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.

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.

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.

Estimating a cost-effectiveness threshold for the Spanish NHS.

The cost of generating a quality-adjusted life year (QALY) within a National Health Service provides an approximation of the average opportunity cost of funding decisions. This information can be used to inform a cost-effectiveness threshold. The aim of this paper is to estimate the cost per QALY at the Spanish National Health Service. We exploit variation across 17 regional health services and the exogenous changes in expenditure that took place as a consequence of the economic crisis over 5 years of data. We conduct fixed effect models and use an instrumental variable approach to test for potential remaining endogeneity. Our results show that health expenditure has a positive and significant effect on population health, with an average spending elasticity of 0.07. This translates into a cost per QALY of between 22,000€ and 25,000€. These values are below the cost-effectiveness threshold figure of 30,000€ commonly cited in Spain.

Clinical and cost-effectiveness analysis of early detection of patients at nutrition risk during their hospital stay through the new screening method CIPA: a study protocol.

BACKGROUND: Malnutrition is highly prevalent in hospitalized patients and results in a worsened clinical course as well as an increased length of stay, mortality, and costs. Therefore, simple nutrition screening systems, such as CIPA (control of food intake, protein, anthropometry), may be implemented to facilitate the patient's recovery process. The aim of this study is to evaluate the effectiveness and cost-effectiveness of implementing such screening tool in a tertiary hospital, consistent with the lack of similar, published studies on any hospital nutrition screening system. METHODS: The present study is carried out as an open, controlled, randomized study on patients that were admitted to the Internal Medicine and the General and Digestive Surgery ward; the patients were randomized to either a control or an intervention group (n = 824, thereof 412 patients in each of the two study arms). The control group underwent usual inpatient clinical care, while the intervention group was evaluated with the CIPA screening tool for early detection of malnutrition and treated accordingly. CIPA nutrition screening was performed upon hospital admission and classified positive when at least one of the following parameters was met: 72 h food intake control < 50%, serum albumin < 3 g/dL, body mass index < 18.5 kg/m2 (or mid-upper arm circumference ≤ 22.5 cm). In this case, the doctor decided on whether or not providing nutrition support. The following variables will be evaluated: hospital length of stay (primary endpoint), mortality, 3-month readmission, and in-hospital complications. Likewise, the quality of life questionnaires EQ-5D-5 L are being collected for all patients at hospital admission, discharge, and 3 months post-discharge. Analysis of cost-effectiveness will be performed by measuring effectiveness in terms of quality-adjusted life years (QALYs). The cost per patient will be established by identifying health care resource utilization; cost-effectiveness will be determined through the incremental cost-effectiveness ratio (ICER). We will calculate the incremental cost per QALY gained with respect to the intervention. DISCUSSION: This ongoing trial aims to evaluate the cost-effectiveness of implementing the malnutrition screening tool CIPA in a tertiary hospital. TRIAL REGISTRATION: Clinical Trial.gov ( NCT02721706 ). First receivevd: March 1, 2016 Last updated: April 8, 2017 Last verified: April 2017.

On the Estimation of the Cost-Effectiveness Threshold: Why, What, How?

BACKGROUND: Many health care systems claim to incorporate the cost-effectiveness criterion in their investment decisions. Information on the system's willingness to pay per effectiveness unit, normally measured as quality-adjusted life-years (QALYs), however, is not available in most countries. This is partly because of the controversy that remains around the use of a cost-effectiveness threshold, about what the threshold ought to represent, and about the appropriate methodology to arrive at a threshold value. OBJECTIVES: The aim of this article was to identify and critically appraise the conceptual perspectives and methodologies used to date to estimate the cost-effectiveness threshold. METHODS: We provided an in-depth discussion of different conceptual views and undertook a systematic review of empirical analyses. Identified studies were categorized into the two main conceptual perspectives that argue that the threshold should reflect 1) the value that society places on a QALY and 2) the opportunity cost of investment to the system given budget constraints. RESULTS: These studies showed different underpinning assumptions, strengths, and limitations, which are highlighted and discussed. Furthermore, this review allowed us to compare the cost-effectiveness threshold estimates derived from different types of studies. We found that thresholds based on society's valuation of a QALY are generally larger than thresholds resulting from estimating the opportunity cost to the health care system. CONCLUSIONS: This implies that some interventions with positive social net benefits, as informed by individuals' preferences, might not be an appropriate use of resources under fixed budget constraints.

Unconditional quantile regressions to determine the social gradient of obesity in Spain 1993-2014.

