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Informed Consent: What Does It Mean?

Informed Consent: What Does It Mean?

The Chiro.Org Blog



SOURCE:   Health Insights Today ~ Sept 2013

Interview with Simon Dagenais, DC, PhD, MSc

Interviewed by Daniel Redwood, DC


Simon Dagenais, DC, PhD, MSc is uniquely qualified as an expert in a wide range of health and health policy areas. Since receiving his doctor of chiropractic degree from the Southern California University of Health Sciences in 2000, 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 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. The list of his other accomplishments is extraordinarily impressive for a relatively young research and policy expert – perhaps best illustrated by the fact that his peer-reviewed articles, commentaries, technical reports, books and book chapters total 100 as of mid-2013.

In 2013, The Back Letter gave extensive coverage to an article by Dagenais et al in The Journal of Manipulative and Physiological Therapeutics on informed consent in the chiropractic profession, calling it, “perhaps the best article ever written on informed consent for low back pain.”

In this Health Insights Today interview, Dr. Dagenais discusses a wide range of issues related to informed consent, including the need for practitioners of all types to become well-informed about all alternative treatment approaches so that they may share these in an unbiased way with patients, thus enabling patients to make informed decisions about their health care choices.

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A recent article in The Back Letter describes a paper from the Journal of Manipulative and Physiological Therapeutics, where you were the lead author about how best to deal with informed consent in cases of low back pain. Your article focused specifically on informed consent in the chiropractic profession but The Back Letter saw it as very relevant for all types of practitioners who treat low back pain, calling it “perhaps the best article ever written on informed consent for low back pain.” Let’s start by looking at the basic purpose of informed consent. Doctors often think of it as a way to minimize their chances of being sued. Is there more to it?

I first learned about informed consent in chiropractic school and didn’t really know what they were trying to teach us. It seemed that some people were approaching informed consent as a way to protect yourself against lawsuits — no matter what else you do, have informed consent. But that wasn’t the only view. Some people also just viewed informed consent as a routine office procedure that they delegated to their front staff, like collecting the person’s insurance information. It was something you were expected to do, but that wasn’t worth spending much time on. And I think other people viewed it as a sales pitch, an opportunity to put whatever treatment you’re offering in the best light, so that during the informed consent, you are further convincing the person that they’ve made the right decision by coming to you. Other doctors probably feel that informed consent is just a waste of time. They don’t understand it, they feel annoyed by it and they don’t see any legitimate purpose for it. Informed consent is just another thing to slow them down, another administrative burden.


Informed Consent Began in Reaction
to World War II Atrocities

Informed consent was not always a part of healthcare. How and why did it begin?

There’s been a big shift in how people view doctors. A hundred years ago, doctors made decisions and people followed them. That’s just the way it was, and no one questioned it. But that patriarchal and paternalistic model was eventually questioned. The ethical foundation for informed consent in health care came out of the atrocities committed by doctors in World War II. In hindsight, people recognized that society shouldn’t assume that doctors are always right and benevolent. But even if they are, we should still make sure it’s the patient making decisions about what really affects them. What came out of all that is the principle that patients have the ability to decide what happens to them. No matter what the doctor thinks is best, it’s up to the patient to determine that for themselves.

Yet the patient, on his or her own, does not necessarily have all the information they would need to make that decision, unless it’s provided by the doctor.

That’s the rub. The doctor might think he has all of the information the patient needs to make the right decision, but he doesn’t get to make the decision. And the patient doesn’t have all that knowledge and expertise, but it’s still their decision. So you’re always left with a bit of friction. This is the “agent problem.” In economics, when you have someone who depends on someone else to help them make a decision because of their expertise, you are counting on that agent acting in your best interest. But it’s a difficult thing to ensure. It’s one thing to trust your mechanic to tell you what’s wrong with your car and how to fix it. But when it comes to your own body and your health, the stakes are high. You always have an uneven amount of knowledge between the person making the decision and the person giving them information to help them.


Should Informed Consent Be the Same
for All Patients?

Can informed consent be effectively standardized in terms of the information that doctors of various kinds are expected to, or possibly required to, provide to patients?

