Challenges for Economic Evaluations of Advanced Therapy Medicinal Products: A Systematic Review.

OBJECTIVES: Advanced therapy medicinal products (ATMPs) are drugs for human use for the treatment of chronic, degenerative, or life-threatening diseases that are based on genes, tissues, or cells. This article aimed to identify and critically review published economic analyses of ATMPs. METHODS: A systematic review of economic analyses of ATMPs was undertaken. Study characteristics, design, sources of data, resources and unit costs, modeling and extrapolation methods, study results, and sensitivity analyses were assessed. RESULTS: A total of 46 economic analyses of ATMP (from 45 articles) were included; 4 were cell therapy medicinal products, 33 gene therapy medicinal products, and 9 tissue-engineered products. 30 therapies had commercial marketing approval; 39 studies were cost-utility analysis, 5 were cost-effectiveness analysis, and 2 were cost only studies. Four studies predicted that the ATMP offered a step change in the management of the condition and 10 studies estimated that the ATMP would offer a lower mean cost. CONCLUSIONS: Comparison with historical controls, pooling of data, and use of techniques such as mixture cure fraction models should be used cautiously. Sensitivity analyses should be used across a plausible range of prices. Clinical studies need to be designed to align with health technology assessment requirements, including generic quality of life, and payers should aim for clarity of criteria. Regulators and national payers should aim for compatibility of registers to allow interchange of data. Given the increasing reliance on industry-funded economic analyses, careful critical review is recommended.

Economic evaluation of adjuvant therapy with osimertinib in patients with early-stage non-small cell lung cancer and mutated EGFR.

PURPOSE: The ADAURA trial demonstrated the superiority of osimertinib over a placebo with regard to disease-free survival, showing it to be indicated as an adjuvant therapy for treatment of non-small cell lung cancer with mutated epidermal growth factor receptor (EGFR). The aim of the present study was to conduct a cost-utility analysis and an analysis of the budgetary impact of adjuvant therapy with osimertinib in patients with non-small cell lung cancer with mutated EGFR who had undergone resection surgery with curative intent. METHODS: Analyses were based on the outcomes of the ADAURA clinical trial and were conducted through a Spanish National Health Service perspective. The outcome measures used were quality-adjusted life years (QALY). RESULTS: The average overall cost of adjuvant treatment with osimertinib over a period of 100 months in the overall sample of trial patients (stages IB-IIIA) was 220,961 €, compared with 197,849 € in the placebo group. Effectiveness, estimated according to QALY, was 6.26 years in the osimertinib group and 5.96 years in the placebo group, with the incremental cost-utility ratio being 77,040 €/QALY. With regard to the budgetary impact, it was estimated that, in 2021, approximately 1130 patients would be subsidiaries to receive osimertinib. This pertains to a difference of 17,375,330 € over 100 months to fund this treatment relative to no treatment. CONCLUSION: Taking into account a Spanish threshold of 24,000 €/QALY, the reduction in the acquisition cost of osimertinib will have to be greater than 10%, to obtain a cost-effective alternative.

Description of day case costs and tariffs of cataract surgery from a sample of nine European countries.

BACKGROUND: The lack of transparency in the methodology of unit cost estimation and the usage of confidential or undisclosed information prevents cost comparisons and makes the transferability of the results across countries difficult. The objective of this article is to compare the methodologies used in the estimation of the cost of a day case cataract extirpation that are described in the official and publicly available sources and to study how these translate into different unit cost estimates. METHODS: A literature review was conducted to identify the main sources of unit costs of cataract extirpation. A semi-structured questionnaire to obtain information on national costing methodologies was developed and sent to consortium partners in nine European countries. Additionally, publicly available sources of unit cost of cataract surgery in those countries included in the European Healthcare and Social Cost Database (EU HCSCD) were analysed. RESULTS: The findings showed a considerable diversity across countries on unit costs varying from 432.5€ in Poland (minor degree of severity) to 3411.96€ in Portugal (major degree of severity). In addition, differences were found in the year of cost publication and on the level of detail of different types of cataract surgery. The unit of activity were Diagnosis-Related Groups in all countries except Slovenia. All unit costs include direct costs and variable overheads (except Germany where nursing costs are financed separately). Differences were identified in the type of fixed overheads included in unit costs. Methodological documents explaining the identification, measurement and evaluation of resources included in the unit costs, as well as use of appropriate cost drivers are publicly available only in England, Portugal and Sweden. CONCLUSIONS: We can conclude that while unit costs of cataract extirpation are publicly available, the information on methodological aspects is scarce. This appears to pose a significant problem for cross-country comparisons of costs and transferability of results from one country to another.

