I’m a reviewer of an ethics application involving PROs: what should I look out for?
The role of Research Ethics Committees is to safeguard the rights, safety, dignity and well-being of people participating in research, as well as facilitating and promoting ethical research that is of potential benefit to participants, science and society. We are currently working in partnership with the HRA and international ethics groups to develop formal guidance for ethics committees reviewing research including PROs.
Patient reported outcome data can provide valuable information to inform patient-centred care but currently the quality of data collection/study reporting is suboptimal which devalues the contribution of patients and limits the use of these data to inform clinical practice and health policy (research waste). As a member of an ethics committee you have an opportunity to help ensure high quality PRO data collection that can make a real difference to patient care.
Here are some key considerations:
- Why are they assessing PROs in the study? What is the rationale and hypothesis?
- How many questionnaires are being used and how often? There should be a clear justification for the assessment of PROs ideally informed through patient and public involvement of feasibility work with patients.
- Are the questionnaires validated? If not patient time may be wasted completing unreliable measures.
- What processes do the team have in place to optimise PRO data collection (e.g. responsible staff, training, methods to minimise missing data, quality assurance)? If the data is poor quality this will have wasted patients time and valuable resources.
- What will happen if a patient completes a questionnaire and indicates concerning levels of psychological distress or physical symptoms that may require an immediate response? Have they considered the management of these PRO Alerts?
- Does the patient information sheet adequately describe how the PRO data will be collected, how often and who will access the PRO data?
- Has the patient been provided with information regarding support services?
- Does the consent form detail PRO specific information?
Please see PROs in Trials Step 5 - Managing PRO Alerts for further details and examples of PIS/consent form content.