Spanish National Health System Research Articles

PP38 Immersion in water during childbirth: A survey to the Spanish National Health System

IntroductionCertain doubts about immersion in water during birth mainly regarding the safety of the infant, warrant analysis of the data to determine whether immersion in water during childbirth is safe and effective. The aim is to describe the situation regarding the use of water immersion during childbirth in hospitals of the Spanish National Health System across Spanish Autonomous Regions and Cities.MethodsA questionnaire was developed to assess the use of water immersion on maternity wards of National Health System hospitals. The survey was reviewed by several categories of health professionals and stakeholders. The online questionnaire was distributed via email. A database was created using the Microsoft Excel 365® computer program. Quantitative results were described through percentages and frequency distributions. In the case of free responses, a content analysis was performed, coding the responses into different categories.ResultsRegarding the status of water birth in Spain, the availability of the option of water birth varies across hospitals of the National Health System. Forty-six hospitals in 13 autonomous regions indicated that they had birthing pools on their delivery wards. Among these hospitals, 20 percent reported having more than 10 years of experience in water births, 45 percent between five and 10 years and 35 percent less than five years. Of the 46 responses received, 78 percent of the hospitals indicated that there was a demand for information on waterbirth by pregnant women. Regarding the existence of criteria for the adequate selection of pregnant women who could opt for immersion in water during childbirth, 89 percent of the hospitals indicated that these did exist, while 11 percent indicated that they did not have agreed criteria for the selection of candidates for water birth.ConclusionsThe availability of the option of water birth varies in hospitals across the Spanish National System. All the hospitals that have birthing pools offer them in the first stage of labor (dilation), while 32 percent also use them in the pushing stage and 15 percent during delivery of the placenta. It would be advisable to have standardized protocols and training to ensure the possibility that all pregnant women, regardless of their place of residence, can safely opt for water immersion during childbirth with satisfactory results.

EE394 Understanding Reasons of Negative Reimbursement Decisions for Orphan Drugs in the Spanish National Health System (APRIL 2019-MAY 2023)

EE394 Understanding Reasons of Negative Reimbursement Decisions for Orphan Drugs in the Spanish National Health System (APRIL 2019-MAY 2023)

OP23 Early Detection Tools For Emotional Distress In Adult Cancer Patients In Spain: A Health Technology Assessment Report

IntroductionPatient-reported outcome measures are being increasingly considered both in clinical practice and in the field of health technology assessment. Although emotional distress is currently recognized as the sixth vital sign in cancer care, its early detection and screening is not yet included in routine clinical practice in Spain. The main objective of this study was to assess the psychometric properties and diagnostic accuracy of validated tools for the early detection of distress among adults with cancer in the Spanish context, at the request of the Spanish National Health System (NHS) Cancer Strategy.MethodsA systematic review was carried out to analyze development and validation studies. The Quality Assessment of Diagnostic Accuracy Studies tool (QUADAS-2) was used for the risk of bias assessment, and a multicriteria global assessment was used for the tests. Ethical and organizational aspects were also addressed.ResultsFifteen validation studies were included, corresponding to seven tests. The tools considered were the Distress Thermometer (DT), the Brief Symptom Inventory-18 (BSI-18), the Edmonton Symptom Assessment System-revised (ESAS-r), the Hospital Anxiety and Depression Scale (HADS), the Visual Analog Scale for Anxiety and Depression (VAS-AD), the Detection of Emotional Distress (DED) scale, and the Psychosocial and Spiritual Needs Evaluation (ENP-E) scale. Evidence of validity, reliability (internal consistency), and diagnostic accuracy (sensitivity, specificity, and area under the receiver operating characteristic curve) were summarized. Three scales were rated as poor (VAS-AD, BSI-18, and ESAS-r), the ENP-E scale was rated as acceptable, and three scales were rated as moderate (DT, DED, and HADS).ConclusionsThe DT (single-item measure) stands out as an appropriate tool for early detection of emotional distress in the Spanish NHS. The use of this scale could be considered a first stage, to be combined later with a longer scale to improve screening specificity. The HADS scale could be utilized for this purpose. The use of these tools should be framed within a structured screening program that ensures further evaluation and subsequent psychological care when needed.

