On June 3rd, 2009, the RCDSO, the dental regulator in Ontario, circulated a draft version of proposed new Guidelines on Infection Prevention and Control in the Dental Office to Ontario Dentists. The purpose of the distribution was to permit provincial dentists the opportunity of reviewing and commenting on the draft guidelines.
My comments address such issues as; the precautionary principle, guideline development, definitions and procedures.
PRECAUTIONARY PRINCIPLE
The RCDSO is basing its revised guidelines on the Precautionary Principle. This principle follows the “better safe than sorry” approach to health care. It permits policies and procedures to be enacted that need not have any scientific or clinical supportive evidence or substantiation. The proponents of the Principle assume that its enactment will produce no unfavorable, untoward or unintended outcomes while being completely ignorant of the extent or nature of the inevitable consequences. Did the advocates of “prophylactic” antibiotics appreciate the development of resistant bacteria?
The primary reason for the RCDSO adopting the Principle is to reduce the risks from future infections that might become pandemics. It is impossible to predict the future. Exercising the Precautionary Principle to conduct such prognostications is simply an illusory attempt at curtailing risks. Wizards and fortunetellers might be able to portend the future. “When health officials play the role of soothsayers, they are granted the path to legitimating their power — a way to make it seem as if they are doing something valuable even while they do nothing.” 1 The Precautionary Principle grants the RCDSO the power to plan for its vision of a future that, in reality, will never arrive. T. Glass, a prominent American public health official, said a number of years ago, ” Disaster planning does not go as planned.” 2
Since the RCDSO does not know what will be actual future risks, the Precautionary Principle demands that the College creates perceived risks. It is simply not possible to determine if an illusionary risk has or has not been removed. Under such circumstances, with no defined risks everything and anything becomes a risk. To counteract this infinite number of imaginary risks the Precautionary Principle-to survive — must create an escalating series of regulations.
By buying into the Precautionary Principle the RCDSO has committed itself to open-ended, ever expanding, untested infection control policies.
GUIDELINE DEVELOPMENT
On June 5th, 1999, a multi disciplinary summit was held in Toronto to discuss Clinical Practice Guidelines. 3 It was called, “Scripting a Future for Clinical Practice Guidelines. What Goals Should Underlie CPG Development? How Can We Improve CPGs? Who Should Participate In CPG Development, Use and Evaluation?”
A total of 53 health related organizations attended this conference including the College of Nurses of Ontario, the Canadian Medical Association and the Ontario Program for Optimal Therapy. Representation from the dental profession was notable by its absence.
Observations from this meeting are pertinent to the draft guidelines of the RCDSO.
• “Many guidelines are not based on evidence, implementation efforts have been haphazard, and we lack information about the changes that guidelines effect on actual patient outcomes.”
• “CPGs that are rigourously developed, based on good clinical evidence, and reflect a good deal of professional consensus are going to be powerful evidence of the legal standard of care. But, no matter how well they are developed, CPGs will remain only a piece of evidence and that evidence can be refuted — CPGs are not a codification of the standard of care. In fact, in extreme situations, the CPG itself may be found to be negligent.”
• “Clinical Guidelines are only one option for improving the quality of care. Too often advocates who view guidelines as a magic bullet for health-care problems ignore some more effective solutions. Clinical guidelines make sense when practitioners are unclear about appropriate practice, and only scientific evidence can provide an answer “
• “As such, physicians may have an obligation to disclose information about alternative treatments that are not in the CPGs.”
These comments are applicable to pertinent features of the RCDSO guidelines.
1. General agreement that guidelines should be based on substantiated scientific and clinical evidence. The RCDSO admits that its guidelines need not “await scientific certainty.” Thus, the College has ignored a fundamental aspect of Clinical Guideline Development agreed upon at a meeting of its peers.
2. The RCSDO has no mechanism for auditing the success or failure of its guidelines. The Toronto summit deemed this to be an essential feature of any guidelines that have a reasonable chance of being effective.
3. The summit recognized that guidelines should permit clinicians the opportunity of offering alternative protocols to patients. The proposed guidelines do not allow this feature. An example of this is the directive regarding the use of gloves. “Gloves must be worn when contact with mucous membranes, non-intact skin or body fluids is anticipated.” This is not a guideline. It is an order!
4. The fact that CPGs may be found to be negligent and that the evidence used to support them may be refuted, should be of concern to the RCDSO since its guidelines are based on evidence that lacks scientific scrutiny.
