Evaluation of randomized clinical trial papers published in medical sci-tech journals depending on 2010 CONSORT statement / 中华医学科研管理杂志

ABSTRACT

Objective To explore the quality of clinical trial papers published in medical SCI-tech journal.Methods A total of 1201 original research projects were published in 6 medical journals from Mar.2012 to Mar.2014 in China.Fifty-four of them were selected according to the key words randomizedcontrolled,and they were evaluated using 2010 CONSORT statement.Results In 54 articles,the section of background and abstract were described clearly and standardize.Fifty-one (94.44 ％)papers described intervention method in details.Thirty-five (64.81％) papers described the experimental design method.Thirty-one (57.41％) papers defined the primary and secondary outcome indicators,only 3 (5.56％)of them described distribution order,and the method of blindness.Four (7.41％) papers provides the information on sample size calculation.The using of flow chart accounted for 7.41％.Ten (18.52％) papers described the reason of drop out.Two (3.70％) papers evaluated the effect and accuracy,and the trial results were explained clearly and consider other evidences.Only 18 (33.33％) papers wrote the limitation of the studies.For other information of the studies,5 (9.26％) of them was registered somewhere,the information on funding support was on 20 (37.04％)papers.Conclusions The description on most RCT papers were clear and complete,but close attention should be paid to the method of blindness and sample size determine.