Changes to the College of Chiropractors of British Columbia Professional Conduct Handbook
Joel Alcantara, DC1 and Justin Ohm, DC2
1Research Director, the International Chiropractic Pediatric Association, Media, PA, USA
2Executive Director, the International Chiropractic Pediatric Association, Media, PA, USA
On December 11, 2019, The College of Chiropractors of British Columbia (CCBC) approved changes to their Professional Conduct Handbook. The CCBC advised that Registrants should immediately review these changes and make any necessary adjustments to their practice.
The changes referred to by the CCBC dealt with Public Relations and Advertising – Amendment of 14.1 (f) to include the Efficacy Claims Policy and Addition of 14.1 (g):
14.1 (f) Chiropractors must not advertise health benefits of their services when there is not acceptable evidence that these benefits can be achieved.
14.1 (g) may advertise or reference the Webster Technique or Certification only as “a specific chiropractic sacral analysis and diversified adjustment for all weight-bearing individuals.”
Specific to their Efficacy Claims Policy; according to the CCBC, due to the absence of acceptable evidence supporting such claims, registrants must NOT represent to patients or the public that chiropractic:
(a) can be used to treat diseases, disorders or conditions such as: Alzheimer’s disease, cancer, diabetes, infections, infertility, or Tourette’s syndrome, or
(b) has any beneficial effect on childhood diseases, disorders or conditions such as: ADHD (or ADD), autism spectrum disorders including Asperger syndrome, cerebral palsy, Down syndrome, fetal alcohol syndrome, or developmental and speech disorders.
(c) has any beneficial effect on fetal development or position such as: breech/breech turning or position and intrauterine/in utero constraint.
(d) has any beneficial effect on labour or birth such as: easier or shorter labour, preventing the need for medical interventions and preventing premature or traumatic birth.
(e) has any beneficial effect on hormone function or postpartum depression.
The International Chiropractic Pediatric Association has long held that the use of the terms “breech turning” or “in-utero constraint” should not be used in relation to the Webster Technique. In 2012, ICPA Research Director, Dr. Joel Alcantara and Dr. Jeanne Ohm published The Webster Technique: Definition, Application, and Implications2 which clarified the intent, definition, and specific analysis of the Webster Technique. The goal of the spinal (and extra-spinal) adjustment is to mitigate the effects of spinal and extra-spinal subluxations and restore function. Specific to the Webster Technique, the goal is to reduce the effects of sacral subluxation/sacroiliac joint dysfunction. In so doing, neuro-biomechanical function in the pelvis is facilitated. The ICPA and its members are committed to delivering chiropractic care throughout pregnancy as part of the chiropractic family lifestyle in order to optimize functioning and physiological adaptation. Along with our patients, we can all draw our own conclusions as to chiropractic care’s beneficial effect on birth outcomes and other aspects of life. With the continuing popularity and utilization of chiropractic globally1, it is clear that both practitioners and their patients are convinced of the many benefits associated with chiropractic care of pregnant women, children and the general population.
The CCBC adopted from the Australian Health Practitioner Regulation Agency what is considered acceptable evidence for advertising health benefits of chiropractic care. We wholeheartedly disagree with the CCBC criteria of acceptable evidence. We find their criteria for acceptable evidence as irresponsible and unacceptable. The CCBC criteria of acceptable evidence have ramifications beyond advertising (i.e., traditional advertisements and printed materials, websites, email newsletters, social media, promotional activities, and public appearances) and run counter to evidence-informed chiropractic practice. The approved changes by the CCBC to their Professional Conduct Handbook virtually places the practice of chiropractic as untenable in British Columbia.
According to the CCBC, when making therapeutic claims, the issues to consider whether there is acceptable evidence include:
While the CCBC acknowledged and recognized that chiropractic care may offer relief for persons experiencing neuro-musculoskeletal symptoms, we are of the opinion that the CCBC would be hard-pressed to provide acceptable evidence on this matter based on their own criteria. Chiropractors are well known for providing relief for patients suffering from neuro-musculoskeletal symptoms such as neck pain and low back pain. The most recent systematic review of the literature by Rubinstein et al.3 to assess the benefits and harms of spinal manipulative therapy (SMT), a modality commonly used by chiropractors for the treatment of chronic low back pain found that SMT produces similar effects to other recommended therapies for chronic low back pain. As for acute low back pain, SMT was found to be no more effective than inert interventions, sham SMT, or when added to another intervention. SMT also appeared to be no better than other recommended therapies for acute low back pain.4 The most recent systematic review of the literature by Coulter et al.5 to determine the efficacy, effectiveness, and safety of various mobilization and manipulation therapies for the treatment of chronic nonspecific neck pain found that studies published since January 2000 provide low-moderate quality evidence that various types of SMT and/or mobilization will reduce pain and improve function for chronic nonspecific neck pain compared to other interventions. Multiple treatment approaches, when integrated, might have the greatest potential clinical impact. According to the authors, this review contributes to the literature base by including both manipulation and mobilization interventions provided not only by chiropractors but also by other approaches such as osteopathy, manual therapy, and physical therapy.
