Approach to patients with diabetes and obesity in primary care / Abordaje de pacientes con diabetes y obesidad en atención primaria

Aims:The aim of this study is to analyse the effect of pharmacological and non-pharmacological treatment on weight control in patients with diabetes and obesity. Design: Epidemiological, descriptive, cross-sectional study. Site: Primary care. In 11 health centres in Málaga and Cádiz during April and October 2022. Participants: 281 patients over 18 years old with type 2 diabetes and obesity are included. Main measurements: Socio-demographics, clinical, treatment and lifestyle habits variables were obtained from medical records and personal interview. Descriptive statistics were obtained for continuous variables. Statistical tests were performed based on the nature of the variables. Results: Variables like marital status, level of education and occupation, and smoking habit, shows differences regarding the sex (p<0.05). 82.3% of those who received education lost weight, compared to 67.5% of lost weight who received no health education (p=0.004). GLP1 and SGLT2 were more commonly prescribed for women (p=0.048), and SGLT2 more commonly prescribed for men (p=0.047). Patients taking GLP1, SGLT2 or both, regardless of sex, weight loss during the study period was −3.1kg (SE: 0.60), while the loss of those who took other medications was −1.33kg (SE: 0.62). The mean difference was 1.75kg (p=0.046). Conclusions: In terms of weight loss, obese diabetics who took GLP1, SGLT2 or both were 2.5 times more likely to lose weight than those who did not. Healthy lifestyle choices are key to weight loss in obese diabetic patients.(AU)

Objetivo: Analizar el efecto del tratamiento farmacológico y no farmacológico en el control del peso en pacientes diabéticos obesos. Diseño: Estudio epidemiológico, descriptivo y transversal. Emplazamiento: Atención primaria: 11 centros de salud en Málaga y Cádiz durante abril y octubre de 2022. Participantes: Fueron incluidos 281 pacientes mayores de 18 años con diabetes tipo 2 y obesidad. Mediciones principales: Se obtuvieron variables sociodemográficas, clínicas, de tratamiento y de hábitos de vida a partir de registros médicos de entrevistas personales. Se obtuvieron estadísticos descriptivos para variables continuas. Se realizaron pruebas estadísticas en función de la naturaleza de las variables. Resultados: Variables como el estado civil, el nivel educativo, la ocupación y el hábito de fumar mostraron diferencias dependiendo del sexo (p<0,05). El 82,3% de los que recibieron educación sobre salud perdieron peso en comparación con el 67,5% de los que perdieron peso y no la recibieron (p=0,004). Los medicamentos GLP1 y SGLT2 se recetaron con mayor frecuencia a las mujeres (p=0,048), mientras que los SGLT2 se prescribieron más en hombres (p=0,047). Los pacientes que tomaron GLP1, SGLT2 o ambos, independientemente del sexo, perdieron 3,1kg durante el estudio (EE: 0,60), mientras que aquellos que tomaron otros medicamentos perdieron 1,33kg (EE: 0,62). La diferencia media fue de 1,75kg (p=0,046). Conclusiones: Los diabéticos obesos que tomaron GLP1, SGLT2 o ambos tenían 2,5 veces más probabilidades de perder peso que aquellos que no los tomaron. Un estilo de vida saludable es fundamental para la pérdida de peso en pacientes diabéticos obesos.(AU)

Approach to patients with diabetes and obesity in primary care.

AIMS: The aim of this study is to analyse the effect of pharmacological and non-pharmacological treatment on weight control in patients with diabetes and obesity. DESIGN: Epidemiological, descriptive, cross-sectional study. SITE: Primary care. In 11 health centres in Málaga and Cádiz during April and October 2022. PARTICIPANTS: 281 patients over 18 years old with type 2 diabetes and obesity are included. MAIN MEASUREMENTS: Socio-demographics, clinical, treatment and lifestyle habits variables were obtained from medical records and personal interview. Descriptive statistics were obtained for continuous variables. Statistical tests were performed based on the nature of the variables. RESULTS: Variables like marital status, level of education and occupation, and smoking habit, shows differences regarding the sex (p<0.05). 82.3% of those who received education lost weight, compared to 67.5% of lost weight who received no health education (p=0.004). GLP1 and SGLT2 were more commonly prescribed for women (p=0.048), and SGLT2 more commonly prescribed for men (p=0.047). Patients taking GLP1, SGLT2 or both, regardless of sex, weight loss during the study period was -3.1kg (SE: 0.60), while the loss of those who took other medications was -1.33kg (SE: 0.62). The mean difference was 1.75kg (p=0.046). CONCLUSIONS: In terms of weight loss, obese diabetics who took GLP1, SGLT2 or both were 2.5 times more likely to lose weight than those who did not. Healthy lifestyle choices are key to weight loss in obese diabetic patients.

Study Protocol on Social Return on Investment (SROI) Project of the Surgical Waiting List Management System.

In Andalusia, the right to maximum waiting times for healthcare clashes with the available supply, leading to an increase in demand in the form of waiting lists. To address this situation, the activity of private centers has been created for certain diagnostic tests. The Social Return on Investment (SROI) model evaluates an intervention from an economic and stakeholder perspective. However, there are no studies on the suitability of waiting lists using SROI, which is why it is intended to be studied as a decision-making tool for the clinical and healthcare management of waiting lists. This research protocol is designed to determine the quality of life gained, with the EuroQol-5D-5L questionnaire, and its social assessment, with the specific survey of the SROI method, and, thus, analyze the social return on investment and determine the suitability of the intervention (diagnostic endoscopy activity arranged in a contracted center). After the study, we will know the economic (cost in public health centers and the incremental cost of extraordinary health resources), social (quality of life with health), and environmental scenarios of the concerted activity intervention in order to adjust waiting list times.

Benefit-risk assessment of sonidegib and vismodegib in the treatment of locally advanced basal cell carcinoma.

Background: Sonidegib and vismodegib are Hedgehog pathway inhibitors (HhIs) that play a relevant role in the management of locally advanced basal cell carcinoma (laBCC). This study compared the efficacy and safety of both HhIs based on their available data using effect size measures such as number needed to treat (NNT), number needed to harm (NNH), and likelihood to be helped or harmed (LHH). Methods: We reviewed data from pivotal trials of sonidegib (BOLT) and vismodegib (ERIVANCE). The NNT for sonidegib and vismodegib was calculated from objective response rate (ORR) values. The NNH was calculated from data relating to treatment discontinuation due to adverse events (AEs) and incidence of AEs. The LHH was calculated as the ratio between the corresponding NNH and NNT. Results: For sonidegib (200 mg), the NNT for ORR at 18 months was 1.65 (95% CI 1.35-2.01) whilst that for vismodegib (150 mg) at 21 months was 2.10 (95% CI 1.65-2.82). The NNH related to treatment discontinuation due to AEs was 1.9 (95% CI 1.6-2.5) for sonidegib and 1.8 (95% CI 1.4-2.2) for vismodegib. The LHH for sonidegib and vismodegib related to treatment discontinuation due to AEs was 1.14 and 0.84, respectively, whilst the LHH according to AEs of grade ≥3 was 1.41 for sonidegib and 0.85 for vismodegib. Conclusions: Sonidegib showed a better benefit-risk ratio compared to vismodegib, being more likely to achieve therapeutic response than to AEs leading to discontinuation. These results should be confirmed in clinical practice and/or in a direct comparison study.

Capturing the value of vaccination within health technology assessment and health economics: Literature review and novel conceptual framework.

BACKGROUND: Vaccination provides significant health gains to individuals and society and can potentially improve health equity, healthcare systems and national economies. Policy decisions, however, are rarely informed by comprehensive economic evaluations (EE) including vaccination's wide-ranging value. The objective of this analysis was to focus on health technology assessment systems to identify relevant value concepts in order to improve current EE of non-pandemic vaccines. METHODS: Following a literature review, a novel Value of Vaccination (VoV) framework was developed with experts in vaccine EE from developed countries with established health technology assessment systems. RESULTS: Forty-four studies presenting value frameworks or concepts applicable to vaccination were included. Eighteen unique value concepts relevant to EE were identified and defined. These were categorised within the VoV framework using three dimensions, moving from a narrow payer perspective to a more expansive and societal perspective. The dimensions were: (I) conventional payer perspective concepts (e.g., health gains in vaccinees, direct medical costs); (II) conventional societal perspective concepts (e.g., indirect health/economic gains to caregivers/households, productivity in vaccinees); and (III) novel societal concepts (e.g., financial risk protection, peace of mind, societal health gains, healthcare systems security, political stability, social equity and macroeconomic gains). While good quality evidence and methods are available to support concepts in Dimensions I and II, further work is needed to generate the required evidence for vaccination impact on Dimension III concepts. CONCLUSIONS: The devastating effect on nations of the COVID-19 pandemic has helped to highlight the potential far-reaching benefits that many vaccination programmes can offer. This VoV framework is particularly relevant to policy decisions considering EE, and the potential future expansion of non-pandemic vaccination value considerations. The framework helps to understand and compare current value considerations across countries and payer versus societal perspectives. It provides decision-makers with a transparent and logical path to broaden consideration of VoV in EE.

Capturing the value of vaccination within health technology assessment and health economics: Country analysis and priority value concepts.

BACKGROUND: A value of vaccination framework for economic evaluation (EE) identified unique value concepts for the broad benefits vaccination provides to individuals, society, healthcare systems and national economies. The objectives of this paper were to work with experts in developed countries to objectively identify three priority concepts to extend current EE. METHODS: The previously developed classification of value concepts in vaccination distinguished 18 concepts, categorised as conventional payer and societal perspective concepts and novel broader societal concepts. Their inclusion in current EE guidelines was assessed. Experts identified eight criteria relevant to decision-making and measurement feasibility, which were weighted and used to score each concept. The relative ranking of concepts by importance and the gaps in guidelines were used to identify three priority concepts on which to focus immediate efforts to extend EE. RESULTS: The EE guidelines review highlighted differences across countries and between guidelines and practice. Conventional payer perspective concepts (e.g., individual and societal health gains and medical costs) were generally included, while gaps were evident for conventional societal perspective concepts (e.g., family/caregiver health and economic gains). Few novel broader societal benefits were considered, and only in ad hoc cases. The top-three concepts for near-term consideration: macroeconomic gains (e.g., benefiting the economy, tourism), social equity and ethics (e.g., equal distribution of health outcomes, reduced health/financial equity gaps) and health systems strengthening, resilience and security (e.g., efficiency gains, reduced disruption, increased capacity). CONCLUSIONS: Gaps, inconsistencies and limited assessment of vaccination value in EE can lead to differences in policy and vaccination access. The three priority concepts identified provide a feasible approach for capturing VoV more broadly in the near-term. Robust methods for measuring and valuing these concepts in future assessments will help strengthen the evidence used to inform decisions, improving access to vaccines that are demonstrably good value for money from society's point of view.

Cross-cultural adaptation and psychometric validation of a Spanish version of the revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire.

