Publications by authors named "Laura Vallejo-Torres"

38 Publications

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

Appl Health Econ Health Policy 2021 Dec 29. Epub 2021 Dec 29.

Flinders Health and Medical Research Institute, Flinders University, Bedford Park, SA, Australia.

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.
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http://dx.doi.org/10.1007/s40258-021-00707-8DOI Listing
December 2021

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

Pharmacoeconomics 2022 Jan 29;40(1):31-43. Epub 2021 Sep 29.

Centre for Health Economics, University of York, Heslington, York, UK.

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.
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http://dx.doi.org/10.1007/s40273-021-01087-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8478606PMC
January 2022

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

Int J Environ Res Public Health 2021 04 28;18(9). Epub 2021 Apr 28.

Research Institute of Biomedical and Health Sciences (IUIBS), University of Las Palmas de Gran Canaria, 35016 Las Palmas, 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.
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http://dx.doi.org/10.3390/ijerph18094708DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8124348PMC
April 2021

[Cost-effectiveness methods of newborn screening assessment.]

Rev Esp Salud Publica 2021 Jan 26;95. Epub 2021 Jan 26.

Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC). Madrid. España.

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.
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January 2021

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

Eur J Health Econ 2020 Apr 28;21(3):363-379. Epub 2019 Nov 28.

Univerity of Navarra, Navarra, Spain.

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.
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http://dx.doi.org/10.1007/s10198-019-01140-4DOI Listing
April 2020

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.

BMC Health Serv Res 2019 Nov 1;19(1):783. Epub 2019 Nov 1.

Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Madrid, Spain.

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.
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http://dx.doi.org/10.1186/s12913-019-4589-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6824022PMC
November 2019

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

Gac Sanit 2020 Jul - Aug;34(4):377-384. Epub 2019 Sep 15.

Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Madrid, España; Centro de Investigación Biomédica de Canarias (CIBICAN), Islas Canarias, España; Servicio de Evaluación del Servicio Canario de la Salud (SESCS), Islas Canarias, España.

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.
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http://dx.doi.org/10.1016/j.gaceta.2019.05.005DOI Listing
October 2021

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

Nutrients 2019 Apr 20;11(4). Epub 2019 Apr 20.

General and Digestive Surgery Department, HUNSC, 38010 Santa Cruz de Tenerife, Spain.

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 ( = 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; < 0.246). There were also fewer cases of exitus (seven vs. one) and fewer transfers to critical care units in this group ( = 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.
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http://dx.doi.org/10.3390/nu11040889DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6520912PMC
April 2019

Cost-effectiveness of the hospital nutrition screening tool CIPA.

Arch Med Sci 2020 11;16(2):273-281. Epub 2019 Jan 11.

Internal Medicine Department, University Hospital Nuestra Señora de Candelaria, Santa Cruz de Tenerife, Spain.

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; = 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; = 0.230). On the surgical ward, more patients from the control group moved to critical care units ( = 0.014); the other clinical variables did not vary. Quality of life at discharge was similar ( = 0.53), although slightly higher in the CIPA group at 3 months ( = 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.
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http://dx.doi.org/10.5114/aoms.2018.81128DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7069439PMC
January 2019

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

Antimicrob Resist Infect Control 2018 14;7:111. Epub 2018 Sep 14.

1Department of Infectious Diseases, Hospital Universitari de Bellvitge, Institut Català de la Salut (ICS-HUB), Feixa Llarga s/n, L'Hospitalet de Llobregat, 08907 Barcelona, Spain.

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, was the most frequent microorganism (559/1074), showing a 14.5% multidrug-resistance rate. was second (168/1074) and exhibited the highest multidrug-resistance rate (54.2%), followed by (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.
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http://dx.doi.org/10.1186/s13756-018-0401-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6137881PMC
September 2019

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

J Eval Clin Pract 2018 08 3;24(4):772-781. Epub 2018 Jul 3.

Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Santa Cruz de Tenerife, 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.
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http://dx.doi.org/10.1111/jep.12987DOI Listing
August 2018

Cost of hospitalised patients due to complicated urinary tract infections: a retrospective observational study in countries with high prevalence of multidrug-resistant Gram-negative bacteria: the COMBACTE-MAGNET, RESCUING study.

