Ponseti Casting for Clubfoot

Published: December 2022

What is the problem?

Congenital talipes equinovarus (CTEV), also known as clubfoot, is a congenital condition characterized by one (unilateral) or both (bilateral) feet twisting inward.1 A 2020 Cochrane review describes clubfoot as “common” and a 2017 systematic review estimated birth prevalence of clubfoot as between 0.5 and 2.0 per 1,000 live births in low- and middle-income countries.2

In a shallow literature review, we found that untreated clubfoot is commonly reported to cause disability, deformity and pain.3 People with untreated clubfoot are also reported to face social exclusion and reduced income.4 We have not vetted these claims but they appear plausible given that clubfoot is not expected to resolve without treatment5 and there are theoretical and empirical associations between physical disability and worse economic outcomes.6

What is the program?

The Ponseti casting method of treating clubfoot aims to correct foot alignment and typically includes:

• Stretching the affected foot and using a series of casts over approximately 6 weeks, which is designed to gradually change the foot’s alignment,
• A surgical procedure (percutaneous achilles tenotomy) aiming to improve the foot’s flexibility, and
• Use of a final cast for three weeks and then use of splints/braces at night in order to maintain the alignment.7

Ponseti guidance recommends targeting children soon after birth, though it reports that the method may be appropriate throughout childhood.8

We are aware of ten non-governmental organizations (NGOs) (eight of which are coordinated by the umbrella group The Global Clubfoot Initiative) that support programs in low- and middle-income contexts that aim to increase treatment of clubfoot with the Ponseti method.9 These programs typically include the provision of funding, technical support, supplies, as well as monitoring and evaluation and awareness raising activities.10 A 2018 review authored by employees of the Global Clubfoot Initiative used self-reported data from clubfoot treatment program coordinators (including programs with domestic or international NGO support) to estimate that about 14% of infants estimated to be born with clubfoot within respondent countries received treatment with the Ponseti method under the age of 1.11

Alternative forms of treatment for clubfoot can include either non-surgical treatments, surgical treatments, or both.12 We focus on the Ponseti method when considering programs that we might recommend funding as opposed to other treatment types because:

• We understand it to be the “gold standard” treatment method13
• We are not aware of any NGOs supporting alternative forms of treatment for clubfoot

In a shallow literature review, we did not find systematic evidence about coverage rates of alternative forms of treatment.14 Given our understanding that the Ponseti method is considered the “gold standard” and our impression that other treatments (e.g., alternative casting methods and/or other types of surgery) may require similar or higher levels of resources to execute,15 we think it is unlikely that there is a high coverage rate of alternative treatments in many low-income contexts.

Does the program have strong evidence of effectiveness?

We think it is plausible that well-implemented treatment with the Ponseti method alleviates some or most of the burden associated with untreated clubfoot. This is based on a shallow review of several systematic reviews, which find short-term treatment success rates around or above 90%.

However, we have several uncertainties about the evidence for the effect of the Ponseti method:

• Different studies use different outcome measures to assess treatment success, and we’re unsure how these translate to levels of disability. As a result, we're uncertain how much treatment reduces the burden of clubfoot.
• There are few long-term follow-ups after treatment. As a result, we are highly uncertain about how long the benefits of treatment persist and the extent of relapse.
• The available evidence does not allow us to estimate the effect of NGOs on the number of children receiving treatment. As a result, we're uncertain about the extent to which programs we might consider recommending funding to increase the number of children treated vs. subsidize treatments that would have occurred even without NGO support.

Does Ponseti treatment restore foot function?

We believe it is plausible that the Ponseti method alleviates some or most of the burden associated with clubfoot but we have a very high degree of uncertainty about the magnitude of benefits.

In a shallow literature review, we identified five systematic reviews that reported on Ponseti treatment. Four of these reviews reported rates of “initial correction” (i.e., following the casting phase) around or above 90%.16 The fifth study (a 2020 Cochrane Review: Bina et al. 2020) does not use the term “initial correction” but reports that Ponseti treatment may produce better foot alignment following casting compared to an alternative casting technique.17 We have not assessed the quality of evidence from the reviews in depth, however, the small sample sizes of individual studies within these reviews raise questions about the precision and reliability of outcome measures. For example, the 2020 Cochrane review identified 21 trials with a total of 905 participants.18 The largest of these (Selmani 2012) involved 100 participants and 150 treated feet.19

More generally, we are unsure how initial correction translates to disability over the course of a treated person’s lifetime, because we are unsure about the:

• Relationship between treatment outcomes and disability. We are uncertain how the outcomes of treatment reported in these reviews relate to the disability burden of untreated clubfoot. The reviews do not define “initial correction,” but we infer that it means that the foot’s alignment is considered typical.20 We are unsure whether the impaired mobility, pain and social stigma associated with untreated clubfoot is fully averted when foot alignment is corrected. The Cochrane Review notes the need to assess function separately from “objective measures” such as x-ray results because those measures and function do not reliably correlate.21
• Rate and severity of relapse following initial correction. Relapse is reported to be relatively common,22 but definitions for relapse and its severity are reported to vary.23 A 2021 systematic review of long-term outcomes following Ponseti treatment found that 47% of patients experienced relapse and, conditional on relapse, 79% of patients required additional surgery.24 Non-adherence to treatment, including not completing night bracing as prescribed, is reported to increase the risk of relapse but we have not evaluated this claim.25

How does Ponseti treatment in programmatic contexts compare to the published literature?

We have a high level of uncertainty about the extent to which findings from published literature will generalize to future implementation, though we haven’t explored this issue in depth yet. In particular we have uncertainty about:

• Impact of programs we might recommend funding to on the number of children treated: Given the relatively low rates of treatment reported in low- and middle-income contexts, it seems plausible that clubfoot programs increase treatment rates.26 However, we are uncertain what proportion of children whose treatment is supported by clubfoot programs would receive some form of treatment absent the program.
• Quality of Ponseti treatment in programmatic settings: We are uncertain how the provided training and clinician skill in programmatic settings compare to those reported in the literature. We generally expect that outcomes in a routine setting tend to be worse than those reported in the literature since our impression is that programs implemented in study settings tend to be of higher quality.
• Populations treated in programmatic settings: Ponseti guidance recommends beginning treatment with very young infants (around a week of age), however it allows for the possibility of treating older children.27 The treatment of older children is reported to be more challenging, although we have not evaluated this claim.28 We are unsure what the typical age distribution of treated children would be in a program we might consider recommending funding to and how this would affect their outcomes.
• Adherence to treatment in programmatic settings and effects on durability of benefits: Some reports suggest that relapse is associated with non-adherence to treatment, which may itself be correlated with demographic factors such as poverty and distance to treatment facilities.29 We expect that programmatic settings to which we might consider directing funding would have high rates of poverty and other potential barriers to adherence, but we are unsure how these might compare to the contexts represented in the literature.

Additional benefits

We think it is plausible that clubfoot treatment programs have additional benefits, though we are highly uncertain about their magnitude:

• Increases in income: We think it is plausible that untreated clubfoot is associated with loss of income (as discussed above) and therefore that treatment which alleviates the condition could increase income, but we have high uncertainty about the magnitude of the potential effect.
• Health system strengthening: It is possible that healthcare workers who receive training will maintain their skill and ability to treat patients beyond the period in which NGOs provide active support, or that NGO support increases the chance that the domestic healthcare system routinely takes on clubfoot treatment in the future.30

Potential offsetting/negative effects

The 2020 Cochrane review notes that most trials did not report on adverse events resulting from treatment, but that those that did reported:

• Cast slippage (needing replacement), plaster sores, and skin irritation associated with serial casting; and
• Infection and the need for skin grafting following surgery.31

How cost-effective is the program?

We conducted a preliminary cost-effectiveness analysis of a Ponseti treatment program. As of October 2022, we estimate that this program may be below the range of cost-effectiveness of programs we expect to direct funding to. However, it is close enough to our threshold that our bottom line could change if we get more information.32

Note that our cost-effectiveness analyses are simplified models that do not take into account a number of factors. There are limitations to this kind of cost-effectiveness analysis, and we believe that cost-effectiveness estimates such as these should not be taken literally due to the significant uncertainty around them. We provide these estimates (a) for comparative purposes and (b) because working on them helps us ensure that we are thinking through as many of the relevant issues as possible.

This cost-effectiveness analysis is at an early stage, and we think it’s likely that our bottom line cost-effectiveness estimate will change with further review.

We think it is likely that untreated clubfoot is associated with a substantial burden of disability and worse economic outcomes. Clubfoot treatment appears to be fairly expensive33 and we expect there may be a substantial risk of relapse.34 This leads to moderate cost-effectiveness.

A sketch of the cost-effectiveness model is below:

• Morbidity due to untreated clubfoot: To compare morbidity due to different conditions, GiveWell typically uses “disability weights,” quantitative estimates of the magnitude of health loss associated with specific health outcomes.35 As of the 2019 version of the Global Burden of Disease Study, clubfoot had not been assigned a disability weight.36 We therefore use a disability weight for a condition which we subjectively judge to be similar to bilateral clubfoot: “disfigurement level 2 with pain and moderate motor impairment due to congenital limb deficiency.”37 Global Burden of Disease defines this as a combined disability weight and we understand it to combine those of "Disfigurement level 2 with pain due to congenital limb deficiency," in which a person "has a visible physical deformity that is sore and itchy. Other people stare and comment, which causes the person to worry. The person has trouble sleeping and concentrating," and “moderate motor impairment,” in which a person “has some difficulty in moving around, and difficulty in lifting and holding objects, dressing and sitting upright, but is able to walk without help.”38
  • We subjectively guess that the disability weight for unilateral clubfoot is 75% that of bilateral clubfoot, based on the intuition that mobility impairment might be substantially lower with unilateral clubfoot but that burden due to “disfigurement” might be similar across the conditions. The value we assign unilateral clubfoot is about 7% higher than that assigned to “severe osteoarthritis of the hip," in which a person "has severe pain in the leg, which makes the person limp and causes a lot of difficulty walking, standing, lifting and carrying heavy things, getting up and down, and sleeping.”39 This seems roughly appropriate given that people with untreated clubfoot may experience stigma beyond that experienced by people with arthritis because untreated clubfoot is visible to others.40
• Years lived with disability absent treatment: We assume that people treated by the program would have the average life expectancy for low SDI countries of about 66 years.41
• Treatment outcomes: We assume that if children achieve “initial correction” without relapse, 100% of the disability of clubfoot is averted. We assume that 80% of treated children achieve initial correction.42 This is a subjective guess based on the assumption that short-term programmatic outcomes are likely to be worse than in the published studies we reviewed, which reported rates of initial correction higher than 90%.43
• Relapse: We assume that 47% of children experience relapse an average of about 7 years after the completion of treatment.44 This is based on the average relapse rate reported in a long-term systematic review and assuming those relapses happened around the midpoint of the approximately 14 years of follow up.45
  • We subjectively guess that 5% of the disability of untreated clubfoot is averted for children who experience relapse, based on the intuition that there may be benefits of treatment for those whose form of relapse is less severe.46
• Income effects: We assume that children who achieve initial correction and do not relapse have income that is 25% (bilateral clubfoot) or 15% (unilateral clubfoot) higher than it would have been had they not been treated.47 We assume that people who experience relapse have no change in income compared to their untreated outcomes. These are subjective guesses.
• Cost of the program: We estimate that the cost per child treated to an NGO program is about $543, based on an estimate for average cost per child treated in Africa from the Global Clubfoot Initiative.48 We assume that domestic governments contribute another $109 per child treated (20% of NGO costs).49 This is a subjective guess of the cost of healthcare worker time and clinic space.
• Marginal children treated: We assume that 5% of children whose treatment is supported by an NGO program would have received treatment even absent the NGO.50 This is a subjective guess based on our impression that clubfoot treatment is relatively rare without external support.51
• Cost-effectiveness: Using a cost estimate of about $652 per child treated, of which $543 is attributed to a philanthropic donation,52 our best guess is that clubfoot treatment programs in a low-income context avert about 6 disability adjusted life years per child treated.

However, we have high uncertainty about the appropriate disability weights to use, the prevalence and impact of relapse, the effect of clubfoot treatment on economic outcomes, the marginal number of children treated that are attributable to the program, and costs in a program setting.

• Appropriate disability weights. We have assigned the disability weight for “Disfigurement level 2 with pain and moderate motor impairment due to congenital limb deficiency” to bilateral clubfoot and subjectively adjusted it downward for unilateral clubfoot.53 We are aware of one cost-effectiveness analysis which uses substantially (30-56%) higher disability weights.54 If we are underestimating the burden of untreated clubfoot, treatment programs could be more cost effective than we have modeled.
• Prevalence and impact of relapse. Based on a shallow literature review, our impression is that there is substantial variation in prevalence of relapse, its severity and thus potentially its impact on function.55 We have not investigated these questions in depth, and expect that further research could cause us to update in ways that meaningfully affect our bottomline estimates of cost-effectiveness either downward (e.g., if adherence to prescribed treatment is worse in programmatic contexts) or upward (e.g., if people who experience relapse regularly access care that successfully treats the relapse at low cost).
• Impact of clubfoot treatment on consumption outcomes. We think it is plausible that treating clubfoot increases treated people’s income and consumption later in life by improving their access to job opportunities. However, we are very uncertain as to the magnitude of this effect. The subjective guess included in our current model implies that increased consumption generates about 20% of the value from treating clubfoot. It seems plausible that this either under or overestimates the benefits of treatment, but based on a shallow literature review (see here), our impression is that data that would allow us to improve this estimate is not readily available.
• Marginal number of children treated that is attributable to NGO programs. We have included a modest downward adjustment of 5% to account for the possibility that children would receive treatment even absent NGO support.56 It is possible that further investigation of a potential funding opportunity could cause us to believe that treatment is more likely absent the NGO program, which would decrease cost-effectiveness.
• Costs. We have high uncertainty about the cost estimates that we use. We used estimates from the Global Clubfoot Initiative’s strategic plan.57 We expect there may be substantial variation in cost per child treated and in particular that as more children are treated costs savings may be achieved through economies of scale. We expect to be able to refine our estimates if we investigate a specific giving opportunity.

We expect to learn more about costs, marginal number of children treated, and possibly relapse rates if we investigate a potential funding opportunity.

Is there room for more funding?

We expect that there is relatively limited room for more funding for clubfoot treatment programs (<$20 million annually). The Global Clubfoot Initiative’s 2017 strategic plan estimates that funding needs for clubfoot treatment across low- and middle-income countries peaks at $16 million in 2022 and declines to about $3 million in 2030.58 We have not reviewed the assumptions underlying these estimates. If they assume that low- and middle-income governments will take over substantial costs over time, they might understate room for more funding. In addition, we are unsure whether there are funding gaps in country contexts which might be above GiveWell’s cost-effectiveness threshold to recommend funding.

Key questions for further investigation

Benefits

• What are the appropriate disability weights for untreated unilateral and bilateral clubfoot?
• What is the appropriate estimate for economic benefits of clubfoot treatment?
• What portion of children experience relapse in a programmatic context? Of the children who experience relapse, what portion will receive further treatment? What is the average disability associated with clubfoot with relapse and no treatment?

Costs

• What is the cost per child treated? Should we expect these costs to decline at feasible levels of treatment coverage through economies of scale?
• What is the marginal effect of NGO support on the number of children treated for clubfoot? Would these children have received alternative forms of treatment absent NGO support, or gone untreated?

Funding opportunities and learning

• Where are there funding gaps for clubfoot treatment programs? Is there an opportunity to learn and address our existing uncertainties in contexts with funding gaps?

Our process

• We conducted a shallow literature review. Many of the reports we were able to find (e.g., on treatment coverage rates and costs) are authored by people with affiliations with clubfoot treatment programs.59
• We have not investigated potential funding opportunities. If we did so, we would expect to update our cost-effectiveness analysis to reflect specific opportunities.
  

  Sources

  Document	Source
  American Academy of Orthopaedic Surgeons, "Clubfoot"	Source (archive)
  Banks et al. 2017	Source (archive)
  Bina et al. 2020	Source
  Clinton Health Access Initiative, Preventing lifelong impairment: Access to clubfoot treatment in low- and middle-income countries, 2021	Source (archive)
  Evans, Chowdhury, and Khan 2021	Source (archive)
  Ferreira et al. 2011	Source
  Ganesan et al. 2017	Source (archive)
  GiveWell, Ponseti method CEA, 2022	Source
  Global Clubfoot Initiative, "Achilles Tenotomy"	Source (archive)
  Global Clubfoot Initiative, Ending Clubfoot Disability: A Global Strategy, 2017	Source (archive)
  Grimes et al. 2016	Source (archive)
  Harmer and Rhatigan 2014	Source
  Institute for Health Metrics and Evaluation, "GBD Compare"	Source
  Institute for Health Metrics and Evaluation, Global Burden of Disease Study 2019 Disability Weights	Source (archive)
  Institute for Health Metrics and Evaluation, Global Burden of Disease Study 2019 Disability Weights, Data Release Information Sheet	Source (archive)
  Institute for Health Metrics and Evaluation, Global Burden of Disease Study 2019 Socio-Demographic Index, Data Release Information Sheet	Source (archive)
  Jowett, Morcuende, and Ramachandran 2011	Source
  MiracleFeet, "India"	Source (archive)
  Owen and Kembhavi 2012	Source
  Owen, Capper, and Lavy 2018	Source (archive)
  Penny 2005	Source
  Penny et al. 2021	Source (archive)
  Pigeolet et al. 2022	Source (archive)
  Rastogi and Agarwal 2021	Source
  Selmani 2012	Source
  Smythe et al. 2017	Source
  Staheli, "Clubfoot: Ponseti Management, Third Edition," 2009	Source
  The GiveWell Blog: An update on GiveWell’s funding projections, July 5, 2022	Source
  World Health Organization, "Congenital anomalies"	Source (archive)
  World Health Organization, World Report on Disability, 2011	Source (archive)
  Wright 2018	Source
  Zhao et al. 2014	Source

  • 1
    • "Congenital talipes equinovarus (CTEV), also known as clubfoot, is a common congenital orthopaedic condition characterised by an excessively turned-in foot (equinovarus) and high medial longitudinal arch (cavus)." Bina et al. 2020
    • " . . . bilateral cases (children with two affected feet) . . . " Bina et al. 2020
    • “Clubfoot is an inborn deformity of the foot, where either or both feet are twisted inward, causing the child to walk on his ankles. Left untreated, the condition causes severe lifelong disability.” World Health Organization, "Congenital anomalies"

  • 2
    • "Congenital talipes equinovarus (CTEV), also known as clubfoot, is a common congenital orthopaedic condition characterised by an excessively turned-in foot (equinovarus) and high medial longitudinal arch (cavus)." Bina et al. 2020
    • “Birth prevalence of clubfoot varies between 0.51 and 2.03/1000 live births in LMICs.” Smythe et al. 2017, p. 269.

  • 3

    For example:

    • A 2020 Cochrane review stated: “If left untreated it can result in long-term disability, deformity and pain.” Bina et al. 2020
    • A 2011 WHO report on disability stated: “If left untreated, clubfoot can result in physical deformity, pain in the feet, and impaired mobility, all of which can limit community participation, including access to education.” World Health Organization, World Report on Disability, 2011, p. 99.

  • 4
    • “Untreated CTEV can lead to severe deformity, but with timely and correct management it is curable. CTEV is defined as an inward rotation of the foot, with four components: cavus, forefoot adductus, hind foot varus and equinus. Two of three patients occur in boys and in every other case, the condition affects both feet.The deformity causes patients to walk on the side or back of their feet leading to callus formation, and potential infections in the skin and bone. With severely hampered mobility, these patients are unable to work; thus, this deformity contributes not only to ill health but also to poverty.” Grimes et al. 2016, p. 1.
    • “Qualitative research in Uganda indicated that the neglected clubfoot deformity was indeed a significant disability for village children, preventing access to education and other social activity. The stigma is a very obvious one and children are often considered cursed or unworthy of advancement in education or social status. There is pain and difficulty with locomotion over longer distances. The pain occurs primarily in the skin and subcutaneous tissues on the dorsum of the foot. There is also abnormal pressure distribution across the midtarsal joints and through the malaligned ankle joint causing pain. Recurrent skin breakdown with infections is not uncommon in the skin bearing weight on the dorsal and lateral aspect of the foot. Severe ulceration in adults can lead to amputation. There is an inability to wear footwear, which aggravates all of the previously stated problems.” Penny 2005, pp. 155-56.

  • 5

    “Regardless of the type or severity, clubfoot will not improve without treatment. A child with an untreated clubfoot will walk on the outer edge of the foot instead of the sole, develop painful calluses, be unable to wear shoes, and have lifelong painful feet that often severely limit activity.” American Academy of Orthopaedic Surgeons, "Clubfoot"

  • 6

    For example:

    • "The onset of disability may lead to the worsening of social and economic well-being and poverty through a multitude of channels including the adverse impact on education, employment, earnings, and increased expenditures related to disability (64).
      • Children with disabilities are less likely to attend school, thus experiencing limited opportunities for human capital formation and facing reduced employment opportunities and decreased productivity in adulthood (65–67).
      • People with disabilities are more likely to be unemployed and generally earn less even when employed (67–72). Both employment and income outcomes appear to worsen with the severity of the disability (52, 73). It is harder for people with disabilities to benefit from development and escape from poverty (74) due to discrimination in employment, limited access to transport, and lack of access to resources to promote self-employment and livelihood activities (71).
      • People with disabilities may have extra costs resulting from disability – such as costs associated with medical care or assistive devices, or the need for personal support and assistance – and thus often require more resources to achieve the same outcomes as non-disabled people. This is what Amartya Sen has called “conversion handicap” (75). Because of higher costs, people with disabilities and their households are likely to be poorer than non-disabled people with similar incomes (75–77).
      • Households with a disabled member are more likely to experience material hardship – including food insecurity, poor housing, lack of access to safe water and sanitation, and inadequate access to health care (29, 72, 78–81).” World Health Organization, World Report on Disability, 2011, p. 10.
    • A 2017 systematic review, "with a focus on the situation in low and middle income countries (LMICs)," found associations between physical disability and more general disability and poverty in LMICs:
      • “Eighteen of the included studies evaluated the link between poverty and physical impairment. Fourteen of these studies (78%) found evidence of a positive association. The remaining four studies found no significant difference in poverty level between people with and without a physical impairment.”
      • “This systematic review finds strong evidence to support the link between disability and economic poverty, with 122 of 150 (81%) included studies reporting a statistically significant, positive relationship between these two variables. This large and comprehensive review therefore provides a robust empirical corroboration to the more theoretical arguments of a link between disability and economic poverty.” Banks et al. 2017.

