Left ventricular assist devices (LVAD) are a therapeutic option in patients with advanced heart failure (HF) not a candidate for cardiac transplant as destination therapy (DT). However, important uncertainties remain regarding the use of LVAD in the long-term in real practice settings. When planning registries, it is important to choose the appropriate outcomes that ensure comparability and reduce the possibility of bias.

The purpose of this study was to establish a minimum dataset (MDS) that should be collected in all LVAD for DT registries to meet the needs and demands of Health Technology Assessment (HTA) doers and health professionals.

To design the MDS for LVAD, a preliminary list of outcome domains and data items were developed attending to the gaps and research needs derived from existing evidence coming from HTA carried out at the European Network of Health Technology Assessment (EUnetHTA) level. The list of data items and domains was agreed upon by all involved HTA organizations and a three-round Delphi was conducted among an experienced panel of cardiologists to rate the importance of the items for measuring uncertainty gaps.

After the three-round Delphi process, the expert panel reached a consensus regarding eighteen outcomes and forty-seven variables divided into seven main domains (safety, effectiveness, patient acceptability, satisfaction, healthcare system impact, pharmaceutical management, and technique-related factors).

The MDS of outcomes and measures, developed based on research gaps and needs, can allow for standardizing data collection and improving the quality of data for decision making and practice.

The ability to remotely monitor cognitive skills is increasing with the ubiquity of smartphones. The Mobile Toolbox (MTB) is a new measurement system that includes measures assessing Executive Functioning (EF) and Processing Speed (PS): Arrow Matching, Shape-Color Sorting, and Number-Symbol Match. The purpose of this study was to assess their psychometric properties.

MTB measures were developed for smartphone administration based on constructs measured in the NIH Toolbox® (NIHTB). Psychometric properties of the resulting measures were evaluated in three studies with participants ages 18 to 90. In Study 1 (N = 92), participants completed MTB measures in the lab and were administered both equivalent NIH TB measures and other external measures of similar cognitive constructs. In Study 2 (N = 1,021), participants completed the equivalent NIHTB measures in the lab and then took the MTB measures on their own, remotely. In Study 3 (N = 168), participants completed MTB measures twice remotely, two weeks apart.

All three measures exhibited very high internal consistency and strong test-retest reliability, as well as moderately high correlations with comparable NIHTB tests and moderate correlations with external measures of similar constructs. Phone operating system (iOS vs. Android) had a significant impact on performance for Arrow Matching and Shape-Color Sorting, but no impact on either validity or reliability.

Results support the reliability and convergent validity of MTB EF and PS measures for use across the adult lifespan in remote, self-administered designs.

Health technology assessment (HTA) agencies in Spain have an important role in informing decisions about the introduction and use of health technologies in the Spanish National Health System. However, although different approaches have been taken to measure and improve their impact, no study to date has explored the perceived impact of HTA products at the national level. The aim of this study was to explore the perspectives of macro-, meso-, and micro-level decision makers on how to improve the impact of HTA.

Three online focus groups were conducted with policy makers, healthcare managers, clinicians, and patients. The transcripts were evaluated using a deductive thematic analysis based on a multidimensional framework to explore mechanisms of impact.

Four key themes were identified:

1. (i) Timeliness and use of HTA assessments: Although the quality of the reports was recognized, the time taken for the elaboration and extension of reports negatively affected their use. Participants considered that reports should be tailored to the needs of end users (e.g., briefer versions available for meso-and micro-level use);

2. (ii) Effective engagement and external communications: The engagement of multiple stakeholders (policy makers, manufacturers, clinicians, and patients) in the elaboration process was considered crucial to improve HTA impact and ensure adequate communication of results;

3. (iii) Good institutional reputation and fit within the healthcare and policy making system: Stakeholders agreed on the need to strengthen collaboration at the national level and increase public understanding of the value of HTA and its use in healthcare decision-making; and

4. (iv) Effective implementation of policy change regarding health technologies: Stakeholders were very receptive to the results and recommendations of HTA reports when new technologies are demanded, but the identification and selection process should be improved to guarantee that these reports are available on time.

