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Practice Guidelines. The Good, The Not-So-Good The Ugly. 1. Where do practice guidelines come from?. Trust us, we’re the experts : Opinion-based/ consensus guidelines Whose opinion? Do they have a conflict of interest? What is their perspective?

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Practice guidelines
Practice Guidelines

The Good,

The Not-So-Good

The Ugly

1


Where do practice guidelines come from
Where do practice guidelines come from?

Trust us, we’re the experts: Opinion-based/ consensus guidelines

Whose opinion? Do they have a conflict of interest? What is their perspective?

Trust us, we have the evidence: “Evidence-based”

How was the evidence used? Patient-oriented? Values?

Evidence-linked:

Here is how we found the evidence, used the evidence

Strength of recommendation noted


Guidelines ultimately a social exercise
Guidelines: Ultimately a social exercise

  • Evidence: It is what it is

  • The human touch:

    • Social judgment layered on top of the evidence

3



How they arrived at these conclusions
How They Arrived at these Conclusions

  • Meta-analysis of 8 randomized controlled trials (RCTs)

    • Invited a total of 348,219 women at age 40 yrs for yearly screening

    • 0-3 studies, individually, showed a decrease in breast cancer mortality

    • Meta-analysis: Combining results from all trials and analyzing the results

    • Results:


Figure. Nelson HD. Screening for breast cancer: An update for the U.S. Preventive Services Task Force. Ann Intern Med 2009; 151:727-737.


Benefits 10 000 women ages 40 49 yrs screened yearly
Benefits for the U.S. Preventive Services Task Force. Ann Intern Med 2009; 151:727-737.10,000 women ages 40-49 yrs screened yearly

USPSTF Recommendation Statement. Ann Intern Med 2009;151(10):716-726


USPSTF Recommendation Grades, 2009 for the U.S. Preventive Services Task Force. Ann Intern Med 2009; 151:727-737.


USPSTF Recommendation Statement: Breast Cancer Screening for the U.S. Preventive Services Task Force. Ann Intern Med 2009; 151:727-737.


Why does the benefit seem to be so small
Why Does The Benefit for the U.S. Preventive Services Task Force. Ann Intern Med 2009; 151:727-737.Seem To Be So Small?


Breast cancer mortality vs all causes of mortality all ages
Breast cancer mortality vs all causes of mortality, all ages for the U.S. Preventive Services Task Force. Ann Intern Med 2009; 151:727-737.

Black WC, et al. All-Cause Mortality in Randomized Trials of Cancer Screening. Journal of the National Cancer Institute, Vol. 94, No. 3, 167-173, February 6, 2002


Causes of death in women, by age for the U.S. Preventive Services Task Force. Ann Intern Med 2009; 151:727-737.

Bunker JP, Houghton J, Baum M. Putting the risk of breast cancer in perspective. BMJ 1998;317:1307-9.


But what about 1 in 8
But What About “1-in-8”? for the U.S. Preventive Services Task Force. Ann Intern Med 2009; 151:727-737.

Ave lifespan = 79 years

Bunker JP, et al. Putting the risk of breast cancer in perspective. BMJ 1998;317:1307-9.


Risks 10 000 women ages 40 49 yrs screened yearly
Risks for the U.S. Preventive Services Task Force. Ann Intern Med 2009; 151:727-737.10,000 women ages 40-49 yrs screened yearly

USPSTF Recommendation Statement. Ann Intern Med 2009;151(10):716-726


Pseudodisease overdiagnosis
Pseudodisease for the U.S. Preventive Services Task Force. Ann Intern Med 2009; 151:727-737. (overdiagnosis)

Cochrane Database Syst. Rev. 2009;CD001877 doi:10.1002/14651858.CD001877.pub3

  • A condition that looks just like the disease, but never would have bothered the patient

    • Disease that would never cause symptoms

    • Asymptomatic disease in people who will die from another cause before disease presents

  • An estimated 10%-30% of breast cancers found and treated would have never affected the patients

    • The question: which ones?


Overdiagnosis bias
Overdiagnosis bias for the U.S. Preventive Services Task Force. Ann Intern Med 2009; 151:727-737.

Gigerenzer G, et al. Helping doctors and patients make sense of health statistics. Psychological Science in the Public Interest 2008;8(2):53-96.


Evaluating screening tests
Evaluating Screening Tests for the U.S. Preventive Services Task Force. Ann Intern Med 2009; 151:727-737.

