Evidence-Based Guidelines and Regulations?

by Peter Nkansah

“Sign, sign, everywhere a sign/Blockin’ out the scenery, breakin’ my mind/Do this, don’t do that/Can’t you read the sign?” – Signs by The Five Man Electrical Band

A repeated discussion that I have with colleagues is that dentistry, as a profession, is over-regulated. While it’s true that we have rules governing everything in our practices from advertising to recordkeeping to the disposal of amalgam waste, most of these rules have pretty good rationales and are necessary to establish (needed) boundaries. The practice of dentistry keeps changing, so it makes sense that some of the rules of practice are updated periodically. In the last few years, most if not all the Canadian provinces have updated some part of their regulations and guidelines for the practice of dentistry. British Columbia, Alberta and Ontario have changed their sedation/anaesthesia rules. Québec has mandated the presence of AEDs in dental offices. New infection control protocols are in place in Ontario. All of this is fine if the various topic’s mandates have been met. For example, if, because of the inadequacy of existing regulations, sedation dentistry was not acceptably safe or patient infections were unacceptably high because of dirty equipment, then the rules should be changed. Two great examples of change where change was needed were the
“Harvard Standards” for anaesthesia and the creation of a universal pre-operative surgical checklist by the World Health Organization.1,2 In both of these healthcare areas, lives were being lost at an unacceptably high rate. After a good deal of study and consideration of the findings, new guidelines were put forward that reduced mortality. Back in our Canadian dental world, were patients being hurt by lax regulations around anaesthesia or infection control? To my understanding, this was not the case. So why the changes? That’s a big question with a multifactorial answer. To be sure, forming regulations is not a purely objective exercise. Optics and politics and egos and patterns of behaviour are all in the mix. This is understandable, but the more complicated the mix, the harder the changes become to support and to follow.

“Change is the law of life. And those who look only to the past or present are certain to miss the future.”– John F. Kennedy

Take, for instance, the topic of sedation/anaesthesia in dentistry for children. There are lots of fingers in the pie on this one. Most recently, in the December 2019 issue of JAMA Pediatrics there was a Viewpoint article by Drs. Coté, Brown and Kaplan that on the one hand supported a recent joint statement from the American Association of Pediatrics (AAP) and the American Association of Pediatric Dentistry (AAPD) about training qualifications of sedation providers, while on the other hand condemning what they called, “[t]he single-clinician–operator/anesthetist model”.3 A Viewpoint article is an opinion-based piece (like the one that you are reading now), and I readily acknowledge and support free speech that is not hateful. Accordingly, the authors of a Viewpoint article can say whatever they want (that is not hateful). However, if you are presenting your opinion in public, there is an increased responsibility because you are speaking to more people than in a private conversation or even in a seminar. Sometimes people either forget or choose to ignore that fact. The article goes on to cite the death of 6-year-old Caleb Sears in California in 2015 as the reason to condemn both this “single” model (in this case by oral surgeons in the U.S.) as well as the Dental Anesthesia Assistant National Certification Examination (DAANCE) program, which trains dental assistants to work with sedated/anaesthetized patients. I’m not going to challenge the opinions presented since I agree with a good portion of what they said; I am challenging the path that they followed to get to their call to action. In Canada, we are a little ahead of many of our colleagues south of the 49th parallel, as most if not all the provinces demand procedural team anaesthesia (PTA) as a minimal approach for sedation levels deeper than that produced by oral and nitrous oxide moderate sedation. The membership of the Canadian Academy of Dental Anaesthesia (full disclosure: I’m currently the president of this group) is trying to change the language around what we do when we provide dentistry and anaesthesia services to patients. The old, familiar but inaccurate term of “operator-anaesthetist” is being replaced by “PTA”, which accurately describes what we do. In short, this model mandates the presence of at least two certified, trained people for each case.

Right. Let’s get back to trusting data to provide objective reasons for change. Before we become too comfortable in that notion, let’s look at the question of antibiotic prophylaxis for the prevention of infective (bacterial) endocarditis. Back in the old days (i.e. in the 20th century, when I was a dental student), we used to load up a lot of patients with a lot of amoxicillin to try to prevent our iatrogenic causes for this dangerous condition. Today, the Canadian Dental Association recommends antibiotic prophylaxis for a much smaller subset of patients undergoing certain procedures. They echo the recommendations of the American Heart Association (AHA) that were formulated in 2007. Evidence and consideration led to this change. Fine. Let’s cross the ocean to see what can happen even in an evidence-based approach. In 2008, the National Institute for Health and Care Excellence (NICE) in the U.K. recommended the elimination of antibiotic prophylaxis for infective (bacterial) endocarditis. This guidance was not echoed by either the AHA or the European Society for Cardiology (ESC).4 In early 2015, Dayer et al. noted that while there was a notable, laudable decrease in the number of antibiotic prescriptions written, there was at the same time a larger-than-expected increase in the incidence of infective endocarditis.5 Both NICE and the ESC chose to separately review the same data on this issue. By September of that year, NICE announced that it had insufficient evidence to change their statement while the ESC continued to recommend antibiotic prophylaxis for high-risk patients, from the same data. Hmph. Maybe this supports economist Ronald Coase’s classic statement, “If you torture data long enough, it will confess.” So, data (evidence) by itself doesn’t light a path to salvation either. That’s okay, because guidelines and regulations should not be automatic.

(Mostly) self-imposed guidelines and regulations are part of the burden of a (mostly) self-regulated profession. Dentistry is a healthcare field that is ever-changing. With our lustful embrace of new and emerging technologies (e.g. digital imaging, computer-controlled…well, lots of stuff), our rules of engagement must keep pace. Here’s my caveat statement: rule-makers and practitioners should all be mindful toward making changes that make sense or that at least have been deliberated. As business leader John Luke Jr. said, “Change simply for the sake of change is an abdication of leadership.”

We may never get it right, but we’ll have to keep on trying. Paying attention to the available evidence can’t hurt.

References

  1. Eichhorn JH, Cooper JB, Cullen DJ, Maier WA, Philip JH and Seeman RG. Standards for Patient Monitoring During Anesthesia at Harvard Medical School. Journal of the American Medical Association, 256(8): 1017-1020, 1986.
  2. Gawande, A. The Checklist Manifesto: How to Get Things Right. New York: Metropolitan Books, 2009.
  3. Coté CJ, Brown Jr. RE and Kaplan A. The Single-Clinician–Operator/Anesthetist Model for Dental Deep Sedation/Anesthesia: A Major Safety Issue for Children. JAMA Pediatrics, 173(12): 1127-1128, 2019.
  4. Thornhill MH, Dayer MJ, Prendergast B, Baddour LM, Jones S and Lockhart PB. Incidence and nature of adverse reactions to antibiotics used as endocarditis prophylaxis. Journal of Antimicrobial Chemotherapy, 70(8): 2382-2388,
    2015.
  5. Dayer MJ, Jones S, Prendergast B, Baddour LM, Lockhart PB and Thornhill MH. An Increase in the Incidence of Infective Endocarditis in England since 2008: A secular trend interrupted time series analysis. Lancet, 385(9974): 1219–1228, 2015.

About the Editor

Peter Nkansah is a Dentist Anaesthesiologist with a private practice in Toronto. He is a member of the editorial board for Oral Health, an Assistant Professor at the University of Toronto’s Faculty of Dentistry and President of the Canadian Academy of Dental Anaesthesia.

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