Objective To investigate the extent and performance of structural lesions in sacroiliac joints on MRI (MRI-SI) in patients with axial spondyloarthritis (axSpA), chronic back pain, postpartum back pain, runners and healthy subjects.Methods MRI-SIs in 172 subjects, including 47 patients with diagnosed axSpA fulfilling the Assessment of SpondyloArthritis international Society (ASAS) criteria, 47 patients with chronic back pain, 7 women with postpartum back pain, 24 runners and 47 healthy individuals, were scored by two well-trained readers for erosions, fatty lesions, sclerosis and ankylosis, using an adjusted Spondyloarthritis Research Consortium of Canada scoring method. In addition, cut-off values proposed by the Imaging workgroups of Leiden and the ASAS were tested.Results Of the axSpA patients, 37 (79%) had structural lesions. Most frequently reported structural lesions were erosions in 35 (75%) patients and fatty lesions in 19 (40%) patients. Erosions and fatty lesions were uncommon in chronic back pain, runners and healthy individuals. There was a statistically significant difference in the prevalence of erosions, fatty lesions and ankylosis between axSpA and chronic back pain. Ankylosis was rare in both groups. Comparing axSpA to non-axSpA, Leiden cut-off definitions were more specific than ASAS cut-offs.Conclusions Structural changes resembling axSpA may occur in individuals who do not have axSpA, but at a lower rate than inflammatory changes. Erosions and fatty lesions are most specific. Using cut-off definitions for these structural lesions results in good discrimination between axSpA and non-axSpA. In axSpA, structural lesions primarily occur in concordance with ongoing inflammation.
Objectives The objective is to develop a pragmatic framework, based on value-based healthcare principles, to monitor health outcomes per unit costs on an institutional level. Subsequently, we investigated the association between health outcomes and healthcare utilisation costs.Design This is a retrospective cohort study.Setting A teaching hospital in Rotterdam, The Netherlands.Participants The study was performed in two use cases. The bariatric population contained 856 patients of which 639 were diagnosed with morbid obesity body mass index (BMI) <45 and 217 were diagnosed with morbid obesity BMI ≥45. The breast cancer population contained 663 patients of which 455 received a lumpectomy and 208 a mastectomy.Primary and secondary outcome measures The quality cost indicator (QCI) was the primary measures and was defined asQCI = (resulting outcome * 100)/average total costs (per thousand Euros)where average total costs entail all healthcare utilisation costs with regard to the treatment of the primary diagnosis and follow-up care. Resulting outcome is the number of patients achieving textbook outcome (passing all health outcome indicators) divided by the total number of patients included in the care path.Results The breast cancer and bariatric population had the highest resulting outcome values in 2020 Q4, 0.93 and 0.73, respectively. The average total costs of the bariatric population remained stable (avg, €8833.55, min €8494.32, max €9164.26). The breast cancer population showed higher variance in costs (avg, €12 735.31 min €12 188.83, max €13 695.58). QCI values of both populations showed similar variance (0.3 and 0.8). Failing health outcome indicators was significantly related to higher hospital-based costs of care in both populations (p <0.01).Conclusions The QCI framework is effective for monitoring changes in average total costs and relevant health outcomes on an institutional level. Health outcomes are associated with hospital-based costs of care.
Burn care quality indicators are used to monitor and improve quality of care and for benchmark purposes. The perspectives of burn survivors, however, are not included in current sets of quality indicators while patient-centred care gains importance. The aim of this study was to explore burn survivors’ perspectives on quality aspects of burn care, which was used to translate their perspectives into patient-centred quality of care indicators. Qualitative descriptive research was conducted in a patient panel group. First, thematic analysis was applied to the focus groups to identify overarching themes. Second, patient-centred quality indicators, informed by burn survivors’ valued aspects of care, were defined. Ten burn survivors with an average age of 54 years (SD = 11; range 38–72 years) and mean TBSA burned of 14% (SD = 11%; range 5–35%) participated in two focus groups. Four overarching themes were identified, pointing to the importance of (1) information tailored to the different phases of recovery, (2) significant others’ wellbeing and involvement, (3) a therapeutic relationship and low-threshold access to healthcare professionals and (4) to participate in decision-making. Eighteen patient-centred process quality of care indicators within nine aspects of care were formulated. The overarching themes are reflected in patient-centred quality indicators, which present a broadened and complementary view of existing clinical quality indicators for burn care. Evaluating these patient-centred quality indicators may increase quality of care and refine patient-centred care.
