Introduction Consolidated Standards of Reporting Trials （CONSORT）, encompasses various initiatives developed by the CONSORT Group to alleviate the problems arising from inadequate reporting of randomized controlled ...Introduction Consolidated Standards of Reporting Trials （CONSORT）, encompasses various initiatives developed by the CONSORT Group to alleviate the problems arising from inadequate reporting of randomized controlled trials （RCTs）.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
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
文摘Introduction Consolidated Standards of Reporting Trials （CONSORT）, encompasses various initiatives developed by the CONSORT Group to alleviate the problems arising from inadequate reporting of randomized controlled trials （RCTs）.
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.
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.
