title: Sodium glucose co-transporter 2 inhibitors for glycemic control in type 2 diabetes mellitus: Quality of reporting of randomized controlled trials.
abstract: BACKGROUND
  Sodium glucose co-transporter 2 inhibitors represent a novel class of antidiabetic drugs. The reporting quality of the trials evaluating the efficacy of these agents for glycemic control in type 2 diabetes mellitus has not been explored. Our aim was to assess the reporting quality of such randomized controlled trials (RCTs) and to identify the predictors of reporting quality.
  
  
  METHODS
  A systematic literature search was conducted for RCTs published till 12 June 2014. Two independent investigators carried out the searches and assessed the reporting quality on three parameters: Overall quality score (OQS) using Consolidated Standards of Reporting Trials (CONSORT) 2010 statement, Jadad score and intention to treat analysis. Inter-rater agreements were compared using Cohen's weighted kappa statistic. Multivariable linear regression analysis was used to identify the predictors.
  
  
  RESULTS
  Thirty-seven relevant RCTs were included in the present analysis. The median OQS was 17 with a range from 8 to 21. On Jadad scale, the median score was three with a range from 0 to 5. Complete details about allocation concealment and blinding were present in 21 and 10 studies respectively. Most studies lacked an elaborate discussion on trial limitations and generalizability. Among the factors identified as significantly associated with reporting quality were the publishing journal and region of conduct of RCT.
  
  
  CONCLUSIONS
  The key methodological items remain poorly reported in most studies. Strategies like stricter adherence to CONSORT guidelines by journals, access to full trial protocols to gain valuable information and full collaboration among investigators and methodologists might prove helpful in improving the quality of published RCT reports.
authors.affiliation: Department of Pharmacology, Pt. B.D. Sharma Post Graduate Institute of Medical Sciences, Rohtak, Haryana, India.
authors.forename: Niti
authors.initials: N
authors.lastname: Mittal
authors.affiliation: Department of Pharmacology, Pt. B.D. Sharma Post Graduate Institute of Medical Sciences, Rohtak, Haryana, India.
authors.forename: Rakesh
authors.initials: R
authors.lastname: Mittal
authors.affiliation: Department of Pharmacology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
authors.forename: Harish
authors.initials: H
authors.lastname: Kumar
authors.affiliation: Department of Pharmacology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
authors.forename: Bikash
authors.initials: B
authors.lastname: Medhi
keywords: Consolidated Standards of Reporting Trials; Jadad score; diabetes mellitus; intention to treat; randomized controlled trials; sodium glucose co-transporter 2 inhibitors