Patient outcomes research teams : managing conflict of interest / Committee on Potential Conflicts of Interest in Patient Outcomes Research Teams, Institute of Medicine ; Molla S. Donaldson and Alexander M. Capron, editors.

Format:

Book

Author/Creator:

Institute of Medicine (U.S.). Committee on Potential Conflicts of Interest in Patient Outcomes Research Teams.

Contributor:

Donaldson, Molla S.

Capron, Alexander Morgan.

Language:

English

Subjects (All):

Outcome assessment (Medical care)--United States.

Outcome assessment (Medical care).

Physical Description:

xii, 170 p.

Edition:

1st ed.

Place of Publication:

Washington, D.C. : National Academy Press, 1991.

Language Note:

English

Summary:

The new Agency for Health Care Policy and Research in the U.S. Public Health Service is funding a set of multidisciplinary groups called Patient Outcomes Research Teams (PORTs). Their purpose is to assess alternative treatments for medical conditions using a variety of outcome measures. In guiding insurance coverage, these PORTs are expected to wield considerable influence on medical practice and health policy. This book addresses possible threats to their credibility that might be based on real or apparent conflicts of interest, including both financial and other conflicts. It raises points to consider for the new agency, for PORTs and their institutions, for industry, for the health services research community, and for the U.S. Congress in avoiding and managing conflicts of interest.

Contents:

Patient Outcomes Research Teams: Managing Conflict of Interest

Copyright

Acknowledgments

Preface

Contents

Summary

INSTITUTE OF MEDICINE STUDY

DEFINING CONFLICT OF INTEREST

MODELS FOR ADDRESSING CONFLICTS OF INTEREST

POINTS TO CONSIDER

1 Introduction

OUTCOMES RESEARCH

THE INSTITUTE OF MEDICINE STUDY

STRUCTURE OF THE REPORT

2 Patient Outcomes Research Teams

THE MEDICAL TREATMENT EFFECTIVENESS PROGRAM

PORT RESEARCH TOPICS

PORT STRUCTURE

PORT METHODS

SPECIAL ASPECTS OF PORT RESEARCH

SUMMARY

3 Conflict of Interest

FINANCIAL RELATIONSHIPS THAT MAY GIVE RISE TO CONFLICTS OF INTEREST

Equity and Other Financial Relationships

Industry Support for University Research

ACADEMIC AND PROFESSIONAL CONFLICTS OF INTEREST

ADDRESSING CONFLICTS OF INTEREST

Legislative Support for Technology Transfer

EFFECTS OF UNIVERSITY-INDUSTRY COLLABORATION

RELEVANT EFFORTS IN OTHER SECTORS

Regulation or Federal Employees

FDA Federal Advisory Committees

The United States Pharmacopeial Convention

Professional Associations

National Research Council

National Institutes of Health Grants Policy

Academic Association and Institutional Guidelines

AAMC Guidelines

AAHC Guidelines

Academic Institutional Guidelines

Medical Publications

Judicial and Legal Approaches

4 Sources of Concern About Conflicts of Interest in PORTs

ELEVEN ISSUES OF SPECIAL CONCERN

PORTs as Hybrid Entities: Research and Quasi-Regulatory Functions

PORTs as a Public Trust for Development of Scientific Knowledge

PORTs as a Quasi-Regulatory Process

Protecting PORT Credibility

Expectations of Cost Savings

Concentration of Expertise

Subjective Judgments and Multidimensional Outcome Assessments.

