Effectiveness of natriuretic peptide-guided treatmen of chronic heart failure. A meta-analysis / Efectividad del tratamiento guiado por el péptido natriurético para la insuficiencia cardiaca crónica. Meta-análisis

Abstract Objective: To evaluate the efficacy of natriuretic peptide (NP)-guided therapy compared to clinically-guided therapy in reducing mortality and hospital admissions in chronic heart failure (HF) patients. Methods: Randomised clinical trials (RCT) were selected through a systematic review. Four meta-analyses were conducted for the outcomes of overall mortality, HF-related mortality, overall hospital admissions, and HF-related hospital admissions. Heterogeneity between studies and publication bias were also assessed. Results: Nine RCTs were found with a total of 1914 patients. NP-guided therapy significantly reduced overall mortality and HF-related hospital admissions. No significant results were found for HF-related mortality and overall hospital admissions. Some clinical heterogeneity regarding interventions performed was found between studies. Publication bias was found for HF-related and overall hospital admissions. Conclusions: NP-guided therapy seems to improve outcomes compared to clinically-guided therapy. However, heterogeneity found between interventions might reduce the generalisation of these results. Specific interventions of the clinical trials should be examined when making recommendations regarding NP-guided therapy. © 2017 Instituto Nacional de Cardiología Ignacio Chávez. Published by Masson Doyma México S.A. This is an open access article under the CC BY-NC-ND license (http://creativecommons. org/licenses/by-nc-nd/4.0/).

Resumen Objetivo: Evaluar la eficacia de la terapia guiada por el péptido natriurético (PN) en comparación con la terapia guiada clínicamente para reducir la mortalidad y la hospitalización de la insuficiencia cardiaca (IC) crónica. Métodos: Los ensayos clínicos aleatorizados fueron seleccionados a través de una revisión sistemática. Cuatro metaanálisis se realizaron para los resultados de mortalidad general, mortalidad por IC, hospitalización general y la hospitalización por IC. Se evaluó la heterogeneidad entre los estudios y el sesgo de publicación. Resultados: Nueve ensayos clínicos aleatorizados se encontraron con un total de 1,914 pacientes. La terapia guiada con el PN reduce significativamente la mortalidad general y la hospitalización por IC. No se encontraron resultados significativos para la mortalidad por IC y la hospitalización general. El sesgo de publicación se encontró para las hospitalizaciones por IC y globales. Conclusiones: La terapia guiada por PN parece mejorar los resultados en comparación con la terapia guiada clínicamente. Sin embargo, la heterogeneidad encontrada entre las intervenciones podría reducir la generalización de estos resultados. Las intervenciones específicas de los ensayos clínicos deben ser analizadas al hacer recomendaciones con respecto a la terapia de guiada por PN. © 2017 Instituto Nacional de Cardiología Ignacio Chávez. Publicado por Masson Doyma México S.A. Este es un artículo Open Access bajo la licencia CC BY-NC-ND (https://creativecommons.org/licenses/by-nc-nd/4.0/).

Cost-effectiveness analysis of real-time continuous monitoring glucose compared to self-monitoring of blood glucose for diabetes mellitus in Spain.

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.

Scale invariance and longitudinal stability of the Physical Functioning Western Ontario and MacMaster Universities Osteoarthritis Index using the Rasch model.

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measures the quality of life of patients with osteoarthritis (OA), and there is a specific scale for the physical functioning dimension, the short version with seven items WOMAC-pf. This study describes the application of the Rasch model to explore scale invariance and response stability of the WOMAC-pf short version across affected joint and over time. A sample of 884 patients with OA, from 15 hospitals in Spain, completed the WOMAC-pf before surgery (baseline) and at 3, 6 and 12 months post-surgery of hip or knee. The invariance by joint was explored through the differential item functioning (DIF) analysis of the Rasch model using baseline data, and time stability (DIF by time) were evaluated in stack data (each participant is represented four times, one by time point). Mean age of the patients was of 69.13 years (SD 10.01), 59.3% of them were women (n = 524), 59.2% had knee OA (n = 523) and 40.8% hip OA (n = 361). Item "putting on socks" showed DIF by joint and time. Fit to the Rasch model using stack data improved when this item was removed. Good reliability for individual use, local independency and unidimensionality of the models were confirmed. WOMAC-pf 7-item short version was invariant over time and joint when item "putting on socks" was removed. Researchers should carefully evaluate this item as it presents problems in scale invariance and stability, which could affect results when comparing data by joint or when computing change scores.

Effectiveness of natriuretic peptide-guided treatment of chronic heart failure. A meta-analysis.

OBJECTIVE: To evaluate the efficacy of natriuretic peptide (NP)-guided therapy compared to clinically-guided therapy in reducing mortality and hospital admissions in chronic heart failure (HF) patients. METHODS: Randomised clinical trials (RCT) were selected through a systematic review. Four meta-analyses were conducted for the outcomes of overall mortality, HF-related mortality, overall hospital admissions, and HF-related hospital admissions. Heterogeneity between studies and publication bias were also assessed. RESULTS: Nine RCTs were found with a total of 1914 patients. NP-guided therapy significantly reduced overall mortality and HF-related hospital admissions. No significant results were found for HF-related mortality and overall hospital admissions. Some clinical heterogeneity regarding interventions performed was found between studies. Publication bias was found for HF-related and overall hospital admissions. CONCLUSIONS: NP-guided therapy seems to improve outcomes compared to clinically-guided therapy. However, heterogeneity found between interventions might reduce the generalisation of these results. Specific interventions of the clinical trials should be examined when making recommendations regarding NP-guided therapy.

Factors associated with professional satisfaction in primary care: Results from EUprimecare project.

BACKGROUND: Given the importance of primary care to healthcare systems and population health, it seems crucial to identify factors that contribute to the quality of primary care. Professional satisfaction has been linked with quality of primary care. Physician dissatisfaction is considered a risk factor for burnout and leaving medicine. OBJECTIVES: This study explored factors associated with professional satisfaction in seven European countries. METHODS: A survey was conducted among primary care physicians. Estonia, Finland, Germany and Hungary used a web-based survey, Italy and Lithuania a telephone survey, and Spain face to face interviews. Sociodemographic information (age, sex), professional experience and qualifications (years since graduation, years of experience in general practice), organizational variables related to primary care systems and satisfaction were included in the final version of the questionnaire. A logistic regression analysis was performed to assess the factors associated with satisfaction among physicians. RESULTS: A total of 1331 primary care physicians working in primary care services responded to the survey. More than half of the participants were satisfied with their work in primary care services (68.6%). We found significant associations between satisfaction and years of experience (OR = 1.01), integrated network of primary care centres (OR = 2.8), patients having direct access to specialists (OR = 1.3) and professionals having access to data on patient satisfaction (OR = 1.3). Public practice, rather than private practice, was associated with lower primary care professional satisfaction (OR = 0.8). CONCLUSION: Elements related to the structure of primary care are associated with professional satisfaction. At the individual level, years of experience seems to be associated with higher professional satisfaction.

Biodegradable stents for the treatment of refractory or recurrent benign esophageal stenosis.

INTRODUCTION: Esophageal stents are used for the treatment of refractory and recurrent dyphagias. In 2007, esophageal biodegradable stents (EBS) were authorised as an alternative to existing metal and plastic stents in Europe. The advantages claimed for EBS are fewer complications concerning tissue ingrowth, stent migration and stent removal. AREAS COVERED: We performed a systematic review to evaluate the efficacy and safety of EBS compared to fully-covered self-expanding metal stents, self-expanding plastic stents, and esophageal dilation for the treatment of refractory or recurrent benign esophageal stenosis. Three comparative studies (one randomized controlled trial and two cohort studies) were assessed. The studies used different inclusion criteria, had a very small (sample) size and the quality of the evidence was very low. Expert commentary: The current evidence is insufficient to determine the relative efficacy or safety of esophageal biodegradable stents. The results of this systematic review should be updated once new evidence is available.

The patient satisfaction questionnaire of EUprimecare project: measurement properties.

OBJECTIVE: The measurement of patient satisfaction is considered an essential outcome indicator to evaluate health care quality. Patient satisfaction is considered a multi-dimensional construct, which would include a variety of domains. Although a large number of studies have proposed scales to measure patient satisfaction, there is a lack of psychometric information on them. This study aims to describe the psychometric properties of the Primary Care Satisfaction Scale (PCSS) of the EUprimecare project. DESIGN: A cross-sectional survey of patient satisfaction with primary care was carried out by telephone interview. SETTING: Primary care services of Estonia, Finland, Germany, Hungary, Lithuania, Italy and Spain. PARTICIPANTS: A total of 3020 adult patients aged 18-65 years old attending primary care services. METHOD: Classic psychometric properties were analysed and Rasch analysis was used to assess the following measurement properties: fit to the Rasch model; uni-dimensionality; reliability; differential item functioning (DIF) by gender, age, civil status, area of residency and country; local independency; adequacy of response scale; and scale targeting. RESULTS: To achieve good fit to the Rasch model, the original response scales of three items (1, 2 and 6) were rescored and Item 3 (waiting time in the room) was removed. The scale was uni-dimensional and Person Separation Index was 0.79, indicating a good reliability. All items were free from bias. PCSS linear measure displayed satisfactory convergent validity with overall satisfaction with primary care. CONCLUSIONS: PCSS, as a reliable and valid scale, could be used to measure patient satisfaction in primary care in Europe.

Cultura organizacional en el Sistema Nacional de Salud. Resultados del estudio realizado en el marco del Foro Gerendia / Organizational culture of the Spanish National Health Care System. Results within the framework of Foro Gerendia

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Cost of care for cystic fibrosis: an investigation of cost determinants using national registry data.

Cystic fibrosis (CF) is a progressive disease with treatments intensifying as patients get older and severity worsens. To inform policy makers about the cost burden in CF, it is crucial to understand what factors influence the costs and how they affect the costs. Based on 1,060 observations (from 731 patients) obtained from the Australian Data Registry, individual annual health care costs were calculated and a regression analysis was carried out to examine the impact of multiple variables on the costs. A method of retransformation and a hypothetical patient were used for cost analysis. We show that an additional one unit improvement of FEV1pp (i.e., forced expiratory volume in 1 s as a percentage of predicted volume) reduces the costs by 1.4%, or for a hypothetical patient whose FEV1pp is 73 the cost reduction is A$252. The presence of chronic infections increases the costs by 69.9-163.5% (A$12,852-A$30,047 for the hypothetical patient) depending on the type of infection. The type of CF genetic mutation and the patient's age both have significant effects on the costs. In particular, being homozygous for p.F508del increases the costs by 26.8% compared to all the other gene mutations. We conclude that bacterial infections have a very strong influence on the costs, so reducing both the infection rates and the severity of the condition may lead to substantial cost savings. We also suggest that the patient's genetic profile should be considered as an important cost determinant.

Willingness to pay for a quality-adjusted life year: an evaluation of attitudes towards risk and preferences.

BACKGROUND: This paper examines the Willingness to Pay (WTP) for a quality-adjusted life year (QALY) expressed by people who attended the healthcare system as well as the association of attitude towards risk and other personal characteristics with their response. METHODS: Health-state preferences, measured by EuroQol (EQ-5D-3L), were combined with WTP for recovering a perfect health state. WTP was assessed using close-ended, iterative bidding, contingent valuation method. Data on demographic and socioeconomic characteristics, as well as usage of health services by the subjects were collected. The attitude towards risk was evaluated by collecting risky behaviors data, by the subject's self-evaluation, and through lottery games. RESULTS: Six hundred and sixty two subjects participated and 449 stated a utility inferior to 1. WTP/QALY ratios varied significantly when payments with personal money (mean €10,119; median €673) or through taxes (mean €28,187; median €915) were suggested. Family income, area income, higher education level, greater use of healthcare services, and the number of co-inhabitants were associated with greater WTP/QALY ratios. Age and female gender were associated with lower WTP/QALY ratios. Risk inclination was independently associated with a greater WTP/QALY when "out of pocket" payments were suggested. Clear discrepancies were demonstrated between linearity and neutrality towards risk assumptions and experimental results. CONCLUSIONS: WTP/QALY ratios vary noticeably based on demographic and socioeconomic characteristics of the subject, but also on their attitude towards risk. Knowing the expression of preferences by patients from this outcome measurement can be of interest for health service planning.

Factors associated with patient satisfaction with primary care in Europe: results from the EUprimecare project.

BACKGROUND: EUprimecare is a study funded by the Seventh Framework Programme of the European Union, aimed at analysing the quality of the different models of primary care in Europe. The objective of this study was to describe and analyse the determinants associated with patient satisfaction in primary care in Europe. METHODS: We conducted telephone population surveys among primary care users in each EUprimecare consortium country (Germany, Spain, Estonia, Finland, Hungary, Italy and Lithuania). The survey was conducted with 3020 patients and the questionnaire included sociodemographic variables, health status, and use and satisfaction with primary care services. We undertook descriptive analyses, bivariate correlations and an ordinal regression model to study the direct relationship between levels of satisfaction and the explanatory variables for demographics, health status and health services for patients. We present the regression coefficients (ß) with 95% confidence intervals and associated tests of statistical significance. RESULTS: The mean age of the respondents was 51 years (SD 14.1). We found significant associations between the level of satisfaction and age (ß = 0.008), specialist visits (ß = -0.030), not having a general practitioner (ß = 0.70), not measuring weight, cholesterol and blood pressure (ß = 0.52), country (ß1 Germany = -1.08 and ß2 Lithuania = -0.60; ß3 Hungary = 0.50 and ß4 Italy = 0.53) and a better perception of health status (ß = 0.33). Specialist visits had a negative association with satisfaction. CONCLUSIONS: Overall, the results indicate factors that may be related to greater satisfaction with primary care services: age, visits to a specialist, having a doctor assigned to primary care and measurement of control parameters are associated with a better perception of the care received.

Atención centrada en el paciente: España, todavía queda por hacer / Patient-centred care in Spain: There is still work to be done

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