University of Manchester
THE 2017 EULAR RECOMMENDATIONS FOR A CORE DATASET TO SUPPORT OBSERVATIONAL RESEARCH AND CLINICAL CARE IN RHEUMATOID ARTHRITISRadner H1; Chatzidionysiou K2, Nikiphorou E3, Gossec L4, Hyrich K5, Zabalan C6, van Eijk-Hustings Y7, Williamson P.R8, Balanescu A9, Burmester G.R10, Carmona L11, Dougados M12, Finckh A13, Haugeberg G14, Hetland M.L15, Oliver S16, Porter D17, Raza K18, Ryan P19, Santos M.J20, van der Helm-van Mil A21, van Riel P22, von Krause G23, Zavada J24, Dixon WG25, Askling J21 Department of Internal Medicine III, Division of Rheumatology; Medical University Vienna; Austria2 Department of Rheumatology, Karolinska University Hospital, and Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden3 Academic Rheumatology Department, King’s College London, London, UK4 Sorbonne Universités, UPMC University Paris 06; AP-HP, Hopital Pitie-Salpetriere, Rheumatology Department, , Paris, France5 NIHR Manchester Musculoskeletal Biomedical Research Unit, Central Manchester NHS Foundation Trust, Manchester Academic Health Science Centre 6 Patient Partner of Romanian League against Rheumatism, Bucharest, Romania 7 Department of Patient & Care, Maastricht, The Netherlands8 MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Waterhouse Building, Brownlow Street, Liverpool, L69 3GL, UK9 Research Center of Rheumatic Diseases, "Sf. Maria" Hospital, University of Medicine and Pharmacy "Carol Davila", Bucharest, Romania10 Department of Rheumatology and Clinical Immunology,?Charité—University Medicine Berlin,?Berlin, Germany11 Instituto de Salud Musculoesquelética, Madrid, Spain12 Medicine Faculty, APHP, Rheumatology B Department,?Paris Descartes University, Cochin Hospital,?Paris, France13 Division of Rheumatology, Department of Internal Medicine Specialties, University Hospitals of Geneva, 26, Ave Beau-Sejour, CH 1211, Geneva, Switzerland.14 Department of Rheumatology, Martina Hansens Hospital, B?rum; Norwegian University of Science and Technology, Trondheim, Norway15 Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Rigshospitalet, Glostrup, and Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark16 North Devon, UK17 Rheumatology Department, Gartnavel General Hospital, Glasgow, UK18 Rheumatology Research Group, Institute of Inflammation and Ageing, University of Birmingham,?Birmingham, UK and Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK19 Department of Biomedical Informatics, Columbia University, New York, NY 10032, United States; Janssen Research and Development, Titusville, NJ 08560, United States20 Department of Rheumatology, Hospital Garcia de Orta and Instituto de Medicina Molecular da Faculdade de Medicina, Universidade de Lisboa, Portugal21 Department of Rheumatology,?Leiden University Medical Center,?Leiden; Department of Rheumatology, Erasmus Medical Center, Rotterdam, the Netherlands22 Department of Rheumatology, Bernhoven, Uden, The Netherlands23 Patient research partner, Paris, France24 Institute of Rheumatology, Prague, and Department of Rheumatology, First Faculty of Medicine, Charles University, Na Slupi 4, 12850, Prague, Czech Republic25 Arthritis Research UK Centre for Epidemiology, Manchester Academic Health Sciences Centre, The University of Manchester, Manchester, UKWord Count 1500499Abstract 192ABSTRACTBackground. 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 in the data collected, both with regards to what is being collected, and how it is defined and collected. Objective. To develop a core set for data collection in rheumatoid arthritis (RA) research which (i) allows harmonization of data collection in future observational studies, (ii) acts as a common data model against which existing databases can be mapped, and (iii) serves as a template for standardized data collection in routine clinical practice to support the generation of research-quality data.Methods. A multi-step, international multi-stakeholder consensus process was carried out involving voting via online surveys and two face-to-face meetings.Results. A fter several iterations a core set of 21 items (“what to collect”) and their instruments (“how to collect”) was agreed: Age, gender, disease duration, diagnosis of RA, BMI, smoking, swollen/tender joints, patient/evaluator global, pain, quality of life, function, composite scores, acute phase reactants, serology, structural damage, treatment and comorbidities..Conclusions. The core set should facilitate collaborative research, allow for comparisons across studies, and has the potential to be implemented in harmonise future data from clinical practice via electronic medical record systems. This EULAR task-force may also serve as an example for other conditions beyond RA. INTRODUCTIONResearch questions of the current era require ever larger study populations which often exceed the number of patients available in individual studies or registries, hence combined or pooled analyses are often required. Such collaborative work is, however, compromised by heterogeneities in the data collected. ADDIN EN.CITE <EndNote><Cite><Author>Radner</Author><Year>2015</Year><RecNum>8</RecNum><DisplayText>(1)</DisplayText><record><rec-number>8</rec-number><foreign-keys><key app="EN" db-id="wfztaz5rdaz99ae5dzb5p5t2tztv9sv2v5ts" timestamp="1482323222">8</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Radner, H.</author><author>Dixon, W.</author><author>Hyrich, K.</author><author>Askling, J.</author></authors></contributors><auth-address>Medical University Vienna, Vienna, Austria.
