Spanish National Health System Research Articles

Retrospective cohort analysis of Spanish national trends of coronary artery bypass grafting and percutaneous coronary intervention from 1998 to 2017

IntroductionSpain is one of the countries with the lowest rates of revascularisation and highest ratio of percutaneous coronary intervention (PCI) to coronary artery bypass grafting (CABG).ObjectivesTo investigate the changes and...

SUMAMOS EXCELENCIA® Project: Results of the Implementation of Best Practice in a Spanish National Health System (NHS).

The use of certain strategies for the implementation of a specific recommendation yields better results in clinical practice. The aim of this study was to assess the effectiveness of an evidence-based model using clinical audits (GRIP model), for the implementation of recommendations in pain and urinary incontinence management as well as fall prevention, in the Spanish National Health System during the period 2015–2018. A quasi-experimental study has been conducted. The subjects were patients treated in hospitals, primary care units and nursing home centers. There were measures related to pain, fall prevention and urinary incontinence. Measurements were taken at baseline and at months 3, 6, 9, and 12. The sample consisted of 22,114 patients. The frequency of pain assessment increased from 59.9% in the first cycle to a mean of 71.6% in the last cycle, assessments of risk of falling increased from 56.8% to 87.8% in the last cycle; and finally, the frequency of assessments of urinary incontinence increased from a 43.4% in the first cycles to a mean of 62.2% in the last cycles. The implementation of specific evidence-based recommendations on pain, fall prevention, and urinary incontinence using a model based on clinical audits improved the frequency of assessments and their documentation.

Obstetric Violence in Spain (Part III): Healthcare Professionals, Times, and Areas.

Background: Obstetric violence is a worldwide public health problem, which seems greater in Spain. As no studies were found that identify the most representative healthcare professionals, times, and areas involved in obstetric violence, the objective of this work was to study at what time of maternity, with which professionals, and in what areas women identified obstetric violence. Methods: This descriptive, retrospective, and cross-sectional study was performed from January 2018 to June 2019. The main variables were the area (hospital, primary care, both), the time (pregnancy, birth, puerperium), and the professionals attending to women. Results: Our sample comprised 17,541 participants. The area identified with the most obstetric violence for the different studied variables was hospitals. Women identified more obstetric violence at time of birth. Findings such as lack of information and informed consent (74.2%), and criticism of infantile behavior and treatment (87.6%), stood out. The main identified healthcare professionals were midwives and gynecologists, and “other” professionals repeatedly appeared. Conclusions: Having identified the professionals, times, and areas of most obstetric violence in Spain, it seems necessary to reflect on not only the Spanish National Health System’s structure and management but also on healthcare professionals’ training.

Direct anterior approach provides better functional outcomes when compared to direct lateral approach in hip hemiarthroplasty following femoral neck fracture.

This study aims to compare the differences between direct anterior approach (DAA) and direct lateral approach (DLA) in hip hemiarthroplasty (HHA) after displaced femoral neck fracture (FNF) in early functional outcome, hospital length of stay, morbidity and mortality rates. This non-interventional retrospective study, carried out at a tertiary trauma centre within the Spanish National Health System, included all patients who underwent a bipolar HHA between 1st January 2018 and 31st December 2019 performed by 2 of our hip unit surgeons. A total of 94 patients were included (40 in DAA group and 54 in DLA group). Median follow-up was 19.2months (range 8-30.8months). Postoperative degree of mobilisation showed statistically significant differences in favour of DAA group, where 35% of patients were able to walk with no assistance after surgery. DAA group had 1day less of hospitalisation in contrast with DLA group overall (8days vs 9days, respectively, p < 0.05). Statistically significant differences were not detected in comparing postoperative complications, re-operations rates or 6-months mortality rate. Our study highlights the benefits of DAA for HHA after displaced FNF in terms of postoperative mobilisation degree and hospitalisation length of stay when compared to DLA.

Reduction in hepatitis C-related hospitalizations after the implementation of the Strategic Plan for Tackling Hepatitis C in the Spanish National Health System: regional level differences.

