The level of care in terms of each treatment or care step is summarized in Table 6.
As multidisciplinary/interdisciplinary care for patients with CL/P has become an indispensable option for optimizing the quality of their life 1,7,19, it is our responsibility to ensure that all patients in Egypt especially those with complete clefts are treated under this model of care. The results of our current study highlight the fact that patients with CL/P in Egypt treated in public or teaching hospitals require more comprehensive and regular care. Establishment of interdisciplinary cleft care centers in all Egyptian Universities is strongly recommended for optimizing the treatment outcomes from infancy through adolescence.
In the current study, the coincidental even distribution of bilateral complete and unilateral complete CLP, as well as isolated CL and isolated CP, was indicative of the fact that the type of care received is not cleft-type related. The age range of patients included was widely distributed, allowing an overview of the current level of care offered across more than three age groups. The mean age was 8.2 years; almost one-third of the sample was older than 9 years of age, which is around the age of secondary ACG. In addition, 50% of the sample was between 4 and 13 years of age, which allows a clear view of the practice adopted at this critical age in preparation for grafting.
As for any chronic disease or medical problems requiring long-term rehabilitation, documentation is considered the key for a successful follow-up. The ACPA parameters state that ‘every team has the responsibility to maintain centralized and comprehensive records on each patient, including histories, diagnoses, reports of evaluations, treatment plans, reports of treatment, and supporting documentation such as photographs, radiographs, dental models, and audiotaped speech recordings’ 19.
However, in the current study, retrieving data from parents or care givers was the most difficult task. This was attributed to the absence of official documentation provided to the parents by the surgeons performing the primary procedures or other interventions. This finding was almost common in all cases, except for individual cases (10%), where the parents showed personal interest in collecting some data and relevant documents. This indicates the need for the use of log books designed especially for this purpose as well as centralized data registry for patients with different craniofacial anomalies and birth defects including CL/P.
When parents face the birth of a baby with CL/P, they usually experience considerable anxiety and require adequate explanation and information on the prognosis, outcome, and treatment options 19. In the current study, as stated earlier, only 60% of the parents had received some kind of an initial undetailed explanation of the CL/P. The explanation was mainly for the surgical repair of the timing of CL/P rather than complete comprehensive care. None of the parents were provided educational/informational material about CL/P explaining the management required for this medical problem. The same applied to the feeding instructions provided to parents following the birth of their cleft-affected child. Feeding instructions provided to 70% of the parents were mainly in the context of babies with CL/P are unable to breast feed and require special bottles rather than exact positioning during feeding and what types of bottles are required and where to buy them. It is also noteworthy that there was no proper system for the registration and referral of these babies to certain hospitals, even though the cleft team members are expected to offer advice to such parents, providing them with basic information about the immediate newborn period, especially with respect to feeding, air way control as well as detailed explanation of the future interventions required 23–25. These findings could be attributed to the lack of adequate training offered to primary healthcare professionals in terms of CL/P as well as the lack of national guidelines/updates for the management of patients with CL/P.
It is known that CL/P may be associated with other congenital defects 26,27. Hence, the ACPA parameters stated that ‘pediatric care provided within the context of the team is fundamental in assuring that the health needs of the child with craniofacial anomalies are fully identified and appropriately treated and that a primary care physician should be identified for each child’ 19. In the current study, only 69% of the sample included had undergone a pediatric assessment following birth, which means that 31% were not assessed and that other congenital defects could not be determined; pediatric care was only sought when these children were sick. This problem might be attributed to several factors: the fact that they were either born at home or in a local clinic in areas where access to full medical care was not available, in addition to the absence of prenatal diagnosis as well as lack of awareness and guidance in terms of the cleft as a medical problem and how it should be managed. Furthermore, there is a lack of multidisciplinary care centers where those patients should be referred immediately after birth.
It is known that more than 300 syndromes and trisomies could be associated with CL/P 13,28–31. Therefore, the standards of care require that all cleft-affected children should undergo a comprehensive clinical genetic evaluation, which is considered as a key component in the management of patients with congenital craniofacial anomalies. This assessment includes diagnosis, recurrence risk counseling, and counseling on the prognosis. On the basis of the fact that complex syndromes involving craniofacial anomalies may not fully express clinical manifestations that can be recognized in the first year of life, genetic screening and follow-up evaluations will be necessary for some patients until puberty. Moreover, it is necessary for those patients who are first seen at later ages to also be evaluated. In contrast, in the current study, only 18% received genetic assessment, among whom 14% had multiple congenital anomalies. However, 82% did not receive any form of genetic assessment including three families with more than one child with cleft.
