Patient experience in systemic lupus erythematosus: development of novel patient-reported symptom and patient-reported impact measures

Author:

Mathias S. D.,Berry P.,De Vries J.,Pascoe K.,Colwell H. H.,Chang D. J.,Askanase A. D.

Funder

GSK

Publisher

Springer Science and Business Media LLC

Subject

Health Information Management,Health Informatics

Reference33 articles.

1. American College of Rheumatology Ad Hoc Committee on Systemic Lupus Erythematosus. (1999). Guidelines for referral and management of systemic lupus erythematosus in adults. American College of Rheumatology ad hoc Committee on systemic lupus erythematosus guidelines. Arthritis Rheum, 42, 1785–1796.

2. Food and Drug Administration (2010) Guidance for Industry: Systemic Lupus Erythematosus - Developing Medical Products for Treatment. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072063.pdf (Accessed May 2015).

3. European Medicines Agency (2015) Guideline on clinical investigation of medicinal products for the treatment of systemic lupus erythematosus and lupus nephritis. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/03/WC500184889.pdf (Accessed May 2015).

4. Food and Drug Administration. (2009). Guidance for industry on patient-reported outcome measures: Use in medical product development to support labeling claims. Fed Regist, 74, 65132–65133.

5. Patrick, D. L., Burke, L. B., Gwaltney, C. J., et al. (2011). Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: Part 1--eliciting concepts for a new PRO instrument. Value Health, 14, 967–977.

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