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Comparison of statistically derived ASAS improvement criteria for ankylosing spondylitis with clinically relevant improvement according to an expert panel

Identifieur interne : 000D13 ( PascalFrancis/Curation ); précédent : 000D12; suivant : 000D14

Comparison of statistically derived ASAS improvement criteria for ankylosing spondylitis with clinically relevant improvement according to an expert panel

Auteurs : A. Van Tubergen [Pays-Bas] ; D. Van Der Heijde [Pays-Bas, Belgique] ; J. Anderson [États-Unis] ; R. Landewe [Pays-Bas] ; M. Dougados [France] ; J. Braun [Allemagne] ; N. Bellamy [Australie] ; G. Udrea [Roumanie] ; Sj Van Der Linden [Pays-Bas]

Source :

RBID : Pascal:03-0167292

Descripteurs français

English descriptors

Abstract

Objective: To investigate whether the recently developed (statistically derived) "Assessment in Ankylosing Spondylitis Working Group" improvement criteria (ASAS-IC) for ankylosing spondylitis (AS) reflect clinically relevant improvement according to the opinion of an expert panel. Methods: The ASAS-IC consist of four domains: physical function, spinal pain, patient global assessment, and inflammation. Scores on these four domains of 55 patients with AS, who had participated in a non-steroidal anti-inflammatory drug efficacy trial, were presented to an international expert panel (consisting of patients with AS and members of the ASAS Working Group) in a three round Delphi exercise. The number of (non-)responders according to the ASAS-IC was compared with the final consensus of the experts. The most important domains in the opinion of the experts were identified, and also selected with discriminant analysis. A number of provisional criteria sets that best represented the consensus of the experts were defined. Using other datasets, these clinically derived criteria sets as well as the statistically derived ASAS-IC were then tested for discriminative properties and for agreement with the end of trial efficacy by patient and doctor. Results: Forty experts completed the three Delphi rounds. The experts considered twice as many patients to be responders than the ASAS-IC (42 v 21). Overall agreement between experts and ASAS-IC was 62%. Spinal pain was considered the most important domain by most experts and was also selected as such by discriminant analysis. Provisional criteria sets with an agreement of ≥80% compared with the consensus of the experts showed high placebo response rates (27-42%), in contrast with the ASAS-IC with a predefined placebo response rate of 25%. All criteria sets and the ASAS-IC discriminated well between active and placebo treatment (X2=36-45; p<0.001). Compared with the end of trial efficacy assessment, the provisional criteria sets showed an agreement of 71-82%, sensitivity of 67-83%, and specificity of 81-88%. The ASAS-IC showed an agreement of 70%, sensitivity of 62%, and specificity of 89%. Conclusion: The ASAS-IC are strict in defining response, are highly specific, and consequently show lower sensitivity than the clinically derived criteria sets. However, those patients who are considered as responders by applying the ASAS-IC are acknowledged as such by the expert panel as well as by patients' and doctors' judgments, and are therefore likely to be true responders.
pA  
A01 01  1    @0 0003-4967
A02 01      @0 ARDIAO
A03   1    @0 Ann. rheum. dis.
A05       @2 62
A06       @2 3
A08 01  1  ENG  @1 Comparison of statistically derived ASAS improvement criteria for ankylosing spondylitis with clinically relevant improvement according to an expert panel
A11 01  1    @1 VAN TUBERGEN (A.)
A11 02  1    @1 VAN DER HEIJDE (D.)
A11 03  1    @1 ANDERSON (J.)
A11 04  1    @1 LANDEWE (R.)
A11 05  1    @1 DOUGADOS (M.)
A11 06  1    @1 BRAUN (J.)
A11 07  1    @1 BELLAMY (N.)
A11 08  1    @1 UDREA (G.)
A11 09  1    @1 VAN DER LINDEN (Sj)
A14 01      @1 Department of Internal Medicine, Division of Rheumatology, University Hospital Maastricht @2 Maastricht @3 NLD @Z 1 aut. @Z 2 aut. @Z 4 aut. @Z 9 aut.
A14 02      @1 Limburg University Centre @2 Diepenbeek @3 BEL @Z 2 aut.
A14 03      @1 Department of Medicine, Clinical Epidemiology Research and Training Unit, Boston University Medical Center @2 Boston @3 USA @Z 3 aut.
A14 04      @1 Department of Rheumatology, Hospital Cochin @2 Paris @3 FRA @Z 5 aut.
A14 05      @1 Department of Rheumatology, Rheumazentrum Ruhrgebiet @2 Herne @3 DEU @Z 6 aut.
A14 06      @1 Department of Medicine, Center of National Research on Disability and Rehabilitation Medicine CONROD @2 Brisbane @3 AUS @Z 7 aut.
A14 07      @1 Department of Rheumatology, Dr Ioan Cantacuzino Hospital @2 Bucharest @3 ROM @Z 8 aut.
A17 01  1    @1 ASAS Working Group @3 INC
