Evidence map›Paper›PMID 32998158›Full record

ArticlePloS one2020

Diagnosing fraudulent baseline data in clinical trials.

Michael A Proschan, Pamela A Shaw

Abstract read
In one paragraph

Article in PloS one, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

2 authors.

Michael A ProschanBiostatistics Research Branch, National Institute of Allergy and Infectious Diseases, Bethesda, MD, United States of America.ORCID 0000-0002-9161-3739
Pamela A ShawDepartment of Biostatistics, Epidemiology, and Informatics, Philadelphia, PA, United States of America.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The first table in many articles reporting results of a randomized clinical trial compares baseline factors across arms. Results that appear inconsistent with chance trigger suspicion, and in one case, accusation and confirmation of data falsification. We confirm theoretically results of simulation analyses showing that inconsistency with chance is extremely difficult to prove in the absence of any information about correlations between baseline covariates. We offer a reasonable diagnostic to trigger further investigation.

Indexed as

Models, StatisticalComputer SimulationHumansRandomized Controlled Trials as TopicResearch DesignScientific Misconduct

Identifiers

PMID32998158
PMCPMC7527254

What OpenQuestion holds

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LicenceCC0
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Registered trials

None linked

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.