BMJ Open 2018 04 12;8(4):e020251. Epub 2018 Apr 12.

UCL Department of Applied Health Research, University College London, London, UK.

Objective: Complicated urinary tract infections (cUTIs) impose a high burden on healthcare systems and are a frequent cause of hospitalisation. The aims of this paper are to estimate the cost per episode of patients hospitalised due to cUTI and to explore the factors associated with cUTI-related healthcare costs in eight countries with high prevalence of multidrug resistance (MDR).

Design: This is a multinational observational, retrospective study. The mean cost per episode was computed by multiplying the volume of healthcare use for each patient by the unit cost of each item of care and summing across all components. Costs were measured from the hospital perspective. Patient-level regression analyses were used to identify the factors explaining variation in cUTI-related costs.

Setting: The study was conducted in 20 hospitals in eight countries with high prevalence of multidrug resistant Gram-negative bacteria (Bulgaria, Greece, Hungary, Israel, Italy, Romania, Spain and Turkey).

Participants: Data were obtained from 644 episodes of patients hospitalised due to cUTI.

Results: The mean cost per case was €5700, with considerable variation between countries (largest value €7740 in Turkey; lowest value €4028 in Israel), mainly due to differences in length of hospital stay. Factors associated with higher costs per patient were: type of admission, infection source, infection severity, the Charlson comorbidity index and presence of MDR.

Conclusions: The mean cost per hospitalised case of cUTI was substantial and varied significantly between countries. A better knowledge of the reasons for variations in length of stays could facilitate a better standardised quality of care for patients with cUTI and allow a more efficient allocation of healthcare resources. Urgent admissions, infections due to an indwelling urinary catheterisation, resulting in septic shock or severe sepsis, in patients with comorbidities and presenting MDR were related to a higher cost.
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http://dx.doi.org/10.1136/bmjopen-2017-020251DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5898316PMC
April 2018

Economic consequences of over-diagnosis of threatened preterm labor.

Int J Gynaecol Obstet 2018 May 14;141(2):200-205. Epub 2018 Feb 14.

Servicio de Ginecología y Obstetricia, Complejo Hospitalario Universitario de Canarias, Universidad de La Laguna, Tenerife, Spain.

Objective: To investigate whether adherence to a cervical length-based protocol can reduce both unnecessary admissions and the socioeconomic costs associated with inappropriately admitted patients.

Methods: The present retrospective observational study included women admitted for threatened preterm labor (TPL) at 24-34 weeks of pregnancy to a tertiary hospital in the Canary Islands, 2009-2014. Data were reviewed from all patients admitted for TPL. Those with a long cervix (>25 mm) were classified as "inappropriate admissions", and both the economic burden based on diagnosis-related group (DRG) and the social costs associated with sick leave for these women were calculated.

Results: During the 6-year study period, 430 women were admitted for TPL. The rate of inappropriate hospital admissions was 45% in the first year, but was reduced to 23% in the final year (P<0.001); the premature delivery rates in these years did not differ (P=0.224). The mean DRG-based cost of the admission per patient with a long cervix was EU euros €2099. The total annual costs from inappropriate admission (both social security sick leave costs and hospital costs) were estimated to be up to €571 047.37 during the 6-year study period, and reduced from €60 420.76 in 2009 to €29 998.04 in 2014.

Conclusion: Reductions in inappropriate admissions from applying cervical length-based management protocol could reduce healthcare costs without increasing the incidence of premature delivery.
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http://dx.doi.org/10.1002/ijgo.12450DOI Listing
May 2018

Estimating a cost-effectiveness threshold for the Spanish NHS.

Health Econ 2018 04 28;27(4):746-761. Epub 2017 Dec 28.

Canary Islands Health Research Foundation (FUNCANIS), Tenerife, Canary Islands, Spain.

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.
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http://dx.doi.org/10.1002/hec.3633DOI Listing
April 2018

Primary care supply and quality of care in England.

