Abstract
Objective
To evaluate the feasibility, usability and acceptability of implementing a treat-to-target (T2T) strategy supported by a Clinical Decision Support System (CDSS), in routine SLE outpatient care.
Methods
A 24-week, non-randomised, multicentre, clustered pilot study was conducted across four rheumatology outpatient centres. Adult patients with SLE were allocated by centre to either a T2T strategy supported by a CDSS (T2T-CDSS) or a routine outpatient care (ROC) group. The CDSS provided evidence-based treatment recommendations based on disease activity measures. Feasibility outcomes included recruitment and retention rates. Usability was assessed with the System Usability Scale (SUS), completed by physicians in the T2T-CDSS group. Acceptability was evaluated using the Treatment Satisfaction Questionnaire (TSQ) and qualitative feedback. Exploratory outcomes included disease activity, remission rates and treatment modifications.
Results
Of 91 screened patients, 38 were enrolled (recruitment rate 42%) and 35 completed the study (retention rate 92%). The SUS score for the CDSS was 73.8, indicating good usability. Global satisfaction scores on the TSQ were stable over time and comparable between groups. Remission was achieved at least once by 61% (11/18) of patients in the T2T-CDSS group and 59% (10/17) in the ROC group. Both treatment intensifications and de-escalations occurred more frequently in the T2T-CDSS group compared with ROC (83% vs 47%). Treatment intensifications were observed in 61% of patients in the T2T-CDSS group vs 29% in the ROC group. Treatment de-escalation, represented by glucocorticoid tapering, occurred in 39% of T2T-CDSS patients compared with 18% in ROC. No statistically significant differences were observed between groups in disease activity outcomes or remission rates.
Conclusions
Implementation of a T2T strategy supported by a CDSS in SLE outpatient care was feasible, usable and acceptable to patients and physicians. Although qualitative feedback revealed important implementation barriers that should be addressed in future trials, the intervention facilitated proactive, target-driven treatment adjustments without compromising patient satisfaction and shows promise for implementing goal-directed therapy in SLE management.
Keywords: Lupus Erythematosus, Systemic; Health-Related Quality Of Life; Outcome Assessment, Health Care; Therapeutics
WHAT IS ALREADY KNOWN ON THIS TOPIC
Treat-to-target (T2T) strategies in SLE are recommended by international task forces but remain unexplored in clinical practice due to barriers such as disease complexity, time constraints and lack of standardised decision-making algorithms.
WHAT THIS STUDY ADDS
This study demonstrates that implementing a T2T strategy supported by a Clinical Decision Support System (CDSS) is feasible and acceptable by physicians in routine SLE outpatient care. The CDSS was associated with high usability and increased rates of target-aligned treatment adjustments.
HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY
The findings provide a foundation for a definitive randomised controlled trial to assess the clinical impact of a T2T-CDSS approach in SLE, while also highlighting key implementation barriers identified by both physicians and patients that must be addressed for broader adoption.
Introduction
The treat-to-target (T2T) approach has emerged as an evidence-based therapeutic paradigm that has transformed the management and outcomes of several chronic diseases, including rheumatoid arthritis (RA), hypertension and type 2 diabetes.1,3 T2T is based on the principle of defining specific, measurable treatment targets and the systematic adjustment of therapy to achieve and maintain these predefined goals within a structured timeframe. In the context of SLE, T2T aims to achieve remission or at least a low lupus disease activity state (LLDAS), as defined by international task force recommendations, as valid treatment targets.4 Attainment of these states has been consistently associated with improved survival, reduced organ damage accrual, fewer disease flares and improved health-related quality of life.5,8 The recent European Alliance of Associations for Rheumatology (EULAR) 2023 recommendations emphasise the need for early and sustained remission or LLDAS as treatment goals, reinforcing the importance of structured and goal-oriented disease management.9
Despite strong theoretical support, the implementation of T2T strategies in routine SLE care remains limited.10 This is in part due to the complexity of SLE, characterised by heterogeneous disease manifestations, unpredictable flares and varying responses to therapy, which makes the consistent application of T2T strategies challenging.10 11 Current therapeutic options for SLE, although expanded in recent years, still pose limitations in achieving and sustaining disease control for many patients.11 Additionally, barriers such as physician uncertainty regarding target definitions, lack of standardised treatment decision-making algorithms, time constraints and limited access to objective disease activity measures hinder widespread adoption.12 Clinical Decision Support Systems (CDSSs) have shown promise in addressing these needs and have been developed in various medical fields to facilitate guideline-based care by integrating patient-specific data and providing therapeutic recommendations.13 In other rheumatic diseases, such as RA, CDSS tools have been shown to support physicians in sorting through treatment strategies and patients’ needs, improving disease outcomes and facilitating shared decision-making.14 However, data on the real-world implementation of a T2T strategy in SLE care, and moreover, supported by a CDSS, are still lacking.