OBJECTIVE:To assess the cost-utility from healthcare and societal perspectives of the digital CaFaSpA referral strategy (CS) for axial spondyloarthritis (axSpA) in primary care patients with chronic low back pain (CLBP). METHOD:A cluster randomized controlled trial was performed in the Netherlands. General practice units were randomized into CS or usual care (UC). Economic evaluation was performed from the healthcare and societal perspectives within a 12-month time horizon. Outcome measures encompassed disability [Roland-Morris Disability Questionnaire (RMDQ)] and health-related quality of life (EQ-5D-3L). Direct medical (iMTA Medical Consumption Questionnaire) and indirect costs (iMTA Productivity Cost Questionnaire), including productivity loss, were evaluated. Incremental cost-utility ratios (ICURs) were calculated. RESULTS:The study included 90 GP clusters with 563 patients (CS: n = 260; UC: n = 303) (mean ± sd age 36.3 ± 7.5 years; 66% female). After 12 months, no minimal important differences in outcomes were observed for RMDQ (-0.21, 95%CI -1.52 to 1.13) or EQ-5D (-0.02, 95%CI -0.08 to 0.05). However, total costs were significantly lower in the CS group owing to lower productivity loss costs. The ICUR for RMDQ was €18,059 per point decrease and €220,457 per quality-adjusted life year increase. CONCLUSIONS:Digital referral did not decrease the overall healthcare status of patients after 1 year of follow-up and appears to be more cost-effective than UC. Therefore, CS can be used as an appropriate primary care referral model for CLBP patients at risk for axSpA. This will accelerate timely provision of care by the right caregiver.
Background Musculoskeletal joint complaints (MSCs) are the most common extraintestinal manifestation of inflammatory bowel disease (IBD). We aimed to investigate the effect of MSC on the health-related quality of life (QoL) in patients with IBD.Design A survey-based cross-sectional study among adult Dutch IBD patients.Setting Primary care, secondary care and patient association.Participants In total, 635 IBD patients were included. The mean age was 46.3 (SD 14.2) years, and 35% were male.Outcome MSC was defined as suffering from any joint complaints. QoL was measured using the IBD questionnaire and a 36-item short form health survey questionnaire.Methods A univariate analysis was performed to estimate the impact of various factors, such as demographic characteristics, setting, type of IBD and fatigue, which was followed by a multiple regression analysis to adjust for the confounding factors.Results Of the 635 IBD patients, 332 suffered from Crohn’s disease (CD) and 303 from ulcerative colitis (UC). After adjusting for confounding factors, MSC was independently associated with reduced QoL among IBD patients (β=−10.6, 95% CI −15.2 to −6.1), both in CD (β=−8.3, 95% CI −14.6 to −2.1) and UC (β=−13.9, 95% CI −20.5 to −7.3). 11% of the IBD patients had a rheumatological diagnosis. QoL in these patients was significantly lower compared with IBD patients with non-rheumatological MSC.Conclusions IBD patients with MSC are associated with a lower QoL, explicitly in patients with a rheumatological diagnosis. Prospective research is necessary to evaluate the causality and suitable interventions to increase QoL in these multimorbid patients.
