A personalized intervention to prevent depression in primary care based on risk predictive algorithms and decision support systems: protocol of the e-predictD study

The predictD is an intervention implemented by general practitioners (GPs) to prevent depression, which reduced the incidence of depression-anxiety and was cost-effective. The e-predictD study aims to design, develop, and evaluate an evolved predictD intervention to prevent the onset of major depression in primary care based on Information and Communication Technologies, predictive risk algorithms, decision support systems (DSSs), and personalized prevention plans (PPPs). A multicenter cluster randomized trial with GPs randomly assigned to the e-predictD intervention + care-as-usual (CAU) group or the active-control + CAU group and 1-year follow-up is being conducted. The required sample size is 720 non-depressed patients (aged 18–55 years), with moderate-to-high depression risk, under the care of 72 GPs in six Spanish cities. The GPs assigned to the e-predictD-intervention group receive brief training, and those assigned to the control group do not. Recruited patients of the GPs allocated to the e-predictD group download the e-predictD app, which incorporates validated risk algorithms to predict depression, monitoring systems, and DSSs. Integrating all inputs, the DSS automatically proposes to the patients a PPP for depression based on eight intervention modules: physical exercise, social relationships, improving sleep, problem-solving, communication skills, decision-making, assertiveness, and working with thoughts. This PPP is discussed in a 15-min semi-structured GP-patient interview. Patients then choose one or more of the intervention modules proposed by the DSS to be self-implemented over the next 3 months. This process will be reformulated at 3, 6, and 9 months but without the GP–patient interview. Recruited patients of the GPs allocated to the control-group+CAU download another version of the e-predictD app, but the only intervention that they receive via the app is weekly brief psychoeducational messages (active-control group). The primary outcome is the cumulative incidence of major depression measured by the Composite International Diagnostic Interview at 6 and 12 months. Other outcomes include depressive symptoms (PHQ-9) and anxiety symptoms (GAD-7), depression risk (predictD risk algorithm), mental and physical quality of life (SF-12), and acceptability and satisfaction (‘e-Health Impact' questionnaire) with the intervention. Patients are evaluated at baseline and 3, 6, 9, and 12 months. An economic evaluation will also be performed (cost-effectiveness and cost-utility analysis) from two perspectives, societal and health systems.Trial registrationClinicalTrials.gov, identifier: NCT03990792

A personalized intervention to prevent depression in primary care based on risk predictive algorithms and decision support systems: protocol of the e-predictD study

The predictD is an intervention implemented by general practitioners (GPs) to prevent depression, which reduced the incidence of depression-anxiety and was cost-effective. The e-predictD study aims to design, develop, and evaluate an evolved predictD intervention to prevent the onset of major depression in primary care based on Information and Communication Technologies, predictive risk algorithms, decision support systems (DSSs), and personalized prevention plans (PPPs). A multicenter cluster randomized trial with GPs randomly assigned to the e-predictD intervention + care-as-usual (CAU) group or the active-control + CAU group and 1-year follow-up is being conducted. The required sample size is 720 non-depressed patients (aged 18–55 years), with moderate-to-high depression risk, under the care of 72 GPs in six Spanish cities. The GPs assigned to the e-predictD-intervention group receive brief training, and those assigned to the control group do not. Recruited patients of the GPs allocated to the e-predictD group download the e-predictD app, which incorporates validated risk algorithms to predict depression, monitoring systems, and DSSs. Integrating all inputs, the DSS automatically proposes to the patients a PPP for depression based on eight intervention modules: physical exercise, social relationships, improving sleep, problem-solving, communication skills, decision-making, assertiveness, and working with thoughts. This PPP is discussed in a 15-min semi-structured GP-patient interview. Patients then choose one or more of the intervention modules proposed by the DSS to be self-implemented over the next 3 months. This process will be reformulated at 3, 6, and 9 months but without the GP–patient interview. Recruited patients of the GPs allocated to the control-group+CAU download another version of the e-predictD app, but the only intervention that they receive via the app is weekly brief psychoeducational messages (active-control group). The primary outcome is the cumulative incidence of major depression measured by the Composite International Diagnostic Interview at 6 and 12 months. Other outcomes include depressive symptoms (PHQ-9) and anxiety symptoms (GAD-7), depression risk (predictD risk algorithm), mental and physical quality of life (SF-12), and acceptability and satisfaction (‘e-Health Impact' questionnaire) with the intervention. Patients are evaluated at baseline and 3, 6, 9, and 12 months. An economic evaluation will also be performed (cost-effectiveness and cost-utility analysis) from two perspectives, societal and health systems.Trial registrationClinicalTrials.gov, identifier: NCT03990792

