Partially clustered designs for clinical trials: Unifying existing designs using consistent terminology.

ABSTRACT:

Introduction

Clinical trial designs based on the assumption of independent observations are well established. Clustered clinical trial designs, where all observational units belong to a cluster and outcomes within clusters are expected to be correlated, have also received considerable attention. However, many clinical trials involve partially clustered data, where only some observational units belong to a cluster. Examples of such trials occur in neonatology, where participants include infants from both singleton and multiple births, and ophthalmology, where one or two eyes per participant may need treatment. Partial clustering can also arise in trials of group-based treatments (e.g. group education or counselling sessions) or treatments administered individually by a discrete numb

SUBMITTER: Lange KM 

PROVIDER: S-EPMC10021130 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature