Expanding the evidence base in transplantation: the complementary roles of randomized controlled trials and outcomes research.

摘要: Transplantation offers a unique opportunity to demonstrate the complementary roles of randomized controlled trials and outcome research. The surgery collaboration necessary for transplant procedure makes randomization blinding difficult. Because essentially every recipient is included in registry, sampling bias minimized. Regulatory agencies generally do not consider outcomes research when assessing efficacy new drugs or medical interventions. This workgroup summary examines suitability complement results related issues: versus effectiveness, internal external validity, data types, limitations, analysis methodologies. Many advances have been pioneered transplantation. A case made regulatory reimbursement authorities use making efficacy, coverage decisions