2017 EULAR recommendations for a core data set to support observational research and clinical care in rheumatoid arthritis

被引：53

作者：

Radner, Helga ^{[1
]}

Chatzidionysiou, Katerina ^{[2
,3
]}

Nikiphorou, Elena ^{[4
]}

Gossec, Laure ^{[5
,6
]}

Hyrich, Kimme L. ^{[7
]}

Zabalan, Condruta ^{[8
]}

van Eijk-Hustings, Yvonne ^{[9
]}

Williamson, Paula R. ^{[10
]}

Balanescu, Andra ^{[11
]}

Burmester, Gerd R. ^{[12
]}

Carmona, Loreto ^{[13
]}

Dougados, Maxime ^{[14
]}

Finckh, Axel ^{[15
]}

Haugeberg, Glenn ^{[16
,17
]}

Hetland, Merete Lund ^{[18
,19
]}

Oliver, Susan ^{[20
]}

Porter, Duncan ^{[21
]}

Raza, Karim ^{[22
,23
,24
,25
]}

Ryan, Patrick ^{[26
,27
]}

Santos, Maria Jose ^{[28
,29
]}

van der Helm-van Mil, Annette ^{[30
,31
]}

van Riel, Piet ^{[32
]}

von Krause, Gabrielle ^{[33
]}

Zavada, Jakub ^{[34
,35
]}

Dixon, William G. ^{[36
]}

Askling, Johan ^{[2
,3
]}

机构：

[1] Med Univ Vienna, Div Rheumatol, Dept Internal Med 3, A-1090 Vienna, Austria

[2] Karolinska Univ Hosp, Dept Rheumatol, Stockholm, Sweden

[3] Karolinska Inst, Dept Med Solna, Stockholm, Sweden

[4] Kings Coll London, Acad Rheumatol Dept, London, England

[5] UPMC Univ Paris, Sorbonne Univ, Dept Rheumatol, Paris, France

[6] Hop La Pitie Salpetriere, AP HP, Dept Rheumatol, Paris, France

[7] Cent Manchester NHS Fdn Trust, Manchester Acad Hlth Sci Ctr, NIHR Manchester Musculoskeletal Biomed Res Unit, Manchester, Lancs, England

[8] Patient Partner Romanian League Rheumatism, Bucharest, Romania

[9] Maastricht Univ, Dept Patient & Care, Med Ctr, Maastricht, Netherlands

[10] Univ Liverpool, MRC North West Hub Trials Methodol Res, Dept Biostat, Liverpool, Merseyside, England

[11] Univ Med & Pharm Carol Davila, Sf Maria Hosp, Res Ctr Rheumat Dis, Res Ctr Rheumat Dis, Bucharest, Romania

[12] Charite Univ Med Berlin, Dept Rheumatol & Clin Immunol, Berlin, Germany

[13] Inst Salud Musculoesquelet, Madrid, Spain

[14] Paris Descartes Univ, Cochin Hosp, AP HP, Med Fac,Rheumatol Dept B, Paris, France

[15] Univ Hosp Geneva, Dept Internal Med Specialties, Div Rheumatol, Geneva, Switzerland

[16] Martina Hansens Hosp, Dept Rheumatol, Gjettum, Norway

[17] Norwegian Univ Sci & Technol, Trondheim, Norway

[18] Rigshosp, Copenhagen Ctr Arthrit Res, Ctr Head & Orthopaed, Ctr Rheumatol & Spine Dis, Glostrup, Denmark

[19] Univ Copenhagen, Fac Hlth & Med Sci, Dept Med Clin, Copenhagen, Denmark

[20] Dept Rheumatol, North Devon, England

[21] Gartnavel Royal Hosp, Rheumatol Dept, Glasgow, Lanark, Scotland

[22] Univ Birmingham, Arthrit Res UK Rheumatoid Arthrit Pathogenesis Ct, Inst Inflammat & Ageing, Birmingham, W Midlands, England

[23] Univ Birmingham, MRC Arthrit Res UK Ctr Musculoskeletal Ageing Res, Birmingham, W Midlands, England

[24] NIHR Birmingham, Biomed Res Ctr, Birmingham, W Midlands, England

[25] Sandwell & West Birmingham Hosp NHS Trust, Birmingham, W Midlands, England

[26] Columbia Univ, Dept Biomed Informat, New York, NY USA

[27] Janssen, Janssen Res & Dev, Titusville, NJ USA

[28] Univ Lisbon, Hosp Garcia de Orta, Dept Rheumatol, Lisbon, Portugal

[29] Univ Lisbon, Fac Med, Inst Med Mol, Lisbon, Portugal

[30] Leiden Univ, Dept Rheumatol, Med Ctr, Leiden, Netherlands

[31] Erasmus MC, Dept Rheumatol, Rotterdam, Netherlands

[32] Dept Rheumatol, Bernhoven, Uden, Netherlands

[33] Patient Res Partner, Paris, France

[34] Inst Rheumatol, Prague, Czech Republic

[35] Charles Univ Prague, Fac Med 1, Dept Rheumatol, Prague, Czech Republic

[36] Univ Manchester, Manchester Acad Hlth Sci Ctr, Arthrit Res UK Ctr Epidemiol, Manchester, Lancs, England

来源：

ANNALS OF THE RHEUMATIC DISEASES | 2018年 / 77卷 / 04期

关键词：

rheumatoid arthritis; outcomes research; quality indicators; DISEASE-ACTIVITY; DEFINITION;

