Guidance on using real-world evidence from Western Europe in Central and Eastern European health policy decision making

Aim: Real-world data and real-world evidence (RWE) are becoming more important for healthcare decision making and health technology assessment. We aimed to propose solutions to overcome barriers preventing Central and Eastern European (CEE) countries from using RWE generated in Western Europe. Materials & methods: To achieve this, following a scoping review and a webinar, the most important barriers were selected through a survey. A workshop was held with CEE experts to discuss proposed solutions. Results: Based on survey results, we selected the nine most important barriers. Multiple solutions were proposed, for example, the need for a European consensus, and building trust in using RWE. Conclusion: Through collaboration with regional stakeholders, we proposed a list of solutions to overcome barriers on transferring RWE from Western Europe to CEE countries. Plain language summary: Collecting real-world data and generating real-world evidence from it is becoming more important for making better decisions in healthcare. We investigated the main barriers which prevent using real-world evidence in Central and Eastern Europe, originally generated in Western Europe. After identifying the nine most important barrier, with the help of local experts we proposed solutions to overcome those barriers. Several possible solutions were proposed, many of them highlighting the need for a European consensus on these matters and building trust in new methods. Our results can hopefully serve as a guidance document to help overcome the barriers. Tweetable abstract: Research investigating ways to overcome barriers preventing Central and Eastern European countries from using Western European real-world evidence for healthcare decision making, using a multi-methods approach to create a list of solutions in collaboration with local stakeholders

Global burden of chronic respiratory diseases and risk factors, 1990–2019: an update from the Global Burden of Disease Study 2019

Background: Updated data on chronic respiratory diseases (CRDs) are vital in their prevention, control, and treatment in the path to achieving the third UN Sustainable Development Goals (SDGs), a one-third reduction in premature mortality from non-communicable diseases by 2030. We provided global, regional, and national estimates of the burden of CRDs and their attributable risks from 1990 to 2019. Methods: Using data from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019, we estimated mortality, years lived with disability, years of life lost, disability-adjusted life years (DALYs), prevalence, and incidence of CRDs, i.e. chronic obstructive pulmonary disease (COPD), asthma, pneumoconiosis, interstitial lung disease and pulmonary sarcoidosis, and other CRDs, from 1990 to 2019 by sex, age, region, and Socio-demographic Index (SDI) in 204 countries and territories. Deaths and DALYs from CRDs attributable to each risk factor were estimated according to relative risks, risk exposure, and the theoretical minimum risk exposure level input. Findings: In 2019, CRDs were the third leading cause of death responsible for 4.0 million deaths (95% uncertainty interval 3.6–4.3) with a prevalence of 454.6 million cases (417.4–499.1) globally. While the total deaths and prevalence of CRDs have increased by 28.5% and 39.8%, the age-standardised rates have dropped by 41.7% and 16.9% from 1990 to 2019, respectively. COPD, with 212.3 million (200.4–225.1) prevalent cases, was the primary cause of deaths from CRDs, accounting for 3.3 million (2.9–3.6) deaths. With 262.4 million (224.1–309.5) prevalent cases, asthma had the highest prevalence among CRDs. The age-standardised rates of all burden measures of COPD, asthma, and pneumoconiosis have reduced globally from 1990 to 2019. Nevertheless, the age-standardised rates of incidence and prevalence of interstitial lung disease and pulmonary sarcoidosis have increased throughout this period. Low- and low-middle SDI countries had the highest age-standardised death and DALYs rates while the high SDI quintile had the highest prevalence rate of CRDs. The highest deaths and DALYs from CRDs were attributed to smoking globally, followed by air pollution and occupational risks. Non-optimal temperature and high body-mass index were additional risk factors for COPD and asthma, respectively. Interpretation: Albeit the age-standardised prevalence, death, and DALYs rates of CRDs have decreased, they still cause a substantial burden and deaths worldwide. The high death and DALYs rates in low and low-middle SDI countries highlights the urgent need for improved preventive, diagnostic, and therapeutic measures. Global strategies for tobacco control, enhancing air quality, reducing occupational hazards, and fostering clean cooking fuels are crucial steps in reducing the burden of CRDs, especially in low- and lower-middle income countries

The global burden of cancer attributable to risk factors, 2010-19 : a systematic analysis for the Global Burden of Disease Study 2019