OBJECTIVES: Successful deprescribing depends largely on factors related to the patient. The revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire was developed with the objective of evaluating the beliefs and attitudes of older adults and caregivers towards deprescribing. The present study was designed to validate a Spanish version of the rPATD questionnaire, both the versions for older adults and for caregivers, through a qualitative validation phase and the analysis of its psychometric properties. DESIGN: Cross-sectional validation study. SETTING: Primary care settings in Málaga (Spain). PARTICIPANTS: A sample of 120 subjects (60 patients with polypharmacy and 60 caregivers of patients with polypharmacy) were enrolled in the study. MAIN OUTCOME MEASURES: In the qualitative validation stage, the rPATD questionnaire was translated/back-translated and subjected to a cross-cultural adaptation to evaluate its face validity and feasibility. Next, its psychometric properties were assessed. Confirmatory factor analysis was used to evaluate construct validity. Internal consistency was determined using Cronbach's alpha test. Criterion validity through pre-established hypotheses from the Beliefs about Medicines Questionnaire (BMQ) Specific-Concerns Scale, and test-retest reliability were analysed. RESULTS: Confirmatory factor analysis verified the four-factor structure of the original rPATD questionnaire, with items loading into four factors: involvement, burden, appropriateness and concerns about stopping. The Cronbach's alpha coefficient of the factors ranged from 0.683 to 0.879. The burden, appropriateness and concerns about stopping factors were significantly correlated with the BMQ Specific-Concerns Score, except for the concerns about stopping factor in the older adults' version. The consistency of the items between administration times (test-retest reliability) showed weighted Cohen's kappa values ranging from moderate (>0.4) to very good (>0.8). CONCLUSIONS: The Spanish version of the rPATD questionnaire is a feasible, valid and reliable instrument to evaluate attitudes towards deprescribing in Spanish-speaking patients and caregivers.

Cost of illness of invasive meningococcal disease caused by serogroup B Neisseria meningitidis in Spain.

INTRODUCTION: Invasive meningococcal disease (IMD) is a severe infectious disease, mainly affecting children under 5 years, associated with long-term physical, neurological and psychological sequelae. In Spain, most IMD cases are caused by meningococcal serogroup B (MenB). This study estimates its economic burden from a societal perspective in Spain. METHODS: A previously published bottom-up, model-based incidence costing approach by Scholz et al. (2019) to estimate the economic burden of MenB in Germany was adapted to the Spanish setting. Diagnosis and age-related costs for a hypothetical Spanish cohort were calculated over a lifetime horizon. Official Spanish databases, literature and expert opinion were used as data sources. The costs were updated to 2019 prices, and a 3% discount rate was applied. Direct costs related to the acute IMD phase, long-term sequelae, rehabilitation and public health response were considered. Indirect costs included productivity losses and premature mortality and were calculated using the human-capital approach (HCA) and friction-cost approach (FCA). Deterministic and probabilistic sensitivity analyses were also performed. RESULT: At base-case, the total cost for a cohort of 142 patients (2017-2018 period) was €4.74 million (€33,484/case) using the FCA and €13.14 million (€92,768/case) using the HCA. Direct costs amounted to €4.65 million (€32,765/case). Sequelae costs represented 62.46% of the total cost using the FCA and 77.63% using the HCA. Deterministic sensitivity analysis showed that variation of ± 20% in the input parameter values (population, epidemiology, productivity, costs) had the greatest influence on the base-case results, and the probabilistic sensitivity analysis showed the probability of fitting base-case estimates was > 99%, both for FCA and HCA. DISCUSSION: MenB IMD is an uncommon but severe disease, with a high economic burden for Spanish society. The elevated costs per IMD case reflect its severity in each patient suffering this disease, especially due to the development of sequelae.

Impact of Covid-19 containment on community pharmaceutical spending in Andalusia - Spain.

BACKGROUND: In the field of health, the year 2020 will be remembered for testing (stressing) all health institutions and their forms of management (centralised and decentralised). The everyday activity of primary and hospital care was significantly altered by the introduction of telephone consultations, which reduce the number of visits to health centres or hospitals and are still relevant today in the face of successive waves of the pandemic. OBJECTIVE: To analyse whether population confinement due to the COVID-19 pandemic had an impact on the dispensing of medications in community pharmacies and the associated spending during the period March-July 2020 in Andalusia (Spain). METHODS: A time series analysis applying econometric model analysis techniques to confirm or rule out whether the lockdown caused by the COVID-19 pandemic had an impact on the dispensing of medications by community pharmacies and the associated expenditures. The variables used were the number of medication containers dispensed by community pharmacies (charged to the public funds of the Spanish National Health System) and the expenditure on prescription drugs, both in relation to the population. The analysis was performed within the region of Andalusia, which has 8,464,441 inhabitants. RESULTS: The data obtained from the time series confirmed that there were no significant differences during the studied period between the number of medication containers actually dispensed and the number that would have been expected to be dispensed according to the trend in this variable for the sample period. The expenditure results followed the same pattern. CONCLUSIONS: The health crisis produced by the COVID-19 lockdown had no impact on medication consumption in Andalusia.

