Increased peripartum mortality associated with maternal subclinical malaria in Mozambique.

BACKGROUND: Plasmodium falciparum infection in pregnant women in sub-Saharan Africa is often asymptomatic. As these forms of malaria are often submicroscopic and difficult to diagnose by conventional methods (microscopy and/or rapid diagnostic test), diagnosis requires the use of molecular techniques such as polymerase chain reaction (PCR). This study analyses the prevalence of subclinical malaria and its association with adverse maternal and neonatal outcomes, a topic that has been scarcely evaluated in the literature. METHODS: A cross-sectional study was conducted using semi-nested multiplex PCR to assess the presence of P. falciparum in placental and peripheral blood of 232 parturient pregnant women at the Hospital Provincial de Tete, Mozambique between March 2017 and May 2019. Multivariate regressions were performed to assess the associations of maternal subclinical malaria with several maternal and neonatal outcomes after controlling for the presence of preeclampsia/eclampsia (PE/E) and HIV infection, as well as for other maternal and pregnancy characteristics. RESULTS: In total, 17.2% (n = 40) of the women studied had positive PCR for P. falciparum (7 in placental blood only, 3 in peripheral blood only). We found a significant association between subclinical malaria and a higher peripartum mortality risk, which persisted after controlling for maternal comorbidity and maternal and pregnancy characteristics (adjusted odds ratio: 3.50 [1.11-10.97]). In addition, PE/E and HIV infections were also significantly associated with several adverse maternal and neonatal outcomes. CONCLUSION: This study demonstrated the association of subclinical malaria, as well as of PE/E and HIV, in pregnant women with adverse maternal and neonatal outcomes. Therefore, molecular methods may be sensitive tools to identify asymptomatic infections that can reduce the impact on peripartum mortality and their contribution to sustained transmission of the parasite in endemic countries.

The Broader Opportunity Costs in the Broader Cost-Effectiveness Analysis Framework.

BACKGROUND: The traditional cost-effectiveness analysis framework usually takes a healthcare system perspective, where the aim is to maximise population health from a fixed budget allocated to healthcare. Extensions to this framework have been suggested, including: (i) incorporating impacts that fall outside the healthcare sector; (ii) accounting for outcomes beyond health; and (iii) assessing equity considerations. Several alternatives have been proposed that serve these purposes, for example, the extended "impact inventory", the "beyond-the-QALY" approach and the distributional cost-effectiveness analysis. OBJECTIVE: This paper aims to develop a comprehensive framework that incorporates into the cost-effectiveness analysis framework some of its most advocated extensions and provides a means of arriving at a unidimensional cost-effectiveness analysis result measure. METHODS: Building on previous work, I proposed a framework that explicitly incorporates the full extent of the opportunity costs that arise when new dimensions and distributional concerns are included in cost-effectiveness analyses. A hypothetical example is provided as a way of illustration. RESULTS: Operationalising the proposed framework requires system-wide representative values and/or robust estimates concerning: (i) selecting dimensions; (ii) measuring opportunity costs associated with each dimension; (iii) quantifying equity weights and percentages of beneficiaries and losers meeting equity considerations; and (iv) attaching monetary values to dimensions measured using a non-monetary metric. CONCLUSIONS: Extending the cost-effectiveness analysis framework entails extending the measurement of the opportunity costs of funding decisions. This implies populating an ambitious puzzle that in some cases poses fundamental conceptual and empirical questions. Potential routes of further research that might facilitate such undertaking are proposed.

Socioeconomic and contextual determinants of the burden of disease attributable to metabolic risks in childhood.

