The Quality Of Systematic Reviews And Randomized Controlled Trials In Nursing Care Field

Background Systematic reviews and/or meta-analysis (SRs/MAs) and randomised controlled trials (RCTs) were not always well reported and had the methodological bias, which would reduce the reliability of their results. Additionally, some variables also affected such reporting quality and methodological bias. However, empirical evidence of both quality still lack in Chinese nursing care field.Objectives This project aims to investigate the reporting quality and the methodological bias of SRs/MAs and RCTs published in Chinese nursing care journals firstly and then to explore to what extent some relevant variables have effects on such both quality.Methods Firstly, scoping review would be used to investigate variables with relationship to reporting quality of RCTs and SRs/MAs. We electronically searched PubMed, Cochrane Library, Chinese Biomedicine Literature Database (CBM) and Wanfang database using the validated searching strategy to retrieve eligible studies from 1996 to Jan 2014. Eligible studies were those assessing reporting completeness and methodological quality of RCTs and SRs/MAs through Consolidated Standards of Reporting Trials (CONSORT) statement, Jadad scale, Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) or Assessment of Multiple Systematic Reviews (AMSTAR) and exploring their determinants. At last, this study showed results by descriptive statistics. In part two and three, a database with SRs/MAs and RCTs was built through conducting the electronic searching for this project, firstly. Eligible SRs/MAs were identified from the CBM and other Chinese databases. Eligible RCTs published in five leading Chinese nursing journals are retrieved from the CBM. Then standardized data extraction forms were developed by including variables and items adapted from the standardised reporting checklist and methodological statement (AMSTAR and PRISMA for SRs/MAs and CONSORT and Jadad for RCTs). By data extraction forms, information related to variables, reporting quality and methodological bias are identified. At last, corresponding scores were calculated. Meanwhile, a regression is used to explore the correlation between relevant variables with overall scores of reporting quality and methodological bias. The descriptive and regression statistics were calculated via SPSS 13.0.ResultsFinally, forty studies were included to our first analysis. Among them, complying with CONSORT statement, thirty two studies investigated variables which potentially influenced reporting completeness of RCTs and eight for that of SRs/MAs with PRISMA or Quality of Reporting of Meta-Analyses (QUOROM). For RCTs, twenty four studies concluded that the reporting quality was low, five studies for moderate or high quality, and 3 studies without definite conclusion. In terms of SRs/MAs, four studies including Chinese SRs indicated a conclusion of low quality and another one did not conclude definitively; and three studies with English SRs concluded a moderate or high reporting quality. Some variables were indicated to relate with reporting quality of RCTs:power calculation, randomization, allocation concealment, epidemiological degree, publication year, CONSORT endorsement, statement of funding, Jadad score, types of intervention and publication language; the following factors would benefit the reporting quality:publication year, PRISMA endorsement, and AMSTAR or Overview Quality Assessment Questionnaire (OQAQ) scores. They were varied between Chinese and English literatures. In part two and three:finally, a database was built based on 74 SRs/MAs and 680 RCTs in Chinese nursing care field. For SRs/MAs, the proportion complying with AMSTAR checklist items ranged from 0-82.4%. No SRs/MAs reported an’a priori’design or conflict of interest. Only four items were found to be reported in more than 50% of the SRs/MAs:a list of included and excluded studies, the scientific quality of included studies, the appropriate use of methods to combine findings, and formulating conclusions appropriately. Funding support was indicated to have relation with both quality. Regarding with RCTs,680 full-texts were included. The overall CONSORT methodological items score was 6.34 ±0.97 (Mean±SD). No RCT reported descriptions and changes in "trial design,’ changes in "outcomes" and "implementation," or descriptions of the similarity of the interventions for "blinding." Poor reporting was found in detailing the "settings of participants", "type of randomization sequence generation", calculation methods of "sample size", explanation of any interim analyses and stopping guidelines for "sample size", "allocation concealment mechanism", additional analyses in "statistical methods", and targeted subjects and methods of "blinding". The regression analysis found that publication year and Intention-To-Treat (ITT) analysis were weakly associated with CONSORT score.Conclusions The majority of SRs/MAs and RCTs in Chinese nursing care field had major methodological and reporting flaws. Among several factors, funding sources were related with reporting and methodological quality of Chinese systematic reviews; publication year and ITT analysis would influence those of RCTs. Authors are recommended to use the AMSTAR, PRISMA or CONSORT to submit reports of SRs/MAs or RCTs to nursing care journals, respectively.