12/12/13 1 1 2 2 Disclosures: A View from the US Preventive - - PDF document

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A View from the US Preventive Services Task Force

Kirsten B n Bibbins ns-Do

• Domi

ming ngo, P , PhD, M hD, MD Lee Goldman, MD Endowed Chair in Medicine Professor of Medicine and Epidemiology University of California, San Francisco

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Disclosures:

I have been a member of the USPSTF since 2010. In the past year, I was a paid faculty in a one-time course on evidence-based medicine and research design for employees of Genentech-Roche in Beijing China.

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Objectives

• Brief introduction to the USPSTF
• Framework for USPSTF recommendations
• Recent recommendations and implications
• Mammography and other breast cancer-related

recommendations

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Which of the following statements about the USPSTF are TRUE?

• A. The USPSTF is a government agency that makes

recommendations to primary care providers on the use of preventive services.

• B. The USPSTF evaluates the cost-effectiveness of preventive

services that may help health systems prioritize provision of these services.

• C. Because the USPSTF makes recommendations for primary care,

the input of sub-specialists is not considered in the process.

• D. The USPSTF uses the policies and procedure of most other

national professional organization making healthcare recommendations.

• E. All of the above

F. None of the above

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Answers

A. B. C. D. E. F.

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The U.S. Preventive Services Task Force (USPSTF)

• Independent panel of non-federal experts (N=16)
• Supported by the AHRQ
• Volunteer, not paid
• Members with expertise in primary care and in evidence-based

medicine/research

• Family medicine, Internal Medicine, OB-Gyn, Pediatrics, Geriatrics,

Nursing, Behavioral Health, Health Systems

• Open nomination process annually

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Overview

The U.S. Preventive Services Task Force…

• Makes recommendations on clinical preventive services to primary

care clinicians

• The USPSTF scope for clinical preventive services includes:
• screening tests
• counseling
• preventive medications
• Services are offered in a primary care setting
• Recommendations apply to adults and children with no signs or

symptoms

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Overview, cont’d.

The U.S. Preventive Services Task Force…

• Makes recommendations based on rigorous review of existing peer-

reviewed evidence

• Does not conduct the research studies, but reviews and assesses the

research (supported by the Evidence-based Practice Centers)

• Evaluates benefits and harms of each service based on factors such

as age and sex

• Costs are not considered in the balance of benefits and harms.

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Contrasting approaches to clinical guidelines

Tradi+onal ¡ consensus-­‑ ¡ based ¡or ¡ expert ¡

• pinion ¡

process ¡ Explicit ¡ evidence ¡ based ¡ structured ¡ approach ¡

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Steps the USPSTF Takes to Solicit Public Input and Make a Recommendation

Topic ¡Nomina+on ¡

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The USPSTF Steps: Brief and Generic

Direct ¡Evidence-­‑ ¡RCTs ¡ Indirect ¡chain ¡of ¡evidence ¡

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The USPSTF Steps: Brief and Generic

• For each key question:
• Define what evidence is acceptable a priori
• Systematically search for and retrieve evidence
• Evaluate the quality of each individual study
• Evaluate the quality of the evidence across each key question
• Across the entire analytic framework (all key questions):
• Judge the cer

ertainty of the estimate of benefits and harms

• Judge the mag

magni nitu tude de of both benefits and harms - the n net b ben enef efit

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Grades of Recommendation

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Gr Grade De Defini nition A

The USPSTF recommends the service. There is high certainty that the net benefit is substantial.

B

The USPSTF recommends the service. There is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial.

C

The USPSTF recommends selectively offering or providing this service to individual patients based on professional judgment and patient preferences. There is at least moderate certainty that the net benefit is small.

D

The USPSTF recommends against the service. There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits.

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The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of the service. Evidence is lacking, of poor quality, or conflicting, and the balance of benefits and harms cannot be determined.

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Gr Grade De Defini nition A

The USPSTF recommends the service. There is high certainty that the net benefit is substantial.

B

The USPSTF recommends the service. There is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial.

C

The USPSTF recommends selectively offering or providing this service to individual patients based on professional judgment and patient preferences. There is at least moderate certainty that the net benefit is small.

D

The USPSTF recommends against the service. There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits.

I I

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of the service. Evidence is lacking, of poor quality, or conflicting, and the balance of benefits and harms cannot be determined.

DO ¡

Don’t ¡Do ¡ Don’t ¡Know ¡

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Gr Grade De Defini nition A Screening for cervical cancer among women 21-65 years. B C D I I

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Gr Grade De Defini nition A

Screening for cervical cancer among women 21-65 years.

B Screening for hepatitis C among persons at risk AND one-time screening among adults born between 1945 and 1965. C D I I

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Gr Grade De Defini nition A

Screening for cervical cancer among women 21-65 years.