We analyze the socioeconomic and political contextual determinants of the burden of disease attributable to three metabolic risks in children: kidney dysfunction, high fasting plasma glucose, and high body-mass index. We use data from 121 countries. We matched data of the Global Burden of Disease project, World Bank and United Nations databases. The burden of disease is measured with the Disability Adjusted Life Years lost. We explore associations with four groups of variables: (i) income level, which measures differences in socioeconomic conditions between countries; (ii) income inequality, which measures within country inequalities in the income distribution; (iii) health care expenditure, which measures the resources allocated to health and healthcare, and (iv) women empowerment, which we measure in terms of both educational and political participation. Our findings point toward the need to act at the root of the underlying factors underpinning the disease burden, namely: reducing between and, particularly, within-country income inequalities, increasing the role of expenditure on health, and ensuring women empowerment and girls education. To our knowledge, this is the first study that have identified the associations of these variables with the burden of disease that is specifically attributable to metabolic risks in childhood.

Association between maternal and paternal employment and their children's weight status and unhealthy behaviours: does it matter who the working parent is?

BACKGROUND: The growing number of employed women has been associated with an increase in the prevalence of overweight and obesity in children. We sought to determine whether childhood overweight/obesity in Spain is associated with labour participation of mothers and fathers, and whether the identity of the main caregiver has an influence on child's weight and unhealthy behaviour. METHODS: We used microdata from the 2010 and 2014 Health Behaviour in School-Aged Children surveys performed in Spain (n = 32,694). Logistic and linear multi-level regression models were applied to assess the association between parental employment and children's self-reported weight status, accounting for school effects and controlling for socioeconomic factors. Separated binary models were also fitted for consumption of fruit, sweets, screen viewing and sedentarism. RESULTS: In most cases, the significant associations between children's weight and their parents' work status disappeared once the models were adjusted for family wealth and education. However, we found persistent associations for some groups. Girls under 13 years-old living in households where the mother was the only employed parent were more likely to be affected by obesity and to report a higher body mass index value. Children in this type of household were more likely to show unhealthy lifestyles related to diet and leisure time activities. CONCLUSIONS: Parents' socioeconomic characteristics had a protective effect on their children's risk of obesity. Unhealthy behaviours were observed in households with a non-working father and a working mother, although the link with obesity was limited to girls. Our results suggest the need for a more equally shared burden of caregiving.

Cost-effectiveness of multicomponent interventions in type 2 diabetes mellitus in a cluster randomised controlled trial: the INDICA study.

OBJECTIVE: To analyse the cost-effectiveness of multicomponent interventions designed to improve outcomes in type 2 diabetes mellitus (T2DM) in primary care in the Canary Islands, Spain, within the INDICA randomised clinical trial, from the public health system perspective. DESIGN: An economic evaluation was conducted for the within-trial period (2 years) comparing the four arms of the INDICA study. SETTING: Primary care in the Canary Islands, Spain. PARTICIPANTS: 2334 patients with T2DM without complications were included. INTERVENTIONS: Interventions for patients (PTI), for primary care professionals (PFI), for both (combined intervention arm for patients and professionals, CBI) and usual care (UC) as a control group. OUTCOMES: The main outcome was the incremental cost per quality-adjusted life-years (QALY). Only the intervention and the healthcare costs were included. ANALYSIS: Multilevel models were used to estimate results, and to measure the size and significance of incremental changes. Missed values were treated by means of multiple imputations procedure. RESULTS: There were no differences between arms in terms of costs (p=0.093), while some differences were observed in terms of QALYs after 2 years of follow-up (p=0.028). PFI and CBI arms were dominated by the other two arms, PTI and UC. The differences between the PTI and the UC arms were very small in terms of QALYs, but significant in terms of healthcare costs (p=0.045). The total cost of the PTI arm (€2571, 95% CI €2317 to €2826) was lower than the cost in the UC arm (€2750, 95% CI €2506 to €2995), but this difference did not reach statistical significance. Base case estimates of the incremental cost per QALY indicate that the PTI strategy was the cost-effective option. CONCLUSIONS: The INDICA intervention designed for patients with T2DM and families is likely to be cost-effective from the public healthcare perspective. A cost-effectiveness model should explore this in the long term. TRIAL REGISTRATION NUMBER: NCT01657227.

Are Estimates of the Health Opportunity Cost Being Used to Draw Conclusions in Published Cost-Effectiveness Analyses? A Scoping Review in Four Countries.