This work evaluates the potential impact at territorial level of the Strategic Plan for Tackling Hepatitis C in the Spanish National Health System on hepatitis C virus (HCV)-associated hospitalizations. Chronic HCV-related hospitalization discharges from 2014 to 2018 were obtained from the National Registry of Hospitalisations. A descriptive analysis of the hospitalizations was performed for all chronic, advanced liver disease and non-advanced liver disease. Hospitalization rates were calculated at national and regional level. Year 2015 and period 2016-2018 hospitalization rates were compared to 2014 hospitalization rates using a Poisson model. Municipal standardized hospitalization rates ratios adjusted by age-group were calculated for 2016-2018 period (2014 hospitalization rates as reference). From 2014 to 2018, there were 22,352 chronic HCV-related hospitalizations. In-hospital fatality rate was 4.3% for non-advanced liver disease and 11.7% for advanced liver disease patients. National hospitalization rate decreased 22% (95% CI: 21%-22%), 16% (95% CI: 15%-17%) and 34% (95% CI: 33%-35%) in 2016-2018 compared to 2014 for all chronic, non-advanced and advanced liver disease, respectively. During 2016-2018 period, 11/19 Spanish regions achieved >20% decrease in the hospitalization rates (p<.001) for non-advanced liver disease and 19/19 (except Melilla, the rest with p<.001) for advanced liver disease. At municipal level, 84.8% and 90.2% municipalities had <20% of chronic HCV-related hospitalization need compared to 2014 adjusted by age-group. Based on the data analysed, a high impact on reducing chronic HCV-associated hospitalizations have been achieved after the implementation of the Strategic Plan for Tackling Hepatitis C in the Spanish National Health System. However, small differences between regions and rural/urban areas were noticed.

Sex bias in admission to tertiary-care centres for acute myocardial infarction and cardiogenic shock.

There are limited data on sex-specific outcomes and management of cardiogenic shock complicating ST-segment elevation myocardial infarction (CS-STEMI). We investigated whether any sex bias exists in the admission to revascularization capable hospitals (RCH) or intensive cardiac care units (ICCU) and its impact on in-hospital mortality. We used the Spanish National Health System Minimum Basic Data from 2003 to 2015 to identify patients with CS-STEMI. The primary outcome was sex differences in in-hospital mortality. Among 340490 STEMI patients, 20262 (6%) had CS and 29.2% were female. CS incidence was higher in women than in men (7.9% vs 5.1%, P=.001). Women were older and had more hypertension and diabetes, and were less often admitted to RCH than men (from 58.7% in 2003 to 79.6% in 2015; and from 61.9% in 2003 to 85.3% in 2015; respectively, P=.01), and to ICCU centres (25.7% vs 29.2%, P=.001). Adjusted mortality was higher in women than men over time (from 79.5±4.3% to 65.8±6.5%; and from 67.8±6% to 58.1±6.5%; respectively, P<.001). ICCU availability was associated with higher use of Percutaneous coronary intervention (PCI) in women (46.8% to 67.2%; P<.001) but was even higher in men (54.8% to 77.4%; P<.001). In ICCU centres, adjusted mortality rates decreased in both sexes, but lower in women (from 74.9±5.4% to 66.3±6.6%) than in men (from 67.8±6.0% to 58.1±6.5%, P<.001). Female sex was an independent predictor of mortality (OR 1.18 95% CI 1.10-1.27, P<.001). Women with CS-STEMI were less referred to tertiary-care centres and had a higher adjusted in-hospital mortality than men.

Impact of Heart Failure on In-Hospital Outcomes after Surgical Femoral Neck Fracture Treatment.