Development of the European Healthcare and Social Cost Database (EU HCSCD) for use in economic evaluation of healthcare programs.

INTRODUCTION: Costs are one of the critical factors for the transferability of the results in health technology assessment and economic evaluation. The objective is to develop a cost database at the European level to facilitate cross-border cost comparisons in different settings and explains the factors that lead to differences in healthcare costs in different countries, taking into account the differences between health systems and other factors. METHODOLOGY: The core of the database is compounded of three main categories (primary resources, composite goods and services, and complex processes and interventions) organized into 13 subcategories. A number of elements providing as detailed information of unit cost as possible were identified in order to mitigate the problem of comparability. Consortium partners validated both the database structure and selected costing items. RESULTS: Twenty-seven costing items included in the EU HCSCD resulted in 1450 unit costs when taking into account all item subtypes and countries. Cross-country differences in costs are driven by the type of resources included in the costing items (e.g., overhead costs in case of complex processes and interventions) or by the variety of existing brands and/or models and the type of unit value in most of the primary resources. CONCLUSION: The EU HCSCD is the only public unit healthcare and social cost database at European level that gather data on unit costs and explains differences in costs across countries. Its maintenance and regular data updating will enable establishing specific systems for generating and recording information that will meet many of its current limitations.

Relationship between exposure to mixtures of persistent, bioaccumulative, and toxic chemicals and cancer risk: A systematic review.

Environmental risks are responsible for one in five of all deaths worldwide. Persistent, bioaccumulative, and toxic substances are chemicals that can subsist for decades in human tissues and the environment. They include heavy metals, organochlorines, polychlorinated biphenyls, organobromines, organofluorines, and polycyclic aromatic hydrocarbons among others. Although humans are often exposed to multiple pollutants simultaneously, their negative effects on health have generally been studied for each one separately. Among the most severe of these harmful effects is cancer. Here, to compile and analyze the available evidence on the relationship between exposure to mixtures of persistent, bioaccumulative, and toxic chemicals and the risk of developing cancer in the general population, we provide a systematic review based on the main databases (Cochrane, PubMed and Embase), together with complementary sources, using the general methodology of the PRISMA Statement. The articles analyzed were selected by two researchers working independently and their quality was evaluated by reference to the Newcastle-Ottawa scale. The initial search yielded 2379 results from the main sources of information and 22 from the complementary ones. After the article selection process, 22 were included in the final review (21 case-control studies and one cohort study). Analysis of the selected studies revealed that most of the mixtures analyzed were positively associated with risk of cancer, especially that of the breast, colon-rectum or testis, and more strongly so than each contaminant alone. In view of the possible stronger association observed with the development of cancer for some mixtures of pollutants than when each one is present separately, exposure to mixtures should also be monitored and measured, preferably in cohort designs, to complement the traditional approach to persistent, bioaccumulative, and toxic chemicals. The results presented should be taken into account in public health policies in order to strengthen the regulatory framework for cancer prevention and control.

Evidence for deprescription in primary care through an umbrella review.

BACKGROUND: There is a high prevalence of potentially inappropriate prescriptions in primary care. This is associated with more frequent adverse events, lower quality of life and more frequent visits to hospital accident & emergency departments. The aim of the present study is to summarise available evidence on the effectiveness of deprescription interventions in primary care, and to describe the barriers and enablers of the process from the point of view of patients and healthcare professionals. METHODS: We designed an umbrella review which includes nine systematic reviews. More than 50% of included studies were performed with adults in primary care. Two reviewers independently performed data extraction and analysis. RESULTS: In considering studies of the effectiveness of interventions, it can be observed that the educational component of deprescription procedures is a key factor, whilst procedures tailored towards the patient's situation offer better results. With regards to studies involving healthcare professionals, the main explored areas were the balance between risks and benefits, and the need to improve communication with patients as well as other colleagues involved in patient care. Amongst the identified barriers we found lack of time, inability to access all information, being stuck in a routine, resistance to change and a lack of willingness to question the prescription decisions made by healthcare colleagues. With regards to patients, it is clear that they have worries and doubts. In order to overcome these issues, a good relationship with healthcare professionals and receipt of their support is required during the process. CONCLUSIONS: Optimizing medication through targeted deprescribing is an important part of managing chronic conditions, avoiding adverse effects and improving outcomes. The majority of deprescription interventions in primary care are effective. Good communication between healthcare professionals is a key element for success in the deprescription process.

Economic assessment of abemaciclib for the adjuvant treatment of luminal HER2- breast cancer from the perspective of the Spanish health system.

INTRODUCTION: Abemaciclib is an oral inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6). Data from the clinical trial monarchE (2023) showed improved survival from invasive disease. The aim of the present article was to conduct an economic assessment of adjuvant treatment with abemaciclib in women with luminal, HER2- and node-positive breast cancer. METHODS: A Markov model was constructed with four mutually exclusive health states (disease-free, local recurrence, distal recurrence and death). Analyses were based on the clinical trial monarchE which compared an intervention group (abemaciclib + hormone therapy [HT]) with HT alone. The effectiveness measure used was quality-adjusted life years (QALY), with unit costs and utilities being obtained from existing literature. The incremental cost-utility ratio (ICUR) was used to compare the two treatment strategies. RESULTS: Total costs were €98,765 and €17,935 for the abemaciclib plus HT group and the HT alone group, respectively. The health outcome was 10.076QALY for the intervention group and 9.495QALY for the control group, with the ICUR being€139,173/QALY. CONCLUSION: Despite the significant gains of abemaciclib as adjuvant treatment in terms of progression-free survival, this treatment is not cost-effective for the Spanish National Health System at published prices. It may be cost-effective with an appropriate discount on the official price.

Effectiveness of two interventions based on improving patient-practitioner communication on diabetes self-management in patients with low educational level: study protocol of a clustered randomized trial in primary care.

BACKGROUND: In the last decades the presence of social inequalities in diabetes care has been observed in multiple countries, including Spain. These inequalities have been at least partially attributed to differences in diabetes self-management behaviours. Communication problems during medical consultations occur more frequently to patients with a lower educational level. The purpose of this cluster randomized trial is to determine whether an intervention implemented in a General Surgery, based in improving patient-provider communication, results in a better diabetes self-management in patients with lower educational level. A secondary objective is to assess whether telephone reinforcement enhances the effect of such intervention. We report the design and implementation of this on-going study. METHODS/DESIGN: The study is being conducted in a General Practice located in a deprived neighbourhood of Granada, Spain. Diabetic patients 18 years old or older with a low educational level and inadequate glycaemic control (HbA1c > 7%) were recruited. General Practitioners (GPs) were randomised to three groups: intervention A, intervention B and control group. GPs allocated to intervention groups A and B received training in communication skills and are providing graphic feedback about glycosylated haemoglobin levels. Patients whose GPs were allocated to group B are additionally receiving telephone reinforcement whereas patients from the control group are receiving usual care. The described interventions are being conducted during 7 consecutive medical visits which are scheduled every three months. The main outcome measure will be HbA1c; blood pressure, lipidemia, body mass index and waist circumference will be considered as secondary outcome measures. Statistical analysis to evaluate the effectiveness of the interventions will include multilevel regression analysis with three hierarchical levels: medical visit level, patient level and GP level. DISCUSSION: The results of this study will provide new knowledge about possible strategies to promote a better diabetes self-management in a particularly vulnerable group. If effective, this low cost intervention will have the potential to be easily incorporated into routine clinical practice, contributing to decrease health inequalities in diabetic patients. TRIAL REGISTRATION: Clinical Trials U.S. National Institutes of Health, NCT01849731.

Value of concerted and hospital hemodialysis through a multi-criteria decision analysis.

