Exact(3)
A study conducted by the present authors found that some acupuncture trialists report that STRICTA items originally included in submitted manuscripts are removed during the editorial process [21].
It is not always clear whether trialists report adequately on the use and the validity of surrogates.
It is therefore important that clinical trialists report whether they have used a surrogate and convey this information to the readers.
Similar(57)
Trials in which the trialists reported conducting an a priori power calculation based on the primary outcome were also significantly more likely to report adequate generation compared with trials not reporting this, after adjusting for other variables.
It also summarises the final model; the three variables that jointly showed the strongest association with reporting of generation of the random sequence were: where the trial was conducted, the inclusion or not of a CONSORT flow diagram and whether the trialists reported conducting an a priori power calculation based on the primary outcome.
Finally, in the MIDEX study, delirium was not routinely assessed with a validated tool while patients were receiving sedative therapy, although the trialists reported no difference in a combined endpoint of neurocognitive adverse events (anxiety, agitation or delirium) between the dexmedetomidine and midazolam groups [ 6].
Only one trial reported median data on the induction-delivery interval and induction to active phase interval, the trialist reported no difference between the Bishop group and the TVUS group for this outcome.
We elected not to extend item 5 (objectives), although we would encourage trialists to report the purpose of the trial in relation to the decisions that it is intended to inform and in which settings; we have included this recommendation in connection with the extension of item 2 (background).
The Cholesterol Treatment Trialists' Collaborators reported that in their study populations of patients with type 2 diabetes, they found a 9% proportional reduction in all-cause mortality and a 21% proportional reduction in major vascular events for each reduction of 1 mmol/l in LDL cholesterol (24).
1 The main finding was that trialists had reported the outcomes in a biased way in over a quarter of the studies.
Information gleaned from correspondence with trialists, trial reports, and the individual patient data suggested that all five trials have used adequate methods of randomisation and allocation concealment.
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