Core Outcomes Sets for trials and Core Information Sets for consultations: keeping them patient centred


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Jane Blazeby1,Angus McNair1
1University of Bristol

Abstract

There are many different patient reported outcome measures available to use in clinical trials in oncology. This creates problems at the design and analysis stage. The heterogeneity of items and domains in studies mean it is difficult to establish the impact of treatments, to synthesise data and it risks outcome reporting bias. There are also many different outcomes/pieces of information that may be used to inform decision-making during consultations with patients. The variety of data means that different things may be said by different clinicians to patients and information provision is not standardised. It may also not be relevant to patient needs. The use of Core Outcome Sets (a minimum agreed set of outcomes to be reported in trials of a particular condition) and Core Information Sets (a minimum agreed set of information to be communicated during consultations as a baseline for a particular intervention) will help this situation. This talk will cover the rationale for core sets and the methods for how to develop them. It will illustrate this with examples from surgical oncology and show how patient centred selection and measurement of outcomes can influence studies and clinical practice and directly inform decision-making.