Strengths and Limitations
This review is the first published report detailing reporting standards
relating to intervention description, standardisation, adherence and
expertise in AVB trials. The search strategy was wide and RCTs with a
non-device comparator arm were also included. The review therefore
provides a detailed inspection of reporting standards to provide an
informative narrative to explain the reporting quality. Despite this,
however, there are limitations. We only retrieved protocols or
associated documents from authors specifically mentioning or referencing
these within the trial report, so some may have been missed.
Additionally, the majority of papers lacked methodological robustness,
making it hard to relate positive findings to the wider research
community. Finally, only eight papers were published after the release
of the CONSORT-NPT guidelines in 2008. This is a key limitation as we
were comparing papers to standards that were not available to the
majority of authors at the time of publication. The present review
however does highlight that the poor quality of reporting standards is
constant, with no noticeable overall change in reporting quality since
the introduction of these guidelines. The reasons for the lack of
guideline adoption is likely to be multifactorial, relating to unclear,
non-specific definitions and instructions, a lack of awareness amongst
clinicians and trialists, and the lack of specificity of these
guidelines towards interventions involving the use of devices.