Patient-reported outcomes in ovarian cancer clinical trials
作者： M.L. Friedlander , M.T. King
关键词: Intensive care medicine 、 Scrutiny 、 Medicine 、 Ovarian cancer 、 Guidance documents 、 Rigour 、 Surrogate endpoint 、 Clinical trial 、 Comparative effectiveness research 、 Quality of life (healthcare) 、 Gynecology
摘要: There is general acceptance of the importance incorporating patient-reported outcome (PRO) measures including health-related quality life (HRQOL) into clinical trials, and there are now a number guidance documents available on how to use PRO's for regulatory authorities in comparative effectiveness research. The methods used collect, analyse report PRO data trials have received considerable scrutiny, revealing many shortcomings standard reporting HRQOL as well been selected analysed trials. This has led recent Consolidated Standards Reporting Clinical Trials-PRO extension statement which lays down framework selection analysis PROs, either primary or secondary trial end points, thus ensuring scientific rigour. Adherence these guidelines can only improve conduct interpretation their results, may help avoid missing out opportunities past. We review pertinent literature discuss various should be applied ovarian cancer
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