Comment on: “Pre-oxygenation using high flow humidified nasal oxygen or face mask oxygen in pregnant people - a prospective randomised controlled crossover non-inferiority study”

Tan P.C., Peyton P.J., Deane A., Unterscheider J., Dennis A.T.

Airway guidelines recommend pre-oxygenation of obstetric patients to an end tidal oxygen concentration (etO

Mauri L., D’Agostino R.B.

In this review, the authors consider the characteristics and challenges of noninferiority trial designs, including seven essential features of noninferiority trials.

Piaggio G., Elbourne D.R., Pocock S.J., Evans S.J., Altman D.G., CONSORT Group F.T.

The CONSORT (Consolidated Standards of Reporting Trials) Statement, which includes a checklist and a flow diagram, is a guideline developed to help authors improve the reporting of the findings from randomized controlled trials. It was updated most recently in 2010. Its primary focus is on individually randomized trials with 2 parallel groups that assess the possible superiority of one treatment compared with another. The CONSORT Statement has been extended to other trial designs such as cluster randomization, and recommendations for noninferiority and equivalence trials were made in 2006. In this article, we present an updated extension of the CONSORT checklist for reporting noninferiority and equivalence trials, based on the 2010 version of the CONSORT Statement and the 2008 CONSORT Statement for the reporting of abstracts, and provide illustrative examples and explanations for those items that differ from the main 2010 CONSORT checklist. The intent is to improve reporting of noninferiority and equivalence trials, enabling readers to assess the reliability of their results and conclusions.

Piaggio G., Elbourne D.R., Altman D.G., Pocock S.J., Evans S.J., CONSORT Group F.T.

The CONSORT (Consolidated Standards of Reporting Trials) Statement, including a checklist and a flow diagram, was developed to help authors improve their reporting of randomized controlled trials. Its primary focus was on individually randomized trials with 2 parallel groups that assess the possible superiority of one treatment compared with another but is now being extended to other trial designs. Noninferiority and equivalence trials have methodological features that differ from superiority trials and present particular difficulties in design, conduct, analysis, and interpretation. Although the rationale for such trials occurs frequently, those designed and described specifically as noninferiority or equivalence trials appear less commonly in the medical literature. The quality of reporting of those that are published is often inadequate. In this article, we present an adapted CONSORT checklist for reporting noninferiority and equivalence trials and provide illustrative examples and explanations for those items amended from the original CONSORT checklist. The intent is to improve reporting of noninferiority and equivalence trials, enabling readers to assess the validity of their results and conclusions.