Five Reasons Why Digital Health Needs Patient Reported Outcomes


According to the National Quality Forum, patient reported outcomes or patient reported outcomes measures (PROs) can be defined as “any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else.”  Initially utilized as a clinical research tool, they have since become a critical component of assessing quality of care.  Digital health technology has long been touted as a way to promote patient engagement. There is significant opportunity for patient and other stakeholder benefit in the incorporation of PROs into any patient-facing digital health technology. In this piece I will try and give a focused look at PROs, why they are becoming important and the interplay with digital health technologies.

1. PROs are now determinants of healthcare payments. A good example of the interplay between PROs and value based payments can be found in a discussion of the Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR).  Some of the lessons learned and described from over 25,000 patients reporting into the registry are interesting and worth sharing because they are universal and not specific to joint replacement; (A) PROs provide actionable data to help guide clinical decision-making. (B) Identifying key risk factors…can go a long way toward managing the entire 90-day episode of care and successfully participating in value-based contract gainsharing.  (C) Making PROM data collection easy for both patient and surgeon’s office is key to success. (D) Post-TJR PROMs can be a valuable patient satisfaction and engagement tool. PROs are not just represented by patient satisfaction surveys.  Payment for care is also tied to PROs relating to patient engagement and clinical outcomes.

2. PROs put the focus back on the patient. Quality of care can only be determined by the patient.  Treatment goals can vary substantially for individual patients with the same clinical problem, whether it is acute or chronic. In this way, care can be liberated from a ‘one size fits all must meet strict evidence-based guideline model’ which dominates pay for performance payment systems today.  PROs can help evaluate the same patients in a longitudinal fashion (at various points in time), maintaining the subject, not necessarily the disease or treatment as the focal point. In this way, patients themselves, armed with PRO data can change the direction of treatment with the identification of logistical, medical, emotional or financial challenges which might adversely or positively affect care.

3. PROs can be used to close gaps in care. Disparities in healthcare in the USA have been well documented. PROs can be used to study patient populations with similar clinical problems from diverse ethnic, socioeconomic, and geographical demographics.  By comparing standardized PROs, best practices might be readily identified.   One recent interesting study examined the disparity between patient reported outcomes measures and assigned triage priority levels for elective surgical procedures in British Columbia, Canada. This is an excellent example of how patient generated data can crystallize an inherent pitfall of healthcare policy and transform it to benefit patients.

4. PROs add a necessary dimension to clinical trials  The incorporation of PROs in oncology care has proven feasible and demonstrated to result in better patient outcomes. PROs are used in various ways in clinical trials.  Some of these include measuring study endpoints, monitoring adverse events, quality of care, symptoms, and longitudinal reporting during the study. PROs provide critical information to longitudinal follow-up of patients either in clinical drug, device or intervention studies or specific population registries.  A fertile area for the use of PROs is comparative effectiveness studies. Pharma needs real world evidence for post-market surveillance, reimbursement support, and relationships with patients. The use of PROs in clinical trials supports those goals. PROs via mobile technology in clinical trials facilitate patient engagement as well.

5. PROs provide real-world evidence. The FDA’s recent Draft Guidance on the Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices is a progressive acknowledgement of the value of non-clinical trial data in evaluating medical devices. Real-world data is data collected from sources outside of traditional clinical trials. These sources may include large simple trials, or pragmatic clinical trials, prospective observational or registry studies, retrospective database studies, case reports, administrative and healthcare claims, electronic health records, data obtained as part of a public health investigation or routine public health surveillance, and registries (e.g., device, procedural, or disease registries)…” Digital health is critical in this type of process, because “…The data is typically derived from electronic systems used in health care delivery, data contained within medical devices, and/or in tracking patient experience during care, including in home-use settings.”  Part of this data will certainly include PRO data which will aid in the FDA process.

As described above, PROs are becoming an integral part of many facets of healthcare: quality assessment, payment models, clinical trials, product evaluation, and patient engagement with digital technologies.  The culture of healthcare is slowly (isn’t that always the case?) shifting to an appreciation of patient reported outcomes and patient generated data. Let’s look forward to PROs becoming something which patients expect to participate in and to benefit from …for that is what will ultimately change healthcare.

About davidleescher

David Lee Scher, MD is Founder and Director at DLS HEALTHCARE CONSULTING, LLC, which specializes in advising digital health technology companies, their partners, investors, and clients. As a cardiac electrophysiologist and pioneer adopter of remote patient monitoring, he understood early on the challenges that the culture and landscape of healthcare present to the development and adoption of digital technologies. He is a well-respected thought leader in mobile and other digital health technologies. Scher lectures worldwide on relevant industry topics including the role of tech in Pharma, patient advocacy, standards for development and adoption, and impact on patients and healthcare systems from clinical, risk management, operational and marketing standpoints. He is a Clinical Associate Professor of Medicine at Penn State College of Medicine.
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