Agencia de Evaluación de Tecnologías Sanitarias (AETS)

Permanent URI for this collectionhttps://hdl.handle.net/20.500.12105/19612

La Agencia de Evaluación de Tecnologías Sanitarias se crea dentro del Instituto de Salud Carlos III (ISCIII) mediante el R.D. 1415/1994, de 25 de junio, para atender las necesidades consultivas del Sistema Nacional de Salud (SNS) en relación con la definición de su Política de Prestaciones Sanitarias, en la línea imperante en los Sistemas Sanitarios socialmente avanzados. La AETS atiende las necesidades de información y evidencia científica del SNS en relación con la definición de su política de prestaciones sanitarias y la mejora de la calidad y eficiencia. Desde el año 2012, gran parte de las funciones de la AETS quedan enmarcadas en la "Red Española de Agencias de Evaluación de Tecnologías Sanitarias y Prestaciones del Sistema Nacional de Salud" (RedETS). La misión de RedETS es generar, difundir y facilitar la implementación de información destinada a los decisores del SNS, contribuyendo a incrementar la calidad, equidad, eficiencia y cohesión en el sistema. RedETS pretende fundamentar la toma de decisiones sobre incorporación, condiciones de financiación/desinversión, y uso apropiado de las tecnologías sanitarias, con el fin de promover la equidad y sostenibilidad del SNS.

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Factors modulating the impact of the COVID-19 pandemic on posttraumatic stress symptomatology of the Spanish healthcare workers: A cohort study.
(Public Library of Science (PLOS), 2025-06-16) Arregui-Gallego, Beatriz; Orts-Cortes, Maria Isabel; Moreno-Casbas, Teresa; Abad-Corpa, Eva; Camacho-Bejarano, Rafaela; Cidoncha-Moreno, Mª Ángeles; Feria-Raposo, Isabel; Iruzubieta-Barragán, Javier; Carmona, Montserrat; Cristóbal-Domínguez, Estíbaliz; Bernués-Caudillo, Leticia; Casado-Ramirez, Elvira; Recas-Martin, Alda; Sánchez-López, Dolores; Company-Sancho, M Consuelo; Rascón, Noelia López; Esteban-Sepúlveda, Silvia; Vidal-Thomàs, María Clara; Alonso, Isabel; Muñoz-Jiménez, Daniel; Segura-Heras, José Vicente; Moncho, Joaquín; Rich-Ruiz, Manuel; Fundación BBVA
Introduction: The COVID-19 pandemic generated a global health crisis that significantly impacted healthcare systems and professionals. Healthcare workers were exposed to high levels of psychological distress, including posttraumatic stress symptomatology (PTSS). Aim: Analyse the evolution of PTSS among Spanish healthcare workers during the COVID-19 pandemic, and to identify associated factors. Method: A multicenter prospective cohort study with a 12-month follow-up was conducted. PTSS was the primary outcome. Secondary variables included sociodemographic, occupational, psychological, and coping-related factors. Statistical analyses comprised bivariate comparisons and multivariate modelling, such as generalized linear models and linear mixed models. Results: Of the 428 participants, 180 completed the 12-month follow-up. At baseline, changes in work posts, negative family-work relations, avoidant coping, burnout symptoms, and emotional intelligence were associated with PTSS levels. Linear mixed models showed a significant decrease in PTSS over the 12-month period, regardless of gender, age, household type, occupational role, contract type, job title, level of care or type of service (p < 0.001). The generalised linear model explained 25.5% of the variance in PTSS levels at baseline, highlighting the role of psychological and coping factors over sociodemographic or occupational characteristics. Conclusions: This study highlights the need for early identification and intervention focused on psychological and coping mechanisms. Promoting emotional regulation, reducing burnout, and addressing maladaptive coping may help mitigate long-term psychological effects among healthcare workers during public health crises.
Cost-effectiveness of extending the HPV vaccination to boys: a systematic review.
(BMJ Publishing Group, 2021-09) Linertová, Renata; Guirado-Fuentes, Carmen; Mar Medina, Javier; Imaz-Iglesia, Iñaki; Rodríguez-Rodríguez, Leticia; Carmona, Montserrat
Background: Human papillomavirus (HPV) infection can have severe consequences both in women and men. Preadolescent girls are vaccinated against HPV worldwide but a gender-neutral vaccination is being adopted only little by little. This systematic review offers an overview of cost-effectiveness of the gender-neutral HPV vaccination. Methods: Economic evaluations of gender-neutral HPV vaccination with a two-dose schedule compared with girls-only strategy were systematically searched in Medline, Embase and WOS up to June 2020. Incremental cost-effectiveness ratios and key parameters were analysed. Results: Nine studies met the inclusion criteria. Four studies concluded in favour of the gender-neutral programme, another four found it cost-effective only in alternative scenarios. The most influential parameters are the discount rate of benefits (same as for costs vs reduced), vaccine price (listed vs publicly negotiated) and included health problems (inclusion of oropharyngeal and penile cancers). Sponsorship was not decisive for the final result, but there were differences between industry-funded and independent studies in some cost categories. Conclusions: The evidence of the cost-effectiveness of extending HPV vaccination to boys is scarce and ambiguous. Before the adoption of such a strategy, countries should carry out context-specific cost-effectiveness analyses, but the decision should also take into account other criteria, such as gender-related equality.
