A systematic evaluation of compliance and reporting of patient-reported outcome endpoints in ovarian cancer randomised controlled trials: implications for generalisability and clinical practice

Journal of Patient-reported Outcomes
Rebecca Mercieca-BebberMadeleine T King

Abstract

This study aimed to evaluate the patient-reported outcome (PRO) content of ovarian cancer randomised-controlled trial (RCT) publications, describe PRO compliance, and explore potential relationships among these and completeness of PRO protocol content. Publications of Phase III ovarian cancer RCTs with PRO endpoints were identified by Medline and Cochrane systematic search: January 2000 to February 2016. Two reviewers determined the number of Consolidated Standards of Reporting Trials (CONSORT)-PRO Extension items addressed in publications. Compliance rates (defined as the proportion of participants included in the principal PRO analysis, of those from whom PRO assessments were expected) were extracted. The relationship between CONSORT-PRO score and compliance rates was explored using scatter plots. Additionally CONSORT-PRO score and PRO compliance rates respectively were compared with corresponding PRO protocol scores obtained from a previous study. Thirty-six eligible RCTs (n = 33 with secondary PRO endpoint) were identified and analysed. The average number of CONSORT-PRO items addressed in publications was 6.7 (48%; Range 0-13.5/14). Three RCTs did not report PRO results; in 1 case due to poor compliance. Some compliance inf...Continue Reading

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Citations

Sep 8, 2020·Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation·Stephanie L PughDeborah W Bruner
Jul 20, 2018·Journal of Gynecologic Oncology·Michelle K WilsonMichael Friedlander
Dec 19, 2019·Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation·Matthew R LeBlancSophia K Smith
Feb 3, 2020·The Lancet Oncology·Corneel CoensUNKNOWN Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium

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Software Mentioned

SPIRIT
CONSORT
PRO
ESMO
SPSS

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