PRISMA harms checklist: improving harms reporting in systematic reviews
BMJPublished 1 February 2016Open access
Liliane Zorzela, Yoon K. Loke, John P. A. Ioannidis, Su Golder, Pasqualina Santaguida, Douglas G. Altman
Citations522
SJR quartileQ1
SJR score2.98
SNIP9.45
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TL;DR
The PRISMA harms checklist identifies a minimal set of items to be reported when reviewing adverse events, intended to improve harms reporting in systematic reviews, whether harms are a primary or secondary outcome.
Abstract
The PRISMA harms checklist identifies a minimal set of items to be reported when reviewing adverse events. This guideline extension is intended to improve harms reporting in systematic reviews, whether harms are a primary or secondary outcome.
Keywords
Decision SciencesMathematicsEconomics, Econometrics and Finance
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