Caregiver Observations of Infant Well-Being Before and After Cleft Lip Surgery

Abstract

Objective: To evaluate the sensitivity to change of daily ratings of the comfort (COMF) and behavioral/emotional health (BEH) domains of the Infants with Clefts Observation Outcomes Instrument (iCOO) at 3 time points, and to assess the association of post-surgical interventions on iCOO ratings.

Design: The COMF and BEH domains were completed by caregivers before (T0), immediately after (T1), and 2-months after (T2) cleft lip (CL) surgery. Analyses included descriptive statistics, correlations, t-tests, and generalized estimating equations.

Participants: Caregivers (N = 140) of infants with CL with/without cleft palate.

Main outcome measures: The COMF and BEH domain scores of the iCOO: Scale (SCALE), a summary of observable signs; and Global Impression (IMPR), a single item measuring caregivers' overall impression.

Results: Daily COMF and BEH SCALE and IMPR scores changed significantly during T1 (P's < 0.001) but not T0 or T2. Day 1 and 7 T0 scores were significantly higher than Day 1 and 7 T1 scores (P's <0.001 to <0.012) but similar at T2 (P's > 0.05). After CL surgery, the combined use of immobilizers and nasal stents and the use of multiple feeding methods with treatment for gastroesophageal reflux were associated with lower daily scores in COMF and BEH SCALE and IMPR (P's: 0.040 to <0.001).

Conclusions: COMF and BEH iCOO scores were sensitive to daily changes in infant well-being following CL surgery. Future studies should further investigate impact of post-surgical treatments on infant well-being.

Keywords: cleft; iCOO; infant well-being; observer-reported outcome; patient reported outcomes.

Figure 1.

Comparison of Comfort (COMF) and Behavioral and Emotional Health (BEH) Scale and Global Impression daily mean scores across observation periods. Note: All scores were scaled 0-100 such that higher scores represent better functioning. Diaries were completed for 7 days at T1 and T2 and 3 days at T3. Data at T0 was based on 856 observations from 140 caregivers; at T1 data was based on 755 observations from 122 caregivers; and at T2 data was based on 318 observations from 119 caregivers. Rates of daily changes were not significant for any of the COMF or BEH variables at T0 or T2 (all p’s > .491). At T1 daily changes were significant for each COMF and BEH outcome (all p’s < .001).

Figure 2.

Comparison of Daily Comfort and Behavioral and Emotional Health Scale and Global Impression estimated mean scores across T1 reporting days by number of feeding methods (Method) and treatment for gastroesophageal reflux disease (GERD) (A-D) and across T1 reporting days by use of immobilizers and nasal stents (E-H). Note: All scores were scaled 0-100 such that higher scores represent better functioning. Diaries providing data for these graphs were completed on at least one day by 84 different caregivers for a total of 545 observations. Differences in daily changes by Method and GERD across time were significant for Comfort and Behavioral and Emotional Health Scale and Global Impression scores (all p’s <.001). Differences in daily scores by use of immobilizers and/or stents were significant for the COMF and BEH IMPR scores (p’s = .014 and .049) with a trend for the COMF SCALE (p = .098) (See Table 4 for details).

Figure 2.

Comparison of Daily Comfort and Behavioral and Emotional Health Scale and Global Impression estimated mean scores across T1 reporting days by number of feeding methods (Method) and treatment for gastroesophageal reflux disease (GERD) (A-D) and across T1 reporting days by use of immobilizers and nasal stents (E-H). Note: All scores were scaled 0-100 such that higher scores represent better functioning. Diaries providing data for these graphs were completed on at least one day by 84 different caregivers for a total of 545 observations. Differences in daily changes by Method and GERD across time were significant for Comfort and Behavioral and Emotional Health Scale and Global Impression scores (all p’s <.001). Differences in daily scores by use of immobilizers and/or stents were significant for the COMF and BEH IMPR scores (p’s = .014 and .049) with a trend for the COMF SCALE (p = .098) (See Table 4 for details).