The Role of ACOEM’s Practice Guidelines in Treatment Decisions
Introduction
In a recent editorial, the Reflex Sympathetic Dystrophy Syndrome Association (RSDSA) explored the possible effect of ACOEM’s practice guidelines on medical decision-making and on the utilization review process as they might affect patients with complex regional pain syndrome (CRPS).
RSDSA raised questions about ACOEM’s guidelines process and urged it to recognize and affirm certain fundamental principles, including: The predominant ethical obligation of the practitioner is to the individual patient; Each patient may choose a physician or treatment team; CRPS patients need to obtain an individually designed treatment plan for their debilitating physical and psychological conditions; and normative recommendations are educational and help to rank potential diagnostic and therapeutic interventions, but they are not prescriptive.
Background
Medical practice guidelines provide a framework for consistent and reliable decision-making regarding the diagnosis, management and treatment of injury and illness. Many organizations publish guidelines, ranging from medical specialty societies to private health companies. The potential for improved health care as a result makes this effort important and worthwhile.
Though expert professional guidance has long been a part of medical practice, evidence based guidelines have changed the nature of medical decision support in recent years. Historically, medical guidance was based largely on tradition, uncontrolled clinical observation and authority. As treatment options have increased in recent years, variation in care has resulted, with availability sometimes driving demand rather than intended outcomes. Evidence-based guidelines, developed with rigorously-researched-and-synthesized scientific studies and a process that allows for incomplete science, becomes a mechanism for minimizing variations in care when properly applied to a given clinical situation. EBM uses the weight of scientific evidence to judge the risks and benefits of various diagnostic and medical treatment options, incorporating the highest quality of scientific evidence to guide health care providers toward the most effective health care, considering the risks, harms and benefits.
The difficulties of achieving consensus among clinical experts are well recognized. There are few “easy” answers in determining best practices for medical care. But relying on the principles of EBM helps ensure that the most solid scientific rationale for medical practice recommendations is used.
As an organization striving to improve the practice of occupational and environmental medicine, and to improve health outcomes broadly for workers, ACOEM encourages adherence to best practices as defined by its Occupational Medicine Clinical Practice Guidelines. At the same time, it does not believe that Guidelines should be considered rigid prescriptions for care. They are just that – guidelines – and cannot replace the judgment of the individual practitioner, supported by the best available evidence, which must be exercised with each individual case.
When the available scientific evidence-base for a test or treatment is weak or non-existent, clinical judgment and expert consensus become paramount. The vital role of clinical judgment is formally recognized in a section of ACOEM’s Guidelines called Core Values:
“ACOEM Practice Guidelines should be utilized as a basis for high quality care, while recognizing that patient variability exists and there is an active role for the treating physician in designing optimal care for a given injured worker.”
To further ensure that logical and reasoned clinical judgment is part of the guidelines development process, ACOEM supports its testing-and-treatment recommendations with a widely accepted set of “First Principles,” which every practitioner should apply. These principles are founded on the fundamental Hippocratic dictum, “First, do no harm”:
- Imaging or testing should generally be done to confirm a clinical impression.
- Tests should affect the course of treatment.
- Treatments should improve on the natural history of the disorder, which in many cases is recovery without treatment.
- Invasive treatment should be preceded by adequate conservative treatment and may be performed if conservative treatment does not improve the health problem.
- The more invasive and permanent, the more caution should be exerted in considering invasive tests or treatments and the stronger should be the evidence of efficacy.
- The more costly the test or intervention, the more caution should be generally exerted prior to ordering the test or treatment and the stronger should be the evidence of efficacy.
- Testing and treatment decisions should be a collaboration between the clinician and patient, with full disclosure of benefits and risks.
- Treatment should create neither dependence nor functional disability.
Beyond recommendations supported by evidence and “first principles” of responsible medical management, Occupational Medicine includes a third critical component to help the individual practitioner determine the best individualized course of treatment: the obligation to injured workers to suggest treatments that rapidly return them to work. Rapid return to work has been shown in many instances to minimize ongoing disability and to support recovery. However, no treatment should be continued without limits, unless a functional gain is demonstrated.
