Electronic Diary Valid PRO Measure to Capture Raynaud Phenomenon Symptoms in SSc

An electronic patient-reported outcome (PRO) measure – Raynaud Diary – was found to be useable and valid for assessing symptoms of Raynaud phenomenon in patients with systemic sclerosis (SSc), according to study results published in ACR Open Rheumatology.

Raynaud Diary was developed as a symptom diary with a 24-hour recall period. Completed daily over the course of a week, the diary captured the number and duration of symptomatic Raynaud attacks; patient-reported worst pain, numbness, and tingling in fingers; and overall disease burden, according to the Raynaud’s Condition Score.

The Raynaud Diary was tested in 2 sets of participants: the first set completed the diary on an electronic tablet and the second set used a smartphone application. Before using the diary, all participants underwent structured qualitative interviews to describe their experiences with Raynaud attacks. Symptoms as described during patients’ interviews were compared with those data collected in the diaries.

A total of 39 patients (mean age, 55.1 years; 87% women) were enrolled in the study.

The most common symptoms as described in the interviews were color change (100%), numbness (90%), tingling (82%), pain (77%), and discomfort (72%). The reported frequency of attacks ranged from several per hour to once per day. Most patients (72%) reported experiencing more attacks during winter. Many patients indicated that Raynaud phenomenon affected their ability to spend time outdoors and hold or grip things.

All participants rated the Raynaud Diary as “easy” or “very easy” to use. The majority of participants noted that they would be able to complete the diary daily for an extended period of time. Data collected during the interviews supported the content validity of the diary regarding attack frequency, severity, and symptoms. No major feasibility issues were identified.

While initial results support its usability, further study of the Raynaud Diary in a larger cohort is necessary.

“The next steps in its development will be to measure its psychometric performance using data from phase 2 and phase 3 trials,” the study authors wrote. “Definitive conclusions about possible applications of the Raynaud Diary will depend on the results of this psychometric evaluation.”

Disclosure: This research was supported by Eicos Sciences, Inc. Please see the original reference for a full list of authors’ disclosures.