OBJECTIVE: To evaluate the value of the provision of contracted versus hospital dialysis services for the treatment of chronic kidney disease in Spain using the multicriteria decision analysis methodology. METHOD: The EVIDEM (Evidence and Value: Impact on Decision Making) evaluation framework was used to calculate the estimated value of both dialysis delivery models (arranged vs. hospital) through a virtual workshop in which different profiles participated: directors and managers, professionals and heads of units and representatives of patients and relatives. The scores were combined using an additive lineal model, which combined the weight of the model with the individual score of the criteria, and each value was transformed to a scale between 0 and 1. RESULTS: The estimated value for arranged dialysis was 0.29 (DS: ±0.2) and 0.39 (DS: ±0.2) for hospital dialysis. All profiles gave a higher value to hospital hemodialysis compared to contracted hemodialysis. The highest value for hospital dialysis was for patients (0.44), with the lowest mean value for directors (0.36) and the range for arranged dialysis being between patients (0.31) and intermediate positions (0.27). CONCLUSIONS: Hospital hemodialysis obtained a higher value than concerted dialysis. In general, the panelists affirmed that it is a useful and interesting exercise and that, to a certain extent, it provides security in decision-making, since it allows ordering, rationalizing and considering, in an explicit and transparent manner, the different criteria involved.

Scoping review of the methodology of large health surveys conducted in Spain early on in the COVID-19 pandemic.

Background: The use of health surveys has been key in the scientific community to promptly communicate results about the health impact of COVID-19. But what information was collected, where, when and how, and who was the study population? Objective: To describe the methodological characteristics used in large health surveys conducted in Spain early on in the COVID-19 pandemic. Methods: Scoping review. Inclusion criteria: observational studies published between January 2020 and December 2021, with sample sizes of over 2,000 persons resident in Spain. Databases consulted: PubMed, CINAHL, Literatura Latinoamericana y del Caribe en CC de la Salud, Scopus, PsycINFO, Embase, Sociological Abstracts, Dialnet and Web of Science Core Collection. We analyzed the characteristics of the literature references, methodologies and information gathered in the surveys selected. Fifty five studies were included. Results: Sixty percentage of the studies included had mental health as their main topic and 75% were conducted on the general adult population. Thirteen percentage had a longitudinal design, 93% used the internet to gather information and the same percentage used non-probability sampling. Thirty percentage made some type of sampling correction to reduce coverage or non-response biases, but not selection biases. Sixty seven percentage did not state the availability of their data. Conclusions: Consistent with the extensive use of non-probability sampling without any bias correction in the extraordinary setting created by COVID-19, quality population frameworks are required so that probability and representative samples can be extracted quickly to promptly address other health crises, as well as to reduce potential coverage, non-response and particularly selection biases by utilizing reweighting techniques. The low data accessibility despite the huge opportunity that COVID-19 provided for Open Science-based research is striking.

Evidence on outsourcing dialysis services: a scoping review.

INTRODUCTION: Chronic kidney disease represents an important health problem, due to its high incidence and prevalence, as well as its significant morbidity and mortality and socioeconomic cost. AIMS: compare the effectiveness and economic consequences of outsourcing versus hospital dialysis. METHOD: A scoping review, for which different databases were consulted, using controlled and free terms. Those articles that compared concerted versus in hospital dialysis in terms of effectiveness were included. Likewise, those publications that compared, in the Spanish field, the cost between both modes of service provision and the public price rates of the different Autonomous Communities were included. RESULTS: 11 articles were included in this review: 8 on comparison of effectiveness, all of them in the USA, and 3 on costs. A higher rate of hospitalization was observed in subsidized centers, but no differences in mortality were observed. Additionally, greater competition among providers was associated with lower hospitalization rates. The cost studies reviewed show that hospital hemodialysis is more expensive than in subsidized centers, due to the structural costs. The data of the public rates of the different Autonomous Communities show a wide heterogeneity in the payment of the concerts. CONCLUSIONS: the coexistence in Spain of public and subsidized centers, the variability in the provision and costs of dialysis techniques, and the low of evidence on the effectiveness of outsourcing treatment show all the need to continue promoting strategies that result in improvement in the care for Chronic Kidney Disease.

