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.

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.

Déclaration de conflit d'intérêts

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.