Validation of the PECUNIA reference unit costs templates in Spain: a useful tool for multi-national economic evaluations of health technologies.

Background: The PECUNIA Project was funded by the H2020 programme in which 10 partners from six countries participated. The aim was to develop standardized, harmonized and validated methods and tools to calculate costs in different sectors (such as health and social care, education among others), with the purpose of facilitating comparability of economic evaluations of health technologies across European countries. In this paper we report the first validation of the developed reference unit cost templates in Spain.

How to present economic evaluations to non-technical audiences? Randomized trials with professionals and the general population.

Background: Cost-effectiveness analyses of health technologies have become a part of the decision-making process in healthcare policies. Nevertheless, economic results are not always presented in comprehensible formats for non-technical audiences, such as the general population, healthcare professionals or decision-makers. The purpose of this study was to observe which formats best convey the key message of an economic evaluation, and which are best received by two different audiences.

Updating and Refining of Economic Evaluation of Rotavirus Vaccination in Spain: A Cost-Utility and Budget Impact Analysis.

Two vaccines against rotavirus diseases, Rotarix and RotaTeq, are being marketed in Spain; but rotavirus is not presently among the diseases covered by universal vaccination in Spain. The aim of this study was to assess the efficiency of extending Spain's current targeted rotavirus vaccination strategy including only preterm babies, to a policy of universal vaccination. A de novo cohort-based Markov model was built to evaluate the efficiency of three compared rotavirus vaccination strategies in Spain: targeted, universal, and no vaccination.

The Development of a New Approach for the Harmonized Multi-Sectoral and Multi-Country Cost Valuation of Services: The PECUNIA Reference Unit Cost (RUC) Templates.

Background: Increasing healthcare costs require evidence-based resource use allocation for which assessing costs rigorously and comparably is crucial. Harmonized cross-country costing methods for evaluating interventions from a societal perspective are lacking. This study presents the development process and content of the service costing templates developed as part of the European project PECUNIA.

A study protocol of a comparative mixed study of the T-Control catheter.

Background: Foley catheters have been subject to limited development in the last few decades. They fulfil their basic function of draining urine from the bladder but cause other associated problems. T-Control is a new silicone Foley catheter with an integrated fluid control valve whose design aims to reduce the risks associated with bladder catheterization by a multifactorial approach.

Effectiveness of the T-Control catheter: A study protocol.

Background: Foley catheters have been subject to limited development in the last few decades. They fulfil their basic function of draining urine from the bladder but cause other associated problems. T-Control is a new silicone Foley catheter with an integrated fluid control valve whose design aims to reduce the risks associated with bladder catheterisation by a multifactorial approach.

Effectiveness, safety and costs of the FreeStyle Libre glucose monitoring system for children and adolescents with type 1 diabetes in Spain: a prospective, uncontrolled, pre-post study.

Objectives: This study aimed to evaluate the effectiveness, safety and costs of FreeStyle Libre (FSL) glucose monitoring system for children and adolescents with type 1 diabetes mellitus (T1DM) in Spain.

Design: Prospective, multicentre pre-post study.

Setting: Thirteen Spanish public hospitals recruited patients from January 2019 to March 2020, with a 12-month follow-up.

Main Challenges of Incorporating Environmental Impacts in the Economic Evaluation of Health Technology Assessment: A Scoping Review.

Health technology assessment (HTA) provides evidence-based information on healthcare technology to support decision making in many countries. Environmental impact is a relevant dimension of a health technology's value, but it has been poorly addressed in HTA processes in spite of the commitment that the health sector must have to contribute to mitigating the effects of climate change. This study aims to identify the state of the art and challenges for quantifying environmental impacts that could be incorporated into the economic evaluation (EE) of HTA.

[Cost-effectiveness of universal childhood vaccination against hepatitis A in Spain: a dynamic approach].

Objective: To evaluate the cost-effectiveness of infant universal vaccination against hepatitis A in Spain.

Method: Using a dynamic model and decision tree model, a cost-effectiveness analysis was performed to compare three vaccination strategies against hepatitis A: non-vaccination strategy versus universal childhood vaccination of hepatitis A with one or two doses. The perspective of the study was that of the National Health System (NHS) and a lifetime horizon was considered.

Health-Related Quality of Life and Perceived Burden of Informal Caregivers of Patients with Rare Diseases in Selected European Countries.

Most of rare disease (RD) patients are assisted in their homes by their family as informal caregivers, causing a substantial burden among family members devoted to care. The role of informal caregivers has been associated with increased levels of stress, poor physical/mental health and impaired HRQOL. The present study assessed the impact on HRQOL and perceived burden of long-term informal caregiving, as well as the inter-relationships of individuals affected by different RD in six European countries, taking advantage of the data provided by the BURQOL-RD project (France, Germany, Italy, Spain, Sweden and UK).

Cost-effectiveness Analysis of Peripherally Inserted Central Catheters Versus Central Venous Catheters for in-Hospital Parenteral Nutrition.

Objective: Our objective was to evaluate the cost-effectiveness of the use of peripherally inserted central venous catheters (PICCs) by a vascular access team (VAT) versus central venous catheters (CVCs) for in-hospital total parenteral nutrition (TPN).

