Background:The increasing number of Alzheimer’s Disease has become a global health issue.Whether randomized controlled trials are fully reported has an immediate effect on the translation as well as implementation of...Background:The increasing number of Alzheimer’s Disease has become a global health issue.Whether randomized controlled trials are fully reported has an immediate effect on the translation as well as implementation of research conclusions.However,the overall reporting quality of randomized controlled trials for cognitive interventions among Alzheimer’s Disease is unclear.Methods:Randomized controlled trials of cognitive inter-ventions among Alzheimer’s Dementia were searched from Cnki,Embase,Pubmed,Web of Science,WanFang Data,Cochrane Library,and VIP from their inception to December9th 2019.Firstly,the average CONSORT(Consolidated Standards of Reporting Trials)compliance of randomized controlled trials for cognitive interventions among Alzheimer’s Disease was estab-lished.Secondly,the compliance of per CONSORT item was calculated.Furthermore,the possible factors that determine the reporting quality were explored using univariate analysis and binary logistic regression.Results:A total of 55 studies were included.Mean CONSORT compliance of randomized controlled trials was 57.16%and standard deviation was 0.11.Univariate analysis showed that journal impact factor(p<0.001),sample size(p=0.002)as well as number of authors(p<0.001)were statistically significant,but post-2010 publication(p=0.206)as well as reporting of funding(p=0.221)had no significance.However,none of the above factors had statistical significance in binary logistic regression.Conclusions:The overall reporting quality was low,which would not be conducive to the evidence transformation and implementation.Furthermore,the reporting quality was not probably affected by aforementioned factors.展开更多
Objective： To evaluate and compare the reports＇ qualities of acupuncture randomized controlled trials （RCTs） conducted in China before and after the implementation of two guidelines, i.e., the Consolidated Standar...Objective： To evaluate and compare the reports＇ qualities of acupuncture randomized controlled trials （RCTs） conducted in China before and after the implementation of two guidelines, i.e., the Consolidated Standards of Reporting Trials （CONSORT） statement and the Standards for Reporting Interventions in Controlled Trials of Acupuncture （STRICTA）. Methods： Proportions of studies that reported CONSORT and STRICTA items were compared for the years before and after implementation of these two guidelines. In addition, the total score of each item＇s reporting were calculated and reported differences during different date ranges were compared. Results： For CONSORT items （maximum score 8）, there was evidence of a slight improvement in reporting between 1994-1995 and 1999-2000 combined （2.5 ± 0.6） and 2004-2006 and 2009-2010 combined （3.0 ± 0.9; difference 0.4, 95% confidence interval, 0.3 to 0.6, P〈0.01）. For STRICTA items （maximum score 17）, there was evidence that a slight improvement in reporting between 1994-1995 and 1999-2000 combined （8.6±2.1） and 2004-2005 and 2009-2010 combined （10.1 ±1.8; difference 1.5, 95% confidence interval, 1.1 to 1.9, P〈0.01）. Conclusion： Quality of reporting for RCTs of acupuncture treatment conducted in China have generally improved since the introduction of the STRICTA and CONSORT guidelines.展开更多
OBJECTIVE: To evaluate the reporting quality of randomized controlled trials(RCT) that compared Bo's abdominal acupuncture with conventional body acupuncture, and compare the efficacy and safetybetweenthembyperfor...OBJECTIVE: To evaluate the reporting quality of randomized controlled trials(RCT) that compared Bo's abdominal acupuncture with conventional body acupuncture, and compare the efficacy and safetybetweenthembyperforminga Meta-analysis.METHODS: All RCTs comparing Bo's abdominalacupuncture with conventional body acupuncture were included. English and Chinese databases were searched from their respective inceptions to March 2014. The reporting quality was assessed according to the "Consolidated Standards of Reporting Trials"(CONSORT) checklist for parallel RCTs and the revised "Standards for Reporting Interventions in Clinical Trials of Acupuncture"(STRICTA). A Meta-analysis was conducted to synthesize the effect sizes,and publication bias was evaluated by the Egger linear regression test using Stata.RESULTS: Ninety-seven studies were included, of which most lacked adequate reporting information, and 80.4% showed that the efficacy of abdominal acupuncture is superior to conventional body acupuncture, especially for the following diseases:lumbar disc herniation, cervical spondylosis, omarthritis and cervical vertigo, except simple obesity.Effect-sizes were controversial when evaluating different outcomes.CONCLUSION: The international standard CONSORT statement and STRICTA guidelines should be strictly applied when reporting acupuncture RCTs in the future. Abdominal acupuncture appears to be more effective compared with conventional body acupuncture for some diseases. However, further high quality blind RCTs using validated outcomeindexesandstandardreportingarewarranted.展开更多
There had been no standardized rules for citing ethical Kampo products used in clinical trials in journal articles. Although the name of a Kampo manufacturer was described in 77.9% of research articles, the name and r...There had been no standardized rules for citing ethical Kampo products used in clinical trials in journal articles. Although the name of a Kampo manufacturer was described in 77.9% of research articles, the name and ratios of crude drug components of Kampo formulas were not described in 77.5% of these papers. Considering the importance of proper characterization of interventions in the Consolidated Standards of Reporting Trials （CONSORT） checklist, we hereby propose the use of the Standards of Reporting Kampo Products （STORK） website, http：//mpdb.nibiohn.go.jp/stork, as a reference for Kampo products. This will provide an official source on the internet for verified information on individual Kampo formulations for citation purposes in clinical research articles.展开更多
Randomized controlled trials (RCTs) are considered the first level of evidence to assess the efficacy of novel interventions/therapies.Proper design and implementation of an RCT can result in convincing causal inferen...Randomized controlled trials (RCTs) are considered the first level of evidence to assess the efficacy of novel interventions/therapies.Proper design and implementation of an RCT can result in convincing causal inferences.RCTs often represent the gold standard for clinical trials when appropriately designed,conducted and reported.However,there are limitations in implementation of RCTs,including sufficiency of randomized allocation (especial for allocation concealment),implementing standard intervention,maintaining follow-up and statement of conflicting interests.Therefore,the basic principles of RCTs are outlined here so that pediatric investigators can further understand what is the best evidence based on RCTs.More importantly,the quality of pediatric RCTs may be improved by following challenges in pediatric clinical trials outlined here.展开更多
基金National Natural Science Foundation of China(No.81603565)Tianjin University of Traditional Chinese Medicine Postgraduate Research Innovation Project(YJSKC-20201032).
文摘Background:The increasing number of Alzheimer’s Disease has become a global health issue.Whether randomized controlled trials are fully reported has an immediate effect on the translation as well as implementation of research conclusions.However,the overall reporting quality of randomized controlled trials for cognitive interventions among Alzheimer’s Disease is unclear.Methods:Randomized controlled trials of cognitive inter-ventions among Alzheimer’s Dementia were searched from Cnki,Embase,Pubmed,Web of Science,WanFang Data,Cochrane Library,and VIP from their inception to December9th 2019.Firstly,the average CONSORT(Consolidated Standards of Reporting Trials)compliance of randomized controlled trials for cognitive interventions among Alzheimer’s Disease was estab-lished.Secondly,the compliance of per CONSORT item was calculated.Furthermore,the possible factors that determine the reporting quality were explored using univariate analysis and binary logistic regression.Results:A total of 55 studies were included.Mean CONSORT compliance of randomized controlled trials was 57.16%and standard deviation was 0.11.Univariate analysis showed that journal impact factor(p<0.001),sample size(p=0.002)as well as number of authors(p<0.001)were statistically significant,but post-2010 publication(p=0.206)as well as reporting of funding(p=0.221)had no significance.However,none of the above factors had statistical significance in binary logistic regression.Conclusions:The overall reporting quality was low,which would not be conducive to the evidence transformation and implementation.Furthermore,the reporting quality was not probably affected by aforementioned factors.
