Rebecca Smith-Bindman, MD Professor , Radiology and Biomedical Imaging

1. Translating Evidence Into PolicyUsing Media, Quality Organization and Professional Societiest0 Deliver Messages to Policy Makers Rebecca Smith-Bindman, MD Professor , Radiology and Biomedical Imaging Epidemiology and Biostatistics Obstetrics, Gynecology and Reproductive Sciences University of California, San Francisco Director, Radiology Outcomes Research Laboratory

2. An Accidental Health Policy Maker • My research has focused on outcomes research and HSR • Our publication on the radiation of CT coincided with CT overdoses at Cedars Sinai, and intense public interest • 2009-2010 visiting research scientist, NCI, provided proximity to decision makers • Experience helped me see large number of ways to impact quality • I was invited to share my experience of using research to influence policy

3. Outline of What I Will Emphasize • Need to create a fertile environment for influence • Need to identify playmakers • Need to communicate effectively: good story

4. Content of ResearchSafety of Medical Imaging with CT Most medical imaging tests use ionizing radiation Exposure to ionizing radiation increases risk of cancer The dose associated with CT are much higher than conventional x-rays – 500 times higher Thus the risks of CT are much higher than x-rays The use of CT is rising rapidly, thus increasing population’s exposure to radiation and cancer risks

5. Risks Associated with Radiation: Good scientific foundation of harm • A large body of epidemiological and biologic evidence links exposure to radiation with development of cancer • The U.S. National Academies of Sciences Biological Effects of Ionizing Radiation Committee (BEIR VII) Conducted an exhaustive review of the literature • They concluded that radiation in the range used in medical imaging (at least with CT) are carcinogenic • It is estimated that 2-4% of future cancers are from CT • Brenner NEJM; Berrington de Gonzales Archives of Internal Medicine

6. Assessment of the Doses Used in Routine CT Smith-Bindman, Arch Intern Med 2009 • We conducted a study to assess the doses used for the most common CT examination types across 4 SF Bay Area institutions • The examinations were grouped by the reasons that patients were sent for CT • We found dramatic variation in doses within and between facilities, and doses that were much higher than widely known

7. Mean and Range of Effective Dose Across FacilitiesSame Study Indications Smith-Bindman, Arch Intern Med 2009

8. Some of our data

9. Some of our data

10. Summary of ResearchDoses from CT High and Variable • Dose from CT higher than cited • Doses highly variable • The risk of cancer from a single test is as high as 1/100 • The doses are much higher than they need to be

11. Why Are Doses So High and Variable • Few data on practice • No dose targets set for CT • No quality standards exist • No professional or governmental group responsible for collecting or reporting dose • The US contrasts with other countries

12. Fixing Radiation Safety in the USCase for this being a Health Policy Issue Imaging is big business and industry has not been willing to take on this issue – it’s a practice of medicine issue Clinical practice groups have conflicting goals and incentives, and have not wanted to bring attention to this issue This seems to be a problem where industry and professional societies won’t (or haven’t) fix itself There is a model of government oversight in other countries There is a precedent of government oversight of radiation in mammography

13. Publication • Our paper was featured prominently in Archives • Received widespread media attention • I and the media saw synergy with theme of radiation safety already in the news • I was able to use this to help education the public about broader systems based issues around CT safety The issue in the news was different from the one I cared about

14. Timing of our Research Provided Opening to Communicate with Policy Makers Cedar’s Sinai reports of radiation overdoses associated with the use of brain perfusion CT NY Times articles by Bogdanich uncovering radiation overdoses from radiation oncology treatments for cancer Our paper describing variation in dose, and higher than needed dose, came at a time of high interest/ public concern

15. Creating a Fertile Environment for InfluenceMedia The media were interested in learning more about the issues Media has profound role in educating public and policy makers Their interest was broad – and they wanted to understand the underlying issues (which are complex) The more people aware of this issues, the greater possibility of having interested partners engaged to help create policy I committed a lot of time educating media not just to get coverage for me and UC, but to broaden depth of interest

16. Purpose of Communicating with Media Reported tend to be smart, good at conveying message You need to help them by having clear, concise messages Be responsive to different perspectives, and tailor your explanations to their interest: $, safety, turf, quality Discretely help press know who to speak to, put them in touch with the playmakers –conversations will continue without you Having media interest improves the medium of conversation among all relevant parties: Help Create a Fertile Environment

