Effectiveness and cost-effectiveness of combined asynchronous telemonitoring and patient-initiated care for spondyloarthritis: protocol for a pragmatic multicentre randomised controlled trial (TeleSpA Study).

INTRODUCTION: During the COVID-19 pandemic, an accelerated uptake of remote monitoring strategies, replacing traditional face-to-face care, has been observed. However, data on the effects of remote care interventions for patients with rheumatic and musculoskeletal diseases remain scarce and interpretation is hampered by study heterogeneity and research quality concerns. High-quality evidence is required to guide future implementation in clinical practice, with health economic analyses identified as an important knowledge gap. Randomised controlled trials (RCTs) comparing telemonitoring with conventional care for patients with spondyloarthritis (SpA) are currently lacking. METHODS AND ANALYSIS: TeleSpA is a pragmatic, multicentre RCT investigating the effectiveness and cost-effectiveness of combined asynchronous telemonitoring and patient-initiated follow-up for patients with SpA, compared with conventional care. Two-hundred patients will be recruited at two hospitals and randomised (1:1) to the study intervention or standard care. The primary endpoint is a reduction in the number of follow-up visits by ≥25% in the intervention compared with standard care group, during a 1-year period. Secondary endpoints are (a) non-inferiority of the study intervention with regard to health outcomes, quality of care and patient-reported experience with care; and (b) cost-effectiveness of the intervention, evaluated through a prospective trial-based cost-utility analysis. In addition, experiences with the study intervention will be assessed among patients and healthcare providers, and factors associated with primary and secondary endpoints will be identified. ETHICS AND DISSEMINATION: This study was approved by the Medical Research Ethics Committee of the Academic Hospital Maastricht/Maastricht University (NL71041.068.19/METC 19-059). Results will be disseminated through publications in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: NCT04673825.

Impact of the COVID-19 pandemic on work productivity in patients with spondyloarthritis: results from the Dutch SpA-Net registry.

OBJECTIVE: To investigate whether work productivity in patients with spondyloarthritis (SpA) changed following the onset of the COVID-19 pandemic. METHODS: Data from the Dutch SpA-Net registry were used. Work productivity was assessed with the Work Productivity and Activity Impairment General Health questionnaire. Proportions of patients employed and their overall work impairment (0%-100%) were compared during a 1-year period before ('pre-pandemic') and a 1-year period after the onset ('post-onset') of the pandemic (March 2020). Generalised estimating equation analysis of all assessments since 2016 explored whether overall work impairment (absenteeism and presenteeism) in employed patients changed with pandemic onset, adjusting for confounders. Similar analyses with disease activity as outcome were used to facilitate interpretation of work productivity results. RESULTS: Data were available during pre-pandemic and post-onset years for 204 patients. Pre-pandemic, 128 (62%) patients were employed. Post-onset, 7 (3.4%) had lost employment, while another 7 (3.4%) originally unemployed gained employment. Overall work impairment was worse following pandemic onset (37.0%) compared with pre-pandemic (27.0%) (p<0.01). Post-onset increase in overall work impairment was mainly observed in patients with lower education (B=9.57, 95% CI 5.63 to 13.51) and largely attributable to absenteeism (B=11.15, 95% CI 7.44 to 14.86). In patients with high education, no such increase was seen. Disease activity did not change with pandemic onset. CONCLUSIONS: Work productivity worsened in patients with SpA after pandemic onset, especially in patients with lower education, while employment losses were limited and disease activity remained stable. Work support should be considered during the COVID-19 pandemic and thereafter for those vulnerable to adverse work outcome.

Consideration of health literacy in patient information: a mixed-methods study of COVID-19 crisis communication in Dutch rheumatology.

BACKGROUND: The rapid spread of COVID-19 required swift action to provide people with rheumatic and musculoskeletal diseases (RMDs) with reliable information. People with limited health literacy constitute a vulnerable group that might have difficulty accessing, understanding and applying health information, particularly in times of crisis. OBJECTIVES: This study explored (a) key aspects of crisis communication and (b) explicit consideration of people's health literacy needs in communication to people with RMDs during the first wave of COVID-19 in the Netherlands. METHODS: We conducted a convergent, qualitatively driven mixed-methods study comprising seven qualitative interviews with professional representatives of organisations responsible for information provision to people with RMDs, and quantitative analysis of 15 patient information materials distributed by these organisations. The study was guided by principles of crisis communication and health literacy. We assessed understandability and actionability of information materials using the Dutch version of the Patient Education Materials Assessment Tool (PEMAT, resulting in a percentage of quality criteria met), and language difficulty level using an online application (assessing difficult words, jargon, passive, complex and long sentences, long paragraphs, and difficulty levels according to the Common European Framework of Reference for Languages (CEFR, from A1 (basic) to C2 (proficient))). RESULTS: Respondents reported lack of preparedness, challenges related to scientific uncertainty and reaching the target group, difficulty simplifying information, and uncertainty regarding adequacy of the communication approach. Patient information materials (written and video) showed variation in actionability (range 60-100%) and understandability (range 58-100%), and 69% of written materials were too difficult, mostly due to the use of long sentences and difficult words. The quantitative findings were in coherence with the limitations in communication reported by respondents. Several potential improvements were formulated in 'lessons learned'. CONCLUSIONS: Although rheumatology organisations mostly adhered to principles of crisis communication and made efforts to adapt information to their audience's needs, we propose recommendations to improve preparedness, strategy, content, reach and consideration of health literacy needs in future crisis communication.

Influence of COVID-19 pandemic on decisions for the management of people with inflammatory rheumatic and musculoskeletal diseases: a survey among EULAR countries.

OBJECTIVES: To investigate how the first wave of COVID-19 pandemic influenced decisions of rheumatologists and health professionals in rheumatology regarding the management of patients with inflammatory rheumatic and musculoskeletal diseases (RMDs). METHODS: An English-language questionnaire was developed by a EULAR working group and distributed via national rheumatology societies of EULAR countries, EMEUNET and individual working group members. Responses were collected using an online survey tool. Descriptive statistics were calculated. RESULTS: We analysed 1286 responses from 35/45 EULAR countries. Due to containment measures, 82% of respondents indicated cancellation/postponement of face-to-face visits of new patients (84% of them offering remote consultation) and 91% of follow-up visits (96% with remote consultation). The majority of respondents (58%) perceived that the interval between symptom onset and first rheumatological consultations was longer during containment restrictions than before. Treatment decisions were frequently postponed (34%), and the majority (74%) of respondents stated that it was less likely to start a biological disease modifying anti-rheumatic drug (DMARD)/targeted synthetic DMARD during the pandemic, mainly because of patients' fear, limited availability of screening procedures and decreased availability of rheumatological services. Use of (hydroxy)chloroquine (HCQ) and tocilizumab (TCZ) for the COVID-19 indication was reported by 47% and 42% of respondents, respectively, leading to a shortage of these drugs for RMDs indications according to 49% and 14% of respondents, respectively. CONCLUSION: Measures related to containment of COVID-19 pandemic led to a perceived delay between symptom onset and a first rheumatological visit, postponement of treatment decisions, and shortage of HCQ and TCZ, thereby negatively impacting early treatment and treat-to-target strategies.