Management of patient-reported outcome (PRO) alerts in clinical trials: A cross sectional survey (19 January 2016)

Summary

Assessment of patient-reported outcomes (PROs) provides valuable information to inform patient-centered care, but may also reveal 'PRO alerts': psychological distress or physical symptoms that may require an immediate response. Ad-hoc management of PRO alerts in clinical trials may result in suboptimal patient care or potentially bias trial results. To gain greater understanding of current practice in PRO alert management, Kyte et al. conducted a national survey of personnel involved in clinical trials with a PRO endpoint.

Content