Evidence map›Paper›PMID 39991459›Full record

ArticleThe New England Journal of Statistics in Data Science2024

Meta-analysis of Censored Adverse Events.

Xinyue Qi, Shouhao Zhou, Christine B Peterson, Yucai Wang, Xinying Fang, Michael L Wang, Chan Shen

Abstract read
In one paragraph

Article in The New England Journal of Statistics in Data Science, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing 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

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

  1. Pooled it
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  3. Pooled it
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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

7 authors.

Xinyue QiDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Shouhao ZhouDepartment of Public Health Sciences, Pennsylvania State University College of Medicine, Hershey, PA, USA.
Christine B PetersonDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Yucai WangDepartment of Hematology, Mayo Clinic, Rochester, MN.
Xinying FangDepartment of Public Health Sciences, Pennsylvania State University College of Medicine, Hershey, PA, USA.
Michael L WangDepartment of Lymphoma, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Chan ShenDepartment of Surgery, Pennsylvania State University College of Medicine, Hershey, PA, USA.

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
Meta-analysis of Adverse Drug Effects in Clinical TrialsR21LM014534 · NLM · PENNSYLVANIA STATE UNIV HERSHEY MED CTR · PI PETERSON, CHRISTINE B, ZHOU, SHOUHAO · 2024 to 2025
$432k
NCI NIH HHS P30 CA016672NLM NIH HHS R21 LM014534
6 · The paper itself

Abstract

Meta-analysis is a powerful tool for assessing drug safety by combining treatment-related toxicological findings across multiple studies, as clinical trials are typically underpowered for detecting adverse drug effects. However, incomplete reporting of adverse events (AEs) in published clinical studies is frequently encountered, especially if the observed number of AEs is below a pre-specified study-dependent threshold. Ignoring the censored AE information, often found in lower frequency, can significantly bias the estimated incidence rate of AEs. Despite its importance, this prevalent issue in meta-analysis has received little statistical or analytic attention in the literature. To address this challenge, we propose a Bayesian approach to accommodating the censored and possibly rare AEs for meta-analysis of safety data. Through simulation studies, we demonstrate that the proposed method can improve accuracy in point and interval estimation of incidence probabilities, particularly in the presence of censored data. Overall, the proposed method provides a practical solution that can facilitate better-informed decisions regarding drug safety.

Indexed as

Adverse drug reactionBayesian inferenceDrug safetyIncomplete reportingMAGECMeta-analysis

Identifiers

PMID39991459
PMCPMC11845246

What OpenQuestion holds

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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.