Abstract
Background
Clubfoot is the most common extremity birth defect. It causes the feet of affected individuals to point inward and downward, preventing them from walking normally. Neglected clubfoot causes disabilities that result in a lack of social integration, creating a psychological and financial burden for the family and community. Clubfoot has been effectively treated through the Ponseti method, a treatment utilizing serial casts to correct the deformity followed by use of an abduction brace for approximately 2-4 years. sustained use of the brace is necessary to prevent relapse and ensure a successful outcome. Brace compliance in the setting of limited resources in the developing world can be challenging. The purpose of this study was to identify the barriers to bracing compliance in southeastern Brazil. In addition to socioeconomic and cultural barriers, this study also looked at improper prescribing practices by physicians as a potential cause of noncompliance. The study sought to identify the role of physician education in the use of the Ponseti method and physicians’ knowledge of the bracing process.
Purpose of the study
Identify the barriers to bracing adherence that could negatively impact the treatment of children with clubfoot.
Methods
Forty-five orthopedists from several centers in southeastern Brazil were interviewed. Physicians were asked about their training in the Ponseti method, their protocol when prescribing the brace, their evaluation of its importance, and a series of open-ended questions designed to identify the positive and negative qualities of local braces. They were also asked what they perceived to be the biggest challenges to sustained brace use.
Results
sixteen of the physicians interviewed were orthopedic residents, and 29 had completed their residencies. Of these two groups, only 25% and 65%, respectively, appropriately prescribe the abduction brace for patients, with the majority recommending use of the brace for an inadequate period of time. The high costs and delays in acquisition of the brace and a lack of orthopedic stores able to adequately construct the orthotic, also present considerable barriers to sustained brace use.
Conclusions
Many of the causes of noncompliance with bracing protocol stem from systemic inequities and challenges, rather than a lack of collaboration from the families themselves. Furthermore, insufficient prescription of the brace by physicians may represent a major barrier to bracing compliance in southeastern Brazil. This research indicates a need to evaluate physician training and continuing medical education in order to ensure that physicians are adequately utilizing the brace.
Introduction
Clubfoot is a congenital birth defect that causes the feet of affected infants to point inward and downward, forcing the child to walk on the sides of his or her feet. It often results in significant disability for affected individuals by limiting mobility, increasing the risk of skin and bone infections, and decreasing opportunities to pursue education and employment1,2. It can also be a source of psychological harm when the child is subjected to ostracism or derision.
Historically, clubfoot has been treated with extensive and invasive surgeries. However, since the 1990s, the Ponseti method of treatment has repeatedly been proven to effectively treat clubfoot with only minimally invasive surgery1,3-8. This technique, which involves a series of manipulations and castings followed by an office- based Achilles tenotomy, is especially groundbreaking in developing countries, where extensive surgery is often prohibitively expensive and where 80% of children with clubfeet are born1,2. Rates of success with the Ponseti method have been reported to be as high as 95%4; however, relapse rates are also high and present a significant problem in treatment9. Relapses occur in 14-41% of patients9, with some patients experiencing multiple relapses or treatment failure. The single factor most frequently associated with relapse is inadequate use of an abduction brace following the casting phase of treatment5,9. According to Ponseti protocol, the brace should be prescribed for 23 hours a day for 3 months, followed by approximately 4 years of nocturnal use9. A lack of adherence to the bracing protocol increases the risk of relapse by 17-fold4. It is thus critically important that physicians trained in the Ponseti method are aware of the importance of the brace, and correctly prescribe the use of the abduction brace in order to prevent relapses. Invasive surgery can be performed in the case of multiple relapses or treatment failure; however, it is associated with long-term pain and impaired quality of life1,10-14. In addition to the role of physicians in the use of the abduction brace, barriers to bracing compliance on behalf of the parents of treated children must be adequately addressed and resolved in order to ensure the best possible outcome for patients treated with the Ponseti method. Various studies have estimated rates of noncompliance regarding use of the brace from 32-61%9. While a number of papers have described a range of causes of noncompliance9’16-18, there have been no studies that are culturally specific to Brazil.
