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Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations

Objective:To make recommendations on how to report disease activity in clinical trials of rheumatoid arthritis (RA) endorsed by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR).Methods:The project followed the EULAR standardised operating procedures, whic... Full description

Journal Title: Annals of the rheumatic diseases 2008-10, Vol.67 (10), p.1360-1364
Main Author: Aletaha, D
Other Authors: Landewe, R , Karonitsch, T , Bathon, J , Boers, M , Bombardier, C , Bombardieri, S , Choi, H , Combe, B , Dougados, M , Emery, P , Gomez-Reino, J , Keystone, E , Koch, G , Kvien, T K , Martin-Mola, E , Matucci-Cerinic, M , Michaud, K , O’Dell, J , Paulus, H , Pincus, T , Richards, P , Simon, L , Siegel, J , Smolen, J S , Sokka, T , Strand, V , Tugwell, P , van der Heijde, D , van Riel, P , Vlad, S , van Vollenhoven, R , Ward, M , Weinblatt, M , Wells, G , White, B , Wolfe, F , Zhang, B , Zink, A , Felson, D
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: Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations
format: Article
creator:
  • Aletaha, D
  • Landewe, R
  • Karonitsch, T
  • Bathon, J
  • Boers, M
  • Bombardier, C
  • Bombardieri, S
  • Choi, H
  • Combe, B
  • Dougados, M
  • Emery, P
  • Gomez-Reino, J
  • Keystone, E
  • Koch, G
  • Kvien, T K
  • Martin-Mola, E
  • Matucci-Cerinic, M
  • Michaud, K
  • O’Dell, J
  • Paulus, H
  • Pincus, T
  • Richards, P
  • Simon, L
  • Siegel, J
  • Smolen, J S
  • Sokka, T
  • Strand, V
  • Tugwell, P
  • van der Heijde, D
  • van Riel, P
  • Vlad, S
  • van Vollenhoven, R
  • Ward, M
  • Weinblatt, M
  • Wells, G
  • White, B
  • Wolfe, F
  • Zhang, B
  • Zink, A
  • Felson, D
subjects:
  • Arthritis, Rheumatoid - complications
  • Arthritis, Rheumatoid - diagnosis
  • Arthritis, Rheumatoid - drug therapy
  • Biological and medical sciences
  • Care and treatment
  • Clinical trials
  • Clinical Trials as Topic - methods
  • Clinical Trials as Topic - standards
  • Collaboration
  • Development and progression
  • Disease
  • Diseases of the osteoarticular system
  • Evaluation
  • Evidence-Based Medicine - methods
  • Experts
  • Fatigue - diagnosis
  • Fatigue - etiology
  • Health risk assessment
  • Humans
  • Inflammatory joint diseases
  • International Cooperation
  • Medical sciences
  • Medicin och hälsovetenskap
  • Practice guidelines (Medicine)
  • Remission Induction
  • Reports
  • Research Design - standards
  • Researchers
  • Response rates
  • Rheumatism
  • Rheumatoid arthritis
  • Severity of Illness Index
  • Societies, Medical
  • Studies
  • Sustainability
  • Treatment Outcome
ispartof: Annals of the rheumatic diseases, 2008-10, Vol.67 (10), p.1360-1364
description: Objective:To make recommendations on how to report disease activity in clinical trials of rheumatoid arthritis (RA) endorsed by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR).Methods:The project followed the EULAR standardised operating procedures, which use a three-step approach: (1) expert-based definition of relevant research questions (November 2006); (2) systematic literature search (November 2006 to May 2007); and (3) expert consensus on recommendations based on the literature search results (May 2007). In addition, since this is the first joint EULAR/ACR publication on recommendations, an extra step included a meeting with an ACR panel to approve the recommendations elaborated by the expert group (August 2007).Results:Eleven relevant questions were identified for the literature search. Based on the evidence from the literature the expert panel recommended that each trial should report the following items: (1) disease activity response and disease activity states; (2) appropriate descriptive statistics of the baseline, the endpoints and change of the single variables included in the core set; (3) baseline disease activity levels (in general); (4) the percentage of patients achieving a low disease activity state and remission; (5) time to onset of the primary outcome; (6) sustainability of the primary outcome; (7) fatigue.Conclusions:These recommendations endorsed by EULAR and ACR will help harmonise the presentations of results from clinical trials. Adherence to these recommendations will provide the readership of clinical trials with more details of important outcomes, while the higher level of homogeneity may facilitate the comparison of outcomes across different trials and pooling of trial results, such as in meta-analyses.
language: eng
source:
identifier: ISSN: 0003-4967
fulltext: no_fulltext
issn:
  • 0003-4967
  • 1468-2060
  • 1468-2060
url: Link


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titleReporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations
creatorAletaha, D ; Landewe, R ; Karonitsch, T ; Bathon, J ; Boers, M ; Bombardier, C ; Bombardieri, S ; Choi, H ; Combe, B ; Dougados, M ; Emery, P ; Gomez-Reino, J ; Keystone, E ; Koch, G ; Kvien, T K ; Martin-Mola, E ; Matucci-Cerinic, M ; Michaud, K ; O’Dell, J ; Paulus, H ; Pincus, T ; Richards, P ; Simon, L ; Siegel, J ; Smolen, J S ; Sokka, T ; Strand, V ; Tugwell, P ; van der Heijde, D ; van Riel, P ; Vlad, S ; van Vollenhoven, R ; Ward, M ; Weinblatt, M ; Wells, G ; White, B ; Wolfe, F ; Zhang, B ; Zink, A ; Felson, D
creatorcontribAletaha, D ; Landewe, R ; Karonitsch, T ; Bathon, J ; Boers, M ; Bombardier, C ; Bombardieri, S ; Choi, H ; Combe, B ; Dougados, M ; Emery, P ; Gomez-Reino, J ; Keystone, E ; Koch, G ; Kvien, T K ; Martin-Mola, E ; Matucci-Cerinic, M ; Michaud, K ; O’Dell, J ; Paulus, H ; Pincus, T ; Richards, P ; Simon, L ; Siegel, J ; Smolen, J S ; Sokka, T ; Strand, V ; Tugwell, P ; van der Heijde, D ; van Riel, P ; Vlad, S ; van Vollenhoven, R ; Ward, M ; Weinblatt, M ; Wells, G ; White, B ; Wolfe, F ; Zhang, B ; Zink, A ; Felson, D
descriptionObjective:To make recommendations on how to report disease activity in clinical trials of rheumatoid arthritis (RA) endorsed by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR).Methods:The project followed the EULAR standardised operating procedures, which use a three-step approach: (1) expert-based definition of relevant research questions (November 2006); (2) systematic literature search (November 2006 to May 2007); and (3) expert consensus on recommendations based on the literature search results (May 2007). In addition, since this is the first joint EULAR/ACR publication on recommendations, an extra step included a meeting with an ACR panel to approve the recommendations elaborated by the expert group (August 2007).Results:Eleven relevant questions were identified for the literature search. Based on the evidence from the literature the expert panel recommended that each trial should report the following items: (1) disease activity response and disease activity states; (2) appropriate descriptive statistics of the baseline, the endpoints and change of the single variables included in the core set; (3) baseline disease activity levels (in general); (4) the percentage of patients achieving a low disease activity state and remission; (5) time to onset of the primary outcome; (6) sustainability of the primary outcome; (7) fatigue.Conclusions:These recommendations endorsed by EULAR and ACR will help harmonise the presentations of results from clinical trials. Adherence to these recommendations will provide the readership of clinical trials with more details of important outcomes, while the higher level of homogeneity may facilitate the comparison of outcomes across different trials and pooling of trial results, such as in meta-analyses.
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publisherLondon: BMJ Publishing Group Ltd and European League Against Rheumatism
subjectArthritis, Rheumatoid - complications ; Arthritis, Rheumatoid - diagnosis ; Arthritis, Rheumatoid - drug therapy ; Biological and medical sciences ; Care and treatment ; Clinical trials ; Clinical Trials as Topic - methods ; Clinical Trials as Topic - standards ; Collaboration ; Development and progression ; Disease ; Diseases of the osteoarticular system ; Evaluation ; Evidence-Based Medicine - methods ; Experts ; Fatigue - diagnosis ; Fatigue - etiology ; Health risk assessment ; Humans ; Inflammatory joint diseases ; International Cooperation ; Medical sciences ; Medicin och hälsovetenskap ; Practice guidelines (Medicine) ; Remission Induction ; Reports ; Research Design - standards ; Researchers ; Response rates ; Rheumatism ; Rheumatoid arthritis ; Severity of Illness Index ; Societies, Medical ; Studies ; Sustainability ; Treatment Outcome
ispartofAnnals of the rheumatic diseases, 2008-10, Vol.67 (10), p.1360-1364
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1Landewe, R
2Karonitsch, T
3Bathon, J
4Boers, M
5Bombardier, C
6Bombardieri, S
7Choi, H
8Combe, B
9Dougados, M
10Emery, P
11Gomez-Reino, J
12Keystone, E
13Koch, G
14Kvien, T K
15Martin-Mola, E
16Matucci-Cerinic, M
17Michaud, K
18O’Dell, J
19Paulus, H
20Pincus, T
21Richards, P
22Simon, L
23Siegel, J
24Smolen, J S
25Sokka, T
26Strand, V
27Tugwell, P
28van der Heijde, D
29van Riel, P
30Vlad, S
31van Vollenhoven, R
32Ward, M
33Weinblatt, M
34Wells, G
35White, B
36Wolfe, F
37Zhang, B
38Zink, A
39Felson, D
title
0Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations
1Annals of the rheumatic diseases
addtitleAnn Rheum Dis
descriptionObjective:To make recommendations on how to report disease activity in clinical trials of rheumatoid arthritis (RA) endorsed by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR).Methods:The project followed the EULAR standardised operating procedures, which use a three-step approach: (1) expert-based definition of relevant research questions (November 2006); (2) systematic literature search (November 2006 to May 2007); and (3) expert consensus on recommendations based on the literature search results (May 2007). In addition, since this is the first joint EULAR/ACR publication on recommendations, an extra step included a meeting with an ACR panel to approve the recommendations elaborated by the expert group (August 2007).Results:Eleven relevant questions were identified for the literature search. Based on the evidence from the literature the expert panel recommended that each trial should report the following items: (1) disease activity response and disease activity states; (2) appropriate descriptive statistics of the baseline, the endpoints and change of the single variables included in the core set; (3) baseline disease activity levels (in general); (4) the percentage of patients achieving a low disease activity state and remission; (5) time to onset of the primary outcome; (6) sustainability of the primary outcome; (7) fatigue.Conclusions:These recommendations endorsed by EULAR and ACR will help harmonise the presentations of results from clinical trials. Adherence to these recommendations will provide the readership of clinical trials with more details of important outcomes, while the higher level of homogeneity may facilitate the comparison of outcomes across different trials and pooling of trial results, such as in meta-analyses.
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0Arthritis, Rheumatoid - complications
1Arthritis, Rheumatoid - diagnosis
2Arthritis, Rheumatoid - drug therapy
3Biological and medical sciences
4Care and treatment
5Clinical trials
6Clinical Trials as Topic - methods
7Clinical Trials as Topic - standards
8Collaboration
9Development and progression
10Disease
11Diseases of the osteoarticular system
12Evaluation
13Evidence-Based Medicine - methods
14Experts
15Fatigue - diagnosis
16Fatigue - etiology
17Health risk assessment
18Humans
19Inflammatory joint diseases
20International Cooperation
21Medical sciences
22Medicin och hälsovetenskap
23Practice guidelines (Medicine)
24Remission Induction
25Reports
26Research Design - standards
27Researchers
28Response rates
29Rheumatism
30Rheumatoid arthritis
31Severity of Illness Index
32Societies, Medical
33Studies
34Sustainability
35Treatment Outcome
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9Dougados, M
10Emery, P
11Gomez-Reino, J
12Keystone, E
13Koch, G
14Kvien, T K
15Martin-Mola, E
16Matucci-Cerinic, M
17Michaud, K
18O’Dell, J
19Paulus, H
20Pincus, T
21Richards, P
