Qualitative Assessment of the Challenges to the Treatment of Idiopathic Clubfoot by the Ponseti Method in Urban India

Abstract

The Ponseti method of clubfoot treatment has been shown to be a very safe, effective and minimally invasive technique when performed in medical centers in Europe and North America. However, only a limited number of studies have helped identify the challenges for effective treatment with the Ponseti method in India. In this study a qualitative approach was used through distribution of questionnaires, personal interviews and focus groups with orthopedic surgeons (in urban centers) and parents of patients with clubfoot. The following factors were evaluated: (i) physician education, (ii) alternative methods of treatment/modification of the Ponseti technique, (iii) compliance by parents, (iv) treatment in underserved areas, (v) culture, (vi) community knowledge of clubfoot, and (vii) the health care system in India. The results showed that all of the factors evaluated hindered outcomes for patients; however, parent's compliance with bracing, lack of proper rural clubfoot treatment clinics, poverty and physician education were the most prominent challenges. The results of this study can be used to implement specific strategies to improve the diffusion and implementation of the Ponseti method for treating clubfoot throughout India.

Introduction

Congenital clubfoot is a common disabling condition that is prevalent across all populations. Clubfoot is a complex three-dimensional deformity of the foot characterized by adductus, cavus, varus, and equinus. Clubfoot can be idiopathic or part of a syndrome (such as myeolomeningocele and arthrogryposis), and tends to affect males more often than females¹. If congenital clubfoot is left untreated, it can prevent normal gait development and result in a crippling lifelong physical disability.

There are a number of treatment options for infants born with clubfoot. Until recent times, the standard treatment was months of casting followed by surgery. There have been many surgical approaches described over the last century; however, long-term follow-up demonstrates poor outcomes from these procedures and a high rate of complication. In addition, surgical procedures are very expensive and require highly trained professionals. Especially in developing countries, this has been a challenge for children receiving treatment for clubfoot.

In recent years, the non-invasive treatment of clubfoot, developed by Dr. Ignacio Ponseti, has been shown to have a success rate above 95% and the best long-term outcomes^2–9. Therefore, the Ponseti method is fast becoming the gold standard for clubfoot treatment and is currently being implemented all over the world. Importantly, several medical centers in India have implemented the method in the past few years. India has a population of approximately 1.157 billion people and an annual birth rate of 21.72 births per 1,000 people¹⁰. Assuming a conservative rate of one clubfoot per 1,000 live births¹¹, the number of infants born with clubfoot is estimated to be approximately 25,000 per year in India. The gross domestic product at purchasing power parity per capita (GDP – PPP) is $3,400 according to a 2010 estimate¹⁰. With such a large population in poverty, an educational program for the treatment of clubfoot based on the Ponseti method has the potential to make a large impact in India. However, there is a lack of information on the challenges to its diffusion and implementation. Therefore the purpose of this study was to evaluate those challenges in urban medical centers in India.

Materials And Methods

Questionnaires were given to, and face-to-face interviews were conducted with physicians practicing the Ponseti method to qualitatively evaluate the challenges to the Ponseti method in urban centers in India. These providers were chosen from lists of attendees at Ponseti training workshops and from referrals made by Ponseti providers already practicing the method. In addition, health care practices in both hospital and clinical settings were recorded which provided an in-depth look at the health care system and the initial impact of and challenges faced by diffusion of the Ponseti method.

Interviews were also conducted with parents of children with clubfoot by a medical student fluent in Hindi and English. Responses were collected over 12 weeks, and the results were translated into English and sorted into themes. Participant's names were removed from the data and the data was stored in a secure location. Informed consent was obtained by having participant's parents review a consent letter. This study was approved by the University of Iowa Institutional Review Board.

Results

A total of 100 physician questionnaires were distributed and 38 were returned from physicians in Delhi (35), Bangalore (2) and Pune (1). All physician questionnaires were completed by orthopedic surgeons and residents. Fifteen face-to-face interviews were conducted with orthopedic surgeons and residents in Delhi (4), Pune (3), Mumbai (3), Bangalore (3), Vellore (1) and Chennai (1). A total of 19 patient questionnaires were completed by parents of clubfoot patients in Pune (4), Mumbai (7) and Bangalore (8). The following paragraphs describe the major challenges to clubfoot treatment identified by the results of this study.

Physician Education

Physicians who graduate with Bachelor of Medicine or Bachelor of Surgery (MBBS) degrees in India are generally regarded by their peers as well-educated medical practitioners. However, a common theme among many physicians interviewed was that many patients were referred to them after failure of treatment in other hospitals. In the physician questionnaires, the percentage of patients who were referred to them after failure of previous treatment averaged 11% (n = 24, range: 0.5% - 40%, SD: 10.7%). Physicians often cited lack of knowledge of clubfoot and treatment options among doctors in rural areas.

