Identifying potential predictable indicators for the management of tertiary hospitals.

BACKGROUND: The European University Hospitals Alliance (EUHA) recognises the need to move from the classical approach of measuring key performance indicators (KPIs) to an anticipative approach based on predictable indicators to take decisions (Key Decision Indicators, KDIs). It might help managers to anticipate poor results before they occur to prevent or correct them early. OBJECTIVE: This paper aims to identify potential KDIs and to prioritize those most relevant for high complexity hospitals. METHODS: A narrative review was performed to identify KPIs with the potential to become KDIs. Then, two surveys were conducted with EUHA hospital managers (n = 51) to assess potential KDIs according to their relevance for decision-making (Value) and their availability and effort required to be predicted (Feasibility). Potential KDIs are prioritized for testing as predictable indicators and developing in the short term if they were classified as highly Value and Feasible. RESULTS: The narrative review identified 45 potential KDIs out of 153 indicators and 11 were prioritized. Of nine EUHA hospitals, 25 members from seven answered, prioritizing KDIs related to the emergency department (ED), hospitalisation and surgical processes (n = 8), infrastructure and resources (n = 2) and health outcomes and quality (n = 1). The highest scores in this group were for those related to ED. The results were homogeneous among the different hospitals. CONCLUSIONS: Potential KDIs related to care processes and hospital patient flow was the most prioritized ones to test as being predictable. KDIs represent a new approach to decision-making, whose potential to be predicted could impact the planning and management of hospital resources and, therefore, healthcare quality.

Development and Pilot Test of the Registry Evaluation and Quality Standards Tool: An Information Technology-Based Tool to Support and Review Registries.

OBJECTIVES: Health technology assessment (HTA) bodies are increasingly making use of real-world evidence and data. High-quality registries could be an asset for this; nevertheless, there is a lack of specified standards to assess the quality of data in the registry, or the registry itself. The European Network for Health Technology Assessment Joint Action 3 led the work to develop a tool for the evaluation of clinical registries: the "Registry Evaluation and Quality Standards Tool" (REQueST). METHODS: REQueST was developed in 4 steps: (1) A partnership between HTA bodies across Europe drafted the assessment criteria. (2) Multiple rounds of consultation across HTA bodies and the public domain developed an Excel version of REQueST. (3) This version was transformed into a web-based application. (4) An external pilot tested this REQueST tool with SMArtCARE and NeuroTransData registries. RESULTS: Haute Autorité de Santé, the National Institute for Health and Care Excellence, and the Croatian Institute of Public Health led the development of REQueST. Another 4 HTA bodies contributed regularly to development meetings, and all European Network for Health Technology Assessment partners were invited to contribute. Eight methodological, 12 essential, and 3 supplementary criteria were identified. Both pilot registries scored well, fulfilling the requirements for >70% of criteria, with none failed. Feedback by registry holders led to streamlining of the process and clarification of the criteria. CONCLUSIONS: The REQueST tool uses an iterative and collaborative methodology with registry holders. It has the potential to maximize the utility of registry data for decision making by regulatory and HTA bodies and provides a foundation for future research.

Coste-efectividad del desfibrilador automático implantable para la prevención primaria de la muerte súbita cardiaca / Cost-effectiveness of implantable cardioverter-defibrillators for primary prevention of sudden cardiac death

Introducción y objetivos: El desfibrilador automático implantable (DAI) es una alternativa coste-efectiva para la prevención secundaria de la muerte súbita cardiaca, pero sigue habiendo dudas sobre su eficiencia en prevención primaria, sobre todo en pacientes con cardiopatía no isquémica.Métodos: Análisis de coste-utilidad del DAI más tratamiento médico convencional frente a tratamiento médico convencional para la prevención primaria de arritmias cardiacas desde la perspectiva del Sistema Nacional de Salud. Se simuló el curso de la enfermedad mediante modelos de Markov en pacientes con y sin cardiopatía isquémica. Los parámetros del modelo se basaron en los resultados obtenidos mediante metanálisis de los ensayos clínicos publicados entre 1996 y 2018 en los que se comparaba el DAI con el tratamiento médico convencional, los resultados de seguridad del ensayo DANISH y el análisis de la práctica clínica habitual en un hospital terciario.Resultados: Se estimó un beneficio del DAI sobre la muerte por cualquier causa con HR = 0,70 (IC95%, 0,58-0,85) en cardiopatía isquémica y HR = 0,79 (IC95%, 0,66-0,96) en no isquémica. La razón de coste-efectividad incremental estimada mediante análisis probabilístico fue de 19.171 euros/año de vida ajustado por calidad (AVAC) en pacientes con cardiopatía isquémica, 31.084 euros/AVAC en pacientes con miocardiopatía dilatada no isquémica y 23.230 euros/AVAC en los menores de 68 años.Conclusiones: La eficiencia del DAI monocameral ha mejorado en la última década y este resulta coste-efectivo para los pacientes con disfunción ventricular izquierda de origen isquémico o no isquémico menores de 68 años considerando una disposición a pagar 25.000 euros/AVAC. En pacientes no isquémicos mayores, la razón de coste-efectividad incremental estimada se sitúa alrededor de los 30.000 euros/AVAC (AU)

Introduction and objective: Implantable cardioverter-defibrillators (ICD) are a cost-effective alternative for secondary prevention of sudden cardiac death, but their efficiency in primary prevention, especially among patients with nonischemic heart disease, is still uncertain.Methods: We performed a cost-effectiveness analysis of ICD plus conventional medical treatment (CMT) vs CMT for primary prevention of cardiac arrhythmias from the perspective of the national health service. We simulated the course of the disease by using Markov models in patients with ischemic and nonischemic heart disease. The parameters of the model were based on the results obtained from a meta-analysis of clinical trials published between 1996 and 2018 comparing ICD plus CMT vs CMT, the safety results of the DANISH trial, and analysis of real-world clinical practice in a tertiary hospital.Results: We estimated that ICD reduced the likelihood of all-cause death in patients with ischemic heart disease (HR, 0.70; 95%CI, 0.58-0.85) and in those with nonischemic heart disease (HR, 0.79; 95%CI, 0.66–0.96). The incremental cost-effectiveness ratio (ICER) estimated with probabilistic analysis was €19 171/quality adjusted life year (QALY) in patients with ischemic heart disease and €31 084/QALY in those with nonischemic dilated myocardiopathy overall and €23 230/QALY in patients younger than 68 years.Conclusions: The efficiency of single-lead ICD systems has improved in the last decade, and these devices are cost-effective in patients with ischemic and nonischemic left ventricular dysfunction younger than 68 years, assuming willingness to pay as €25 000/QALY. For older nonischemic patients, the ICER was around €30 000/QALY (AU)

Cost-effectiveness of implantable cardioverter-defibrillators for primary prevention of sudden cardiac death.

INTRODUCTION AND OBJECTIVES: Implantable cardioverter-defibrillators (ICD) are a cost-effective alternative for secondary prevention of sudden cardiac death, but their efficiency in primary prevention, especially among patients with nonischemic heart disease, is still uncertain. METHODS: We performed a cost-effectiveness analysis of ICD plus conventional medical treatment (CMT) vs CMT for primary prevention of cardiac arrhythmias from the perspective of the national health service. We simulated the course of the disease by using Markov models in patients with ischemic and nonischemic heart disease. The parameters of the model were based on the results obtained from a meta-analysis of clinical trials published between 1996 and 2018 comparing ICD plus CMT vs CMT, the safety results of the DANISH trial, and analysis of real-world clinical practice in a tertiary hospital. RESULTS: We estimated that ICD reduced the likelihood of all-cause death in patients with ischemic heart disease (HR, 0.70; 95%CI, 0.58-0.85) and in those with nonischemic heart disease (HR, 0.79; 95%CI, 0.66-0.96). The incremental cost-effectiveness ratio (ICER) estimated with probabilistic analysis was €19 171/quality adjusted life year (QALY) in patients with ischemic heart disease and €31 084/QALY in those with nonischemic dilated myocardiopathy overall and €23 230/QALY in patients younger than 68 years. CONCLUSIONS: The efficiency of single-lead ICD systems has improved in the last decade, and these devices are cost-effective in patients with ischemic and nonischemic left ventricular dysfunction younger than 68 years, assuming willingness to pay as €25 000/QALY. For older nonischemic patients, the ICER was around €30 000/QALY.