Background: Femoral neck fracture (FNF) is a common condition with a rising incidence, partly due to aging of the population. It is recommended that FNF should be treated at the earliest opportunity, during daytime hours, including weekends. However, early surgery shortens the available time for preoperative medical examination. Cardiac evaluation is critical for good surgical outcomes as most of these patients are older and frail with other comorbid conditions, such as heart failure. The aim of this study was to determine the impact of heart failure on in-hospital outcomes after surgical femoral neck fracture treatment. Methods: We performed a retrospective study using the Spanish National Hospital Discharge Database, 2007–2015. We included patients older than 64 years treated for reduction and internal fixation of FNF. Demographic characteristics of patients, as well as administrative variables, related to patient’s diseases and procedures performed during the episode were evaluated. Results: A total of 234,159 episodes with FNF reduction and internal fixation were identified from Spanish National Health System hospitals during the study period; 986 (0.42%) episodes were excluded, resulting in a final study population of 233,173 episodes. Mean age was 83.7 (±7) years and 179,949 (77.2%) were women (p < 0.001). In the sample, 13,417 (5.8%) episodes had a main or secondary diagnosis of heart failure (HF) (p < 0.001). HF patients had a mean age of 86.1 (±6.3) years, significantly older than the rest (p < 0.001). All the major complications studied showed a higher incidence in patients with HF (p < 0.001). Unadjusted in-hospital mortality was 4.1%, which was significantly higher in patients with HF (18.2%) compared to those without HF (3.3%) (p < 0.001). The average length of stay (LOS) was 11.9 (±9.1) and was also significantly higher in the group with HF (16.5 ± 13.1 vs. 11.6 ± 8.7; p < 0.001). Conclusions: Patients with HF undergoing FNF surgery have longer length of stay and higher rates of both major complications and mortality than those without HF. Although their average length of stay has decreased in the last few years, their mortality rate has remained unchanged.

Economic burden of recurrent Clostridioides difficile infection in adults admitted to Spanish hospitals. A multicentre retrospective observational study.

ABSTRACTIntroductionClostridioides difficile infection (CDI) is associated with increased hospital stays and mortality and a high likelihood of rehospitalization, leading to increased health resource use and costs. The objective was to estimate the economic burden of recurrent CDI (rCDI).Material and methodsObservational, retrospective study carried out in six hospitals. Adults aged ≥18 years with ≥1 confirmed diagnosis (primary or secondary) of rCDI between January 2010 and May 2018 were included. rCDI-related resource use included days of hospital stay (emergency room, ward, isolation and ICU), tests and treatments. For patients with primary diagnosis of rCDI, the complete hospital stay was attributed to rCDI. When diagnosis of rCDI was secondary, hospital stay attributed to rCDI was estimated using 1:1 propensity score matching as the difference in hospital stay compared to controls. Controls were hospitalizations without CDI recorded in the Spanish National Hospital Discharge Database. The cost was calculated by multiplying the natural resource units by the unit cost. Costs (euros) were updated to 2019.ResultsWe included 282 rCDI episodes (188 as primary diagnosis): 66.31% of patients were aged ≥65 years and 57.80% were female. The mean hospital stay (SD) was 17.18 (23.27) days: 86.17% of rCDI episodes were isolated for a mean (SD) of 10.30 (9.97) days. The total mean cost (95%-CI) per episode was €10,877 (9,499-12,777), of which the hospital stay accounted for 92.56%.ConclusionsThere is high cost and resource use associated with rCDI, highlighting the importance of preventing rCDI to the Spanish National Health System.

Cost-effectiveness analysis of using innovative therapies for the management of moderate-to-severe ulcerative colitis in Spain

ABSTRACT Background To evaluate the cost-effectiveness of tofacitinib in comparison to vedolizumab for the treatment of moderate-to-severe ulcerative colitis (UC) after failure or intolerance to conventional therapy (bio-naive) or first-line biologic treatment (bio-experienced), from the Spanish National Health System (NHS) perspective. Methods A lifetime Markov model with eight-week cycles was developed including five health states: remission, response, active UC, remission after surgery, and death. Response and remission probabilities (for induction and maintenance periods) were obtained from a multinomial network meta-analysis. Drug acquisition – biosimilar prices included – (ex-factory price with mandatory deductions), administration, surgery, patient management, and adverse event management costs (€, year 2019) were considered. A 3% discount rate (cost/outcomes) was applied. Probabilistic and deterministic sensitivity analyses (PSA) were conducted. Results Tofacitinib was dominant versus vedolizumab (both in bio-naive and bio-experienced patients) entailing total cost savings of €23,816 (bio-naïve) and €11,438 (bio-experienced). Differences in quality-adjusted life-year (QALY) were smaller than 0.1 for both populations. PSA results showed that tofacitinib has a high probability of being cost-effective (bio-naïve: 82.5%; bio-experienced: 90.6%) versus vedolizumab. Conclusions From the Spanish NHS perspective, tofacitinib could be a dominant treatment (less costly and more effective) in comparison to vedolizumab, with relevant cost savings and similar QALY gains.