Demographic transition and hospital admissions in Spanish centenarians, 2004–2020: Geographical variations and sex-related differences

BackgroundThis study aims to describe the distribution and temporal trends of the centenarian population and their hospital admissions in Spain over the past two decades, focusing on regional and sex-based differences. MethodsA retrospective study was conducted using data from the Spanish National Health System's Hospital Discharge Records-Minimum Basic Data Set. The analysis included all hospitalized patients ≥100 years between January 2004 and December 2020. The crude annual centenarian population and admission rates were calculated. Joinpoint regression analysis and cross-correlation analysis were used to identify trends and associations. ResultsFrom 2004 to 2020, the centenarian population in Spain increased by 89.0 %, with a larger increase observed in women (86.6 %) than men (32.9 %). Significant geographic variability was found, with rates from 1.1 to 5.2 × 10,000 inhabitants per year across different regions. Joinpoint analysis identified three trends: a decline from 2004 to 2008, an increase from 2008 to 2015, and a slower increase from 2015 to 2020. Hospital admissions of centenarians increased by 121.5 %, with a larger increase in women than men (212.1% vs 90.7 %); women represented 75.4 % of admissions. The proportion of centenarian admissions to total hospitalizations showed an upward trend until 2015 and then stabilized; it also varied among regions. ConclusionThere was a significant increase in the centenarian population and hospital admissions of centenarians in Spain. There are regional disparities in their distribution, with women representing a larger proportion of centenarians and hospital admissions. Understanding these trends and differences is crucial for implementing interventions that ensure adequate healthcare for centenarians.

Regional differences in infective endocarditis epidemiology and outcomes in Spain. A population-based study

Abstract Introduction Population-based studies of infective endocarditis (IE) provide nationwide representative information of the disease, with a lower risk of selection and referral bias. Purpose Our aim was to describe the contemporary epidemiological profile of IE in Spain, and to evaluate regional variations in the incidence, characteristics and outcomes of IE in the different Spanish regions (autonomous communities, AC). Methods Retrospective population-based study to analyse the incidence, epidemiological and clinical characteristics and outcomes of all patients discharged with a diagnosis of IE from hospitals included in the Spanish National Health System, from January 2016 to December 2019. Differences in the IE profile among the 17 Spanish AC were also evaluated. Results A total of 9008 episodes were identified during the study period. Mean age was 69.5 (14.6) years, and 66.1% of the patients were male. 52.6% of episodes were treated at referral centers. Direct standardized incidence of IE in the study period was 5.77 (95% CI: 5.12-6.41) cases per 100000 person-years. 26.8% of episodes were prosthetic valve carriers, 36.8% had some kind of valve heart disease, and 10.6% had a cardiac implantable electronic device. The most frequently isolated microorganisms were staphylococci (33.3%; 19.0% Staphylococcus aureus and 14.3% coagulase-negative staphylococci), followed by gram-negative (21.0%) and streptococci (20.8%). Culture-negative IE accounted for 20.7% of episodes. 38.6% of patients developed heart failure during hospitalization, and 27.5% had acute renal failure. Cardiac surgery was performed in 19.3% of episodes in the total cohort, and in 33.4% of episodes treated in high-volume referral centres. In-hospital mortality was 25.1%. The standardized incidence of IE in Spain in the period 2016-2019 was 5.77 (95% CI: 5.12-6.41) cases per 100000 person-years. Standardized incidence rates (cases per 1000000 person-years) and risk-adjusted in-hospital mortality rates of infective endocarditis among AC are shown at Figure 1, were significant differences were found. In a multilevel logistic regression analysis, cardiogenic shock (OR 5.95, CI 4.98-7.9) and septic shock (OR 4.54, CI 3.78-5.44) were associated with the highest odds ratio for in-hospital mortality, whereas Streptococci viridans was associated with the lowest (OR 0.44, CI 0.37-0.52). Irrespectively of the AC, patients treated at high-volume centres (> 22 episodes per year) had a slightly lower risk-adjusted mortality (22.7±4.1 vs 23±3.6) p<0.001) (Figure 2, blue dots represent low-volume hospitals, red dots represent high-volume hospitals). Conclusions We found relevant and statistically significant differences in standardized incidence rates of IE, and risk-adjusted in-hospital mortality rates among regions. Regardless of the AC, patients treated in high-volume centres (>22 episodes per year) had a slightly lower risk-adjusted mortality.Figure 1Figure 2

The role of cardiac magnetic resonance imaging in patients with MINOCA in daily clinical practice