Disability and quality of life in heart failure patients: a cross-sectional study.
(Oxford University Press, 2019-11-18) García-Olmos, Luis; Batlle, Maurice; Aguilar, Rio; Porro, Carlos; Carmona, Montserrat; Alberquilla, Angel; Sanchez-Gomez, Luis Maria; Monge, Elena; López-Rodríguez, Ana B; Benito, Luis; Baños, Nicolas; Simón, Amaya; Martínez-Álvarez, Miguel A; Luque, Eva M; García-Benito, Cristina; Instituto de Salud Carlos III; Unión Europea. Fondo Europeo de Desarrollo Regional (FEDER/ERDF)
Background: Although both hospitalization and mortality due to heart failure (HF) have been widely studied, less is known about the impact of HF on disability and quality of life. Aim: To assess the degree of disability and quality of life in HF patients attended at family medicine centres. Design and setting: Cross-sectional study of a cohort of HF patients attended at family medicine centres. Methods: Disability was assessed with the WHODAS 2 questionnaire, which provides a global and six domain scores that is understanding and communication, getting around, self-care, getting along with people, life activities and participation in society. Quality of life was assessed with the Minnesota Living with Heart Failure Questionnaire, which furnishes a global and two domain scores, physical and emotional. Results: A breakdown of the results showed that 28% of patients had moderate disability and 16.7% had severe disability, with the most important areas affected being: life activities, 8.9% extreme disability and 30.3% severe disability; getting around, 34.6% severe disability and 2% extreme disability; and participation in society, 53.3% moderate-severe disability. Quality of life was mildly affected. New York Heart Association (NYHA) Functional Classification and sex were the major determinants of disability and quality of life. Angiotensin-converting enzyme inhibitors and angiotensin II receptor antagonists were associated with better scores in the "getting around" and "life activity" domains. Conclusion: HF patients in primary care show an important degree of disability and an acceptable quality of life.
Cognitive Screening Tools in Spanish for Mild Cognitive Impairment: A Systematic Review and Meta-analysis
(2025-05-28) Barderas Manchado, Rodrigo; Ropero-Sánchez, Andrea; Escudero Pérez, Guillermo; Lozano González, Pilar; Alonso-del-Cura, Olatz; Camacho-Montaño, Lucia; Pascual García, Marcos; Sánchez Ruano, Raquel; Martín Saborido, Carlos; Moreno-Casbas, Teresa; Instituto de Salud Carlos III
Mild Cognitive Impairment (MCI) represents the earliest stage of a chronic and degenerative condition, often undetected, impacting individuals, families, and healthcare systems. Early identification is critical. This study evaluates the diagnostic accuracy of MCI screening tools in Spanish-speaking populations, aiming to enhance early detection, reduce misdiagnosis and underdiagnosis, and improve clinical outcomes. This systematic review stems from the Project Dendrite (PMP22/00084 - "Personalized Medicine in the Identification of Preclinical Cognitive Impairment: Development of a Predictive Risk Model") in which it was demonstrated that the five screening tests employed in the study (MMSE, MoCA, Fototest, MiniCog, T@M) lacked consistency and yielded variable results, even in the same participant. This finding highlights the need to evaluate the diagnostic accuracy of the screening tools and their applicability in early cognitive decline detection.
Genicular artery embolization for knee osteoarthritis: a systematic review with meta-analysis and cost-analysis
(Elsevier, 2025-02-17) Hernández-Yumar, Aránzazu; González-Hernández, Yadira; Del Pino-Sedeño, Tasmania; Valcárcel-Nazco, Cristina; de Armas-Castellano, Aythami; Herrera-Ramos, Estefanía; Portero Navarro, Julián; Carmona, Montserrat; Rojas-Reyes, María Ximena; Trujillo-Martín, María M; Ministerio de Sanidad (España); Instituto de Salud Carlos III
Objective: To assess the effectiveness, safety, and cost-effectiveness of genicular artery embolization (GAE) for the treatment of mild or moderate knee osteoarthritis (KO) refractory to standard treatment, and/or severe KO in individuals not eligible for surgery. Method: We conducted a systematic review with meta-analysis, supplemented by a cost-analysis, comparing GAE and standard treatment, from the perspective of the Spanish National Health System (NHS) over a one-year time horizon. The health improvement required for GAE to be deemed cost-effective was quantified, considering a willingness-to-pay threshold of 25 000 €/quality-adjusted life year (QALY). Results: We included two randomized controlled trials in our analysis. Pain estimates showed inconsistent results, and no significant effects were observed for overall function, health-related quality of life, or changes in the need for pain management medication. No serious complications or major adverse events were observed. GRADE quality of evidence ranged from moderate to low. No economic evaluations were identified. Our cost-analysis revealed that GAE would result in an incremental cost of € 3432.37 per patient, requiring a health improvement of 0.137 QALY per patient to be deemed a cost-effective technology. Conclusions: In summary, based on moderate to low-certainty evidence, it remains inconclusive whether there is any difference between GAE and standard treatment for KO. However, the use of GAE would increase the costs. Larger randomized controlled trials are needed to determine the effects of using GAE for chronic pain secondary to KO and, consequently, to ascertain whether this technology could potentially become cost-effective from the NHS perspective.
