Preferred reporting items for a systematic review and meta-analysis of individual participant data: The PRISMA-IPD statement

Lesley A. Stewart; Mike Clarke; Maroeska Rovers; Richard D. Riley; Mark Simmonds; Gavin Stewart; Jayne F. Tierney

doi:10.1001/jama.2015.3656

Preferred reporting items for a systematic review and meta-analysis of individual participant data: The PRISMA-IPD statement

Lesley A. Stewart, Mike Clarke, Maroeska Rovers, Richard D. Riley, Mark Simmonds, Gavin Stewart^*, Jayne F. Tierney

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

Abstract

IMPORTANCE: Systematic reviews and meta-analyses of individual participant data (IPD) aim to collect, check, and reanalyze individual-level data from all studies addressing a particular research question and are therefore considered a gold standard approach to evidence synthesis. They are likely to be used with increasing frequency as current initiatives to share clinical trial data gain momentum and may be particularly important in reviewing controversial therapeutic areas.

OBJECTIVE: To develop PRISMA-IPD as a stand-alone extension to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) Statement, tailored to the specific requirements of reporting systematic reviews and meta-analyses of IPD. Although developed primarily for reviews of randomized trials, many items will apply in other contexts, including reviews of diagnosis and prognosis.

DESIGN: Development of PRISMA-IPD followed the EQUATOR Network framework guidance and used the existing standard PRISMA Statement as a starting point to draft additional relevant material. A web-based survey informed discussion at an international workshop that included researchers, clinicians, methodologists experienced in conducting systematic reviews and meta-analyses of IPD, and journal editors. The statement was drafted and iterative refinements were made by the project, advisory, and development groups. The PRISMA-IPD Development Group reached agreement on the PRISMA-IPD checklist and flow diagram by consensus.

FINDINGS: Compared with standard PRISMA, the PRISMA-IPD checklist includes 3 new items that address (1) methods of checking the integrity of the IPD (such as pattern of randomization, data consistency, baseline imbalance, and missing data), (2) reporting any important issues that emerge, and (3) exploring variation (such as whether certain types of individual benefit more from the intervention than others). A further additional item was created by reorganization of standard PRISMA items relating to interpreting results. Wording was modified in 23 items to reflect the IPD approach.

CONCLUSIONS AND RELEVANCE: PRISMA-IPD provides guidelines for reporting systematic reviews and meta-analyses of IPD.

Original language	English
Pages (from-to)	1657-1665
Number of pages	9
Journal	Journal of the American Medical Association
Volume	313
Issue number	16
DOIs	https://doi.org/10.1001/jama.2015.3656
Publication status	Published - 28 Apr 2015

Keywords

Checklist
Data Interpretation, Statistical
Guidelines as Topic
Meta-Analysis as Topic
Publishing
Reporting guidelines
Research Subjects
Review Literature as Topic

Access to Document

10.1001/jama.2015.3656

Cite this

@article{c2f477ceca5040269aba7af3237488a4,

title = "Preferred reporting items for a systematic review and meta-analysis of individual participant data: The PRISMA-IPD statement",

abstract = "IMPORTANCE: Systematic reviews and meta-analyses of individual participant data (IPD) aim to collect, check, and reanalyze individual-level data from all studies addressing a particular research question and are therefore considered a gold standard approach to evidence synthesis. They are likely to be used with increasing frequency as current initiatives to share clinical trial data gain momentum and may be particularly important in reviewing controversial therapeutic areas.OBJECTIVE: To develop PRISMA-IPD as a stand-alone extension to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) Statement, tailored to the specific requirements of reporting systematic reviews and meta-analyses of IPD. Although developed primarily for reviews of randomized trials, many items will apply in other contexts, including reviews of diagnosis and prognosis.DESIGN: Development of PRISMA-IPD followed the EQUATOR Network framework guidance and used the existing standard PRISMA Statement as a starting point to draft additional relevant material. A web-based survey informed discussion at an international workshop that included researchers, clinicians, methodologists experienced in conducting systematic reviews and meta-analyses of IPD, and journal editors. The statement was drafted and iterative refinements were made by the project, advisory, and development groups. The PRISMA-IPD Development Group reached agreement on the PRISMA-IPD checklist and flow diagram by consensus.FINDINGS: Compared with standard PRISMA, the PRISMA-IPD checklist includes 3 new items that address (1) methods of checking the integrity of the IPD (such as pattern of randomization, data consistency, baseline imbalance, and missing data), (2) reporting any important issues that emerge, and (3) exploring variation (such as whether certain types of individual benefit more from the intervention than others). A further additional item was created by reorganization of standard PRISMA items relating to interpreting results. Wording was modified in 23 items to reflect the IPD approach.CONCLUSIONS AND RELEVANCE: PRISMA-IPD provides guidelines for reporting systematic reviews and meta-analyses of IPD.",

keywords = "Checklist, Data Interpretation, Statistical, Guidelines as Topic, Meta-Analysis as Topic, Publishing, Reporting guidelines, Research Subjects, Review Literature as Topic",

author = "Stewart, {Lesley A.} and Mike Clarke and Maroeska Rovers and Riley, {Richard D.} and Mark Simmonds and Gavin Stewart and Tierney, {Jayne F.}",

year = "2015",

month = apr,

day = "28",

doi = "10.1001/jama.2015.3656",

language = "English",

volume = "313",

pages = "1657--1665",

journal = "Journal of the American Medical Association",

issn = "0098-7484",

publisher = "American Medical Association",

number = "16",

}

TY - JOUR

T1 - Preferred reporting items for a systematic review and meta-analysis of individual participant data

T2 - The PRISMA-IPD statement

AU - Stewart, Lesley A.

