Annette Bar-Cohen, MA, MPH Executive Director Center for Advocacy Training

1. AHRQ Annual Meeting Helping Patients, Policy Makers, and Providers Make Health Decisions:Systematic Reviews in Action Annette Bar-Cohen, MA, MPH Executive Director Center for Advocacy Training National Breast Cancer Coalition

2. National Breast Cancer Coalition • A coalition of hundreds of organizations and thousands of individuals since 1991 • Mission: to end breast cancer • Goals: Research, Access and Influence • Grassroots advocacy, evidence-based • Many accomplishments over the years • But….not enough…so we launched… Breast Cancer Deadline 2020®

3. Breast Cancer Deadline 2020® • Mission: end breast cancer by January 1, 2020 • Strategic plan • Reinvigorate a sense of urgency • New way to collaborate, out of the box thinking • Focus on: Prevention of metastasis, primary prevention of breast cancer and prophylactic vaccine • A key ingredient – Educated Advocates

4. Educated Consumers at all meaningful breast cancer decision-making tables What Does That Really Mean? • Find the tables and secure the seats • Define “educated consumers” and find some! • Set criteria for “meaningful” decisions

5. Educating Breast Cancer Consumers: Project LEAD® • Creation of Project LEAD course in 1995 • Curriculum created by advocates, educators and scientists • Foundational, basic concepts, language of science • Built on adult learning principles • Outstanding teachers • Highly committed students

6. Center for NBCC Advocacy Training • Multiple courses, levels, areas of focus, locations • Research Advocacy - Project LEAD • Project Lead Institute, Workshop, Clinical Trials • Quality Care Project LEAD • Mentoring • Continuing Education • LEADgradsOnline, • LEADcasts, • Advanced Topics

7. Teaching Science to Adults:Using Adult Learning Principles

8. Now... Seats at Many Tables… The Cochrane Collaboration

9. Implications of being Evidence –Based Be OK with taking unpopular positions: • Breast Self Exam • Mammography guidelines • Bone marrow transplant therapy • Hormone Replacement Therapy • Technology – e.g.Digital and 3DMammography, MRI, etc • Overuse, underuse, misuse of interventions • Guaranteed access to quality care for all

10. Evidence and Systematic Reviews: Basis for Positions, Education, Policy Priorities • Position Papers on website • Knowbreastcancer.org • LEADcasts, Continuing education • CUE online course: “Understanding Evidence-based Healthcare: A Foundation for Action” • Project LEAD courses, conference • Policy, legislative priorities • International courses, forums

11. NBCC Mammography Screening Position ConclusionEvidence from studies of varied quality indicate that, overall, mammography screening has a modest effect on breast cancer mortality. When analyzed in absolute terms, the death rate is reduced by just 0.05%. Like with all medical interventions, there are harms associated with screening mammography such as misdiagnosis and overtreatment. Two comprehensive reviews of the evidence conclude that the overall impact in mortality is small and biases in the trials could either "erase or create it." Women should discuss with their doctors their own risk profile, the potential benefits, harms, and complexities of screening mammography, and make informed decisions about screening. Mammography may provide benefits for some women, but it may also harm others. From NBCC Position Paper: “Mammography for Breast Cancer Screening: Harm/Benefit Analysis”Updated July 2011

12. Use of Meta Analyses and Systematic Reviews as basis for NBCC Positions Analyses of the Mammography Screening Studies The studies listed above have been subject to meta-analyses and systematic reviews by the research community. NBCC believes that the most thorough evaluations to date have been conducted by researchers affiliated with the Cochrane Collaboration4-5, by researchers for the U.S. Preventive Services Task Force (USPSTF) in 20092 and 20026, and by Dr. Armstrong, et al. in 2007 for the American College of Physicians.7 These scientists reviewed and evaluated the evidence on benefits and harms of mammography screening and assessed the quality of the trials.

13. Breast Self-Exam: Position Statement Updated July 2011 Research on BSE [Excerpt] A systematic review that analyzed the Russian and the Chinese trials together – greatly expanding the statistical power – found no evidence for beneficial effects of BSE on breast cancer. The review did, however, confirm that there were twice as many biopsies with benign results in the screened groups compared to the control groups. The review also considered a trial looking at the benefit of clinical physical breast exam, but that trial was discontinued prematurely and did not accrue adequate data to answer the question.15 In summary, most studies have not demonstrated a benefit of BSE in women. Results from several studies, including the two randomized trials, show that BSE screening greatly increases the number of benign lumps detected. This negative consequence of BSE results in increased anxiety, physician visits, and unnecessary biopsies. Although breast biopsies are relatively simple surgeries, they can cause distress, scarring and disfigurement. Kosters JP and Gotszsche PC. Regular self-examination or clinical examination for early detection of breast cancer (Review). John Wiley & Sons Ltd. (for The Cochrane Collaboration). 2008.

14. Is Lumpectomy Equal to Mastectomy? • At least 6 large randomized trials show no difference in survival • Not all women candidates for lumpectomy • But for those that are: • There are still great difference in lumpectomy/RT rates based on geography and socio-economic status

15. Polychemotherapy for Early Breast Cancer • 2005 meta-analysis by Early Breast Cancer Trialist Collaboration Group on polychemotherapy vs. no chemotherapy and various regimens (CMF, anthracyclines, etc) • Results: Women < 50 years, 10% absolute gain in 15-year survival • Women aged 50 to 69 years, 3% absolute gain in 15-year survival

16. Other Examples • Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Clarke M, Collins R, Darby S, et al. Lancet. Dec 17 2005;366(9503):2087-2106. • Meta-analysis of breast cancer outcomes in adjuvant trials of aromatase inhibitors versus tamoxifen. Dowsett M, Cuzick J, Ingle J, et al. J Clin Oncol. 28(3):509-18, 2010. • Avastin (bevacizumab), with chemotherapy associated with a greater risk of death from side effects, than chemotherapy alone, according to an analysis of 16 randomized controlled trials. Ranpura, V, et al. JAMA. Feb 2, 2011; 305(5), 487-494..

17. Consumer Involvement in Systematic Reviews • Commenting on pre-published systematic reviews of best evidence • Commenting on protocols on how the review is to be done • Commenting on summaries of reviews in plain English • Preparing plain language summaries Consumers are also involved in: • Raising people’s awareness about evidence-based health care • Recruiting other consumers to help with the work • Disseminating information about particular reviews • Co-authoring systematic reviews of best evidence • Searching journals • Translating reviews and plain language summaries

18. Example: Advocate Co-Author, Systematic Review

19. Example: Advocate Co-Author, Systematic Review

20. Example: Peer-Reviewer

21. Consumers United for Evidence-based Healthcare (CUE)

22. Barriers to use of Systematic Reviews, Meta – analyses, EBHC • Library may not provide information in consumer’s first language; search terms and review titles are often unintelligible. • Plain language summaries not always monitored for quality and standards are vague.  • High quality consumer training is not readily available • Basing decision-making/policy setting on EBHC, is not easy for consumers or clinicians