Effectiveness of a home-based nursing support and cognitive restructuring intervention on the quality of life of family caregivers in primary care: A pragmatic cluster-randomized controlled trial.

BACKGROUND: Caregivers of patients with chronic conditions or disability experience fatigue, burden and poor health-related quality of life. There is evidence of the effectiveness of support interventions for decreasing this impact. However, little is known about the benefits of home-based nursing intervention in primary health care. OBJECTIVES: To evaluate the effectiveness of a home-based, nurse-led-intervention (CuidaCare) on the quality of life of caregivers of individuals with disabilities or chronic conditions living in the community, measured at 12-month follow-up. METHODS: A pragmatic, two-arm, cluster-randomized controlled trial with a 1-year follow-up period was performed between June 2013 and December 2015. Consecutive caregivers aged 65 years or older, all of whom assumed the primary responsibility of caring for people with disabling conditions for at least 6 months a year, were recruited from 22 primary health care centers. Subsequently, 11 centers were randomly assigned to usual care group, and 11 were assigned to the intervention group. The caregivers in the intervention group received the usual care and additional support (cognitive restructuring, health education and emotional support). The primary outcome was quality of life, assessed with the EQ-5D instrument (visual analog scale and utility index score); the secondary outcome variables were perception of burden, anxiety, and depression. Data were collected at baseline, at the end of the intervention, and at the 6- and 12-month follow-up visits. We analyzed the primary outcome as intention-to-treat, and missing data were added using the conditional mean single imputation method. RESULTS: A total of 224 caregivers were included in the study (102 in the intervention group and 122 in the usual care group). Generalized Estimating Equation models showed that the CuidaCare intervention was associated with a 5.46 point (95% CI: 2.57; 8.35) change in the quality of life, as measured with the visual analog scale adjusted for the rest of the variables at 12 months. It also produced an increase of 0.04 point (95% CI: 0.01; 0.07) in the utilities. No statistically significant differences were found between the two groups at 12 months with respect to the secondary outcomes. CONCLUSIONS: The findings suggest that incorporating a home-based, nurse-led-intervention for caregivers into primary care can improve the health-related quality of life of caregivers of patients with chronic or disabling conditions.

[Evaluation of COVID-19 emergency and state of alarm impact on Neonatal Screening Programs in Madrid: endocrine and metabolic disorders program and hearing program review.] / Evaluación rápida del impacto de la crisis sanitaria generada por la epidemia de COVID-19 en los programas de cribado neonatal en la Comunidad de Madrid: programa de cribado neonatal de enfermedades endocrino-metabólicas y programa de detección precoz de hipoacusia en recién nacidas/os.

OBJECTIVE: Under the declaration of the state of alarm (SA) in efforts to control COVID-19, normal development of health programs was threatened. The aim of the study was the evaluation of COVID 19 emergency and SA approval impact on neonatal Endocrine and Metabolic Disorders Program (EMDP) and Neonatal Hearing Program (HP) in Madrid. METHODS: Qualitative and quantitative descriptive study was conducted. Semistructured interview was designed and developed to picture newborn screening activities taking place from January 1st to 31st of April 2020. To describe the undergo rates of newborn screening, neonatal screening information system (RECRINE) and martenity and prenatal care units were studied. Differences were analyzed using Chi2 test (p value = 0.05). RESULTS: More than 70% interviews were reported. Early hospital discharges, between 24 and 48h, were made in more than 80% hospitals. Screening programs were adapted in more than 75% health care centers. EMDP 19 diseases, RECRINE and Clinical Reference Units (RCU) referral were conducted. No significant incidences were observed in diagnostic confirmation and treatment in the RCU. RCU were adapted because of the reorganization of health care. 88.5% of the hospitals showed higher than 95% coverage rates on Hearing screening and SEM. No differences were observed compared to the pre-epidemic period. CONCLUSIONS: Our study demonstrates PCN professionals resilience. The importance of designing periodic evaluations to understand and alleviate the COVID-19 impact is remarkable. We need to assure 2020 newborns attention health care quality.

