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Background@#In Korea, during the early phase of the coronavirus disease 2019 (COVID-19) pandemic, we responded to the uncertainty of treatments under various conditions, consistently playing catch up with the speed of evidence updates. Therefore, there was high demand for national-level evidence-based clinical practice guidelines for clinicians in a timely manner. We developed evidence-based and updated living recommendations for clinicians through a transparent development process and multidisciplinary expert collaboration. @*Methods@#The National Evidence-based Healthcare Collaborating Agency (NECA) and the Korean Academy of Medical Sciences (KAMS) collaborated to develop trustworthy Korean living guidelines. The NECA-supported methodological sections and 8 professional medical societies of the KAMS worked with clinical experts, and 31 clinicians were involved annually. We developed a total of 35 clinical questions, including medications, respiratory/critical care, pediatric care, emergency care, diagnostic tests, and radiological examinations. @*Results@#An evidence-based search for treatments began in March 2021 and monthly updates were performed. It was expanded to other areas, and the search interval was organized by a steering committee owing to priority changes. Evidence synthesis and recommendation review was performed by researchers, and living recommendations were updated within 3–4 months. @*Conclusion@#We provided timely recommendations on living schemes and disseminated them to the public, policymakers and various stakeholders using webpages and social media.Although the output was successful, there were some limitations. The rigor of development issues, urgent timelines for public dissemination, education for new developers, and spread of several new COVID-19 variants have worked as barriers. Therefore, we must prepare systematic processes and funding for future pandemics.
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Purpose@#Improving survival and health-related quality of life (HRQOL), along with symptom relief, is important for the treatment of metastatic breast cancer (MBC). This study measured HRQOL and analyzed its influence on sociodemographic and clinical factors in patients with MBC. @*Methods@#We interviewed 298 patients with MBC to investigate their sociodemographic characteristics and HRQOL by using EuroQol-5D-5L (EQ-5D) between September and October 2014. We also reviewed medical records to examine the clinical condition of the patients, including disease progression, adverse events, treatments, chronic disease, and metastatic areas. The distribution of the EQ-5D index was compared between different clinical conditions by using the Kruskal-Wallis test. We also conducted multiple regression analyses to identify the factors affecting HRQOL in patients with MBC. @*Results@#The mean EQ-5D index was 0.79 for all patients surveyed. The mean EQ-5D index score was significantly lower in patients in the progressed state than in those in the progression-free survival state (0.73 vs. 0.80, p = 0.0002). The HRQOL of patients treated with chemotherapy alone was significantly lower than that of patients treated with hormonal or targeted therapy (0.76 vs. 0.82 or 0.85; p = 0.0020). Regression analysis revealed that the clinical factors associated with lower HRQOL were progressed state, chemotherapy, and adverse events, such as hair loss or stomatitis. Finally, young age, high income, and employment were the sociodemographic factors that were positively associated with better HRQOL. @*Conclusion@#This study provides new information on the health utility of MBC patients on the basis of various patient characteristics and offers insights that can assist medical professionals in treating patients with MBC and help policymakers implement cancer strategies. Further research is needed to reflect the changing environment of cancer treatment and enrich available evidence.
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Purpose@#To evaluate the efficacy and safety of coronavirus disease 2019 (COVID-19) vaccines in children aged 5–11 years, a rapid systematic review was conducted on published clinical trials of COVID-19 vaccines and studies that analyzed real-world data on adverse events after COVID-19 vaccination. @*Methods@#A systematic search was conducted on medical literature in international (Ovid-MEDLINE) and pre-published literature databases (medRxiv), followed by handsearching up to January 4, 2022. We used terms including COVID-19, severe acute respiratory syndrome coronavirus 2, and vaccines, and the certainty of evidence was graded using the GRADE approach. @*Results@#A total of 1,675 studies were identified, of which five were finally selected. Among the five studies, four consisted of data from clinical trials of each of the four types of COVID-19 vaccines (BNT162b2, mRNA-1273, CoronaVac, and BBIBP-CorV). The remaining study consisted of real-world data on the safety of the BNT162b2 vaccine in children aged 5–11 years. This systematic review identified that COVID-19 vaccines in recipients aged 5–11 years produced a favorable immune response, and were vaccines were effective against COVID-19. The safety findings for the BNT162b2 vaccine in children and early adolescents aged 5–11 years were similar to those data noted in the clinical trial. @*Conclusions@#There is limited data on COVID-19 vaccines in children aged 5–11 years.Consequently continuous and comprehensive monitoring is necessary for the evaluation of the safety and effectiveness of the COVID-19 vaccines.
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Despite the global effort to mitigate the spread, coronavirus disease 2019 (COVID-19) has become a pandemic that took more than 2 million lives. There are numerous ongoing clinical studies aiming to find treatment options and many are being published daily. Some effective treatment options, albeit of variable efficacy, have been discovered. Therefore, it is necessary to develop an evidence-based methodology, to continuously check for new evidence, and to update recommendations accordingly. Here we provide guidelines on pharmaceutical treatment for COVID-19 based on the latest evidence.
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Neutralizing antibodies targeted at the receptor-binding domain of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein have been developed and now under evaluation in clinical trials. The US Food and Drug Administration currently issued emergency use authorizations for neutralizing monoclonal antibodies in non-hospitalized patients with mild to moderate coronavirus disease 2019 (COVID-19) who are at high risk for progressing to severe disease and/or hospitalization. In terms of this situation, there is an urgent need to investigate the clinical aspects and to develop strategies to deploy them effectively in clinical practice. Here we provide guidance for the use of anti-SARS-CoV-2 monoclonal antibodies for the treatment of COVID-19 based on the latest evidence.
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Despite the global effort to mitigate the spread, coronavirus disease 2019 (COVID-19) has become a pandemic that took more than 2 million lives. There are numerous ongoing clinical studies aiming to find treatment options and many are being published daily. Some effective treatment options, albeit of variable efficacy, have been discovered. Therefore, it is necessary to develop an evidence-based methodology, to continuously check for new evidence, and to update recommendations accordingly. Here we provide guidelines on pharmaceutical treatment for COVID-19 based on the latest evidence.
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Neutralizing antibodies targeted at the receptor-binding domain of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein have been developed and now under evaluation in clinical trials. The US Food and Drug Administration currently issued emergency use authorizations for neutralizing monoclonal antibodies in non-hospitalized patients with mild to moderate coronavirus disease 2019 (COVID-19) who are at high risk for progressing to severe disease and/or hospitalization. In terms of this situation, there is an urgent need to investigate the clinical aspects and to develop strategies to deploy them effectively in clinical practice. Here we provide guidance for the use of anti-SARS-CoV-2 monoclonal antibodies for the treatment of COVID-19 based on the latest evidence.
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Background@#As the survival rate of cancer patients increases, the clinical importance of rehabilitation provided by healthcare professionals also increases. However, the evidence supporting the relevance of rehabilitation programs is insufficient. This study aimed to review the literature on effectiveness in physical function, quality of life (QOL) or fatigue of supervised physical rehabilitation in patients with advanced cancer. @*Methods@#A systematic review and meta-analysis was conducted following the Cochrane guidelines. We narratively described the results when meta-analysis was not applicable or appropriate. Literature databases including Ovid-MEDLINE, Ovid-EMBASE, and the Cochrane Library, as well as several Korean domestic databases, were searched up to June 2017 for studies that investigated the effectiveness of supervised physical rehabilitation programs on physical function, QOL or fatigue in patients with advanced cancer. The quality of the selected studies was evaluated independently by paired reviewers. @*Results@#Eleven studies with 922 participants were finally selected among 2,459 articles. The meta-analysis revealed that after physical exercise, the physical activity level and strength of patients with advanced cancer increased significantly. The QOL showed a statistically significant improvement after physical rehabilitation according to the European Organization for Research and Treatment of Cancer version C30. Though some of measurements about cardiovascular endurance or strength in several studies were not able to be synthesized, each study reported that they were significantly improved after receiving rehabilitation. @*Conclusion@#Supervised physical rehabilitation for patients with advanced cancer is effective in improving physical activity, strength, and QOL. However, more trials are needed to prove the effectiveness of supervised exercise and to strengthen the evidence.
