Patients In Spain Research Articles

Primary care provider expectations of addiction services and patients in Spain.

Primary care (PC) is crucial in the care of substance use disorder (SUD) patients. However, the relationship between PC and addiction settings is complex and collaboration issues stand out. Available evidence suggests that integration of SUD and PC services can improve physical and mental health of SUD patients and reduce health expenses. To explore the experiences, views and attitudes of PC professionals towards the interaction between PC and SUD services. Twenty-seven GPs took part in three focus groups. The focus group sessions were audio-taped, transcribed verbatim and analysed using reflexive thematic analysis. Recurrent themes were identified. Four main themes were devised: (1) Differences and specificities of SUD patients, (2) Interaction between providers of PC and addiction services, (3) Patient management (4) Addiction stigma. These main themes reflect the consideration that SUD patients are a specific group with specific care needs that yield specific challenges to GPs themselves. Improved training, availability of a shared medical record system, increased feedback between GP and addiction specialists and the efficiency of the circuit are to be considered the main priority for the majority of the participants. An efficient and effective referral circuit, with increased feedback and shared medical records is considered key to GPs. Its implementation should keep in mind the specific features of both SUD patients and GPs.

Mental Health among Spanish Adults with Diabetes: Findings from a Population-Based Case–Controlled Study

Background: The purpose of this study was to assess and compare the prevalence of self-reported mental disorders, psychological distress, and psychotropic drug consumption among people with diabetes mellitus (DM) and matched non-DM controls. Methods: A case–controlled study using data from the Spanish National Health Interview Survey was conducted in 2017. We identified 2116 DM adults (aged ≥35 years). Non-DM controls were matched 1:1 by age, sex, and province of residence. Results: Prevalence of mental disorders (25.0% vs. 19.2%; p < 0.001), psychological distress (29% vs. 19.5%; p < 0.001), and consumption of psychiatric medications (29.7% vs. 23.5%; p < 0.001) among DM cases were higher than those among matched non-DM controls. The DM patient variables associated with experiencing a mental disorder, psychological distress, and consumption of psychiatric medications were: being a woman, worse self-rated health, and a visit to a psychologist within the last year. Older age (≥80 years) was associated with a lower probability of reporting mental disorders and psychological distress among DM cases. Not practicing physical exercise was significantly associated with experiencing psychological distress. Conclusions: Adults with DM included in our investigation have a significantly higher prevalence of mental disorders, psychological distress, and consumption of psychiatric medications than non-DM controls. It is necessary to implement screening strategies and psychological interventions to improve the mental health of DM patients in Spain, focusing especially on women and those aged 35 to 59 years.

Treatment resistant depression in the UK: sub-analysis of a European real-world evidence study

AimsTreatment resistant depression (TRD) affects ≤20% of patients with major depressive disorder and is defined as failure to respond to ≥2 different antidepressants in the same major depressive episode (MDE). TRD patients’ outcomes are poor and real-world data from the UK are limited. The Treatment Resistant Depression in Europe Cohort was established to study patients being treated in local, routine clinical practice. The analysis presented here aimed to compare UK-specific data with data from other European countries included in the study.MethodA prospective, multicentre, observational cohort study of TRD patients in Italy, Germany, Spain, Portugal, the Netherlands, the UK and Belgium was conducted. Patients aged 18–74 years with current TRD, Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥20, and initiating a new treatment for depression, were eligible. Data from medical records, clinician assessments and patient-reported questionnaires were collected over time, with follow-up of ≥6 months.ResultData from 411 patients were analysed. At baseline, UK patients (n = 49) had similar depression severity to the whole European cohort (34.7% vs 32.6% of patients categorised as severe based on MADRS score, respectively). Patients had experienced the current MDE for a mean (standard deviation [SD]) of 6.1 (7.9) years vs 2.6 (3.9) years and 14.3% vs 4.9% had experienced ≥5 treatment failures during this time in the UK and whole cohort, respectively. Total mean (SD) Sheehan Disability Scale (SDS) scores of 24.5 (5.1) and 22.4 (5.5) were reported for the UK and whole cohort, respectively. Unemployment and long-term sick leave rates were 38.8% and 20.4% in the UK and 30.2% and 19.0% in the whole cohort, respectively. At 6 months, 8.9% of UK patients were in remission, and 82.2% had not responded to treatment, representing the lowest remission and highest non-response rates across all countries.ConclusionUK patients had been ill for longer and had more prior treatment failures than other countries in the study. They had high work and functional impairment, and the worst treatment outcomes of all the countries studied. UK TRD patients experience high disease burden; there is an unmet need for treatment strategies with better response rates.AcknowledgementsWe thank all participating patients. Study, and medical writing (Costello Medical, UK), funded by Janssen. AHY's independent research is funded by the National Institute for Health Research. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health.