This study has identified different proposals and mechanisms that could improve the impact of HTA in Spain.

The need for timely access to innovative technologies has placed a special focus on the development of policies and practices that can guarantee the availability whilst ensuring the safety of these technologies after launch or licensure. The aim of this paper is to present and discuss Post-Launch Evidence Generation (PLEG) practices among health technology assessment (HTA) bodies at the European level to explore cross-border collaboration opportunities.

In December 2019, a survey composed of nine closed-ended questions with multiple choice answers about the PLEG practices in each country was sent to 25 partners of the European Network of Health Technology Assessment (EUnetHTA) Joint Action 3. In addition to the survey, the national practices were discussed during a face-to-face meeting with all partners of the dedicated work package. A quantitative analysis and a qualitative synthesis of the results was carried out.

Twelve HTA bodies completed the survey. Of these, 11 reported procedures in place for official PLEG requests. In nine of the agencies, the requests are made at the time of the assessment/appraisal. Data collection and analysis mainly lies with companies for pharmaceuticals (60%) while it is more the responsibility of the HTA body for medical devices (75%). Only one agency reported owning the data and being able to exchange the data without asking permission. During the face-to face discussions, it was acknowledged that PLEG practices differ between countries depending on the topic concerned, but most rely on the usage of registries (mainly disease registries) for data collection. Most agencies estimated that a European collaboration could take place.

PLEG practices are in the remit of many European HTA bodies. Data sharing should be anticipated as only some own the data and can exchange them without asking permission. European collaboration on PLEG could commence once the evidence gaps have been defined or during the production of the HTA reports in the case of joint assessments.

A disruptive technology has been defined as an innovation that completely changes the way things are done. Early identification of potential disruptive health technologies has become a key point in the agenda of decision makers and health technology assessment (HTA) bodies. The PriTec tool is an automatically executable web application that was developed in 2009 by the Galician HTA Agency to facilitate decision-making regarding the selection of technologies for post-launch observation. The tool has been updated to allow scoring and ranking of technologies before their introduction into the healthcare portfolio. The aim of this work was to propose a framework for assessing the usefulness of the PriTec tool in relation to identifying possible disruptive innovations.

To evaluate the applicability of the PriTec tool for distinguishing disruptive from non-disruptive innovations, we selected a few examples from prior acknowledged disruptive and non-disruptive innovations. These technologies were scored against the predefined criteria and the results were compared and analyzed globally and by type of domain. The PriTec tool assesses six domains of technologies: clinical condition, comparative effectiveness and safety, economic impact, implementation consequences, and dissemination speed.

Disruptive technologies (e.g., transcatheter aortic valve implantation or point-of-care tests) had higher weighted global scores than non-disruptive technologies. In the domain analysis, the scores for implementation consequences were higher for disruptive than for non-disruptive technologies. Both types of technologies had similar scores in the other domains.

The PriTec tool seems to be useful for identifying potential disruptive technologies through its implementation domain. Further validation strategies are required to confirm the tool’s applicability and to improve its accuracy in the field of health disruption. The tool could be used by governments, horizon scanning organizations, and HTA organizations to promote the evidence-based detection of disruptive technologies in clinical practice. However, it is advisable that the tool be further tested and validated in other contexts.

Health technology assessment (HTA) reports are complex technical documents that address multiple aspects of the incorporation of a technology into the healthcare system applying complicated methodologies coming from different disciplines. The purpose of HTA is to support decision makers, who should have an adequate level of training to fully understand these assessments. However, most HTA education programs and courses are intended for HTA doers and there is a lack of practical guidance training aimed at preparing health managers or policy makers in HTA. The objective is to describe an HTA training program developed for decision makers of the three levels (health care administration, hospital management and clinical practice).

