Informed Consent in Clinical Medicine as a Concern for Ethicists

The always excellent Kaiser Foundation's Daily Health Report http://www.kaisernetwork.org/daily_reports/rep_index.cfm 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 http://blog.healthcommunicationresearch.com/search?q=women
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 http://blog.healthcommunicationresearch.com/search?q=women
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).

Policy briefing: requiring individual health insurance

The health care problem is not only an ethical issue (many people, myself included, believe that Americans should not go without needed health care because they're poor) but also, increasingly, a major factor in the overall economic picture. (This isn't a new problem--check out the news on GM, for example--but one that is becoming ever more pressing for a variety of reasons.)

You've likely heard about plans -- some in place (as in Massachusetts), some proposed (like the one just rejected this week in California) -- to require that individuals purchase health insurance. It being an election year, we're likely to start hearing more, soon, about the candidates' plans for fixing the health care "system." Such individual-mandate approaches may be part of that picture.

Just in time, here's a chance to learn more: you can tune in to a live webcast today at 1:30 ET, sponsored by the Henry J. Kaiser Family Foundation. It should be an informative session, featuring a panel of well-known experts in health policy and finance.

If you can't tune in today (sorry for the short notice!), the archived webcast will be available online afterward.

US healthcare: we spend and spend, but....

This week the Department of Health and Human Services released the news that US healthcare spending broke the $2 trillion mark in 2006. Yes, you read that right: TWO TRILLION DOLLARS. This is despite the fact that the annual increase in healthcare costs has actually slowed down a bit in the past few years. (Read more at the NYT here.)

What do we get for this enormous outlay? Well, not so much as you might think, and not as much (in terms of outcomes) as lots of other countries that spend less.

In 2007, the Commonwealth Fund surveyed 12,000 people in 7 countries: Australia, Canada, Germany, the Netherlands, New Zealand, the UK, and the US. (You can find the abstract in Health Affairs, here.) Despite spending nearly double what some of the other countries spend per capita on healthcare, US respondents were more likely to report experiencing medical errors; going without needed care because they can't afford it; and to say that the healthcare system needs to be completely rebuilt. We--along with our neighbors to the north--are also least likely to be able to get a same-day appointment when we're sick, and more likely to show up in the ER because we don't have an alternative.

Consider just this one fact: 32% of Americans surveyed who had two or more chronic conditions said that they'd experienced a medical error in the prior 2 years. Keep in mind that these are just the errors patients know about!

So, it being election time (as if we could forget!), let's see if we can't get the candidates to say more than just "Healthcare is broken, and I'm gonna fix it." Covering more people is an excellent start--but just a start. Among other items on the healthcare to-do list: figure out how to improve quality, how to re-value primary care, and how to help people be more effective self-advocates.