A20       @1 215-221
A21       @1 2003
A23 01      @0 ENG
A43 01      @1 INIST @2 6381 @5 354000107714430050
A44       @0 0000 @1 © 2003 INIST-CNRS. All rights reserved.
A45       @0 13 ref.
A47 01  1    @0 03-0167292
A60       @1 P
A61       @0 A
A64 01  1    @0 Annals of the rheumatic diseases
A66 01      @0 GBR
C01 01    ENG  @0 Objective: To investigate whether the recently developed (statistically derived) "Assessment in Ankylosing Spondylitis Working Group" improvement criteria (ASAS-IC) for ankylosing spondylitis (AS) reflect clinically relevant improvement according to the opinion of an expert panel. Methods: The ASAS-IC consist of four domains: physical function, spinal pain, patient global assessment, and inflammation. Scores on these four domains of 55 patients with AS, who had participated in a non-steroidal anti-inflammatory drug efficacy trial, were presented to an international expert panel (consisting of patients with AS and members of the ASAS Working Group) in a three round Delphi exercise. The number of (non-)responders according to the ASAS-IC was compared with the final consensus of the experts. The most important domains in the opinion of the experts were identified, and also selected with discriminant analysis. A number of provisional criteria sets that best represented the consensus of the experts were defined. Using other datasets, these clinically derived criteria sets as well as the statistically derived ASAS-IC were then tested for discriminative properties and for agreement with the end of trial efficacy by patient and doctor. Results: Forty experts completed the three Delphi rounds. The experts considered twice as many patients to be responders than the ASAS-IC (42 v 21). Overall agreement between experts and ASAS-IC was 62%. Spinal pain was considered the most important domain by most experts and was also selected as such by discriminant analysis. Provisional criteria sets with an agreement of ≥80% compared with the consensus of the experts showed high placebo response rates (27-42%), in contrast with the ASAS-IC with a predefined placebo response rate of 25%. All criteria sets and the ASAS-IC discriminated well between active and placebo treatment (X2=36-45; p<0.001). Compared with the end of trial efficacy assessment, the provisional criteria sets showed an agreement of 71-82%, sensitivity of 67-83%, and specificity of 81-88%. The ASAS-IC showed an agreement of 70%, sensitivity of 62%, and specificity of 89%. Conclusion: The ASAS-IC are strict in defining response, are highly specific, and consequently show lower sensitivity than the clinically derived criteria sets. However, those patients who are considered as responders by applying the ASAS-IC are acknowledged as such by the expert panel as well as by patients' and doctors' judgments, and are therefore likely to be true responders.
C02 01  X    @0 002B15D
C03 01  X  FRE  @0 Spondylarthrite ankylosante @5 01
C03 01  X  ENG  @0 Ankylosing spondylitis @5 01
C03 01  X  SPA  @0 Espondiloartritis anquilosante @5 01
C03 02  X  FRE  @0 Critère @5 02
C03 02  X  ENG  @0 Criterion @5 02
C03 02  X  SPA  @0 Criterio @5 02
C03 03  X  FRE  @0 Amélioration @5 03
C03 03  X  ENG  @0 Improvement @5 03
C03 03  X  SPA  @0 Mejoría @5 03
C03 04  X  FRE  @0 Psychométrie @5 04
C03 04  X  ENG  @0 Psychometrics @5 04
C03 04  X  SPA  @0 Psicometría @5 04
C03 05  X  FRE  @0 Questionnaire @5 05
C03 05  X  ENG  @0 Questionnaire @5 05
C03 05  X  SPA  @0 Cuestionario @5 05
C03 06  X  FRE  @0 Méthodologie @5 06
C03 06  X  ENG  @0 Methodology @5 06
C03 06  X  SPA  @0 Metodología @5 06
C03 07  X  FRE  @0 Fidélité test @5 07
C03 07  X  ENG  @0 Test reliability @5 07
C03 07  X  SPA  @0 Fidelidad pruebra @5 07
C03 08  X  FRE  @0 Spécificité @5 08
C03 08  X  ENG  @0 Specificity @5 08
C03 08  X  SPA  @0 Especificidad @5 08
C03 09  X  FRE  @0 Sensibilité @5 09
C03 09  X  ENG  @0 Sensitivity @5 09
C03 09  X  SPA  @0 Sensibilidad @5 09
C03 10  X  FRE  @0 Homme @5 10
C03 10  X  ENG  @0 Human @5 10
C03 10  X  SPA  @0 Hombre @5 10
C03 11  X  FRE  @0 Chronique @5 25
C03 11  X  ENG  @0 Chronic @5 25
C03 11  X  SPA  @0 Crónico @5 25
C03 12  X  FRE  @0 Assessment in Ankylosing Spondylitis Working Group @4 INC @5 86
C07 01  X  FRE  @0 Système ostéoarticulaire pathologie @5 37
C07 01  X  ENG  @0 Diseases of the osteoarticular system @5 37
C07 01  X  SPA  @0 Sistema osteoarticular patología @5 37
C07 02  X  FRE  @0 Rhumatisme inflammatoire @5 38
C07 02  X  ENG  @0 Inflammatory joint disease @5 38
C07 02  X  SPA  @0 Reumatismo inflamatorio @5 38
C07 03  X  FRE  @0 Spondylarthropathie @2 NM @5 39
C07 03  X  ENG  @0 Spondylarthropathy @2 NM @5 39
C07 03  X  SPA  @0 Espondilartropatia @2 NM @5 39
N21       @1 097
N82       @1 PSI

