Concerns About Practice Guidelines

December 1, 2006

Several readers have responded with comments and concerns regarding my column, "Do Physicians Use Practice Guidelines?" Since the issues these readers raised are important and concern many psychiatrists, they merit some discussion.

Several readers have responded with comments and concerns regarding my column, "Do Physicians Use Practice Guidelines?" (Psychiatric Times, June 2006, page 13). The concerns center on the relevance of clinical practice guidelines (CPGs) to the practice of psychiatry; specifically, what makes a CPG more valid than other forms of research such as literature, meetings, and lectures, and how can physicians be sure that CPGs are free of bias from managed care and insurance companies? Since the issues these readers raised are important and concern many psychiatrists, they merit some discussion.

Expert consensus
Many CPGs are created through a process of expert consensus in which clinicians who specialize in studying a specific psychiatric illness are asked to rate the appropriateness of various treatments for the disorder. For example, in the development of a consensus guideline for the pharmacologic treatment of psychosis, 50 expert clinicians were asked to rate the appropriateness of 11 antipsychotic medications for the treatment of an initial episode of psychosis with predominantly positive psychopathology.1 Medications were subsequently designated as first-, second-, and third-line choices based on statistical analysis of the combined expert ratings.It is reasonable to question how these experts were selected and why they should be considered more qualified to draw conclusions from the research data than practicing psychiatrists who are, by definition, also experts.2 Clinicians and researchers, like those who create CPGs, often disagree among themselves about the meaning of research results and the relative effectiveness of the various treatments for a psychiatric disorder. Sometimes they cannot provide convincing evidence that certain treatments are better than others.

However, these problems don't necessarily invalidate the use of CPGs. In an ideal world, research would provide definitive answers about the effective treatment of various disorders. Every clinician would know this and could appropriately apply it in patient care.

Unfortunately, the world of psychiatric treatment is far from ideal. Research is a messy proposition that often produces tentative and inconclusive results that are open to various interpretations. If disagreement about research results were the criterion for rejection, science would make little progress in discovering successful treatments for medical disorders. In fact, science actually thrives on disagreement because it drives further research and exploration. The challenge for clinicians and researchers is to provide the best possible interpretation of the data while controlling for the cognitive biases that inevitably enter into any such judgment process.3,4

I don't know exactly how clinical experts are chosen, but I presume they are selected by their colleagues based on who has published the most relevant papers on the diagnosis and treatment of specific psychiatric disorders. There is certainly potential for bias in this process, but I cannot think of a better way to identify experts in the field. Selecting a large number of experts ensures that the guidelines will include the broadest possible knowledge about treating the disorder. It also provides a peer review process that decreases the likelihood of bias in the interpretation of research results. This does not mean that bias is extinguished-it is simply reduced.

Physicians often argue that it is sufficient to attend professional meetings, read the literature, listen to lectures, and consult with colleagues in order to draw their own conclusions about how to treat their patients. They maintain that they do not need anyone to tell them how to practice medicine. Yet practitioners, like experts, need to guard against bias in their own interpretation of clinical and research data. Individual clinical experts may be no more skillful than practicing psychiatrists in the management of a complex case, but the collective wisdom of a large number of experts is more likely to be correct than is the judgment of a single clinician.

An expert consensus panel is also a useful method for filling in the gaps in formal research. No study can address all of the questions associated with the clinical treatment of a disorder. As the number of treatment subgroups in a research study increases, a greater number of subjects will be required to provide the statistical power necessary to detect differences among the subgroups. Eventually, the number of subjects and the cost of the study will become too large to manage. An expert consensus guideline provides some direction to practitioners about treatments that are not included in the formal research.

CPGs represent a compilation of the current best practices or standards in the treatment of various disorders. They are meant to be a supplement to physician education, not a "cookbook" for treatment. Every guideline that I have seen emphasizes the role of clinical judgment. Knowing when and how to apply the recommendations in the guidelines requires knowledge and experience. Most CPGs, even algorithms, contain broad outlines of care with multiple choices at each stage of treatment. These choices are under the clinician's control. Encouraging compliance with CPGs simply means encouraging psychiatrists to provide treatment that lies within the broad acceptable standards of care.

Applicability of CPGs
When psychiatrists argue that CPGs have "limited applicability" to their patients, they are usually referring to the inability of guidelines to effectively address the variations in patient responses to treatment. This is a valid and important issue. Although many patients respond to initial treatment with a single medication, a substantial number appear to require a more complex regimen of multiple medications. To be useful, CPGs must address these real-world clinical problems.

One of the readers who responded to my column correctly observed that this limitation is currently being addressed in studies such as the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) and the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD).5-7 The STAR*D, in particular, focuses on the clinical management of patients who have failed 1 or more treatment trials with a single medication. When the results from this and other new research are incorporated into CPGs, they should be able to address more of the clinical variability seen in everyday practice.

It may also be worth studying the types of variability and problems that clinicians face in the treatment of complex cases. Yet, even these types of studies cannot control for all the sources of patient variation. There will always be a role for clinical judgment in adjusting treatment for patients who do not quite fit the guidelines or who do not respond to treatment in a typical manner. CPGs are, as the name implies, guides to clinical care, not laws dictating how treatment should be provided.

