Nagato Natsume
David S. Precious
Since World War II, there has been a remarkable increase in international activities concerned with public health, an important example of which is the treatment of patients with cleft lip and palate. Most of this treatment is carried out by volunteers from developed countries, who either belong to or participate with nongovernment organizations (NGOs). The stated goals of these NGOs are to provide free surgery, which would otherwise not be available, to patients who have cleft lip and palate; to train surgeons in developing countries to perform these operations; and to donate equipment, instruments, teaching aids, and the like to regions where there is need.
“Safari” Surgery
It is encouraging to note that today many individuals and NGOs perform charitable operations on patients with cleft lip and palate in developing countries. Several organizations send missions to as many as 20 different countries spanning South America, Africa, Asia, and the Middle East. Emphasis on volunteer treatment in Asia is particularly important given the proportionally higher incidence of cleft lip and palate in that population. Thanks to these contributions, many children have been helped and the skills of local surgeons have improved.
Also encouraging is the greater emphasis some organizations are now placing on local self-sufficiency as a necessary condition for long-term treatment of cleft lip and palate in developing nations. Operation Smile (http://www.operationsmile.org), for instance, trains local medical providers from the mission site while there and, upon departure, leaves behind necessary medical equipment. In 1999, the organization donated sufficient equipment to supply both an operating room and a recovery room in 18 countries. They have also relied on multimedia as a means to pass on knowledge to local missions by donating instructional videos and video equipment. SmileTrain (http://www.smiletrain.org) also works toward local self-sufficiency. One means that they employ is to co-sponsor educational scholarships for doctors from developing nations to attend international cleft lip and palate meetings.
Strides toward technological enhancement and genetic research are also commendable expansions in the volunteer medical arena. Initiatives taken by SmileTrain include the use of computer animation in teaching and perfecting surgical techniques for cleft lip and palate and the creation of a web-based patient database. Most organizations currently carrying out volunteer surgery are also researching genetic patterns to help explain the cause of cleft lip and palate.
While the increase in volunteer missions and related medical advances is undoubtedly positive, serious considerations remain. The risk of injury to physicians occurring during the mission, for instance, highlights the need to establish comprehensive insurance policies with coverage extending not only to the particular injury but also, potentially, to the long-term disability suffered by a physician unable to carry out his or her former position upon return home.
By far the most critical area in need of attention relates to patient safety, rights, and quality of care. The current situation is in effect a regulatory void. The conduct of a clinician/surgeon at home is governed by the guidelines and standards of relevant licensing and professional bodies. These organizations are generally responsible not only for establishing the principles and rules dictating standards of care but also for enforcing these with disciplinary action in the event of breaches. While abroad, though, there exists no global body with these responsibilities or powers. Despite its ambitious work on a global scale and universal recognition, some argue that the World Health Organization has been reluctant in adopting treaties and creating guidelines with the authority that it does have (Fidler, 1999).
The result of this void is that there is effectively nothing prohibiting a surgeon, untrained in a particular operation at home, from performing such a procedure voluntarily in a developing nation, yet the risk of harm to the patient is potentially serious. There are few provisions for compensation to the patient in the event that the surgery is carried out improperly. Moreover, there is currently no uniform procedure for ensuring informed consent of mission patients either for the actual surgery or for cooperation in genetic research and analysis. Some have argued that there is no need for such a procedure owing to the already desperate medical situation of both the mission communities generally and the patients in particular. One can also envision, though, how a physician-patient information asymmetry that is even greater abroad than at home and compounded by cultural differences underscores the very need to proceed with surgery only under circumstances where patients' rights and safety are accorded the same respect as at home.
This said, there have been some laudable efforts to address this regulatory void. SmileTrain now requires all healthcare providers performing cleft lip and palate surgery for its organization to meet its Safety and Quality Improvement Protocol. This document specifically addresses the issues of patient safety and adequacy of surgeons' qualifications but remains silent with respect to informed consent. The World Health Organization Human Genetics Program (1997) has published Proposed International Guidelines on Ethical Issues in Medical Genetics and Genetic Services, which addresses the issue of genetic research being carried out as part of the surgical mission.