With respect to the ACPA parameters, it has been noted that ‘surgical techniques should be individualized according to the needs and condition of the patient. Surgical procedures should be coordinated to minimize the number of aesthetic exposures and hospitalizations. Evaluation of complications of CL/P repairs should be subjected to peer review. The major factor in the quality of surgical outcome is the skill, training, and experience of the cleft care team’ 19. Unfortunately, this recommendation has not been followed; in the current study, most of the affected patients were dealt with by individual low-volume surgeons of different specialities including plastic, pediatric, general, and ENT surgeons. Parents were not systematically directed to experienced surgeons but rather upon availability in nearby local hospitals or upon the advice of others (family, work associates, friends, or neighbors). Parents were not fully aware of the implication of the surgeons’ speciality, training, and expertise required for optimal CL/P repair. Moreover, there are no national guidelines for the management of CL/P and hence patients did not receive systematic care by following specific timelines. It is also noteworthy that parents did not necessarily seek the same surgeon for the management of complications or for the second repair.
In terms of the surgical repair of a CL, the current consensus is 10–12 weeks of age, where the ‘rule of tens’ is a commonly adopted guideline 19,32–34. In the current study, the mean timing of primary lip repair was 5.5 months and the median was 4 months. This is considered slightly higher than that of the ‘rule of tens,’ but could still be within the acceptable range. However, the quality of the repair varied widely from excellent repairs to obviously distorted repairs that would require staged revisions to achieve acceptable outcomes, but this was still not assessed qualitatively as it was not within the scope of this study.
The timing of primary repair of the secondary palate is one of the most controversial issues related to the overall management of CP, as there are two major conflicts: speech and maxillary growth 35,36. Therefore, it is feasible to perform the palatal surgery sufficiently early. Moreover, staging palatal repair in wider clefts with only the soft palate at 12 months of age and postponement of hard palate closure until 3 or 5 years of age or even later appeared to be a reasonable strategy 37,38.
In the current study, the mean age for primary CP repair was 16.7 months and the median was 12 months; these values are in accordance with international and ACPA guidelines, but still no data could be obtained related to the staging of palatal repair as this was not clarified by surgeons to the majority of parents before or after the operations. In contrast, Kotby et al.20 have reported that the mean age for CP repair among their sample was 2.5 years because of the late presentation of some cases.
In the majority of cases included in this study, CL as well as CP were mainly perceived by parents as ‘a defect that should be closed’ rather than a defect that should be managed by certain surgical operations adopted to minimize postsurgical morbidities and problems related to speech and maxillary growth. Although interesting, the quality of repair, the number of procedures carried out as well as postoperative problems were not recorded as this was not within the scope of this particular study.
It is well known that children with either complete CL/P or isolated CP are at a risk of middle ear infection, especially otitis media with effusion, which predisposes to conductive hearing loss. Therefore, the assessment of the type and degree of any hearing loss and its effects on speech perception is essential. Hence, all patients undergoing CP repair should undergo audiological assessment early in their life and a follow-up in order to avoid such complications 19,39,40.
Moreover, after CP repair, all patients should be referred for speech evaluation around 2–3 years of age and speech therapy whenever required to stimulate speech development and to prevent undesirable compensatory articulations. It is recommended that early and aggressive management for speech and language disorders should be carried out in order to achieve intelligible speech and language usage by the time the child reaches the school-age years 41.
However, in the current study, only 55% underwent audiological assessment, which was mainly on symptomatic rather than routine bases. Moreover, only 49% had undergone speech assessment, partly on the advice of the treating surgeon and partly self-referred by the parents themselves either upon observing their children or driven by complaints concerning their child's hearing at school. This can be attributed to a lack of awareness and understanding of the problems associated with clefts involving the secondary palate as well as the lack of long-term follow-up. Those findings are in agreement with those of Kotby et al.20, who reported that families sought treatment only ‘when an important milestone was eminent.’ This was clear as the average age of patients included in their study was 28 years; they also reported a dropout rate of 70% at various stages of treatment in cases with velopharyngeal insufficiency.
