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Abstract Background Type 2 diabetes is an important preventable disease and a growing public health problem. Based on information provided by clinical trials, we know that Type 2 diabetes can be prevented or delayed by lifestyle intervention. In view of translating the findings of diabetes prevention research into real-life it is necessary to carry out community-based evaluations so as to learn about the feasibility and effectiveness of locally designed and implemented programmes. The aim of this project was to assess the effectiveness of an active real-life primary care strategy in high-risk individuals for developing diabetes, and then evaluate its efficiency. Methods/Design Cost-Effectiveness analysis of the DE-PLAN (Diabetes in Europe - Prevention using Lifestyle, physical Activity and Nutritional intervention) project when applied to a Mediterranean population in Catalonia (DE-PLAN-CAT). Multicenter, longitudinal cohort assessment (4 years) conducted in 18 primary health-care centres (Catalan Health Institute). Individuals without diabetes aged 45-75 years were screened using the Finnish Diabetes Risk Score - FINDRISC - questionnaire and a 2-h oral glucose tolerance test. All high risk tested individuals were invited to participate in either a usual care intervention (information on diet and cardiovascular health without individualized programme), or the intensive DE-PLAN educational program (individualized or group) periodically reinforced. Oral glucose tolerance test was repeated yearly to determine diabetes incidence. Besides measuring the accumulated incidence of diabetes, information was collected on economic impact of the interventions in both cohorts (using direct and indirect cost questionnaires) and information on utility measures (Quality Adjusted Life Years). A cost-utility and a cost-effectiveness analysis will be performed and data will be modelled to predict long-term cost-effectiveness. Discussion The project was intended to evidence that a substantial reduction in Type 2 diabetes incidence can be obtained at a reasonable cost-effectiveness ratio in real-life primary health care setting by an intensive lifestyle intervention. As far as we know, the DE-PLAN-CAT/PREDICE project represents the first assessment of long-term effectiveness and cost-effectiveness of a public healthcare strategy to prevent diabetes within a European primary care setting.

There has been a lot of discussion on the technical aspects of the soon to be implemented European Union's Health Technology Assessment (EU HTA) regulation. However, there has been limited discussion on the implementation aspects and the potential limitations from a policy perspective. In May 2024, a group of HTA experts with previous policy responsibilities met in Rome to propose some policy aspects to be considered. As a result of the discussion, several proposals were made. Building mutual trust, improving collaboration and engaging all relevant stakeholders seems a must. Equally important are the communication aspects, and ensuring equal commitment by all parties, allocating the appropriate incentives at all levels. Finally, it is noted that the EU HTA regulation has to be seen from the perspective of a wider policy change within the large EU legal framework., Competing Interests: Conflict of interest: None of the participants declares any conflict of interest. FM, IL, and PL-C received participation fees for attending the meeting., (© 2025 The Authors.)

Background: The European Regulation on Health Technology Assessment (EU HTA R), effective since January 2022, aims to harmonize and improve the efficiency of common HTA across Member States (MS), with a phased implementation from January 2025. At "midterms" of the preparation phase for the implementation of the Regulation our aim was to identify and prioritize tangible action points to move forward., Methods: During the 2023 Spring Convention of the European Access Academy (EAA), participants from different nationalities and stakeholder backgrounds discussed readiness and remaining challenges for the Regulation's implementation and identified and prioritized action points. For this purpose, participants were assigned to four working groups: (i) Health Policy Challenges, (ii) Stakeholder Readiness, (iii) Approach to Uncertainty and (iv) Challenges regarding Methodology. Top four action points for each working group were identified and subsequently ranked by all participants during the final plenary session., Results: Overall "readiness" for the Regulation was perceived as neutral. Prioritized action points included the following: Health Policy, i.e. assess adjustability of MS laws and health policy processes; Stakeholders, i.e. capacity building; Uncertainty, i.e. implement HTA guidelines as living documents; Methodology, i.e. clarify the Population, Intervention, Comparator(s), Outcomes (PICO) identification process., Conclusions: At "midterms" of the preparation phase, the focus for the months to come is on executing the tangible action points identified at EAA's Spring Convention. All action points centre around three overarching themes: harmonization and standardization, capacity building and collaboration, uncertainty management and robust data. These themes will ultimately determine the success of the EU HTA R in the long run., (© 2024. The Author(s).)