Background Understanding the magnitude of cancer burden attributable to potentially modifiable risk factors is crucial for development of effective prevention and mitigation strategies. We analysed results from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019 to inform cancer control planning efforts globally. Methods The GBD 2019 comparative risk assessment framework was used to estimate cancer burden attributable to behavioural, environmental and occupational, and metabolic risk factors. A total of 82 risk-outcome pairs were included on the basis of the World Cancer Research Fund criteria. Estimated cancer deaths and disability-adjusted life-years (DALYs) in 2019 and change in these measures between 2010 and 2019 are presented. Findings Globally, in 2019, the risk factors included in this analysis accounted for 4.45 million (95% uncertainty interval 4.01-4.94) deaths and 105 million (95.0-116) DALYs for both sexes combined, representing 44.4% (41.3-48.4) of all cancer deaths and 42.0% (39.1-45.6) of all DALYs. There were 2.88 million (2.60-3.18) risk-attributable cancer deaths in males (50.6% [47.8-54.1] of all male cancer deaths) and 1.58 million (1.36-1.84) risk-attributable cancer deaths in females (36.3% [32.5-41.3] of all female cancer deaths). The leading risk factors at the most detailed level globally for risk-attributable cancer deaths and DALYs in 2019 for both sexes combined were smoking, followed by alcohol use and high BMI. Risk-attributable cancer burden varied by world region and Socio-demographic Index (SDI), with smoking, unsafe sex, and alcohol use being the three leading risk factors for risk-attributable cancer DALYs in low SDI locations in 2019, whereas DALYs in high SDI locations mirrored the top three global risk factor rankings. From 2010 to 2019, global risk-attributable cancer deaths increased by 20.4% (12.6-28.4) and DALYs by 16.8% (8.8-25.0), with the greatest percentage increase in metabolic risks (34.7% [27.9-42.8] and 33.3% [25.8-42.0]). Interpretation The leading risk factors contributing to global cancer burden in 2019 were behavioural, whereas metabolic risk factors saw the largest increases between 2010 and 2019. Reducing exposure to these modifiable risk factors would decrease cancer mortality and DALY rates worldwide, and policies should be tailored appropriately to local cancer risk factor burden. Copyright (C) 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license.Peer reviewe

Global investments in pandemic preparedness and COVID-19: development assistance and domestic spending on health between 1990 and 2026

Background The COVID-19 pandemic highlighted gaps in health surveillance systems, disease prevention, and treatment globally. Among the many factors that might have led to these gaps is the issue of the financing of national health systems, especially in low-income and middle-income countries (LMICs), as well as a robust global system for pandemic preparedness. We aimed to provide a comparative assessment of global health spending at the onset of the pandemic; characterise the amount of development assistance for pandemic preparedness and response disbursed in the first 2 years of the COVID-19 pandemic; and examine expectations for future health spending and put into context the expected need for investment in pandemic preparedness. Methods In this analysis of global health spending between 1990 and 2021, and prediction from 2021 to 2026, we estimated four sources of health spending: development assistance for health (DAH), government spending, out-of-pocket spending, and prepaid private spending across 204 countries and territories. We used the Organisation for Economic Co-operation and Development (OECD)'s Creditor Reporting System (CRS) and the WHO Global Health Expenditure Database (GHED) to estimate spending. We estimated development assistance for general health, COVID-19 response, and pandemic preparedness and response using a keyword search. Health spending estimates were combined with estimates of resources needed for pandemic prevention and preparedness to analyse future health spending patterns, relative to need. Findings In 2019, at the onset of the COVID-19 pandemic, US$9·2 trillion (95$7·3 trillion (95% UI 7·2–7·4) in 2019; 293·7 times the $24·8 billion (95$43·1 billion in development assistance was provided to maintain or improve health. The pandemic led to an unprecedented increase in development assistance targeted towards health; in 2020 and 2021, $1·8 billion in DAH contributions was provided towards pandemic preparedness in LMICs, and$37·8 billion was provided for the health-related COVID-19 response. Although the support for pandemic preparedness is 12·2% of the recommended target by the High-Level Independent Panel (HLIP), the support provided for the health-related COVID-19 response is 252·2% of the recommended target. Additionally, projected spending estimates suggest that between 2022 and 2026, governments in 17 (95% UI 11–21) of the 137 LMICs will observe an increase in national government health spending equivalent to an addition of 1% of GDP, as recommended by the HLIP. Interpretation There was an unprecedented scale-up in DAH in 2020 and 2021. We have a unique opportunity at this time to sustain funding for crucial global health functions, including pandemic preparedness. However, historical patterns of underfunding of pandemic preparedness suggest that deliberate effort must be made to ensure funding is maintained