Outcomes of Small Incidental Abdominal Aortic Aneurysms in Octogenarian and Nonagenarian Patients in Northern Spain

Greater population life expectancy and consistent improvement in diagnostic techniques have increased the diagnosis of abdominal aortic aneurysms (AAAs) in the elderly population. The aim was to study the natural history of small (< 55 mm) incidental AAAs in octogenarian and nonagenarian patients to assess the need for follow up and/or invasive treatment. This was a retrospective analysis of a prospective registry. Patients ≥ 80 years old at the time of diagnosis of a < 55 mm AAA in 1988-2018 were selected. Clinical and anatomical characteristics were registered. Patients were divided in three groups: 30 - 39 mm, 40 - 49 mm, and 50 - 54 mm AAA. The outcome variables were aorto-iliac rupture, AAA reaching a surgical threshold (≥ 55 mm), and death. A descriptive statistical analysis was performed and life tables, Kaplan-Meier curves, and uni- and multivariable Cox regression were used. Three hundred and ten patients were included, 256 (82.6%) men, with mean index age of 84.5 years (standard deviation [SD] 3.5), and median follow up of 37.9 months (interquartile range [IQR] 18.2 - 65.4). Eighteen (5.8%) AAAs ruptured; four of these patients were operated on and only one survived. Sixty-two (20%) AAA reached a surgical size; eight were repaired electively, with 0% early mortality. The survival rates were 81%, 70%, and 38% at one, two, and five years. The rupture rates were 1%, 2%, and 6% and the AAAs reaching surgical threshold were 1%, 4%, and 19% for the same time periods. AAA size < 40 mm was an independent protective factor from rupture (0.13; 95% confidence interval [CI] 0.03 - 0.48), reaching surgical threshold (0.08; 95% CI 0.04 - 0.16) and death (0.63; 95% CI 0.42 - 0.95). The risk of late rupture of small incidental AAA diagnosed in octogenarian and nonagenarian patients is very small, especially when the AAA is < 40 mm in diameter. In contrast, global mortality is high. Conservative management seems sensible, with strict selection of the patients who would benefit from follow up and eventual repair.

P185 Psychosocial impact of the COVID-19 pandemic on patients with inflammatory bowel disease in Spain

BackgroundFew studies have examined the effects of COVID-19 on the mental health of patients with inflammatory bowel disease (IBD), who are already at higher risk of depression, anxiety and stress than the general population. This cross-sectional study was conducted to assess the psychosocial impact of COVID-19 on patients with IBD in Spain during lockdown and the first wave of the pandemic.MethodsA self-report questionnaire that integrated the Spanish version of the Depression, Anxiety and Stress Scale–21 items (DASS-21) and the Perceived Stress Questionnaire (PSS) was designed to gather sociodemographic data and information related to the effects of COVID-19 on the lives of IBD patients. Twelve IBD units invited their patients to answer the anonymous online survey via email or by using a QR code displayed at the unit. A link to the survey was also published on the GETECCU (Spanish IBD group) website and social media account. The survey was conducted between the 1st July and the 25th August 2020.ResultsOf the 693 survey participants with IBD, 67% were female, mean age 43 (12y SD). 61% had ulcerative colitis, 36% Crohn’s disease 3% indeterminate colitis. Only 15 participants were diagnosed with COVID-19: 3 of them required hospital admission and none required ICU admission. Physical activity levels and sleep habits were adversely affected for 79% and 67% of respondents, respectively. In addition, 39% reported a decrease in income due to the pandemic. 95% report having complied with IBD treatment during the COVID-19 pandemic, despite over 50% of them feeling that they were more at risk of infection due to their medication. DASS-21 scores indicate that during the lockdown the estimated prevalence of depression was 10.5% [95% CI 8.2–13%], anxiety 20% [95% CI –17–23%] and stress 18% [95% CI 8.2–13%]. Multivariate analysis is described in table 1. ConclusionIn the short-term, lockdown during the COVID-19 pandemic seemed to have an impact on the mental health of our IBD patients in Spain. Further follow-up studies should be carried out to determine the real long-term impact, as it’s known that the wellbeing of this population might be affected because of IBD itself.