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Objective@#The Australian Pharmaceutical Benefits Scheme (PBS) is a national drug subsidy program. Given the similarity and comprehensiveness of the Australian PBS and the Korean National Health Insurance (NHI) data, these data are increasingly used for pharmacoepidemiological investigations, as well as international comparative studies. This study aims to introduce the various sources of publicly available PBS data and provide a practical guide to researchers conducting drug utilization studies. @*Methods@#We searched literature and websites to detail and compare the collection, structure, components, and characteristics of each PBS data format. We identified different characteristics of the PBS data from the Korean NHI claims data which are mainly owing to their unique co-payment policies and data collection processes. In addition, the utilization and expenditure of atorvastatin, a widely used treatment for hyperlipidemia, were analyzed using two different sources of PBS data and the different results were interpreted. @*Results@#There exist differences in when data were collected or non-subsidized uses of medicine were included among sources of PBS data. Additionally, two countries have different cost sharing methods inmedicine subsidy scheme; co-payment in Australia and co-insurance in Korea. Therefore, it should be noted that prescriptions under co-payment are not included in some data sources in Australia. @*Conclusion@#Despite several analytical challenges, open access and easy data management are the strengths of the PBS data sources. A detailed knowledge of the PBS data can ensure robust methodology and interpretation of pharmacoepidemiological investigations or international comparative studies.
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Hemophilia is a serious rare disease that requires continuous management and treatment for which the medicine is costly at the annual average of 100 million KRW for an individual. The aim of this study was to investigate trends in the utilization of coagulation factor (CF) used for hemophilia treatment using the National Health Insurance database from 2010 to 2013 in Korea and compare the utilization of CF with other countries. The consumption of CF per capita (IU) in Korea was not more than other countries with similar income to Korea. However, CF usage per patient IU was higher because the prevalence rate of hemophilia in Korea was lower than in other countries while the number of serious patients was much more. Therefore, it is difficult to say that the consumption of hemophilia medicine in Korea is higher than that in other countries. The consumption and cost of hemophilia medicine in Korea is likely to increase due to the increased utilization of expensive bypassing agents and the widespread use of prophylaxis for severe hemophilia. Even during the research period, it increased slightly and other countries show a similar trend. Thus, hemophilia patient management should accompany active monitoring on the health and cost outcomes of pharmaceutical treatment in the future. This study is expected to contribute to further insight into drug policies for other countries that face similar challenges with high price pharmaceuticals.
Assuntos
Adolescente , Adulto , Idoso , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Adulto Jovem , Transtornos Herdados da Coagulação Sanguínea/tratamento farmacológico , Fatores de Coagulação Sanguínea/uso terapêutico , Bases de Dados Factuais , Programas Nacionais de Saúde/estatística & dados numéricos , República da Coreia , Índice de Gravidade de DoençaRESUMO
OBJECTIVES: To suggest direction for improving policies by understanding current management of narcotics or psychotropic drugs and analyzing their distributions and usage. METHOD: We conducted a comparison analysis between health insurance claims and the amount supplied to health care institutions for narcotics or psychotropic drugs through health insurance claims data and drug distribution supply data from 2010 to 2012 collected from Korea Pharmaceutical Information Service Center (KPIS). Furthermore, we carried out literature investigation and online search to comprehend the current management of narcotics drugs in Korea. RESULTS: The amount supplied to medical institutions for all drugs in 2012 was 19.4 trillion won, which increased from 19.5 trillion in 2011 by 0.54%. For narcotic drugs, the amount supplied was 318.4 billion won in 2011 and increased to 335.1 billion won by 5.3% in 2012, which exceeded the rate of increase for the amount supplied for all drugs. The proportion of amount claimed in the total amount supplied to medical institutions for all drugs was 60.5% in 2012, whereas the proportion of amount claimed for narcotic drugs was 55.6%, which showed that narcotic drugs were used relatively less within health insurance. Furthermore, management of the current domestic distribution supply data focuses on manufacturing and medical institution supply stages. CONCLUSION: Hereafter, the management of narcotics or psychotropic drugs needs to be improved by reinforcing active monitoring in optimal prescription and usage in patients by collecting and analyzing information on drug usage of patients.