The education program has been designed through a collaboration between the Public Health Department of the Faculty of Medicine of the University of Santiago de Compostela (USC) and the Galician Health Technology Assessment Agency that belongs to the Spanish HTA Bodies Network. The duration of the course is 200 hours and the methodology will be distance learning, through the virtual classroom of the USC. The teaching collaborators come from the academic field and the HTA area.

The course will cover the legal, clinical and organizational framework in which the HTA is developed in Spain and in Europe; and will approach the methodology used in HTA. The course is structured in six modules: (i) Research, development and regulation of health technologies; (ii) Role of HTA as a decision support tool; (iii) HTA Methodology; (iv) Health information systems (including use of real world data); (v) Incorporation of HTA into society (stakeholders); (vi) Future challenges (personalized medicine and e-health).

A specific training about HTA from a practical approach not theoretical could be of interest for different stakeholders involved in the decision-making process across the health systems. This type of educational program will allow decision makers to have a good understanding of the wide range of information they handle.

The PriTec Tool is an automatically executable multicriteria web application developed in 2009 by the Galician Health Knowledge Agency (avalia-t; ACIS) for the prioritization of technologies susceptible of post-introduction observation or obsolescence. Currently, the tool has been updated and improved to support the selection process of technologies to be assessed for inclusion into the National Public Health Care Portfolio. The aim of this work is to present the updated version of the tool (PriTec Tool 2) with the new functionalities.

The development of the tool was based on a mixed-method approach, comprising a systematic review, followed by a five-step process: (i) development of the preliminary proposal of prioritization criteria and domains; (ii) contextualization and validation of the criteria and domains by a multidisciplinary group of key stakeholders; (iii) assessment of validity, reliability and suitability of criteria; (iv) weighting of domains; and (v) evaluation of applicability, reliability and reproducibility of the tool.

The tool consists of 15 criteria categorized in 5 domains. The web application ranks the technologies through automatic computation of the weighted average of the different criteria and generates a comparative analysis of the individual or working group results. The application allows access to different options: working groups, case studies or technology comparison. It allows for individual prioritizations or managing working groups. When applied to prioritize the Spanish Network of Health Technology Assessment (HTA) Agencies yearly workplan it achieved an intraclass correlation coefficient of 0.71 (95% confidence interval 0.62, 0.88).

The updated PriTec Tool-2 can be very useful to guide decision-making regarding the assessments that would be mostly needed to ensure health, equity and sustainability. The tool stands out for its simplicity and ease of application. It is acknowledged that the tool could be of great interest to policy makers, HTA bodies and other health decision-makers worldwide.

The term Postlaunch Evidence Generation (PLEG) refers to evidence generated after the launch or licensing of a health technology. The aim of this paper is to provide an overview of the implementation of these practices in the European Union in order to explore cross-border cooperation opportunities.

In December 2019, a survey composed of nine closed-ended questions with multiple choice answers about the PLEG practices in each country was sent to all twenty-five dedicated work package (WP5B) partners of the European Network of Health Technology Assessment (EUnetHTA) Joint Action 3. In addition to the survey, the national practices were discussed during a face-to-face meeting with WP5B partners.

Twelve Health TechnologyAssessment (HTA) bodies completed the survey. Of these, eleven reported procedures in place for official requests for PLEGs in their remit. In the large majority of cases, the requests are made at the time of the assessment/appraisal. Several agencies participate in the definition of the scope of the PLEG or review of its protocol. Data collection and analysis mainly lie with companies for pharmaceuticals, whereas it is more the responsibility of the HTA bodies for medical devices. Only one agency owns the data and is able to exchange them without asking permission.

Most agencies recommend European collaboration on PLEG commence once the evidence gaps have been defined or during the production of the HTA report in the case of European joint assessment.