Electrical impedance tomography for PEEP titration in ARDS patients: a systematic review and meta-analysis
(Springer, 2025-02-26) Sanchez-Piedra, Carlos; Rodriguez Ortiz de Salazar, Begoña; Roca, Oriol; Prado-Galbarro, Francisco-Javier; Perestelo-Perez, Lilisbeth; Sanchez-Gomez, Luis Maria
To assess the efficacy of electrical impedance tomography (EIT)-guided positive end-expiratory pressure (PEEP) titration in improving outcomes for patients with acute respiratory distress syndrome (ARDS). A systematic review and meta-analysis was conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Randomized controlled trials and observational studies with a control group comparing EIT-guided PEEP titration to other strategies were included. Endpoints analysed included mortality, days of mechanical ventilation (MV), intensive care unit (ICU) length of stay (LOS), weaning success rate, barotrauma, driving pressure (∆P), mechanical power (MP), Sequential Organ Failure Assessment (SOFA) score and adverse events. Pooled results were presented as Risk Ratio (RR) for dichotomous outcomes and standardized difference in means (SMD) for continuous outcomes. A total of 4 studies were identified (3 randomized controlled trials and one observational study). All studies were single-center studies (N total = 271 patients). The main limitations were related to potential bias in selecting reported outcomes. EIT-guided PEEP titration was associated with a significant reduction in mortality among critically ill patients with ARDS (RR = 0.64, 95% CI: 0.45-0.91). No significant differences were found in other outcomes. Our findings suggest that EIT may be a valuable tool for PEEP titration in critically ill patients with ARDS. By optimizing lung mechanics, EIT-guided PEEP titration may potentially reduce mortality rates. While larger, multicenter studies are needed to definitively establish the clinical role of EIT in ARDS management, our results provide promising evidence for its potential clinical impact.
Early childhood development in México before and after the Covid-19 pandemic: national results from 2018 to 2021
(Springer, 2025-04-12) Prado-Galbarro, Francisco-Javier; Gamiño-Arroyo, Ana-Estela; Baldwin, Jasmine-Rena; Sanchez-Piedra, Carlos
Background: Children were exposed to the social, psychological and academic effects of the COVID-19 pandemic. The objective of this analysis was to assess the prevalence of delayed early childhood development (ECD) among children aged 36 to 59 months in Mexico, both before (2018) and after the COVID-19 pandemic (2021). Methods: Observational study. ECD was assessed through the Early Childhood Development Index (ECDI) following the methodology of the Cluster Indicator Surveys (MICS), using data from the ENSANUT 2018–19 and 2021. Prevalences were estimated with population weights and Poisson regression models were applied to analyze association between ECD delay and covariates. Results: A total of 19.34% of children aged 36 to 59 months had ECD delay in 2018 and 18.52% in 2021. The factors associated with ECD delay in 2018 were socioeconomic status, access to at least three children’s books, domestic violence, and severe functioning difficulties, and the associated factors in 2021 were sex, region, learning support, access to at least three children’s books, early education attendance, being an adolescent mother, severe functioning difficulties, and the child’s age. Conclusion: Factors associated with delayed ECD in Mexico changed after the pandemic: there was an increase in learning support within the family, and the impact of socioeconomic differences on ECD was reduced.
Phase IV adaptive randomised clinical trials evaluating efficacy and cost-efficacy of pre-emptive pharmacogenetic genotyping strategies in the Spanish National Health System: iPHARMGx Master Protocol and PREVESTATGx nested clinical trial
(BMJ Publishing Group, 2024-11-07) Stewart, Stefan; Seco-Meseguer, Enrique; Diago-Sempere, Elena; Marín-Candón, Alicia; Carmona, Montserrat; Estébanez, Miriam; López-Fernández, Luis A; Imaz-Iglesia, Iñaki; Del Mar García Saiz, María; Laserna-Mendieta, Emilio J; Peiró, Ana M; Farré, Magí; Rodriguez-Jimenez, Consuelo; Saiz-Rodriguez, Miriam; Sanabria-Cabrera, Judith; Rosas-Alonso, Rocío; Abad-Santos, Francisco; Pedrosa-Pérez, Lucía; Carcas, Antonio J; García García, Irene; Borobia, Alberto M; iPHARMGx study group; Instituto de Salud Carlos III; Unión Europea. Comisión Europea. NextGenerationEU
Introduction: Genetic variations impact drug response, driving the need for personalised medicine through pre-emptive pharmacogenetic testing. However, the adoption of pre-emptive pharmacogenetic testing for commonly prescribed drugs, such as statins, outside of tertiary hospitals is limited due to a lack of pharmacoeconomic evidence to support widespread implementation by healthcare policy-makers. The Spanish Consortium for the Implementation of Pharmacogenetics (iPHARMGx Consortium) addresses this by developing a clinical trial master protocol that will govern multiple nested adaptive clinical trials that compare genotype-guided treatments to standard care in specific drug-gene-population triads, asses their cost-efficacy and identify novel biomarkers through advanced sequencing techniques. The first of these studies aims to assess whether a pre-emptive statin therapy genotyping scheme reduces the incidence of statin-associated muscle symptoms (SAMS) in a population at risk of cardiovascular disease susceptible of receiving high-intensity or moderate-intensity doses of statins: The PREVESTATGx trial. Methods and analysis: the PREVESTATGX trial is a multicentre, adaptive randomised controlled pragmatic phase IV clinical trial nested to the iPHARMGx master protocol with two parallel arms, aiming for superiority. Randomisation will be conducted on an individual basis with a centralised approach and stratification by centre. After inclusion in the trial and genotyping has been performed, subjects will be randomly allocated to experimental