Methods: The study used a cost-effectiveness analysis based on observational data retrospectively obtained from electronic medical records from 2018 to 2019 in a teaching hospital. We included all interventional procedures requiring PICCs or CVCs with the indication of TPN.

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.

In Search for Comparability: The PECUNIA Reference Unit Costs for Health and Social Care Services in Europe.

Improving the efficiency of mental healthcare service delivery by learning from international best-practice examples requires valid data, including robust unit costs, which currently often lack cross-country comparability. The European ProgrammE in Costing, resource use measurement and outcome valuation for Use in multi-sectoral National and International health economic evaluAtions (PECUNIA) aimed to harmonize the international unit cost development. This article presents the methodology and set of 36 externally validated, standardized reference unit costs (RUCs) for five health and social care services (general practitioner, dentist, help-line, day-care center, nursing home) in Austria, England, Germany, Hungary, The Netherlands, and Spain based on unambiguous service definitions using the extended DESDE PECUNIA coding framework.

Health Related Quality of Life in Major Depressive Disorder: evolution in time and factors associated.

Major Depressive Disorder (MDD) is the most prevalent mental disorder. We aimed to analyze which factors were associated to their Health-Related Quality of Life (HRQoL) perception in patients diagnosed of MDD and how they evolved over six months.

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.

Patient-reported outcome measures for knowledge transfer and behaviour modification interventions in type 2 diabetes-the INDICA study: a multiarm cluster randomised controlled trial.

Objective: This study assesses the effectiveness of different interventions of knowledge transfer and behaviour modification to improve type 2 diabetes mellitus patients' (T2DM) reported outcomes measures (PROMs) in the long-term. : open, community-based pragmatic, multicentre, controlled trial with random allocation by clusters to usual care (UC) or to one of the three interventions.

Participants: A total of 2334 patients with uncomplicated T2DM and 211 healthcare professionals were included of 32 primary care centres.

Stepped care for the treatment of depression: a systematic review and meta-analysis.

Background: The Stepped Care Model (SCM) proposes a sequential approach in the treatment of depression, applying interventions of increasing intensity according to the level of severity of the individual.

Methods: A systematic review was carried out until January 2020 in eight electronic databases. We included randomized (RCT) and non-randomized controlled trials comparing the SCM to usual non-sequential care.

Response Mapping Methods to Estimate the EQ-5D-5L From the Western Ontario McMaster Universities Osteoarthritis in Patients With Hip or Knee Osteoarthritis.

Objectives: The mapping technique can estimate generic preference-based measure scores through a specific measure that cannot be used in economic evaluations. This study compared 2 response mapping methods to estimate EQ-5D-5L scores using the Western Ontario McMaster Universities Osteoarthritis (WOMAC).

Methods: The sample consisted of 758 patients with the hip or knee osteoarthritis recruited in baseline.

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.

Cost-of-illness studies in rare diseases: a scoping review.

Objective: The aim of this scoping review was to overview the cost-of-illness studies conducted in rare diseases.

Methods: We searched papers published in English in PubMed from January 2007 to December 2018. We selected cost-of-illness studies on rare diseases defined as those with prevalence lower than 5 per 10,000 cases.

Psychometric properties of the EQ-5D-5L in patients with major depression: factor analysis and Rasch analysis.

Background: The EQ-5D is one of the most recommended questionnaires for cost-effectiveness studies.

Aims: To study the psychometric properties of the EQ-5D-5L in patients with major depression.

Methods: This prospective observational study included 433 patients with major depression who completed the EQ-5D-5L and Patient Health Questionnaire-9 (PHQ-9) questionnaires at baseline, of whom 310 also did six months later.

[Cost-effectiveness methods of newborn screening assessment.].

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.

Effectiveness of Internet-Based Multicomponent Interventions for Patients and Health Care Professionals to Improve Clinical Outcomes in Type 2 Diabetes Evaluated Through the INDICA Study: Multiarm Cluster Randomized Controlled Trial.

Background: Type 2 diabetes mellitus (T2DM) is a chronic disease in which health outcomes are related to decision making by patients and health care professionals.

Objective: This study aims to assess the effectiveness of internet-based multicomponent interventions to support decision making of all actors involved in the care of patients with T2DM in primary care.

Methods: The INDICA study is an open, community-based, multicenter trial with random allocation to usual care or the intervention for patients, the intervention for health care professionals in primary care, or the combined intervention for both.

Interventions to improve medication adherence in mental health: the update of a systematic review of cost-effectiveness.

Objective: Medication non-adherence in mental health problems has social and economic costs. The objective of the study was to review the cost-effectiveness of interventions to enhance medication adherence in patients with mental health problems.

Methods: The update of a previous systematic review was performed.

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

Background: The EQ-5D-5 L is a quality-of-life questionnaire based on individuals' preferences that is widely employed for cost-effectiveness analysis. Given the current demand for mapping algorithms to directly assign "utilities", this study aimed to generate different mapping models for predicting EQ-5D-5 L utility values based on scores of the Oxford Hip Score (OHS) and Oxford Knee Score (OKS) questionnaires provided by patients suffering from hip and knee osteoarthritis (OA), respectively, and to assess the predictive capability of these functions.

Methods: This was a prospective, observational study.