Background: This work aimed to determine the role and action points for the involvement of medical societies in the European Health Technology Assessment (EU HTA) Methods: An online pre-convention survey was developed addressing four areas related to the EU HTA: (i) medical societies' role; (ii) role of clinical guidelines; (iii) interface with the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS); and (iv) approaching 'best-available evidence' (BAE). A descriptive analysis of questionnaire outcomes was conducted to inform the European Access Academy (EAA) Fall Convention 2023. Within the working groups (WGs), action points were identified and prioritised., Results: A total of 57 experts from 15 countries responded to the survey. The WGs were attended by (i) 11, (ii) 10, (iii) 12, and (iv) 12 experts, respectively, representing a variety of national backgrounds and stakeholder profiles. The most relevant action points identified were as follows: (i) incorporation of clinical context into population, intervention, comparator, outcomes (PICO) schemes, (ii) timely provision of up-to-date therapeutic guidelines, (iii) ensuring the inclusion of MCBS insights into the EU HTA process, and (iv) considering randomized controlled trials (RCTs) as the gold standard and leveraging regulatory insights if development programs only include single-arm trials., Conclusions: The involvement of medical societies is a critical success factor for the EU HTA. The identified key action points foster the involvement of patient associations and medical societies., Competing Interests: Conflicts of InterestJR and EJ received an unrestricted grant from Abbvie, AstraZeneca, Bayer, Novartis, Roche, Sanofi, and Seagen that partially funded this research. The authors have no further financial or non-financial interests to disclose. BPV has received personal honoraria for advisory boards from Pfizer, Astellas Pharma, Bristol Myers Squibb, Ipsen, EUSA Pharma, MSD, EUSA Pharma, Novartis, AAA, Bayer, and Merck; has been an invited speaker for Astellas Pharma, Janssen, Roche, Pfizer, Bristol Myers Squibb, Roche, Bayer, EUSA Pharma, MSD, AstraZeneca, and Merck; and has received travel support from Merck/Pfizer and Bristol Myers Squibb., (© 2024 by the authors.)

Objectives: Stakeholder involvement has long been considered a success factor for a joint European health technology assessment (HTA) process, and its relevance is now anchored in the EU HTA Regulation's (EU HTAR) legislative wording. Therefore, we aimed to explore the roles, challenges, and most important activities to increase the level of involvement per stakeholder group., Methods: At the 2022 Fall Convention of the European Access Academy (EAA), working groups addressed the involvement of patients, clinicians, regulators, health technology developers (HTD), and national HTA bodies and payers within the EU HTA process. Each working group revisited the pre-convention survey results, determined key role characteristics for each stakeholder, and agreed on the most important activities to fulfill the role profile. Finally, the activities suggested per group were prioritized by plenary group., Results: The prioritized actions for patients included training and capacity building, the establishment of a patient involvement committee, and the establishment of a patient unit at the EC secretariat. For clinicians, it included alignment on evidence assessment from a clinical vs. HTA point of view, capacity building, and standardization of processes. The most important actions for regulators are to develop joint regulatory-HTA guidance documents, align processes and interfaces under the regulation, and share discussions on post-licensing evidence generation. HTDs prioritized scientific advice capacity and the review of the scoping process, and further development of the scope of the assessment report fact checks. The top three actions for national HTA bodies and payers included clarification on the early HTD dialogue process, political support and commitment, and clarification on financial support., Conclusions: Addressing the activities identified as the most important for stakeholders/collaborators in the EU HTA process (e.g., in the implementation of the EU HTA Stakeholder Network and of the guidance documents developed by the EUnetHTA 21 consortium) will be key to starting an " inclusive civil society dialogue ", as suggested by the European Commission's Pharmaceutical Strategy., Competing Interests: Conflicts of InterestT.D.: no CoI; W.V.D.: no CoI; S.S.: no CoI; I.H.: no CoI; R.G.: no CoI; M.T.: no CoI; C.D.: as a strategic and legal consultant, regularly receives honoraria for consulting from numerous health technology developers; J.D.: as a strategic and legal consultant, regularly receives honoraria for consulting from numerous health technology developers; A.C.: no CoI; F.H.: no CoI; M.P.: no CoI; M.B.: no CoI; P.M.: no CoI; A.S.: no CoI; W.G.: no CoI; F.G.: no CoI; S.C.: no CoI; J.R. (James Ryan): employed by AstraZeneca; P.D.: employed by Abbvie; O.S.-M.: no CoI., (© 2024 by the authors.)