Problemas clínicos durante el mantenimiento del donante potencial de órganos. Clinical problems during the maintenance of potential organ-donors

Se realizó un estudio descriptivo y retrospectivo de los donantes de órganos para trasplantes en el Hospital Abel Santamaría Cuadrado de Pinar del Río en el período comprendido entre enero del 2000 y diciembre del 2003 para conocer los principales problemas durante el mantenimiento de los 23 donantes reales. Hubo un incremento del número de casos con el transcurso de los años. El trauma cráneo encefálico fue la causa principal de muerte encefálica. La hipotensión arterial y las arritmias fueron los eventos hemodinámicos más reportados. Los disturbios hidroelectrolíticos más relevantes fueron la hipopotasemia y la hipernatremia. La alcalosis mixta fue la alteración del equilibrio ácido - básico de mayor incidencia. La hipotermia, la poliuria y la hiperglicemia constituyeron otras alteraciones también presentes. Demostramos la importancia de un estrecho seguimiento del donante para prevenir y/o tratar los problemas clínicos que se presentan en este tipo de paciente. La información recogida fue procesada y analizada con la utilización de frecuencias absolutas y porcentajes, los resultados obtenidos se mostraron en tablas para una mejor comprensión de los mismos permitiéndonos arribar a conclusiones finales y hacer recomendaciones pertinentes. DeCS: DONADORES DE TEJIDO/ transplante, TRANSPLANTE ABSTRACT A descriptive and retrospective study on donors of organs for transplantations was performed at Abel Santamaría Hospital in Pinar del Río in the period of January 2000 and December 2003 aimed at assessing the most significant disorders during the management of 23 potential donors. There was an increase in the number in cases in years. Cranioencephalic trauma was the main cause of encephalic death. Hypotension and dysrrythmias were the most relevant hemodynamic disorders as well as electrolyte imbalance (hypokalemia and hypernatremia); mixed alkalosis was the most significant disorder of the acid-base balance, hypothermia, polyuria and hyperglycemia were other present disorders. The importance of a close follow-up of the donors to prevent and/or manage clinical disorders of these kinds of patients was shown. The information recorded was processed and analyzed using absolute frequencies and percentages, the results obtained were registered in tables in order to understand conclusions and recommendations. DeCS: DONORS OF TISSUES/transplantation, TRANSPLANTATION

Problemas clínicos durante el mantenimiento del donante potencial de órganos. Clinical problems during the maintenance of potential organ-donors

