Patient-reported outcomes and the importance of data standards

Sally Lewis & Said Shadi give an overview of patient-recorded outcome measures

The FCI are setting up a Special Interest Group (SIG) on patient-reported outcomes, in collaboration with HDR UK. If you're interested in finding out more or getting involved in the SIG, please contact Sally.Lewis2@wales.nhs.uk.

Patient-reported outcome measures (PROMs) are structured questionnaires that enable patients to provide detailed information about their quality of life and the symptom burden which may be specific to the condition that they have. Historically PROMs have been designed as research tools, for example to contribute to analyses of effectiveness in pharmaceutical and other trials, and they are validated to produce reliable and consistent results across populations. However in recent years there has been a growing interest in the use of PRO’s to support direct care and in the planning and development of services and new models of care, driven by the focus on outcomes espoused by value-based healthcare and the growth in digital health.

Digital communication between clinical teams and their patients has enabled a wide range of tasks to be completed online and support remote models of care, chronic disease monitoring and a flexible access to clinical advice that has reduced the dependence on face to face appointments. This approach has accelerated as a necessity throughout the Covid-19 pandemic. PROMs can be very useful in this regard, providing confidence that patients are stable in their condition and allowing patients to communicate in a structured and codifiable way that enables them to track their condition over time/monitor their own progress. One can see a future state where there is increasing sophistication in the information used to support care, enabling patients to use a blend of test results, PROMs, wearable data and care plans to support ongoing management of their condition. It has been shown that the use of PROMs to support patient care can improve outcomes as a result. (Basch, 2017)

Linking PROM data to the clinical outcome data set (what has traditionally been regarded as audit or registry data), is important to understand how people’s needs are being met and how outcomes van be improved both at an individual and a population level. Real world evidence is often cited as an essential adjunct to health technology assessments post market entry of drugs and devices.

However, in order to realise the full potential of patient-reported outcome data, however, there are some key technical challenges to overcome. 

The first is the need for standards for interoperability to ensure that suppliers and those deploying patient-facing applications that are used to collect PROM data have clear, shared expectations for the content, context and meaning of the data, as well as how this is represented and shared. This is particularly important when multiple applications and devices are used to maintain the integrity of data exchange across all applications. Failure to achieve this will ultimately limit the potential of PROMs utilisation, both to support direct care, and for efficient data extraction for analysis later.

Interoperability standards should be addressed from several perspectives. Firstly, the ‘technical’ information exchange structure that defines the process for reliable, consistent and seamless data exchange; for instance, the use of HL7 FHIR (Saripalle et al. 2019). Secondly, the semantic structure for PROMs should allow common underlying models and codification of the data elements collected; for instance, use of national data standard control notices (DSCNs), data dictionaries, classification systems, terminologies such as SNOMED-CT, etc. Addressing this challenge will enable the collection and storage of PROM data in near real-time, ensuring the data is complete, consistent, conformant and accurate without the need for manual intervention, or for the need to create complex data mapping workarounds. (Figure 1)

A separate challenge relates to representing and interpreting such codified longitudinal PROM data and embedding this in direct care systems as a digital communication.  Healthcare organisations typically use a myriad of healthcare clinical applications, data repositories and visualisation tools. Therefore, a mechanism is required for these systems to be able to seamlessly communicate whilst maintaining data meaning. This challenge can be addressed if the applications and repositories communicate using nationally agreed data federated application programme interface (API) standards, for instance RESTful APIs (Hussain et al. 2018). This, together with use of the other interoperability standards will provide a potential approach to collect, combine, analyse, present the PROM data and visualise it in the clinical record for healthcare professionals to use. Finally, it is also important to recognise that the benefits of delivering the digital enablers will not be attained if we do not embed digital inclusion in health, care and well-being strategies (Gann, 2018).

Dr Sally Lewis

National Clinical Director for Value-Based Healthcare, NHS Wales
FCI Fellow

Said Shadi

Assistant Director, Health Informatics and Analytics at Value in Health, NHS Wales


References:

Basch, E. (2017). Patient-Reported Outcomes — Harnessing Patients’ Voices to Improve Clinical Care. New England Journal of Medicine. https://doi.org/10.1056/nejmp1611252

Gann, B. (2018). Digital Inclusion in Health and Care in Wales.  The Wales Co-operative Centre. Available at: https://wales.coop/digital-inclusion-report-2018 [Accessed: 15 February 2021]

Hussain, M. A., Langer, S. G. and Kohli, M. (2018).  Learning HL7 FHIR Using the HAPI FHIR Server and Its Use in Medical Imaging with the SIIM Dataset. Journal of Digital Imaging, 31, pp. 334–340.

Mandel, J. C., Kreda, D. A., Madl, K. D., Kohane, I. S. and Ramoni, R. B. (2016). SMART on FHIR: a standards-based, interoperable apps platform for electronic health records. Journal of the American Medical Informatics Association, 23(5), pp 899-908. https:// doi:10.1093/jamia/ocv189

Saripalle, R., Runya, C. and Russell, M. (2019). Using HL7 FHIR to achieve interoperability in patient health record. Journal of Biomedical Informatics, 94. https://doi.org/10.1016/j.jbi.2019.103188