Patient-reported outcome instruments for assessing Raynaud’s phenomenon in systemic sclerosis: A SCTC vascular working group report

John D. Pauling, Tracy M. Frech, Michael Hughes, Jessica K. Gordon, Robyn T. Domsic, Marina E. Anderson, Francesca Ingegnoli, Neil J. McHugh, Sindhu R. Johnson, Marie Hudson, Francesco Boin, Voon H. Ong, Marco Matucci-Cerinic, Nezam Altorok, Marina Scolnik, Mandana Nikpour, Ankoor Shah, Janet E. Pope, Dinesh Khanna, Ariane L. Herrick

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Abstract

The episodic nature of Raynaud’s phenomenon in systemic sclerosis has led to a reliance on patient-reported outcome instruments such as the Raynaud’s Condition Score diary. Little is known about the utilization in routine clinical practice and health professional attitudes toward existing patient-reported outcome instruments for assessing systemic sclerosis- Raynaud’s phenomenon. Members of the Scleroderma Clinical Trials Consortium Vascular Working Group (n = 28) were invited to participate in a survey gauging attitudes toward the Raynaud’s Condition Score diary and the perceived need for novel patient-reported outcome instruments for assessing patient-reported outcome. Nineteen Scleroderma Clinical Trials Consortium Vascular Working Group members (68% response rate) from academic units based in North America (n = 9), Europe (n = 8), South America (n = 1) and Australasia (n = 1) took part in the survey. There was broad consensus that Raynaud’s Condition Score diary returns could be influenced by factors including seasonal variation in weather, efforts made by patients to avoid or ameliorate attacks of Raynaud’s phenomenon, habituation to Raynaud’s phenomenon symptoms, evolution of Raynaud’s phenomenon symptom characteristics with progressive obliterative microangiopathy, patient-coping strategies, respondent burden and placebo effect. There was consensus that limitations of the Raynaud’s Condition Score diary might be a barrier to drug development (79% of respondents agree/strongly agree) and that a novel patient-reported outcome instrument for assessing systemic sclerosis-Raynaud’s phenomenon should be developed with the input of both clinicians and patients (84% agree/strongly agree). Perceived potential limitations of the Raynaud’s Condition Score diary have been identified along with concerns that such factors might impede drug development programs for systemic sclerosis-Raynaud’s phenomenon. There is support within the systemic sclerosis community for the development of a novel patient-reported outcome instrument for assessing systemic sclerosis-Raynaud’s phenomenon.

Original languageEnglish
Pages (from-to)249-252
Number of pages4
JournalJournal of Scleroderma and Related Disorders
Volume3
Issue number3
Early online date24 May 2018
DOIs
Publication statusPublished - 1 Oct 2018

Keywords

  • Patient-reported outcomes
  • Raynaud’s phenomenon
  • Scleroderma
  • Survey
  • Systemic sclerosis

ASJC Scopus subject areas

  • Immunology and Allergy
  • Rheumatology
  • Immunology

Cite this

Pauling, J. D., Frech, T. M., Hughes, M., Gordon, J. K., Domsic, R. T., Anderson, M. E., Ingegnoli, F., McHugh, N. J., Johnson, S. R., Hudson, M., Boin, F., Ong, V. H., Matucci-Cerinic, M., Altorok, N., Scolnik, M., Nikpour, M., Shah, A., Pope, J. E., Khanna, D., & Herrick, A. L. (2018). Patient-reported outcome instruments for assessing Raynaud’s phenomenon in systemic sclerosis: A SCTC vascular working group report. Journal of Scleroderma and Related Disorders, 3(3), 249-252. https://doi.org/10.1177/2397198318774307