a check list, it aids the surgeon in discussing each issue with the patient so that all of the important topics are covered," Dr. Kondziolka said. "Our study involved questions asked in an open-ended format, but the patients had a finite list of items to recall. A secretary, with no medical background or pretenses, administered the questionnaire. In this way, we avoided the potential pitfall of having a physician misrepresent any portion of the informed consent process. We believe this method to obtain and document informed consent should be considered for use by physicians."