Generalizability Analyses with a Partially Nested Trial Design: The Necrotizing Enterocolitis Surgery Trial.

ABSTRACT: We discuss generalizability analyses under a partially nested trial design, where part of the trial is nested within a cohort of trial-eligible individuals, while the rest of the trial is not nested. This design arises, for example, when only some centers participating in a trial are able to collect data on non-randomized individuals, or when data on non-randomized individuals cannot be collected for the full duration of the trial. Our work is motivated by the Necrotizing Enterocolitis Surgery Trial, which compared initial laparotomy versus peritoneal drain for infants with necrotizing enterocolitis or spontaneous intestinal perforation. During the first phase of the study, data were collected from randomized individuals as well as consenting non-randomized individuals; during the second p

SUBMITTER: Robertson SE 

PROVIDER: S-EPMC12393179 | biostudies-literature | 2026 Mar

REPOSITORIES: biostudies-literature