Dynamic Chiropractic – January 1, 2014, Vol. 32, Issue 01

Informed Consent and Your Practice (Part 2)

More Q&A With Dr. Simon Dagenais

Editor's note: Click here to read part 1 of this interview.

Chiropractic Colleges: Varied Approaches to Informed Consent

In your review of the various chiropractic colleges' informed consent processes, or forms they used in those processes, how well did the various colleges live up to the standards you just described? I know that in your paper, you did not name the specific schools.

Your emphasis was on the data, not identifying which schools did better and which did worse. The questions we came up with are not a validated instrument to determine the quality of informed-consent documents. They're simply something we thought would be interesting to use. But based on those 20 questions, the informed-consent documents used in chiropractic colleges did pretty poorly.

I was also surprised by the variation in the documents we reviewed, and wondered why they were so different when they are essentially all trying to do the same thing. It looks like some colleges might have put more effort into writing these documents than others. Some were quite short; others were much longer. Length doesn't necessarily equate with quality, but the idea that you can capture everything you need in an informed-consent document in one page is probably not a good starting point. I think our article highlights that there is room for improvement.

Describing Risks Matters, But Need Not Be thtehe Primary Focus

What would you identify as some of the areas in which there is the greatest room for improvement? Almost none of the informed-consent documents talk about why the treatment is being recommended. Many of the documents did not describe the benefits of the proposed treatment. They focused almost exclusively on risks. But informed consent is about presenting a risk-benefit balance and letting the patient decide if they're comfortable with that trade-off. If you ignore the potential benefits and focus mainly on risks, that's not a good balance.

After receiving his doctor of chiropractic degree from the Southern California University of Health Sciences in 2000, Dr. Dagenais received a PhD in environmental health, science and policy (with emphasis in epidemiology and public health) from the University of California, Irvine in 2005, followed by a Master of Science degree in health economics, policy and management from the London School of Economics in 2011. He is also certified in biomedical regulatory affairs by the University of California, San Diego and certified as a clinical research coordinator by the Association of Clinical Research Professionals.

Along with Scott Haldeman, DC, MD, PhD, Dr. Dagenais was an instrumental contributor to the widely respected Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders, whose work was documented in eight papers in Spine in 2008. Currently, he is the program co-chair for nonoperative treatment of the North American Spine Society (NASS) and also serves on the NASS value committee.
So, the discussion becomes unnecessarily negative in tone. If informed consent is mainly about describing risks, it becomes more of a disclaimer, where a doctor might try to say, "I told you everything that could go wrong and you still signed off, so if anything goes wrong, I did warn you." That's not the same as an honest attempt to inform about risks and benefits, and explain why the benefits might outweigh the risks in your situation.

Even though the informed-consent documents we reviewed were focused mainly on risks, they were not standardized in how they presented these risks. Some documents had very broad and vague statements like, "The risks have been explained to me," which did not seem very helpful on their own. Many of the documents had lists of potential risks, but some had very short lists, and others had much longer lists.

But even long lists of potential risks are not very helpful without providing some information about their possible frequency, severity, and sequelae. Terms like rare were used in a few documents, but what does that really mean? And how does the frequency of "rare" compare to "very rare" and "remote"? There was no standardization in the perception of frequency for the risks listed. But since all chiropractic colleges were presumably looking at the same literature on risks when writing these documents, why was there so much variation in how that literature was interpreted?

Accurately Explaining Alternative Treatment Choices Is Crucial

If there are hundreds of alternatives and we don't want to take hundreds of pages describing them, how do we present the right amount of information? I was disappointed in that so few documents did not describe the alternatives to the treatment proposed, because I'm aware of hundreds of treatments being offered for back pain. It's clearly too long to list them all, but they probably fit within just a few categories – education, self-care, medications, manual therapies, exercise, complementary medicine, injections, surgery.

Maybe listing those broad categories would let patients know that there are many treatment options for back pain, and if one of them sparks your interest, maybe you should look into it a bit more. The informed-consent document can't be a textbook about all treatments for back pain, but part of the doctor's role is to educate patients.

Does the need to inform patients about the various alternative treatment options apply to all types of practitioners? I think that no matter who you go to for back pain, no matter which treatment is proposed, the informed-consent document should refer to those same broad categories of other treatments that are available as alternatives. If you go to a chiropractor, the alternatives might be medication, exercise, injection, surgery and so on. If you go to a pain-management specialist, the alternatives might be manual therapy, exercise, medication, and so on. Ideally, they would all paint the same picture, from different angles.

It seems that one of the reasons that the section on alternatives may be weak is that practitioners may not be well-informed about all of the alternatives, their effectiveness and their risks and benefits. It sounds like we're talking about a need for a long-term project of interprofessional education, where we're all working off the same database, essentially. I think most doctors are not very knowledgeable about the treatments that they don't offer. If you're a chiropractor, I'm not sure that you necessarily know the benefits and harms for different types of injections, medications and surgeries that are also available. And if you're a surgeon, you probably don't know much about the risks and benefits of functional restoration, acupuncture, or other non-surgical treatments. Ideally, though, because patients with back pain go to all kinds of different doctors, they should all be getting consistent information. That's a long-term vision.

Are there any other areas related to informed consent we haven't covered that we should? Informed consent will probably continue to evolve and might eventually morph into something like a decision aid. Instead of reading a static document on paper, there could be something more interactive that asks you questions about your condition, your personal preferences, your risk tolerance, etc. And then, based on all of that information, brings you through the thought process needed to help you determine the right treatment for your specific situation. A good decision-aid tool would be far better than a standard informed-consent document, and provide far more information that might be helpful to achieve shared decision-making.

Dr. Daniel Redwood, the interviewer, is a professor at Cleveland Chiropractic College – Kansas City. He is the editor-in-chief of Health Insights Today, associate editor of Topics in Integrative Healthcare, and serves on the editorial board of the Journal of the American Chiropractic Association. Click here to visit Dr. Redwood's website and health-policy blog.

This interview (both parts) originally appeared in its entirety in the October 2013 issue of Health Insights Today. It is reprinted with permission.


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