To perform a transcultural adaptation and validation of a Spanish version of the compliance questionnaire in rheumatology (sCQR). In this transversal study of transcultural adaptation of the sCQR, validity was evaluated in patients with rheumatoid arthritis (RA) and a minimum 6-month follow-up by determining compliance with the electronic prescription system in consuming steroids or nonbiologic disease-modifying antirheumatic drugs. A two-week retest was proposed to all patients. All patients completed the health assessment questionnaire (HAQ), and the Morisky-Green test was also performed. Reliability was analyzed using Cronbach's alpha and the intraclass correlation coefficient (ICC). Convergent construct validity was tested in the electronic prescription system using discriminative analysis, and divergent construct validity was tested by comparing it to the HAQ. Sensitivity, specificity and ROC curves were evaluated for the sCQR and the Morisky-Green test. Of 123 recruited patients, 101 fulfilled the inclusion criteria, and 61 were on biologic therapy. 23 performed the retest. Test-retest reliability (ICC) was 0.76 (Cronbach's alpha 0.86). Multiple regression analysis showed correlation with each item of the sCQR as independent variables (r = 0.60). No correlation was seen between total score punctuation of the sCQR and the HAQ (r = 0.22). Discriminative analysis weighting each sCQR item showed a cutoff point of - 0.9991 (sensibility and 58.8%, specificity 98.3%). The likelihood ratio of the sCQR to detect ≤ 80% adherence with electronic prescriptions was 35.3. The Morisky-Green test revealed sensibility and specificity were 29.4 and 83.3%, respectively. This study validates the transcultural adaptation of sCQR in RA patients. A high reliability of sCQR for measuring adherence was found. Its predictive value suggests that it could be used as a screening instrument.
In the original published article, the family name was incorrectly tagged for two co-authors. The correct family names of authors José Ramón Maneiro Fernández is Maneiro Fernández and Alejandro Souto Vilas is Souto Vilas.
Background:Osteoporosis (OP) is the most common cause of fragility fractures. It is characterized by a loss of bone mass that modifies the bone microstructure, increases fragility and predisposes to fractures. There are numerous risk factors for fragility fracture that must be evaluated for diagnosis and treatment. The treatment consists of non-pharmacological measures (balanced diet and exercise), adequate intake of calcium and vitamin D and specific pharmacological treatment (bisphosphonates, teriparatide, denosumab or selective estrogen receptor modulator) 1-3.Objectives:To perform a descriptive evaluation of the demographic and clinical characteristics of patients with osteoporosis treated with Denosumab, their degree of compliance with the therapy as well as the evaluation of the possible causes of treatment cessation.Methods:All patients diagnosed with OP from January 2015 to January 2020 have been reviewed in the Rheumatology Service of the University Hospital of Santiago de Compostela and patients treated with denosumab have been selected. Demographic, clinical and treatment data have been collected from data collected in their electronic medical recordResults:Of the 507 patients diagnosed with Osteoporosis from January 2015 to January 2020, a total of 133 patients (26.2%) have received treatment with Denosumab. The majority are women (92.5% n = 122) with a mean age of 76 years (age range: 49-105 years). Previously, 38% (n = 51) had vertebral fractures, with 8% (n = 11) standing out who had presented 3 or more vertebral fractures prior to Denosumab treatment.The mean time to start Denosumab therapy since the diagnosis of Osteoporosis (by Densitometry or established by fractures) has been 35 months (0 to 84 months from diagnosis)Through the electronic Medical Record the dispensations were accessed in the Denosumab pharmacy office and its administration in Primary Care was verified. Complete adherence to treatment (without skipping any dose) was observed in 73% of patients (n = 97). In 5.2% (n = 7) an omission was avoided. In 21.8% (n = 29) 2 or more dose omissions were corroborated 9 patients (6.8%) completed treatment with Denosumab in the follow-up period (55% due to the need for dental interventions, 33% for loss of follow-up and 12% for fear of secondary effects).In 66 patients (49.6%) risk factors were identified to present