1. U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH). Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims;2006.
2. Reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products;EMEA,2006
3. Interpretation of quality of life changes;Lydick;Qual Life Res,1993
4. Defining clinically meaningful change in health-related quality of life;Crosby;J Clin Epidemiol,2003
5. Measuring change over time: assessing the usefulness of evaluative instruments;Guyatt;J Chronic Dis,1987