# Planning for a Trial of Comparative Effectiveness of Gout Management Strategies

> **NIH NIH R34** · MASSACHUSETTS GENERAL HOSPITAL · 2020 · $239,567

## Abstract

Gout is the most common inflammatory arthritis, affecting approximately 9 million Americans. It is a chronic
metabolic disease characterized by monosodium urate (MSU) crystal deposition in the joints and elsewhere.
Gout causes its major morbidity through acute disabling arthritis flares that represent the most common cause
of arthritis visits to US emergency departments; gout can also cause tophi, bone erosions, and a chronic
arthropathy with joint damage, and is associated with cardiovascular-metabolic complications. Acute gout flares
can be treated effectively with anti-inflammatory medications. When flares are frequent and burdensome enough,
urate lowering therapy (ULT) can be administered to reduce the frequency, reduce tophi, and prevent other
complications. Using ULT to reduce serum urate (SU) levels below 6.0 mg/dL (below the MSU saturation point)
should dissolve MSU crystals, the likely culprit of gout flares, and mitigate other complications. This “treat to
target” serum urate (TTT-SU) approach has been advocated by rheumatologists. However, the majority of gout
cases are seen in primary care and many rheumatologists have concerns that primary care management of gout
is not aggressive enough, with too high a threshold to initiate ULT, and use of insufficient doses of ULT to achieve
the “target.” Under-treatment of gout may lead to impairments in patient function due to frequent flares and
chronic tophaceous arthropathy with joint damage. However, the TTT-SU approach to manage gout is largely
based on pathophysiologic rationale, rather than clinical trials. A recent systematic review for the American
College of Physicians' (ACP) Clinical Guidelines Committee confirmed the effectiveness of anti-inflammatory
medications for gout flares, and effectiveness of ULT for lowering the risk of acute attacks, but acknowledged,
“treatment to a specific target level has not been tested” and “…we remain uncertain about the value of a treat-
to-target strategy compared with a strategy of basing treatment intensity on minimizing symptoms.” The ACP
gout management guideline neither recommended a specific threshold for the initiation of ULT, nor a specific SU
treatment target. The rheumatology community reacted negatively to the ACP guideline, with the main concern
being it might worsen the already suboptimal management of gout in primary care. To attempt to resolve this
controversy, we convened an NIH-funded meeting in Boston in the Spring of 2018 that included key stakeholders
in gout care. The consensus of this meeting was that a comparative effectiveness trial of strategies of gout
management would be the best way to resolve the controversy in an evidence-based manner. Thus, our
overarching goal is to design a trial that will fill critical evidence gaps and directly inform current practice. In this
application, we propose the following aims to plan such a trial: 1) to conduct a Delphi Panel process to determine
the optimal design and parameters for the...

## Key facts

- **NIH application ID:** 9969825
- **Project number:** 1R34AR076077-01A1
- **Recipient organization:** MASSACHUSETTS GENERAL HOSPITAL
- **Principal Investigator:** MICHAEL J BARRY
- **Activity code:** R34 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $239,567
- **Award type:** 1
- **Project period:** 2020-06-03 → 2022-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9969825

## Citation

> US National Institutes of Health, RePORTER application 9969825, Planning for a Trial of Comparative Effectiveness of Gout Management Strategies (1R34AR076077-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9969825. Licensed CC0.

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