Clifton O. Bingham III, MD

During an office visit, the first question I typically ask my patients is, “How are you feeling?” Despite that opening dialogue, tools measuring a patient’s self-reported fatigue, sleep disturbance or depression aren’t usually documented or tracked when a patient is assessed in the doctor’s office. Traditionally, objective measures such as blood work, scans and X-rays have more weight when evaluating a patient’s progress.

Yet, it’s those everyday symptoms that directly affect a patient’s quality of life. Lack of sleep, pain and fatigue are often concerns that patients find most debilitating and therefore should be a research priority. Research into patient reported outcomes (PRO) arose from the recognition that scentists and physicians, particularly those treating chronic diseases like arthritis, need to better understand patients’ everyday life experience with chronic disease and to quantify individuals’ perceptions of their symptoms for the development of new treatment strategies. There is a need to balance what we, as physicians, know about treating their disease with what patients really care about, which is how they feel, function, and participate in daily activities and social roles.

Patient Reported Outcomes Are Real Data Points

PROs are reports that come directly from patients without interpretation of a clinician regarding their symptoms and impacts. Many PROs have been developed for following people with various medical conditions. These may be general measures of symptoms that are common across many conditions (such as pain, fatigue and sleep), or may be specific symptoms that would be seen in only a particular conditions (such as shortness of breath for someone with asthma or COPD).  Many of the PROs that were previously developed were intended for use in clinical trials rather than in clinical practice.  And, even the PROs that are commonly used to follow people with arthritis, such as the HAQ or RAPID, do not include the things that people with arthritis really care about.

To address some of the heterogeneity of PRO measures used, in 2004, the National Institutes of Health developed the

 Patient Reported Outcomes Measurement Information System (PROMIS)

 which included measures to assess multiple aspects of Physical Health, Emotional Health and Social Health, that could be used as a standard across all conditions. These measures were designed using the most advanced measurement methods to develop a highly precise estimate of symptoms, that can be taken using paper forms or as web-accessible tests that minimize participant burden. The results from PROMIS are provided as a T-score which provides a result in comparison to the entire U.S. population (not just those with arthritis). These results can provide a snapshot of how someone is doing in terms of their symptoms at a point in time and can be followed over time to see how these symptoms change.

Essentially, PROMIS is set up to measure with high precision how people feel and the impact of illness on their overall health. Because of the way the PROMIS measures are designed, they are intended to provide a very accurate picture of someone’s overall health.

PROs (and PROMIS measures in particular) represent a scientifically tested, quantifiable approach to measuring patients’ perceptions and quality of life, and because of this, the Patient Centered Outcomes Research Institute (PCORI) is interested in understanding how PROs can be used in research and care. PCORI is an independent nonprofit, nongovernmental organization located in Washington, D.C., that was authorized by Congress in 2010. Their mission is to improve the quality and relevance of evidence available to help patients, caregivers, clinicians, employers, insurers, and policy makers make informed health decisions by funding comparative clinical effectiveness research, or CER, and supporting work that will improve the methods used to conduct such studies. To that latter point, there is a need to confirm that PROs have benefit for patients and physicians in clinical practice, particularly in the arthritis community.

Given that arthritis is a leading cause of disability in the U.S. and the fact that rheumatoid arthritis is disabling, destructive and shortens lifespan, the arthritis community is an optimal patient population to evaluate how the collection of PROMIS data impacts clinical encounters. Researchers at Johns Hopkins University have received three awards from PCORI since 2011 to evaluate the use of PROMIS measures in people with rheumatoid arthritis seen in a clinical practice setting. They were interested in understanding both how the measures performed (because this had never been reported for people with rheumatoid arthritis) and how patients and their doctors interpreted the information and used it in making treatment decisions.

The Johns Hopkins team recently completed a pilot study with members of the arthritis patient community, 

registry. Created in collaboration with the University of Alabama at Birmingham, Arthritis Power is a patient-led, patient-generated, patient-centered research registry for arthritis. Arthritis Power is funded through PCORI to obtain PRO and PROMIS measures for pain interference, physical function and fatigue and other health data from thousands of arthritis patients. Johns Hopkins used the Arthritis Power “Opportunity Central” function in the platform to attract participants to the pilot study.

The goal of the recent pilot study was to provide initial evidence about how well the individual PROMIS measures reflected patients’ perception of the domains being assessed and whether patients respond to measures different when they consider them as specifically related to their rheumatoid arthritis.

Ultimately, the larger study will work with PROMIS data collected from patients and clinicians at three different rheumatoid arthritis clinics to determine what levels of PROMIS symptoms and impacts are seen in rheumatoid arthritis patients, how these correlate with other measures of disease activity, and how they change with treatment.

The goal of this research is to determine what PROMIS measures “mean” and what is “meaningful” for patients and their clinicians to help in making treatment decisions. The results from this study will be important for Arthritis Power as it collects PROMIS data from larger numbers of patients so that we can ultimately provide patients and their providers information such as alerts for significant changes, what is “normal” for people with rheumatoid arthritis compared to the general population, and how much change patients and doctors can expect for their patients with rheumatoid arthritis.

Improving the Practice of Rheumatology to Benefit our Patients

The participation of doctors and patients in research like this will advance the science of patient input in clinical decision making. Your support of Arthritis Power, in office, can help us complete this study and better understand the value of PROMIS measures for the arthritis community. The results will also be shared with this specific community in order to keep patients engaged and interested in the research process. 

 that explain to patients how to enroll in Arthritis Power are available from CreakyJoints at

Anecdotally, we know that patients experience their chronic disease in ways that go beyond what their lab tests say. Understanding and quantifying the reporting of symptoms will enhance the practice of rheumatology and treatment for our patients.

Clifton O. Bingham III, MD, is an associate professor of medicine at Johns Hopkins University and director of the Johns Hopkins Arthritis Center.

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Tools measuring a patient’s self-reported fatigue, sleep disturbance or depression aren’t usually tracked in the doctor’s office.

Author | Clifton O. Bingham III, MD

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“How are you feeling?”