Statistical methods and graphical displays of quality of life with survival outcomes in oncology clinical trials for supporting the estimand framework.

ABSTRACT:

Background

Although there are discussions regarding standards of the analysis of patient-reported outcomes and quality of life (QOL) in oncology clinical trials, that of QOL with death events is not within their scope. For example, ignoring death can lead to bias in the QOL analysis for patients with moderate or high mortality rates in the palliative care setting. This is discussed in the estimand framework but is controversial. Information loss by summary measures under the estimand framework may make it challenging for clinicians to interpret the QOL analysis results. This study illustrated the use of graphical displays in the framework. They can be helpful for discussions between clinicians and statisticians and decision-making by stakeholders.

Methods

We reviewed the tim

SUBMITTER: Sakamaki K 

PROVIDER: S-EPMC9531431 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature