近年来实效性临床试验受到更多重视,尤其在传统医学临床评价研究领域。为了提高实效性临床试验报告的质量,CONSORT声明组和医疗保健体系中的实效性随机对照临床试验(pragmatic randomized controlled trials in health care systems,PRA...近年来实效性临床试验受到更多重视,尤其在传统医学临床评价研究领域。为了提高实效性临床试验报告的质量,CONSORT声明组和医疗保健体系中的实效性随机对照临床试验(pragmatic randomized controlled trials in health care systems,PRACTIHC)小组对《CONSORT声明》进行了修改,以帮助读者评估试验质量和结果的可靠性。实效性试验报告指南,作为《CONSORT声明》的一个特殊扩展,能在报告、评价和应用实效性试验方面帮助编辑、系统评价者、试验设计者和决策者评估实效性试验报告中的信息,判定其结论是否适用,以及干预措施是否可行、可否被接受。2005年1月和2008年3月,在加拿大多伦多分别举行了为期两天的会议来探讨提高随机对照试验对卫生保健决策贡献的方法,焦点集中于实效性试验。2005年会,后扩展版草案修订清单发送至编写组成员,经过几次修订,编写组起草了一份摘要草案。在2008年讨论并修改了这一草案。这份草案发给CONSORT声明组以供修改并发表。这份声明的扩展版提出了对8个条目的补充。及时向国内读者和临床试验研究人员介绍该指南有重要的现实意义和学术价值。北京中医药大学循证医学中心刘建平教授等在短时间内翻译了该指南。本刊希望通过介绍中文版"提高实效性临床试验报告的质量——《CONSORT声明》的扩展"以提高国内实效性临床试验报告的质量,相信也有助于改进试验设计的方法学质量。展开更多
CONSORT声明被广泛用于提高随机对照临床试验的报告质量。Kenneth Schulz等对CONSORT声明的最新版本CONSORT2010作了详细说明,该版本基于新获得的方法学证据和经验的积累对报告指南作了更新。为了鼓励更多的人使用"CONSORT2010声明...CONSORT声明被广泛用于提高随机对照临床试验的报告质量。Kenneth Schulz等对CONSORT声明的最新版本CONSORT2010作了详细说明,该版本基于新获得的方法学证据和经验的积累对报告指南作了更新。为了鼓励更多的人使用"CONSORT2010声明",本文可从bmj.com免费获取,也将在Lancet,Obstetrics and Gynecology,PLoS Medicine,Annals of Internal Medicine,Open Medicine,Journal of Clinical Epidemiology,BMC Medicine和Trials等杂志发表。展开更多
AIM:To examine the determinants of maternal-neonatal transmission of hepatitis B virus(HBV) METHODS:A nested case-control study was conducted in Changsha,Hunan,People's Republic of China from January 1,2005 to Sep...AIM:To examine the determinants of maternal-neonatal transmission of hepatitis B virus(HBV) METHODS:A nested case-control study was conducted in Changsha,Hunan,People's Republic of China from January 1,2005 to September 31,2006 To avoid potential maternal blood contamination,we collected vein blood of newborns immediately after birth and before initial hepatitis B vaccination to determine the HBV infection status of the newborn For each HBsAg-positive infant,one HBsAg-negative infant born to an HBsAg-positive mother was matched by hospital at birth(same),gender(same),and date of birth(within 1 mo) A faceto-face interview was conducted to collect clinical and epidemiological data Conditional logistic regression analysis was used to estimate the independent effects of various determinants on maternal-neonatal transmission of HBV RESULTS:A total of 141 HBsAg-positive infants and 141 individually matched HBsAg-negative infants were included in the final analysis Maternal first-degree family history of HBV infection,intrahepatic cholestasis,and premature rupture of membranes were risk factors for perinatal transmission of HBV,whereas systematic treatment and HBV immunoglobulin injections for mothers with HBV infection were protective factors for maternal-neonatal transmission of HBV,after adjustment for potential confounding factors CONCLUSION:For HBsAg-positive mothers,systematic treatment,HBV immunoglobulin administration,and controlling intrahepatic cholestasis and pregnancy complications may reduce the incidence of perinatal transmission of HBV.展开更多
Transparent reports of randomized trials occupy a central position in the delivery of evidence-based medicine;they can be used in systematic reviews and meta-analyses and,in turn,these reviews are often the starting p...Transparent reports of randomized trials occupy a central position in the delivery of evidence-based medicine;they can be used in systematic reviews and meta-analyses and,in turn,these reviews are often the starting point for appropriately developed practice guidance for clinicians.The most useful trial reports are those that are transparent,namely,the design and conduct is accurately and completely reported.Such reports enable readers to understand how the trial was conducted and therefore interpret the results.Reports that fail to meet this criterion are problematic for everybody — readers are left with an incomplete picture of what was done.As such,they are not able to judge the reliability and validity of the results and interpret them.Inadequate reporting is also problematic for those who participate in trials in the hope that their contributions will be of use to future patients;it diminishes this possibility.展开更多
In August of 2022,I gave the opening keynote address at the 5th North American Congress on Biomechanics,in Ottawa,Canada.The topic of my talk was about whether the research ecosystem was getting a reasonable return on...In August of 2022,I gave the opening keynote address at the 5th North American Congress on Biomechanics,in Ottawa,Canada.The topic of my talk was about whether the research ecosystem was getting a reasonable return on its investment in biomedical research.I provided several examples as to why I posed this question.展开更多
The ongoing coronavirus disease 2019(COVID-19)pandemic continues to present diagnostic challenges.The use of thoracic radiography has been studied as a method to improve the diagnostic accuracy of COVID-19.The‘Living...The ongoing coronavirus disease 2019(COVID-19)pandemic continues to present diagnostic challenges.The use of thoracic radiography has been studied as a method to improve the diagnostic accuracy of COVID-19.The‘Living’Cochrane Systematic Review on the diagnostic accuracy of imaging tests for COVID-19 is continuously updated as new information becomes available for study.In the most recent version,published in March 2021,a meta-analysis was done to determine the pooled sensitivity and specificity of chest X-ray(CXR)and lung ultrasound(LUS)for the diagnosis of COVID-19.CXR gave a sensitivity of 80.6%(95%CI:69.1-88.6)and a specificity of 71.5%(95%CI:59.8-80.8).LUS gave a sensitivity rate of 86.4%(95%CI:72.7-93.9)and specificity of 54.6%(95%CI:35.3-72.6).These results differed from the findings reported in the recent article in this journal where they cited the previous versions of the study in which a metaanalysis for CXR and LUS could not be performed.Additionally,the article states that COVID-19 could not be distinguished,using chest computed tomography(CT),from other respiratory diseases.However,the latest review version identifies chest CT as having a specificity of 80.0%(95%CI:74.9-84.3),which is much higher than the previous version which indicated a specificity of 61.1%(95%CI:42.3-77.1).Therefore,CXR,chest CT and LUS have the potential to be used in conjunction with other methods in the diagnosis of COVID-19.展开更多
How to select a research topic that is appropriate for a clinician and that can lead to a peer-reviewed publication?In this essay,I will provide 5 tips:keep it interesting,keep it relevant,keep it inclusive,keep it si...How to select a research topic that is appropriate for a clinician and that can lead to a peer-reviewed publication?In this essay,I will provide 5 tips:keep it interesting,keep it relevant,keep it inclusive,keep it simple,and keep it trying.Keep it展开更多
Objective The concept of the‘self-fulfilling prophecy’is well established in intracerebral haemorrhage(ICH).The ability to improve prognostication and prediction of long-term outcomes during the first days of hospit...Objective The concept of the‘self-fulfilling prophecy’is well established in intracerebral haemorrhage(ICH).The ability to improve prognostication and prediction of long-term outcomes during the first days of hospitalisation is important in guiding conversations around goals of care.We previously demonstrated that incorporating delayed imaging into various prognostication scores for ICH improves the predictive