Manchester Academic Health Science Centre, University of Manchester, Manchester, UK.
NIHR Manchester Musculoskeletal Biomedical Research Unit, Central Manchester NHS Foundation Trust, and Manchester Academic Health Science Centre, Manchester, UK.
Karolinska Institute, Stockholm, Sweden.</auth-address><titles><title>Consistency and Utility of Data Items Across European Rheumatoid Arthritis Clinical Cohorts and Registers</title><secondary-title>Arthritis Care Res (Hoboken)</secondary-title></titles><periodical><full-title>Arthritis Care Res (Hoboken)</full-title></periodical><pages>1219-29</pages><volume>67</volume><number>9</number><keywords><keyword>*Arthritis, Rheumatoid</keyword><keyword>Cohort Studies</keyword><keyword>Europe</keyword><keyword>Humans</keyword><keyword>Registries/standards/*statistics & numerical data</keyword></keywords><dates><year>2015</year><pub-dates><date>Sep</date></pub-dates></dates><isbn>2151-4658 (Electronic)
2151-464X (Linking)</isbn><accession-num>25892245</accession-num><urls><related-urls><url>;(1) More recently, routinely collected data from electronic medical records (EMR) has the potential to support research, but there is no agreed set of data that would be desirable to collect in order to generate research-quality data if used beyond direct clinical care. To facilitate collaborative research, standardizing items (“what to collect”) and their instruments (“how to collect”) across studies and data collections is critical. Although guidelines on data reporting and outcome measures have been developed, such core sets have so far pertained to randomized control trials and trial extension studies in rheumatoid arthritis (RA) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BbGV0YWhhPC9BdXRob3I+PFllYXI+MjAwODwvWWVhcj48
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ADDIN EN.CITE.DATA (4), underpinned by an inventory of data collection in existing RA clinical cohorts and registers ADDIN EN.CITE <EndNote><Cite><Author>Radner</Author><Year>2015</Year><RecNum>8</RecNum><DisplayText>(1)</DisplayText><record><rec-number>8</rec-number><foreign-keys><key app="EN" db-id="wfztaz5rdaz99ae5dzb5p5t2tztv9sv2v5ts" timestamp="1482323222">8</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Radner, H.</author><author>Dixon, W.</author><author>Hyrich, K.</author><author>Askling, J.</author></authors></contributors><auth-address>Medical University Vienna, Vienna, Austria.
Manchester Academic Health Science Centre, University of Manchester, Manchester, UK.
NIHR Manchester Musculoskeletal Biomedical Research Unit, Central Manchester NHS Foundation Trust, and Manchester Academic Health Science Centre, Manchester, UK.
Karolinska Institute, Stockholm, Sweden.</auth-address><titles><title>Consistency and Utility of Data Items Across European Rheumatoid Arthritis Clinical Cohorts and Registers</title><secondary-title>Arthritis Care Res (Hoboken)</secondary-title></titles><periodical><full-title>Arthritis Care Res (Hoboken)</full-title></periodical><pages>1219-29</pages><volume>67</volume><number>9</number><keywords><keyword>*Arthritis, Rheumatoid</keyword><keyword>Cohort Studies</keyword><keyword>Europe</keyword><keyword>Humans</keyword><keyword>Registries/standards/*statistics & numerical data</keyword></keywords><dates><year>2015</year><pub-dates><date>Sep</date></pub-dates></dates><isbn>2151-4658 (Electronic)
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ADDIN EN.CITE.DATA (2, 3) and with the EULAR outcome measures library. Items and instruments felt to be missing could be added by the steering committee. (b) In an online survey, the expert panel rated the perceived importance of each of the above items (and instruments) to be included in a core set, using a grading scale from 1 (not important) to 9 (very important). Again, items and instruments could be added. (c) At the first face-to-face meeting of the working group, electronic voting on individual items and instruments to include in the core set took place. We defined consensus as >70% of participants voting either YES or NO to the inclusion of a given item; if no consensus was reached, a second vote took place after a brief discussion which was led by an independent moderator (DP). In this second round, the threshold for consensus was lowered to 60%. The resultant list of items that had reached consensus for inclusion informed a single round of voting on the instruments with which to collect information on the items. (d) Additional information on items and instruments for which no consensus was reached was collected. Ratification of items included, reasons for any exclusion, and voting on items that had not reached consensus at the face-to-face meeting was performed via an online survey within the working group. (e) At the second face-to-face meeting of the working group, voting was conducted for outstanding items, then for final approval of the complete core list of items, followed by voting on instruments for all items in the final list using the same method of moderated discussion and voting cut-offs as outlined above.In all voting processes, the panellists were reminded of the importance of striking a balance between clinical feasibility and the potential to generate research-quality data.RESULTS(a) Literature reviewPublished articles from 67 different European RA registers and clinical cohorts were included. In total, 39 items and 125 instruments were identified; 8 additional items for consideration were added (supplementary table 1 and 21). (b) Online survey90 experts from 28 different European countries including patients (18%), allied health professionals (18%), physicians (55%) and researchers (10%) participated in the survey. 29 of the 47 proposed items were considered important enough for inclusion into a core set (supplementary table 21).(c) First face-to-face meeting 21/25 (84%) members attended. In the first voting round consensus for inclusion was reached for 16/47 (34%) items, and consensus for exclusion for 16/47 (34%) items. After discussion and a second round of voting on the remaining 15 items, consensus was reached for inclusion of 5 and for exclusion of 7, leaving two items (“health related quality of life”, and “socioeconomic status”) without consensus (supplementary table 21). (d) Online ratification23/25 (92%) members participated. The voting results from the face-to-face meeting were confirmed except for socioeconomic status, health-related quality of life, fatigue, and joint surgery (lack of consensus).(e) Second face-to-face meeting 17/25 (68%) members attended. Voting led to the exclusion of items “fatigue”, “joint surgery” and “socioeconomic status” but inclusion of “health-related quality of life”. Next, the resultant set of the remaining 21 items was voted on in its entirety, and 100% of the participants agreed (Table 1). Moderated discussion and sequential voting on the instruments with which to collect these 21 items resulted in consensus for all but two instruments (how to collect data for items “glucocorticoids”, and “comorbidity”).(f) Second online surveyA final ad hoc online survey with pre-specified suggestions provided by the steering committee for the outstanding instruments for items ‘glucocorticoids’ and ‘comorbidity’ was performed (supplementary table 3). 21/25 (84%) members participated, and consensus was reached. The final core set thus contained 21 items, each with its preferred instrument (see BOX).BOX. Structure and content of the RA core set developed by the EULAR Task ForceITEMRECOMMENDATION OF STANDARDIZED WAY OF ASSESSMENT1) Agedate of birth2) Gendermale / female3) Disease durationdate of diagnosis4) Diagnosis of RARheumatologist reported diagnosis of RA5) Body mass index (BMI)weight and height6) Smokingcurrent / previous / never7) Tender joints28 joint count8) Swollen joints28 joint count9) Patient globalmeasured on VAS or NRS scale capturing: 1) global assessment of disease activity; 2) related to arthritis; 3) today Example wording: “Considering all the ways your arthritis has affected you, how do you feel your arthritis is today?” anchors: excellent - very poor 10) Evaluator globalmeasured on VAS or NRS scale capturing: 1) global assessment of disease activity; 2) related to arthritis; 3) todayExample wording: ”What is your overall assessment of the patient's RA disease activity today?” anchors: excellent - very poor11) Painmeasured on VAS or NRS