Evidence map›Paper›PMID 33956789›Full record

ArticlePLoS medicine2021

A framework for prospective, adaptive meta-analysis (FAME) of aggregate data from randomised trials.

Jayne F Tierney, David J Fisher, Claire L Vale, Sarah Burdett, Larysa H Rydzewska, Ewelina Rogozińska, Peter J Godolphin, Ian R White, Mahesh K B Parmar

Abstract read
In one paragraph

Article in PLoS medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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  9. How can we make sound replication decisions?Proceedings of the National Academy of Sciences of the United States of America · 2025
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  17. Biomedicines · 2021
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Jayne F TierneyMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College London, United Kingdom.ORCID 0000-0002-4734-3014
David J FisherMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College London, United Kingdom.ORCID 0000-0002-2512-2296
Claire L ValeMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College London, United Kingdom.
Sarah BurdettMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College London, United Kingdom.ORCID 0000-0001-8687-2851
Larysa H RydzewskaMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College London, United Kingdom.ORCID 0000-0001-6205-7457
Ewelina RogozińskaMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College London, United Kingdom.ORCID 0000-0003-3455-0644
Peter J GodolphinMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College London, United Kingdom.ORCID 0000-0003-0648-0992
Ian R WhiteMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College London, United Kingdom.ORCID 0000-0002-6718-7661
Mahesh K B ParmarMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College London, United Kingdom.ORCID 0000-0003-0166-1700

Funding

Medical Research Council MC_UU_00004/06Medical Research Council MC_UU_12023/24
6 · The paper itself

Abstract

backgroundThe vast majority of systematic reviews are planned retrospectively, once most eligible trials have completed and reported, and are based on aggregate data that can be extracted from publications. Prior knowledge of trial results can introduce bias into both review and meta-analysis methods, and the omission of unpublished data can lead to reporting biases. We present a collaborative framework for prospective, adaptive meta-analysis (FAME) of aggregate data to provide results that are less prone to bias. Also, with FAME, we monitor how evidence from trials is accumulating, to anticipate the earliest opportunity for a potentially definitive meta-analysis. METHODOLOGY: We developed and piloted FAME alongside 4 systematic reviews in prostate cancer, which allowed us to refine the key principles. These are to: (1) start the systematic review process early, while trials are ongoing or yet to report; (2) liaise with trial investigators to develop a detailed picture of all eligible trials; (3) prospectively assess the earliest possible timing for reliable meta-analysis based on the accumulating aggregate data; (4) develop and register (or publish) the systematic review protocol before trials produce results and seek appropriate aggregate data; (5) interpret meta-analysis results taking account of both available and unavailable data; and (6) assess the value of updating the systematic review and meta-analysis. These principles are illustrated via a hypothetical review and their application to 3 published systematic reviews.

conclusionsFAME can reduce the potential for bias, and produce more timely, thorough and reliable systematic reviews of aggregate data.

Indexed as

Meta-Analysis as TopicHumansMaleProstatic Neoplasms

Identifiers

PMID33956789
PMCPMC8115774

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.