Conclusion
This paper presents a methodological review of reporting standards
relating to intervention description, standardisation, adherence and
expertise for RCTs in AVB, comparing them with CONSORT-NPT guidance.
Reporting standards in AVB trials are currently vague, lack
transparency, detail and clarity, especially surrounding adherence.
Although tools such as the CONSORT-NPT guidance attempt to address this
issue, consideration of the details required specifically for
interventions involving the use of devices is required. Such tools need
to provide unambiguous and accessible detail by providing definitions of
the key terms, such as standardisation and adherence. Bespoke guidance
for RCTs involving devices may help address this problem by describing
and defining standards for trialists and clinicians, to improve
methodological standards, facilitate replication of successful
interventions in clinical practice, and reduce research waste.