Evidence map›Paper›PMID 25660826›Full record

SynthesisThe journal of pain2015

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 and 3 more

Abstract readSystematic Review
In one paragraph

Synthesis in The journal of pain, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Suspected inappropriate use of prescription and non-prescription drugs among requesting customers: A Saudi community pharmacists' perspective.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2023
    Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Shannon M SmithDepartment of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, New York. Electronic address: shannon1_smith@urmc.rochester.edu.
Florence PaillardFocus Biocom, Durango, Colorado.
Andrew McKeownDepartment of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, New York.
Laurie B BurkeLORA Group, LLC, Royal Oak, Maryland.
Robert R EdwardsDepartment of Anesthesiology, Brigham & Women's Hospital, Boston, Massachusetts.
Nathaniel P KatzDepartment of Anesthesia, Tufts University, Boston, Massachusetts; Analgesic Solutions, Natick, Massachusetts.
Elektra J PapadopoulosUnited States Food and Drug Administration, Silver Spring, Maryland.
Bob A RappaportUnited States Food and Drug Administration, Silver Spring, Maryland.
Ashley SlagleUnited States Food and Drug Administration, Silver Spring, Maryland.
Eric C StrainDepartment of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Ajay D WasanDepartments of Anesthesiology and Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.
Dennis C TurkDepartment of Anesthesiology and Pain Medicine, University of Washington, Seattle, Washington.
Robert H DworkinDepartments of Anesthesiology and Neurology, and Center for Human Experimental Therapeutics, University of Rochester School of Medicine and Dentistry, Rochester, New York.

Funding

Analgesic Clinical Trial Innovations,Opportunities,and Networks(ACTION)U01FD004187 · FDA · UNIVERSITY OF ROCHESTER · PI DWORKIN, ROBERT H · 2011 to 2014
$1.8M
FDA HHS U01 FD004187FDA HHS U01 FD005936
6 · The paper itself

Abstract

unlabelledMeasurement 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.

Indexed as

Prescription Drug MisuseClinical Trials as TopicGuidelines as TopicHumansOutcome Assessment, Health CareSurveys and QuestionnairesAbuse potentialclinical trialmeasurement propertiesmisuse

Identifiers

PMID25660826
PMCPMC5460153

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.