According to the CCBC, the studies by Rubinstein et al.3,4 and Coulter et al.5 provide the highest level of evidence (i.e., systematic reviews of clinical trials). Unfortunately, these studies provide clear evidence that SMT is only but one of a number of possible treatment approaches and as such is not acceptable evidence to support the chiropractic care of patients with chronic nonspecific neck pain, acute and chronic low back pain.
The CCBC clearly defined the following types of studies as insufficient acceptable evidence for advertising claims:
This standard imposes an unrealistic burden on the chiropractic profession in B.C. In 1991, Smith6 quoted Eddy concerning “the poverty of medical evidence.” Eddy stated, “Only about 15% of medical interventions are supported by scientific evidence…This is partly because only 1% of the articles in medical journals are scientifically sound.” More recently, Ebell7 et al reported on the level of evidence supporting primary care evidence. They reported, “In conclusion, approximately half of the recommendations for primary care practice are based on patient-oriented evidence, but only 18% are based on patient-oriented evidence from consistent, high-quality studies.”
Imposing the B.C.C. standard on conventional medicine would effectively silence the flow of research information for the overwhelming majority of medical and surgical interventions. It is inappropriate and unfair to impose a more burdensome standard on chiropractic than other health disciplines.
Furthermore, as Montiri r al8 reported, “Research evidence is necessary but insufficient for making patient care decisions… Patient preferences refer to patient perspectives, beliefs, expectations, and goals for health and life, and to the processes that individuals use in considering the potential benefits, harms, costs, and inconveniences of the management options in relation to one another. Patients may have preferences when it comes to defining the problem, identifying the range of management options, selecting the outcomes used to compare these options, and ranking these outcomes by importance.” Chiropractors, like other practitioners, must be free to integrate the three components of evidence-informed practice: external evidence, knowledge, and experience of the practitioner, and patient preferences and values. This includes sharing all levels of evidence.
An important element of informed consent is the discussion of alternative courses of care, including balancing risks and benefits. Hall et al9 note that informed consent should be “designed to systematically address not only the risks of care, but also the expected benefits, relevant alternatives and what to anticipate before and after the procedure.” It should be noted that these authors state, regarding their own paper, “Our bibliography includes randomized controlled trials, meta-analyses, systematic reviews, qualitative descriptions of patient and physician experience, and observational studies.”
According to the CCBC, the only acceptable studies as providing acceptable evidence are from studies that control for bias. The only study design that meets these criteria are experimental designs that incorporates randomization, control, and manipulation of the care protocol to control for bias as well as known or unknown factors. This research design is commonly referred to as the randomized controlled clinical trial or RCT. Many clinical situations posing questions of effectiveness require the randomized controlled clinical trial research design to answer. As a consequence, research evidence from the quantitative tradition assumed superiority over all other types of evidence with the RCT as the “gold standard” with evidence from systematic reviews and meta-analyses at the top of the evidence hierarchy.10
While the RCT is the “gold standard” in the world of post-positivist research paradigms, it is not without limitations. Beyond the scope of this paper to address all the limitations of randomized controlled clinical trials, we mention a few here. These limitations include:
Chiropractic care is patient-centered care. Chiropractic incorporates the principles of vitalism, holism, humanism, conservatism, naturalism, and rationalism. Chiropractic acknowledges and embraces the self-healing capacity of the individual as a unified whole. Chiropractic respects each patient’s values, beliefs, and dignity and involve the patient in an egalitarian partnership towards optimization of function and salutogenic adaptation to all of life’s challenges.11 Such aspects of patient-centered care may not follow the paradigm of standardized care.
Based on CCBC criteria of acceptable evidence, evidence from lower-level research designs in the evidence hierarchy pyramid consisting of case reports and case series to cohort studies are not acceptable evidence. Medicine, dentistry, nursing, osteopathy, acupuncture, naturopathy and all other healthcare professions find studies from these research designs as providing acceptable evidence. Sacket et al.10 clearly pointed out that evidence-based medicine (or evidence-informed practice for that matter) is not restricted to RCTs and systematic reviews/meta-analyses but rather its about tracking down the best external evidence with which to answer the clinical question. Case reports and case series have importance in the evidence hierarchy. They inform higher-level research designs.12
Although not the focus of interest here, it is worth discussing the medical practice of “off-label prescribing” to demonstrate the unrealistic expectation of the CCBC of its registrants when compared to other healthcare systems. Medicine finds as acceptable clinical protocols those treatment approaches that have not been scrutinized with a randomized clinical trial or for that matter scrutinized with any type of research. In the medical care of children, physicians often perform “off-label prescribing.” This is the prescribing of medication for children at a different dose from that with which it has been approved, the prescribing of medication for a different indication, the prescribing of medication for a different age group from that with which it has been approved, the prescribing of medication through a different route as recommended by the manufacturer and the prescribing of medication that are specifically contraindicated for children.13 One study found that children were prescribed at least 1 “off-label” prescription in 62% of office visits during the years 2001 through 2004.14 Worldwide – reported rates of off-label prescribing to children range from 11% to 79%.13 Estimates from office-based practices found that 21% of prescriptions are off-label.15 Of these, 73% had little or no scientific support, raising concerns about patient safety and costs to the healthcare system.16 Another consideration of worth is the Framingham Study. Began in 1948 as a cohort, observational study of cardiovascular disease, this ongoing study has come to revolutionize our thinking about cardiovascular disease, change the study of epidemiology, and have forced the biostatistics community to develop multivariate analysis.17 According to Shanthi Mendis, MD, of the World Health Organization, the Framingham study established the concept of risk factors and generated seminal findings such as the effects of tobacco use, unhealthy diet, physical inactivity, obesity, raised blood cholesterol, raised blood pressure, and diabetes on cardiovascular disease (REPEAT). The myopic perspective of the CCBC would find the evidence gleaned from this groundbreaking study as insufficient evidence.
