Postlaunch evidence-generation studies for medical devices in Spain: the RedETS approach to integrate real-world evidence into decision making.

The Monitoring Studies (MS) program, the approach developed by RedETS to generate postlaunch real-world evidence (RWE), is intended to complement and enhance the conventional health technology assessment process to support health policy decision making in Spain, besides informing other interested stakeholders, including clinicians and patients. The MS program is focused on specific uncertainties about the real effect, safety, costs, and routine use of new and insufficiently assessed relevant medical devices carefully selected to ensure the value of the additional research needed, by means of structured, controlled, participative, and transparent procedures. However, despite a clear political commitment and economic support from national and regional health authorities, several difficulties were identified along the development and implementation of the first wave of MS, delaying its execution and final reporting.

Toward a common understanding of competencies for health technology assessment: enhancing educational and training programs around the globe.

Background: Depending on the health system context and the demands of relevant stakeholders in countries, the need, organizational structure, and prerequisites for enabling capacity building and development in health technology assessment (HTA) will vary. Core competencies are instrumental in this and include essential knowledge, skills, and attitudes (KSAs). They provide building blocks for delivering high-quality and effective practices of HTA.

Evaluation and refinement of the PRESTARt tool for identifying 12-14 year olds at high lifetime risk of developing type 2 diabetes compared to a clinicians assessment of risk: a cross-sectional study.

Background: Traditionally Type 2 Diabetes Mellitus (T2DM) was associated with older age, but is now being increasingly diagnosed in younger populations due to the increasing prevalence of obesity and inactivity. We aimed to evaluate whether a tool developed for community use to identify adolescents at high lifetime risk of developing T2DM agreed with a risk assessment conducted by a clinician using data collected from five European countries. We also assessed whether the tool could be simplified.

Efficacy of a self-management education programme on patients with type 2 diabetes in primary care: A randomised controlled trial.

Aim: The purpose of this study was to assess the efficacy of the Spanish Diabetes Self-Management Program (SDSMP) versus usual care in adults with type 2 diabetes mellitus (T2DM) residing in a Spanish region.

Methods: A two-year follow-up randomised controlled trial. The intervention consisted of 6 weekly structured peer-to-peer workshops.

Incidence of severe hypoglycaemic episodes in patients with type 2 diabetes in the Basque country: impact on healthcare costs.

Background: Hypoglycaemia is an acute complication of diabetes mellitus which poses a serious threat. This study aims to describe the annual rate of people suffering episodes of severe hypoglycaemia and to estimate the healthcare costs for individuals who have suffered such events.

Methods: A descriptive study involving all patients with type 2 diabetes (T2DM) from the Basque Country (period: 1/09/2010 to 31/08/2011) aged ≥35 years (N = 134,413).

Multimorbidity in risk stratification tools to predict negative outcomes in adult population.

Introduction: Risk stratification tools were developed to assess risk of negative health outcomes. These tools assess a variety of variables and clinical factors and they can be used to identify targets of potential interventions and to develop care plans. The role of multimorbidity in these tools has never been assessed.

Health-related quality of life and multimorbidity in community-dwelling telecare-assisted elders in the Basque Country.

Introduction: Multimorbidity is more common in the elderly population and negatively affects health-related quality of life (QoL). The aims of the study were to report the QoL of users of the Basque telecare public service (BTPS) and to establish its relationship with multimorbidity.

Methods: The EuroQol questionnaire was administered to 1125 users of the service.

Multimorbidity in people with type 2 diabetes in the Basque Country (Spain): Prevalence, comorbidity clusters and comparison with other chronic patients.

Background: Multimorbidity is a common problem in ageing societies and has a wide range of individual and social consequences. The objective of this study was to compare multimorbidity in a population with type 2 diabetes (T2DM) with that in other chronic patients, and identify disease clusters in patients with T2DM.

Methods: We included all citizens in the Basque Health Service aged ≥ 35 years, and identified the population with chronic conditions (from a list of 51 diseases) and those with T2DM.

Comorbidity and healthcare expenditure in women with osteoporosis living in the basque country (Spain).

Objectives. This study aimed to establish the prevalence of multimorbidity in women diagnosed with osteoporosis and to report it by deprivation index. The characteristics of comorbidity in osteoporotic women are compared to the general female chronic population, and the impact on healthcare expenditure of this population group is estimated.

The prevalence of diabetes-related complications and multimorbidity in the population with type 2 diabetes mellitus in the Basque Country.

Background: Type 2 diabetes mellitus is associated with a diverse range of pathologies. The aim of the study was to determine the incidence of diabetes-related complications, the prevalence of coexistent chronic conditions and to report multimorbidity in people with type 2 diabetes living in the Basque Country.

Methods: Administrative databases, in four cross sections (annually from 2007 to 2011) were consulted to analyse 149,015 individual records from patients aged ≥ 35 years with type 2 diabetes mellitus.