Informed consent

by Academyhealth on June 14, 2012 · 4 comments

One thing that seems routinely overlooked in the health policy debate as it is conducted by us non-lawyer types is how much the law shapes the delivery of health care, as distinct from health insurance. For example, it is common for folks to propose some newfangled insurance scheme or increased funding for more comparative effectiveness research, seemingly not recognizing that those won’t do much to change how health care is delivered unless something is done to the laws that hem it in. I’m guilty of missing this point as much as anyone else, or was. I’m starting to know better.

I got into this a little bit several months ago when I posted on how private insurers have difficulty defending their evidence-based coverage decisions in court.

More recently, I’ve come across similar issues related to informed consent and shared decision making. Take this sob story by Dr. Daniel Merenstein (ungated PDF):

The date was July 19, 1999, when as a third-year resident I saw a highly educated 53-year-old patient. In June 2002, my residency and I were served with court papers.[...]

On that day in July 1999 I saw the 53-year-old man for a physical examination. I discussed with him, and documented in his chart, the importance of colon cancer screening, seat belts, dental care, exercise, improved diet, and sunscreen use. I also presented the risks and benefits of screening for prostate cancer and documented the discussion. I never saw the patient again, and after I graduated, he went to another office. His new doctor ordered prostate-specific antigen (PSA) testing without discussing the risks and benefits of screening with him. Unfortunately for the patient, his PSA level was very high and he was subsequently diagnosed with incurable advanced prostate cancer. [...]

My residency was found liable for $1 million.

You would think that the law would protect physicians that conscientiously involve their patients in an informed decision making process about their care. You would be wrong. You would think all we need to do is to develop more and better patient decision aids and get more doctors and patients to use them in shared decision making-based treatment choices. No, as hard as that may be, that is not enough.

Jaime King and Benjamin Moulton (ungated PDF) describe the legal landscape that leaves doctors like Merenstein (or their residency) at risk even when they implement a shared decision making process.

Currently, the states are almost evenly split between two types of standards for informed consent— the physician-based standard, effective in 25 states, and the patient-based standard, effective in 23 states and the District of Columbia. Physician-based standards generally require physicians to inform a patient of the risks, benefits and alternatives to a treatment in the same manner that a “reasonably prudent practitioner” in the field would. On the other hand, patient-based standards hold physicians responsible for providing patients with all information on the risks, benefits and alternatives to a treatment that a “reasonable patient” would attach significance to in making a treatment decision. As can be seen in the cases listed in Appendix A, while each state may have its own variation on the language of its informed consent standard, they are quite representative of classification, and so, we will discuss the physician and patient-based standards each as a unified standard for the remainder of the paper.

Appendix A is a nice resource, as is the rest of the paper in which King and Moulton describe the subtle problems with the patient-based standard and the more obvious problems with the physician-based one. It’s the latter that caught Merenstein because at his trial several physicians testified that it was standard to conduct a PSA test without asking the patient. Hence, in the eyes of the law and despite the shared decision making process he employed, Merenstein delivered sub-standard care.

In fact, Merenstein’s care style may have been ahead of its time. Rather than sub-standard, it may have been above-standard. For that, his residency lost $1 million.

-Austin

Austin Frakt is a health economist at the Department of Veterans Affairs and Boston University’s Schools of Medicine and Public Health. He blogs on health economics and policy at The Incidental Economist.

As part of our ongoing effort to raise awareness of health services research and increase its application in policy and practice, AcademyHealth has partnered with Austin Frakt, Ph.D., and Aaron Carroll, M.D., M.S., to contribute posts on the subjects of health care costs, delivery system transformation, and public and population health – areas AcademyHealth has identified as a priority in the current policy environment. As regular contributors, they’ll be discussing current events with an eye toward how new and existing research informs the issues.

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{ 2 comments… read them below or add one }

Will June 14, 2012 at 12:44 pm

Dangerous reasoning. The definition of optimal care must be divorced from popularity/cultural norms. This is immediately evident to any clear thinking person.

You’ve scared me Austin. This case was rotten, and people need to acknowledge the harm in a circular definition of standard care.

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Ramsey June 28, 2012 at 11:08 pm

Bravo! A successful healthcare system can not allow patients to abdicate all responsibility for their own health outcomes.

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