Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Oct 11;17(10):e0275893.
doi: 10.1371/journal.pone.0275893. eCollection 2022.

Development of a checklist of standard items for processing individual participant data from randomised trials for meta-analyses: Protocol for a modified e-Delphi study

Kylie E Hunter  1 , Angela C Webster  1 , Mike Clarke  2 , Matthew J Page  3 , Sol Libesman  1 , Peter J Godolphin  4 , Mason Aberoumand  1 , Larysa H M Rydzewska  4 , Rui Wang  5 , Aidan C Tan  1 , Wentao Li  5 , Ben W Mol  5 , Melina Willson  1 , Vicki Brown  6 , Talia Palacios  1 , Anna Lene Seidler  1
Affiliations

Development of a checklist of standard items for processing individual participant data from randomised trials for meta-analyses: Protocol for a modified e-Delphi study

Kylie E Hunter et al. PLoS One. .

Abstract

Individual participant data meta-analyses enable detailed checking of data quality and more complex analyses than standard study-level synthesis of summary data based on publications. However, there is limited existing guidance on the specific systematic checks that should be undertaken to confirm and enhance data quality for individual participant data meta-analyses and how to conduct these checks. We aim to address this gap by developing a checklist of items for data quality checking and cleaning to be applied to individual participant data meta-analyses of randomised trials. This study will comprise three phases: 1) a scoping review to identify potential checklist items; 2) two e-Delphi survey rounds among an invited panel of experts followed by a consensus meeting; and 3) pilot testing and refinement of the checklist, including development of an accompanying R-markdown program to facilitate its uptake.

PubMed Disclaimer

Conflict of interest statement

I have read the journal’s policy and the authors of this manuscript have the following competing interests: KEH receives research funding support via two scholarships administered by the University of Sydney (Postgraduate Research Supplementary Scholarship in Methods Development (SC3504), and Research Training Program Stipend (SC3227)). ALS is co-convenor and KEH & ACW are associate convenors of the Cochrane Prospective Meta-analysis Methods Group. MJP is recipient of the Australian Research Council Discovery Early Career Researcher Award (DE200101618), co-convenor of the Cochrane Bias Methods Group, and President of the Association for Interdisciplinary Meta-research and Open Science. RW is recipient of a National Health and Medical Research Council Investigator Grant. VB is supported by an Alfred Deakin Postdoctoral Research Fellowship. MC is co-convenor (unpaid) of the Cochrane Individual Participant Data Meta-analysis Methods Group; LHMR is coordinator of this group; KEH, PJG, BWM, MC and ALS are members. LHMR is supported by the UK Medical Research Council (https://protect-au.mimecast.com/s/iksjCK1DvKTqkx5mBI3AxP2?domain=mrc.ukri.org) Grant number: MC_UU_00004/06. ALS is recipient of a National Health and Medical Research Council Investigator Grant. BWM is recipient of a National Health and Medical Research Council Investigator grant (GNT1176437), reports consultancy for ObsEva at an hourly rate, reports consultancy for Merck Merck KGaA at an hourly rate and received travel support from Merck Merck KGaA. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1. Stages of an individual participant data meta-analysis, highlighting where CHIPPR fits in and interrelated types of data checks (adapted from Rydzewska & Tierney) [4].
Fig 2
Fig 2. Overview of project phases.
See this image and copyright information in PMC