Global, regional, and national burden of disorders affecting the nervous system, 1990–2021: a systematic analysis for the Global Burden of Disease Study 2021

BackgroundDisorders affecting the nervous system are diverse and include neurodevelopmental disorders, late-life neurodegeneration, and newly emergent conditions, such as cognitive impairment following COVID-19. Previous publications from the Global Burden of Disease, Injuries, and Risk Factor Study estimated the burden of 15 neurological conditions in 2015 and 2016, but these analyses did not include neurodevelopmental disorders, as defined by the International Classification of Diseases (ICD)-11, or a subset of cases of congenital, neonatal, and infectious conditions that cause neurological damage. Here, we estimate nervous system health loss caused by 37 unique conditions and their associated risk factors globally, regionally, and nationally from 1990 to 2021.MethodsWe estimated mortality, prevalence, years lived with disability (YLDs), years of life lost (YLLs), and disability-adjusted life-years (DALYs), with corresponding 95% uncertainty intervals (UIs), by age and sex in 204 countries and territories, from 1990 to 2021. We included morbidity and deaths due to neurological conditions, for which health loss is directly due to damage to the CNS or peripheral nervous system. We also isolated neurological health loss from conditions for which nervous system morbidity is a consequence, but not the primary feature, including a subset of congenital conditions (ie, chromosomal anomalies and congenital birth defects), neonatal conditions (ie, jaundice, preterm birth, and sepsis), infectious diseases (ie, COVID-19, cystic echinococcosis, malaria, syphilis, and Zika virus disease), and diabetic neuropathy. By conducting a sequela-level analysis of the health outcomes for these conditions, only cases where nervous system damage occurred were included, and YLDs were recalculated to isolate the non-fatal burden directly attributable to nervous system health loss. A comorbidity correction was used to calculate total prevalence of all conditions that affect the nervous system combined.FindingsGlobally, the 37 conditions affecting the nervous system were collectively ranked as the leading group cause of DALYs in 2021 (443 million, 95% UI 378–521), affecting 3·40 billion (3·20–3·62) individuals (43·1%, 40·5–45·9 of the global population); global DALY counts attributed to these conditions increased by 18·2% (8·7–26·7) between 1990 and 2021. Age-standardised rates of deaths per 100 000 people attributed to these conditions decreased from 1990 to 2021 by 33·6% (27·6–38·8), and age-standardised rates of DALYs attributed to these conditions decreased by 27·0% (21·5–32·4). Age-standardised prevalence was almost stable, with a change of 1·5% (0·7–2·4). The ten conditions with the highest age-standardised DALYs in 2021 were stroke, neonatal encephalopathy, migraine, Alzheimer's disease and other dementias, diabetic neuropathy, meningitis, epilepsy, neurological complications due to preterm birth, autism spectrum disorder, and nervous system cancer.InterpretationAs the leading cause of overall disease burden in the world, with increasing global DALY counts, effective prevention, treatment, and rehabilitation strategies for disorders affecting the nervous system are needed

Burden of Chronic Heart Failure in Romania

Chronic heart failure (CHF) affects millions of people across the world, with increasing trends in prevalence, putting ever increasing pressure on the healthcare system. The aim of this study was to assess the financial burden of CHF hospital care on the public healthcare sector in Romania by estimating the number of inpatient episodes and the associated costs. Additionally, societal costs associated with missed work and premature death of CHF patients were also estimated. The national claims database was analyzed to estimate the number of CHF patients. Cost data was extracted from a pool of nine public hospitals in Romania. In 2019, 375,037 CHF patient episodes were identified on specific wards at the national level. The average cost calculated for the selected nine hospitals was EUR 996. The calculated weighted national average cost per patient episode was EUR 1002, resulting in a total cost of EUR 376 million at the national level. The cost of workdays missed summed up to EUR 122 million, while the annual costs associated with the premature death of CHF patients was EUR 230 million. In conclusion, the prevalence of CHF in Romania is high, accounting for a large proportion of hospitalizations, which translates into large costs for the national payer

Jó ötlet-e a paraszolvencia kriminalizálása? A szabad orvosválasztás szerepe a jelenség megszüntetésében