group (pharmacogenetic genotype-guided statin prescription) or standard-of-care statin prescription (as deemed by attending physician). The main objective is to assess the efficacy of a statin pre-emptive genotyping strategy in reducing the incidence of SAMS. A total of 225 subjects will be recruited among the 10 participating centres if no futility/efficacy boundary is reached in the prespecified interim analyses. Recruitment will be carried out during a 12-month period and subjects will be followed for a 9-month period. Ethics and dissemination: The PREVESTATGx trial received ethical approval on 24 April 2024. Results will be disseminated via publication in peer-reviewed journals as well as presentation at international conferences. Trial results will be submitted for publication in an open-access peer-reviewed medical speciality-specific publication. Trial registration number: EU CT number: 2023-509418-12-00/Clinical trial Identifier (ClinicalTrials.gov): NCT06262685. Protocol version 1.2 12 April 2024 (includes non-substantial modification number 14 June 2024). Trial registration of this study can be located at both the EU Clinical Trials Register available from https:// euclinicaltrials.eu/search-for-clinical-trials/?lang=en and https://clinicaltrials.gov. Registration on both websites was done before the enrolment of the first patient complying with European regulations. EU Clinical Trials Register is a primary registry according to the WHO.
Updating and Refining of Economic Evaluation of Rotavirus Vaccination in Spain: A Cost-Utility and Budget Impact Analysis
(Multidisciplinary Digital Publishing Institute (MDPI), 2024-07-25) Imaz-Iglesia, Iñaki; Carmona, Montserrat; Garcia-Carpintero, Esther Elena; Pedrosa-Pérez, Lucía; Martínez-Portillo, Alejandro; Alcalde-Cabero, Enrique; Linertová, Renata; García-Pérez, Lidia; Instituto de Salud Carlos III; Ministerio de Sanidad (España)
Two vaccines against rotavirus diseases, Rotarix® and RotaTeq®, are being marketed in Spain; but rotavirus is not presently among the diseases covered by universal vaccination in Spain. The aim of this study was to assess the efficiency of extending Spain's current targeted rotavirus vaccination strategy including only preterm babies, to a policy of universal vaccination. A de novo cohort-based Markov model was built to evaluate the efficiency of three compared rotavirus vaccination strategies in Spain: targeted, universal, and no vaccination. Using Rotarix® or RotaTeq®, we compared the cost-utility of these strategies from both a societal perspective and Spanish National Health System (SNHS) perspective. The model represents the most important clinical events conceivably linked to rotavirus infection. Efficacy, effectiveness, safety, costs, and utilities were identified by systematic reviews. Incremental cost-utility ratio (ICUR) is EUR 23,638/QALY (Quality-Adjusted Life Year) for targeted vaccination with Rotarix® compared with no vaccination. The ICUR for the rest of the strategies evaluated are above EUR 30,000/QALY. The sensitivity analysis shows price as the only parameter that could make the universal vaccination strategy efficient. Considering a threshold of EUR 25,000/QALY, only targeted vaccination with Rotarix® would be efficient from societal perspective. Price drops of 36.9% for Rotarix® and 44.6% for RotaTeq® would make universal vaccination efficient.
How to present economic evaluations to non-technical audiences? Randomized trials with professionals and the general population
(BioMed Central (BMC), 2024-11-25) Linertová, Renata; Hernández-Yumar, Aránzazu; Guirado-Fuentes, Carmen; Rodríguez-Díaz, Benjamín; Valcárcel-Nazco, Cristina; Imaz-Iglesia, Iñaki; Carmona, Montserrat; García-Pérez, Lidia; Instituto de Salud Carlos III; Unión Europea. Fondo Europeo de Desarrollo Regional (FEDER/ERDF)
Background: Cost-effectiveness analyses of health technologies have become a part of the decision-making process in healthcare policies. Nevertheless, economic results are not always presented in comprehensible formats for non-technical audiences, such as the general population, healthcare professionals or decision-makers. The purpose of this study was to observe which formats best convey the key message of an economic evaluation, and which are best received by two different audiences. Methods: The summary of a hypothetical cost-effectiveness analysis was edited in different formats: infographic, plain language text and video-abstract for the general population; executive summary and policy brief for a specialized population, i.e. clinicians, clinical and non-clinical managers, or methodologists in health-technology assessment. Participants were randomly shown one of the formats, and data on objective and subjective comprehension, and perceived usefulness/acceptability were gathered by means of online questionnaires. Statistical differences between formats within each audience were analysed. Results: In the general population (N = 324), objective comprehension was statistically significantly better for infographic than for video-abstract (p = 0.005), and for plain text than for video-abstract (p = 0.024). There were no differences in subjective comprehension, but video-abstract was considered statistically significantly more useful to understand the information than plain text (p = 0.011). In the specialized population (N = 100), no statistically significant differences were observed for objective and subjective comprehension, although policy brief was perceived as statistically significantly more useful than executive summary (p = 0.005). Conclusions: A balance between effectivity of conveying the message and attractivity of the format needs to be sought, to facilitate non-technical audiences' understanding of economic data and, consequently, perceive decision-making processes as more transparent and legitimate. The infographic and policy brief could be robust ways to present economic data to the general public and specialized audience, respectively.
