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)

Abstract

The IO group (n = 10) obtained a statistically significant higher rating, compared with the non-IO group (n = 10). The effect size was large, indicating that the improvement may be considered a clinically important 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 limited. Thus, from the perspective of speech development, the cost-effectiveness of IO over non-IO seems acceptable at this point in time.

Assessing methods to specify the target difference for a randomised controlled trial: DELTA (Difference ELicitation in TriAls) review

“…Other outcomes of interest included disability, functional ability, goal attainment, speech function and cognitive ability. In considering change, some studies often used a clinician to assess subjects' health, 282,287,290,293,301,303 whereas others used the subjects' self-assessment 292,297,302,[309][310][311] or both 296,299,312,313 (not necessarily for the same instrument). The view of the parents of children who were being treated was often used in studies in paediatric care along with clinical and/or child assessment.…”

“…306 Some papers were interested in assessing the effect of a treatment on health or comparing the effects of different treatments. 289,301,304,305 The study by Fredrickson and colleagues 304 included repeated measures over time, as well as different doses of a medication, as the authors were also interested in using standardised effects to investigate when changes in health occurred. Four papers specifically calculated effect sizes to inform the design of a future study.…”

“…However, this view is not universally accepted. For example, Konst and colleagues 301 specify that a large effect size indicates a clinically important change in health.…”

“…289,290,[300][301][302] A further variation on the choice of SD was described by Horton, 303 who compared the difference in means between two groups, divided by the largest SD value.…”

Long-Term Effects of Presurgical Infant Orthopedics in Patients with Cleft Lip and Palate: A Systematic Review

“…Among these, presurgical nasoalveolar molding (PNAM) appliances have generated considerable interest in recent years and have been in use as a new approach to traditional presurgical infant orthopedics (TPSIO) Maull et al, 1999;Grayson et al, 2001;Suri and Tompson, 2004;Singh et al, 2005). Some of the major advantages of TPSIO are claimed to be the improvement of arch form, the facilitation of surgical closure, and thus improvement of aesthetic outcome, the facilitation of feeding, and improvement of speech (Ross and MacNamera, 1994;Kuijpers-Jagtman et al, 2000;Mishima et al, 2000;Prahl et al, 2001;Konst et al, 2004;Berkowitz, 2006). Advocates of PNAM state that, beside the other advantages of traditional plates, the main objectives of PNAM appliances are improving nasal symmetry and lip aesthetics while elongating the columella and correcting the nasal cartilage Grayson et al, 2001;Liou et al, 2004;Ezzat et al, 2007;Singh et al, 2007;Lee et al, 2008).…”