Implementation of an observational study in a hospital setting: experiences from the Assessment of Cost and ouTcomes of chemotherapy In an Observational setting in patients with advanced Non-small cell lung cancer (ACTION) study

摘要

Observational studies offer an alternative approach to conducting clinical research, in which the course of patient care is not directed. ACTION (Assessment of Cost and ouTcomes of chemotherapy In an Observational setting in patients with advanced Non-small cell lung cancer) is a large, 18-month prospective European observational study. It is the first study of its kind and aims to provide information about the costs and outcomes of treating patients with advanced non-small cell lungcancer (NSCLC) in routine clinical practice. This paper describes the setting up of ACTION, problems encountered with its implementation, and details of its methods and current status. It is hoped that ACTION will provide a meaningful guide to health care policy and prescribing in Europe, by gathering information internationally regarding first- and second-line chemotherapy of advanced NSCLC in clinical practice and how this affects costs, outcomes and quality of life.