P630 Inflammatory bowel disease in immigrants to Spain: results of the EIIMIGRA study from GETECCU (ENEIDA registry)

Abstract Background Previous studies comparing inflammatory bowel disease(IBD) features between migrant and native patients have shown clinical phenotype differences. To date, no study has focused on IBD immigrants(MP) in Spain. The aim of this study was to explore the features of MP in Spain and to compare age of disease onset, IBD phenotype and therapeutic requirements with native-born IBD patients(NP). Methods This was an observational, multicentric and case-control study of the nationwide ENEIDA registry. We selected all IBD patients who were born outside of Spain and compared with a control cohort of NP. All included patients were diagnosed with IBD before 2015. Results A total of 13,524 patients were included(1864 MP and 11660 NP).The most prevalent ethnic migrant group was Caucasian(771, 41%), followed by Latin American(572, 31%) and Arabian(341,18%), whereas Asian represented only 6%. Table 1 summarizes the demographic and phenotypic features. 71% of MP were diagnosed with IBD in Spain. There was not a gender predisposition to IBD in the overall migrant group, however more female UC MP were detected compared to UC NP(52 % vs 45%, p&amp;lt;0.001). MP were younger at the onset of the disease and had a shorter disease duration compared to NP, in both UC and CD patients. Significantly more CD patients were diagnosed under 16 years(A1) among MP, and more patients over 40 years(A3) among NB. More NB patients had CD stricturing phenotype(24% vs 19%, p=0,002) compared to MP. Disease extension in CD and UC did not differ between groups. The overall proportion of abdominal or perianal surgery was similar in both groups but the use of biologic therapy was more common in MP(36% vs 30%, p=0,001). Conclusion In the largest cohort of migrant IBD patients in Spain, immigrants were younger, had a shorter disease duration and required a higher use of biologics than natives, pointing phenotypic differences in this population and a universal access to the healthcare system all over the country.

Common Mental Disorders, Functional Limitation and Diet Quality Trends and Related Factors among COPD Patients in Spain, 2006-2017: Evidence from Spanish National Health Surveys.

Certain conditions such as common mental disorders (CMDs), functional limitation (FL) and poor diet quality may affect the lives of individuals who suffer from chronic obstructive pulmonary disease (COPD). This study sought to examine time trends in the prevalence of CMDs, FL and diet quality among male and female COPD patients living in Spain from 2006 to 2017 and to identify which factors were related to CMDs, FL and a poor/improvable diet quality in these patients. We performed a cross-sectional study among COPD patients aged ≥ 40 years old using data from the Spanish National Health Surveys conducted in 2006, 2011 and 2017, identifying a total of 2572 COPD patients. Binary logistic regressions were performed to determine the characteristics related to CMDs, FL and poor/improvable diet quality. Over the years of the study, the prevalence of FL among female COPD patients increased (p for trend <0.001). In addition, CMDs were associated to body mass index (BMI), educational level, physical activity, smoking status, occupation, chronic conditions and alcohol consumption; FL was related to age, living with a partner, educational level, physical activity and chronic conditions; and poor/improvable diet quality was associated to age, smoking status, BMI and physical activity.

Analysis of Homeopathic Genus Epidemicus for COVID-19 Patients in Spain.

Homeopathy has had documented success treating epidemics in the last two centuries. We aimed to obtain a clear homeopathic clinical picture of coronavirus disease 2019 (COVID-19) and postulate the genus epidemicus of the disease in order to inform and enhance future treatment and prophylaxis options. We conducted a prospective case series study, collecting data from 19 homeopaths in Catalonia, Spain, from patients who presented with fever and/or cough and/or breathlessness and/or confirmed COVID-19 infection or close contact with a confirmed case. We included 107 patients, and data were recorded through a checklist questionnaire on the day of the case analysis and at day 10-15 after commencing treatment. Symptoms were collected and analyzed with the help of homeopathic repertories. A total of 103 cases were mild or moderate; four were severe. The severe cases were excluded from the analysis and the 103 mild and moderate cases were analyzed and a clear overall clinical picture with mental, general, and particular symptoms was achieved. Eighty-eight cases had a complete recorded follow-up. The most prescribed medicines were Bry, Ars, Phos and Gels, whilst those with the best rates of good response were Sulph, Puls and Bry. Time to full recovery after homeopathic treatment ranged from 3.5 to 14.4 days, depending on the medicine used. The potency 200c was associated with faster rates of full recovery and a lesser need to change remedy. We have defined the symptomatic homeopathic characteristics of mild and moderate COVID-19 in Spain and established a set of medicines that might be useful to consider as effective genus epidemicus.

