Evidence map›Paper›PMID 41023636›Full record

ArticleBMC medical research methodology2025

Handling missing outcomes in time-to-event analyses in randomised controlled trials: a scoping review with a focus on multiple imputation.

Saravanaraj Karuppasamy, Prasanna Samuel Premkumar, Venkata Raghava Mohan

Abstract readScoping Review
In one paragraph

Article in BMC medical research methodology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
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.

Saravanaraj KaruppasamyDepartment of Biostatistics, Christian Medical College, Vellore, India.
Prasanna Samuel PremkumarDepartment of Biostatistics, Christian Medical College, Vellore, India. prasanna.samuel@cmcvellore.ac.in.
Venkata Raghava MohanDepartment of Community Medicine, Christian Medical College, Vellore, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRandomised Controlled Trials (RCTs) are the gold standard for evaluating treatment effects. However, missing outcomes can threaten the validity of the results. Missing data pose a unique challenge in time-to-event analyses, where the event time may be censored rather than completely missing. Proper handling of missing event times is crucial to ensure unbiased and reliable conclusions in RCTs. This scoping review examines how missing outcomes in time-to-event studies have been addressed in high-impact medical journals and evaluates the implementation and reporting of multiple imputation (MI) techniques in RCTs.

methodThis scoping review assessed methods for handling missing time-to-event outcomes in RCTs published between 2019 and 2024 in three high-impact medical journals: The New England Journal of Medicine, The Lancet, and The Journal of the American Medical Association. Studies were reviewed to identify whether missing outcome data were present and, if so, which methods were used to handle them. Studies that applied MI were examined in detail to assess how the MI approach was implemented and reported. The review also explored theoretical approaches for imputing censored event times.

resultsA total of 834 articles were identified through a PubMed search. After screening, 383 RCTs underwent full-text review. Of these, 354 (92.4%) had no or < 10% missing outcomes without imputation. The remaining 29 studies (7.6%) addressed missing data using statistical approaches: 12 applied MI, 10 used complete case analysis, 6 conducted best-/worst-case sensitivity analyses, and 1 used a propensity score-based method. MI approaches varied, with some studies lacking detailed reporting.

conclusionIn RCTs with survival outcomes, properly handling missing event times is essential. This scoping review reveals that, despite the availability of statistical methods, the treatment of missing time-to-event outcomes remains underutilised and often poorly documented. While many studies reported non-administrative censoring, limited information was provided on whether such censoring was informative or non-informative. Additionally, the reporting of MI techniques is frequently insufficient. These findings highlight a critical gap in the handling and reporting of missing outcomes in survival analysis. Strengthening these practices will enhance the reliability and reproducibility of survival analyses in RCTs.

Indexed as

Outcome Assessment, Health CareRandomized Controlled Trials as TopicResearch DesignData Interpretation, StatisticalHumansMissing outcomesMultiple imputationSurvival analysisTime-to-event data

Identifiers

PMID41023636
PMCPMC12482435

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LicenceCC BY-NC-ND
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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.