Core outcome domains for chronic pain clinical trials: IMMPACT recommendations.
OBJECTIVE
To provide recommendations for the core outcome domains that should be considered by investigators conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain. Development of a core set of outcome domains would facilitate comparison and pooling of data, encourage more complete reporting of outcomes, simplify the preparation and review of research proposals and manuscripts, and allow clinicians to make informed decisions regarding the risks and benefits of treatment.


METHODS
Under the auspices of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT), 27 specialists from academia, governmental agencies, and the pharmaceutical industry participated in a consensus meeting and identified core outcome domains that should be considered in clinical trials of treatments for chronic pain.


CONCLUSIONS
There was a consensus that chronic pain clinical trials should assess outcomes representing six core domains: (1) pain, (2) physical functioning, (3) emotional functioning, (4) participant ratings of improvement and satisfaction with treatment, (5) symptoms and adverse events, (6) participant disposition (e.g. adherence to the treatment regimen and reasons for premature withdrawal from the trial). Although consideration should be given to the assessment of each of these domains, there may be exceptions to the general recommendation to include all of these domains in chronic pain trials. When this occurs, the rationale for not including domains should be provided. It is not the intention of these recommendations that assessment of the core domains should be considered a requirement for approval of product applications by regulatory agencies or that a treatment must demonstrate statistically significant effects for all of the relevant core domains to establish evidence of its efficacy.
Turk
Dennis C
DC
Department of Anesthesiology, University of Washington, Seattle, WA 98195, USA University of Rochester, Rochester, NY, USA AstraZeneca, Wilmington, DE, USA University of Queensland, Australia Pfizer Pharmaceutical Group New York, NY, USA Department of Anesthesiology, Tufts University, Medford, MA, USA MD Anderson Cancer Center, Houston, TX, USA National Institute of Dental and Craniofacial Research, Bethesda, MA, USA Center for Clinical Epidemiology & Biostatistics, University of Pennsylvania, Philadelphia, PA, USA Endo Pharmaceuticals Inc., Chadds Ford, PA, USA Ortho-McNeil Pharmaceutical Inc., Raritan, NJ, USA University Health Network and University of Toronto, Toronto, ON, Canada Harvard University, Cambridge, MA, USA Purdue Pharma, Stamford, CT, USA Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA National Institutes of Health, Bethesda, MD, USA Department of Psychology, Dalhousie University, Halifax, Nova Scotia, Canada GlaxoSmithKline, Research Triangle Park, NC, USA Food and Drug Administration, Rockville, MD, USA Department of Physical Medicine and Rehabilitation, University of Washington, Seattle, WA, USA Elan Pharmaceuticals, San Diego, CA, USA Abbott Laboratories, Lake Forrest, IL, USA University of California San Diego, La Jolla, CA, USA US Department of Veterans Affairs, Washington, DC, USA.
Dworkin
Robert H
RH
Allen
Robert R
RR
Bellamy
Nicholas
N
Brandenburg
Nancy
N
Carr
Daniel B
DB
Cleeland
Charles
C
Dionne
Raymond
R
Farrar
John T
JT
Galer
Bradley S
BS
Hewitt
David J
DJ
Jadad
Alejandro R
AR
Katz
Nathaniel P
NP
Kramer
Lynn D
LD
Manning
Donald C
DC
McCormick
Cynthia G
CG
McDermott
Michael P
MP
McGrath
Patrick
P
Quessy
Steve
S
Rappaport
Bob A
BA
Robinson
James P
JP
Royal
Mike A
MA
Simon
Lee
L
Stauffer
Joseph W
JW
Stein
Wendy
W
Tollett
Jane
J
Witter
James
J
D002908:Chronic Disease; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards; D004644:Emotions / Q000502:physiology; D006287:Health Planning Guidelines; D006801:Humans; D010146:Pain / Q000503:physiopathology / Q000523:psychology; D059408:Pain Management; D011788:Quality of Life / Q000523:psychology; D016896:Treatment Outcome