Abstract Background In patients with ‘myocardial infarction with non-obstructive coronary arteries’ (MINOCA), the underlying cause is not always known. Cardiac magnetic resonance imaging (CMRI) is recommended as a key investigation in MINOCA because it can exclude myocarditis, takotsubo syndrome, and cardiomyopathies, as well as provide imaging confirmation of AMI. However, CMRI is not widely available. The aim of our study was to analyze the role of CMRI in patients with MINOCA in routine clinical practice in a non-tertiary hospital of the Spanish national health system. Methods We analyzed 62 consecutive MINOCA patients admitted to our University Hospital from 2019 to January 2023. The database were revised by a group of experts in order to adequate MINOCA to 2020 ESC Guidelines definition and the American Heart Association position paper. The tako-tsubo syndrome was excluded. According to these guidelines CMRI is recommended in the evaluation of MINOCA patients. Results Only in 32 patients, corresponding to 52% of the patients with MINOCA, the CMRI was performed because of the limited availability of this test in our health System. Of the CMRI performed, 46% provided the underlying mechanism of the MINOCA: myocarditis (21%) or confirmation of AMI (25%). The other CMRI were normal (54%) (figure). Although patients with normal CMRI had a significantly lower mean TropT hs (236.02 vs 794.02 ng/L, p=0.03), troponin levels were not able to discriminate patients with normal CMRI. Thus up to 33% of patients with pathological CMRI had a TropThs level less than 244 ng/L (which was the median of the series). There were no significant differences in other biomarkers (PCR, CK) or clinical or analytical parameters. There were also no differences in prognosis at follow-up (death or readmissions) between patients with normal CMRI and patients with diagnostic CMRI. Conclusions 1) In routine clinical practice, only 52% of patients with MINOCA underwent CMRI, 2) Of the patients who underwent CMRI, it provided the underlying mechanism of the MINOCA in 46% of them, 3) Although the TropThs level was lower in patients with normal CMRI, the troponin level was not useful to select the patients that would benefit most from such a test.CMRI in MINOCA patients

Cost-minimisation analysis of chronic lymphocytic leukemia in Spain in the era of oral targeted therapies

ObjectiveChronic lymphocytic leukaemia places a considerable economic burden on the Spanish National Health System. This study estimated the direct costs of chronic lymphocytic leukaemia oral targeted therapies from 2011 to 2025, inclusive, in a scenario with fixed treatment oral targeted therapies and in a scenario without them. MethodThe clinical course of adult chronic lymphocytic leukaemia patients was represented by a Markov model with four health states: watchful waiting, first-line treatment, relapse, and death. The treatment pattern was defined according to patient type by disease status or situation, age, presence or absence of deletion in the short arm of chromosome 17, immunoglobulin heavy chain mutation status, and year of treatment. The treatment algorithm was simulated from 2011 to 2025, and included therapies funded by the Spanish National Health System and their use in routine clinical practice, validated by leading experts. A single treatment option was assumed for each type of patient and time period (the most widely option used at each time point). Direct costs were included: pharmacological, administration, tests performed, routine visits, hospitalizations, and adverse events. ResultsFrom 2011 to 2025, there would be a mean annual chronic lymphocytic leukaemia prevalence of 16,436 patients in the scenario without fixed treatment oral targeted therapies and 16,413 in the scenario with fixed treatment oral targeted therapies. In the same period, the total costs in the scenario without fixed treatment oral targeted therapies would be €4,676.7 million and in the scenario with fixed treatment oral targeted therapies they would be €4,111.8 million. Thus, the introduction of fixed treatment oral targeted therapies would entail a saving of €564.9 million (12.1% of the total cost of care of chronic lymphocytic leukaemia patients during the period assessed). In this period, the total cost per patient would decrease from €266,019 in the scenario without fixed treatment oral targeted therapies to €236,852 in the scenario with fixed treatment oral targeted therapies, representing a saving of €29,167 per patient. ConclusionsThis study estimates that, between 2011 and 2025, the introduction of fixed treatment oral targeted therapies for the treatment of chronic lymphocytic leukaemia would entail €564.9 million cost savings for the Spanish National Health System (12.1% of the total cost of care of chronic lymphocytic leukaemia patients during the period assessed).

Cost-utility analysis of venetoclax in combination with obinutuzumab as first-line treatment of chronic lymphocytic leukaemia in Spain

ObjectiveVenetoclax in combination with obinutuzumab has significantly improved efficacy versus immunochemotherapy (progression-free survival) in patients with chronic lymphocytic leukaemia who have not received prior treatment. The objective of this study was to evaluate its efficiency in Spain using a cost-utility analysis. MethodUsing a partitioned-survival analysis model adapted to the Spanish context and based on three health states (progression-free survival, survival after progression, and death), a simulation of the evolution of patients who were candidates for initiating first-line treatment was conducted for a lifetime time horizon. Venetoclax in combination with obinutuzumab was compared to the most commonly used therapeutic options for these patients at the time of study design: chlorambucil in combination with obinutuzumab, ibrutinib, fludarabine in combination with cyclophosphamide and rituximab, and bendamustine in combination with rituximab. In order to estimate survival curves, efficacy data were derived from the CLL14 trial and a network meta-analysis. The analysis was conducted from the perspective of the Spanish National Healthcare System and included direct healthcare costs (i.e. pharmacological costs and their administration), and those associated with the management of the disease and adverse events. The resource use was validated by an expert group. Quality of life data were used to estimate the quality-adjusted life years obtained for each alternative. A threshold of €25,000/quality-adjusted life years was used. The robustness of the model was evaluated using deterministic and probabilistic sensitivity analyses. ResultsVenetoclax in combination with obinutuzumab was shown to be a dominant alternative compared to the rest of the treatment alternatives, with a lower cost per patient (€-67,869 compared to chlorambucil in combination with obinutuzumab, €-375,952 compared to ibrutinib, €-61,996 compared to fludarabine in combination with cyclophosphamide and rituximab, and €-77,398 compared to bendamustine in combination with rituximab). It also had a greater gain in quality-adjusted life years (0.551 quality-adjusted life years gained compared to chlorambucil in combination with obinutuzumab and ibrutinib, 1.639 quality-adjusted life years gained compared to fludarabine in combination with cyclophosphamide and rituximab, and 1.186 quality-adjusted life years gained compared to bendamustine in combination with rituximab). Between 68% and 85% of the simulations performed in the sensitivity analysis showed that venetoclax in combination with obinutuzumab had lower costs and more quality-adjusted life years gained. ConclusionsVenetoclax in combination with obinutuzumab is an efficient and dominant alternative for treating previously untreated patients with chronic lymphocytic leukaemia compared to the available alternatives and from the perspective of the Spanish National Health System.

Impact of hospitalization on nutritional status in persons aged 65 years and over (NUTRIFRAG Study): Protocol for a prospective observational study.

Malnutrition is a recurring problem that has become more relevant in recent years. The aim of this study is to assess the risk of malnutrition and nutritional status on admission and its evolution until discharge in patients aged 65 and over admitted to medical and surgical hospitalization units in hospitals of the Spanish National Health System. Prospective observational study to be carried out in the medical-surgical hospitalization units of 9 public hospitals between 01/09/2022 and 31/12/2024. Using consecutive sampling, a total of 4077 patients will be included (453 in each hospital). Variables included are related to the care process, functionality, cognition and comorbidity, risk profile, nutritional status and dysphagia; as well as frailty, dietary quality and contextual variables. The incidence of risk of malnutrition, undernutrition and dysphagia during the care process and at discharge will be calculated. The association with risk factors will be studied with logistic regression models and multivariate Cox regression models. In addition, an analysis of participants' satisfaction with food services will be carried out. The study was approved by the Ethics and Research Committee on 30/09/2020, approved for funding on 02/12/2021 and with registration number RBR-5jnbyhk in the Brazilian clinical trials database (ReBEC) for observational studies. Some studies address nutritional status or dysphagia in older people in various care settings. However, there is a lack of large sample studies including both processes of the impact of hospitalization. The results of the project will provide information on the incidence and prevalence of both pathologies in the study subjects, their associated factors and their relationship with the average length of stay, mortality and early readmission. In addition, early detection of a problem such as malnutrition related to the disease and/or dysphagia during a hospital stay will favor the action of professionals to resolve both pathologies and improve the health status of patients.

Weekend and holiday admissions for decompensated heart failure and in-hospital mortality. A cumulative effect of “nonworking” days?