17. What Comes Next: Identifying Playmakers Many different types of organizations have a role in shaping and influencing policy They very much depend and rely on each other Congress is particularly interested (?only interested) if the topic is important to their constituents, professional groups, consumer groups, the public ,

18. Avenues for Influencing Health Care Quality and Policy Professional & Academic Societies ACR, RSNA, ABMS FDA Regulation and Oversight Research Direct Scientific Influence Legislation National & State Industry Commissioned Research IOM, National Academies, US Preventive Task Force Payers CMS Quality Organizations National Quality Forum Integrated Health Care Plans

19. Avenues for Improving Health Care Quality Professional & Academic Societies ACR, RSNA, ABMS Integrated Health Care Plans FDA Regulation and Oversight Research broad range of forums Legislation National & State Industry Commissioned Research IOM, National Academies, US Preventive Task Force Payers CMS Quality Organizations NQF, Joint Commission

20. Media Provides an Ideal Medium Across All Possible Groups for Influencing Care Quality and Policy Professional & Academic Societies FDA Regulation and Oversight Research Legislation National & State Industry Payers Commissioned Research Quality Organizations Integrated Health Care Plans

21. Possible Playmakers In Radiation Safety • The more groups you speak to (and influence), the greater the cross talk –influence magnified • The more groups you speak to, the greater your legitimacy • The Groups that were relevant to my area Congress: Staff and Legislators Executive Branch: FDA Quality Organizations: NQF, Joint Commission Payers: CMS IOM: Professional Societies, NIH Industry

22. Playmakers: Influencing Legislators Staff are open to hearing from researchers You are 1 voice among many – need to speak up to be heard You need to communicate effectively: tell a good story

23. Communicating with Legislators and Staff Message straight forward Why should they care about your view - alliances allegiances useful - a single researcher’s view less effective Becoming a reliable source of information as a knowledge broker is a win-win : You become someone to trust

24. Speaking as an Expert: Testifying at Congress During discussions with staff, they asked about whether I thought it made sense to have a hearing With no experience I said it could be extremely useful and agreed to participate The hearing was going to be broad – all of radiation How I approached opportunity Message was simple What is the problem: Why is this a health policy question Recommendations about what needs to be done

25. Smith-Bindman Testimony • Explained issue in clear terms Number of people exposed high, risks potentially high • Oversight fragmented – regulatory environment -inadequate FDA has some role, but not enough to fix this problem Professional societies: have done little, and difficult to do Some standards exist for quality, but few and not monitored • What Needs to Happen to Improve the Safety of CT Imaging Legislative oversight should broaden Quality Standards need to be developed Improve FDA oversight Public Reporting Create Consortium to study this issue (plug for more research)

26. McCollough Testimony Extraordinarily detailed – showed busy power point slides Went into subtle nuance, without clear message She expected her role as a respected scientist to convince the legislators that they should trust that the issue was already being taken care of by professional societies and that there was no need for involvement of the Congress She was rebuked by one of the Congress woman who said she was clearly smart, but ill informed regarding safety

27. FDA: Current Regulatory Environment FDA in charge of radiation safety Responsible for approving machines , but no legislative mandate focused on assessing use in clinical practice I found out where decisions are made, and contacted FDA I felt they needed to expand their oversight- and I tried to get involved in brokering changes (FDA, Congress, societies) I spoke several times –first on my initiative, and then on theirs I emphasized the need for standards, and several recommendations – such as need for standards- were adopted into their subsequent White paper on Radiation Safety

28. Influencing Playmakers: Quality Organizations Organizations at Cross Roads of Practice and Policy I mentioned to Congress need for standards / public reporting The FDA suggested “reporting” but not who should do this What should be reported and by whom? I thought it should be FDA, but have not yet been successful On a practical level there is a need for someone to write standards that can be used. There are numerous organizations focused on setting, adhering to standards in medicine

29. The National Quality Forum (NQF) NQF non-profit organization focused on improving the quality of health care They set standards based on implementation of guidelines based on evidenced-base practice Consensus organization (stakeholders, set priorities) Endorse national standards for measuring and publicly reporting performances Promotes reaching goals through education and outreach

30. Seizing Opportunities I had never heard of the National Quality Forum They approached me to be on their expert review panel relating to a quality metric on mammography I agreed to serve with intent of learning about their process with goal of submitting a metric on Radiation Safety FDA decided public reporting would be good, did not have a way to do this, and using this parallel opportunity, I became knowledge broker

