PMID- 31055175
OWN - NLM
STAT- MEDLINE
DCOM- 20200525
LR  - 20200525
IS  - 1878-5921 (Electronic)
IS  - 0895-4356 (Linking)
VI  - 113
DP  - 2019 Sep
TI  - Harms are assessed inconsistently and reported inadequately part 1: systematic 
      adverse events.
PG  - 20-27
LID - S0895-4356(18)31107-7 [pii]
LID - 10.1016/j.jclinepi.2019.04.022 [doi]
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.
CI  - Copyright (c) 2019 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Mayo-Wilson, Evan
AU  - Mayo-Wilson E
AD  - Department of Epidemiology, Johns Hopkins University Bloomberg School of Public 
      Health, 615 North Wolfe Street, Baltimore, MD 21205, USA. Electronic address: 
      evan.mayo-wilson@jhu.edu.
FAU - Fusco, Nicole
AU  - Fusco N
AD  - Department of Epidemiology, Johns Hopkins University Bloomberg School of Public 
      Health, 615 North Wolfe Street, Baltimore, MD 21205, USA.
FAU - Li, Tianjing
AU  - Li T
AD  - Department of Epidemiology, Johns Hopkins University Bloomberg School of Public 
      Health, 615 North Wolfe Street, Baltimore, MD 21205, USA.
FAU - Hong, Hwanhee
AU  - Hong H
AD  - Department of Mental Health, Johns Hopkins University Bloomberg School of Public 
      Health, 624 N Broadway, Hampton House, Baltimore, MD 21205, USA.
FAU - Canner, Joseph K
AU  - Canner JK
AD  - Department of Surgery, Johns Hopkins University School of Medicine, 600 North 
      Wolfe Street, Blalock 1202, Baltimore, MD 21287, USA.
FAU - Dickersin, Kay
AU  - Dickersin K
AD  - Department of Epidemiology, Johns Hopkins University Bloomberg School of Public 
      Health, 615 North Wolfe Street, Baltimore, MD 21205, USA.
CN  - MUDS investigators
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Systematic Review
DEP - 20190502
PL  - United States
TA  - J Clin Epidemiol
JT  - Journal of clinical epidemiology
JID - 8801383
RN  - 2S3PL1B6UJ (Quetiapine Fumarate)
RN  - 6CW7F3G59X (Gabapentin)
SB  - IM
MH  - Bipolar Disorder/*drug therapy
MH  - Data Accuracy
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Gabapentin/*adverse effects/*therapeutic use
MH  - Humans
MH  - Neuralgia/*drug therapy
MH  - Quetiapine Fumarate/*adverse effects/*therapeutic use
MH  - Randomized Controlled Trials as Topic/*statistics & numerical data
MH  - Research Report
OTO - NOTNLM
OT  - Adverse events
OT  - Clinical trials
OT  - Drug safety
OT  - Harms
OT  - Open science
OT  - Reporting bias
FIR - Bertizzolo, Lorenzo
IR  - Bertizzolo L
FIR - Cowley, Terrie
IR  - Cowley T
FIR - Doshi, Peter
IR  - Doshi P
FIR - Ehmsen, Jeffrey
IR  - Ehmsen J
FIR - Gresham, Gillian
IR  - Gresham G
FIR - Guo, Nan
IR  - Guo N
FIR - Haythornthwaite, Jennifer
IR  - Haythornthwaite J
FIR - Heyward, James
IR  - Heyward J
FIR - Pham, Diana
IR  - Pham D
FIR - Payne, Jennifer
IR  - Payne J
FIR - Rosman, Lori
IR  - Rosman L
FIR - Stuart, Elizabeth
IR  - Stuart E
FIR - Suarez-Cuervo, Catalina
IR  - Suarez-Cuervo C
FIR - Tolbert, Elizabeth
IR  - Tolbert E
FIR - Twose, Claire
IR  - Twose C
FIR - Vedula, Swaroop
IR  - Vedula S
EDAT- 2019/05/06 06:00
MHDA- 2020/05/26 06:00
CRDT- 2019/05/06 06:00
PHST- 2018/12/13 00:00 [received]
PHST- 2019/03/04 00:00 [revised]
PHST- 2019/04/05 00:00 [accepted]
PHST- 2019/05/06 06:00 [pubmed]
PHST- 2020/05/26 06:00 [medline]
PHST- 2019/05/06 06:00 [entrez]
AID - S0895-4356(18)31107-7 [pii]
AID - 10.1016/j.jclinepi.2019.04.022 [doi]
PST - ppublish
SO  - J Clin Epidemiol. 2019 Sep;113:20-27. doi: 10.1016/j.jclinepi.2019.04.022. Epub 
      2019 May 2.