Improving rheumatoid arthritis management within the Spanish National Health System: a social return on investment study

To define a set of proposals that would improve the current management of patients with rheumatoid arthritis (RA) within the Spanish National Health System (SNHS), and to estimate the impact of their implementation from a social perspective. A one-year forecast-type Social Return on Investment (SROI) analysis was performed on the basis of information collected from a scientific literature review, official data, and multiple stakeholders regarding RA. A sub-analysis was performed within the areas of diagnosis, early RA (<2 years from diagnosis), and established RA (≥2 years from diagnosis). Stakeholders agreed on a set of 22 proposals, which included incorporating specialised nursing, addressing adherence issues, providing psychological support, or promoting the role of patient associations, among others. Their implementation would require an investment of 289 million euros and yield a social return of 913 million euros, i.e. a social return of 3.16 euros per euro invested (2.92 euros in the worst-case scenario and 3.40 euros in the best-case scenario). The greatest social return relative to investment and the greatest attributed to intangible aspects were observed within the area of early RA. Evidence-based recommendations for the management of RA are aspirational. Nevertheless, the present study estimated that the implementation of the set of proposals would result in a positive impact relative to the investment needed to implement them. The results may guide management decisions to reduce the burden associated with RA, and help bridge the gap between evidence-based recommendations and routine clinical practice.

Mindfulness in primary care healthcare and teaching professionals and its relationship with stress at work: a multicentric cross-sectional study

BackgroundWork stress is a common problem among the health personnel of the Spanish National Health System. The objective of this paper is to assess the state of mindfulness among Spanish primary care providers and to evaluate its potential relationship with work stress and basic labor and sociodemographic characteristics.MethodsCross-sectional, multi-centric study. Primary care nurses, teachers, teaching collaborators and residents assigned to six Spanish Family Medicine/Family and Community Care Departments were invited to participate (n = 475). A template was designed in Google Forms, including sociodemographic and work-related variables. The state of mindfulness was measured with the Five Facet Mindfulness Questionnaire (FFMQ), while work-related stress was measured using an ordinal scale ranging from 0 to 10 points. Descriptive and inferential statistical analyses were carried out, as well as bivariate and multivariate statistics.ResultsThe mean age of participants was 40,14 ± 13.12 (range:23–65 years); 66.9% were women, 42.5% internal medicine residents, 29.3% family physicians, and 20.2% nurses. More than half (54.5%) knew about mindfulness, with 24.0% have received training on it, and 22.5% were usual practitioners. The average level of mindfulness was 127.18 ± 15.45 (range: 89–177). The average score of stress at work was 6.00 ± 2.44; 49.9% (range: 0–10). 49.9% of participants scored 7 or more on the stress at work scale. There was an inverse correlation between the levels of mindfulness (FFMQ total score) and work-related stress (Spearman’s r = − 0.155, p = 0.003). Significant relationships between the mindfulness practice and the level of mindfulness (F = 29.80, p < 0.001), as well as between the mindfulness practice and the level of work-related stress (F = 9.68, p = 0.042), were also found.ConclusionsLevels of mindfulness in primary care health providers were in line with those levels observed in other groups of health professionals. Half of all of the primary care providers suffered from a high degree of stress. Although weak, inverse relationships were observed between levels of mindfulness and stress at work, with lower values of stress at work among those who practiced mindfulness.Trial registrationNCT03629457.

Frecuencia de aparición y validez predictiva de la disfunción olfatoria y del gusto en pacientes con infección por SARS-CoV-2

