Discussion
low disease activity, RA, RA disease
ADVERSE EVENTS, DISEASE, REMISSION, CHRONIC DISEASES
This randomized clinical trial demonstrated a higher rate of patients with a DAS28-CRP score of 3.2 or less at month 6 in the SSDM group than in the conventional care control group. The observed difference between the 2 groups was supported by the results of sensitivity analyses using the IPCW and per-protocol analysis. Switching to SSDM in the patients randomized into the control group in the initial phase resulted in a comparable rate of patients with a DAS28-CRP of 3.2 or less at the end of the extension period. The rate of patients with a DAS28-CRP of 3.2 or less was also higher in the SSDM group in all subgroup analyses based on age and educational level, suggesting older age and low educational level (as long as the patients were literate) are not significant barriers to using SSDM to manage their disease.The impact of digital applications on electronic PROs (ePROs) has been examined in several previous studies.There are at least 2 factors that may contribute to the effectiveness of the smartphone application in RA disease control. First, a higher number of outpatient visits were observed in the SSDM group. It is likely that using SSDM per se increases patients’ awareness of health, which in turn brings them back to rheumatologists more often. More frequent visits contributing to better disease control was also supported by other chronic diseases (eg, hypertension).To our knowledge, this study was the largest randomized clinical trial to identify the validity of application-based RA management. Smartphone applications, such as SSDM, could be used in daily clinical practice to reduce the management burden of rheumatologists. The inclusion of patients with a DAS28-CRP of 3.2 or less at baseline could increase the generalizability of this study. Although the inclusion may diminish the effect size of this study, these patients represent a large subset of patients in a daily practice setting (approximately 40% of the study population in this trial). As such, the inclusion of these patients is important from a clinical perspective, particularly for measures (such as SSDM in this trial) that are more likely to be used in patients with low disease activity or at remission. The results of our study suggest that the SSDM system has the potential to serve as a supplementary platform for reporting adverse events, confirming the findings of previous research.