Evidence map›Paper›PMID 21372003›Full record

Trial reportRheumatology (Oxford, England)2011

Minimally important differences of the gout impact scale in a randomized controlled trial.

Dinesh Khanna, Andrew J Sarkin, Puja P Khanna, Marian M Shieh, Arthur F Kavanaugh, Robert A Terkeltaub, Susan J Lee, Jasvinder A Singh, Jan D Hirsch

Registry-linked trialOpen access · bronzeAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Rheumatology (Oxford, England), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00610363 (A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study, Tolerability, and Efficacy of Rilonacept for the Prevention of Gout Flares During Initiation of Allopurinol Therapy), which is not on this map. Cited by 18 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 5 pooled it
2.9field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00610363 phase2completednot on this map

A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study, Tolerability, and Efficacy of Rilonacept for the Prevention of Gout Flares During Initiation of Allopurinol Therapy

TypeinterventionalSponsorRegeneron PharmaceuticalsRan2007 to 2008Enrolled83ConditionsGoutArmsRilonacept, Placebo (for Rilonacept)
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 5 syntheses or guidelines pooled it, 38 citations in OpenAlex.

  1. Pooled it
  2. Uricosuric medications for chronic gout.The Cochrane database of systematic reviews · 2014
    Pooled it
  3. Allopurinol for chronic gout.The Cochrane database of systematic reviews · 2014
    Pooled it
  4. Pooled it
  5. Lifestyle interventions for chronic gout.The Cochrane database of systematic reviews · 2013
    Pooled it
  6. Trial
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  14. Observational
  15. Observational
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

Dinesh KhannaDepartment of Medicine, Division of Rheumatology, David Geffen School of Medicine at UCLA, Los Angeles, University of California at San Diego, La Jolla, CA 90095, USA. dkhanna@mednet.ucla.edu
Andrew J Sarkin
Puja P Khanna
Marian M Shieh
Arthur F Kavanaugh
Robert A Terkeltaub
Susan J Lee
Jasvinder A Singh
Jan D Hirsch
University of Montana · USUniversity of California, San Diego · US

Funding

Academic Training in RheumatologyT32AR053463 · NIAMS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI SINGH, RAM RAJ · 2007 to 2011
$1.1M
Health Values and Minimally Important Differences in Systemic SclerosisK23AR053858 · NIAMS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI KHANNA, DINESH · 2007 to 2011
$617k
NIAMS NIH HHS 1 T32 AR053463NIAMS NIH HHS K23 AR053858NIAMS NIH HHS T32 AR053463
6 · The paper itself

Abstract

objectiveThe Gout Impact Scale (GIS) is a gout-specific quality of life instrument that assesses impact of gout during an attack and impact of overall gout. The GIS has five scales and each is scored from 0 to 100 (worse health). Our objective was to assess minimally important differences (MIDs) for the GIS administered in a randomized controlled trial (RCT) assessing rilonacept vs placebo for prevention of gout flares during initiation of allopurinol therapy.

methodsTrial subjects (n = 83) included those with two or more gout flares (self-reported) in the past year. Of these, 73 had data for Weeks 8 vs 4 and formed the MID analysis group and were analysed irrespective of the treatment assignment. Subjects completed the GIS and seven patient-reported anchors. Subjects with a one-step change (e.g. from very poor to poor) were considered as the MID group for each anchor. The mean change in GIS scores and effect size (ES) was calculated for each anchor's MID group. The average of these created the overall summary MID statistics for each GIS. An ES of 0.2-0.5 was considered to represent MID estimates. Results. Trial subjects (n = 73) were males (96.0%), White (90.4%), with mean age of 50.5 years and serum uric acid of 9.0 mg/dl. The mean change score for the MID improvement group for scales ranged from -5.24 to -7.61 (0-100 scale). The ES for the MID improvement group for the four scales ranged from 0.22 to 0.38.

conclusionThe MID estimates for GIS scales are between 5 and 8 points (0-100 scale). This information can aid in interpreting the GIS results in future gout RCTs. Trial Registration. Clinicaltrials.gov, www.clinicaltrials.gov, NCT00610363.

Indexed as

Quality of LifeAdultAgedAge DistributionAllopurinolFollow-Up StudiesGoutGout SuppressantsHumansIncidenceMaleMiddle AgedPain MeasurementRecombinant Fusion ProteinsReference ValuesSecondary PreventionAllopurinolGout SuppressantsRecombinant Fusion Proteinsrilonacept

Identifiers

PMID21372003
PMCPMC3307519
OpenAlexW2132149731

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.