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One of our core beliefs at PCORI is that if studies look at outcomes important to patients and those who care for them, the results will help those stakeholders make more-informed healthcare decisions. So I’m pleased to pass along a particularly strong example of that approach, from a recently published paper reporting results of such a PCORI-funded study.

Looking at Real-World Outcomes

To see what happens to patients during real-world medical care, the project used information from health and Medicare records of 12,000 stroke survivors to see whether those prescribed the blood thinner warfarin did better than those who didn’t receive that prescription. Adrian Hernandez, MD, MS, of the Duke Clinical Research Institute and his colleagues learned that warfarin helped patients discharged from a hospital after a stroke do better over the next two years. These patients all had irregular, often rapid, heart rates, known as atrial fibrillation.

Previous trials in research settings had indicated a benefit of warfarin for such patients but tended to exclude elderly people or patients with more than one health problem. There had been concern that the benefit would not hold in clinical care for a full range of patients. However, the PCORI-funded researchers found that the benefit appeared in all groups they examined—and was slightly stronger in women, patients older than 80, and those who had experienced the most severe stroke.

“This study was a true effort to do research side-by-side with patients,” says Hernandez. “Its major aims were informed by conversations with stroke survivors, which revealed two dominant themes: how long-term medication affects quality of life and daily activities, and its safety and effectiveness.”

Patients made an invaluable contribution to the design of this research procedure. Focus groups of stroke survivors and other stakeholders led to a new outcome for the research team to measure. What they said is most important to them is “home time.” This is the number of days when a patient is living at home, not hospitalized or in another institution. Patients who received the warfarin prescription averaged 47.6 more days of home time over two years than those who didn’t receive that prescription.

Refocusing Research to Guide Healthcare Decisions

An accompanying editorial calls this work “a solid example of how to refocus research on questions, outcomes, and approaches that could help patients and clinicians to make better healthcare decisions.” The author, Thomas W. Concannon, PhD, of the Rand Corporation, leads a PCORI-funded project collecting stakeholder views on patient-centered comparative effectiveness research. He says, “The study gets the basics of patient centeredness right: investigators took on a question and measured outcomes that matter, designed a pragmatic study to answer the question, and used a robust and participatory approach in conducting the research.”

Concannon suggests that the new outcome may improve how well patients take their prescribed medicine taking. He notes that patients leaving the hospital may better remember that taking warfarin can help them stay healthy at home longer—the patient-devised outcome—than the medication’s relationship to “MACE,” the measure researchers typically use, which is a composite of all-cause mortality and cardiovascular readmission rates.

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