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  1. 1. Informing Care Decisions: Emerging Technologies, Scientific Evidence, and Communication AHRQ 2009 Annual Conference Research to Reform: Achieving health System Change September 13-16, 2009 Speakers Elise Berliner Agency for Healthcare Research and Quality Amy P. Abernethy Duke University Medical Center Mellanie True Hills StopAfib.org Michael Fordis, MD, Moderator Baylor College of Medicine, Houston, Texas
  2. 2. Framing Discussion  Background in problem of communicating uncertainties  Emerging technologies and evidence—  Scientist’s Perspective from AHRQ. Elise Berliner  Clinician’s Perspective—Oncology Amy Abernethy  Patient’s Perspective—Atrial Fibrillation Melanie Hill
  3. 3. Emerging Technologies  Challenge: Mismatch between published evidence and adoption into clinical practice  Questions:  Perception of stakeholders about the state of the evidence and balance of potential harms and benefits?  Messages reaching patients from the media, DTC advertising, and other sources?  Communicating what is known and what is not?  Role for AHRQ in communicating the broader questions of development of emerging technologies and evidence generation?
  4. 4. Overview  Problem of uncertainty across treaments—how common is it?  Case example—audiences facing challenges of uncertainty.  The John M. Eisenberg Center—charge to translate and disseminate.  What patients want, what they get, and how prepared are they to act upon information.  Sources of uncertainty—it is certain that we will remain uncertain
  5. 5. Ratings of Clinical Effectiveness Source: Clinical Evidence. http://clinicalevidence.bmj.com/ceweb/about/knowledge.jsp Accessed September 12, 2009 N=2500 Treatments
  6. 6. Decisions Must be Made  Patient confronting decisions about care alternatives  Clinicians evaluating and engaging in shared decision-making  Policymaker confronting coverage decisions  Decision-making in setting of uncertainty  Drugs, devices, services  Emerging technologies
  7. 7. Case Study  Fallopian tube occlusive device performed in physician’s office iv sedation or paracervical block  Comparator is tubal ligation with general anesthesia, performed as outpatient or with hospitalization  Prospective uncontrolled studies  Phase III multicenter observational series –Cooper 2003 premarketing approval:  507 women; 464 (92%) bilateral placement; 456 (3 month f/u) 437 (96%) satisfactory placement; 421 (92%) bilateral occlusion and all demonstrated bilateral occlusion at 6 months.  4.5% adverse events with expulsion (14), perforation (4), proximal location and perforation (1), and proximal location (2).  No RCTs and no long term data
  8. 8. AHRQ’s Effective Health Care Program: Components Translation Clinicians Consumers Policymakers Translation Translation Eisenberg Center New Knowledge CERTs (14 Centers) New Knowledge DEcIDE (13 Centers) Existing Literature Evidence-based Practice Centers (15 Centers) New Knowledge New Effectiveness and Comparative Effectiveness Research (Individual Investigators) Research & Education On Therapeutics Research & Education On Therapeutics Accelerated Practical Studies Accelerated Practical Studies Comparative Effectiveness Reviews Comparative Effectiveness Reviews Original Research Original Research
  9. 9. EHC Process – Evolving
  10. 10. Summary Guide for Clinicians
  11. 11. Summary Guide for Patients
  12. 12. Summary Guides for Policy Makers
  13. 13. Source: U.S. National Cancer Institute’s Health Information National Trends Survey (HINTS), 2005 Internet Print Providers 0% 10% 20% 30% 40% 50% 60% 70% African Americans Hispanics Non-Hispanic Other Whites 29% 21% 29% 33% 14% 22% 17% 15% 56% 66% 54% 53% Consumer Cancer Information and Channel Preference by Ethnicity
  14. 14. -9% -7% -6% -6% -2% 0% 2% 4% 4% 5% 6% 11% 12% 14% 17% 17% 18% 18% 20% 21% 29% 33% 33% 36% 44% Radio news coverage Online message boards, forums or newsgroups Articles in newspapers TV news coverage Wikipedia Articles in magazines Publications or brochures from non-profit orgs or NGOs Books Government agencies Health companies' web sites Health expert blogs Web sites for specific brands of medication Conversations with someone like me Health-related newsletters Non-profit or health advocacy Web sites Conversations with friends and family members Google or other Internet search engines Medical journals Consumer health Web sites Conversations with my doctor Base = U.S. Health Info-entials For each of the following sources of health information, please indicate whether that source is becoming more important to you, less important to you, or remaining the same. (Net = becoming more important – becoming less important) Films or documentaries Net becoming more important Net becoming less important Many more channels in the U.S. are of emerging importance than globally. HealthEngagement Barometer: US Findings. Edelman:2008 Personal blogs Web-based video sharing sites Social networking websites Corporate and product advertising Personal and Health Expert Channels Becoming More Important Corporate and product advertising diminishing most in importance
  15. 15. Source: U.S. National Cancer Institute’s Health Information National Trends Survey (HINTS), 2005 Consumer Cancer Information and Channel Use by Ethnicity
  16. 16. Level of Activation of U.S. Adults Level 1 (least activated) 6.8% Level 2 14.6% Level 3 37.2% Level 4 (most activated) 41.4% Four levels of patient activation have been identified through the Patient Activation Measure. Level 1, the least-activated level, people tend to be passive and may not feel confident enough to play an active role in their own health. Level 2, people may lack basic knowledge and confidence in their ability to manage their health. Level 3, people appear to be taking some action but may still lack confidence and skill to support all necessary behaviors. Level 4, the most-activated level, people have adopted many of the behaviors to support their health but may not be able to maintain them in the face of life stressors. Source: HSC 2007 Health Tracking Household Survey — sample of 15,500 adults 18 years and older. Hibbard JH and Cunningham PJ. HSC Research Brief, No. 8 October 2008.
  17. 17. Sources of Uncertainty  Risk or uncertainty about future outcomes.  Ambiguity or uncertainty about the strength or validity of evidence about risks.  Uncertainty about personal implications of specific risks, e.g., identity, permanence, timing, value (severity), probability.  Uncertainty arising from complexity of risk information—instability of risks and benefits over time and multiplicity of risks and benefits  Incomplete information from patient or about patient Politi MC, et al. Med Decis Making (2007);27:681-695. Bogardus, et. Al. JAMA (1999) 281:1037-1041.
  18. 18. Uncertainty in One’s Outcomes
  19. 19. Sources of Uncertainty  Risk or uncertainty about future outcomes.  Ambiguity or uncertainty about the strength or validity of evidence about risks.  Uncertainty about personal implications of specific risks, e.g., identity, permanence, timing, value (severity), probability.  Uncertainty arising from complexity of risk information—instability of risks and benefits over time and multiplicity of risks and benefits  Incomplete information from patient or about patient Politi MC, et al. Med Decis Making (2007);27:681-695. Bogardus, et. Al. JAMA (1999) 281:1037-1041.
  20. 20. Factors Affecting Quality of Evidence  Combining best evidence on benefits and on adverse events (Vandenbroucke JP, Psaty BM. JAMA (2008) 300:2417-2419.)  Short follow-up time  Design characteristics  Study reporting characteristics (Sedrakyan A, Shih C. Medical Care (2007) 45: 10 (Supp 2):S23-28.)  Research design—redesigning RCTs (Luce BR, et. al., Ann Intern Med (2009) 151:206-209.)  Persistence of inavailability of high level of evidence
  21. 21. Case Study  5 Peer-reviewed studies  Permanent contraception 85-97% with relatively few complications  F/u times 6 months to 3years  Long term efficacy and safety unknown as well as comparison to standard surgical treatment.  Decision to cover.

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