Eur J Health Econ 2018 May 30;19(4):499-519. Epub 2017 May 30.

Department of Applied Health Research, University College London, Gower Street, London, WC1E 6BT, UK.

We investigated the relationship between primary care supply and quality of care in England. We analysed 35 process measures of quality of care covering 13 medical conditions using English Longitudinal Study of Aging data linked to area of residence indicators. Greater GP density had a statistically significant and positive association with quality of care, and distance to GP practice had a statistically significant and negative association. The effects were concentrated in indicators of care related to cardiovascular diseases and arthritis, and on specific indicators for diabetes, incontinence and hearing problems. The results suggest that better primary care supply can improve quality of care.
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http://dx.doi.org/10.1007/s10198-017-0898-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5913392PMC
May 2018

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.

BMC Health Serv Res 2017 04 20;17(1):292. Epub 2017 Apr 20.

General and digestive surgery Department, Hospital Universitario Nuestra Señora de Candelaria, Santa Cruz de Tenerife, Spain.

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/m (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.
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http://dx.doi.org/10.1186/s12913-017-2218-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5397674PMC
April 2017

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

Int J Equity Health 2016 10 19;15(1):175. Epub 2016 Oct 19.

Department of Quantitative Methods, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain.

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.
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http://dx.doi.org/10.1186/s12939-016-0454-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5070139PMC
October 2016

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

Value Health 2016 Jul-Aug;19(5):558-66. Epub 2016 Apr 23.

Spanish Network of Health Services Research for Chronic Diseases (REDISSEC); Servicio de Evaluación del Servicio Canario de la Salud (SESCS), Canary Islands, Spain.

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.
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http://dx.doi.org/10.1016/j.jval.2016.02.020DOI Listing
May 2017

Time and travel costs incurred by women attending antenatal tests: A costing study.

Midwifery 2016 Sep 21;40:148-52. Epub 2016 Jun 21.

Department of Applied Health Research, University College London, London, UK.

Objective: to estimate the costs to women, their friends and family for different antenatal tests in the Down's syndrome (DS) screening pathway.

Design: questionnaire-based costing study.

Setting: eight maternity clinics across the UK.

Participants: pregnant women (n=574) attending an appointment for DS screening, NIPT or invasive testing between December 2013 and September 2014.

Measurements: using data collected from the questionnaires we calculated the total costs to women by multiplying the time spent at the hospital and travelling to and from it by the opportunity costs of the women and accompanying person and adding travel and childcare costs. Assumptions about the value of opportunity costs were tested in one-way sensitivity analyses. The main outcome measure was the mean cost to the women and friends/family for each test (DS screening, NIPT, and invasive testing).

Findings: mean costs to women and their family/friend were £33.96 per visit, of which £22.47 were time costs, £9.15 were travel costs and £2.34 were childcare costs. Costs were lowest for NIPT (£22), £32 for DS screening (£44 if combined with NIPT), and highest for invasive testing (£60). Sensitivity analysis revealed that variations around the value of leisure time opportunity costs had the largest influence on the results.

Key Conclusions: there are considerable costs to women, their friends and family when attending different tests in the DS screening pathway.

Implications For Practice: when assessing the cost-effectiveness of changes to this pathway, costs to women should be considered.
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http://dx.doi.org/10.1016/j.midw.2016.06.013DOI Listing
September 2016

Retrospective observational study to assess the clinical management and outcomes of hospitalised patients with complicated urinary tract infection in countries with high prevalence of multidrug resistant Gram-negative bacteria (RESCUING).

BMJ Open 2016 07 29;6(7):e011500. Epub 2016 Jul 29.

Departament of Infectious Diseases, Institut Català de la Salut-Hospital Universitari de Bellvitge (ICS-HUB)-IDIBELL, Barcelona, Spain Spanish network for research in Infectious Diseases (REIPI RD12/0012), Instituto de Salud Carlos III, Madrid Spain.

