Statistical analysis plan for the OPTIMUM study: optimising immunisation using mixed schedules, an adaptive randomised controlled trial of a mixed whole-cell/acellular pertussis vaccine schedule
DiscussionA detailed, prospective statistical analysis plan (SAP) is presented for this Bayesian adaptive design. The plan was written by the trial statistician and details the study design, pre-specified adaptive elements, decision thresholds, statistical methods, and the simulations used to evaluate the operating characteristics of the trial. Application of this SAP will minimise bias and supports transparent and reproducible research.Trial registrationAustralia& New Zealand Clinical Trials Registry,ACTRN12617000065392. Registered on 12 January 2017Study protocolhttps://doi.org/10.1136/bmjopen-2020-042838 (Source: Trials)
Source: Trials - February 7, 2022 Category: Research Source Type: clinical trials
Friends, Family & Food: Food Allergy App for Youth - II
Condition: Food Allergy in Children Intervention: Behavioral: Friends, Family, and Food App (F3A-App) Sponsors: Rhode Island Hospital; Virtually Better, Inc. Completed (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - November 8, 2021 Category: Research Source Type: clinical trials
Friends, Family & Food: Food Allergy App for Youth ( F3A-App )
Condition: Food Allergy in Children Intervention: Sponsor: Rhode Island Hospital Completed (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - October 26, 2021 Category: Research Source Type: clinical trials
