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David W. Schab, MD Nhi -Ha T. Trinh, MD Journal of Developmental and Behavioral Pediatrics 25(6):423-434, 2004

Do Artificial Food Colors Promote Hyperactivity in Children with Hyperactive Syndromes? A Meta-Analysis of Double-Blind Placebo-Controlled Trials. David W. Schab, MD Nhi -Ha T. Trinh, MD Journal of Developmental and Behavioral Pediatrics 25(6):423-434, 2004. Hypothesis.

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David W. Schab, MD Nhi -Ha T. Trinh, MD Journal of Developmental and Behavioral Pediatrics 25(6):423-434, 2004

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  1. Do Artificial Food Colors Promote Hyperactivity in Children with Hyperactive Syndromes? A Meta-Analysis of Double-Blind Placebo-Controlled Trials David W. Schab, MD Nhi-Ha T. Trinh, MD Journal of Developmental and Behavioral Pediatrics 25(6):423-434, 2004

  2. Hypothesis • AFCs symptoms of hyperactivity in children with hyperactive syndromes • Parents and teachers differ • Screening methods can identify responders • Rigor/presence of dx predicts response

  3. Inclusion Criteria • Double-blind, placebo-controlled • Isolate effects of AFCs • <18 yo • Any diagnostic criterion • Any rating scale

  4. Methods • Abstracted data • Graded for validity/bias threats • Segregation • Random effects • Variance for SMD 2(1-r)/n • Imputation & Noncontinuous • Homogeneity tests • Sensitivity tests • Publication bias tests

  5. Primary Analysis

  6. Secondary Analysis

  7. 0.283 (0.079, 0.588)

  8. 0.107 (-0.128, 0.343) 0.441 (0.161, 0.721) 0.081 (-0.073, 0.235)

  9. × ×: failed test of statistical homogeneity

  10. -0.112 (-0.393, 0.169) 0.316 (0.157, 0.475)

  11. Sensitivity Analysis & Critiques • Funnel plot & fail-safe n (13.30 for ES of 0.15) • Exclusion of smallest trials • Exclusion of trials with lowest validity score • “Validity” • Parent Ratings

  12. Validity • Sources of bias Sources of systematic error -Alderson/Cochrane approach • “A” All criteria are met • “B” >1 criteria are only partly met • “C” >1 criteria are not me

  13. Parents vs. Clinicians/Teachers • Time of assessment if medicated • Differential sensitivity • Rating scale matters • Symptom cluster matters • Nature of ADHD • Diurnal variation in concentration • Worse in complex settings • Better in simple settings

  14. Parents vs. Teachers Biederman et al., How Informative are Parent Reports? Pediatrics (2004); 113: 1667-1671

  15. Conclusions • 1°H: AFCs  hyperactivity in hyperactive kids • ES meaning? What to make of sub-hypothesis conclusions? • Parents > teachers/clinicians • Screening not helpful…unless heterogeneous response among heterogeneous kids? • Rigor/presence of diagnosis does not predict outcome

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