Abstract
Background: Nonoperative management of clubfoot with the Ponseti method has proven to be effective, and it is the accepted initial form of treatment. Although several studies have shown that problems with compliance with the brace protocol are principally responsible for recurrence, no distinction has been made with regard to whether the distance from the site of care affects the early recurrence rate. We compared early recurrence after Ponseti treatment between rural and urban ethnically diverse North American populations to analyze whether distance from the site of care affects compliance and whether certain patient demographic characteristics predict recurrence.
Methods: One hundred consecutive infants with a total of 138 clubfeet treated with the Ponseti method were followed prospectively for at least two years from the beginning of treatment. Early recurrence, defined as the need for subsequent cast treatment or surgical treatment, and compliance, defined as strict adherence to the brace protocol described by Ponseti, were analyzed with respect to the distance from the site of care, age at presentation, number of casts needed for the initial correction, need for tenotomy, and family demographic variables.
Results: Of eighteen infants from a rural area who had early recurrence, fourteen were Native American. The families of these children, like those of all of the children with early recurrence, discontinued orthotic use earlier than was recommended by the physician. Discontinuation of orthotic use was related to recurrence, with an odds ratio of 120 (p < 0.0001), in patients living in a rural area. Native American ethnicity, unmarried parents, public or no insurance, parental education at the high-school level or less, and a family income of less than $20,000 were also significant risk factors for recurrence in patients living in a rural area. Intrinsic factors of the clubfoot deformity were not correlated with recurrence or discontinuation of bracing.
Conclusions: Compliance with the orthotic regimen after cast treatment is imperative for the Ponseti method to succeed. The striking difference in outcome in rural Native American patients as compared with the outcomes in urban Native American patients and children of other ethnicities suggests particular problems in communicating to families in this subpopulation the importance of bracing to maintain correction. An examination of communication styles suggested that these communication failures may be culturally related.
Level of Evidence: Prognostic Level I. See Instructions to Authors for a complete description of levels of evidence.
Since its inception, the Ponseti method has proven to be effective in the treatment of idiopathic clubfoot in >95% of reported cases1,2. When the Ponseti method is unsuccessful, the failure is frequently due to noncompliance with the use of the abduction orthosis after the cast treatment3-5. Dobbs et al. suggested that noncompliance (p < 0.00001) and the educational level of parents (p < 0.03) are significant risk factors for the recurrence of clubfoot deformity and that treating physicians should consider those factors when employing the Ponseti method2. More recently, Haft et al. reiterated that compliance with the postcorrection abduction-bracing protocol is crucial to avoid recurrence of the clubfoot5. To our knowledge, no one has examined an ethnically diverse North American population to assess whether the distance from the site of care affects the clinical outcome of the Ponseti method.
According to the 2005 United States Census Bureau, New Mexico is composed of approximately 1.8 million people, 50% of whom live in rural, medically underserved areas6. Approximately 44% of the state population is Hispanic and 10% is Native American. Twenty-two percent of the population has less than a high-school education, and 22% is uninsured. The orthopaedic needs of the rural population are underserved, with many patients traveling a substantial distance to receive care in Albuquerque, the only site in the state providing pediatric orthopaedic services and with physicians trained in the Ponseti method. A rural family must commute weekly to Albuquerque for about two months for cast applications and intermittently thereafter for follow-up and orthotic management. This travel may be difficult or impossible for families living a great distance from the treatment site. While prior studies have demonstrated the effectiveness of the Ponseti treatment method in certain rural populations, no distinction has been made between patients living close to and those living a substantial distance from the site of treatment7,8. Compliance with the abduction-orthosis protocol is essential to maintain clubfoot correction, but orthotic follow-up, fitting, and compliance become less likely as the travel to the site of care becomes more difficult.
New Mexico, with its large rural areas and economic and ethnic diversity, offers an opportunity to examine how these factors affect both initial deformity correction and the maintenance of that correction with use of the abduction orthosis. Our hypothesis was that the success of the Ponseti treatment was related to economic factors coupled with the distance from the care center.