BACKGROUND: When healthcare budgets are exogenous, cost-effectiveness thresholds (CETs) used to inform funding decisions should represent the health opportunity cost (HOC) of such funding decisions, but HOC-based CET estimates have not been available until recently. In recent years, empirical HOC-based CETs for multiple countries have been published, but the use of these CETs in the cost-effectiveness analysis (CEA) literature has not been investigated. Analysis of the use of HOC-based CETs by researchers undertaking CEAs in countries with different decision-making contexts will provide valuable insights to further understand barriers and facilitators to the acceptance and use of HOC-based CETs. OBJECTIVES: We aimed to identify the CET values used to interpret the results of CEAs published in the scientific literature before and after the publication of jurisdiction-specific empirical HOC-based CETs in four countries. METHODS: We undertook a scoping review of CEAs published in Spain, Australia, the Netherlands and South Africa between 2016 (2014 in Spain) and 2020. CETs used before and after publication of HOC estimates were recorded. We conducted logit regressions exploring factors explaining the use of HOC values in identified studies and linear models exploring the association of the reported CET value with study characteristics and results. RESULTS: 1171 studies were included in this review (870 CEAs and 301 study protocols). HOC values were cited in 28% of CEAs in Spain and in 11% of studies conducted in Australia, but they were not referred to in CEAs undertaken in the Netherlands and South Africa. Regression analyses on Spanish and Australian studies indicate that more recent studies, studies without a conflict of interest and studies estimating an incremental cost-effectiveness ratio (ICER) below the HOC value were more likely to use the HOC as a threshold reference. In addition, we found a small but significant impact indicating that for every dollar increase in the estimated ICER, the reported CET increased by US$0.015. Based on the findings of our review, we discuss the potential factors that might explain the lack of adoption of HOC-based CETs in the empirical CEA literature. CONCLUSIONS: The adoption of HOC-based CETs by identified published CEAs has been uneven across the four analysed countries, most likely due to underlying differences in their decision-making processes. Our results also reinforce a previous finding indicating that CETs might be endogenously selected to fit authors' conclusions.

Empirical Estimates of the Marginal Cost of Health Produced by a Healthcare System: Methodological Considerations from Country-Level Estimates.

Many health technology assessment committees have an explicit or implicit reference value (often referred to as a 'threshold') below which new health technologies or interventions are considered value for money. The basis for these reference values is unclear but one argument is that it should be based on the health opportunity costs of funding decisions. Empirical estimates of the marginal cost per unit of health produced by a healthcare system have been proposed to capture the health opportunity costs of new funding decisions. Based on a systematic search, we identified eight studies that have sought to estimate a reference value through empirical estimation of the marginal cost per unit of health produced by a healthcare system for England, Spain, Australia, The Netherlands, Sweden, South Africa and China. We review these eight studies to provide an overview of the key methodological approaches taken to estimate the marginal cost per unit of health produced by the healthcare system with the aim to help inform future estimates for additional countries. The lead author for each of these papers was invited to contribute to the current paper to ensure all the key methodological issues encountered were appropriately captured. These included consideration of the key variables required and their measurement, accounting for endogeneity of spending to health outcomes, the inclusion of lagged spending, discounting and future costs, the use of analytical weights, level of disease aggregation, expected duration of health gains, and modelling approaches to estimating mortality and morbidity effects of health spending. Subsequent research estimates for additional countries should (1) carefully consider the specific context and data available, (2) clearly and transparently report the assumptions made and include stakeholder perspectives on their appropriateness and acceptability, and (3) assess the sensitivity of the preferred central estimate to these assumptions.

The Economic Impact of the SARS-COV-2 (COVID-19) Pandemic in Spain.

