The reasons for this failure were complicated. While the large number of centers and individuals providing treatment for CFA in North America improved patients’ geographical accessibility to care, it simultaneously created a fractionation of the study population, thereby reducing the probability of developing patient samples of adequate size to enable valid research. The entire landscape was further complicated by noncomparable patient populations, noncomparable treatment records, unquantifiable differences in operator skills, and difficulties in letting go of biases. Also, while collaborative research could be structured without violating patient privacy laws, the rigors of doing so were sufficient discouragement for many clinicians to participate. Finally, there remained a general lack of agreement between centers on minimal standards for reporting and recording outcomes, as well as cost and ethical concerns over taking records which cannot be clearly identified as essential for diagnosis and treatment purposes.

In summary, although the desire, research talent, and patient samples were all readily available in the North America, before 2006, the failure to get centers to agree on something as basic as standardization of recording and reporting outcomes, as well as governmental hurdles and a serious lack of funding, all resulted in a huge and ongoing missed opportunity. The WHO (2002) concluded by stating that … “it seems most likely, that the most promising avenue to break out of this inertia, may still lie in the original Eurocleft approach. With a core of interested and experienced clinicians, operating at high volume centers, and willing to agree on records, outcome measures of significance, and research protocols, and additionally with the possible guidance from those involved in the successful Eurocleft, Scandcleft and Eurocran programs, it might still be possible to initiate a major inter-center collaborative research effort.”

Based on this report, in 2006, the American Cleft Palate-Craniofacial Association (ACPA) and the Cleft Palate Foundation (CPF) approved funds to organize a pilot project which has become the “Americleft Project” and ACPA’s Americleft Task Force. From ACPA’s strategic plan, the purpose of this initiative is “….to continue to develop strategies and execute intercenter collaborative outcomes studies in multiple disciplines for the purpose of documenting the outcomes and assessing best practices of team care.”

Five centers were identified to participate in the pilot project which was modeled exactly after the Eurocleft study and resulted in completion of initial comparisons of dental arch relationship outcomes, cephalometric skeletodental morphology outcomes, and nasolabial appearance outcomes. The results of these, to be discussed below, confirmed the value and benefits of well-controlled and well-designed intercenter outcome comparisons. Most importantly, however, was the experience and insight that was gained in understanding the requirements, demands, and possible obstacles that must be overcome in order to participate successfully in such collaborative studies.

The success of Americleft has always been based on the integrity and intellectual honesty of those choosing to participate and several key requirements for participation. Participating centers’ team members had to be experienced and focally interested in CLP and with an interest in seeking knowledge about the relative merits of various treatment protocols rather than having an unquestioning loyalty to particular procedures. While we as care providers all believe that the procedures we are doing are the best possible for our patients, involvement in collaborative outcome studies implies a degree of uncertainty about the true effectiveness of our individual protocols, the ability to question our own beliefs and to accept the possibility that there may be other equally good or better outcomes with protocols different from the one(s) used by our own team. In addition, the Americleft centers had to have a high volume of patients and well-defined protocols for management of their patient population. Centers also had to have the resources to support team representatives in dedicating the time and absorbing the costs of the effort as well as the availability of the necessary records (privacy protected) and ability to secure IRB approval from the parent institution.

The initial studies conducted as part of the Americleft Project were identical to those carried out in the original Eurocleft study (Long et al. 2011): 9-year-old, mixed dentition comparison of dental arch relationship (Hathaway et al. 2011), craniofacial form (Daskalogiannakis et al. 2011), and nasolabial appearance (Mercado et al. 2011 b). The patients were consecutively treated by high-volume surgeons in their respective centers. The outcome measures were also identical to those used in the Eurocleft study, including dental arch relationship ratings using dental casts and the Goslon yardstick (Mars et al. 1987