In the last decade, evidence-based medical practice has been supported on a large scale by computerized decision support tools, aiming to reduce diagnostic and therapeutic uncertainty, complementing the actions of the...In the last decade, evidence-based medical practice has been supported on a large scale by computerized decision support tools, aiming to reduce diagnostic and therapeutic uncertainty, complementing the actions of the health professional. With technological developments, it is now possible to consider these systems as part of clinical intervention, both for the diagnosis and treatment of diseases. The literature has described the implementation of e-health tools, that is, technological innovations in the health area such as software, applications, serious games, among others, as a strategy to improve the process and adherence to treatment. However, there is still no standardized instrument in Brazil that can be used to guide the development, from the research phase, and the implementation of these tools as a health intervention, also impacting patient outcomes. With the objective of investigating a new therapeutic and preventive form, based on intervention with a computerized system, this work proposes the creation of guidelines for the registration and implementation of e-health tools as a clinical intervention. The proposal aims to be able to assist in the reporting standardization from the development stage to the application of the e-health tool helping in the treatment of diseases, registering all the experience lived in the research and applying it in different contexts of health.展开更多
Background: A number of strategies exist for the implementation of clinical practice guides (CPGs). Aim: To assess the efficacy of implementing a cardiovascular risk CPG based on an educational method involving opinio...Background: A number of strategies exist for the implementation of clinical practice guides (CPGs). Aim: To assess the efficacy of implementing a cardiovascular risk CPG based on an educational method involving opinion leaders, and the habitual method of dissemination among primary healthcare teams. Design and Setting: Controlled, blinded, community intervention trial randomised by clusters. Methods: 21 primary healthcare centres were randomly assigned to either the intervention arm (n = 11) or the control arm (n = 10). The study subjects were patients aged ≥45 years assigned to the centres. The overall impact of the intervention was measured as the difference between the increase in the proportion of patients whose medical records showed the recording of all the variables necessary to calculate cardiovascular risk in both arms. Analyses were performed with Generalized Lineal Model on an intention-to-treat basis. Results: 917 subjects were included at the beginning of the trial (437 in the intervention arm and 480 in the control arm). 826 subjects were included in the final evaluation (436 in the intervention group and 390 in the control arm). At the end of the trial, the recording of the variables necessary for the calculation of the cardiovascular risk in the intervention group had increased more than in the control group (difference between increases 7.49% (95% CI 4.62 - 10.35)) after adjusting for confounding variables. Conclusions: Compared to the habitual method of dissemination, the implementation of this CPG using an educational method involving opinion leaders, improved the recording of the variables needed to calculate patients’ cardiovascular risk.展开更多
Major advances have occurred within the last decade in the understanding of the pathogenesis of coronary artery disease. Not only are the underlying mechanisms now clearly defined, but effective medical therapies are ...Major advances have occurred within the last decade in the understanding of the pathogenesis of coronary artery disease. Not only are the underlying mechanisms now clearly defined, but effective medical therapies are available at low cost and minimal side effects. In spite of these advances, cardiovascular events are still the leading cause of death in the United States and the Western world. Analysis of the many factors involved in the delivery of appropriate cardiovascular care strongly suggests that the primary reason is the overly restrictive guidelines published by medical societies. This article proposes a much broader basis for constructing atherosclerosis clinical guidelines, namely the known pathophysiology of atherosclerosis. If pathophysiology forms the basis of atherosclerotic treatment recommendations, then a risk/benefit analysis can be used to determine appropriate preventive therapy for any specific individual. The result will be that many additional individuals will be eligible for preventive treatment of atherosclerosis, and the saving of many lives at minimal cost will result.展开更多
