title: Patient phenotyping in clinical trials of chronic pain treatments: IMMPACT recommendations.
abstract: There is tremendous interpatient variability in the response to analgesic therapy (even for efficacious treatments), which can be the source of great frustration in clinical practice. This has led to calls for "precision medicine" or personalized pain therapeutics (ie, empirically based algorithms that determine the optimal treatments, or treatment combinations, for individual patients) that would presumably improve both the clinical care of patients with pain and the success rates for putative analgesic drugs in phase 2 and 3 clinical trials. However, before implementing this approach, the characteristics of individual patients or subgroups of patients that increase or decrease the response to a specific treatment need to be identified. The challenge is to identify the measurable phenotypic characteristics of patients that are most predictive of individual variation in analgesic treatment outcomes, and the measurement tools that are best suited to evaluate these characteristics. In this article, we present evidence on the most promising of these phenotypic characteristics for use in future research, including psychosocial factors, symptom characteristics, sleep patterns, responses to noxious stimulation, endogenous pain-modulatory processes, and response to pharmacologic challenge. We provide evidence-based recommendations for core phenotyping domains and recommend measures of each domain.
authors.affiliation: Harvard Medical School, Boston, MA, USA.
authors.forename: Robert R
authors.initials: RR
authors.lastname: Edwards
authors.affiliation: University of Rochester, Rochester, NY, USA.
authors.forename: Robert H
authors.initials: RH
authors.lastname: Dworkin
authors.affiliation: University of Washington, Seattle, WA, USA.
authors.forename: Dennis C
authors.initials: DC
authors.lastname: Turk
authors.affiliation: Stanford University, Palo Alto, CA, USA.
authors.forename: Martin S
authors.initials: MS
authors.lastname: Angst
authors.affiliation: East Carolina University, Greenville, NC, USA.
authors.forename: Raymond
authors.initials: R
authors.lastname: Dionne
authors.affiliation: Harvard Medical School, Boston, MA, USA.
authors.forename: Roy
authors.initials: R
authors.lastname: Freeman
authors.affiliation: Oslo University Hospital, Oslo, Norway and Karolinska Institute, Stockholm, Sweden.
authors.forename: Per
authors.initials: P
authors.lastname: Hansson
authors.affiliation: Washington University, St. Louis, MO, USA.
authors.forename: Simon
authors.initials: S
authors.lastname: Haroutounian
authors.affiliation: Aalborg University, Aalborg, Denmark.
authors.forename: Lars
authors.initials: L
authors.lastname: Arendt-Nielsen
authors.affiliation: Hôpital Ambroise Paré, APHP and INSERM U 987, Boulogne-Billancourt, France and University Versailles Saint Quentin, Versailles, France.
authors.forename: Nadine
authors.initials: N
authors.lastname: Attal
authors.affiliation: University of Kiel, Kiel, Germany.
authors.forename: Ralf
authors.initials: R
authors.lastname: Baron
authors.affiliation: MetroHealth Medical Center, Cleveland, OH, USA.
authors.forename: Joanna
authors.initials: J
authors.lastname: Brell
authors.affiliation: Depomed, Newark, CA, USA.
authors.forename: Shay
authors.initials: S
authors.lastname: Bujanover
authors.affiliation: LORA Group, LLC, Royal Oak, MD, USA.|University of Maryland, Baltimore, MD, USA.
authors.forename: Laurie B
authors.initials: LB
authors.lastname: Burke
authors.affiliation: Tufts University, Boston, MA, USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Carr
authors.affiliation: Eli Lilly, Indianapolis IN, USA.
authors.forename: Amy S
authors.initials: AS
authors.lastname: Chappell
authors.affiliation: American Chronic Pain Association, Rocklin, CA, USA.
authors.forename: Penney
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authors.lastname: Cowan
authors.affiliation: Johnson and Johnson, Titusville, NJ, USA.
authors.forename: Mila
authors.initials: M
authors.lastname: Etropolski
authors.affiliation: University of Florida, Gainesville, FL, USA.
authors.forename: Roger B
authors.initials: RB
authors.lastname: Fillingim
authors.affiliation: University of Rochester, Rochester, NY, USA.
authors.forename: Jennifer S
authors.initials: JS
authors.lastname: Gewandter
authors.affiliation: Tufts University, Boston, MA, USA.|Analgesic Solutions, Natick, MA, USA.
authors.forename: Nathaniel P
authors.initials: NP
authors.lastname: Katz
authors.affiliation: Collegium Pharmaceutical, Inc., Canton, MA, USA.
authors.forename: Ernest A
authors.initials: EA
authors.lastname: Kopecky
authors.affiliation: University of Rochester, Rochester, NY, USA.
authors.forename: John D
authors.initials: JD
authors.lastname: Markman
authors.affiliation: Astellas Pharma, Northbrook, IL, USA.
authors.forename: George
authors.initials: G
authors.lastname: Nomikos
authors.affiliation: National Institutes of Health, Bethesda, MD, USA.
authors.forename: Linda
authors.initials: L
authors.lastname: Porter
authors.affiliation: Arlington, VA, USA.
authors.forename: Bob A
authors.initials: BA
authors.lastname: Rappaport
authors.affiliation: Imperial College, London, United Kingdom.
authors.forename: Andrew S C
authors.initials: ASC
authors.lastname: Rice
authors.affiliation: Pfizer, Groton, CT, USA.
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Scavone
authors.affiliation: Columbia University, New York, NY, USA.
authors.forename: Joachim
authors.initials: J
authors.lastname: Scholz
authors.affiliation: SDG LLC, Cambridge, MA, USA.
authors.forename: Lee S
authors.initials: LS
authors.lastname: Simon
authors.affiliation: University of Rochester, Rochester, NY, USA.
authors.forename: Shannon M
authors.initials: SM
authors.lastname: Smith
authors.affiliation: Jazz Pharmaceuticals, Palo Alto, CA, USA.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Tobias
authors.affiliation: Ceres Consulting, Fort Montgomery, NY, USA.
authors.forename: Tina
authors.initials: T
authors.lastname: Tockarshewsky
authors.affiliation: Chronic Pain Research Alliance, North Kingstown, RI, USA.
authors.forename: Christine
authors.initials: C
authors.lastname: Veasley
authors.affiliation: Zalicus, Cambridge, MA, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Versavel
authors.affiliation: University of Pittsburgh, Pittsburgh, PA, USA.
authors.forename: Ajay D
authors.initials: AD
authors.lastname: Wasan
authors.affiliation: Purdue Pharma, Stamford, CT, USA.
authors.forename: Warren
authors.initials: W
authors.lastname: Wen
authors.affiliation: Rambam Health Care Campus and Technion Faculty of Medicine, Haifa, Israel.
authors.forename: David
authors.initials: D
authors.lastname: Yarnitsky
mesh_terms: D000700:Analgesics / Q000627:therapeutic use*; D059350:Chronic Pain / Q000188:drug therapy* / Q000523:psychology; D002986:Clinical Trials as Topic / Q000379:methods*; D006801:Humans; D010147:Pain Measurement / Q000379:methods* / Q000592:standards*; D010641:Phenotype; D016896:Treatment Outcome
chemical_list: D000700:Analgesics