OBJETIVO: El estado de alarma decretado como medida de control de la epidemia COVID-19 supuso una amenaza en el correcto desarrollo de los programas de salud de la Comunidad de Madrid. El objetivo de este trabajo fue evaluar el impacto de la epidemia por COVID-19 y el estado de alarma decretado en los Programas de Cribado Neonatal (PCN) de Enfermedades Endocrino-Metabólicas (EEM) e hipoacusias en la Comunidad de Madrid. METODOS: Se realizó un estudio descriptivo cuali-cuantitativo del 1 enero al 31 abril de 2020. Para describir las actividades desarrolladas en las etapas de los PCN se diseñaron cuestionarios semiestructurados. Para conocer las coberturas de cribado se analizaron el REgistro de CRIbado Neonatal (RECRINE) e información de los Servicios de Maternidad. Se analizaron diferencias utilizando el test de Chi2 (p valor=0,05). RESULTADOS: Las tasas de respuesta a los cuestionarios fueron mayores del 70%. Más del 80% de los hospitales dieron altas precoces entre las 24 y 48 horas de vida del recién nacido. Se diseñaron circuitos alternativos para realizar los PCN en más del 75% de los centros. Se aseguró el cribado de las diecinueve enfermedades del PCN de EEM, el RECRINE y la derivación a las Unidades Clínicas de Referencia (UCR). No se observaron incidencias importantes en confirmación diagnóstica y tratamiento en las UCR que se adaptaron a la reorganización de la asistencia sanitaria. Se observaron coberturas de cribado auditivo y de EEM superiores al 95% en el 88,5% de los hospitales. No se observaron diferencias frente al periodo preepidémico. CONCLUSIONES: Nuestro estudio demuestra la resiliencia de los profesionales que participan en el desarrollo de los PCN. Es remarcable la importancia de continuar diseñando evaluaciones periódicas para conocer y subsanar el impacto de la epidemia de COVID-19 según los estándares de calidad de atención a la población nacida en 2020 y sus madres.

[Evaluation of a meningococcal ACWY catch-up vaccination program for adolescents on Community of Madrid.] / Evaluación de la vacunación de rescate frente a meningococo ACWY en adolescentes de la Comunidad de Madrid.

OBJECTIVE: In 2019 the Interterritorial Board of the Spanish National Health System approved the modification of the vaccination strategy against meningococcus. The objective of this study was to evaluate the meningococcal ACWY catch-up vaccination program in adolescents born in 2001 and 2002 in the Community of Madrid. METHODS: Cross-sectional population-based study. Vaccine coverage was estimated and factors associated with vaccination were assessed using logistic regression models. RESULTS: Vaccination coverage was 57.1% for those born in 2001 and 51.9% for those born in 2002. The probability of vaccination was higher in women (ORa=1.18), adolescents with chronic conditions (ORa=1.38), residents in rural areas (ORa=1.76) and in areas with lower socioeconomic level. Being born in 2002 (ORa=0.78) and abroad (ORa=0.35) were associated with a lower probability of vaccination. CONCLUSIONS: Coverage is high compared to similar campaigns in other settings, although there is significant room for improvement, so our study can contribute to the design of strategies to optimize results.

OBJETIVO: En 2019, el Consejo Interterritorial del Sistema Nacional de Salud aprobó la modificación de la estrategia de vacunación frente a meningococo. El objetivo de este estudio fue evaluar la vacunación de rescate frente a meningococo A, C, W, Y en adolescentes nacidos en 2001 y 2002 en la Comunidad de Madrid. METODOS: Se realizó un estudio transversal de base poblacional. Se determinó la cobertura vacunal y los factores asociados a la vacunación, utilizando modelos de regresión logística. RESULTADOS: La cobertura vacunal fue del 57,1% para nacidos en 2001 y del 51,9% para nacidos en 2002. La probabilidad de vacunación fue mayor en mujeres (ORa=1,18), adolescentes con alguna enfermedad crónica (ORa=1,38), residentes en el ámbito rural (ORa=1,76) y en zonas con menor nivel socioeconómico. Haber nacido en 2002 (ORa=0,78) y en el extranjero (ORa=0,35) se asociaron a una menor probabilidad de vacunación. CONCLUSIONES: La cobertura es elevada en comparación con campañas similares en otros entornos, aunque existe un importante margen de mejora, por lo que nuestro estudio puede contribuir al diseño de estrategias para optimizar los resultados.