Patients
In a prospective study, 210 patients with idiopathic clubfoot (102 [125 feet] living in an urban area and 108 [151 feet] living in a rural area) were treated at the University of New Mexico Carrie Tingley Hospital, Albuquerque, New Mexico, from 2003 to 2006. Infants who had not received treatment prior to referral were invited to enroll in an institutional review board-approved database used to track patient data and obtain clinical photographs. Of the 210 infants, 102 (fifty [sixty-eight clubfeet] from an urban area and fifty-two [seventy-two clubfeet] from a rural area) were enrolled in this study. Two patients who lived in a rural area were lost to follow-up, leaving fifty patients with sixty-eight clubfeet who lived in an urban area and fifty patients with seventy clubfeet who lived in a rural area.
Demographic Data
Patients were divided into two groups, urban and rural, on the basis of the distance that they traveled to the site of care. "Urban" was defined as living <75 mi (<121 km) from the study hospital; this specific radius was chosen since it includes the peripheral Albuquerque metropolitan area, encompasses surrounding communities that are within a short driving distance from the hospital, and is an area with public transportation. While there are other areas in the state that can be considered "urban" according to other definitions, the remainder of the state was defined as "rural" because of the distance from the only site of pediatric orthopaedic specialty care.
The sex and ethnicity of the infant were obtained from the hospital electronic database. The electronic database did not include the marital status, educational level, or income of the parents, or the type of insurance (private, public, or none), so a questionnaire was created to obtain that information and was mailed to each family. If the questionnaire was not returned, a telephone interview was conducted to complete this form.
Additional Data
Additional data noted in the study database included the number of casts required to obtain correction, whether an Achilles tenotomy had been performed, and the number of recurrences, either early or late. The severity of the clubfoot deformity was defined as mild (a score of 0.5 to <2 points according to the system described by Pirani et al.9,10), moderate (a score of 2 to =4 points), or severe (a score of >4 points). The frequency of orthotic use was quantified as reported by the family. Compliance was measured in terms of when orthotic use was discontinued and whether discontinuation was recommended by the treating physician or was done without physician consent.
Grading with the Pirani System
The degree of deformity of each child's clubfoot was graded at every visit with use of the scoring system described by Pirani et al.9,10. This system scores three clinical signs related to midfoot contracture and three clinical signs related to hindfoot contracture. Each component of the deformity is scored either as 0 (no abnormality), 0.5 (moderate abnormality), or 1 (severe abnormality), for a total score of between 0 and 6. Three cast technicians were trained in the use of this scoring technique, and the consistency of the scoring among the observers was verified. After employing the technique for approximately one month, each technician independently graded the same twenty clubfeet; the difference in the scores was assessed and not found to be significant. Sequential scoring with the Pirani system was not blinded, as the subsequent scores for each child were recorded on the same clinic form. Scoring was done at the time of presentation, prior to each cast application, and at the beginning and end of orthotic treatment.
Questionnaires
The Pediatric Outcomes Data Collection Instrument (PODCI) questionnaire11,12, a validated instrument that reflects the parent's impression of his or her child's function after treatment, was administered. In addition, we created our own, unvalidated questionnaire that inquired about the demographic variables mentioned above and assessed compliance with use of the brace, satisfaction with the final result, and difficulty commuting to the site of care. Both questionnaires were sent by mail to the patient's family at an average of 3.2 years (range, 2.3 to four years) following completion of the cast treatment. If the questionnaires were not completed and returned, a telephone interview was conducted to obtain answers for both questionnaires.
Ponseti Method for Manipulative Treatment
All children were treated by one of three fellowship-trained pediatric orthopaedic surgeons. Children with clubfeet were routinely treated according to the protocol outlined by Ponseti13,14. During the children's weekly visits to the clinic, the physician gently manipulated and stretched the foot and applied a molded plaster cast from the toes to the proximal part of the thigh. Cavus was corrected first, and then varus and adductus were addressed, with the emphasis on abduction and external rotation of the foot distal to the talus. Most children required an Achilles tenotomy to correct the equinus deformity. The tenotomy was generally performed in the clinic. When the final cast was removed, usually at three weeks following the tenotomy, the infant was fitted with an abduction orthosis, which was to be worn full time for three months. The orthosis maintained the affected foot at 70° of external rotation while the normal foot was held at 40° of external rotation. After the initial three months of full-time orthotic use, the orthosis was to be worn at naptime and nighttime. The parents were advised of the importance of wearing the brace to prevent recurrence of the deformity, and it was reinforced that this regimen must be continued until the child was three or four years of age.
