目前开展的真实世界研究(real world study,RWS)仍存在诸多局限性,而未能在卫生技术评估方面充分发挥应有的作用。因此,有必要改进传统RWS设计,以产生高质量的医学证据。策略之一是仿照随机对照试验(randomized controlled trial,RCT)...目前开展的真实世界研究(real world study,RWS)仍存在诸多局限性,而未能在卫生技术评估方面充分发挥应有的作用。因此,有必要改进传统RWS设计,以产生高质量的医学证据。策略之一是仿照随机对照试验(randomized controlled trial,RCT)开展观察性研究(又称RCT仿真或模拟研究),既借鉴了RCT设计优势,增强了因果推断的强度,又保留了RWS的代表性,可以作为打通药品上市前与上市后证据链的桥梁,以期为医疗决策提供合理的证据支撑。仿照RCT开展观察性研究分为两步:第一步,基于临床问题构建一个目标试验,参照目标试验关键特征构建相应的RWS方案(包括纳排标准、治疗策略、分配程序、随访、结局定义、因果对比和统计分析策略),特别注意减小模拟差异和控制相关偏倚;第二步,使用真实世界数据(real world data,RWD)按照既定研究方案进行数据分析,得到相应结果。展开更多
目的:对全球范围内现有结直肠癌筛查指南进行系统梳理和质量评价。方法:采用系统综述的方法,对CNKI、万方、VIP、SinoMed、PubMed、Embase、Web of Science等中、英文数据库进行系统检索,检索时间截至2018年6月20日,同时检索了指南制订...目的:对全球范围内现有结直肠癌筛查指南进行系统梳理和质量评价。方法:采用系统综述的方法,对CNKI、万方、VIP、SinoMed、PubMed、Embase、Web of Science等中、英文数据库进行系统检索,检索时间截至2018年6月20日,同时检索了指南制订机构网站和主要搜索引擎,检索时间为2018年8月3日。对所有文献采用双人独立筛选、信息提取,由4名经培训的评价者使用AGREE Ⅱ(Appraisal of Guidelines for Research & Evaluation)工具对纳入指南进行质量评价。结果:共纳入符合标准的结直肠癌筛查指南46部,发布年代为1994—2018年,来自10个国家,5个地区。AGREE Ⅱ工具的评价结果显示,各指南质量在领域1(范围及目的)与领域4(表述清晰性)方面较高,在领域2(参与人员)方面中等,在领域3(过程严谨性)、领域5(适用性)和领域6(独立性)差异较大,循证指南(基于WHO指南制定标准进行定义)的质量总体优于一般指南。我国大陆现有结直肠癌筛查指南5部,均非循证指南,质量总体较低。结论:全球范围内结直肠癌筛查指南总体呈现数量多、质量较低的现状,中国大陆现有指南均不是循证指南,因此需要根据我国国情,建立高质量的结直肠筛查指南,为公共卫生实践提供可行的指导。展开更多
目的:采用系统评价和meta分析的方法评价主动脉瓣置换术中使用生物瓣膜的远期安全性结局。方法:计算机系统检索Medline、Embase、Web of Science、CENTRAL、ClinicalTrial.gov、SinoMed、中国知网、维普和万方数据库在2000年1月1日至201...目的:采用系统评价和meta分析的方法评价主动脉瓣置换术中使用生物瓣膜的远期安全性结局。方法:计算机系统检索Medline、Embase、Web of Science、CENTRAL、ClinicalTrial.gov、SinoMed、中国知网、维普和万方数据库在2000年1月1日至2019年1月26日期间发表的随机临床试验、非随机临床试验、队列研究和病例系列研究,纳入标准还包括使用生物瓣膜进行主动脉瓣膜置换术、平均随访时间≥5年、报告了相关安全性结局等。提取研究特征和相关数据,使用Stata 14.0进行meta分析。结果:最终纳入53篇文献共57个研究组,包含47803名患者。(1)全因死亡率为6.33/100人年(95%CI:5.85~6.84),亚组分析结果显示,猪瓣膜和牛心包瓣膜的死亡率分别为5.69/100人年(95%CI:5.05~6.41)和7.29/100人年(95%CI:6.53~8.13);有支架和无支架瓣膜的死亡率分别为6.69/100人年(95%CI:6.12~7.30)和5.21/100人年(95%CI:4.43~6.14)。(2)血栓栓塞的发生率为1.16/100人年(95%CI:0.96~1.40),心脏起搏器植入率为1.08/100人年(95%CI:0.75~1.54),再手术率为0.77/100人年(95%CI:0.65~0.91),脑卒中的发生率为0.74/100人年(95%CI:0.51~1.06),结构性瓣膜退化的发生率为0.73/100人年(95%CI:0.59~0.91),大出血的发生率为0.52/100人年(95%CI:0.41~0.65),心内膜炎的发生率为0.38/100人年(95%CI:0.33~0.44),非结构性瓣膜退化的发生率为0.20/100人年(95%CI:0.13~0.31)。结论:生物瓣膜的全因死亡率为6.33/100人年,血栓栓塞、心脏起搏器植入、再手术、脑卒中和结构性瓣膜退化是主要的远期并发症。展开更多
Background Pain is a common post-operative complication. Incidence of pain directly affects patients' quality of life in terms of patient physiology, psychology, and social characteristics. This study was to understa...Background Pain is a common post-operative complication. Incidence of pain directly affects patients' quality of life in terms of patient physiology, psychology, and social characteristics. This study was to understand clinical attitudes with regards to