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Development and validation of the Scleroderma Clinical Trials Consortium Damage Index (SCTC-DI): a novel instrument to quantify organ damage in systemic sclerosis
  1. Nava Ferdowsi1,2,
  2. Molla Huq1,2,
  3. Wendy Stevens2,
  4. Marie Hudson3,
  5. Mianbo Wang4,
  6. Tien Tay1,2,
  7. Jodie L Burchell1,
  8. Sam Mancuso1,
  9. Candice Rabusa2,
  10. Vijaya Sundararajan5,
  11. David Prior1,
  12. Susanna M Proudman6,
  13. Murray Baron7,
  14. Mandana Nikpour1,2
  15. The Scleroderma Clinical Trials Consortium Damage Index Working Group, The Australian Scleroderma Interest Group, Canadian Scleroderma Research Group
    1. 1 Department of Medicine, University of Melbourne at St. Vincent Hospital, Melbourne, Fitzroy, Victoria, Australia
    2. 2 Rheumatology, St. Vincent Hospital, Melbourne, Fitzroy, Victoria, Australia
    3. 3 Medicine, University of McGill, Montreal, Quebec, Canada
    4. 4 Lady Davis Institute for Medical Research, Montreal, Quebec, Canada
    5. 5 Public Health, LaTrobe University, Melbourne, Victoria, Australia
    6. 6 Rheumatology, Royal Adelaide Hospital, Adelaide, Victoria, Australia
    7. 7 Rheumatology, Jewish General Hospital, Montreal, Quebec, Canada
    1. Correspondence to Dr Mandana Nikpour, Department of Medicine, University of Melbourne, Fitzroy 3065, Victoria, Australia; m.nikpour{at}unimelb.edu.au

    Footnotes

    • MB and MN contributed equally.

    • Handling editor Prof Josef S Smolen

    • Collaborators Scleroderma Clinical Trials Consortium Damage Index (SCTC-DI) Working Group members: Mandana Nikpour (Co-chair), The University of Melbourne at St. Vincent’s Hospital Melbourne, Australia; Murray Baron (Co-Chair), Lady Davis Institute for Medical Research and Jewish General Hospital Montreal, Canada; Nava Ferdowsi, The University of Melbourne at St. Vincent’s Hospital Melbourne, Australia; Tracy Frech, University of Utah, USA; Marie Hudson, Lady Davis Institute for Medical Research and Jewish General Hospital Montreal, Canada; Susanna Proudman, The University of Adelaide at Royal Adelaide Hospital, Australia; Wendy Stevens, St Vincent’s Hospital, Melbourne, Australia; Tien Tay, The University of Melbourne, Australia; Souyma Chatterjee, Cleveland Clinic, Ohio, USA; Lorinda Chung, Stanford University, USA; Jessica K Gordon, Hospital for Special Surgery New York, USA; Anna Haemel, University of California San Francisco, USA; Sindhu R Johnson, University of Toronto, Canada; Dinesh Khanna, University of Michigan, USA; Thomas A Medsger, University of Pittsburgh, USA; Peter Merkel, University of Pennsylvania, USA; John Pauling, Royal National Hospital for Rheumatic Diseases, Bath, UK; Janet E Pope, University of Ontario, Canada; Tatiana Rodriguez-Reyna, National Institute of Medical Sciences, Mexico; Lesley Saketkoo, Louisiana State University, USA; James R Seibold, Scleroderma Research Consultants, USA; Ankoor Shah, Duke University, USA; Virginia Steen, Georgetown University, USA; Gemma Strickland, Barwon Health, Australia. Australian Scleroderma Interest Group (ASIG) members: Catherine Hill, Adelaide, South Australia; Gene-Siew Ngian, Melbourne, Victoria; Mandana Nikpour, Melbourne, Victoria; Susanna Proudman, Adelaide, South Australia; Maureen Rischmueller, Adelaide, South Australia; Janet Roddy, Perth, Western Australia; Joanne Sahhar, Melbourne, Victoria; Wendy Stevens, Melbourne, Victoria; Gemma Strickland, Geelong, Victoria; Jenny Walker, Adelaide, South Australia; Peter Youssef, Sydney, New South Wales. Canadian Scleroderma Research Group (CSRG) members: J. Pope, London, Ontario; M. Baron, Montreal, Quebec; J. Markland, Saskatoon, Saskatchewan (deceased); D. Robinson, Winnipeg, Manitoba; N. Jones, Edmonton, Alberta; N. Khalidi, Hamilton, Ontario; P. Docherty, Moncton, New Brunswick; E. Kaminska, Calgary, Alberta; A. Masetto, Sherbrooke, Quebec; E. Sutton, Halifax, Nova Scotia; J-P. Mathieu, Montreal, Quebec; M. Hudson, Montreal, Quebec; S. Ligier, Montreal, Quebec; T. Grodzicky, Montreal, Quebec; S. LeClercq, Calgary, Alberta; C. Thorne, Newmarket, Ontario; G. Gyger, Montreal, Quebec; D. Smith, Ottawa, Ontario; P.R. Fortin, Quebec, Quebec; M. Larché, Hamilton, Ontario; M. Abu-Hakima, Calgary; TS Rodriguez-Reyna, Mexico City, Mexico; AR Cabral, Mexico City, Mexico; M. Fritzler, Mitogen Advanced Diagnostics Laboratory, Cumming School of Medicine, Calgary, Alberta.

    • Contributors NF: study design, data collection, data analysis, interpretation of results, preparation of manuscript; MoH (biostatistician): data analysis, interpretation of results, preparation of manuscript; WS: study design, data collection, interpretation of results, preparation of manuscript; MaH: study design, data collection, data analysis, interpretation of results, preparation of manuscript; TT: study design, data collection, interpretation of results, preparation of manuscript; JLB: study design, data analysis, interpretation of results, preparation of manuscript; SM: study design, data analysis, interpretation of results, preparation of manuscript; CR: data collection, interpretation of results, preparation of manuscript; VS: study design, data analysis, interpretation of results, preparation of manuscript; DP: study design, interpretation of results, preparation of manuscript; SMP: study design, data collection, interpretation of results, preparation of manuscript; MB: study design, data collection, data analysis, interpretation of results, preparation of manuscript; MN: study design, data collection, data analysis, interpretation of results, preparation of manuscript.

    • Funding The development of the SCTC-DI was supported by SCTC Working Group grants. The Australian Scleroderma Cohort Study is supported by Scleroderma Australia, Arthritis Australia, Actelion Australia, Bayer, CSL Biotherapies, GlaxoSmithKline Australia and Pfizer. A/Prof Nikpour holds an NHMRC Fellowship (APP1126370). The Canadian Scleroderma Research Group (CSRG) is funded by the Canadian Institutes of Health Research (CIHR) (grant #FRN 83518), the Scleroderma Society of Canada and its provincial Chapters, Scleroderma Society of Ontario, Scleroderma Society of Saskatchewan, Sclérodermie Québec, Cure Scleroderma Foundation, INOVA Diagnostics (San Diego, CA), Fooke Laboratorien (Neuss, Germany), Euroimmun (Lubeck, Germany), Mikrogen (Neuried, Germany), Fonds de la rechercheen santé du Québec (FRSQ), the Canadian Arthritis Network (CAN) and the Lady Davis Institute of Medical Research of the Jewish General Hospital, Montreal, QC. The CSRG has also received educational grants from Pfizer and Actelion pharmaceuticals.

    • Competing interests None declared.

    • Patient consent for publication Not required

    • Ethics approval Ethics approval for the survey of international experts was obtained from the Human Research Ethics Committee of St. Vincent’s Hospital Melbourne. Ethics approval for the ASCS was obtained from the Human Research Ethics Committees of each of the participating centres, led by St. Vincent’s Hospital Melbourne. Ethics approval for the CSRG registry was obtained from the Human Research Ethics Committees of each of the participating centres, led by the Jewish General Hospital, Montreal.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement All data that can be made available have been included in online supplementary files.

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    Footnotes

    • MB and MN contributed equally.

    • Handling editor Prof Josef S Smolen

    • Collaborators Scleroderma Clinical Trials Consortium Damage Index (SCTC-DI) Working Group members: Mandana Nikpour (Co-chair), The University of Melbourne at St. Vincent’s Hospital Melbourne, Australia; Murray Baron (Co-Chair), Lady Davis Institute for Medical Research and Jewish General Hospital Montreal, Canada; Nava Ferdowsi, The University of Melbourne at St. Vincent’s Hospital Melbourne, Australia; Tracy Frech, University of Utah, USA; Marie Hudson, Lady Davis Institute for Medical Research and Jewish General Hospital Montreal, Canada; Susanna Proudman, The University of Adelaide at Royal Adelaide Hospital, Australia; Wendy Stevens, St Vincent’s Hospital, Melbourne, Australia; Tien Tay, The University of Melbourne, Australia; Souyma Chatterjee, Cleveland Clinic, Ohio, USA; Lorinda Chung, Stanford University, USA; Jessica K Gordon, Hospital for Special Surgery New York, USA; Anna Haemel, University of California San Francisco, USA; Sindhu R Johnson, University of Toronto, Canada; Dinesh Khanna, University of Michigan, USA; Thomas A Medsger, University of Pittsburgh, USA; Peter Merkel, University of Pennsylvania, USA; John Pauling, Royal National Hospital for Rheumatic Diseases, Bath, UK; Janet E Pope, University of Ontario, Canada; Tatiana Rodriguez-Reyna, National Institute of Medical Sciences, Mexico; Lesley Saketkoo, Louisiana State University, USA; James R Seibold, Scleroderma Research Consultants, USA; Ankoor Shah, Duke University, USA; Virginia Steen, Georgetown University, USA; Gemma Strickland, Barwon Health, Australia. Australian Scleroderma Interest Group (ASIG) members: Catherine Hill, Adelaide, South Australia; Gene-Siew Ngian, Melbourne, Victoria; Mandana Nikpour, Melbourne, Victoria; Susanna Proudman, Adelaide, South Australia; Maureen Rischmueller, Adelaide, South Australia; Janet Roddy, Perth, Western Australia; Joanne Sahhar, Melbourne, Victoria; Wendy Stevens, Melbourne, Victoria; Gemma Strickland, Geelong, Victoria; Jenny Walker, Adelaide, South Australia; Peter Youssef, Sydney, New South Wales. Canadian Scleroderma Research Group (CSRG) members: J. Pope, London, Ontario; M. Baron, Montreal, Quebec; J. Markland, Saskatoon, Saskatchewan (deceased); D. Robinson, Winnipeg, Manitoba; N. Jones, Edmonton, Alberta; N. Khalidi, Hamilton, Ontario; P. Docherty, Moncton, New Brunswick; E. Kaminska, Calgary, Alberta; A. Masetto, Sherbrooke, Quebec; E. Sutton, Halifax, Nova Scotia; J-P. Mathieu, Montreal, Quebec; M. Hudson, Montreal, Quebec; S. Ligier, Montreal, Quebec; T. Grodzicky, Montreal, Quebec; S. LeClercq, Calgary, Alberta; C. Thorne, Newmarket, Ontario; G. Gyger, Montreal, Quebec; D. Smith, Ottawa, Ontario; P.R. Fortin, Quebec, Quebec; M. Larché, Hamilton, Ontario; M. Abu-Hakima, Calgary; TS Rodriguez-Reyna, Mexico City, Mexico; AR Cabral, Mexico City, Mexico; M. Fritzler, Mitogen Advanced Diagnostics Laboratory, Cumming School of Medicine, Calgary, Alberta.

    • Contributors NF: study design, data collection, data analysis, interpretation of results, preparation of manuscript; MoH (biostatistician): data analysis, interpretation of results, preparation of manuscript; WS: study design, data collection, interpretation of results, preparation of manuscript; MaH: study design, data collection, data analysis, interpretation of results, preparation of manuscript; TT: study design, data collection, interpretation of results, preparation of manuscript; JLB: study design, data analysis, interpretation of results, preparation of manuscript; SM: study design, data analysis, interpretation of results, preparation of manuscript; CR: data collection, interpretation of results, preparation of manuscript; VS: study design, data analysis, interpretation of results, preparation of manuscript; DP: study design, interpretation of results, preparation of manuscript; SMP: study design, data collection, interpretation of results, preparation of manuscript; MB: study design, data collection, data analysis, interpretation of results, preparation of manuscript; MN: study design, data collection, data analysis, interpretation of results, preparation of manuscript.

    • Funding The development of the SCTC-DI was supported by SCTC Working Group grants. The Australian Scleroderma Cohort Study is supported by Scleroderma Australia, Arthritis Australia, Actelion Australia, Bayer, CSL Biotherapies, GlaxoSmithKline Australia and Pfizer. A/Prof Nikpour holds an NHMRC Fellowship (APP1126370). The Canadian Scleroderma Research Group (CSRG) is funded by the Canadian Institutes of Health Research (CIHR) (grant #FRN 83518), the Scleroderma Society of Canada and its provincial Chapters, Scleroderma Society of Ontario, Scleroderma Society of Saskatchewan, Sclérodermie Québec, Cure Scleroderma Foundation, INOVA Diagnostics (San Diego, CA), Fooke Laboratorien (Neuss, Germany), Euroimmun (Lubeck, Germany), Mikrogen (Neuried, Germany), Fonds de la rechercheen santé du Québec (FRSQ), the Canadian Arthritis Network (CAN) and the Lady Davis Institute of Medical Research of the Jewish General Hospital, Montreal, QC. The CSRG has also received educational grants from Pfizer and Actelion pharmaceuticals.

    • Competing interests None declared.

    • Patient consent for publication Not required

    • Ethics approval Ethics approval for the survey of international experts was obtained from the Human Research Ethics Committee of St. Vincent’s Hospital Melbourne. Ethics approval for the ASCS was obtained from the Human Research Ethics Committees of each of the participating centres, led by St. Vincent’s Hospital Melbourne. Ethics approval for the CSRG registry was obtained from the Human Research Ethics Committees of each of the participating centres, led by the Jewish General Hospital, Montreal.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement All data that can be made available have been included in online supplementary files.

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