To explore the proportion of axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) diagnoses within all newly referred patients visiting rheumatology outpatient clinics. And more specifically, to analyze whether there is an effect of the introduction of the ASAS and CASPAR classification criteria for axSpA and PsA. We systematically searched Embase, Medline Ovid, Cochrane Central and Web of Science from database inception to November 2022. Articles that investigated new onsets of axSpA and PsA in adults from rheumatology clinics were included. In total, 170 out of 7139 studies were found eligible for full-text review, after which 33 unique studies were included. Seventeen studies reported new onsets of axSpA, and 20 studies of PsA. The pooled proportion of axSpA within all newly referred patients was 19% (95% CI 15–23%) and 18% (95% CI 14–22%) for PsA. The proportion of axSpA before 2009 was 3% (95% CI 0–6%) and increased up to 21% (95% CI 14–28%) after 2009. For PsA, limited data were available in order to analyze the proportions of PsA before 2006. Overall, heterogeneity was high (I2 > 95%, p < 0.001) that was most likely caused by geographical area, study design, setting and use of different referral strategies. The pooled proportion of axSpA and PsA among patients referred to the rheumatology outpatient clinic was 19 and 18%, respectively. Although the proportion of diagnosed axSpA patients seemed to increase after the introduction of the ASAS criteria, due to the large heterogeneity our findings should be interpreted with caution.
Lumbar bone marrow edema, also known as Modic type-1 endplate change, has a prevalence of 43% in low back pain populations and 6% in general populations. Besides mechanical factors and genetic predisposition it has been hypothesized that lumbar bone marrow edema is caused by a latent infection of low-virulence anaerobic bacteria in degenerated lumbar intervertebral discs. The hypothesis is supported by the observation that the presence of Cutibacterium acnes is more frequently found in samples of disci with Modic-1 than in discs without and by the positive effects of antibiotics in patients with back pain and Modic-1 as shown in placebo-controlled RCT's. Opponents of the hypothesis argue that the findings of bacteria are most likely a result of contamination during harvesting the samples. We conclude that time has come to make a start in the Netherlands with treatment with antibiotics of a small group of well-selected patients in well-selected clinics.
Background Methotrexate (MTX) is the cornerstone therapy for rheumatoid arthritis (RA) patients, with well-established safety and efficacy profiles and support in international guidelines. Guidelines state that the maximal effect of MTX in a dose around 25 mg/wk can be seen after 3-6 months of therapy. However, older studies showed that the maximum dosage usually is up to 15 mg/wk and <40% had started treatment with MTX within 3–6 months from the diagnosis.[1,2,3] Santeon hospitals showed by analysis that disease activity score (DAS 28 CRP) of newly diagnosed RA patients was comparable after 6 months of treatment. However, initial treatment protocols showed large variation leading to difference in MTX dosage, mono and/or combination csDMARD therapy[4]. This suggests that under and/or overtreatment might be the fact. Objectives To get insight in the actual induction DMARD treatment strategies in newly diagnosed RA patients based on real world data. Methods We used data of the Santeon RA program[4]. Maasstad Hospital, Medisch Spectrum Twente, St. Antonius Hospital treat over 4,500 RA patients/year. Although there are no (inter)national protocols for induction dose of MTX, all hospitals had a protocol but they varied between the hospital.[4] We included all newly diagnosed RA patients during Jan 2016 – June 2021. For analysis we assessed the initial conventional DMARD therapy and MTX dose at baseline, at 3 months and 6 months. Results In total 1238 new RA patients (714 Maasstad, 284 MST, 240 Antonius) were diagnosed during a 5.5 year period. A large variation in initial MTX dosages was seen (Figure 1). Data shown are of all Santeon hospitals combined, but differences within hospitals varied even more (data not shown). In 551 of 1238 patients (44%) does not start with MTX within 3 weeks after diagnosis. 