Patient-reported outcome (PRO) instruments are related to risk management programmes in that they are tools to measure the benefits and risks of exposure to pharmaceutical products from the patient's perspective. Clinical measures of improvement of certain conditions may not necessarily correlate with improvements in a patient's ability to perform daily activities. PRO data, when properly administered, collected, analysed and returned to physicians are a very useful source of information. This will ultimately address safety concerns, facilitate the physician-patient relationship and improve patients' compliance to treatment in routine patient care. In this article we stress the importance of PRO in risk management.
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