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Effect Modification Analyses in Individual Participant Data Meta-Analyses: A Systematic Review.

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Effect modification analyses in individual participant data meta-analyses (IPDMAs) are frequently planned but poorly reported. Protocols and reports often lack concordance, with omitted planned analyses and added unplanned ones.

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Area of Science:

  • Biostatistics
  • Epidemiology
  • Clinical Trials

Background:

  • Effect modification analyses are crucial for understanding subgroup effects in meta-analyses.
  • The prespecification and consistent reporting of these analyses in individual participant data meta-analyses (IPDMAs) remain unclear.

Purpose of the Study:

  • To investigate the planning of effect modification analyses in IPDMA protocols.
  • To evaluate the concordance between planned effect modification analyses in protocols and their reporting in published IPDMA reports.

Main Methods:

  • Systematic review of IPDMA protocols and published reports from Medline, Embase, Cochrane, and PROSPERO.
  • Paired reviewers independently extracted data on planning and reporting characteristics of effect modification analyses.
  • Comparison of matched protocol-report pairs for concordance in prespecification.

Main Results:

  • Most protocols (94.4%) planned effect modification analyses, but few specified direction (3.6%) or handled continuous variables consistently.
  • A high proportion of reports (89.8%) included effect modification analyses, yet only 56.4% reported prespecified ones.
  • Concordance between protocols and reports was poor (19.3%), with frequent omission of planned and addition of unplanned analyses.

Conclusions:

  • Protocols and reports in IPDMAs often fail to prespecify effect modification directions and handle continuous variables appropriately.
  • There is poor concordance between planned and reported effect modification analyses, with frequent omissions and additions.
  • The findings highlight a need for improved standardization and reporting practices in IPDMAs.