Novel Methods for Ascertainment of Gout Flares -A Pilot Study

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 (1).

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effectiveness studies of urate lowering therapy (ULT) (unpublished results).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 (2-6)
or anti-inflammatory prophylaxis (7) 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 (8, 9). 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 (10). Self-report of 4
criteria had the greatest discriminatory ability with an area under the curve (AUC) of 0.931
(10). 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 (2). Another study counted a flare only when it was treated
by a healthcare provider (4). Still other studies assessed flares during physician visits
occurring at variable time points (3, 6). 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).