Authors (including presenting author) :
So H(1)(2), Chow E(2), Cheng IT(2), LAU S-L(2), LI TK(2), Szeto C-C(2), Tam L-S(2)
Affiliation :
(1) Department of Medicine and Therapeutics, Prince of Wales Hospital, (2) Department of Medicine and Therapeutics, The Chinese University of Hong Kong
Introduction :
Patients with systemic lupus erythematosus (SLE) are at increased risk of severe COVID-19 due to the underlying disease, comorbidities and use of immunosuppressants (IS). During the pandemic, vulnerable patients such as those with lupus nephritis (LN) face the difficult choice between COVID-19 infection risk during a clinic visit and postponing the needed care. An alternative option would be to adopt telemedicine (TM) or telehealth, the use of telecommunication technologies to provide medical information and services, to maintain medical care while minimizing exposure. Indeed, the use of TM has been recommended by international rheumatology societies and after the outbreak.
Despite being widely adopted during this pandemic, the evidence supporting the use of TM in rheumatology has been limited. According to a systematic review in 2017, there is no good evidence in supporting the use of TM for managing rheumatic diseases due to the high risk of bias of the published studies. In a subsequent randomized controlled trial (RCT), it was concluded that a TM follow-up (FU) could achieve similar disease control as conventional care in rheumatoid arthritis patients with low disease activity or remission. Two studies conducted during COVID-19 outbreak reported moderate acceptance of TM as the mode of care in patients with connective tissue diseases. However, there is no data on the outcome of TM FU in patients with LN. We hypothesize that TM is a feasible and safe mode of health-care delivery while maintaining disease control in patients with LN, and thus we conducted a RCT comparing TM and standard in-person FU in these patients.
Objectives :
In this study, we primarily aim to evaluate the effectiveness to maintain disease activity control using TM delivered care compared to conventional in-person outpatient follow-up in SLE via a pragmatic trial. The secondary objective is to compare the patient reported outcomes and safety between the two modes of health care delivery as well as to determine the patient factors associated with the use of TM.
Methodology :
This was a one-year, single-center, open-label RCT conducted at a regional hospital in Hong Kong. From May 2020, consecutive adult patients with a diagnosis of SLE according to the 2019 EULAR/ACR classification criteria followed up at the LN clinic were invited to participate in the study. Patients (or carers) needed to possess the technology for conducting a TM visit (a smartphone, tablet or computer with audio and video capabilities and internet connection). Patients were excluded if they were pregnant or incapable of answering a questionnaire. Participants were randomized 1:1 to either TM (TM group) or standard FU (SF group) using a computer-generated random number sequence. They were asked to fill in an online questionnaire post-consultation regarding their satisfaction of the various aspects of the FU. The responses were assigned a value of 0 to 4 (strongly disagree to strongly agree), with a higher score indicating that the respondent was satisfied with the FU and a 2 indicating a neutral response.
Patients randomized to receive TM FU were scheduled for a video consultation via a real-time video conferencing software ZOOM (Zoom Video Communications Inc, California, US). Patients in the SF group received standard in-person outpatient care. An in-person clinic consultation could be arranged as required by the patients or clinicians. Similarly, a TM consultation could be arranged as required. The frequency of visits was based on clinical judgements, as well as joint decisions of the attending rheumatologists and patients. Prior to each consultation the patients needed to have blood and 24-hr urine total protein checked. SLE disease activity at each consultation was assessed by SLEDAI-2k and physician global assessment (PGA). All FUs were performed by rheumatologists or nephrologists with more than 3 years of experience in managing patients with LN. All patients were asked to complete the LupusPRO, Health Assessment Questionnaire (HAQ), Medical Outcomes Survey Short Form (SF-36) and Hospital Anxiety and Depression Scale (HADS).
Result & Outcome :
A total of 144 patients with LN were randomized (TM: 72, SF: 72) and 3 patients self-withdrew from the study. The mean age of the patients was 44.3±11.4 years and there was a female predominance of 91%. At the end of the study (December 2021), 70 patients in the TM group and 71 patients in the SF completed one-year FU. There were no baseline differences, including age (TM: 44.4±11.6, SF: 44.5±11.3, p=0.98), SLEDAI-2k (TM: 3.8±2.3, SF: 3.2±2.3, p=0.14, PGA (TM: 6.2±6.5, SF: 4.6±5.9, p=0.15) and SLE damage index (TM: 1.1±1.3, SF: 0.8±1.1, p=0.09), between the 2 groups. At the end of the study, the SLE disease activity indices including SLEDAI-2k (TM: 3.3±2.3, SF: 2.8±2.6, p=0.24) and PGA (TM: 4.0±5.0, SF: 3.6±4.6, p=0.64) remained similar between the 2 treatment groups. There were no differences in the SF-36, lupusQoL and HADS scores between the 2 groups except a slightly higher HAQ in the TM group (TM: 0.28±0.49, SF: 0.14±0.31, p=0.04). The overall patient satisfaction score was higher in the TM group (3.4±0.6 vs 3.2±0.8, p=0.03) with a significantly shorter waiting time from entering the clinic waiting room (virtual or real) to seeing a rheumatologist (16.2±22.8 vs 63.0±35.6 minutes, p< 0.01). Although the total number of FU was similar in the 2 groups (TM: 6.0±2.0, SF: 5.7±1.7, p=0.40), significantly more patients in the TM group (28/70, 40% vs 3/71, 4%; p< 0.01) requested change mode of FU. The proportions of patients requiring hospitalization throughout the study period were similar (TM: 22/70, 31% vs 16/71, 23%; p=0.23) in the 2 groups. At the end of one year, none of the patients had COVID-19.
To conclude, TM FU resulted in similar short-term disease control and better patient satisfaction in patients with LN compared to standard care. However, a high proportion of patients cared by TM required in-person visits within one year. The results of the study suggest that TM delivered care could help minimizing exposure to SARS-CoV-2 infection, while maintaining disease activity control, and addressing psychosocial aspects during the pandemic, but it might need to be complemented by in-person visits as required.