The T2T-SLE pilot study was designed to provide a first establishment and evaluation of a T2T approach implemented in clinical practice through a CDSS digital e-Health tool, providing physicians with a road map for clinical decision-making. By addressing key implementation readouts, we sought to provide foundational insights for future large-scale trials and contribute to the development of scalable strategies for routine T2T implementation in SLE.
Methods
Study design
This was a 24-week, non-randomised, cluster-based, multicentre pilot study designed to evaluate the feasibility, usability and acceptability of a T2T strategy supported by a CDSS in the routine management of SLE. The trial was conducted across four outpatient rheumatology centres in the Netherlands, comprising outpatient clinics of two locations of one university medical centre (UMC) and two regional outpatient clinics, between March 2023 and October 2024. The T2T intervention and routine outpatient care (ROC) were assigned by cluster, with each centre constituting a cluster to avoid contamination between arms. Two centres (one UMC and one regional centre) were allocated to the T2T-CDSS intervention group, and two centres (one UMC and one regional centre) to the ROC control group.
Participants
Eligible participants were ≥18 years old, had a diagnosis of SLE fulfilling the 1997 American College of Rheumatology (ACR) or 2019 EULAR/ACR classification criteria15 16 and able to provide informed consent. Patients with life-threatening SLE manifestations requiring intensive care, pregnancy or current breastfeeding were excluded due to ethical and safety considerations, as well as the absence of pregnancy-specific recommendations in the CDSS algorithms. Participants were recruited from the outpatient clinics of Amsterdam UMC (locations AMC and VUmc), Reade (Amsterdam) and Flevoziekenhuis (Almere). Potential participants were identified through physician referral at ROC visits and were provided with detailed study information by the research staff. Clinicians were encouraged to refer patients with a range of disease activity levels to reflect real-world heterogeneity, though no formal stratification procedure was applied. A target sample size of 40 patients was chosen in accordance with guidelines for pilot trials,17 allowing for dropouts while ensuring sufficient feasibility evaluation, and informing power calculations for a future definitive trial.
Participating physicians
The CDSS was implemented by two board-certified rheumatologists with clinical expertise in SLE, each based at one of the two intervention sites. Only physicians were eligible to use the CDSS, and no non-physician providers (eg, nurse specialists or physician assistants) were invited to participate. In the ROC group, patient care was provided by three rheumatologists at two separate clinical sites. All participating physicians had no prior experience with the CDSS platform before the start of the study. Each received standardised training consisting of a 1-hour onboarding session, a digital user manual and access to the tool environment to practice CDSS use prior to patient enrolment.
Interventions
T2T-CDSS group
Patients in the T2T group were managed with the support of a custom-built, web-based CDSS developed specifically for this pilot study (https://www.sle-t2t.nl) and in compliance with data privacy regulations. A detailed description of the CDSS development process, including the rule-based architecture, input parameters, decision logic and usability testing, is available in our prior publication.18 In summary, the tool integrated patient-specific clinical and laboratory data, including the SLE Disease Activity Index 2K (SLEDAI-2K),19 Physician Global Assessment (PGA),20 relevant laboratory measures (ie, complement levels, anti-dsDNA antibodies) and prior treatment history. Based on these inputs, the CDSS automatically calculated disease activity status and generated evidence-based treatment recommendations in alignment with the 2023 EULAR guidelines9 and the T2T International Task Force framework.4 Targets were predefined as either: (a) Remission (per 2021 DORIS criteria)21: clinical SLEDAI-2K=0, PGA<0.5 and stable treatment (hydroxychloroquine and/or prednisone ≤5 mg/day allowed) and (b) LLDAS5: SLEDAI-2K≤4 with no major organ involvement, PGA≤1, prednisone dose ≤7.5 mg/day and stable immunosuppressives. The CDSS provided visual dashboards for physicians to facilitate shared decision-making with patients, allowing treatment goals to be codefined. Physicians retained full discretion over whether to accept or reject CDSS-generated recommendations, given the nature of the pilot study. Patients in this group had structured clinical assessments at baseline and week 24. Patients in the T2T-CDSS group had an additional mid-study visit at week 12, consistent with T2T principles emphasising tighter disease control through more frequent monitoring and timely treatment adjustments. Additional visits could be scheduled based on clinical need and physicians were encouraged to adjust therapy in response to CDSS recommendations at each visit if the predefined targets were not met. Although the CDSS dashboard was accessible outside scheduled visits, it was primarily used during structured clinical encounters and not routinely accessed between visits in this pilot study.
