Using observational study data as an external control group for a clinical trial: an empirical comparison of methods to account for longitudinal missing data.

ABSTRACT:

Background

Observational data are increasingly being used to conduct external comparisons to clinical trials. In this study, we empirically examined whether different methodological approaches to longitudinal missing data affected study conclusions in this setting.

Methods

We used data from one clinical trial and one prospective observational study, both Norwegian multicenter studies including patients with recently diagnosed rheumatoid arthritis and implementing similar treatment strategies, but with different stringency. A binary disease remission status was defined at 6, 12, and 24 months in both studies. After identifying patterns of longitudinal missing outcome data, we evaluated the following five approaches to handle missingness: analyses of patients with complete fol

SUBMITTER: Norvang V 

PROVIDER: S-EPMC9148529 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature