作者: Sally Hopewell , Isabelle Boutron , Douglas G Altman , Ginny Barbour , David Moher
DOI: 10.1186/S12916-016-0736-X
关键词:
摘要: The CONSORT Statement is an evidence-informed guideline for reporting randomised controlled trials. A number of extensions have been developed that specify additional information to report more complex aim this study was evaluate the impact using a simple web-based tool (WebCONSORT, which incorporates different extensions) on completeness trials published in biomedical publications. We conducted parallel group trial. Journals endorsed (i.e. referred it Instruction Authors) but do not actively implement require authors submit completed checklist) were invited participate. Authors requested by editor use at manuscript revision stage. registering (centralised computer generated) WebCONSORT or control. In group, they had access allowing them combine relevant their trial and generate customised checklist flow diagram must editor. control only generator. Authors, journal editors, outcome assessors blinded allocation. primary proportion items (main reported each article post revision. total 46 journals recruited into (25 March 2013 22 September 2015); 324 author manuscripts (WebCONSORT n = 166; n = 158), 197 reports (n = 94; n = 103). Over third (39%; n = 127) registered excluded from analysis, mainly because Of those included most common selected non-pharmacologic (n = 43; n = 50), pragmatic (n = 20; n = 16) cluster (n = 10; n = 9). quarter manuscripts, either wrongly extension failed select right when site. Overall, there no important difference overall mean score between (mean 0.51) (0.47) pertaining given difference, 0.04; 95% CI −0.02 0.10). This show beneficial effect help prepare complete reports. However, exclusion large inappropriately meant we less precision than anticipated detect difference. Better education needed, earlier publication process, both editorial staff how and, particular, CONSORT-related extensions. ClinicalTrials.gov: NCT01891448 [registered 24 May 2013].