Assessment of Patient-Reported Outcome Instruments to Assess Chronic Low Back Pain.
To identify patient-reported outcome (PRO) instruments that assess chronic low back pain (cLBP) symptoms (specifically pain qualities) and/or impacts for potential use in cLBP clinical trials to demonstrate treatment benefit and support labeling claims.



Literature review of existing PRO measures.



Publications detailing existing PRO measures for cLBP were identified, reviewed, and summarized. As recommended by the US Food & Drug Administration (FDA) PRO development guidance, standard measurement characteristics were reviewed, including development history, psychometric properties (validity and reliability), ability to detect change, and interpretation of observed changes.



Thirteen instruments were selected and reviewed: Low Back Pain Bothersomeness Scale, Neuropathic Pain Symptom Inventory, PainDETECT, Pain Quality Assessment Scale Revised, Revised Short Form McGill Pain Questionnaire, Low Back Pain Impact Questionnaire, Oswestry Disability Index, Pain Disability Index, Roland-Morris Disability Questionnaire, Brief Pain Inventory and Brief Pain Inventory Short Form, Musculoskeletal Outcomes Data Evaluation and Management System Spine Module, Orebro Musculoskeletal Pain Questionnaire, and the West Haven-Yale Multidimensional Pain Inventory Interference Scale. The instruments varied in the aspects of pain and/or impacts that they assessed, and none of the instruments fulfilled all criteria for use in clinical trials to support labeling claims based on recommendations outlined in the FDA PRO guidance.



There is an unmet need for a validated PRO instrument to evaluate cLBP-related symptoms and impacts for use in clinical trials.
Forest Research Institute, Jersey City, New Jersey.
Abhilasha
A
Ramasamy
Health Research Associates, Mountlake Terrace, Washington.
Mona L
ML
Martin
GlaxoSmithKline, Collegeville, Pennsylvania.
Steven I
SI
Blum
Grunenthal, GermanyGmbH, Aachen, Germany.
Hiltrud
H
Liedgens
Albany Medical College, Albany, New York, USA.
Charles
C
Argoff
Benedictus Krankenhaus Tutzing and Technische Universität, München, Germany.
Rainer
R
Freynhagen
University of California San Diego, San Diego, California.
Mark
M
Wallace
Health Research Associates, Mountlake Terrace, Washington.
Kelly P
KP
McCarrier
Health Research Associates, Mountlake Terrace, Washington.
Donald M
DM
Bushnell
Health Research Associates, Mountlake Terrace, Washington.
Noël V
NV
Hatley
University of Washington, Seattle, Washington, USA.
Donald L
DL
Patrick
D059350:Chronic Pain / Q000175:diagnosis* / Q000453:epidemiology; D006801:Humans; D017116:Low Back Pain / Q000175:diagnosis* / Q000453:epidemiology; D010147:Pain Measurement / Q000379:methods* / Q000592:standards; D000071066:Patient Reported Outcome Measures
Chronic Low Back Pain; FDA; Instrument Review;  Patient-Reported Outcome Measure