@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}
}

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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  - 

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