ReviewClinical trials (London, England)2015
Measures of follow-up in time-to-event studies: Why provide them and what should they be?
Review in Clinical trials (London, England), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 3 of them syntheses that pooled it.
What it found
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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.
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.
Who cites it
25 citing papers in PubMed, 3 syntheses or guidelines pooled it.
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- Efficacy and safety of low dose rivaroxaban in patients with coronary heart disease: a systematic review and meta-analysis.Journal of thrombosis and thrombolysis · 2020Pooled it
- Twelve-month results of ab interno trabeculectomy with Kahook Dual Blade: an interventional, randomized, controlled clinical study.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2021Trial
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- Glioblastoma in young adult patients: contemporary patterns of care and survival in the United States.Journal of neuro-oncology · 2025Article
- Incident thrombocytopenia and bleeding risk in elderly patients with atrial fibrillation on direct oral anticoagulants: insights from the ATHEROsclerosis in Atrial Fibrillation study.Research and practice in thrombosis and haemostasis · 2024Article
- Outcomes of possible and probable rheumatic fever: A cohort study using northern Australian register data, 2013-2019.PLOS global public health · 2024Article
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- Real-world treatment patterns of metastatic non-small cell lung cancer patients receiving epidermal growth factor receptor tyrosine kinase inhibitors.Cancer medicine · 2023Observational
- Dynamic contrast enhanced MRI of pulmonary adenocarcinomas for early risk stratification: higher contrast uptake associated with response and better prognosis.BMC medical imaging · 2022Article
- Replication of Overall Survival, Progression-Free Survival, and Overall Response in Chemotherapy Arms of Non-Small Cell Lung Cancer Trials Using Real-World Data.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022Article
- Artificial Intelligence-Based Prognostic Model for Urologic Cancers: A SEER-Based Study.Cancers · 2022Article
- Estimation of the censoring distribution in clinical trials.Contemporary clinical trials communications · 2021Article
- Adverse Impact of DNA Methylation Regulatory Gene Mutations on the Prognosis of AML Patients in the 2017 ELN Favorable Risk Group, Particularly Those Defined byDiagnostics (Basel, Switzerland) · 2021Article
- Revised Korean Antiviral Guideline Reduces the Hepatitis B-related Hepatocellular Carcinoma Risk in Cirrhotic Patients.Journal of Korean medical science · 2021Article
Corrections and comments
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1 author.
Funding
Abstract
BACKGROUND/
aimsThere is some consensus among authors of reports of clinical studies that a measure of follow-up time is informative for the interpretation of the Kaplan-Meier estimate of the survivor function of the event time of interest. Previous authors have suggested that length of follow-up is important to report because the findings of a study should be extracted from the time frame in which most of the subjects have had the event or have remained under observation. This time frame is where the Kaplan-Meier estimate is most stable. This concept of stability is relative to the potential maximum information about the event time distribution contained in the sample; it is not relative to the true, population survivor function. A measure of stability is useful for the interpretation of an interim analysis in which an immature survivor function is presented. Our interest in this article lies in characterizing the unobserved, complete follow-up Kaplan-Meier estimate based on the observed, partial follow-up estimate. Our focus is not on characterizing the true event time distribution relative to its estimate. The concept of stability has not been well-defined in the literature, which has led to inconsistency and lack of transparency across trials in their attempts to capture it through a variety of measures of follow-up.
methodsWe report the results of a survey of recent literature on cancer clinical trials and summarize whether follow-up is reported and if so, whether it is well-defined. We define commonly used measures of follow-up in clinical studies.
resultsWe explain how each measure should be assessed to evaluate the stability of the Kaplan-Meier estimate for the event, and we identify relationships among measures. We propose a new measure that better conveys the desired information about the stability of the current Kaplan-Meier estimate relative to one based on complete follow-up. We apply the proposed measure to a meningioma study for illustration.
conclusionIt is useful for reports of clinical studies to supplement Kaplan-Meier estimates with quantitative assessments of the stability of those estimates relative to the potential follow-up of study participants. We justify the use of one commonly used measure, and we propose a new measure that most directly accomplishes this goal.
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