Factors associated with mortality in patients hospitalized for COVID-19 in Spain. Data from the RERFAR registry.

OBJECTIVE: To determine the baseline characteristics associated with higher  mortality at 42 days in patients hospitalized for COVID-19 in Spain. METHOD: The study analyzed a prospective cohort of hospitalized COVID-19  patients. The dependent variable was 42-day mortality. Data on the subjects'  demographic and clinical characteristics, comorbidities, usual therapy and  supportive interventions and treatments was collected within 48 hours from  admission. To determine the potential association of the data with mortality, a  multivariate analysis was performed using logistic regression. RESULTS: 15,628 patients were included, 18.2% of whom (n = 2,806) died  during the study period. According to the multivariate analysis, the variables  that were significantly associated (p < 0.05) with mortality upon admission  were: being referred from a nursing home (OR 1.9); having a high respiratory  rate (OR 1,5); having moderate (OR 1.7) or severe (OR 2.9) pneumonia  (CURB-65); aspartate aminotransferase transaminase ≥ 100 IU/l (OR 2.1);  lactate dehydrogenase ≥ 360 IU/L (OR 1.6); procalcitonin > 0.5 ng/mL (OR  1.8); creatine kinase ≥ 294 U/L (OR 1.5); D-dimer > 3,000 ng/mL (OR 1.5);  hemoglobin < 11.6 g/dL (OR 1.4) and C-reactive protein > 120 mg/L (OR 1.2;  requiring respiratory support within the first 48 hours (oxygen therapy [OR  2.0], non-invasive ventilation [OR 2.8], and mechanical ventilation [OR 3.5]);  and being treated with interferon-beta (OR 1.5). On the contrary, being under  80 years of age was associated with lower mortality. CONCLUSIONS: The analysis, based on the data in the RERFAR registry, showed that the factors associated with poorer prognosis were older age,  assessed using the CURB-65 scale, level of respiratory support required,  severe pneumonia (CURB-65), hypertransaminasemia, elevated creatine  kinase, lactate dehydrogenase, and D-dimer levels, anemia, and elevated  respiratory rate.

OBJETIVO: Determinar las características basales que se asocian a una mayor  mortalidad a los 42 días en aquellos pacientes hospitalizados por COVID-19 en  España.Método: Cohorte prospectiva de pacientes COVID-19 hospitalizados. La  variable dependiente fue la mortalidad a los 42 días. Además, se recogieron  características demográficas, clínicas, comorbilidades, tratamiento habitual,  intervenciones de soporte y tratamientos en las primeras 48 horas del ingreso.  Para determinar la asociación con la mortalidad, se realizó un análisis  multivariante mediante regresión logística. Resultados: Se incluyeron 15.628 pacientes, de ellos falleció el 18,2% (n =  2.806). El análisis multivariante mostró que las variables asociadas significativamente (p < 0,05) con la mortalidad al ingreso fueron:  proceder de un centro sociosanitario (odds ratio OR 1,9), frecuencia  respiratoria (odds ratio 1,5), gravedad de neumonía (CURB-65) moderada  (odds ratio 1,7) o alta (odds ratio 2,9), transaminasa aspartato  aminotransferasa ≥ 100 UI/l (odds ratio 2,1), lactato-deshidrogenasa ≥ 360  UI/l (odds ratio 1,6), procalcitonina > 0,5 ng/ml (odds ratio 1,8), creatina- quinasa ≥ 294 U/l (odds ratio 1,5), dímero D > 3.000 ng/ml (odds ratio 1,5),  hemoglobina < 11,6 g/dl (odds ratio 1,4) y proteína C reactiva > 120 mg/l  (odds ratio 1,2), necesidad de soporte respiratorio en las primeras 48 horas  (odds ratio 2,0 de oxigenoterapia; odds ratio 2,8 ventilación no invasiva y odds ratio 3,5 ventilación mecánica) y tratamiento con interferón-beta (odds ratio  1,5). Por el contrario, ser menor de 80 años se asoció a una menor mortalidad. Conclusiones: El análisis del Registro Español de Resultados de  farmacoterapia frente a COVID-19 muestra que los factores asociados a peor pronóstico son: mayor edad, valoración mediante la escala CURB­65, el nivel de requerimiento de soporte respiratorio, neumonía grave (CURB­65), hipertransaminasemia, elevación de creatina-quinasa, lactato- deshidrogenasa, y dímero-D, anemia y elevación de la frecuencia respiratoria.

