Review of Endocrinology Guidelines
Decision-makers frequently rely on the body of pertinent research in making decisions regarding clinical management decisions. The goal is to critically appraise and synthesize the evidence before making recommendations, developing protocols and making other decisions. Serious attention is paid to the validity of the primary studies to determine reliability before accepting them into the review. Brito and colleagues have described the rigor of systematic reviews (SRs) cited from 2006 until January 2012 in support of the clinical practice guidelines put forth by the Endocrine Society using the Assessment of Multiple Systematic Reviews (AMSTAR) tool .
The authors included 69 of 2817 studies. These 69 SRs had a mean AMSTAR score of 6.4 (standard deviation, 2.5) of a maximum score of 11, with scores improving over time. Thirty five percent of the included SRs were of low-quality (methodological AMSTAR score 1 or 2 of 5, and were cited in 24 different recommendations). These low quality SRs were the main evidentiary support for five recommendations, of which only one acknowledged the quality of SRs.
The authors conclude that few recommendations in field of endocrinology are supported by reliable SRs and that the quality of the endocrinology SRs is suboptimal and is currently not being addressed by guideline developers. SRs should reliably represent the body of relevant evidence. The authors urge authors and journal editors to pay attention to bias and adequate reporting.
Delfini note: Once again we see a review of guideline work which suggests using caution in accepting clinical recommendations without critical appraisal of the evidence and knowing the strength of the evidence supporting clinical recommendations.
1. Brito JP, Tsapas A, Griebeler ML, Wang Z, Prutsky GJ, Domecq JP, Murad MH, Montori VM. Systematic reviews supporting practice guideline recommendations lack protection against bias. J Clin Epidemiol. 2013 Jun;66(6):633-8. doi: 10.1016/j.jclinepi.2013.01.008. Epub 2013 Mar 16. PubMed PMID: 23510557.
Proton Beam Therapy For Prostate Cancer
As of this writing, there is insufficient evidence to conclude that proton beam is more effective in treating prostate cancer than conventional radiation therapy; and there is no evidence of significant differences between proton therapy and radiation therapy in total serious adverse events. Readers may be interested in a recent article where the investigators point out that patients diagnosed with prostate cancer and living in areas where proton beam therapy is readily available are more likely to be treated with this new technology than with conventional radiation therapy. The cost of treating prostate cancer with proton beam therapy can exceed $50,000 per patient which is twice the cost of radiation therapy. Increasingly, we are seeing new technologies with staggering costs. In prostate cancer, for example, as we write this, proton centers are being built all over the country at a cost of up to $200 million.
Aaronson DS, Odisho AY, Hills N, Cress R, Carroll PR, Dudley RA, Cooperberg MR. Proton beam therapy and treatment for localized prostate cancer: if you build it, they will come. Arch Intern Med. 2012 Feb 13;172(3):280-3. PubMed PMID:22332166.
Critical Appraisal Matters
Mike and I make it a practice to study the evidence on the evidence. Doing effective critical appraisal to evaluate the validity and clinical usefulness of studies makes a difference. This page on our website may be our most important one and we have now added a 1-page fact sheet for downloading: http://www.delfini.org/delfiniFactsCriticalAppraisal.htm
Caution About Screening Tests
Dr. John Henning Schumann has written an informative article about screening tests: On the Sordid Sale of Screening Tests, by John Henning Schumann, MD, The Atlantic, October 2012.
A Performance Measure for Overuse? The Loosening Of Tight Control In Diabetes
Performance measures for tighter glycemic control appeared following the DCCT trial (Type 1 diabetes) in 1993 and the UKPDS trial (type 2 diabetes) in 1998., About 7 years ago groups recommended that glycohemoglobin concentrations be less than 7%, even though clear evidence of improved net outcomes was lacking.
Now in an editorial in the online version of Archives of Internal Medicine, Pogach and Aron have nicely summarized details of this journey into overuse of hypoglycemic agents resulting in the problem of harms probably outweighing benefits—at least for some diabetics—in an editorial entitled, The Other Side of Quality Improvement in Diabetes for Seniors: A Proposal for an Overtreatment Glycemic Measure.
The authors review the ACCORD, ADVANCE and VADT trials and remind readers that tight glycemic control did not yield cardiovascular benefits in these trials and that severe hypoglycemia occurred in the intensive treatment groups of all three trials. Of concern was the finding that ACCORD was terminated early because of increased mortality in the intensive glycemic treatment group. These trials appear to have increased concern about the risks of severe hypoglycemia in elderly patients and patients with existing cardiovascular disease, and the National Committee for Quality Assurance Healthcare Effectiveness Data and Information Set (HEDIS) modified its glycohemoglobin goal to less than 7% for persons younger than 65 years without cardiovascular disease or end-stage complications and diabetes and established a new, more relaxed goal of less than 8% for persons 65 to 74 years of age.
Kirsh and Aron took this a step further in 2011 and proposed a glycohemoglobin concentration of less than 7.0% as a threshold measure of potential overtreatment of hyperglycemia in persons older than 65 years who are at high risk for hypoglycemia. They point out that the risk for hypoglycemia could be assessed by utilizing data from the electronic medical record regarding prescriptions for insulin and/or sulfonylurea medications and retrieving information on comorbidities such as chronic kidney disease, cognitive impairment or dementia, neurologic conditions that may interfere with a successful response to a hypoglycemic event.
This commentary is worth reading and thinking about. We agree with them that the time has come to take more actions to prevent the risk of possible overtreatment in diabetes.
 The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial Research Group. N Engl J Med. 1993 Sep 30;329(14):977-86. PubMed PMID: 8366922.
 Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):854-65. Erratum in: Lancet 1998 Nov 7;352(9139):1558. PubMed PMID: 9742977.
 Pogach L, Aron DC. Sudden acceleration of diabetes quality measures. JAMA. 2011 Feb 16;305(7):709-10. PubMed PMID: 21325188.
 Published Online: September 10, 2012. doi:10.1001/archinternmed.2012.4392.
 Kirsh SR, Aron DC. Choosing targets for glycaemia, blood pressure and low-density lipoprotein cholesterol in elderly individuals with diabetes mellitus. Drugs Aging. 2011 Dec 1;28(12):945-60. doi: 10.2165/11594750-000000000-00000. PubMed PMID: 22117094.
Best Care at Lower Cost: The Path to Continuously Learning Health Care in America
“If home building were like health care, carpenters, electricians, and plumbers each would work with different blueprints, with very little coordination.”
“If airline travel were like health care, each pilot would be free to design his or her own preflight safety check, or not to perform one at all.”
The Institute of Medicine (IOM) has just released this latest “state of our health care” report which is well worth reading.  We have a long ways to go before we have a health system. The report, released September 6, 2012, concludes that our dysfunctional health care system wastes about $760 billion each year. Much of the waste is due to inefficiencies and administrative duplications, but $210 billion of the waste is due to unnecessary services (e.g., overuse, unnecessary choice of higher cost services) and $55 billion is wasted on missed primary, secondary and tertiary prevention opportunities.
Here are just a few of the interesting points and recommendations the 18 authors make:
- The volume of the biomedical and clinical knowledge base has rapidly expanded, with research publications having risen from more than 200,000 a year in 1970 to more than 750,000 in 2010;
- We can achieve striking improvements in safety, quality, reliability, and value through the use of systematic evidence-based process improvement methods;
- We need digital platforms supporting real-time access to knowledge;
- We need to engage empowered patients;
- We need full transparency in all we do;
- We need improved decision support; improved patient-centered care through tools that deliver reliable, current clinical knowledge to the point of care; and, organizations’ support for, and adoption of, incentives that encourage the use of these tools.
The pre-publication issue of this IOM report is currently available free of charge at this URL.
 Smith M, Cassell G, Ferguson B, Jones C, Redberg R; Institute of Medicine of the National Academies. Best care at lower cost: the path to continuously learning health care in America. http://iom.edu/Activities/Quality/LearningHealthCare/2012- SEP-06.aspx.
Why People Tend to Overuse Healthcare Interventions
This nice piece in Time Magazine by Maia Szalavitz provides some clues about our major problem of overuse. Ms. Szalavitz documents the convincing power of anecdotes compared to statistics which are poorly understood by most people. She provides a really nice example of decision support from the Harding Center for Risk Literacy for prostate cancer screening that illustrates graphically how prostate cancer screening is likely to create more harms than benefits. For more information go to—
Critical Appraisal Matters
Most of us know that there is much variation in healthcare that is not explained by patient preference, differences in disease incidence or resource availability. We think that many of the healthcare quality problems with overuse, underuse, misuse, waste, patient harms and more stems from a broad lack of understanding by healthcare decision-makers about what constitutes solid clinical research.
We think it’s worth visiting (or revisiting) our webpage on “Why Critical Appraisal Matters.”
Dr. John Ioannidis on Clinical Trials Issues, Cost and Inappropriate Care
Since 1949, the NIH has provided a biweekly newsletter for employees of the National Institute of Health. Mostly the NIH Record announces talks to be given on-campus, but also summarizes some of the talks. In a recent issue the Record summarized a recent talk on bias in healthcare trials, delivered by Dr.John Ioannidis, director of the Stanford Prevention Research Center. Some of his key points are quite thought-provoking and relate to our our huge problem of costly and inappropriate care. Here is some food for thought from Dr Ioannidis:
- Most statistically significant findings are not real at all—they’re just false positives
- Many of these false positives are revealed when larger-scale studies attempt to replicate the findings of smaller studies
- One of every four such trials is refuted when a larger trial is conducted
- Journal editorial policies are responsible for much of this trend— editors want to see research that is novel and will have a large impact on the field. This generally means that editors are looking for papers that report very large, statistically significant effects.
- An important safeguard is “repeatability” of positive findings
- Individuals with a track record for doing high quality research should be recognized and given priority in publishing.
To read the entire entry go to: