Reporting and methodological quality of systematic reviews and meta-analysis with protocols in Diabetes Mellitus Type II: A systematic review.

backgroundSystematic reviews with or without meta-analyses (SR/MAs) are strongly encouraged to work from a protocol to facilitate high quality, transparent methodology. The completeness of reporting of a protocol (PRISMA-P) and manuscript (PRISMA) is essential to the quality appraisal (AMSTAR-2) and appropriate use of SR/MAs in making treatment decisions.

objectivesThe objectives of this study were to describe the completeness of reporting and quality of SR/MAs, assess the correlations between PRISMA-P, PRISMA, and AMSTAR-2, and to identify reporting characteristics between similar items of PRISMA-P and PRISMA.

methodsWe performed a systematic review of Type 2 Diabetes Mellitus SR/MAs of hypoglycemic agents with publicly available protocols. Cochrane reviews, guidelines, and specific types of MA were excluded. Two reviewers independently, (i) searched PubMed and Embase between 1/1/2015 to 20/3/2019; (ii) identified protocols of included studies by searching the manuscript bibliography, supplementary material, PROSPERO, and Google; (iii) completed PRISMA-P, PRISMA, and AMSTAR-2 tools. Data analysis included descriptive statistics, Pearson correlation, and multivariable linear regression.

resultsOf 357 relevant SR/MAs, 51 had available protocols and were included. The average score for PRISMA-P was 15.8±3.3 (66%; maximum 24) and 25.2±1.1 (93%; maximum 27) for PRISMA. The quality of SR/MAs assessed using the AMSTAR-2 tool identified an overall poor quality (63% critically low, 18% low, 8% moderate, 12% high). The correlation between the PRISMA-P and PRISMA was not significant (r = 0.264; p = 0.06). Correlation was significant between PRISMA-P and AMSTAR-2 (r = 0.333; p = 0.02) and PRISMA and AMSTAR-2 (r = 0.555; p<0.01). Discrepancies in reporting were common between similar PRISMA-P and PRISMA items.

conclusionAdherence to protocol reporting guidance was poor while manuscript reporting was comprehensive. Protocol completeness is not associated with a completely reported manuscript. Independently, PRISMA-P and PRISMA scores were weakly associated with higher quality assessments but insufficient as a surrogate for quality. Critical areas for quality improvement include protocol description, investigating causes of heterogeneity, and the impact of risk of bias on the evidence synthesis.