Instruments to Identify Prescription Medication Misuse, Abuse, and Related Events in Clinical Trials: An ACTTION Systematic Review

JOURNAL OF PAIN

卷:16

Review

Smith, Shannon M.¹  Paillard, Florence²  McKeown, Andrew¹  Burke, Laurie B.³  Edwards, Robert R.⁴  Katz, Nathaniel P.^5,6  Papadopoulos, Elektra J.⁷  Rappaport, Bob A.⁷  Slagle, Ashley⁷  Strain, Eric C.⁸  Wasan, Ajay D.^9,10  Turk, Dennis C.¹¹  Dworkin, Robert H.^1,12,13 

[1] Univ Rochester, Sch Med & Dent, Dept Anesthesiol, Rochester, NY 14642 USA

[2] Focus Biocom, Durango, CO USA

[3] LORA Grp LLC, Royal Oak, MD USA

[4] Brigham & Womens Hosp, Dept Anesthesiol, Boston, MA 02115 USA

[5] Tufts Univ, Dept Anesthesia, Boston, MA 02111 USA

[6] Analges Solut, Natick, MA USA

[7] US FDA, Silver Spring, MD USA

[8] Johns Hopkins Univ, Sch Med, Dept Psychiat & Behav Sci, Baltimore, MD 21205 USA

[9] Univ Pittsburgh, Sch Med, Dept Anesthesiol, Pittsburgh, PA 15261 USA

[10] Univ Pittsburgh, Sch Med, Dept Psychiat, Pittsburgh, PA USA

[11] Univ Washington, Dept Anesthesiol & Pain Med, Seattle, WA 98195 USA

[12] Univ Rochester, Sch Med & Dent, Dept Neurol, Rochester, NY 14642 USA

[13] Univ Rochester, Sch Med & Dent, Ctr Human Expt Therapeut, Rochester, NY 14642 USA

关键词: Abuse potential;    misuse;    clinical trial;    measurement properties;   

DOI  :  10.1016/j.jpain.2015.01.009

来源: Elsevier

【 摘 要 】

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. Perspective: 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. (C) 2015 by the American Pain Society

【 授权许可】

Free