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Methods of deriving EULAR/ACR recommendations on reporting disease activity in clinical trials of patients with rheumatoid arthritis

Objective:To use an evidence-based and consensus-based approach to elaborate recommendations on how to report disease activity in clinical trials of patients with rheumatoid arthritis (RA) endorsed by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR).Metho... Full description

Journal Title: Annals of the rheumatic diseases 2008, Vol.67 (10), p.1365-1373
Main Author: Karonitsch, T
Other Authors: Aletaha, D , Boers, M , Bombardieri, S , Combe, B , Dougados, M , Emery, P , Felson, D , Gomez-Reino, J , Keystone, E , Kvien, T K , Martin-Mola, E , Matucci-Cerinic, M , Richards, P , van Riel, P , Siegel, J , Smolen, J S , Sokka, T , van der Heijde, D , van Vollenhoven, R , Ward, M , Wells, G , Zink, A , Landewe, R
Format: Electronic Article Electronic Article
Language: English
Subjects:
Publisher: London: BMJ Publishing Group Ltd and European League Against Rheumatism
ID: ISSN: 0003-4967
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title: Methods of deriving EULAR/ACR recommendations on reporting disease activity in clinical trials of patients with rheumatoid arthritis
format: Article
creator:
  • Karonitsch, T
  • Aletaha, D
  • Boers, M
  • Bombardieri, S
  • Combe, B
  • Dougados, M
  • Emery, P
  • Felson, D
  • Gomez-Reino, J
  • Keystone, E
  • Kvien, T K
  • Martin-Mola, E
  • Matucci-Cerinic, M
  • Richards, P
  • van Riel, P
  • Siegel, J
  • Smolen, J S
  • Sokka, T
  • van der Heijde, D
  • van Vollenhoven, R
  • Ward, M
  • Wells, G
  • Zink, A
  • Landewe, R
subjects:
  • Arthritis, Rheumatoid - complications
  • Arthritis, Rheumatoid - diagnosis
  • Arthritis, Rheumatoid - drug therapy
  • Biological and medical sciences
  • Clinical Trials as Topic - methods
  • Clinical Trials as Topic - standards
  • Consensus Development Conferences as Topic
  • Development and progression
  • Diseases
  • Diseases of the osteoarticular system
  • Evidence-Based Medicine - methods
  • Fatigue - etiology
  • Humans
  • Inflammatory joint diseases
  • Information Storage and Retrieval - standards
  • International Cooperation
  • Medical sciences
  • Medicin och hälsovetenskap
  • Methods
  • Reporting
  • Rheumatoid arthritis
  • Severity of Illness Index
  • Standards
  • Synovitis - diagnosis
  • Synovitis - etiology
  • Treatment Outcome
ispartof: Annals of the rheumatic diseases, 2008, Vol.67 (10), p.1365-1373
description: Objective:To use an evidence-based and consensus-based approach to elaborate recommendations on how to report disease activity in clinical trials of patients with rheumatoid arthritis (RA) endorsed by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR).Methods:After an initial expert meeting, during which relevant research questions were identified, a systematic literature search was performed using Medline, Embase and the Cochrane Library as sources. To ensure literature retrieved was comprehensive, we emphasised search algorithms that were sensitive rather than specific. The results of the literature search were discussed by the expert panel, modified and expanded, and were used as the basis for the elaboration of the recommendation in the consensus process. Finally, an independent ACR panel approved these items with some minor modifications.Results:The following pieces of evidence were obtained from the literature search: (1) timing and the sustaining of a response is relevant to achieve better outcomes; (2) composite disease activity indices have been used to define low disease activity and remission and these definitions have been validated as has the American Rheumatism Association (ARA) remission criteria. The “patient-reported symptom state” (PASS) is not yet well validated; (3) evidence was obtained to identify those measures, scales and patient-reported instruments, for which there is a documented association with relevant outcomes; (4) baseline disease activity is associated with disease activity levels at the end of follow-up; and (5) there was not sufficient evidence relating the added benefit of MRI or ultrasound over clinical assessments. Most data stemmed from observational studies rather than clinical trials and literature review was supplemented by input from experts. The results served as the basis for the elaboration of the seven recommendations by the experts.Conclusions:The approach based on scientific evidence from the literature as well as on expert input provided sufficient information to derive recommendations on reporting disease activity in RA clinical trials. The methodology, results and conclusions of this project were endorsed by EULAR and the ACR.
