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

PROGRAM AND SUMMARY

On June 11 and 12, 1990, the Institute of Medicine (IOM) sponsored a workshop on Conflicts of Interest in Patient Outcomes Research Teams (PORTs). The workshop was planned by a steering committee formally appointed to the task by the IOM. The purpose of the IOM workshop was to assist the Agency for Health Care Policy and Research (AHCPR), PORTs, and other parties to anticipate conflicts of interest and to identify issues to consider in dealing with them to ensure the credibility of PORT assessments.

Invitations to attend the conference were sent to the principal investigators of all currently funded PORTs and planning grantees and to others who represented the perspectives of academic institutions, industry, health services research, law, third party payers, policymakers, AHCPR, and congressional staff. About 60 participants and IOM staff attended the one-and-a-half day meeting. Background materials, such as recent policy statements on conflicts of interest in academic centers and papers commissioned for the workshop, were distributed to participants before or at the time of the conference.

The first day of the workshop included introductory remarks by Samuel O. Thier, president of the IOM, and a presentation by John Wennberg, principal investigator of the Dartmouth PORT. J. Jarrett Clinton, acting administrator of AHCPR, provided an update on and his views of the Medical Treatment Effectiveness Program.

The remainder of the first day included panel and participant discussions of three scenarios written for the workshop. Topics raised in the scenarios ranged from relatively straightforward equity and consulting



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Patient Outcomes Research Teams: Managing Conflict of Interest Appendix A Institute of Medicine Workshop on Conflicts of Interest in Patient Outcomes Research Teams PROGRAM AND SUMMARY On June 11 and 12, 1990, the Institute of Medicine (IOM) sponsored a workshop on Conflicts of Interest in Patient Outcomes Research Teams (PORTs). The workshop was planned by a steering committee formally appointed to the task by the IOM. The purpose of the IOM workshop was to assist the Agency for Health Care Policy and Research (AHCPR), PORTs, and other parties to anticipate conflicts of interest and to identify issues to consider in dealing with them to ensure the credibility of PORT assessments. Invitations to attend the conference were sent to the principal investigators of all currently funded PORTs and planning grantees and to others who represented the perspectives of academic institutions, industry, health services research, law, third party payers, policymakers, AHCPR, and congressional staff. About 60 participants and IOM staff attended the one-and-a-half day meeting. Background materials, such as recent policy statements on conflicts of interest in academic centers and papers commissioned for the workshop, were distributed to participants before or at the time of the conference. The first day of the workshop included introductory remarks by Samuel O. Thier, president of the IOM, and a presentation by John Wennberg, principal investigator of the Dartmouth PORT. J. Jarrett Clinton, acting administrator of AHCPR, provided an update on and his views of the Medical Treatment Effectiveness Program. The remainder of the first day included panel and participant discussions of three scenarios written for the workshop. Topics raised in the scenarios ranged from relatively straightforward equity and consulting

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Patient Outcomes Research Teams: Managing Conflict of Interest issues to more elaborate situations involving possible academic and professional conflicts of interest and joint ventures involving industry, payers, academic institutions, PORTs and AHCPR. The discussions were led by the chairman of the committee, Alexander Capron. After each scenario a rapporteur summarized the discussion (Appendix C). On the second day, Christine Williams, a member of the staff of Senator George Mitchell, spoke about ''Congressional Views and Expectations for the PORTs." Judith Lave, a health economist, discussed PORTs' impact on health services research, technology innovation, and payment policy. The conference concluded with a discussion among a panel composed of the committee chairman, the rapporteurs of the three scenarios, and all workshop participants. The workshop discussions illuminated the difficulty of forming specific rules for dealing with problematic and complex cases. Such decisions tend to be made more on the basis of what is perceived to be common practice than on consideration of whether such common practice constitutes a reasonable and defensible action. Participants expressed a wide spectrum of views about the inherent danger of any given activity. Understanding how such ad hoc rules would affect researchers, research, funding and, more distantly, the public welfare, are beyond our current capacity. Such complex cases will, however, form the "case law" for managing conflicts of interest. As an exercise for the committee, the discussions helped to make concrete the risks and benefits of various financial and professional relationships intrinsic to the PORT methodology. They broadened the views of the committee to include the experiences and expectations of current PORT investigators and others.

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Patient Outcomes Research Teams: Managing Conflict of Interest Agenda Day 1: Monday, June 11, 1990 (Salons D&E) 8:00 a.m. Registration and Continental Breakfast 8:40 a.m. Welcome and Opening Remarks   Samuel Thier, President   Institute of Medicine 9:00 a.m. PORT Structures and Methods   John Wennberg, Dartmouth Medical School 9:30 a.m. Discussion 9:45 a.m. Scenario I: Presentation and Panel Discussion   Moderator: Alexander Capron   Panel: Bernard Barber, Bruce Brennan, Barbara Hansen, Barbara Mishkin, Earl Steinberg   Rapporteur: David Blumenthal 10:30 a.m. BREAK 10:45 a.m. Continue Panel Discussion and Participants' Views 11:45 a.m. Rapporteur Summary 12:00 p.m. LUNCH (SALON H) 1:00 p.m. Luncheon Speaker: Update on Activities of the Medical Treatment Effectiveness Program   J. Jarrett Clinton, Acting Administrator   Agency for Health Care Policy and Research 1:30 p.m. Scenario II: Presentation and Panel Discussion   Moderator: Alexander Capron   Panel: Marilyn Bergner, John Brown, Peter Budetti, C. K. Gunsalus, David Pryor   Rapporteur: Marcia Angell

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Patient Outcomes Research Teams: Managing Conflict of Interest 2:15 p.m. Participants' Views and Discussion 2:45 p.m. Rapporteur Summary 3:00 p.m. BREAK 3:15 p.m. Scenario III: Presentation and Panel Discussion   Moderator: Alexander Capron   Panel: Peter Barton Hutt, David Korn, Bryan Luce, Barbara McNeil, Lawrence Morris   Rapporteur: Michael Pollard 4:00 p.m. Participants' Views and Discussion 4:30 p.m. Rapporteur Summary 4:45 p.m. What Emergent Issues Have Not Been Revealed by the Scenarios?   Discussion 5:30 p.m. BREAK 6:00 p.m. RECEPTION (SOUTH GALLERY) 6:30 p.m. DINNER (SALON H) Day 2: Tuesday, June 12, 1990 (SALON II) 8:30 a.m. Continental Breakfast 9:00 a.m. Congressional Views and Expectations of Outcomes   Research by PORTs   Christine Williams, Legislative Assistant   Office of Senator George J. Mitchell 9:30 a.m. Envisioning the Role and Significance of PORTs for Health Services Research, Technology Innovation, and Payment Policy   Judith Lave

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Patient Outcomes Research Teams: Managing Conflict of Interest 10:00 a.m. BREAK 10:30 a.m. Anticipating and Managing Conflicts of Interest: Points to Consider for AHCPR, PORTs, Industry, and Others   Roundtable Discussion and Participants' Views   Alexander Capron (Moderator), Marcia Angell, David Blumenthal, Michael Pollard 11:30 a.m. Summary of Discussion Noon Adjourn Workshop 12:15 p.m. Executive Luncheon Session of Steering Committee   (SALON C)