Assessment of the reporting quality of ophthalmic diseases related randomized controlled trials published in SCI journals from mainland China / 中华实验眼科杂志

ABSTRACT

Background Randomized controlled trial (RCT) can offer high quality of evidence for the medical decisions.Consolidated standards of reporting trials (CONSORT) statement,an international criteria for RCT report,is a guideline and methodology of RCT report.However,the assessment and application of RCT according to CONSORT are dissatisfactory in China.Objective This study was to evaluate the reporting quality of ophthalmic diseases related RCTs published in SCI journals from mainland China and offer a good methodology of RCT report.Methods The RCT literature were searched on PubMed database according to Ophthalmology, Eye and all of their inferior subjective terms,and the published papers were limited in mainland China and before March,2013.Included papers were evaluated independently and checked by two searchers.The methodology and results of all retrieved papers were stratifiedly analyzed by the year of CONSORT published and revised.Results Sixty eligible RCTs were assessed,and the intervention methods were primarily surgery trials (34/60).Forty-four papers presented the comparison study of two groups with the median sample size of 76.0.Only 22％ (13/60) trial reports gave the clear identification of RCT in the title.Majority of papers described trial design,eligibility criteria for participants,detail of interventions and outcome measures.Twelve pieces of articles reported how sample size was determined,and 41 pieces referred settings and locations,but only 6 pieces recorded interim analyses and stopping guidelines.After CONSORT 2010 Statement was published,the proportion of trial reports that included details of the randomization had little improvement (RR=1.06,95％ CI0.62-1.82).Only 42％ trial reports (25/60) offered a description about blinding method.Conclusions RCT reports related to ophthalmic diseases from mainland China in SCI journals are still flawed with certain shortcomings.Following the guidance of the CONSORT statement can improve the quality of ophthalmic diseases related RCT from mainland China.