RESUMEN
OBJECTIVES: Although the painful and disabling features of early diffuse cutaneous systemic sclerosis (dcSSc) have an inflammatory basis and could respond to corticosteroids, corticosteroids are a risk factor for scleroderma renal crisis. Whether or not they should be prescribed is therefore highly contentious. Our aim was to examine safety and efficacy of moderate dose prednisolone in early dcSSc. METHODS: PRedSS set out as a Phase II, multicentre, double-blind randomised controlled trial, converted to open-label during the Covid-19 pandemic. Patients were randomised to receive either prednisolone (â¼0.3 mg/kg) or matching placebo (or no treatment during open-label) for 6 months. Co-primary endpoints were the Health Assessment Questionnaire Disability Index (HAQ-DI) and modified Rodnan skin core (mRSS) at 3 months. Over 20 secondary endpoints included patient reported outcome measures reflecting pain, itch, fatigue, anxiety and depression, and helplessness. Target recruitment was 72 patients. RESULTS: Thirty-five patients were randomised (17 prednisolone, 18 placebo/control). The adjusted mean difference between treatment groups at 3 months in HAQ-DI score was -0.10 (97.5% CI -0.29-0.10), p= 0.254, and in mRSS -3.90 (97.5% CI -8.83-1.03), p= 0.070, both favouring prednisolone but not significantly. Patients in the prednisolone group experienced significantly less pain (p= 0.027), anxiety (p= 0.018) and helplessness (p= 0.040) than control patients at 3 months. There were no renal crises, but sample size was small. CONCLUSION: PRedSS was terminated early primarily due to the Covid-19 pandemic, and so was underpowered. Therefore, interpretation must be cautious and results considered inconclusive, indicating the need for a further randomised trial. TRIAL REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov, NCT03708718.
RESUMEN
OBJECTIVE: The aim was to assess the use of telehealthcare in rheumatology before coronavirus disease 2019 (COVID-19), to which future comparisons of newer interventions adapted during the crisis can be made. METHODS: We performed a registered systematic literature search using MEDLINE, EMBASE, CENTRAL and PubMed databases. All full-length articles comparing telehealthcare delivery models with standard care (face-to-face consultation) in the management of patients with rheumatic conditions were assessed for inclusion. RESULTS: A total of 4809 studies were identified; 108 studies were suitable for review by full text, and 13 studies were appropriate to be included in this review. Five studies (38%) included patients with RA, four studies (31%) included patients with mixed disease cohorts, two studies (15%) included patients with OA, one study (8%) included patients with JIA, and one study (8%) included patients with FM. Six studies (46%) used telephone consultation, three studies (23%) used mixed method communication, three studies (23%) used videoconferencing, and one study (8%) used website-delivered telecommunication as their method of telehealthcare delivery. Overall, seven studies (54%) identified the telehealthcare intervention to be an effective method of consultation, and six studies (46%) identified the telehealthcare intervention as non-inferior when compared with standard care. CONCLUSION: Current evidence for telehealthcare in rheumatology is lacking, and the evidence for effectiveness is limited by methodological bias and clinical heterogeneity of telehealthcare interventions, preventing definitive inferences. Scrutinous assessment of the current telehealthcare interventions used during COVID-19 is required to accommodate recommendations and guideline reviews directed from international working groups.