Beijing surgeons, and patients' attitude towards pain treatment after orthopedic surgery. Methods A hospital-based cross-sectional and cluster sample survey of 40 hospitals in Beijing was conducted, including 20 level III (tier three) and 20 level II (tier two) general hospitals. Enrolled subjects completed a specifically designed interview-questionnaire. Results The prevalence of pain 2 weeks post-orthopedic surgery was high in Beijing (96.1%). Meanwhile, collected data indicated most subjects in Beijing suffered moderate to severe pain, 45.1% and 41.4%, respectively, post-surgery. And for the concern of patients before surgery, most subjects chose full recovery from surgery (78.6%), as well as, the pain after operation was 39.2% ranked the third. According to the data from the study, Tramadol use was more common in Level III hospitals, where Somiton was preferred in Level II hospitals. When it came to the education of pain before and after operation, more patients get educated before operation than after it. In our study, case physicians or attending physicians enacted education before and after surgery. Related to the sense of patients, among the surgeons preferring post-operative analgesia, 67.6% considered administration when receiving complaints of moderate level pain, 50.0% indicated they will terminate analgesic treatment once pain degree scale wise decreases to benign pain. Conclusions The majority of orthopedic patients experience post-operative pain. Identification of post-operative pain will facilitate future awareness on pain treatment and nursing care in Beijing hospitals, with pain relief through regulated improvements in strategic pain management.展开更多
文摘目前开展的真实世界研究(real world study,RWS)仍存在诸多局限性,而未能在卫生技术评估方面充分发挥应有的作用。因此,有必要改进传统RWS设计,以产生高质量的医学证据。策略之一是仿照随机对照试验(randomized controlled trial,RCT)开展观察性研究(又称RCT仿真或模拟研究),既借鉴了RCT设计优势,增强了因果推断的强度,又保留了RWS的代表性,可以作为打通药品上市前与上市后证据链的桥梁,以期为医疗决策提供合理的证据支撑。仿照RCT开展观察性研究分为两步:第一步,基于临床问题构建一个目标试验,参照目标试验关键特征构建相应的RWS方案(包括纳排标准、治疗策略、分配程序、随访、结局定义、因果对比和统计分析策略),特别注意减小模拟差异和控制相关偏倚;第二步,使用真实世界数据(real world data,RWD)按照既定研究方案进行数据分析,得到相应结果。
文摘目的:对全球范围内现有结直肠癌筛查指南进行系统梳理和质量评价。方法:采用系统综述的方法,对CNKI、万方、VIP、SinoMed、PubMed、Embase、Web of Science等中、英文数据库进行系统检索,检索时间截至2018年6月20日,同时检索了指南制订机构网站和主要搜索引擎,检索时间为2018年8月3日。对所有文献采用双人独立筛选、信息提取,由4名经培训的评价者使用AGREE Ⅱ(Appraisal of Guidelines for Research & Evaluation)工具对纳入指南进行质量评价。结果:共纳入符合标准的结直肠癌筛查指南46部,发布年代为1994—2018年,来自10个国家,5个地区。AGREE Ⅱ工具的评价结果显示,各指南质量在领域1(范围及目的)与领域4(表述清晰性)方面较高,在领域2(参与人员)方面中等,在领域3(过程严谨性)、领域5(适用性)和领域6(独立性)差异较大,循证指南(基于WHO指南制定标准进行定义)的质量总体优于一般指南。我国大陆现有结直肠癌筛查指南5部,均非循证指南,质量总体较低。结论:全球范围内结直肠癌筛查指南总体呈现数量多、质量较低的现状,中国大陆现有指南均不是循证指南,因此需要根据我国国情,建立高质量的结直肠筛查指南,为公共卫生实践提供可行的指导。
