Procedures
RP burden before the start of the trial was assessed based on self-report of the patients, asked by their treating physician at the outpatient clinic. If a patient fulfilled the inclusion criteria and was willing to participate, the study investigators called the patient with additional information. After 1 week, the patient was contacted again to confirm participation by signing informed consent. Included patients received instructions on how to complete the online questionnaires using Castor EDC (electronic data capture) software (Supplementary File, available at Rheumatology online) and how to wear the gloves, i.e. at least 10 h/day during the study period. After signing an informed consent, the first online questionnaire was sent. In this questionnaire patients had to complete general information, the RP burden of the past 2 weeks (prior RCS) and the Scleroderma Health Assessment Questionnaire (SHAQ). During the baseline visit, the number of digital ulcers and pitting scars were recorded and a nailfold capillaroscopy was performed.
During the study, data on RP attacks and the RCS were collected three times per week using automatically generated questionnaires that were sent by e-mail through Castor EDC. During the study, completeness of the online questionnaires was continuously monitored. If a patient missed more than one questionnaire in a row, he/she was called during that same week by the researcher.
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At week 6, patients had to return the gloves of period 1 and were provided with the gloves of period 2. The gloves were wrapped in opaque foil, making it impossible to compare the gloves of both periods with each other. At weeks 6 and 12, the number of digital ulcers and pitting scars were recorded by physical inspection by the researcher, quality of life was measured using the SHAQ and a nailfold capillaroscopy was performed. At the end of the study, all participants were asked to state during which period they thought they had worn the silver fibre gloves.
Due to the coronavirus disease 2019 (COVID-19) pandemic, protocol alterations had to be made: a nailfold capillaroscopy before the study was not repeated if patients had a nailfold capillaroscopy <3 months prior to the start of the study. Moreover, if indicated by the pandemic regulations, the follow-up visits were performed remotely or by video call. As a consequence, gloves of period 1 were sent by post from the patients to the hospital and the gloves of period 2 were sent by post from the hospital to the patients. Follow-up assessments of nailfold capillaroscopy are lacking for the majority of patients. In addition, to check for development of digital ulcers, patients were requested to take photographs of both sides of both hands and send them digitally to the researchers for inspection for the presence of digital ulcers and/or pitting scars.
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