22Simon, L
23Siegel, J
24Smolen, J S
25Sokka, T
26Strand, V
27Tugwell, P
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titleReporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations
authorAletaha, D ; Landewe, R ; Karonitsch, T ; Bathon, J ; Boers, M ; Bombardier, C ; Bombardieri, S ; Choi, H ; Combe, B ; Dougados, M ; Emery, P ; Gomez-Reino, J ; Keystone, E ; Koch, G ; Kvien, T K ; Martin-Mola, E ; Matucci-Cerinic, M ; Michaud, K ; O’Dell, J ; Paulus, H ; Pincus, T ; Richards, P ; Simon, L ; Siegel, J ; Smolen, J S ; Sokka, T ; Strand, V ; Tugwell, P ; van der Heijde, D ; van Riel, P ; Vlad, S ; van Vollenhoven, R ; Ward, M ; Weinblatt, M ; Wells, G ; White, B ; Wolfe, F ; Zhang, B ; Zink, A ; Felson, D
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0Arthritis, Rheumatoid - complications
1Arthritis, Rheumatoid - diagnosis
2Arthritis, Rheumatoid - drug therapy
3Biological and medical sciences
4Care and treatment
5Clinical trials
6Clinical Trials as Topic - methods
7Clinical Trials as Topic - standards
8Collaboration
9Development and progression
10Disease
11Diseases of the osteoarticular system
12Evaluation
13Evidence-Based Medicine - methods
14Experts
15Fatigue - diagnosis
16Fatigue - etiology
17Health risk assessment
18Humans
19Inflammatory joint diseases
20International Cooperation
21Medical sciences
22Medicin och hälsovetenskap
23Practice guidelines (Medicine)
24Remission Induction
25Reports
26Research Design - standards
27Researchers
28Response rates
29Rheumatism
30Rheumatoid arthritis
31Severity of Illness Index
32Societies, Medical
33Studies
34Sustainability
35Treatment Outcome
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1Landewe, R
2Karonitsch, T
3Bathon, J
4Boers, M
5Bombardier, C
6Bombardieri, S
7Choi, H
8Combe, B
9Dougados, M
10Emery, P
11Gomez-Reino, J
12Keystone, E
13Koch, G
14Kvien, T K
15Martin-Mola, E
16Matucci-Cerinic, M
17Michaud, K
18O’Dell, J
19Paulus, H
20Pincus, T
21Richards, P
22Simon, L
23Siegel, J
24Smolen, J S
25Sokka, T
26Strand, V
27Tugwell, P
28van der Heijde, D
29van Riel, P
30Vlad, S
31van Vollenhoven, R
32Ward, M
33Weinblatt, M
34Wells, G
35White, B
36Wolfe, F
37Zhang, B
38Zink, A
39Felson, D
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1Landewe, R
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3Bathon, J
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7Choi, H
8Combe, B
9Dougados, M
10Emery, P
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atitleReporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations
jtitleAnnals of the rheumatic diseases
addtitleAnn Rheum Dis
date2008-10
risdate2008
volume67
issue10
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pages1360-1364
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abstractObjective:To make recommendations on how to report disease activity in clinical trials of rheumatoid arthritis (RA) endorsed by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR).Methods:The project followed the EULAR standardised operating procedures, which use a three-step approach: (1) expert-based definition of relevant research questions (November 2006); (2) systematic literature search (November 2006 to May 2007); and (3) expert consensus on recommendations based on the literature search results (May 2007). In addition, since this is the first joint EULAR/ACR publication on recommendations, an extra step included a meeting with an ACR panel to approve the recommendations elaborated by the expert group (August 2007).Results:Eleven relevant questions were identified for the literature search. Based on the evidence from the literature the expert panel recommended that each trial should report the following items: (1) disease activity response and disease activity states; (2) appropriate descriptive statistics of the baseline, the endpoints and change of the single variables included in the core set; (3) baseline disease activity levels (in general); (4) the percentage of patients achieving a low disease activity state and remission; (5) time to onset of the primary outcome; (6) sustainability of the primary outcome; (7) fatigue.Conclusions:These recommendations endorsed by EULAR and ACR will help harmonise the presentations of results from clinical trials. Adherence to these recommendations will provide the readership of clinical trials with more details of important outcomes, while the higher level of homogeneity may facilitate the comparison of outcomes across different trials and pooling of trial results, such as in meta-analyses.
copLondon
pubBMJ Publishing Group Ltd and European League Against Rheumatism
pmid18791055
doi10.1136/ard.2008.091454
oafree_for_read