文摘目的:采用系统评价和meta分析的方法评价主动脉瓣置换术中使用生物瓣膜的远期安全性结局。方法:计算机系统检索Medline、Embase、Web of Science、CENTRAL、ClinicalTrial.gov、SinoMed、中国知网、维普和万方数据库在2000年1月1日至2019年1月26日期间发表的随机临床试验、非随机临床试验、队列研究和病例系列研究,纳入标准还包括使用生物瓣膜进行主动脉瓣膜置换术、平均随访时间≥5年、报告了相关安全性结局等。提取研究特征和相关数据,使用Stata 14.0进行meta分析。结果:最终纳入53篇文献共57个研究组,包含47803名患者。(1)全因死亡率为6.33/100人年(95%CI:5.85~6.84),亚组分析结果显示,猪瓣膜和牛心包瓣膜的死亡率分别为5.69/100人年(95%CI:5.05~6.41)和7.29/100人年(95%CI:6.53~8.13);有支架和无支架瓣膜的死亡率分别为6.69/100人年(95%CI:6.12~7.30)和5.21/100人年(95%CI:4.43~6.14)。(2)血栓栓塞的发生率为1.16/100人年(95%CI:0.96~1.40),心脏起搏器植入率为1.08/100人年(95%CI:0.75~1.54),再手术率为0.77/100人年(95%CI:0.65~0.91),脑卒中的发生率为0.74/100人年(95%CI:0.51~1.06),结构性瓣膜退化的发生率为0.73/100人年(95%CI:0.59~0.91),大出血的发生率为0.52/100人年(95%CI:0.41~0.65),心内膜炎的发生率为0.38/100人年(95%CI:0.33~0.44),非结构性瓣膜退化的发生率为0.20/100人年(95%CI:0.13~0.31)。结论:生物瓣膜的全因死亡率为6.33/100人年,血栓栓塞、心脏起搏器植入、再手术、脑卒中和结构性瓣膜退化是主要的远期并发症。
文摘Background Pain is a common post-operative complication. Incidence of pain directly affects patients' quality of life in terms of patient physiology, psychology, and social characteristics. This study was to understand clinical attitudes with regards to Beijing surgeons, and patients' attitude towards pain treatment after orthopedic surgery. Methods A hospital-based cross-sectional and cluster sample survey of 40 hospitals in Beijing was conducted, including 20 level III (tier three) and 20 level II (tier two) general hospitals. Enrolled subjects completed a specifically designed interview-questionnaire. Results The prevalence of pain 2 weeks post-orthopedic surgery was high in Beijing (96.1%). Meanwhile, collected data indicated most subjects in Beijing suffered moderate to severe pain, 45.1% and 41.4%, respectively, post-surgery. And for the concern of patients before surgery, most subjects chose full recovery from surgery (78.6%), as well as, the pain after operation was 39.2% ranked the third. According to the data from the study, Tramadol use was more common in Level III hospitals, where Somiton was preferred in Level II hospitals. When it came to the education of pain before and after operation, more patients get educated before operation than after it. In our study, case physicians or attending physicians enacted education before and after surgery. Related to the sense of patients, among the surgeons preferring post-operative analgesia, 67.6% considered administration when receiving complaints of moderate level pain, 50.0% indicated they will terminate analgesic treatment once pain degree scale wise decreases to benign pain. Conclusions The majority of orthopedic patients experience post-operative pain. Identification of post-operative pain will facilitate future awareness on pain treatment and nursing care in Beijing hospitals, with pain relief through regulated improvements in strategic pain management.