capturing: 1) pain; 2) related to arthritis; 3) last weekExample wording: “How much pain did you have due to your arthritis last week?” anchors: no pain – worst imaginable pain12) Physical functionHealth Assessment Questionnaire (HAQ)13) Health related quality of lifeEuro-Qol 5 dimensions (EQ5D)* 14) Composite Scores Collection of Core Items 7-12 and 15 enables to calculate following composite scores: CDAI(Clinical disease activity index)SDAI (Simplified disease activity index)DAS28 (Disease activity Score 28 joints)EULAR response criteriaACR response criteria15) Acute phase reactants C-reactive protein (CRP) AND erythrocyte sedimentation rate (ESR)16) SerologyRheumatoid factor (RF) AND anti-CCP antibodies (ACPA)Seropositivity (RF and/or ACPA)17) Structural Damage Presence of erosions on X-ray Yes/No18) DMARD Historyname of previous DMARD(s) (including biological, synthetic and targeted synthetic DMARDs19) Ongoing / most recent DMARDname of DMARD start and stop date reason for stopping 20) Glucocorticoids current use of oral glucocorticoids: 1) dose taken today __mg prednisolone equivalent; and 2) continuous (> 3 months) intake YES/NO21) Comorbiditiesbinary assessment YES/NO of the six EULAR comorbidity domains (cardiovascular disease, malignancies, infections, gastrointestinal disease, osteoporosis, depression) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CYWlsbGV0PC9BdXRob3I+PFllYXI+MjAxNjwvWWVhcj48
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ADDIN EN.CITE.DATA (5)* free licence available after registration for non-commercial parties according to DISCUSSIONThis EULAR taskforce has defined an RA core set, including both items and instruments to support standardised RA data collection in clinical practice and research. This will enable collaborative research studies, and increase comparability across studies. Unlike most previous core sets, this set was specifically developed keeping clinical feasibility in mind. Importantly, “core” underscores that the set represents a minimum, acknowledging that individual stakeholders are likely to add items or instruments of particular interest to their own data collection.Consensus for inclusion was straightforward for the majority of items: 16 of the final 21 items were agreed in the first round of voting. Six additional items were included, and after a ratification survey and discussion, ‘joint surgery’ was excluded in the subsequent process. Discussion for each item is summarized in supplementary table 32. Of the 26 items ultimately excluded from the core dataset 9 were seen as important by the expert group. One item, ‘fatigue’, was excluded from our core dataset yet is present in the OMERACT core outcome set for RA trials. ADDIN EN.CITE <EndNote><Cite><Author>Kirwan</Author><Year>2007</Year><RecNum>35</RecNum><DisplayText>(6)</DisplayText><record><rec-number>35</rec-number><foreign-keys><key app="EN" db-id="wfztaz5rdaz99ae5dzb5p5t2tztv9sv2v5ts" timestamp="1487581541">35</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Kirwan, J. R.</author><author>Minnock, P.</author><author>Adebajo, A.</author><author>Bresnihan, B.</author><author>Choy, E.</author><author>de Wit, M.</author><author>Hazes, M.</author><author>Richards, P.</author><author>Saag, K.</author><author>Suarez-Almazor, M.</author><author>Wells, G.</author><author>Hewlett, S.</author></authors></contributors><auth-address>University of Bristol Academic Rheumatology Unit, and United Bristol Healthcare NHS Trust, Bristol, UK. John.Kirwan@Bristol.ac.uk</auth-address><titles><title>Patient perspective: fatigue as a recommended patient centered outcome measure in rheumatoid arthritis</title><secondary-title>J Rheumatol</secondary-title></titles><periodical><full-title>J Rheumatol</full-title></periodical><pages>1174-7</pages><volume>34</volume><number>5</number><keywords><keyword>Arthritis, Rheumatoid/*complications/diagnosis/therapy</keyword><keyword>Endpoint Determination</keyword><keyword>Fatigue/diagnosis/*etiology/therapy</keyword><keyword>Humans</keyword><keyword>International Cooperation</keyword><keyword>Outcome Assessment (Health Care)/*methods</keyword><keyword>*Patient Satisfaction</keyword><keyword>Reproducibility of Results</keyword><keyword>*Rheumatology/education/methods</keyword><keyword>Treatment Outcome</keyword></keywords><dates><year>2007</year><pub-dates><date>May</date></pub-dates></dates><isbn>0315-162X (Print)
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ADDIN EN.CITE.DATA (7) to enable robustness and transparency. To ensure inclusiveness, all national European rheumatology societies were invited to contribute. Dissemination of the core set will be facilitated by publication online (EULAR website) and via national societies. Following agreement on this core set, it is important that it is adopted by future observational data collections and research studies in RA. For EMR systems to deliver to RA research, the core set also needs to be integrated into EMR systems. Additional clinical benefits of collection of structured data such as informing consultations, viewing longitudinal disease progression, supporting audit, and benchmarking care quality ADDIN EN.CITE <EndNote><Cite><Author>Ibfelt</Author><Year>2016</Year><RecNum>38</RecNum><DisplayText>(8)</DisplayText><record><rec-number>38</rec-number><foreign-keys><key app="EN" db-id="wfztaz5rdaz99ae5dzb5p5t2tztv9sv2v5ts" timestamp="1487582289">38</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Ibfelt, E. H.</author><author>Jensen, D. V.</author><author>Hetland, M. L.</author></authors></contributors><auth-address>Registry Support Centre (East), Epidemiology and Biostatistics, Research Centre for Prevention and Health, Rigshospitalet, Glostrup University Hospital.
