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There is growing interest in cost-effectiveness thresholds as a tool to inform resource allocation decisions in health care. Studies from several countries have sought to estimate health system opportunity costs, which supply-side cost-effectiveness thresholds are intended to represent. In this paper, we consider the role of empirical estimates of supply-side thresholds in policy-making. Recent studies estimate the cost per unit of health based on average displacement or outcome elasticity. We distinguish the types of point estimates reported in empirical work, including marginal productivity, average displacement, and outcome elasticity. Using this classification, we summarise the limitations of current approaches to threshold estimation in terms of theory, methods, and data. We highlight the questions that arise from alternative interpretations of thresholds and provide recommendations to policymakers seeking to use a supply-side threshold where the evidence base is emerging or incomplete. We recommend that: (1) policymakers must clearly define the scope of the application of a threshold, and the theoretical basis for empirical estimates should be consistent with that scope; (2) a process for the assessment of new evidence and for determining changes in the threshold to be applied in policy-making should be created; (3) decision-making processes should retain flexibility in the application of a threshold; and (4) policymakers should provide support for decision-makers relating to the use of thresholds and the implementation of decisions stemming from their application.

Due to population ageing and medical advances, people with advanced chronic diseases (ACD) live longer. Such patients are even more likely to face either temporary or permanent reduced functional reserve, which typically further increases their healthcare resource use and the burden of care on their caregiver(s). Accordingly, these patients and their caregiver(s) may benefit from integrated supportive care provided via digitally supported interventions. This approach may either maintain or improve their quality of life, increase their independence, and optimize the healthcare resource use from early stages. ADLIFE is an EU-funded project, aiming to improve the quality of life of older people with ACD by providing integrated personalized care via a digitally enabled toolbox. Indeed, the ADLIFE toolbox is a digital solution which provides patients, caregivers, and health professionals with digitally enabled, integrated, and personalized care, supporting clinical decisions, and encouraging independence and self-management. Here we present the protocol of the ADLIFE study, which is designed to provide robust scientific evidence on the assessment of the effectiveness, socio-economic, implementation, and technology acceptance aspects of the ADLIFE intervention compared to the current standard of care (SoC) when applied in real-life settings of seven different pilot sites across six countries. A quasi-experimental trial following a multicenter, non-randomized, non-concurrent, unblinded, and controlled design will be implemented. Patients in the intervention group will receive the ADLIFE intervention, while patients in the control group will receive SoC. The assessment of the ADLIFE intervention will be conducted using a mixed-methods approach.

Science and technology have evolved quickly during the two decades of the 21st century, but healthcare systems are grounded in last century’s structure and processes. Changes in the way health care is provided are demanded; digital transformation is a key driver making healthcare systems more accessible, agile, efficient, and citizen-centered. Nevertheless, the way healthcare systems function challenges the development (Innovation + Development and regulatory requirements), assessment (methodological guidance weaknesses), and adoption of digital applications (DAs). WtsWrng (WW), an innovative DA which uses images to interact with citizens for symptom triage and monitoring, is used as an example to show the challenges faced in its development and clinical validation and how these are being overcome. To prove WW’s value from inception, novel approaches for evidence generation that allows for an agile and patient-centered development have been applied. Early scientific advice from NICE (UK) was sought for study design, an iterative development and interim analysis was performed, and different statistical parameters (Kappa, B statistic) were explored to face development and assessment challenges. WW triage accuracy at cutoff time ranged from 0.62 to 0.94 for the most frequent symptoms attending the Emergency Department (ED), with the observed concordance for the 12 most frequent diagnostics at hospital discharge fluctuating between 0.4 to 0.97; 8 of the diagnostics had a concordance greater than 0.8. This experience should provoke reflective thinking for DA developers, digital health scientists, regulators, health technology assessors, and payers.

Objective The aim of this study was to investigate the prevalence of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) in women with pelvic inflammatory disease (PID) and the usefulness and cost-effectiveness of a rapid molecular test for the diagnosis and clinical management of PID. Methods This observational study included 75 patients with mild-to-moderate PID (n = 33), severe PID (n = 29) and non-specific lower abdominal pain (NSAP) (n = 13). CT/NG infections were analyzed using a standard and a rapid test. A cost analysis was carried out. Results Samples of 19 patients (25.3%) were CT/NG positive. Concordance between rapid and standard tests was 100%. No significant differences were observed in the incidence of CT/NG in mild-to-moderate compared to severe PID. Costs differed according only to disease severity. Conclusions Rapid molecular tests could help with the diagnosis of PID in sexually active women in clinical settings in which a standard technique is not available.

