PRISMA for reviews including harms outcomes (PRISMA-Harms)
The PRISMA harms checklist contains four extension items that must be used in any systematic review addressing harms, irrespective of whether harms are analysed alone or in association with benefits. These items are added to the original PRISMA statement, such that a systematic review addressing adverse events should report the PRISMA statement items and the PRISMA harms.
We also added recommendations for reporting harms in systematic reviews for those items in the original PRISMA checklist that require special consideration when reporting on harms. These items can be seen in the checklist as "recommendations for reporting harms in systematic reviews"; they are desirable items to be reported for a more complete information of harms.
Key documents
Statement paper: Zorzela L, Loke YK, Ioannidis JP, Golder S, Santaguida P, Altman DG, et al. PRISMA harms checklist: improving harms reporting in systematic reviews. BMJ 2016;352:i157. doi: 10.1136/bmj.i157