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<term>Chronic</term>
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<term>Human</term>
<term>Improvement</term>
<term>Methodology</term>
<term>Psychometrics</term>
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<term>Questionnaire</term>
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<term>Sensibilité</term>
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<div type="abstract" xml:lang="en">Objective: To investigate whether the recently developed (statistically derived) "Assessment in Ankylosing Spondylitis Working Group" improvement criteria (ASAS-IC) for ankylosing spondylitis (AS) reflect clinically relevant improvement according to the opinion of an expert panel. Methods: The ASAS-IC consist of four domains: physical function, spinal pain, patient global assessment, and inflammation. Scores on these four domains of 55 patients with AS, who had participated in a non-steroidal anti-inflammatory drug efficacy trial, were presented to an international expert panel (consisting of patients with AS and members of the ASAS Working Group) in a three round Delphi exercise. The number of (non-)responders according to the ASAS-IC was compared with the final consensus of the experts. The most important domains in the opinion of the experts were identified, and also selected with discriminant analysis. A number of provisional criteria sets that best represented the consensus of the experts were defined. Using other datasets, these clinically derived criteria sets as well as the statistically derived ASAS-IC were then tested for discriminative properties and for agreement with the end of trial efficacy by patient and doctor. Results: Forty experts completed the three Delphi rounds. The experts considered twice as many patients to be responders than the ASAS-IC (42 v 21). Overall agreement between experts and ASAS-IC was 62%. Spinal pain was considered the most important domain by most experts and was also selected as such by discriminant analysis. Provisional criteria sets with an agreement of ≥80% compared with the consensus of the experts showed high placebo response rates (27-42%), in contrast with the ASAS-IC with a predefined placebo response rate of 25%. All criteria sets and the ASAS-IC discriminated well between active and placebo treatment (X
<sup>2</sup>
=36-45; p<0.001). Compared with the end of trial efficacy assessment, the provisional criteria sets showed an agreement of 71-82%, sensitivity of 67-83%, and specificity of 81-88%. The ASAS-IC showed an agreement of 70%, sensitivity of 62%, and specificity of 89%. Conclusion: The ASAS-IC are strict in defining response, are highly specific, and consequently show lower sensitivity than the clinically derived criteria sets. However, those patients who are considered as responders by applying the ASAS-IC are acknowledged as such by the expert panel as well as by patients' and doctors' judgments, and are therefore likely to be true responders.</div>
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<s1>Comparison of statistically derived ASAS improvement criteria for ankylosing spondylitis with clinically relevant improvement according to an expert panel</s1>
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<s1>Department of Internal Medicine, Division of Rheumatology, University Hospital Maastricht</s1>
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<s1>Department of Medicine, Clinical Epidemiology Research and Training Unit, Boston University Medical Center</s1>
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<sZ>8 aut.</sZ>
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<s0>Objective: To investigate whether the recently developed (statistically derived) "Assessment in Ankylosing Spondylitis Working Group" improvement criteria (ASAS-IC) for ankylosing spondylitis (AS) reflect clinically relevant improvement according to the opinion of an expert panel. Methods: The ASAS-IC consist of four domains: physical function, spinal pain, patient global assessment, and inflammation. Scores on these four domains of 55 patients with AS, who had participated in a non-steroidal anti-inflammatory drug efficacy trial, were presented to an international expert panel (consisting of patients with AS and members of the ASAS Working Group) in a three round Delphi exercise. The number of (non-)responders according to the ASAS-IC was compared with the final consensus of the experts. The most important domains in the opinion of the experts were identified, and also selected with discriminant analysis. A number of provisional criteria sets that best represented the consensus of the experts were defined. Using other datasets, these clinically derived criteria sets as well as the statistically derived ASAS-IC were then tested for discriminative properties and for agreement with the end of trial efficacy by patient and doctor. Results: Forty experts completed the three Delphi rounds. The experts considered twice as many patients to be responders than the ASAS-IC (42 v 21). Overall agreement between experts and ASAS-IC was 62%. Spinal pain was considered the most important domain by most experts and was also selected as such by discriminant analysis. Provisional criteria sets with an agreement of ≥80% compared with the consensus of the experts showed high placebo response rates (27-42%), in contrast with the ASAS-IC with a predefined placebo response rate of 25%. All criteria sets and the ASAS-IC discriminated well between active and placebo treatment (X
<sup>2</sup>
=36-45; p<0.001). Compared with the end of trial efficacy assessment, the provisional criteria sets showed an agreement of 71-82%, sensitivity of 67-83%, and specificity of 81-88%. The ASAS-IC showed an agreement of 70%, sensitivity of 62%, and specificity of 89%. Conclusion: The ASAS-IC are strict in defining response, are highly specific, and consequently show lower sensitivity than the clinically derived criteria sets. However, those patients who are considered as responders by applying the ASAS-IC are acknowledged as such by the expert panel as well as by patients' and doctors' judgments, and are therefore likely to be true responders.</s0>
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