ROC group
Patients in the ROC group received standard care without CDSS support. Treatment decisions were based on the physician’s clinical judgement in accordance with routine practice. Study visits for this group occurred at baseline and week 24, with data collected for comparison purposes. Patients in the ROC group were scheduled for two visits over 24 weeks, reflecting standard outpatient care in the Netherlands.
Outcomes
The main study parameters are represented by a mixed-methods approach, adopted to establish: (a) Feasibility, assessed by recruitment rate, retention rate, time to first patient inclusion (FPI) and study completion rate. (b) Usability of the CDSS, measured using the System Usability Scale (SUS).22 (c) Acceptability of the T2T strategy from both the physician’s, through qualitative assessment of barriers and facilitators to T2T-CDSS implementation and the patient’s perspective, assessed using the Treatment Satisfaction Questionnaire (TSQ),23 adjusted for our study, focusing on effectiveness, convenience and global satisfaction and assessed preintervention and postintervention. Secondary outcomes included exploratory assessments of changes in disease activity (SLEDAI-2K, PGA), rates of achieving remission and record of treatment modifications; although the pilot study was not powered to detect clinically significant changes in clinical outcome measures, but to evaluate whether the testing components that would be used in a larger evaluation are feasible.
Data collection
Demographic, clinical and laboratory data were collected at baseline and follow-up visits (week 12 and week 24 for the T2T-CDSS group; baseline and week 24 for the ROC group). These included disease activity measures, SLEDAI-2K, clinical SLEDAI-2K (cSLEDAI-2K) and PGA; along with treatment modifications, patient-reported outcomes (Patient Global Assessment, FACIT-Fatigue, SF-36) and patient satisfaction (TSQ). Race and ethnicity data were collected through patient self-report at baseline. Usability of the CDSS was evaluated by physicians at study completion using the SUS. Although physicians in the T2T-CDSS group were encouraged to consider and follow CDSS recommendations, adherence to these recommendations and reasons for any deviations were not systematically recorded or analysed in this pilot study. All treatment decisions and adjustments were made during scheduled in-person study visits; no modifications were initiated between visits or through remote communication.
Statistical analysis
Descriptive statistics were used to summarise participant characteristics, feasibility outcomes and implementation measures. Continuous variables were summarised as means with SD if normally distributed, or medians with IQRs for skewed distributions. Categorical variables were presented as counts and percentages. Between-group comparisons to assess differences in TSQ scores between T2T-CDSS and ROC groups at week 24; and for SLEDAI-2K and cSLEDAI-2K comparisons at week 24 were performed using Mann-Whitney U test. Within-group comparisons were assessed using Wilcoxon signed-rank test for changes over time in TSQ, SLEDAI-2K and cSLEDAI-2K within each group (baseline vs week 24). Fisher’s exact test was applied to compare proportion of patients achieving remission (T2T-CDSS vs ROC), and the proportion of patients with any treatment modification. A p<0.05 was considered statistically significant, though the pilot study was not powered for definitive hypothesis testing. Qualitative data from physician interviews and patient feedback were analysed manually using thematic content analysis and structured coding framework to identify recurring themes related to CDSS usability and T2T acceptability. Statistical analyses on quantitative data were performed using SPSS Statistics V.28.0 (IBM).
Results
Study population and recruitment
A total of 91 participants were screened for eligibility across the four participating centres, of whom, 38 patients were enrolled (42% recruitment rate). The most common reasons for declining participation were unspecified reasons (25%), lack of interest (23%) and scheduling conflicts due to life events (4%). Among those who declined to participate and selected ‘unspecified reasons’, the most frequently reported concerns fell into three categories: (1) time and convenience-related reasons (eg, difficulty taking time off work, burden of extra visits or questionnaires); (2) privacy concerns (eg, discomfort with sharing personal data) and (3) logistical issues (eg, long travel distances, family responsibilities or cost-related barriers). Participants were then allocated to either the T2T (T2T-CDSS) intervention group (n=19) or the ROC group (n=19) (figure 1). Three patients (7.9%) were lost to follow-up after enrolment: one in the T2T group and two in the ROC group. In the T2T-CDSS group, one patient was unable to attend the scheduled follow-up appointment and requested to postpone it for an extended period beyond the study timeline. In the ROC group, two patients did not have new follow-up appointments scheduled due to administrative issues at the clinical site. No participants withdrew due to adverse events or concerns related to the intervention. A total of 35 participants (92.1% retention rate) completed the 24-week follow-up period. Baseline characteristics were comparable between the T2T-CDSS and ROC groups (table 1), with no significant differences in demographics, comorbidities or prior treatment history. Patients in regional outpatient clinics were more likely to have milder disease activity compared with those included in the UMC.
Figure 1. Flow diagram of patients eligible, recruited, numbers followed-up and included in analysis. CDSS, Clinical Decision Support System; ROC, routine outpatient care; T2T, treat-to-target.
Table 1. Baseline characteristics of patients from the T2T and the ROC groups.
| T2T-CDSS (n=18) |
ROC (n=17) |
|
|---|---|---|
| Age, mean (SD) | 40.2 (11.9) | 46.8 (8.7) |
| Female gender, n (%) | 16 (88.8) | 16 (94) |
| White (%)* | 14 (77.7) | 14 (82.3) |
| Disease activity measures | ||
| SLEDAI-2K, median (IQR) | 2 (1–8) | 2 (0–5) |
| cSLEDAI-2K, median (IQR) | 1 (0–2) | 0 (0–4) |
| PGA (0–3), median (IQR) | 0.65 (0.3–1.4) | 0.4 (0.3–0.6) |
| SLICC/ACR damage index, median (IQR) | 1 (0–2) | 1 (0–4) |
| Treatment variables | ||
| Glucocorticoids, n (%) | 9 (50) | 11 (64.7) |
| Antimalarials, n (%) | 17 (94.4) | 17 (100) |
| Immunosuppressants, n (%) | 10 (55.5) | 8 (47) |
| Biologics, n (%) | 2 (11) | 0 (0) |
| PROMs | ||
| PaGA (0–10), median (IQR) | 3 (1–7) | 4.5 (2–7) |
| FACIT score, median (IQR) | 26 (17–42) | 33 (31–47) |
| SF-36 | ||
| PCS, mean (SD) | 41.2 (12.7) | 44.5 (11.1) |
| MCS, mean (SD) | 50.3 (10.8) | 48.1 (12.3) |
Race/ethnicity was patient-reported.
cSLEDAI-2K, clinical SLEDAI-2K; FACIT, Functional Assessment of Chronic Illness Therapy–Fatigue Scale; MCS, mental component score; PaGA, Patient Global Assessment; PCS, physical component score; PGA, Physician Global Assessment; PROMs, patient-reported outcome measures; ROC, routine outpatient care; SF-36, Short Form 36 Health Survey Questionnaire; SLEDAI-2K, SLE Disease Activity Index 2000; SLICC/ACR, Systemic Lupus International Collaborating Clinics/American College of Rheumatology.
Feasibility and implementation outcomes
The median time to FPI was 4.19 months. This delay was mainly due to logistical challenges at the site level, including the coordination of staff availability, aligning clinical and research activities and integrating the study procedures into ROC workflows. Furthermore, some patients expressed reluctance to participate due to concerns about increased time commitment, scepticism towards digital health interventions, or a lack of perceived personal benefit from engaging in a pilot study (figure 1). These factors collectively contributed to slower-than-anticipated recruitment. Study completion rates were high across both groups (90% retention in the ROC group, 95% in the T2T group), indicating strong participant adherence despite differences in follow-up intensity. No serious adverse events related to study participation were reported.
Usability of the CDSS
The SUS was completed by physicians who implemented the T2T intervention. The mean SUS score was 72.3 (SD 9.8), indicating good usability (online supplemental table 1). The mean time required to use the CDSS during clinical visits—including data entry, target selection and review of treatment recommendations—was 6.0 min (SD=1.8) per visit. Qualitative feedback suggested that while the CDSS was generally easy to use, its integration with electronic health records was limited, and time constraints during clinic visits were perceived as barriers to optimal use. Suggested improvements included enhanced automation of treatment recommendations, integration of real-time guideline updates and a refined user interface.