Recurrence was defined as any relapse of deformity requiring repeat manipulation and cast application, or a relapse requiring surgical intervention. Such recurrence was manifested by difficulty in applying, or discomfort when wearing, the abduction orthosis and was reflected by an increase in the Pirani score. One or more new casts were applied to regain correction, and a repeat Achilles tenotomy was performed if dorsiflexion of the foot was <15°. If there was another recurrence, the surgeon decided whether surgical intervention was appropriate, usually on the basis of the stiffness of the deformity and the degree of resistance to manipulative treatment.
Educational Materials
At the onset of treatment, each patient's family received a written handout, in English, describing the cast and orthotic phases of treatment, along with a copy of an article about the long-term success of the treatment. The handouts emphasized the importance of compliance with use of the brace to maintain successful correction of the deformity. Several Internet web site addresses were recommended in the handout, including the web site of Dr. Ponseti entitled, "To Parents of Children Born with Clubfeet,"15 and "."10 It was assumed that many families would use the Internet to gain a better understanding of the deformity and its treatment and that this would reinforce compliance with the brace protocol. In addition to this written material, the treating physician outlined the brace protocol for the caregiver and emphasized the importance of compliance. This message was verbally reinforced at every follow-up visit.
Statistical Analysis
Univariate Analysis
To compare the two groups (rural and urban), the improvement in the Pirani score was calculated by subtracting the initial score from the final score. The relationship of all other variables with the Pirani score was evaluated with use of the Student paired t test or analysis of variance as appropriate. Recurrence was tallied as either remanipulation or surgical intervention. The proportions of recurrences in the rural and urban groups and other two-by-two tables were compared by using univariate odds ratios with 95% confidence intervals.
Multivariate Analysis
Variables that were found to be significantly related to improvement in the Pirani score in the univariate analysis were evaluated with use of a general linear model. Variables were fitted with use of a forward procedure and were kept in the model only if p was <0.05. Two-tailed tests and a Type-I error rate of 0.05 were employed throughout.
Source of Funding
No external funding was used for this study. One author received a $2500 student research stipend from the Carrie Tingley Hospital Foundation.
Baseline Patient Characteristics
The urban and rural groups were comparable with respect to demographic variables related to the family and with respect to patient characteristics and the initial Pirani score (Table I). The duration of the commute and the distance to the site of care were the only significant differences between the two groups. The average duration of follow-up of the 100 patients (138 clubfeet) was 28.3 months (range, twenty-five to thirty-four months).
Pirani Score as a Measure of Treatment Success
There was no measurable difference in treatment outcome among the three surgeons.
Initial correction was achieved in 131 (95%) of the 138 clubfeet (Table II). Seven feet were incompletely corrected by the initial cast treatment, and they underwent a surgical release because they were very stiff. The initial manipulative treatment was considered to have failed for these seven feet, and they are not discussed further with respect to recurrence. The degrees of correction resulting from the initial manipulation and cast treatment were similar between the remaining children in the two groups.
One technician graded eighty-two of the 100 patients included in the final analysis. At the time of final follow-up, the mean improvement in the Pirani score was 3.94 points (95% confidence interval, 3.72 to 4.15 points) in the urban group and 2.51 points (95% confidence interval, 2.08 to 2.93 points) in the rural group (p < 0.001). The strong association between urban residence and the mean improvement in the Pirani score after the total treatment persisted in a multivariate model that simultaneously adjusted for the effect of ethnicity and family income (p < 0.001). However, as shown in Table II, correction of the deformity was not significantly different between the urban and rural non-Hispanic white patients or between the urban and rural Hispanic patients. Compared with their urban counterparts, rural Native Americans had a significantly higher Pirani score after what should have been the orthotic wear component of treatment (p < 0.0001).