The first widespread use of the Ponseti method in Brazil took place in 2001, when the first large Ponseti clinic was introduced at Universidade Estadual Julio de Mesquita Filho (UNESP) in the state of São Paulo. Since that time, a number of conferences have offered formal training in the Ponseti Method. In 2004, the Brazilian handbook of treatment guidelines according to the Society of Brazilian Orthopedists and Traumatologists cited the Ponseti method as the preferred treatment for clubfoot15. At that time, the Ponseti method was introduced into a number of orthopedic residency programs in Brazil, and has since become increasingly incorporated into curricu- lums across the country. However, the training varies greatly depending on the residency, and the physicians teaching the technique have not necessarily had formal training in the Ponseti method. As a result, physicians may or may not be familiar with appropriate bracing protocol.
As the Ponseti method becomes more widely dispersed throughout Brazil, a need has developed to evaluate whether or not physicians are appropriately prescribing the abduction brace, as well as the need to identify barriers to bracing compliance on behalf of families of children with clubfoot. As Brazil was the first country in South America to begin a national Ponseti initiative, its successes and challenges may be applicable to other countries in earlier stages of developing their own national initiatives.
Methods
Forty-five physicians completed surveys that were followed by interviews over a 10-week period regarding their use of the abduction brace following treatment for clubfoot with the Ponseti method. Participating physicians were either residents in orthopedic surgery or orthopedic specialists who had completed their residencies. Participants were recruited from two large hospitals in São Paulo, Brazil and included residents and fellows from other institutions who were participating in rotations or continuing education at the primary hospitals. All physicians had been trained in the Ponseti method at the time of the survey or interview. Participants were divided into three groups: residents, physicians who had completed their residencies, and physicians who had completed their residencies and additionally participated in post-residency Ponseti training. Responses regarding their use of the abduction brace were divided into four categories and assigned a grade ranging from A – D according to how well their use of the brace was in accordance with Ponseti protocol (see Table 1). Physicians were also asked about the costs of braces, difficulties in acquiring the brace, time spent educating patients regarding brace use, the positive and negative qualities of the brace they use, and what they considered to be the biggest barrier to bracing compliance. Informed consent was obtained by having participants review a consent letter in Portuguese. IRB approval was obtained from the University of Iowa for the project, and local standards of ethical research were strictly adhered to.
Table 1.
Classification of physician responses regarding prescription of the abduction brace in Ponseti treatment
| A | Brace is prescribed appropriately according to Ponseti protocol: 23 hours a day for 3 months followed by 12-14 hours for 2-4 years8 |
| B | Brace is prescribed for less than 2 years, or for fewer hours of day than indicated for 2-4 years |
| C | Brace is prescribed for less than 1 year |
| D | Brace is prescribed for less than 6 months |
Results
Forty-five orthopedic surgeons were surveyed or interviewed regarding their use of the abduction brace as part of the Ponseti method of treatment. Sixteen residents participated, as well as 29 physicians who had completed their orthopedic residencies. All participants, including residents, had been formally trained in the Ponseti method at the time of the surveys. Of the physicians who had completed their residencies, 23 of the 29 had participated in post-residency training in the Ponseti method, and the remaining six had learned the Ponseti method during residency. All participants were asked their standard prescription protocol for the use of the abduction brace following serial castings. They were graded on a scale of A to D regarding their prescription of the brace (see Table 1). Their responses to semi-structured questions regarding perceived difficulties to bracing were divided into ten categories (see Table 2).
Table 2.