Strengthening patients' triage in community pharmacies: A cluster randomised controlled trial to evaluate the clinical impact of a minor ailment service.

BACKGROUND: Self-perceived minor ailments might conceal other health conditions if patients are not appropriately assisted by health care professionals. The aim of the study was to evaluate the patient-related outcomes of a community pharmacy Minor Ailment Service (MAS) compared to usual pharmacist care (UC). METHODS: A cluster randomised controlled trial was conducted over six months in community pharmacy in the province of Valencia (Spain). Patients seeking care or requesting a product for a minor ailments considered in the study (dermatological problems, gastrointestinal disturbance, pain and upper respiratory tract related symptoms) were included. The intervention consisted of a standardised pharmacist-patient consultation guided by a web-based program using co-developed management protocols and patients' educational material. Patients were followed up by phone ten days later. Primary clinical outcomes were appropriate medical referral and modification of direct product request. Secondary outcomes were symptom resolution and reconsultation rates. RESULTS: A total of 808 patients (323 MAS and 485 UC) were recruited in 27 pharmacies of 21 municipalities. Patients visiting MAS pharmacies had higher odds for being referred to a physician (OR = 2.343, CI95% = [1.146-4.792]) and higher reconsultation rates (OR = 1.833, CI95% = [1.151-2.919]) compared to UC. No significant differences between groups were observed for modification of direct product request and symptom resolution. CONCLUSIONS: The use of management protocols through the MAS strengthened the identification of referral criteria such as red flags in patients suffering minor ailments. These patients with symptoms of minor ailments possibly due to more severe illness were to be referred and evaluated by physicians. Results reinforce that MAS increases safety for those patients consulting in community pharmacy for minor ailments. TRIAL REGISTRATION: Trial registration number: ISRCTN17235323. Retrospectively registered 07/05/2021, https://www.isrctn.com/ISRCTN17235323.

The use of masks to protect against respiratory infections: An umbrella review.

INTRODUCTION: The global health emergency caused by the current COVID-19 pandemic is resulting in a huge challenge at all levels. The use of masks may reduce the spread of the infection by minimising the excretion of Flügge droplets. The objective of this study was to compile the evidence available on the use of masks in relation to respiratory infections. METHODOLOGY: An umbrella review (review of systematic reviews) was conducted. Two reviewers independently carried out the screening process, data extraction and data analysis. Discrepancies were resolved with a third reviewer, and the assessment of the risk of bias of the studies was carried out using the AMSTAR 2 tool. The Rayyan QCRI program was used for the screening process. RESULTS: A total of eight systematic reviews were included. The studies analysed the use of masks in the general population, in long-term care facilities, in hospitals and at mass gatherings, and compared the effectiveness thereof in preventing infection. The results of this review revealed that the use of masks is associated with a protective effect against respiratory infections in healthcare facilities, in long-term care facilities and at mass gatherings. CONCLUSIONS: In light of the results, it seems reasonable to recommend the use of masks to the general population, but this use should be accompanied by a training programme to improve compliance, as not using them properly may increase the risk of infection.

Cost-utility of talazoparib monotherapy treatment for locally advanced or metastatic breast cancer in Spain.