931 (74%) started MTX treatment within 3 months after the diagnosis. Of those 921 MTX users, 253 (27%) started with a dose of 15mg/week. At three months the MTX dosages differed between the hospitals: in two of the three hospitals the most patients used 25 mg/week while in the other 15 mg/week (data not shown). Overall at 6 months 29% (361/1238) Santeon RA patients were on a dose of 25mg MTX. Of all 258 patients that did not start with MTX during 6 months, 216 (84%) started with other csDMARD where hydroxychloroquine (HCQ) was most frequent. The prescription of HCQ in combination with MTX varied strongly between the centers (69% vs 33% and13% per center) 3.3% of all new RA patients no csDMARD was started. The top 3 was 1. missing data (n= 19) 2. patients decision (n=7) and 3. unclear diagnosis (n=3). Conclusion We can conclude from real-world benchmark data from Dutch Santeon hospitals that a large variance in MTX dose was observed within and between hospitals. Moreover a large group of new RA patients did not start with MTX, within 3 months but with other csDMARD like HCQ. Our findings rise the urgency of an international induction protocol since the DAS28 did not vary after 3 and 6 months. Moreover this raises the urgency for precision treatment based on patients characteristics (gender, rheumafactor, anti CCP) can achieve similar outcomes (low disease activity) using a lower dose of MTX. To identify these characteristic is topic for further analysis. References [1]Rohr MK, Mikuls TR, Cohen SB, Thorne CJ, O’Dell JR. The underuse of methotrexate in the treatment of RA: a national analysis of prescribing practices in the U.S. Arthritis Care Res (Hoboken) 2016 Nov 18; Epub. [2]Curtis JR, Zhang J, Xie F, et al. Use of oral and subcutaneous methotrexate in rheumatoid arthritis patients in the United States. Arthritis Care Res (Hoboken) 2014;66(11):1604–1611. [3]Manara M, Bianchi G, Bruschi E, et al. Adherence to current recommendations on the use of methotrexate in rheumatoid arthritis in Italy: results from the MARI study. Clin Exp Rheumatol. 2016;34(3):473–479. [4]Santeon Better Together for Inflammatory Arthritis. October 2021 (https://santeon.nl/app/uploads/2021/10/Santeon_Rheumatoid-Arthritis.pdf) Acknowledgements We wish to thank the entire Santeon Better Together Inflammatory Arthritis team, in particular Sabine Zwakenberg and Iris Hoekstra. Disclosure of Interests None Declared.
As first‐degree relatives (FDRs) of HLA–B27–positive patients with axial spondyloarthritis (SpA) have an increased risk of developing axial SpA, the objectives were 1) to evaluate the presence of highly specific imaging features as well as clinical signs of SpA at baseline and after 1 year of follow‐up, and 2) to describe the evolution toward clinical disease within 1 year of follow‐up in a cohort of seemingly healthy FDRs of HLA–B27–positive axial SpA patients.
Abstract Background: Healthcare expenditure has increased rapidly over the last decades. Despite conceptual differences, healthcare expenditure and health outcomes play a significant role in Cost Effectiveness Analysis (CEA) and Value Based Health Care (VBHC). Better health outcomes can prevent additional costs to treat symptoms, adverse events and/or comorbidities. Therefore a partially inverse relationship between health outcomes and healthcare expenditure can be expected. Because it can be quite difficult to utilize this relationship to one’s benefit we developed a framework to model the relationship and tested it for breast cancer and bariatric surgery. Methods: The Quality Cost Indicator is calculated as QCI = 100 – average total costs / (resulting outcome ^2 * 100) and rests on three main measures. (1) Optimal outcome which is accomplished when patients meet all the defined health outcomes which differs per diagnoses/treatment; (2) Resulting outcome, the proportion of patients who accomplish optimal outcomes divided by the total patient population; (3) Average total costs, all costs related to the treatment including costs of AEs and comorbidities. Costs were determined using the Dutch cost price model. The Mann-Whitney U test was used to determine if costs of patients achieving optimal outcome were lower than costs of those who did not. Results: For the bariatric surgery population, 60.75% of patients reached optimal outcome excluding health related quality of life (HRQoL) and 60.74% including HRQoL. For breast cancer surgery 86.88% (excluding HRQoL) achieved optimal outcome. In the bariatric population (excluding HRQoL) and the Breast cancer population, patients achieving optimal outcome had significantly lower cost than those who didn’t. With € 8,442.48 vs. € 9,546.89 (p < .001) and €11,565.65 vs. € 16,119.56 (p < .001) respectively. For both populations QCI values were highest in 2020 Q4 as costs were average and optimal outcome was highest. Conclusions: The QCI framework is useful for modeling the partially inverse relationship between health outcomes and medical costs in bariatric and breast surgery. Future research should indicate if the QCI framework is applicable to other (non-surgical) treatments. Finally, comparing hospitals using the QCI framework could be helpful for comparing/optimizing health outcomes and costs.