In a 2001 article describing the development of CPGs in dentistry, Dr. Sutherland and her colleagues were of the opinion that, “Credible and useful guidelines employ the evidence-based process to assemble, organize and synthesize the best available evidence from clinical research.” 4 The Precautionary Principle adopted by the RCDSO does not require evidence to be obtained from clinical research. The College’s attitude in this regard is in complete contradiction to its 1996 announcement that it had, “developed evidence-based guidelines on the use of universal infection control precautions.” 5
A paper was published in 1999 titled, “Are Guidelines Following Guidelines?” 6 The purpose of the article was to establish if published practice guidelines are adhering to established methodological standards for practice guidelines. According to the authors, “Unfortunately, guidelines are most deficient in the identification and summary of evidence. A properly performed evaluation of the scientific evidence is critical in ensuring the scientific validity of a guideline.”
The RCDSO guidelines have not been subjected to such an evaluation. Therefore, the College should admit to dentists and their patients that its recommended guidelines have no scientific validation.
The failure to include cost benefit analyses was a significant featue of the above article. 6 The authors noted that, “Almost 60% of guidelines, however, did not mention costs at all, and only 14% provided any quantitative cost estimates. Clearly, if guidelines are to improve the cost effectiveness of health care, greater attention must be given to economic analysis.”
The College’s guidelines are bereft of any costs estimates. This should not be surprising since the Precautionary Principle does not recognize financial or economic factors.
The paper, “Are Guidelines Following Guidelines?” 6 listed 25 criteria against which the quality of a guideline may be judged. These are identified in Tables 1-3. It will be noted that the RCDSO guidelines do not satisfy the crite ria 11 through 25. The guidelines do satisfy approximately 50% of the criteria listed in Table 1.
With a score of 20% (five out of 25) the RCDSO receives a falling grade in terms of adhering to established principles regarding guideline development.
DEFINITIONS
The phrase, “Infection Prevention and Control” is used t
hroughout the guidelines. However, the term is never defined.
Infection Prevention implies that activities have taken place to prevent the occurrence of an infectious disease. Satisfying this fact requires knowledge of the specific disease, the extent of its presence in the “at risk” population, its mode of transmission, effective eradication processes and follow-up surveillance to prove that the disease is no longer present.
Infection Control implies that an infectious disease has not been prevented but that its incidence has been reduced or its severity lessened. These decreases would qualify as “control” if they had been reduced by 95% or only 5%.
There has never been a detailed study or assessment of the infectious diseases that are capable of being transmitted in the dental office. Without such information how is it possible to determine if any infections have been prevented or controlled-assuming agreement is reached on what percentage of control is acceptable?
In consideration of the above circumstances, it is obvious why the term “Infection Prevention and Control” is not defined. It is simply not possible to define the unknown.
Since no definition is possible the phrase, “Infection Prevention
d Control” is a meaningless construct.
PROCEDURES
No attempt will be made to question every procedure in the guideline that is of doubtful validity. Nevertheless a few are worthy of being brought to attention.
Concept that all patients are potentially infective
While it is true that all patients could harbor an infectious disease, in reality the overwhelming majority of the population is noninfectious. According to Alcabes, “Empirically speaking, our world is far, far safer than that of our grandparents and great-grandparents.” 1 This positive state of affairs was brought about by public health measures such as improved sanitation, better housing, mass vaccination programs and increased nutritional awareness. Therefore, to what extent are policies directed at a few infected patients advantageous to the entire population? This was answered by Stock et al who showed that in a Canadian hospital the application of universal precautions, to curb the spread of HIV, was neither efficacious nor cost effective. 7 Similar studies have not been done in the dental environment. Consequently in terms of effectiveness and fiscal viability, the above concept is untested as the foundation on which to build infection control policies.
Antimicrobial Soap
The CDC published a report in 2001 called, “Antibacterial Household Products: Cause for Concern.” 8 The authors suggested that the increasing use of antimicrobial soaps and similar products could result in bacterial resistance, decreasing sensitivity of bacteria to antibiotics and an increase in childhood allergies. This is another example of the unintended consequence of what would appear to be a safe precaution.
Perhaps, the RCDSO should reconsider its recommendation of this soap and related products.
Routine Care and Surgical Procedures
It would be useful to clearly define what these terms mean. When for example does a routine extraction become a surgical procedure? Does the preparation of the distal aspect of a restoration that produces profuse bleeding convert a routine procedure into a surgical one?