Aims: Increasing focus on improvement and optimisation of the treatment in primary care and reduction of healthcare costs emphasize the need to understand which factors determines adherence and non-adherence to clinic...Aims: Increasing focus on improvement and optimisation of the treatment in primary care and reduction of healthcare costs emphasize the need to understand which factors determines adherence and non-adherence to clinical guidelines. In the present study, we examined attitudes towards clinical guidelines in Danish general practitioners (GPs). Methods: We conducted a survey among Danish GPs from all five regions of Denmark. In total, 443 GPs answered the web-based questionnaire that contained questions about attitudes and barriers to clinical guidelines. Results: More than 90% of the GPs reported that they have good knowledge of the guidelines and in general follows the guidelines. A majority of the GPs (81%) found it acceptable that economic considerations are part of the guidelines. The most important factors for non- adherence to guidelines were “need of adjustment to clinical practice” and “lack of confidence in guidelines”. The attitudes to clinical guidelines were not significantly associated with practice characteristics such as gender, years of experience, practice organisation and localisation. Conclusions: Our findings show that clinical guidelines are an integrated or internalised part of everyday practice among GPs in Denmark. Furthermore, the findings indicate that Danish GPs are positive towards applying priority setting in their practice. This is decisive in the light of rising healthcare costs due to development of new expensive technologies and ageing populations that puts pressure on the healthcare system in general and primary healthcare in particular.展开更多
Chronic hepatitis B(CHB)virus infection is a global public health problem,affecting more than 400 million people worldwide.The clinical spectrum is wide,ranging from a subclinical inactive carrier state,to progressive...Chronic hepatitis B(CHB)virus infection is a global public health problem,affecting more than 400 million people worldwide.The clinical spectrum is wide,ranging from a subclinical inactive carrier state,to progressive chronic hepatitis,cirrhosis,decompensation,and hepatocellular carcinoma.However,complications of hepatitis B virus(HBV)-related chronic liver disease may be reduced by viral suppression.Current international guidelines recommend first-line treatment of CHB infection with pegylated interferon,entecavir,or tenofovir,but the optimal treatment for an individualpatient is controversial.The indications for treatment are contentious,and increasing evidence suggests that HBV genotyping,as well as serial on-treatment measurements of hepatitis B surface antigen and HBV DNA kinetics should be used to predict antiviral treatment response.The likelihood of achieving a sustained virological response is also increased by extending treatment duration,and using combination therapy.Hence the paradigm for treatment of CHB is constantly evolving.This article summarizes the different indications for treatment,and systematically reviews the evidence for the efficacy of various antiviral agents.It further discusses the shortcomings of current guidelines,use of rescue therapy in drug-resistant strains of HBV,and highlights the promising clinical trials for emerging therapies in the pipeline.This concise overview presents an updated practical approach to guide the clinical management of CHB.展开更多
目的:为完善我国药物临床试验中的药品管理提出建议。方法:以"药物临床试验质量管理规范""临床试验药物""临床试验用药品""GCP""Investigational drug products"等为关键词,组合查...目的:为完善我国药物临床试验中的药品管理提出建议。方法:以"药物临床试验质量管理规范""临床试验药物""临床试验用药品""GCP""Investigational drug products"等为关键词,组合查询中国知网、万方数据、PubMed、OVID等数据库2014年7月-2018年7月收录的相关文献,对中美药物临床试验中的药品管理指南、管理体系(包括管理模式、人员配置、预算评估)的差异进行归纳总结,并对我国临床试验用药品管理过程中的不足提出建议。结果与结论:共检索到相关文献154篇,其中有效文献33篇。美国临床试验用药品管理指南较为完善,比如有美国医院药师学会颁布的《临床试验药品管理指南》,而我国尚未出台此类全国性指南。美国临床试验用药品管理包括医院药事部门药师兼职管理和多名专职药师与药学技术员管理2种模式,由药师或药学技术人员参与管理的全流程,且对临床试验用药品管理预算评估开展了较多研究;我国临床试验用药品管理包括专职药师管理、专职药师与兼职护士管理、兼职药师与兼职护士管理3种模式,由药师和护士共同参与管理但尚未做到全流程管理,且对临床试验用药品管理预算评估研究较少。建议我国临床试验用药品管理可通过细化临床试验用药品管理制度、规范临床试验用药品管理模式以及开展管理预算评估等方式,提高临床试验用药品的管理效率和水平,促进我国药物临床试验管理质量的提升。展开更多
