Orofacial clefts are among the most frequent congenital anomalies, occurring in approximately 1 in 750 live births in the U.S. During the first year of a life, children born with cleft lip and/or cleft palate (CL/CP) in developed countries typically undergo one two reconstructive surgeries. Over 8,000 such primary CL/CP repair procedures are performed in the U.S. each year. In European health care systems, standardization of care and higher patient volume predict better long-term functional and aesthetic outcomes in children with CL/CP. In the U.S., however, there has been little effort to evaluate the quality of craniofacial care, including surgical outcomes. In the United Kingdom, studies of the volume-outcome relationship have led to the centralization of cleft care. Preliminary analysis of year 2000 data indicates that the majority (75%) of U.S. hospitals performing CL/CP repair procedures had low volumes, yet 67% of cleft lip (CL) and 73% of cleft palate (CP) repair procedures occurred in high-volume hospitals. Complication rates were higher in low-volume hospitals. However, centralization could further concentrate providers in a limited number of geographic locations, potentially worsening access to cleft care. Thus centralization could either ameliorate or exaggerate disparities in orofacial cleft outcomes. We propose to quantify the volume-outcome association for orofacial cleft repair procedures by analyzing the Kids'Inpatient Database (KID), a large administrative dataset available through the Agency for Health Research and Quality. We will use the KID datasets from the years 1997 to 2009, and (pending availability) 2012 to 1a) how CL and CP repair procedures are distributed nationally, according to procedure volumes and other hospital- and child-level characteristics, and 1b) whether the distributions have changed over time;2) whether complication rates following CL or CP repair are higher in low-volume hospitals or with low-volume surgeons;and 3) whether patients from traditionally underserved groups are likelier to receive care in low-volume hospitals. The proposed project will address gaps in knowledge about the costs and distribution of CL/CP care. The results will also enhance evaluations of centralization with evidence regarding its likely effect on health care disparities, whether positive or negative. Quantification of volume-outcome associations has been performed for a wide variety of surgical procedures, frequently leading to formal programs that incorporate procedure volume as a metric for reimbursement or accreditation. Particularly with regard to underserved populations, it is critical to quantify the potential benefits before pursuing similar programs or centralization of cleft care in the U.S. Thus the results of our proposed project will directly infrm efforts to improve quality of care for infants with CL/CP in the U.S.

Public Health Relevance

The proposed project will address gaps in knowledge about the costs and distribution of surgical care for cleft lip and/or palate, which are among the most frequent congenital anomalies. The results will enhance evaluations of the possibility of centralization of care with evidence regarding its likely effect on health care disparities, whethe positive or negative. Thus the proposed work will directly inform efforts to improve quality of care for infants with cleft lip and/or palate in the U.S.

National Institute of Health (NIH)
National Institute of Dental & Craniofacial Research (NIDCR)
Small Research Grants (R03)
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Special Emphasis Panel (ZDE1)
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Fischer, Dena
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Forsyth Institute
United States
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