Shutdown message
Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at USA.gov.
Workshop on Control/Comparison Groups for Trials of Non-Pharmacologic Interventions
Bethesda North Marriott Hotel and Conference Center
Goals of Workshop
- 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.
- 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- Acupuncture—Karen Sherman, Ph.D.
- 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- Group I: Active Clinician—Passive Subject
David Lowenstein, Ph.D., Leader
Room: Linden Oak - Group II: Instructor/Trainer—Active Subject
Karen Sherman, Ph.D., Leader
Room: Oakley - Group III: Active Clinician—Active Subject
Lynda Powell, M.Ed., Ph.D., Leader
Room: Brookside A & B
- Group I: Active Clinician—Passive Subject
- 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
- Group I: No Clinician/Instructor—Active Subject
David Lowenstein, Ph.D., Leader
Room: Linden Oak - Group II: Instructor/Trainer—Active Subject
Karen Sherman, Ph.D., Leader
Room: Oakley - Group III: Active Clinician—Active Subject
Lynda Powell, M.Ed., Ph.D., Leader
Room: Brookside A & B
- Group I: No Clinician/Instructor—Active Subject
- 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