Epidemiology of Clostridioides difficile infection in hospitalized patients in Spain: An eight-year review (2012–2019)

BackgroundClostridioides difficile infection (CDI) is a disease that is potentially preventable by vaccination. A good knowledge of its epidemiology, which can change over time, is warranted for prevention purposes and to help decision-making on the use of vaccines in public health programs. The objective of the research was to determine the epidemiology of healthcare-associated CDI (HA-CDI) and community-associated CDI (CA-CDI) in hospitalized patients in Spain using point prevalence data. MethodsPoint prevalence survey data on infections of hospitalized patients for years 2012–2019 were analyzed. HA-CDI and CA-CDI prevalence rates were calculated. Both HA-CDI and CA-CDI, as well as age group prevalence rates, were examined for trends. Patient comorbidities were tested for association to CDI. ResultsThe prevalence of CDI in Spanish hospitals has grown exponentially from 14.1% in 2012 to 35.9% in 2019 (cases/10.000 hospitalized patients). Almost two thirds of the cases are of nosocomial onset. This increase was observed for HA-CDI and CA-CDI at an annual rate of 1.11% (CI 95% 1.08–1.15) and 1.09% (CI 95% 1.04–1.13), respectively. Patients 50 years old or older represent 87% of the total number of cases. Patients suffering from neoplasm (OR 1.39), immunodeficiency (OR 3.26), neutropenia (OR 3.70), cirrhosis (OR 1.92) and chronic renal failure (OR 1.91) have a significant increased risk of developing CDI, after adjusting for age. ConclusionIn Spain, the prevalence rate of both HA-CDI and CA-CDI have been increasing. Burden of CDI as well as clinical and epidemiological characteristics of CDI patients will help to support public health decision-making.

Genotype\u2013phenotype correlation of 17 cases of Pompe disease in Spanish patients and identification of 4 novel GAA variants

BackgroundPompe disease (PD) is an autosomal recessive metabolic disorder caused by pathogenic variants in the acid α-glucosidase gene (GAA) that produces defects in the lysosomal acid α-1,4-glucosidase. We aimed to identify genetic variations and clinical features in Spanish subjects to establish genotype–phenotype correlation.MethodsA total of 2637 samples of patients who showed symptoms or susceptible signs of PD were enrolled in this observational study. Enzymatic activity was detected by fluorometric techniques and the genetic study was carried out using Next-Generation Sequencing.ResultsFourteen different variants from 17 diagnosed patients were identified, seven males and nine females with LOPD (mean age 36.07, SD 20.57, range 7–64) and a 2-day-old boy with IOPD, four genetic variants had not been described in the literature previously, including a homozygous variant. In all of them α-glucosidase activity was decreased. Muscle weakness, respiratory distress, exercise intolerance, hypotonia, dysphagia and myalgia were commonly observed in patients.ConclusionsThis study report four new genetic variants that contribute to the pathogenic variants spectrum of the GAA gene. We confirm that patients in Spain have a characteristic profile of a European population, with c.-32-13T>G being the most prevalent variant. Furthermore, it was confirmed that the c.236_246delCCACACAGTGC pathogenic variant in homozygosity is associated with early disease and a worse prognosis.

AB0675 COUNTRY COMPARISON ON THE IMPACT OF THE COVID-19 PANDEMIC ON PATIENTS WITH RHEUMATIC DISEASES. RESULTS FROM THE REUMAVID STUDY (PHASE 1)

