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Informing Care Decisions: Emerging Technologies, Scientific Evidence, and CommunicationAHRQ 2009 Annual ConferenceResearch to Reform: Achieving health System ChangeSeptember 13-16, 2009
Speakers
Elise BerlinerAgency for Healthcare Research and Quality
Amy P. Abernethy Duke University Medical Center
Mellanie True Hills StopAfib.org
Michael Fordis, MD, ModeratorBaylor College of Medicine, Houston, Texas
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
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?
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
Ratings of Clinical Effectiveness
Source: Clinical Evidence. http://clinicalevidence.bmj.com/ceweb/about/knowledge.jspAccessed September 12, 2009
N=2500 Treatments
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
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
AHRQ’s Effective Health Care Program:Components
Translation
Clinicians
Consumers
Policymakers
Translation
Translation
Eisenberg Center
New KnowledgeCERTs
(14 Centers)
New KnowledgeDEcIDE
(13 Centers)
Existing Literature
Evidence-basedPractice Centers
(15 Centers)
New Knowledge
New Effectiveness
and Comparative Effectiveness
Research(Individual
Investigators)
Research &Education On Therapeutics
Research &Education On Therapeutics
AcceleratedPractical Studies
AcceleratedPractical Studies
ComparativeEffectiveness
Reviews
ComparativeEffectiveness
Reviews
Original ResearchOriginal Research
EHC Process – Evolving
Summary Guide for Clinicians
Summary Guide for Patients
Summary Guides for Policy Makers
Source: U.S. National Cancer Institute’s Health Information National Trends Survey (HINTS), 2005
Internet
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
-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 coverageOnline message boards, forums or newsgroups
Articles in newspapersTV news coverage
WikipediaArticles in magazines
Publications or brochures from non-profit orgs or NGOsBooks
Government agenciesHealth companies' web sites
Health expert blogsWeb sites for specific brands of medication
Conversations with someone like meHealth-related newsletters
Non-profit or health advocacy Web sitesConversations with friends and family members
Google or other Internet search enginesMedical journals
Consumer health Web sitesConversations with my doctor
Base = U.S. Health Info-entialsFor 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 blogsWeb-based video sharing sitesSocial networking websitesCorporate and product advertising
Personal and Health Expert Channels Becoming More ImportantCorporate and product advertising diminishing most in importance
Source: U.S. National Cancer Institute’s Health Information National Trends Survey (HINTS), 2005
Consumer Cancer Information and Channel Use by Ethnicity
Level of Activation of U.S. Adults
Level 1(least activated)
6.8%
Level 214.6%
Level 337.2%
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.
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.
Uncertainty in One’s Outcomes
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.
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
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.