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Randomised controlled trials aim to assess the impact of one (or more) healthinterventions relative to other standard interventions. RCTs sometimes use anordinal outcome, which is an endpoint that comprises of multiple, monotonicallyordered categories that are not necessarily separated by a quantifiabledistance. Ordinal outcomes are appealing in clinical settings as disease statescan represent meaningful categories that may be of clinical importance. Theycan also retain information and increase statistical power compared todichotomised outcomes. Target parameters for ordinal outcomes in RCTs may varydepending on the nature of the research question, the modelling assumptions,and the expertise of the data analyst. The aim of this scoping review is tosystematically describe the use of ordinal outcomes in contemporary RCTs.Specifically, we aim to (i) identify which target parameters are of interest intrials that use an ordinal outcome; (ii) describe how ordinal outcomes areanalysed in RCTs to estimate a treatment effect; and (iii) describe whetherRCTs that use an ordinal outcome adequately report key methodological aspectsspecific to the analysis of the outcome.  Results from this review will outline the current state of practice of theuse of ordinal outcomes in RCTs. Ways to improve the analysis and reporting ofordinal outcomes in RCTs will be discussed. We will review RCTs that arepublished in the top four medical journals (BMJ, NEJM, The Lancet and JAMA)between 1 January 2012 and 31 July 2022 that use an ordinal outcome. The reviewwill be conducted using PubMed. Our review will adhere to guidelines forscoping reviews as described in the PRISMA-ScR checklist. The studycharacteristics and design, including the target parameter(s) and statisticalmethods will be extracted from eligible studies. The data will be summarisedusing descriptive statistics.

Statistical analyses of ordinal outcomes in randomised controlled trials: protocol for a scoping review