Recurrence of Deformity
There was early recurrence of the clubfoot deformity in thirty-four feet (26%). In the rural group, eighteen patients had early recurrence. Two non-Hispanic white patients with recurrence had initially presented with a severe unilateral deformity; one of these patients had a relapse to a moderate deformity and the other, a relapse to a severe deformity. Two Hispanic patients with recurrence had presented with a severe bilateral deformity; one had a relapse to a severe bilateral deformity and one, to a moderate bilateral deformity. Twenty-eight clubfeet of fourteen Native American patients demonstrated early recurrence: all had presented with severe deformities and had relapse to severe deformities.
The eighteen patients with early recurrence in the rural group were treated with repeat manipulation and cast application, and seven of the eighteen required a second Achilles tenotomy. Following this second corrective treatment, all patients were again fitted with an abduction orthosis. Six patients, all Native American, subsequently had a second recurrence. Five of these six patients again underwent cast treatment followed by an anterior tibial tendon transfer, and one underwent a posterior medial release.
Eight children in the urban group exhibited early recurrence. Of three non-Hispanic white patients with recurrence, one had presented with a severe bilateral deformity and two, with a severe unilateral deformity, and all three had a relapse to the previous deformity. Three Hispanic infants with recurrence had presented with a severe unilateral deformity, and two Native American patients with recurrence had presented with a severe bilateral deformity; all five had a relapse to the previous deformity. These eight patients were treated with repeat manipulation and cast applications, and four of the eight received a second Achilles tenotomy. One patient had a tibialis anterior tendon transfer after a second relapse. There was a significant difference in the recurrence rate between the Native American children who lived in a rural area and those who lived in an urban setting (p = 0.002) (Table II).
Compliance with Bracing
The abduction bracing had been prematurely abandoned for the majority of children who experienced a relapse, but not all children for whom the bracing had been abandoned experienced a relapse. Seven patients for whom the bracing protocol was not followed as outlined did not have a recurrence of the deformity; four of these patients (one Native American, two Hispanic, and one non-Hispanic white infant) were in the urban group and three (one Native American, one Hispanic, and one non-Hispanic white infant) were in the rural group.
The remaining twenty-five patients for whom bracing was discontinued experienced recurrence: seven infants (three Native American, two Hispanic, and two non-Hispanic white infants) were in the urban group, and eighteen (fourteen Native American, two Hispanic, and two non-Hispanic white infants) were in the rural group. The difference in brace usage rates between the urban and rural Native American patients was found to be significant (Table II).
PODCI as a Measure of Parent Satisfaction with Outcome
The results from the PODCI questionnaire suggested that the parents of the rural and urban non-Hispanic white and Hispanic patients had similar levels of satisfaction (Table III) with respect to their children's global functioning, pain and comfort, sports and physical functioning, and transfer and mobility. The rural and urban Native American parents differed significantly in their assessment of the outcomes as related to sports and physical functioning as well as global functioning (p < 0.0001). There were no other detectable differences in the outcomes measured with the PODCI instrument.
Odds Ratios as a Measure of Early Recurrence with Respect to Various Demographic Variables
Of the variables tested, abandonment of the brace protocol was associated with a 33.3-fold increase in the likelihood of early recurrence in the urban group (odds ratio = 33.3, 95% confidence interval = 5.2 to 212.2, p < 0.001). In the rural population (Table IV), a patient whose family abandoned brace usage prematurely was 120 times more likely to have a relapse (odds ratio = 120, 95% confidence interval = 18.8 to 765.1, p < 0.0001). A patient in a family with an annual income of less than $20,000 had a 12.5-fold increased likelihood of recurrence (odds ratio = 12.5, 95% confidence interval = 2.4 to 65.5, p = 0.007). Having unmarried parents increased the chance of recurrence 4.5-fold (odds ratio = 4.5, 95% confidence interval = 1.3 to 15.8, p = 0.04), having public or no insurance was associated with an eightfold increased likelihood (odds ratio = 8.0, 95% confidence interval = 1.8 to 35.6, p = 0.01), and a parental educational level of high school or less was associated with a 5.6-fold increased likelihood of recurrence (odds ratio = 5.6, 95% confidence interval = 1.45 to 21.7, p = 0.02). Native American ethnicity increased the likelihood of recurrence 9.3 times (odds ratio = 9.3, 95% confidence interval = 1.7 to 50.4, p = 0.02). Sex, age at the onset of treatment, Pirani score, and duration of the commute to the facility were not found to have a significant effect on the risk of recurrence in the rural group.