Acceptability of the T2T Approach
Patient-reported satisfaction with the T2T strategy remained stable over the 24 weeks period, with no statistically significant differences in global satisfaction scores between baseline and follow-up assessments (online supplemental figure 1). Effectiveness, convenience and global satisfaction subscale scores were comparable between T2T and ROC groups at week 24, although global satisfaction scores were slightly higher in the T2T group over time, the observed change did not exceed commonly accepted thresholds for a minimum clinically important difference (online supplemental figure 2). In the qualitative assessment, some patients expressed concerns regarding the perceived burden of more frequent clinical visits, highlighting challenges related to balancing healthcare with personal responsibilities. Despite this, patients valued structured goal-setting discussions, emphasising the importance of shared decision-making in SLE management. An overview of the identified barriers and facilitators, including representative quotes and the number of patients expressing similar sentiments, is presented in the online supplemental table 2.
Changes in disease activity and treatment modifications
As part of the secondary exploratory outcomes, changes in disease activity and the attainment of remission were assessed to explore potential clinical effects of implementing a T2T strategy.
At week 24, no significant differences were observed in mean disease activity scores (SLEDAI-2K, cSLEDAI-2K) between the T2T and ROC groups (mean 3.13 vs mean 1.75, respectively, p=0.097) (figure 2). Remission, as defined by the DORIS 2021 criteria, was achieved at least once during the study by 61% (11/18) of patients in the T2T-CDSS group (figure 3a), compared with 58.8% (10/17) in the ROC group (figure 4a). In the T2T-CDSS group, six patients who achieved remission were able to sustain this state over consecutive visits, whereas in the ROC group, seven patients maintained remission through the 24 weeks of follow-up (figure 3a and figure 4b).
Figure 2. Changes in disease activity measured by SLEDAI-2K and cSLEDAI-2K. cSLEDAI-2K, clinical SLEDAI-2K; ROC, routine outpatient care; SLEDAI-2K, SLE Disease Activity Index 2000; T2T, treat-to-target.
Figure 3. Achievement of remission and treatment modifications in the T2T-CDSS group. (a) The proportion of patients who achieve remission at least once during the follow-up. (b) Individual patients (n=18) and the treatment categories in which they experienced at least one modification over the 24-week follow-up. Cells in blue indicate patients in remission at that time point. The four categories of treatment changes include glucocorticoid (GC) tapering, GC increase, immunosuppressive therapy (IST) modification and biologic addition. CDSS, Clinical Decision Support System; T2T, treat-to-target.
Figure 4. Achievement of remission and treatment modifications in the ROC group. (a) The proportion of patients who achieve remission at least once during the follow-up. (b) Individual patients (n=17) and the treatment categories in which they experienced at least one modification over the 24-week follow-up. Cells in blue indicate patients in remission at that timepoint. The four categories of treatment changes include glucocorticoid (GC) tapering, GC increase, immunosuppressive therapy (IST) modification and biologic addition. ROC, routine outpatient care.
Treatment modifications, an important element of the T2T strategy, were more frequent and aligned with disease activity assessments and target attainment. In the T2T-CDSS group, a total of 83% (15/18) of patients underwent at least one treatment adjustment over the course of the study (figure 3b), in comparison to 47% (8/17) in the ROC group (figure 4b). In the T2T-CDSS group, most patients 80% (12/15) had modifications in a single treatment category, and 20% (3/15) patients required adjustments in two distinct treatment categories. In contrast, among ROC patients, all patients experienced changes in only one category. Notably, no patients in either group underwent treatment adjustments across three or more categories, and biological therapies were initiated exclusively in the T2T-CDSS group. Treatment modifications per category in the T2T-CDSS group included glucocorticoid (GC) tapering in 39% of cases (7/18), increase in GC dosage 22% (4/18), modification of immunosuppressive therapy in 22% (4/18) and initiation of biological agents in 17% (3/18). In those patients where no change in treatment was recorded, it was due to the criteria of the physician and the state of disease activity that did not allow for it. In contrast, treatment modifications in the ROC group were less frequent, with fewer instances of GC tapering in 18% (3/17) of patients, escalation of GCs dosage in 18% (3/17), and modifications in immunosuppressive therapy in 12% (2/17) (figure 3b and figure 4b).