Breast cancer is one of the most frequent malignancies. The aim of the article is to analyse the cost-utility ratio and budgetary impact of talazoparib treatment for patients with locally advanced or metastatic gBRCA + breast cancer from the perspective of the Spanish National Health System. Analyses were based on the EMBRACA clinical trial and the model was constructed according to "partitioned survival analysis". Two scenarios were considered in order to compare talazoparib with the alternatives of capecitabine, vinorelbine and eribulin: 1. Chemotherapy in patients pre-treated with anthracyclines/taxanes and, 2. A second- and subsequent-line treatment option. Treatment types following relapse were recorded in the mentioned clinical trial. The effectiveness measure used was quality-adjusted life years (QALY). The average health cost of patients treated at 43 months with talazoparib was 84,360.86€, whilst current treatment costs were 26,683.90€. The effectiveness of talazoparib was 1.93 years of survival (1.09 QALY) relative to 1.58 years (0.83 QALY) in the treatment group. The incremental cost-utility ratio was 252,420.04€/QALY. This represents the additional cost required to earn an additional QALY when changing from regular treatment to talazoparib. Regarding budgetary impact, the number of patients susceptible to receiving treatment with between 94 and 202 talazoparib was estimated, according to scenario and likelihood. The 3-year cost difference was between 6.9 and 9 million euros. The economic evaluation conducted shows an elevated incremental cost-utility ratio and budgetary impact. Taking these results into account, the price of talazoparib would have to be lower than that taken as a reference to reach the cost-utility thresholds.

Hyperkalaemia management and related costs in chronic kidney disease patients with comorbidities in Spain.

BACKGROUND: Hyperkalaemia (HK) is a common electrolyte disorder in patients with chronic kidney disease (CKD) and/or treated with renin-angiotensin-aldosterone system inhibitors (RAASis). The aim of this study is to determine the severity, current management and cost of chronic HK. METHODS: We performed a retrospective cohort study of patients with chronic HK and CKD, heart failure or diabetes mellitus between 2011 and 2018. The study follow-up was 36 months. RESULTS: A total of 1499 patients with chronic HK were analysed: 66.2% presented with mild HK, 23.4% with moderate HK and 10.4% with severe HK. The severity was associated with CKD stage. Most patients (70.4%) were on RAASi therapies, which were frequently discontinued (discontinuation rate was 39.8, 49.8 and 51.8% in mild, moderate and severe HK, respectively). This RAASi discontinuation was similar with or without resin prescription. Overall, ion-exchange resins were prescribed to 42.5% of patients with HK and prescriptions were related to the severity of HK, being 90% for severe HK. Adherence to resin treatment was very low (36.8% in the first year and 17.5% in the third year) and potassium remained elevated in most patients with severe HK. The annual healthcare cost per patient with HK was €5929, reaching €12 705 in severe HK. Costs related to HK represent 31.9% of the annual cost per HK patient and 58.8% of the specialized care cost. CONCLUSIONS: HK was usually managed by RAASi discontinuation and ion-exchange resin treatment. Most patients with HK were non-adherent to resins and those with severe HK remained with high potassium levels, despite bearing elevated healthcare expenditures.

Sex differences in the use of the Internet as a source of health information among adolescents.

BACKGROUND: The Internet is a fundamental part of the day-to-day lives of adolescents. Faced with the difficulties of accessing conventional health services, adolescents use the Internet as a confidential and safe means of accessing information about health issues. OBJECTIVES: To describe sex differences in the way in which adolescents search for health information on the Internet. METHODS: Cross-sectional survey with a questionnaire administered by an interviewer. Sociodemographic and health variables and those related to the conditions of access and use of information and communication technologies were gathered (multivariate analysis). RESULTS: About 823 school-age youths were interviewed (21 questionnaires were discarded due to low quality), among whom 54.1% were girls and 46% were boys. The girls had a lower self-assessed level of health than the boys. About 86.5% of the girls used the Internet, compared with 89.9% of the boys (p = 0.155). About 21.7% and 48.3% of the boys used it daily/weekly and occasionally, respectively, compared with 17.9% and 59.1% of the girls who used it daily/weekly and occasionally, respectively. The multivariate analysis shows that girls (odds ratio [OR], 1.709; 95% confidence interval [CI], 1.277-2.287), those in their last year of secondary school (OR, 1.369; 95% CI, 1.025-1.830) and those who had visited the doctor most often the previous year (OR, 1.061; 95% CI, 1.017-1.107), were statistically significantly more likely to search for health information on the Internet. CONCLUSION: Adolescent girls tend to seek more information about health than boys and there are differences in the way in which these girls search for health information on the Internet. The Internet provides adolescents, especially adolescent girls, with an opportunity for relaying health recommendations.

The use of masks to protect against respiratory infections: an umbrella review. / El uso de las mascarillas en la protección de las infecciones respiratorias: una revisión de revisiones.