BACKGROUND: The COVID-19 pandemic has hit both the Spanish economy and the population's health hard. The result is an unprecedented economic and social crisis due to uncertainty about the remedy and the socioeconomic effects on people's lives. METHODS: We performed a retrospective analysis of the macroeconomic impact of the COVID-19 pandemic in 2020 using key indicators of the Spanish economy for the 17 Autonomous Communities (ACs) of the country. National statistics were examined in the search for impacts or anomalies occurring since the beginning of the pandemic. To estimate the strength of the impact on each of the indicators analyzed, we used Bayesian structural time series. We also calculated the correlation between the rate of GDP decline during 2020 and the cumulative incidence of COVID-19 cases per 100,000 inhabitants in the ACs. RESULTS: In 2020, the cumulative impact on the gross domestic product was of -11.41% (95% credible interval: -13.46; -9.29). The indicator for business turnover changed by -9.37% (-12.71; -6.07). The Spanish employment market was strongly affected; our estimates showed a cumulative increase of 11.9% (4.27; 19.45) in the rate of unemployment during 2020. The worst indicators were recorded in the ACs most economically dependent on the services sector. There was no statistical association between the incidence of COVID-19 in 2020 and the fall in GDP in the ACs. CONCLUSIONS: Our estimates portray a dramatic situation in Spain, where the COVID-19 crisis has had more serious economic and health consequences than in other European countries. The productive system in Spain is too dependent on sectors vulnerable to the pandemic, and it is necessary to design and implement profound changes through the European Next Generation program.

[Cost-effectiveness methods of newborn screening assessment.] / Métodos para la evaluación económica de programas de cribado neonatal.

Newborn screening programs are a fundamental tool for secondary prevention or pre-symptomatic detection of certain conditions. The implementation of a newborn screening program requires an evaluation of effectiveness, safety, cost-effectiveness, feasibility and budget impact. Economic evaluation aims to contribute to the sustainability and solvency of health systems, especially when it comes to informing about financing health interventions with public funds. This funding must be justified on the basis of robust evidence of effectiveness, safety, cost-effectiveness, and acceptability. One of the most important limitations when evaluating the cost-effectiveness of a newborn screening program for hereditary disorders or congenital errors of metabolism is the scarcity of scientific evidence that limits the robustness of the economic analysis. Given the low availability of data, the use of expert opinion as a data source is unavoidable to complete the information. However, two main problems make it difficult to synthesize data obtained from various sources: biases and heterogeneity. Moreover, the measurement of quality-adjusted life years (QALYs) in pediatric populations poses serious methodological challenges. In Spain, although there is some heterogeneity in the supply of newborn screening programs between regions, guidelines are being established based on the best available scientific evidence to achieve the homogenization of newborn screening policies and programs at national level.

Los programas de cribado neonatal son una herramienta fundamental para la prevención secundaria o detección presintomática de determinadas afecciones. La implantación de un programa de cribado neonatal requiere necesariamente de una evaluación de su efectividad, seguridad, coste-efectividad, factibilidad e impacto presupuestario. La evaluación económica pretende contribuir a la sostenibilidad y solvencia de los sistemas sanitarios, especialmente a la hora de informar sobre la posible financiación, con fondos públicos, de intervenciones sanitarias como el cribado poblacional. Esta financiación debe justificarse en base a pruebas robustas de efectividad, seguridad, coste-efectividad y aceptabilidad. Una de las limitaciones más importantes a la hora de evaluar el coste-efectividad de un programa de cribado neonatal de trastornos hereditarios o de errores congénitos del metabolismo es la escasez de evidencia científica que limita la solidez y robustez del análisis de evaluación económica. Dada la baja disponibilidad de datos, el uso de la opinión de expertos como fuente de datos es inevitable para completar la información necesaria. Sin embargo, dos problemas principales dificultan la síntesis de datos obtenidos de varias fuentes: sesgos y heterogeneidad. Por otro lado, la medición de los años de vida ajustados por calidad (AVAC) en poblaciones pediátricas plantea serios desafíos metodológicos en un análisis de evaluación económica. En España, aunque existe cierta heterogeneidad en la oferta de programas de cribado neonatal entre CC.AA., se están estableciendo directrices basadas en la mejor evidencia científica disponible para conseguir la homogeneización de políticas y programas de cribado neonatal a nivel nacional.