AU - Clarke, Mike

AU - Rovers, Maroeska

AU - Riley, Richard D.

AU - Simmonds, Mark

AU - Stewart, Gavin

AU - Tierney, Jayne F.

PY - 2015/4/28

Y1 - 2015/4/28

N2 - IMPORTANCE: Systematic reviews and meta-analyses of individual participant data (IPD) aim to collect, check, and reanalyze individual-level data from all studies addressing a particular research question and are therefore considered a gold standard approach to evidence synthesis. They are likely to be used with increasing frequency as current initiatives to share clinical trial data gain momentum and may be particularly important in reviewing controversial therapeutic areas.OBJECTIVE: To develop PRISMA-IPD as a stand-alone extension to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) Statement, tailored to the specific requirements of reporting systematic reviews and meta-analyses of IPD. Although developed primarily for reviews of randomized trials, many items will apply in other contexts, including reviews of diagnosis and prognosis.DESIGN: Development of PRISMA-IPD followed the EQUATOR Network framework guidance and used the existing standard PRISMA Statement as a starting point to draft additional relevant material. A web-based survey informed discussion at an international workshop that included researchers, clinicians, methodologists experienced in conducting systematic reviews and meta-analyses of IPD, and journal editors. The statement was drafted and iterative refinements were made by the project, advisory, and development groups. The PRISMA-IPD Development Group reached agreement on the PRISMA-IPD checklist and flow diagram by consensus.FINDINGS: Compared with standard PRISMA, the PRISMA-IPD checklist includes 3 new items that address (1) methods of checking the integrity of the IPD (such as pattern of randomization, data consistency, baseline imbalance, and missing data), (2) reporting any important issues that emerge, and (3) exploring variation (such as whether certain types of individual benefit more from the intervention than others). A further additional item was created by reorganization of standard PRISMA items relating to interpreting results. Wording was modified in 23 items to reflect the IPD approach.CONCLUSIONS AND RELEVANCE: PRISMA-IPD provides guidelines for reporting systematic reviews and meta-analyses of IPD.

AB - IMPORTANCE: Systematic reviews and meta-analyses of individual participant data (IPD) aim to collect, check, and reanalyze individual-level data from all studies addressing a particular research question and are therefore considered a gold standard approach to evidence synthesis. They are likely to be used with increasing frequency as current initiatives to share clinical trial data gain momentum and may be particularly important in reviewing controversial therapeutic areas.OBJECTIVE: To develop PRISMA-IPD as a stand-alone extension to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) Statement, tailored to the specific requirements of reporting systematic reviews and meta-analyses of IPD. Although developed primarily for reviews of randomized trials, many items will apply in other contexts, including reviews of diagnosis and prognosis.DESIGN: Development of PRISMA-IPD followed the EQUATOR Network framework guidance and used the existing standard PRISMA Statement as a starting point to draft additional relevant material. A web-based survey informed discussion at an international workshop that included researchers, clinicians, methodologists experienced in conducting systematic reviews and meta-analyses of IPD, and journal editors. The statement was drafted and iterative refinements were made by the project, advisory, and development groups. The PRISMA-IPD Development Group reached agreement on the PRISMA-IPD checklist and flow diagram by consensus.FINDINGS: Compared with standard PRISMA, the PRISMA-IPD checklist includes 3 new items that address (1) methods of checking the integrity of the IPD (such as pattern of randomization, data consistency, baseline imbalance, and missing data), (2) reporting any important issues that emerge, and (3) exploring variation (such as whether certain types of individual benefit more from the intervention than others). A further additional item was created by reorganization of standard PRISMA items relating to interpreting results. Wording was modified in 23 items to reflect the IPD approach.CONCLUSIONS AND RELEVANCE: PRISMA-IPD provides guidelines for reporting systematic reviews and meta-analyses of IPD.

KW - Checklist

KW - Data Interpretation, Statistical

KW - Guidelines as Topic

KW - Meta-Analysis as Topic

KW - Publishing

KW - Reporting guidelines

KW - Research Subjects

KW - Review Literature as Topic

UR - http://www.scopus.com/inward/record.url?scp=84928753669&partnerID=8YFLogxK

U2 - 10.1001/jama.2015.3656

DO - 10.1001/jama.2015.3656

M3 - Article

C2 - 25919529

SN - 0098-7484

VL - 313

SP - 1657

EP - 1665

JO - Journal of the American Medical Association

JF - Journal of the American Medical Association

IS - 16

ER -

Preferred reporting items for a systematic review and meta-analysis of individual participant data: The PRISMA-IPD statement

Abstract

Keywords

Access to Document

Other files and links

Cite this