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Patient-reported outcome (PRO) instruments for children and adolescents are often included in clinical trials with the intention of collecting data to support claims in a medical product label.The purpose of the current task force report is to recommend good practices for pediatric PRO research that is conducted to inform regulatory decision making and support claims made in medical product labeling...
One of the recent advances in assessing outcomes of medical care is the inclusion of the patient perspective. The term patient-reported outcome (PRO) is used to reflect the patient perceptions of disease and its consequences as well as of treatment and health-care provision. The development of PRO measures has advanced rapidly, and implementation in clinical research and practice is now underway....
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