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The critical need for patient‐reported outcome measures to assess the severity and impact of systemic sclerosis

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matol 2022; 186:86–95. 8 U.S. Food and Drug Administration. Patient-reported outcome measures: use in medical product development to support labeling claims. Available at: https://www.fda.gov/regulatory-information/searchfda-guidance-documents/patient-reported-outcome-measures-usemedical-product-development-support-labeling-claims (last accessed 24 August 2021). 9… Click to show full abstract

matol 2022; 186:86–95. 8 U.S. Food and Drug Administration. Patient-reported outcome measures: use in medical product development to support labeling claims. Available at: https://www.fda.gov/regulatory-information/searchfda-guidance-documents/patient-reported-outcome-measures-usemedical-product-development-support-labeling-claims (last accessed 24 August 2021). 9 Terwee CB, Prinsen CA, Chiarotto A et al. COSMIN methodology for assessing the content validity of Patient-Reported Outcome Measures (PROMs). User manual. Available at: https://www.cosmin. nl/tools/guideline-conducting-systematic-review-outcome-measures (last accessed 24 August 2021).

Keywords: outcome measures; reported outcome; patient reported; need patient; critical need

Journal Title: British Journal of Dermatology
Year Published: 2021

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