Systematic review on abdominal aortic aneurysm screening cost-efficiency and methodological quality assessment.

INTRODUCTION: Abdominal aortic aneurysm (AAA) is a silent, progressive disease that can lead to death. It is easily diagnosed with noninvasive methods and its routine treatment has excellent results. This creates an optimal situation for population screening programs. The aim of this paper was to assess results and methodological quality of cost-utility studies on screening versus no screening scenarios for AAA to assess future establishment of new AAA screening programs. EVIDENCE ACQUISITON: A systematic review of efficiency (cost-effectiveness and cost-utility) studies was performed, finally selecting cost-utility studies on AAA screening versus no screening. Papers were selected that dealt with efficiency of screening for AAA according to PICOTS framework and the methodological quality assessed according to the economic evaluation analyses described by Drummond and Caro. Two independent reviewers were involved in the procedure. EVIDENCE SYNTHESIS: Research retrieved 88 studies. From those, 26 showed cost-effectiveness and cost-utility results. Finally, 10 studies had cost-utility results and suited criteria (published in the last 10 years; time-horizon: 10 years or more) for exhaustive analysis. All publications, except one, showed adequate incremental cost-utility ratios according to different national perspectives. Methodological assessment showed some quality limitations, but the majority of items analyzed were favorably answered after applying the questionnaires. CONCLUSIONS: Confirmation of the cost-utility results in this revision at a national/regional level should be the basis for the implantation of new national screening programs worldwide. The methodological evaluation applied in this revision is crucial for the corresponding future piggy-back trials to assess routine application of national AAA screening programs.

Once años de evaluaciones económicas de productos sanitarios en la Red de Agencias de Evaluación. Calidad metodológica e impacto del coste-utilidad / Eleven years of economic evaluations of medical devices by the Spanish Network of Assessment Agencies. Methodological quality and cost-utility impact

OBJETIVO: Analizar la calidad y el impacto de los análisis de coste-utilidad de productos sanitarios realizados por la Red de Agencias de Evaluación (RedETS). MÉTODO: Los análisis de coste-utilidad de productos sanitarios se identificaron buscando entre los informes de evaluación de la base de datos de la web de RedETS (2006-2016). La calidad se evaluó con un listado de verificación de calidad de RedETS, y su impacto, comparando resultados de coste-utilidad y la inclusión en la cartera común de servicios del Sistema Nacional de Salud. Se analizó la inclusión en la cartera común si la ratio de coste-efectividad incremental superaba o no los 25.000 € por año de vida ajustado por calidad. RESULTADOS: Se encontraron 25 análisis de coste-utilidad de productos sanitarios (12 de coste-utilidad, 10 de coste-efectividad y 3 de ambos). De ellos, 15 estudios con 19 ratios de coste-utilidad seleccionados cumplían al menos 18 de 25 criterios de verificación. Asimismo, 12 de los 15 estudios cumplían 18 de los 25 criterios. Sobre el impacto, en 6 de los 19 resultados se incluyó el producto en cartera aunque la ratio superó los 25.000 € por año de vida ajustado por calidad. En tres casos se está en proceso de reevaluación; en otro, de replanteamiento una vez realizados los informes de eficacia-seguridad de nuevos dispositivos; y en dos casos se señala en la cartera que debe seguirse un protocolo. CONCLUSIONES: La mayoría de los análisis de coste-utilidad de productos sanitarios analizados cumplieron casi todos los ítems del listado de verificación y, por tanto, fueron exhaustivos. Estos análisis de coste-utilidad de productos sanitarios fueron coherentes con el marco de toma de decisiones para manejar eficientemente la cartera del Sistema Nacional de Salud

