Using input from consumers, clinical staff, and quality of life experts, we developed a self-administered, health-related quality of life instrument for individuals with schizophrenia living in the community the Schizophrenia Outcomes Assessment Project 51-item Health Status Survey (SOAP-51). OBJECTIVES: To establish the concurrent and discriminatory validity of the SOAP-51 Health Status Survey. METHODS: We asked 1500 individuals with schizophrenia and their caregivers in 5 ethnically and geographically diverse states to complete the SOAP-51; retention was 84.2%. For concurrent validation, consumers were asked to globally rate the impact of their condition on each of SOAP-51 s 8 factors; Cronbach s alpha was 0.711-0.881, test-retest reliability was 0.781-0.994. Factor scores were compared across self-reported degree of impact. For discriminate validity, the staff placed each consumer into one of 4 quartiles to describe their perception of the consumer s ability to function in each factor area. Consumer factor scores then were compared to staff-reported functional levels. RESULTS: For all factors, consumer factor scores progressively lowered as consumers felt the condition had more negative impact on their lives (p<0.001). For all factors but medication effects, consumer factor scores improved with improving staff-perceived assessment of consumer functionality (p<0.001). Consumer scores from the lowest to the highest assigned quartile had average scores of 42.7%, 49.3%, 54.7%, and 60.0%, respectively. 92% of consumers considered the survey useful, 92% of staff considered the survey valuable for monitoring consumer progress. CONCLUSION: We have established concurrent and discriminatory validity for the SOAP-51 which can be used as an outcomes measure in patient monitoring and management, and health policy decision making.