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A patient-reported outcome or PRO is a questionnaire specifically used in clinical trial research. A PRO can be used to register the Quality Of Life (QOL) of a clinical trial participant during a clinical trial.

In general a PRO consists of a physical component and a mental component. The physical component measures items such as general health, physical function, and bodily pain. The mental component in general deals with items such as mental health, emotional role, social functioning and vitality.

Generic PRO tools are the SF-36 Health Survey (SF-36® Health Survey), SF-12 Health Survey (SF-12® Health Survey), Duke Health Profile (DUKE), and BASIS-32, to name a few.

Condition specific tools are the Adult Asthma Quality of Life Questionnaire (AQLQ), Migraine Specific Quality of Life (MSQOL) and the Seattle Angina Questionnaire (SAQ), to name a few.

See also Edit

References Edit

  • Debbie Kennedy, CRF Designer, Canary Publications, ISBN 0-9531174-7-2
  • Wiklund I., Assessment of patient-reported outcomes in clinical trials: the example of health-related quality of life, Fundam Clin Pharmacol. 2004 Jun;18(3):351-63.
  • Willke RJ, Burke LB, Erickson P., Measuring treatment impact: a review of patient-reported outcomes and other efficacy endpoints in approved product labels, Control Clin Trials. 2004 Dec;25(6):535-52.

External linksEdit

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