Background:The COVID-19 pandemic has impacted every aspect of life of European patients with rheumatic and musculoskeletal diseases (RMDs).Objectives:The aim is to evaluate country differences on the impact of the first wave of the COVID-19 pandemic on life habits, healthcare access, health status, mental health and wellbeing in European patients with RMDs.Methods:REUMAVID is an international collaboration led by the Health &amp; Territory Research group at the University of Seville, together with a multidisciplinary team including patient organisations and rheumatologists. This cross-sectional study consisting of an online survey gathering data from patients with a diagnosis of 15 RMDs in Cyprus, France, Greece, Italy, Portugal, Spain, and the United Kingdom. Participants were recruited by patient organisations (April-July 2020). The Kruskal-Wallis and χ2 tests were used to analyse differences between countries and independent variables.Results:1,800 patients participated in the first wave of the COVID-19 pandemic (REUMAVID). 37.8% of Spanish patients increased their smoking consumption during the pandemic followed by Cyprus (32.1%) and Portugal (31.0%), while alcohol consumption was higher in the UK (36.3%) and France (27.0%). 82.3% of patients in Spain unable to attend their appointment with their rheumatologist, either due to cancellations or other personal reasons. Access to primary care was most limited in Portugal and Italy, where only 45.0% and 51.6% got access. 61.9% in Italy and 53.3% in Spain experienced a worsening of their health during the pandemic. 68.5% in Spain and 67.8% in Portugal were at risk of anxiety. The highest proportion at risk of depression was found in Greece (55.4%), Cyprus (55.1%), and Italy (54.8%). 66.9% of patients in Spain reported poor wellbeing, compared to 23.8% in Italy and 30.1% in Portugal (Table 1).Conclusion:The first wave of the pandemic and the related containment measures heterogeneously affected patients with RMDs across European countries, who overall increased harmful habits, experienced more difficulties in accessing healthcare and, reported poor mental health and well-being.Table 1.Bivariate analysis between European countries (N=1,800, unless specified)Mean ± SD or n (%)UKn: 558Spainn: 464Francen: 229Greecen: 57Cyprusn: 101Italyn: 127Portugaln: 264- Inflammatory arthritis1509 (91.2)402 (86.6)147 (64.2)33 (57.9)57 (56.4)89 (70.1)120 (45.5)- Fibromyalgia53 (9.5)14 (3.0)26 (11.4)14 (24.6)28 (27.7)53 (41.7)124 (47.0)- Connective tissue disease236 (6.5)15 (3.2)13 (5.7)25 (43.9)33 (32.7)30 (23.6)61 (23.1)- Osteoarthritis140 (25.1)29 (6.3)102 (44.5)0 (0.0)8 (7.9)15 (11.8)13 (4.9)- Osteoporosis50 (9.0)3 (0.6)20 (8.7)2 (3.5)9 (8.9)18 (14.2)12 (4.5)- Vasculitis39 (1.6)1 (0.2)6 (2.6)3 (5.3)3 (3.0)5 (3.9)9 (3.4)- Sapho (only France)15 (6.6)Smoking, More than before.N= 55616 (10.3)48 (37.8)22 (24.7)8 (23.5)9 (32.1)8 (20.5)26 (31.0)Alcohol consumption, More than before. N= 1,08599 (36.3)48 (10.3)27 (27.0)4 (7.0)4 (4.0)4 (13.3)11 (18.3)Unable to meet rheumatologist. N= 72283 (48.8)186 (82.3)27 (30.3)18 (64.3)22 (51.2)9 (31.0)77 (56.2)Access to primary care. N= 68987 (76.3)65 (67.7)32 (76.2)14 (60.9)17 (60.7)65 (51.6)117 (45.0)Change in health status, Much worse or worse. N=1,786214 (38.4)245 (53.3)98 (43.0)24 (42.9)38 (38.4)78 (61.9)135 (51.9)WHO-5. Poor well-being (≤50).N= 1,777292 (52.5)303 (66.9)100 (43.9)21 (37.5)46 (46.5)30 (23.8)78 (30.1)Risk of anxiety. N= 1,769241 (43.6)309 (68.5)118 (52.0)31 (55.4)61 (62.2)78 (61.9)175 (67.8)Risk of depression. N= 1,769186 (33.6)232 (51.4)101 (44.5)31 (55.4)54 (55.1)69 (54.8)138 (53.8)Note: all relations were significant at the 0.001 level. 1Including: Axial Spondyloarthritis, Rheumatoid Arthritis, Psoriatic Arthritis, Juvenile Idiopathic Arthritis, Gout and Peripheral Spondyloarthritis; 2Including: Systemic Lupus Erythematosus, Sjögren’s Syndrome, Systemic Sclerosis and Myositis; 3Including: Polymyalgia Rheumatic and Vasculitis or Arteritis.Acknowledgements:This study was supported by Novartis Pharma AG. We would like to thank all patients that completed the survey as well as all of the patient organisations that participated in the REUMAVID study including: the Cyprus League Against Rheumatism (CYPLAR) from Cyprus, the Association Française de Lutte Anti-Rhumatismale (AFLAR) from France, the Hellenic League Against Rheumatism (ELEANA) from Greece, the Associazione Nazionale Persone con Malattie Reumatologiche e Rare (APMARR) from Italy, the Portuguese League Against Rheumatic Diseases (LPCDR), from Portugal, the Spanish Federation of Spondyloarthritis Associations (CEADE), the Spanish Patients’ Forum (FEP), UNiMiD, Spanish Rheumatology League (LIRE), Andalusian Rheumatology League (LIRA), Catalonia Rheumatology League and Galician Rheumatology League from Spain, and the National Axial Spondyloarthritis Society (NASS), National Rheumatoid Arthritis (NRAS) and Arthritis Action from the United Kingdom.Disclosure of Interests:Marco Garrido-Cumbrera: None declared, Helena Marzo-Ortega Speakers bureau: AbbVie, Biogen, Celgene, Janssen, Lilly, Novartis, Pfizer, Takeda and UCB, Consultant of: AbbVie, Celgene, Janssen, Lilly, Novartis, Pfizer and UCB, Grant/research support from: Janssen and Novartis, Laura Christen Employee of: Novartis Pharma AG, Loreto Carmona: None declared, José Correa-Fernández: None declared, Sergio Sanz-Gómez: None declared, Elsa Mateus Grant/research support from: Lilly Portugal, Sanofi, AbbVie, Novartis, Grünenthal S.A., MSD, Celgene, Medac, Janssen-Cilag, Pharmakern, GAfPA., Souzi Makri Grant/research support from: Novartis, GSK and Bayer., Pedro Plazuelo-Ramos: None declared, LAURENT GRANGE: None declared, Serena Mingolla: None declared, KATY ANTONOPOULOU: None declared, Dale Webb Grant/research support from: AbbVie, Biogen, Janssen, Lilly, Novartis and UCB, Clare Jacklin Grant/research support from: Abbvie, Amgen, Biogen, Eli Lilly, Gilead, Janssen, Pfizer, Roche, Sanofi &amp; UCB, Shantel Irwin: None declared, Victoria Navarro-Compán Grant/research support from: Abbvie, BMS, Lilly, MSD, Novartis, Pfizer, Roche, and UCB