Introduction and objectives: The aim of this study was to analyze whether nonelective admissions in patients with heart failure (HF) on nonworking days (NWD) are associated with higher in-hospital mortality.Methods: We conducted a retrospective (2018-2019) observational study of episodes of nonelective admissions in patients aged 18 years and older discharged with a principal diagnosis of HF in acute general hospitals of the Spanish National Health System. NWD at admission were defined as Fridays after 14:00 hours, Saturdays, Sundays, and national and regional holidays. In-hospital mortality was analyzed with logistic regression models. The length of NWD was considered as an independent continuous variable. Propensity score matching was used as a sensitivity analysis.Results: We selected 235 281 episodes of nonelective HF admissions. When the NWD periods were included in the in-hospital mortality model, the increases in in-hospital mortality compared with weekday admission were as follows: 1 NWD day (OR, 1.11; 95%CI, 1.07-1.16); 2 days (OR, 1.13; 95%CI, 1.09-1.17); 3 (OR, 1.16; 95%CI, 1.05-1.27); and ≥ 4 days (OR, 1.20; 95%CI, 1.09-1.32). There was a statistically significant association between a linear increase in NWD and higher risk-adjusted in-hospital mortality (chi-square trend P = .0002). After propensity score matching, patients with HF admitted on NWD had higher in-hospital mortality than those admitted on weekdays (OR, 1.11; average treatment effect, 12.2% vs 11.1%; P < .001).Conclusions: We found an association between admissions for decompensated HF on an NWD and higher in-hospital mortality. The excess mortality is likely not explained by differences in severity. In this study, the “weekend effect” tended to increase as the NWD period became longer.

Cost-effectiveness of weekly gastro-resistant risedronate 35mg, compared with weekly alendronate 70mg tablets, in the treatment of postmenopausal osteoporosis in Spain.

Aim: To estimate the cost-effectiveness of treating postmenopausal osteoporosis (PMO) with weekly gastro-resistant risedronate 35mg gastro-resistant tablets (RIS-GR), compared with weekly alendronate 70mg tablets (ALN) in Spain. Methods: A probabilistic analysis (second-order Monte Carlo simulation) was performed with a time horizon of 5years, from the perspective of the Spanish National Health System. The bone fracture probabilities were obtained from a cohort study of 3614 women from USA with PMO treated with RIS-GR (1807) or ALN (1807) (Thomasius, 2022). The pharmacological cost and the cost of fractures were obtained from Spanish sources (€ 2022). The utilities of patients with and without fracture (quality-adjusted life years [QALYs]) were obtained from the medical literature. Results: Compared with ALN, treatment with RIS-GR can avoid 79 fractures (between 75 and 82) every 1000 patients treated, and 0.0119 QALYs would be gained (between 0.0098 and 0.0140) per patient. Additionally, GR-RIS would generate a cost saving per patient of €1994 (€1437-2904) with a probability of 99.7%. The scenario analyses confirmed the stability of the base case results. Conclusion: According to this study, RIS-GR would be the dominant treatment (lower costs with QALY gain) compared with ALN.

Economic evaluation and budgetary burden of mepolizumab in severe refractory eosinophilic asthma

ObjectiveMepolizumab is indicated as an additional treatment of severe refractory eosinophilic asthma. The observed differences in population subgroups according to plasma eosinophil count, the existence of patients with high levels of immunoglobulin E who are candidates of omalizumab and mepolizumab, as well as mepolizumab's economic impact, lead to make efficient economic studies for clinical decision making. The aim was to analyze mepolizumab's cost-efficacy and budget impact. MethodCost comparison and the use of mepolizumab's budgetary impact was performed, from the Spanish National Health System's perspective. Among the assessed alternatives, inhaled systemic corticosteroids, plus long acting beta agonist (β2) and/or oral systemic corticosteroids in patients with non immunoglobulin E-mediated severe allergic asthma, and said treatment along with omalizumab in patients with immunoglobulin E mediated eosinophilic allergic asthma were included. Its efficacy was evaluated through avoided clinically relevant exacerbations. The direct costs associated with exacerbation were assessed. ResultsMepolizumab's long run average incremental cost regarding omalizumab's is 797 euros per patient a year. Considering omalizumab's alternative discounted price, including mepolizumab for patients with immunoglobulin E mediated eosinophilic allergic asthma would increase public spending from 2.3 to 4.6 million euros. Given omalizumab's notified price, the gradual introduction of mepolizumab in the Spanish National Health System would save 3.6 million euros in three years. For non immunoglobulin E-mediated severe asthma patients, the avoided cost/exacerbation by introducing mepolizumab is 15,085 euros, assuming a gradual market penetration of mepolizumab. In patients with ≥ 500 eosinophils/µL, this cost decreases to 7,767 euros per avoided exacerbation with a budgetary impact of 183.2 million euros in three years with a progressive penetration of mepolizumab. ConclusionsThe cost comparison between mepolizumab and omalizumab in immunoglobulin E mediated eosinophilic asthma patients suggests a use of the lower cost drug, promoting price competition. Additionally, prioritizing its use among non immunoglobulin E-mediated severe refractory eosinophilic asthma patients and ≥ 500 eosinophils/µL plasma level patients, would improve its efficiency as well as reducing its budgetary impact.