Overcitation and overrepresentation of review papers in the most cited papers
(Elsevier, 2018-11) Miranda, Ruben; Garcia-Carpintero, Esther Elena
Review papers tend to be cited more frequently than regular research articles. This fact, together with the continuous increase of the share of reviews in scientific literature, can have important consequences for the measurement of individuals’ research output, usually based on citation analysis. However, studies evaluating the differences in citations of review papers compared to original research articles are almost non-existing in the literature. This paper presents a thorough analysis of the overcitation and overrepresentation of review papers in the most cited papers of the 35 largest subject categories in Science Citation Index-Expanded. Results indicate the average citations received by reviews depends largely on the research area considered, varying from 1.34 to 6.74 times the citations received by original research articles (average value is 2.95). Correlated with this overcitation, there is an important overrepresentation of reviews in the most cited papers, this overrepresentation being greater when the most highly cited papers are considered, i.e. 0.05% and 0.1% most cited papers, where the share of reviews have increased from 16 to 18% in 1990 to around 40% in 2010. Interestingly, the overcitation and overrepresentation in the most cited papers is more important in the areas with the lowest shares of reviews in total publications.
Comparison of the share of documents and citations from different quartile journals in 25 research areas
(Springer, 2019-08-19) Miranda, Ruben; Garcia-Carpintero, Esther Elena
The total number of publications and/or the share of total publications in a given quartile, usually first quartile (Q1), is increasingly used in performance-based funding of public research. However, the quality significance of publishing in Q1 journals is very different depending on the research areas. Both the expected probability to publish in Q1 journals, given by the number of papers published in each quartile, as well as the average citations received by Q1 publications compared to other quartiles, is largely dependent on the research area. This study analyzes the share of articles published in each quartile in the 25 largest research areas indexed by Science Citation Index-Expanded (Web of Science) and their main citation characteristics aiming to enrich the discussion about journal-based evaluation systems and specifically the number and/or the share of publications in Q1. It was found that the average share of documents published in Q1 was 45.7% (38.4% for articles and reviews), varying from 25.4 to 85.6% (from 17.1 to 88.9% for articles and reviews) depending on the area. Q1 publications were cited, on average, 2.07 times more than Q2 publications (2.41 times for articles plus reviews), however, depending on the area, this ratio varied from 0.9 to 6.1 (from 1.7 to 5.4 times for articles plus reviews). Q1 (total publications or articles plus reviews), received, on average, 65% of total citations of the research area, but again this value varied from 46 to 98% depending on the area.
Incidence and prevalence of multiple sclerosis in Spain: a systematic review
(Elsevier, 2024-10) Garcia Lopez, Fernando Jose; García-Merino, A; Alcalde-Cabero, Enrique; Pedro-Cuesta, Jesus de; Biogen
[EN] Introduction: Greater understanding of the prevalence and incidence of multiple sclerosis in Spain and their temporal trends is necessary to improve the allocation of healthcare resources and to study aetiological factors. Methods: We performed a systematic search of the MedLine database and reviewed the reference lists of the articles gathered. We collected studies reporting prevalence or incidence rates of multiple sclerosis in any geographical location in Spain, with no time limits. In 70% of cases, data were extracted by 2 researchers (FGL and EAC); any discrepancies were resolved by consensus. Results: We identified 51 prevalence and 33 incidence studies published between 1968 and 2018. In the adjusted analysis, the number of prevalent cases per 100 000 population increased by 26.6 (95% confidence interval [CI], 21.5-31.8) every 10 years. After adjusting for year and latitude, the number of incident cases per 100 000 population increased by 1.34 (95% CI, 0.98-1.69) every 10 years. We observed a trend toward higher prevalence and incidence rates at higher latitudes. Conclusions: The prevalence of multiple sclerosis in Spain has increased in recent decades, although case ascertainment appears to be incomplete in many studies. Incidence rates have also increased, but this may be due to recent improvements in the detection of new cases. [ES] Introducción: El conocimiento de la prevalencia y de la incidencia de la esclerosis múltiple en España y de sus tendencias temporales es necesario para planificar mejor los servicios clínicos y estudiar los factores etiológicos. Método: Se efectuó una revisión sistemática mediante una búsqueda en Medline y en las referencias de cada artículo, de todos los estudios que describieran cifras de prevalencia o de incidencia de la esclerosis múltiple en algún lugar geográfico de España, sin límites temporales. En el 70% de los casos la extracción de datos la hicieron 2 observadores (FGL y EAC), que resolvieron las discrepancias por consenso. Resultados: Se identificaron 51 estudios de prevalencia y 33 de incidencia entre 1968 y 2018. En el análisis ajustado, por cada 10 años la prevalencia por 100.000 habitantes aumentó en 26,6 (intervalo de confianza [IC] del 95%: 21,5-31,8). Según los datos del análisis ajustado por el año y la latitud, por cada 10 años la incidencia por 100.000 habitantes aumentó en 1,34 (IC 95%: 0,98-1,69). Se observó una tendencia de mayores prevalencias e incidencias en latitudes más altas. Conclusiones: La prevalencia de la esclerosis múltiple aumentó en las últimas décadas en España, aunque en muchos estudios la verificación de casos parece haber sido incompleta. La incidencia también aumentó, pero eso puede deberse a una detección de casos nuevos más exhaustiva en los últimos años.