BACKGROUND: There is a well-documented social gradient in obesity in most developed countries. Many previous studies have conventionally categorised individuals according to their body mass index (BMI), focusing on those above a certain threshold and thus ignoring a large amount of the BMI distribution. Others have used linear BMI models, relying on mean effects that may mask substantial heterogeneity in the effects of socioeconomic variables across the population. METHOD: In this study, we measure the social gradient of the BMI distribution of the adult population in Spain over the past two decades (1993-2014), using unconditional quantile regressions. We use three socioeconomic variables (education, income and social class) and evaluate differences in the corresponding effects on different percentiles of the log-transformed BMI distribution. Quantile regression methods have the advantage of estimating the socioeconomic effect across the whole BMI distribution allowing for this potential heterogeneity. RESULTS: The results showed a large and increasing social gradient in obesity in Spain, especially among females. There is, however, a large degree of heterogeneity in the socioeconomic effect across the BMI distribution, with patterns that vary according to the socioeconomic indicator under study. While the income and educational gradient is greater at the end of the BMI distribution, the main impact of social class is around the median BMI values. A steeper social gradient is observed with respect to educational level rather than household income or social class. CONCLUSION: The findings of this study emphasise the heterogeneous nature of the relationship between social factors and obesity across the BMI distribution as a whole. Quantile regression methods might provide a more suitable framework for exploring the complex socioeconomic gradient of obesity.

Income-related inequity in healthcare utilisation among individuals with cardiovascular disease in England-accounting for vertical inequity.

Economic analyses of equity which focus solely on horizontal inequity offer a partial assessment of socioeconomic inequity in healthcare use. We analyse income-related inequity in cardiovascular disease-related healthcare utilisation by individuals reporting cardiovascular disease in England, including both horizontal and vertical aspects. For the analysis of vertical inequity, we use target groups to estimate the appropriate relationship between healthcare needs and use. We find that including vertical inequity considerations may lead us to draw different conclusions about the nature and extent of income-related inequity. After accounting for vertical inequity in addition to horizontal inequity, there is no longer evidence of inequity favouring the poor for nurse visits, whereas there is some evidence that doctor visits and inpatient stays are concentrated among richer individuals. The estimates of income-related inequity for outpatient visits, electrocardiography tests and heart surgery become even more pro-rich when accounting for vertical inequity.

Socioeconomic variation in the burden of chronic conditions and health care provision--analyzing administrative individual level data from the Basque Country, Spain.

BACKGROUND: Chronic diseases are posing an increasing challenge to society, with the associated burden falling disproportionally on more deprived individuals and geographical areas. Although the existence of a socioeconomic health gradient is one of the main concerns of health policy across the world, health information systems commonly do not have reliable data to detect and monitor health inequalities and inequities. The objectives of this study were to measure the level of socioeconomic-related inequality in prevalence of chronic diseases and to investigate the extent and direction of inequities in health care provision. METHODS: A dataset linking clinical and administrative information of the entire population living in the Basque Country, Spain (over 2 million individuals) was used to measure the prevalence of 52 chronic conditions and to quantify individual health care costs. We used a concentration-index approach to measure the extent and direction of inequality with respect to the deprivation of the area of residence of each individual. RESULTS: Most chronic diseases were found to be disproportionally concentrated among individuals living in more deprived areas, but the extent of the imbalance varies by type of disease and sex. Most of the variation in health care utilization was explained by morbidity burden. However, even after accounting for differences in morbidity, pro-poor horizontal inequity was present in specialized outpatient care, emergency department, prescription, and primary health care costs and this fact was more apparent in females than males; inpatient costs exhibited an equitable distribution in both sexes. CONCLUSIONS: Analyses of comprehensive administrative clinical information at the individual level allow the socioeconomic gradient in chronic diseases and health care provision to be measured to a level of detail not possible using other sources. This frequently updated source of information can be exploited to monitor trends and evaluate the impact of policy reforms.

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.

Neurological Impairment Among Survivors of Intracerebral Hemorrhage: The FAST Trial.