文摘In the last decade, evidence-based medical practice has been supported on a large scale by computerized decision support tools, aiming to reduce diagnostic and therapeutic uncertainty, complementing the actions of the health professional. With technological developments, it is now possible to consider these systems as part of clinical intervention, both for the diagnosis and treatment of diseases. The literature has described the implementation of e-health tools, that is, technological innovations in the health area such as software, applications, serious games, among others, as a strategy to improve the process and adherence to treatment. However, there is still no standardized instrument in Brazil that can be used to guide the development, from the research phase, and the implementation of these tools as a health intervention, also impacting patient outcomes. With the objective of investigating a new therapeutic and preventive form, based on intervention with a computerized system, this work proposes the creation of guidelines for the registration and implementation of e-health tools as a clinical intervention. The proposal aims to be able to assist in the reporting standardization from the development stage to the application of the e-health tool helping in the treatment of diseases, registering all the experience lived in the research and applying it in different contexts of health.
文摘Background: A number of strategies exist for the implementation of clinical practice guides (CPGs). Aim: To assess the efficacy of implementing a cardiovascular risk CPG based on an educational method involving opinion leaders, and the habitual method of dissemination among primary healthcare teams. Design and Setting: Controlled, blinded, community intervention trial randomised by clusters. Methods: 21 primary healthcare centres were randomly assigned to either the intervention arm (n = 11) or the control arm (n = 10). The study subjects were patients aged ≥45 years assigned to the centres. The overall impact of the intervention was measured as the difference between the increase in the proportion of patients whose medical records showed the recording of all the variables necessary to calculate cardiovascular risk in both arms. Analyses were performed with Generalized Lineal Model on an intention-to-treat basis. Results: 917 subjects were included at the beginning of the trial (437 in the intervention arm and 480 in the control arm). 826 subjects were included in the final evaluation (436 in the intervention group and 390 in the control arm). At the end of the trial, the recording of the variables necessary for the calculation of the cardiovascular risk in the intervention group had increased more than in the control group (difference between increases 7.49% (95% CI 4.62 - 10.35)) after adjusting for confounding variables. Conclusions: Compared to the habitual method of dissemination, the implementation of this CPG using an educational method involving opinion leaders, improved the recording of the variables needed to calculate patients’ cardiovascular risk.
文摘Major advances have occurred within the last decade in the understanding of the pathogenesis of coronary artery disease. Not only are the underlying mechanisms now clearly defined, but effective medical therapies are available at low cost and minimal side effects. In spite of these advances, cardiovascular events are still the leading cause of death in the United States and the Western world. Analysis of the many factors involved in the delivery of appropriate cardiovascular care strongly suggests that the primary reason is the overly restrictive guidelines published by medical societies. This article proposes a much broader basis for constructing atherosclerosis clinical guidelines, namely the known pathophysiology of atherosclerosis. If pathophysiology forms the basis of atherosclerotic treatment recommendations, then a risk/benefit analysis can be used to determine appropriate preventive therapy for any specific individual. The result will be that many additional individuals will be eligible for preventive treatment of atherosclerosis, and the saving of many lives at minimal cost will result.