Introduction: Different remote interventions, such as applications (apps), have been used to continue promoting healthy ageing and preventing disability during the COVID-19 pandemic. The growing trend of apps in health is exponential and may facilitate scaling up physical activity prescription. Numerous tools are available, but little is known regarding their appropriateness, validation and recommendation, especially for frail older adults., Methods: In-house, we developed an application that makes both the Apple app Store and the Google Play Store searchable using topic-related keywords and facilitates the extraction of basic app-information of the search results. The study was aimed at apps available to an English-speaking market. The resulting apps were filtered using various inclusion and exclusion criteria. The resultant apps underwent a more in-depth characterisation and searches for scientific publications on each app website and PubMed., Results: From an initial search result of >2,800 apps, 459 met the initial inclusion criteria. After a more in-depth review of their features, 39 apps remained for possible app in older frail patients. After testing them, 22 apps were excluded. Seventeen apps fit the inclusion and exclusion criteria and were deemed appropriate after peer review. Of these, only one app, Vivifrail, had any type of publication/published evidence., Conclusion: Apps can be valuable tool in prescribing exercise for frail older adults living in the community. However, few apps seem useful on a large scale, and there is limited evidence to support their effectiveness. It is important to invest in adapting Information and Communication Technologies to this population group., (© The Author(s) 2023. Published by Oxford University Press on behalf of the British Geriatrics Society.)

Background: Depression is a significant public health issue that can lead to considerable disability and reduced quality of life. With the rise of technology, mobile health (mHealth) interventions, particularly smartphone apps, are emerging as a promising approach for addressing depression. However, the lack of standardized evaluation tools and evidence-based principles for these interventions remains a concern., Objective: In this systematic review and meta-analysis, we aimed to evaluate the efficacy and safety of mHealth interventions for depression and identify the criteria and evaluation tools used for their assessment., Methods: A systematic review and meta-analysis of the literature was carried out following the recommendations of the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement. Studies that recruited adult patients exhibiting elevated depressive symptoms or those diagnosed with depressive disorders and aimed to assess the effectiveness or safety of mHealth interventions were eligible for consideration. The primary outcome of interest was the reduction of depressive symptoms, and only randomized controlled trials (RCTs) were included in the analysis. The risk of bias in the original RCTs was assessed using version 2 of the Cochrane risk-of-bias tool for randomized trials., Results: A total of 29 RCTs were included in the analysis after a comprehensive search of electronic databases and manual searches. The efficacy of mHealth interventions in reducing depressive symptoms was assessed using a random effects meta-analysis. In total, 20 RCTs had an unclear risk of bias and 9 were assessed as having a high risk of bias. The most common element in mHealth interventions was psychoeducation, followed by goal setting and gamification strategies. The meta-analysis revealed a significant effect for mHealth interventions in reducing depressive symptoms compared with nonactive control (Hedges g=-0.62, 95% CI -0.87 to -0.37, I 2 =87%). Hybrid interventions that combined mHealth with face-to-face sessions were found to be the most effective. Three studies compared mHealth interventions with active controls and reported overall positive results. Safety analyses showed that most studies did not report any study-related adverse events., Conclusions: This review suggests that mHealth interventions can be effective in reducing depressive symptoms, with hybrid interventions achieving the best results. However, the high level of heterogeneity in the characteristics and components of mHealth interventions indicates the need for personalized approaches that consider individual differences, preferences, and needs. It is also important to prioritize evidence-based principles and standardized evaluation tools for mHealth interventions to ensure their efficacy and safety in the treatment of depression. Overall, the findings of this study support the use of mHealth interventions as a viable method for delivering mental health care., Trial Registration: PROSPERO CRD42022304684; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=304684., (©Andrea Duarte-Díaz, Lilisbeth Perestelo-Pérez, Estel Gelabert, Noemí Robles, Antoni Pérez-Navarro, Josep Vidal-Alaball, Oriol Solà-Morales, Ariadna Sales Masnou, Carme Carrion. Originally published in JMIR Mental Health (https://mental.jmir.org), 27.09.2023.)

