Reporting of compliance in randomised controlled trials investigating the effect of maternal nutritional supplementation on infant outcomes

Abstract

The Consolidated Standards of Reporting Trials (CONSORT) group comprises medical journal editors, epidemiologists and clinical trialists and was established in 1996 with the aim of developing scales to assess the quality of randomised controlled trial (RCT) reports. The group have since developed several evidence-based initiatives to improve the reporting of RCT. One of these initiatives is the Revised CONSORT Statement (1) that is made up of a checklist and participant flow diagram to be utilised by authors when reporting trials. The participant flow diagram specifies the data that should be reported to describe the progress of participants through a trial. It is recommended that the number of participants that ‘received’ the treatment and the number that ‘discontinued’ treatment be stated. The flow chart does not, however, specify that the percentage of participants complying with the treatment protocol be reported. This information is particularly important in long-term supplementation trials where poor compliance may influence the way in which study findings are interpreted. The aim of the present study was to investigate the adequacy of reporting of: (1) participant flow data as recommended by CONSORT; (2) participant compliance data (using criteria developed for the purpose of the current study) from RCT that studied the effect of maternal nutritional supplementation during pregnancy on neonatal and infant outcomes including birth weight, mortality and nutritional status. A literature search of MEDLINE, EMBASE, CINAHL and AMED databases was carried out using the following combination of