Management of Patient-Reported Outcome (PRO) Alerts in Clinical Trials: A Cross Sectional Survey

PloS One
Derek KyteMelanie Calvert

Abstract

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 we conducted a national survey of personnel involved in clinical trials with a PRO endpoint. We conducted a national cross-sectional survey of 767 UK-based research nurses, data managers/coordinators, trial managers and chief/principal investigators involved in clinical trials using PROs. Respondents were self-selected volunteers from a non-randomised sample of eligible individuals recruited via 55 UK Clinical Research Collaboration Registered Clinical Trials Units and 19 Comprehensive Local Research Networks. Questions centred on the proportion of trial personnel encountering alerts, how staff responded to PRO alerts and whether current guidance was deemed sufficient to support research personnel. We undertook descriptive analyses of the quantitative data and directed thematic analysis of free-text comments. ...Continue Reading

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Mar 24, 2015·Lancet·Melanie CalvertDavid Moher

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Citations

Apr 9, 2019·Journal of the National Cancer Institute·Derek KyteMelanie Calvert
Jun 14, 2016·Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation·Rebecca Mercieca-BebberMadeleine T King
Oct 14, 2017·Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation·Isabelle ToupinBertrand Lebouché

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