COLLISIONS BETWEEN MEDICAL HUMANISM AND EVIDENCE-BASED GUIDELINES FOR STANDARDIZED MEDICAL CARE

Outright collisions between medical humanism and evidence-based guidelines for standardized care can be avoided as long as clinical guidelines (beyond safety measures) remain recommendations rather than mandates. Hartzman and Groopman believe it is essential to respect the ethical principle that any choice of treatment must ultimately be made by the patient who will benefit or suffer from it. Many patients have become aware of the scientific limitations of guidelines through reports in the media about recent reversals of expert advice on hormone-replacement therapy for postmenopausal women, low-fat diets for obesity, the use of erythropoietin for cancer-associated anemia, and tight regulation of glucose levels in various settings. Because guidelines are derived from clinical studies carried out in selected groups of patients and their statistical conclusions are based on study populations, they may not apply to an individual patient, especially if he or she has coexisting conditions. In many instances, the results of larger and better-designed clinical trials have contradicted what appeared to be firm conclusions from earlier research. Furthermore, there are frequently experts who dissent from the majority opinion on which guidelines are based, and their views are not routinely represented in the guidelines.

What is the remedy ask Hartzband and Groopman writing in the NEJM?
They suggest that shared decision making be central to any changes resulting from current health care reform initiatives. All national guidelines should acknowledge the dissenting opinions of experts. Furthermore, these guidelines should indicate which specific populations were studied and which important coexisting conditions constituted criteria for exclusion from the trials, so that physicians can judge whether and how the guidelines apply to an individual patient. Currently, some guideline committees receive financial support from pharmaceutical and device companies, and there are indications that such support has influenced the recommendations.4,5 In order to assure the public that there is no potential for a conflict of interest that would taint the guidelines, an independent government body should be established to develop guidelines without industry support — analogous to the role of the Food and Drug Administration as an unbiased party for the approval of treatments. Funding could come instead from the federal monies already designated for comparative-effectiveness research.

*Tune in later for Post-cholecystectomy cystic duct stump leak.

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