Measuring what matters to healthcare professionals, patients and service providers

Programme stream(s): Cancer control / living with and beyond and cancer outcomes
Programme session type(s): Specialist session

Chair: Lesley Fallowfield, University of Sussex, UK
Speaker: Angus McNair, NIHR, UK
Speaker: David Cella, CORE Core Outcomes Research Centre, Chicago, USA
Speaker: Derek Kyte, University of Birmingham, UK


Room: Dochart

Although most now acknowledge and recognise the importance of including assessment of patient reported outcomes (PROs) or Quality of Life measures into clinical treatment trials, many problems remain. Firstly choice of measure is frequently inappropriate and often statistical analysis and interpretation somewhat naïve. Secondly PRO data that should assist shared decision-making about treatment options and/or be used to populate decision aids is not always available or understood sufficiently by either HCPs or patients. PROs are rarely seen as primary trial endpoints even when appropriate. Finally adoption of validated PRO measures outwith the trial setting should form part of the electronic record.

Core Outcomes Sets for trials and Core Information Sets for consultations: keeping them patient centred
Speaker: Jane Blazeby
Affiliation: University of Bristol


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.

Best practices for integration of Patient-Reported Outcomes (PROs) into trials
Speaker: Derek Kyte
Affiliation: University of Birmingham


Patient-Reported Outcomes (PROs) data, for example quality of life and symptom burden, are increasingly captured within cancer clinical trials to provide the patient perspective on the physical, functional, psychological and social consequences of treatment and the degree and impact of disease symptoms. This information is important in supporting patients to make more informed treatment decisions at the point of cancer diagnosis and beyond. The utility of such data been recognized by all sectors of the health care community, including patients, clinicians, funders, regulators and policy-makers. Despite this, emerging evidence suggests that PRO information is commonly omitted from protocols, potentially leading to impaired data collection, and PRO results are poorly reported in trial publications, or may not be reported at all. This represents a waste of limited healthcare and research resources, and may restrict the effective use of PRO data to inform clinical decisions made by patients and other stakeholders. This presentation will outline the latest evidence regarding best-practice integration of PROs into cancer clinical trials, with a focus on recent international guidelines including the SPIRIT and CONSORT PRO extensions and the EMA perspective.