We are keenly aware of the use of the Graston Technique or Active Release Technique by BC chiropractors and advertised as such on their websites. A Pubmed search (January 4, 2020) of “chiropractic AND Graston Technique” revealed 14 articles. The majority of the published studies involving the Graston Technique were case reports with one study involving an RCT comparing SMT, Graston Technique and placebo for non-specific thoracic spine pain. According to the study authors18, there was no difference in outcome at any time point for pain or disability when comparing SMT, Graston Technique® or sham therapy for thoracic spine pain. The advertisement of the use of the Graston Technique® for thoracic spine pain or any kind of pain for that matter by a BC chiropractor would be in violation of advertisement requirements as set forth by the CCBC. A Pubmed search of “chiropractic AND Active Release Technique” revealed 19 articles. The study designs of these published studies are insufficient acceptable evidence for advertising claims.
The BIG question, therefore, is what counts as evidence in evidence-informed practice?
Germane to this article is the issue of what is appropriate evidence for advertising and ultimately, what is appropriate evidence for evidence-informed practice. As one can already surmise, there is no unequivocal understanding or agreement of what constitutes acceptable evidence. However, despite these disagreements, Shlonsky and Mildon19 identified some essential truths about the nature of evidence:
Before further discussions, we want to acknowledge the work of Rycroft-Malone et al.20 in addressing what evidence is and how practitioners use it in decision-making faced with the reality of the many clinical contexts that present itself in clinical practice.
Evidence from Research
This type of research evidence is assumed by many as having superiority over other sources of evidence in the delivery of evidence-informed health care. In chiropractic (as in the other healthcare professions), definitive studies are rare or do not exist. We would challenge the CCBC to come up with one definitive RCT study that demonstrates the superiority of the chiropractic intervention for any patient complaint known in healthcare. As many have pointed out, the production and dissemination of research is not only a scientific process but also a historical and social process. There is much uncertainty about what is appropriate research evidence given its dependence on context. The evidence produced from research may result in multiple interpretations depending on the stakeholder so that there is variation in interpretation by individuals within one group, by group, and by profession. What has become obvious to those in healthcare is that despite the importance of research evidence in informing practice and improving patient care, it is not the only element in evidence-informed practice to inform practitioners’ decision-making.
Evidence from Clinical Experience
Knowledge gained from professional practice and life experience is another factor to consider in evidence-informed practice. Referred to as “practical knowledge”, this knowledge is firmly and deeply rooted in practice based on the individual clinician’s clinical experience but also on the experience of others to inform clinical care. Arguably this type of knowledge is subject to bias and assessed as lacking credibility. However, it has also been argued that this type of knowledge is required for personalized patient-centered care and facilitates the integration of the research evidence and the needs and wants of patients.
Evidence from Patients
Patient-centered care and “good practice” necessitates that one considers the personal knowledge and experience of patients. It affects the way they respond to their health challenges and the decisions they make in adopting or not adopting a healthcare system or healthcare approach. While ethically and morally the experiences and preferences of patients should be central in evidence-informed practice and patient-centered care, these same experiences and preferences are counter to the generalizable research evidence (i.e., RCTs) that is often emphasized towards clinical decision making. The incorporation of an individuals’ values, experiences, and preferences into evidence-informed practice is a complex issue and takes a certain level of expertise.
Duty of Veracity
Veracity, an ethical imperative for professionals, is the principle of truth-telling. There is a basic expectation that we are honest in our professional interactions. Bennett-Woods20 notes, “Truth-telling is violated in at least two ways. The first is by the act of lying…However, the principle of veracity is also violated by omission, the deliberate withholding of all or portions of the truth.” Limiting evidence to randomized controlled trials is a breach of this duty. Doing so requires active concealment of material facts. Specifically, it forecloses use of a vast body of peer-reviewed literature, textbooks, and other scholarly sources.
In closing, we note that the message is clear to ICPA chiropractors on the requirements of evidence-informed practice. It is our belief that censoring the language of chiropractors to the extent that the CCBC is proposing is not in the public health interest and in fact, restricts access to appropriate care. We must ensure that our patients receive the best care possible based on the best possible evidence. That is evidence from the published research tempered with one’s clinical experience and expertise while at the same time respecting the needs and wants of our individual patients. We would encourage that the CCBC take a similar stance on behalf of their registrants and the patients they serve.
References
