Abstract
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.
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.
| Original language | English |
|---|---|
| Pages (from-to) | 504-512 |
| Number of pages | 9 |
| Journal | BJU International |
| Volume | 4 |
| Issue number | 5 |
| Early online date | 28 Jun 2023 |
| DOIs | |
| Publication status | Published - Sept 2023 |
Bibliographical note
The data collection for the interview study is funded by NHS Grampian Endowments, and the costs of the interview transcriptions and eDelphi licences will be paid by the Arcobaleno Cancer Trust. Neither funder had any role in the design of the study. All other parts of the study are currently unfunded. The research team is not personally reimbursed for their time and efforts apart from research input by SD, which is financed by Swedish government funding of clinical research (ALF).
Access to Document
- MacLennan_etal_BJUI_A_Protocol_For_VOR
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