October 2009




Informing patients

by Matt Young EyeWorld Contributing Editor


The process of informed consent has not traditionally been an issue open to rigorous academic discussion among ophthalmologists, and for good reason. In-formed consent relates to professional negligence and can establish “a break of the duty of care owed to the patient,” according to the online collaborative encyclopedia, Wikipedia.com. It’s a touchy subject. “However, in an increasingly litigious climate, this communication runs the risk of becoming an act primarily to serve the physician’s legal defence, undermining other important aspects of patient care,” according to recent research by Michael Austin, F.R.C.Ophth., Department of Ophthalmology, Singleton Hospital, Swansea, Wales, and colleagues, published in the October 2008 issue of Therapeutics and Clinical Risk Management.

As a result, Dr. Austin and colleagues performed a study unique to the field of ophthalmology: assessing the level of information that patients themselves would like to hear during the informed consent process. In actuality, what patients want to hear is all over the map. But the findings justify a customized in-formed consent approach, rather than a “one size fits all” one, as Dr. Austin put it. The danger of generic informed consent relates to too much information being divulged. “Patients may be burdened with unsolicited information about what might go wrong for the sake of explicit documentation of having been told,” Dr. Austin reported. “This is potentially counterproductive as some studies have shown increased patient anxiety following extensive counseling of risks, and that too much information may actually prevent the patient from making a reasoned autonomous decision.”

What they want to hear

Leaving the law aside for the moment, let’s take a look at what patients would like to hear during the informed consent process. According to Dr. Austin’s study of 100 patients undergoing cataract surgery, less than a third of patients wanted to be informed of all possible complications.

“A significant third did not want to know anything at all and wished to leave the decision-making to the doctors, reflecting a high level of trust and an assumption that doctors act in the best interests of their patients,” Dr. Austin reported. A quarter of the patients opted to undergo a detailed discussion of specific risks, but less than two-thirds of this sub-group felt it was important to hear about each individual risk linked to cataract surgery.

Four patients initially erroneously believed there was no risk at all involved with cataract surgery. They were informed that there is a risk, but then declined further discussion. “Thus while it is necessary to emphasize that surgery carries some risk, and discuss in broad terms the consequences of complications, including loss of vision or the eye, our study would suggest that it may be unnecessary to discuss each specific complication with every patient unless this is their wish,” Dr. Austin wrote. When more information was desired, Dr. Austin gave it in detail. He assessed how much information patients desired by first asking some preliminary questions to determine knowledge of cataract, risk perception, and level of information desired. Those who did want further information were guided through an audio-visual presentation that included standardized information. Clearly, informed consent laws differ worldwide. But being flexible in one’s informed consent approach, wherever one is in practice, may have benefits to patient care and vice versa. “If clinicians decide it is invariably their role to set the agenda for the discussions relating to consent then they will inevitably generate their own dilemma as to what patients want to know and how they wish to discuss risks and benefits issues,” Dr. Austin noted. There also is evidence to suggest that informed consent should not be a litigation fear factor. “Although of relevance, the lack of informed consent is usually not the main issue in litigation,” Dr. Austin noted. “In a majority of cases, it is the lack of an immediate and full explanation following occurrence of a complication or a delay in diagnosis and appropriate management resulting in adverse outcomes that prompted patients to file for malpractice. In a 10-year period, claims related to endophthalmitis incurred the largest amount of indemnity paid by OMIC [Ophthalmic Mutual Insurance Company], a single-specialty insurer in the U.S., and comprised the largest percentage of claims in any group resulting in an indemnity payment. Yet this is a complication of cataract surgery that is invariably mentioned during the consent process.”

Dr. Austin’s message is clear: Keep the focus of informed consent on patients, not on fear of lawyers. “Informed consent is not the signing of a document following a litany of complications; it should constitute a process by which the intended surgery is discussed with each patient as an individual, addressing their specific needs and concerns,” Dr. Austin concluded. EyeWorld, meanwhile, interviewed Randall E. Cole, M.D., medical director, Boozman-Hof Eye Surgery and Laser Center, Rogers, Ark., about that clinic’s informed consent process. If Dr. Cole’s informed consent process is any indication of what’s happening in America, then informed consent is relatively standard, although there are some more customized areas. “Our informed consent process is fairly standard,” Dr. Cole said. It’s based on informed consent material from the American Academy of Ophthalmology. However, there are expanded areas of informed consent relating to lens choice. “A big part of today’s cataract practice is lifestyle lenses, like toric, multifocal, and accommodative lenses,” Dr. Cole said. “This adds another feature to the informed consent process. It’s a critical part and the final leg of informed consent relating to ensuring and documenting that patients are presented the options in terms of what IOLs are available today.” Dr. Cole’s informed consent process may not entirely fit the individualized approach that Dr. Austin advocates, but certainly discussing informed consent openly and critically gets the ball rolling in a new direction for ophthalmology. Arguably, that’s a good thing.

Editors’ note: Dr. Austin has no financial interests related to his study. Dr. Cole has no financial interests related to his comments.

Contact information

Austin: 44 1 792 285 036, mike.austin@swansea-tr.wales.nhs.uk
Cole: 479-246-1751, dreyerecole@aol.com

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