1. Independent patient information Selling Sickness: Influence on influence - Amsterdam, 8 October 2010 Hilda Bastian, IQWiG, Germany

2. German healthcare reform of 2003 „In addition, as part of the Institute‘s mandate, it is to prepare information about the current status of scientific knowledge, so that citizens can benefit directly from its work.“ The goal: „to strengthen citizens‘ autonomy.“

3. IQWiG: German Institute for Quality and Efficiency in Health Care Began work in October 2004 Legislative mandate: All of IQWiG's work is to be based on the principles and methods of evidence-based medicine Remit: Effectiveness evaluations and patient information Can be commissioned by:

4. Ensuring scientific independence IQWiG: Governance – the foundation and board Non-government, non-profit foundation established by legislation Board of governors include the Secretary of State for Health and representatives of the health care system self-governors (the statutory health insurance funds and service providers – hospitals and doctors) Funding through a levy on healthcare transactions

5. Ensuring stakeholder input IQWiG: Governance – the Board of Trustees Providers: medical and professional associations, hospitals Patients: Representatives of patient organisations, Federal Commissioner for Patients' Concerns Community: employers, churches Pharmaceutical industry

6. The long slow birth of the „Gesundfuchs“ Oct 2004: IQWiG 2005: Concept – but few resources Feb 2006: Minister launches the website Dec 2006: Evidence-based encyclopaedia proposal 2007: Legislation expands IQWiG‘s mandate July 2007: „Proof of concept“ approved 2008: Green light - a team of 14 inside

7. Specialist expertise (plus IQWiG statistics department): Evidence assessment Clinical Communication Qualitative research External expertise

9. „Patient HTA“ Evidence scanning and assessment Assessing qualitative research International, bi-lingual peer review Stakeholder consultation on all drafts User-testing (focus groups) Post-publication criticism / correction system Kept up-to-date

10. Evidence-based patient information Developed using systematic methods to minimise bias and maintain neutrality Uncertainties addressed, as well as potential benefits and harms Kept up-to-date so that it remains evidence-based It‘s non-directive Uses evidence to try to achieve its aims (patients who are informed, psychologically supported and empowered to achieve their goals)

11. Empowering, patient-centred communication: Addresses what patients want to know Shows interest and respect for what patients think Respects patients‘ competence Dixon-Woods. Writing wrongs? An analysis of Published discourses about the use of patient Information leaflets. Soc Sci Med 2001;52:1417-1432. Kettunen et al. Developing empowering health Counseling measurement: preliminary results. Patient Educ Counsel 2006;64:159-166 Virtanen et al. Empowering discourse in patient Education. Patient Educ Counsel 2007;66:140-146

12. People telling their stories Angelika, 48 – the fear of bowel cancer (high risk) There were nights I lay awake for a long time and thought. There were some tears, too. I kept wondering if I was doing the right thing and how I could come to terms with the fear. It was damn hard. But those difficult times are a long time ago.

13. Determine scope and key messages Research (quantitative and qualitative) (possibly interviews and online survey) Commission Evidence scanning & Updating Development of products; Translation & translation QA Production Cycle & Quality Assurance User monitoring & evaluation Content QA (both languages) and IQWiG approval Reader feedback Stakeholder consultation (core products): IQWiG bodies including GBA, Ministry, and Board of Trustees plus German test readers (independent of IQWiG) Final version, Internal QA and IQWiG approval Publication

17. Building an up-to-date evidence-based encyclopedia: Currently around 350 articles: aiming for 1,000 (plus a new form of medicines databank)

18. Evaluation Before and after publication Internal and external: qualitative and measurement (readability, usage etc) Methods and process evaluated by the WHO Regional Office for Europe

19. Trust and our readers They just say openly, „We don‘t know the answer.“ That is what I meant when I said, it‘s honest. That‘s just the way it is. Yet you hardly ever read that – it doesn‘t matter what kind of information, you know – that is usually completely missing. (Are they believable?) I‘d say that, yes, for sure. I judge them to be very believable because of all those sources. You wouldn‘t just make up that many numbers.

20. As neutral and non-manipulative as humanly possible Directive patient information is not particularly effective and it is paternalistic A high level of expertise is needed to avoid and identify „spin“ „Spin can be defined as specific reporting that could distort the interpretation of results and mislead readers…(I)t can result from ignorance of the scientific issue, unconscious bias, or willful intent to deceive.“ Boutron (2010). JAMA; 303:2058-2064.

21. We occupy an uncomfortable position TRAITOR !

23. Competing for attention

24. Breaking out – of the niche and past the border

25. The future for evidence-based patient information

26. It‘s not easy, but it‘s not „MISSION: IMPOSSIBLE“

27. Conclusions: A core set of independent public patient information that could be widely translated / adapted is achievable and it is affordable But it needs support to thrive and become the most used information Good quality translation that preserves accuracy and quality of communication is essential – spin can be introduced during translation Patient information should not be medicines-driven, but driven by what patients want to know

28. Conclusions: We need better access to very basic product information in Europe – but its role can and should be tightly restricted We need a clear and simple mechanism for an authority such as IQWiG to correct errors and „spin“ in product information The regulators and the „new“ authorities need to create organisational and informational bridges, so that basic information about appropriate medicine use is linked to up-to-date evidence

29. Vielen Dank!www.informedhealthonline.org