Article type
Year
Abstract
Background: A large number of randomized controlled trials (RCTs) in pediatrics have been published in China. However, there have been no systematic assessments whether the reporting quality has improved since the CONSORT checklists were introduced in China in 1997.
Objectives: This study was undertaken to evaluate the reporting quality of RCTs published in pediatric journals in China.
Methods: Six core pediatric journals were searched from inception through December 2010 which included Journal of Clinical Pediatrics, Chinese Journal of Contemporary Pediatrics, Chinese Journal of Practical Pediatrics, Chinese Journal of Evidence-based Pediatrics, Chinese Journal of Pediatrics, and Chinese Journal of Pediatric Surgery. The CONSORT checklists were used to assess the trial reporting quality. Data was collected using a standardized form. Analyses were performed using Excel and SPSS.
Results: A total of 619 RCTs were identified, in which 157 RCTs were published before 1997. Compared to literature published before 1997, there was significant improvement of quality in some aspects of the trial reporting such as: title and abstract, introduction, trial design, statistical methods, recruitment, baseline data and ancillary analyses (P < 0.05). However, some important methodological components of RCTs were still incompletely reported such as: sample-size (0.63% vs.1.08%), sequence generation (3.18% vs. 7.58%), allocation concealment (0% vs. 1.08%), and blinding (0% vs. 0.87%), same as in funding (2.55% vs. 4.55%) and protocol (0% vs. 2.16%). Besides, no trials reported the registry.
Conclusions: Overall, the reporting quality of RCTs in pediatrics has changed significantly in most of the aspects we analyzed since the introduction of CONSORT checklists in China; however, there is room for improvement in some aspects such as methodology components, registry, protocol and funding. Therefore, despite the advancements observed, there are still several areas that can be improved in pediatric RCTs.
Objectives: This study was undertaken to evaluate the reporting quality of RCTs published in pediatric journals in China.
Methods: Six core pediatric journals were searched from inception through December 2010 which included Journal of Clinical Pediatrics, Chinese Journal of Contemporary Pediatrics, Chinese Journal of Practical Pediatrics, Chinese Journal of Evidence-based Pediatrics, Chinese Journal of Pediatrics, and Chinese Journal of Pediatric Surgery. The CONSORT checklists were used to assess the trial reporting quality. Data was collected using a standardized form. Analyses were performed using Excel and SPSS.
Results: A total of 619 RCTs were identified, in which 157 RCTs were published before 1997. Compared to literature published before 1997, there was significant improvement of quality in some aspects of the trial reporting such as: title and abstract, introduction, trial design, statistical methods, recruitment, baseline data and ancillary analyses (P < 0.05). However, some important methodological components of RCTs were still incompletely reported such as: sample-size (0.63% vs.1.08%), sequence generation (3.18% vs. 7.58%), allocation concealment (0% vs. 1.08%), and blinding (0% vs. 0.87%), same as in funding (2.55% vs. 4.55%) and protocol (0% vs. 2.16%). Besides, no trials reported the registry.
Conclusions: Overall, the reporting quality of RCTs in pediatrics has changed significantly in most of the aspects we analyzed since the introduction of CONSORT checklists in China; however, there is room for improvement in some aspects such as methodology components, registry, protocol and funding. Therefore, despite the advancements observed, there are still several areas that can be improved in pediatric RCTs.