D O I：

10.1136/annrheumdis-2017-212256

中图分类号：

R5 [内科学];

学科分类号：

100201 [内科学];

摘要：

Personalised medicine, new discoveries and studies on rare exposures or outcomes require large samples that are increasingly difficult for any single investigator to obtain. Collaborative work is limited by heterogeneities, both what is being collected and how it is defined. To develop a core set for data collection in rheumatoid arthritis (RA) research which (1) allows harmonisation of data collection in future observational studies, (2) acts as a common data model against which existing databases can be mapped and (3) serves as a template for standardised data collection in routine clinical practice to support generation of research-quality data. A multistep, international multistakeholder consensus process was carried out involving voting via online surveys and two face-to-face meetings. A core set of 21 items (what to collect') and their instruments (how to collect') was agreed: age, gender, disease duration, diagnosis of RA, body mass index, smoking, swollen/tender joints, patient/evaluator global, pain, quality of life, function, composite scores, acute phase reactants, serology, structural damage, treatment and comorbidities. The core set should facilitate collaborative research, allow for comparisons across studies and harmonise future data from clinical practice via electronic medical record systems.

引用

页码：476 / 479

页数：4

共 11 条

[1]

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

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. .

ANNALS OF THE RHEUMATIC DISEASES, 2008, 67 (10) :1360-1364

[2]

Points to consider for reporting, screening for and preventing selected comorbidities in chronic inflammatory rheumatic diseases in daily practice: a EULAR initiative [J].

Baillet, Athan ;

Gossec, Laure ;

Carmona, Loreto ;

de Wit, Maarten ;

van Eijk-Hustings, Yvonne ;

Bertheussen, Heidi ;

Alison, Kent ;

Toft, Mette ;

Kouloumas, Marios ;

Ferreira, Ricardo J. O. ;

Oliver, Susan ;

Rubbert-Roth, Andrea ;

van Assen, Sander ;

Dixon, William G. ;

Finckh, Axel ;

Zink, Angela ;

Kremer, Joel ;

Kvien, Tore K. ;

Nurmohamed, Michael ;

van der Heijde, Desiree ;

Dougados, Maxime .

ANNALS OF THE RHEUMATIC DISEASES, 2016, 75 (06) :965-973

[3]

Development of EULAR recommendations for the reporting of clinical trial extension studies in rheumatology [J].

Buch, Maya H. ;

Silva-Fernandez, Lucia ;

Carmona, Loreto ;

Aletaha, Daniel ;

Christensen, Robin ;

Combe, Bernard ;

Emery, Paul ;

Ferraccioli, Gianfranco ;

Guillemin, Francis ;

Kvien, Tore K. ;

Landewe, Robert ;

Pavelka, Karel ;

Saag, Kenneth ;

Smolen, Josef S. ;

Symmons, Deborah ;

van der Heijde, Desiree ;

Welling, Joep ;

Wells, George ;

Westhovens, Rene ;

Zink, Angela ;

Boers, Maarten .

ANNALS OF THE RHEUMATIC DISEASES, 2015, 74 (06) :963-969

[4]

Felson DT, 2011, ANN RHEUM DIS, V70, P404, DOI [10.1136/ard.2011.149765, 10.1002/art.30129]

[5]

The Danish nationwide clinical register for patients with rheumatoid arthritis: DANBIO [J].

Ibfelt, Else Helene ;

Jensen, Dorte Vendelbo ;

Hetland, Merete Lund .

CLINICAL EPIDEMIOLOGY, 2016, 8 :737-742

[6]

Core Outcome Set-STAndards for Reporting: The COS-STAR Statement [J].

Kirkham, Jamie J. ;

Gorst, Sarah ;

Altman, Douglas G. ;

Blazeby, Jane M. ;

Clarke, Mike ;

Devane, Declan ;

Gorgon, Elizabeth ;

Moher, David ;

Schmitt, Jochen ;

Tugwell, Peter ;

Tunis, Sean ;

Williamson, Paula R. .

PLOS MEDICINE, 2016, 13 (10)

[7]

Kirwan JR, 2007, J RHEUMATOL, V34, P1174

[8]

Patient global assessment in measuring disease activity in rheumatoid arthritis: a review of the literature [J].

Nikiphorou, Elena ;

Radner, Helga ;

Chatzidionysiou, Katerina ;

Desthieux, Carole ;

Zabalan, Codruta ;

van Eijk-Hustings, Yvonne ;

Dixon, William G. ;

Hyrich, Kimme L. ;

Askling, Johan ;

Gossec, Laure .

ARTHRITIS RESEARCH & THERAPY, 2016, 18

[9]

Consistency and Utility of Data Items Across European Rheumatoid Arthritis Clinical Cohorts and Registers [J].

Radner, Helga ;

Dixon, William ;

Hyrich, Kimme ;

Askling, Johan .

ARTHRITIS CARE & RESEARCH, 2015, 67 (09) :1219-1229

[10]

Proposal for a new nomenclature of disease-modifying antirheumatic drugs [J].

Smolen, Josef S. ;

van der Heijde, Desiree ;

Machold, Klaus P. ;

Aletaha, Daniel ;

Landewe, Robert .

ANNALS OF THE RHEUMATIC DISEASES, 2014, 73 (01) :3-5

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