Novel Methods for Ascertainment of Gout Flares -A Pilot Study
Novel Methods for Ascertainment of Gout Flares -A Pilot Study
The purpose of this study is to determine the feasibility and acceptability of using
 different remote data collection technologies to ascertain flare occurrence among gout
 patients. Two technologies will be the focus of this study: a telephone based interactive
 voice response (IVR) and a smartphone mobile application (called RheumPRO). The results of
 this study will not only guide research approaches in clinical trials, but may also have
 direct implications for monitoring patient outcomes in the context of day-to-day clinical
 practice.

 The investigators hypothesize that acceptability will be greater for RheumPRO application
 than IVR. Additionally, the investigators hypothesize that RheumPRO will be associated with a
 greater frequency of patient-initiated interactions.
Acute gout flares are a major cause of morbidity. Flares lead to substantial reductions in
 health-related quality of life, increased work absenteeism, productivity loss, and
 substantial healthcare costs. Acute gout flares are likely related to more than 174,000
 emergency department visits in the U.S. annually with corresponding charges approaching $166
 million.

 In recent surveys, gout patients and healthcare providers alike identified the reduction of
 gout flares as the highest priority outcome that should be examined in future comparative
 effectiveness studies of urate lowering therapy (ULT) (unpublished results). Despite
 consensus about the importance of capturing flares, clinical trials investigating ULTs or
 anti-inflammatory prophylaxis have used inconsistent flare definitions and methods of flare
 ascertainment. The inconsistency has likely been driven by the absence of a standardized
 definition or ascertainment method. These deficits limit comparisons that can be made across
 investigations.

 Recently, a group supported by the American College of Rheumatology & European League Against
 Rheumatism (ACR & EULAR) has attempted to define a gout flare (8-10). For simplicity, the
 group focused on defining only those flares occurring after a definitive gout diagnosis. Nine
 elements of a flare definition emerged from the first two studies. These nine elements
 included physician reported information, laboratory data and patient self-report. In a third
 study, Gaffo et al. compared the discriminatory ability of the self-reported items against
 the gold standard of a rheumatologist's judgment of flare presence. Self-report of 4 criteria
 had the greatest discriminatory ability with an area under the curve (AUC) of 0.931. These
 promising results indicate the important role for a standardized self-report definition of a
 gout flare.

 In addition to variability in gout flare definitions, the optimal method for obtaining
 self-reported flares remains undefined. An early study of febuxostat, for example, assessed
 flares weekly at physician visits Another study counted a flare only when it was treated by a
 healthcare provider. Still other studies assessed flares during physician visits occurring at
 variable time points. These inconsistent methods also pose practical limitations given by
 their time and resource intensive nature. Opportunities to increase efficiency have only
 recently become available with the validation of the self-reported definition for gout flares
 described above. Self-report can now be combined with technological advances in remote data
 collection to develop novel and highly efficient methods to identify gout flares. The
 investigators propose a study to address this pressing need by leveraging technological
 advances that facilitate the remote and real-time collection of patient reported flares and
 outcomes (PROs) in gout.
Inclusion Criteria:

 -  >/= to 18 yrs of age with Current physician diagnosed gout

 -  current hyperuricemia (serum urate level >6.8 mg/dl)

 -  self-report of at least two gout flares in the previous 6 months

 -  current smartphone user utilizing a FitBit compatible smart Phone (with the ability to
 download RheumPRO from Apple/Google Play store).