基金Supported by National Natural Science Foundation for Distinguished Young Scholars of China(No.81303069)
文摘Objective： To evaluate and compare the reports＇ qualities of acupuncture randomized controlled trials （RCTs） conducted in China before and after the implementation of two guidelines, i.e., the Consolidated Standards of Reporting Trials （CONSORT） statement and the Standards for Reporting Interventions in Controlled Trials of Acupuncture （STRICTA）. Methods： Proportions of studies that reported CONSORT and STRICTA items were compared for the years before and after implementation of these two guidelines. In addition, the total score of each item＇s reporting were calculated and reported differences during different date ranges were compared. Results： For CONSORT items （maximum score 8）, there was evidence of a slight improvement in reporting between 1994-1995 and 1999-2000 combined （2.5 ± 0.6） and 2004-2006 and 2009-2010 combined （3.0 ± 0.9; difference 0.4, 95% confidence interval, 0.3 to 0.6, P〈0.01）. For STRICTA items （maximum score 17）, there was evidence that a slight improvement in reporting between 1994-1995 and 1999-2000 combined （8.6±2.1） and 2004-2005 and 2009-2010 combined （10.1 ±1.8; difference 1.5, 95% confidence interval, 1.1 to 1.9, P〈0.01）. Conclusion： Quality of reporting for RCTs of acupuncture treatment conducted in China have generally improved since the introduction of the STRICTA and CONSORT guidelines.
基金Guangdong Provincial Science&Technology Department and the Guangdong Provincial Academy of Chinese Medical Sciences(Development of Evidence-based Knowledge Management System for Traditional Chinese Medicine,No.2012A032500009)
文摘OBJECTIVE: To evaluate the reporting quality of randomized controlled trials(RCT) that compared Bo's abdominal acupuncture with conventional body acupuncture, and compare the efficacy and safetybetweenthembyperforminga Meta-analysis.METHODS: All RCTs comparing Bo's abdominalacupuncture with conventional body acupuncture were included. English and Chinese databases were searched from their respective inceptions to March 2014. The reporting quality was assessed according to the "Consolidated Standards of Reporting Trials"(CONSORT) checklist for parallel RCTs and the revised "Standards for Reporting Interventions in Clinical Trials of Acupuncture"(STRICTA). A Meta-analysis was conducted to synthesize the effect sizes,and publication bias was evaluated by the Egger linear regression test using Stata.RESULTS: Ninety-seven studies were included, of which most lacked adequate reporting information, and 80.4% showed that the efficacy of abdominal acupuncture is superior to conventional body acupuncture, especially for the following diseases:lumbar disc herniation, cervical spondylosis, omarthritis and cervical vertigo, except simple obesity.Effect-sizes were controversial when evaluating different outcomes.CONCLUSION: The international standard CONSORT statement and STRICTA guidelines should be strictly applied when reporting acupuncture RCTs in the future. Abdominal acupuncture appears to be more effective compared with conventional body acupuncture for some diseases. However, further high quality blind RCTs using validated outcomeindexesandstandardreportingarewarranted.
文摘There had been no standardized rules for citing ethical Kampo products used in clinical trials in journal articles. Although the name of a Kampo manufacturer was described in 77.9% of research articles, the name and ratios of crude drug components of Kampo formulas were not described in 77.5% of these papers. Considering the importance of proper characterization of interventions in the Consolidated Standards of Reporting Trials （CONSORT） checklist, we hereby propose the use of the Standards of Reporting Kampo Products （STORK） website, http：//mpdb.nibiohn.go.jp/stork, as a reference for Kampo products. This will provide an official source on the internet for verified information on individual Kampo formulations for citation purposes in clinical research articles.
文摘Randomized controlled trials (RCTs) are considered the first level of evidence to assess the efficacy of novel interventions/therapies.Proper design and implementation of an RCT can result in convincing causal inferences.RCTs often represent the gold standard for clinical trials when appropriately designed,conducted and reported.However,there are limitations in implementation of RCTs,including sufficiency of randomized allocation (especial for allocation concealment),implementing standard intervention,maintaining follow-up and statement of conflicting interests.Therefore,the basic principles of RCTs are outlined here so that pediatric investigators can further understand what is the best evidence based on RCTs.More importantly,the quality of pediatric RCTs may be improved by following challenges in pediatric clinical trials outlined here.