Involvement of all relevant stakeholders will be of utmost importance for the success of the developing EU HTA harmonization process. A multi-step procedure was applied to develop a survey across stakeholders/collaborators within the EU HTA framework to assess their current level of involvement, determine their suggested future role, identify challenges to contribution, and highlight efficient ways to fulfilling their role. The 'key' stakeholder groups identified and covered by this research included: patients', clinicians', regulatory, and Health Technology Developer representatives. The survey was circulated to a wide expert audience including all relevant stakeholder groups in order to determine self-perception by the 'key' stakeholders regarding involvement in the HTA process (self-rating), and in a second, slightly modified version of the questionnaire, to determine the perception of 'key' stakeholder involvement by HTA bodies, payers, and policymakers (external rating). Predefined analyses were conducted on the submitted responses. Fifty-four responses were received (patients 9; clinicians: 8; regulators: 4; HTDs 14; HTA bodies: 7; Payers: 5; policymakers 3; others 4). The mean self-perceived involvement score was consistently lower for each of the 'key' stakeholder groups than the respective external ratings. Based on the qualitative insights generated in the survey, a RACI Chart (Responsible/Accountable/Consulted/Informed) was developed for each of the stakeholder groups to determine their roles and involvement in the current EU HTA process. Our findings suggest extensive effort and a distinct research agenda are required to ensure adequate involvement of the key stakeholder groups in the evolving EU HTA process., Competing Interests: The views expressed in this article are the personal views of the author(s) and may not be understood or quoted as being made on behalf of or reflecting the position of the regulatory agency/agencies or organizations with which the author(s) is/are employed/affiliated., (© 2023 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.)

Objectives: Real-world data (RWD) and real-world evidence (RWE) can provide extensive information on healthcare for use in health technology assessment and decision making. Nevertheless, there is a lack of consensus surrounding the appropriate data governance (DG) practices for RWD/RWE. Data sharing is also a large concern, especially considering evolving data protection regulations. Our objective is to propose recommendations for international standards of evaluating the acceptability of RWD governance practices., Methods: After reviewing the literature, we created a checklist targeting DG practices for RWD/RWE. We then carried out a 3-round Delphi panel, including European policy makers, health technology assessment experts, and hospital managers. The consensus for each statement was measured and the checklist adjusted accordingly., Results: The literature review identified the main topics regarding RWD/RWE DG practices: data privacy and security, data management and linkage, data access management, and the generation and use of RWE. Members of the Delphi panel (21 experts/25 invited) were presented a total of 24 statements related to each of the topics. Experts demonstrated a progressive level of consensus and importance ratings in all topics and to most statements. We suggest a refined checklist in which the statements rated less important or with less consensus have been removed., Conclusions: This study suggests how the DG of RWD/RWE could be qualitatively evaluated. We propose checklists that could be used by all RWD/RWE users to help ensure the quality and integrity of RWD/RWE governance and complement data protection law., (Copyright © 2023 International Society for Pharmacoeconomics and Outcomes Research, Inc. Published by Elsevier Inc. All rights reserved.)

