Rebecca Mercieca?Bebber|Madeleine King|Melanie Calvert|Martin R. Stockler|Michael Friedlander
The importance of patient-reported outcomes in clinical trials and strategies for future optimization
University of Sydney|National Health and Medical Research Council|University of Sydney|Central Clinical Hospital|NIHR Birmingham Biomedical Research Centre|University of Birmingham|National Health and Medical Research Council|University of Sydney|UNSW Sydney|University of Sydney|National Health and Medical Research Council
patientreported outcomes pros included clinical trials primary secondary endpoints increasingly recognized regulators clinicians patients valuable tools collect patientcentered datapros provide unique information impact medical condition treatment patients perspective therefore pros included clinical trials ensure impact trial intervention comprehensively assessedthis review first discusses examples pro endpoints added value clinical trial interpretationsecond describes problems current practices designing implementing reporting pro studies problems may addressed complying guidance protocol development selecting appropriate pro measures match clinically motivated pro hypotheses minimizing rates avoidable missing pro data analyzing interpreting pro data transparently reporting pro findings