Patient-Reported Outcomes (PROs) and PRO Remission Rates in 12,262 Biologic-Naïve Patients With Psoriatic Arthritis Treated With Tumor Necrosis Factor Inhibitors in Routine Care
(Journal Of Rheumatology Publishing Co, 2024-04-01) Ørnbjerg, Lykke M; Rugbjerg, Kathrine; Georgiadis, Stylianos; Rasmussen, Simon H; Jacobsson, Lennart; Loft, Anne G; Iannone, Florenzo; Fagerli, Karen M; Vencovsky, Jiri; Santos, Maria J; Möller, Burkhard; Pombo-Suarez, Manuel; Rotar, Ziga; Gudbjornsson, Bjorn; Cefle, Ayse; Eklund, Kari; Codreanu, Catalin; Jones, Gareth; van der Sande, Marleen; Wallman, Johan K; Sebastiani, Marco; Michelsen, Brigitte; Závada, Jakub; Nissen, Michael J; Sanchez-Piedra, Carlos; Tomšič, Matija; Love, Thorvardur J; Relas, Heikki; Mogosan, Corina; Hetland, Merete L; Østergaard, Mikkel; Novartis; IQVIA
Objective: To evaluate patient-reported outcomes (PROs) after initiation of tumor necrosis factor inhibitor (TNFi) treatment in European real-world patients with psoriatic arthritis (PsA). Further, to investigate PRO remission rates across treatment courses, registries, disease duration, sex, and age at disease onset. Methods: Visual analog scale or numerical rating scale scores for pain, fatigue, patient global assessment (PtGA), and the Health Assessment Questionnaire-Disability Index (HAQ-DI) from 12,262 patients with PsA initiating a TNFi in 13 registries were pooled. PRO remission rates (pain ≤ 1, fatigue ≤ 2, PtGA ≤ 2, and HAQ-DI ≤ 0.5) were calculated for patients still on the treatment. Results: For the first TNFi, median pain score was reduced by approximately 50%, from 6 to 3, 3, and 2; as were fatigue scores, from 6 to 4, 4, and 3; PtGA scores, from 6 to 3, 3, and 2; and HAQ-DI scores, from 0.9 to 0.5, 0.5, and 0.4 at baseline, 6, 12, and 24 months, respectively. Six-month Lund Efficacy Index (LUNDEX)-adjusted remission rates for pain, fatigue, PtGA, and HAQ-DI scores were 24%, 31%, 36%, and 43% (first TNFi); 14%, 19%, 23%, and 29% (second TNFi); and 9%, 14%, 17%, and 20% (third TNFi), respectively. For biologic-naïve patients with disease duration < 5 years, 6-month LUNDEX-adjusted remission rates for pain, fatigue, PtGA, and HAQ-DI scores were 22%, 28%, 33%, and 42%, respectively. Corresponding rates for patients with disease duration > 10 years were 27%, 32%, 41%, and 43%, respectively. Remission rates were 33%, 40%, 45%, and 56% for men and 17%, 23%, 24%, and 32% for women, respectively. For patients aged < 45 years at diagnosis, 6-month LUNDEX-adjusted remission rate for pain was 29% vs 18% for patients ≥ 45 years. Conclusion: In 12,262 biologic-naïve patients with PsA, 6 months of treatment with a TNFi reduced pain by approximately 50%. Marked differences in PRO remission rates across treatment courses, registries, disease duration, sex, and age at onset of disease were observed, emphasizing the potential influence of factors other than disease activity on PROs.
