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Patient-reported outcome instruments in clinical trials of systemic sclerosis.


ABSTRACT: Patient-reported outcome instruments provide valuable insight into disease-related morbidity known only to the patient and complement more objective outcome tools in the clinical trial setting. They are of particular importance in systemic sclerosis owing to the challenges around defining disease activity, the episodic nature of many disease-specific manifestations and the paucity of validated objective surrogate outcome measures for use in clinical trials. Early clinical trials of systemic sclerosis often incorporated legacy patient-reported outcome instruments, but the last 20 years has witnessed the emergence of several scleroderma-specific instruments that are now being routinely used alongside other outcomes in systemic sclerosis clinical trials. More recently, the value of patient-re

SUBMITTER: Pauling JD 

PROVIDER: S-EPMC8922614 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature