In 71% of cases of informed consent disputes, the primary allegation was that the physicians failed to mention or properly explain risks of complications.

A great deal of research has been published over the years regarding informed consent, and although more empirical research has been published, there is very little information available on how the consent process actually works in clinical practice.

Australian researchers, however, recently investigated informed consent disputes in a large sample of medical negligence claims and health care complaints that were resolved over a seven-year period. They found that in 71% of cases, the primary allegation was that the physician, most often a surgeon, failed to mention or properly explain risks of complications.

“This is the first study to investigate, in a real-world setting, what happens when informed consent goes poorly from the patient’s perspective,” David Studdert, a professor at the Melbourne School of Population Health and Melbourne Law School, said in a statement. The research was published in a recent issue of the Medical Journal of Australia.

Studdert and his co-authors reviewed nearly 2,000 negligence claims against doctors insured by Avant Mutual Group Limited and complaints lodged with the Health Services Commissioner of Victoria between January 2002 and December 2008.

Of those cases, more than 92% involved surgical procedures and 16% involved cosmetic procedures. The researchers found that patients’ concerns about problems in the informed consent process were matched by concerns about other aspects of care in about half the cases.

Five treatment types accounted for almost 50% of the total cases. These were surgical procedures on reproductive organs (12%), the face (12%), breast (7%), and the eyes (7%), and the side effects of prescription medications (8%). The research showed that plastic surgeons experienced complaint rates that were more than twice those of any other specialty or subspecialty group.

“In my experience, most doctors feel that they adequately discuss the risks of a procedure as part of their practice. Our findings show that our patients do not always share this view,” lead author Andrew Gogos, MD, neurosurgical registrar at the Royal North Shore Hospital in Sydney, said in a statement. Gogos added that the main problem was communication.

“The typical dispute over informed consent involves an operation and relates to the adequacy of explanations about risks of a particular complication. The complication may be anything from the risk of infection, pain or scarring, paralysis, even death.” Gogos said.

“With cosmetic surgery, patients are typically healthy going into the procedure and their expectations of a positive outcome tend to be very high. This causes them to worry about even small risks.”

Studdert said improved understanding of these situations would help highlight areas where there is a gap between what doctors talk about and what patients want to hear. “Much more can be learned about how to improve medical care from close analysis of disputes over preventable events,” he said.

SourcesPatient Complaints Allege Doctors Fail to Disclose Risks [University of Melbourne]When Informed Consent Goes Poorly: A Descriptive Study of Medical Negligence Claims and Patient Complaints [Medical Journal of Australia]