Clinical Practice Guidelines on Trial

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David Cundiff

On March 23, the Institute of Medicine issued a report entitled, “Standards for Developing Trustworthy Clinical Practice Guidelines (CPGs).”  The report noted that the National Guideline Clearinghouse accepted722 new guidelines to its database in 2008, bringing the total to nearly 2,700. Almost 1,000 CPGs have been updated because they didn’t quite get it right the first time. A staggering 1,978 CPGs were withdrawn from the database, presumably because they were just too wrong to be updated.

For example, the U.S. Agency for Health care Research and Quality (AHRQ) withdrew 12 guidelines, including ones for treatment of acute low back pain, cancer pain management, cardiac rehabilitation and stroke rehabilitation. If your doctor followed these government-endorsed guidelines in the 1990s, you might well have received sub-optimal care. Alternatively, if your doctors ignored those now retracted  guidelines, you might have received superior treatment and had better health outcomes.

With no hint at the irony at the requirement that medical professionals either slavishly adhere to often-flawed CPGs or risk malpractice suits, the Institute of Medicine’s elite 17-member “Committee on Standards for Developing Trustworthy Clinical Practice Guidelines” (Committee) worked more than two years with six support staff, and reported that. . . some CPGs are not trustworthy!

In turgid bureaucratic language, the Committee declared that “Dubious trust in guidelines is the result of many factors, including failure to represent a variety of disciplines in guideline development groups, lack of transparency in how recommendations are derived and rated, and omission of a thorough external review process.” The Committee issued six criteria for considering CPGs “trustworthy,” and proposed eight standards to identify trustworthy CPGs.

Pointedly, it did not claim that adopting their eight standards would yield CPGs with more patient benefit than we have now. That would require that the U.S. Department of Health and Human Services(HHS) create an actual mechanism to identify trustworthy guidelines. HHS currently does not have such a mechanism.

The Committee recommends that a future expert committee appointed by HHS develop and validate the as yet non-existent trustworthiness guidelines for vetting CPGs. Then this future committee would issue an “easy guide to identify guidelines that are trustworthy.” The development of this “easy guide” will require government funding “to pilot-test the standards, to assess their reliability and validity, and to evaluate the effects of the standards on clinical practice guideline development and healthcare quality and outcomes.” This will presumably require mega-bucks, but without a guarantee of a valid and easily usable end result.

More medical experts from HHS and academia must first evaluate the proposed new standards for vetting CPGs. Once the new standards pass muster, unbiased scientists can analyze existing CPGs, according to the new improved eight (or whatever number) validated standards. Next, the National Guidelines Clearinghouse would cease publishing guidelines that do not measure up to HHS’ trustworthiness criteria. By applying this future “easy trustworthiness guide” to all CPGs, physicians could be coerced into complying with the guidelines through electronic medical records and other means.

The default alternative to this tyranny of top-down governmental medical practice control is for any physician to prescribing any test or treatment, at whatever cost, according to his or her beliefs, possibly influenced by hidden financial conflicts (In other words, the status quo).

A better alternative approach would be to decentralize health care management by vesting the determination of CPGs within individual Accountable Care Organizations (ACOs). Physicians and their consultants in each ACO could define the CPGs for their patients, with input from the medical literature, published guidelines, medical specialists, alternative healers, and patients. Private ACOs could compete with each other to provide the most appropriate health services and best health outcomes. Patients and health care workers could join the ACOs with the CPGs that suited their preferences.

Using evidence-based analysis methods, researchers could study the variation between ACOs with regard to CPCs, medical interventions delivered, and health outcomes. With this information, they could determine which tests and treatments are associated with good clinical outcome and which waste money and harm patients. The resulting health care free market environment would assure that worthless tests and treatments would be discarded over time, with the savings going to valuable medical interventions and lower insurance premiums.

With HHS out of the way, the CPGs of the ACOs with the best health outcomes would be widely adopted.

David Cundiff MD is writing a book, The Health Economy, that details a complete health care reform plan, including the decentralization of health care regulation to ACOs. A paperback version of his earlier book, Whistleblower Doctor—The Politics and Economics of Pain and Dying, will become available Friday.

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