The Long Game: Patient-Reported Outcomes

If your car has a flat tire, it can be repaired within a day – or even an hour – and you are on the road again. But if you want to pitch a baseball perfectly or play violin in an orchestra, it takes years of practice. Unlike fixing a flat, there is no quick route to the big league. In the same way, biomedical research and clinical trials take years, making patient participation a long game.

Like a coach who can adjust your practice to meet the goal, patients can expose problems in long-term disease research. As patients live longer and have more experience with chronic conditions because of advances in medicine, patient-centricity becomes more valuable.

Translational and clinical research depends upon patients, families, and caregivers providing their time and effort. One way to ease their path is to align study designs with their needs. Patient-reported outcome (PRO) data does that by highlighting findings that stand apart from the clinical-trial angle. In other words, PROs have the potential to pinpoint difficulties that might be brewing within a procedure, or even identify trends within a population.

Patient Insight Was an Untapped Resource

PROs are status reports that come directly from a patient—not edited or interpreted by a clinician. The Food and Drug Administration prefers ePROs to paper PROs, so improved technical platforms to smooth data collection are emerging and evolving. Anecdotal details woven into reports can buttress findings. New technological tools, in the form of easy-to-use patient and caregiver surveys, are helping us do that. To that end, the Patient-Reported Outcomes Measurement Information System, or PROMIS®, is a National Institutes of Health initiative to create, validate, and standardize PROs across medical conditions.

Fill in The Blanks

Physical specimens and personal perceptions combine to paint a fuller picture of safety and effectiveness. From inside patients’ homes, Sanguine has a 360-degree view of study participants, as we perform prospective biospecimen collection together with PRO collection. We can administer quality-of-life surveys to capture real-world data, supplementing the specimens we collect.

A number of pharmaceutical collaborators, and even medical societies, are using more patient-reported data in their trial-registry programs. The National Hemophilia Foundation, for example, centers their registries on patient-provided data. The number of registries is expanding. Input from patients, families, and caregivers is growing because PROs spotlight factors that matter to them.

We Have a Match

Correlation between patient feedback and clinician-collected data is increasingly reported in the literature. If both a doctor and a patient note a particular side effect, we know it was not an anomaly. Was medication taken correctly? At the right time and in the correct dose? Was there a side effect? How long did it last? With only a doctor’s viewpoint, or only the patient’s, the answer might be biased. But when they match, they are more reliable.

Similarly, if both researchers and participants agree about the impacts of diet, exercise, disruption in family routine, or caffeine/nicotine/alcohol intake on a particular day, that agreement can be interpreted as more accurate than if reports come from one party alone. Turns out they work well together.

What’s Your Story?

PROs are more than just an insider’s tale tucked into a study’s findings. With an emphasis on intuitive design – and by “intuitive,” we mean something that’s easy for both patients and researchers – new electronic tools will clarify protocols.

The history of medicine is no stranger to patients feeling dismissed or being told their pain is “all in your head.” But here, on the frontier of patient-centric technology, we are actually looking for those very things that are in your head. We have those direct relationships with our patient member communities.


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  2. Council of Medical Specialty Societies. Engaging Patients in Clinical Registries. CMSS Primer For Specialty Societies and Organizations Developing And Advancing Clinical Data Registries. November 2019,
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