Best-Practice for Patient Reported Outcomes (PROs) in Randomised Clinical Trials
Workshop leaders: Dr Melanie Calvert and Mr Derek Kyte
Patient reported outcomes (PROs) are increasingly assessed in clinical trials and provide 'the patient voice' in evidence on treatment effectiveness. PROs commonly evaluate health-related quality of life, symptoms such as pain or fatigue, health utility, adherence and patient satisfaction and may be used to influence clinical care and decision-making, predict long-term outcomes and inform health policy. Despite this, processes relating to PRO trial design and data collection are suboptimal and the results are often poorly reported. These practices devalue important patient-centred data, diluting the impact of PRO results in the clinical setting. Researchers at the University of Birmingham (chaired by Dr Calvert) are leading a programme of work, which aims to enhance the design, implementation, analysis and reporting of PROs in trials, to improve the way that results are used to inform clinical care. This two-day workshop aims to bring together leading experts in PRO trials methodology with key personnel within the Birmingham Clinical Trials Units, UHB clinical leads, researchers involved in PRO data collection and patient representatives, who will collectively work on a strategy to improve standards of PRO trial measurement and reporting:
- Locally, through collaboration, academic detailing and other knowledge transfer initiatives.
- Internationally, through high-impact publications and via collaboration with the International Society of Quality of Life Research (ISOQOL) on an international knowledge transfer process.
- To disseminate key findings of recent advances in PRO methodology for trials with members of the three clinical trials units and other key stakeholders, including clinicians and patient representatives. [Knowledge transfer]
- Generate and prioritise key research/logistical questions surrounding the future identification, dissemination and implementation of best-practice for PROs in randomised clinical trials and develop a resulting publication/funding/knowledge transfer strategy. [Strategy]
- Form working groups tasked with addressing aspects of this strategy, both at a local level and from an international perspective. [Continued action]
- To develop a theme proposal for consideration by the IAS. [Longevity]
- Patient engagement, local & international knowledge translation, publications, collaborative grants.
- Output from the workshop will help to improve the quality of PRO information collected from trials, thus ensuring that the clinical care of patients is informed by robust results.