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Workshop on Control/Comparison Groups for Trials of Non-Pharmacologic Interventions

Bethesda North Marriott Hotel and Conference Center

Goals of Workshop

  1. The purpose of this workshop is to review the strengths and weaknesses of the various control/comparison groups used in studies of non-pharmacological interventions (NPI) and the most appropriate use of these control/comparison groups.
  2. Provide guidance to NIH and the scientific community on the most appropriate control/comparison groups for various research questions testing the efficacy or effectiveness of non-pharmacological interventions (NPI).

Agenda

Day 1, Monday, April 26, 2010

All sessions will be held in Brookside A & B unless otherwise stated in the agenda.

7:30–8:30
Registration
Brookside Foyer
8:30–8:45
Introduction and Welcome
Josephine Briggs, M.D., and Richard Nahin, Ph.D., M.P.H.
8:45–9:45
Overview
General concepts and key issues in selection of controls groups for non-pharmacological interventions—Catherine Stoney, Ph.D.
Case Studies of NPI
  1. Acupuncture—Karen Sherman, Ph.D.
  2. Cognitive Behavioral Therapy—Linda Craighead, Ph.D.
9:45–11:00
Session I
Discuss control and/or comparison groups that would be appropriate for research studies that address the hypothesis,
“Does this intervention work at all?”
David Mohr, Ph.D.

General Discussion

11:00–11:15
Break
11:15–12:30
Session II
Discuss control and/or comparison groups that would be appropriate for research studies that address the hypothesis,
“What Is/Are The Major Active Component(s) Of The NPI?”
Ted Kaptchuk, O.M.D.

General Discussion

12:30–2:00
Lunch
2:00–3:15
Session III
Discuss control and/or comparison groups that would be appropriate for research studies that address the hypothesis,
“What Is/Are The Major Effective Mechanism(s) Of The NPI?”
Margaret Chesney, Ph.D.

General Discussion

3:15–3:30
Break
3:30–5:00
Breakout Groups I
Panelists will be divided into groups
  1. Group I: Active Clinician—Passive Subject
    David Lowenstein, Ph.D., Leader
    Room: Linden Oak
  2. Group II: Instructor/Trainer—Active Subject
    Karen Sherman, Ph.D., Leader
    Room: Oakley
  3. Group III: Active Clinician—Active Subject
    Lynda Powell, M.Ed., Ph.D., Leader
    Room: Brookside A & B
5:00–5:30
Mini-report back from each group

Day 2, Tuesday, April 27, 2010

All sessions will be held in Brookside A & B unless otherwise stated in the agenda.

7:30–8:30
Registration
Brookside Foyer
8:30–8:45
Recap of Day 1: What have we learned so far?
8:45–10:00
Session IV
Discuss control and/or comparison groups that would be appropriate for research studies that address the hypothesis,
“Is This NPI As Good As (Or Better Than) _____?”
Edward Nunes, M.D.

General Discussion

10:00–10:15
Break
10:15–11:30
Session V
Discuss control and/or comparison groups that would be appropriate for research studies that address the hypothesis,
“Does This NPI Improve Standard-of-Care?”
Ken Freedland, Ph.D.

General Discussion

11:30–12:30
Lunch
12:30–2:00
Breakout Groups II
  1. Group I: No Clinician/Instructor—Active Subject
    David Lowenstein, Ph.D., Leader
    Room: Linden Oak
  2. Group II: Instructor/Trainer—Active Subject
    Karen Sherman, Ph.D., Leader
    Room: Oakley
  3. Group III: Active Clinician—Active Subject
    Lynda Powell, M.Ed., Ph.D., Leader
    Room: Brookside A & B
2:00–2:30
Mini-report back from each group
2:30–2:45
Break
2:45–3:15
Integration of Ideas Across Breakout Groups
3:15–4:00
Summary
Conclusions and Overall Assignments for Developing Guidance Documents

Presenters

Josephine Briggs, M.D.
National Center for Complementary and Alternative Medicine, NIH

Richard Nahin, Ph.D.
National Center for Complementary and Alternative Medicine, NIH

Catherine Stoney, Ph.D.
National Heart, Lung, and Blood Institute, NIH

Karen Sherman, Ph.D.
Group Health of Puget Sound

Linda Craighead, Ph.D.
Emory University

David Mohr, Ph.D.
Northwestern University

Ted Kaptchuk, O.M.D.
Harvard University

Margaret Chesney, Ph.D.
University of California San Francisco

Edward Nunes, M.D.
Columbia University

Ken Freeland, Ph.D.
Washington University

Discussants and Breakout Leaders

Donald Klein, M.D., D.Sc.
Columbia University

David Loewenstein, Ph.D.
University of Miami

Frank Miller, Ph.D.
National Institutes of Health

Denise Park, Ph.D.
University of Texas Dallas

Lynda Powell, M.Ed., Ph.D.
Rush University

Ken Resnicow, Ph.D.
University of Michigan

Joseph Schwartz, Ph.D.
Columbia University

Karen Sherman, Ph.D.
Group Health of Puget Sound

Dennis Turk, Ph.D.
University of Washington

Overview and Registration Information