Objectives: To evaluate the performance of the Visual Analogue Scale (VAS), in measuring overall health-related Quality of Life (HRQoL) in children with oral clefts relative to the Pediatric Quality of Life Inventory 4.0 (PedsQL^TM) Generic Core Scales, one of the most validated and commonly used methods to measure pediatric HRQoL. Methods: The study included a population-based sample of 307 children aged 5 to 10 years who were born in Iowa, New York, and Arkansas with non-syndromic oral clefts. Data on HRQoL were obtained using a VAS and PedsQL^TM via self-administered interviews with the parents. We evaluated the correlations between the VAS and PedsQL^TM total scores, and the correlations of each of these two scales with a series of child health and wellbeing indicators. Results: The VAS and PedsQL^TM scores were well-correlated (r = 0.67). There were no prominent differences between the correlations of VAS and PedsQL^TM with the selected indicators of child health and wellbeing; differences in correlations were less than 0.1. Differences in HRQoL by cleft type were more pronounced on the PedsQL^TM. Conclusions: Our study finds the VAS to perform relatively well in measuring overall HRQoL among children with oral clefts. The VAS may be useful as a screening tool to identify children with oral clefts at risk of low HRQoL for referral into more comprehensive evaluations and for measuring average HRQoL across a sample of children. Full article

Objectives: To evaluate the effects of folic acid supplementation on isolated oral cleft recurrence and fetal growth. Patients and Methods: The study included 2,508 women who were at-risk for oral cleft recurrence and randomized into two folic acid supplementation groups: 0.4 and 4 mg per day before pregnancy and throughout the first trimester. The infant outcome data were based on 234 live births. In addition to oral cleft recurrence, several secondary outcomes were compared between the two folic acid groups. Cleft recurrence rates were also compared to historic recurrence rates. Results: The oral cleft recurrence rates were 2.9% and 2.5% in the 0.4 and 4 mg groups, respectively. The recurrence rates in the two folic acid groups both separately and combined were significantly different from the 6.3% historic recurrence rate post the folic acid fortification program for this population (p = 0.0009 when combining the two folic acid groups). The rate of cleft lip with palate recurrence was 2.9% in the 0.4 mg group and 0.8% in the 4 mg group. There were no elevated fetal growth complications in the 4 mg group compared to the 0.4 mg group. Conclusions: The study is the first double-blinded randomized clinical trial (RCT) to study the effect of high dosage folic acid supplementation on isolated oral cleft recurrence. The recurrence rates were similar between the two folic acid groups. However, the results are suggestive of a decrease in oral cleft recurrence compared to the historic recurrence rate. A RCT is still needed to identify the effect of folic acid on oral cleft recurrence given these suggestive results and the supportive results from previous interventional and observational studies, and the study offers suggestions for such future studies. The results also suggest that high dosage folic acid does not compromise fetal growth. Full article