Responsiveness of the core set, response criteria, and utilities in early rheumatoid arthritis.

Abstract:

OBJECTIVE:Validation of responsiveness and discriminative power of the World Health Organisation/International League of Associations for Rheumatology (WHO/ILAR) core set, the American College of Rheumatology (ACR), and European League for Rheumatology (EULAR) criteria for improvement/response, and other single and combined measures (indices) in a trial in patients with early rheumatoid arthritis (RA). METHODS:Ranking of measures by response (standardised response means and effect sizes) and between-group discrimination (unpaired t test and chi(2) values) at two time points in the COBRA study. This study included 155 patients with early RA randomly allocated to two treatment groups with distinct levels of expected response: combined treatment, high response; sulfasalazine treatment, moderate response. RESULTS:At week 16, standardised response means of core set measures ranged between 0.8 and 3.5 for combined treatment and between 0.4 and 1.2 for sulfasalazine treatment (95% confidence interval +/-0.25). Performance of patient oriented measures (for example, pain, global assessment) was best when the questions were focused on the disease. The most responsive single measure was the patient's assessment of change in disease activity, at 3.5. Patient utility, a generic health status measure, was moderately (rating scale) to poorly (standard gamble) responsive. Response means of most indices (combined measures) exceeded 2.0, the simple count of core set measures improved by 20% was most responsive at 4.1. Discrimination performance yielded similar but not identical results: best discrimination between treatment groups was achieved by the EULAR response and ACR improvement criteria (at 20% and other percentage levels), the pooled index, and the disease activity score (DAS), but also by the Health Assessment Questionnaire (HAQ) and grip strength. CONCLUSIONS:Responsiveness and discrimination between levels of response are not identical concepts, and need separate study. The WHO/ILAR core set comprises responsive measures that discriminate well between different levels of response in early RA. However, the performance of patient oriented measures is highly dependent on their format. The excellent performance of indices such as the ACR improvement and EULAR response criteria confirms that they are the preferred primary end point in RA clinical trials.

journal_name

Ann Rheum Dis

authors

Verhoeven AC,Boers M,van Der Linden S

doi

10.1136/ard.59.12.966

subject

Has Abstract

pub_date

2000-12-01 00:00:00

pages

966-74

issue

12

eissn

0003-4967

issn

1468-2060

journal_volume

59

pub_type

临床试验,杂志文章,随机对照试验
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    doi:10.1136/ard.50.11.765

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    更新日期:1991-11-01 00:00:00

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    doi:10.1136/ard.53.3.197

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    更新日期:1994-03-01 00:00:00

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    pub_type: 杂志文章

    doi:10.1136/annrheumdis-2015-208529

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    doi:10.1136/ard.54.11.904

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    更新日期:1995-11-01 00:00:00

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    更新日期:2014-10-01 00:00:00

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    pub_type: 杂志文章

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    authors: Low AS,Symmons DP,Lunt M,Mercer LK,Gale CP,Watson KD,Dixon WG,Hyrich KL,British Society for Rheumatology Biologics Register for Rheumatoid Arthritis (BSRBR-RA) and the BSRBR Control Centre Consortium.

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    pub_type: 杂志文章

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    pub_type: 杂志文章

    doi:10.1136/ard.48.9.771

    authors: Goldman JA

    更新日期:1989-09-01 00:00:00

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    pub_type: 共识发展会议,杂志文章

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    journal_title:Annals of the rheumatic diseases

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    doi:10.1136/ard.51.2.238

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    更新日期:1992-02-01 00:00:00

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    journal_title:Annals of the rheumatic diseases

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1136/ard.47.10.793

    authors: Magaro M,Altomonte L,Zoli A,Mirone L,De Sole P,Di Mario G,Lippa S,Oradei A

    更新日期:1988-10-01 00:00:00

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    pub_type: 杂志文章

    doi:10.1136/ard.2007.073932

    authors: Pattison E,Harrison BJ,Griffiths CE,Silman AJ,Bruce IN

    更新日期:2008-05-01 00:00:00

  • CCL2/CCR2, but not CCL5/CCR5, mediates monocyte recruitment, inflammation and cartilage destruction in osteoarthritis.

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    doi:10.1136/ard.61.6.540

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    更新日期:2015-01-01 00:00:00

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    doi:10.1136/annrheumdis-2016-209958

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    pub_type: 杂志文章,评审

    doi:10.1136/ard.2009.126748

    authors: Knevel R,Schoels M,Huizinga TW,Aletaha D,Burmester GR,Combe B,Landewé RB,Smolen JS,Sokka T,van der Heijde DM

    更新日期:2010-06-01 00:00:00

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    pub_type: 杂志文章

    doi:10.1136/ard.2003.011734

    authors: Haugeberg G,Griffiths B,Sokoll KB,Emery P

    更新日期:2004-08-01 00:00:00

  • Systemic and mucosal antibodies to Klebsiella in patients with ankylosing spondylitis and Crohn's disease.

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    pub_type: 杂志文章

    doi:10.1136/ard.51.12.1296

    authors: O'Mahony S,Anderson N,Nuki G,Ferguson A

    更新日期:1992-12-01 00:00:00