The International Cleft Lip and Palate Foundation (ICPF) has addressed these problems. The following guidelines were adopted as the “Zurich Declaration” at the ICPF Cleft 2000 meeting, with 550 members from 56 countries, held in Zurich, Switzerland, in July 2000.
1. A long-term technology transfer plan is needed for charitable operations. A memorandum of understanding between the local people and/or government and the volunteer mission is necessary when the visiting doctors perform operations, donate equipment, and provide education.
2. Medical humanitarian aid, including cosmetic surgery, should not be profit-motivated. These projects should be carried out in a charitable spirit. Furthermore, these operations should not entail an additional financial burden to the host community.
3. Participants should fully understand the host country's laws, customs, and systems and conduct themselves as guests.
4. These charitable activities should not be religiously or politically motivated.
5. Surgeons should act as teachers, practitioners, and learners.
6. Surgery and other treatment should be performed in collaboration with the local doctors, to allow more effective treatment and technology transfer.
7. We must take responsibility for the patients' convalescence. We should also establish a plan of assistance for the patients' independence.
8. The governing body of the organization should maintain a record of the volunteer participants' professional licenses and personal histories. Measures should be taken to ensure the health and safety of the volunteer participants.
9. A fund should be established for medical accident and/or travel insurance for the staff.
10. An important charity mission goal is establishment of centers of excellence.
These guidelines include important items that individuals and NGOs ought to keep in mind when they undertake aid projects abroad. In subscribing to such guidelines, surgeons volunteering in developing countries would be able to work toward the important goal of a universal standard of care for patients, irrespective of nationality or need.
Assessment of Quality of Surgery
There is a need not only to enhance the research infrastructure but also to meet the challenge of improving quality of services by sharing examples of good practice, recognition and appreciation of common problems, and application of one country's demonstrated success to other countries. This task is all the more difficult in countries where patient follow-up is hindered, and sometimes even prevented, by distance, cost of travel, lack of trained clinicians, and culture.
Attempts to assess outcomes of cleft lip and palate surgery based on pre- and postoperative photographs are limited by the inability to assess dynamic function. Even in developed countries, rigor must be applied in the selection of parameters on which will be based the methodology of outcome studies.
In cleft lip/palate patients, aberrations in craniofacial morphology and growth have often been attributed to the technique and timing of lip and palate surgery (Moisted, 1999). This attribution overlooks the influence of inherent growth tendencies, such as those resulting from variation in cranial base morphology. Cranial base patterns may predispose an individual to certain growth patterns irrespective of the technique and timing of cleft surgery. Thus, when evaluating the results of surgical treatment in CLP patients, cranial base morphology should be included as one influential factor in dental/skeletal relationships. For this reason, one must use caution in interpreting studies based on the examination of dental casts, as is done using the Goslon yardstick (Mars et al., 1987).
In cleft lip and palate, an important (perhaps the most important) event for the patient is what happens on the operating table. The aims of physiological surgery for cleft lip and palate are to restore the best anatomy and physiology of the divided muscles, to recover all normal orofacial functions, not to interfere with the process of maxillary growth, and to ensure good development of the facial skeleton. A priori, seemingly, aesthetics is not the primary concern of this surgery, but in fact, it is the best anatomical and physiological reconstruction of the muscles involved in the cleft that ensures the most beautiful facial aesthetics, both at rest and in function (Delaire, 1978).
Assessment of outcomes of primary and secondary surgery based on functional parameters, such as vestibular oral-nasal fistula, palatal deviation of the nasal septum to the noncleft side, dental over jet, and coincidence of the maxillary dental midline with that of the mandible (to list a few), offers the advantages not only of simplicity and certainty (there is either a fistula or there is not) but also of providing a means by which the clinician can determine the extent to which the specific goals of surgery were achieved (Precious, 2000). An oral-nasal fistula is not a complication of palatal surgery; rather, it is a failure to achieve the purpose of the surgery. This functional approach to outcomes assessment is seen as one practical innovation by the ICPF.