Background: In rheumatoid arthritis (RA) care, patients and professionals face treatment decisions regularly due to the high number of treatment options, the chronic character of the disease and challenges around multi-morbidity. Recent studies have underlined the added value of shared decision making (SDM) between patients and professionals in RA care for health outcomes (i.e. disease activity, pain and joint damage) 1-4 . Therefore, effort is needed to facilitate the implementation of SDM in daily clinical practice in order to advance patient centred RA care. Objectives: The aim of this implementation project was to improve SDM about treatment options for patients with RA. In addition the use of (Patient Reported) Outcome Measures in the process of SDM was taken into account. Methods: An implementation programme was developed by the National Association ReumaZorg Nederland (RZN) in co-creation with patientpartners and RMD professionals. Three hospital departments of rheumatology in the Netherlands participated in the project between January 2020 and March 2021. The implementation of SDM was supported by a project team of RZN. Results: The implementation programme started with the recording of RMD consultations in three participating departments of rheumatology. The consultations were then evaluated on the process of SDM (OPTION5) and discussed during the training of professionals that followed. Three observed improvements in SDM in RA care were: a. A more explicit introduction of choice for a patient is needed during the consultation; b. Tasks within the process of SDM should be allocated clearly among RMS specialists and nurses working together, in order to avoid unnecessary repetition of the same - or even inconsistent information; c. Besides the use of (patient reported) outcome measures in the SDM process, it is also important to include patients’ values (what matters to them?) when deciding on the best fitting treatment option. After the training, implementation support for SDM was given and aids to support the SDM process (i.e. redesign of health care processes, task allocation, hand card with explanation of the 4 steps of SDM) were developed. The implementation programme was tailored to the needs and stage of change for each hospital. Implementation materials for the hospital teams were developed in co-creation with patientpartners and the professionals. At the end of the project, a second set of consultations was recorded and evaluated on SDM. The hospital teams concluded that a continuous improvement cycle is needed to further enhance SDM. Conclusion: A continuous implementation programme on shared decision making could stimulate the enhancement of patient centred care in daily practice. Patient organisations could take a significant role in such a programme. References: [1]Pablos JL et al. Patient. 2020 Feb;13(1):57-69. [2]Fautrel B et al. Rheumatol Int. 2018 Jun;38(6):935-947. doi: 10.1007/s00296-018-4005-5. [3]Mathijssen EGE et al. RMD Open. 2020 Jan;6(1):e001121. doi: 10.1136/rmdopen-2019-001121. [4]Nota, I. 2017. Shared Decision-Making in rheumatology: What matters to patients? Thesis, University of Twente. Acknowledgements: This project of the National Association ReumaZorg Nederland (RZN) was made possible thanks to the effort of the following patientpartners, RMD specialists and researchers within the field of RMDs: Helene R Voogdt-Pruis, (AP PhD, RZN projectmanager Shared Decision Making within RMD care), Bertha Maat (RZN patient research partner), Theo Foekens (RZN patient research partner), Laura Kranenburg-van Koppen (MD, Msc, rheumatologist Erasmus and IJsselland Medical Centre), Annelieke Pasma (PhD, researcher Erasmus Medical Centre), Jos Hoes (MD PhD, rheumatologist Bravis Medical Centre), Inge Schoonen-Nuijten (RMD nurse, Bravis Medical Centre), Marijke van den Dikkenberg, (MSc, researcher Maasstad Medical Centre), Natalja Basoski (MD MSc, rheumatologist Maasstad Medical Centre), Angelique Weel-Koenders (Prof. Dr., rheumatologist Maasstad Medical Centre, Erasmus University), Gerardine Willemsen- de Mey (MSc, Chair of RZN). Disclosure of Interests: None declared.