language: eng
source:
identifier: ISSN: 0003-4967
fulltext: no_fulltext
issn:
  • 0003-4967
  • 1468-2060
  • 1468-2060
url: Link


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titleMethods of deriving EULAR/ACR recommendations on reporting disease activity in clinical trials of patients with rheumatoid arthritis
creatorKaronitsch, T ; Aletaha, D ; Boers, M ; Bombardieri, S ; Combe, B ; Dougados, M ; Emery, P ; Felson, D ; Gomez-Reino, J ; Keystone, E ; Kvien, T K ; Martin-Mola, E ; Matucci-Cerinic, M ; Richards, P ; van Riel, P ; Siegel, J ; Smolen, J S ; Sokka, T ; van der Heijde, D ; van Vollenhoven, R ; Ward, M ; Wells, G ; Zink, A ; Landewe, R
creatorcontribKaronitsch, T ; Aletaha, D ; Boers, M ; Bombardieri, S ; Combe, B ; Dougados, M ; Emery, P ; Felson, D ; Gomez-Reino, J ; Keystone, E ; Kvien, T K ; Martin-Mola, E ; Matucci-Cerinic, M ; Richards, P ; van Riel, P ; Siegel, J ; Smolen, J S ; Sokka, T ; van der Heijde, D ; van Vollenhoven, R ; Ward, M ; Wells, G ; Zink, A ; Landewe, R
descriptionObjective:To use an evidence-based and consensus-based approach to elaborate recommendations on how to report disease activity in clinical trials of patients with rheumatoid arthritis (RA) endorsed by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR).Methods:After an initial expert meeting, during which relevant research questions were identified, a systematic literature search was performed using Medline, Embase and the Cochrane Library as sources. To ensure literature retrieved was comprehensive, we emphasised search algorithms that were sensitive rather than specific. The results of the literature search were discussed by the expert panel, modified and expanded, and were used as the basis for the elaboration of the recommendation in the consensus process. Finally, an independent ACR panel approved these items with some minor modifications.Results:The following pieces of evidence were obtained from the literature search: (1) timing and the sustaining of a response is relevant to achieve better outcomes; (2) composite disease activity indices have been used to define low disease activity and remission and these definitions have been validated as has the American Rheumatism Association (ARA) remission criteria. The “patient-reported symptom state” (PASS) is not yet well validated; (3) evidence was obtained to identify those measures, scales and patient-reported instruments, for which there is a documented association with relevant outcomes; (4) baseline disease activity is associated with disease activity levels at the end of follow-up; and (5) there was not sufficient evidence relating the added benefit of MRI or ultrasound over clinical assessments. Most data stemmed from observational studies rather than clinical trials and literature review was supplemented by input from experts. The results served as the basis for the elaboration of the seven recommendations by the experts.Conclusions:The approach based on scientific evidence from the literature as well as on expert input provided sufficient information to derive recommendations on reporting disease activity in RA clinical trials. The methodology, results and conclusions of this project were endorsed by EULAR and the ACR.
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languageeng
publisherLondon: BMJ Publishing Group Ltd and European League Against Rheumatism
subjectArthritis, Rheumatoid - complications ; Arthritis, Rheumatoid - diagnosis ; Arthritis, Rheumatoid - drug therapy ; Biological and medical sciences ; Clinical Trials as Topic - methods ; Clinical Trials as Topic - standards ; Consensus Development Conferences as Topic ; Development and progression ; Diseases ; Diseases of the osteoarticular system ; Evidence-Based Medicine - methods ; Fatigue - etiology ; Humans ; Inflammatory joint diseases ; Information Storage and Retrieval - standards ; International Cooperation ; Medical sciences ; Medicin och hälsovetenskap ; Methods ; Reporting ; Rheumatoid arthritis ; Severity of Illness Index ; Standards ; Synovitis - diagnosis ; Synovitis - etiology ; Treatment Outcome
ispartofAnnals of the rheumatic diseases, 2008, Vol.67 (10), p.1365-1373
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1Aletaha, D
2Boers, M
3Bombardieri, S
4Combe, B
5Dougados, M
6Emery, P
7Felson, D
8Gomez-Reino, J
9Keystone, E
10Kvien, T K
11Martin-Mola, E
12Matucci-Cerinic, M
13Richards, P
14van Riel, P
15Siegel, J
16Smolen, J S
17Sokka, T
18van der Heijde, D
19van Vollenhoven, R
20Ward, M
21Wells, G
22Zink, A
23Landewe, R
title
0Methods of deriving EULAR/ACR recommendations on reporting disease activity in clinical trials of patients with rheumatoid arthritis
1Annals of the rheumatic diseases
addtitleAnn Rheum Dis
descriptionObjective:To use an evidence-based and consensus-based approach to elaborate recommendations on how to report disease activity in clinical trials of patients with rheumatoid arthritis (RA) endorsed by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR).Methods:After an initial expert meeting, during which relevant research questions were identified, a systematic literature search was performed using Medline, Embase and the Cochrane Library as sources. To ensure literature retrieved was comprehensive, we emphasised search algorithms that were sensitive rather than specific. The results of the literature search were discussed by the expert panel, modified and expanded, and were used as the basis for the elaboration of the recommendation in the consensus process. Finally, an independent ACR panel approved these items with some minor modifications.Results:The following pieces of evidence were obtained from the literature search: (1) timing and the sustaining of a response is relevant to achieve better outcomes; (2) composite disease activity indices have been used to define low disease activity and remission and these definitions have been validated as has the American Rheumatism Association (ARA) remission criteria. The “patient-reported symptom state” (PASS) is not yet well validated; (3) evidence was obtained to identify those measures, scales and patient-reported instruments, for which there is a documented association with relevant outcomes; (4) baseline disease activity is associated with disease activity levels at the end of follow-up; and (5) there was not sufficient evidence relating the added benefit of MRI or ultrasound over clinical assessments. Most data stemmed from observational studies rather than clinical trials and literature review was supplemented by input from experts. The results served as the basis for the elaboration of the seven recommendations by the experts.Conclusions:The approach based on scientific evidence from the literature as well as on expert input provided sufficient information to derive recommendations on reporting disease activity in RA clinical trials. The methodology, results and conclusions of this project were endorsed by EULAR and the ACR.
