Patient Reported Outcome Measures, or Patient Reported Outcomes (PROs) have their roots in clinical research. In the beginning, they were used as a research tool to keep track of clinical trials. But with the digital healthcare coming to the forefront, PROs can evolve to be so much more.
PROs are any reports that communicate the status of the patient’s health condition without any input from a medical professional. It’s a vital component as it enables real-time assessment of the quality of care that also takes in non-clinical factors into consideration. Further, it also allows for enhanced patient engagement by embedding it into patient-facing technology.
So why are PROs critical for eHealth development?
1. Clinical trials benefit from better patient outcomes
PROs add a much-needed dimension to clinical trials which have a direct impact on enhancing patient outcomes. When you’re conducting research, it’s important to collect information from all of the participants.
Without keeping track of the other factors related to the symptoms and quality of life, poor reporting can render research efforts useless. As a result, PROs have played an important role in recent clinical trials in oncology.
It can be utilized as a tool to collect data with regard to the following:
- Longitudinal reporting
- Measuring study endpoints
- Monitoring adverse events
- Quality of care
This information is critical to longitudinal follow-up of patients whether it’s in a clinical device, drug, or intervention study. Further, Big Pharma needs to conduct post-market surveillance to collect real-world evidence, build relationships with patients, and reimbursement support.
That being said, PROs make all these clinical trial goals attainable while engaging with the patient via mobile technology.
2. PROs are patient focused
There’s no one who can comment on the quality of care except for the patient that’s receiving treatment. Patients can experience significantly different treatment goals for the same clinical problem (chronic or acute). So by incorporating PROs, we can finally move away from a one size fits all paradigm.
As healthcare nowadays follows a strict evidence-based guideline model (which has a direct impact on pay for performance systems), PROs can be utilized to focus on the subject rather than the treatment or disease over a long period of time. All this can only be possible by using eHealth technologies effectively.
This enables patients to arm themselves with this valuable data to change the direction of treatment by identifying the emotional, medical, logistical, and financial challenges which may affect the quality of care.
3. Healthcare payments can be determined by PROs
Linking performance to access to resources or pay is nothing new to the healthcare industry. But PROs can help to internalize external incentives like waiting times.
As efficiency and performance vary from hospital to hospital, this can have a direct impact on the quality of care. By getting access to this data early, hospital managers can try to work out what’s lacking and make decisions that will have a positive impact on the output.
The data provided by PROs is actionable, so it can help improve the clinical decision-making process. As a result, the collection of PRO data must be made as easy as possible for all stakeholders in the process. Further, PROs can be utilized as an engagement tool to affect patient satisfaction.
4. Close the gaps in healthcare
There are significant inconsistencies in healthcare that’s well documented in the United States. PROs can be vital here to study patient populations with similar clinical issues that cover diverse socioeconomic, ethnic, and geographical demographics.
By comparing the data from PROs, it will make it easier to identify best practices. This, in turn, can significantly improve the quality of care within a short period of time.
5. PROs offer real-world evidence
The value of non-clinical data in evaluating medical devices is recognized in the FDA’s Draft Guidance on the User of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. The sources where data is collected is quite vast from pragmatic clinical trials to electronic health records to registry studies.
The data will be derived from digital health devices in both a clinical and home setting. It’s going to be a lot more than what’s happening within a clinical setting. So this information can be critical and as a result, some parts of the PRO data will be used to help FDA processes.
The different roles within PROs are in synergy and if they’ve been collected routinely, the care of individual patients can be aggregated to assess the quality of conduct across all patients. At the same time, outside a clinical trial setting, you may come across missing data from those unable to self-report and those unwilling to report.
In this scenario, backup data-collection strategies must be implemented to ensure that the required data is complete. This can be done by making efforts to engage with the people who failed to report by calling them.
So PROs are growing in importance every day and becoming a vital component in healthcare and eHealth. The culture within the industry is also slowly changing to a patient reported data paradigm. But we will have to wait and see how this shift progresses in the coming months within the healthcare system.