title: Pain intensity rating training: results from an exploratory study of the ACTTION PROTECCT system.
abstract: Clinical trial participants often require additional instruction to prevent idiosyncratic interpretations regarding completion of patient-reported outcomes. The Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership developed a training system with specific, standardized guidance regarding daily average pain intensity ratings. A 3-week exploratory study among participants with low-back pain, osteoarthritis of the knee or hip, and painful diabetic peripheral neuropathy was conducted, randomly assigning participants to 1 of 3 groups: training with human pain assessment (T+); training with automated pain assessment (T); or no training with automated pain assessment (C). Although most measures of validity and reliability did not reveal significant differences between groups, some benefit was observed in discriminant validity, amount of missing data, and ranking order of least, worst, and average pain intensity ratings for participants in Group T+ compared with the other groups. Prediction of greater reliability in average pain intensity ratings in Group T+ compared with the other groups was not supported, which might indicate that training produces ratings that reflect the reality of temporal pain fluctuations. Results of this novel study suggest the need to test the training system in a prospective analgesic treatment trial.
authors.affiliation: Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA Department of Rehabilitation Medicine, University of Washington, Seattle, WA, USA Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA School of Professional Psychology, Pacific University, Hillsboro, OR, USA Department of Biostatistics and Computational Biology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA Evidera, Seattle, WA, USA LORA Group, LLC, Royal Oak, MD, USA University of Maryland, Baltimore, MD, USA Department of Pediatrics, Dalhousie University, Halifax, NS, Canada Department of Psychology and Neuroscience, Dalhousie University, Halifax, NS, Canada Centre for Pediatric Pain Research, IWK Health Center, Halifax, NS, Canada Palm Beach Gardens, FL, USA American Chronic Pain Association, Rocklin, CA, USA Desjardins Associates, Maplewood, NJ, USA Johnson & Johnson, Titusville, NJ, USA Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, PA, USA Department of Anesthesia, University of Pennsylvania, Philadelphia, PA, USA Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA Department of Anesthesiology & Perioperative Medicine, Queen's University, Kingston, ON, Canada Department of Biomedical & Molecular Sciences, Queen's University, Kingston, ON, Canada Jazz Pharmaceuticals, Palo Alto, CA, USA Purdue Pharma L.P., Stamford, CT, USA VA Connecticut Healthcare System, West Haven, CT, USA Department of Psychiatry, Yale University, New Haven, CT, USA Department of Neurology, Yale University, New Haven, CT, USA Department of Psychology, Yale University, New Haven, CT, USA Collegium Pharmaceutical, Inc, Canton, MA, USA Analgesic Concepts, Arlington, VA, USA Pfizer, Inc, New York, NY, USA Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, USA Chronic Pain Research Alliance, North Kingstown, RI, USA vZenium LLC, Arlington, MA, USA Department of Anesthesiology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA Department of Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA Center for Human Experimental Therapeutics, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
authors.forename: Shannon M
authors.initials: SM
authors.lastname: Smith
authors.forename: Dagmar
authors.initials: D
authors.lastname: Amtmann
authors.forename: Robert L
authors.initials: RL
authors.lastname: Askew
authors.forename: Jennifer S
authors.initials: JS
authors.lastname: Gewandter
authors.forename: Matthew
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authors.lastname: Hunsinger
authors.forename: Mark P
authors.initials: MP
authors.lastname: Jensen
authors.forename: Michael P
authors.initials: MP
authors.lastname: McDermott
authors.forename: Kushang V
authors.initials: KV
authors.lastname: Patel
authors.forename: Mark
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authors.lastname: Williams
authors.forename: Elizabeth D
authors.initials: ED
authors.lastname: Bacci
authors.forename: Laurie B
authors.initials: LB
authors.lastname: Burke
authors.forename: Christine T
authors.initials: CT
authors.lastname: Chambers
authors.forename: Stephen A
authors.initials: SA
authors.lastname: Cooper
authors.forename: Penney
authors.initials: P
authors.lastname: Cowan
authors.forename: Paul
authors.initials: P
authors.lastname: Desjardins
authors.forename: Mila
authors.initials: M
authors.lastname: Etropolski
authors.forename: John T
authors.initials: JT
authors.lastname: Farrar
authors.forename: Ian
authors.initials: I
authors.lastname: Gilron
authors.forename: I-Zu
authors.initials: IZ
authors.lastname: Huang
authors.forename: Mitchell
authors.initials: M
authors.lastname: Katz
authors.forename: Robert D
authors.initials: RD
authors.lastname: Kerns
authors.forename: Ernest A
authors.initials: EA
authors.lastname: Kopecky
authors.forename: Bob A
authors.initials: BA
authors.lastname: Rappaport
authors.forename: Malca
authors.initials: M
authors.lastname: Resnick
authors.forename: Vibeke
authors.initials: V
authors.lastname: Strand
authors.forename: Geertrui F
authors.initials: GF
authors.lastname: Vanhove
authors.forename: Christin
authors.initials: C
authors.lastname: Veasley
authors.forename: Mark
authors.initials: M
authors.lastname: Versavel
authors.forename: Ajay D
authors.initials: AD
authors.lastname: Wasan
authors.forename: Dennis C
authors.initials: DC
authors.lastname: Turk
authors.forename: Robert H
authors.initials: RH
authors.lastname: Dworkin
mesh_terms: D000368:Aged; D003929:Diabetic Neuropathies / Q000175:diagnosis*; D005260:Female; D006801:Humans; D007318:Inservice Training; D017116:Low Back Pain / Q000175:diagnosis*; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000175:diagnosis*; D010147:Pain Measurement / Q000379:methods*; D015203:Reproducibility of Results; D013223:Statistics as Topic