Reporting standards for patient-reported outcomes in clinical trial protocols and publications
A partir de l'analyse de 228 essais cliniques, cette étude évalue la qualité des protocoles destinés à collecter les résultats auto-rapportés, puis examine la présence de ces résultats dans les publications scientifiques
Over the past 20 years, interest has grown to include patient-reported outcomes (PRO) in cancer clinical trials, evidenced by guidance documents from international regulatory authorities(1) and a steady increase of PRO-basedendpoints in protocols(e.g., pain improvement)(2).But is inclusion of PRO endpoints rigorous and systematic? Concerns have been raised previously about incomplete reporting of PRO results in clinical trial publications, which may reflect underlying design weaknesses(3). These concerns have prompted recent international collaborative efforts to standardize expectations for describing PRO endpoints in protocols and publications.
Journal of the National Cancer Institute , éditorial en libre accès, 2018