  • 7
    • “The Ponseti casting method has become common practice in high-income countries during the last decade and a half [4]. It has changed the treatment of clubfoot so that complex posterior medial release of multiple tendons and joint capsules, which was once the standard, is now rarely needed. This new treatment involves sequentially stretching the deformed foot and holding the stretches in a series of casts to restore the correct alignment of the foot gradually (Fig. 2) [1]. Following the stretching sequence, a minor surgical procedure, percutaneous tenotomy, is nearly always required but can often be done in an outpatient clinic with local anesthetic [4].” Harmer and Rhatigan 2014, p. 839.
    • “When treatment is started early, how many cast changes are usually required? Most clubfoot deformities can be corrected in approximately 6 weeks by weekly manipulations followed by plaster cast applications. If the deformity is not corrected after six or seven plaster cast changes, the treatment is most likely faulty. . . . What are the usual steps of clubfoot management? Most clubfoot can be corrected by brief manipulation and then casting in maximum correction. After approximately five casting periods, the cavus, adductus and varus are corrected. A percutaneous heel-cord tenotomy is performed in nearly all feet to complete the correction of the equinus, and the foot is placed in the last cast for 3 weeks. This correction is maintained by night splinting using a foot abduction brace, which is continued until approximately 2 to 4 years of age.” Staheli, "Clubfoot: Ponseti Management, Third Edition," 2009, pp. 6-7.
    • “The Achilles tenotomy is an integral part of Ponseti management of clubfoot. Tenotomy is necessary because the Achilles tendon, unlike the ligaments of the foot, is made up of thick, non-stretchable fibres. After the tenotomy the foot is placed in a final cast in an over-corrected position of maximal abduction and dorsiflexion. The tendon re-grows in this lengthened position, allowing the range of motion needed at the ankle joint. Achilles tenotomy is required in around 80-95% of patients and should be performed when complete correction of adduction deformity is achieved but equinus deformity remains.” Global Clubfoot Initiative, "Achilles Tenotomy"

  • 8

    “When should treatment with Ponseti management be undertaken? When possible, start soon after birth (7 to 10 days). However, most clubfoot deformities can be corrected throughout childhood using this management.” Staheli, "Clubfoot: Ponseti Management, Third Edition," 2009, p. 6.
    

  • 9
    • “Global Clubfoot Initiative (GCI) is an umbrella organization for organizations working with children with clubfoot in LMICs. Through advocacy, education and collaboration GCI works towards the goal it shares with its partners: that every child born with clubfoot should receive the treatment they need to live a life free from disability. GCI partners with all of the major organizations providing services for children with clubfoot in LMICs who between them enroll more than 23,000 children for Ponseti treatment each year. Collectively these organizations have a vast wealth of knowledge and experience in setting up and running national clubfoot programs in some of the most challenging environments in Africa, Asia and Latin America. Governing Partners: CBM International; CURE; Feetfirst Worldwide; International Committee of the Red Cross (ICRC); Miraclefeet; Mobility Outreach International; STEPS UK and Walk for Life.” Global Clubfoot Initiative, Ending Clubfoot Disability: A Global Strategy, 2017, p. 28.
    • “Non-governmental organizations (NGOs) collaborate with governments to deliver clubfoot services. Clubfoot treatment programs in most LMICs are implemented by NGOs. Some implementation partners such as the International Committee of the Red Cross (ICRC), CBM International and Hope and Healing International operate in rehabilitation more broadly. Others such as MiracleFeet, Hope Walks, and Walk for Life focus on clubfoot only (see Annex). These NGOs collaborate with ministries of health on the planning of clubfoot treatment programs. They also typically provide technical support, funding, products (including braces), monitoring and evaluation tools, management support and support for awareness raising and training initiatives. Governments on their end allocate clinic space, staff time and, on occasion, supplies and treatment materials.” Clinton Health Access Initiative, Preventing lifelong impairment: Access to clubfoot treatment in low- and middle-income countries, 2021, p. 7.

  • 10

    “Non-governmental organizations (NGOs) collaborate with governments to deliver clubfoot services. Clubfoot treatment programs in most LMICs are implemented by NGOs. Some implementation partners such as the International Committee of the Red Cross (ICRC), CBM International and Hope and Healing International operate in rehabilitation more broadly. Others such as MiracleFeet, Hope Walks, and Walk for Life focus on clubfoot only (see Annex). These NGOs collaborate with ministries of health on the planning of clubfoot treatment programs. They also typically provide technical support, funding, products (including braces), monitoring and evaluation tools, management support and support for awareness raising and training initiatives. Governments on their end allocate clinic space, staff time and, on occasion, supplies and treatment materials.” Clinton Health Access Initiative, Preventing lifelong impairment: Access to clubfoot treatment in low- and middle-income countries, 2021, p. 7.

  • 11

    “Methods: The authors conducted global surveys of clubfoot services every 2 years since 2007 through GCI, a UK-based charity. In 2016, known contacts were accessed through the GCI contacts database. Three categories of LMIC were defined:
    

    1. Countries with Ponseti services and a contact person known to GCI.
    2. Countries with some evidence of Ponseti services (scientific or grey literature) with no contact person known to GCI.
    3. Countries with no known Ponseti services or contact persons and no evidence of Ponseti services.
       For all category B and C countries, a literature search was carried out in order to assess whether there was any evidence for provision of Ponseti services. The inclusion criteria were:
    1. Publication in a peer-reviewed scientific journal documenting Ponseti services.
    2. A website or report from an NGO giving evidence of Ponseti services.

    Exclusion criteria: If there was evidence of training of a limited number (<5) of healthcare workers from a country in the Ponseti technique, but no evidence of service provision, this was not considered to be evidence for Ponseti provision. Countries were categorised as A, B or C based on the GCI contacts database and this literature search.
    In September–November 2016, GCI requested data from programme coordinators or, in the absence of these, individuals known to be providing Ponseti services in all category A countries (55). For category B countries, we attempted to make contact with either the authors of publications identified or other contacts identified through the literature search. A contact was found for, and data requested from, 21 out of 40 category B countries. There were 46 category C countries with no evidence of Ponseti treatment.
    In total, data were requested from 74 countries across categories A and B for the period January–December 2015. Data were self-reported by programme coordinators or individual practitioners using a standardised data collection form (online supplementary file 1).
    [...]

    The contacts database and literature review found that, of 141 countries, there were 55 with a known Ponseti treatment provider (category A), 40 with no Ponseti provider known to GCI but evidence of Ponseti services (category B) and 46 with no known Ponseti provider and no evidence of Ponseti provision (category C). After contacting all category A countries, and category B where a contact was identified, there was a response rate of 74%; clubfoot treatment data were submitted from 55 of the 74 countries contacted for information. Survey respondents were a mixture of representatives of international or country level NGOs supporting clubfoot services, and individual clinicians reporting on a single clinic, regional or country level.
    [...]

    Coverage: A total of 16 982 cases enrolled under the age of 1 year, representing coverage within all LMIC of 11%. Coverage within respondent countries was 14%."

    See "Author information" for Rosalind M Owen and Beth Capper's affiliations with the Global Clubfoot Initiative. Owen, Capper, and Lavy 2018.
    

  • 12

    "Treatment can be non-surgical, surgical or both. Non-surgical treatment (for example, casting or stretches) gently stretches the foot into a normal position. Surgery may involve the muscles, tendons, ligaments or joints. Kite and Ponseti techniques both involve prolonged joint manipulation and serial casting to correct foot alignment. The Ponseti technique involves manipulation (of the ankle joint) and usually Achilles tendon surgery, while Kite is a technique involving manipulation of the foot." Bina et al. 2020.

  • 13
    • "The Ponseti method is now considered to be the gold standard of treatment in the USA, and its use has spread widely throughout high-income countries (HICs),2–4 largely replacing previously used surgical and conservative techniques. It is also more cost-effective, less invasive and has lower risks of complications than surgical treatments.5 As such, it is an ideal solution for low-resource settings." Owen, Capper, and Lavy 2018.
    • “Multiple treatment protocols have been studied and the Ponseti method is now considered the gold standard treatment that is followed from birth to 4-5 years of age. The Ponseti method is minimally invasive and combines serial casting, orthotic treatment (bracing) and a minor surgical procedure (percutaneous tenotomy) to lengthen the Achilles tendon (see Figure 2).” Clinton Health Access Initiative, Preventing lifelong impairment: Access to clubfoot treatment in low- and middle-income countries, 2021, p. 3.
    • "Clubfoot is one of the most common nontraumatic disorders in pediatric orthopaedics. The treatment of clubfoot has undergone several paradigm shifts over the past 60 years. Historically, different nonoperative regimens were largely the mainstay of the initial treatment for clubfeet. The techniques were described eponymically and often involved long periods, even years, of cast immobilization. After treatment, the feet were often stiff with high rates of incomplete correction. The treatment then shifted from nonoperative to extensive surgical release. Extensive surgery achieved a plantigrade foot immediately but later follow-up revealed stiff, sometimes painful feet. While practiced in Iowa for many decades, the Ponseti treatment protocol has subsequently become the standard of treatment for clubfoot worldwide. The Ponseti protocol has completely changed the treatment of clubfeet with results so obviously superior to extensive surgical release that a randomized controlled trial would not be appropriate." Wright 2018.

  • 14

    A 2012 review article notes “The current state of services for clubfoot intervention in most LMIC is not well documented. However, it has been reported that in some countries, the predominant treatment option being offered is the Kite method, as in parts of Brazil [9] and India [10]. In others, such as Malawi, before the introduction of a national programme, there were almost no services for clubfoot and no unified, nationwide approach to clubfoot management [5]. In recent years, a number of articles have acknowledged the lack of services for clubfoot as a serious public health issue, resulting in high levels of impairment, which may be preventable [1,5,11].” Owen and Kembhavi 2012, p. 59.

  • 15

    While we have not found extensive documentation of the costs of alternative forms of treatment, our shallow literature review suggests that the Ponseti method is well-suited for low-resource settings and we believe it is unlikely that alternative treatments would require significantly less resources (since they appear to include alternative forms of casting interventions).
    On the Ponseti method:

    • The Ponseti method is "more cost-effective, less invasive and has lower risks of complications than surgical treatments.5 As such, it is an ideal solution for low-resource settings." Owen, Capper, and Lavy 2018.
    • "The Ponseti method is cost efficient and has been shown to be effective when done correctly in up to 98% of cases (8). Given the relatively simple process the treatment is well suited to low resource settings." Global Clubfoot Initiative, Ending Clubfoot Disability: A Global Strategy, 2017, p. 5.

    On alternative treatments:

    • A 2012 review article notes “The current state of services for clubfoot intervention in most LMIC is not well documented. However, it has been reported that in some countries, the predominant treatment option being offered is the Kite method, as in parts of Brazil [9] and India [10]. In others, such as Malawi, before the introduction of a national programme, there were almost no services for clubfoot and no unified, nationwide approach to clubfoot management [5]." Owen and Kembhavi 2012, p. 59.
    • "Treatment can be non-surgical, surgical or both. Non-surgical treatment (for example, casting or stretches) gently stretches the foot into a normal position. Surgery may involve the muscles, tendons, ligaments or joints. Kite and Ponseti techniques both involve prolonged joint manipulation and serial casting to correct foot alignment. The Ponseti technique involves manipulation (of the ankle joint) and usually Achilles tendon surgery, while Kite is a technique involving manipulation of the foot." Bina et al. 2020.
    • One comparison of Ponseti and Kite treatment costs found lower costs with Ponseti than Kite treatment. Note though that we have not completed a thorough literature review on this question and are unsure if these results are generalizable. “Treatment costs using the Kite protocol totaled R$947.56 for one clubfoot and R$1895.52 for bilateral clubfeet. Treatment costs using the Ponseti protocol totaled R$340.34 for the treatment of one foot, and R$510.68 for treatment of bilateral clubfeet. Costs were about 2.5 times lower in the Ponseti protocol than with the Kite protocol. The duration of treatment to complete correction was, on average, 225.8 days with the Kite protocol and an average of 55.6 days with the Ponseti protocol.” Ferreira et al. 2011.

  • 16
    • “We present a systematic review of the results of the Ponseti method of management for congenital talipes equinovarus (CTEV). . . . Our results showed that the Ponseti method provides excellent results with an initial correction rate of around 90% in idiopathic feet.” Jowett, Morcuende, and Ramachandran 2011.
    • “We found the details of manipulation, casting, or percutaneous Achilles tenotomy were poorly described in 11 studies [7, 17, 18, 20, 21, 23, 26, 35, 44, 50, 52], and three studies did not adhere to the basic principles of the Ponseti method [20, 36, 50]. Some authors reported high initial correction rates using this method [17–19, 21, 26, 34]. Ponseti and Smoley reported the results of treatment for 67 patients (94 clubfeet), in which the abnormal relationship between the talus and calcaneus had not been completely corrected in only five cases after initial treatment [39]. Subsequent studies had 92% to 100% initial correction rates in patients who were younger than 2 years [1, 2, 6, 8, 19, 24, 25, 29, 34]. Patients between 1 and 3 years old who were treated with the Ponseti method had an initial success rate of nearly 90% according to Verma et al. [52]. For patients with a nonidiopathic clubfoot, the Ponseti method is also effective [16]. The initial correction rates were greater than 94% when clubfeet associated with myelomeningocele or arthrogryposis were treated with the Ponseti method [4, 14, 28].” Zhao et al. 2014.
    • "The 14 studies included in the review had 774 patients/1122 clubfeet (Table 2). Based on available data from 692 patients, the male and female proportions were 70.7% and 29.3%, respectively. Mean age at treatment was 7.1±7.8 weeks (based on data for 460 patients). The mean follow-up was 14.5±9.4 years (Table 2). Initial correction was achieved in 661/686 feet (96.4%) [1–3, 5, 9, 11, 14]." Rastogi and Agarwal 2021, p. 2602.
    • "In this review, we assessed the number of castings used in the studies, and all of the selected 12 studies reported the number of casts used to achieve the full correction of clubfoot (35–46). Five studies [50, 55–57, 59] used Kite method techniques to compare with the Ponseti method in the correction of clubfoot. These studies reported that Ponseti method achieved the initial correction in shorter time and used fewer casts than the Kite method. The percentages of Ponseti method’s correction success rate was 96% (follow-up time- 36.2 months) and the Kite’s method full correction success rate was 74.3% at the time of an average of 35.1 months [59]; Another study by Sud et al.2008, achieved 91.7% in Ponseti method (Average of 27.24 follow-up) and Kite method 67.7% at time of 24.8 months follow-up [50]." Ganesan et al. 2017.

  • 17

    "Fourteen trials evaluated initial presentations of CTEV. One trial found low-certainty evidence that the Ponseti technique may produce better foot alignment at the end of serial casting compared to the Kite technique. Adverse events were not reported (summary of findings Table 1). Following relapse, the risk difference for major surgery in the Kite group was 25% and 50% higher in two trials compared to Ponseti. The certainty of the evidence is too low to draw conclusions about foot alignment after Ponseti casting compared to a traditional treatment (summary of findings Table 1). This trial had small numbers, as a formal stopping rule was activated after the Kite technique was seen to lead to higher rates of major surgery than the Ponseti technique. One trial examined modification of the Ponseti technique through the use of different plaster-casting products (semi-rigid fibreglass casting versus plaster of Paris) and did not find any difference between the two treatment groups, based on low-certainty evidence (summary of findings Table 1). We could draw no conclusions for other interventions, i.e. surgery, and the addition of botulinum toxin A to the Ponseti technique. The reporting of adverse events was limited in all trials. In those involving serial casting (plaster casting) adverse events included pressure areas, cast slippage and skin irritations." Bina et al. 2020.

  • 18

    "We identified 21 trials with 905 participants; seven trials were newly included for this update. Fourteen trials assessed initial cases of CTEV (560 participants), four trials assessed resistant cases (181 participants) and three trials assessed cases of unknown timing (153 participants)." Bina et al. 2020.

  • 19

    See "Table 1. Characteristics of included trials," Bina et al. 2020.

  • 20
    • “‘Correction’ of deformity, clinically assessed ‘plantigrade’ position, Pirani [48] and Dimeglio [49] scores, all measure essentially the same thing: the extent of correction of the foot deformity. The first two are more subjective and may be unreliable [8], whereas the last two are more objective, with the Pirani score reported to have good intrarater and inter-rater reliability and validity. Even so, Pirani [48] and Dimeglio [49] scores are suitable for measuring the extent of deformity but not necessarily the outcomes of treatment. These four measures are the most popular way of measuring the outcomes of conservative and Ponseti interventions. Almost all are assessed after the initial corrective phase of the treatment consisting of manipulation, casting or stretching and tenotomy in the Ponseti technique and therefore do not reflect the outcome of the complete course of the treatment.” Owen and Kembhavi 2012, p. 64.
    • "Foot alignment: All trials but one (Chong 2014) assessed foot alignment. Sixteen trials used validated outcome measures (Chen 2015; El-Deeb 2007; Elgohary 2014; Gintautiene 2016; Harnett 2011; Hui 2014; Lahoti 2008; Manzone 1999; Maripuri 2013; Pittner 2008; Rijal 2010; Sanghvi 2009; Selmani 2012; Svehlik 2017; Zeifang 2005; Zwick 2009). As CTEV deformity occurs in several planes of movement (Ponseti 2005), assessment of foot alignment using valid scales is essential to report on all aspects of the deformity. Poor foot alignment correlates with the requirement for further intervention." Bina et al. 2020.

  • 21

    "Function and quality of life: Function was an outcome in seven trials (El-Deeb 2007; Kaewpornsawan 2007; Manzone 1999; Sanghvi 2009; Sud 2008; Svehlik 2017; Zwick 2009), with two using a validated scale (Svehlik 2017; Zwick 2009). However, these trials combined bilateral and unilateral cases and raw data were not available to appropriately re-analyse. Valid assessment of function is required as part of CTEV assessment because routine objective measures for CTEV (for example, x-ray) do not reliably correlate with function (Farsetti 2006; Fridman 2007)." Bina et al. 2020.

  • 22

    "Relapse of the deformity during the bracing period, after full resolution of the deformity was achieved during the casting phase, is a common complication of the Ponseti treatment." Pigeolet et al. 2022.

  • 23

    “Many factors define relapse, making it difficult to report. In CTEV, a relapse can include multiple deformities, for example, equinus (tightness of the heel), adductus (in-turning of the foot) or cavus (high arch). Two main types of relapse are recognised: passive and dynamic (or residual). Passive relapse refers to a loss in range of movement, whereas dynamic refers to a positional relapse where passive range is still present. Dynamic relapse, if left untreated, can lead to a passive relapse (Ponseti 2005). Treatment options depend on the type of relapse (Farsetti 2006; Haft 2007; Nogueira 2009; Ponseti 2005). Treatment to correct relapse can therefore be an indication of the severity of the deformity." Bina et al. 2020.

  • 24

    “The following systematic review aimed to provide a comprehensive overview of the published articles on long-term outcomes of the Ponseti method. . . . Fourteen studies with 774 patients/1122 feet were included. The male:female ratio was 2.4:1. Mean follow-up recorded in studies was 14.5 years. Relapses occurred in 47% patients with additional surgery being required in 79% patients with relapses. Of these, 86% of surgery were extra-articular while 14% were intra-articular. Plantigrade foot was achieved in majority patients with mean ankle dorsifexion of 11 degrees. The outcome scores were in general good in contrast to radiological angles which were mostly outside normal range with talar fattening/navicular wedging/degenerative osteoarthritis changes occurring in 60%, 76%, and 30%, respectively.” Rastogi and Agarwal 2021, p. 2599.

  • 25

    "Non-adherence to the prescribed treatment protocol, including not wearing the brace as often as prescribed, leads to a 5−183-times increased risk of relapse of the deformity." Pigeolet et al. 2022.

  • 26

    "The numbers of children accessing Ponseti treatment for clubfoot in LMIC has risen steadily since 2005. However, coverage remains low, and we estimate that less than 15% of children born with clubfoot in LMIC start treatment..” Owen, Capper, and Lavy 2018.

  • 27

    “When should treatment with Ponseti management be undertaken? When possible, start soon after birth (7 to 10 days). However, most clubfoot deformities can be corrected throughout childhood using this management.” Staheli, "Clubfoot: Ponseti Management, Third Edition," 2009, p. 6.

  • 28
    • “With advancing age, there is increased stiffness of the soft tissue structures and decreased remodeling potential of the bones of the foot. Not all clubfeet in older children are rigid—some are flexible and amenable to stretching and conservative treatment. Hence, the initial evaluation of the deformity must include an assessment of correctability. The treatment of clubfoot in the older child is challenging and was traditionally performed using complex soft tissue and bony surgeries, often with poor outcomes in the long term. Recent literature has focused on the role of conservative treatment utilizing Ponseti principles of serial manipulation and casting, combined with limited surgery.” Penny et al. 2021.
    • “We also tabulated what authors noted as weaknesses or barriers to success. Eight studies reported late presentation or older age at the beginning of treatment as a major contributor to failure [9, 18, 20–24].” Harmer and Rhatigan 2014, p. 843.

  • 29
    • "Non-adherence to the prescribed treatment protocol, including not wearing the brace as often as prescribed, leads to a 5−183-times increased risk of relapse of the deformity." Pigeolet et al. 2022.
    • “Background: The Ponseti treatment is considered the gold standard for clubfoot globally, but requires strong engagement from parents. The aim of this review is to assess the impact of socio-economic factors on the presence of dropout, relapse or non-compliance during Ponseti treatment in low and middle-income countries (LMICs). Methods: This scoping review includes all articles available from inception until 4.4.2022. All articles describing an association between one or more socio-economic factors and one or more adverse outcomes during the Ponseti treatment in an LMICs were considered for inclusion. Studies were identified by searching Medline/PubMed, Embase, Global Health and Global Index Medicus. Data extraction was done using Covidence extraction 2.0 by two independent reviewers. Findings: A total of 281 unique references were retrieved from the database searches, 59 abstracts were retained for full-text review, of which 19 studies were included in the final review. We grouped the identified socio-economic factors into 4 larger themes: poverty and physical accessibility of clubfoot clinics, presence of support systems, educational level of the parents, and household-level factors and cultural norms. Reduced access to care for girls was considered an important risk factor in South Asia and the Caribbean. Lack of family and community support was an issue raised more often in studies from Eastern Africa. The extreme heterogeneity among collected variables within a small sample of papers made it not possible to perform a metaanalysis. Interpretation: The identified factors are very similar to the socio-economic factors identified in studies looking at the barriers parents and children face when seeking care initially. Poverty was identified as a cross-cutting risk factor in all 4 domains and the most important socio-economic risk factor based on this review, reconfirming poverty eradication as the challenge for the 21st century.” Pigeolet et al. 2022.
    • “When treatment was discontinued for six months, 309 families were audited. A social profile of families was developed, showing that most lived in tin houses with one working family member, indicating low affluence. Family issues, brace difficulty, travel distances, and insufficient understanding of ongoing bracing and follow-up were the main reasons for discontinuing treatment. Overt deformity relapse was found in 9% of children, while half of the children recommenced brace use after review.” Evans, Chowdhury, and Khan 2021.

  • 30

    We are aware of one instance in which a clubfoot treatment NGO (MiracleFeet) stopped serving a country (India) and highlighted government provision of treatment after it stopped providing support:

    “As of 2021, MiracleFeet is no longer serving India. During our time there, we were able to help over 17,000 children enroll in treatment. MiracleFeet has a long history of strengthening access to high-quality clubfoot treatment in India, providing strategic and financial support to local partners for ten years from 2011 through 2021. Through these partnerships, we have helped over 17,000 children enroll in treatment in India. While we are no longer actively funding any partners or programs in India, we remain very interested in this work and are open to supporting local clubfoot initiatives in India, especially in the form of providing affordable braces, training in the Ponseti method, and other technical assistance.

    MiracleFeet started working in India in FY 2011–12 through a partnership with Cure India, an Indian-based affiliate of Cure Clubfoot Worldwide (now HopeWalks), fully funding Cure India’s programs in Maharashtra, Rajasthan, Uttar Pradesh, Uttarakhand, Madhya Pradesh, Odisha, and the Northeast India. The programs we supported represented approximately half of Cure India’s clubfoot enrollments at the time, and Cure India was able to enroll over 12,300 new children in treatment from 2011–2017, as a result of MiracleFeet’s support.

    During that time, MiracleFeet incubated the MiracleFeet Foundation for Eliminating Clubfoot as a stand-alone non-profit to enable Indian donors to support the work there. Once this entity was fully approved and registered with the Indian government (with its FCRA approval received in 2018), MiracleFeet began supporting treatment of clubfoot in India through this Indian-based affiliate organization. This included programs in Uttar Pradesh, Maharashtra, Madhya Pradesh, Himachel Pradesh, Haryana, and in Northeast India. MiracleFeet Foundation for Eliminating Clubfoot enrolled over 4,800 children from 2018-2021.

    MiracleFeet is pleased that the government of India, through its National Health Mission and Ministry of Health and Family Welfare, is committed to ending clubfoot disability in the country. India has a strong network of orthopedic surgeons; they are supported by the Accredited Social and Health Activist (ASHA) and Rashtriya Bal Swasthya Karyakram (RBSK) programs, which aid in early identification, referral and follow-up with children born with clubfoot across the country.” MiracleFeet, "India"
    

  • 31

    “Most trials did not report on adverse events. Two trials found that further serial casting was more likely to correct relapse after Ponseti treatment than after the Kite technique, which more often required major surgery (risk differences 25% and 50%). In trials evaluating serial casting techniques, adverse events included cast slippage (needing replacement), plaster sores (pressure areas), and skin irritation. Adverse events following surgical procedures included infection and the need for skin grafting.” Bina et al. 2020.
    

  • 32
    • We often use GiveDirectly's unconditional cash transfers as a benchmark for comparing the cost-effectiveness of different programs. When discussing cost-effectiveness, we generally refer to the cost-effectiveness of a program in multiples of "cash." Thus, if a program is estimated to be "10x cash," this means it is estimated to be ten times as cost-effective as unconditional cash transfers.
    • “Based on our current pipeline of spending opportunities and our projection of funds raised, we will likely increase our cost-effectiveness bar to 10x cash (up from 6x). At the end of the year, if we end up raising more funding than we expect, we’ll either roll over funding (which we’ll do if we expect that we’ll soon find additional opportunities that are greater than 10x cash) or allocate these funds to opportunities we’ve already identified that are less than 10x cash.” The GiveWell Blog: An update on GiveWell’s funding projections, July 5, 2022.
    • Our cost-effectiveness analysis estimates that this program will be about 7 times as cost-effective as GiveDirectly.

  • 33

    The Global Clubfoot Initiative estimated the cost of treatment per child in Africa to be $443 in 2017, based on 2016 budget data. Global Clubfoot Initiative, Ending Clubfoot Disability: A Global Strategy, 2017, p. 32.
    

  • 34

    A 2021 systematic review of long-term outcomes of Ponseti treatment found a relapse rate of 47%: “Fourteen studies with 774 patients/1122 feet were included. The male:female ratio was 2.4:1. Mean follow-up recorded in studies was 14.5 years. Relapses occurred in 47% patients with additional surgery being required in 79% patients with relapses." Rastogi and Agarwal 2021, p. 2599.

  • 35

    "Disability weights, which represent the magnitude of health loss associated with specific health outcomes, are used to calculate years lived with disability (YLD) for these outcomes in a given population. The weights are measured on a scale from 0 to 1, where 0 equals a state of full health and 1 equals death. This table provides disability weights for the 440 health states (including combined health states) used to estimate nonfatal health outcomes for the GBD 2019 study." Institute for Health Metrics and Evaluation, Global Burden of Disease Study 2019 Disability Weights, Data Release Information Sheet, p. 1.

  • 36

    See Institute for Health Metrics and Evaluation, Global Burden of Disease Study 2019 Disability Weights.

  • 37

    Institute for Health Metrics and Evaluation, Global Burden of Disease Study 2019 Disability Weights.

  • 38

    Institute for Health Metrics and Evaluation, Global Burden of Disease Study 2019 Disability Weights.

  • 39

    We assign a disability weight of 0.178 for unilateral clubfoot. The disability weight for severe osteoarthritis of the hip is 0.165.
    0.178 - 0.165 / 0.178 = ~0.073.
    See the "Unilateral disability weight" and "Intuition check" rows of our cost-effectiveness analysis here.

  • 40

    “Qualitative research in Uganda indicated that the neglected clubfoot deformity was indeed a significant disability for village children, preventing access to education and other social activity. The stigma is a very obvious one and children are often considered cursed or unworthy of advancement in education or social status.” Penny 2005, p. 155.
    

  • 41
    • See 2019 life expectancy for low SDI countries (65.57 years), Institute for Health Metrics and Evaluation, "GBD Compare"
    • "Developed by GBD researchers and used to help produce these estimates, the Socio-demographic Index (SDI) is a composite indicator of development status strongly correlated with health outcomes. It is the geometric mean of 0 to 1 indices of total fertility rate under the age of 25 (TFU25), mean education for those ages 15 and older (EDU15+), and lag distributed income (LDI) per capita. As a composite, a location with an SDI of 0 would have a theoretical minimum level of development relevant to health, while a location with an SDI of 1 would have a theoretical maximum level." Institute for Health Metrics and Evaluation, Global Burden of Disease Study 2019 Socio-Demographic Index, Data Release Information Sheet, p. 1.

  • 42

    See our cost-effectiveness analysis here.