Reusable Daisy Chain
What evidence exists that the lowly daisy chain is a vector for disease transmission?
Gloves
As stated previously, the mandatory nature regarding the use of gloves is not a guideline but an order.
Appendix 2 of the guideline refers to the CDC “Guidelines for Infection Control in Dental Health-Care Settings.” 9 The research section of this CDC document indicates that the effectiveness of gloves has yet to be determined. Why, with this knowledge, would the College make the wearing of gloves mandatory?
Spaulding Classification The guidelines employ the Spaulding classification to distinguish between critical, semi-critical and non-critical items. Spaulding intended this to be used such that the processing of items would be commensurate with their use and their risk of transmitting disease. The College has modified Spaulding’s approach because, according to the guideline, critical and semi-critical items are processed in the same way. Therefore, the guideline should consist of only two classes, namely, critical and non-critical.
Regular Monitoring for Quality Assurance
The word “regular” should be defined as to the specific period of time. For example, is the monitoring performed regularly once a year, every six months, weekly, daily or hourly. There are other references to “periodic” cleaning and “regular” cleaning. These poorly defined words provide no guide whatsoever to the clinical staff.
CONCLUSION
The RCDSO guidelines are concerned with the “impact of emerging, highly contagious respiratory and other illnesses.” The College is unable to predict the etiology, pathogenicity or infectivity of these emerging diseases. The term, “other illnesses” is so vague and all encompassing that attempting to develop precautions against them is simply impossi ble. Nevertheless, with its guidelines the College is indicating that it knows how to deal with calamitous infections and epidemics that it is forecasting will occur. Perhaps, it is time for the RCDSO to relinquish predicting the future to prophets, fortune-tellers and mystics and instead concentrate on determining what diseases current recommendations have prevented or controlled.
In recent years various health related associations have developed criteria against which Clinical Practice Guidelines are assessed. The RCDSO guidelines receive a failing grade when compared to these established standards. Significant deficiencies are the absence of substantiated clinical evidence and cost benefit analyses. This failure begs the question as to why the College abandoned its 1996 evidence-based guidelines in favour of ones that do not require scientific certainty?
The Precautionary Principle deludes the RCDSO into believing that it can create a safe risk free future. Unfortunately, accurate predictions of the future are impossible and the concept of a risk free environment is a complete illusion.
It is concluded that the profession should demand that the RCDSO guidelines are revised to reflect the actual status of disease transmission in dental practice rather than on fanciful predictions of a perceived future. OH
Dr. Hardie was intimately involved in the development of the RCDSO 1996 evidence-based guidelines. Since then he has maintained an interest in this topic and how it and related diseases have influenced dental infection control recommendations.
REFERENCES
1. Alcabes P. Dread, How Fear and Fantasy Have Fueled Epidemics from the Black Death to the Avian Flu. Public Affairs, Perseus Books Group, Philadelphia, PA 2009.
2. Glass TA., Understanding Public Response to Disasters. Available at: www.upmc-biosecurity.org/website/events/2000_symposium-2/glass/trans_glas. html
3. Scripting a Future for Clinical Practice Guidelines. Proceedings from a Multidisciplinary Summit, Toronto, June 5, 1999.
4. Sutherland SE, Matthews DC, Fendrich P. Clinical Practice Guidelines in Dentistry: Part 1. Navigating New Waters. J Can Dent Assoc 2001; 67(7): 379-383.
5. CDA, ODA and RCDSO. Clarify Guidelines on Universal Precautions and the Application of the Human Rights Code. RCDS Dispatch 1996;10 (3).
6. Shaneyfelt TM
, Mayo-Smith MF, Rothwangl J. Are Guidelines Following Guidelines? The Methodological Quality of Clinical Practice Guidelines in the Peer-Reviewed Medical Literature. JAMA 1999; 281(20): 1900-1905.
7. Stock SR, Gafni A, Bloch RF. Universal precautions to prevent HIV transmission to health care workers: an economic analysis. CMAJ 1990; 142 (9): 937-946.
8. Levy SB, Antibacterial Household Products: Cause for Concern. CDC Emerging Infectious Diseases 2001; 7 (3) Suppl..
9. CDC Guidelines for Infection Control in Dental Health-Care Settings -2003. Available at: www.cdc.gov/mmwr/PDF/rr/rr5217.pdf
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The College should admit to dentists and their patients that its recommended guidelines have no scientific validation
