PowerPoint® File

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

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

-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.