B

Screening for hepatitis C among persons at risk AND one-time screening among adults born between 1945 and 1965.

C D I I Vitamin supplementation to prevent cancer or cardiovascular disease

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Gr Grade De Defini nition A

Screening for cervical cancer among women 21-65 years.

B

Screening for hepatitis C among persons at risk AND one-time screening among adults born between 1945 and 1965.

C D Vitamin E or beta carotene supplementation to prevent cancer or cardiovascular disease. I I

Vitamin supplementation to prevent cancer or cardiovascular disease

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Mammography to screen for breast cancer

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Key questions in analytic framework addressed in update…

• When to start, when to stop, what to use and how often?
• Important questions
• For virtually all topics (including breast cancer

screening) - no comparative trials of screening program efficacy

• Questions must be answered indirectly

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Three primary sources of Evidence: 1: RCTs of screening in women Age 40-49

Pooled relative risk for breast cancer mortality from mammography screening trials compared with control for women aged 39 to 49 years.CNBSS-1 = Canadian National Breast Screening Study-1; CrI = credible interval; HIP = Health Insurance Plan of Greater New York.* Swedish Two-County trial. 23 23

Age stratified meta-analysis for mammography trials

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Harms of Screening: Radiation

• Radiation is not harmless
• Currently there seems to be an increased focus on

the cumulative effects of radiation related to diagnostic testing

• Opinion: harms of radiation did not weigh heavily on

the decisions made by the Task Force

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Harms of Screening

• Pain
• Common
• Few consider it a major deterrent
• Anxiety, distress, and other psychological responses
• No consistent effect of false positives on general anxiety

and depression, but…

• Increased breast cancer-specific distress, anxiety,

apprehension, and perceived breast cancer risk for some

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Harms: Overdiagnosis

• Diagnosis of a cancer that would never have

progressed to become clinically detectable in the patient’s lifetime

• Eight studies of varying methodology reported

rates from 1-30% - with most in 1-10% range

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Three primary sources of Evidence: 2: Breast Cancer Surveillance Consortium

(7.5 million mammograms, 2 million women, 86,000 breast CA)

False ¡ posi1ve ¡ Biopsy ¡ Invasive ¡CA ¡ DCIS ¡ Age ¡40-­‑49 ¡y ¡ 97.82 ¡ 9.3 ¡ 1.8 ¡ 0.8 ¡ Age ¡50-­‑59 ¡y ¡ 86.6 ¡ 10.8 ¡ 3.4 ¡ 1.3 ¡ Age ¡60-­‑69 ¡y ¡ 79.0 ¡ 11.6 ¡ 5.0 ¡ 1.5 ¡ Age ¡70-­‑79 ¡y ¡ 68.8 ¡ 12.2 ¡ 6.5 ¡ 1.4 ¡ Age ¡80-­‑89 ¡y ¡ 59.4 ¡ 10.5 ¡ 7.0 ¡ 1.5 ¡

Per ¡1000 ¡women ¡screened ¡

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Three primary sources of Evidence: 2: Breast

Cancer Surveillance Consortium

Pa1ents ¡ screened ¡ per ¡CA ¡ Addi1onal ¡ images ¡per ¡ CA ¡ Biopsies ¡ per ¡CA ¡ Age ¡40-­‑49 ¡y ¡ 556 ¡ 47 ¡ 5 ¡ Age ¡50-­‑59 ¡y ¡ 294 ¡ 22 ¡ 3 ¡ Age ¡60-­‑69 ¡y ¡ 200 ¡ 14 ¡ 2 ¡ Age ¡70-­‑79 ¡y ¡ 154 ¡ 10 ¡ 2 ¡ Age ¡80-­‑89 ¡y ¡ 143 ¡ 8 ¡ 1.5 ¡

Per ¡1000 ¡women ¡screened ¡

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Three primary sources of Evidence: 3: CisNET Computer simulations of screening

strategies

• Lifetime risk of dying from breast cancer is 3%
• For every 1000 women alive at age 40 who are followed to death from

any cause, 30 will die from breast cancer without screening

• Biennial mammography in women 50-74
• Reduce life-time risk of dying of breast cancer from 3.0% to 2.3%
• For 1000 women screened, incremental life-years gained ~110

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Extending Biennial Screening from Age 50-69 to Age 40 – 69 for 1000 women

• 5000 additional mammograms
• 500 false positives
• 33 biopsies
• Reduce life-time risk of dying of breast cancer from 2.3% to 2.2%
• ~ 20 life-years gained

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What is your grade for mammography for women age 40-49?

