Inference in randomized trials with death and missingness.
Biometrics
; 73(2): 431-440, 2017 06.
Article
en En
| MEDLINE
| ID: mdl-27753071
ABSTRACT
In randomized studies involving severely ill patients, functional outcomes are often unobserved due to missed clinic visits, premature withdrawal, or death. It is well known that if these unobserved functional outcomes are not handled properly, biased treatment comparisons can be produced. In this article, we propose a procedure for comparing treatments that is based on a composite endpoint that combines information on both the functional outcome and survival. We further propose a missing data imputation scheme and sensitivity analysis strategy to handle the unobserved functional outcomes not due to death. Illustrations of the proposed method are given by analyzing data from a recent non-small cell lung cancer clinical trial and a recent trial of sedation interruption among mechanically ventilated patients.
Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Ensayos Clínicos Controlados Aleatorios como Asunto
Tipo de estudio:
Clinical_trials
Límite:
Female
/
Humans
/
Pregnancy
Idioma:
En
Año:
2017
Tipo del documento:
Article