Fryback DG, Thornbury JR. The efficacy of diagnostic imaging. Med Decis Making 1991; 11:88-94

Evidence

  • Sensitivity &specificity

  • Does it change diagnoses?

  • Does it change treatment?

  • Does it change outcomes?

    Judgment:

    Is it worthwhile (to an individual and/or society)?


Can we trust guidelines from specialty societies

Can We Trust Guidelines from Specialty Societies? for the U.S. Preventive Services Task Force. Ann Intern Med 2009; 151:727-737.

Or

Never ask a barber if you need a haircut

18


“. . . The guild of health care professionals – including their specialty societies – has a primary responsibility to promote its members’ interests. . .

Quanstrum KH, Hayward RA. Lessons from the mammography wars. N Engl J Med 2010; 363:1076-1079

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. . . It is a fool’s dream to expect the guild of any service industry to harness its self-interest and to act according to beneficence alone – to compete on true value when the opportunity to inflate perceived value is readily available.”

Quanstrum KH, Hayward RA. Lessons from the mammography wars. N Engl J Med 2010; 363:1076-1079

20


Screening for breast cancer yearly at age 40
Screening for breast cancer: yearly at age 40 service industry to harness its self-interest and to act according to beneficence alone – to compete on true value when the opportunity to inflate perceived value is readily available.”

  • American College of Radiology

  • Society of Breast Imaging

  • American Society of Breast Disease

  • American Cancer Society

  • ACOG


Evidence based and the evolution of evidence subclinical hypothyroidism
“Evidence-based” and the evolution of evidence: subclinical hypothyroidism

Step 1

Search of 10 databases

Studies summarized

12 experts rated the evidence

Recommendations:

“Recommend against routine screening for subclinical hypothyroidism”

“Recommend against routine treatment of 4.5 – 10.0 mIU/L”

Surks MI, et al. Subclinical thyroid disease. Scientific Review and Guidelines for diagnosis and management. JAMA 2004;291:228-238.


Evidence based and the evolution of evidence subclinical hypothyroidism1
“Evidence-based” and the evolution of evidence: subclinical hypothyroidism

Step 2:

Consensus meeting among members of the American Association of Clinical Endocrinologists, The American Thyroid Association, and The Endocrine Society.

New recommendation statement

Recommendations sent to leadership of the organizations


The evolution of evidence subclinical hypothyroidism
The evolution of evidence: subclinical hypothyroidism subclinical hypothyroidism

The result:

New recommendations from the three societies:

Most patients with TSH levels 4.5 – 10 mIU/L should be treated

Shouldperform routine screening for subclinical hypothyroidism

Why?

“Although good evidence is unavailable [to support our recommendation], there is a sizable amount of fair evidence and an abundance of opinion by experts . . . The [scientific panel recommendations] are contrary to the practice of many. . . experts”

Gharib H, et al. Consensus statement: Subclinical thyroid dysfunction: A joint statement on management from the American Association of Clinical Endocrinologists, The American Thyroid Association, and The Endocrine Society. J Clin Endocrinol Metab 2005;90:581-5.


Bilirubin in term infants sept 2009
Bilirubin in term infants (Sept 2009) subclinical hypothyroidism

USPSTF: Summary of Recommendation

“The U.S. Preventive Services Task Force (USPSTF) concludes that the evidence is insufficient to recommend screening infants for hyperbilirubinemia to prevent chronic bilirubin encephalopathy”

American Academy of Pediatrics Restatement and Clarification

“. . .We recommend universal predischarge bilirubin screening,which helps to assess the risk of subsequent severehyperbilirubinemia. We also recommend a more structured approachto management and follow-up according to the predischarge TSB/TcB,gestational age, and other risk factors for hyperbilirubinemia.These recommendations represent a consensus of expert opinionbased on the available evidence, and they are supported by severalindependent reviewers. Nevertheless, their efficacy in preventingkernicterus and their cost-effectiveness are unknown. “


Evidence linked guidelines
Evidence Linked subclinical hypothyroidismGuidelines

Brief Summary Statement for each recommendation

Detailed Discussion of the evidence

Long Reference section pointing to original research

Methods section showing how evidence was obtained and evaluated


Detailed overview of the evidence subclinical hypothyroidism

Brief statement

Evidence table

Evidence Linked Guidelines


National guideline clearinghouse
National Guideline Clearinghouse subclinical hypothyroidism

www.ngc.gov

Vetted guidelines from various groups

Standard organization so that information can be compared across various guidelines

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