Qualitative Interviews to Assess the Content Validity and Usability of the Electronic Raynaud Diary in Patients with Systemic Sclerosis

Robyn T. Domsic, Robin Pokrzywinski, Larissa Stassek, Wade W. Benton, Christa Lynn Vampola, Daniel E. Furst, Lorinda Chung, Virginia Steen, Maureen D. Mayes, Ami A. Shah, Jerry A. Molitor, Kelly Oliver, Vivek Nagaraja, Dinesh Khanna

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: To better understand the symptoms and impacts of Raynaud phenomenon (RP) in patients with systemic sclerosis (SSc) and to evaluate the content validity and usability of a new electronic patient-reported outcome (PRO) measure for RP: the Raynaud Diary. Methods: The Raynaud Diary was developed as a daily eDiary for assessing the number and duration of symptomatic Raynaud attacks; worst pain, numbness, tingling, and discomfort in the fingers; and overall disease severity, captured using the Raynaud's Condition Score. The Raynaud Diary was debriefed in two waves of qualitative interviews with adults with self-reported RP secondary to SSc. All interviews included open-ended questions about participants' experiences of RP. Results: Participants (N = 39) had a mean age of 55.1 years, and 87% were female. Frequently reported RP symptoms were color change (reported by all participants), numbness (90%), tingling (82%), pain (77%), and discomfort (72%). Common attack triggers included temperature-related factors and stress. Participants reported being unable to be outside or do outdoor activities and had problems gripping objects. All participants demonstrated understanding of the Raynaud Diary instructions. Most participants indicated that they would be able to use the Raynaud Diary to record the worst severity of individual RP symptoms in the previous 24 hours. Conclusion: Patients with RP secondary to SSc bear a heavy symptom burden. The Raynaud Diary is a content valid PRO measure that captures the most frequent symptoms of RP in patients with SSc.

Original languageEnglish (US)
Pages (from-to)132-141
Number of pages10
JournalACR Open Rheumatology
Volume5
Issue number3
DOIs
StatePublished - Mar 2023

Bibliographical note

Funding Information:
The study was funded by Eicos Sciences, Inc. (Eicos).

Publisher Copyright:
© 2023 Eicos Sciences, Inc. ACR Open Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology.

PubMed: MeSH publication types

  • Journal Article

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