OBJECTIVE: To analyse the quality and impact of cost-utility evaluations of medical devices carried out by the Spanish Network of Assessment Agencies (RedETS). METHOD: The cost-utility evaluations of medical devices were identified by searching the evaluation reports of the RedETS website database (2006-2016). Quality and its impact were evaluated with a RedETS quality checklist, comparing cost-utility results and inclusion in the portfolio of common services of the National Health System. The portfolio inclusion status was analysed considering whether the cost-effectiveness incremental ratio was or was not less than €25,000/quality adjusted life years. RESULTS: 25 cost-utility evaluations of medical devices were found (12 cost-utility, 10 cost-effectiveness and 3 both). Fifteen selected cost-utility studies with 19 cost-utility ratios met at least 18 of 25 verification criteria. Also, 12 of the 15 studies met 19 of the 25 criteria. On the impact, in 6 out of the 19 results, the product was included in the portfolio even though the ratio exceeded €25,000/quality adjusted life years. There are three cases undergoing a re-evaluation process, another case being reconsidered once the efficacy-safety of new devices has been reported and in two cases the portfolio states that protocols are required. CONCLUSIONS: Most of the cost-utility evaluations of medical devices published by RedETS fulfil most of the items on the checklist and, therefore, were thorough. These cost-utility evaluations of medical devices are consistent with the decision-making framework to efficiently manage the National Health System portfolio

[Eleven years of economic evaluations of medical devices by the Spanish Network of Assessment Agencies. Methodological quality and cost-utility impact]. / Once años de evaluaciones económicas de productos sanitarios en la Red de Agencias de Evaluación. Calidad metodológica e impacto del coste-utilidad.

OBJECTIVE: To analyse the quality and impact of cost-utility evaluations of medical devices carried out by the Spanish Network of Assessment Agencies (RedETS). METHOD: The cost-utility evaluations of medical devices were identified by searching the evaluation reports of the RedETS website database (2006-2016). Quality and its impact were evaluated with a RedETS quality checklist, comparing cost-utility results and inclusion in the portfolio of common services of the National Health System. The portfolio inclusion status was analysed considering whether the cost-effectiveness incremental ratio was or was not less than €25,000/quality adjusted life years. RESULTS: 25 cost-utility evaluations of medical devices were found (12 cost-utility, 10 cost-effectiveness and 3 both). Fifteen selected cost-utility studies with 19 cost-utility ratios met at least 18 of 25 verification criteria. Also, 12 of the 15 studies met 19 of the 25 criteria. On the impact, in 6 out of the 19 results, the product was included in the portfolio even though the ratio exceeded €25,000/quality adjusted life years. There are three cases undergoing a re-evaluation process, another case being reconsidered once the efficacy-safety of new devices has been reported and in two cases the portfolio states that protocols are required. CONCLUSIONS: Most of the cost-utility evaluations of medical devices published by RedETS fulfil most of the items on the checklist and, therefore, were thorough. These cost-utility evaluations of medical devices are consistent with the decision-making framework to efficiently manage the National Health System portfolio.

Indirect and non-medical economic burden, quality-of-life, and disabilities of the myelofibrosis disease in Spain.