Az egészségügyi szolgálati jogviszonyról szóló törvény a köz- és magánellátás szétválasztásával, az orvosbérek jelen- tős megemelésével és a pénzadás kriminalizálásával igyekszik megszüntetni a paraszolvenciát Magyarországon. Ko- rábbi munkáinkra, a nemzetközi szakirodalom feldolgozására, a releváns jogszabályok, illetve bírói gyakorlat elemzé- sére, valamint egy, a szülészetre fókuszáló, internetes kutatásra építve azt vizsgáltuk, hogy a választott eszközök valóban alkalmasak-e a cél elérésére, szükséges-e a módosításuk, és ha igen, hogyan. Az elméleti megfontolások és az empirikus bizonyítékok is arra utalnak, hogy a törvény megközelítése hibás, mert a betegek többsége nem az orvosok alacsony fizetése miatt ad pénzt, hanem azért, mert csak így látja biztosítottnak, hogy megfelelő egészségügyi ellátás- hoz jut. Ez a „díjtétel típusú” paraszolvencia nem korrupció, az egészségügyi hiányhelyzetből ered, amellyel a törvény által előirányzott intézkedések érdemben nem foglalkoznak, inkább súlyosbítják azt. A nemzetközi tapasztalatok szerint e káros jelenség visszaszorításához nem elégségesek a hiányhelyzetet csökkentő hosszú távú intézkedések, ha nem társul melléjük egy azonnali helyettesítő mechanizmus, amely formális keretet teremt a paraszolvenciához kapcsolódó többletszolgáltatás legális megvásárlására. A szabad orvosválasztást annak ellenére tekinti fizetősnek a betegek és orvosok többsége, hogy az szabály szerint térítésmentes. A paraszolvencia ezen keretrendszerben történő formalizálása nem ismeretlen gondolat a magyar egészségpolitikában, a bírói gyakorlatban, de a magán szülészeti ellátásban sem, sőt olyan, kormányzati finanszírozással támogatott szülészeti modellprogram is létezik, amelyben deklarált cél a paraszolvencia kiváltása az orvosválasztás formális díjfizetéshez kötésével. Mindez reális kiindulópont egy kísérleti projekt technikai-politikai megvalósíthatóságához, a részletszabályokat azonban úgy célszerű kialakítani, hogy minden szereplőnek érdekében álljon az új rendszer diszkriminációmentes működtetése, ezért az orvost nem választó páciensek után is szükséges teljesítményarányos bérkiegészítést adni

Riding the Pandemic Waves—Lessons to Be Learned from the COVID-19 Crisis Management in Romania

In our analysis, we assessed how Romania dealt with the numerous challenges presented by the COVID-19 pandemic during 2021. In that year, the government had to deal with two waves of COVID-19 pandemics caused by the new variants, the low vaccination rate of the population, the overload of the healthcare system and political instability at the same time. Based on publicly available databases and international literature, we evaluated government measures aimed at reducing the spread of the pandemic and ensure the operation of the healthcare workforce and infrastructure. In addition, we evaluated measures to provide health services effectively and the government’s pandemic responses regarding excess mortality in 2021. In the absence of a complex monitoring system, limited information was available on the spread of the pandemic or the various risk factors at play. Due to incomplete and inadequate management systems, the government was unable to implement timely and adequate measures. Our analysis concludes that the management of a pandemic can only be successful if data are collected and evaluated using complex systems in a timely manner, and if members of society adhere to clearly communicated government measures due to high levels of trust in the government

