OBJECTIVES: The objective of the literature review was to describe generic and specific PRO instruments developed and/or used in atrial fibrillation. The review focuses 1) on the description of generic and specific PRO instruments, including Quality of life, Symptoms, Activities of Daily Living and Patient Satisfaction and 2) on the use of PRO instruments in clinical trials of patients with atrial fibrillation. METHODS: A systematic literature review of published studies was conducted using MEDLINE (1966-2004), EMBASE (1974-2004) and the Mapi Research Trust databases. Only studies with named, referenced PRO instruments used in patients with atrial fibrillation were reviewed. Based on the review of the domains covered and the availability of psychometric properties for all the instruments retrieved, a selection of instruments were further analyzed for their psychometric properties and their use in randomized clinical trials. RESULTS: Forty five PRO instruments have been identified: 18 cardiac-specific, 17 generic and 10 psychological instruments . After examination of the domains assessed and the availability of psychometric properties, 19 of the 45 instruments were further analyzed. From these 19 instruments, only 5 instruments (2 cardiac-specific, 2 generic and 1 psychological instruments) were found to have good psychometric properties, including sensitivity to change in randomized clinical trials. CONCLUSIONS: Despite the large amount of PRO identified, only two cardiovascular disease-specific instruments were found to be well validated in patients with atrial fibrillation and to be responsive to change in randomized clinical trials.