Cost-effectiveness analysis of a surveillance program to prevent hip dislocation in children with cerebral palsy / Análisis de coste-utilidad de un programa de vigilancia para prevenir la luxación de cadera en niños y niñas con parálisis cerebral

OBJECTIVE: In this study we conducted an economic evaluation of a surveillance programme to prevent hip dislocation in children with cerebral palsy. METHOD: We developed a model that compared costs and health outcomes of children with cerebral palsy with and without a surveillance programme. Information from a number of sources was combined into a decision analytical model, primarily based on data from a comparative study with a 20-year follow-up. Effectiveness was measured using Quality-Adjusted Life Years (QALYs). The analysis took the perspective of the Spanish National Health Service. We undertook extensive sensitivity analyses including a probabilistic sensitivity analysis. RESULTS: The surveillance programme led to higher QALYs and higher health care costs, with an estimated incremental cost per QALY gained of 12,282€. The results were robust to model assumptions. The probability that the programme was cost-effective was estimated to be over 80% at the threshold of 25.000€/QALY recommended in Spain. CONCLUSION: This study indicates that surveillance programmes to prevent hip dislocation in children with cerebral palsy are likely to be cost-effective

OBJETIVO: En este estudio se realiza una evaluación económica de un programa de vigilancia para prevenir la luxación de cadera en niños y niñas con parálisis cerebral. MÉTODO: Se desarrolló un modelo que comparó los costes y los resultados en salud de niños y niñas con parálisis cerebral incluidas y no incluidas en un programa de vigilancia. Se combinó la información proveniente de diversas fuentes en un modelo analítico de decisión, principalmente basado en datos de un estudio comparativo con 20 años de seguimiento. La efectividad se midió empleando los años de vida ajustados por calidad (AVAC). El análisis tomó la perspectiva del Sistema Nacional de Salud de España. Se realizó un extenso análisis de sensibilidad, incluyendo un análisis de sensibilidad probabilístico. RESULTADOS: El programa de vigilancia estuvo asociado a más AVAC y mayores costes sanitarios, con un coste incremental por AVAC ganado estimado en 12.282 €. Los resultados fueron robustos a los supuestos del modelo. La probabilidad de que el programa fuera coste-efectivo se estimó en un valor por encima del 80% para el umbral de 25.000 € por AVAC recomendado en España. CONCLUSIÓN: Este estudio indica que es probable que los programas de vigilancia para prevenir la luxación de cadera en niños y niñas con parálisis cerebral sean coste-efectivos

Cost-effectiveness of the hospital nutrition screening tool CIPA.

INTRODUCTION: Hospital malnutrition is very common and worsens the clinical course of patients while increasing costs. Lacking clinical-economic studies on the implementation of nutrition screening encouraged the evaluation of the CIPA (Control of Food Intake, Protein, Anthropometry) tool. MATERIAL AND METHODS: An open, non-randomized, controlled clinical trial was conducted on patients admitted to internal medicine and general and digestive surgery wards, who were either assigned to a control (standard hospital clinical care) or to an intervention, CIPA-performing ward (412 and 411, respectively; n = 823). Length of stay, mortality, readmission, in-hospital complications, and quality of life were evaluated. Cost-effectiveness was analysed in terms of cost per quality-adjusted life years (QALYs). RESULTS: The mean length of stay was higher in the CIPA group, though not significantly (+ 0.95 days; p = 0.230). On the surgical ward, more patients from the control group moved to critical care units (p = 0.014); the other clinical variables did not vary. Quality of life at discharge was similar (p = 0.53), although slightly higher in the CIPA group at 3 months (p = 0.089). Patients under CIPA screening had a higher mean cost of € 691.6 and a mean QALY gain over a 3-month period of 0.0042. While the cost per QALY for the internal medicine patients was € 642 282, the results for surgical patients suggest that the screening tool is both less costly and more effective. CONCLUSIONS: The CIPA nutrition screening tool is likely to be cost-effective in surgical but not in internal medicine patients.

