raniofacial cleft anomalies are common, affecting 1 in 600 live births annually. 1 However, cleft lip and/or palate (CL/P) disproportionately affects newborns in low-and middle-income countries (LMICs) owing to substandard nutrition and a lack of prenatal care. 2,3 Infants born with CL/P in LMICs face significant barriers to treatment, which often lead to prolonged disfigurement, social stigma, speech impairment, and feeding difficulty that may result in malnutrition and even death. [4][5][6] Although CL/P is a complex condition that benefits from comprehensive care, the provision of safe, timely, and effective surgery helps to achieve a successful outcome. 5,6 Like other LMICs, India lacks reliable documentation of birth anomalies 7 ; thus, accurate estimates of the burden of CL/P in India are few. 4 A multicenter hospital-based study of 94 610 births 8 reported that the incidence of CL/P was 9.3 per 10 000 births and the incidence of cleft palate was 1.7 per 10 000 births. Khajanchi et al 4 performed a populationbased assessment of the unmet need for CL/P treatment in a single district. They reported a CL/P incidence of 7.3 per 10 000 live births. With a crude birth rate of 200 per 10 000 population and 1.25 billion people, as many as 3 infants with CL/P are born in India every hour. The proportion of these cases that receive safe, timely, and effective surgical care IMPORTANCE The unmet need for cleft lip and/or palate (CL/P) care in India is significant. However, estimates required for CL/P care program planning are lacking.OBJECTIVE To estimate the unmet need for CL/P surgery in India at the state level.
DESIGN, SETTING, AND PARTICIPANTSTo determine the proportion of individuals with CL/P who presented for care in India, data were used from patients who received care at Operation Smile programs in 12 low-and middle-income countries from June 1, 2013, to May 31, 2014. The resulting model describes the prevalent unmet need for cleft surgery in India by state and includes patients older than the surgery target ages of 1 and 2 years for cleft lip and cleft palate repair, respectively. Next, the total number of unrepaired CL/P cases in each state was estimated using state-level economic and health system indicators.
MAIN OUTCOMES AND MEASURESPrevalent unmet need for CL/P repair.
RESULTSIn the 28 states with available data, an estimated 72 637 cases of unrepaired CL/P (uncertainty interval, 58 644-97 870 cases) were detected. The percentage of individuals with unrepaired CL/P who were older than the respective target ages ranged from 37.0% (95% CI, 30.6%-43.8%) in Goa to 65.8% (95% CI, 60.3%-70.9%) in Bihar (median, 57.9%; interquartile range, 52.6%-63.4%). The rate of unrepaired CL/Ps ranged from less than 3.5 per 100 000 population in Kerala and Goa to 10.9 per 100 000 population in Bihar (median rate, 5.9 [interquartile range, 4.6-7.3] per 100 000 population).CONCLUSIONS AND RELEVANCE An estimated 72 000 cases of unrepaired CL/P are found in India. Poor states with less health care infrastructure have exception...