IMPORTANȚA RAPORTĂRII CORECTE A CAZURILOR DE INFECȚII ASOCIATE ASISTENȚEI MEDICALE ÎN SISTEMUL DRG

HAI (Health Care Associated Infections) represent the infections that a healthy or sick patient contacts during an episode of hospitalization, except for the pre-existing manifestations. These infections have become a real burden for hospitals in Romania due to the long duration of hospitalization and the high costs of treatment. A big problem of the system is the poor reporting of these cases, both because of the ignorance of the reporting rules and the possible repercussions. Through this study we want to trigger an alarm signal that there is the possibility that many such infections have been omitted, thus justifying the huge difference between the Romanian and European reports. This study was performed using data from a hospital in Romania for the period of 2016. A number of 34578 cases in continuous hospitalization (both acute and chronic) enterde the study, of which a number of 27 were reported as cases of HAI and analyzed in the present study. Of the 27 reported cases, only 10 (37%) had the infectious pathology coded, while 17 (63%) did not have any diagnostic code to detect the presence of an infection; none of the cases were coded with code Y95- Nosocomial disorder.   Keywords: HAI, DRG, Y95, Epidemiology, Public HealthIAAM (infecții asociate asistenței medicale) reprezintă infecțiile pe care un pacient sănătos sau bolnav le contactează în cadrul unui episod de internare intraspitalicesc, cu excepția manifestărilor preexistente. Aceste infecții au devenit o adevărată povară pentru spitalele din România datorită duratei lungi de spitalizare și a costurilor ridicate de tratament. O mare problemă a sistemului este proasta raportare a acestor cazuri, atât datorită necunoașterii regulilor de raportare, cât și a posibilelor repercusiuni. Prin acest studiu dorim să tragem un semnal de alarmă că există posibilitatea ca foarte multe astfel de infecții să fi fost omise, astfel justificându-se și diferența enormă între raportările din România și cele europene. Acest studiu a fost realizat pe datele unui spital din România pentru perioada anului 2016, în studiu intrând  un număr de 34.578 cazuri în spitalizare continuă (atât acuți cât și cronici) dintre care un număr de 27 au fost raportate ca și cazuri de IAAM și analizate în prezentul studiu. Din cele 27 cazuri raportate doar 10 (37%) au avut codificată patologia infecțioasă, în timp  ce 17 (63%) nu au avut nici un cod de diagnostic care să releve prezența unei infecții; niciunul dintre cazuri nu a fost codificat cu codul Y95- Afecțiune nosocomială.   Cuvinte cheie: IAAM, DRG, Y95, Epidemiology, Public Healt

PRACTICI DE ANTIBIOTICOTERAPIE, STUDIU PRIVIND CONSUMUL ȘI CHELTUIELILE PE ANTIBIOTICE ÎN MAI MULTE SPITALE DIN ROMÂNIA

Antibiotics are substances that destroy or prevent the development of microorganisms such as bacteria, fungi, or protozoa, and are a valuable resource for infections, the efficacy of which must be maintained by administering them only when recommended by the physician. Microbial resistance to antibiotics has risen to alarming levels in all parts of the world and is today one of the most serious threats to public health and global development. Microbial resistance to antibiotics also implies an economic burden, as these infections induce an increase in the average duration of hospitalization, and thus, additional health costs and losses in labor productivity. The total consumption of antibiotics in Romania in 2015 was extremely high and it was characterized by the increased use of antibiotics at risk of selecting bacterial resistance and inducing severe infections and thus, Romania was on the second place in Europe. Romania is still among the first countries in the use of antibiotics for systemic use, in 2016 it ranked fourth in the European Union. This critical situation is due to insufficient information in the general population regarding the role, benefits, and risks of antibiotics, their excessive prescription in both hospital and outpatient settings, and still relatively easy access to antibiotics, disobeying the rules of prescription release only.   Keywords: antibiotics, bacterial resistance, antibiotic costsAntibioticele sunt substanțe, care distrug sau împiedică dezvoltarea microorganismelor, cum ar fi bacteriile, fungii sau protozoarele și reprezintă o resursă prețioasă împotriva infecțiilor, a cărei eficacitate trebuie menținută prin administrarea lor numai la recomandarea medicului. Rezistența microbiană la antibiotice se ridică astăzi la niveluri alarmante în toate părțile lumii și este astăzi una din cele mai grave amenințări pentru sănătatea publică și dezvoltarea mondială. Rezistența microbiană la antibiotice înseamnă și o povoară economică, deoarece aceste infecții induc creșterea duratei medii de spitalizare, și astfel cheltuieli suplimentare în sănătate și pierderi în productivitatea muncii. Consumul total de antibiotice în România în anul 2015 a fost extrem de mare și caracterizat de accentuarea utilizării preferențiale a antibioticelor cu risc de a selecta rezistență bacteriană și de a induce infecții severe și astfel a ocupat locul al doilea în Europa. România este în continuare printre primele țări în consumul antibioticelor pentru uz sistemic, în anul 2016 ocupa locul al patrulea din Uniunea Europeană. Această situație critică este pusă pe seama informării insuficiente la nivelul populației generale privind rolul, beneficiile și riscurile administrării de antibiotice, prescrierea lor excesivă, atât în spital cât și în ambulatoriu și accesibilitatea încă relativ facilă la antibiotice, cu nerespectarea reglementărilor privind eliberarea lor doar pe bază de prescripție.   Cuvinte cheie: antibiotics, bacterial resistance, costuri antibiotice &nbsp