Objectives. Management of early arthritis is based upon early recognition of individuals at high risk of developing persistent arthritis. Therefore, this study investigates whether the number of risk factors for persistent disease or treatment determines the clinical course of early arthritis by comparing the chance at (sustained) DMARD-free remission ((S)DFR) after 2 years follow-up. Methods. Data from the tREACH trial, a stratified single-blinded multicentre strategy trial with a treat-to-target approach were used. We selected all patients with >= 1 swollen joint who did not fulfil 1987 and/or 2010 criteria for RA. The number of risk factors present; autoantibody-positivity, polyarthritis (>4), erosive disease and elevated acute phase reactants, determined risk group stratification. Multivariate logistic regression analyses were performed with (S)DFR as dependent variables and baseline disease activity score (DAS), treatment, symptom duration and number of risk factors present as independent variables. Results. In total, 130 early arthritis patients were included and respectively 31, 66 and 33 had 0, 1 and >= 2 risk factors present. DFR rates were respectively 74%, 48% and 45% for early arthritis patients with 0, 1 and >= 2 risk factors present. In accordance SDFR rates were 61%, 32% and 30%. In our logistic model (S)DFR was not influenced by the initial treatment strategies when stratified for risk groups. Conclusion. The chance at (S)DFR in early arthritis diminishes when more risk factors are present, which is irrespective of the given initial treatment. Our data point out to a stratified management approach in early arthritis based on their risk profile, but validation is needed.
Objectives: To evaluate the 1-year cost-effectiveness between three different initial treatment strategies in autoantibody-negative RA patients, according to 2010 criteria. Methods: For this analysis we selected all RA patients within the intermediate probability stratum of the treatment in the Rotterdam Early Arthritis Cohort (tREACH) trial. The tREACH had a treat-to-target approach, aiming for low DAS <2.4, and treatment adjustments could occur every 3 months. Initial treatment strategies consisted of MTX 25 mg/week (initial MTX, iMTX), iHCQ 400 mg/day or an oral glucocorticoids tapering scheme without DMARDs (iGCs). Data on quality-adjusted life-years, measured with the European Quality of Life 5-Dimensions 3 Levels (EQ-5D-3L), healthcare and productivity costs were used. Results: Average quality-adjusted life-years (S.D.), for iMTX, iHCQ and iGCs were respectively 0.71 (0.14), 0.73 (0.14) and 0.71 (0.15). The average total costs (S.D.) for iMTX, iHCQ and iGCs were, respectively, (sic)10 832 (14.763), (sic)11 208 (12.801) and (sic)10 502 (11.973). Healthcare costs were mainly determined by biological costs, which were significantly lower in the iHCQ group compared with iGCs (P < 0.05). However, costs due to presenteeism were the highest in the iHCQ group (55%) followed by iMTX (27%) and iGCs (18%). The incremental cost-effectiveness ratios did not differ between treatment strategies. At a willingness-to-pay level of (sic)50 000, the Dutch threshold for reimbursement of medical care, iHCQ had the highest probability (38.7%) of being cost-effective, followed by iGCs (31.1%) and iMTX (30.2%). Conclusion: iHCQ had the lowest healthcare and highest productivity costs, resulting in a non-significant incremental cost-effectiveness ratio. However, iHCQ had the highest chance of being cost-effective at the Dutch willingness-to-pay threshold for healthcare reimbursement. Therefore, we believe that iHCQ is a good alternative to iMTX in autoantibody-negative RA patients, but validation is needed.
Objectives. To compare patient-reported outcome (PRO) domains between three arthritis phenotypes [undifferentiated arthritis (UA), autoantibody-negative RA (RA(-)) and autoantibody-positive RA (RA(+))] at diagnosis, after 2 years and over time. Methods. All UA (n = 1 30) , RA(-) (n = 176) and RA(+) (n = 331) patients from the tREACH trial, a stratified single-blinded trial with a treat-to-target approach, were used. PRO comparisons between phenotypes at baseline and after 2 years were performed with analysis of variance, while a linear mixed model compared them over time. Effect sizes were weighted against the minimal clinically important differences (MCIDs) for each PRO. Results. RA(-) patients had a higher disease burden compared with RA(+) and UA. At baseline and after 2 years, RA(-) patients had more functional impairment and a poorer Physical Component Summary (PCS) compared with the other phenotypes, while they only scored worse for general health and morning stiffness duration at baseline. The MCIDs were exceeded at baseline, except for functional ability between RA(+) and UA, while after 2 years only the MCID of the PCS was exceeded by RA(-) compared with UA and RA. After 2 years the PROs of all phenotypes improved, but PROs measuring functioning were still worse compared with the general population, even when patients had low disease activity. Conclusion. RA(-) patients had the highest disease burden of all phenotypes. Although most patients have low disease activity after treatment, all clinical phenotypes still have a similar significant impact on patients' lives, which is mainly physical. Therefore it is important to assess and address PROs in daily practice because of persistent disease burden despite low disease activity.