Objectives: This study aimed to describe the role of real-world data (RWD) and real-world evidence (RWE) in health technology assessment (HTA) in 5 European countries and to identify the hurdles to the acceptance of RWE and suggest directions toward its more effective use., Methods: Authors from France, Germany, Italy, and Sweden used a common template to extract evidence. For England, the Cancer Drugs Fund was described and analyzed as a particular model for the use of RWD to provide evidence for coverage decisions and managed entry agreements., Results: In all countries except Germany, HTA bodies acknowledged the relevance of RWD/RWE to address postlaunch uncertainties. In Germany, evidence from randomized controlled trials remains the gold standard, and evidence based on RWD is generally rejected. Multiple sources of RWD exist, but the quality, the immediate relevance of existing sources, and their interoperability limit their adaptation to the specifics of a given drug. This leads to skepticism about the validity of the evidence. Timing is also a key issue: the production of evidence may not be synchronized with the HTA and pricing bodies' agendas. The Cancer Drugs Fund case emphasizes that a strong partnership among all stakeholders and a pragmatic use of existing data, alongside clinical evidence provided by companies, are key success factors., Conclusions: A continuous investment in national health information systems is a key issue for providing valid RWE. Processes and aids to guide the acceptability and usage of RWE derived from pairing between sources and questions are essential., (Copyright © 2023 International Society for Pharmacoeconomics and Outcomes Research, Inc. Published by Elsevier Inc. All rights reserved.)

This is one of a series of articles that consider the barriers to optimal use of real-world evidence (RWE) in health technology assessment (HTA) as well as ways to overcome them. The work was carried out as part of EUreccA 2025 (European Initiative for New Reimbursement and Access Approaches 2025), in particular with the RWE workstream embodied within that collaboration. The starting premises of this workstream were as follows: (1) the acceptance of RWE by HTA agencies and payers in the assessment of drugs is suboptimal and variable between jurisdictions, and (2) if that were not the case, the path of new pharmaceuticals to patients could be quicker and less expensive. Elsewhere in this issue we set out the conclusions we had reached in the EUreccA RWE workstream. In this article, we set out the methodology used to conduct the totality of the EureccA 2025 RWE workstream effort, which led us to those conclusions. The main results, strengths, and limitations of the individual parts are discussed further in separate articles in this supplement. Through scoping work, we generated 4 key topics within which to identify and address the barriers to optimal RWE use in HTA. Through pragmatic literature searches, stakeholder engagement, and case studies, we suggest ways in which the problems identified may be addressed as a contribution to progress in this area., (Copyright © 2023 International Society for Pharmacoeconomics and Outcomes Research, Inc. Published by Elsevier Inc. All rights reserved.)

This is one of a series of articles that consider the barriers to optimal use of real-world evidence (RWE) in health technology assessment and how to overcome them. The work was performed as part of EUreccA 2025, in particular with the RWE workstream embodied within that collaboration. Elsewhere in this issue we described the reasoning and process that led us to develop practical tools to support RWE use, including this taxonomy and explained the methods used to do so. The taxonomy classifies questions that are typically addressed using real-world data in health technology assessment and the data sources typically used to address these questions. In this article, we describe the taxonomy itself. For as many of the pairings as possible, we have provided links to advice and methods on how to address the associated question using those data. We have also provided links to examples of RWE use in practical decision making to answer the questions posed. Our work is not complete, but we believe it is sufficient to demonstrate the value of such a taxonomy and information source if it is completed and curated as a "wiki" by the community that would use it., (Copyright © 2023 International Society for Pharmacoeconomics and Outcomes Research, Inc. Published by Elsevier Inc. All rights reserved.)