Background and objectiveOlfactory and taste dysfunction (OD, TD) have been considered symptoms of SARS-CoV-2 infection. However, its presence in certain populations, especially those with mild clinical symptoms, has not been clarified. The objective was to estimate the frequency of OD and TD, and its predictive validity in patients detected in Primary Care. Patients and methodsA cross-sectional study was carried out in the Spanish National Health System. An epidemiological survey was administered to patients who were requested the PCR test for SARS-CoV-2. Odds ratio (OR) were estimated to measure the magnitude of the association between OD and TD and the existence of SARS-CoV-2 infection. The sensitivity, specificity, and positive and negative predictive values (PPV, NPV) of these symptoms in SARS-CoV-2 infection were calculated. ResultsOf 1,038 patients screened, 20.1% had SARS-CoV-2 infection. OD and DG were present in 64.4% (95% CI 56.0-72.1) and 56.2% (95% CI 47.9-64.2) of the subjects with infection, respectively. The OR for OD was 12.2 (95% CI 8.26-18.06) and for TD was 7.95 (95% CI 5.48-11.53). TD presented a sensitivity of 41.1% (95% CI 34.4-46.1), a specificity of 91.9% (95% CI 89.8-93.7), a PPV of 56.2% (95% CI48.0-64.2) and a NPV of 86.1% (95% CI 83.6-88.3), while the OD showed a sensitivity of 45.0% (95% CI 37.6-51.5), a specificity of 93.7% (95% CI 91.8-95.0), a PPV of 64.4% (95% CI 56.0-72.1) and a NPV of 87.1% (95% CI 84.7-89.2). ConclusionsMore than half of the subjects with SARS-CoV-2 infection have OD or TD. The presence of OD or TD could be of diagnostic utility due to its ability to predict infection in more than half of the cases.

Proposed global prognostic score for systemic mastocytosis: a retrospective prognostic modelling study

Several risk stratification models have been proposed in recent years for systemic mastocytosis but have not been directly compared. Here we designed and validated a risk stratification model for progression-free survival (PFS) and overall survival (OS) in systemic mastocytosis on the basis of all currently available prognostic factors, and compared its predictive capacity for patient outcome with that of other risk scores. We did a retrospective prognostic modelling study based on patients diagnosed with systemic mastocytosis between March 1, 1983, and Oct 11, 2019. In a discovery cohort of 422 patients from centres of the Spanish Network on Mastocytosis (REMA), we evaluated previously identified, independent prognostic features for prognostic effect on PFS and OS by multivariable analysis, and designed a global prognostic score for mastocytosis (GPSM) aimed at predicting PFS (GPSM-PFS) and OS (GPSM-OS) by including only those variables that showed independent prognostic value (p<0·05). The GPSM scores were validated in an independent cohort of 853 patients from centres in Europe and the USA, and compared with pre-existing risk models in the total patient series (n=1275), with use of Harrells' concordance index (C-index) as a readout of the ability of each model to risk-stratify patients according to survival outcomes. Our GPSM-PFS and GPSM-OS models were based on unique combinations of independent prognostic factors for PFS (platelet count ≤100 × 109 cells per L, serum β2-microglobulin ≥2·5 μg/mL, and serum baseline tryptase ≥125 μg/L) and OS (haemoglobin ≤110 g/L, serum alkaline phosphatase ≥140 IU/L, and at least one mutation in SRSF2, ASXL1, RUNX1, or DNMT3A). The models showed clear discrimination between low-risk and high-risk patients in terms of worse PFS and OS prognoses in the discovery and validation cohorts, and further discrimination of intermediate-risk patients. The GPSM-PFS score was an accurate predictor of PFS in systemic mastocytosis (C-index 0·90 [95% CI 0·87-0·93], vs values ranging from 0·85 to 0·88 for pre-existing models), particularly in non-advanced systemic mastocytosis (C-index 0·85 [0·76-0·92], within the range for pre-existing models of 0·80 to 0·93). Additionally, the GPSM-OS score was able to accurately predict OS in the entire cohort (C-index 0·92 [0·89-0·94], vs 0·67 to 0·90 for pre-existing models), and showed some capacity to predict OS in advanced systemic mastocytosis (C-index 0·72 [0·66-0·78], vs 0·64 to 0·73 for pre-existing models). All evaluated risk classifications predicted survival outcomes in systemic mastocytosis. The REMA-PFS and GPSM-PFS models for PFS, and the International Prognostic Scoring System for advanced systemic mastocytosis and GPSM-OS model for OS emerged as the most accurate models, indicating that robust prognostication might be prospectively achieved on the basis of biomarkers that are accessible in diagnostic laboratories worldwide. Carlos III Health Institute, European Regional Development Fund, Spanish Association of Mastocytosis and Related Diseases, Rare Diseases Strategy of the Spanish National Health System, Junta of Castile and León, Charles and Ann Johnson Foundation, Stanford Cancer Institute Innovation Fund, Austrian Science Fund.