accuracy of 90-day mortality.However,delayed prognostication scores have not been used to predict long-term functional outcomes beyond 90 days.Design,setting and participants We analysed data from the ICH Deferoxamine trial to see if delaying the use of prognostication scores to 96 hours after ICH onset will improve performance to predict outcomes at 180 days.276 patients were included.Interventions and measurements We calculated the original ICH score(oICH),modified-ICH score(MICH),max-ICH score and the FUNC score on presentation(baseline),and on day 4(delayed).Outcomes assessed were mortality and poor functional outcome in survivors(defined as modified Rankin Scale of 4-5)at 180 days.We generated receiver operating characteristic curves,and measured the area under the curve values(AUC)for mortality and functional outcome.We compared baseline and delayed AUCs with non-parametric methods.Results At 180 days,21 of 276(7.6%)died.Out of the survivors,54 of 255 had poor functional outcome(21.2%).The oICH,MICH and max-ICH performed significantly better at predicting 180-day mortality when calculated 4 days later compared with their baseline equivalents((0.74 vs 0.83,p=0.005),(0.73 vs 0.80,p=0.036),(0.74 vs 0.83,p=0.008),respectively).The delayed calculation of these scores did not significantly improve our accuracy for predicting poor functional outcomes.Conclusion Delaying the calculation of prognostication scores in acute ICH until day 4 improved prediction of 6-month mortality but not functional outcomes.Trial registration number ClinicalTrials.gov Registry(NCT02175225).展开更多
“It is the responsibility of everyone involved to ensure that the published record is an unbiased,accurate representation of research”[1].The research record is often manipulated for short term gain but at the risk ...“It is the responsibility of everyone involved to ensure that the published record is an unbiased,accurate representation of research”[1].The research record is often manipulated for short term gain but at the risk of harm to patients.The medical research community needs to implement changes to ensure that readers obtain the truth about all research,especially reports of randomised trials,which hold a special place in answering what works best for patients.展开更多
Background Changing health care providers frequently breaks the continuity of care,which is associated with many health care problems.The purpose of this study was to examine the association between a change of health...Background Changing health care providers frequently breaks the continuity of care,which is associated with many health care problems.The purpose of this study was to examine the association between a change of health care providers and pregnancy exposure to FDA category C,D and X drugs.Methods A 50% random sample of women who gave a birth in Saskatchewan between January 1,1997 and December 31,2000 were chosen for this study.The association between the number of changes in health care providers and with pregnancy exposure to category C,D,and X drugs for those women with and without chronic diseases were evaluated using multiple logistical regression,with adjusted odds ratios （ORs） and its 95% confidence intervals （C/s） as the association measures.Results A total of 18 568 women were included in this study.Rates of FDA C,D,and X drug uses were 14.35%,17.07%,21.72%,and 31.14%,in women with no change of provider,1-2 changes,3-5 changes,and more than 5 changes of health care providers.An association between the number of changes of health care providers and pregnancy exposure to FDA C,D,and X drugs existed in women without chronic diseases but not in women with chronic disease.Conclusion Change of health care providers is associated with pregnancy exposure to FDA category C,D and X drugs in women without chronic diseases.展开更多
文摘近年来实效性临床试验受到更多重视,尤其在传统医学临床评价研究领域。为了提高实效性临床试验报告的质量,CONSORT声明组和医疗保健体系中的实效性随机对照临床试验(pragmatic randomized controlled trials in health care systems,PRACTIHC)小组对《CONSORT声明》进行了修改,以帮助读者评估试验质量和结果的可靠性。实效性试验报告指南,作为《CONSORT声明》的一个特殊扩展,能在报告、评价和应用实效性试验方面帮助编辑、系统评价者、试验设计者和决策者评估实效性试验报告中的信息,判定其结论是否适用,以及干预措施是否可行、可否被接受。2005年1月和2008年3月,在加拿大多伦多分别举行了为期两天的会议来探讨提高随机对照试验对卫生保健决策贡献的方法,焦点集中于实效性试验。2005年会,后扩展版草案修订清单发送至编写组成员,经过几次修订,编写组起草了一份摘要草案。在2008年讨论并修改了这一草案。这份草案发给CONSORT声明组以供修改并发表。这份声明的扩展版提出了对8个条目的补充。及时向国内读者和临床试验研究人员介绍该指南有重要的现实意义和学术价值。北京中医药大学循证医学中心刘建平教授等在短时间内翻译了该指南。本刊希望通过介绍中文版"提高实效性临床试验报告的质量——《CONSORT声明》的扩展"以提高国内实效性临床试验报告的质量,相信也有助于改进试验设计的方法学质量。
文摘CONSORT声明被广泛用于提高随机对照临床试验的报告质量。Kenneth Schulz等对CONSORT声明的最新版本CONSORT2010作了详细说明,该版本基于新获得的方法学证据和经验的积累对报告指南作了更新。为了鼓励更多的人使用"CONSORT2010声明",本文可从bmj.com免费获取,也将在Lancet,Obstetrics and Gynecology,PLoS Medicine,Annals of Internal Medicine,Open Medicine,Journal of Clinical Epidemiology,BMC Medicine和Trials等杂志发表。
基金United Kingdom National Institute for Health ResearchCanadian Institutes of Health Research+4 种基金Presidents FundCanadian Institutes of Health ResearchJohnson & JohnsonBMJthe American Society for Clinical Oncology
文摘大量证据显示随机对照临床试验(randomised controlled trial,RCT)的报告质量不理想。报告不透明,则读者既不能评判试验结果是否真实可靠,也不能从中提取可用于系统综述的信息。最近的方法学分析表明,报告不充分和设计不合理与对治疗效果产生评价偏倚有关。这种系统误差对RCT损害严重,而RCT正是以其能减少或避免偏倚而被视为评价干预措施的金标准。为了提高RCT的报告质量,一个由专家和编辑组成的工作组制定了临床试验报告的统一标准(Consolidated Standards of Reporting Trials,CONSORT)声明。CONSORT声明于1996年首次发表,并于2001年更新。声明由对照检查清单和流程图组成,供作者在报告RCT时使用。许多核心医学期刊和主要国际性编辑组织都已认可CONSORT声明。该声明促进了对RCT的严格评价和解释。2001年,在对CONSORT进行修订时,人们就已经清楚地认识到,解释和说明制定CONSORT声明的原理,有助于研究人员等撰写或评价临床试验报告。一篇CONSORT说明与详述文章于2001年同2001版CONSORT声明一起发表。2007年1月的专家会议之后,对CONSORT声明作了进一步修订并已发表,即"CONSORT2010声明"。这次更新对原版对照检查清单作了文字上的修改,使其更为明晰,并收入了与一些新近才认识到的主题相关的建议,如选择性报告结局产生的偏倚。说明与详述文件旨在加强人们对CONSORT声明的理解、应用和传播,这次也作了大量修订,对每一项新增或更新的清单条目的含义和增改理由进行了解释,提供了优秀的报告实例,还尽可能地提供了相关的经验性研究的参考文献。文中收入了若干流程图实例。"CONSORT2010声明"、其说明与详述文件,以及相关网站(www.consort-statement.org),对于改进随机临床试验报告必将有所裨益。
基金Supported by Hunan Ministry of Science and Technology,No.06FJ3177,China
文摘AIM:To examine the determinants of maternal-neonatal transmission of hepatitis B virus(HBV) METHODS:A nested case-control study was conducted in Changsha,Hunan,People's Republic of China from January 1,2005 to September 31,2006 To avoid potential maternal blood contamination,we collected vein blood of newborns immediately after birth and before initial hepatitis B vaccination to determine the HBV infection status of the newborn For each HBsAg-positive infant,one HBsAg-negative infant born to an HBsAg-positive mother was matched by hospital at birth(same),gender(same),and date of birth(within 1 mo) A faceto-face interview was conducted to collect clinical and epidemiological data Conditional logistic regression analysis was used to estimate the independent effects of various determinants on maternal-neonatal transmission of HBV RESULTS:A total of 141 HBsAg-positive infants and 141 individually matched HBsAg-negative infants were included in the final analysis Maternal first-degree family history of HBV infection,intrahepatic cholestasis,and premature rupture of membranes were risk factors for perinatal transmission of HBV,whereas systematic treatment and HBV immunoglobulin injections for mothers with HBV infection were protective factors for maternal-neonatal transmission of HBV,after adjustment for potential confounding factors CONCLUSION:For HBsAg-positive mothers,systematic treatment,HBV immunoglobulin administration,and controlling intrahepatic cholestasis and pregnancy complications may reduce the incidence of perinatal transmission of HBV.