The May 2022 proposal from the European commission for a 'European health data space' envisages advantages for health from exploiting the growing mass of health data in Europe. However, key stakeholders have identified aspects that demand clarification to ensure success. Data will need to be freed from traditional silos to flow more easily and to cross artificial borders. Wide engagement will be necessary among healthcare professionals, researchers, and the patients and citizens that stand to gain the most but whose trust must be won if they are to allow use or transfer of their data. This paper aims to alert the wider scientific community to the impact the ongoing discussions among lawmakers will have. Based on the literature and the consensus findings of an expert multistakeholder panel organised by the European Alliance for Personalised Medicine (EAPM) in June 2022, it highlights the key issues at the intersection of science and policy, and the potential implications for health research for years, perhaps decades, to come.

Objectives: The main objective of this work was to explore and characterize the current landscape of mobile applications available to treat mood disorders such as depression, bipolar disorder, and dysthymia., Methods: We developed a tool that makes both the Apple App Store and the Google Play Store searchable using keywords and that facilitates the extraction of basic app information of the search results. All app results were filtered using various inclusion and exclusion criteria. We characterized all resultant applications according to their technical details. Furthermore, we searched for scientific publications on each app's website and PubMed, to understand whether any of the apps were supported by any type of scientific evidence on their acceptability, validation, use, effectiveness, etc. Results: Thirty apps were identified that fit the inclusion and exclusion criteria. The literature search yielded 27 publications related to the apps. However, these did not exclusively concern mood disorders. 6 were randomized studies and the rest included a protocol, pilot-, feasibility, case-, or qualitative studies, among others. The majority of studies were conducted on relatively small scales and 9 of the 27 studies did not explicitly study the effects of mobile application use on mental wellbeing., Conclusion: While there exists a wealth of mobile applications aimed at the treatment of mental health disorders, including mood disorders, this study showed that only a handful of these are backed by robust scientific evidence. This result uncovers a need for further clinically oriented and systematic validation and testing of such apps.

Among stakeholders and decision-makers in advanced breast cancer, the demand for insights from real-world data (RWD) is increasing. Although RWD can be used to support decisions throughout different stages of a breast cancer drug's life cycle, barriers exist to its use and acceptance. We propose a collaborative approach to generating and using RWD that is meaningful to multiple stakeholders, and encourage frameworks toward international guidelines to help standardize RWD methodologies to achieve more efficient use of RWD insights., Competing Interests: Declaration of competing interest Author PC has received grants, personal fees and non-financial support from Novartis; personal fees, non-financial support, and travel support from Roche; personal fees from Pfizer; and personal fees and travel support from AstraZeneca. Author SDR has served as a consultant for Pfizer. Author OSM has received grants from the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) and consulting fees and honoraria from numerous multinational pharmaceutical companies. Authors PS and LT have no conflicts of interest to disclose., (Copyright © 2021. Published by Elsevier Ltd.)