Drug effectiveness of 2nd and 3rd TNF inhibitors in psoriatic arthritis - relationship with the reason for withdrawal from the previous treatment
(Elsevier, 2024-04-04) Ørnbjerg, Lykke Midtbøll; Brahe, Cecilie Heegaard; Linde, Louise; Jacobsson, Lennart; Nissen, Michael J; Kristianslund, Eirik Klami; Santos, Maria José; Nordström, Dan; Rotar, Ziga; Gudbjornsson, Bjorn; Onen, Fatos; Codreanu, Catalin; Lindström, Ulf; Möller, Burkhard; Kvien, Tore K; Barcelos, Anabela; Eklund, Kari K; Tomšič, Matija; Love, Thorvardur Jon; Can, Gercek; Ionescu, Ruxandra; Loft, Anne Gitte; Mann, Herman; Pavelka, Karel; van de Sande, Marleen; van der Horst-Bruinsma, I E; Pombo Suarez, Manuel; Sanchez-Piedra, Carlos; Macfarlane, Gary J; Iannone, Florenzo; Michelsen, Brigitte; Hyldstrup, Lise Hejl; Krogh, Niels Steen; Østergaard, Mikkel; Hetland, Merete Lund; Novartis
Objective: To investigate real-world retention and remission rates in PsA patients initiating a 2nd or 3rd TNFi and the association with reason for discontinuation from the previous TNFi-treatment. Methods: Prospectively collected routine care data from 12 European registries were pooled. Retention rates (Kaplan-Meier estimation) and crude/LUNDEX-adjusted rates of Disease Activity Score 28 and Disease Activity index for PSoriatic Arthritis (DAS28 and DAPSA28) remission were calculated and compared with adjusted Cox regression analyses and Chi-squared test, respectively). Results: We included 5233 (2nd TNFi) and 1906 (3rd TNFi) patients. Twelve-month retention rates for the 2nd and 3rd TNFi were 68% (95%CI: 67-70%) and 66% (64-68%), respectively. Patients who stopped the previous TNFi due to AE/LOE had 12-month retention rates of 66%/65% (2nd TNFi), and 65%/63% (3rd TNFi), respectively. Patients who stopped the previous TNFi due to LOE after less vs more than 24 weeks had 12-month retention rates of 54%/69% (2nd TNFi), and 58%/65% (3rd TNFi). Six-month crude/LUNDEX-adjusted DAS28 remission rates were 48%/35% and 38%/27%, and DAPSA28 remission rates were 19%/14% and 14%/10%, for the 2nd and 3rd TNFi. Conclusion: Two-thirds of patients remained on TNFi at 12months for both the 2nd and 3rd TNFi, while one-third and one-quarter of patients were in DAS28 remission after 6months on the 2nd and 3rd TNFi. While drug effectiveness was similar in patients who stopped the previous TNFi due to AE compared to overall LOE, drug effectiveness was better in patients who had stopped the previous TNF due to secondary LOE compared to primary LOE.
Recent trends of invasive mechanical ventilation in older adults: a nationwide population-based study
(Oxford University Press, 2021-09-11) Bouza, Carmen; Martínez-Alés, Gonzalo; Lopez-Cuadrado, Teresa; Instituto de Salud Carlos III
Background: Critical care demand for older people is increasing. However, there is scarce population-based information about the use of life-support measures such as invasive mechanical ventilation (IMV) in this population segment. Objective: To examine the characteristics and recent trends of IMV for older adults. Methods: Retrospective cohort study on IMV in adults ≥65 years using the 2004-15 Spanish national hospital discharge database. Primary outcomes were incidence, inhospital mortality and resource utilization. Trends were assessed for average annual percentage change in rates using joinpoint regression models. Results: 233,038 cases were identified representing 1.27% of all-cause hospitalizations and a crude incidence of 248 cases/100,000 older adult population. Mean age was 75 years, 62% were men and 70% had comorbidities. Inhospital mortality was 48%. Across all ages, about 80% of survivors were discharged home. Incidence rates of IMV remained roughly unchanged over time with an average annual change of -0.2% (95% confidence interval (CI): -0.9, 0.6). Inhospital mortality decreased an annual average of -0.7% (95% CI: -0.5, -1.0), a trend detected across age groups and most clinical strata. Further, there was a 3.4% (95% CI: 3.0, 3.8) annual increase in the proportion of adults aged ≥80 years, an age group that showed higher mortality risk, lower frequency of prolonged IMV, shorter hospital stays and lower costs. Conclusions: Overall rates of IMV remained roughly stable among older adults, while inhospital mortality showed a decreasing trend. There was a notable increase in adults aged ≥80 years, a group with high mortality and lower associated hospital resource use.
Safety of balloon kyphoplasty in the treatment of osteoporotic vertebral compression fractures in Europe: a meta-analysis of randomized controlled trials
(Springer, 2015-04) Bouza, Carmen; Lopez-Cuadrado, Teresa; Almendro, Nuria; Amate, Jose Maria
Purpose: The study aims to evaluate the safety of balloon kyphoplasty in the treatment of painful osteoporotic vertebral compression fractures in Europe. Methods: Systematic review of the literature, until September 2013, and meta-analysis of randomized controlled trials performed in Europe assessing the safety of balloon kyphoplasty in patients with symptomatic osteoporotic vertebral fractures. Outcomes sought include cement leaks, serious clinical complications and new vertebral fractures. Results: Six randomized controlled trials fulfilled the inclusion criteria. These studies included data on 525 treated levels in 424 patients. Cement leakages were detected in 18.3 % (95 % CI 11.6, 23.0) of fractures intervened. In about 0.5 % (95 % CI 0.1, 1.1) of fractures leakages proved to be symptomatic. Serious clinical complications were recorded in 11.5 % (95 % CI 1.1, 21.7) of patients treated with balloon kyphoplasty with several of these cases requiring intensive treatment or postoperative surgery. New vertebral fractures were detected in 20.7 % (95 % CI 0.4, 40.9) of patients treated but rates showed an upward pattern when the follow-up period increased. In 54 % of such cases, the fractures were located in regions adjacent to the treated level. Conclusions: The safety profile and associated complications of balloon kyphoplasty shown in this analysis, based on the evidence provided by existing randomized controlled trials, can be of help to the practicing clinician who must contrast them with the potential benefits of the technique. These data represent an important step towards a balanced evaluation of the intervention though, a better reporting and more reliable data on long-term assessment of potential sequelae are needed.
