Sunday, February 10, 2008

Informed Consent in Clinical Medicine as a Concern for Ethicists

The always excellent Kaiser Foundation's Daily Health Report calls attention to a startling new research finding--apparently "most patients don't read the forms they sign before undergoing surgery or medical treatment." What I find interesting, though, is that the Wall Street Journal Article that Kaiser quotes from concludes that hospitals are studyng this in an effort "to improve their informed consent processes amid 'mounting concern about patient safety and lawsuits arising from botched communications.'" At least the priorities are in that order. As a lawyer/bioethicist is is always interesting to me to see that despite the visceral hatred doctors have for the concept of civilian oversight (which is an accurate description of the current medical malpractice system which relies on lay juries for final decision making)combined with a reflexive support of any "tort reform" legislation which makes it harder for patients to sue. This support is unrelated to realities that medical malpractice litigation is not a factor in rising medical malpractice rates.

And this is of special interest to women how? Because of two phenomena. First, because women are still battling for true informed consent when it comes to issues such as breast conservation surgery and caesarian sections
and second because efforts to make it harder to sue for medical malpractice ("tort reform") are harmful to women. See Professor Linda Finley (Lucinda M. Finley, Female Trouble: The Implications of Tort Reform for Women, 64 Tenn. L. Rev. 847 (1997) [hereinafter Finley, Female Trouble]; Lucinda Finley, The Hidden Victims of Tort Reform: Women, Children, and the Elderly, 53 Emory L.J. 1263 (2004) .

While bioethicists think more about the ethical issues in the informed consent process of clinical research, in fact the informed consent issues in day to day medical treatment are just as important. Although it may seem as if consent for medical treatment is less problematic because unlike areas of clinical research where the interventions may not benefit the patient these interventions seem designed only for the patient's benefit, in fact medical care is not so simple. There is always a range of options when it comes to medical treatment and one of the least understood of these options (to patients at least) is the option of doing nothing. Another frequent problem is that patients are not informed of the range of options but only those options available through their doctor or health care center.

There is an entire field devoted to communicating with patients and this blog
provides many interesting examples of how the way women receive information can impact their health care decisions.

It would be ideal if the kind of improvements to informed consent such as moving away from handing over sheets of typed paper to sign towards a more interactive process that included different ways of presenting information, could be made without any need for the penalties of either civil litigation or administrative fines. However, there is nothing in recent history to show that informed consent is such a basic good that it would always be a priority without these incentives.

I would encourage all of us interested in informed consent to think more about its role in medical treatment in general and women's health care in specific from the ethics or human rights perspective rather than just to see this as yet another imposition of the legal system on the already over-burdened health care system.

Wall Street Journal Examines Efforts by U.S. Hospitals To Improve Informed Consent Processes[Feb 06, 2008]
The Wall Street Journal on Wednesday examined how U.S. hospitals have begun to improve their informed consent processes amid "mounting concern about patient safety and lawsuits arising from botched communications." According to the Journal, researchers have found that "most patients don't read the forms they sign before undergoing surgery or medical treatment." In addition, more than "half of those who do read the forms don't understand them, and only a quarter of forms include all of the data patients need to make an informed decision," the Journal reports.In response, some hospitals have begun "offering explanatory videos and diagrams" to patients when they complete consent forms, as well as "translating medical lingo into simple English" and "offering materials in other languages" to explain medical procedures and provide information about alternative treatments, according to the Journal. Some hospitals also have begun to use new technologies, such as online databases that calculate the risk of medical procedures for patients before they complete consent forms and electronic forms to address problems with lost paper forms that can delay procedures and increase costs.CMS recently issued new guidelines that require hospitals to develop "patient-friendly" informed consent processes, and facilities that do not comply could lose their eligibility to participate in Medicare. The Joint Commission, which accredits hospitals nationwide, also has advocated improvements to the informed consent processes used by the facilities (Landro, Wall Street Journal, 2/6).


Wanda Reese said...

Not surprising at all, given the legalese and other complexities, now being read by and misunderstood by an ever growing multicultural patient population. Something needed to be done eons ago.

Anonymous said...

Hi Jennifer,

My question about IC is whether it really ought to continue to be the ethics dogma it has always been given virtually every empirical finding supports the idea that meaningful IC is still very far away.

Of course, this is not to say that IC is unimportant or that we shouldn't strive for better IC. Of course we should. But given the staggering problems in health literacy we have, and the significant problem that individuals facing life-threatening illness or injury are often in a poor position to evaluate the proposed treatment, meaningful IC seems like a long shot. Which, again, is what the evidence shows.

As such, I continue to suspect that ethicists might be well-advised to consider thinking about what other kinds of criteria are important for clinical practice and research outside of IC.

Helen said...

Two tough issues that need addressing before we get to the point of informed consent

1) Is informed consent a cultural construct - many cultures I have encountered are uncomfortable if they are not given directive advice

2) With poor health literacy, how are we going to convey the messages required for an informed consent discussion so we can besure it is true informed consent?

bob koepp said...

I've diskliked the "laundry list" of required elements of informed consent from day one. Informed consent should be driven by, and responsive to, the values and concerns of individual patients, not what somebody else "surmises" a patient needs to understand to make an informed decision. Forget the list of required elements, and start asking very personal questions of patients. You might be surprised what you find.

Jennifer Bard said...

Given that the founding principle of post-Nuremberg human subject research is informed consent, I think we still have to make it a priority to explore different ways of providing the information that individuals need. It is hard to believe anyone ever thought the written laundry list was effective--certainly no one who has ever given a reading assignment and a quiz!
I think we need to bring in the communication experts, but I also think we need to abandon laundry lists and insist on interactive, discussion base informed consent (and yes, that will take longer).

Anonymous said...

Can you update the link or cite the research?