Evidence map›Paper›PMID 28479207›Full record

ArticleThe journal of pain2017

Measures That Identify Prescription Medication Misuse, Abuse, and Related Events in Clinical Trials: ACTTION Critique and Recommended Considerations.

Shannon M Smith, Judith K Jones, Nathaniel P Katz, Carl L Roland, Beatrice Setnik, Jeremiah J Trudeau, Stephen Wright, Laurie B Burke, Sandra D Comer, Richard C Dart and 10 more

Abstract read
In one paragraph

Article in The journal of pain, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Trial
  2. 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

20 authors.

Shannon M SmithDepartment of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, New York. Electronic address: shannon1_smith@urmc.rochester.edu.
Judith K JonesThe Degge Group, Fairfax, Virginia; Departments of Pharmacology and Health Sciences, Georgetown University School of Medicine, Washington, DC; School of Public Health, University of Michigan School of Public Health, Ann Arbor, Michigan.
Nathaniel P KatzAnalgesic Solutions, Natick, Massachusetts; Departments of Anesthesiology and Public Health and Community Medicine, Tufts University, Boston, Massachusetts.
Carl L RolandPfizer Inc, Cary, North Carolina.
Beatrice SetnikINC Research, Raleigh, North Carolina.
Jeremiah J TrudeauBoehringer Ingelheim, Ridgefield, Connecticut.
Stephen WrightGW Pharmaceuticals, plc, London, United Kingdom.
Laurie B BurkeLORA Group, LLC, Royal Oak, and School of Pharmacy, University of Maryland, Baltimore, Maryland.
Sandra D ComerDepartment of Psychiatry, Columbia University, New York State Psychiatric Institute, New York, New York.
Richard C DartDivision of Clinical Pharmacology and Toxicology, University of Colorado School of Medicine and Rocky Mountain Poison & Drug Center, Denver Health, Denver, Colorado.
Raymond DionneDepartment of Pharmacology and Toxicology, Brody School of Medicine, East Carolina University, Greenville, North Carolina.
J David HaddoxDepartments of Anesthesiology and Public Health and Community Medicine, Tufts University, Boston, Massachusetts; Purdue Pharma LP, Stamford, Connecticut.
Jerome H JaffeDepartment of Psychiatry, University of Maryland School of Medicine, Baltimore, Maryland.
Ernest A KopeckyCollegium Pharmaceutical, Inc, Canton, Massachusetts.
Bridget A MartellBAM Consultants, Guilford, Connecticut; Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.
Ivan D MontoyaNational Institute on Drug Abuse, Bethesda, Maryland.
Marsha StantonHorizon Pharma, Inc, Deerfield, Illinois.
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 DworkinDepartment of Anesthesiology, Neurology, and Center for Human Experimental Therapeutics, University of Rochester School of Medicine and Dentistry, Rochester, New York.

Funding

Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) Public-Private PartnershipU01FD005936 · FDA · UNIVERSITY OF ROCHESTER · PI DWORKIN, ROBERT H · 2016 to 2020
$2.5M
FDA HHS U01 FD005936
6 · The paper itself

Abstract

Accurate assessment of inappropriate medication use events (ie, misuse, abuse, and related events) occurring in clinical trials is an important component in evaluating a medication's abuse potential. A meeting was convened to review all instruments measuring such events in clinical trials according to previously published standardized terminology and definitions. Only 2 approaches have been reported that are specifically designed to identify and classify misuse, abuse, and related events occurring in clinical trials, rather than to measure an individual's risk of using a medication inappropriately: the Self-Reported Misuse, Abuse, and Diversion (SR-MAD) instrument and the Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS). The conceptual basis, strengths, and limitations of these methods are discussed. To our knowledge, MADDERS is the only system available to comprehensively evaluate inappropriate medication use events prospectively to determine the underlying intent. MADDERS can also be applied retrospectively to completed trial data. SR-MAD can be used prospectively; additional development may be required to standardize its implementation and fully appraise the intent of inappropriate use events. Additional research is needed to further demonstrate the validity and utility of MADDERS as well as SR-MAD. PERSPECTIVE: Identifying a medication's abuse potential requires assessing inappropriate medication use events in clinical trials on the basis of a standardized event classification system. The strengths and limitations of the 2 published methods designed to evaluate inappropriate medication use events are reviewed, with recommended considerations for further development and current implementation.

Indexed as

Clinical Trials as TopicPrescription Drug MisuseAnalgesics, OpioidHumansOpioid-Related DisordersAnalgesics, Opioidabuse potentialMedication abusemedication misuse

Identifiers

PMID28479207
PMCPMC5660635

What OpenQuestion holds

Textmetadata
LicenceTDM
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.