Odds Ratios as a Measure of Brace Compliance with Respect to Various Demographic Variables
In the urban group, no significant association was found between compliance with the brace protocol and any of the analyzed characteristics. In the rural group (Table V), Native American ethnicity was associated with a sevenfold increase in the likelihood that brace wear would be discontinued prematurely (odds ratio = 7.0, 95% confidence interval = 1.4 to 34.6, p = 0.04), and a parental income of less than $20,000 was associated with a 7.1-fold increase in the likelihood that the brace wear would be discontinued prematurely (odds ratio = 7.1, 95% confidence interval = 1.6 to 31.2, p = 0.02).
Parental Report of Reasons for Discontinuing Use of Orthosis
The parents of eighteen infants (two non-Hispanic white, two Hispanic, and fourteen Native American infants) in the rural group did not adhere to the brace protocol as outlined by the physician. The reasons why they discontinued applying the brace were elicited by telephone interview. Parents of children in all ethnic groups reported that use of the orthosis was discontinued, or the brace was worn only intermittently, because the infant became agitated when wearing the brace, because it seemed that the deformity was much decreased or completely corrected, and/or because they were unaware that the brace was a critical component in the clubfoot treatment.
Every Native American family of an infant with early recurrence participated in a telephone interview. Five different families noted that they did not fully understand the treatment regimen and that it was difficult to understand the written material. In two households, a grandmother was the infant's primary caregiver, and she did not receive the instructions pertaining to the brace regimen. English was not the primary language spoken in these two households. Native American families who discontinued brace use also reported that, to them, the foot appeared to have been corrected by the cast treatment so they did not persist with bracing if the child became fussy.
The families of seven children (two non-Hispanic white, two Hispanic, and three Native American), of the eight in the urban group in whom the deformity recurred, were interviewed by telephone. They too reported that, because the deformity appeared corrected, brace use was not enforced when the infant became agitated, particularly during activity. Three of these urban families were Native American: the parents reported that they themselves were the primary caregivers and that English was the primary language spoken at home.
The Ponseti method is an effective and appropriate initial treatment for idiopathic clubfoot16-19. However, this technique, as described, requires dedicated, meticulous care on the part of both the treating physician and the parents. Several previous studies have shown that compliance with use of the abduction orthosis is essential to the method's success1,2,5,19.
Since Ponseti and colleagues demonstrated initial correction in 98% of patients, with only an 11% relapse rate1, investigators have assessed the reproducibility of the method at numerous centers throughout the world. Studies in the United States have demonstrated initial correction rates ranging from 92% to 100%16,20-22 with rates of early relapse ranging from 10% to 31%1,2,20. Noncompliance with the bracing protocol has been identified as an important cause of recurrence1,2,16,20,21, a phenomenon confirmed by the studies by Thacker et al.19 and Dobbs et al.2.
The effectiveness of the technique has also been examined in culturally diverse populations. Haft et al. showed, in a New Zealand population, an early recurrence rate of 41% with a noncompliance rate that was statistically unrelated to the intrinsic clubfoot deformity or ethnicity5. Because of its simplicity, low cost of application, and effectiveness, the Ponseti method has also been assessed in developing countries. Tindall et al.7 reported an initial correction rate of 98% in an African population, and Gupta et al.8 demonstrated a 100% initial correction rate in Ahmadabad, India. However, the follow-up periods were short, and the authors were unable to thoroughly assess early recurrence. Pirani and colleagues initiated a national program in Uganda for the treatment of clubfoot23,24. Although specific details pertaining to that study are unclear, 80% of the children had complete correction of the deformity within two years.
