Author:
Holzner Bernhard,Giesinger Johannes M,Pinggera Jakob,Zugal Stefan,Schöpf Felix,Oberguggenberger Anne S,Gamper Eva M,Zabernigg August,Weber Barbara,Rumpold Gerhard
Publisher
Springer Science and Business Media LLC
Subject
Health Informatics,Health Policy,Computer Science Applications
Reference54 articles.
1. Bottomley A, Jones D, Claassens L: Patient-reported outcomes: assessment and current perspectives of the guidelines of the Food and Drug Administration and the reflection paper of the European Medicines Agency. Eur J Cancer. 2009, 45 (3): 347-53. 10.1016/j.ejca.2008.09.032.
2. U.S. Food and Drug Administration: Guidance for Industry - Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf . U.S. FDA, Clinical/Medical; 2009. Accessed 8th November 2012
3. Basch E: The missing voice of patients in drug-safety reporting. N Engl J Med. 2010, 362 (10): 865-9. 10.1056/NEJMp0911494.
4. Ware JE: Conceptualization and measurement of health-related quality of life: comments on an evolving field. Arch Phys Med Rehabil. 2003, 84 (4 Suppl 2): S43-51.
5. Gutteling JJ, Busschbach JJ, de Man RA, Darlington AS: Logistic feasibility of health related quality of life measurement in clinical practice: results of a prospective study in a large population of chronic liver patients. Health Qual Life Outcomes. 2008, 6: 97-10.1186/1477-7525-6-97.