The Health Determinants of Accessibility to Clubfoot Treatment in LMICs: A Global Exploration of Barriers and Solutions

2.1. Study Sample

Between January 1, 2007 and December 31, 2016, we identified hospitals that responded and did not respond to the portion of the WHO related to CTEV management. The survey primarily characterized hospitals responding as either (1) treating CTEV or (2) not treating CTEV, and those (3) not responding to the CTEV management section. Among the hospitals responding, we also captured hospital characteristics, specific reasons for not treating CTEV, namely (1) lack of training, (2) lack of medical supplies/drugs, and (3) lack of functioning equipment, in addition to the type of hospital, ranging from Level 1 to Level 3. According to the World Health Organization (WHO), Surgical Care at the District Hospital guidelines, Level 1 (Small Hospital or Health Center) is defined as a hospital with a small number of beds, the ability to perform minor procedures, and the availability of oxygen concentrator. Level 2 (District/Provincial Hospital) is defined as the first referral hospital of 100-300 beds with the ability to perform the same as Level 1, with the addition of complete anesthesia, resuscitation, and airway management system including oxygen concentrators (cylinder), and pediatric anesthesia systems. Level 3 (Referral Hospitals) is defined as a hospital with greater than 300 beds, basic intensive care facilities, the ability to perform the same as Levels 1 and 2 with the addition of pediatric and neonatal surgery, facial and intracranial surgery, and bowel surgery, among other interventions.10

A comparative analysis to evaluate characteristics of institutions responding to the CTEV section of the survey was conducted to evaluate for survey bias. Next, descriptive analysis was conducted, including frequencies and proportions by associated country of each hospital institution treating CTEV, as well as based on the type of hospital. We utilized a multivariate linear regression technique, a statistical modeling approach to evaluate the key factors for hospitals associated with management vs non-management of CTEV. This regression analysis was conducted based on the following independent variables, namely lack of skills, lack of function equipment and lack of supplies/drugs, with a single dependent outcome variable being treatment vs nontreatment of CTEV. All tests of hypotheses were two-tailed with a type-1 error rate set at 5%. All statistical analyses were performed using SPSS IBM version 23 (Armonk, NY, USA). The institutional review board determined this study as exempt as the study uses institutional-level data.

4.1 Discussion

This study highlights institutions in low and middle-income countries that lack sufficient management of CTEV. The Ponseti method offers a non-invasive and cost-effective method of treatment to those across the globe, especially in LMICs.11

The method has become widely accepted as the gold standard of treatment and has rapidly spread across the globe, drastically improving the care of those with CTEV.5 Despite this, there continue to be disparate levels of treatment across LMICs, especially within local and district hospitals. Our analysis reveals that a lack of appropriate skills in handling the treatment of CTEV is the most common reason for a lack of treatment and subsequent referral to another institution from level 1 and 2 institutions. The lack of appropriate equipment and medical supplies were also cited as common reasons for the non-treatment of CTEV. Despite being able to be managed with minimal, non-surgical training, a large proportion of patients are not being treated in local or district hospitals in LMICs. Multiple barriers exist to proper care include financial barriers for the hospital and patient, lack of parental knowledge of the disease, and lack of follow-up.12–16 Follow up has been shown to be influenced by transportation availability and costs, proper brace use, and perceived health status among other factors.17

4.2. Training Programs

This study further supports the notion that the major challenge for the availability of surgical services for children in LMICs worldwide is the low-skilled workforce and appropriate infrastructure.6,18,19 A recent Zambian study using the WHO SAT tool also demonstrated that lack of surgical skill was the leading factor in limiting the availability of 93% of pediatric procedures.20 We further confirmed this notion in our analysis which revealed a significant correlation between lack of skills and the non-treatment of CTEV at a rate of 86.1%. Addressing the lack of a skilled workforce is paramount in the proper treatment of CTEV across the globe. Training programs specific to CTEV have been previously explored and have been reported to significantly increase the proper use of the Ponseti method globally.21 Programs such as the early nationwide manipulation of CTEV established in Malawi’s 25 health districts have already proven to be successful. One year following the intervention, 20 out of the 25 clinics that were created were still operational and had successfully managed over 300 patients (out of 482 cases of CTEV, 327 were corrected to the plantigrade position).22 Similar training programs for other low-cost technologies such as ultrasound used in low- and middle-income countries have also proven to be successful. 12,23

Training programs that focus specifically on non-invasive methods of treating CTEV have proven to be efficacious. However, CTEV cases in LMICs have been reported to have the highest rates of disease relapse and follow-up in previous training programs have been minimal.21,24 Addressing the root causes of relapse must be a priority in any educational program. Solutions identified in a systematic review of 24 studies examining CTEV barriers in LMICs were primarily education, in addition to financial assistance, for the patient and providers.17 As the Ponseti method includes serial casting, consistent follow-up is of the utmost importance. However, one of the highest barriers to care is the financial and temporal cost of travel to CTEV clinics. Subsequently, mapping the locations of Ponseti clinics has been suggested to understand the further current burden of travel on patients within LMICs. The formation of strategically placed clinics in low-access areas may help reduce transportation costs and increase the access and continuation of care. In addition to reducing transportation costs, the standardization of correct CTEV management must also be encouraged. This has been studied extensively and the six best practices to ensure sustainability in CTEV training programs have been elucidated. These include diagnosing CTEV early, organizing high volume Ponseti casting centers, the use of non-physician health workers, engaging families care, reducing barriers to access, and providing follow-up. 25

4.3. Lack of Supplies

Our analysis highlights a correlation between lack of medical equipment and insufficient treatment of CTEV. Many institutions reported damaged or faulty materials including plaster casts and braces, which are essential to the proper non-surgical approach to CTEV treatment. This lack of supplies has placed a higher burden on patients and providers in the acquisition of appropriate care. A previous study was in agreeance with this finding, showing that out of a population of 27 LMICs, only 67% had access to splints/braces all of the time.17 In contrast with the rest of the cohort where the lack of adequate skills was the primary cited reason for the non-management of CTEV, level 1 hospitals in Bangladesh cited the lack of medical supplies as their leading cause. Bangladesh has one of the highest rates of idiopathic CTEV, reporting over 5000 new cases per annum.26,27

This could suggest that the high rate of CTEV puts significant pressure on the clinical material available for each patient, such as material available for plaster casts. Furthermore, in an initiative named the Bangladesh Sustainable Clubfoot Project, Walk for Life (WFL), 13% of CTEV cases were noted to be atypical requiring special casts, furthering material costs.26 WFL consisted of 35 clinics involving overseas experts training a team of national paramedical staff including physiotherapists and non-medics. All cases underwent Ponseti casting and a total of 3,922 patients were successfully treated between 2009 and 2011. With a low complication rate of 2%, the program provides evidence for the notion that physiotherapists, paramedics and non-medics can be trained to deliver clubfoot manipulative treatment with good outcomes.

The treatment that the Ponseti method offers is often considered highly cost-effective with a ratio of USD 22.46 per disability-adjusted life year averted. Despite this, 60% of the participants in WFL reported that the material costs of USD 40 were unaffordable. This highlights that despite the relatively “low-cost” and high cost-effectiveness, barriers continue to exist in terms of accessing proper CTEV care, even when treatment is available.28 The WFL program was especially successful as the non-governmental organization was welcomed with local and government support and was provided free of cost to patients and their families.

4.4. Possible Solutions

Results from studies examining CTEV management in LMICs using the Ponseti method have demonstrated that the use of local material and craftsmen are important to maintain the stability of clinical material production and use.26,29–31 A Steenbeek foot abduction brace made by local Kenyan craftsmen was trialed in 233 patients and was shown to increase rates of compliance, decrease discomfort, and reduce complications as compared to the widely used, low-cost, Dennis Brown brace.32 Increasing the rates of Steenbeek braces will likely help to develop the necessary CTEV workforce and reduce foreign material aid dependence – creating local, low-cost, and sustainable programs. It has also been shown that the use of recyclable plaster casts can also reduce the cost of equipment and increase the availability of CTEV braces and treatment.17

4.5. Building Sustainable Infrastructure

Ultimately, external interventions are often required to meet the financial needs of both the patient and practitioner in order to address shortfalls such as costs of transportation to health care facilities and clinical materials. Proper CTEV management in the context of service delivery in a national health system was shown to be successful in the Uganda sustainable CTEV program. Practitioners, medics, and non-medics participated in structured training programs on manipulative conservative techniques and were shown to improve CTEV outcomes. Non-governmental organizations have also played a vital role in the proper care of individuals with CTEV.30 In 2007 a collaboration of non-governmental organizations and ministers of health established a national training program across 10 different countries. Overall, 110 CTEV clinics were formed consisting of 643 trained practitioners in which 7,705 children were treated over a three-year span. The model was found to be successful and further supports the validity of training programs.33

Overall, this analysis highlights that lack of skills and effective medical equipment to manage CTEV are important contributory factors for the non-management of CTEV in LMICs. The importance of these factors compared to other parameters such as lack of interest, poor financial compensation, previous poor results or advanced disease on presentation to level 1 and 2 hospitals should also be explored in further studies. A recent study highlighted the importance of succinct surgical referrals and a process to monitor dropout rates of patients as an important factor for improved clubfoot management.34 Although it is impossible to conclude a direct link with lack of skills and lack of equipment from a snapshot study of institutions that responded to the WHO SAT questionnaire, our study does provide a strong correlation and proposed direction in managing the global burden of CTEV.

4.6. Strengths and Limitations

Although there have been previous reports assessing the strength of CTEV training programs, this is the first study to assess the CTEV surgical capacity in multiple LMICs worldwide using the WHO SAT tool. This study has highlighted targets for policy in specific LMICs. Limitations include the retrospective collection of data via the WHO situational analysis tool. The study is only a snapshot of institutions that filled out the tool and may not be fully representative of the demographics of the entire country and region in general. Furthermore, as the sampling strategy was based on all participating invited survey participants that actively answered the survey and were WHO institution affiliated hospitals, there may be a lack of representation from specific countries. There may also be reporting bias in responding vs non-responding institutions and WHO-institution affiliated vs unaffiliated hospitals.

The type of facility also needs to be considered. Despite CTEV being listed as an essential intervention in the WHO Surgical Care at the district hospital publication, depending on the institution specialized CTEV care may not be expected to be available at primary referral facilities. Since most of the SAT data comes from primary referral facilities, in some instances this may impact the representation of CTEV management. As a result, responding institutions may not be representative of the entire health care treatment options of that country. Also of note, the SAT data were collected over a 10-year period and CTEV management has changed gradually as adoption of the Ponseti technique has spread. Those centers reporting that they were unable to manage CTEV at the start of the data collection period may now be able to, due to the availability of Ponseti training courses and materials. Isolated centers that advocate and use the Ponseti technique may not be captured by the SAT data.