Discussion
This pilot study explored the feasibility, usability and acceptability of implementing a T2T strategy in SLE clinical practice, supported by a novel CDSS. Our findings suggest that the T2T approach is feasible to implement in routine outpatient settings supported by a CDSS, acceptable to patients and physicians, and associated with good usability from the physician’s perspective, offering potential as a scalable tool to support T2T implementation in clinical practice.
In terms of study protocol implementation, several challenges were faced. The recruitment rate was 42%, with the most common reasons for non-participation being lack of interest and scheduling conflicts. Although this rate appears modest, it aligns with findings from similar non-pharmacological intervention studies in chronic diseases. Recruitment rates of 32% and 36% have been reported in two pilot studies evaluating a self-monitoring smartphone app for RA, with declining patient engagement in participation over time.24 Additionally, in a randomised controlled trial testing patient care supported by smartphone self-monitoring in RA, 103 out of an eligible population of 458 patients consented to participate (recruitment rate ~22%).25 Recruitment rates in digital health research often vary between 30% and 50% and are affected by factors such as patient burden, intervention complexity and disease context.26 In this sense, our recruitment rate falls within an expected range. Furthermore, our high retention rate (92%) and adherence to study procedures support the feasibility of the T2T-CDSS approach once patients are enrolled.
Despite long-standing recommendations advocating T2T in SLE, real-world uptake has been limited, largely due to the disease’s complexity and the lack of pragmatic implementation frameworks. This study tried to address these barriers by operationalising T2T via a CDSS, enabling physicians to set measurable treatment targets and adjust therapy in alignment with international guidelines. The high retention rates and patient adherence observed reinforce the earlier observation that patients with SLE are willing to engage with structured, goal-directed care when implemented thoughtfully and with opportunities for shared decision-making.27 While static decision trees may offer a low-cost alternative, their practicality is limited in complex conditions like SLE; the CDSS adds value by dynamically integrating multiple data sources and simplifying decision-making in real time.28 Importantly, both rheumatologists who used the CDSS completed the study and reported good usability scores following standardised training. This is consistent with literature on other chronic diseases, which reported CDSS tools improved practitioner performance, guideline adherence and treatment intensification.28 29 While this provides initial support for the tool’s acceptability, the limited integration of the tool with existing electronic health records, the highlighted key operational challenges and the small number of users remain a limitation for generalisability. These technical and workflow-related barriers are not unique to this study but reflect broader issues in the digital health landscape that will need to be addressed to facilitate widespread adoption.30 Notably, the mean time required to complete CDSS use during consultations was 6 min, which was considered feasible by clinicians and did not interfere with the standard flow of outpatient visits. This supports the potential scalability of the tool in routine practice.
From the patient’s perspective, the T2T strategy supported by the CDSS was well accepted. Treatment satisfaction remained stable over 24 weeks. In the qualitative analysis, patients highlighted positive aspects of the intervention, particularly valuing the structured discussions regarding treatment goals and shared decision-making. This feedback aligns with previous evidence showing that patient engagement and clarity in treatment objectives are key facilitators for the successful implementation of T2T strategies.27 A commonly cited concern in implementing T2T strategies in rheumatology is the potential burden of regular monitoring and frequent clinical visits, especially for patients in remission who may not perceive the need for close follow-up.31 Although we did not directly assess patient perceptions of visit frequency or burden in this study, the stable global satisfaction scores observed in the T2T-CDSS group suggest that patients did not experience a significant negative impact during the study period. However, we recognise that treatment satisfaction scores alone may not fully capture potential concerns about visit frequency.
Although changes in disease activity and remission rates were explored, this pilot study was not designed or powered to evaluate clinical efficacy. Nevertheless, the observed frequency of treatment adjustments in the T2T-CDSS group suggests the strategy promoted a more proactive, target-driven approach to disease management compared with routine care. Whether this translates to improved long-term outcomes remains an open question for future trials. It is important to emphasise that the CDSS in this study served as an advisory tool, designed to support but not replace clinical judgement. The recommendations generated by the system were intentionally general and suggestive, providing evidence-based guidance while allowing flexibility for physicians to tailor treatment decisions to individual patient contexts. While the greater number of scheduled visits in the T2T group may have contributed to the increased frequency of treatment changes, this aligns with the core principle of the T2T strategy, which encourages tighter monitoring and more proactive clinical adjustments—a pattern that, to our knowledge, has not been systematically evaluated in SLE before. The treatment modifications observed in the T2T-CDSS group reflect the system’s structured recommendations, supporting physicians in making timely adjustments aimed at achieving or maintaining the predefined treatment target, or improving patient quality of life when the target was already attained. Despite higher treatment intensification rates in the T2T-CDSS group, remission rates at week 24 were similar between groups. This may be due to the relatively short follow-up period, which may not be sufficient to observe clinical benefits. Furthermore, low baseline disease activity likely limited the potential for significant improvement. Treatment adjustments may also take time to show an effect. This approach acknowledges the complex nature of SLE management, where disease heterogeneity and patient-specific factors often necessitate personalised clinical decision-making beyond algorithmic outputs.