BACKGROUND: Intracerebral hemorrhage (ICH) is the deadliest and most disabling form of stroke. Little is known about the causes of persistent neurological impairment among ICH survivors. METHODS: Factor seven for acute hemorrhagic stroke (FAST) was a randomized, multicenter, double-blind, placebo-controlled trial conducted at 122 sites in 22 countries. Neurological impairment was evaluated according to the NIHSS in all patients at hospital admission, and at days 1, 2, 3, 15 and day 90 after ICH onset. Multivariate stepwise logistic regression was applied to identify predictors of neurological impairment 90 days after hospital admission. RESULTS: A total of 821 patients were enrolled; 638 survivors were evaluated with the NIHSS at day 90. Mean NIHSS score at admission was 13.2 (SD 6.6), decreasing to 9.6 (SD 7.7) at day 15 and 5.1 (SD 5.5) at day 90. Twenty-five percent of patients had severe neurological impairment (NIHSS ≥ 15) at baseline compared to 6% of those alive at day 90. Neurological worsening within the first 72 h (defined as worsening of GCS of two or more points or increase in NIHSS score ≥ 4) predicted greater neurological impairment at day 90 in all models. A decrease of <10% in systolic blood pressure (SBP) within the first 24 h was significantly associated with less severe neurologic impairment compared to more severe reductions. CONCLUSION: Neurological deterioration within 24 h of ICH onset is a powerful determinant of persistent neurological impairment. Careful reduction of the SBP by 1­10% in the first 24 h may lower the risk.

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.

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.

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.

Quality of life after severe trauma: results from the global trauma trial with recombinant Factor VII.

BACKGROUND: Physical disability and psychologic morbidity are frequent and important complications of severe trauma injury with serious consequences for long-term health-related quality of life (HRQOL). Little prospective data exist, however, in a global trauma population on the risk factors for poor HRQOL. METHODS: The CONTROL trial was a prospective, randomized, double-blinded, multicenter, placebo-controlled trial conducted from August 2005 to September 2008. HRQOL was assessed 3 months after injury using the Polytrauma Outcome Chart (Glasgow Outcomes Scale, Short Form 36, European Quality of Life-5 Dimensions (EQ-5D), and Trauma Outcome Profile). Multivariate stepwise regression analysis identified predictors of poor HRQOL. RESULTS: Three hundred forty-seven (72%) patients completed at least one HRQOL instrument. Three percent had an EQ-5D score <0 (worse than death); 92% had a score <0.87 (average score in the general population). All HRQOL instruments identified physical functioning and activities of daily living as the dimensions of health most significantly affected by trauma injury. Mental functioning was also significantly affected according to the Trauma Outcome Profile. Independent predictors of poor HRQOL were higher age, female gender, extremity injury, blunt injury, intensive care unit stay >3 days, repeated nonadherence to transfusion guidelines, and inability to work postinjury. CONCLUSIONS: Three months after severe trauma injury, survivors report very poor HRQOL. Physical wellbeing is generally more negatively affected than mental wellbeing. A trauma-specific HRQOL instrument reveals more diverse mental health problems than generic instruments. In a global trauma population, postinjury HRQOL is predicted by demographic and socioeconomic characteristics, type of injury, and treatment received.

Neurosurgical outcomes after intracerebral hemorrhage: results of the Factor Seven for Acute Hemorrhagic Stroke Trial (FAST).

The value of neurosurgical interventions after spontaneous intracerebral hemorrhage (SICH) is uncertain. We evaluated clinical outcomes in patients diagnosed with SICH within 3 hours of symptom onset who underwent hematoma evacuation or external ventricular drainage (EVD) of the hematoma in the Factor Seven for Acute Hemorrhagic Stroke Trial (FAST). FAST was a randomized, multicenter, double-blind, placebo-controlled trial conducted between May 2005 and February 2007 at 122 sites in 22 countries. Neurosurgical procedures (hematoma evacuation and external ventricular drainage) performed at any point after hospital admission were prospectively recorded. Clinical outcomes evaluated were post-SICH disability, as assessed by the modified Rankin Scale; neurologic impairment, as assessed by the National Institutes of Health Stroke Scale; and mortality at 90 days after SICH onset. The impact of neurosurgical procedures on clinical outcomes was evaluated using multivariate logistic regression analysis, controlling for relevant baseline characteristics. Fifty-five of 821 patients underwent neurosurgery. Patients who underwent hematoma evacuation or EVD were on average younger, had greater baseline neurologic impairment, and lower levels of consciousness compared with patients who did not undergo neurosurgery. After adjusting for these differences and other relevant baseline characteristics, we found that neurosurgery was generally associated with unfavorable outcomes at day 90. Among the patients who underwent hematoma evacuation, those with lobar ICH had less ICH expansion than those with deep gray matter ICH, and the smaller expansion was associated with lower mortality. ICH volume was substantially decreased in patients who underwent hematoma evacuation between 24 and 72 hours after hospital admission, and this was associated with better clinical outcome. In conclusion, a small number of patients who underwent neurosurgery in FAST exhibited no overall clinical benefit from neurosurgical intervention, although outcomes varied by type of surgery, time of surgery, and hematoma location. Our findings support the need for further research into the value of neurosurgery in patients with SICH.

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.

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.