Observations by Caregivers Using the Infant with Clefts Observation Outcomes Instrument (iCOO): A Comparison of Three Versus Seven-day Daily Diaries

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Abstract
Objective: Our goal was to compare data collected from 3- and 7-day Infant with Clefts Observation Outcomes (iCOO) diaries. Design: Secondary data analysis of an observational longitudinal cohort study. Caregivers completed the daily iCOO for 7 days before cleft lip surgery (T0) and for 7 days after cleft lip repair (T1). We compared 3- and 7-day diaries collected at T0 and 3- and 7-day diaries collected at T1. Setting: United States. Participants: Primary caregivers of infants with cleft lip with and without cleft palate (N = 131) planning lip repair and enrolled in original iCOO study. Main Outcomes Measure(s): Mean differences and Pearson correlation coefficients. Results: Correlation coefficients were high for global impressions (>0.90) and scaled scores (0.80–0.98). Mean differences were small across iCOO domains at T0. T1 comparisons reflected the same pattern. Conclusions: Three-day diary data is comparable to 7-day diaries for measuring caregiver observations using iCOO across T0 and T1.
Funding Information
  • National Institute of Dental and Craniofacial Research (R01 DE024986)
  • National Institutes of Health (KL2 TR002317, TL1 TR002318, UL1 TR002319)

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