Harms are assessed inconsistently and reported inadequately Part 2: nonsystematic adverse events

MUDS investigators

Research output: Contribution to journalArticle

Abstract

Objective: We examined nonsystematic adverse events (AEs) in Part 2 (of 2) of a study describing the assessment and reporting AEs in clinical trials. Study Design and Setting: We examined 21 trials of gabapentin for neuropathic pain (52 sources) and seven trials of quetiapine for bipolar depression (80 sources) using data from the Multiple Data Sources study. We extracted and compared information about nonsystematic AEs (i.e., AEs that were not assessed for every participant), including AEs categorized as “serious.” We recorded whether AEs were grouped by anatomic or physiological system. Results: Trials of the same drug reported information about different AEs. Information in public sources was inadequate for decision-making. No public source reported all AEs, or all serious AEs, identified in nonpublic sources about the same trial. Of trials with only public sources, 2/15 (13%) gabapentin and 0/3 (0%) quetiapine trials grouped AEs by anatomic or physiological system. Conclusion: Public sources contained little information about nonsystematic AEs, including serious AEs. Grouping might make nonsystematic AEs easier to detect; however, most public sources did not report grouped AEs. Standards are needed to improve the collection and reporting of nonsystematic AEs so that stakeholders can use trials to assess the balance of potential benefits and harms.

Original languageEnglish (US)
Pages (from-to)11-19
Number of pages9
JournalJournal of Clinical Epidemiology
Volume113
DOIs
StatePublished - Sep 1 2019

Fingerprint

Information Storage and Retrieval
Neuralgia
Bipolar Disorder
Decision Making
Clinical Trials
Pharmaceutical Preparations
Quetiapine Fumarate
gabapentin

Keywords

  • Adverse events
  • Clinical trials
  • Drug safety
  • Harms
  • Open science
  • Reporting bias

ASJC Scopus subject areas

  • Epidemiology

Cite this

Harms are assessed inconsistently and reported inadequately Part 2 : nonsystematic adverse events. / MUDS investigators.

In: Journal of Clinical Epidemiology, Vol. 113, 01.09.2019, p. 11-19.

Research output: Contribution to journalArticle

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title = "Harms are assessed inconsistently and reported inadequately Part 2: nonsystematic adverse events",
abstract = "Objective: We examined nonsystematic adverse events (AEs) in Part 2 (of 2) of a study describing the assessment and reporting AEs in clinical trials. Study Design and Setting: We examined 21 trials of gabapentin for neuropathic pain (52 sources) and seven trials of quetiapine for bipolar depression (80 sources) using data from the Multiple Data Sources study. We extracted and compared information about nonsystematic AEs (i.e., AEs that were not assessed for every participant), including AEs categorized as “serious.” We recorded whether AEs were grouped by anatomic or physiological system. Results: Trials of the same drug reported information about different AEs. Information in public sources was inadequate for decision-making. No public source reported all AEs, or all serious AEs, identified in nonpublic sources about the same trial. Of trials with only public sources, 2/15 (13{\%}) gabapentin and 0/3 (0{\%}) quetiapine trials grouped AEs by anatomic or physiological system. Conclusion: Public sources contained little information about nonsystematic AEs, including serious AEs. Grouping might make nonsystematic AEs easier to detect; however, most public sources did not report grouped AEs. Standards are needed to improve the collection and reporting of nonsystematic AEs so that stakeholders can use trials to assess the balance of potential benefits and harms.",
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author = "{MUDS investigators} and Mayo-Wilson, {Evan R} and Nicole Fusco and Tianjing Li and Hwanhee Hong and Canner, {Joseph K.} and Kay Dickersin and Lorenzo Bertizzolo and Terrie Cowley and Peter Doshi and Jeffrey Ehmsen and Gillian Gresham and Nan Guo and Jennifer Haythornthwaite and James Heyward and Diana Pham and Jennifer Payne and Lori Rosman and Elizabeth Stuart and Catalina Suarez-Cuervo and Elizabeth Tolbert and Claire Twose and Swaroop Vedula",
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T2 - nonsystematic adverse events

AU - MUDS investigators

AU - Mayo-Wilson, Evan R

AU - Fusco, Nicole

AU - Li, Tianjing

AU - Hong, Hwanhee

AU - Canner, Joseph K.

AU - Dickersin, Kay

AU - Bertizzolo, Lorenzo

AU - Cowley, Terrie

AU - Doshi, Peter

AU - Ehmsen, Jeffrey

AU - Gresham, Gillian

AU - Guo, Nan

AU - Haythornthwaite, Jennifer

AU - Heyward, James

AU - Pham, Diana

AU - Payne, Jennifer

AU - Rosman, Lori

AU - Stuart, Elizabeth

AU - Suarez-Cuervo, Catalina

AU - Tolbert, Elizabeth

AU - Twose, Claire

AU - Vedula, Swaroop

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KW - Clinical trials

KW - Drug safety

KW - Harms

KW - Open science

KW - Reporting bias

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