DAPA-RWE: a retrospective multicenter study comparing dapagliflozin and sitagliptin in patients with Type 2 diabetes treated under routine clinical practice in Spain.

Background: Weight reduction and glycemic control are key goals during Type 2 diabetesmanagement. However, there are few country-specific, real-world data on cotransporter 2 inhibitors. Materials & methods: DAPA-RWE was a retrospective, multicenter study comparing the efficacy of dapagliflozin versus sitagliptin in Type 2 diabetes patients in Spain. Results: The study population comprised 1046 patients (594 with dapagliflozin, 452 with sitagliptin). Age was 61.8±10.0 and 66.2±11.4years andglycosylated hemoglobin (HbA1c) 8.9 and 8.8%, respectively. The main end point (reduction in weight and HbA1c) was reached by 24.4 and 56.1% of patients, respectively; p<0.05. This was confirmed with a propensity score matching analysis balanced for obesity-related variables at baseline. Conclusion: DAPA-RWE confirmed dapagliflozin to be more effective than sitagliptin in reducing HbA1c and weight.

Seguridad y efectividad del edoxabán en la práctica clínica tras un año de seguimiento en España. Registro ETNA-AF-EUROPE

Introduction and objectivesTo ascertain the safety and effectiveness of edoxaban in clinical practice in Spain after one-year of follow-up among patients with atrial fibrillation. MethodsETNA-AF-EUROPE is a non-interventional, post-authorization study performed in 10 European countries. Data after one-year of follow-up, comparing those patients from Spain with the rest of Europe are presented. ResultsA total of 824 patients in Spain and 13 224 in the rest of Europe were included. In Spain, mean age was 73.9 ± 9.9 years, 45.8% were women, CHA2DS2-VASc and HAS-BLED were 3.2 ± 1.4 and 2.3 ± 1.0, respectively. 75.4% of patients were taking edoxaban 60 mg and the remaining 24.6% edoxaban 30 mg. Overall, 84.2% of patients were taking the appropriate dose of edoxaban. Compared with the rest of Europe, in Spain the proportion of patients ≥ 85 years was higher, as well as the thromboembolic risk (CHA2DS2-VASc ≥ 2: 90.2% vs 87.5%; P = .02), but with a lower bleeding risk (HAS-BLED ≥ 3: 40.4% vs 49.2%; P < .01). No significant differences were observed regarding the dose of edoxaban. In Spain, the annualized incidence of ischemic stroke was 0.5%, cardiovascular mortality 1.63%, major bleeding 1.39% and intracranial hemorrhage 0.13%. Except for the incidence of major bleeding or clinically relevant non-major bleeding that was more common in Spain compared with the rest of Europe, no significant differences were observed in the rest of events. ConclusionsIn clinical practice in Spain, patients with atrial fibrillation treated with edoxaban have a low incidence of bleeding and thromboembolic risk.

Validation of the Spanish Version of the VERITAS-PRN Scale to Assess Adherence to on Demand Regimens in Patients with Hemophilia.

IntroductionThe episodic or on-demand administration of clotting factor concentrates in hemophilia patients in the event of hemorrhage is employed to restore hemostasis. Adherence to on-demand treatments needs to be assessed in order to improve patient management, avoiding adverse effects and serious clinical complications.AimTo validate the Spanish version of the treatment adherence scale in patients with hemophilia, namely, Validated Hemophilia Regimen Treatment Adherence Scale-PRN (VERITAS-PRN).MethodsEighty-five patients were recruited in three hemophilia patient associations in Spain. The VERITAS-PRN scale was adapted through a back-translation process from English to Spanish. A native Spanish bilingual translator translated the scale from English to Spanish, and subsequently another native English bilingual translator translated the scale from Spanish to English. The scale was applied twice (two months apart) to assess test–retest reliability.ResultsInternal consistency reliability was slightly lower in the VERITAS-PRN in Spanish (0.80) versus the English version (0.85). There were no differences (p > 0.05) between the means of the dimensions or in the total scores between the sample of patients in Spain and the USA. The test–retest reliability coefficient of the scores on the total scale was 0.80 [CI, 0.74–0.86]. The test–retest reliability coefficient was greater than 0.90 in all subscales.ConclusionThe Spanish version of VERITAS-PRN has high consistency and empirical validity. This scale is useful for assessing the degree of adherence to treatment in adult patients with hemophilia following episodic infusion treatment.

