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, PRISMA-IPD Dev Grp

*Corresponding author for this work

Research output: Contribution to journalLiterature review

453 Citations (Scopus)

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 languageEnglish
Pages (from-to)1657-1665
Number of pages9
JournalJAMA : the journal of the American Medical Association
Volume313
Issue number16
DOIs
Publication statusPublished - 28 Apr 2015

Keywords

  • PATIENT DATA METAANALYSIS
  • RISK
  • MORTALITY
  • OUTCOMES
  • TRIALS

Cite this

Stewart, Lesley A. ; Clarke, Mike ; Rovers, Maroeska ; Riley, Richard D. ; Simmonds, Mark ; Stewart, Gavin ; Tierney, Jayne F. ; PRISMA-IPD Dev Grp. / Preferred Reporting Items for a Systematic Review and Meta-analysis of Individual Participant Data The PRISMA-IPD Statement. In: JAMA : the journal of the American Medical Association. 2015 ; Vol. 313, No. 16. pp. 1657-1665.
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Preferred Reporting Items for a Systematic Review and Meta-analysis of Individual Participant Data The PRISMA-IPD Statement. / Stewart, Lesley A.; Clarke, Mike; Rovers, Maroeska; Riley, Richard D.; Simmonds, Mark; Stewart, Gavin; Tierney, Jayne F.; PRISMA-IPD Dev Grp.

In: JAMA : the journal of the American Medical Association, Vol. 313, No. 16, 28.04.2015, p. 1657-1665.

Research output: Contribution to journalLiterature review

TY - JOUR

T1 - Preferred Reporting Items for a Systematic Review and Meta-analysis of Individual Participant Data 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.

AU - PRISMA-IPD Dev Grp

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 - PATIENT DATA METAANALYSIS

KW - RISK

KW - MORTALITY

KW - OUTCOMES

KW - TRIALS

U2 - 10.1001/jama.2015.3656

DO - 10.1001/jama.2015.3656

M3 - Literature review

VL - 313

SP - 1657

EP - 1665

JO - JAMA : the journal of the American Medical Association

JF - JAMA : the journal of the American Medical Association

SN - 0098-7484

IS - 16

ER -