Pre-enrolment screening reporting in randomized controlled trials from five pharmacology journals

Abstract

<p class="abstract"><strong><span lang="EN-US">Background:</span></strong>Randomized controlled trials (RCTs) when appropriately conducted and reported represent the gold standard in evidence based medicine. Various guidelines including <span lang="EN-US">the consolidated standards of reporting trials (</span>CONSORT 2010) recommend the reporting of the number of participants screened for potential recruitment. The aim of this study was to assess the reporting of pre-enrolment screening figure in randomized controlled trials from five pharmacology journals.</p><p class="abstract"><strong><span lang="EN-US">Methods:</span></strong>RCTs from the five pharmacology journals with descending order of impact factor i.e. The journal of clinical pharmacology (JCP), British journal of clinical pharmacology (BJCP), European journal of clinical pharmacology (EJCP), Journal of pharmacology and pharmacotherapeutics (JPP) and Indian journal of pharmacology (IJP) published between January 2013 to December 2014 were reviewed using standardized criteria.</p><p class="abstract"><strong><span lang="EN-US">Results:</span></strong>37 out of 174 (21.27%) did not report the number of participants screened prior to recruitment. From the 137 RCTs that reported this screening figure, 95,494 (46.30%, range: 41-60.60%) of the screened participants (2, 06,243) were subsequently enrolled. About 52.49% of those screened and not enrolled, did not meet inclusion criteria or met exclusion criteria and about 11.89% declined to participate in an RCT. </p><p class="abstract"><strong><span lang="EN-US">Conclusions:</span></strong><span lang="EN-US"> Thus, there was about 80% reporting of pre-enrolment screening figure in RCTs from five pharmacology journals which need further improvement. The practice of documenting pre-enrolment screening figure and associated exclusion reasons will help to plan appropriate recruitment strategies during protocol development.</span></p>