The Reporting Quality Of Randomized Controlled Trials Of Complex Interventions

Objective Based on CONSORT2010checklist, all the quality of published RCTs of complex interventions were assessed systematically, all the items of coincidence rate were compared, to investigate the report quality status of complex intervention of RCTs and the existing problems, to provide comprehensive, scientific reference for subsequent researches.Method The databases of PubMed, Embase.com, Cochrane Library, CBM, VIP CNKI and Wanfang were searched for the published RCTs of complex interventions, irrespective of allocation concealment or blinding. Based on CONSORT2010checklists, we critically assessed the quality of reports and designed data forms to extract the basic characteristics of RCTs of complex intervention (citation number, researcher and quantity, sample size, and informed consent and ethical review etc.) and the CONSORT checklists of the included RCTs. All the data were analyzed the published RCTs of complex intervention from foreign and Chinese journals. Data were input using EXCEL analyzed using SPSS19.0software.Results According to include/exclude criteria, and ultimately.into75RCTs complex intervention study,69papers published in the journal of foreign countries, Chinese is only6papers published in the journal. Foreign periodicals published in the cited frequency of complex intervention RCTs was obviously higher than that of the journal of the Chinese study,67%of Chinese published studies cited number is zero, while64%of the foreign periodicals published studies cited times greater than5. In addition,69%(52/69) complex intervention of foreign periodicals published RCTs test for center, but Chinese complex intervention RCTs reported in the journal are all single center study. In terms of the accuracy of the CONSORT checklist, foreign periodicals published69papers in complex intervention in RCTs, nearly half (18/37,49%) entry entirely coincidence rate lower than50%, coincidence rate of39%(7/18) of the items even to zero. Complex intervention and Chinese journals published RCTs, completely coincidence rate of70%(26/37) of the items below50%,88%(23/26) of the entry of coincidence rate is zero. Complex intervention but foreign periodicals published RCTs in some key items, such as the calculation of sample size (23%), randomly assigned sequence method(38%), concealed group(14.5%) and blinded(5.8%) fully in aspects of the implementation of the coincidence rate is still low. Conclusion Foreign periodicals published report quality of RCTs of complex intervention study was obviously higher than that of complex intervention RCTs reported in the journal research in Chinese, but still part of the methodology, the influence of the important such as random sequence generation method andmechanism, the calculation of sample size, blinded by using, after the trial began on the test method of important change, the generation of random sequence, recruitment and the distribution of the intervention and intervention measures of similarity were lower. So, tit’s not only difficult to let the reader or evidence clear and accurate understanding of the study design, implement detailed link to science and to assess the validity of the results, more importantly may mislead the clinical practice. Therefore, we strongly recommend that:(1) to strengthen domestic researchers and journal editors to CONSORT statement and other clinical trials report specification and cognitive aspects of training, to standardize the RCTs research report.(2)The methodology of complex intervention, the CONSORT statement and other clinical research report specification introduced the content of the medical education in school.