Cancer diagnosis in a Spanish cohort of multiple sclerosis patients under dimethylfumarate treatment

BackgroundPotential increase of cancer incidence is one of the main safety concerns of the disease-modifying therapies employed in Multiple Sclerosis (MS). ObjectiveDetailed description of patients who developed cancer among a prospective cohort of Spanish MS patients on dimethyl fumarate (DMF) treatment. MethodsWe describe patients who developed cancer among a cohort of 886 MS patients on DMF treatment (2681 patient-years), with a median time of exposure of 39.5 months (IQR 23-51.5), who participated in a multicentre and prospective real-world study conducted in 16 Spanish National Health System hospitals from February 2014 to May 2019. Local researchers were periodically contacted by the investigation team to monitor safety issues. Cancer histories were collected from the medical records and the information was updated at July 30th 2020. ResultsEight Caucasian women developed cancer, which accounts for 0.9% and an accumulated malignancy rate of 298.39 cases per 100,000 patient-years of DMF exposure. At the time of cancer diagnosis, age was between 33 to 67 years and median time on DMF treatment 16.5 months (range 1-53). Two patients had familiar history of cancer. No specific cancer lines were found (breast cancer in 2 cases, thyroid in 3, urothelial carcinoma, cervix and a progression to leiomyosarcoma from a mitotically active leiomyoma). DMF was withdrawn during cancer treatment in 6 patients and reintroduced later. All cancers except one are in complete remission. The patient with leiomyosarcoma died by cancer progression. ConclusionA relationship between cancers and DMF is unlikely because the malignancy rate was similar to that of the age-and sex-matched general population, and because of the absence of specific tumour cell lines. Nevertheless, as with other immunosuppressive DMTs, clinicians treating MS should be aware of any potential cancer symptom and demand proper testing.

Disease Burden and Costs in Moderate-to-Severe Chronic Osteoarthritis Pain Refractory to Standard of Care: Ancillary Analysis of the OPIOIDS Real-World Study.

IntroductionTo determine the disease burden and costs in moderate-to-severe chronic osteoarthritis (OA) pain refractory to standard-of-care treatment in the Spanish National Health System (NHS).MethodsAncillary analysis of the OPIOIDS real-world, non-interventional, retrospective, 4-year longitudinal study including patients aged at least 18 years with moderate-to-severe chronic OA pain refractory to standard-of-care with sequential NSAIDs plus opioids. Burden assessment included measurement of analgesia, cognitive functioning, basic activities of daily living, severity and frequency of comorbidities, and all-cause mortality. Costs accounted for healthcare resource utilization and related costs (year 2018).ResultsRecords of 13,317 patients were analyzed; 68.9 (14.7) years old, 71.3% (70.5–72.1%) women, 58.1% refractory to NSAID plus weak opioid and 41.9% to NSAID plus strong opioid, accounting for 10.7% (10.5–10.8%) of patients with chronic OA pain. Mean number of comorbidities was 2.9 (1.8) and its severity was 1.8 (1.7). Pain decreased by 0.9 points (12.2%) and cognitive declined by 2.3 points (9.1%, with 4.3% more patients with cognitive deficit) and dependency worsened by 0.4 points (0.5%, with 2.3% more patients with severe-to-total dependence) over a mean treatment period of 188.6 (185.4–191.8) days on NSAIDs followed by 400.6 (393.7–407.5) days on opioids. The adjusted mortality rate was higher in patients with OA taking NSAID plus strong opioids; hazard ratio 1.44 (1.26–1.65; p < 0.001). The 4-year healthcare cost was €7350/patient (€7193–7507 or €1838/year) and was higher in those taking strong versus weak opioids; €9886 (€9608–10,164, €2472/year) vs. €5519 (€5349–5689, €1380/year), p < 0.001. Analgesia cost (16.0% of total cost, 70.2% opioids) was higher with strong versus weak opioids, 19.6% vs. 11.3%, p < 0.001.ConclusionsIn routine clinical practice in Spain, patients with moderate-to-severe chronic OA pain refractory to standard analgesic treatment with NSAIDs plus opioids reported modest reductions in pain, while presenting a considerable burden of comorbidities, cognitive impairment, and dependency. Healthcare costs significantly increased for the NHS particularly with NSAIDs plus strong opioids.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40744-020-00271-y.