Mapping analysis to predict EQ-5D-5 L utility values based on the Oxford Hip Score (OHS) and Oxford Knee Score (OKS) questionnaires in the Spanish population suffering from lower limb osteoarthritis.

BACKGROUND: The EQ-5D-5 L is a quality-of-life questionnaire based on individuals' preferences that is widely employed for cost-effectiveness analysis. Given the current demand for mapping algorithms to directly assign "utilities", this study aimed to generate different mapping models for predicting EQ-5D-5 L utility values based on scores of the Oxford Hip Score (OHS) and Oxford Knee Score (OKS) questionnaires provided by patients suffering from hip and knee osteoarthritis (OA), respectively, and to assess the predictive capability of these functions. METHODS: This was a prospective, observational study. Following the criteria of the American Rheumatism Association, 361 patients with hip OA and 397 with knee OA from three regions in Spain were included. Health-related quality of life (HRQoL) was assessed through the EQ-5D-5 L general questionnaire and the OHS and OKS specifically for lower limb OA. Based on the scores on the OHS and OKS questionnaires, EQ-5D-5 L utilities were estimated using 4 models: ordinary least squares (OLS), Tobit, generalized linear model (GLM), and beta regression (Breg). The models were validated on the same patients after 6 months: the mean absolute error (MAE) and mean squared error (MSE) with their 95% confidence intervals (CI), mean values of standard errors (SE), intraclass correlation coefficients (ICC), and Bland-Altman plots were obtained. RESULTS: The lowest MAEs were obtained using GLM and Breg models, with values of 0.1103 (0.0993-0.1214) and 0.1229 (0.1102-0.1335) for hip OA, and values of 0.1127 (0.1014-0.1239) and 0.1141 (0.1031-0.1251) for knee OA. MSE values were also lower using GLM and Breg. ICCs between predicted and observed values were around or over the 0.8 cut-off point. Bland-Altman plots showed an acceptable correlation, but precision was lower for subjects with worse HRQoL, which was also evident when comparing MAEs of the bottom and top halves of the utilities scale. Predictive equations for utilities based on OHS/OKS scores were proposed. CONCLUSIONS: The OHS and OKS scores allow for estimating EQ-5D-5 L utility indexes for patients with hip and knee OA, respectively, with adequate validity and precision. GLM and Breg produce the best predictions. The predictive power of proposed equations is more consistent for subjects in better health condition.

A primary healthcare information intervention for communicating cardiovascular risk to patients with poorly controlled hypertension: The Education and Coronary Risk Evaluation (Educore) study-A pragmatic, cluster-randomized trial.

PURPOSE: Uncertainty exists regarding the best way to communicate cardiovascular risk (CVR) to patients, and it is unclear whether the comprehension and perception of CVR varies according to the format used. The aim of the present work was to determine whether a strategy designed for communicating CVR information to patients with poorly controlled high blood pressure (HBP), but with no background of cardiovascular disease, was more effective than usual care in the control of blood pressure (BP) over the course of a year. METHODS: A pragmatic, two-arm, cluster-randomized controlled trial was performed. Consecutive patients aged 40-65 years, all diagnosed with HBP in the last 12 months, and all of whom showed poor control of their condition (systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg), were recruited at 22 primary healthcare centres. Eleven centres were randomly assigned to the usual care arm, and 11 to the informative intervention arm (Educore arm). At the start of the study, the Educore arm subjects were shown the "low risk SCORE table", along with impacting images and information pamphlets encouraging the maintenance of good cardiovascular health. The main outcome variable measured was the control of HBP; the secondary outcome variables were SCORE table score, total plasma cholesterol concentration, use of tobacco, adherence to prescribed treatment, and quality of life. RESULTS: The study participants were 411 patients (185 in the Educore arm and 226 in the usual care arm). Multilevel logistic regression showed that, at 12 months, the Educore intervention achieved better control of HBP (OR = 1.57; 1.02 to 2.41). No statistically significant differences were seen between the two arms at 12 months with respect to the secondary outcomes. CONCLUSIONS: Compared to usual care, the Educore intervention was associated with better control of HBP after adjusting for age, baseline SBP and plasma cholesterol, at 12 months.

