PMID- 22000868
OWN - NLM
STAT- MEDLINE
DCOM- 20120308
LR  - 20220129
IS  - 1872-6844 (Electronic)
IS  - 0920-1211 (Linking)
VI  - 97
IP  - 1-2
DP  - 2011 Nov
TI  - Reporting of adverse events in randomised controlled trials of antiepileptic 
      drugs using the CONSORT criteria for reporting harms.
PG  - 20-9
LID - 10.1016/j.eplepsyres.2011.06.015 [doi]
AB  - PURPOSE: To assess the reporting of adverse events (AEs) in randomised controlled 
      trials (RCTs) of antiepileptic drugs (AEDs) using the CONSORT statement for harms 
      2004, and to determine if reporting has changed since introduction of this 
      standard. PRINCIPAL RESULTS: One hundred and fifty two RCTs were included from a 
      search of papers published between 1999 and 2008 inclusive. We identified 23 
      criteria in the CONSORT statements. The mean number of criteria met per trial was 
      11.3 (95%CI 10.6-12.0). Commercially funded studies met 12.6 and non-commercially 
      funded met 9.4 (p<0.001). Trials recruiting adults met 12.5 and trials recruiting 
      children met 9.3 (p<0.001). Trials published before 2004 met 11.6 and trials 
      published after 2004 met 11.1 (p=0.53). Commercially funded trials met the 
      majority of criteria more than non-commercially sponsored trials, particularly 
      for definition of AEs (RR 3.15, CI 1.67-5.95) and the use of a validated 
      dictionary of terms (RR 3.46, CI 1.41-8.44). Definitions for AEs (RR 2.32, CI 
      1.07-5.02) and details of analyses (RR 2.05, CI 1.01-4.15) were reported in adult 
      trials more often than trials in children. MAJOR CONCLUSIONS: Reporting of AEs in 
      RCTs of AEDs is poor and has not improved since the publication of the CONSORT 
      guidelines on the reporting of harms. Commercially funded trials were better 
      reported than non-commercially funded trials and trials recruiting adults were 
      better reported than trials recruiting children. These findings have serious 
      implications as poor reporting precludes bias being detected and hinders adequate 
      risk benefit analyses. Journal editors, authors and reviewers should be 
      encouraged to follow current guidance.
CI  - Copyright (c) 2011 Elsevier B.V. All rights reserved.
FAU - Shukralla, Arif A
AU  - Shukralla AA
AD  - Institute of Translational Medicine, Department of Molecular and Clinical 
      Pharmacology, University of Liverpool, UK. arifshukralla@gmail.com
FAU - Tudur-Smith, Catrin
AU  - Tudur-Smith C
FAU - Powell, Graham A
AU  - Powell GA
FAU - Williamson, Paula R
AU  - Williamson PR
FAU - Marson, Anthony G
AU  - Marson AG
LA  - eng
GR  - RP-PG-0606-1062/DH_/Department of Health/United Kingdom
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
DEP - 20111014
PL  - Netherlands
TA  - Epilepsy Res
JT  - Epilepsy research
JID - 8703089
RN  - 0 (Anticonvulsants)
SB  - IM
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems/*standards
MH  - Anticonvulsants/*adverse effects
MH  - Child
MH  - Epilepsy/*drug therapy
MH  - Guideline Adherence/standards
MH  - Humans
MH  - Quality Control
MH  - Randomized Controlled Trials as Topic/*methods/*standards
EDAT- 2011/10/18 06:00
MHDA- 2012/03/09 06:00
CRDT- 2011/10/18 06:00
PHST- 2011/04/14 00:00 [received]
PHST- 2011/06/15 00:00 [revised]
PHST- 2011/06/24 00:00 [accepted]
PHST- 2011/10/18 06:00 [entrez]
PHST- 2011/10/18 06:00 [pubmed]
PHST- 2012/03/09 06:00 [medline]
AID - S0920-1211(11)00177-X [pii]
AID - 10.1016/j.eplepsyres.2011.06.015 [doi]
PST - ppublish
SO  - Epilepsy Res. 2011 Nov;97(1-2):20-9. doi: 10.1016/j.eplepsyres.2011.06.015. Epub 
      2011 Oct 14.