Introduction: The emergence of multidrug resistant (MDR) Gram-negative bacteria (GNB), including carbapenemase-producing strains, has become a major therapeutic challenge. These MDR isolates are often involved in complicated urinary tract infection (cUTI), and are associated with poor clinical outcomes. The study has been designed to gain insight into the epidemiology, clinical management, outcome and healthcare cost of patients with cUTI, especially in countries with high prevalence of MDR GNB.

Methods And Analysis: This multinational and multicentre observational, retrospective study will identify cases from 1 January 2013 to 31 December 2014 in order to collect data on patients with cUTI as a cause of hospital admission, and patients who develop cUTI during their hospital stay. The primary end point will be treatment failure defined as the presence of any of the following criteria: (1) signs or symptoms of cUTI present at diagnosis that have not improved by days 5-7 with appropriate antibiotic therapy, (2) new cUTI-related symptoms that have developed within 30 days of diagnosis, (3) urine culture taken within 30 days of diagnosis, either during or after completion of therapy, that grows ≥10(4) colony-forming unit/mL of the original pathogen and (4) death irrespective of cause within 30 days of the cUTI diagnosis.

Sample Size: 1000 patients afford a power of 0.83 (α=0.05) to detect an absolute difference of 10% in the treatment failure rate between MDR bacteria and other pathogens. This should allow for the introduction of about 20 independent risk factors (or their interaction) in a logistic regression model looking at risk factors for failure.

Ethics And Dissemination: Approval will be sought from all relevant Research Ethics Committees. Publication of this study will be considered as a joint publication by the participating investigator leads, and will follow the recommendations of the International Committee of Medical Journal Editors (ICMJE).

Trial Registration Number: NCT02641015; Pre-results.
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http://dx.doi.org/10.1136/bmjopen-2016-011500DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4985830PMC
July 2016

[Economic evaluation seeks threshold to support decision-making].

Rev Esp Salud Publica 2015 Nov-Dec;89(6):537-44

To incorporate economic evaluation into decision-making, we need to know how much a health system is willing and able to invest in a quality-adjusted life year (QALY). In Spain, the figure of €30,000 per QALY as cost-effectiveness (CE) threshold has been widely cited. However, as in most health systems, no value has been formally adopted; mainly because of the arbitrariness, the lack of theoretical and scientific basis, and the controversy around its estimation and what the threshold should represent. Based on a systematic review of empirical studies on the estimation of the CE threshold undertaken by this research team, we conducted a critical appraisal of the state of the art, using a Delphi with the participation of 13 national experts. This paper contributes to assess the research progress on the CE threshold in Spain, to consider its utility in the decision making process supported by economic evaluation, and to propose further research to improve what has been achieved so far.
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http://dx.doi.org/10.4321/S1135-57272015000600002DOI Listing
September 2016

Cost of Stem Cell-Based Tissue-Engineered Airway Transplants in the United Kingdom: Case Series.

Tissue Eng Part A 2016 Feb 24;22(3-4):208-13. Epub 2015 Dec 24.

7 Advanced Centre for Biochemical Engineering, University College London , London, United Kingdom .

Stem cell-based tissue-engineered tracheas are at an early stage in their product development cycle. Tens of patients have been treated worldwide in predominantly compassionate use settings, demonstrating significant promise. This potentially life-saving treatment is complex, and the cost and its implications for such treatments are yet to be fully understood. The costs are compounded by varying strategies for graft preparation and transplant, resulting in differing clinical and laboratory costs from different research groups. In this study, we present a detailed breakdown of the clinical and manufacturing costs for three of the United Kingdom (UK) patients treated with such transplants. All three patients were treated under Compassionate Use legislation, within the UK National Health Service (NHS) hospital setting. The total costs for the three UK patients treated ranged from $174,420 to $740,500. All three patients were in a state of poor health at time of treatment and had a number of complexities in addition to the restricted airway. This is the first time a cost analysis has been made for a tissue-engineered organ and provides a benchmark for future studies, as well as comparative data for use in reimbursement considerations.
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http://dx.doi.org/10.1089/ten.TEA.2015.0283DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4779280PMC
February 2016

Cost-Effectiveness Analysis of a National Newborn Screening Program for Biotinidase Deficiency.

