There is inconsistency in outcomes collected in renal cell cancer (RCC) intervention effectiveness studies and variability in their definitions. This makes critical summaries of the evidence base difficult and sub-optimally informative for clinical practice guidelines and decision-making by patients and healthcare professionals. A solution is to develop a core outcome set (COS), an agreed minimum set of outcomes to be reported in all trials in a clinical area.
To develop three COS for (a) localised, (b) locally advanced and (c) metastatic.
The methods are the same for each of our three COS and are structured in two phases. Phase 1 identifies potentially relevant outcomes by conducting both a systematic literature review and patient interviews (N ~ 30 patients). Qualitative data will be analysed using framework analysis. In phase 2, all outcomes identified in phase 1 will be entered in a modified eDelphi, whereby patients and healthcare professionals (50 of each) will score each outcome's importance (Likert scale from 1 [not important] to 9 [critically important]). Outcomes scored in the 7-9 range by ≥70% and 1-3 by ≤15% will be regarded as 'consensus in', and the vice versa of this will constitute 'consensus out'. All other combinations will be regarded as equivocal and discussed at consensus meetings (including 10 patients and 10 healthcare professionals) in order to vote on them and ratify the results of the eDelphi.
The R-COS will reduce outcome reporting heterogeneity and improve the evidence base for RCC.
The study is registered with the COMET initiative: https://www.comet-initiative.org/studies/details/1406.
BJUI compass. 2023 Jun 28*** epublish ***
Steven MacLennan, Lisa M Wintner, Katharina Beyer, Ailbhe Lawlor, Sheela Tripathee, Saeed Dabestani, Lorenzo Marconi, Rachel H Giles, Rose Woodward, Mieke Van Hemelrijck, Axel Bex, Patricia Zondervan
Academic Urology Unit, Institute of Applied Health Sciences University of Aberdeen Aberdeen UK., University Hospital of Psychiatry II Medical University of Innsbruck Austria., Translational Oncology and Urology Research (TOUR) King's College London London UK., Department of Translational Medicine, Division of Urological Cancers Lund University Lund Sweden., Department of Urology Coimbra University Hospital Coimbra Portugal., International Kidney Cancer Coalition Duivendrecht The Netherlands., Action Kidney Cancer Charity Manchester UK., Department of Urology Amsterdam University Medical Centers Amsterdam The Netherlands.