Assume ¡the ¡certainty ¡is ¡at ¡least ¡moderate ¡

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Mammography for women age 40-49

• A. A
• B. B
• C. C
• D. D
• E. I

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Mammography for women age 40-49

A. B. C. D. E.

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IF THE NET BENEFIT OF MAMMOGRAPHY FOR WOMEN AGE 40-49 IS SMALL, WHAT SHOULD WE TRY TO COMMUNICATE TO WOMEN AND THEIR PROVIDERS?

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Intent: ¡move ¡from ¡recommend ¡to ¡discuss ¡– ¡ a ¡vote ¡in ¡favor ¡of ¡shared ¡decision ¡making ¡

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Communication challenges

• With each subsequent recommendation, reports continue that ….. “this

is the same group that recommended against mammography for women in their 40’s, stating that the harms outweigh the benefits.”

• Not true
• The Task Force did not communicate effectively to patients and

providers.

• Improved effort at stakeholder and public engagement throughout the

process

• Improved communication and dissemination of recommendations.

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Communicating what a “C” recommendation means

• New language
• The USPSTF recommends selectively offering or providing this

service to individual patients based on professional judgment and patient preferences. There is at least moderate certainty that the net benefit is small.

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Increasing ¡use ¡of ¡medical ¡service/ resources ¡ …and ¡increasing ¡harm ¡ Propor+on ¡of ¡deaths ¡from ¡disease ¡averted ¡

What ¡is ¡the ¡role ¡of ¡shared ¡decision ¡making? ¡

At ¡what ¡point ¡should ¡our ¡ dialogue ¡shiU ¡from ¡ “recommending” ¡to ¡ “discussing?” ¡

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What to do when benefit is small and there are harms?

• Selectively offer
• Recent modeling suggests women in their 40’s with a family history,
• r dense breasts, have same risk as a woman in her 50’s
• Offer universally and counsel +/- recommendation
• Simply recommend; counsel only if questioned

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“What do I recommend?” – M. Lefevre (USPSTF vice-

chair)

• Discuss at age 40
• Encourage at age 50 (or age 40 with family history)
• Strongly encourage at age 60
• Individualize, discuss uncertainties but do not discourage healthy

women age 75

• By age 85, we almost inevitably have declining returns and few

are likely to benefit

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Recent and upcoming recommendations

• Breast C

Canc ncer S Screeni ning ng

• 2009 recommendation is scheduled for update

next year

• Work plan is now available for public comment

ht http:/ ://www.u .usprevent ntiveservicestaskf kforce.o .org/

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Screening for BRCA

• The U.S. Preventive Services Task Force (USPSTF) recommends that primary

care providers screen women who have family members with breast or ovarian cancer with one of several screening tools (see the Clinical Considerations) designed to identify a family history that may be associated with an increased risk for potentially harmful mutations in breast cancer susceptibility genes (BRCA1 or BRCA2). Women with a positive screen should receive genetic counseling and, if indicated after counseling, BRCA testing.

• Thi

his i is a a B r recomme mmend ndation.

• The USPSTF recommends against routine genetic counseling or routine BRCA

testing for women whose family history is not associated with an increased risk for potentially harmful mutations in the BRCA1 or BRCA2 genes.

• Thi

his i is a a D r D recomme mmend ndation.

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Medications to prevent breast cancer

• The

he US USPSTF r recomme mmend nds t tha hat c cli lini nicians ns e eng ngage i in s n sha hared, , inf nforme med d decision-ma n-maki king ng w with w h wome men w n who ho a are a at i inc ncreased r risk f k for breast c canc ncer a about me medications ns t to r reduce t the heir r

• risk. F

. For w wome men n who ho a are a at i inc ncreased r risk f k for b breast c canc ncer a and nd a at lo low r risk f k for adverse me medication e n effects, c , cli lini nicians ns s sho hould ld o

• ffer t

to p prescribe r risk- reducing ng me medications ns, s , such a h as tamo moxifen o

• r ralo

loxifene ne. Grade: B Recommendation.

• The

he US USPSTF r recomme mmend nds a agains nst t the he r routine ne u use o

• f me

medications ns, , such a h as tamo moxifen o

• r ralo

loxifene ne, f , for r risk r k reduction o n of p prima mary b y breast canc ncer i in w n wome men w n who ho a are no not a at i inc ncreased r risk f k for b breast c canc ncer. Gr Grade: D Recommendation.

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Conclusions

• The USPSTF is an independent entity that uses a structured

systematic review of the scientific evidence, combined with expert judgment, to make recommendations about preventive services

• ffered in primary care.
• The USPSTF offers a structure and process for arriving at evidence-

based recommendations that is open and transparent and thereby contributes to the discussion of healthcare preventive practices.

• Please read our reports! Our rationale and other clinical

considerations are outlined there. Use them as a starting point to engage in the ongoing discussion of how to achieve effective evidence-based healthcare.