Informing Care Decisions: Emerging Technologies, Scientific Evidence, and Communication (Text Version)

On September 14, 2009, Elise Berliner, Amy P. Abernethy, Mellanie True Hills, and Michael Fordis made this presentation at the 2009 Annual Conference. Select to access the PowerPoint® presentation (2.3 KB) (Plugin Software Help).

Slide 1

Informing Care Decisions: Emerging Technologies, Scientific Evidence, and Communication

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

Slide 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

Slide 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?

Slide 4

Overview

Problem of uncertainty across treatments—"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

Slide 5

Ratings of Clinical Effectiveness

Image: Pie Chart shows the following ratings:

Beneficial: 12%
Likely to be Beneficial: 23%
Trade-off between benefits and harms: 8%
Unlikely to be Beneficial: 5%
Likely to be ineffective or harmful: 3%
Unknown Effectiveness: 49%

N=2500 Treatments

Source: Clinical Evidence. http://clinicalevidence.bmj.com/ceweb/about/knowledge.jsp
Accessed September 12, 2009

Slide 6

Decisions Must be Made

Patient confronting decisions about care alternatives
Clinicians evaluating and engaging in shared decision-making
Policy maker confronting coverage decisions
Decision-making in setting of uncertainty
- Drugs, devices, services
- Emerging technologies

Slide 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

Slide 8

AHRQ's Effective Health Care Program: Components

Image: Chart shows the following components:

• Evidence-based Practice Centers (15 Centers) Existing Literature → Comparative Effectiveness Reviews
• DEcIDE (13 Centers) New Knowledge → Accelerated Practical Studies
• CERTs (14 Centers) New Knowledge → Research & Education On Therapeutics
• New Effectiveness and Comparative Effectiveness Research (Individual Investigators) (14 Centers) New Knowledge → Original Research

These components converge at the Eisenberg Center, where they are translated to:

• Clinicians
• Consumers
• Policymakers

Slide 9

EHC Process—Evolving

Image: Chart shows the evolution of the EHC process through topic triage and refinement, key questions, CER, key concepts and messages, translation dissemination, and evaluation. Feedback on multiple and varied information products restarts this cycle.

Slide 10

Summary Guide for Clinicians

Image: First page of a sample summary guide.

Slide 11

Summary Guide for Patients

Image: First page of a sample summary guide.

Slide 12

Summary Guides for Policy Makers

Image: First page of a sample summary guide.

Slide 13

Consumer Cancer Information and Channel Preference by Ethnicity

Image: Bar chart shows the following preferences by ethnicity:

Providers:

• African Americans: 56%
• Hispanics: 66%
• Non-Hispanic Other 54%
• Whites: 53%

Print:

• African Americans: 14%
• Hispanics: 22%
• Non-Hispanic Other 17%
• Whites: 15%

Internet:

• African Americans: 29%
• Hispanics: 21%
• Non-Hispanic Other 29%
• Whites: 33%

Source: U.S. National Cancer Institute's Health Information National Trends Survey (HINTS), 2005

Slide 14

Personal and Health Expert Channels Becoming More Important

Corporate and product advertising diminishing most in importance.

Image: Chart shows that the internet is becoming more important as a health information resource to consumers (36%); only "conversations with my doctor" (44%) is higher. A note besides the chart reads "Many more channels in the U.S. are of emerging importance than globally."

Source: HealthEngagement Barometer: US Findings. Edelman: 2008.

Slide 15

Consumer Cancer Information and Channel Use by Ethnicity

Image: Bar chart shows the following preferences by ethnicity:

Providers:

• African Americans: 27%
• Hispanics: 23%
• Non-Hispanic Other 19%
• Whites: 27%

Print:

• African Americans: 14%
• Hispanics: 22%
• Non-Hispanic Other 17%
• Whites: 15%

Internet:

• African Americans: 43%
• Hispanics: 36%
• Non-Hispanic Other 48%
• Whites: 50%

Source: U.S. National Cancer Institute's Health Information National Trends Survey (HINTS), 2005

Slide 16

Level of Activation of U.S. Adults

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.

Image: Pie Chart shows:

• Level 1 (least-activated), 6.8%
• Level 2, 14.6%
• Level 3, 37.2%
• Level 4 (most-activated), 41.4%

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.

Slide 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.

Slide 18

Uncertainty in One's Outcomes

Image: Chart shows outcome of reduction of risk of heart attack or heart failure by either standard therapy or use of ACE Inhibitor.

Slide 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

Slide 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

Slide 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.