Ponseti and his colleagues have, at least in part, attributed the high correction rate that they were able to achieve to the population of patients seen at their institution in Iowa City1. The Internet has provided families direct access to information about clubfoot and the Iowa clubfoot center, increasing the number of patients, many of whom are self-referred, treated in their clinic25,26. These families are self-educated regarding the treatment for clubfoot and motivated to make the method succeed. They therefore may be more willing to comply with the orthotic phase, the most difficult and demanding segment of treatment.
The challenge of the Ponseti treatment regimen lies not in the initial cast correction, but in the success of educating the parents and family regarding their role in the maintenance of correction by long-term abduction bracing and in the provision of a brace that is acceptable to the child and family alike. "Noncompliance" with brace wear is difficult to define: in many cases, as the deformity recurs, the brace no longer fits and the infant becomes uncomfortable. When the infant cries, the compassionate parent or caregiver removes the brace to alleviate the discomfort. Without the brace, the deformity becomes more severe, thus promoting recurrence. The distinction between when the infant is merely annoyed by the brace and when he or she is expressing pain is difficult to ascertain. Intervention early in this process, by timely stretching of the slowly contracting foot in casts or modification of the ill-fitting brace, is a key to success, but this requires excellent communication between the physician and family.
Our study demonstrated that certain patient characteristics and several parental demographic variables confer a greater risk of clubfoot recurrence. The overall early recurrence rate seen in our study was 25%, higher than that reported in previous studies1,2,20. We believe that cultural factors coupled with the distance from the site of care resulted in this difference in clinical outcome. As in other studies1,2,5,16,27, we found that abduction bracing, after the cast treatment, is a key factor in the success or failure of the method. We also found that a yearly family income of less than $20,000, unmarried parents, having public or no insurance, and a parental educational level of high school or less correlated with recurrence. The effect of these factors was exacerbated by the caretaker's need to miss work for an all-day trip to the clinic, especially with increasingly higher gasoline prices. Such demographic variables were correlated with each other and would be expected to parallel one another. The initial severity of the deformity and the patient's age at presentation did not appear to influence the recurrence rate.
As was found in other studies1,2,5,19, recurrence of the deformity correlated statistically with premature abandonment of the orthotic program. An infant in a cast is a compelling reason to drive a long distance for care. Difficulty with a brace is more easily overlooked and can be mitigated by abandoning the brace regimen in lieu of driving many hours to visit the clinic. This would suggest that all individuals living in rural areas might demonstrate decreased compliance with the brace protocol. The fact that this was not the case for Hispanic and non-Hispanic white patients living in rural areas suggests that there were factors beyond mere distance and inconvenience.
Urban Native American children had recurrence rates that were no different from those of children of other ethnicities, living in either urban or rural areas. In contrast, the Native American children with clubfoot deformity who lived in rural areas demonstrated a higher prevalence of early recurrence than did the Native American infants living in urban areas. This striking difference in outcome predicated on where a family lives suggests that there is no intrinsic difference in clubfoot pathology in Native American children. The fact that the only difference seemed to be a combination of ethnicity with locale challenged us to provide an explanation for these findings.
In New Mexico, the Native American families who live a distance from Albuquerque are more likely to follow native traditions, speak their native language at home, and utilize native healers in addition to modern medicine28. While families of all ethnicities frequently reported, when their child had a recurrence of the deformity, that they did not perceive the abduction orthosis to be an important component in the ongoing success of the treatment of their child, interviews with some of the rural Native American families in this study revealed that English was not the primary language spoken at home, which would further complicate communication regarding the importance of the orthosis. In many Native American homes, grandparents play an important role, particularly as valued teachers and resources in child rearing. Furthermore, there is often a notion of shared responsibility within an interdependent family system that can result in many family members sharing childcare. In a traditional Native American home, there may be a strong connection with traditional spiritual and natural healing practices, and the family may have consulted with a medicine man or native healer.
