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Deconstructing the Kaplan-Meier curve: Quantification of treatment effect using the treatment effect process.

ABSTRACT: In studies of survival and its association with treatment and other prognostic variables, elapsed time alone will often show itself to be among the strongest, if not the strongest, of the predictor variables. Kaplan-Meier curves will show the overall survival of each group and the general differences between groups due to treatment. However, the time-dependent nature of treatment effects is not always immediately transparent from these curves. More sophisticated tools are needed to spotlight the treatment effects. An important tool in this context is the treatment effect process. This tool can be potent in revealing the complex myriad of ways in which treatment can affect survival time. We look at a recently published study in which the outcome was relapse-free survival, and we illustrate how the use of the treatment effect process can provide a much deeper understanding of the relationship between time and treatment in this trial.

SUBMITTER: Devlin SM

PROVIDER: S-EPMC9918692 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

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Deconstructing the Kaplan-Meier curve: Quantification of treatment effect using the treatment effect process.

Devlin Sean M SM O'Quigley John J

Contemporary clinical trials 20221205

In studies of survival and its association with treatment and other prognostic variables, elapsed time alone will often show itself to be among the strongest, if not the strongest, of the predictor variables. Kaplan-Meier curves will show the overall survival of each group and the general differences between groups due to treatment. However, the time-dependent nature of treatment effects is not always immediately transparent from these curves. More sophisticated tools are needed to spotlight the ...[more]

PMID: 36473681

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Project description:BackgroundMeta-analyses of studies evaluating survival (time-to-event) outcomes are a powerful technique to assess the strength of evidence for a given disease or treatment. However, these studies rely on the adequate reporting of summary statistics in the source articles to facilitate further analysis. Unfortunately, many studies, especially within the field of prognostic research do not report such statistics, making secondary analyses challenging. Consequently, methods have been developed to infer missing statistics from the commonly published Kaplan-Meier (KM) plots but are liable to error especially when the published number at risk is not included.MethodsWe therefore developed a method using non-linear optimisation (nlopt) that only requires the KM plot and the commonly published P value to better estimate the underlying censoring pattern. We use this information to then calculate the natural logarithm of the hazard ratio (ln (HR)) and its variance (var) ln (HR), statistics important for meta-analyses.ResultsWe compared this method to the Parmar method which also does not require the number at risk to be published. In a validation set consisting of 13 KM studies, a statistically significant improvement in calculating ln (HR) when using an exact P value was obtained (mean absolute error 0.014 vs 0.077, P?=?0.003). Thus, when the true HR has a value of 1.5, inference of the HR using the proposed method would set limits between 1.49/1.52, an improvement of the 1.39/1.62 limits obtained using the Parmar method. We also used Monte Carlo simulations to establish recommendations for the number and positioning of points required for the method.ConclusionThe proposed non-linear optimisation method is an improvement on the existing method when only a KM plot and P value are included and as such will enhance the accuracy of meta-analyses performed for studies analysing time-to-event outcomes. The nlopt source code is available, as is a simple-to-use web implementation of the method.

Dataset Information

Deconstructing the Kaplan-Meier curve: Quantification of treatment effect using the treatment effect process.

Publications

Deconstructing the Kaplan-Meier curve: Quantification of treatment effect using the treatment effect process.

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