The European Health Technology Assessment Network (EUnetHTA) Work Package 5B1, is focused on testing the levels of cross-border collaboration on real world data for supporting reimbursement/pricing decision-making. Within this Work Package, we are conducting a pilot on Left Ventricular Assist Device on destination therapy in collaboration with the National Institute for Health and Care Excellence (NICE, UK), the Belgian Health Care Knowledge Centre (KCE, Belgium) and the Italian National Agency for Regional Health Services (AGENAS, Italy). This pilot aims to define the minimum data set for gathering and sharing high quality registry data on key uncertainties found at the time of the health technology assessment (HTA). Furthermore, the pilot will assess the feasibility of carrying out a common analysis or reusing this data for National or Joint Reassessments.

Evidence gaps were based on the four national assessments. Collaborating partners were responsible for agreeing on the key outcomes and proposing the minimum dataset to be registered. European clinical experts and patients rated and prioritized the dataset using a two round Delphi technique (not relevant, important but not critical; critical). The dataset will confirm the basis for the Spanish LVAD registry, implemented at the national health service level to inform inclusion into the healthcare portfolio.

The key outcomes agreed upon by agencies relate to safety, effectiveness, satisfaction and acceptability of the patient and cost-effectiveness, budget impact and organizational impact. Expert cardiologists and cardiac surgeons representing the European and Spanish Society, among others, participated in the prioritization of basic data. The final dataset is expected by December 2020.

The variation in the quality and definition of outcome measures for measuring key evidence gaps reduces the utility of registries for HTA, making it difficult to compare, link, and aggregate data across countries. The EUnetHTA pilot is intended to offer a model for cross-border collaboration on real world data for supporting the decision-making process for pricing and reimbursement.

In recent years, the GRADE system has been adopted internationally to make judgments about evidence and/or recommendations. Recently, the Spanish Network of HTA (RedETS) has promoted among its members the use of the GRADE system, especially the “Evidence to Decision” tool (EtD) where a multidisciplinary panel is involved. The objective is to describe the methodological approach with the first AQuAS experience using this methodology in HTA, focused on inclusion/exclusion of these technologies in the Spanish National Health Service (NHS) portfolio.

The standard EtD tool was used for clinical and financial decisions. Four multidisciplinary panels were constituted by relevant professionals in clinical practice and, where possible, patients. The four panels discussed on the following four interventions: in two cases, AQuAS prepared preliminary recommendations and participants provided feedback, while in the other two cases, experts received the evidence review and were asked to formulate recommendations. These recommendations were voted on and, in the case of disagreement, adapted and then voted on for a second time. Finally, any discrepancies were noted in the report. Evaluated interventions were: maxillofacial 3D-reconstruction, cataract surgery equipment, non-invasive surgery in obesity and pharmacological treatment in secondary fracture prevention.

Especially when more than one evaluative question was addressed in the HTA report the EtD and the consensus results required discussion. Consensus was fast but not immediate. Meeting length depended on the number of HTA questions and the amount of original disagreement in the recommendations. The nuances on how to write recommendations also affected the panel duration. All panels were successful in formulating the final recommendations.

Standardizing methodologies increased the homogeneity across HTA reports. The GRADE system is a feasible and useful tool because it favors transparency and rigor in drawing up recommendations on the inclusion/exclusion of technologies in the NHS portfolio. The EtD framework complements GRADE tables, which display the relevant evidence in a way that can be used by multidisciplinary groups to reach a consensual recommendation.

Although all participants received a short training video, more experience in the use of these methodologies might shorten the duration of the process and facilitate reaching consensus. Some considerations on how to overcome the difficulties and complexity of this methodological approach are discussed.

The increasing prevalence of overweight and obesity has developed into an epidemic public health problem worldwide. In this regard, in the last years several investigations have suggested that water intake and water balance could have important implications for both weight management and body composition. The aim of this study was to analyse the association between fluid intake, water balance and body composition in a sample of healthy young adults from Spain.

