Poor reporting quality of key Randomization and Allocation Concealment details is still prevalent among published RCTs in 2011: a review

Abstract

Rationale, aims and objectives Randomized controlled trials (RCTs) are powerful tools; it is essential that these trials are not only conducted rigorously, but reported accurately. The aim of this paper was to describe the reporting quality among a set of RCTs published in 2011 on methodological details essential to judging the adequacy of allocation concealment methods employed. Methods Medline was searched using the Ovid platform to identify all those RCTs published in January 2011 in core clinical journals. Methodological details in relation to allocation concealment were extracted from the identified RCTs to allow the reporting quality to be assessed. If the information was not available in the paper the corresponding author was contacted. Results Eighty-five papers were identified, 74% (n = 63) endorsed the CONSORT statement. 73% (n = 62) required the author to be contacted for further information. Sequence generation methods were ascertained in 74% of trials, allocation concealment method in 41%, details of who recruited participants and who generated the randomization sequence in 38%. Conclusions There is evidence to suggest that in 2011 key methodological information relating to allocation concealment is still not reported well in RCTs. Authors and journal editors need to ensure explicit and clear methods are reported in RCTs published.