XV Cochrane Colloquium

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    Assessing and reporting outcomes that are important to patients in trials and reviews / Avaliando e relatando desfechos importantes para pacientes em ensaios e revisões

    Participants:
    • speaker
      Professor of Health Services and Director, Seattle Quality of Life Group, School of Public Health and Community Medicine, University of Washington  - United States
    Documents:
    Patient-Reported Outcomes (PROs) are reports from patients about how they function or feel regarding a health condition and its therapy, without interpretation by anyone.  PROs provide patients’ perspective on treatment benefit beyond survival, disease, and physiologic markers, and are often the outcomes of most significance to patients. Trials incorporating PROs increased sixfold in the last decade.  Search strategies must be creative and comprehensive with multiple keywords.  Concepts included in PROs can only be determined by examining the actual content of instruments and requires intuitive judgement.  Evidence on measurement properties of PROs in the RCT population is critical. Review ers should consult o r iginal development articles.  Translation and cultural adaptation major issue in global trials. Studies that show no difference in PROs between intervention and control may indicate lack of instrument’s ability to detect change. Interpretation of  PRO endpoints is challenging. Systematic revie wers must decide how to categorize PROs and when to pool results. Studies with multiple PROs present a major risk of reporting bias if only significant effects reported.  PRO research rapidly evolving around regulation and clinical trial design considerations.