Number of physicians attributing bracing noncompliance to the following causes
| Parents think correction has been achieved and the brace is no longer necessary | 17 |
| TLack of education / information | 12 |
| Parents believe the brace is uncomfortable | 11 |
| Child cries or complains | 9 |
| Difficult to use / put on | 8 |
| Parents believe the brace is painful | 6 |
| Cultural reasons / stigma | 5 |
| Cost / financial difficulties | 3 |
| Aesthetic reasons | 2 |
| Childcare difficulties | 1 |
Physician training and prescription of the brace
Of the residents, 25% appropriately prescribe the abduction brace and received an A classification. Thirteen percent received a classification of B, 19% a C, and 25% a D (See Figure 1). Nineteen percent of residents did not know how to answer the question.
Figure 1. Physicians’ adherence to Ponseti bracing protocol.
Of physicians who had completed their residencies, 65% appropriately prescribe the brace. Of these, 74% of physicians who had attended post-residency Ponseti training correctly prescribed the brace, compared to 40% of physicians who did not have post-residency training. All physicians who had completed their residencies were able to answer all the questions. Five physicians had completed their additional Ponseti training in Europe or the United States; these five physicians all received scores of “A.”
Parent education regarding the brace
The physicians and residents interviewed estimated that a total of approximately 3,000 patients had been treated since they began practicing the Ponseti method. In all but two cases, physicians are responsible for educating parents about the appropriate use of the brace. In one hospital, physical therapists are responsible for parent education and bracing follow-up; in another, physiatrists are accountable. Physicians reported that they spend an average of 17 minutes explaining the brace to parents, ranging from 5 to 60 minutes. Thirty-four percent of physicians have educational or written materials regarding the brace available for parents and families.
Brace acquisition
Physicians reported that it takes an average of 30 days to acquire the brace once it is ordered, ranging from 7 days to 6 months. Patients dependent on social services to acquire the brace face significantly longer wait times, and occasionally the brace cannot be obtained due to cost or the delay in acquisition. While the brace is provided at no cost to patients at some public hospitals, other public hospitals require patients to purchase the brace. Of the private stores where the braces can be acquired, physicians reported that the average cost of the brace is 249 Brazilian reais, or approximately 160 American dollars. One physician uses a philanthropic organization to help pay for braces, and 58% of physicians recycle braces in order to assist families who may have difficulty purchasing them.
Physicians perceived barriers to compliance
Physicians were also asked what they believed were the most significant causes of parental noncompliance with regard to the abduction brace. The attributed causes of compliance were divided into ten categories, outlined in Table 2.
All but six physicians use what were described as Dennis-Brown braces, also called a foot abduction or- thosis (FAO). This brace is the most commonly used orthotic in Brazil for the treatment of clubfoot. It consists of an aluminum bar attached to shoes that hold the feet in a dorsiflexed position with 60-70°of external rotation. The majority of physicians expressed satisfaction with the brace, primarily because it effectively maintains the correction. Seven physicians added that the brace is easy for parents to use. However, several physicians also emphasized that they had no experience working with other braces, and as a result couldn’t compare the Dennis-Brown brace to other varieties. Complaints about the Dennis-Brown brace included the fact that it’s very heavy, and has a lack of flexibility for nocturnal use. Additionally, a number of doctors reported that the screws responsible for holding the feet in 70° of external rotation frequently come loose due to poor construction of the brace, which causes the feet to be rotated at an incorrect angle from the time the screws loosen until the patient returns for a follow-up visit.
Discussion
Barriers related to physician education
This study was limited by the fact that only a small number of physicians clustered at two primary hospitals were interviewed, which may mean that the results are not representative of the nation as a whole. However, the results indicate that many children are being prescribed braces for an inadequate period of time. Only 25% of residents (all of whom had been formally trained in the Ponseti method) appropriately utilize the abduction brace. Many of these residents are not pediatric orthopedists and the Ponseti method is less likely to be an area of expertise for them. Physicians who had completed their orthopedic residencies and practice the Ponseti method in their clinical practice only prescribe the brace appropriately 65% of the time. Seven percent of physicians prescribe the brace for less than six months of use; only one eighth of the time it should be utilized.
