Session: Outcomes

Accurate and consistent selection and reporting of clinical and patient reported outcomes in trials is critical to inform systematic reviews and meta-analyses, to allow cross study comparisons and to reduce reporting bias. Inclusion of patient reported outcomes (PROs) alongside clinical outcomes in trials has greatly increased, but PROs still seem to be under used once their relevance to clinical decision-making has been taken into account. Selection and reporting of valid and reliable clinical and patient reported outcomes in trials is needed. There is also a need to improve methods for reporting patient reported outcomes from trials to ensure that they are clinically meaningful, understood by clinicians, and used in clinical practice.

Aims

- review strategies for the process of designing trials with PRO endpoints

- address the challenges of PRO and clinical data analyses and presentation with examples of successes and problems

- consider future research on strategies to optimize the use of PROs in trials

- highlight methods for developing core outcomes sets to be reported as a minimum in trials

- review methods for incorporating patient reported outcomes into core outcomes sets

Oral Presentations

Click on the links below to view the presentations.

Patient-reported outcomes: Where are we and where are we heading?

Use of an objective measure of time to recovery after cardiac surgery: the STET randomised controlled trial

Patient reported outcomes: misinference from ordinal scales?

Win Ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities