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EULAR Scleroderma Trial and Research group (EUSTAR) recommendations for the treatment of systemic sclerosis: Methods of elaboration and results of systematic literature research
  1. J Avouac (javouac{at}
  1. Service de Rhumatologie, Hôpital Cochin, France
    1. O Kowal-Bielecka (otylia{at}
    1. Medical University of Bialystok, Poland
      1. R BM Landewé (r.landewe{at}
      1. University of Maastricht, Netherlands
        1. S Chwiesko (sychw{at}
        1. Medical University of Bialystok, Poland
          1. I Miniati (irene_miniati{at}
          1. Rheumatology department, UF, Florence, Italy
            1. L Czirják (laszlo.czirjak{at}
            1. University of Pecs, Hungary
              1. P J Clements (pclements{at}
              1. UCLA School of Medicine, United States
                1. C P Denton (c.denton{at}
                1. Royal Free Hospital, United Kingdom
                  1. D Farge (dominique.farge-bancel{at}
                  1. Hopital Saint-Louis, France
                    1. K Fligelstone (info{at}
                    1. FESCA, United Kingdom
                      1. I Foeldvari (foeldvari{at}
                      1. Rheumatology department, Klin Eilbek, Hamburg, Germany
                        1. D E Furst (defurst{at}
                        1. Univ of Cal at Los Angeles, United States
                          1. U Müller-Ladner (u.mueller-ladner{at}
                          1. Justus-Liebig-University Giessen, Germany
                            1. J Seibold (jseibold{at}
                            1. Rheumatology department, UMI, Ann Arbor, United States
                              1. R M Silver (silverr{at}
                              1. Medical University SC, Charleston, United States
                                1. K Takehara (takehara{at}
                                1. Kanazawa University Graduate School of Medical Science, Japan
                                  1. B Garay Toth (gtbea{at}
                                  1. FESCA, Hungary
                                    1. A Tyndall (alan.tyndall{at}
                                    1. Felix Platter Spital, Switzerland
                                      1. G Valentini (gabriele.valentini{at}
                                      1. Second University of Naples, Italy
                                        1. F van den Hoogen (f.vandenhoogen{at}
                                        1. UMC Nijmegen, Netherlands
                                          1. F Wigley (fwigley{at}
                                          1. Rheumatology department, JHU, Baltimore, United States
                                            1. F Zulian (zulian{at}
                                            1. University of Padua, Italy
                                              1. M Matucci-Cerinic (cerinic{at}
                                              1. University of Florence, Italy


                                                Objective: To describe methods and procedures used for the development of the EULAR/EUSTAR recommendations for the treatment of systemic sclerosis. In particular, the results of web-based Delphi exercise aimed at selection of research questions and evidence from systematic literature research, as parts of the development of these recommendations, are presented in detail.

                                                Method: In agreement with the EULAR standard operating procedures the Task Force was created which consisted of the EUSTAR board members, 10 SSc experts invited from outside the EUSTAR board and representing Europe, United States and Japan, a clinical epidemiologist, 2 SSc patients and 3 fellows for literature research. All EUSTAR Centers were invited to contribute to the development of recommendations through submission and preliminary selection of the research questions. The systematic literature research was performed using Pubmed, Medline, EMBASE, and Cochrane databases. Retrieved trials were evaluated according to the Jadad classification, and the level of evidence was graded from 1 to 4. Outcome data for efficacy and adverse events were abstracted, and effect size, NNT and NNH were calculated when appropriate.

                                                Results: 65 EUSTAR Centers provided 304 research questions concerning SSc treatment. These questions were aggregated, were subdivided into 19 treatment categories, and were subjected to preliminary selection by a web-based Delphi technique. The final set of 26 research questions was created by the Expert Committee based on the results of the Delphi exercise and the expert’s experience.

                                                Conclusion: This paper is a comprehensive summary of the methods we used to build recommendations for the drug treatment of systemic sclerosis, combining an evidence based approach and expert opinion.

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