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Individuals with sickle cell disease (SCD) and central venous catheters (CVC) are at high risk for venous thromboembolism (VTE). Minimal data exist regarding the use of anticoagulation as thromboprophylaxis of VTE in this demographic, and as a result, clinical equipoise exists. Prophylactic dose rivaroxaban, a direct oral anticoagulant, is efficacious and safe as thromboprophylaxis in other demographics, and may be an optimal agent in SCD with CVC. Prior to conducting a full clinical trial to assess rivaroxaban as thromboprophylaxis in SCD with CVC, a pilot study is needed to gauge its feasibility.
THromboprophylaxis In Sickle Cell Disease pilot trial is an investigator-initiated, multicentre, double-blinded, randomised controlled trial (RCT) assessing if it is feasible and safe to conduct an adequately powered RCT comparing rivaroxaban to matching placebo as thromboprophylaxis in those with SCD and CVC. Fifty adult patients with SCD and CVC will be randomised to receive either rivaroxaban 10 mg daily or matching placebo for the duration of the CVC in situ for up to 1 year. After randomisation, follow-up visits will occur every 3 months. The primary outcomes pertain to the feasibility of a full trial and include numbers of eligible and recruited participants. Exploratory outcomes include overall incidence of VTE and bleeding complications, as well as quality of life. If the full trial is feasible, blinding will be maintained and patients in the pilot study will be included in the full trial.
The trial was initially approved by the University Health Network Research Ethics Board (REB) in Toronto, Canada. All sites will obtain approval from their respective REB prior to commencement of study activities. Study results will be disseminated through presentations at medical conferences and peer-reviewed publications.
by Mila Pacheco, Pedro Sá, Gláucia Santos, Ney Boa-Sorte, Kilma Domingues, Larissa Assis, Marina Silva, Ana Oliveira, Daniel Santos, Jamile Ferreira, Rosemeire Fernandes, Flora Fortes, Raquel Rocha, Genoile Santana
AimsEvaluate the impact of an intervention program in non-adherent patients with ulcerative colitis.
MethodsParallel controlled randomized clinical trial (1:1), approved by the ethics committee (No. 3.068.511/2018) and registered at The Brazilian Clinical Trials Registry (No. RBR-79dn4k). Non-adherent ulcerative colitis patients according to the Morisky-Green-Levine-test were included. Recruitment began in August 2019 until August 2020, with 6-month follow-up. All participants received standard usual care, and additionally the intervention group received educational (video, educational leaflet, verbal guidance) and behavioral interventions (therapeutic scheme, motivational and reminder type short message services). Researchers were blinded for allocation prior to data collection at Visits 1 and 2 (0 and 6 months). Primary outcome: 180-day adherence rate, with relative risk 95%CI. Secondary outcome: 180-day quality of life according to SF-36 domains, using Student’s t test. Variables with p Results
Forty-six and 49 participants were allocated in control and intervention groups, respectively. Two were excluded due to intervention refusal, and 4 and 6 were lost to follow-up in control and intervention groups. There was no post-intervention adherence rate difference, even after adjustment for type of non-adherence (unintentional/both/intentional) as confounder, or if considered as adherent the intervention group participants lost in follow-up. Interventions promoted better quality of life scores even after multivariate analysis for “Pain”, when adjusted for ulcerative colitis severity, sex, and marital status (β = 18.352, p = 0.004), “Vitality”, when adjusted for ulcerative colitis severity (β = 10.568, p = 0.015) and “Emotional Aspects”, when adjusted for disease severity, income, and education (β = 24.907, p = 0.041).
ConclusionsThe intervention program was not able to produce a significant medication adherence rate difference between comparative groups, however, there was a significant improvement in quality of life. Study limitations may include: sample size calculated to identify differences of 30%, leading to a possible insufficient power; non blinded participants, exposing the results to the risk of performance bias; outcomes based on self-reported data.
Objetivo: analizar los factores de riesgo cardiovascular del personal sanitario mediante la tabla REGICOR, en función edad, sexo, categoría profesional y turno de trabajo, así como el estrés laboral que experimenta nuestro equipo. Método: estudio descriptivo transversal cuya población fueron profesionales quirúrgicos Área V, Murcia, entre Enero y julio de 2020. Búsqueda bibliográfica y el instrumento un cuestionario con variables sociodemográficas y los factores de riesgo. Se explicó todo el proceso y firmaron Consentimiento Informado. Se calculó el RCV mediante REGICOR. El estrés con test de Hock y Escala General de Satisfacción. Resultados: muestra final n= 55, 18,2% (n =10) hombres y 81,8% (n= 45) mujeres, edades 35 y 64 y X= 49,4 años (DT = 8,7). Según la categoría profesional: 60% enferme-ros/as y 45,5% turno rodado. FRCV recogidos: IMC X=24,6 Kg/m2 presentando sobrepeso 32,1%, colesterol 30,9%, 22,6% hipertensos y 7,3% diabéticos. Edad y el riesgo coronario se relacionan de forma directa y significativa (r=0,550, p<0,001). Estrés< 42 puntos. Escala de satisfacción laboral 61,1 (DT=1,06). Conclusiones: los resultados obtenidos muestran elevadas prevalencias de factores de riesgo modificables especialmente obesidad, dislipemia y tabaquismo. Según la tabla Regicor elevada prevalencia de riesgo alto o muy alto. Sexo y edad fuertemente asociados al riesgo coronario. Mientras que el turno de trabajo y categoría profesional no existe asociación. El estrés no está relacionado en la población del Hospital Virgen del Castillo.
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