CPGs and managed care
Some clinicians believe that managed care and insurance companies encourage clinicians to comply with CPGs as a way of reducing costs-often to the detriment of the patient. This assumption mistakenly equates CPGs with the medical necessity criteria used by managed care companies to control costs; these are 2 entirely different sets of guidelines with very different goals. CPGs can actually run counter to the cost-saving goals of managed care medical necessity criteria because CPGs are primarily focused on the provision of care that is defined to be appropriate by clinical experts in the field. CPGs can (but usually do not) explicitly take the cost of care into account in their recommendations.

Intrusion in practice
Some physicians believe that any attempt to convince them to comply with CPGs represents an intrusion into the doctor-patient relationship. Physicians are also concerned that increased emphasis on CPGs will lead to a loss of professional autonomy.8,9

Given these concerns, it is worth remembering why CPGs were developed. Investigators have repeatedly observed significant and unexplained variations in the type and quality of care that clinicians provide in different areas of the country. Moreover, the number of mistakes made in the provision of clinical care in the United States should be sobering to any clinician.10 The Institute of Medicine has referred to these and other problems in care as the "quality chasm."11 No well-intentioned physician would consciously offer poor care to patients, but we can all be misled by our biases and limited knowledge in some areas. CPGs attempt to address these problems by outlining the best medical practices and acceptable parameters of care.

One way to think of a CPG is as a set of treatment principles that fit a significant proportion of patients (perhaps 90% of those with a specific disorder). The remaining patients have a less typical response to treatment. Given this premise, the majority of a physician's patients should fall within the parameters outlined in a specific CPG. A smaller proportion will have to be treated in a manner that deviates from the guidelines. Most physicians will probably discover that they already treat the majority of their patients according to the relevant guidelines. If they find themselves consistently disagreeing with the guidelines, they might want to examine their reasons for doing so.

All clinicians are subject to some regulation by their specialty and by society to ensure that the patients they treat are receiving appropriate care. That is simply a fact of professional life that is unlikely to change. The question is, what is the balance between freedom of action and regulation? The best solution is the one that ensures the most appropriate care for patients while interfering the least in the physician-patient relationship.

Since physicians look to their colleagues the most for consultation and guidance, perhaps this process can be formalized as a method of correcting potential biases and misinformation.12 An effective system might provide some type of real-time online peer review and consultation system that physicians could use both to ask their colleagues for clinical advice and to observe how their colleagues have managed comparable clinical problems. The goal, as always, would be to improve the quality of care.

Dr Fauman is the author of Negotiating Managed Care: A Manual for Clinicians and Study Guide to DSM-IV-TR, both published by American Psychiatric Publishing, Inc. He is adjunct clinical associate professor of psychiatry at the University of Michigan and medical director of Magellan Health Services of Michigan.

References:

References1. Kane JM, Leucht S, Carpenter D, Docherty JP. Expert consensus guideline series. Optimizing pharmacologic treatment of psychotic disorders. Introduction: methods, commentary, and summary. J Clin Psychiatry. 2003;64(suppl 12):5-19.
2. Hampton JR. Guidelines-for the obedience of fools and the guidance of wise men? Clin Med. 2003;3:279-284.
3. Tversky A, Kahneman D. Judgment under uncertainty: heuristics and biases. Science. 1974;185:1124-1131.
4. Kahneman D, Slovic P, Tversky A, eds. Judgment Under Uncertainty: Heuristics and Biases. Cambridge, United Kingdom: Cambridge University Press; 1982.
5. Rush AJ, Fava M, Wisniewski SR, et al. Sequenced treatment alternatives to relieve depression (STAR*D): rationale and design. Control Clin Trials. 2004;25:119-142.
6. Rush AJ, Trivedi MH, Wisniewski SR, et al. Bupropion-SR, sertraline, or venlafaxine-XR after failure of SSRIs for depression. N Engl J Med. 2006;354:1231-1242.
7. Sachs GS, Thase ME, Otto MW, et al. Rationale, design, and methods of the systematic treatment enhancement program for bipolar disorder (STEP-BD). Biol Psychiatry. 2003;53:1028-1042.
8. Hayward RS, Guyatt GH, Moore KA, et al. Canadian physicians' attitudes about and preferences regard-ing clinical practice guidelines. CMAJ. 1997;156:1715-1723.
9. Cabana MD, Rand CS, Powe NR, et al. Why don't physicians follow clinical practice guidelines? A framework for improvement. JAMA. 1999;282:1458-1465.
10. Kohn LT, Corrigan JM, Donaldson MS, eds. To Err Is Human: Building a Safer Health System. Washington, DC: The National Academies Press; 2000.
11. Committee on Quality of Health Care in America, Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: The National Academies Press; 2001.
12. Cranney M, Warren E, Barton S, et al. Why do GPs not implement evidence-based guidelines? A descriptive study. Fam Pract. 2001;18:359-363.