The Impact of Covid-19 containment on community pharmaceutical spending in Andalusia - Spain

Background: In the field of health, the year 2020 will be remembered for testing (stressing) all health institutions and their forms of management (centralised and decentralised). The everyday activity of primary and hospital care was significantly altered by the introduction of telephone consultations, which reduce the number of visits to health centres or hospitals and are still relevant today in the face of successive waves of the pandemic. Objective: To analyse whether population confinement due to the COVID-19 pandemic had an impact on the dispensing of medications in community pharmacies and the associated spending during the period March-July 2020 in Andalusia (Spain). Methods: A time series analysis applying econometric model analysis techniques to confirm or rule out whether the lockdown caused by the COVID-19 pandemic had an impact on the dispensing of medications by community pharmacies and the associated expenditures. The variables used were the number of medication containers dispensed by community pharmacies (charged to the public funds of the Spanish National Health System) and the expenditure on prescription drugs, both in relation to the population. The analysis was performed within the region of Andalusia, which has 8,464,441 inhabitants. Results: The data obtained from the time series confirmed that there were no significant differences during the studied period between the number of medication containers actually dispensed and the number that would have been expected to be dispensed according to the trend in this variable for the sample period. The expenditure results followed the same pattern. Conclusions: The health crisis produced by the COVID-19 lockdown had no impact on medication consumption in Andalusia (AU)

[Validation into Spanish of the revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire to assess patients' attitudes towards deprescribing. Research protocol]. / Validación al castellano del cuestionario revised Patients' Attitudes Towards Deprescribing (rPATD) para evaluar las actitudes de los pacientes hacia la deprescripción. Protocolo de investigación.

INTRODUCTION AND OBJECTIVE: Polypharmacy has become a priority public health problem in developed countries. In response to its approach, deprescription stands out. Its success will depend largely on the attitudes and beliefs of patients towards the number of drugs they are taking and their willingness to initiate a process of deprescription. To explore these factors, researchers have developed the revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire, originally in English. The objective of this study is the validation into Spanish of rPATD questionnaire, both older adults and caregivers versions. MATERIAL AND METHODS: A first qualitative validation phase and a second phase of analysis of its psychometric characteristics will be carried out through an observational descriptive study of validation of a measurement instrument. One hundred and twenty subjects (polymedicated older adults and caregivers) from three health centers will be selected by consecutive sampling. The questionnaire will be provided and clinical and sociodemographic data will be collected. Feasibility, reliability (through internal consistency and intraobserver reliability) and validity (apparent, construct and criterion) of the questionnaire will be evaluated. EXPECTED RESULTS: It is expected to obtain a questionnaire that will serve as a tool for the clinician to identify patients with a favorable predisposition to deprescription and that will allow to contribute the patient's perspective to this process. CONCLUSION: The use of the rPATD questionnaire, alone or integrated into other more complex interventions, may lead to an improvement in the quality of care for the polymedicated patients.

Medicines use review service in community pharmacies in Spain: REVISA project.

Background Community pharmacy services play an important role in controlling some factors related to medicine use and patients can benefit from these services to improve the adherence and knowledge of their medications, besides to reduce medicine-related problems. Objective The aim of the REVISA project is to carry out a study on preliminary implementation of the medicines use review service in Spanish community pharmacies. Setting Sixty-four community pharmacies from all regions of Spain. Method A preliminary implementation, cross-sectional multicentre study was conducted using a convenience sample of voluntary community pharmacies. A structured interview enabled to pharmacists to obtain a better understanding of patient's medicines use. Main outcome measure Medicines use review-related time and cost, satisfaction and willingness to pay. Results A total of 495 patients were enrolled. The mean age of the patients was 66.1 years, with the majority females (56.4%) and a mean consumption of 5.7 medicines. A total of 2811 medicines were evaluated and 550 referral recommendations were made (29.8% to Primary Care). The mean time employed by the pharmacists in the medicines use review service was 52.8 min (medicines use review-related cost of €17.27). Most patients expressed a high level of satisfaction with this service (98.5%) and a willingness to pay for it (84%). Conclusion Medicines use review service in community pharmacies in Spain can be delivered, that it appears to be acceptable to patients and that most patients said they would be willing to pay for it. This service may offer an opportunity to promote inter-professional collaboration between pharmacists and general practitioners.

Value-Based Healthcare in Ostomies.

In order to achieve significant improvements in quality, cost, and accessibility (the health "iron triangle"), innovation in organizational and service delivery models is necessary to increase the value of healthcare. The aim of this study is to evaluate the efficiency of a model of organizational innovation based on advanced practice nurse in the care of people with ostomies (APN-O) versus usual care. An observational, exploratory, analytical, prospective study with a six-month follow-up was carried out at 12 hospitals that implemented this model in Andalusia. A total of 75 patients who had undergone a digestive elimination ostomy and/or a urinary ostomy were followed for six months. Clinical outcomes, healthcare resources, health-related quality of life, and willingness to pay (WTP) were analyzed. The economic evaluation was conducted from a societal perspective, including healthcare costs and indirect costs. The cost difference between the two models was €136.99 and the quality-adjusted life year (QALY) gained was 0.05965 (€2297 per QALY gained). At six months, the mean of WTP was €69 per APN-O consultation. This model contributes to increasing the value-based healthcare in ostomies. Results of this study suggested that APN-O is an effective patient management model for improving their health status and is highly efficient.

Long term COST-minimization analysis of robot-assisted hysterectomy versus conventional laparoscopic hysterectomy.

BACKGROUND: The aim of this study is to carry out the economic evaluation, in term of a cost-minimization analysis that considers healthcare costs and indirect costs, of robot-assisted hysterectomy (RAH) compared with conventional laparoscopic hysterectomy (CLH) in female adults scheduled for total laparoscopic hysterectomy for benign conditions. METHODS: Cost-minimization analysis based on an analytic observational study of prospective cohorts with a five-year time horizon. Eligible participants were all female adults scheduled for total laparoscopic hysterectomy for benign conditions at tertiary hospital. The economic evaluation was conducted from a Spanish National Health Service and societal perspective, including healthcare costs and indirect costs. The costs are expressed in Euros from the year 2015. RESULTS: One hundred sixty nine patients were analyzed, 68 in the RAH group and 101 in the CLH group. Average cost for the RAH group was €8982.42 compared to €8015.14 for the CLH group (incremental cost €967.27; p = 0.054). Healthcare cost is the most important component of total cost and represents 86.4% for the RAH group and 82.3% for the CLH group. The difference of €1169 (p = 0.01) in the average healthcare cost is mainly due to the cost of purchasing and maintaining the equipment (difference of €1206.39 in favor of RAH; p < 0.005). With regard to indirect costs, for patients in the RAH group the costs associated with loss of productivity were lower (difference of €203.42; p = 0.17), while the cost of trips to the hospital was higher (difference of €1.98; p = 0.66) in respect to CLH. CONCLUSIONS: Our findings reveal similar effectiveness between RAH and CLH, although CLH is the more efficient option from the point of view of an economic analysis based on cost-minimization.

[Crisis, Public Spending on Health and Policy]. / Modelos de gestión según el proveedor y sus efectos en la dinámica de los equipos de atención primaria en Cataluña.

OBJECTIVE: The Spanish economic crisis began in 2008 and according to the Ministry of Economy, Industry and Compe- titiveness it concluded in 2014. During the crisis the main macroeconomic indicators had an adverse evolution and the effects have lasted for more than six years to the present. Aim: To assess the influence on public spending (health and pharmaceutical) that the governing policies have had and the time of crisis suffered. METHODS: Public expenditure per inhabitant (health and pharmaceutical) is compared according to the study period (pre, crisis and post), the political ideology of the ruling party (conservative/ progressive) and each autonomous community in reference to GDP per inhabitant in each of they respect the national average (poor, average or rich) according to the quartiles. The sources of the data have been the National Statistics Institute (GDP and inhabitants of each Autonomous Community and study period) and the Ministry of Health, Social Services and Equality (public health and pharmaceutical expenditure). The statistical procedures (SPSS v24) included descriptive and inferential analysis for public healthcare and pharmaceutical expenditure according to the period of study and ideology. There was also a regression fit to know the relative importance of predictor varibles. RESULTS: During the crisis period there were differences in public health expenditure per inhabitant in the different types of Autonomous Communities (poor / medium / rich) and according to political ideology (p <0.05). Public pharmaceutical expenditure was € 327 / inhab (pre-crisis) to € 366 / inhabitant in the final period of the study. There were statistically significant differences in pharmaceutical expenditure according to the different types of CCAA. Likewise, differences were found in per capita pharmaceutical expenditure between the Autonomous Communities run by conservatives and type of Autonomous Communities throughout the study period. CONCLUSIONS: The community pharmaceutical expenditure per capita has decreased by more than 13% since 2006 until 2017, while the hospital pharmaceutical expenditure has increased by more than 84%. Rich regions invest more in the health care costs and the poor more than drugs.

OBJETIVO: La crisis económica española se inició en el año 2008 y según el Ministerio de Economía, Industria y Compe- titividad concluyó en el año 2014. Durante la crisis los principa- les indicadores macro-económicos tuvieron una evolución adversa y los efectos se han prolongado durante más de seis años hasta la actualidad. El objetivo de este trabajo fue valorar la influencia en el gasto público (sanitario y farmacéutico) que han tenido las políticas gobernantes y el tiempo de crisis sufrido. METODOS: Se compara el gasto público por habitante (sanitario y farmacéutico) según el período de estudio (pre, crisis y post), la ideología política del partido gobernante (conservador/ progresista) y cada comunidad autónoma en referencia al PIB por habitante en cada una de ellas respecto de la media nacional (pobres, en la media o ricas) según los cuartiles. Las fuentes de los datos han sido el INE (PIB y habitantes de cada CCAA y periodo de estudio) y del Ministerio de Sanidad, Servicios Sociales e Igualdad (gasto público sanitario y farmacéutico). El examen estadístico (SPSS 24) incluyó análisis descriptivo e inferencial del gasto sanitario y farmacéutico publico según el período de estudio e ideología, también se realizó un ajuste de regresión para conocer la importancia relativa de las variables predictoras. RESULTADOS: Durante el período de crisis hubo diferencias en el gasto sanitario público por habitante en los distintos tipos de CCAA (pobres/medias/ricas) y según ideología política gobernante (p <0,05). El gasto farmacéutico público pasó de 327 €/hab (pre-crisis) a 366 €/hab en el período final del estudio. Hubo diferencias estadísticamente significativas en el gasto farmacéutico según los distintos tipos de CCAA. De igual forma se encontraron diferencias en el gasto farmacéutico por habitante entre las CCAA regentadas por conservadores y tipo de CCAA a lo largo de todo el período de estudio. CONCLUSIONES: El gasto farmacéutico comunitario por habitante ha disminuido en más del 13% desde 2006 hasta 2017, mientras que el gasto farmacéutico hospitalario se ha incrementado en más del 84%. Las CCAA ricas invierten más en gasto sanitario y las pobres más de medicamentos.

Crisis, gasto público sanitario y política / Crisis, Public Spending on Health and Policy

OBJETIVO: La crisis económica española se inició en el año 2008 y según el Ministerio de Economía, Industria y Competitividad concluyó en el año 2014. Durante la crisis los principales indicadores macroeconómicos tuvieron una evolución adversa y los efectos se han prolongado durante más de seis años hasta la actualidad. El objetivo de este trabajo fue valorar la influencia en el gasto público (sanitario y farmacéutico) que han tenido las políticas gobernantes y el tiempo de crisis sufrido. MÉTODOS: Se compara el gasto público por habitante (sanitario y farmacéutico) según el período de estudio (pre, crisis y post), la ideología política del partido gobernante (conservador/ progresista) y cada comunidad autónoma en referencia al PIB por habitante en cada una de ellas respecto de la media nacional (pobres, en la media o ricas) según los cuartiles. Las fuentes de los datos han sido el INE (PIB y habitantes de cada CCAA y periodo de estudio) y del Ministerio de Sanidad, Servicios Sociales e Igualdad (gasto público sanitario y farmacéutico). El examen estadístico (SPSS 24) incluyó análisis descriptivo e inferencial del gasto sanitario y farmacéutico publico según el período de estudio e ideología, también se realizó un ajuste de regresión para conocer la importancia relativa de las variables predictoras. RESULTADOS: Durante el período de crisis hubo diferencias en el gasto sanitario público por habitante en los distintos tipos de CCAA (pobres/medias/ricas) y según ideología política gobernante (p <0,05). El gasto farmacéutico público pasó de 327 €/hab (pre-crisis) a 366 €/hab en el período final del estudio. Hubo diferencias estadísticamente significativas en el gasto farmacéutico según los distintos tipos de CCAA. De igual forma se encontraron diferencias en el gasto farmacéutico por habitante entre las CCAA regentadas por conservadores y tipo de CCAA a lo largo de todo el período de estudio. CONCLUSIONES: El gasto farmacéutico comunitario por habitante ha disminuido en más del 13% desde 2006 hasta 2017, mientras que el gasto farmacéutico hospitalario se ha incrementado en más del 84%. Las CCAA ricas invierten más en gasto sanitario y las pobres más de medicamentos

OBJECTIVE: The Spanish economic crisis began in 2008 and according to the Ministry of Economy, Industry and Competitiveness it concluded in 2014. During the crisis the main macroeconomic indicators had an adverse evolution and the effects have lasted for more than six years to the present. AIM: To assess the influence on public spending (health and pharmaceutical) that the governing policies have had and the time of crisis suffered. METHODS: Public expenditure per inhabitant (health and pharmaceutical) is compared according to the study period (pre, crisis and post), the political ideology of the ruling party (conservative/ progressive) and each autonomous community in reference to GDP per inhabitant in each of they respect the national average (poor, average or rich) according to the quartiles. The sources of the data have been the National Statistics Institute (GDP and inhabitants of each Autonomous Community and study period) and the Ministry of Health, Social Services and Equality (public health and pharmaceutical expenditure). The statistical procedures (SPSS v24) included descriptive and inferential analysis for public healthcare and pharmaceutical expenditure according to the period of study and ideology. There was also a regression fit to know the relative importance of predictor varibles. RESULTS: During the crisis period there were differences in public health expenditure per inhabitant in the different types of Autonomous Communities (poor / medium / rich) and according to political ideology (p <0.05). Public pharmaceutical expenditure was € 327 / inhab (pre-crisis) to € 366 / inhabitant in the final period of the study. There were statistically significant differences in pharmaceutical expenditure according to the different types of CCAA. Likewise, differences were found in per capita pharmaceutical expenditure between the Autonomous Communities run by conservatives and type of Autonomous Communities throughout the study period. CONCLUSIONS: The community pharmaceutical expenditure per capita has decreased by more than 13% since 2006 until 2017, while the hospital pharmaceutical expenditure has increased by more than 84%. Rich regions invest more in the health care costs and the poor more than drugs

Comparación directa de los costes sanitarios en los 2últimos meses de vida en pacientes oncológicos a partir de certificados de defunción en un área periurbana según reciban o no atención en su domicilio por un equipo de cuidados paliativos / Direct comparison of health costs in the last 2months of life of oncological patients from death certificates in a peri-urban area, according to whether or not they had received care from a palliative home care team

OBJETIVO: Comparar de manera directa los costes sanitarios que supone la atención en los 2últimos meses de vida de los pacientes con enfermedad oncológica avanzada a partir de los certificados de defunción en una zona metropolitana de Madrid, según reciban o no seguimiento en su domicilio por un Equipo de Soporte de Atención Paliativa Domiciliaria (ESAPD). METODOLOGÍA: DISEÑO: análisis de costes directos con base poblacional comparando 2opciones de atención de pacientes oncológicos en los 2últimos meses de vida: seguimiento habitual, seguimiento por ESAPD. Ámbito: el ESAPD está formado por 2médicos y 2enfermeras, y atienden una población de 350.000 habitantes de un área metropolitana de Madrid. Tamaño muestral y muestreo: 226 pacientes. A partir de los certificados de defunción se incluyó a todos los pacientes mayores de 18 años, fallecidos por cáncer durante el año 2005, en el área metropolitana de Madrid que atiende dicho ESAPD. Variables a partir de los certificados de defunción sociodemográficas y clínicas: edad, sexo, estado civil, localización del tumor y fecha del fallecimiento. A partir de los registros de los hospitales públicos: número de ingresos hospitalarios, duración y visitas a urgencias y a partir de la base datos ESAPD: seguimiento o no por el ESAPD. Análisis de costes: para el cálculo de los costes empleados de ingresos por urgencias o estancia hospitalaria se tomaron los precios públicos oficiales de la base de datos Oblikue actualizados con el IPC de medicinas a 2015. Análisis estadístico: se han descrito las variables cualitativas con frecuencias y porcentajes, y las variables cuantitativas con media, mediana y desviación típica. Para la comparación entre 2 variables se usó el test t de Student, el test de la chi al cuadrado y la Tau-c de Kendall. RESULTADOS: N: 226, edad media fue de 68,0 (14,0) años, con un rango de 23 a 94 años, un 65,9% fueron varones, solteros 16 (7,1%), casado 148 (65,5%), viudo 55 (25,3%) y separado 7 (3,1%). Tipo de tumor: hematológico 21, respiratorio 61, mama 14, genitourinario 19 y digestivo 69. Pacientes fallecidos en el hospital 5 (13,5%) vs.133 (70,4%), en domicilio 25 (67,5%) vs.22 (11,6%), en unidades de cuidados paliativos 5 (13,5%) vs.21 (11,1%) según hayan recibido o no seguimiento por ESAPD, respectivamente, p < 0,005. Número de ingresos hospitalarios: ningún ingreso 22 (59%) vs.54 (28,6%), un ingreso 12 (32,4) vs.98 (51,9%) y 2o más ingresos 3 (8,1%) vs.37 (19,6%) según hayan recibido o no seguimiento por ESAPD, respectivamente, p < 0,001. La media en el número de días de ingresos fue de 7,5 vs.16,5 según hubieran recibido o no seguimiento por ESAPD, respectivamente, p < 0,001. El coste medio en euros por paciente fue de 3.158, IC 1.626.7-4689,2, rango máximo de 15.186 vs.6.941, IC 5.919-7.963,1) y rango máximo de 26.153, p = 0,002, según hubieran recibido o no seguimiento por ESAPD, respectivamente. CONCLUSIONES: Se observa una disminución muy significativa del gasto por paciente en aquellos que son seguidos por un equipo domiciliario de cuidados paliativos. Esta disminución está asociada principalmente al menor número de ingresos y estancias hospitalarias en el grupo de pacientes que fueron seguidos por un equipo de cuidados paliativos

PURPOSE: direct comparison of the health costs of care in the last 2 months of life, of patients with advanced oncological illness, from death certificates, in a metropolitan area in Madrid, depending on whether or not they had been home monitored by a Palliative Home Care Team (PHCT). Methods: Design population-based direct costs analysis, comparing 2care options for oncological patients in the last 2months of life: standard monitoring vs. PHCT monitoring. Setting: The PHCT is formed by 2physicians and 2nurses, attending 350 000 inhabitants of a metropolitan area of Madrid. Sample size and sampling: 226 patients. From death certificates, all patients older than 18, who died of cancer during 2005, in the Madrid metropolitan area attended by the abovementioned PHCT, were included. Variables sociodemographic and clinical variables from death certificates: age, sex, marital status, tumour location, date of death. From the public hospitals' registries: number of hospital admissions, visits to emergency room and their length. And from the PHCT database: PHCT monitoring. Costs analysis: the official public prices of the Oblikue database were used to calculate the costs of emergency admissions and/or hospital stays, updated with the 2015 medicines IPC. Statistical analysis: The qualitative variables were described with frequency and percentage, and the quantitative variables with mean, median and standard deviation. For the comparison between 2variables the T-Student test, the Chi-square test and the Kendall c-Tau were used. Results: N: 226. Mean age was 68.0 (14.0) with a range from 23 to 94 years old, 65.9% were male, 16 single (7.1%), 148 married (65.5%), 55 widowed (25.3%) and 7 separated (3.1%). Tumour type: 21 haematological, 61 respiratory, 14 breast, 19 genitourinary, 69 digestive. Patients who died in hospital 5 (13.5%) vs. 133 (70.4%), at home 25 (67.5%) vs. 22 (11.6%), in palliative care units 5 (13.5%) vs. 21 (11.1%) according to whether or not they had been monitored by PHCT respectively, P<.005. Number of hospital admissions: no admission 22 (59%) vs. 54(28.6%), one admission 12(32.4) vs. 98(51.9%) and 2or more admissions 3(8.1%) vs. 37(19.6%), according to whether or not they had been monitored by PHCT respectively, P<.001. The mean number of admission days was 7.5 vs. 16.5, according to whether or not they had been monitored by PHCT respectively, P<.001. The mean cost in euros per patient was 3158, CI (1626.7-4689.2), maximum range 15186 vs. 6941, CI (5919-7963.1) and maximum range 26153, P=.002, according to whether or not they had been monitored by PHCT respectively. Conclusions: A significant reduction in the expense per patient, in those monitored by a PCHT is observed. This reduction is mainly associated with a lower number of admissions and hospital stays in the group of patients that were monitored by a palliative areteam

Efficacy of the Treatments Used in Multiple Sclerosis: From Meta-analysis to Number Needed to Treat.

The aim of this study was to analyze the efficacy of drugs used in relapsing-remitting multiple sclerosis, first- and second-line drugs, using the number needed to treat (NNT) as a measure of efficacy. METHODS: Data from randomized clinical trials were analyzed for 3 categories of clinical efficacy outcomes: relapse, change in Expanded Disability Status Scale, and number of new lesions in magnetic resonance imaging. Meta-analysis results are expressed as odds ratios. RESULTS: The global odds ratio was 0.41 (95% confidence interval [CI], 0.34-0.49). For analyzed clinical outcomes, the odds ratio was less for second-line drugs (odds ratio, 2.0). For all studied clinical conditions, in the control group, 47 of 100 patients do not get benefits, compared with 25 (95% CI, 18-32 patients) of 100 for the active treatment group. The NNT was 5 patients (95% CI, 4-7 patients). For the proportion of patients free of relapses, in the control group, 56 of 100 patients had a relapse at 2 years, compared with 37 of 100 patients in the treatment group, with an NNT of 6 patients (95% CI, 5-8 patients). CONCLUSIONS: Active treatments produced statistically significant improvements compared with placebo.

Estudio farmacoeconómico del tratamiento de la enfermedad de Parkinson avanzada / Pharmacoeconomic study of the treatment of advanced Parkinson’s disease

Introducción. Cuando el tratamiento farmacológico oral o transdérmico de la enfermedad de Parkinson pierde eficacia, se dispone de tres terapias mediante dispositivos asistidos que pueden reducir las complicaciones motoras y no motoras: la apomorfina en infusión subcutánea (ASBI), la bomba de infusión duodenal continua de levodopa/carbidopa (IDL) y la estimulación cerebral profunda (ECP). Objetivo. Efectuar un análisis farmacoeconómico comparativo del uso de ASBI con IDL y ECP; como objetivo secundario, discutir el perfil del candidato ideal para cada una de las técnicas. Pacientes y métodos. Se extrajo información sobre datos de años de vida ganados y años de vida ganados ajustados por calidad (AVAC) según la escala de Hoehn y Yahr, e información sobre costes y consumo de recursos para cada alternativa. La perspectiva del análisis fue la del Sistema Nacional de Salud, y el horizonte temporal fue de cinco años para los costes y toda la vida del paciente para las utilidades. Las medidas de resultado utilizadas fueron los años de vida ganados y AVAC, y en su comparación se usó la ratio coste-utilidad incremental. Resultados. El coste-utilidad obtenido para cada opción fue: 31.956 euros/AVAC para la ECP, 38.249 euros/AVAC para la ASBI y 75.206 euros/AVAC para la IDL. Conclusiones. Los resultados permiten evaluar la efectividad y utilidad de los diferentes tratamientos para la enfermedad de Parkinson avanzada, pues se presentan en ganancias de años vividos en plena salud. Los datos obtenidos contribuyen a la toma de decisiones que determinen la planificación y gestión de cada caso, sin olvidar las preferencias del paciente y del neurólogo, así como las limitaciones presupuestarias (AU)

Introduction. When oral or transdermal drug therapy in Parkinson’s disease becomes less effective, there are three therapies using assisted devices that can reduce motor and non-motor complications: subcutaneous apomorphine infusion pump (SAIP), continuous levodopa/carbidopa duodenal infusion (LDI) and deep brain stimulation (DBS). Aim. Conduct a comparative pharmacoeconomic analysis of the use of SAIP, with LDI and DBS. As a secondary objective arises discuss the profile of the ideal candidate for each of the technicals. Patients and methods. Information on life years gained and quality adjusted life years (QALY) according to Hoehn & Yahr scale was obtained, as well as data on costs and resource use for each of the alternatives. The perspective of the analysis was the National Health System and the time horizon was 5 years for costs and patient´s lifetime for utilities. Outcome measures used were life years gained and QALYs, and incremental cost/utility ratio for comparison. Results. Cost/utility ratio was obtained for each option: 31,956 euros/QALY for DBS, 38,249 euros/QALY for SAIP, and 75,206 euros/QALY for LDI. Conclusions. Our results allow us to add information about effectiveness of different treatments, as these are presented in gain of years lived in full health (QALY). Data obtained contribute to decision making that determine planning and management of each case, without forgetting patient and neurologist preferences, as well as budgetary limitations (AU)

Gasto económico del tratamiento del dolor irruptivo / Cost of the treatment of breakthrough pain

A continuación se exponen 2 estudios farmacoeconómicos que comparan el comprimido oral de fentanilo con aplicador para administración bucofaríngea (Actiq®), el comprimido de fentanilo sublingual (Abstral®), el comprimido bucal efervescente de fentanilo (Effentora®) y el fentanilo por vía nasal, con 2 tecnologías: una formulación en gel con pectina (fentanilo intranasal con pectina, PecFent®) y otra en solución acuosa sin pectina (Instanyl®). El estudio de López et al buscaba analizar los ahorros potenciales derivados de la introducción progresiva del fentanilo intranasal con pectina, para el tratamiento de pacientes mayores de edad con dolor irruptivo oncológico. El estudio de Blanco et al tenía como objetivo conocer la efectividad y eficiencia del fentanilo intranasal con pectina comparado con los otros tratamientos transmucosos comercializados en ese momento. El primer estudio mostró una disminución del coste sanitario con la introducción progresiva del fentanilo intranasal con pectina en el Sistema Sanitario Español para el tratamiento del dolor irruptivo. El segundo estudio demostró que la opción más eficiente (mayor efectividad y menor coste) en todos los casos analizados fue el espray intranasal de fentanilo con pectina

This article presents two pharmacoeconomic studies comparing the compressedfentanyl lozengewith an integral oromucosalapplicator (Actiq®); fentanyl sublingual tablets(Abstral®); effervescent fentanylbuccal tablets(Effentora®) and nasal fentanyl with two technologies: a formulation that contains pectin in a gel-based nasal spray (PecFent®) and another formulation in an aqueous solution without pectin (Instanyl®). The first of these studies aimed to analyze the potential savings due to the progressive introduction of fentanyl pectin nasal spray for the treatment of adult patients with breakthrough cancer pain. The second study aimed to determine the effectiveness and efficiency of fentanyl pectin nasal spray compared with the other tansmucosal treatments currently on the market. The first study showed a reduction in healthcare costs with the progressive introduction of fentanyl pectin nasal spray for the treatment of breakthrough pain in the publicly-funded health system in Spain. The second study showed that the most efficient option (greatest effectiveness and lowest cost) in all the cases analyzed was the fentanyl-pectin nasal spray