Impact of the COVID-19 pandemic on the care of cancer patients in Spain

BackgroundStudies evaluating the effects of the COVID-19 pandemic on public healthcare systems are limited, particularly in cancer management. As no such studies have been carried out in Spain, our objective is to describe and quantify the impact of the COVID-19 pandemic on cancer patients in Spanish hospitals during the first wave of the pandemic.Materials and methodsThis retrospective, multicenter, nationwide study collected information from hospital departments treating oncology patients. An electronic questionnaire comparing outcomes and management of oncohematological patients for the March-June 2019 and March-June 2020 periods was used.ResultsInformation from 78 departments (36 tertiary hospitals) was analyzed. Forty-four departments implemented adapted protocols during March 2020. Most of these (n = 38/44; 86.4%) carried out COVID-19 triage, while 26 of 44 (59.1%) carried out onsite polymerase chain reaction tests for clinically suspected cases. A shift from in-person to telephone visits was observed in 43 of 44 (97.7%) departments. Comparing the March-June 2019 and March-June 2020 periods, the number of new patients decreased by 20.8% (from 160.2 to 126.4). Decreases were also seen in the mean number of total (2858.2 versus 1686.1) and cancer (465.5 versus 367.2) biopsies, as well as the mean number of bone marrow biopsies (30.5 versus 18.6). Concerning the number of patients visiting specific cancer care departments, a decrease from 2019 to 2020 was seen for mean number of chemotherapy treatments (712.7 versus 643.8) and radiation therapy (2169.9 versus 2139.9). Finally, a reduction from 2019 to 2020 of 12.9% (from 8.6 to 7.4) in the mean number of patients included in clinical trials was noted.ConclusionsThis study provides the first comprehensive data concerning the impact of COVID-19 on cancer care in Spain. The pandemic caused a 20.8% decrease in newly diagnosed patients, which may impact future outcomes. Measures must be taken to ensure cancer management receives priority in times of healthcare emergencies.

Predictive Factors for Anxiety during Blood Sampling and Insertion of Peripheral Intravenous Catheters in Paediatric Patients in Spain

IntroductionInvasive procedures for diagnosis purposes such as venepuncture and peripheral venous catheter insertion are painful procedures that cause great stress for paediatric patients. The objective of this study is to find out the factors that have an impact on the level of anxiety experienced by children undertaken these procedures. Design and methodsProspective study, 359 children between 2 and 15 years old were included, treated in a tertiary reference hospital in the region of Navarra (Spain). The impact of the variables recorded was analysed using a regressive analysis, the Wong-Baker and FLACC scales were used to measure the level of pain and the PACBIS scale to measure the level of stress and anxiety. ResultsThe average age of the participants was 7.93 years (SD: 4.04), with 51.8% (n = 186) boys and 48.2% (n = 173) girls. The mean value of pain recorded was 4.43 (SD:3.10). 45.7% (n = 123) of the venepuncture techniques was associated with minimum level of anxiety, including 11.1% of intravenous catheterization. Variables determining the anxiety has been detected such as age, sex, level of pain, parental conduct and time spent on the procedure. ConclusionsPaediatric patients experience high levels of anxiety when undergoing painful procedures which are conditioned by multifactorial reasons. The increase in stress is directly related to the older age (>6 years old) of the patient, and statistically significant by the female gender, the longer duration of the technique and the parental block. Practice implicationsHealthcare professionals should work on some of the variables and apply measures aimed to mitigate anxiety levels. For example, reducing the duration of the procedure, training parents, and distracting techniques.

Should healthcare workers be prioritised during the COVID-19 pandemic? A view from Madrid and New York

While COVID-19 has generated a massive burden of illness worldwide, healthcare workers (HCWs) have been disproportionately exposed to SARS-CoV-2 coronavirus infection. During the so-called ‘first wave’, infection rates among this...

Incidence, diagnosis, and outcome of immune-mediated thrombotic thrombocytopenic purpura: A nationwide survey by the Spanish registry of thrombotic thrombocytopenic purpura.