Pediatrics 2015 Aug 13;136(2):e424-32. Epub 2015 Jul 13.

Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Spain; Servicio de Evaluación del Servicio Canario de la Salud (SESCS), El Rosario, Spain.

Background And Objectives: There are conflicting views as to whether testing for biotinidase deficiency (BD) ought to be incorporated into universal newborn screening (NBS) programs. The aim of this study was to evaluate the cost-effectiveness of adding BD to the panel of conditions currently screened under the national NBS program in Spain.

Methods: We used information from the regional NBS program for BD that has been in place in the Spanish region of Galicia since 1987. These data, along with other sources, were used to develop a cost-effectiveness decision model that compared lifetime costs and health outcomes of a national birth cohort of newborns with and without an early detection program. The analysis took the perspective of the Spanish National Health Service. Effectiveness was measured in terms of quality-adjusted life years (QALYs). We undertook extensive sensitivity analyses around the main model assumptions, including a probabilistic sensitivity analysis.

Results: In the base case analysis, NBS for BD led to higher QALYs and higher health care costs, with an estimated incremental cost per QALY gained of $24,677. Lower costs per QALY gained were found when conservative assumptions were relaxed, yielding cost savings in some scenarios. The probability that BD screening was cost-effective was estimated to be >70% in the base case at a standard threshold value.

Conclusions: This study indicates that NBS for BD is likely to be a cost-effective use of resources.
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http://dx.doi.org/10.1542/peds.2014-3399DOI Listing
August 2015

Income related inequalities in avoidable mortality in Norway: A population-based study using data from 1994-2011.

Health Policy 2015 Jul 6;119(7):889-98. Epub 2015 May 6.

Department of Applied Health Research, University College London, London, United Kingdom. Electronic address:

Objective: The aim of this study was to measure income-related inequalities in avoidable, amenable and preventable mortality in Norway over the period 1994-2011.

Methods: We undertook a register-based population study of Norwegian residents aged 18-65 years between 1994 and 2011, using data from the Norwegian Income Register and the Cause of Death Registry. Concentration indices were used to measure income-related inequalities in avoidable, amenable and preventable mortality for each year. We compared the trend in income-related inequality in avoidable mortality with the trend in income inequality, measured by the Gini coefficient for income.

Results: Avoidable, amenable and preventable deaths in Norway have declined over time. There were persistent pro-poor socioeconomic inequalities in avoidable, amenable and preventable mortality, and the degree of inequality was larger in preventable mortality than in amenable mortality throughout the period. The income-avoidable mortality association was positively correlated with income inequalities in avoidable mortality over time. There was little or no relationship between variations in the Gini coefficient due to tax reforms and socioeconomic inequalities in avoidable mortality.

Conclusions: Income-related inequalities in avoidable, amenable and preventable mortality have remained relatively constant between 1994 and 2011 in Norway. They were mainly correlated with the relationship between income and avoidable mortality rather than with variations in the Gini coefficient of income inequality.
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http://dx.doi.org/10.1016/j.healthpol.2015.04.016DOI Listing
July 2015

Effectiveness and cost-effectiveness of knowledge transfer and behavior modification interventions in type 2 diabetes mellitus patients--the INDICA study: a cluster randomized controlled trial.

Implement Sci 2015 Apr 9;10:47. Epub 2015 Apr 9.

Servicio de Evaluación del Servicio Canario de la Salud (SESCS), Tenerife, Spain.

Background: Type 2 diabetes mellitus is a chronic disease whose health outcomes are related to patients and healthcare professionals' decision-making. The Diabetes Intervention study in the Canary Islands (INDICA study) aims to evaluate the effectiveness and cost-effectiveness of educational interventions supported by new technology decision tools for type 2 diabetes patients and primary care professionals in the Canary Islands.

