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The Art and The Science of Ensuring Inter-rater Reliability

Clinician-rated Outcome Assessments in Orphan Disease Research

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Within the world of clinical research, clinical outcome assessments (COAs) can measure patients’ health status and define end points that can be interpreted to indicate the benefits of a medical intervention on how patients feel, function, or survive. COAs can take many forms—clinician-rated, patient-rated, interview-based, functional performance, observer-rated, and still others—and individual COAs can be used in different ways in different settings. This article focuses on clinician-rated outcome assessments (ClinRos), some of which may be novel; others may be well-established and familiar to individuals practicing in clinics and research settings alike. When the right ClinRo is selected and patient data is collected in a consistent manner over time, it can enable key insights into a patient’s state of mind, behavior, cognitions, visual acuity, limb movement, gait, and much more, providing clinical context for measures reflecting pharmacological attributes of a novel therapy.

Authors:

Chief Medical and Scientific Officer
Vice President of Clinical Projects, Clinical Assessment Technologies

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