2.1 Study design

A descriptive design study explored parents' opinions, apprehensions, and requirements about their child's CTEV treatment.

2.2 Sample

The participants were recruited from a PMR (Physical Medicine and Rehabilitation) department of a multi-specialty hospital in Jaipur, Rajasthan, specializing in CTEV treatment through the Ponseti Technique and receiving patients from very distant areas, even up to 1200 km. The inclusion criteria required a parent/caregiver with a child of 1.5–24 months in the bracing protocol for idiopathic clubfoot between October 2020 and October 2021. The exclusion criteria were the patients with syndromic clubfoot or relapse cases.

2.3 Data collection

The Institute Ethics Committee granted the ethical approval, and the participants were recruited. An interview guide was used to conduct semi-structured telephone interviews of the participants at convenient times. Highlighting the voluntary and confidential data policy for all participants', telephonic consent was obtained. Data were collected in October 2021 by the leading researcher. The lead researcher was not involved in the treatment. The parents from 4 neighboring states of Rajasthan were available.

Five pilot interviews were used to evaluate the guide and the process. The data of these five interviews were excluded from the final analysis. In total, 246 participants were available, of which 39 parents did not meet the participants' inclusion criteria. After obtaining consent from 207 participants, seven pilot interviews were conducted. Two hundred participants were interviewed with audio recording. The interviews lasted between 10 and 20 min. The recorded interviews were translated verbatim, and data was analyzed. The leading researcher simultaneously conducted all the interviews and translations to continuously reflect the evolving ideas during the study (Add Table 1 here).

2.4 Data analysis

Data analysis was carried out using the software package IBM SPSS® Statistics for Windows, version 25 (IBM Corp., Armonk, N.Y., USA). Univariate analysis is used to find out the correlation between various parameters.

3.1 statistical analysis

The statistical analysis provides novel insights into CTEV management. The cases of neglected clubfoot were excluded from statistical analysis to avoid bias in the results. As shown in Table 2, various statistical tests are used to find the co-relation among treatment factors like the number of casts, follow-up, casting discomfort and bracing discomfort, etc. The child's discomfort was reported by parents as excessive crying during casting or bracing. The treatment start age significantly relates to gender (p=0.031). The comparison of means has shown that the mean age of presentation is 3.7 weeks, with female children (mean age: 2.3 weeks) being presented significantly earlier than male children (mean age: 4 weeks). However, gender has no other correlation with any other treatment factor. The type of deformity, i.e., unilateral or bilateral, also does not associate with treatment factors (Add Table 2 here).

The casting (p=0.045) and bracing discomfort (p=0.021) significantly correlate with distance from the treatment center. The residence (locality) and treatment start age do not correlate with any treatment factor. However, the number of casts significantly correlates with bracing discomfort (p=0.037). The bracing discomfort was more common among the children with casts six or more. While the travel mode does not have any correlation with the start age of treatment, it is strongly associated with follow-up (p=0.028), child discomfort in casting (p=0.005) as well, and the bracing phase (p=0.004). The public transport causes more travel time for the same distance and booking has to be made well in advance. Apart from that, there are other issues in public transport like over-crowding, noise pollution, etc., which adds to the child's discomfort. Therefore, parents using public transport were more irregular in follow-ups and reported child discomfort more commonly than parents using a personal vehicle. The travel time to the hospital significantly affects the number of casts (p=0.022) and follow-up (p=0.012). With the increased travel time, the irregularity in follow-up increases, resulting in a greater number of casts. Parents' literacy level is significantly associated with child discomfort during castings (p=0.037). This may be attributed to the fact that maintenance of casts in the home is not as per doctors' instructions. The parents might ignore instructions about handling the child with a cast, like keeping the cast dry. The income level of parents is strongly associated with follow-up (p=0.008), child discomfort in casting (p=0.002) as well as bracing (p=0.015). The parents from lower-income groups have reported more irregular follow-ups and child discomfort. In some cases, the direct cost of treatment is lower than indirect costs like food and lodging. Travel problems become a big challenge for parents who belong to the lower-income group and reside in rural areas. It is challenging to find trains/buses as per the appointment schedule. 16% of participants said they have to start the journey the day before and travel by bus/train at night. The bus/train reaches Jaipur early in the morning, between 1 a.m. and 4 a.m. Then, they spend 4–8 h at a bus stand/railway station before proceeding to the clinic between 8 or 9 a.m. A typical travel arrangement for low-income rural parents is shown in Fig. 2 (Add Fig. 2 here).

Close

Fig. 2 Typical travel arrangement of low-income rural parents for CTEV treatment of their child.

Export to PPT

3.2 Discussion

In India, CTEV management has undergone several changes in the last decade due to improvements in infrastructure, road and internet connectivity, literacy rate, economy, etc. These improvements helped eliminate some challenges like social stigma and lack of awareness to a certain extent. The free treatment in government hospitals, NGOs' support, and awareness campaigns have increased the number of patients seeking CTEV treatment. At the start of the last decade, a study was conducted including 19 parents and highlighted the challenges of doctor expertise, treatment cost, social stigma, lack of awareness, physical distance, and brace compliance.¹⁰ These challenges were similar as reported by studies in low income countries like Uganda, Kenya and Madagascar^16–19 conducted around same time. With decreased biased by directly talking to parents and large sample size has resulted in increased power of this study. The statistical analysis results are useful to categorically summarize the contemporary challenges.

With the government and NGOs supporting the treatment, the direct costs of treatment are not a challenge anymore in India, but indirect costs are still a hindrance. A study has shown that gender and transport duration significantly affect CTEV treatment in India.²⁰ However, our study shows that female children are presented for treatment earlier than male children. The reason is that the parents are more protective of male children, and in many cases, some rituals are performed at a certain age without which the male child is not supposed to travel.

3.3 Conclusions

This study is the first of its kind in India conducted with the direct participation of parents. India has the second-highest population globally, with a 64.6% rural population and a poverty rate of 21.9%. The doctor availability is 8.6/per 10,000 people, with a per capita health expenditure of 3.5%.¹⁴ The availability of an expert doctor for CTEV treatment can be assumed to be less than 8.6 therefore it is challenging to provide quality health services in India. The challenges become more prominent for patients when the treatment duration is long and regular follow-ups are required, as in the case of Clubfoot. The study shows that patients who travel long distances in public transport are the most vulnerable regardless of gender.

One solution is to use the Uganda model, where the weekly clinics specialize in CTEV treatment. Along with a better skill set of the expert doctor, it also provides the opportunity to sensitize the paramedical staff about the deformity and treatment practice, which increases the confidence and awareness among parents. However, this approach requires a massive push from the government to overcome infrastructure and administrative hurdles.

Another more suitable approach may include using latest technologies to develop novel solutions. As far as brace compliance is concerned, there is a need for continuous monitoring of the compliance. The researchers have attempted various solutions including development of corrective orthosis, dynamic braces and integration of sensors.²¹ The solution might lie in a low-cost orthosis for correction and maintenance. Such orthosis should be based on Ponseti's understanding of the biomechanics of the Clubfoot to achieve effective outcomes.