The arrival of precision oncology is challenging the evidence standards under which technologies are evaluated for regulatory approval as well as for health technology assessment (HTA) purposes. Several key concepts are discussed to highlight the source of the challenges in evaluating these products, particularly those impacting the HTA of histology-independent therapies. These include the basket trial design, high uncertainty in (potentially substantial) benefits for histology-independent therapies, and the inability to identify and quantify benefits of standard of care in daily practice when the biomarker is not currently used in practice. There is little precedent for a technology with the unique mixture of challenges for HTA of histology-independent therapies and they will be evaluated using standard HTA, as there currently is no evidence suggesting the standard HTA framework is not appropriate. A number of questions proposed to help guide HTA bodies when assessing the appropriateness of local processes to optimally evaluate histology-independent therapies. Pragmatic solutions are further proposed to decrease uncertainty in the benefits of histology independent therapies as well as fill gaps in comparative evidence. The proposed solutions ensure a consistent and streamlined approach to evaluation across histology-independent products, although with varying strengths and limitations. Alongside these solutions, sponsors should engage early with HTA bodies/payers and regulatory agencies through parallel/joint scientific advice to facilitate the integration of both regulatory and HTA perspectives into one clinical development programme, potentially reconciling evidence requirements., (© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Objectives: Capacity building exercises are important to increase understanding of healthcare processes by key stakeholders, and to facilitate open discussions to build consensus. This study explored the views of a multi-stakeholder group of local Saudi experts on possible value elements that could be important for health technology assessment (HTA) processes and methods regarding pharmaceutical products in Saudi Arabia ('value drivers')., Methods: A diversified group of local experts were invited to a two-day capacity building workshop from 18 to 19 December 2019 in Riyadh, Saudi Arabia. Information regarding the participants' demographic and educational/professional background, along with their self-assessed knowledge and experience of HTAs and the concept of value in the pharmaceutical market was collected. For each of 22 value drivers identified during a targeted literature search, participants were asked either to 'opt out' of its consideration for future HTA assessments, or rate it from 1 to 10 (low-high) on feasibility and acceptability., Results: Efficacy and safety were the highest rated value drivers for acceptability and feasibility. Explicit cost-effectiveness thresholds had the lowest ratings for acceptability and feasibility. Participants highlighted data availability and accuracy as a potential challenge to HTA implementation in Saudi Arabia., Conclusions: Participants valued a pharmaceutical product's efficacy and safety alongside the consideration of disease characteristics for HTA processes. Participants also valued a binding HTA recommendation and the use of local real-world evidence, where available, to support HTA submissions., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2021 The Author(s).)

Diabetes mellitus (DM) is the leading cause of polyneuropathy in the Western world. Diabetic neuropathy (DNP) is the most common complication of diabetes and is of great clinical significance mainly due to the pain and the possibility of ulceration in the lower limbs. Early detection of neuropathy is essential in the medical management of this complication. Early unmyelinated C-fiber dysfunction is one of the typical findings of diabetic neuropathy and the first clinical manifestation of dysfunction indicating sudomotor eccrine gland impairment. In order to assess newly developed technology for the measurement of dermal electrochemical conductance (DEC), we analyzed the feasibility and effectiveness of DEC (quantitative expression of sudomotor reflex) as a screening test of DNP in primary health care centers. The study included 197 people (with type 2 diabetes, prediabetes and normal tolerance) who underwent all the protocol tests and electromyography (EMG). On comparing DEC with EMG as the gold standard, the area under the receiver operating characteristic (ROC) curve (AUC, area under the curve) was 0.58 in the whole sample, AUC = 0.65 in the diabetes population and AUC = 0.72 in prediabetes, being irrelevant in subjects without glucose disturbances (AUC = 0.47). Conclusions: In usual clinical practice, DEC is feasible, with moderate sensitivity but high specificity. It is also easy to use and interpret and requires little training, thereby making it a good screening test in populations with diabetes and prediabetes. It may also be useful in screening general populations at risk of neuropathy.

Background: The cost-effectiveness of childhood obesity prevention interventions is critical for their sustained implementation. This study evaluated the cost-effectiveness of the Educació en Alimentació (EdAl) program, a school-based intervention for reducing obesity., Methods: Total EdAl program implementation costs and per-child costs were estimated. Cost-effectiveness, defined using the incremental cost-effectiveness ratio (ICER), was estimated as the difference between the intervention and control group costs divided by the obesity-related outcome effects for boys (avoided cases of obesity, obesity prevalence, body mass index [BMI], and BMI z-score units) for each group. As a significant difference (4.39%) in the reduction of obesity prevalence between the intervention and control groups was observed for boys in the EdAl program, the data were calculated only for boys., Results: The intervention cost was 24,246.53 € for 1,550 children (15.64 €/child/3 years) or 5.21 €/child/year. The ICERs/boy were 968.66 € to avoid one case of obesity, 3.6 € to reduce the obesity prevalence by 1%, 44.68 € to decrease BMI by one unit, and 65.16 € to reduce the BMI z-score by one unit., Conclusions: The cost of reducing the obesity prevalence in boys by 4.39% was 5.21 €/child/year, half the cost proposed by the Spanish Health Ministry, indicating that the EdAl program is cost-effective.