Main Findings
This systematic review summarised reporting standards of AVB in RCTs. Although the majority of the interventions or comparators were named, only half of the studies provided any description of how the interventions should be delivered and none were considered to be ‘precise’. The majority of papers did not discuss intervention standardisation, focusing instead on criteria for device use (such as gestation or presentation of baby) rather than how the device should be used. Information regarding adherence was similarly poorly reported. Two-thirds of papers provided data regarding clinician expertise; however, this often was not detailed or specific. The overall lack of detail in the studies makes it hard to know exactly how procedures were intended to be performed and actually delivered, creating difficulties in interpreting results or replicating procedures in routine clinical practice.
Although this is the first study exploring reporting standards in RCTs of interventions for AVB, there have been several similar systematic reviews in RCTs of other invasive procedures (e.g. surgery). Predominantly, these concluded that reporting standards were poor and surmised that this could be related to both a lack of uptake of CONSORT-NPT and a degree of ambiguity in the language used to define descriptions, standardisation and adhernece. It was particularly noted that despite provision of some intervention descriptions, they were often ambiguous and descriptions of all operative components were rarely included. Moreover, it may not always be practical or desirable to provide ‘precise’ details of intervention delivery. In a multicentre pragmatic trial, for example, it may be very difficult to achieve standardisation of every procedural component and step, and this is unlikely to reflect the heterogeneity of routine clinical practice. In reality, there may need to be a reasonable compromise between the level of detail and the flexibility permitted during procedural components, as complex interventions are influenced by patient, operator, device and centre-specific factors that may alter the way in which interventions can be delivered.