A Protocol for a Systematic Evaluation of Patient-Reported Outcome (PRO) Protocol Content and Reporting in UK Cancer Clinical Trials: the EPiC study.


Session type:


Thomas Keeley1,Derek Kyte2,Khaled Ahmed2,Jo Armes3,Julia Brown4,Michael Brundage5,Lynn Calman6,Chris Copland7,Fabio Efficace8,Anna Gavin9,Adam Glaser4,Diana Greenfield10,Madeleine King11,Anne Lanceley12,Rebecca Mercieca-Bebber11,Rachel Taylor13,Galina Velikova4,Melanie Calvert2
1The University of Birmingham,2University of Birmingham,3Kings College London,4University of Leeds,5Queen's University,6University of Southampton,7NCRI Psychosocial Oncology and Survivorship CSG,8Health Outcomes Reserach Unit, Italian Group for Adult Hematologic Diseases,9Queen's University Belfast,10Sheffield Teaching Hospital NHS Foundation Trust,11University of Sydney,12University College London,13University College London Hospital



Patient Reported Outcome (PRO) data collected in cancer trials are increasingly valued by international health-policy and regulatory authorities, and by cancer patients. Despite their importance, PRO results are often poorly reported or may not be reported at all. Emerging evidence from a small sample of cancer trials suggests PRO information is commonly omitted from protocols1. This study will: (1) evaluate the standards of PRO-specific protocol content and PRO results reporting in a large sample of UK cancer trials, and (2) model factors associated with rates of PRO protocol and publication reporting and the quality of this reporting.


The protocols and subsequent publications of 80-120 completed UK NIHR Portfolio Cancer trials (all specialities/age-groups) containing a primary or secondary PRO endpoint will be evaluated. 

Information on key trial characteristics will be extracted. Completeness of PRO aspects of trial protocols will be evaluated using, the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) checklist and a 33-item PRO protocol checklist.  Completeness of PRO reporting will be evaluated using the CONSORT-PRO extension checklist and general quality of reporting will be assessed by the 37-item 2010 CONSORT checklist.


Descriptive analyses will be conducted on the number of SPIRIT and PRO checklist items present in the included trial protocols; on rates of incomplete PRO reporting; and, where appropriate, on the number of CONSORT and CONSORT PRO Extension checklist items included in trial publications. To explore factors associated with PRO-specific protocol and reporting quality, we will perform pre-specified multiple regression analyses.


This review will provide original data regarding the potential factors associated with PRO protocol quality and reporting. This information will assist the scientific community in determining how best we can bring about methodological improvements in the way PROs are assessed, managed and reported in future cancer trials.