DANBIO Registry and Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, Rigshospitalet, Glostrup; Department of Rheumatology, Herlev and Gentofte University Hospital, Hellerup.
DANBIO Registry and Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, Rigshospitalet, Glostrup; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.</auth-address><titles><title>The Danish nationwide clinical register for patients with rheumatoid arthritis: DANBIO</title><secondary-title>Clin Epidemiol</secondary-title></titles><periodical><full-title>Clin Epidemiol</full-title></periodical><pages>737-742</pages><volume>8</volume><keywords><keyword>DANBIO register clinical quality</keyword><keyword>axial spondyloarthritis</keyword><keyword>epidemiology</keyword><keyword>psoriatic arthritis</keyword><keyword>rheumatoid arthritis</keyword></keywords><dates><year>2016</year></dates><isbn>1179-1349 (Linking)</isbn><accession-num>27822121</accession-num><urls><related-urls><url>;(8) should be recognised and may encourage its clinical adoption.In summary, through a multi-step, multi-stakeholder, and evidence-based process, this task force has developed an RA core set that may (i) harmonize data collection in future observational studies, (ii) act as a common data model against which existing databases can be mapped, and (iii) serve as a template for standardized data collection in routine clinical practice to support the generation of research-quality data. This effort, which will continue to be updated and revised after evaluation of its implementation, may serve as an example for other conditions beyond RA. ACKNOWLEDGMENT: The authors want to thank all contributing experts who participated in the online survey. FUNDINGThis project was funded by a EULAR project grantREFERENCES ADDIN EN.REFLIST 1.Radner H, Dixon W, Hyrich K, et al. Consistency and Utility of Data Items Across European Rheumatoid Arthritis Clinical Cohorts and Registers. Arthritis Care Res (Hoboken). 2015;67(9):1219-29.2.Aletaha D, Landewe R, Karonitsch T, et al. Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations. Ann Rheum Dis. 2008;67(10):1360-4.3.Buch MH, Silva-Fernandez L, Carmona L, et al. Development of EULAR recommendations for the reporting of clinical trial extension studies in rheumatology. Ann Rheum Dis. 2015;74(6):963-9.4.van der Heijde D, Aletaha D, Carmona L, et al. 2014 Update of the EULAR standardised operating procedures for EULAR-endorsed recommendations. Ann Rheum Dis. 2015;74(1):8-13.5.Baillet A, Gossec L, Carmona L, et al. Points to consider for reporting, screening for and preventing selected comorbidities in chronic inflammatory rheumatic diseases in daily practice: a EULAR initiative. Ann Rheum Dis. 2016;75(6):965-73.6.Kirwan JR, Minnock P, Adebajo A, et al. Patient perspective: fatigue as a recommended patient centered outcome measure in rheumatoid arthritis. J Rheumatol. 2007;34(5):1174-7.7.Kirkham JJ, Gorst S, Altman DG, et al. Core Outcome Set-STAndards for Reporting: The COS-STAR Statement. PLoS Med. 2016;13(10):e1002148.8.Ibfelt EH, Jensen DV, Hetland ML. The Danish nationwide clinical register for patients with rheumatoid arthritis: DANBIO. Clin Epidemiol. 2016;8:737-42.9.Nikiphorou E, Radner H, Chatzidionysiou K, Desthieux C, Zabalan C, van Eijk-Hustings Y, et al. Patient global assessment in measuring disease activity in rheumatoid arthritis: a review of the literature. Arthritis Res Ther. 2016;18(1):251.10.Felson DT, Smolen JS, Wells G, Zhang B, van Tuyl LH, Funovits J, et al. American College of Rheumatology/European League against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials. Ann Rheum Dis. 2011;70(3):404-13.11.van der Heijde D, van der Helm-van Mil AH, Aletaha D, Bingham CO, Burmester GR, Dougados M, et al. EULAR definition of erosive disease in light of the 2010 ACR/EULAR rheumatoid arthritis classification criteria. Ann Rheum Dis. 2013;72(4):479-81. ................
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