A total of 358 healthy subjects (121 males; 237 females) aged 18–39 years participated in the current study. The validated questionnaire entitled “The hydration status questionnaire” was used to assess fluid intake, elimination, and water balance. Anthropometric measurements (height, weight and waist circumference) were performed according to the recommendations of the International Standards for Anthropometric Assessment (ISAK). The estimates of total body water (TBW), fat mass (FM) and fat free mass (FFM) were acquired by bioelectrical bioimpedance analysis. Physical activity was estimated through the Short form of the International Physical Activity Questionnaire (IPAQ-SF). Differences in anthropometric and body composition variables were assessed through the ANOVA test and considered significant at p < 0.05.

Fluid intake was correlated with body water content in females (r = 0.180, p = 0.006) and males (r = 0.266, p = 0.003). An inverse association between water consumption per weight (ml/kg) with body weight (females (f): r = -0.318, p = 0.000; males (m): r = -0.220, p = 0.015), body fat mass (f: r = -0.320, p = 0.000; m: r = -0.200, p = 0.028), and waist circumference (f: r = -0.237, p = 0.000; m: r = -0.215, p = 0.018) was found. Finally, significant differences in body water content in females according to water balance were observed (p = 0.04).

Higher fluid intake seems to be related with a better body composition, therefore the improvement of water intake and water balance could be useful in weight management and in the prevention of overweight and obesity in healthy young adults.

Age-related hearing loss (ARHL) is a sensory impairment, with a dramatic increase in its incidence, which is caused by genetic and environmental factors such as noise and ototoxic drugs. Recent studies correlated ARHL to elevated plasma homocysteine (Hcy) by folate deficiency, suggesting that reduction of Hcy levels by folate supplementation could potentially ameliorate ARHL.

Hyperhomocysteinemia (HHcy), a status that contributes to ARHL, may also arise from malfunction of Hcy remethylation by betaine homocysteine S-methyltransferases (BHMTs) and methionine synthase in the methionine cycle. The expression and/or activity of these enzymes may be altered by ototoxic drugs, including paracetamol (APAP).

To determine the effect of APAP in cochlear morphology and function of control and Bhmt-/- mice, and to analyze putative preventive effects of folic acid (FA) supplementation.

Two-month-old Bhmt-/- mice (n = 47), with greater dependence on folate metabolism for Hcy remethylation, and Bhmt + / + mice (n = 42) were fed control or FA supplemented diets for 30 days. The last day APAP (250 mg/kg) or placebo were injected intraperitoneally.

Hearing was evaluated by recording auditory brainstem responses (ABR) at the beginning of the experiment and after treatments. Picrosirius red staining was used for evaluation of the cochlear lateral wall cytoarchitecture. Plasma and hepatic metabolite levels were determined by HPLC or on Spinlab 100® autoanalyzer.

Loss of Bhmt expression induced HHcy, but an impact on hearing acuity was not observed. Acute APAP administration did not induce ABR threshold shifts. However, following ototoxic treatment, changes of 5–17% in the areas of the stria vascularis and spiral ligament were detected between Bhmt-/- mice under different dietary treatments; cochlear structures of Bhmt-/- mice receiving APAP plus FA supplementation resemble those of the control group. APAP increases susceptibility to ototoxic damage in the presence of HHcy.

BHMT plays a central role in cochlear methionine metabolism. FA supplementation modulates Hcy levels, contributing to a proper remethylation status that prevents ARHL.

The objective was to evaluate maternal Mediterranean diet (MD) pattern adherence during pregnancy and its association with small for gestational age (SGA) and preterm birth. A secondary objective of the current study was to describe the sociodemographic, lifestyle and obstetric profile of the mothers studied as well as the most relevant paternal and newborn characteristics.

The current study is a two-phase retrospective population-based study of maternal dietary habits during pregnancy and their effect on newborn size and prematurity. The descriptive first phase examined maternal dietary habits during pregnancy along with the maternal sociodemographic, lifestyle and obstetric profile in a cross-sectional period study. In the second phase, newborn outcomes were evaluated in a nested case–control study. Adherence to MD during pregnancy was measured with the Spanish version of Kidmed index.