Background:The Rotterdam Early Arthritis Cohort (REACH) rule [1] and Clinical Arthritis RulE (CARE) [2] are both evidence-based and easy-to-use methods developed to identify the presence of inflammatory arthritis (IA) in patients suspected by their general practitioner (GP). However, the clinical utility of both models in daily clinical practice in an independent primary care setting has not yet been established. While developed for recognizing IA, we believe that it is also important that the broader spectrum of inflammatory rheumatic diseases (IRDs) is correctly classified from primary care, to facilitate appropriate referral towards outpatient rheumatology clinics.Objectives:The primary objective was to determine the diagnostic performance and clinical utility of the REACH and CARE referral rules in identifying IA in an independent population of unselected suspected patients from primary care. Secondly we will assess the diagnostic performance and clinical utility of both models in identifying IRDs.Methods:This prospective observational diagnostic study consisted of adults newly suspected by their GP for the need of referral to the rheumatology outpatient clinic of the Maasstad Hospital in Rotterdam. Primary outcome was IA, consisting of rheumatoid arthritis, axial spondylitis and psoriatic arthritis. Secondary outcome was IRD, defined as IA plus arthritis in systemic disorders such as systemic lupus erythematosus, systemic sclerosis and morbus sjögren. Rheumatologist diagnosis was used as gold standard. To evaluate the clinical performance of the REACH and CARE referral rules in this population, diagnostic accuracy measures were investigated using the Youden index (J) [3]. Moreover, a net benefit approach [4] was used to determine clinical utility of both rules when compared to usual care.Results:This study consisted of 250 patients (22.8% male) with a mean age of 50.8 years (SD 13.9 years). In total 42 (17%) patients were diagnosed with IA and 55 (22%) with an IRD. Figure 1 presents the diagnostic performance in IA (Figure 1A) and in IRD (Figure 1B). For the primary outcome, the REACH model shows an AUC of 0.72 (95% CI 0.64-0.80) and the optimal cut-off point is indicated (J). The CARE model shows an AUC of 0.82 (95% CI 0.75-0.88) and at J there is a somewhat higher sensitivity and specificity. When taking the broader spectrum of IRDs as outcome, the AUC was 0.66 (95% CI 0.58-0.74) for the REACH and 0.76 (95% CI 0.69-0.83) for the CARE model. The net benefit analysis with either IA or IRD as outcome showed that the CARE was of the highest clinical value when compared to usual care.Conclusion:Both the REACH and CARE model showed a good diagnostic performance for detecting IA in an independent population of unselected suspected patients from primary care. Although not specifically developed to recognize the entire spectrum of IRDs, the CARE shows a good performance in doing so. When evaluating clinical utility, we see that both rules have a net benefit in recognizing IA as well as IRDs compared to usual care, however the CARE shows superiority over the REACH. By using the CARE, over half of all suspected patients can be withheld from expensive outpatient rheumatology care, implied by the high specificity of 70%. These results support the idea that incorporating these easy-to-use methods into primary care could lead to providing patients the right care at the right place and improving value based health care.References:[1]ten Brinck RM, van Dijk BT, van Steenbergen HW, le Cessie S, Numans ME. Development and validation of a clinical rule for recognition of early inflammatory arthritis. BMJ Open; 2018: 8[2]Alves, C. Improving early referral of inflammatory arthritis. In Early detection of patients at risk for rheumatoid arthritis – a challenge for primary and secondary care; 2015: 27-38 Ridderkerk, the Netherlands.[3]Fluss R, Faraggi D, Reiser B. Estimation of the Youden Index and its associated cutoff point. Biom J; 2005: 47(4): 458-472[4]Vickers AJ, Elkin EB. Decision curve analysis: a novel method for evaluating prediction models. Med Decis Making; 2006: 26(6): 565-574Disclosure of Interests:None declared
