Instruments to identify prescription medication misuse, abuse, and related events in clinical trials: An ACTTION systematic review

Shannon M. Smith, Florence Paillard, Andrew McKeown, Laurie B. Burke, Robert R. Edwards, Nathaniel P. Katz, Elektra J. Papadopoulos, Bob A. Rappaport, Ashley Slagle, Eric C Strain, Ajay D. Wasan, Dennis C. Turk, Robert H. Dworkin

Research output: Contribution to journalArticle

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. 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.

Original languageEnglish (US)
Pages (from-to)389-411
Number of pages23
JournalJournal of Pain
Volume16
Issue number5
DOIs
StatePublished - May 1 2015

Fingerprint

Prescriptions
Clinical Trials
Outcome Assessment (Health Care)
Aptitude
Anger
Psychometrics
Terminology
Reproducibility of Results
Documentation
Opioid Analgesics

Keywords

  • Abuse potential
  • Clinical trial
  • Measurement properties
  • Misuse

ASJC Scopus subject areas

  • Anesthesiology and Pain Medicine
  • Neurology
  • Clinical Neurology
  • Medicine(all)

Cite this

Smith, S. M., Paillard, F., McKeown, A., Burke, L. B., Edwards, R. R., Katz, N. P., ... Dworkin, R. H. (2015). Instruments to identify prescription medication misuse, abuse, and related events in clinical trials: An ACTTION systematic review. Journal of Pain, 16(5), 389-411. https://doi.org/10.1016/j.jpain.2015.01.009

Instruments to identify prescription medication misuse, abuse, and related events in clinical trials : An ACTTION systematic review. / Smith, Shannon M.; Paillard, Florence; McKeown, Andrew; Burke, Laurie B.; Edwards, Robert R.; Katz, Nathaniel P.; Papadopoulos, Elektra J.; Rappaport, Bob A.; Slagle, Ashley; Strain, Eric C; Wasan, Ajay D.; Turk, Dennis C.; Dworkin, Robert H.

In: Journal of Pain, Vol. 16, No. 5, 01.05.2015, p. 389-411.

Research output: Contribution to journalArticle

Smith, SM, Paillard, F, McKeown, A, Burke, LB, Edwards, RR, Katz, NP, Papadopoulos, EJ, Rappaport, BA, Slagle, A, Strain, EC, Wasan, AD, Turk, DC & Dworkin, RH 2015, 'Instruments to identify prescription medication misuse, abuse, and related events in clinical trials: An ACTTION systematic review', Journal of Pain, vol. 16, no. 5, pp. 389-411. https://doi.org/10.1016/j.jpain.2015.01.009
Smith, Shannon M. ; Paillard, Florence ; McKeown, Andrew ; Burke, Laurie B. ; Edwards, Robert R. ; Katz, Nathaniel P. ; Papadopoulos, Elektra J. ; Rappaport, Bob A. ; Slagle, Ashley ; Strain, Eric C ; Wasan, Ajay D. ; Turk, Dennis C. ; Dworkin, Robert H. / Instruments to identify prescription medication misuse, abuse, and related events in clinical trials : An ACTTION systematic review. In: Journal of Pain. 2015 ; Vol. 16, No. 5. pp. 389-411.
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