Abstract
Quantitative evidence synthesis through meta-analysis is central to evidence-based medicine. For well-documented reasons, the meta-analysis of individual patient data is held in higher regard than aggregate data. With access to individual patient data, the analysis is not restricted to a "two-stage" approach (combining estimates and standard errors) but can estimate parameters of interest by fitting a single model to all of the data, a so-called "one-stage" analysis. There has been debate about the merits of one- and two-stage analysis. Arguments for one-stage analysis have typically noted that a wider range of models can be fitted and overall estimates may be more precise. The two-stage side has emphasised that the models that can be fitted in two stages are sufficient to answer the relevant questions, with less scope for mistakes because there are fewer modelling choices to be made in the two-stage approach. For Gaussian data, we consider the statistical arguments for flexibility and precision in small-sample settings. Regarding flexibility, several of the models that can be fitted only in one stage may not be of serious interest to most meta-analysis practitioners. Regarding precision, we consider fixed- and random-effects meta-analysis and see that, for a model making certain assumptions, the number of stages used to fit this model is irrelevant; the precision will be approximately equal. Meta-analysts should choose modelling assumptions carefully. Sometimes relevant models can only be fitted in one stage. Otherwise, meta-analysts are free to use whichever procedure is most convenient to fit the identified model.
Keywords
individual-patient data
meta-analysis
one-stage
two-stage
MeSH Terms
Data Interpretation, Statistical
Humans
Linear Models
Meta-Analysis as Topic
Models, Statistical
Normal Distribution
Authors & Affiliations
4 authors, click to expand affiliations / ORCID
Morris Tim P
ORCID
London Hub for Trials Methodology Research, MRC Clinical Trials Unit at UCL, London, UK.
Fisher David J
London Hub for Trials Methodology Research, MRC Clinical Trials Unit at UCL, London, UK.
Kenward Michael G
ORCID
Ashkirk, UK.
Carpenter James R
London Hub for Trials Methodology Research, MRC Clinical Trials Unit at UCL, London, UK. | Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.
References (26)
26 references, click to expand
-
Arcsine test for publication bias in meta-analyses with binary outcomes.
Stat Med. 2008 Feb 28;27(5):746-63
PMID: 17592831
-
INDANA: a meta-analysis on individual patient data in hypertension. Protocol and preliminary results.
Therapie. 1995 Jul-Aug;50(4):353-62
PMID: 7482389
-
Improper analysis of trials randomised using stratified blocks or minimisation.
Stat Med. 2012 Feb 20;31(4):328-40
PMID: 22139891
-
On the relative efficiency of using summary statistics versus individual-level data in meta-analysis.
Biometrika. 2010 Jun;97(2):321-332
PMID: 23049122
-
One-stage individual participant data meta-analysis models: estimation of treatment-covariate interactions must avoid ecological bias by separating out within-trial and across-trial information.
Stat Med. 2017 Feb 28;36(5):772-789
PMID: 27910122
-
Meta-analysis of Gaussian individual patient data: Two-stage or not two-stage?
Stat Med. 2018 Apr 30;37(9):1419-1438
PMID: 29349792
-
To IPD or not to IPD? Advantages and disadvantages of systematic reviews using individual patient data.
Eval Health Prof. 2002 Mar;25(1):76-97
PMID: 11868447
-
Comparison of meta-analysis versus analysis of variance of individual patient data.
Biometrics. 1998 Mar;54(1):317-22
PMID: 9544524
-
Meta-analysis using individual participant data: one-stage and two-stage approaches, and why they may differ.
Stat Med. 2017 Feb 28;36(5):855-875
PMID: 27747915
-
The demise of the randomised controlled trial: bibliometric study of the German-language health care literature, 1948 to 2004.
BMC Med Res Methodol. 2006 Jul 06;6:30
PMID: 16824217
-
A critical review of methods for the assessment of patient-level interactions in individual participant data meta-analysis of randomized trials, and guidance for practitioners.
J Clin Epidemiol. 2011 Sep;64(9):949-67
PMID: 21411280
-
Assessing potential sources of clustering in individually randomised trials.
BMC Med Res Methodol. 2013 Apr 16;13:58
PMID: 23590245
-
Meta-analysis of genome-wide association studies: no efficiency gain in using individual participant data.
Genet Epidemiol. 2010 Jan;34(1):60-6
PMID: 19847795
-
Investigating heterogeneity in an individual patient data meta-analysis of time to event outcomes.
Stat Med. 2005 May 15;24(9):1307-19
PMID: 15685717
-
Meta-analytical methods to identify who benefits most from treatments: daft, deluded, or deft approach?
BMJ. 2017 Mar 3;356:j573
PMID: 28258124
-
Hans van Houwelingen and the art of summing up.
Biom J. 2010 Feb;52(1):85-94
PMID: 20140900
-
Fully Bayesian hierarchical modelling in two stages, with application to meta-analysis.
J R Stat Soc Ser C Appl Stat. 2013 Aug;62(4):551-572
PMID: 24223435
-
Individual Participant Data (IPD) Meta-analyses of Randomised Controlled Trials: Guidance on Their Use.
PLoS Med. 2015 Jul 21;12(7):e1001855
PMID: 26196287
-
The risks and rewards of covariate adjustment in randomized trials: an assessment of 12 outcomes from 8 studies.
Trials. 2014 Apr 23;15:139
PMID: 24755011
-
A re-evaluation of random-effects meta-analysis.
J R Stat Soc Ser A Stat Soc. 2009 Jan;172(1):137-159
PMID: 19381330
-
Get real in individual participant data (IPD) meta-analysis: a review of the methodology.
Res Synth Methods. 2015 Dec;6(4):293-309
PMID: 26287812
-
Effect of antihypertensive drug treatment on cardiovascular outcomes in women and men. A meta-analysis of individual patient data from randomized, controlled trials. The INDANA Investigators.
Ann Intern Med. 1997 May 15;126(10):761-7
PMID: 9148648
-
Small sample inference for fixed effects from restricted maximum likelihood.
Biometrics. 1997 Sep;53(3):983-97
PMID: 9333350
-
A decade of individual participant data meta-analyses: A review of current practice.
Contemp Clin Trials. 2015 Nov;45(Pt A):76-83
PMID: 26091948
-
Comparison of one-step and two-step meta-analysis models using individual patient data.
Biom J. 2010 Apr;52(2):271-87
PMID: 20349448
-
Meta-analysis of individual participant data: rationale, conduct, and reporting.
BMJ. 2010 Feb 05;340:c221
PMID: 20139215