Summary – PROMs 2.0 is not research, it is service evaluation. However, the data collected may be used for research projects. This paper summarises advice from National Research Ethics Service
Patient reported outcome measures (PROMs) are standardised, validated questionnaires that are completed by patients to measure their perceptions of their own functional status and wellbeing.. They are designed to measure either patients’ perceptions of their general health (generic measures) or their perceptions of their health in relation to specific diseases or conditions (specific measures).
PROMs 2.0 is a system for more efficient collection of this data and use it for direct clinical care with patient empowerment. The information from analysis of the data is expected to provide quantified evidence of current practice.
PROMs have been used in clinical trials national audits and registers for joint replacement and other conditions
It is likely that PROMs 2.0 data will provide information about performance of healthcare providers. This will require accurate risk stratification.
Measures and collection timetables will be defined – the model followed here is that of a longitudinal study
Health professionals are expected to undertake audit and service evaluation as part of quality assurance. This is not the same as research which can be defined as ‘attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous method ’. Research generates evidence to refute or support or develop a hypothesis.
Service evaluation, on the other hand, is seen as ‘a set of procedures to judge a service by providing a systematic assessment of its aims, objectives, activities, outputs, outcomes, and costs’. This may include elements of research e.g. collecting additional data or changes to choices of treatment. This definition fits PROMs 2.0 accurately.
Intent - The primary aim of research is to derive generalizable new knowledge, whereas the aim of audit and service evaluation projects is to measure standards of care.
Treatment/service - Neither audit nor service evaluation uses an intervention without a firm basis of support in the clinical or health community.
Allocation - Neither audit nor service evaluation allocate treatment or service by protocol. It is a joint decision by the clinician and patient.
Randomisation – if used, the project is research
Evaluation concerned with producing internal recommendations for improvements that are not intended to be generalised beyond the setting in which the evaluation took place should therefore not be managed within the Research Governance Framework, and other appropriate systems should be used. However, where it is intended to publish the results of an evaluation in a form that aims to generalise the results to others situations, the evaluation should be managed within the Research Governance Framework.
Organisations implementing PROMs 2.0 should involve their R&D departments. There should be a clear intent that if the collected data is to be used outside of service evaluation purposes (i.e. for a specific research project) the methods of research governance should be followed.
1. Dawson, J., et al., The routine use of patient reported outcome measures in healthcare settings. BMJ. 340: p. c186.
2. Defining Research, NHS, Editor. 2009, National Research Ethics Service.
3. Newton, J., et al., Change in primary health care: new wine in old bottles? J Manag Med, 2000. 14(1): p. 37-46.