Se realizó un estudio descriptivo y retrospectivo de los donantes de órganos para trasplantes en el Hospital Abel Santamaría Cuadrado de Pinar del Río en el período comprendido entre enero del 2000 y diciembre del 2003 para conocer los principales problemas durante el mantenimiento de los 23 donantes reales. Hubo un incremento del número de casos con el transcurso de los años. El trauma cráneo encefálico fue la causa principal de muerte encefálica. La hipotensión arterial y las arritmias fueron los eventos hemodinámicos más reportados. Los disturbios hidroelectrolíticos más relevantes fueron la hipopotasemia y la hipernatremia. La alcalosis mixta fue la alteración del equilibrio ácido - básico de mayor incidencia. La hipotermia, la poliuria y la hiperglicemia constituyeron otras alteraciones también presentes. Demostramos la importancia de un estrecho seguimiento del donante para prevenir y/o tratar los problemas clínicos que se presentan en este tipo de paciente. La información recogida fue procesada y analizada con la utilización de frecuencias absolutas y porcentajes, los resultados obtenidos se mostraron en tablas para una mejor comprensión de los mismos permitiéndonos arribar a conclusiones finales y hacer recomendaciones pertinentes. DeCS: DONADORES DE TEJIDO/ transplante, TRANSPLANTE ABSTRACT A descriptive and retrospective study on donors of organs for transplantations was performed at Abel Santamaría Hospital in Pinar del Río in the period of January 2000 and December 2003 aimed at assessing the most significant disorders during the management of 23 potential donors. There was an increase in the number in cases in years. Cranioencephalic trauma was the main cause of encephalic death. Hypotension and dysrrythmias were the most relevant hemodynamic disorders as well as electrolyte imbalance (hypokalemia and hypernatremia); mixed alkalosis was the most significant disorder of the acid-base balance, hypothermia, polyuria and hyperglycemia were other present disorders. The importance of a close follow-up of the donors to prevent and/or manage clinical disorders of these kinds of patients was shown. The information recorded was processed and analyzed using absolute frequencies and percentages, the results obtained were registered in tables in order to understand conclusions and recommendations. DeCS: DONORS OF TISSUES/transplantation, TRANSPLANTATION

Satisfacción con los Servicios de Salud Mental de Distrito en familiares de pacientes psicóticos.

Mediante una adaptación de la Escala de Satisfacción Familiar con los Servicios, los familiares-clave de 126 pacientes psicóticos atendidos en el C.S.M. Distrito Guadalquivir (Sevilla)-informaron sobre su grado de satisfacción con los Servicios de Salud Mental. Aunque con grandes porcentajes de satisfacción general, los resultados muestran niveles de insatisfacción notable en aspectos específicos, como Información sobre la enfermedad y Particias en los Programas de Tratamiento

Satisfacción con los Servicios de Salud Mental de Distrito en familiares de pacientes psicóticos.

Mediante una adaptación de la Escala de Satisfacción Familiar con los Servicios, los familiares-clave de 126 pacientes psicóticos atendidos en el C.S.M. Distrito Guadalquivir (Sevilla)-informaron sobre su grado de satisfacción con los Servicios de Salud Mental. Aunque con grandes porcentajes de satisfacción general, los resultados muestran niveles de insatisfacción notable en aspectos específicos, como Información sobre la enfermedad y Particias en los Programas de Tratamiento

Cellular and humoral functional responses after BNT162b2 mRNA vaccination differ longitudinally between naive and subjects recovered from COVID-19

We have analyzed BNT162b2 vaccine-induced immune responses in naive subjects and individuals recovered from coronavirus disease 2019 (COVID-19), both soon after (14 days) and later after (almost 8 months) vaccination. Plasma spike (S)-specific immunoglobulins peak after one vaccine shot in individuals recovered from COVID-19, while a second dose is needed in naive subjects, although the latter group shows reduced levels all along the analyzed period. Despite how the neutralization capacity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mirrors this behavior early after vaccination, both groups show comparable neutralizing antibodies and S-specific B cell levels late post-vaccination. When studying cellular responses, naive individuals exhibit higher SARS-CoV-2-specific cytokine production, CD4+ T cell activation, and proliferation than do individuals recovered from COVID-19, with patent inverse correlations between humoral and cellular variables early post-vaccination. However, almost 8 months post-vaccination, SARS-CoV-2-specific responses are comparable between both groups. Our data indicate that a previous history of COVID-19 differentially determines the functional T and B cell-mediated responses to BNT162b2 vaccination over time.C.d.F., J.G.-P., and J.A. are supported by Instituto de Salud Carlos III (ISCII). We thank JM Ligos and Cytek Biosciences for their technical support. Research in E.L.-C.’s lab was supported by Fundación Familia Alonso, Santander Bank, Real Seguros, Fundación Mutua Madrileña, Fundación Uria, Fundación La Caixa, and Ayuntamiento de Madrid.S

