PRISMA harms checklist: improving harms reporting in systematic reviews

Zorzela, Liliane, Loke, Yoon K., Ioannidis, John P., Golder, Su, Santaguida, Pasqualina, Altman, Douglas G., Moher, David and Vohra, Sunita (2016) PRISMA harms checklist: improving harms reporting in systematic reviews. British Medical Journal, 352. ISSN 0959-535X

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Abstract

Introduction: For any health intervention, accurate knowledge of both benefits and harms is needed. Systematic reviews often compound poor reporting of harms in primary studies by failing to report harms or doing so inadequately. While the PRISMA statement (Preferred Reporting Items for Systematic reviews and Meta-Analyses) helps systematic review authors ensure complete and transparent reporting, it is focused mainly on efficacy. Thus, a PRISMA harms checklist has been developed to improve harms reporting in systematic reviews, promoting a more balanced assessment of benefits and harms. Methods: A development strategy, endorsed by the EQUATOR Network and existing reporting guidelines (including the PRISMA statement, PRISMA for abstracts, and PRISMA for protocols), was used. After the development of a draft checklist of items, a modified Delphi process was initiated. The Delphi consisted of three rounds of electronic feedback followed by an in-person meeting. Results: The PRISMA harms checklist contains four essential reporting elements to be added to the original PRISMA statement to improve harms reporting in reviews. These are reported in the title (“Specifically mention ‘harms’ or other related terms, or the harm of interest in the review”), synthesis of results (“Specify how zero events were handled, if relevant”), study characteristics (“Define each harm addressed, how it was ascertained (eg, patient report, active search), and over what time period”), and synthesis of results (“Describe any assessment of possible causality”). Additional guidance regarding existing PRISMA items was developed to demonstrate relevance when synthesising information about harms. Conclusion: 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.

Item Type:	Article
Additional Information:	Please note a correction has been issued for this article: Corrections: PRISMA harms checklist: improving harms reporting in systematic reviews, BMJ 2016; 353 doi: https://doi.org/10.1136/bmj.i2229 (Published 19 April 2016). Cite this as: BMJ 2016;353:i2229. In table 1 of this research methods and reporting paper (BMJ 2016;352:i157, doi:10.1136/bmj.i157), the definitions for adverse event and adverse effect have been switched: An adverse event should have been defined as “an unfavourable outcome that occurs during or after the use of a drug or other intervention but is not necessarily caused by it.” While an adverse effect should have been defined as “an unfavourable outcome that occurs during or after the use of a drug or other intervention and the causal relation between the intervention and the event is at least a reasonable possibility.”
Faculty \ School:	Faculty of Medicine and Health Sciences > Norwich Medical School
UEA Research Groups:	Faculty of Science > Research Groups > Norwich Epidemiology Centre Faculty of Medicine and Health Sciences > Research Groups > Norwich Epidemiology Centre Faculty of Medicine and Health Sciences > Research Groups > Health Services and Primary Care Faculty of Medicine and Health Sciences > Research Centres > Lifespan Health Faculty of Medicine and Health Sciences > Research Centres > Population Health
Depositing User:	LivePure Connector
Date Deposited:	02 Aug 2018 08:46
Last Modified:	25 Sep 2024 13:34
URI:	https://ueaeprints.uea.ac.uk/id/eprint/67940
DOI:	10.1136/bmj.i157

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