With the proliferation of clinical trials and emphasis on evidence-based practice in health professions, clinicians have become increasingly reliant on clinical practice guidelines (CPGs) to guide them in the management of their patients. At best, these guidelines represent a thorough analysis of the available evidence combined with the clinical acumen of the developers and can provide sound practical advice. At worst, they can perpetuate medical myths and disseminate tenuously-founded beliefs of the developers and the interests of their sponsors. (1)
Evidence-based medicine (EBM) has been defined as "the integration of best research evidence with clinical expertise and patient values." Patient values are defined as "the unique preferences, concerns and expectations each patient brings to a clinical encounter and which must be integrated into clinical decisions if they are to serve the patient". (2) The integration of these three critical elements ensures that clinicians and patients can form a diagnostic and therapeutic alliance that will optimize clinical outcomes and quality of life. (2)
To determine whether or not the "third element" of EBM, namely integration of patients' values, was embodied in the creation of clinical practice guidelines, we decided to review three recently published, widely distributed and influential guidelines pertaining to the treatment of three different chronic medical conditions. These documents were:
Our specific goal was to identify the extent to which integration of patient values in therapeutic decision making was discussed. The results were surprising.
The 12-page (~7,500 word) 2001 NCEP guidelines designed to optimize the detection, evaluation, and treatment of elevated lipids in adult patients contained no mention of patient values, nor did the guidelines promote the involvement of patients in the therapeutic decision-making process. There was, however, a discussion of the procedures that can be followed to determine absolute risk based on an assessment of risk factors, and we presumed that the authors intended this information to be shared with the patient.
The 35-page (~19,000 word) 2002 Canadian guidelines for the diagnosis and management of osteoporosis contains only two statements that are suggestive of incorporating patient values. The first statement says that "…when a patient is identified as having a high risk for fracture, a discussion regarding treatment is recommended…" The second states that "…it seems prudent to begin the identification of people at high risk for osteoporosis in their 50s, if they are willing to accept a treatment…"
Finally, the 13-page (~5,000 word) 2003 JNC report contains only two statements that might be interpreted as attempts at encouraging integration of patient values. The first statement reads, "…physicians should provide to patients, verbally and in writing, their specific BP numbers and goals…" and the second states, "…the patient and physician must agree on BP goals…". Interestingly, these statements refer to the surrogate marker of blood pressure rather than the more clinically relevant cardiovascular endpoints.
While these three recent and important guideline documents contained clear and specific recommendations about whom to treat and how to treat them, only 0.2% of the ~60 pages (~31,500 words) was devoted to integration of patient values into the therapeutic decision-making process.
In 1999, the National Health and Medical Research Council of Australia produced a document entitled "A guide to the development, implementation and evaluation of clinical practice guidelines". (6) In this extensive publication, the authors state that one of the key principles for developing guidelines is that "…guidelines should…make provision for accommodating the different values and preferences of patients…" and that guidelines should be developed using a "…multidisciplinary approach that includes consumers..." It is not apparent that any of the guidelines we examined involved patients or consumers in their development, nor was much attention paid to the incorporation of patient values and preferences.
There are several potential reasons why the guidelines we reviewed neglected to adequately address patient values. It is conceivable that the developers were not aware of the "third element" of the EBM definition at the time of their construction. It is also possible that no consensus could be reached on what processes should be employed to incorporate patient values into therapeutic decision making. These processes would probably vary depending on the condition involved. Alternatively, the developers may have been unfamiliar with the actual magnitudes of risk and risk reduction associated with the conditions and therapies they are discussing, which relegates discussion with patients about these parameters to an implicit, qualitative exchange. The developers may have assumed that their readers were well aware of the magnitudes of benefit and risk associated with the treatments that they recommend and were already actively incorporating patients values into therapeutic decision making. Finally, it is possible that the authors of the guidelines concluded that patients would not understand the concept or wish to have their values incorporated into therapeutic decision-making. We can only speculate as to the etiology of these omissions.
Recently, one of us (JM) encouraged an author of a review article on the treatment and prevention of osteoporosis to present absolute risk and risk reduction in addition to relative risk and risk reduction data and suggested that this information should be used in the discussion of treatment options with patients. (7) With this information, patients can be informed about what their risk for fractures is, the degree to which this risk may be reduced by taking a medication, the chance that they would experience a benefit from doing so, the potential of developing side effects and even how much money they could expect to spend on drugs in order to "buy" this chance of benefit. The author, who is one of the foremost experts on osteoporosis and bone density monitoring in the USA, President of the International Society of Clinical Densitometry and Vice President of the American College of Endocrinology, responded that "… physicians don't talk to their patients with these conditions in the terms proposed. We tell our patients, 'Your blood pressure is too high; you should be on medication to reduce it;' or 'Your cholesterol level remains elevated despite diet and exercise; we need to add medication to bring it down.' If …[one] takes the approach he (JM) advocates for patients who have osteoporosis, I doubt that many of his patients opt for therapy. I agree with the request for including more complete information about the results of clinical trials. I strongly disagree with his proposal for using this information in clinical practice. I tell patients who have low bone density or a fragility fracture that they have osteoporosis … I tell them that patients who have osteoporosis should be treated. Most patients want my advice, not a lesson in data analysis." (8)
We find this response troubling. If these comments represent the views of opinion leaders in other areas of clinical practice, it seems unlikely that patient values will be incorporated into consensus guidelines anytime soon. In the absence of these values, practice guidelines will never truly reflect the fundamental principles of evidence-based practice.
P. Loewen, Pharm.D.
J. McCormack, Pharm.D.
P. Jewesson, Ph.D. FCSHP
J Inform Pharmacother 2003;14:1-4.
Copyright © 2003 by the Journal of Informed Pharmacotherapy. All rights reserved.