adolescent’s health Perceptions of E-Cigarettes: a Systematic Review.

The document focuses on assessing various aspects of a randomized controlled trial (RCT) related to its design, conduct, and analysis. here are the key aspects of the RCT being evaluated:

1. The trial design is being assessed for appropriateness, and any deviations from the standard RCT design (individual randomization, parallel groups) are being evaluated for their impact on the trial's conduct and analysis.
2. Participants' analysis is being evaluated based on whether they were analyzed in the groups to which they were randomized.
3. The consistency of outcome measurement is being assessed between treatment groups and whether outcomes were measured in a reliable way.
4. The use of appropriate statistical analysis is being assessed.
5. The trial's treatment groups are being evaluated for identical treatment, except for the intervention of interest.
6. The completeness of follow-up is being assessed, and any differences between groups in terms of follow-up are being described and analyzed.
7. The blinding of participants, those delivering treatment, and outcomes assessors is being evaluated.

The document does not provide information about the FDa regulations directly, but it assesses the RCT's design, conduct, and analysis based on the Joanna Briggs Institute's criteria.

In summary, the document provides an assessment of an RCT's design, conduct, and analysis based on the Joanna Briggs Institute's criteria, including appropriateness of trial design, consistency of outcome measurement, blinding, and statistical analysis. however, it does not directly address FDa regulations.

Sharma a, McCausland K, Jancey J. adolescent’s health Perceptions of E-Cigarettes: a Systematic Review. american journal of preventive medicine. 2021;60(5):716-725. doi:10.1016/j.amepre.2020.12.013