文摘Aims: Increasing focus on improvement and optimisation of the treatment in primary care and reduction of healthcare costs emphasize the need to understand which factors determines adherence and non-adherence to clinical guidelines. In the present study, we examined attitudes towards clinical guidelines in Danish general practitioners (GPs). Methods: We conducted a survey among Danish GPs from all five regions of Denmark. In total, 443 GPs answered the web-based questionnaire that contained questions about attitudes and barriers to clinical guidelines. Results: More than 90% of the GPs reported that they have good knowledge of the guidelines and in general follows the guidelines. A majority of the GPs (81%) found it acceptable that economic considerations are part of the guidelines. The most important factors for non- adherence to guidelines were “need of adjustment to clinical practice” and “lack of confidence in guidelines”. The attitudes to clinical guidelines were not significantly associated with practice characteristics such as gender, years of experience, practice organisation and localisation. Conclusions: Our findings show that clinical guidelines are an integrated or internalised part of everyday practice among GPs in Denmark. Furthermore, the findings indicate that Danish GPs are positive towards applying priority setting in their practice. This is decisive in the light of rising healthcare costs due to development of new expensive technologies and ageing populations that puts pressure on the healthcare system in general and primary healthcare in particular.
基金Supported by Collaborative Research Fund(CUHK3/CRF/12RHKU3/CRF11R)of the Research Grant Council Hong Kong+2 种基金National Basic Research Program of China,973 Program,No.2013CB531401CUHK Focused Investments Scheme B to HY LanTheme-based Research Scheme of the Hong Kong Re-search Grants Council,No.T12-403-11
文摘Chronic hepatitis B(CHB)virus infection is a global public health problem,affecting more than 400 million people worldwide.The clinical spectrum is wide,ranging from a subclinical inactive carrier state,to progressive chronic hepatitis,cirrhosis,decompensation,and hepatocellular carcinoma.However,complications of hepatitis B virus(HBV)-related chronic liver disease may be reduced by viral suppression.Current international guidelines recommend first-line treatment of CHB infection with pegylated interferon,entecavir,or tenofovir,but the optimal treatment for an individualpatient is controversial.The indications for treatment are contentious,and increasing evidence suggests that HBV genotyping,as well as serial on-treatment measurements of hepatitis B surface antigen and HBV DNA kinetics should be used to predict antiviral treatment response.The likelihood of achieving a sustained virological response is also increased by extending treatment duration,and using combination therapy.Hence the paradigm for treatment of CHB is constantly evolving.This article summarizes the different indications for treatment,and systematically reviews the evidence for the efficacy of various antiviral agents.It further discusses the shortcomings of current guidelines,use of rescue therapy in drug-resistant strains of HBV,and highlights the promising clinical trials for emerging therapies in the pipeline.This concise overview presents an updated practical approach to guide the clinical management of CHB.
文摘目的:为完善我国药物临床试验中的药品管理提出建议。方法:以"药物临床试验质量管理规范""临床试验药物""临床试验用药品""GCP""Investigational drug products"等为关键词,组合查询中国知网、万方数据、PubMed、OVID等数据库2014年7月-2018年7月收录的相关文献,对中美药物临床试验中的药品管理指南、管理体系(包括管理模式、人员配置、预算评估)的差异进行归纳总结,并对我国临床试验用药品管理过程中的不足提出建议。结果与结论:共检索到相关文献154篇,其中有效文献33篇。美国临床试验用药品管理指南较为完善,比如有美国医院药师学会颁布的《临床试验药品管理指南》,而我国尚未出台此类全国性指南。美国临床试验用药品管理包括医院药事部门药师兼职管理和多名专职药师与药学技术员管理2种模式,由药师或药学技术人员参与管理的全流程,且对临床试验用药品管理预算评估开展了较多研究;我国临床试验用药品管理包括专职药师管理、专职药师与兼职护士管理、兼职药师与兼职护士管理3种模式,由药师和护士共同参与管理但尚未做到全流程管理,且对临床试验用药品管理预算评估研究较少。建议我国临床试验用药品管理可通过细化临床试验用药品管理制度、规范临床试验用药品管理模式以及开展管理预算评估等方式,提高临床试验用药品的管理效率和水平,促进我国药物临床试验管理质量的提升。