In retrospect, we do not believe that the educational materials regarding the Ponseti method supplied to the families were well geared to a traditional Native American family. Many Native Americans prefer visual examples or illustrations over voluminous written instructions. The readability of the handouts was higher than a twelfth-grade level29, making them unsuitable for many of our families of all ethnicities.
With respect to our teaching methods, we should have taken into account that, in the Native American culture, what one says and does influences outcome and, consequently, many Native Americans respond to positive directions ("If the brace is used, the foot will remain straight") while avoiding negative admonitions as harbingers of bad luck ("If you don't use the brace, the foot will be deformed again and surgery will be needed")30. The nature of our admonitions regarding use of the orthosis tended more toward the negative than the positive.
A 1997 survey at an Indian Health Service Hospital in Crownpoint, New Mexico, demonstrated that 17% of 300 consecutive patients required a translator to be able to complete the survey interview28. While Native American translators are available at our institution, they are seldom utilized because patients rarely voluntarily request an interpreter. Native American patients are often reticent and polite: if they do not understand instructions they may prefer not to question or confront the physician because they consider it rude to do so. When they arrive home, other family members may consider it impolite to ask about the visit to the doctor, so verbal instructions might not be passed on to family members involved in the care of the child. Our questionnaire did not ask, and it was not our habit to inquire, if a Native American healer was involved in the care of a child with clubfoot, but this would be useful information in fostering communication about the child's care. While Native American healers seldom interfere with modern treatment, if it is known that such healers are involved they can be enlisted as allies and a source of family support. Finally, in traditional Native American families from remote and traditional regions of New Mexico, the use and availability of technology, specifically the Internet, are limited. This minimizes the degree to which a family may educate itself about the treatment of clubfoot.
This study shows that there are cultural factors impacting patient education and understanding that are pivotal to parental motivation for doing what is necessary to achieve a positive outcome in the treatment of clubfoot deformity. A physician can emphasize orthotic wear at every patient encounter, but if caregivers have not understood the importance of their own role in the treatment, the outcome will suffer. Similarly, if the physician does not understand the milieu in which the child is living and the cultural perspective from which the parents are operating, the mutual trust needed for communication to foster education will not be possible.
This study has several limitations. The patients were evaluated and treated by three surgeons, each of whom had his or her own communication style. As each surgeon maintained continuity of care of each patient, there was the potential for a provider to have been more or less aggressive with education and treatment. The potential for differences in scoring or the reliability of the scoring system may explain the lack of a correlation between the severity of the clubfoot deformity and the recurrence rate. However, the magnitude of change from one end of the Pirani scale to the other is clinically relevant as it reflects the difference between a functional foot and one that is disabled10. In addition, the study population was small, which made assessment of multiple variables problematic. The lack of objective measures to assess behavior, attitude, and comprehension with regard to brace usage also limited the study. Although every parent was queried regarding the details of brace usage, not every parent answered questions pertaining to their comprehension of the treatment regimen.
Finally, the cultural implications of the outcomes were a surprise to us and, in this otherwise prospective study, we had to go back to retrieve data that only became important in retrospect. The identity of the primary caregiver (i.e., the grandparent or the parent), how often the primary caregiver was present during clinic appointments, and the primary language spoken at home were not uniformly recorded in our database.
In conclusion, the large difference in outcomes observed between urban and rural Native American children was likely related to our inability to adequately communicate the importance of orthotic wear after the cast treatment to the rural Native American families. The challenge will be to design an educational program geared to these families, with community outreach support, so that these children will experience the excellent long-term results that the Ponseti method can provide.
The physician's skill as an educator is pivotal to a positive outcome of the Ponseti technique, as it is in many other areas. His or her ability to communicate across cultural divides, despite unfamiliar health values and behaviors, is essential to providing quality health care for diverse populations within the United States and globally. 
Note: The authors acknowledge Dan Tandberg, MD, of the University of New Mexico Department of Emergency Medicine, for providing statistical analysis; Jude McMullan, for providing administrative assistance; and Letitia Lansing, MD, Debra Richards, and Linda Henderson for providing advice regarding Native American cultural issues.
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