Real-life parameters in rheumatology
PDF
Cite
Share
Request
Invited Review
P: 73-80
December 2020

Real-life parameters in rheumatology

1. Hacettepe Üniversitesi Tıp Fakültesi, İç Hastalıkları Anabilim Dalı, Romatoloji Bilim Dalı, Ankara, Türkiye
2. Dokuz Eylül Üniversitesi Tıp Fakültesi, İç Hastalıkları Anabilim Dalı, Romatoloji Bilim Dalı, İzmir, Türkiye
No information available.
No information available
Publish Date: 11.12.2020
PDF
Cite
Share
Request

ABSTRACT

Real-world data is derived from many sources associated with outcomes in a heterogeneous patient population in real-world settings, such as patient surveys, clinical trials, and observational cohort studies. Real-world data is increasingly being demanded by researchers, clinicians, the medical industries, and governments. To validate the clinical findings in real life is the best way to test scientific facts. For this reason, real-world data should be collected and analyzed well. In this article, we aimed to clarify the features, advantages, and disadvantages of real world data with examples from all over the world.

References

1Garrison LP Jr, Neumann PJ, Erickson P, Marshall D, Mullins CD. Using real-world data for coverage and payment decisions: the ISPOR Real-World Data Task Force report. Value Health 2007;10:326-35.
2Marciniak TA, Ellerbeck EF, Radford MJ, et al. Improving the quality of care for Medicare patients with acute myocardial infarction: results from the Cooperative Cardiovascular Project. JAMA 1998;279:1351-7.
3Sherman RE, Anderson SA, Dal Pan GJ, et al. Real-World Evidence - What Is It and What Can It Tell Us? N Engl J Med 2016;375:2293-7.
4Webster J, Smith BD. The Case for Real-world Evidence in the Future of Clinical Research on Chronic Myeloid Leukemia. Clin Ther 2019;41:336-49.
5Berger M, Daniel G, Frank K, et al. Duke-Margolis Center for Health Policy. A Framework for Regulatory Use of Real-World Evidence, 2018.
6Kim HS, Lee S, Kim JH. Real-world Evidence versus Randomized Controlled Trial: Clinical Research Based on Electronic Medical Records. J Korean Med Sci 2018;33:213.
7Curtis JR, Foster PJ, Saag KG. Tools and Methods for Real-World Evidence Generation: Pragmatic Trials, Electronic Consent, and Data Linkages. Rheum Dis Clin North Am 2019;45:275-89.
8Askling J, Baecklund E, Granath F, et al. Anti-tumour necrosis factor therapy in rheumatoid arthritis and risk of malignant lymphomas: relative risks and time trends in the Swedish Biologics Register. Ann Rheum Dis 2009;68:648-53.
9Lapadula G, Ferraccioli G, Ferri C, Punzi L, Trotta F, Gisea. GISEA: an Italian biological agents registry in rheumatology. Reumatismo 2011;63:155-64.
10Mariette X, Gottenberg JE, Ravaud P, Combe B. Registries in rheumatoid arthritis and autoimmune diseases: data from the French registries. Rheumatology (Oxford, England) 2011;50:222-9.
11Strangfeld A, Eveslage M, Schneider M, et al. Treatment benefit or survival of the fittest: what drives the time-dependent decrease in serious infection rates under TNF inhibition and what does this imply for the individual patient? Ann Rheum Dis 2011;70:1914-20.
12de la Vega M, da Silveira de Carvalho HM, Ventura Rios L, Goycochea Robles MV, Casado GC. The importance of rheumatology biologic registries in Latin America. Rheumatol Int 2013;33:827-35.
13Ibfelt EH, Jensen DV, Hetland ML. The Danish nationwide clinical register for patients with rheumatoid arthritis: DANBIO. Clin Epidemiol 2016;8:737-42.
14Mercer LK, Galloway JB, Lunt M, et al. Risk of lymphoma in patients exposed to antitumour necrosis factor therapy: results from the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis. Annals of the rheumatic diseases 2017;76:497-503.
15Strand V, Miller P, Williams SA, Saunders K, Grant S, Kremer J. Discontinuation of Biologic Therapy in Rheumatoid Arthritis: Analysis from the Corrona RA Registry. Rheumatol Ther 2017;4:489-502.
16Misra DP, Agarwal V. Real-world evidence in rheumatic diseases: relevance and lessons learnt. Rheumatol Int 2019;39:403-16.
17Almodovar R, Font P, Zarco-Montejo P, et al. Phenotypic differences between familial versus sporadic ankylosing spondylitis: a cross-sectional Spanish registry of spondyloarthropathies (REGISPONSER). Clin Exp Rheumatol 2011;29:822-7.
18Gallinaro AL, Ventura C, Sampaio Barros PD, Goncalves CR. Spondyloarthritis: analysis of a Brazilian series compared with a large Ibero-American registry (RESPONDIA group). Rev Bras Reumatol 2010;50:581-9.
19Rudwaleit M, Haibel H, Baraliakos X, et al. The early disease stage in axial spondylarthritis: results from the German Spondyloarthritis Inception Cohort. Arthritis Rheum 2009;60:717-27.
20van der Linden S, Valkenburg HA, Cats A. Evaluation of diagnostic criteria for ankylosing spondylitis. A proposal for modification of the New York criteria. Arthritis and rheumatism 1984;27:361-8.
21Dougados M, van der Linden S, Juhlin R, et al. The European Spondylarthropathy Study Group preliminary criteria for the classification of spondylarthropathy. Arthritis and rheumatism 1991;34:1218-27.
22Gladman DD, Rahman P, Cook RJ, et al. The Spondyloarthritis Research Consortium of Canada registry for spondyloarthritis. The Journal of rheumatology 2011;38:1343-8.
23Ward MM, Learch TJ, Gensler LS, Davis JC Jr, Reveille JD, Weisman MH. Regional radiographic damage and functional limitations in patients with ankylosing spondylitis: differences in early and late disease. Arthritis care & research 2013;65:257-65.
24Lui NL, Haroon N, Carty A, et al. Effect of pregnancy on ankylosing spondylitis: a case-control study. The Journal of rheumatology 2011;38:2442-4.
25Quinzanos I, Luong PT, Bobba S, et al. Validation of disease activity and functional status questionnaires in spondyloarthritis. Clin Exp Rheumatol 2015;33:146-52.
26Spoorenberg A, van der Heijde D, de Klerk E, et al. Relative value of erythrocyte sedimentation rate and C-reactive protein in assessment of disease activity in ankylosing spondylitis. J Rheumatol 1999;26:980-4.
27Dougados M, d’Agostino MA, Benessiano J, et al. The DESIR cohort: a 10-year follow-up of early inflammatory back pain in France: study design and baseline characteristics of the 708 recruited patients. Joint Bone Spine 2011;78:598-603.
28van den Berg R, de Hooge M, Rudwaleit M, et al. ASAS modification of the Berlin algorithm for diagnosing axial spondyloarthritis: results from the SPondyloArthritis Caught Early (SPACE)-cohort and from the Assessment of SpondyloArthritis international Society (ASAS)-cohort. Annals of the rheumatic diseases 2013;72:1646-53.
29Rudwaleit M, van der Heijde D, Landewe R, et al. The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection. Annals of the rheumatic diseases 2009;68:777-83.
30Kim TJ, Kim TH. Clinical spectrum of ankylosing spondylitis in Korea. Joint Bone Spine 2010;77:235-40.
31Mease PJ, Heijde DV, Karki C, et al. Characterization of Patients With Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis in the US-Based Corrona Registry. Arthritis Care Res 2018;70:1661-70.
32Hetland ML. DANBIO--powerful research database and electronic patient record. Rheumatology (Oxford, England) 2011;50:69-77.
33Kvien TK, Heiberg, Lie E, et al. A Norwegian DMARD register: prescriptions of DMARDs and biological agents to patients with inflammatory rheumatic diseases. Clin Exp Rheumatol 2005;23(5 Suppl 39):188-94.
34Carmona L, Gomez-Reino J, Gonzalez-Gonzalez R. [Spanish registry of adverse events of biological therapies in rheumatic diseases (BIOBADASER): report as of january 14, 2005]. Reumatol Clin 2005;1:95-111.
35Sanchez-Piedra C, Hernandez Miguel MV, Manero J, et al. Objectives and methodology of BIOBADASER phase iii. Reumatologia clinica 2019;15:229-36.
36Simard JF, Arkema EV, Sundstrom A, et al. Ten years with biologics: to whom do data on effectiveness and safety apply? Rheumatology (Oxford) 2011;50:204-13.
37Mann HF, Zavada J, Senolt L, et al. Real world use of secukinumab for treatment of axial spondyloarthritis and psoriatic arthritis: nationwide results from the ATTRA registry. Clin Exp Rheumatol 2019;37:342-3.
38Armagan B, Sari A, Erden A, et al. Starting of biological disease modifying antirheumatic drugs may be postponed in rheumatoid arthritis patients with multimorbidity: Single center real life results. Medicine 2018;97:9930.
39Kalyoncu U, Kiraz S, Bilgen SA, et al. Change in PsAID-12 scores in patients continuing or discontinuing anti-TNF treatments in psoriatic arthritis: results from the HUR-BIO biologic registry. Clin Rheumatol 2019;38:1187-92.
40Güllüoğlu H, Çetin P, Sarı İ, Birlik M, Önen F, Akkoç N. TÜRKBİO veritabanında kayıtlı biyolojik ilaç tedavisi kullanan ankilozan spondilit hastalarının değerlendirilmesi (The analysis of ankylosing spondylitis patients receiving biological therapies: data from TURKBIO registry). RAED 2014;6:13-8.
41Ornbjerg LM, Brahe CH, Askling J, et al. Treatment response and drug retention rates in 24 195 biologic-naive patients with axial spondyloarthritis initiating TNFi treatment: routine care data from 12 registries in the EuroSpA collaboration. Ann Rheum Dis 2019;78:1536-44.
42Kalyoncu U, Tascilar EK, Ertenli AI, et al. Methodology of a new inflammatory arthritis registry: TReasure. Turk J Med Sci 2018;48:856-61.
Article is only available in PDF format. Show PDF
2024 ©️ Galenos Publishing House