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    Wednesday, May 6, 2009


    PART II of III

    In summary this previous outcome study on Diabetes showed that:

    1) patients with type 2 diabetes and no symptoms of coronary artery disease derive little benefit from screening for inducible myocardial ischemia,

    2) based on a study of 1100 patients aged 50 to 75 with type 2 diabetes and without CAD symptoms.

    3) During 5 years' follow-up, the incidence of the primary endpoint — a composite of nonfatal myocardial infarction and cardiac death — did not differ between the groups (about 3% in each).

    4) Among screened patients, moderate or large perfusion defects were associated with greater risk for coronary events, but, the authors point out, only 12% of patients with such defects had an event (positive predictive value, 12%).

    5) The authors thus conclude that routine screening for CAD "cannot be advocated" for asymptomatic patients with type 2 diabetes.

    Before this study was complete arguments would rage about which technologies was cheaper (or in insurance company lingo) more cost effective to rule out coronary disease in diabetics. Experts would debate the armamentarium of technologies and after a prolonged discussion would come up with a workup process which would be adopted as P4P guidelines for the treatment of asymptomatic diabetics. With this outcome study, however, we see that routine screening for CAD "cannot be advocated" for asymptomatic patients with type 2 diabetes in the first place. Only an outcome study; not a process study can determine this conclusion.
    Dr. J. Groopman whom we discussed in our books on Medical Expert Testimony –see references below-in the chapters on how doctors make mistakes, has joined a colleague Harvard professor Dr. P. Hartzband to proclaim [4/8/09 WSJ] that “buoyed by some successes on patient safety, public health care measures that governmental and private insurance regulators now have overreached.”

    Soon they point out all Medicare payments will be tied to "quality metrics." Specifically in "pay-for-performance [P4P] programs, "private insurers define quality as clinical practice that conforms to consensus guidelines written by experts. These guidelines present specific "quality metrics" for physicians to meet in order to get fully paid.

    In too many cases, they complain, the quality measures have been hastily adopted, only to be proven wrong and even potentially dangerous to patients.

    In fact in Massachusetts, known snidely by their practicing doctors as the “People’s Republic of Massachusetts” physicians who “fail to comply with quality guidelines from certain state-based insurers are publicly discredited and their patients required paying up to three times as much out of pocket to see them report the authors.
    They have turned clinical guidelines for complex diseases into ironclad rules, to deleterious effect,” say Groopman and Hartzband.

    As examples of poor and misguided “quality” guidelines that turned out to be dangerous to patients, Groopman and Hartzband point to:

    • The Joint Commission on Accreditation of Healthcare Organizations, which generates report cards on hospitals, and governmental and private insurers that pay for care, adopted as a suggested quality metric a tight control of blood sugar. However, this approach was turned on its head when the New England Journal of Medicine published a randomized study, of more than 6,000 critically ill patients in the ICU. More patients died in the tightly regulated group than those cared for with a more flexible protocol.

    • Indeed, in one study of more than 10,000 ambulatory diabetics with cardiovascular diseases conducted by a group of researchers (the "ACCORD" study) so many diabetics died in the group where sugar was tightly regulated that the researchers discontinued the trial 17 months before its scheduled end.

    • Another clinical trial contradicted another expert consensus guideline that patients with kidney failure on dialysis should be given statin drugs to prevent heart attack and stroke.

    • Doubts about the relevance of quality metrics to clinical reality are even emerging from the federal pilot programs launched in 2003. An analysis of Medicare pay-for-performance for hip and knee replacement by orthopedic surgeons at 260 hospitals in 38 states showed that conforming to or deviating from expert quality metrics had no relationship to the actual complications or clinical outcomes of the patients.

    • Similarly, a study led by UCLA researchers of over 5,000 patients at 91 hospitals published in 2007 in the Journal of the American Medical Association found that the application of most federal quality process measures did not change mortality from heart failure.
    These so called quality metrics which are the foundation of P4P guidelines, according to Groopman and Hartzband “are no substitute for a good doctor who exercises sound clinical judgment by consulting expert guidelines and assessing ongoing research, but then decides what quality care is for the individual patient. Moreover, “what is best sometimes deviates from the norms.”

    Book I - “Medical Malpractice Expert Witnessing: Introductory Guide for Physicians and Medical Professionals” (Hardcover) by Perry Hookman, MD (Author) : 592 pages.27 chapters. Publisher: CRC; Potomac Press; Language: English ISBN-10: 1420058959 ISBN-13: 978-1420058956; Dimensions: 10.1 x 7.1 x 1.4 inches; Shipping Weight: 2.6 pounds; price $239.95.
    For author information visit; for book purchase visit

    Book II –“Medical Expert Testimony: Advanced Syllabus for Physicians and Medical Professionals”
    (Hardcover) by Perry Hookman MD (Author) 32 chapters; 936 pages. Proj.Pub date Spring 2009. Publisher: Potomac Press-CRC; ; Language: English ISBN: 978-0-9817570-0-1; ISBN:10:0-9817570-0-6 - Barcode (9780981757001.eps) Dimensions: 10.1 x 7.1 x 2.1 inches; Shipping Weight: 3.0 pounds; Price $289.95; includes CD-ROM. For author information visit; for book purchase visit

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