Methods/design: The INDICA study is an open, community-based, multicenter, clinical controlled trial with random allocation by clusters to one of three interventions or to usual care. The setting is primary care where physicians and nurses are invited to participate. Patients with diabetes diagnosis, 18-65 years of age, and regular users of mobile phone were randomly selected. Patients with severe comorbidities were excluded. The clusters are primary healthcare practices with enough professionals and available places to provide the intervention. The calculated sample size was 2,300 patients. Patients in group 1 are receiving an educational group program of eight sessions every 3 months led by trained nurses and monitored by means of logs and a web-based platform and tailored semi-automated SMS for continuous support. Primary care professionals in group 2 are receiving a short educational program to update their diabetes knowledge, which includes a decision support tool embedded into the electronic clinical record and a monthly feedback report of patients' results. Group 3 is receiving a combination of the interventions for patients and professionals. The primary endpoint is the change in HbA1c in 2 years. Secondary endpoints are cardiovascular risk factors, macrovascular and microvascular diabetes complications, quality of life, psychological outcomes, diabetes knowledge, and healthcare utilization. Data is being collected from interviews, questionnaires, clinical examinations, and records. Generalized linear mixed models with repeated time measurements will be used to analyze changes in outcomes. The cost-effectiveness analysis, from the healthcare services perspective, involves direct medical costs per quality-adjusted life year gained and two periods, a 'within-trial' period and a lifetime Markov model. Deterministic and probabilistic sensitivity analyses are planned.

Discussion: This ongoing trial aims to set up the implementation of evidence-based programs in the clinical setting for chronic patients.

Trial Registration: Clinical Trial.gov NCT01657227.
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http://dx.doi.org/10.1186/s13012-015-0233-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4397722PMC
April 2015

Income-related inequality in health and health-related behaviour: exploring the equalisation hypothesis.

J Epidemiol Community Health 2014 Jul 11;68(7):615-21. Epub 2014 Mar 11.

UCL Institute of Child Health, University College London, London, UK.

Background: Previous studies have found the socioeconomic gradient in health among adolescents to be lower than that observed during childhood and adulthood. The aim of this study was to examine income-related inequalities in health and health-related behaviour across the lifespan in England to explore 'equalisation' in adolescence.

Methods: We used five years of data (2006-2010) from the Health Survey for England to explore inequalities in six indicators: self-assessed general health, longstanding illness, limiting longstanding illness, psychosocial wellbeing, obesity and smoking status. We ran separate analyses by age/gender groups. Inequality was measured using concentration indices.

Results: Our findings for longstanding illnesses, psychosocial wellbeing and obesity were consistent with the equalisation hypothesis. For these indicators, the extent of income-related inequality was lower among late adolescents (16-19 years) and young adults (20-24 years) compared to children and young adolescents (under 15 years), mid- and late-adults (25-44 and 45-64 years) and the elderly (65+ years). The remaining indicators showed lower inequality among adolescents compared to adults, but higher inequality when compared with children.

Conclusions: Our work shows that inequalities occur across the life-course but that for some health issues there may be a period of equalisation in late adolescence and early adulthood.
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http://dx.doi.org/10.1136/jech-2013-203306DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4112435PMC
July 2014

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

BMC Public Health 2013 Sep 22;13:870. Epub 2013 Sep 22.

Oberri (The Basque Institute for Health Innovation), Sondika, Bizkaia, 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.
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http://dx.doi.org/10.1186/1471-2458-13-870DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3852590PMC
September 2013

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

Health Econ 2013 May 6;22(5):533-53. Epub 2012 Jun 6.

UCL Clinical Trials Unit, University College London, London, UK.

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.
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http://dx.doi.org/10.1002/hec.2821DOI Listing
May 2013

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

Neurocrit Care 2012 Apr 6;16(2):224-31. Epub 2011 Oct 6.

Regulatory Affairs, Novo Nordisk A/S, Vandta°rnsvej 114, 2860 Søborg, Denmark.

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 1–10% in the first 24 h may lower the risk.
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http://dx.doi.org/10.1007/s12028-011-9632-6DOI Listing
April 2012

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

J Trauma 2011 Jun;70(6):1524-31

Regulatory Affairs, Novo Nordisk A/S, Søborg, Denmark.

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.
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http://dx.doi.org/10.1097/TA.0b013e3181f053c2DOI Listing
June 2011
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