The Institute of Medicine has been an advocate for clinical guidelines for many years. Although the value of guidelines has never really been established, both clinicians and medical malpractice attorneys often want to ascribe greater credibility to them than they deserve. The issue was raised again in the past few months and I review it briefly here.
A few years ago Dr. Robert Ewart discussed the ethics of using guidelines to screen patients for medical conditions in a review entitled “Primum Non Nocere and the Quality of Evidence: Rethinking the Ethics of Screening” (J Am Bd Fam Pract. 2000:13(3):188-196). Dr. Ewart concluded that many of the “guidelines” in use at that time had insufficient evidence to be used as a standard for clinical practice. He pointed out that there is a marked difference between “investigation” (seeking to better define a known problem) and “screening” (seeking to find if there is a problem) in terms of four ethical principles: beneficence, nonmaleficence, autonomy, and distributive justice. Since the healthy bear the harms of screening, nonmaleficence takes ethical precedence over beneficence in individual cases. Both the cost of and the consent for such screening programs for both the individual and society have ethical implications and differ for screening vs. investigation. This review/essay is worth the consideration of attorneys, especially, for example, those who may be involved in situations where “loss of chance” is an issue.
Now, Dr. Pierluigi Tricoci et al. have revisited the value of clinical practice guidelines in an article in JAMA, (JAMA. 2009; 301(8): 831-841). While guidelines published by the American College of Cardiology and the American Heart Association have become important benchmarks for quality of care, the vast majority are based on inadequate evidence or biased expert opinion. They find that the evidence from which clinical practice guidelines are derived as well as the process of writing guidelines needs improvement. A variety of print and online media provide more comprehensive analysis.
In an accompanying editorial titled “Reassessment of Clinical Practice Guidelines: Go Gently Into That Good Night” (JAMA, February 25, 2009. 301(8):868-869), Dr. Terrence Shayneyfelt and Robert Centor find that:
- Guidelines have become marketing and opinion-based pieces with a widely recognized financial bias.
- Guidelines are being developed and used as “marketing tools for device and pharmaceutical manufacturers.”
- As many as “87% of guideline authors had some form of industry tie.”
- Guidelines need greater individualization for specific patient situations.
- The guideline development process needs major changes to prevent conflicts of interest, reduce bias, improve flexibility and decrease redundancy.
In summary, they state that “clinical guidelines are supposed to be guides, not rules.” Because one size does not fit all patients, the authors suggest that “perhaps guidelines should be avoided completely,” and add that, given the present state of guidelines, “clinicians and policy makers must reject calls for adherence to guidelines. Physicians would be better off making clinical decisions based on valid primary data.”
They conclude that, because of the disarray found in guidelines, many clinicians (appropriately) do not use them.
Nor, in this editor’s opinion, should malpractice attorneys for either plaintiff or defense use them as a place to hang one’s hat.