As a rheumatoid arthritis patient, you probably care more about your daily experiences with pain and fatigue than you care about the precise number of swollen joints you have during a doctor’s appointment. A large portion of speakers at the American College of Rheumatology Conference this weekend feels the same way. The first two days of the conference included 20 speakers discussing the challenges and benefits of patient-centered and patient-reported outcomes.
What Patients Care About
Patient centered outcomes are precisely what they sound like- they are the outcomes that patients understand and care about most. Sometimes they differ from the ones doctors and researchers consider the most valuable ones to monitor. For example, many RA patients suffer from intense fatigue and would prefer a treatment that minimizes it. However, Saturday morning, one rheumatologist explained why she would rather not collect data on fatigue. “Let’s capture sleep, physical function, but not fatigue – because if a patient—like many lupus or fibromyalgia patients—has fatigue, there are not good solutions for what to do about it.” Not only is fatigue difficult to monitor, but it is also difficult to treat, which discourages doctors from monitoring it.
How Doctors and Researchers Understand Patient Needs
One approach to the problem of capturing and quantifying patient centered outcomes like fatigue, is employing measures called patient reported outcomes. These are the types of symptoms or feelings that a patient can relay directly to a doctor. Along with the familiar tests for physical and biological signs of disease severity, researchers are looking to collect valuable data regarding the patient’s physical, mental, and social quality of life, directly from the patient. The problem is that all patients are different. If a doctor or researcher just asks the patients how they are doing, the answers would be extremely difficult to compare to each other. How can you quantify fatigue?
How Patient Report Outcomes Influence Industry
Not only are patient reported outcomes important for patients and doctors, but they are of particular interest to companies developing drugs to treat RA. If a drug company develops a drug to treat the disease, and in trials patients report feeling better than they did before taking the drug, the company needs to be able to rank this improvement. If the better feelings can’t be quantified, chances are low that the new drug will be approved.
How Researchers are Addressing the Issue
Ten years ago, in an attempt to combat these challenges, the National Institute of Health (NIH) funded a project called PROMIS (Patient-Reported Outcomes Measurement Information System in Rheumatology.) The primary goal of PROMIS is to create a system through which doctors and researchers can collect patient reported outcomes, and compare them in a consistent and valid way.
Up to this point, more than 50,000 people have provided data on symptoms of rheumatoid diseases. PROMIS has developed scales to rate more than 51 disease outcomes spanning the categories of physical, mental, and social experiences. Now, the scales are being translated and used internationally. The NIH is no longer funding the project, but PROMIS is continuing nonetheless. Jim Witter, MD, PhD, FARC, and chief
science officer of PROMIS assured a conference room of doctors, patients, researchers, and advocates on Saturday that PROMIS will continue to collect data and improve reporting of patient reported outcomes, “validity is not a destination but a journey” he said.