To maintain good oral health, prevention and control of caries are essential for all cleft children, as it has been proposed that clefts are associated with other dental anomalies resulting from disturbed development of the dentition 42,43. At regular intervals, a pediatric or a general dentist should provide topical fluoride prophylaxis, dietary advice, and restorative care. The importance of dental assessment and treatment cannot be overlooked with children with CL/P as it is known in the ACPA parameters that patients with craniofacial anomalies will require dental services as a direct result of the medical condition, and the dental treatment is an integral part of the rehabilitative process. Provision of dental services for these patients includes not only primary care but also routine maintenance throughout life 19,44,45.
However, almost half of the patients included in the current study (53%) received dental care only for symptomatic treatment. These findings indicate the extent to which oral hygiene is neglected at the cost of CL/P repairs. None of the patients were directed toward prophylactic dental regimens specially tailored for the needs of CL/P as there is no known center that offers this service for cleft patients all over the country. This mandates the need for urgent attention from pediatric dentists toward raising awareness among dentists toward the special needs of those patients, including what should and what should not be done to avoid further complications. This finding seems to be in agreement with Dabed and Cauvi’s 46 survey of dentists’ experience with cleft children in Chile, where they reported that a majority of dentists included in their survey were not routinely exposed to the management of children with clefts and had treated a low number (1–3) of children over a period of several years using a combination of preventive-curative and radical treatments. Their results suggested the need for more information and clinical experience with children with CL/P in the dental school curricula.
The role of the orthodontist in the cleft team has become more established over the past 60 years. Currently, orthodontists are considered the main pillars in any team dealing with CL/P as the malocclusions associated with clefts are often linked to speech articulation defects, involve restraints in terms of dental hygiene, and problems with mastication, compromising the esthetics, and are related to growth defects 47–51.
The ACPA parameters stated that necessary assessments should be carried out to evaluate and monitor dental and facial growth and development. As for patients at risk of developing malocclusion or maxillary–mandibular discrepancy, diagnostic records should be collected at appropriate intervals. Regular timely check-up appointments are essential during all three stages of dentition to determine whether a malocclusion is present or developing. Orthodontic management of malocclusion must be performed and this each stage of therapy may be followed by orthodontic retention and regular observation 19.
However, only 41% of the patients included in the current study received orthodontic care as part of the management of the CL/P deformity even though all patients older than 7 years of age required an orthodontic intervention to variable degrees. This fact is attributed to the limited awareness, understanding and inadequate financial support, and most importantly, limited number of orthodontists. These restraining factors should be resolved so that any attempt to establish an integrated cleft care can be successful. It is also noteworthy that none of the patients included had received any form of nasoalveolar molding or presurgical orthopedics before lip repair. In addition, speech devices such as a palatal lift or a pharyngeal bulb prosthesis were not used for any of the patients with CP; only palatal plates for obliteration of large oronasal fistulae were used in a few cases.
ACG is a mandatory surgical procedure and continues to be an essential part of different treatment protocols for patients with clefts involving the primary palate as it provides several benefits 48,52–54.
As a general consensus, the best timing for ACG in the secondary grafting is from 9 to 12 years before the eruption of the canines 53,55–57. Moreover, the ACPA parameters also require that in late-presenting patients, bone grafting may necessarily take place after the full eruption of the permanent teeth. The timing of the operative procedure should be determined in collaboration with the orthodontist 19.
In the current study, a disappointing and alarming finding, to us as the surgeons responsible for ACG, was that approximately 82% of patients older than 9 years of age who are due for ACG did not receive any grafting attempts and parents/patients mainly had other complaints, and were not even aware of the need or the importance of this procedure. In the remaining 18%, only 12% had undergone successful grafting associated with presurgical and postsurgical orthodontic work. Meanwhile, 6% had failed grafting because of the lack of orthodontic preparation and follow-up after surgery. These alarming findings could be attributed to the lack of adequate referral systems and the lack of awareness of the other medical specialities of the importance of grafting.
