The Prognostic Significance of Patient-Reported Outcomes in Cancer Clinical Trials

Cancer clinical trials that assessed baseline PROs and mortality were identified through MEDLINE (through December 2006) supplemented by the Cochrane database, American Society of Clinical Oncology/European Society for Medical Oncology abstracts and hand searches. Inclusion criteria were publication in English language and use of multivariate analyses of PROs that controlled for one or more clinical factors. Two raters reviewed each study, abstracted data, and assessed study quality; two additional raters verified abstractions.

In 36 of 39 studies (N = 13,874), at least one PRO was significantly associated with survival (P