Cost-effectiveness analysis of anti–IL-5 therapies of severe eosinophilic asthma in Spain

Aim To analyse the cost-effectiveness of MEP with standard of care (SoC) versus other anti-IL-5 therapies approved for the treatment of severe eosinophilic asthma (SEA) patients, within the Spanish National Health System (NHS) perspective. Methods A Markov model with a 4-week cycle length was used to compare MEP with BEN and RES as therapies added to SoC in the management of SEA, in terms of cost per QALY gained and incremental cost-effectiveness ratio (ICER). Costs (€2019) were obtained from public sources, while utilities and transition probabilities were retrieved from literature, e.g. network meta-analysis. Continuation criteria for biological treatment and reduction of oral corticosteroids (OCS) was set at 50% minimum reduction of exacerbation rate. Adverse events related to chronic OCS use included diabetes, osteoporosis, cataracts, acute myocardial infarct, and peptic ulcer. The analysis was performed over a 5-year time horizon from the National Healthcare System (NHCS) perspective, with a yearly discount rate of 3% applied to both costs and QALYs. Probabilistic sensitivity analysis and univariate deterministic sensitivity analysis were performed to address uncertainty around the cost-effectiveness results. Results On top of SoC, the model indicates that MEP is dominant (lower cost, higher benefit) compared to BEN and RES: For BEN and RES, respectively, treatment with MEP had a point estimate of 0.076 and 0.075 additional QALYs, and savings of €3,173.47 and €7,772.95 per patient. The findings were robust to variation as estimated using sensitivity analysis. Conclusions MEP is a cost-effective treatment in comparison with BEN and RES added to SoC for patients with SEA in the Spanish setting.

Guidelines for the Management of Children and Adolescent with COVID-19: protocol for an update.

BackgroundCoronavirus disease 2019 (COVID-19) has become a constant threat to people’s lives, bringing huge challenges to the global public health and medical service system. In order to ensure the timeliness and reliability of the recommendations in guidelines, the working group of the Rapid Advice Guidelines for Management of Children with COVID-19 decided to update the guideline to incorporate the latest evidence to guide the management of COVID-19 in children and adolescent.MethodsWe will update the guidelines, originally developed as a rapid advice guideline, into a standard guideline. We will follow the clinical practice guideline (CPG) update manuals of the National Institute for Health and Clinical Excellence (NICE) and the Spanish National Health System (SNHS). The updated guidelines will also follow the RIGHT (Reporting Items for Practice Guidelines in Healthcare) checklist and Checklist for the Reporting of Updated Guidelines (CheckUp).DiscussionThrough systematic search, evaluation and grading of the best available relevant clinical evidence, combined with the experience of frontline clinical experts in the fight against the epidemic and the wishes of patients and their caretakers, we will update our previous rapid advice guidelines into a high-quality, implementable standard guidelines for the management of COVID-19 in children and adolescent.Trial registrationThe standard guideline update has been registered at the International Practice Guidelines Registry Platform (http://guidelines-registry.cn/?lang=en, registration No. IPGRP-2020CN101).

Future projections of opioid use and cost in patients with chronic osteoarthritis pain in Spain.