INTRODUCTION: Myelofibrosis is a non-frequent chronic myeloproliferative Philadelphia-negative chromosome neoplasm. It is a heavy incapacitating orphan disease and associated with high morbidity and mortality. In this context, indirect and non-medical costs are expected to be high. The main objective of this project is to estimate the economic burden of this disease in Spain. METHODS: Thirty-three patients with a diagnosis of myelofibrosis for at least 1 year participated in a questionnaire in three Spanish centers. The study consisted of analyzing in various aspects the cost and impact of the disease; indeed, daily life time limitations with a need of informal care, symtomatology. Additionally, information concerning the clinical management of the disease was collected through a focus group of eight experts. RESULTS: The mean age was 65 years. 15 of 33 patients were at their productive stage. Six had difficulties at work and eight have received informal care. Bone and muscular pain were the main symptoms of patients (72%). The estimated global indirect and non-medical costs of the disease were 86,315€ per patient (20% working and 80% informal care), which reached 104,153€ at productive stage patients (45%) and 168,459€ for more symptomatic patients. CONCLUSIONS: The economic burden of indirect and non-medical costs of myelofibrosis are important (15,142€/annual) as a result, and should be considered in economic evaluation, as well as in preventive plans for patients and caregivers, despite the fact that studies with larger numbers of patients should be done.

Conjoint analysis en tratamientos con anticoagulantes orales. Réplica / Conjoint analysis in treatments with oral anticoagulants. Reply

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[Preferences for oral anticoagulant treatment in the medium and long term prevention of stroke in non valvular atrial fibrillation]. / Preferencias por los tratamientos anticoagulantes orales para la prevencion a medio y largo plazo del ictus en la fibrilacion auricular no valvular.

INTRODUCTION: About 40% of patients who receive oral anticoagulation would not start treatment with vitamin K antagonists due to the regular control they require and their interference with the diet and other concomitant medications. AIM: To analyze the preferences of patients with non valvular atrial fibrillation for oral anticoagulants (OAs) for the stroke prevention. PATIENTS AND METHODS: Observational, multicentric study on preferences and maximum willingness to pay based on conjoint analysis: literature review, focus groups and semi-structured interviews with physicians and patients (n = 295) to define the attributes of OAs and their levels. Definition of scenarios that patients ordered according to their preferences. Clusters analysis to identify population groups by their preferences. RESULTS: Eight scenarios were defined based on five attributes: efficacy, security, a fixed dose, need for coagulation controls and interactions with diet and medication. The most preferred attribute was the smaller number of embolisms in a year (importance: 30.15%) followed by the fixed dose of the OA (25.45%) and the smaller number of intracranial hemorrhage in a year (21.57%). Three clusters population were identified. The maximum amount patients' were willingness to pay for the OA was 66.76 ± 54.64 euros (mean) per month. CONCLUSIONS: Efficacy and a fixed dose are the attributes of OA most valued by non valvular atrial fibrillation patients. There are groups of patients who differ in their preferences. This differences should be taken into account when deciding instauration or change on the OA treatment to ameliorate the accomplishment and prevention in this patients.

Longitudinal effects of the European smoking prevention framework approach (ESFA) project in Spanish adolescents.

BACKGROUND: To describe the effects of a Spanish smoking prevention programme in the context of an European project on regular smoking, in a sample of Barcelona adolescents. METHOD: A quasi-experimental design was conducted. An experimental group (EG) (1080 pupils) was exposed to programme and compared with a control group (CG) (872 students). The intervention included a school-based programme (16 sessions in 3 years), reinforcement of a smoke-free school policy, smoking cessation for teachers, brochures for parents and other community-based activities involving youth clubs and tobacco sales. RESULTS: At 12 months, 4.5% of boys and 5.6% of girls were new smokers in the EG versus 6.7% and 11.7% in the CG (P < 0.001). At 36 months, 18.6% of boys and 31.2% of girls in the EG were regular smokers versus 21.6% of boys and 38.3% of girls in the CG (P < 0.001). The main factors associated with progression to regular smoking at 36 months were to be girl, to attend to a public school and to belong to the CG. CONCLUSION: These results endorse the effectiveness of multi-modal smoking prevention programmes, which include strategies with adults who influence adolescents.

Negative mood states and related factors in a sample of adolescent secondary-school students in Barcelona (Spain).

