title: Instruments to Identify Prescription Medication Misuse, Abuse, and Related Events in Clinical Trials: An ACTTION Systematic Review.
abstract: Measurement of inappropriate medication use events (eg, abuse or misuse) in clinical trials is important in characterizing a medication's abuse potential. However, no gold standard assessment of inappropriate use events in clinical trials has been identified. In this systematic review, we examine the measurement properties (ie, content validity, cross-sectional reliability and construct validity, longitudinal construct validity, ability to detect change, and responder definitions) of instruments assessing inappropriate use of opioid and nonopioid prescription medications to identify any that meet U.S. and European regulatory agencies' rigorous standards for outcome measures in clinical trials. Sixteen published instruments were identified, most of which were not designed for the selected concept of interest and context of use. For this reason, many instruments were found to lack adequate content validity (or documentation of content validity) to evaluate current inappropriate medication use events; for example, evaluating inappropriate use across the life span rather than current use, including items that did not directly assess inappropriate use (eg, questions about anger), or failing to capture information pertinent to inappropriate use events (eg, intention and route of administration). In addition, the psychometric data across all instruments were generally limited in scope. A further limitation is the heterogeneous, nonstandardized use of inappropriate medication use terminology. These observations suggest that available instruments are not well suited for assessing current inappropriate medication use within the specific context of clinical trials. Further effort is needed to develop reliable and valid instruments to measure current inappropriate medication use events in clinical trials.
  
  
  CONCLUSIONS
  This systematic review evaluates the measurement properties of inappropriate medication use (eg, abuse or misuse) instruments to determine whether any meet regulatory standards for clinical trial outcome measures to assess abuse potential.
authors: Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, New York. Electronic address: shannon1_smith@urmc.rochester.edu.
authors: Shannon M
authors: SM
authors: Smith
authors: Focus Biocom, Durango, Colorado.
authors: Florence
authors: F
authors: Paillard
authors: Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, New York.
authors: Andrew
authors: A
authors: McKeown
authors: LORA Group, LLC, Royal Oak, Maryland.
authors: Laurie B
authors: LB
authors: Burke
authors: Department of Anesthesiology, Brigham & Women's Hospital, Boston, Massachusetts.
authors: Robert R
authors: RR
authors: Edwards
authors: Department of Anesthesia, Tufts University, Boston, Massachusetts; Analgesic Solutions, Natick, Massachusetts.
authors: Nathaniel P
authors: NP
authors: Katz
authors: United States Food and Drug Administration, Silver Spring, Maryland.
authors: Elektra J
authors: EJ
authors: Papadopoulos
authors: United States Food and Drug Administration, Silver Spring, Maryland.
authors: Bob A
authors: BA
authors: Rappaport
authors: United States Food and Drug Administration, Silver Spring, Maryland.
authors: Ashley
authors: A
authors: Slagle
authors: Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors: Eric C
authors: EC
authors: Strain
authors: Departments of Anesthesiology and Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.
authors: Ajay D
authors: AD
authors: Wasan
authors: Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, Washington.
authors: Dennis C
authors: DC
authors: Turk
authors: Departments of Anesthesiology and Neurology, and Center for Human Experimental Therapeutics, University of Rochester School of Medicine and Dentistry, Rochester, New York.
authors: Robert H
authors: RH
authors: Dworkin
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D017408:Guidelines as Topic / Q000592:standards*; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000379:methods / Q000592:standards*; D063487:Prescription Drug Misuse; D011795:Surveys and Questionnaires / Q000592:standards*
keywords: Abuse potential; clinical trial; measurement properties; misuse