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What are PRO data? PRO are defined by the FDA 1 as “any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else.” Participant- (including patients, donors, caregivers, and others) reported outcomes (collectively referred to as ...

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Patient-Reported Outcome (PRO) Data Dictionary User Guide Last Updated 9/1/2022 3 the macro-enabled data entry worksheet of the PRO Data Collection Template, which helps users by graying out non-applicable data fields based on whether data are relevant to the pre- or post-operative period and are for THA or TKA procedures.

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