¿Cuál es el verdadero coste de incluir la vacuna 4CMenB (Bexsero) en el calendario infantil? / No disponible

No disponible

Evaluación económica de programas de vacunación en la población pediátrica / Economic evaluation of vaccine programmes in paediatric populations

En el contexto generalizado de recursos limitados para financiar las intervenciones sanitarias disponibles para una población, se requieren criterios explícitos que permitan seleccionar el conjunto de prestaciones que aporten el mayor beneficio en salud posible con los recursos existentes. La evaluación económica de intervenciones sanitarias es una herramienta de análisis que compara los costes y los resultados en salud de programas sanitarios alternativos con el fin de informar sobre su eficiencia. El marco tradicional de la evaluación económica presenta algunas limitaciones para la evaluación específica de intervenciones de salud pública, como son los programas de vacunación, especialmente los destinados a la población pediátrica. Entre ellos se destacan los desafíos que presenta evaluar intervenciones donde los efectos en salud ocurren en el largo plazo, sobre poblaciones diferentes a las que se aplica la intervención, con posibles efectos adversos en población sana, con efectos intangibles considerables, con implicaciones relevantes sobre la desigualdad, y que requieren de la medición de resultados en salud en niños y niñas, así como en sus entornos. Entre las principales vías de avance para que las evaluaciones económicas sean capaces de abordar las problemáticas inherentes a los programas de vacunación en población pediátrica destacamos la posibilidad de emplear medidas de resultados capaces de captar beneficios de bienestar social más allá de las mejoras en salud individuales, así como la aplicación de los métodos que caractericen los efectos dinámicos y los altos niveles de incertidumbre cuando estos sean necesarios

In the widespread context of limited resources to fund health care interventions available to a population, explicit criteria are required to select the health care package that achieves the maximum population health with existing resources. Economic evaluation of health interventions is an analytical tool that compares the costs and health benefits of alternative health programmes with the aim to inform about their efficiency. The traditional economic evaluation framework has some limitations for the specific evaluation of public health programmes such as vaccine programmes, especially for those targeted to the paediatric population. Among these, we highlight the challenges of evaluating interventions with long-term health effects on different populations to which the intervention is applied, with possible adverse events on healthy individuals, with considerable intangible effects, with relevant implications on inequalities, and that require the quantification of health effects on children as well as their relatives. The main lines of further developments for economic evaluation to address the inherent issues of vaccine programmes for children that we highlight consist in the possibility of using outcomes measures capable of capturing social well-being benefits beyond individual health improvements, as well as the application of methods to characterise dynamic effects and high levels of uncertainty when these are needed

Cost-effectiveness analysis of a surveillance program to prevent hip dislocation in children with cerebral palsy.

OBJECTIVE: In this study we conducted an economic evaluation of a surveillance programme to prevent hip dislocation in children with cerebral palsy. METHOD: We developed a model that compared costs and health outcomes of children with cerebral palsy with and without a surveillance programme. Information from a number of sources was combined into a decision analytical model, primarily based on data from a comparative study with a 20-year follow-up. Effectiveness was measured using Quality-Adjusted Life Years (QALYs). The analysis took the perspective of the Spanish National Health Service. We undertook extensive sensitivity analyses including a probabilistic sensitivity analysis. RESULTS: The surveillance programme led to higher QALYs and higher health care costs, with an estimated incremental cost per QALY gained of 12,282€. The results were robust to model assumptions. The probability that the programme was cost-effective was estimated to be over 80% at the threshold of 25.000€/QALY recommended in Spain. CONCLUSION: This study indicates that surveillance programmes to prevent hip dislocation in children with cerebral palsy are likely to be cost-effective.

The societal monetary value of a QALY associated with EQ-5D-3L health gains.

