Evidence map›Paper›PMID 35934915›Full record

Trial reportBiometrical journal. Biometrische Zeitschrift2023

On the relevance of prognostic information for clinical trials: A theoretical quantification.

Sandra Siegfried, Stephen Senn, Torsten Hothorn

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Biometrical journal. Biometrische Zeitschrift, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed.

  1. Trial
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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

3 authors.

Sandra SiegfriedInstitut für Epidemiologie, Biostatistik und Prävention, Universität Zürich, Zürich, Switzerland.ORCID 0000-0002-7312-1001
Stephen SennSchool of Health and Related Research, University of Sheffield, Sheffield, UK.
Torsten HothornInstitut für Epidemiologie, Biostatistik und Prävention, Universität Zürich, Zürich, Switzerland.ORCID 0000-0001-8301-0471

Funding

Horizon 2020 Research and Innovation Programme of the European Union 681094Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung 200021_184603Swiss State Secretariat for Education, Research and Innovation (SERI) 15.0137
6 · The paper itself

Abstract

The question of how individual patient data from cohort studies or historical clinical trials can be leveraged for designing more powerful, or smaller yet equally powerful, clinical trials becomes increasingly important in the era of digitalization. Today, the traditional statistical analyses approaches may seem questionable to practitioners in light of ubiquitous historical prognostic information. Several methodological developments aim at incorporating historical information in the design and analysis of future clinical trials, most importantly Bayesian information borrowing, propensity score methods, stratification, and covariate adjustment. Adjusting the analysis with respect to a prognostic score, which was obtained from some model applied to historical data, received renewed interest from a machine learning perspective, and we study the potential of this approach for randomized clinical trials. In an idealized situation of a normal outcome in a two-arm trial with 1:1 allocation, we derive a simple sample size reduction formula as a function of two criteria characterizing the prognostic score: (1) the coefficient of determination R

Indexed as

Research DesignBayes TheoremComputer SimulationHumansPrognosisSample Sizeclinical trialscovariate adjustmentmachine learningprognostic covariatessample size reduction

Identifiers

PMID35934915
PMCPMC10087947

What Socratic holds

Textmetadata
LicenceCC BY-NC
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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 Socratic graph.