In addition to the lack of an adequate number of multidisciplinary care centers and, according to what has been reported by Cassell et al.2, other challenging factors can impede timely cleft surgery as well as nonsurgical interventions and therefore contribute toward the outcomes of the current study. These factors include financial, nonfinancial, and personal barriers. Earlier, Kotby et al.20, referred to those factors as sociocultural and socioeconomic aspects. Even though our study did not examine these barriers separately, it worth pointing them out because of their expected impact on the results.
The overall optimal management of CL/P involves high costs. Therefore, financial barriers among families of children with CL/P are clear, especially for uninsured families who belong to the middle and low income levels. As reported by Kotby et al.20, in developing countries, major problems exist in terms of ‘macro-allocation for Medicare where infectious and life threatening disease are considered more vital in health care financial concerns.’ As for nonfinancial barriers, healthcare policies, service organizations, referral systems to identify and refer children with CL/P to specialized services, and providers are not yet standardized for new borns with CL/P; the same findings have been reported in several studies 20,58–63.
The situation in Egypt is not different from that reported in earlier studies discussing the personal barriers behind the lack of adequate care 20,58–60,62–64. These barriers include confusion because of what different doctors say about the problem owing to the absence of national guidelines that individual providers should follow, in addition to the inability to find the way through the healthcare system effectively, transportation, timing of appointments, missed work and school days, location of services, and a general distrust of healthcare professionals, particularly among low-income populations can disrupt the continuity of care for patients with CL/P and results in an increase in the dropout rate at various stages of rehabilitation, especially after the CL/P are primarily repaired.
Furthermore, grown-up patients with complete CL/P can still present with more than one problem related to their cleft, a finding that is consistent with the observations of other studies 9,20,65–67. In our study, each patient presented with several clinical problems related to a lack of awareness that these problems can or need to be addressed and a lack of adequate guidance because of the absence of long-term follow-up. Furthermore, a list of secondary problems that should be staged will certainly prolong the treatment time, and adds to the overall cost of rehabilitation and increases the financial burdens on the parents, society, and healthcare systems.
In summary, the findings of our study were as follows: (a) There is a lack of documentation, and retrieving accurate data from parents was a difficult task; (b) CL and CP repairs were the main focus of both parents and healthcare professionals; (c) There is a lack of awareness of the magnitude of otological and phonetic problems in children with CP; (d) Orthodontic treatment is not always performed even though urgently required because of the high cost as well as the limited number of orthodontists; (e) Nasoalveolar molding is not a common practice for patients with CL/P; (f) No prophylactic dental programs have been especially tailored for patients with CL/P; and (g) There is a lack of awareness and understanding of the need and importance for ACG among healthcare professionals as well as parents.
Ways to improve
To improve the quality of care delivered to the cleft population in Egypt, these challenges need to be addressed through collaborative efforts between different systems offering care for patients with CL/P, mainly those related to the Ministry of Health, Health Insurance, and Ministry of Higher Education and Research. Suggested ways to improve the level of cleft care can be summarized as follows:
- Establishing a national registry for birth defects including CL/P.
- Establishing national guidelines for cleft care in Egypt.
- Establishing multidisciplinary cleft centers in all Egyptian Universities.
- Organization of a cohort referral system to those centers.
- Improving awareness among healthcare professionals about the exact needs of patients with CL/P is necessary in the nursing, medical. and dental school curricula.
- Conducting comprehensive training and continuing educational programs for medical and dental specialties in direct relationship with CL/P patients.
- The need for informational and educational material/booklets and log books that should be provided to parents immediately after the birth of babies with CL/P to enhance parental awareness as well as keep track of treatment progress.
- Exerting every effort to make interdisciplinary cleft care financially feasible and informing the families about the different possibilities of financial support.
- Improving public awareness about the needs of CL/P.
Despite the limitations encountered, to our knowledge, this study was the first to examine the care provided for a group of Egyptian patients with CL/P as compared with the international guidelines with special reference to the ACPA recommendations. These data can be considered an important nidus for service and program planning as well as development of care offered to patients with CL/P in Egypt.
The author is grateful to Prof. Dr Abdelfattah A. Sadakah, Professor of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tanta University, for his valuable contribution and to Amr Amin Ghanem, Assistant Lecturer Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Ain-Shams University, for his help in collecting and organizing the data. Many thanks are due to all families who participated in this study.
Conflicts of interest
There are no conflicts of interest.
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