Orthopedic surgeons who had attended any form of post-residency training in the Ponseti method were significantly more likely to follow appropriate bracing protocol. Seventy-four percent of physicians with post-residency training complied with Ponseti bracing protocol, compared to 40% of physicians who completed their Ponseti training during their orthopedic residency. This has significant implications for the administration of continuing education in Brazil: at this moment, residency programs may not be sufficient to adequately prepare physicians to treat patients with the Ponseti method.
Moreover, when physicians fail to appropriately prescribe the brace, it indicates a decreased level of comprehension regarding the Ponseti method itself, and further exemplifies the need for additional training. Considering that the bracing protocol is an integral part of the Ponseti treatment, failure to adequately prescribe the brace may indicate that physicians are not practicing the method as described by Dr. Ponseti, but rather a modified, and less effective, version.
The lack of adequate understanding of bracing protocol on the part of physicians may represent an important barrier to the use of the abduction brace in Ponseti treatment. Other barriers to compliance become irrelevant if patients are provided inaccurate information regarding the brace. Additionally, physicians need to recognize that they are frequently the only healthcare professionals involved in prescribing and explaining the brace to their patients; as such, it is essential that they take a degree of responsibility in ensuring parental compliance and comprehension of the importance of bracing. Parents are unlikely to be compliant if the physician has a laissez-faire attitude towards the abduction brace: rather, physicians must be the driving force behind parental compliance and understanding of the importance of the brace in maintaining the correction.
Barriers related to cost and acquisition of the brace
A problem that was frequently brought up in the interviews was the difficulty in acquiring braces. Braces are provided by certain, but not all, public hospitals, and many institutions in southern Brazil have arrangements to provide braces for families who can’t afford them. However, even when the brace is free or partially subsidized, there is often a considerable delay in acquiring it. When this is the case, physicians are either forced to prescribe the brace extremely early, without knowing the appropriate size of the brace they are ordering, or apply additional casts until the brace arrives. Some physicians reported that parents went without the brace due to the delay or expense of acquiring it. Additionally, multiple braces must be purchased as the child outgrows each brace, adding to the financial burden of the brace. Up to two pairs of orthotic shoes may be required in the first year of bracing, followed by one new pair of shoes for each following year9; as a result, families may have to purchase up to five pairs of orthotic shoes, which is a considerable cost for low-income families. Previous studies have consistently identified costs as one of the most significant barriers to bracing adherence in developing countries2,18, making it a difficulty worth addressing.
The difficulties in acquiring the brace were substantially greater for families dependent on public social services. This two-tiered health care system increases the health disparities between social classes, and presents a challenge and a great deal of frustration for practitioners working in the Brazilian setting. However, only three physicians considered cost to be a potential cause of bracing noncompliance. The failure of physicians to recognize the economic considerations that may result in noncompliance represents a lack of understanding of the significance of these financial barriers. While 58% of the physicians in the survey recycle braces, only one hospital reported having a program designed to facilitate this type of initiative. A unified program throughout the major cities of southeastern Brazil could potentially help remedy this dilemma. Additionally, another form of sustainable program – such as governmental assistance to public hospitals who do not currently provide the brace for free – may be one way to improve bracing adherence in southeastern Brazil.
Physicians outside of major metropolitan areas also expressed frustration due to an inability to find orthopedic stores able to adequately construct the brace. Information about brace construction in low-income settings is widely available through non-profit organizations, including booklets available in Portuguese19. Dissemination of this information may be one way to promote the utilization of a low-cost and easy-to-construct brace.
