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with joint limitation, joint swelling, and deformity. Up to 50 % of patients with
chronic gouty arthropathy have structural damage on radiographs [ 1 ]. Palpable
tophi occur in various locations such as olecranon bursa, ear, and various joints.
Urate nephropathy is a complication resulting from urate stones seen in 20 % of
patients with gout [ 2 ].
Systemic manifestations including low-grade fever may also be seen, especially
with a polyarticular gout fl are. Chronic systemic infl ammation, occurring with
chronic uncontrolled gout, may also put patients at risk for increased cardiovascular
morbidity and mortality, a topic of recent interest [ 3 – 5 ]. Regardless of whether gout
is a risk factor for cardiovascular disease or is commonly associated with it due to a
common underlying mechanism/risk factors [ 6 ], its increased prevalence in patients
with gout is a cause for additional concern in patients with gout.
Due to multiple manifestations of gout, and its signifi cant impact on HRQOL,
studies of assessment of patient reported outcomes (PROs) in gout are key to our
understanding its true impact on patient lives and associated morbidity [ 7 , 8 ].
Patient Reported Outcomes: Defi nitions, Initiatives,
and the Difference Between Outcomes and Outcome Measures
The term PRO was fi rst coined in 2000 in order to avoid the confusion surrounding
the term “quality of life” in the regulatory process as a part of clinical trials [ 9 ].
Historically, the use of PRO measures has been far less common in clinical practice
than in clinical trials, where PROs are often selected as trial outcome measures [ 10 ].
The U.S. Food and Drug Administration (FDA) defi ned PRO as “a measurement
of any aspect of a patient’s health status that comes directly from the patient (i.e.,
without the interpretation of the patient’s responses by a physician or anyone else)”
[ 11 , 12 ]. An FDA PRO consensus group defi ned PRO as a broad term that includes
direct subjective assessment by the patient of elements of their health including:
symptoms, function, well-being, perceptions about treatment, satisfaction with care
received, and satisfaction with professional communication [ 13 ].
Patient Reported Outcomes Measures Information System (PROMIS) , a leading
research initiative by the National Institutes of Health (NIH), defi ned PRO as denot-
ing health data that is provided by the patient through a system of reporting. A
patient reported outcome is basically a patient’s feedback on their feelings or what
they are able to do as they are dealing with chronic diseases or conditions. PROs can
also be measured when patients are undergoing treatment or are participating in a
clinical trial [ 14 ]. Others have defi ned PRO as an umbrella term that can be applied
to an array of different outcomes, including symptoms, functioning, perceived
health status, and HRQOL [ 15 ].
J. Singh and N. Shah