PRISMA harms checklist: improving harms reporting in systematic reviews

Liliane Zorzela; Yoon K Loke; John P Ioannidis; Su Golder; Pasqualina Santaguida; Douglas G Altman; David Moher; Sunita Vohra; PRISMAHarms Group

doi:10.1136/bmj.i157

PRISMA harms checklist: improving harms reporting in systematic reviews

Liliane Zorzela, Yoon K Loke, John P Ioannidis, Su Golder, Pasqualina Santaguida, Douglas G Altman, David Moher, Sunita Vohra, PRISMAHarms Group

Health Sciences

Research output: Contribution to journal › Review article › peer-review

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.

Original language	English
Article number	i157
Pages (from-to)	i157
Journal	British medical journal
Volume	352
DOIs	https://doi.org/10.1136/bmj.i157
Publication status	Published - 1 Feb 2016

Keywords

Checklist
Delphi Technique
Evidence-Based Medicine
Humans
Publishing
Research Design
Review Literature as Topic
Journal Article
Research Support, Non-U.S. Gov't

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10.1136/bmj.i157

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title = "PRISMA harms checklist: improving harms reporting in systematic reviews",

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.",

keywords = "Checklist, Delphi Technique, Evidence-Based Medicine, Humans, Publishing, Research Design, Review Literature as Topic, Journal Article, Research Support, Non-U.S. Gov't",

author = "Liliane Zorzela and Loke, {Yoon K} and Ioannidis, {John P} and Su Golder and Pasqualina Santaguida and Altman, {Douglas G} and David Moher and Sunita Vohra and {PRISMAHarms Group}",

note = "Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.",

year = "2016",

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doi = "10.1136/bmj.i157",

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AU - Zorzela, Liliane

AU - Loke, Yoon K

AU - Ioannidis, John P

AU - Golder, Su

AU - Santaguida, Pasqualina

AU - Altman, Douglas G

AU - Moher, David

AU - Vohra, Sunita

AU - PRISMAHarms Group

N1 - Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

PY - 2016/2/1

Y1 - 2016/2/1

N2 - 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.

AB - 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.

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KW - Publishing

KW - Research Design

KW - Review Literature as Topic

KW - Journal Article

KW - Research Support, Non-U.S. Gov't

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DO - 10.1136/bmj.i157

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SN - 0959-535X

VL - 352

SP - i157

JO - British medical journal

JF - British medical journal

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ER -

PRISMA harms checklist: improving harms reporting in systematic reviews

Abstract

Keywords

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