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http://hdl.handle.net/1942/43630
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DC Field | Value | Language |
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dc.contributor.author | Stijven, Florian | - |
dc.contributor.author | ALONSO ABAD, Ariel | - |
dc.contributor.author | MOLENBERGHS, Geert | - |
dc.date.accessioned | 2024-09-02T09:54:13Z | - |
dc.date.available | 2024-09-02T09:54:13Z | - |
dc.date.issued | 2024 | - |
dc.date.submitted | 2024-09-02T09:41:15Z | - |
dc.identifier.citation | Statistical methods in medical research, 33 (7) , p. 1278 -1296 | - |
dc.identifier.uri | http://hdl.handle.net/1942/43630 | - |
dc.description.abstract | The selection of the primary endpoint in a clinical trial plays a critical role in determining the trial's success. Ideally, the primary endpoint is the clinically most relevant outcome, also termed the true endpoint. However, practical considerations, like extended follow-up, may complicate this choice, prompting the proposal to replace the true endpoint with so-called surrogate endpoints. Evaluating the validity of these surrogate endpoints is crucial, and a popular evaluation framework is based on the proportion of treatment effect explained (PTE). While methodological advancements in this area have focused primarily on estimation methods, interpretation remains a challenge hindering the practical use of the PTE. We review various ways to interpret the PTE. These interpretations-two causal and one non-causal-reveal connections between the PTE principal surrogacy, causal mediation analysis, and the prediction of trial-level treatment effects. A common limitation across these interpretations is the reliance on unverifiable assumptions. As such, we argue that the PTE is only meaningful when researchers are willing to make very strong assumptions. These challenges are also illustrated in an analysis of three hypothetical vaccine trials. | - |
dc.description.sponsorship | The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by Agentschap Innoveren & Ondernemen (VLAIO) and Janssen through a Baekeland Mandate [grant number HBC.2022.0145]. | - |
dc.language.iso | en | - |
dc.publisher | SAGE PUBLICATIONS LTD | - |
dc.rights | The Author(s) 2024 | - |
dc.subject.other | Surrogacy | - |
dc.subject.other | Surrogacy | - |
dc.subject.other | Prentice's criteria | - |
dc.subject.other | Prentice's criteria | - |
dc.subject.other | mediation analysis | - |
dc.subject.other | mediation analysis | - |
dc.subject.other | principal stratification | - |
dc.subject.other | principal stratification | - |
dc.subject.other | causal inference | - |
dc.subject.other | causal inference | - |
dc.title | Proportion of treatment effect explained: An overview of interpretations | - |
dc.type | Journal Contribution | - |
dc.identifier.epage | 1296 | - |
dc.identifier.issue | 7 | - |
dc.identifier.spage | 1278 | - |
dc.identifier.volume | 33 | - |
local.format.pages | 19 | - |
local.bibliographicCitation.jcat | A1 | - |
dc.description.notes | Stijven, F (corresponding author), Katholieke Univ Leuven, I BioStat, Leuven, Belgium. | - |
dc.description.notes | florian.stijven@kuleuven.be | - |
local.publisher.place | 1 OLIVERS YARD, 55 CITY ROAD, LONDON EC1Y 1SP, ENGLAND | - |
local.type.refereed | Refereed | - |
local.type.specified | Review | - |
dc.identifier.doi | 10.1177/09622802241259177 | - |
dc.identifier.pmid | 39053571 | - |
dc.identifier.isi | 001276826200001 | - |
dc.contributor.orcid | Stijven, Florian/0000-0002-4574-8261 | - |
local.provider.type | wosris | - |
local.description.affiliation | [Stijven, Florian; Alonso, Ariel] Katholieke Univ Leuven, I BioStat, Leuven, Belgium. | - |
local.description.affiliation | [Molenberghs, Geert] Univ Hasselt, I BioStat, Hasselt, Belgium. | - |
local.uhasselt.international | no | - |
item.fullcitation | Stijven, Florian; ALONSO ABAD, Ariel & MOLENBERGHS, Geert (2024) Proportion of treatment effect explained: An overview of interpretations. In: Statistical methods in medical research, 33 (7) , p. 1278 -1296. | - |
item.fulltext | With Fulltext | - |
item.embargoEndDate | 2025-01-25 | - |
item.contributor | Stijven, Florian | - |
item.contributor | ALONSO ABAD, Ariel | - |
item.contributor | MOLENBERGHS, Geert | - |
item.accessRights | Embargoed Access | - |
crisitem.journal.issn | 0962-2802 | - |
crisitem.journal.eissn | 1477-0334 | - |
Appears in Collections: | Research publications |
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Proportion of treatment effect explained_ An overview of interpretations.pdf Restricted Access | Published version | 456.51 kB | Adobe PDF | View/Open Request a copy |
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