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

12/12/13 ¡ 1 1 2 2 Disclosures: A View from the US Preventive Services Task Force I have been a member of the USPSTF since 2010. Kirsten B n Bibbins ns-Do -Domi ming ngo, P , PhD, M hD, MD In the past year, I was a paid faculty in a one-time Lee Goldman, MD Endowed Chair in Medicine course on evidence-based medicine and research Professor of Medicine and Epidemiology design for employees of Genentech-Roche in University of California, San Francisco Beijing China. 3 3 4 4 Which of the following statements about the USPSTF Objectives are TRUE? A. The USPSTF is a government agency that makes • Brief introduction to the USPSTF 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 • Framework for USPSTF recommendations these services. C. Because the USPSTF makes recommendations for primary care, the input of sub-specialists is not considered in the process. Recent recommendations and implications • D. The USPSTF uses the policies and procedure of most other national professional organization making healthcare recommendations. E. All of the above • Mammography and other breast cancer-related recommendations F. None of the above 1 ¡

12/12/13 ¡ 5 5 6 6 The U.S. Preventive Services Task Force Answers (USPSTF) A. • Independent panel of non-federal experts (N=16) B. • Supported by the AHRQ C. • Volunteer, not paid D. • Members with expertise in primary care and in evidence-based E. medicine/research F. • Family medicine, Internal Medicine, OB-Gyn, Pediatrics, Geriatrics, Nursing, Behavioral Health, Health Systems • Open nomination process annually 7 7 8 8 Overview Overview, cont’d. The U.S. Preventive Services Task Force… The U.S. Preventive Services Task Force… • Makes recommendations on clinical preventive services to primary • Makes recommendations based on rigorous review of existing peer- care clinicians reviewed evidence • The USPSTF scope for clinical preventive services includes: • Does not conduct the research studies, but reviews and assesses the • screening tests research (supported by the Evidence-based Practice Centers) • counseling • Evaluates benefits and harms of each service based on factors such • preventive medications as age and sex • Services are offered in a primary care setting • Costs are not considered in the balance of benefits and harms. • Recommendations apply to adults and children with no signs or symptoms 2 ¡

12/12/13 ¡ Contrasting approaches to clinical 9 9 10 10 Steps the USPSTF Takes to Solicit Public Input guidelines and Make a Recommendation Topic ¡Nomina+on ¡ Tradi+onal ¡ Explicit ¡ consensus-­‑ ¡ evidence ¡ based ¡or ¡ based ¡ expert ¡ structured ¡ opinion ¡ approach ¡ process ¡ 11 11 12 12 The USPSTF Steps: Brief and Generic The USPSTF Steps: Brief and Generic Direct ¡Evidence-­‑ ¡RCTs ¡ • 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 Indirect ¡chain ¡of ¡evidence ¡ 3 ¡

12/12/13 ¡ 13 13 14 14 Grade Gr Defini De nition Grades of Recommendation The USPSTF recommends the service. There is high certainty that the net A benefit is substantial. The USPSTF recommends the service. There is high certainty that the net B benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial. The USPSTF recommends selectively offering or providing this service to C individual patients based on professional judgment and patient preferences. There is at least moderate certainty that the net benefit is small. The USPSTF recommends against the service. There is moderate or high D certainty that the service has no net benefit or that the harms outweigh the benefits. The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of the service. Evidence is lacking, of I I poor quality, or conflicting, and the balance of benefits and harms cannot be determined. 15 15 16 16 Gr Grade De Defini nition Gr Grade Defini De nition The USPSTF recommends the service. There is high certainty that the net Screening for cervical cancer among women A A benefit is substantial. 21-65 years. The USPSTF recommends the service. There is high certainty that the net DO ¡ B benefit is moderate or there is moderate certainty that the net benefit is B moderate to substantial. The USPSTF recommends selectively offering or providing this service to C C individual patients based on professional judgment and patient preferences. There is at least moderate certainty that the net benefit is small. The USPSTF recommends against the service. There is moderate or high Don’t ¡Do ¡ D D certainty that the service has no net benefit or that the harms outweigh the benefits. The USPSTF concludes that the current evidence is insufficient to assess I I Don’t ¡Know ¡ the balance of benefits and harms of the service. Evidence is lacking, of I I poor quality, or conflicting, and the balance of benefits and harms cannot be determined. 4 ¡

12/12/13 ¡ 17 17 18 18 Grade Gr De Defini nition Grade Gr Defini De nition A A Screening for cervical cancer among women 21-65 years. Screening for cervical cancer among women 21-65 years. Screening for hepatitis C among persons at risk AND one-time screening Screening for hepatitis C among persons at risk B among adults born between 1945 and 1965. B AND one-time screening among adults born between 1945 and 1965. C C D Vitamin supplementation to prevent cancer or D I I cardiovascular disease I I 19 19 20 20 Gr Grade De Defini nition Mammography to screen for breast cancer A Screening for cervical cancer among women 21-65 years. Screening for hepatitis C among persons at risk AND one-time screening B among adults born between 1945 and 1965. C Vitamin E or beta carotene supplementation to D prevent cancer or cardiovascular disease. I I Vitamin supplementation to prevent cancer or cardiovascular disease 5 ¡

12/12/13 ¡ 21 21 22 22 Three primary sources of Evidence: Key questions in analytic framework 1: RCTs of screening in women Age 40-49 addressed in update… • When to start, when to stop, what to use and how often? • Important questions For v irtually all topics (including breast cancer • screening) - no comparative trials of screening program efficacy • Questions must be answered indirectly 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 24 24 Age stratified meta-analysis for Harms of Screening: Radiation mammography trials • 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 6 ¡

12/12/13 ¡ 25 25 26 26 Harms of Screening Harms: Overdiagnosis • Pain • Diagnosis of a cancer that would never have progressed to become clinically detectable in • Common the patient’s lifetime • Few consider it a major deterrent • Anxiety, distress, and other psychological responses • Eight studies of varying methodology reported rates from 1-30% - with most in 1-10% range • No consistent effect of false positives on general anxiety and depression, but… apprehension, and perceived breast cancer risk for some • Increased breast cancer-specific distress, anxiety, 27 27 28 28 Three primary sources of Evidence: Three primary sources of Evidence: 2: Breast 2: Breast Cancer Surveillance Consortium Cancer Surveillance Consortium (7.5 million mammograms, 2 million women, 86,000 breast CA) Pa1ents ¡ Addi1onal ¡ Biopsies ¡ False ¡ Biopsy ¡ Invasive ¡CA ¡ DCIS ¡ screened ¡ images ¡per ¡ per ¡CA ¡ posi1ve ¡ per ¡CA ¡ CA ¡ Age ¡40-­‑49 ¡y ¡ 97.82 ¡ 9.3 ¡ 1.8 ¡ 0.8 ¡ Age ¡40-­‑49 ¡y ¡ 556 ¡ 47 ¡ 5 ¡ Age ¡50-­‑59 ¡y ¡ 86.6 ¡ 10.8 ¡ 3.4 ¡ 1.3 ¡ Age ¡50-­‑59 ¡y ¡ 294 ¡ 22 ¡ 3 ¡ Age ¡60-­‑69 ¡y ¡ 79.0 ¡ 11.6 ¡ 5.0 ¡ 1.5 ¡ Age ¡60-­‑69 ¡y ¡ 200 ¡ 14 ¡ 2 ¡ Age ¡70-­‑79 ¡y ¡ 68.8 ¡ 12.2 ¡ 6.5 ¡ 1.4 ¡ Age ¡70-­‑79 ¡y ¡ 154 ¡ 10 ¡ 2 ¡ Age ¡80-­‑89 ¡y ¡ 59.4 ¡ 10.5 ¡ 7.0 ¡ 1.5 ¡ Age ¡80-­‑89 ¡y ¡ 143 ¡ 8 ¡ 1.5 ¡ Per ¡1000 ¡women ¡screened ¡ Per ¡1000 ¡women ¡screened ¡ 7 ¡