Background: The need to involve patient reported outcomes (PROs) in the management of rheumatoid arthritis (RA) increases, since PROs quantify patient relevant outcomes. Although PROs have been incorporated in the core-outcome sets in clinical trials, knowledge about the treatment effects on these PROs is scarce. Therefore, we performed a systematic review on the effects of disease modifying anti-rheumatic drugs (DMARDs), of any type, on relevant PRO domains mentioned in the ICHOM standard set. This might support rheumatologists and RA patients during treatment decisions. Objectives: To get insight in the treatment effects of DMARDs of any type on three PRO domains that matter to patients (pain, activity limitations and fatigue). Methods: A systematic review was performed in Embase, Medline, Web of Science, Cochrane and Google Scholar. Included were all studies that were published before August 2019 and showed DMARD treatment effects in RA on PROs that are part of the ICHOM standard set. Three Bayesian network meta-analyses were performed for the PRO domains pain, activity limitations and fatigue. Preliminary results of DMARDs (in)directly compared to placebo were visualized by forest plots using R. Results: The search strategy yielded n=5974 articles. After selection was performed by 2 independent researchers, n=70 individual articles representing n=53 studies were extracted, over the three PRO domains; pain (n=31), activity limitations (n=41) and fatigue (n=21). In all RCTs, PROs were only reported as secondary or tertiary endpoints. In figure 1, we show the effects on PROs for any type of DMARD investigated compared to placebo. Overall, DMARDs show a greater reduction in pain (standardized mean difference (SMD); -0.97 – -0.22) and most of them in activity limitations (SMD; -0.81 – 0.56). In fatigue, this clear direction is lacking (SMD; -0.86 – 3.5). csDMARDs and anti-TNF seem to perform slightly, but nog significantly, worse than other bDMARDs and tsDMARDs in the first two domains. Conclusion: Within in this systematic review we report a reduction for DMARDs of any type on the domains of pain and activity limitations compared to placebo. However, results are still preliminary and should be interpreted with care. A more comprehensive network analysis might give a more definitive answer which DMARD performs best. Figure 1. Disclosure of Interests: None declared
Background: To compare the clinical efficacy of different initial treatment strategies in autoantibodynegative rheumatoid arthritis(RA) patients. Methods and findings: Data of the tREACH trial, a stratified single-blinded randomized clinical trial with a treat-to-target strategy, were used. For this analysis, we selected all autoantibodynegative RA patients, defined as fulfillment of 2010-criteria and absence of both rheumatoid factor and anti-citrullinated protein antibody, within the intermediate probability stratum. We compared the following initial treatment strategies in our autoantibody-negative RA population: 25mg methotrexate(iMTX) per week, 400mg hydroxychloroquine(iHCQ) daily or 15mg glucocorticoids(iGCs) orally in a 10-week tapering scheme without any DMARDs. Primary outcome was the proportion of patients with active disease, defined as a disease activity score(DAS)≥2.4, after 3 months of treatment. Secondary outcomes were DAS and functional ability(HAQ) over time using a linear mixed model(LMM), in which we respectively corrected for baseline DAS and HAQ. 116 patients were included and started with iMTX(n=44), iHCQ(n=35) or iGCs(n=37). After 3 months 34%, 34% and 76% of patients respectively treated with iMTX, iHCQ and iGCs had an active disease(p<.0005 for iHCQ and iMTX versus iGCs). Our corrected LMM showed no significant difference in DAS and HAQ over time between the different initial treatment strategies. Conclusions: Initial GCs without csDMARDs are also not indicated for autoantibody-negative RA patients. However, iHCQ and iMTX show similar (early) treatment responses in this subgroup of patients, which suggests that initial treatment can be stratified for autoantibody-negative and autoantibody-positive RA, but validation is needed.