Validation of the Dutch Registry of Common Oral Clefts: Quality of Recording Specific Oral Cleft Features

Objective Since 1997, common oral clefts in the Netherlands have been recorded in the national oral cleft registry using a unique descriptive recording system. This study validates data on the topographic-anatomical structure, morphology, and side of individual anomalies of the primary palate and secondary palate that form the oral cleft. Design Validation study. Setting All 15 Dutch cleft palate teams reporting presurgery oral cleft patients to the national registry. Patients A random sample of 250 cases registered in the national database with oral clefts from 1997 through 2003; of these, 13 cases were excluded. Main Outcome Measures By linking registry data with clinical data, we identified differential recording rates by comparing the prevalence, and we measured the degree of agreement by computing validity and reliability statistics. Results The topographic-anatomical structures (lip, alveolus, and hard and soft palates) of the anomalies had near-perfect interdatabase agreement with a sensitivity of 88% to 99%. However, when analyzing the individual anomalies in detail (morphology and side), validity decreased and depended on morphological severity. This association was most evident for anomalies of the secondary palate. For example, sensitivity was higher for “complete cleft hard palate” (92%) than for “submucous cleft hard/soft palate” (69%). Conclusions Overall, the validity of Dutch registry data on oral clefts is good, supporting the feasibility of this unique recording system. However, when analyzing oral cleft data in detail, the quality appears to be related to anatomical location and morphological severity. This might have implications for etiologic research based on registry data and for guidelines on neonatal examination.