Biases Arising from Ties to Professional Colleagues and Associations

Access to Data

Adequacy of Existing Institutional Guidelines

Multi-Institutional PORTs

Nonuniversity Clinicians and Their Patients

Private Funding for Technological Modifications and New Practices

Additional Study Arms

Secondary Protocols

Consulting and Other Financial Arrangements

Spin-Off Ventures and Intellectual Property Rights

Equity Interests of PORT Investigators

Freedom of Communication Within PORTs

5 Managing Conflicts of Interest: General Models and Approaches

TWO MODELS OF CONFLICT OF INTEREST MANAGEMENT

Prohibition Model

Disclosure and Peer Review Model

GENERAL APPROACHES TO DEALING WITH CONFLICTS OF INTEREST

Disclosure

Financial Distancing

Self-Regulation

Defining Categories of Acceptable Activities and Implementing Oversight

Defining Categories of Unacceptable Activities and Implementing Prohibitions

Sanctions

6 Points to Consider

ASSUMPTION

CONSIDERATIONS FOR PORTS AND THEIR INSTITUTIONS

Attributes of Conflict of Interest Management

Education for Researchers, Faculty, and Students

Clearly Stated Expectations for Early and Complete Disclosure

Well-Formulated and Well-Implemented Institutional Processes and Responses

Emphasis on the Role of the Principal Investigator

Professional Conflicts and Implications for PORT Research

Freedom of Communication for PORT Researchers

CONSIDERATIONS FOR AHCPR

Industry-Sponsored Research

Intra- and Inter-PORT Differences

Review of Grant Applications

CONSIDERATIONS FOR THE HEALTH SERVICES RESEARCH COMMUNITY

CONSIDERATIONS FOR INDUSTRY

Publication and Communication of Findings among PORT Members and Industry

CONSIDERATIONS FOR CONGRESS

CONCLUDING REMARKS

References.

Appendix A Institute of Medicine Workshop on Conflicts of Interest in Patient Outcomes Research Teams

PROGRAM AND SUMMARY

Appendix B Workshop Participants

INVITED PARTICIPANTS

PRESS REPRESENTATIVE

INSTITUTE OF MEDICINE

Appendix C Scenarios and Rapporteur Summaries

APPENDIX C1. SCENARIO I

Discussion of Scenario I

APPENDIX C2. SCENARIO II

CARDPAK: Start of Study

Outside Activities of the PORT Members

Preliminary Results of the PORT Analyses: Four Years into the Study

Discussion of Scenario II

APPENDIX C3. SCENARIO III

Discussion of Scenario III

Appendix D Background Papers

APPENDIX D1. PORT RESEARCH COMPARED WITH CLINICAL RESEARCH: CONFLICTS OF INTEREST IN PATIENT OUTCOME RESEARCH

Introduction

Patient Outcomes Research Teams

Conflicts of Interest in Patient Outcomes Research Teams

Opportunity and Motive

Traditional Conflicts of Interest: Funding, Consulting, and Equity

Spinoff Ventures and Intellectual Property Rights

Changing Stakeholders

Conclusions: What's Different about Outcomes Research?

References

APPENDIX D2. PORTS: THEIR IMPACT ON HEALTH SERVICES RESEARCH, TECHNOLOGY INNOVATION, AND PAYMENT POLICY

Health Services Research

Structure

Possible Threats to PORT Success

Cost of the PORTS

Technology Innovation

Payment Policy

Kinds of Uses for Information

Magnitude of Impact

Discussion

Conclusions

APPENDIX D3. THE EVOLUTION AND CURRENT STATUS OF CONFLICT OF INTEREST REGULATION IN BIOMEDICAL SCIENCE

Historical Overview

Recent Concerns Regarding Clinical Studies

NIH Activity in the Area

Recent Self-Regulation in Clinical Studies

Recent Moves by Consortia and Individual Institutions

Conclusions and Applications to the PORTs

Notes.

APPENDIX D4. THE STRUCTURE AND METHODS OF PORTS: SOURCES OF BIAS

PORT Mission

Experiences of the Dartmouth Assessment Team

Vulnerability of PORT Mission to Conflict of Interest and Corruption of Purpose

Economic Conflict of Interest

Ideological Corruption

Existential Corruption

Corruption of Discursive Practices.

Notes:

Bibliographic Level Mode of Issuance: Monograph

Includes bibliographical references (p. 93-97).

ISBN:

9786610203819

9781280203817

1280203811

9780309583244

0309583241

9780585143316

0585143315

OCLC:

923261970