# Presentation: 445398

## What do we know about how evidence of harm and benefit is communicated in other countries?

**Valerie King MD, MPH and David Hickam MD, MPH **
**John M. Eisenberg Clinical Decisions and Communications Science Center**
**Oregon Health & Science University**

## Overview

- Set the Stage—International Context
- Literature Review
- Describe International Examples
- Overall Goals for Today:
- Identify Best Practices
- Identify Gaps in Research
- Apply Discussion to Eisenberg Center’s Work

## Methods

- Literature Review
- Medline--1996-2006
- Search Terms:
- Patient Education
- Evidence-based Medicine
- Pharmaceutical Preparations
- Consumer Information Products from Other Countries
- Description
- Compare characteristics

## Literature Review

- Criteria for inclusion:
- Describes an information tool for use by consumers/patients
- Addresses treatment of a defined condition
- Addresses risks and benefits
- Uses evidence

## Results of Literature Review

- Search retrieved 544 citations
- 18 citations met inclusion criteria and were reviewed in full
- 5 citations excluded for accessibility
- 3 non-English
- 2 inaccessible journal
- 13 final articles included in review
- 2 systematic reviews
- 11 original studies

## Description of Evidence Translation Approaches in the Medical Literature

- Many examples of descriptive reports of tools used for single diseases, without evaluation
- Many programs deal with health promotion or high stakes treatments (oncology topics)
- Evolution from booklets to internet sites
- Health literacy is a frequent theme
- Evaluations focus on understandability and motivation to talk to provider
- Sample sizes generally small

## Example from Medical Literature (United States)

- Decision: prostate cancer treatment
- Multiple formats: booklet, web-based, audiotape
- Explicit approach to translation of evidence (but not rating of strength)
- Explicit description of harms of treatments
- Booklet not available for review
- Holmes-Rovner M et al.  Evidence-based patient choice: a prostate cancer decision aid in plain language.  BMC Medical Informatics and Decision Making 2005; 5(1):16.

## Example from Medical Literature (Northern Ireland)

- Decision: hormonal therapy for prostate cancer
- Format: booklet (not available for review)
- Approach to translating evidence not described
- Included description of harms of treatments
- Evaluated knowledge and satisfaction
- Templeton H, Coates V.  Evaluation of an evidence-based education package for men with prostate cancer on hormonal manipulation therapy.  Patient Education and Counseling 2004; 55:55-61.

## Information Products from Other Countries

- How is risk and benefit communicated to health care consumers?

## Criteria for selection of consumer information products for description

- Topic related to a pharmaceutical agent
- Product available in print or web-based format
- Related to an evidence review with or without an associated clinical practice guideline
- Government involvement in review and/or product
- English speaking country with advanced healthcare system
- Canada
- Australia
- New Zealand
- United Kingdom

## Framework for Description of Consumer Information Products 

- Does product describe the audience to whom it applies?
- Does it discuss alternative treatment options?
- Does product discuss harm and benefit of treatment with the drug?
- Does it give guidance on how the information can be used in decision-making?
- How is information presented?
- How does product discuss strength of evidence about benefits and/or harms?

## Canada and New Zealand

- Canada
- Clinical Practice Guidelines for Diagnosis and Management of Osteoporosis in Canada (2002)
*Osteoporosis Canada Website, “Drug Treatments”*
- New Zealand
- New Zealand Guidelines Group—Hormone Replacement Therapy (2004)
*HRT—New Information for Women*

## Australia and United Kingdom

- Australia
- Australian Acute Musculoskeletal Pain Guidelines Group—Evidence-based Management of Acute Musculoskeletal Pain (2003)
*Acute Low Back Pain*
- United Kingdom
- National Institute for Health and Clinical Excellence (NICE)—Statins for the prevention of cardiovascular events (2006)
*Statins for the prevention of cardiovascular events. Understanding NICE guidance—information for people who have or are at increased risk of cardiovascular disease, their families and the public*