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0Arthritis, Rheumatoid - complications
1Arthritis, Rheumatoid - diagnosis
2Arthritis, Rheumatoid - drug therapy
3Biological and medical sciences
4Clinical Trials as Topic - methods
5Clinical Trials as Topic - standards
6Consensus Development Conferences as Topic
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13Inflammatory joint diseases
14Information Storage and Retrieval - standards
15International Cooperation
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18Methods
19Reporting
20Rheumatoid arthritis
21Severity of Illness Index
22Standards
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24Synovitis - etiology
25Treatment Outcome
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titleMethods of deriving EULAR/ACR recommendations on reporting disease activity in clinical trials of patients with rheumatoid arthritis
authorKaronitsch, T ; Aletaha, D ; Boers, M ; Bombardieri, S ; Combe, B ; Dougados, M ; Emery, P ; Felson, D ; Gomez-Reino, J ; Keystone, E ; Kvien, T K ; Martin-Mola, E ; Matucci-Cerinic, M ; Richards, P ; van Riel, P ; Siegel, J ; Smolen, J S ; Sokka, T ; van der Heijde, D ; van Vollenhoven, R ; Ward, M ; Wells, G ; Zink, A ; Landewe, R
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1Arthritis, Rheumatoid - diagnosis
2Arthritis, Rheumatoid - drug therapy
3Biological and medical sciences
4Clinical Trials as Topic - methods
5Clinical Trials as Topic - standards
6Consensus Development Conferences as Topic
7Development and progression
8Diseases
9Diseases of the osteoarticular system
10Evidence-Based Medicine - methods
11Fatigue - etiology
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13Inflammatory joint diseases
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15International Cooperation
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21Severity of Illness Index
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16Smolen, J S
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abstractObjective:To use an evidence-based and consensus-based approach to elaborate recommendations on how to report disease activity in clinical trials of patients with rheumatoid arthritis (RA) endorsed by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR).Methods:After an initial expert meeting, during which relevant research questions were identified, a systematic literature search was performed using Medline, Embase and the Cochrane Library as sources. To ensure literature retrieved was comprehensive, we emphasised search algorithms that were sensitive rather than specific. The results of the literature search were discussed by the expert panel, modified and expanded, and were used as the basis for the elaboration of the recommendation in the consensus process. Finally, an independent ACR panel approved these items with some minor modifications.Results:The following pieces of evidence were obtained from the literature search: (1) timing and the sustaining of a response is relevant to achieve better outcomes; (2) composite disease activity indices have been used to define low disease activity and remission and these definitions have been validated as has the American Rheumatism Association (ARA) remission criteria. The “patient-reported symptom state” (PASS) is not yet well validated; (3) evidence was obtained to identify those measures, scales and patient-reported instruments, for which there is a documented association with relevant outcomes; (4) baseline disease activity is associated with disease activity levels at the end of follow-up; and (5) there was not sufficient evidence relating the added benefit of MRI or ultrasound over clinical assessments. Most data stemmed from observational studies rather than clinical trials and literature review was supplemented by input from experts. The results served as the basis for the elaboration of the seven recommendations by the experts.Conclusions:The approach based on scientific evidence from the literature as well as on expert input provided sufficient information to derive recommendations on reporting disease activity in RA clinical trials. The methodology, results and conclusions of this project were endorsed by EULAR and the ACR.
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pubBMJ Publishing Group Ltd and European League Against Rheumatism
pmid18791056
doi10.1136/ard.2008.092353