Preventing the onset of major depression based on the level and profile of risk of primary care attendees: protocol of a cluster randomised trial (the predictD-CCRT study)

BACKGROUND: The 'predictD algorithm' provides an estimate of the level and profile of risk of the onset of major depression in primary care attendees. This gives us the opportunity to develop interventions to prevent depression in a personalized way. We aim to evaluate the effectiveness, cost-effectiveness and cost-utility of a new intervention, personalized and implemented by family physicians (FPs), to prevent the onset of episodes of major depression. METHODS: This is a multicenter randomized controlled trial (RCT), with cluster assignment by health center and two parallel arms. Two interventions will be applied by FPs, usual care versus the new intervention predictD-CCRT. The latter has four components: a training workshop for FPs; communicating the level and profile of risk of depression; building up a tailored bio-psycho-family-social intervention by FPs to prevent depression; offering a booklet to prevent depression; and activating and empowering patients. We will recruit a systematic random sample of 3286 non-depressed adult patients (1643 in each trial arm), nested in 140 FPs and 70 health centers from 7 Spanish cities. All patients will be evaluated at baseline, 6, 12 and 18 months. The level and profile of risk of depression will be communicated to patients by the FPs in the intervention practices at baseline, 6 and 12 months. Our primary outcome will be the cumulative incidence of major depression (measured by CIDI each 6 months) over 18 months of follow-up. Secondary outcomes will be health-related quality of life (SF-12 and EuroQol), and measurements of cost-effectiveness and cost-utility. The inferences will be made at patient level. We shall undertake an intention-to-treat effectiveness analysis and will handle missing data using multiple imputations. We will perform multi-level logistic regressions and will adjust for the probability of the onset of major depression at 12 months measured at baseline as well as for unbalanced variables if appropriate. The economic evaluation will be approached from two perspectives, societal and health system. DISCUSSION: To our knowledge, this will be the first RCT of universal primary prevention for depression in adults and the first to test a personalized intervention implemented by FPs. We discuss possible biases as well as other limitations.Trial registration: ClinicalTrials.gov identifier: NCT01151982

Evolution of the use of corticosteroids for the treatment of hospitalised COVID-19 patients in Spain between March and November 2020: SEMI-COVID national registry

Objectives: Since the results of the RECOVERY trial, WHO recommendations about the use of corticosteroids (CTs) in COVID-19 have changed. The aim of the study is to analyse the evolutive use of CTs in Spain during the pandemic to assess the potential influence of new recommendations. Material and methods: A retrospective, descriptive, and observational study was conducted on adults hospitalised due to COVID-19 in Spain who were included in the SEMI-COVID- 19 Registry from March to November 2020. Results: CTs were used in 6053 (36.21%) of the included patients. The patients were older (mean (SD)) (69.6 (14.6) vs. 66.0 (16.8) years; p < 0.001), with hypertension (57.0% vs. 47.7%; p < 0.001), obesity (26.4% vs. 19.3%; p < 0.0001), and multimorbidity prevalence (20.6% vs. 16.1%; p < 0.001). These patients had higher values (mean (95% CI)) of C-reactive protein (CRP) (86 (32.7-160) vs. 49.3 (16-109) mg/dL; p < 0.001), ferritin (791 (393-1534) vs. 470 (236- 996) µg/dL; p < 0.001), D dimer (750 (430-1400) vs. 617 (345-1180) µg/dL; p < 0.001), and lower Sp02/Fi02 (266 (91.1) vs. 301 (101); p < 0.001). Since June 2020, there was an increment in the use of CTs (March vs. September; p < 0.001). Overall, 20% did not receive steroids, and 40% received less than 200 mg accumulated prednisone equivalent dose (APED). Severe patients are treated with higher doses. The mortality benefit was observed in patients with oxygen saturation </=90%. Conclusions: Patients with greater comorbidity, severity, and inflammatory markers were those treated with CTs. In severe patients, there is a trend towards the use of higher doses. The mortality benefit was observed in patients with oxygen saturation </=90%