ObjectiveThe diagnosis of pelvic inflammatory disease (PID) is challenging. Testing forChlamydia trachomatis(CT) andNeisseria gonorrhoeae(NG) in the lower genital tract is recommended, since a positive result supports the diagnosis. The aim of this study was to investigate the prevalence of CT/NG infection in women suspected of having PID and the usefulness of a rapid molecular test to detect CT/NG.MethodsThis observational study included 3 groups of patients: mild-to-moderate PID (n=33), severe PID (n=29) and non-specific lower abdominal pain (NSAP) (n=13). CT/NG infection were analyzed using a standard and a rapid test. A cost analysis was carried out.ResultsThe presence of CT/NG was determined in 75 endocervical and urine samples. Endocervical samples of 19 patients (25.3%) were CT/ NG positive (two cases of co-infection). NG was not detected in urine in one case. Concordance between rapid and standard tests was 100%. However, the mean time to achieve results was shorter with the rapid test: 2.22vs.24.37 hours, respectively (p< 0.001). No significant differences were observed in the presence of CT/NG in mild-to-moderate compared to severe PID. Costs differed according only to disease severity but to the presence of CT/NG. Only one patient with NSAP was positive for CT.ConclusionsRapid molecular tests could help with the diagnosis of PID in sexually active women in clinical settings in which a standard technique is not available. Nonetheless, a positive test for CT/NG may not be determinant of the clinical management. The only cost difference relates to disease severity.

BACKGROUND:The measurement and valuation of health-related quality of life for and by young people are increasingly important, yet research on the impact of study perspective and validity of preferences obtained from young populations remains limited. OBJECTIVE:The objective of this study was to evaluate the feasibility and validity of collecting EQ-5D Youth version (EQ-5D-Y) preferences from adolescents, adults, and adults from a child perspective. METHODS:A profile case best-worst scaling (BWS) online survey was administered to representative Australian and Spanish adult (age ≥ 18 years) and child (age 11-17 years) samples. Adults were told to either answer from their own perspective or for a hypothetical 10-year-old child. Marginal best- and worst-choice frequencies, analysis of dominant choices, self-reported difficulty completing the tasks, and time to complete tasks were used to determine the validity of responses. RESULTS:In Australia, 2134 adults and 1010 adolescents completed the survey. In Spain, 2007 adults and 1000 adolescents completed it. Analysis of marginal choice frequencies and dominant choices indicated that the pattern of responses between adolescents and adults was similar. For Australian respondents, having no mobility problems was rated as best by adolescents, while adults rated having no pain and discomfort as 'best'. In Spain, both adults and adolescents rated no pain or discomfort as 'best'. Australian adolescents rated very worried, sad or unhappy as 'worst', while Spanish adolescents, Spanish adults and Australian adults rated a lot of pain and discomfort as 'worst'. CONCLUSIONS:Results suggest preferences from adolescents using direct BWS are valid. Our descriptive analysis also suggest that there are age-related and country-specific differences in elicitation values for the EQ-5D-Y.

To evaluate preventive interventions on alcohol consumption has been long recommended in Spain. The impact evaluation of structured programs and specific actions for the prevention and treatment of alcohol consumption (PAPTCA) would allow making better informed decisions on public health financing based on the efficiency criteria. To the best of our knowledge, there is no scientific document that illustrates the situation of the PAPTCAs' evaluation in Spain. This paper aims to classify and describe PAPTCAs in Spain, focused on their impact evaluation and information on financing for accountability to society.A systematic literature review of the PAPTCAs implemented in Spain, from 2000 till 2017, at regional (autonomous communities) and local level was carried out, and a descriptive analysis of the PAPTCA database obtained from the literature review was carried out.145 structured programs and 45 specific actions were identified. Only 25% of structured programs provided an impact evaluation, besides, only 15% presented some information about their financing. Regarding the specific actions, the numbers were less encouraging where 10% provided an impact evaluation while a similar figure of PAPTCAs showed financing information.There is a need to systematize the information of the PAPTCA that serves as an instrument to conduct impact evaluations in Spain. This should ease the scarce presence of evaluative culture in this area and promote the accountability of resources spent on public health to society.Hace tiempo que se recomienda evaluar las intervenciones preventivas en España. La evaluación del impacto de los programas estructurados y de las acciones puntuales de prevención y tratamiento del consumo de alcohol (PAPTCA) permitiría tomar las decisiones de financiación mejor informadas en materia de salud pública, desde el punto de vista de la eficiencia. No obstante, no se conoce un documento que ilustre la situación de la evaluación de los PAPTCA en España. Este artículo pretendió clasificar y describir los PAPTCA en España, prestando especial atención a la evaluación de impacto y a la información sobre financiación para la rendición de cuentas.Se realizó una revisión bibliográfica sistematizada de los PAPTCA implementados en España tanto a nivel regional (comunidades autónomas) como local durante el periodo 2000-2017, y se llevó a cabo un análisis descriptivo de la base de datos obtenida de los PAPTCA a partir de la revisión de la bibliografía realizada.Se identificaron 145 programas estructurados y 45 acciones puntuales. Solo el 25% de los programas estructurados evaluaron los resultados. Además, únicamente un tercio de ellos presentaron alguna información sobre su financiación. Por su parte, los números fueron menos alentadores en las acciones puntuales, donde solo el 10% evaluaron sus resultados, y una cifra similar aportó información sobre su financiación.Existe una necesidad de sistematizar la información de los PAPTCA, para que sirva de instrumento en la evaluación de su impacto en España y, de esta manera, paliar la escasa presencia de cultura evaluativa en este ámbito y promover la rendición de cuentas a la sociedad de los recursos en salud pública.