文摘Transparent reports of randomized trials occupy a central position in the delivery of evidence-based medicine;they can be used in systematic reviews and meta-analyses and,in turn,these reviews are often the starting point for appropriately developed practice guidance for clinicians.The most useful trial reports are those that are transparent,namely,the design and conduct is accurately and completely reported.Such reports enable readers to understand how the trial was conducted and therefore interpret the results.Reports that fail to meet this criterion are problematic for everybody — readers are left with an incomplete picture of what was done.As such,they are not able to judge the reliability and validity of the results and interpret them.Inadequate reporting is also problematic for those who participate in trials in the hope that their contributions will be of use to future patients;it diminishes this possibility.
文摘In August of 2022,I gave the opening keynote address at the 5th North American Congress on Biomechanics,in Ottawa,Canada.The topic of my talk was about whether the research ecosystem was getting a reasonable return on its investment in biomedical research.I provided several examples as to why I posed this question.
文摘The ongoing coronavirus disease 2019(COVID-19)pandemic continues to present diagnostic challenges.The use of thoracic radiography has been studied as a method to improve the diagnostic accuracy of COVID-19.The‘Living’Cochrane Systematic Review on the diagnostic accuracy of imaging tests for COVID-19 is continuously updated as new information becomes available for study.In the most recent version,published in March 2021,a meta-analysis was done to determine the pooled sensitivity and specificity of chest X-ray(CXR)and lung ultrasound(LUS)for the diagnosis of COVID-19.CXR gave a sensitivity of 80.6%(95%CI:69.1-88.6)and a specificity of 71.5%(95%CI:59.8-80.8).LUS gave a sensitivity rate of 86.4%(95%CI:72.7-93.9)and specificity of 54.6%(95%CI:35.3-72.6).These results differed from the findings reported in the recent article in this journal where they cited the previous versions of the study in which a metaanalysis for CXR and LUS could not be performed.Additionally,the article states that COVID-19 could not be distinguished,using chest computed tomography(CT),from other respiratory diseases.However,the latest review version identifies chest CT as having a specificity of 80.0%(95%CI:74.9-84.3),which is much higher than the previous version which indicated a specificity of 61.1%(95%CI:42.3-77.1).Therefore,CXR,chest CT and LUS have the potential to be used in conjunction with other methods in the diagnosis of COVID-19.
文摘How to select a research topic that is appropriate for a clinician and that can lead to a peer-reviewed publication?In this essay,I will provide 5 tips:keep it interesting,keep it relevant,keep it inclusive,keep it simple,and keep it trying.Keep it
基金support ongoing meetings was provided by ISPOR-The Professional Society for Health Economics and Outcomes ResearchThe funders had no role in considering the study design or in the collection,analysis,interpretation of data,or writing of the report.Funding for DH and the Delphi Panel exercise was provided by 9363980 Canada Ine+1 种基金the NIHR Applied Research Collaboration(ARC)West Midlandsthe NIHR Health Protection Research Unit(HPRU)Gastrointestinal Infections,and the NIHR HPRU Genomics and Enabling data.