  • 43

    For example:

    • “Our results showed that the Ponseti method provides excellent results with an initial correction rate of around 90% in idiopathic feet.” Jowett, Morcuende, and Ramachandran 2011.
    • “We found the details of manipulation, casting, or percutaneous Achilles tenotomy were poorly described in 11 studies [7, 17, 18, 20, 21, 23, 26, 35, 44, 50, 52], and three studies did not adhere to the basic principles of the Ponseti method [20, 36, 50]. Some authors reported high initial correction rates using this method [17–19, 21, 26, 34]. Ponseti and Smoley reported the results of treatment for 67 patients (94 clubfeet), in which the abnormal relationship between the talus and calcaneus had not been completely corrected in only five cases after initial treatment [39]. Subsequent studies had 92% to 100% initial correction rates in patients who were younger than 2 years [1, 2, 6, 8, 19, 24, 25, 29, 34]. Patients between 1 and 3 years old who were treated with the Ponseti method had an initial success rate of nearly 90% according to Verma et al. [52]. For patients with a nonidiopathic clubfoot, the Ponseti method is also effective [16]. The initial correction rates were greater than 94% when clubfeet associated with myelomeningocele or arthrogryposis were treated with the Ponseti method [4, 14, 28].” Zhao et al. 2014.
    • "In this review, we assessed the number of castings used in the studies, and all of the selected 12 studies reported the number of casts used to achieve the full correction of clubfoot (35–46). Five studies [50, 55–57, 59] used Kite method techniques to compare with the Ponseti method in the correction of clubfoot. These studies reported that Ponseti method achieved the initial correction in shorter time and used fewer casts than the Kite method. The percentages of Ponseti method’s correction success rate was 96% (follow-up time- 36.2 months) and the Kite’s method full correction success rate was 74.3% at the time of an average of 35.1 months [59]; Another study by Sud et al.2008, achieved 91.7% in Ponseti method (Average of 27.24 follow-up) and Kite method 67.7% at time of 24.8 months follow-up [50]." Ganesan et al. 2017.
    • "The 14 studies included in the review had 774 patients/1122 clubfeet (Table 2). Based on available data from 692 patients, the male and female proportions were 70.7% and 29.3%, respectively. Mean age at treatment was 7.1±7.8 weeks (based on data for 460 patients). The mean follow-up was 14.5±9.4 years (Table 2). Initial correction was achieved in 661/686 feet (96.4%) [1–3, 5, 9, 11, 14]." Rastogi and Agarwal 2021, p. 2602.

  • 44

    See here.

  • 45

    “Fourteen studies with 774 patients/1122 feet were included. The male:female ratio was 2.4:1. Mean follow-up recorded in studies was 14.5 years. Relapses occurred in 47% patients with additional surgery being required in 79% patients with relapses. Of these, 86% of surgery were extra-articular while 14% were intra-articular. Plantigrade foot was achieved in majority patients with mean ankle dorsifexion of 11 degrees. The outcome scores were in general good in contrast to radiological angles which were mostly outside normal range with talar fattening/navicular wedging/degenerative osteoarthritis changes occurring in 60%, 76%, and 30%, respectively.” Rastogi and Agarwal 2021, p. 2599.

  • 46

    See our cost-effectiveness analysis here.
    

  • 47

    See the "Income effects from treatment" section of our cost-effectiveness analysis here.

  • 48

    GCI's estimate of the cost per child treated in Africa was $443 based on 2016 budget data. We adjust this estimate to 2022 prices to account for inflation. Global Clubfoot Initiative, Ending Clubfoot Disability: A Global Strategy, 2017, p. 32; See our inflation adjustment calculation here.

  • 49

    See here.

  • 50

    See here.

  • 51

    “Non-governmental organizations (NGOs) collaborate with governments to deliver clubfoot services. Clubfoot treatment programs in most LMICs are implemented by NGOs. Some implementation partners such as the International Committee of the Red Cross (ICRC), CBM International and Hope and Healing International operate in rehabilitation more broadly. Others such as MiracleFeet, Hope Walks, and Walk for Life focus on clubfoot only (see Annex). These NGOs collaborate with ministries of health on the planning of clubfoot treatment programs. They also typically provide technical support, funding, products (including braces), monitoring and evaluation tools, management support and support for awareness raising and training initiatives. Governments on their end allocate clinic space, staff time and, on occasion, supplies and treatment materials.” Clinton Health Access Initiative, Preventing lifelong impairment: Access to clubfoot treatment in low- and middle-income countries, 2021, p. 7.
    

  • 52

    NGO costs per child treated ($543) + government costs per child treated ($109) = $652. See here.

  • 53

    See the "Counterfactual burden of disability" section of our cost-effectiveness analysis here.

  • 54

    "Since the Global Burden of Disease study has yet to define a specific disability weight for CTEV, we used a disability weight of 0.231 for unilateral CTEV. This is the same as for untreated cleft palate,29 and has been used previously as a surrogate for CTEV.30 In the case of bilateral CTEV, however, we used the disability weight assigned to disability due to poliomyelitis as a surrogate, 0.369.29" Grimes et al. 2016, p. 2.

  • 55
    • “Many factors define relapse, making it difficult to report. In CTEV, a relapse can include multiple deformities, for example, equinus (tightness of the heel), adductus (in-turning of the foot) or cavus (high arch). Two main types of relapse are recognised: passive and dynamic (or residual). Passive relapse refers to a loss in range of movement, whereas dynamic refers to a positional relapse where passive range is still present. Dynamic relapse, if left untreated, can lead to a passive relapse (Ponseti 2005). Treatment options depend on the type of relapse (Farsetti 2006; Haft 2007; Nogueira 2009; Ponseti 2005). Treatment to correct relapse can therefore be an indication of the severity of the deformity." Bina et al. 2020.
    • "Fourteen studies with 774 patients/1122 feet were included. The male:female ratio was 2.4:1. Mean follow-up recorded in studies was 14.5 years. Relapses occurred in 47% patients with additional surgery being required in 79% patients with relapses. Of these, 86% of surgery were extra-articular while 14% were intra-articular. Plantigrade foot was achieved in majority patients with mean ankle dorsifexion of 11 degrees. The outcome scores were in general good in contrast to radiological angles which were mostly outside normal range with talar fattening/navicular wedging/degenerative osteoarthritis changes occurring in 60%, 76%, and 30%, respectively.” Rastogi and Agarwal 2021, p. 2599.
    • "Non-adherence to the prescribed treatment protocol, including not wearing the brace as often as prescribed, leads to a 5−183-times increased risk of relapse of the deformity." Pigeolet et al. 2022.

  • 56

    See here.

  • 57

    GCI's estimate of the cost per child treated in Africa was $443 based on 2016 budget data. We adjust this estimate to 2022 prices to account for inflation. Global Clubfoot Initiative, Ending Clubfoot Disability: A Global Strategy, 2017, p. 32; See our inflation adjustment calculation here.

  • 58

    "The cost per child will steadily decrease over time from an average of $317 in 2017 to $82/child in 2030 as costs decline as many elements of the program become integrated into the public health system. For example, training costs decline as Ponseti training is delivered by medical and physical therapy programs, identification and referral systems become embedded in government-run birth defect screening and newborn and maternal health programs, and the government ensures basic casting supplies are readily available. Funding reaches its peak in 2022 with annual needs of approximately $16M from outside sources. It declines to $3M/year by 2030." Global Clubfoot Initiative, Ending Clubfoot Disability: A Global Strategy, 2017, p. 22.

  • 59
    • For example, we rely on the Owen, Capper, and Lavy 2018 study for Ponseti treatment coverage rates, which was authored by employees of the Global Clubfoot Initiative. See "Author information" for Rosalind M Owen and Beth Capper's affiliations with the Global Clubfoot Initiative.
    • Our estimates of the costs of clubfoot treatment are based on GCI's 2017 strategic plan: Global Clubfoot Initiative, Ending Clubfoot Disability: A Global Strategy, 2017.