There is an extensive body of empirical research that focuses on the societal monetary value of a quality-adjusted life year (MVQALY). Many of these studies have found the estimates to be inversely associated with the size of the health gain, and thus not conforming to the linearity assumption imposed in the QALY model. In this study, we explore the extent to which the MVQALY varies when it is associated with different types and magnitudes of quality of life (QoL) improvements. To allow for a comprehensive assessment, we derive the MVQALY corresponding to the full spectrum of health gains defined by the EQ-5D-3L instrument. The analysis was based on a large and representative sample of the population in Spain. A discrete choice experiment and a time trade-off exercise were used to derive a value set for utilities, followed by a willingness to pay questionnaire. The data were jointly analysed using regression analyses and bootstrapping techniques. Our findings indicate that societal values for a QALY corresponding to different EQ-5D-3L health gains vary approximately between 10,000€ and 30,000€. MVQALY associated with larger improvements on QoL was found to be lower than that associated with moderate QoL gains. The potential sources of the observed non-constant MVQALY are discussed.

Effectiveness and cost-effectiveness of a multicomponent intervention to implement a clinical practice guideline for systemic lupus erythematosus: protocol for a cluster-randomized controlled trial.

BACKGROUND: Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease with significant potential morbidity and mortality. Substantial gaps have been documented between the development and dissemination of clinical practice guidelines (CPG) and their implementation in practice. The aim of this study is to assess the effectiveness and cost-effectiveness of a multi-component knowledge transfer intervention to implement a CPG for the management of SLE (CPG-SLE). METHODS: The study is an open, multicentre, controlled trial with random allocation by clusters to intervention or control. Clusters are four public university hospitals of the Canary Islands Health Service where rheumatologists are invited to participate. Patients diagnosed with SLE at least one year prior to recruitment are selected. Rheumatologists in intervention group receive a short educational group programme to both update their knowledge about SLE management according to CPG-SLE recommendations and to acquire knowledge and training on use of the patient-centred approach, a decision support tool embedded in the electronic clinical record and a quarterly feedback report containing information on management of SLE patients. Primary endpoint is change in self-perceived disease activity. Secondary endpoints are adherence of professionals to CPG-SLE recommendations, health-related quality of life, patient perception of their participation in decision making, attitudes of professionals towards shared decision making, knowledge of professionals about SLE and use of healthcare resources. Calculated sample size is 412 patients. Data will be collected from questionnaires and clinical records. Length of follow-up will be 18 months. Multilevel mixed models with repeated time measurements will be used to analyze changes in outcomes over time. Cost-effectiveness, from both social and healthcare services perspectives, will be analyzed by measuring effectiveness in terms of quality-adjusted life years gained. Deterministic and probabilistic sensitivity analyses are planned. DISCUSSION: Impact of CPGs in clinical practice could be improved by applying proven value interventions to implement them. The results of this ongoing trial are expected to generate important scientifically valid and reproducible information not only on clinical effectiveness but also on cost-effectiveness of a multi-component intervention for implementation of a CPG based on communication technologies for chronic patients in the hospital setting. TRIAL REGISTRATION: ClinicalTrial.gov NCT03537638 . Registered on 25 May 2018.

Comparison of Clinical Outcomes in Surgical Patients Subjected to CIPA Nutrition Screening and Treatment versus Standard Care.

Malnutrition is prevalent in surgical patients and leads to comorbidities and a poorer postoperative course. There are no studies that compare the clinical outcomes of implementing a nutrition screening tool in surgical patients with standard clinical practice. An open, non-randomized, controlled study was conducted in general and digestive surgical hospitalized patients, who were either assigned to standard clinical care or to nutrition screening using the Control of Food Intake, Protein, and Anthropometry (CIPA) tool and an associated treatment protocol (n = 210 and 202, respectively). Length of stay, mortality, readmissions, in-hospital complications, transfers to critical care units, and reinterventions were evaluated. Patients in the CIPA group had a higher Charlson index on admission and underwent more oncological and hepatobiliary-pancreatic surgeries. Although not significant, a shorter mean length of stay was observed in the CIPA group (-1.48 days; p < 0.246). There were also fewer cases of exitus (seven vs. one) and fewer transfers to critical care units in this group (p = 0.068 for both). No differences were detected in other clinical variables. In conclusion, patients subjected to CIPA nutrition screening and treatment showed better clinical outcomes than those receiving usual clinical care. The results were not statistically significant, possibly due to the heterogeneity across patient groups.

