title: Assessment of adherence to the statistical components of consolidated standards of reporting trials statement for quality of reports on randomized controlled trials from five pharmacology journals.
abstract: BACKGROUND
  The Consolidated Standards of Reporting Trials (CONSORT) statement is a device to standardize reporting and improve the quality of controlled trials. However, little attention is paid to the statistical components in the CONSORT checklist. The present study evaluates the randomized controlled trials [RCTs] published in five high impact pharmacology journals with respect to its statistical methods.
  
  
  METHODS
  Randomized Controlled Trials [RCTs] published in the years 2013 & 2014 in five pharmacology journals with high impact factor, The Journal of Clinical Pharmacology (JCP), British Journal of Clinical Pharmacology (BJCP), European Journal of Clinical Pharmacology (EJCP), Journal of Pharmacology & Pharmacotherapeutics (JPP) and Indian Journal of Pharmacology (IJP) were assessed for adherence to the statistical components of CONSORT statement.
  
  
  RESULTS
  Of the 174 RCTs analysed, 103 described the method of sample size calculation. Of the five journals, maximum reports in JCP (34/50) and minimum in IJP (13/31) adhered to the CONSORT checklist [item 7a-sample size calculation]. Most reports mentioned the statistical methods used for analysis of data. (171/174) as per the checklist [item 12=statistical methods used]. Analysis of variance (ANOVA) was the most commonly used test (88/174). The software used for statistical analysis was mentioned in 111 RCTs and SPSS was used more frequently (58/111). The exact p value was stated in 108 reports. Certain errors in statistical analysis were also noted (40/174).
  
  
  CONCLUSIONS
  These findings show inconsistencies and non- adherence to the statistical components of the CONSORT statement especially with respect to sample size calculation. Special attention must be paid to the statistical accuracy of the reports.
authors.affiliation: Department of Pharmacology, Topiwala National Medical College and BYL Nair Charitable Hospital, Mumbai Central, Mumbai, Maharashtra, India.
authors.forename: Sachin
authors.initials: S
authors.lastname: Satpute
authors.affiliation: Department of Pharmacology, Topiwala National Medical College and BYL Nair Charitable Hospital, Mumbai Central, Mumbai, Maharashtra, India.
authors.forename: Manthan
authors.initials: M
authors.lastname: Mehta
authors.affiliation: Department of Pharmacology, Topiwala National Medical College and BYL Nair Charitable Hospital, Mumbai Central, Mumbai, Maharashtra, India.
authors.forename: Sandeep
authors.initials: S
authors.lastname: Bhete
authors.affiliation: Department of Pharmacology, Seth G. S. Medical College and KEM Hospital, Parel, Mumbai, Maharashtra, India.
authors.forename: Dnyneshwar
authors.initials: D
authors.lastname: Kurle
keywords: Consolidated standards of reporting trials; randomized controlled trials; sample size; statistical component