INTRODUCTION: Poor mental health is a common problem in adolescence. Little information is available, however, about the factors influencing negative mood states in otherwise healthy adolescents. We aimed to describe the mood states and related factors in a sample of adolescents in the city of Barcelona (Spain). METHODS: We administered a health survey to a sample of 2,727 students from public, subsidized, and private schools in Barcelona, aged approximately 14, 16, and 18 years old. To analyze the associations among moods and related factors, we used bivariate logistic regression, and fitted multivariate logistic regressions using the statistically significant variables from the bivariate analysis. To examine the possible group effects of the school on individual students, we employed multilevel analysis. RESULTS: The frequencies of negative mood states increased with age, with girls consistently reporting more frequent negative mood states than boys. The factors associated with negative mood states were problematic alcohol use, perceived mistreatment or abuse, antisocial behavior, intention to use or current use of illegal drugs (not including cannabis), lower perceived academic performance, and feeling isolated. CONCLUSIONS: Mood states are influenced by lifestyle and social factors, about which there is little local information. To plan and implement appropriate public health interventions, more complete information about the possible areas of influence is required. To complement the information obtained from studies such as the present study, longitudinal and qualitative studies would be desirable.

Negative mood states and related factors in a sample of adolescent secondary-school students in Barcelona (Spain)

Introducción: El deterioro de la salud mental es un problema frecuente en la adolescencia. Sin embargo, se sabe poco de los factores influyentes en los estados de ánimo negativos en adolescentes saludables. Pretendemos describir los estados de ánimo negativos y los factores relacionados en una muestra de adolescentes de la ciudad de Barcelona. Métodos: Administramos una encuesta de salud a 2.727 estudiantes de escuelas públicas, concertadas y privadas en Barcelona con edades de 14, 16 y 18 años. Usamos análisis regresión logística bivariada para estudiar las relaciones entre los estados de ánimo negativo y los factores relacionados, para ajustar después un modelo logístico multivariante con los factores significativos del análisis bivariado. Para examinar la posible influencia de los factores grupales de los centros escolares en los individuos, hemos empleado el análisis multinivel. Resultados: Las frecuencias de los estados de ánimo negativos aumentaban con la edad, y las chicas consistentemente relataban estados de ánimo peores que los chicos. El uso problemático del alcohol, el abuso y el maltrato percibido, las conductas antisociales, la intención de usar o el uso actual de drogas ilegales, el bajo rendimiento escolar percibido y el sentirse marginado se relacionaron también con estados de ánimo negativos. Conclusiones: Hay factores personales, sociales y de estilos de vida, sobre los que tenemos poca información local, que influyen sobre los estados de ánimo. Para planear e implementar intervenciones de salud pública apropiadas, necesitamos una información más completa sobre las áreas de posible influencia. Para complementar la información obtenida en estudios como éste, sería deseable llevar a cabo estudios longitudinales y cualitativos

Introduction: Poor mental health is a common problem in adolescence. Little information is available, however, about the factors influencing negative mood states in otherwise healthy adolescents. We aimed to describe the mood states and related factors in a sample of adolescents in the city of Barcelona (Spain). Methods: We administered a health survey to a sample of 2,727 students from public, subsidized, and private schools in Barcelona, aged approximately 14, 16, and 18 years old. To analyze the associations among moods and related factors, we used bivariate logistic regression, and fitted multivariate logistic regressions using the statistically significant variables from the bivariate analysis. To examine the possible group effects of the school on individual students, we employed multilevel analysis. Results: The frequencies of negative mood states increased with age, with girls consistently reporting more frequent negative mood states than boys. The factors associated with negative mood states were problematic alcohol use, perceived mistreatment or abuse, antisocial behavior, intention to use or current use of illegal drugs (not including cannabis), lower perceived academic performance, and feeling isolated. Conclusions: Mood states are influenced by lifestyle and social factors, about which there is little local information. To plan and implement appropriate public health interventions, more complete information about the possible areas of influence is required. To complement the information obtained from studies such as the present study, longitudinal and qualitative studies would be desirable

Tendencias en el consumo de tabaco, alcohol y cannabis en los adolescentes de Barcelona entre 1987 y 2004 / Trends in the consumption of tobacco, alcohol and cannabis among adolescents of Barcelona, Spain, between 1987 and 2004

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