Statistical Considerations of Food Allergy Prevention Studies

Henry T Bahnson, George Du Toit, Gideon Lack

Research output: Contribution to journalArticlepeer-review

10 Citations (Scopus)
181 Downloads (Pure)

Abstract

Clinical studies to prevent the development of food allergy have recently helped reshape public policy recommendations on the early introduction of allergenic foods. These trials are also prompting new research, and it is therefore important to address the unique design and analysis challenges of prevention trials. We highlight statistical concepts and give recommendations that clinical researchers may wish to adopt when designing future study protocols and analysis plans for prevention studies. Topics include selecting a study sample, addressing internal and external validity, improving statistical power, choosing alpha and beta, analysis innovations to address dilution effects, and analysis methods to deal with poor compliance, dropout, and missing data.
Original languageEnglish
Pages (from-to)274-282
Number of pages9
JournalThe Journal of Allergy and Clinical Immunology: In Practice
Volume5
Issue number2
Early online date7 Mar 2017
DOIs
Publication statusE-pub ahead of print - 7 Mar 2017

Keywords

  • Prevention studies
  • Food allergy
  • Statistical considerations
  • Complier average causal effect
  • LEAP
  • EAT
  • Dilution effects
  • Dropout
  • Imputation
  • Missing data
  • Tipping point analysis
  • Type I error
  • Type II error

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