## Canada

- Osteoporosis Canada
*“**Drug Treatments” (website)*

## Brown, et al.  CMAJ 2002.

## Osteoporosis Society of Canada.  Osteoporosis Update 2003.

## www.osteoporosis.ca

## Slide 18

## Osteoporosis Canada:  About Osteoporosis--Drug Treatments

| Appropriate Audience | Compare Alternatives | Benefits and Harms | Assist Decision-making | Information
Presentation
 | Strength of
Evidence |
| --- | --- | --- | --- | --- | --- |
| Implicit | Discusses various treatments, but no direct
comparison of alternatives | Yes, both discussed, but not in detail | Yes,
Explore with doctor and find best drug for person | Narrative,
Q&A format, Table of bisphos-phonates | Not discussed |

## New Zealand

- The New Zealand Guidelines Group
*HRT—New Information for Women*

## http://www.nzgg.org.nz/guidelines/0078/HRT_summary_web.pdf

## http://www.nzgg.org.nz/index.cfm?fuseaction=download&fusesubaction=template&libraryID=219

## Slide 23

## NZGG:  HRT—New Information for Women

| Appropriate Audience | Compare Alternatives | Benefits and Harms | Assist Decision-making | Information
Presentation
 | Strength of
Evidence |
| --- | --- | --- | --- | --- | --- |
| Implicit | Yes; 
Hot flushes (botanicals)

Vaginal dryness (lubricants & topical E2)
 | Yes;
includingWHI results table | Clear key messages 
without specific guidance on how to use  | Web (pdf) and Pamphlet.

Narrative, Q&A, Table on WHI results. 
 | No direct statement
(extensive info on WHI) |

## Australia

- Australian Acute Musculoskeletal Pain Guidelines Group
*Acute Low Back Pain*

## http://www.nhmrc.gov.au/publications/synopses/cp94syn.htm

## Associated Patient Materials on Acute Musculoskeletal Pain

- Low Back Pain
- Thoracic Spinal Pain
- Neck Pain
- Shoulder Pain
- Anterior Knee Pain
- Complete clinician guide also available

## Slide 28

## Slide 29

## Australian Acute Musculoskeletal Pain Guidelines Group:Acute Low Back Pain

| Appropriate Audience | Compare Alternatives | Benefits and Harms | Assist Decision-making | Information
Presentation
 | Strength of
Evidence |
| --- | --- | --- | --- | --- | --- |
| Implicit | Yes | Benefits in general, harms only in context on not being effective for pain | Clear steps to follow, but no help in weighing alterna-tives | Narrative, Q&A format | Discusses which alternatives have research to support effective-ness, but not strength of evidence |

## United Kingdom

- Statins for the Prevention of Cardiovascular Events

## http://www.nhmrc.gov.au/publications/synopses/cp94syn.htm

## Slide 33

## Slide 34

## NICE:  Statins for the Prevention of Cardiovascular Events

| Appropriate Audience | Compare Alternatives | Benefits and Harms | Assist Decision-making | Information
Presentation
 | Strength of
Evidence |
| --- | --- | --- | --- | --- | --- |
| Yes | Only among statins | Brief info on benefits only, no info on specific harms | No, except for advice to talk to doctor | Web (pdf) and flyer

Narrative
Text | No, only that advice based on good-quality studies |

## AHRQ:Effective Health Care ProgramThe John M. Eisenberg Center

## Slide 37

## Example of an Eisenberg Center Product in Development

*Choosing Pain Medicine—*
*A guide for people with osteoarthritis*

## Slide 39

## Eisenberg Center:  Choosing Pain Medicine—A guide for people with osteoarthritis

| Appropriate Audience | Compare Alternatives | Benefits and Harms | Assist Decision-making | Information
Presentation
 | Strength of
Evidence |
| --- | --- | --- | --- | --- | --- |
| Yes | Yes, 
OTC meds,
NSAIDs, COX-2s,
Topicals, Supple-ments | Yes, pain relief and risk of CV event or GI bleeding | Yes, sort out benefit, risk, cost of choices  | Narrative,
Q&A,
Price comparisonchart | Not discussed directly |

## An International Perspective

- Information for consumers contains background info, going beyond the systematic evidence review
- Other countries develop clinical practice guidelines for use in health service—different context
- UK has very explicit link between evidence review and consumer products
- Detailed harm and benefit information rare
- Decision-making referred to doctor consultation
- None provide explicit strength of evidence

## What can we learn?

- Are there best practices employed in other countries that can help guide how the Eisenberg Center develops information products?
- How can the Eisenberg Center best contribute to narrowing the gaps in our knowledge of how best to communicate with health care consumers?