Intervention standardisation (CONSORT-NPT item 5b)
Standardisation was defined as the process of making an intervention
conform to a standard (i.e. falling into an accepted range of quality).
Reporting of standardisation (of both interventions and
co-interventions) was assessed by recording i) specific details about
the criteria for using the device and ii) whether there was any
permitted flexibility in this standardisation, in terms of whether the
operative components or steps were described as mandatory, prohibited,
optional or flexible.