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.