Patient Self-Report

Definition 1

Subjective reports made by a patient. (NCI Thesaurus)

Definition 2

Report coming directly from patients or subjects through interviews or self-completed questionnaires or other data capture tools such as diaries about their life, health condition(s) and treatment. NOTE: PROs are used to assess outcomes involving the patients'/subjects' perceptions, symptoms, satisfaction with treatment, adherence to prescribed regimens. PROs include outcomes recorded by interviewers transcribing the views expressed by the patient, but the term does not apply to outcomes recorded by observers who rely on their own judgment. A PRO is usually distinguished from a self-reported objective measurement such as a PEF score or body weight [from PRO Draft Guidance, Gordon Guyatt and Holger Schuneman - personal communication; Patrick, D.L., 2003. After Acquardo C., Berzon C., et al., 2001] See also outcome, subject, patient. (NCI Thesaurus/CDISC)

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