Article

Variability in the Reporting of Serum Urate and Flares in Gout Clinical Trials: Need for Minimum Reporting Requirements.

The Journal of Rheumatology, The Journal of Rheumatology, ISSN 0315-162X

Volume 45, 3, 2018

DOI:10.3899/jrheum.170911, Dimensions: pub.1099849041, PMID: 29247147,

Authors

Stamp, Lisa K (1) (2) (3) (4) (5)
Morillon, Melanie B (3) (4) (5) (6) (7)
Taylor, William J (3) (4) (5) (6) (7)
Dalbeth, Nicola (3) (4) (5) (6) (7)
Singh, Jasvinder A (3) (4) (5) (6) (7)
Lassere, Marissa (3) (4) (5) (6) (7)
Christensen, Robin (3) (4) (5) (6) (7)

Affiliations

Organisations

  1. (1) From the Department of Medicine, University of Otago, Christchurch, Wellington; Department of Medicine, University of Auckland, Auckland, New Zealand; Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen; Department of Rheumatology, Odense University Hospital, Odense; Department of Medicine, Vejle Hospital, Vejle, Denmark; Department of Medicine, University of Alabama at Birmingham and Birmingham Veterans Affairs Medical Center, Birmingham, Alabama, USA; Department of Rheumatology, St. George Hospital, University of New South Wales (NSW), Sydney, Australia. lisa.stamp@cdhb.health.nz.
  2. (2) L.K. Stamp, MBChB, PhD, FRACP, Department of Medicine, University of Otago; M.B. Morillon, MD, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Department of Rheumatology, Odense University Hospital, and Department of Medicine, Vejle Hospital; W.J. Taylor, MBChB, PhD, FRACP, Department of Medicine, University of Otago; N. Dalbeth, MBChB, MD, FRACP, Department of Medicine, University of Auckland; J.A. Singh, MD, MPH, Department of Medicine, University of Alabama at Birmingham and Birmingham Veterans Affairs Medical Center; M. Lassere, MBBS (Hons) Grad Dip Epi, PhD, FRACP, FAFPHM, Department of Rheumatology, St. George Hospital, University of NSW; R. Christensen, MSc, PhD, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital. lisa.stamp@cdhb.health.nz.
  3. (3) University of Alabama at Birmingham, grid.265892.2
  4. (4) University of Otago, grid.29980.3a
  5. (5) Vejle Sygehus, grid.417271.6, Southern Denmark Region
  6. (6) From the Department of Medicine, University of Otago, Christchurch, Wellington; Department of Medicine, University of Auckland, Auckland, New Zealand; Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen; Department of Rheumatology, Odense University Hospital, Odense; Department of Medicine, Vejle Hospital, Vejle, Denmark; Department of Medicine, University of Alabama at Birmingham and Birmingham Veterans Affairs Medical Center, Birmingham, Alabama, USA; Department of Rheumatology, St. George Hospital, University of New South Wales (NSW), Sydney, Australia.
  7. (7) L.K. Stamp, MBChB, PhD, FRACP, Department of Medicine, University of Otago; M.B. Morillon, MD, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Department of Rheumatology, Odense University Hospital, and Department of Medicine, Vejle Hospital; W.J. Taylor, MBChB, PhD, FRACP, Department of Medicine, University of Otago; N. Dalbeth, MBChB, MD, FRACP, Department of Medicine, University of Auckland; J.A. Singh, MD, MPH, Department of Medicine, University of Alabama at Birmingham and Birmingham Veterans Affairs Medical Center; M. Lassere, MBBS (Hons) Grad Dip Epi, PhD, FRACP, FAFPHM, Department of Rheumatology, St. George Hospital, University of NSW; R. Christensen, MSc, PhD, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital.

Description

OBJECTIVE: To describe the ways in which serum urate (SU) and gout flares are reported in clinical trials, and to propose minimum reporting requirements. METHODS: This analysis was done as part of a systematic review aiming to validate SU as a biomarker for gout. The ways in which SU and flares were reported were extracted from each study by 2 reviewers. RESULTS: A total of 22 studies (10 randomized controlled trials, 3 open-label extension studies, and 9 observational studies) were identified. There were 3 broad categories of SU reporting: percentage at target SU, mean SU, and change in SU. A median of 2 (range 1-3) categories were reported across all studies. The most common method of reporting SU was percentage at target in 17/22 (77.3%) studies, with all studies reporting a target of SU < 6 mg/dl. There were 12/22 (54.5%) studies reporting mean SU at some time after study entry, with 7 (58.3%) of these reporting at more than just the final study visit. Two ways of reporting gout flares were identified: mean flare rate and percentage of participants with flares. There was variability in time periods over which flares rates were reported. CONCLUSION: There is inconsistent reporting of SU and flares in gout studies. Reporting the percentage of participants who achieve a target SU reflects international treatment guidelines. SU should also be reported as a continuous variable with a relevant central and dispersion estimate. Gout flares should be reported as both percentage of participants and mean flare rates at each timepoint.

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Times Cited: 4

Field Citation Ratio (FCR): 3.2

Relative Citation ratio (RCR): 0.24