I think many elements could become standardized, but the difficulty there is that we start assuming all patients are alike. But my risk for experiencing harms with manipulation is not the same as your risk, or the same as an elderly woman with osteoporosis in her spine. So if we want to start to standardize things, how do you do that? Do you include all information applicable to anyone, so that standardizing means that people have to read through a bunch of things that don’t apply to them? Or do you take the worst case scenario? Do you write informed consent for the highest possible risk and make people who don’t have that high a risk sign off anyway? It’s not easy. I think in an ideal world, the informed consent would be an extension of everything else your doctor does. When doctors take a history, the questions are a little bit standardized, but the follow-up questions are based on your answers. And when they do an exam, the outline is somewhat standardized, but if they find something abnormal, they’ll tailor the rest of the exam to pursue those findings. If doctors already have the ability to individualize their history and exam, why not bring the same level of professionalism to informed consent?

To study the current state of informed consent in chiropractic, or at least within chiropractic educational institutions, for your 2012 JMPT article, your group evaluated the informed consent forms at all but one of the institutions that are part of the Association of Chiropractic Colleges, seeking to determine whether 20 different questions were addressed either directly or implicitly. Without asking you to list all 20 questions, what are some key examples that illustrate the areas that need to be covered?

I should clarify that we did look at all of the informed consent documents, but it turned out that one of the institutions did not use a written informed consent document.

I approached the questions against which the informed consent documents would be evaluated from an informed patient’s perspective. Instead of making up arbitrary criteria about informed consent document quality, we came up with a list of questions that, in an ideal world, informed consent would be able to answer. So that after reading the informed consent, the patient would be in a better position to make a decision about the treatment.

The basic elements that you would expect are the risks and benefits of the treatment, and the alternatives. Taking a step back from that, I thought it would also be important to tell the person why that treatment is being recommended in the first place. What condition do I have? What’s my diagnosis? Why do you think I have that? If you don’t start there, how do you evaluate potential benefits and risks? It’s also important to describe the treatment. People often skip over that part in the informed consent, perhaps assuming that people listen perfectly when you describe the treatment, but I think putting it in the informed consent document is a good reminder.

So if an informed consent document covers why the treatment is being recommended, what the treatment is, the benefits, the risks and the alternatives, those are probably the main elements patients need to know.


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 Primary Focus

What would you identify as some of the areas where 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 informed consent 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 tradeoff. But if you ignore the potential benefits and focus mainly on risks, that’s not a good balance.

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 to me 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 to me 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.


Primary Spine Care Practitioner?

Since we’re projecting somewhat into the future, it has been suggested that chiropractors and some other practitioners may be able to fill an emerging role as a primary spine care practitioner. These would be doctors who are knowledgeable about the full range of spine care options and can use this knowledge to guide patients toward appropriate care that meets both their needs and individual preferences. Do you think this is desirable and if so, what would be the initial steps to move in that direction?

There’s little question about need. The costs for back pain keep going up, outcomes are not improving, and quite a few stakeholders are realizing that something needs to be done to improve the way that society manages back pain. I think there’s a need for someone to describe all of those different therapies available for back pain, and help patients navigate through them, especially for chronic or recurrent back pain, where this choice needs to be made over and over.

I think that some chiropractors, given more training and opportunities to be exposed to other types of treatments, could become a trusted source of information on treatments for back pain, but we’re talking about a pretty radical shift. Chiropractic training is focused on learning manual therapy, and some schools seem to pride themselves on the exclusion of medications and surgery from their scope and want nothing to do with it. If chiropractors were educated more broadly about how back pain is handled in other settings by other disciplines, and read the literature supporting different treatment options, they would probably change their perceptions about their role in health care.

Why should the education of a chiropractor be limited to reviewing the limited or conflicting evidence about spinal manipulation while ignoring the limited or conflicting evidence for all other treatments? All treatments need to be put in context and the evidence is always relative. The evidence supporting chiropractic care for low back pain is much better than many alternatives.

Are there any other areas related to informed consent that 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.


Daniel Redwood, DC, 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. Dr. Redwood’s website and health policy blog are at www.redwoodhealthspeak.com.

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