Characteristics, incidence and temporal trends of sepsis in elderly patients undergoing surgery
(Oxford University Press, 2016-01) Bouza, Carmen; Lopez-Cuadrado, Teresa; Amate, Jose Maria; Plan Nacional de I+D+i (España)
Background: Despite increasing rates of surgery in the elderly, there is limited population-based information on sepsis in this age group. This study aimed to characterize the epidemiology and national trends of sepsis among elderly patients undergoing surgery in Spain. Methods: This population-based longitudinal study of patients aged 65 years or older, undergoing surgery between 2006 and 2011, used data from the national hospital discharge database. Patients were identified by ICD coding. Primary endpoints were incidence and case-fatality rates of sepsis. Predefined age groups were examined. In-hospital mortality-related factors were assessed by means of exploratory logistic regression. Trends were assessed for annual percentage change in rates using Joinpoint regression analysis. Results: A total of 44 342 episodes of sepsis were identified, representing 1·5 per cent of all 2 871 199 surgical hospital admissions of patients aged 65 years or older. The rates varied with age and sex. The in-hospital case-fatality rate was 43·9 per cent (19 482 patients), and associated with age, co-morbidity and organ dysfunction. Standardized rates of sepsis increased over time, with an annual change of 4·7 (95 per cent c.i. 1·4 to 8·5) per cent, whereas the case-fatality rate declined, with an overall annual change of -3·6 (-4·3 to -2·8) per cent. The decrease in mortality was more limited in patients with organ dysfunction and in the oldest age group. Conclusion: Rates of sepsis are increasing among elderly patients undergoing surgery, whereas in-hospital case fatality, although common, is showing a decreasing trend.
Hospital admissions due to physical disease in people with schizophrenia: a national population-based study
(Elsevier, 2010) Bouza, Carmen; Lopez-Cuadrado, Teresa; Amate, Jose Maria; Instituto de Salud Carlos III; Plan Nacional de I+D+i (España)
Objectives: To examine nonpsychiatric hospitalizations in people with schizophrenia and to describe the epidemiological features of these admissions. Methods: We analyzed the 2000-2004 Spanish National Hospital Discharge Registry, identified records coded for schizophrenia (295.xx), selected admissions due to non-psychiatric causes and characterized the physical diseases using the International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) system and the Deyo-Charlson Index. Results: From all 2000-2004 hospitalizations in subjects with schizophrenia, 21 484 records (34%) were eligible for analysis. The mean age was 53 years, 61% were men. The mean number of ICD-9-CM codes was 2.3. The main diagnoses at discharge were injury-poisoning (19%) and respiratory (15%), digestive (14%) and circulatory diseases (12%), but there were significant age and gender-related differences. Inhospital mortality was 6.9% and the mean age of death was 63 years. Circulatory, respiratory diseases and neoplasms accounted for 21%, 18% and 17% of deaths, respectively. Inhospital mortality significantly correlated with age, the Deyo-Charlson Index and some specific processes. Conclusions: Hospitalizations due to physical disease are frequent among people with schizophrenia and associated with a substantial burden and in-hospital mortality in Spain. This information may prove useful for the design and application of preventive and therapeutic programs in the early and silent phases of the most prevalent physical diseases.
Outcomes of new quality standards of follitropin alfa on ovarian stimulation: meta-analysis of previous studies
(Springer, 2009) Saz-Parkinson, ZuleiKa; Lopez-Cuadrado, Teresa; Bouza, Carmen; Amate, Jose Maria
Background: Human follicle-stimulating hormone (hFSH; follitropin alfa) can be employed therapeutically to induce ovarian follicular development in assisted reproduction treatments. Current recombinant hFSH (r-hFSH) preparations available for clinical use are labeled either in terms of the bioactivity expressed in international units (IU) or in mass (microg). Several clinical trials have tried to assess the clinical implications of the physicochemical improvements in the dosing of follitropin alfa filled by mass (FbM). The aim of this study was to perform a meta-analysis of previous studies in order to assess the efficacy and safety of ovarian stimulation using follitropin alfa FbM compared with follitropin alfa filled by international units (FbIU). Methods: A literature search was carried out in scientific databases to find published articles and abstracts comparing both hormone preparations. A fixed effects model meta-analysis was performed. The variables studied include the average dose (IU), days of treatment, estradiol peak, follicles >14 mm, number of extracted oocytes, number of embryos obtained, number of cases of ovarian hyperstimulation syndrome (OHSS), and clinical pregnancies. Results: A total of six studies met the stated criteria and were included in the meta-analysis. In these studies, the average r-hFSH dose per patient was 230.29 IU less with administration of follitropin alfa FbM compared with FbIU, and the number of days of treatment was reduced by 0.48. In addition, a significantly greater number of oocytes (0.84) were extracted, more embryos (0.88) were obtained, and a higher peak level of estradiol (613.08 pmol/L) was achieved in the patients undergoing ovarian stimulation with follitropin alfa FbM. However, no statistically significant differences were observed in the number of follicles >14 mm, clinical pregnancies, or OHSS cases. Conclusion: Follitropin alfa FbM, a technologically modified formulation of r-hFSH, is as safe as follitropin alfa FbIU but requires a smaller dose over a shorter period to produce more oocytes and final embryos.

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