During interviews, an orthopedic resident stated that their curriculum in medical school had introduced them to the Ponseti method. In the questionnaires, physicians were asked if and at what point in their medical education they received training in the Ponseti method. Physicians were allowed to choose more than one answer with results as follows: 6% in medical school, 70% in residency, 24% in fellowship training and 9% as extracurricular. One of the physicians stated that he had not received any formal training in the Ponseti method and had learned the method through self study, including reading literature and using online resources. Another physician mentioned that he had come to the University of Iowa to be trained in the Ponseti method. Lastly, one physician stated that he had learned the Ponseti method at the Western India Regional Orthopaedic Conference (WIROC) under the guidance of orthopedic surgeons who were formally trained in the Ponseti method.

An interesting story which highlights physician knowledge as a challenge is of a neglected patient in Delhi. Both of the girl's parents were physicians but weren’t aware of the Ponseti method of treatment. Their child's clubfoot received treatment via the Ponseti method at an older age.

Alternative methods of Treatment/modification of the Ponseti method

A number of physicians stated that they have, at least at times, departed from the Ponseti method principles and protocols. Approximately 24% of physicians stated that they used ankle foot orthoses (AFOs) instead of the recommended foot abduction brace (FAB), and 18% stated they used short casts instead of long–leg casts.

All physicians (37/37) had used the Ponseti method in the last year and 38% had used surgery in the treatment of clubfoot within the last year. A minority, 12% of physicians, considered the Ponseti method a challenge to proper treatment due to its being time and/or labor intensive. Approximately 28% and 33% respectively, replied that they combined massage and physical therapy with the Ponseti method to treat clubfoot. When physicians were asked what other methods they use to treat clubfoot, 5% reported the JESS (Joshi external skeletal stabilization) method of clubfoot treatment.

Because of parental compliance issues and difficulty accessing health care, surgery and longer gaps between castings have become alternative forms of treatment to fit patient and family needs. One physician reported that if he believed the patient would likely not return within a week of casting, he would request the parents bring the patient back in two weeks. Another interview revealed that if it seemed unlikely that the patient would return, then the idea of surgery seemed more appealing. In a different interview, a physician mentioned that he used general anesthesia for casting patients older than six months of age. Some physicians also apply additional casts to decrease rigidity in the Achilles tendon to avoid Achilles tenotomy.

Compliance of Parents

Approximately 78% of physicians considered lack of follow-up to be a major challenge to proper treatment of clubfoot. Physician interviews revealed that parents were often very compliant during the initial casting. However, problems with compliance often occurred after initial correction was completed and the foot was no longer deformed. Many parents come great distances but decide to return to their villages after correction, and not return for follow-up. Since Ponseti treatment requires regimented follow-up and compliance with bracing, parents often return when their child's foot has relapsed.

During interviews, a number of common concerns about parental post-correction compliance were noted. A common concern was with parents who returned to their villages; the children subsequently outgrew their foot-abduction braces in a few months. Treatment with the Ponseti method involves long-term use of the FAB and parents often don’t have access to larger-size bracing in their local area. This was often the reason mentioned for relapse. Other concerns included the child's crying during the first nights of bracing. Some parents give in to the child's cries and remove the brace. It has also been reported that parents may continue bracing, but not for the appropriate amount of time required each day. In an attempt to change this trend, a physician in Vellore explained in an interview that he is currently creating a brace that will be able to monitor the amount of time a patient wears the brace each day.

Poverty

Approximately 64% of physicians considered financial limitations of the patient's parents to be a challenge for proper use of the Ponseti method. The average costs for the Ponseti method, the surgical method and for post corrective braces are shown in Table 1. The average cost of the Ponseti method of treatment is lower than the average cost of the surgical method according to the physician questionnaires. The average costs for bracing, 785 INR (Indian rupees) as assessed by physician questionnaire, and 1017 INR per patient interview, are consistent with the costs of 800–1000 INR typically stated during physician interviews. During an interview with one doctor, it was learned that some children with clubfoot are not brought in for treatment because their parents believe the child could earn more money as a crippled beggar than they could without the clubfoot.

Table 1.

Cost related to clubfoot treatment from physician and patient questionnaires.

Cost
Category	Source	n	Average Cost (INR)	Average Cost (USD)	St Dev	min	max
Ponseti	Physicians	25	5090	$108	6481	0	22500
Surgery	Physicians	18	9833	$209	11346	0	30000
Braces	Physicians	24	785	$17	426	50	1500
Braces	Parents	9	1017	$22	245	850	1600

Hospitals in urban centers are often completely full and cannot admit new patients. Families that come from long distances then sleep overnight at the train station. The cost of transportation, a missed day's wages and the cost of medical treatment are additional financial burdens on parents in the process of clubfoot treatment.

