BibTex format
@article{Duffy:2018:10.1111/1471-0528.14969,
author = {Duffy, JMN and Hirsch, M and Pealing, L and Showell, M and Khan, KS and Ziebland, S and McManus, RJ and vant, Hooft J and Gale, C and Brown, M and Grobman, W and Fitzpatrick, R and Karumanchi, SA and Lucas, N and Magee, L and Mol, B and Stark, M and Thangaratinam, S and Wilson, M and von, Dadelszen P and Williamson, P},
doi = {10.1111/1471-0528.14969},
journal = {BJOG: An International Journal of Obstetrics and Gynaecology},
pages = {795--803},
title = {Inadequate safety reporting in pre-eclampsia trials: a systematic evaluation},
url = {http://dx.doi.org/10.1111/1471-0528.14969},
volume = {125},
year = {2018}
}
RIS format (EndNote, RefMan)
TY - JOUR
AB - © 2017 Royal College of Obstetricians and Gynaecologists Background: Randomised trials and their syntheses in meta-analyses offer a unique opportunity to assess the frequency and severity of adverse reactions. Objective: To assess safety reporting in pre-eclampsia trials. Search strategy: Systematic search using bibliographic databases, including Cochrane Central Register of Controlled Trials, Embase, and MEDLINE, from inception to August 2017. Selection criteria: Randomised trials evaluating anticonvulsant or antihypertensive medication for pre-eclampsia. Data collection and analysis: Descriptive statistics appraising the adequacy of adverse reaction and toxicity reporting. Main results: We included 60 randomised trials. Six trials (10%) were registered with the International Clinical Trials Registry Platform, two registry records referred to adverse reactions, stating ‘safety and toleration’ and ‘possible side effects’ would be collected. Twenty-six trials (43%) stated the frequency of withdrawals within each study arm, and five trials (8%) adequately reported these withdrawals. Adverse reactions were inconsistently reported across eligible trials: 24 (40%) reported no serious adverse reactions and 36 (60%) reported no mild adverse reactions. The methods of definition or measurement of adverse reactions were infrequently reported within published trial reports. Conclusions: Pre-eclampsia trials regularly omit critical information related to safety. Despite the paucity of reporting, randomised trials collect an enormous amount of safety data. Developing and implementing a minimum data set could help to improve safety reporting, permitting a more balanced assessment of interventions by considering the trade-off between the benefits and harms. Tweetable abstract: Developing @coreoutcomes could help to improve safety reporting in #preeclampsia trials. @NIHR_DC.
AU - Duffy,JMN
AU - Hirsch,M
AU - Pealing,L
AU - Showell,M
AU - Khan,KS
AU - Ziebland,S
AU - McManus,RJ
AU - vant,Hooft J
AU - Gale,C
AU - Brown,M
AU - Grobman,W
AU - Fitzpatrick,R
AU - Karumanchi,SA
AU - Lucas,N
AU - Magee,L
AU - Mol,B
AU - Stark,M
AU - Thangaratinam,S
AU - Wilson,M
AU - von,Dadelszen P
AU - Williamson,P
DO - 10.1111/1471-0528.14969
EP - 803
PY - 2018///
SN - 1470-0328
SP - 795
TI - Inadequate safety reporting in pre-eclampsia trials: a systematic evaluation
T2 - BJOG: An International Journal of Obstetrics and Gynaecology
UR - http://dx.doi.org/10.1111/1471-0528.14969
VL - 125
ER -
