Background: 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.
Objectives: To develop three COS for (a) localised, (b) locally advanced and
(c) metastatic
RCC study design, participants and methods: 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.
Discussion: The R-COS will reduce outcome reporting heterogeneity and improve
the evidence base for RCC.
Study registration: The study is registered with the COMET initiative: https://www.
comet-initiative.org/studies/details/1406.
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
Disease Category: Urology
Disease Name: Renal cell cancer
Age Range: Unknown
Sex: Either
Nature of Intervention: Any
- Charities
- Clinical experts
- Consumers (patients)
- Methodologists
- Patient/ support group representatives
- Researchers
- COS (Other)
- Consensus meeting
- Delphi process
- Interview
- Systematic review