Osteoporosis; being corticosteroid therapy at doses greater than 5 mg / day of Prednisone or equivalent (26% n = 33) the most frequently identified risk factor.No vertebral fractures were registered at the end of treatment with Denosumab, with an average time since the end of treatment of 2.77 years (6 months - 8 years).Conclusion:The rate of patients diagnosed with Osteoporosis who receive Denosumab therapy at some time reaches 26%, being the most frequent drug used after bisphosphonates.Complete adherence to treatment has been observed in 73% of patients.We have not observed vertebral fractures after suspension of Denosumab in our series of patients, although the total exposure time (from the end of treatment to the end of follow-up) is short: 2.77 yearsReferences:[1]Passini M. Osteoporosis diagnosis and treatment. Rev Bras Ortop. 2010;45(3):220-229.[2]Lems WF, et al. EULAR/EFORT recommendations for management of patients older than 50 years with a fragility fracture and prevention of subsequent fractures. Ann Rheum Dis. 2017;76:802-810.[3]Naranjo A, et al. Recomendaciones de la Sociedad Española de Reumatología sobre osteoporosis. Reumatol Clin. 2019;15(4):188-210.Disclosure of Interests:None declared
Background:Systemic sclerosis (SSc) is a chronic autoimmune disease of the connective tissue characterized by vascular disease and fibrosis in different organs and systems such as lung and skin (1). Recently, several case reports and small series of patients reported on the efficacy of rituximab in SSc, showing a possible improvement in skin and lung affectations (2). However, registered clinical trials are lacking to determine factors associated with response, maintenance regimen, and long-term efficacy of rituximab in SSc.Objectives:To analyze the efficacy of Rituximab in the treatment of skin fibrosis using the changes of the modified Rodnan Skin Score (mRSS) of patients diagnosed with systemic sclerosis from the data published in Registered Clinical Trials (RCTs) in the scientific literature.Methods:We perform a systematic review and a meta-analysis using the main electronic databases to locate all the articles available so far: Medline, Embase, Cochrane Library and Web of science and ACR and EULAR abstracts congress were extracted to assess efficacy outcomes. That efficacy was measured based on the variation of mRSS at 12, 24 and 48 weeks for patients treated with Rituximab versus patients treated with another drug or placebo.Results:3 RCTs contained data regarding mRSS at week 12 of treatment with Rituximab. The estimated SMD was -1.071 (95% CI -1.608, -0.535 [p <0.001]) with a non-significant P value in the Egger Test (P = 0.703) and non-significant heterogeneity through I2 (I2 = 0.00%).9 studies contained data regarding mRSS at week 24 of treatment with Rituximab. The estimated SMD was -1.743 (CI95% -2.622, -0.864 [p <0.001], see image below) with a non-significant P value in the Egger Test (P = 0.072) and significant heterogeneity through I2 (I2 = 86.6%). Meta-regression analysis could not be performed to assess such heterogeneity, due to the lack of comparable data.8 RCTs contained data regarding mRSS at week 48 of Rituximab treatment. The estimated SMD was -1.327 (CI95% -2.018, -0.636 [p <0.001]) with a significant P value in the Egger Test (P = 0.018), estimating that there may be publication bias in the studies analyzed and significant heterogeneity by I2 (I2 = 85.2%). Meta-regression analysis could not be performed to assess such heterogeneity, due to the lack of comparable data.Conclusion:Our meta-analysis shows that Rituximab treatment in patients affected with systemic sclerosis shows efficacy in the treatment of cutaneous fibrosis measured by the mRSS, turning this molecule into a potential drug to add to the therapeutic armamentarium of systemic sclerosis. However, more studies are necessary to try to elucidate whether this change is powerful enough to become the new gold standard for the treatment of systemic sclerosis skin involvement.References:[1]Stern EP, Denton CP. The pathogenesis of systemic sclerosis. Rheum Dis Clin North Am 2015;41:367–82. https://doi.org/10.1016/j.rdc.2015.04.002.[2]Thiebaut M, Launay D, Rivière S, et al. Efficacy and safety of rituximab in systemic sclerosis: French retrospective study and literature review. Autoimmun Rev. 2018;17(6):582-587. https://doi:10.1016/j.autrev.2017.12.010.Disclosure of Interests:None declared
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