The science of collecting and analyzing patient-reported outcomes (PROs) is well developed in clinical research.1 Almost a quarter of US drug labels include information about treatment benefits based on patient symptom questionnaires.2 International organizations and regulatory agencies have developed methodological standards for the use of PROs in clinical trials.1,3
Basch E, Torda P, Adams K. Standards for Patient-Reported Outcome–Based Performance Measures. JAMA. 2013;310(2):139–140. doi:https://doi.org/10.1001/jama.2013.6855
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