Background:Opioids are widely used in moderate-to-severe chronic pain which is non-responsive to standard analgesics. Prescriptions have increased in Europe in the last decade, although remain lower than in USA. This work projected the future utilization and costs of opioids in chronic osteoarthritis (OA) pain in the Spanish National Health System (NHS).Methods:An epidemiological model was populated with the opioid dispensing trends from 2010 to 2019 using Spanish Medicinal Agency rates of opioid utilization in subjects over 18 years of age and the real-world OPIOIDS study to estimate chronic-OA-pain patients receiving opioids. A best-fitted trend analysis model was applied estimating the likely number of DHD (defined daily dose/1000 inhabitants per day) to calculate projected opioid utilization and costs for the period 2020–2029.Results:In 2010, an estimated 5.67 DHD were dispensed for the equivalent of 217,076 chronic OA pain patients per day [1.99 DHD, 76,084 refractory to non-steroidal anti-inflammatory drugs (NSAIDs)]. From these trends and OA prevalence, the projected number of DHDs is expected to increase more than threefold to 17.98 DHDs by the year 2029 for the equivalent of 727,356 chronic OA pain patients per day (8.18 DHD, 330,720 refractory to NSAIDs); 41.8% on strong opioids. The estimated cost was €116.9m (€45.0m in NSAID-refractory OA) in 2010 rising by 222% to €376.1m (€199.7m refractory to NSAIDs) by 2029.Conclusion:Chronic-OA-pain-related opioid dispensing and costs to the NHS are set to increase more than threefold from 2010 to 2029 in Spain. Using opioids for OA pain is concerning given disease chronicity and other related costs not computed in these projections.Plain language summary• Opioids are widely used in chronic pain which is non-responsive to standard analgesics. Prescriptions have increased in Europe, although remain lower than in USA. Osteoarthritis (OA) is a degenerative joint disease usually accompanied by pain. Despite not recommended, opioids use in OA have been expanded because this health condition is increasing with ageing and, also, because physicians both primary and specialist boosted their use.• This study aimed to quantify the current burden of opioids used for chronic moderate-to-severe OA pain by estimating the number of defined daily doses per 1000 inhabitants per day (DHD) and associated costs, and to forecast the likely burden on the National Health System (NHS) in Spain for the years 2020–2029.• In 2010, an estimated 5.67 DHDs were dispensed for the equivalent of 217,076 chronic OA pain patients per day. From these trends, the projected number of DHDs is expected to increase more than threefold to 17.98 DHDs by the year 2029 for the equivalent of 727,356 chronic OA pain patients per day; 41.8% on strong opioids. The estimated cost was €116.9m in 2010 rising by 222% to €376.1m by 2029.• Chronic OA-pain-related opioid dispensing and costs to the NHS are set to increase substantially (threefold to more than fourfold) from 2010 to 2029 in Spain. Thus, using opioids for OA pain is concerning given disease chronicity, aging population and other related costs not computed in these projections. Our findings can inform payors and clinicians about ongoing discussions on appropriate analgesic management for longer-term OA pain, including resource requirements at a national level. Clinicians who prescribe opioids for OA pain should consider the potential implications of side effects such as sedation, cognitive deterioration, incremental need of caregivers, particularly in older people, and carefully consider the risk–benefit balance.

La eutanasia en España. Análisis comparado con otros ordenamientos jurídicos del entorno comunitario

The publication of Organic Law 3/2021 regulating euthanasia (BOE 03.25.2021), converted Spain in the fourth country in the European Union to decriminalize such practice. In this article we analyze this rule and the introduction of euthanasia in the Health Service of the Spanish National Health System, which guarantees access to the provision. On the other hand, we will carry out a comparative study of other legal systems in the European Union in which this practice is allowed or penalized.

Identification of the multimorbidity training needs of primary care professionals: Protocol of a survey.

Background:Current epidemiological situation has prompted the consideration of multimorbility (MM) as a prevalent condition, influenced by age, educational level and social support, related to unfavorable social and health determinants. Primary Care (PC) has a key role in its approach but further training of professionals in MM is required. The evidence on the effectiveness of training interventions in MM is still limited. Knowing the experiences, opinions and training needs of professionals is essential to enhance training interventions. Objectives: Identify perceived training needs by PC health professionals (doctors and nurses) in MM and polypharmacy. Methods: Design: Cross-sectional study based on an online survey (anonymous-ad hoc questionnaire). Participants and recruitment: 384 doctors and nurses working in healthcare centers and out-of-hospital emergencies of the Spanish National Health System. Non-probabilistic convenience sampling via email addressed to Health Institutions, and social networks. Data: Demographic characteristics and professional profile data (close-ended and multiple-choice questions) will be collected. Open-ended questions will be used to identify training needs, difficulties and resources about MM; required skills to care patients with MM will be assessed using a 4-item ordinal scale. Analysis: Coding of data prior to analysis. Descriptive statistical analysis, participation and completion rates of the questionnaire and estimation of absolute and relative frequencies and 95% confidence intervals in close-ended questions. Content analysis with inductive methodology in open-ended questions. Ethics: Ethical approval, Online informed consent. Conclusions: The identification of training needs of health professionals who care for patients with MM will be necessary data for developing highly effective training activities.