Rationale, aims and objectives Self-monitoring of blood glucose (SMBG) is recommended to monitor glycaemic levels. The recent development of real-time continuous glucose monitoring (RT-CGM) enables continuous display of glucose concentration alerting patients in the event of relevant glucose fluctuations, potentially avoiding hypoglycaemic events and reducing long-term complications related to glycosylated haemoglobin (HbA1c) levels. This paper aims to evaluate the cost-effectiveness of RT-CGM compared to SMBG in patients with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) which should support decision-making on public funding of RT-CGM in Spain. Methods We performed a systematic review and meta-analyses on the effectiveness of RT-CGM in the reduction of HbA1c levels and severe hypoglycaemic events. A cost-effectiveness analysis was conducted using a Markov model which simulates the costs and health outcomes of individuals treated under these alternatives for a lifetime horizon from the perspective of the Spanish Health Service. The effectiveness measure was quality-adjusted life years (QALYs). We ran extensive sensitivity analyses, including a probabilistic sensitivity analysis. Results Real-time continuous glucose monitoring provides a significant reduction of HbA1c for T1DM (13 studies; weighted mean difference (WMD) = -0.23%, 95% CI: -0.35, -0.11) and T2DM (5 studies; WMD = -0.48%, 95% CI: -0.79, -0.17). There were no statistically significant differences in the rate of severe hypoglycaemic events in T1DM (9 studies; OR = 1.16, 95% CI: 0.78, 1.72) or T2DM (no severe hypoglycaemic events were reported in any study). In the base case analysis, RT-CGM led to higher QALYs and health care costs with an estimated incremental cost-effectiveness ratio of €2 554 723 and €180 553 per QALY for T1DM and T2DM patients respectively. Sensitivity analyses revealed that the study results were robust. Conclusions Real-time continuous glucose monitoring is not a cost-effective technology when compared to SMBG in Spain.

Given the economic burden of seasonal influenza for the healthcare system, we performed a systematic review aiming to update available evidence on the cost-effectiveness of vaccination of seasonal influenza in different age groups, including children.A systematic review of the literature on economic evaluations of seasonal influenza vaccination programs in children and adults was carried out. The following databases were searched (January 2013 - April 2018): Medline and PREMEDLINE, EMBASE, EconLit and databases of the Centre for Reviews and Dissemination (DARE, HTA, NHS EED).A total of 11 economic evaluations were included. Methodological quality of included studies was acceptable. Scientific evidence shows that seasonal influenza vaccination programs in school-age children can be a cost-effective alternative from national health system perspective and can be cost-saving from societal perspective in European countries. However, available evidence does not allow us to conclude that influenza vaccination programs in healthy adults under 65 years of age were a cost-effective alternative in our context, due to the high uncertainty and the lack of studies carried out in Spanish context.Vaccination programs for the prevention of seasonal influenza in school-age children (3-16 years) can be a cost-effective strategy.Dada la carga económica que supone para el sistema sanitario la gripe estacional, se plantea esta revisión sistemática cuyo objetivo fue actualizar la evidencia disponible sobre el coste-efectividad de vacunación contra la gripe estacional en diferentes grupos de edad, incluyendo población infantil.Se llevó a cabo una revisión sistemática de la literatura de evaluaciones económicas de los programas de vacunación contra la gripe estacional en niños y adultos. Se realizaron búsquedas en las bases de datos (enero 2013 – abril 2018): Medline y PREMEDLINE, EMBASE, EconLit y en las bases de datos del Centre for Reviews and Dissemination (DARE, HTA, NHS EED).Se incluyeron 11 evaluaciones económicas. La calidad metodológica de los estudios incluidos fue buena. La evidencia científica muestra que los programas de vacunación contra la gripe estacional en niños en edad escolar pueden ser una estrategia coste-efectiva desde la perspectiva sanitaria en países europeos. La evidencia científica disponible hasta el momento no nos permite concluir que los programas de vacunación antigripal en adultos sanos de menos de 65 años de edad sean una alternativa costeefectiva en nuestro contexto, debido a la elevada incertidumbre existente y a la escasez de estudios realizados en el contexto español.Los programas de vacunación contra la gripe estacional en niños en edad escolar (3-16 años) pueden ser una estrategia coste-efectiva desde la perspectiva del SNS.

To incorporate economic evaluation into decision-making, we need to know how much a health system is willing and able to invest in a quality-adjusted life year (QALY). In Spain, the figure of €30,000 per QALY as cost-effectiveness (CE) threshold has been widely cited. However, as in most health systems, no value has been formally adopted; mainly because of the arbitrariness, the lack of theoretical and scientific basis, and the controversy around its estimation and what the threshold should represent. Based on a systematic review of empirical studies on the estimation of the CE threshold undertaken by this research team, we conducted a critical appraisal of the state of the art, using a Delphi with the participation of 13 national experts. This paper contributes to assess the research progress on the CE threshold in Spain, to consider its utility in the decision making process supported by economic evaluation, and to propose further research to improve what has been achieved so far.