Obstetrics ward of the La Fe Hospital in Valencia.

All mother–child pairs admitted after delivery during a 12-month period starting from January 2018 were assessed for eligibility. A total of 1118 provided complete outcome data after signing informed consent.

14·5 % met the criteria of poor adherence (PA); 34·8 %, medium adherence (MA); and 50·7 %, optimal adherence (OA). Medium adherence to MD was associated in the adjusted scenarios with a higher risk of giving birth to a preterm newborn. No association was found between MD adherence and SGA.

Early intervention programmes geared towards pregnant women, where women were aided in reaching OA to MD, might reduce the risk of preterm newborn.

In the past decades the community-based participatory research method known as PhotoVoice has gained relevance, but there are few published studies on its application in the field of health technology assessment (HTA) and clinical practice guidelines (CPGs). The aim of this presentation was to describe a PhotoVoice project linked to a CPG on major depression in children and adolescents.

The design of the study was adapted to the main objective, which was to enhance the understanding of major depression and improve clinical practice with the contributions of clinicians, methodologists, and patients. Seven adolescents and ten of their family members participated in the study through PhotoVoice sessions and focus groups. The audio recordings of all sessions were transcribed verbatim and coded, and a thematic analysis was undertaken.

Six themes emerged: (i) a lack of understanding and information about depression in childhood and adolescence; (ii) the importance of support groups; (iii) the need to favor early care and access to services; (iv) the adaptation of therapeutic strategies tailored to individual needs; (v) the sensitivity of professionals; and (vi) fostering interaction between the health and education systems. Photographic exhibitions were planned to share the main results. These exhibitions were promoted to increase public awareness and reduce stigmatization, and to reach clinicians and policy makers. From a methodological point of view, the use of PhotoVoice in this study helped to effectively incorporate the lived experiences, concerns, and preferences of patients and their relatives into the CPG. The study also confirmed the value of photographs and participatory methods. The main limitations and strengths of the study, as well as suggestions for future research, are also outlined.

PhotoVoice is a flexible, effective, and innovative method of obtaining information about patients’ perspectives and experiences, and it offers the added value of being able to reach the main stakeholders, including policymakers and the public.

The specificities of non-pharmaceuticals can require adapting classical health technology assessment (HTA) methodologies and developing additional regional approaches to support decision-making processes. However, little information exists regarding the explicit approaches used in different countries. The aim of this work is to provide an overview of the role and activities of the Galician HTA agency (avalia-t, Spain) regarding assessment, appraisal and continued evaluation across the whole life cycle of non-pharmaceutical technologies.

In depth review and analysis of the activities undertaken by avalia-t during the past five years to support the introduction and appropriate use of non-pharmaceutical health care technologies at the regional level.

A multidisciplinary Commission judges the added value of new non-pharmaceuticals and establishes the indications and conditions for use. HTAs, which are mandatory for all relevant technologies, rely on the best available evidence on safety and effectiveness but also provide fit for purpose contextualized information based on organizational data and administrative registers. Interaction with multidisciplinary stakeholders is commonly needed to complement the evidence base (ad hoc working groups, face to face discussions), and post-launch studies can be implemented to analyze the utilization and results in real world practice. Performance indicators and other HTA based products can also be required to ensure the quality of health care (e.g., appropriate use indications, quality indicators, evidence based patient information). In addition, technical and scientific advice/support can be provided at different decision levels of the health organization to promote the quality of care and appropriate use of technologies (e.g., regional mental health program, suicide management strategy, bariatric surgery surveillance registry).

Rigorous, comprehensive and systematic processes for supporting non-pharmaceutical technology adoption and implementation are required. Although it is acknowledged that core information does not differ substantially within countries, contextualized information is recognized as essential for establishing the conditions for use at the regional level.