Protocol - Gout Flare
A 9-item questionnaire. Questions 1–4 are asked directly of the patient. Questions 5–9 are answered by an investigator/clinician.
Criteria from the 2012 provisional gout flare definition (Gaffo et al.) were evaluated with the questions included in this protocol.
Questions 1–4 are asked directly of the patient. Questions 5–9 are answered by the investigator/clinician. The investigator/clinician is to respond to these questions without knowing the answers provided by the patient in questions 1–4.
Note: It was left to the discretion of the study site investigators whether to let the patients complete the questionnaires, to have an investigator or research assistant query or actively assist the patient with the questionnaire, or to use a combination of these methods.
Additionally, information confirming that the patient fulfilled the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR)>
This definition is, at the moment, intended only for classification of gout flares in the context of clinical research in patients known to have gout.
1. Are you having a gout attack (flare) today?
[ ] yes
[ ] no
2. Are any of your joints swollen?
[ ] yes
[ ] no
3. Are any of your joints warm to touch?
[ ] yes
[ ] no
4. Considering pain from your gout over the last 1 week when you are resting (for example, in bed or sitting quietly), please circle the number indicating the level of pain when it was at its worst:
5. Do you believe the patient is having a gout attack (flare) today?
6. Patient’s global assessment score:
7. Anatomic location of swollen and warm joints: ___________________
8. Duration of the gout flare (if present): __________________________
9. Gout medications used: _____________________________________
Personnel and Training Required
Nurses, physician assistants, study coordinators, and physicians are trained to standardize the administration of questions 1–4. The “Provider” that administers questions 5–9 includes research assistants who are trained to administer those questions.
|Specialized requirements for biospecimen collection||No|
|Average time of greater than 15 minutes in an unaffected individual||No|
Mode of Administration
Patients with established gout aged 18 and older.
More investigation is necessary to determine whether this, or a similar gout flare definition, can be applied in clinical practice; however, at this time, this definition is available and accepted for classification of gout flares in the context of clinical research in patients known to have gout.
|caDSR Common Data Elements (CDE)||Gout Flare||11136927||CDE Browser|
Process and Review
Protocol Name from Source
Definition of Flare in Patients with Established Gout
Gaffo, A. L., Schumacher, H. R., Saag, K. G., Taylor, W. J., Dinnella, J., Outman, R., … Singh, J. A. (2012). Developing a provisional definition of flare in patients with established gout. Arthritis & Rheumatism, 64(5), 1508–1517. https://doi.org/10.1002/art.33483
Gaffo, A. L., Dalbeth, N., Saag, K. G., Singh, J. A., Rahn, E. J., Mudano, A. S., … Taylor, W. (2018). Brief report: Validation of a definition of flare in patients with established gout. Arthritis & Rheumatology, 70(3), 462–467. https://doi.org/10.1002/art.40381
|Variable Name||Variable ID||Variable Description||dbGaP Mapping|
|PX171401010000||Are you having a gout attack (flare) today?||N/A|
|PX171401080000||Duration of the gout flare (if present):||N/A|
|PX171401020000||Are any of your joints swollen?||N/A|
|PX171401030000||Are any of your joints warm to touch?||N/A|
|PX171401070000||Anatomic location of swollen and warm joints:||N/A|
|PX171401090000||Gout medications used:||N/A|
|PX171401040000||Considering pain from your gout over the more||N/A|
|PX171401050000||Do you believe the patient is having a gout more||N/A|
|PX171401060000||Patient’s global assessment score:||N/A|
October 21, 2022
Gout flare is present when three of the four patient questions are positive. Positive is defined as self-defined gout flare, pain at rest >3/10, yes to any swollen joint, and yes to any warm joint. Provider questions are not used to define flare.
Gout flares are responsible for a significant proportion of the disease burden in patients and are highly correlated with worsening functional status and disability over time.
gout flare, bone and joint, rheumatism, swelling, swollen joint, warm joint
|Protocol ID||Protocol Name|
There are no publications listed for this protocol.