Economic impact of olaparib on maintenance treatment of patients with BRCA-mutation positive, platinum-sensitive relapsing high-grade serous epithelial ovarian cancer in Spain

ObjectiveTo estimate the economic impact of the introduction of olapa- rib in the Spanish National Health System as maintenance monotherapy in patients with BRCA-mutation positive high-grade serous ovarian cancer. Method: A budget impact model was developed from the Spanish NHS perspective and a time horizon of 5 years for four treatment lines. The model included prevalent and incident patients estimated according to Spanish epidemiological data. Patients moved between treatment lines according to the progression-free survival and overall survival curves obtained from the respective clinical trials. Only direct costs (€2017) were considered: pharmacological, administration, adverse effects and genetic tests. The robustness of the model was verified by a univariate sensitivity analysis. ResultsThe use of olaparib meant that, after 5 years, 6% fewer patients progressed to later lines compared to scenario without olaparib, remaining longer in the second line and delaying the initiation of subsequent lines. The total estimated budgetary impact ranged between € 1.6 and € 5.4 million (1-5 years). The economic impact associated to the introduction of olaparib is partially offset by the lower cost of chemotherapy, related adverse events, and palliative care in patients with olaparib than in patients without it. ConclusionsOlaparib as maintenance treatment in patients with BR- CA-mutation positive high-grade serous ovarian cancer increases progression-free survival and delays the use of subsequent chemotherapy, with an budgetary impact for the Spanish National Health System of 5.4 million euros after 5 years.

Cost-per-responder analysis for eltrombopag and rituximab in the treatment of primary immune thrombocytopenia in Spain

ObjectiveSplenectomy, thrombopoietin receptor agonists and rituximab are the second-line treatments for steroid-resistant adult primary immune thrombocytopenia. The last two are becoming the most widely used treatments to avoid splenectomy adverse effects and inconveniences. However, the choice between rituximab and thrombopoietin receptor agonists is unclear. Therefore, the treatment cost may be of particular interest to prioritize the therapy option. Our aim is to determine the cost per responding-patient after 6 months of use of rituximab compared to thrombopoietin receptor agonists eltrombopag in the treatment of chronic primary immune thrombocytopenia in the Spanish National Health Service. MethodA 26-week decision tree model was developed to assess the cost of treatment response of adult patients with chronic-refractory primary immune thrombocytopenia to eltrombopag and rituximab from the perspective of the Spanish National Health System. Effectiveness was obtained from the literature, and cost was obtained from the official rates. Costs were expressed in € (2018). Due to the short period of assessment, no discount rate was applied. ResultsThe average cost per patient after 6 months of treatment was slightly higher for eltrombopag (€13,089.40) than for rituximab (€11,852.60). However, the greater response rate of eltrombopag decreases the bleeding costs, resulting in a 29% higher cost per responding-patient with rituximab (€18,964.15) than for eltrombopag (€14,732.65). This result is consistent with the results of the 15 sensitivity analyses carried out where eltrombopag always represents a lower cost per responding patient, except in the sensitivity analysis in which treatment with eltrombopag is performed at its maximum dose (75mg). Only in this case, the cost per responder of eltrombopag is €48 more expensive than that of rituximab. Likewise, the greatest difference in favor of eltrombopag occurs in the scenario that uses the minimum dose of this drug —25mg— (eltrombopag €7,622.14 compared to €18,964.15 for rituximab). Thus, the cost per responding patient is lower in eltrombopag even if a second cycle of retreatment with rituximab is not performed (€14,732.65 versus €15,298.61). ConclusionsThe treatment cost of rituximab, including monitoring and bleeding costs, is higher than eltrombopag, favoring the latter over rituximab treatment.

Cost-utility analysis of the fixed-dose combination of dolutegravir/abacavir/lamivudine as initial treatment of HIV+ patients in Spain

ObjectiveFixed-dose combinations of antiretroviral drugs have meant an important step forward in simplifying treatment and improving compliance and has led to an increased effectiveness of therapy, a viral load decrease and improving the quality of life of patients.The single-table formulation of dolutegravir with abacavir and lamivudine (DTG/ABC/3TC) is a highly efficacious and well-tolerated once-daily regimen for HIV-infected patients. The objective of the study was to assess the incremental cost-utility ratio of the fixed-dose combination of (DTG/ ABC/3TC) versus the combinations emtricitabine/tenofovir/efavirenz (FTC/TDF/EFV), and darunavir/r (DRV/r) or raltegravir (RAL) with emtrici- tabine/tenofovir (FTC/TDF) or abacavir/lamivudine (ABC/3TC) as initial antiretroviral therapy in patients infected with HIV-1 from the perspective of the Spanish National Health System. MethodThe ARAMIS model, which uses a microsimulation approach to simulate the individual changes in each patient from the start of treatment to death through a Markov chain of descriptive health states of the disease, was adapted to Spain. The alternatives used for comparison were the fixed-dose combination of emtricitabine/tenofovir/efavirenz (FTC/TDF/ EFV), and the fixed-dose combinations of emtricitabine/tenofovir (FTC/TDF) or abacavir/lamivudine (ABC/3TC) with darunavir/r (DRV/r) or ral- tegravir (RAL). The probability of achieving virological suppression by the treatments included in the model was obtained from clinical trials SINGLE, SPRING-2 and FLAMINGO and the costs were expressed in € (2015). The model use the perspective of the Spanish National Health System, with a lifetime horizon and a discount rate of 3% was applied to cost and effectiveness. ResultsTreatment initiation with DTG/ABC/3TC was dominant when it was compared with treatment initiation with all the comparators: vs. FTC/TDF/EFV (-67 210.71€/QALY), vs. DRV/r + FTC/TDF or ABC/3TC (-1 787 341.44€/QALY), and vs. RAL + FTC/TDF or ABC/3TC (-1 005 117.13€/QALY). All the sensitivity analyses performed showed the consistency of these findings. ConclusionsWith the premises considered, treatment initiation with DTG/ABC/3TC STR appears to be the most cost-effective option in ARTnaive HIV infected patients from the Spanish Health System perspective

Knowledge and use of ICT-based coordination mechanisms in three regions of Spain

Abstract Background Although there is a consensus on the potential benefits of information and communications technology (ICT) based mechanisms to improve cross-level clinical coordination, their introduction varies greatly among regions and services. The aim is to analyse the knowledge and use of digital coordination mechanisms and the factors related to the use in the health services of three autonomous communities (ACs) of the Spanish national health system. Methods Cross-sectional study based on an on-line survey by means of self-administration of the COORDENA-TICs questionnaire to primary and secondary care doctors of the health services in Catalonia (CAT) (n = 2277), Balearic Islands (BI) (n = 441), Basque Country (BC) (n = 572). Outcome variables: Knowledge and use of digital coordination mechanisms and difficulties of use. Explanatory variables: sociodemographic, labour-related, contextual, organizational, and interactional factors. Descriptive and multivariate analysis were performed to compare the ACs. Results There were some differences between the ACs: the access to and use of ICT-based coordination mechanisms in BI was limited, with the electronic health record (EHR) being the most available but infrequently used, whereas in BC and CAT there was wide access to and use of the EHR and virtual consultations between levels. In all three ACs common difficulties in EHR use emerged such as, technical problems, disorganized and/or insufficient information. Different contextual, organizational, and interactional factors were associated to their use in all three ACs. Conclusions There were differences in the type and level of implementation of ICT-based coordination mechanisms between the ACs that can be related to organizational and contextual factors, that should be further analysed. Addressing the relevant factors in each context should contribute to design effective strategies based on ICT-based coordination mechanisms to improve cross-level clinical coordination. Key messages • Implementation and use of ICT-based coordination mechanisms differed across the three ACs and could be related to differences in contextual and organizational factors in each context. • It is necessary to explore factors and difficulties related to the use of these mechanisms to develop more effective strategies to improve their use and hence impact on clinical coordination.

Non-clinical factors and citizens’ satisfaction: A way to improve the quality of health systems

ABSTRACT Citzens’ self-reported satisfaction is often employed to assess the quality of health services and systems and guide actions for improvement. Health providers and policymakers are increasingly interested in identifying factors that promote higher satisfaction with health systems. Using data from the Spanish Healthcare Barometer survey, this paper aims at analysing the relationship between non-clinical factors of responsiveness and overall satisfaction with the public Spanish National Health System. Specifically, the study examines whether better experiences with aspects such as doctor-patient communication, dignity, or prompt attention are relevant in improving overall satisfaction with the health system. Factors that contribute most to satisfaction are also identified. The methodology relies on probit-adapted ordinary least squares, a method that is increasingly employed in the most recent subjective well-being literature. The findings show that non-clinical factors are relevant in reporting higher overall satisfaction with the health system. Factors related to prompt attention and dignity contribute most to increasing satisfaction. As our readings suggest, this is the first study to present empirical evidence on the relevance of non-clinical factors of responsiveness in improving users’ experience with the whole Spanish health system. These results provide health policymakers with information to improve the quality of the system.

Estudio demográfico de las personas con nuevo diagnóstico de infección por VIH en el área sanitaria de un hospital de tercer nivel

IntroductionCountering HIV infection remains a primary objective of the Spanish National Health System. Emergency services play a crucial role in reducing missed diagnostic opportunities, with estimates suggesting that one in 3 such opportunities occur here. The aim of the study is to examine the geographical dispersion of newly diagnosed HIV cases, within a downtown Madrid hospital. MethodsThis is an observational, descriptive, retrospective study evaluating the geographical distribution of new HIV diagnoses in the care area of a tertiary University Hospital in the Community of Madrid. ResultsThree hundred and eighty-seven individuals with a new diagnosis of HIV infection between 2018 and 2020 were analysed, the majority being young people with an average age of 36±9 years. 86% were gay, bisexual and other men who have sex with men and 48.6% were immigrants. 15.3% presented with CD4+<200cells/mm3 and 9.5% with an AIDS-defining illness. 32.7% and 5.1% had an RNA-HIV-1>100,000copies/mL and >500,000copies/mL, respectively, with up to 13.7% of subjects presenting resistance mutations at diagnosis. Geographically, 51.4% of individuals came from 4 Health Centres and more than 70% of the new diagnoses were included in nine Health Centres. ConclusionBetter understanding the geographical distribution of new HIV diagnoses by health areas allows us to identify areas of higher transmission risk, thereby directing and implementing prevention, early diagnosis, and treatment measures.

Surgical vs. transcatheter aortic valve replacement in patients over 75 years with aortic stenosis: sociodemographic profile, clinical characteristics, quality of life and functionality.

Aortic valve stenosis (AVS) affects 25% of the population over 65 years. At present, there is no curative medical treatment for AVS and therefore the surgical approach, consisting of transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR), is the treatment of choice. The aim of this study was to analyze the sociodemographic and clinical characteristics, quality of life and functionality of a sample of patients with AVS over 75 years of age, who underwent TAVR or SAVR, applying standard clinical practice. A prospective multicenter observational study was conducted in two hospitals of the Spanish National Health System. Data were collected at baseline, 1, 6 months and 1 year. In total, 227 participants were included, with a mean age of 80.6 [SD 4.1]. Statistically significant differences were found in terms of quality of life, which was higher at 1 year in patients who underwent SAVR. In terms of functionality, SAVR patients obtained a better score (p < 0.01). However, patients who underwent TAVR began with a worse baseline situation and managed to increase their quality of life and functionality after 1 year of follow-up. The individualized choice of TAVR or SAVR in patients with AVS improves patients' quality of life and function. Moreover, the TAVR procedure in patients with a worse baseline situation and a high surgical risk achieved a similar increase in quality of life and functionality compared to patients undergoing SAVR with a better baseline situation.

Evaluación de los costes asociados a la enfermedad de pacientes con linfoma cutáneo de células T en España: análisis en función del estadio clínico (estudio MICADOS)

Background and objectiveThe cost of treating cutaneous T-cell lymphoma (CTCL) in Spain is unknown. With the advent of new treatments, it is more important than ever to gain an accurate picture of the true costs involved. The MICADOS study had 2 primary objectives: 1)to evaluate the impact of CTCL on patient quality of life, and 2)to evaluate the costs associated with the disease. This article reports the results of the cost analysis. MethodsWe estimated the cost of treating CTCL over a period of 1year from the perspective of the Spanish National Health System. Twenty-three dermatologists and hematologists from 15 public hospitals analyzed data for adult patients with mycosis fungoides (MF) or Sézary syndrome (SS). ResultsA total of 141 patients (57.4% male) with a mean age of 63.6 years (95%CI: 61.4-65.7 years) were included. The mean direct annual cost of treating CTCL was €34,214 per patient. The corresponding costs by stage were €11,952.47 for stageI disease, €23,506.21 for stageII disease, €38,771.81 for stageIII disease, and €72,748.84 for stageIV disease. The total direct annual cost of treating MF/SS in public hospitals in Spain was estimated at €78,301,171; stageI disease accounted for 81% of all costs, stageII for 7%, and stagesIII andIV for 6% each. ConclusionsThe MICADOS study offers an accurate picture of the direct cost of treating CTCL in patients with MF/SS in Spain and shows that costs vary significantly according to disease stage. Patient-borne and indirect costs should be analyzed in future studies.