Harms are assessed inconsistently and reported inadequately part 1: systematic adverse events

MUDS investigators

Research output: Contribution to journalArticle

Abstract

Objectives: We examined systematic adverse events (AEs) in Part 1 (of 2) of a study describing the assessment and reporting of AEs in clinical trials. Study Design and Setting: We examined 52 public and nonpublic data sources about trials of quetiapine for bipolar depression using data from the Multiple Data Sources study. We extracted and compared information about systematic AEs (i.e., AEs assessed for all participants) in six prespecified domains: cardiovascular, cholesterol, endocrine, extrapyramidal symptoms, mania, and weight. Results: Eligible trials did not assess and report the same systematic AEs, and most results were not available in public sources. Overall, public sources reported 159 results, of which 92 of 159 (58%) included sufficient statistical information to calculate the treatment effect and its precision. Nonpublic sources reported 636 results; 630 of 636 (99%) reported sufficient statistical information. Conclusion: Systematic AEs were defined and analyzed in many ways, which led to many numerical results. Most systematic AEs were not mentioned in public sources. To minimize bias, methods for defining and analyzing potential AEs should be prespecified in trial registers and protocols. All trial results should be publicly available so that stakeholders can compare benefits and AEs. Trials could report core sets of AEs to facilitate decision-making.

Original languageEnglish (US)
Pages (from-to)20-27
Number of pages8
JournalJournal of Clinical Epidemiology
Volume113
DOIs
StatePublished - Sep 1 2019

Fingerprint

Information Storage and Retrieval
Bipolar Disorder
Clinical Protocols
Decision Making
Cholesterol
Clinical Trials
Weights and Measures
Therapeutics
Quetiapine Fumarate

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 1 : systematic adverse events. / MUDS investigators.

In: Journal of Clinical Epidemiology, Vol. 113, 01.09.2019, p. 20-27.

Research output: Contribution to journalArticle

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title = "Harms are assessed inconsistently and reported inadequately part 1: systematic adverse events",
abstract = "Objectives: We examined systematic adverse events (AEs) in Part 1 (of 2) of a study describing the assessment and reporting of AEs in clinical trials. Study Design and Setting: We examined 52 public and nonpublic data sources about trials of quetiapine for bipolar depression using data from the Multiple Data Sources study. We extracted and compared information about systematic AEs (i.e., AEs assessed for all participants) in six prespecified domains: cardiovascular, cholesterol, endocrine, extrapyramidal symptoms, mania, and weight. Results: Eligible trials did not assess and report the same systematic AEs, and most results were not available in public sources. Overall, public sources reported 159 results, of which 92 of 159 (58{\%}) included sufficient statistical information to calculate the treatment effect and its precision. Nonpublic sources reported 636 results; 630 of 636 (99{\%}) reported sufficient statistical information. Conclusion: Systematic AEs were defined and analyzed in many ways, which led to many numerical results. Most systematic AEs were not mentioned in public sources. To minimize bias, methods for defining and analyzing potential AEs should be prespecified in trial registers and protocols. All trial results should be publicly available so that stakeholders can compare benefits and AEs. Trials could report core sets of AEs to facilitate decision-making.",
keywords = "Adverse events, Clinical trials, Drug safety, Harms, Open science, Reporting bias",
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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T1 - Harms are assessed inconsistently and reported inadequately part 1

T2 - systematic 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

PY - 2019/9/1

Y1 - 2019/9/1

N2 - Objectives: We examined systematic adverse events (AEs) in Part 1 (of 2) of a study describing the assessment and reporting of AEs in clinical trials. Study Design and Setting: We examined 52 public and nonpublic data sources about trials of quetiapine for bipolar depression using data from the Multiple Data Sources study. We extracted and compared information about systematic AEs (i.e., AEs assessed for all participants) in six prespecified domains: cardiovascular, cholesterol, endocrine, extrapyramidal symptoms, mania, and weight. Results: Eligible trials did not assess and report the same systematic AEs, and most results were not available in public sources. Overall, public sources reported 159 results, of which 92 of 159 (58%) included sufficient statistical information to calculate the treatment effect and its precision. Nonpublic sources reported 636 results; 630 of 636 (99%) reported sufficient statistical information. Conclusion: Systematic AEs were defined and analyzed in many ways, which led to many numerical results. Most systematic AEs were not mentioned in public sources. To minimize bias, methods for defining and analyzing potential AEs should be prespecified in trial registers and protocols. All trial results should be publicly available so that stakeholders can compare benefits and AEs. Trials could report core sets of AEs to facilitate decision-making.

AB - Objectives: We examined systematic adverse events (AEs) in Part 1 (of 2) of a study describing the assessment and reporting of AEs in clinical trials. Study Design and Setting: We examined 52 public and nonpublic data sources about trials of quetiapine for bipolar depression using data from the Multiple Data Sources study. We extracted and compared information about systematic AEs (i.e., AEs assessed for all participants) in six prespecified domains: cardiovascular, cholesterol, endocrine, extrapyramidal symptoms, mania, and weight. Results: Eligible trials did not assess and report the same systematic AEs, and most results were not available in public sources. Overall, public sources reported 159 results, of which 92 of 159 (58%) included sufficient statistical information to calculate the treatment effect and its precision. Nonpublic sources reported 636 results; 630 of 636 (99%) reported sufficient statistical information. Conclusion: Systematic AEs were defined and analyzed in many ways, which led to many numerical results. Most systematic AEs were not mentioned in public sources. To minimize bias, methods for defining and analyzing potential AEs should be prespecified in trial registers and protocols. All trial results should be publicly available so that stakeholders can compare benefits and AEs. Trials could report core sets of AEs to facilitate decision-making.

KW - Adverse events

KW - Clinical trials

KW - Drug safety

KW - Harms

KW - Open science

KW - Reporting bias

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