This study has several strengths. It represents one of the first real-world evaluations of a T2T strategy in SLE facilitated by a purpose-built CDSS, conducted in both tertiary and regional outpatient settings, enhancing generalisability. The high retention rates and positive usability feedback suggest that the intervention is both acceptable and sustainable in clinical practice. Several limitations must be acknowledged. Although the final enrolment reached 38 of the 40 planned participants, this outcome itself served as a feasibility readout and demonstrated strong recruitment potential for a pilot study. Importantly, we acknowledge that the non-randomised cluster design and potential self-selection bias—where more engaged or motivated patients may have been more likely to enrol in the intervention arm—could have influenced perceived usability and satisfaction. This may limit the generalisability of acceptability outcomes and underscores the need for a randomised trial to minimise such bias. Additionally, the small sample size, short follow-up period and mild baseline disease activity restrict the ability to assess sustainability and clinical impact over time. Pregnant and breastfeeding individuals were excluded from this pilot due to ethical and safety concerns, and because the CDSS was not yet programmed to provide pregnancy-specific treatment guidance—a recognised limitation given the importance of shared decision-making in this population. Furthermore, although only two physicians used the CDSS in this pilot study, the SUS is commonly applied in early-stage evaluations with small samples, and our goal was to obtain initial feasibility and usability insights to inform broader future implementation. The small number of evaluators limits generalisability regarding usability and acceptability of the CDSS. Lastly, the study was conducted in a specific healthcare setting within the Netherlands, which may limit the applicability of findings to other healthcare systems.
Nevertheless, this pilot study provides critical insights that inform the design of a future definitive trial. Specifically, the feasibility outcomes support the potential for scaling up, but also indicate the need for technical enhancements to the CDSS, including electronic health records integration and improved user interface design. Our findings complement recent work, which demonstrated the feasibility of a patient-directed decision-aid for SLE.32 While our CDSS was clinician-facing, combining such tools with patient-facing aids may enhance shared decision-making and support more effective implementation of T2T strategies. A larger randomised controlled trial, incorporating diverse clinical settings, a broader range of disease activity and extended follow-up, is warranted to evaluate the clinical efficacy and cost-effectiveness of a T2T-CDSS approach in SLE.
Conclusions
In this pilot study, the implementation of a T2T strategy supported by a CDSS in SLE outpatient care was feasible, usable and acceptable to both patients and physicians. The intervention promoted proactive, target-driven treatment adjustments, including both treatment intensifications and GC tapering, without compromising patient satisfaction. These findings support the potential for a T2T-CDSS approach to enhance shared decision-making and disease management in SLE.
Supplementary material
Acknowledgements
We would like to thank all the patients with SLE who participated in the study. In addition, we acknowledge the European Reference Network on Rare and Complex Connective Tissue Diseases (ERN ReCONNET) for declaring the Department of Rheumatology and Clinical Immunology of our centre as a member.
Footnotes
Funding: The work of ARPS is supported by the European Union’s Horizon 2020 research and innovation programme (‘ARCAID’; www.arcaid-h2020.eu; grant agreement number 847551).
Provenance and peer review: Not commissioned; externally peer reviewed.
Patient consent for publication: Not applicable.
Ethics approval: The trial was approved by the Medical Research Ethics Committee of Amsterdam UMC (protocol ID NL78830.018.22) and conducted in compliance with the Declaration of Helsinki and Good Clinical Practice guidelines. All participants provided written informed consent before inclusion.
Data availability free text: The data that support the findings of this study are available from the corresponding author on reasonable request.
Patient and public involvement: Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Data availability statement
Data are available on reasonable request.
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Supplementary Materials
Data Availability Statement
Data are available on reasonable request.