Immune-mediated thrombotic thrombocytopenic purpura (iTTP) is a rare disease characterized by the presence of anti-ADAMTS13 autoantibodies. Achieving accurate information on incidence and customary disease management is important to provide appropriate diagnostic and therapeutic resources. The aim of this study was to determine the incidence and outcomes of iTTP in Spain. A cross-sectional survey was carried out among Spanish hospitals, focused on iTTP patients ≥16 years old attended between 2015 and 2017, and those at follow-up before that interval. Incidence, prevalence, mortality, refractoriness, exacerbations, treatment complications, relapses, and sequelae were estimated. Forty-two hospitals covering roughly 20 million inhabitants answered the survey and reported 203 episodes (138 newly-diagnosed and 65 relapses), of which 193 (95.1%) were treated. Incidence was 2.67 (95% CI 1.90-3.45) patients per million inhabitants per year and prevalence 21.44 (95% CI% 19.10-23.73) patients per million inhabitants. At diagnosis, ADAMTS13 activity and anti-ADAMTS13 autoantibody were measured in 97% and 84.3% of reported episodes, respectively. Fifteen patients (7.4%) died as a direct consequence of iTTP, 6 of them before receiving any iTTP-specific treatment. Thirty-one (16.1%) of the 193 treated episodes were refractory to plasma exchange and corticosteroids, and 51 (26.4%) suffered at least one exacerbation. iTTP incidence and prevalence were somewhat higher than those documented in neighboring countries. Together with data on treatments and outcomes, this information will allow us to better estimate what is needed to improve diagnosis and prognosis of iTTP patients in Spain.

Patient self-reported functioning by pain severity and usual analgesic treatment among older adults with osteoarthritis: analysis of the 2017 Spanish National Health Survey.

Osteoarthritis (OA) pain is among the leading causes of disability worldwide in older people. Since its prevalence is growing in aging, a significant burden for society is expected. This work ascertained whether level of disability in self-reported functioning differs by pain severity and usual analgesic treatment among older OA patients in Spain. The Spanish-National-Health-Survey, a large, nationally representative, cross-sectional general health survey including 23,089 persons, was analyzed. Patients aged 65 + years with a self-reported physician OA diagnosis were classified according to severity of pain (no/mild, moderate or severe pain) and treated or untreated with analgesia. Assessment of function included basic and instrumental activities-of-daily-living (BADL, IADL), mental, social, and cognitive functions, scored on a 0% (no limitation) to 100% (complete limitation) standardized metric. Caregiver need for BADL and IADL was also recorded. A total of 3526 patients were analyzed (women 73.3%; age 77.4 [SD: 7.5]). Adjusted functioning scores showed significant association with pain severity, and for BADL, IADL and social function. Patients with severe pain and treated with analgesia had higher limitation scores, ranging on average between 31.5% on BADL, 34.1% on IADL, 45.0% on mental, 42.2% on social, and 23.4% in cognitive domain. The proportions of patients needing a caregiver for BADL (43.4%) and IADL (56.2%) were also the highest in patients with severe pain and treated with analgesia. Regardless of usual utilization of analgesics, the severity of pain seemed to be the major determinant of functional impairment, and caregiving need, in all domains of functioning in older OA patients in Spain. Existing treatment strategies are analgesics based and do not meet patient needs for adequate pain management.

Healthcare resource utilization in adult patients with relapsed/refractory FLT3 mutated acute myeloid leukemia: A retrospective chart review from Spain.

Information regarding impact on healthcare systems of relapsed or refractory (R/R) FLT3 mutated (FLT3mut) acute myeloid leukemia (AML) is scarce. To assess the time and reimbursement associated with hospitalizations of patients with R/R FLT3mut AML in a tertiary Spanish hospital. Retrospective review of medical charts identified patients aged≥18years with R/R FLT3mut AML between 1998 and 2018. Data were collected from the date of first diagnosis of R/R FLT3mut AML (index) until death or loss to follow-up. The primary end point was duration and frequency of hospitalization, use of outpatient resources and transfusion burden. Reimbursement associated with hospitalizations (including associated chemotherapy) was also assessed. Thirty-eight patients were eligible for inclusion. Their median age was 52years, and 30 (79%) received intensive salvage chemotherapy; FLAG-IDA-based regimens were the most frequent (24 patients, 63%). Overall, there were 150 hospitalizations (mean 3.9/patient; mean duration 21days). Patients spent a mean of 24% of the study period in hospital. Total mean reimbursement was €108293 per patient; the majority (€89834) attributable to inpatient stays (€22576 /hospitalization). During chemotherapy period (prior to first alloHSCT), there were 73 hospitalizations (mean duration 22days); mean reimbursement was €19776 per hospitalization and €49819 per patient. AlloHSCT (n=16) involved 77 hospitalizations (mean duration 21days), mean reimbursement €25231/hospitalization and €131515 per patient. Data from this study suggest that there is a substantial healthcare resource utilization and cost burden on R/R FLT3mut AML patients in Spain receiving active treatments.