文摘Objective The concept of the‘self-fulfilling prophecy’is well established in intracerebral haemorrhage(ICH).The ability to improve prognostication and prediction of long-term outcomes during the first days of hospitalisation is important in guiding conversations around goals of care.We previously demonstrated that incorporating delayed imaging into various prognostication scores for ICH improves the predictive accuracy of 90-day mortality.However,delayed prognostication scores have not been used to predict long-term functional outcomes beyond 90 days.Design,setting and participants We analysed data from the ICH Deferoxamine trial to see if delaying the use of prognostication scores to 96 hours after ICH onset will improve performance to predict outcomes at 180 days.276 patients were included.Interventions and measurements We calculated the original ICH score(oICH),modified-ICH score(MICH),max-ICH score and the FUNC score on presentation(baseline),and on day 4(delayed).Outcomes assessed were mortality and poor functional outcome in survivors(defined as modified Rankin Scale of 4-5)at 180 days.We generated receiver operating characteristic curves,and measured the area under the curve values(AUC)for mortality and functional outcome.We compared baseline and delayed AUCs with non-parametric methods.Results At 180 days,21 of 276(7.6%)died.Out of the survivors,54 of 255 had poor functional outcome(21.2%).The oICH,MICH and max-ICH performed significantly better at predicting 180-day mortality when calculated 4 days later compared with their baseline equivalents((0.74 vs 0.83,p=0.005),(0.73 vs 0.80,p=0.036),(0.74 vs 0.83,p=0.008),respectively).The delayed calculation of these scores did not significantly improve our accuracy for predicting poor functional outcomes.Conclusion Delaying the calculation of prognostication scores in acute ICH until day 4 improved prediction of 6-month mortality but not functional outcomes.Trial registration number ClinicalTrials.gov Registry(NCT02175225).
文摘“It is the responsibility of everyone involved to ensure that the published record is an unbiased,accurate representation of research”[1].The research record is often manipulated for short term gain but at the risk of harm to patients.The medical research community needs to implement changes to ensure that readers obtain the truth about all research,especially reports of randomised trials,which hold a special place in answering what works best for patients.
基金United Kingdom National Institute for Health Research and the Medical Research CouncilCanadian Institutes of Health Research+7 种基金Presidents FundCanadian Institutes of Health ResearchJohnson&JohnsonBMJthe American Society for Clinical OncologyDouglas G Altman受Cancer Research UK资助David Moher受University of Ottawa Research Chair资助Kenneth F Schulz受Fami-ly Health International资助
文摘CONSORT声明被广泛应用于提高随机对照临床试验的报告质量。Kenneth Schulz等对CONSORT声明的最新版本CONSORT 2010作了详细说明,该版本基于新获得的方法学证据和经验的积累对报告指南作了更新。为了鼓励更多的人使用"CONSORT 2010声明",本文可从www.bmj.com免费获取,也将在Lancet,Obstetrics and Gynecology,PLoS Medicine,Annals of Internal Medicine,Open Medicine,Journal of Clinical Epidemiology,BMC Medicine和Trials等杂志发表。
文摘Background Changing health care providers frequently breaks the continuity of care,which is associated with many health care problems.The purpose of this study was to examine the association between a change of health care providers and pregnancy exposure to FDA category C,D and X drugs.Methods A 50% random sample of women who gave a birth in Saskatchewan between January 1,1997 and December 31,2000 were chosen for this study.The association between the number of changes in health care providers and with pregnancy exposure to category C,D,and X drugs for those women with and without chronic diseases were evaluated using multiple logistical regression,with adjusted odds ratios （ORs） and its 95% confidence intervals （C/s） as the association measures.Results A total of 18 568 women were included in this study.Rates of FDA C,D,and X drug uses were 14.35%,17.07%,21.72%,and 31.14%,in women with no change of provider,1-2 changes,3-5 changes,and more than 5 changes of health care providers.An association between the number of changes of health care providers and pregnancy exposure to FDA C,D,and X drugs existed in women without chronic diseases but not in women with chronic disease.Conclusion Change of health care providers is associated with pregnancy exposure to FDA category C,D and X drugs in women without chronic diseases.