Treatment in Underserved Areas

Many physicians stated that the only way for patients to receive proper clubfoot treatment was to have their parents bring them to medical centers in urban areas. Doctors in rural areas often used massage as a sole treatment and some used incorrect casting methods. One parent stated that their child had been given 100 casts before coming for treatment at a medical center in Mumbai. Upon observation and subsequent interview with a physician in Pune, the family was extremely hesitant to proceed with the Ponseti method as casting had previously failed for their child.

Eighty-one percent of doctors considered distance and transportation to be a challenge for the proper treatment of children with clubfoot. Parent questionnaires revealed travel of an average 2.2 hours for treatment (n = 17, range = 5 minutes to 8 hours, SD = 1.95 hours). Some parents came from several states away and as far as 800 miles according to one physician's questionnaire. When questioned about why parents choose to travel such distances when they often had the same-quality government and charity hospitals closer to their village, a physician stated that parents often go to hospitals that have received positive reviews from other community members.

Culture

During interviews, it seemed a common belief among physicians that girls were often treated for club foot much later in life than boys. One physician gave the example of many girls coming in for first treatment when they were of marrying age - since the deformity would hurt their chances of finding a husband. Of interest was that in some locations, the mother and the maternal uncle were responsible for care of the child's deformity. The father's role in treatment was unclear in these cases. One physician believed that patient compliance with treatment, bracing and follow-up would likely increase if the fathers could become involved in the process.

Community Knowledge of Clubfoot

Approximately 17% of cases (n = 26, range = 0–55%, SD = 16.7) of clubfoot were considered neglected according to physician questionnaires. Neglected clubfoot was defined as incomplete or absence of correction by the time the patient was expected to walk. Many of the neglected cases were away from urban cities with well-established medical centers. This was largely due to a lack of public knowledge about clubfoot. Some villagers believed that clubfoot was a polio deformity, according to one physician. People from villages were often unaware of possible treatments available to their children for completely deformity correction.

Healthcare System in India

Approximately 27% of physicians considered the healthcare system in India a challenge to the treatment of clubfoot. Physician and hospital financial constrains were considered a challenge to proper treatment in approximately 36% of physician questionnaires. The response included an example of orthopedists or hospitals receiving less income because the Ponseti method of clubfoot treatment was less expensive. One physician commented that orthopedists were reluctant to use or spread the Ponseti method as a treatment when surgery was more lucrative.

Approximately 88% of physicians considered parent compliance with bracing to be a challenge in the treatment of clubfoot using the Ponseti method. This is largely an infrastructure problem since the healthcare system in India is not as stratified with different levels of healthcare practitioners as in the US. Often, the only two well-defined roles of healthcare workers are nurses and physicians, for most communities. Social workers, nurse practitioners and other health care personnel could help fill a lot of gaps in India's healthcare. For example, 95% of physicians stated that they follow up with parents after their child's clubfoot treatment. Most of the physicians in this study work in very busy public hospitals and have little time to educate parents about bracing or to call them to ensure follow-up. One physician wrote that with appropriate education, parents could be persuaded to be compliant with their child's bracing and that compliance may increase if nurse practitioners were available.

Discussion

India is the second most-populous country in the world with 25% of its people (about 375 million) living below the poverty line¹⁰. Approximately 25,000 children are estimated to be born with idiopathic clubfoot every year in India. With such a large population living in poverty, the non-invasive and inexpensive treatment of clubfoot with the Ponseti method has the potential to make a large impact on health outcomes for children who would otherwise be crippled by clubfoot. Table 2 shows the challenges to clubfoot treatment in India, and proposed solutions.

Table 2.

Barriers and possible solutions to treatment of clubfoot using the Ponseti method.

Challenges	Proposed Solutions
Physician education	Introduce education about the Ponseti method of clubfoot treatment in medical school curriculum, residency and fellowship training
Parent awareness of treatment	Use paper (newspapers), electronic media (radio, television, movies and internet) and health visitors (Anganwadi workers) to increase awareness of appropriate clubfoot recognition and treatment
Modification of Ponseti Method	Prevent modification by educating and training physicians in the Ponseti method and building capacity to treat clubfoot using the Ponseti method
Compliance with treatment and bracing	Educate parents using non-physician health professionals, provide incentives for adequate follow-up (free braces, transportation cost etc)
Poverty	Get government agencies to recognize the Ponseti method as the gold standard and subsidize treatment costs.
Culture	Educate parents and the community and involve both parents in care of the child
Treatment in underserved areas	Build awareness using the Anganwadi workers at the village level to recognize and refer clubfoot to clubfoot clinics, establish specialist clinics in each state and outreach clinics at district and Taluk levels using a hub-and-spoke model
Healthcare system	Establish a collaborative effort involving the central and state governments of India, WHO, the Ponseti International Association, private and public sector industries, physicians and parents.