Evaluación de la vacunación de rescate frente a meningococo ACWY en adolescentes de la Comunidad de Madrid / Evaluation of a meningococcal ACWY catch-up vaccination program for adolescents on Community of Madrid

OBJETIVO: En 2019, el Consejo Interterritorial del Sistema Nacional de Salud aprobó la modificación de la estrategia de vacunación frente a meningococo. El objetivo de este estudio fue evaluar la vacunación de rescate frente a meningococo A, C, W, Y en adolescentes nacidos en 2001 y 2002 en la Comunidad de Madrid. MÉTODOS: Se realizó un estudio transversal de base poblacional. Se determinó la cobertura vacunal y los factores asociados a la vacunación, utilizando modelos de regresión logística. RESULTADOS: La cobertura vacunal fue del 57,1% para nacidos en 2001 y del 51,9% para nacidos en 2002. La probabilidad de vacunación fue mayor en mujeres (ORa=1,18), adolescentes con alguna enfermedad crónica (ORa=1,38), residentes en el ámbito rural (ORa=1,76) y en zonas con menor nivel socioeconómico. Haber nacido en 2002 (ORa=0,78) y en el extranjero (ORa=0,35) se asociaron a una menor probabilidad de vacunación. CONCLUSIONES: La cobertura es elevada en comparación con campañas similares en otros entornos, aunque existe un importante margen de mejora, por lo que nuestro estudio puede contribuir al diseño de estrategias para optimizar los resultados

OBJECTIVE: In 2019 the Interterritorial Board of the Spanish National Health System approved the modification of the vaccination strategy against meningococcus. The objective of this study was to evaluate the meningococcal ACWY catch-up vaccination program in adolescents born in 2001 and 2002 in the Community of Madrid. METHODS: Cross-sectional population-based study. Vaccine coverage was estimated and factors associated with vaccination were assessed using logistic regression models. RESULTS: Vaccination coverage was 57.1% for those born in 2001 and 51.9% for those born in 2002. The probability of vaccination was higher in women (ORa=1.18), adolescents with chronic conditions (ORa=1.38), residents in rural areas (ORa=1.76) and in areas with lower socioeconomic level. Being born in 2002 (ORa=0.78) and abroad (ORa=0.35) were associated with a lower probability of vaccination. CONCLUSIONS: Coverage is high compared to similar campaigns in other settings, although there is significant room for improvement, so our study can contribute to the design of strategies to optimize results

Evaluación rápida del impacto de la crisis sanitaria generada por la epidemia de COVID-19 en los programas de cribado neonatal en la Comunidad de Madrid: programa de cribado neonatal de enfermedades endocrino-metabólicas y programa de detección precoz de hipoacusia en recién nacidas/os / Evaluation of COVID-19 emergency and state of alarm impact on Neonatal Screening Programs in Madrid: endocrine and metabolic disorders program and hearing program review

OBJETIVO: El estado de alarma decretado como medida de control de la epidemia COVID-19 supuso una amenaza en el correcto desarrollo de los programas de salud de la Comunidad de Madrid. El objetivo de este trabajo fue evaluar el impacto de la epidemia por COVID-19 y el estado de alarma decretado en los Programas de Cribado Neonatal (PCN) de Enfermedades Endocrino-Metabólicas (EEM) e hipoacusias en la Comunidad de Madrid. MÉTODOS: Se realizó un estudio descriptivo cuali-cuantitativo del 1 enero al 31 abril de 2020. Para describir las actividades desarrolladas en las etapas de los PCN se diseñaron cuestionarios semiestructurados. Para conocer las coberturas de cribado se analizaron el REgistro de CRIbado Neonatal (RECRINE) e información de los Servicios de Maternidad. Se analizaron diferencias utilizando el test de Chi2 (p valor=0,05). RESULTADOS: Las tasas de respuesta a los cuestionarios fueron mayores del 70%. Más del 80% de los hospitales dieron altas precoces entre las 24 y 48 horas de vida del recién nacido. Se diseñaron circuitos alternativos para realizar los PCN en más del 75% de los centros. Se aseguró el cribado de las diecinueve enfermedades del PCN de EEM, el RECRINE y la derivación a las Unidades Clínicas de Referencia (UCR). No se observaron incidencias importantes en confirmación diagnóstica y tratamiento en las UCR que se adaptaron a la reorganización de la asistencia sanitaria. Se observaron coberturas de cribado auditivo y de EEM superiores al 95% en el 88,5% de los hospitales. No se observaron diferencias frente al periodo preepidémico. CONCLUSIONES: Nuestro estudio demuestra la resiliencia de los profesionales que participan en el desarrollo de los PCN. Es remarcable la importancia de continuar diseñando evaluaciones periódicas para conocer y subsanar el impacto de la epidemia de COVID-19 según los estándares de calidad de atención a la población nacida en 2020 y sus madres

