Supervised multicomponent exercise as an adjuvant program for people with unilateral and/or bilateral chronic vestibular hypofunction: EXERVEST study protocol.

Background: Unilateral and bilateral peripheral vestibular hypofunction (UVH and BVH) often complains of dizziness, gaze, and balance disturbances. There is a lack of evidence on exercise intervention in UVH and BVH patients. To investigate the effect of an eight-week supervised multicomponent exercise program in people suffering from UVH or BVH in comparison with a control group doing conventional vestibular rehabilitation at home. Methods: This longitudinal, controlled, randomized, prospective, single-blinded, two-arm, parallel intervention study will include 66 adults (≥18 years old) with chronic UVH or BVH. Participants will be randomly assigned to an exercise intervention group or an attention control group. Participants will be assessed at baseline, after a two-month intervention period, and after a six-month follow-up. The primary variable will be the balance, measured by the dynamic posturography sensory organization test and the Modified Dynamic Gait Index test. Secondary outcome variables will include cardiorespiratory fitness (peak cardiopulmonary exercise test), body composition (bioimpedance and anthropometric variables), physical activity level and sleep quality (accelerometry), health-related quality of life (Dizziness Handicap Inventory questionnaire), emotional state (Beck Depression and Anxiety Inventory questionnaires), and blood pressure monitoring. Discussion: This study will try to answer whether in people with UVH/BVH, an adjuvant program of multicomponent exercise will help the prognosis of this population. Trial registration: ClinicalTrials.gov, identifier [NCT05192564]. Verification date: April 2023.

Match Loads May Predict Neuromuscular Fatigue and Intermittent-Running Endurance Capacity Decrement after a Soccer Match.

How the match-derived load metrics relate to post-match fatigue in soccer is scarcely researched. Thus, the aim of this study was to determine the associations between soccer match-related internal and external loads, neuromuscular performance decrease and intermittent-running endurance capacity decrement immediately post-match. Vertical jump (countermovement jump), straight-line sprinting (10- and 20-m sprint), change of direction ability (T-test) and intermittent-running endurance capacity (YO-YO intermittent recovery level 2) were measured one day before and immediately after a friendly match in male soccer players. During the match, players' internal and external loads were also monitored, including heart rate-derived indices, total distance at various speed thresholds, average running velocity, maximal running velocity, number of sprints and number of accelerations and decelerations at various intensity thresholds. The results show that match-induced fatigue was reflected on neuromuscular performance and intermittent-running endurance capacity immediately post-match (p < 0.05). The quantification of percentage change of match external-load metrics, particularly accelerations and decelerations, provides a useful non-invasive predictor of subsequent neuromuscular fatigue status in soccer players immediately post-match (p < 0.05). However, only internal load metrics present a practical application for predicting intermittent-running endurance capacity impairment (p < 0.05). In summary, internal and external load metrics may allow for predicting the extent of acute fatigue, and variability between halves may represent a valuable alternative to facilitate the analysis of match-related fatigue both for research and applied purposes.

Biochemical and Physical Performance Responses to a Soccer Match after a 72-Hour Recovery Period.

The physiological and neuromuscular responses at 72 h post-match are not widely researched, despite evidence showing substantial changes in recovery markers at 72 h post-match. Consequently, the aim of this study was to determine the biochemical and physical performance responses to a soccer match after a 72-h recovery period. Male soccer players of a semiprofessional team participated in this study. Before playing a friendly match, blood values of testosterone, cortisol, the testosterone-to-cortisol ratio and urea were collected and the squat jump and the Bangsbo Repeated Sprint Ability test were performed. These measurements were considered as baseline (pre match) and were obtained again after a 72-h recovery period. Results indicate that physical performance at 72 h post-match was similar to baseline (squat jump: p = 0.974; total Repeated Sprint Ability time: p = 0.381; Repeated Sprint Ability fatigue index: p = 0.864). However, perturbations in the biochemical milieu derived from the soccer match metabolic and physiological stress were still evident at this time point. While no significant differences compared to pre match were obtained in testosterone and urea concentrations after the recovery period, cortisol and testosterone-to-cortisol ratio values were significantly higher (14.74 ± 3.68 µg/dL vs. 17.83 ± 2.65 µg/dL; p = 0.045; ES 0.92 [0.00; 1.84], very likely) and lower (39.08 ± 13.26 vs. 28.29 ± 7.45; p = 0.038; ES -0.96 [-1.89; -0.04], very likely), respectively. In conclusion, soccer players have similar physical performance to the pre match after a 72-h recovery period, even with signs of biochemical and physiological stress.

Clinical, physical, physiological, and cardiovascular risk patterns of adults with schizophrenia: CORTEX-SP study: Characterization of adults with schizophrenia.

Schizophrenia (SP) is a severe mental illness with high rates of premature morbidity and mortality, associated with an unhealthy lifestyle and the side effects of drug treatment. The aims of the study were: 1) to determine some key physical, physiological and biochemical markers of health status, including sleep quality, in adults (42±10 yr) with SP (n=126), 2) to estimate cardiovascular risk (CVR), and 3) to compare all studied variables with a healthy control (HC) population (n=30). Assessment was based on body composition, blood pressure, cardiorespiratory condition, sleep quality with triaxial accelerometry for eight days and biochemical analysis. Participants with SP showed a cardiovascular risk profile including "overweight metabolically abnormal", low cardiorespiratory fitness, and impairment of ventilatory efficiency. Although individuals with SP slept more compared to HC, similar sleep efficiency was shown by both groups, but with significantly higher levels of wake after sleep onset by SP. The assessment of CVR revealed significantly higher values in SP (moderate risk) compared to HC (low risk) regardless of the estimation system. The identification of specific clinical, physical, and physiological CVR profiles in SP illness compared to healthy people strongly suggests targeting a comprehensive approach including non-pharmacological interventions. Clinical Trials.gov identifier, NCT03509597. Date of registration: April 26th, 2018.

A Metabolically Healthy Profile Is a Transient Stage When Exercise and Diet Are Not Supervised: Long-Term Effects in the EXERDIET-HTA Study.

Metabolically unhealthy obesity (MUO) is a regular state in people with primary hypertension (HTN), obesity, and who are physically inactive. To achieve and maintain a metabolically healthy overweight/obese (MHO) state should be a main treatment goal. The aims of the study were (1) to determine differences in metabolic profiles of overweight/obese, physically inactive individuals with HTN following a 16-week (POST) supervised aerobic exercise training (SupExT) intervention with an attentional control (AC) group, and (2) to determine whether the changes observed were maintained following six months (6 M) of unsupervised time. Participants (n = 219) were randomly assigned into AC or SupExT groups. All participants underwent a hypocaloric diet. At POST, all participants received diet and physical activity advice for the following 6 M, with no supervision. All measurements were assessed pre-intervention (PRE), POST, and after 6 M. From PRE to POST, MUO participants became MHO with improved (p < 0.05) total cholesterol (TC, ∆ = -12.1 mg/dL), alanine aminotransferase (∆ = -8.3 U/L), glucose (∆ = -5.5 mg/dL), C-reactive protein (∆ = -1.4 mg/dL), systolic blood pressure (SBP), and cardiorespiratory fitness (CRF) compared to unhealthy optimal cut-off values. However, after 6 M, TC, glucose, and SBP returned to unhealthy values (p < 0.05). In a non-physically active population with obesity and HTN, a 16-week SupExT and diet intervention significantly improves cardiometabolic profile from MUO to MHO. However, after 6 M of no supervision, participants returned to MUO. The findings of this study highlight the need for regular, systematic, and supervised diet and exercise programs to avoid subsequent declines in cardiometabolic health.

Effects of different aerobic exercise programs on cardiac autonomic modulation and hemodynamics in hypertension: data from EXERDIET-HTA randomized trial.

The aims of the present study were to analyze the effects of 16 weeks of different aerobic exercise training (ExT) programs with diet on cardiac autonomic modulation and hemodynamics in nonphysically active and overweight/obese adults (n = 249, 53.7 ± 8.0 years) with primary hypertension, and the possible differences among ExT programs and their effects on heart rate (HR), blood pressure (BP), and long-term BP variability (BPV). Participants were randomly assigned into an attention control (AC) group (physical activity recommendations) or one of three supervised ExT groups: high volume of moderate-intensity continuous training, high-volume and high-intensity interval training (HIIT), and low-volume-HIIT. Twenty-four hours of ambulatory BP monitoring was used to analyze systolic (SBP) and diastolic (DBP) BP, HR, and BPV. A cardiopulmonary exercise test was performed to determine peak oxygen uptake (VO2peak). Following intervention, resting and submaximal exercise (HR, SBP, and DBP), along with diurnal and nocturnal SBP and DBP values decreased (P < 0.05) in all groups with no differences between groups. When the ExT groups were combined, submaximal SBP (P = 0.048) and DBP (P = 0.004), VO2peak (P = 0.014) and HR reserve (P = 0.030) were significantly improved compared with AC. Intervention did not have significant effects on BPV. In the present study better improvements in the autonomic nervous system were seen when the aerobic ExT was individually designed and supervised with pari passu effects irrespective of exercise intensity and volume. Low-volume-HIIT ExT combined with a healthy diet should be considered as a time efficient and safe mechanism for reducing the cardiovascular risk in hypertensive individuals.

Long-Term Effects in the EXERDIET-HTA Study: Supervised Exercise Training vs. Physical Activity Advice.

Purpose: To determine whether improvements in cardiorespiratory fitness (CRF), blood pressure (BP) and body composition previously seen after a 16-week exercise intervention (POST) with hypocaloric diet are maintained following six months (6M) of unsupervised exercise time. Methods: Overweight/obese, physically inactive participants with primary hypertension (HTN) (n = 190) were randomly assigned into an attention control group (physical activity recommendations) or one of three supervised exercise groups. After POST, all participants received diet and physical activity advice for the following 6M but no supervision. All anthropometric and physiological measurements were taken pre and post the 16-week supervised intervention period, as well as after 6M of no supervision. Results: After 6M: 1) body mass (BM) (Δ = 2.5%) and waist circumference (Δ = 1.8%) were higher (P < .005) than POST, but lower (P < .005) than pre-intervention (BM, Δ = -5.1%; waist circumference, Δ = -4.7%), with high-volume and high-intensity interval training group revealing a higher BM reduction (Δ = -6.4 kg) compared to control group (Δ = -3.5 kg); 2) BP variables were higher (P < .001) compared to POST with no change from pre-intervention; and 3) CRF was higher compared to pre-intervention (Δ = 17.1%, P < .001) but lower than POST (Δ = -5.7%, P < .001). Conclusions: When an overweight/obese population with HTN attains significant improvements in cardiometabolic health POST intervention with diet restriction, there is a significant reduction following 6M when exercise and diet supervision is removed, and only recommendations were applied. These results suggest the need for a regular, systematic and supervised diet and exercise programs to avoid subsequent declines in cardiometabolic health.

Is cardiorespiratory fitness independently associated with the biochemical profile in overweight/obese adults with primary hypertension? The EXERDIET-HTA study.

Cardiorespiratory fitness (CRF) is positively associated with enhanced cardiovascular health. This cross-sectional study aimed to determine associations between CRF and the biochemical profile of overweight/obese adults diagnosed with primary hypertension (HTN). Does cardiorespiratory fitness (exposure) positively affect the biochemical profile (outcome) in overweight/obese individuals suffering from HTN? Assessment with anthropometric, ambulatory blood pressure monitoring (24 h), CRF (peak oxygen uptake, V̇O2peak) and biochemical analysis was performed on 214 participants (138 men, 76 women). A series of linear and logistic regression analyses were conducted. Participants were divided into CRF tertiles (classified as low, moderate and high CRF). The CRF was independently and inversely associated with aspartate aminotransferase (AST; ß = -0.328, p < .05) and alanine aminotransferase (ALT; ß = -0.376, p < .01) concentrations. C-reactive protein, AST/ALT ratio, gamma-glutamyl transpeptidase, total cholesterol/high-density lipoprotein cholesterol ratio, glucose, insulin and insulin resistance index (HOMA-IR), were all associated, but not independently, with CRF in linear and/or unadjusted logistic regression models. However, independently, logistic regression revealed that glucose was associated with the moderate CRF group. Findings suggest that a lower CRF is associated with an unhealthy biochemical profile in non-physically active and overweight/obese individuals with HTN. As such, this population should look to increase physical activity in order to improve their CRF and biochemical profile.

Clinical, physical, physiological, and dietary patterns of obese and sedentary adults with primary hypertension characterized by sex and cardiorespiratory fitness: EXERDIET-HTA study.

The main purpose of this study was to determine some key physical, physiological, clinical, and nutritional markers of health status in obese and sedentary adults (54.0 ± 8.1 years, 141 men and 68 women) with primary hypertension (HTN) characterized by sex and cardiorespiratory fitness (CRF) level. The studied population showed a high cardiovascular risk (CVR) profile including metabolically abnormal obese, with poor CRF level (22.5 ± 5.6 mL·kg-1·min-1), exercise-induced HTN (Systolic Blood Pressure>210 mmHg in men and >190 mmHg in women at the end of the exercise test) and with non-healthy adherence to dietary pattern (Dietary Approaches to Stop Hypertension, 46.3%; Mediterranean Diet, 41.1%; and Healthy Diet Indicator, 37.1%). Women showed a better biochemical and dietary pattern profile than men (lower values, P < 0.05, in triglycerides, mean difference = 26.3; 95% CI = 0.9-51.7 mg/dL, aspartate transaminase, mean difference = 4.2; 95% CI = 0.3-8.0 U/L; alanine transaminase, mean difference = 8.2; 95% CI = 1.6-14.8 U/L; gamma-glutamyl transpeptidase, mean difference = 11.0; 95% CI = -1.1-23.2 U/L and higher values, P = 0.002, in high-density lipoprotein cholesterol, mean difference = 5.0, 95% CI = -13.3-3.3 mg/dL), but physical and peak exercise physiological characteristics were poorer. A higher CRF level might contribute to the attenuation of some CVR factors, such as high body mass index, non-dipping profile, and high hepatic fat. The results strongly suggest that targeting key behaviors such as improving nutritional quality and CRF via regular physical activity will contribute to improving the health with independent beneficial effects on CVR factors.

Influence of different types of compression garments on exercise-induced muscle damage markers after a soccer match.

There is not enough evidence of positive effects of compression therapy on the recovery of soccer players after matches. Therefore, the objective was to evaluate the influence of different types of compression garments in reducing exercise-induced muscle damage (EIMD) during recovery after a friendly soccer match. Eighteen semi-professional soccer players (24 ± 4.07 years, 177 ± 5 cm; 71.8 ± 6.28 kg and 22.73 ± 1.81 BMI) participated in this study. A two-stage crossover design was chosen. Participants acted as controls in one match and were assigned to an experimental group (compression stockings group, full-leg compression group, shorts group) in the other match. Participants in experimental groups played the match wearing the assigned compression garments, which were also worn in the 3 days post-match, for 7 h each day. Results showed a positive, but not significant, effect of compression garments on attenuating EIMD biomarkers response, and inflammatory and perceptual responses suggest that compression may improve physiological and psychological recovery.

Estudio de la validez en la medición de los valores de lactato sanguíneo entre los dos modelos existentes de LactatePro / Validity of blood lactate measurements between the two LactatePro versions

Introducción: La medición de la concentración de lactato sanguíneo ([La-]) para el control de la intensidad del esfuerzo, tanto en laboratorio como sobre el terreno, es muy habitual en la fisiología del ejercicio y en el control del entrenamiento. El objeto de este estudio es analizar la validez y concordancia en la medición de [La-] entre los dos modelos existentes de LactatePro en el mercado. Métodos: Han participado 34 deportistas voluntarios (3 ciclistas, 17 remeros, 10 corredores de larga distancia y 4 de montaña), los cuales llevaron a cabo un test Escalonado Progresivo Incremental Máximo (EPIM) con escalones de 3 minutos hasta el agotamiento subjetivo, con toma de una muestra sanguínea con un capilar heparinizado, la cual se analizó simultáneamente ambos modelos. Resultados y conclusión: El análisis mostró una alta correlación entre aparatos (r = 0,991 y r2 = 0,983; p <0.001), con concordancia alta para la media de resultados (0,31 mmol/l), siendo ligeramente más alta en el modelo LactatePro LT-1710. El tramo (0 - 5,0 mmol/l) muestra una alta correlación entre aparatos (r = 0,965 y r2= 0,931; p <0,001). El tramo de lactato medios (5,1 - 10,0 mmol/l) determina una alta correlación entre ambos (r = 0,921 y r2= 0,848; p <0,001) y concordancia alta (0,54 mmol/l). En el tramo de valores de lactato (10,1 - 20,0 mmol/l) la correlación es alta, similar a la del tramo medio (r = 0,926 y r2= 0,858). La concordancia en este grupo es alta para la media de los resultados (0,40 mmol/l). Para los de [La] mayor (>10 mmol/l) la correlación y la concordancia son altas. El cambio en la medición de los valores de [La-], sustituyendo el modelo antiguo de LactatePro LT-1710 por el nuevo LT 1730 del mismo fabricante (Akray Factory Inc. KDK Corporation, Siga, Japan), es posible dada la alta correlación y concordancia tanto para todo el conjunto como para los grupos

Introduction: The blood lactate concentration to measure the exercise intensity in the lab or in the field is very usual in the exercise physiology and training control. The main aim was to measure the validity and the concordance in the measurement between two lactate-pro models in the market. Methods: 34 voluntary sportmen (3 cyclist, 17 rowers, 10 long distance runners and 4 mountains runners) performed a staggered, progressive, intervallic, maximal test of effort. Constant increases of intensity (every 3 min) were done. The peripheral blood lactate was measured at the same time in both models by a heparinized capilar during the 10 next second after the step. Results and Conclusion: A high correlation between devices was presented (r = 0,991 and r2= 0,983; p <0.001), with a high concordance for the medium results (0,31 mmol/l), being a little beat higher in the model LactatePro LT-1710. The stretch of values (0 -5,0 mmol/l) presented a high correlation between devices (r = 0,965 and r2= 0,931; p <0.001). The stretch of medium values (5,1 - 10,0 mmol/l) determined a high correlation between them (r = 0,921 and r2= 0,848; p <0.001) and high concordance (0,54 mmol/l). In the stretch (10,1 - 20,0 mmol/l) the correlation is high, similar than the medium group (r = 0,926 and r2= 0,858). The concordance in this group is for the mean results (0,40 mmol/l). For high [La-] (>10 mmol/l), the correlations and the concordance are high. The measurements of the [La-] values by the old model LactatePro LT-1710 versus the new one LT 1730 (Akray Factory Inc. KDK Corporation, Siga, Japan) is possible, given that the correlation and the concordance for the total data as well as groups are high

Lack of concordance amongst measurements of individual anaerobic threshold and maximal lactate steady state on a cycle ergometer.

INTRODUCTION: The calculation of exertion intensity, in which a change is produced in the metabolic processes which provide the energy to maintain physical work, has been defined as the anaerobic threshold (AT). The direct calculation of maximal lactate steady state (MLSS) would require exertion intensities over a long period of time and with sufficient rest periods which would prove significantly difficult for daily practice. Many protocols have been used for the indirect calculation of MLSS. OBJECTIVES: The aim of this study is to determine if the results of measurements with 12 different AT calculation methods and calculation software [Keul, Simon, Stegmann, Bunc, Dickhuth (TKM and WLa), Dmax, Freiburg, Geiger-Hille, Log-Log, Lactate Minimum] can be used interchangeably, including the method of the fixed threshold of Mader/OBLA's 4 mmol/l and then to compare them with the direct measurement of MLSS. METHODS: There were two parts to this research. Phase 1: results from 162 exertion tests chosen at random from the 1560 tests. Phase 2: sixteen athletes (n = 16) carried out different tests on five consecutive days. RESULTS: There was very high concordance among all the methods [intraclass correlation coefficient (ICC) > 0.90], except Log-Log in relation to the Stegamnn, Dmax, Dickhuth-WLa and Geiger-Hille. The Dickhuth-TKM showed a high tendency towards concordance, with Dmax (2.2 W) and Dickhuth-WLa (0.1 W). The Dickhuth-TKM method presented a high tendency to concordance with Dickhuth-WLa (0.5 W), Freiburg (7.4 W), MLSS (2.0 W), Bunc (8.9 W), Dmax (0.1 W). The calculation of MLSS power showed a high tendency to concordance, with Dickhuth-TKM (2 W), Dmax (2.1 W), Dickhuth-WLa (1.5 W). CONCLUSION: The fixed threshold of 4 mmol/l or OBLA produces slightly different and higher results than those obtained with all the methods analyzed, including MLSS, meaning an overestimation of power in the individual anaerobic threshold. The Dickhuth-TKM, Dmax and Dickhuth-WLa methods defined a high concordance on a cycle ergometer. Dickhuth-TKM, Dmax, Dickhuth-WLa described a high concordance with the power calculated to know the MLSS.

A polypill strategy to improve adherence: results from the FOCUS project.

BACKGROUND: Adherence to evidence-based cardiovascular (CV) medications after an acute myocardial infarction (MI) is low after the first 6 months. The use of fixed-dose combinations (FDC) has been shown to improve treatment adherence and risk factor control. However, no previous randomized trial has analyzed the impact of a polypill strategy on adherence in post-MI patients. OBJECTIVES: The cross-sectional FOCUS (Fixed-Dose Combination Drug for Secondary Cardiovascular Prevention) study (Phase 1) aimed to elucidate factors that interfere with appropriate adherence to CV medications for secondary prevention after an acute MI. Additionally, 695 patients from Phase 1 were randomized into a controlled trial (Phase 2) to test the effect of a polypill (containing aspirin 100 mg, simvastatin 40 mg, and ramipril 2.5, 5, or 10 mg) compared with the 3 drugs given separately on adherence, blood pressure, and low-density lipoprotein cholesterol, as well as safety and tolerability over a period of 9 months of follow-up. METHODS: In Phase 1, a 5-country cohort of 2,118 patients was analyzed. Patients were randomized to either the polypill or 3 drugs separately for Phase 2. Primary endpoint was adherence to the treatment measured at the final visit by the self-reported Morisky-Green questionnaire (MAQ) and pill count (patients had to meet both criteria for adherence at the in-person visit to be considered adherent). RESULTS: In Phase 1, overall CV medication adherence, defined as an MAQ score of 20, was 45.5%. In a multivariable regression model, the risk of being nonadherent (MAQ <20) was associated with younger age, depression, being on a complex medication regimen, poorer health insurance coverage, and a lower level of social support, with consistent findings across countries. In Phase 2, the polypill group showed improved adherence compared with the group receiving separate medications after 9 months of follow-up: 50.8% versus 41% (p = 0.019; intention-to-treat population) and 65.7% versus 55.7% (p = 0.012; per protocol population) when using the primary endpoint, attending the final visit with MAQ = 20 and high pill count (80% to 110%) combined, to assess adherence. Adherence also was higher in the FDC group when measured by MAQ alone (68% vs. 59%, p = 0.049). No treatment difference was found at follow-up in mean systolic blood pressure (129.6 mm Hg vs. 128.6 mm Hg), mean low-density lipoprotein cholesterol levels (89.9 mg/dl vs. 91.7 mg/dl), serious adverse events (23 vs. 21), or death (1, 0.3% in each group). CONCLUSIONS: For secondary prevention following acute MI, younger age, depression, and a complex drug treatment plan are associated with lower medication adherence. Meanwhile, adherence is increased in patients with higher insurance coverage levels and social support. Compared with the 3 drugs given separately, the use of a polypill strategy met the primary endpoint for adherence for secondary prevention following an acute MI. (Fixed Dose Combination Drug [Polypill] for Secondary Cardiovascular Prevention [FOCUS]; NCT01321255).

Sensor applications of soft magnetic materials based on magneto-impedance, magneto-elastic resonance and magneto-electricity.

The outstanding properties of selected soft magnetic materials make them successful candidates for building high performance sensors. In this paper we present our recent work regarding different sensing technologies based on the coupling of the magnetic properties of soft magnetic materials with their electric or elastic properties. In first place we report the influence on the magneto-impedance response of the thickness of Permalloy films in multilayer-sandwiched structures. An impedance change of 270% was found in the best conditions upon the application of magnetic field, with a low field sensitivity of 140%/Oe. Second, the magneto-elastic resonance of amorphous ribbons is used to demonstrate the possibility of sensitively measuring the viscosity of fluids, aimed to develop an on-line and real-time sensor capable of assessing the state of degradation of lubricant oils in machinery. A novel analysis method is shown to sensitively reveal the changes of the damping parameter of the magnetoelastic oscillations at the resonance as a function of the oil viscosity. Finally, the properties and performance of magneto-electric laminated composites of amorphous magnetic ribbons and piezoelectric polymer films are investigated, demonstrating magnetic field detection capabilities below 2.7 nT.

Budget impact and cost-utility analysis of universal infant rotavirus vaccination in Spain.

Rotavirus is not included in the Spanish mass infant vaccination schedule but has also not been economically evaluated for its inclusion. We analysed cost-utility of the universal infant rotavirus vaccination using RotaTeq® versus no vaccination in Spain. We also carried out a budget impact analysis and determined the effect on results of different variables introduced in the model. A deterministic Markov model was built considering loss of quality of life for children and their parents, and introducing direct and indirect costs updated to 2011. The introduction of the vaccination using RotaTeq® as a universal infant vaccination would increase the annual health care budget in 10.43 million euro and would result in a gain of an additional Quality Adjusted Life Year at a cost of 280,338€ from the healthcare system perspective and 210,167€ from the societal perspective. The model was stable to variable modifications. To sum up, according to our model and estimates, the introduction of a universal infant rotavirus vaccination with RotaTeq® in Spain would cause a large impact on the health care budget and would not be efficient unless significant variations in vaccine price, vaccine efficacy and/or utilities took place.

Developing the HTA core model for the online environment.

BACKGROUND: A framework for collaborative production and sharing of HTA information, the HTA Core Model, was originally developed within EUnetHTA in 2006-08. In this paper, we describe the further development of the Model to allow implementation and utilization of the Model online. The aim was to capture a generic HTA process that would allow effective use of the HTA Core Model and resulting HTA information while at the same time not interfering with HTA agencies' internal processes. METHODS: The work was coordinated by a development team in Finland, supported by an international expert group. Two pilot testing rounds were organized among EUnetHTA agencies and two extensive core HTA projects tested the tool in a real setting. The final work was also formally validated by a group of HTA agencies. RESULTS: The HTA Core Model Online--available at http://www.corehta.info--is a web site hosting a) a tool to allow electronic utilization of the HTA Core Model and b) a database of produced HTA information. While access to the HTA information is free to all, the production features are currently available to EUnetHTA member agencies only. A policy was crafted to steer the use of the Model and produced information. CONCLUSIONS: We have successfully enabled electronic use of the HTA Core Model and agreed on a policy for its utilization. The system is already being used in subsequent HTA projects within EUnetHTA Joint Action 2. Identified shortcomings and further needs will be addressed in subsequent development.

Post-introduction observation of healthcare technologies after coverage: the Spanish proposal.

OBJECTIVES: When a new health technology has been approved by a health system, it is difficult to guarantee that it is going to be efficiently adopted, adequately used, and that effectiveness, safety, and consumption of resources and costs are in line with what was expected in preliminary investigations. Many governmental institutions promote the idea that efficient mechanisms should be established aimed at developing and incorporating continuous evidence into health technologies management. The purpose of this article is to stimulate the discussion on systematic post-introduction observation of health technologies. METHODS: Literature review and input of HTA experts. RESULTS: The study addresses the key issues related to post-introduction observation and presents a summary of the guide commissioned by the Spanish Ministry of Health, Social Policy and Equality to the Galician HTA agency for the prioritization and implementation of systematic post-introduction observation in Spain. The manuscript describes the prioritization tool developed as part of this project and discusses the main aspects of protocol development, observation implementation, and assessment of results. CONCLUSIONS: The observation of prioritized health technologies after they are introduced in standard clinical practice can provide useful information for health organizations. However, implementing the observation of health technologies can require specific policy frameworks, commitment from different stakeholders, and dedicated funding.

Diagnosis and management of acute pharyngitis in a paediatric population: a cost-effectiveness analysis.

Acute pharyngitis is one of the most frequent causes of primary care physician visits; however, there is no agreement about which is the best strategy to diagnose and manage acute pharyngitis in children. The aim of the current study was to evaluate the cost-effectiveness of the recommended strategies to diagnose and manage acute pharyngitis in a paediatric population. A decision tree analysis was performed to compare the following six strategies: "treat all", "clinical scoring", "rapid test", "culture", "rapid test + culture" and "clinical scoring + rapid test". The cost data came from the Spanish National Health Service sources. Cost-effectiveness was calculated from the payer's perspective. Effectiveness was measured as the proportion of patients cured without complications from the disease and did not have any reaction to penicillin therapy; a sensitivity analysis was performed. The findings revealed that the "clinical scoring + rapid test" strategy is the most cost-effective, with a cost-effectiveness ratio of 50.72 . This strategy dominated all others except "culture", which was the most effective but also the most costly. The sensitivity analysis showed that "rapid test" became the most cost-effective strategy when the clinical scoring sensitivity was <91% and its specificity was ≤9%. In conclusion, the use of a clinical scoring system to triage the diagnoses and performing a rapid antigen test for those with a high score is the most cost-effective strategy for the diagnosis and management of acute pharyngitis in children. When the clinical scoring system has a low diagnostic accuracy, testing all patients with rapid test becomes the most cost-effective strategy.

Internal evaluation of the European network for health technology assessment project.

OBJECTIVES: The internal evaluation studied the development of the European network for Health Technology Assessment (EUnetHTA) Project in achieving the general objective of establishing an effective and a sustainable network of health technology assessment (HTA) in Europe. METHODS: The Work Package 3 group was dedicated to this task and performed the work. Information on activities during the project was collected from three sources. First, three yearly cross-sectional studies surveyed the participants' opinions. Responses were by individuals or by institutions. The last round included surveys to the Steering Committee, the Stakeholder Forum, and the Secretariat. Second, the Work Package Lead Partners were interviewed bi-annually, five times in total, to update the information on the Project's progress. Third, additional information was sought in available documents. RESULTS: The organizational structure remained stable. The Project succeeded in developing tools aimed at providing common methodology with intent to establish a standard of conducting and reporting HTA and to facilitate greater collaboration among agencies. The participants/agencies expressed their belief in a network and in maintaining local/national autonomy. The Work Package Leaders expressed a strong belief in the solid base of the Project for a future network on which to build, but were aware of the need for funding and governmental support. CONCLUSIONS: Participants and Work Package Leaders have expressed support for a future network that will improve national and international collaboration in HTA based on the experience from the EUnetHTA project.

Safety and effectiveness of the intragastric balloon for obesity. A meta-analysis.

BACKGROUND: Intragastric balloons have been used since 1985 to treat obesity, but an evidence-based systematic review had not been previously performed. The objective of this study is to determine the safety, efficacy, and effectiveness of the most widely used balloon, BioEnterics Intragastric Balloon (BIB), to treat obesity. METHODS: Systematic literature review of Medline, Embase, and other information sources from inception to March 2006. The quality of selected studies was assessed. Meta-analysis of weighted mean difference was made using the inverse variance method. RESULTS: We pooled 15 articles (3,608 patients) to estimate BIBs effectiveness. The estimates for weight lost at balloon removal for BIB were the following: 14.7 kg, 12.2% of initial weight, 5.7 kg/m(2), and 32.1% of excess weight. However, data were scant after balloon removal. Yet, efficacy at balloon removal was estimated with a meta-analysis of two randomized controlled trials (75 patients) that compared balloon versus placebo, indicating the balloon group lost more weight than the placebo group. These differences in weight lost were 6.7 kg, 1.5% of initial weight, 3.2 kg/m(2), and 17.6% of excess weight. Regarding BIB safety, the majority of complications were mild and the early removal rate was 4.2%. CONCLUSION: The use of the BIB, within a multidisciplinary weight management program, is a short-term effective treatment to lose weight, but it is not yet possible to verify its capacity to maintain the weight lost over a long period of time.