Studies on the development of sustainable Ponseti programs, and the challenges to Ponseti clubfoot treatment have been published from China⁸, Malawi¹² and Uganda^13–14. These countries have very different populations when compared to India. For example, Malawi and Uganda have relatively small populations (16 million and 35 million respectively) when compared to the world's two most populous countries of China and India (1.34 billion and 1.19 billion respectively). The medical staff available to treat these populations is also quite different. Malawi and Uganda have < 1 and 1 physician per 10000 people. respectively¹⁵. India and China have 6 and 14 physicians per 10000 people, respectively, which should allow for more access to treatment. Although these countries have very different populations, resources and cultures, the challenges that all countries face in treatment of clubfoot are very similar.

Poverty has been perceived as challenge to proper treatment of clubfoot in all four countries. A large proportion of the population in all these countries is the working poor. Since a large part of the population of these countries lives in rural areas, it can be very difficult for parents to take time off from work and travel to seek treatment for their children.

Compliance is one of the major challenges with clubfoot treatment, whether in developed countries or developing countries^16–17. Compliance with follow-up and bracing are considered challenges among physicians in India, similar to that found in China, Uganda and Malawi. However, as pointed out in a publication from Uganda¹⁵, patient compliance should not be used as an excuse to remove responsibility for treatment failure from clubfoot programs. Parents in India would typically complete initial clubfoot correction but would often not return for follow-up. This suggests that the parents might not fully understand the implications of non-compliance after correction. Educating parents that bracing and subsequent follow-ups are essential to prevent relapse would likely help increase compliance significantly.

In India, Malawi and Uganda, the primary person responsible for the health of the child is the mother. However, in China, it was often the responsibility of both parents to take care of the child during clubfoot treatment. As stated by one physician during an interview, if fathers were more involved in their child's care and understood the importance of follow-up and bracing, the rate of compliance would likely improve.

As shown from the model of clubfoot treatment in Uganda, it is important to create clubfoot-specific clinics for one to two days per week, with high quality standards, in an established hospital or clinic. This is essential to guarantee a high quality of treatment by physicians who are fully trained and who treat clubfoot patients on a regular basis. Physicians who only see clubfoot patients a few times a year often lose skill in performing the technique correctly, which can lead to a bad reputation for casting in the community. This was demonstrated by the physician in Pune who was trying to convince the parents that the Ponseti method would successfully treat their child after previous casting had failed.

Specialized clinics also allow for other staff, such as nurses, physical therapists and trained counselors, to share responsibility in treating the patient^18–19. For example, ncillary medical staff can educate the child's family on the importance of bracing and follow-ups after correction. Physical therapists, nurses and other medi-cal staff could be trained to follow up with patients. This would free physicians to treat more patients. Another advantage of having specialized clinics is that parents and patients at all stage of treatment can speak with each other about their children living without disability. When parents see previously treated children walking and running at the clinic, it can give them hope that their child will be able to do the same, with treatment.

Currently, major medical centers in urban India have very well trained medical professionals to treat clubfoot patients. Establishing high quality clinics in each of the 28 states should be the next logical step for the Ponseti method in India. Ideally, this would be followed by establishing clinics at District and Taluk headquarters (close to most villages) in each state of India, so that the Ponseti method of treatment is accessible to the majority of the population. To achieve this, the central and state governments of India must be persuaded to recognize the Ponseti method as the gold standard to provide safe, effective, economical and efficient treatment for idiopathic clubfoot. This would require a collaborative effort involving the World Health Organization, the Ponseti International Association, international and national NGOs, public and private industry, physicians and government agencies in India.

The authors are aware of the limitations of this study, as it is a qualitative assessment. The physicians interviewed were limited to those practicing in large urban cities, and the parents of clubfoot children who were being treated in those centers. However, the data collected was valid, arising directly from the experiences of the participants. In addition, triangulation of the data was possible as a number of different sources were interviewed; this showed differences in perspectives, but no major differences in reporting what challenges were encountered. Interestingly, interviews with practitioners and parents both showed remarkably similar findings. The main source of possible bias was that almost all participants were beneficiaries of the project in some way, either as employees or patients. Despite these limitations, the challenges that have been identified could help NGOs and local governments in India to focus their time and resources, and tailor future interventions to those specific challenges.

In conclusion, there are a number of challenges in India to the diffusion and implementation of the Ponseti method, many of which are similar to those encountered in other countries. The specific challenges found to be most important were lack of physician education, parent compliance with bracing, lack of proper rural clubfoot clinics and limited financial resources. The results of this study can be used to implement specific strategies to improve the diffusion and implementation of the Ponseti method for treating clubfoot throughout India.