OBJECTIVE: Under the declaration of the state of alarm (SA) in efforts to control COVID-19, normal development of health programs was threatened. The aim of the study was the evaluation of COVID 19 emergency and SA approval impact on neonatal Endocrine and Metabolic Disorders Program (EMDP) and Neonatal Hearing Program (HP) in Madrid. METHODS: Qualitative and quantitative descriptive study was conducted. Semistructured interview was designed and developed to picture newborn screening activities taking place from January 1st to 31st of April 2020. To describe the undergo rates of newborn screening, neonatal screening information system (RECRINE) and martenity and prenatal care units were studied. Differences were analyzed using Chi2 test (p value = 0.05). RESULTS: More than 70% interviews were reported. Early hospital discharges, between 24 and 48h, were made in more than 80% hospitals. Screening programs were adapted in more than 75% health care centers. EMDP 19 diseases, RECRINE and Clinical Reference Units (RCU) referral were conducted. No significant incidences were observed in diagnostic confirmation and treatment in the RCU. RCU were adapted because of the reorganization of health care. 88.5% of the hospitals showed higher than 95% coverage rates on Hearing screening and SEM. No differences were observed compared to the pre-epidemic period. CONCLUSIONS: Our study demonstrates PCN professionals resilience. The importance of designing periodic evaluations to understand and alleviate the COVID-19 impact is remarkable. We need to assure 2020 newborns attention health care quality

Effectiveness of an intervention for improving drug prescription in primary care patients with multimorbidity and polypharmacy: study protocol of a cluster randomized clinical trial (Multi-PAP project).

BACKGROUND: Multimorbidity is associated with negative effects both on people's health and on healthcare systems. A key problem linked to multimorbidity is polypharmacy, which in turn is associated with increased risk of partly preventable adverse effects, including mortality. The Ariadne principles describe a model of care based on a thorough assessment of diseases, treatments (and potential interactions), clinical status, context and preferences of patients with multimorbidity, with the aim of prioritizing and sharing realistic treatment goals that guide an individualized management. The aim of this study is to evaluate the effectiveness of a complex intervention that implements the Ariadne principles in a population of young-old patients with multimorbidity and polypharmacy. The intervention seeks to improve the appropriateness of prescribing in primary care (PC), as measured by the medication appropriateness index (MAI) score at 6 and 12 months, as compared with usual care. METHODS/DESIGN: Design: pragmatic cluster randomized clinical trial. Unit of randomization: family physician (FP). Unit of analysis: patient. SCOPE: PC health centres in three autonomous communities: Aragon, Madrid, and Andalusia (Spain). POPULATION: patients aged 65-74 years with multimorbidity (≥3 chronic diseases) and polypharmacy (≥5 drugs prescribed in ≥3 months). SAMPLE SIZE: n = 400 (200 per study arm). INTERVENTION: complex intervention based on the implementation of the Ariadne principles with two components: (1) FP training and (2) FP-patient interview. OUTCOMES: MAI score, health services use, quality of life (Euroqol 5D-5L), pharmacotherapy and adherence to treatment (Morisky-Green, Haynes-Sackett), and clinical and socio-demographic variables. STATISTICAL ANALYSIS: primary outcome is the difference in MAI score between T0 and T1 and corresponding 95% confidence interval. Adjustment for confounding factors will be performed by multilevel analysis. All analyses will be carried out in accordance with the intention-to-treat principle. DISCUSSION: It is essential to provide evidence concerning interventions on PC patients with polypharmacy and multimorbidity, conducted in the context of routine clinical practice, and involving young-old patients with significant potential for preventing negative health outcomes. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02866799.