31. NQF Standards • When they adopt standards the impact may be large • The standard development process is grueling • The review process is also grueling: most “standards” rejected • Requirements: broadly applicable, easy applied, validated to be associated with quality and publically reportable • For my metric, I tried to engage support from ACR professional group HPS scientific group FDA executive branch

32. CMS Several initiatives at CMS focus on quality, with consideration of measures that will improve quality and lower cost As part of MIPPA (Medicare Improvements for Patients and Providers Act) CMS requires facilities in non-hospital settings to become accredited 1/2012 – I am trying to have them adopt a measure that will cover dose and other aspects of radiation quality

33. Other Opportunities Each opportunity comes with the capacity to increase reach The Institute of Medicine was commissioned to write a paper on environmental causes of breast cancer (Komen Foundation) The feedback I received from congress was that to create laws, they needed to see interest from consumer advocates When approached to write the back ground paper on radiation, I seized the opportunity The IOM used report to conclude radiation most important environmental cause of breast cancer

34. Other Stakeholder Collaborations: Ongoing • Industry They have the most to gain / lose I have met with several to help design projects to lower dose Collaborating with dose software companies • Professional Societies Serve on ABMS-ABR-ACR, committee to design safety metric. Served on a large number of committees ICRP, NCRP, CMS • Payers • Joint Commission

35. Ongoing Challenges The messages of my research / advocacy has not fully overlapped with all professional radiology groups NQF experience disheartening I continue to provided evidence from ongoing studies to support my (independent) views I have also reached out the scientific community - related societies -to further shore up the science UC DOSE grant – organized research project across the UC medical Centers that has organized physicists, and the UC weight, behind the safety agenda

36. Avenues for Improving Health Care Quality Professional & Academic Societies Integrated Health Care Plans FDA Regulation and Oversight Research broad range of forums Legislation National & State Industry Commissioned Research IOM, National Academies, US Preventive Task Force Payers CMS Quality Organizations NQF, Joint Commission

37. Planning for Translation It’s never too early to plan for how you will use your research to influence policy Ideal to think about from the time you write grant You don’t know the results of your research but you know topic –hopefully better than anyone else- as well as the stakeholders you need to engage Engage these stakeholders at the point of applying for funding

38. How Does A Busy Researcher Have Time I was on sabbatical - unique opportunity These activities take a time –as important as science If you want research to have impact, this needs to be an integral and valued part of time Resources to support these activities – investigator and staff time, need to be built into research proposals This needs to be an integral part of research and thoughtful consideration of what entails, protected time.

39. Planning for Translation: Think about Stakeholders Practice Organizations Professional Societies Quality Organizations Policy Organizations Media, Public Relations, Patient Representatives You may need to think creatively

40. ARISE Program Project Grant This grant focuses on many aspects of imaging: Appropriate Radiology Imaging for Safety and Effectiveness Project 1 – Cost / Utilization Project 2 – Effectiveness Project 3 – Dose/Safety Project 4 – Cancer Risk The stakeholders for different projects are different A dissemination and implementation plan is a significant and portion of project: several investigators involved

41. ARISE Program Project Dissemination Plan Project 1 – Cost / Utilization Payers, Health Plans, CMS Project 2 – Effectiveness Health Plans, Professional Groups, Quality Organizations Project 3 – Dose/Safety Health Policy Organizations, Professional Groups, Quality Organizations, Legislators Project 4 – Cancer Risk Scientific and Lay Audience

42. Multidisciplinary Stakeholder Council • Our Stakeholder Council Involves 25 collaborators who have all agreed to attend our annual meeting and conference calls • Practice based groups • Professional Societies • Quality Organizations • Policy Organizations: NCRP, FDA • Other: Patient Groups, Media

43. Translating Research Into Policy The process of how to use research to connect parties and communicate results is separate from content Need to work on research and impacting policy/practice in parallel Need to have a message that’s relevant to policy decision makers , but if you do, this part of the research is the part that will lead to change in quality and practice

44. Translating Research Into Policy Starts with clear communication For me, previous research had focused on nuance, my research was presented in an easily understood fashion which helped Luck / timing is necessary, but not sufficient Need to take advantage of opportunities Need to identify stakeholder and forge collaborations so that you can create a critical mass of interest in topic Need to identify appropriate policy makers and figure out how to educate and influence their decisions