71 Cost-Effectiveness of Infant Orthopedic Treatment Regarding Speech in Patients With Complete Unilateral Cleft Lip and Palate: A Randomized Three-Center Trial in the Netherlands (Dutchcleft) EMMY M. KONST,PH.D. CHARLOTTE PRAHL, D.D.S. HANNY WEERSINK-BRAKS, M.A. THEO DE BOO, M.SC. BIRTE PRAHL-ANDERSEN, D.D.S., PH.D. ANNE M. KUIJPERS-JAGTMAN, D.D.S., PH.D. JOHAN L. SEVERENS,PH.D. Objective: To investigate the cost-effectiveness of infant orthopedic treat- ment (IO), compared with no such treatment in children with complete unilat- eral cleft lip and palate (UCLP) focusing on the effects on speech development at age 2.5 years. Design: In a three-center prospective, randomized clinical trial (Dutchcleft), two groups of children with complete UCLP were followed longitudinally: one group was treated with IO based on a modified Zurich approach in the first year of life (IO group) and the other group did not receive this treatment (non-IO group). Patients: The participants had complete UCLP without soft tissue bands or other malformations. They were born at term and their parents were native Dutch speakers. Outcome Measures: The effect of IO on speech development at age 2.5 years was measured blindly by five expert listeners judging the ‘‘total impression of speech quality’’ on a 10-point equal-appearing interval scale. Costs were mea- sured from a societal viewpoint in Euro. Results and Conclusion: The IO group (n  10) obtained a statistically sig- nificant higher rating, compared with the non-IO group (n  10). The effect size was large, indicating that the improvement may be considered a clinically im- portant change. The cost for treatment by the orthodontist was higher in the IO group. For both groups, the mean cost was related to the mean rating for ‘‘total impression of speech quality.’’ The resulting cost-effectiveness for IO, compared to non-IO was €1041 for 1.34 point speech quality improvement. The financial investment that is necessary to obtain this improvement seems lim- ited. Thus, from the perspective of speech development, the cost-effectiveness of IO over non-IO seems acceptable at this point in time. KEY WORDS: cleft lip and palate, cost-effectiveness analysis, infant orthope- dics, speech In many cleft palate centers, especially in Europe, infant orthopedics (IO) is used in the comprehensive care of children Dr. Konst is a Speech Language Pathologist, Dr. Prahl is an Orthodontist, and Dr. Kuijpers-Jagtman is Professor of Orthodontics at the Department of Orthodontics and Oral Biology, Ms. Weersink-Braks is a Speech Language Pathologist formerly affiliated with the Department of Voice and Speech Pathology, and Mr. De Boo is Senior Statistician at the Department of Epidemiology and Biostatistics of the Uni- versity Medical Centre St. Radboud, University of Nijmegen, the Netherlands. Dr. Prahl-Andersen is Professor of Orthodontics, Department of Orthodontics, Academic Center for Dentistry Amsterdam, Amsterdam, the Netherlands. Dr. Severens is cur- rently Professor of Medical Technology Assessment at the Department of Health Organization, Policy, and Economics, University of Maastricht, Maastricht, the Netherlands. During this study, he was affiliated with the Department of Medical Technology Assessment of the University Medical Centre St. Radboud, University of Nijmegen, the Netherlands. with cleft lip and palate. The relevance of this treatment, how- ever, is controversial. In past decades, both proponents and opponents of IO have expressed their opinions in the literature. Among the advantages of IO claimed in the literature are cor- rect alignment of the alveolar segments and narrowing of the cleft (McNeil, 1956), facilitation of surgical closure of the cleft and thus improved esthetic outcome (Gnoinski, 1990), facili- tation of feeding (Oliver, 1973; Lubit, 1976), parental support (Lubit, 1976; Huddart, 1990), and improved speech (Stuffins, Submitted June 2002; Accepted March 2003. Address correspondence to: Emmy M. Konst, Department of Orthodontics and Oral Biology, University of Nijmegen, P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands. E-mail e.konst@dent.umcn.nl.