Similar articles

  • Preferred Reporting Items for a Systematic Review and Meta-analysis of Diagnostic Test Accuracy Studies: The PRISMA-DTA Statement.
    McInnes MDF, Moher D, Thombs BD, McGrath TA, Bossuyt PM; and the PRISMA-DTA Group; Clifford T, Cohen JF, Deeks JJ, Gatsonis C, Hooft L, Hunt HA, Hyde CJ, Korevaar DA, Leeflang MMG, Macaskill P, Reitsma JB, Rodin R, Rutjes AWS, Salameh JP, Stevens A, Takwoingi Y, Tonelli M, Weeks L, Whiting P, Willis BH. McInnes MDF, et al. JAMA. 2018 Jan 23;319(4):388-396. doi: 10.1001/jama.2017.19163. JAMA. 2018. PMID: 29362800
  • SPIRIT 2025 statement: updated guideline for protocols of randomised trials.
    Chan AW, Boutron I, Hopewell S, Moher D, Schulz KF, Collins GS, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne DR, Farmer AJ, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson DJ, Vohra S, White IR, Hróbjartsson A. Chan AW, et al. BMJ. 2025 Apr 28;389:e081477. doi: 10.1136/bmj-2024-081477. BMJ. 2025. PMID: 40294953 Free PMC article.
  • SPIRIT 2025 statement: Updated guideline for protocols of randomised trials.
    Chan AW, Boutron I, Hopewell S, Moher D, Schulz KF, Collins GS, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne DR, Farmer AJ, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson DJ, Vohra S, White IR, Hróbjartsson A. Chan AW, et al. PLoS Med. 2025 Apr 28;22(4):e1004589. doi: 10.1371/journal.pmed.1004589. eCollection 2025 Apr. PLoS Med. 2025. PMID: 40294521 Free PMC article.
  • Development of a standardised set of metrics for monitoring site performance in multicentre randomised trials: a Delphi study.
    Whitham D, Turzanski J, Bradshaw L, Clarke M, Culliford L, Duley L, Shaw L, Skea Z, Treweek SP, Walker K, Williamson PR, Montgomery AA; Site Performance Metrics for Multicentre Randomised Trials Collaboration. Whitham D, et al. Trials. 2018 Oct 16;19(1):557. doi: 10.1186/s13063-018-2940-9. Trials. 2018. PMID: 30326967 Free PMC article.
  • A Guideline for Reporting Mediation Analyses of Randomized Trials and Observational Studies: The AGReMA Statement.
    Lee H, Cashin AG, Lamb SE, Hopewell S, Vansteelandt S, VanderWeele TJ, MacKinnon DP, Mansell G, Collins GS, Golub RM, McAuley JH; AGReMA group; Localio AR, van Amelsvoort L, Guallar E, Rijnhart J, Goldsmith K, Fairchild AJ, Lewis CC, Kamper SJ, Williams CM, Henschke N. Lee H, et al. JAMA. 2021 Sep 21;326(11):1045-1056. doi: 10.1001/jama.2021.14075. JAMA. 2021. PMID: 34546296 Free PMC article.
See all similar articles

Cited by

References

    1. Vale CL, Rydzewska LHM, Rovers MM, Emberson JR, Gueyffier F, Stewart LA. Uptake of systematic reviews and meta-analyses based on individual participant data in clinical practice guidelines: descriptive study. BMJ: British Medical Journal. 2015;350:h1088. - PMC - PubMed
    1. Akobeng AK. Understanding systematic reviews and meta-analysis. Archives of Disease in Childhood. 2005;90(8):845–8. doi: 10.1136/adc.2004.058230 - DOI - PMC - PubMed
    1. Lasserson TJ, Thomas J, Higgins JPT. Chapter 1: Starting a review. In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, et al., editors. Cochrane Handbook for Systematic Reviews of Interventions version 62 (updated February 2021): Cochrane, 2021. www.training.cochrane.org/handbook; 2021.
    1. Tierney JF, Riley RD, Rydzewska LHM, Stewart LA. Chapter 4: Running an IPD Meta-Analysis Project. In: Riley RD, Tierney JF, Stewart LA, editors. Individual participant data meta-analysis: a handbook for healthcare research: Wiley, Chichester; 2021.
    1. Wang H, Chen Y, Lin Y, Abesig J, Wu IX, Tam W. The methodological quality of individual participant data meta-analysis on intervention effects: systematic review. BMJ. 2021;373:n736. doi: 10.1136/bmj.n736 - DOI - PMC - PubMed