Improvement in the primary end-point, trough FEV1 was both statistically and clinically significant (considered to be ≥100 mL in COPD) over placebo, and versus active comparators it approached clinical significance.
In the 30 active comparator studies, composite approach detected larger differences in effect size than LOCF (ES=.05) and MMRM (ES=.076).
With this approach, the comparator doesn't need to match the test product.
However, no studies have assessed clinical outcomes using the continuous approach compared to an intermittent system; furthermore, the different sensors used, the different comparators, and the lack of standardized performance metrics make it difficult to compare results.
Only one trial specified a theoretical approach underpinning the comparator control intervention.
It could, however, be considered a useful comparator instrument in a construct approach" [ 1].
The World Health Organisation (WHO) [ 28] who advocate use of a generalised cost-effectiveness analysis approach, where the comparator is "doing nothing", as opposed to the "usual care" allowing decision makers to see what could be achieved if all health care resources were re-allocated.
Across fifteen studies (n = 1922 participants), hypertonic saline, compared with any comparator, reduced mean LoS by approximately a third of a day using a fixed effect approach [mean difference = −0.36, 95 % CI −0.50 to −0.22 days; Fig. 3].
Ideally, a title reflecting the PICOS approach (participants, interventions, comparators, outcomes, and study design) (see item 11 and box 2) may help readers as it provides key information about the scope of the review.