Barriers related to family perceptions and utilization of the brace
There appear to be discrepancies between what physicians consider the primary causes of bracing noncompliance and what families believe to be the most difficult aspects of the bracing process. The majority of physicians interviewed attributed patient noncompliance with regard to the abduction brace to either lack of education or the parents’ belief that the deformity had been corrected and would not recur. Previous studies have identified a number of considerations as barriers to bracing compliance, including a child that cries or fusses, skin irritations, incorporating the brace into the family’s social life, and difficulty taking the brace on and off9. However, physicians were more likely to attribute noncompliance to a lack of understanding of the process than to the practical difficulties of bracing. Nine of the 45 physicians acknowledged that parents may believe the brace is uncomfortable or painful, which is an adherence barrier that has been cited in previous articles regarding brace use9. Only eight of the 45 identified practical problems with using the brace, such as difficulty putting the brace on, as barriers to compliance. A better understanding of some of the daily complexities of using the brace might allow physicians to better relate to their patients, anticipate problems that may arise, and address them proactively in order to improve compliance. Regular and frequent follow-ups during the first weeks of bracing have been identified as one way to recognize difficulties as they arise9. This could allow physicians the opportunity to intervene before small problems result in parents discontinuing the brace.
Even as physicians cited a lack of education as a major cause of noncompliance, very little time was spent explaining the bracing process – and its importance – to parents. Additionally, few physicians (34%) had any kind of written information available for parents regarding the brace. Although some physicians attributed this to low literacy and comprehension levels among parents, there is still a place for written materials in order to solidify information provided orally during the patient consult.
While some of the causes of noncompliance are systems-based and difficult to remedy on an individual level (such as the high cost of multiple braces), a number of the causes of noncompliance could be diminished through increased parental education. For example, emphasizing to parents that the brace is absolutely essential to maintaining correction of the deformity - even if it appears painful, uncomfortable, if the child doesn’t like it, or it is a hassle to use – could potentially improve adherence. This is especially true in southern Brazil, where the majority of physicians are the only healthcare professionals responsible for educating parents about the use of the brace. Discussing the importance of the brace at the beginning of treatment, before the deformity has been corrected, may be the most effective way to encourage parents to use the brace: once the child’s feet are normal, the parents are more likely to consider the child “cured” and ignore the role of bracing.
In one public hospital, physical therapists are responsible for explaining the use of the abduction brace for parents. This is a model that seems to work well for this hospital, and perhaps it could be expanded to other large institutions as a way of increasing the amount of time spent on parental education, including increased follow-up following initiation of the bracing period. Incorporating parental education as an integral part of the Ponseti method by designating specific appointments and professionals to explain the abduction brace might be one way to improve bracing adherence.
This study was limited by the fact that only 45 physicians were interviewed, while there are several hundred trained Ponseti practitioners in Brazil. Additionally, the participants were clustered within two urban hospitals, which may introduce a level of bias. As a result, the findings of this study may not be representative of the nation as a whole.
Conclusions
Many of the causes of noncompliance with bracing protocol stem from systemic inequities and challenges, rather than a lack of collaboration from the families themselves. One of the biggest barriers to bracing compliance in southeastern Brazil is the acquisition of the brace itself. Its high cost and long delays in the time it takes to acquire the brace create noteworthy obstacles that must be overcome by patients, thus making the already difficult process of following the bracing protocol even more challenging. The fact that long waits are faced only by patients dependent on social services is also indicative of the economic discrepancies between Brazil’s social classes. A unified system of recycling braces and sustainable program for purchasing new braces may be helpful towards increasing bracing compliance. Promoting the use of a low-cost brace may be one way to increase the availability of braces in rural areas.
Furthermore, insufficient prescription of the brace by physicians may represent a major barrier to bracing compliance in southeastern Brazil. Encouraging Ponseti practitioners to undertake further training following their residencies may be one way to promote better adherence to the bracing protocol in Brazil. Physicians who were most familiar with appropriate bracing protocol had frequently attended additional trainings outside of their residencies, either in the form of travel abroad or Brazilian orthopedic conferences and workshops. Physicians who were trained only during their residencies were less likely to know the appropriate protocol. Given that patients can only be compliant to the extent that they are given appropriate instructions, this represents an important barrier to use of the abduction brace in southern Brazil.
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