1. Considering the Control Group: The Influence of Follow-Up Assessments on Asthma Symptoms
- Author
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Nicolas P.N. Goldstein, Sean M. Frey, Maria Fagnano, Reynaldo Tajon, and Jill S. Halterman
- Subjects
Male ,medicine.medical_specialty ,Research Subjects ,New York ,Psychological intervention ,Asthma care ,Article ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,Risk Factors ,law ,030225 pediatrics ,Internal medicine ,Humans ,Medicine ,030212 general & internal medicine ,Child ,Randomized Controlled Trials as Topic ,Asthma ,business.industry ,Asthma symptoms ,medicine.disease ,Uncontrolled asthma ,Clinical trial ,Research Design ,Child, Preschool ,Pediatrics, Perinatology and Child Health ,Female ,business ,Medicaid ,Follow-Up Studies - Abstract
OBJECTIVE: It is unclear whether research participation effects contribute to an improvement in asthma symptoms during clinical trials in the absence of any active intervention. We examined the impact of additional follow-up surveys on caregiver-reported symptoms among control subjects in a series of randomized controlled asthma trials. METHODS: We analyzed baseline and follow-up data for children (3–10 yrs.) with poorly controlled persistent asthma that participated as control subjects in 1 of 3 randomized trials of urban school-based asthma care (study duration: 7–10 months). We compared mean symptom-free days (SFD) per 2 weeks between baseline and final follow-up; performed bivariate regressions to explore associations between demographics and changes in SFD; and performed multivariate random-effects generalized least square regression to examine the relationship between number of follow-ups beyond baseline (range: 1–10) and changes in SFD over time. RESULTS: 516 children were enrolled as controls across the 3 trials (mean age 7.5 yrs., 61% Black, 28% Hispanic, 81% Medicaid). Mean SFDs increased significantly from baseline to final follow-up (7.8 to 11.4 days, P
- Published
- 2020
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