INTRODUCTION: The global health emergency caused by the current COVID-19 pandemic is resulting in a huge challenge at all levels. The use of masks may reduce the spread of the infection by minimising the excretion of Flügge droplets. The objective of this study was to compile the evidence available on the use of masks in relation to respiratory infections. METHODOLOGY: An umbrella review (review of systematic reviews) was conducted. Two reviewers independently carried out the screening process, data extraction and data analysis. Discrepancies were resolved with a third reviewer, and the assessment of the risk of bias of the studies was carried out using the AMSTAR 2 tool. The Rayyan QCRI program was used for the screening process. RESULTS: A total of eight systematic reviews were included. The studies analysed the use of masks in the general population, in long-term care facilities, in hospitals and at mass gatherings, and compared the effectiveness thereof in preventing infection. The results of this review revealed that the use of masks is associated with a protective effect against respiratory infections in healthcare facilities, in long-term care facilities and at mass gatherings. CONCLUSIONS: In light of the results, it seems reasonable to recommend the use of masks to the general population, but this use should be accompanied by a training programme to improve compliance, as not using them properly may increase the risk of infection.

A general framework for classifying costing methods for economic evaluation of health care.

According to the most traditional economic evaluation manuals, all "relevant" costs should be included in the economic analysis, taking into account factors such as the patient population, setting, location, year, perspective and time horizon. However, cost information may be designed for other purposes. Health care organisations may lack sophisticated accounting systems and consequently, health economists may be unfamiliar with cost accounting terminology, which may lead to discrepancy in terms used in the economic evaluation literature and management accountancy. This paper identifies new tendencies in costing methodologies in health care and critically comments on each included article. For better clarification of terminology, a pragmatic glossary of terms is proposed. A scoping review of English and Spanish language literature (2005-2018) was conducted to identify new tendencies in costing methodologies in health care. The databases PubMed, Scopus and EconLit were searched. A total of 21 studies were included yielding 43 costing analysis. The most common analysis was top-down micro-costing (49%), followed by top-down gross-costing (37%) and bottom-up micro-costing (14%). Resource data were collected prospectively in 12 top-down studies (32%). Hospital database was the most common way of collection of resource data (44%) in top-down gross-costing studies. In top-down micro-costing studies, the most resource use data collection was the combination of several methods (38%). In general, substantial inconsistencies in the costing methods were found. The convergence of top-down and bottom-up methods may be an important topic in the next decades.

No differences in quality of life between men and women undergoing HIV antiretroviral treatment. Impact of demographic, clinical and psychosocial factors.

INTRODUCTION: The health-related quality of life (HRQL) is therefore a highly important tool for the evaluation of the health status of HIV positive patients. However, very little information is available about the differences between HRQL in men and women. The aim of this study is to analyse gender differences in HRQL in HIV positive patients. METHODOLOGY: A sample group of 540 patients infected with HIV and undergoing antiretroviral treatment was studied. All of these patients attended outpatient appointments in the infectious disease units of four hospitals in the southern Spanish region of Andalusia. HRQL was measured using the MOS-HIV health survey, which had been validated for use in this setting. RESULTS: One hundred forty-nine women (26.6%) and 411 men (73.4%) took part in the study. On the whole, the women were younger, more likely to be married and had more children. The men, on the other hand, were more likely to present with coinfection with hepatitis C, have a history of intravenous drug use, be undergoing methadone treatment or have lower levels of CD4. Both the overall average scores and the scores for specific dimensions were higher in women than in men. When these scores were adjusted using different clinical variables, these differences were not statistically significant. Amongst the women, psychic morbidity, longer periods of time as HIV carriers and low levels of social support were linked to lower MHS and PHS scores. An independent link was established between older age and a lower PHS score. Amongst the men, psychic morbidity, difficulty in taking tablets, intravenous drug use and low levels of social support were linked to lower PHS and MHS scores. AIDS and a higher number of antiretroviral medicines were linked to a lower PHS score. CONCLUSIONS: By carrying out an analysis according to gender it is possible to see different factors associated with a poorer quality of physical and mental health. This makes it possible to identify areas which could be developed and to optimise results in terms of patients' health.