Predictive factors for multidrug-resistant gram-negative bacteria among hospitalised patients with complicated urinary tract infections.

Background: Patients with complicated urinary tract infections (cUTIs) frequently receive broad-spectrum antibiotics. We aimed to determine the prevalence and predictive factors of multidrug-resistant gram-negative bacteria in patients with cUTI. Methods: This is a multicenter, retrospective cohort study in south and eastern Europe, Turkey and Israel including consecutive patients with cUTIs hospitalised between January 2013 and December 2014. Multidrug-resistance was defined as non-susceptibility to at least one agent in three or more antimicrobial categories. A mixed-effects logistic regression model was used to determine predictive factors of multidrug-resistant gram-negative bacteria cUTI. Results: From 948 patients and 1074 microbiological isolates, Escherichia coli was the most frequent microorganism (559/1074), showing a 14.5% multidrug-resistance rate. Klebsiella pneumoniae was second (168/1074) and exhibited the highest multidrug-resistance rate (54.2%), followed by Pseudomonas aeruginosa (97/1074) with a 38.1% multidrug-resistance rate. Predictors of multidrug-resistant gram-negative bacteria were male gender (odds ratio [OR], 1.66; 95% confidence interval [CI], 1.20-2.29), acquisition of cUTI in a medical care facility (OR, 2.59; 95%CI, 1.80-3.71), presence of indwelling urinary catheter (OR, 1.44; 95%CI, 0.99-2.10), having had urinary tract infection within the previous year (OR, 1.89; 95%CI, 1.28-2.79) and antibiotic treatment within the previous 30 days (OR, 1.68; 95%CI, 1.13-2.50). Conclusions: The current high rate of multidrug-resistant gram-negative bacteria infections among hospitalised patients with cUTIs in the studied area is alarming. Our predictive model could be useful to avoid inappropriate antibiotic treatment and implement antibiotic stewardship policies that enhance the use of carbapenem-sparing regimens in patients at low risk of multidrug-resistance.

Cost-effectiveness analysis of real-time continuous monitoring glucose compared to self-monitoring of blood glucose for diabetes mellitus in Spain.

RATIONALE, AIMS AND OBJECTIVES: Self-monitoring of blood glucose (SMBG) is recommended to monitor glycaemic levels. The recent development of real-time continuous glucose monitoring (RT-CGM) enables continuous display of glucose concentration alerting patients in the event of relevant glucose fluctuations, potentially avoiding hypoglycaemic events and reducing long-term complications related to glycosylated haemoglobin (HbA1c) levels. This paper aims to evaluate the cost-effectiveness of RT-CGM compared to SMBG in patients with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) which should support decision-making on public funding of RT-CGM in Spain. METHODS: We performed a systematic review and meta-analyses on the effectiveness of RT-CGM in the reduction of HbA1c levels and severe hypoglycaemic events. A cost-effectiveness analysis was conducted using a Markov model which simulates the costs and health outcomes of individuals treated under these alternatives for a lifetime horizon from the perspective of the Spanish Health Service. The effectiveness measure was quality-adjusted life years (QALYs). We ran extensive sensitivity analyses, including a probabilistic sensitivity analysis. RESULTS: Real-time continuous glucose monitoring provides a significant reduction of HbA1c for T1DM (13 studies; weighted mean difference (WMD) = -0.23%, 95% CI: -0.35, -0.11) and T2DM (5 studies; WMD = -0.48%, 95% CI: -0.79, -0.17). There were no statistically significant differences in the rate of severe hypoglycaemic events in T1DM (9 studies; OR = 1.16, 95% CI: 0.78, 1.72) or T2DM (no severe hypoglycaemic events were reported in any study). In the base case analysis, RT-CGM led to higher QALYs and health care costs with an estimated incremental cost-effectiveness ratio of €2 554 723 and €180 553 per QALY for T1DM and T2DM patients respectively. Sensitivity analyses revealed that the study results were robust. CONCLUSIONS: Real-time continuous glucose monitoring is not a cost-effective technology when compared to SMBG in Spain.