The way forward is through collaborative research to improve understanding, treatment, and prevention of clefts of the lip and palate. There will never be one best technique or one best protocol. We must broaden our approach so that we respect the patient's right to choose, on the basis of adequate information, from alternate treatment plans that meet professional standards of care. Our duty to secure informed consent is of an even higher order when the patient and the family have little or no information about the proposed surgery.
International Charity Operation Network
When NGO aid activities are undertaken without any criteria such as those outlined in the above-mentioned guidelines, unnecessary confusion can occur in aidrecipient countries. If we share our own information, not only can we avoid such risks but also both the NGO and the local people can make use of that information. With this network system, multiple NGOs can exchange information about their activities through the Internet so that more than two NGOs can cooperate with each other when they undertake activities in the same place or arrange a mutually acceptable schedule of activities to avoid ineffectiveness.
The ICPF has established an incubator program, whereby a meeting of like-minded groups and individuals will be held once every 2 years at the ICPF congress. The incubator program facilitates participation and meeting of NGOs in each country, senders of charity operation missions, and recipients. Accordingly, if there is a certain group which is planning to send a mission and another which is seeking surgeons to perform care, they can talk about their needs face to face at the meeting. It is generally agreed that this will foster the establishment of effective new aid projects.
World Gene Bank
Gene analyses used to improve treatment will become much more important for cleft lip and/or palate treatment in the twenty-first century. However, there are still problems with treatment in developing countries, particularly with regard to psychological support for every patient and family. In the twentieth century, individuals, hospitals, and countries made efforts to solve these problems. What is required in the twenty-first century is that all nations, including developing countries, address these problems.
A prerequisite to progress in the twenty-first century is worldwide establishment of an informed consent system in gene analysis therapies and global registration of patients with rare diseases. Thus, the World Cleft Gene Bank was established to ensure patients' rights in gene analysis therapies and to determine the cause of syntrophus in collaboration with the global community. It is vitally important to determine the causes not only of cleft lip and palate alone but also of all congenital syndromes that affect the maxillofacial region. A registration system for rare diseases is as important as the cause-determination project in the gene analysis therapies. Further, the World Cleft Gene Bank will keep a close watch on patients' rights, especially regarding protection of privacy, which sometimes can be overlooked due to competition among researchers.
Information Exchange for Patients/Families and Doctors
Since cleft lip/palate rarely results in death or serious disease, administrative bodies tend to be reluctant to take quick measures, but in Japan roughly 30% of mothers who delivered a child with cleft lip and palate said that they had considered committing suicide. Mothers who delivered a child with serious bilateral cleft lip and palate said that they had considered not only committing suicide but also killing their own child. Actually, there is a recorded case of a grandmother who killed her cleft lip and palate grandchild. Why do families think of such dreadful things? The reasons are that cleft lip and palate can cause an unaesthetic facial appearance, speech problems, and disadvantages regarding marriage and other social relationships.
Organizations like the ICPF want patients, their families, and doctors to discuss how they can cope with these difficulties, including prejudice by their neighbors and bullying by classmates. In addition, this same initiative includes preparation of a database compiled by contacting governments, including information about what policies the government has in place to care for cleft lip and palate. This is the challenge of the future.
References
Delaire, J (1978). Theoretical principles and technique of functional closure of the lip and nasal aperture. J Maxillofac Surg 6: 109–116.
Fidler, DP (1999). International law and global public health. Kansas Law Rev
Mars, M, Flint, D, Houston, W, et al. (1987). The Goslon yardstick: a new system of assessing dental arch relationships in children with unilateral clefts of the lip and palate. Cleft Palate J 24: 314–322.
Moisted, K (1999). Treatment outcome in cleft lip and palate: issues and perspectives. Grit Rev Oral Biol Med 10: 225–239.
Precious, DS (2000). Unilateral cleft lip and palate. In: Cleft Lip and Palate—A Physiological Approach. Oral and Maxillofacial Clinics of North America. Vol. 12. Philadelphia: Saunders, pp. 399–420.
World Health Organization Human Genetics Program. (0000) Proposed International Guidelines on Ethical Issues in Medical Genetics and Genetic Services. Geneva: World Health Organization.