Effective treatment options are validated over time as well-designed studies provide better evidence and experience evolves. As the body of evidence related to treatments evolves, the system of evaluating it must be structured so evidence can periodically be weighted for relevance and quality. This requires exhaustive scrutiny of the scientific literature. Unlike other guideline developers, ACOEM bases its recommendations on primary, original-source search and review of all available scientific evidence related to specific treatments. ACOEM then applies nine categories of recommendation, driven by the quality of the evidence supporting the treatment, ranging from “strongly recommended FOR” to “strongly recommended AGAINST.” In each case, the recommendation is based on exhaustive investigation of the strength and quality of the evidence available – which the individual practitioner should assess if the evidence counters a clinical presentation.
ACOEM guidelines provide an exhaustive review of the primary scientific evidence, a methodologically sound process for determining the quality of that evidence, and a framework in which a physician’s clinical judgment and the recognition of patient variability are fundamentally acknowledged and made a part of the equation. ACOEM believes that these components create a balance that advances best practices while protecting and preserving individualized patient care.
In short, when using ACOEM’s guidelines to help identify effective testing and treatment options, “not recommended” means exactly what it says – either there is evidence that a given test or treatment is ineffective, or that the expert panel composing the guidelines has recommended against a test or treatment on the basis of collective clinical experience and judgment. “Not Recommended” should not be taken to mean “never.” And, by the same token, “recommended” should not be taken to mean “always.” Physician judgment and individual circumstances must always be taken into account.
ACOEM’s guidelines are developed by independent panels of experts who use a transparent, publicly available methodology grounded in science. They are published by ACOEM alone – without “collaboration” with state government, as inaccurately stated in the RSDSA editorial.
At the very heart of ACOEM’s guidelines is the goal of returning function to injured or ill workers. This is fundamental to the work of occupational and environmental physicians, particularly as productive work is among the greatest sources of a person’s self worth -- and a societal goal.
Any set of occupational health guidelines – regardless of the developer – may be used by the utilization review community. ACOEM’s first responsibility is to create a scientifically and methodologically sound guidelines system for the use of health-care practitioners; then to ensure that the parameters for its use are clearly explained and publicly communicated.
ACOEM fully agrees with RSDSA that the guidelines should not be used to arbitrarily deny authorization for coverage and recognizes the potential for UR organizations to misapply guidelines in their coverage decisions. Guidelines should never replace the judgment of physicians. ACOEM recognizes that URAC certified UR programs insist that only physicians can deny care.
ACOEM will continue to advocate publicly for a general standard of UR that recognizes patient variability, the need for physician judgment and the avoidance of rigid, unilaterally applied coverage decisions. Furthermore, the obligation of Occupational Medicine is to optimally return the injured worker to pre-injury functionality, regardless of the needed interventions. Optimal utilization should be a by-product.
As stated by the RSDSA, the predominant ethical obligation of the practitioner is to the individual patient. ACOEM agrees that patients should have informed choice and shared decision-making as they consider their healthcare decisions – including selection of treatment providers. While the focus of its editorial is on CRPS patients, ACOEM believes that the notion that patients need to obtain “an individually designed treatment plan for their debilitating physical and psychological conditions” is a general principle that applies to all patients. Every patient should be considered an individual – but a corollary principle is that the patient’s healthcare team should use the best available evidence, rooted in strong methodology, to inform the development of the highest quality treatment plan that will be consistently and reliably effective in improving both symptoms and function. Finally, we agree in principle that medical-care recommendations should not be considered universally prescriptive; they are intended to help practitioners form judgments based on the circumstances of individual cases.
Jeff Harris, MD, MPH
Kurt Hegmann, MD, MPH
Robert McLellan, MD, MPH
Kathryn Mueller, MD, MPH
On behalf of the ACOEM Guideline Oversight Committee