Clinician expertise (CONSORT-NPT item 15)
Some data were provided about the expertise of clinicians performing AVB
in 23 papers (64%). None of the papers explicitly outlined the
clinicians’ qualifications although their grade was reported in 22
papers (61%). One paper stated that ‘trained registrars or
specialist obstetricians performed all deliveries’ but there was no
clarification of the nature of this training. A further paper reported
the number of AVBs previously undertaken by each clinician and grouped
them according to whether they had performed fewer or greater than 20
procedures however, it was not clear if they used the intervention or
comparator to determine the grouping. Only eight papers (22%) reported
the number of AVB performed per year in the trial centres. Although 15
(42%) reported the number of clinicians performing AVB in the study,
none explicitly stated that the same clinicians performed interventions
across all trial arms.
Descriptions of the supervision of clinicians was provided in eight
papers (22%); in the majority (n= 7) this referred to trainees
being supported by senior clinicians. The one pilot study stated that‘all applications of the device were supervised, and assisted as
required, by another obstetrician trained in the use of the device’ but
did not specify what this training entailed. Clinician eligibility
criteria was mentioned in two papers (6%) ‘obstetric registrars
(year 2 to year 4) trained in the use of the vacuum extractor’ and ‘each
operator was classified according to prior experience with each
instrument [vacuum extractor and forceps]’. None of the papers
required clinicians to have completed a certain number of AVBs prior to
joining the study. Some information about pre-study training was
reported in three papers (8%): ‘opportunity to watch a training
video’ , ‘…verbal and written advice’ and
‘…instructed in the use of both methods…’ . An additional
paper clarified that ‘clinicians had no specific training in the
use of the disposable cup before the trial’ despite the authors
acknowledging that this was a new device.
Eight papers (22%) made reference to clinicians’ learning curve, two of
which were in relation to devices that were described as new. Of these
eight studies, two accounted for the learning curve by comparing event
rates across two time periods. The remaining six papers acknowledged
that the learning curve may impact on study findings but did not adjust
for this.