Introduction of the flash-lamp pulsed-dye laser treatment of facial port-wine stains in childhood: A case of health care technology assessment.

BACKGROUND AND OBJECTIVE Lasers have been used in the treatment of port-wine stains (PWS) for more than 30 years. With the introduction of the flash-lamp pulsed-dye laser (FPDL) it was assumed that infants could be treated safely, effectively, and probably more efficiently. Nowadays, FPDL treatment is an established form of treatment of PWS in childhood. STUDY DESIGN/MATERIALS AND METHODS On the basis of the iterative Health Care Technology Assessment (HCTA) loop, we examined whether sufficient evidence from evaluations has been present to support the introduction of FPDL treatment for facial PWS at an early age. Such an assessment requires an interdisciplinary approach focusing on aspects of safety, efficacy, effectiveness, quality of life, costs, and the ethical issues of treatment. RESULTS Assessment of the FPDL in PWS treatment of children did not follow the model of medical innovation and evaluation. Most assessments have been focused on laser applications that were already in clinical use. Efficacy and effectiveness of laser treatment have been the major concern in most assessments. Only a few studies have looked at costs and ethical aspects of treating children. CONCLUSIONS The introduction and diffusion of the use of the FPDL in the treatment of PWS in childhood were uncontrolled, and the field was not prepared to use this technique properly. We believe that this nonadherence to the iterative HCTA model reflects the gradual way by which innovations find their way into clinical practice.