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

Translating Evidence Into PolicyUsing Media, Professional Organizations & Quality Organization to help 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

An Accidental Health Policy Maker • My research has focused on clinical and health services research • 2009-2010 visiting research scientist, NCI • Our Archives on Internal Med paper on radiation associated with CT coincided with overdoses at Cedars Sinai, and intense public interest • My location in DC provided proximity to many decision makers • Its been an eye opening experience that has helped me to appreciate there are many ways to impact health care quality /policy • I was invited to speak to you as a case study in using research to influence policy: new for me, share my ongoing trials , tribulations and success

Outline of Points I Want to Emphasize • Need to create a fertile environment for influence • Need to identify playmakers • Need to communicate effectively

Topic: Safety 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

Mean Effective Radiation Dose for Common Study Types: Variation within Anatomic Area Smith-Bindman, Arch Intern Med 2009

Some of our data Doses associated with Typical CTs

Research: Doses from CT: High and Variable Dose from CT 1.5 – 5 times higher than widely sited Dose highly variable: doses vary 20 times between patients and facilities for the same test The risk of cancer from a single test is as high as 1/100 The doses are much higher than they need to be These results were clearly dramatic, made efforts to disseminate prior to publication

Why Are Doses So High and Variable • There are no clear dose targets set for CT in the US • There is no professional organization or governmental organization responsible for collecting and reporting dose data – and no quality standards • There are virtually no data on actual practice • The US starkly contrasts with other countries where both professional groups and the government have been involved in over sight in this area

Fixing Radiation Safety in the USCase for this being a Health Policy Issue Imaging is big business, 100 billion dollars/year industry, and industry has not been willing to take on this issue This seems to be a problem where industry won’t fix itself Clinical practice groups have conflicting goals and incentives There is a model of government oversight in other countries There is a precedent of government oversight of radiation in mammography

Publication • Our paper was a featured prominently in Archives publication • 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

Timing of our Research Provided Opening to Communicate with Policy Makers There were several media reports of radiation over-dosing Dosing errors from diagnostic CT led to exposure 100 X higher than needed, resulting in hair loss,, acute radiation effects Radiation dosing errors from therapeutic radiation used to treat cancer resulted in several deaths High public awareness and concern regarding radiation Our paper describing variation in dose, and higher than needed dose, came at a time of high interest/ public concern

Creating a Fertile Environment for Influence: Media The media were interested in learning more about the issues Media has a profound role in educating the public, professional societies, policy makers Their interest was broad – and they wanted to understand the underlying issues 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 – it was not just to get coverage, but to broaden depth of their interest

Purpose of Communicating with Media In general, reporters smart, interested and really good at conveying your message to their audience 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 You can discretely help press knows who to speak to, put them in touch with the playmakers – you want the conversations to continue without you Having media interest improves the medium of conversation among all relevant parties: Help Create a Fertile Environment -

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 , etc.

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

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 National Quality Forum

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

Possible Playmakers In Radiation Safety • The more groups you speak to and influence, the greater the cross talk –the more your influence is 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 Professional Societies Payers IOM (influence legislators) Industry

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

Communicating with Legislators and Staff The message needs to be straight forward What is your position that they should care about your view - alliances, allegiances, very 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

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

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

McCollough: Testimony • Extraordinarily detailed – many busy power point slides • Went into subtle nuance, without clear message • 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 said she is clearly smart, but ill informed regarding safety

FDA: Current Regulatory Environment FDA in charge of radiation safety Responsible for approving machines , but no clear legislative mandate focused on radiation safety at the patient level 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 many of my recommendations – such as need for standards- were adopted into their subsequent White paper on Radiation Safety

Influencing Playmakers: Quality Organizations Organizations at Cross Roads of Practice and Policy I mentioned to Congress the need for standards and public reporting The FDA suggested reporting-by no clear group who should do this: what should be reported and by whom 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

The National Quality Forum The National Quality Forum is a non-profit organization focused on improving the quality of health care They have a pretty large impact on implementation of guidelines/evidenced base practice Consensus organization  large membership of stakeholders, set priorities Endorses national standards for measuring and publicly reporting on performances Promotes reaching national goals through education and outreach

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 an intent of learning about their process in order to design and submit a metric on Radiation Safety that would respond to FDA call for quality standards FDA decided public reporting would be good, did not have a way to do this, and using this parallel opportunity, I became knowledge broker

NQF Standards • When they adopt standards the impact may be enormous • The standard development process is grueling  lot of work • The review process is also grueling: most “standards” rejected • Requirements: they should be broadly applicable, easy applied, validated to be associated with quality and publically reportable • For my metric, I engaged support from ACR : professional group HPS: scientific group FDA:

Other Outreach Efforts to Stakeholders • Industry: GE They have the most to gain and to lose around radiation safety concerns GE is developing program to reduce dose – and I have been working with them to try to design appropriately • Professional Societies I was nominated to serve on joint ABMS, ABR, ACR, committee to design radiation safety quality metric. ICRP, NCRP, CMS • IOM

Other Outreach Efforts to Stakeholders • IOM Commissioned to write summary on radiation safety and breast cancer • Integrated Health Care Plans

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 proposal 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

How Does A Busy Researcher Have Time I was on sabbatical last year- unique opportunity – I learned lessons along the way These activities took a huge amount of time – but I realized this was as important as the science If I want my research to have impact, this needs to be an integral and valued part of how I spend my 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.

Planning for Translation: Think about Stakeholders Practice Organizations Professional Societies Quality Organizations Policy Organizations Media, Public Relations, Patient Representatives

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

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

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

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

Translating Research Into Policy Starts with Clear Communication In my area, previous research had focused on radiation issues with less policy impact – 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

Thank you

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