ABSTRACT
Aims: The gold standard for percutaneous Achilles tendon tenotomy during the Ponseti treatment for idiopathic clubfoot is a tenotomy with a No. 15 blade. This trial aims to establish the technique where the tenotomy is performed with a large-bore needle as noninferior to the gold standard. Methods: We randomized feet from children aged below 36 months with idiopathic clubfoot on a 1:1 basis in either the blade or needle group. Follow-up was conducted at three weeks and three months postoperatively, where dorsiflexion range, Pirani scores, and complications were recorded. The noninferiority margin was set at 4° difference in dorsiflexion range at three months postoperatively. Results: The blade group had more dorsiflexion at both follow-up consultations: 18.36° versus 18.03° (p = 0.115) at three weeks and 18.96° versus 18.26° (p = 0.001) at three months. The difference of the mean at three months 0.7° is well below the noninferiority margin of 4°. There was no significant difference in Pirani scores. The blade group had more extensive scar marks at three months than the needle group (8 vs 2). No major complications were recorded. Conclusion: The needle tenotomy is noninferior to the blade tenotomy for usage in Ponseti treatment for idiopathic clubfoot in children aged below 36 months.
Subject(s)
Achilles Tendon , Clubfoot , Needles , Tenotomy , Humans , Achilles Tendon/surgery , Clubfoot/surgery , Clubfoot/therapy , Tenotomy/methods , Tenotomy/instrumentation , Female , Male , Infant , Child, Preschool , Treatment Outcome , Range of Motion, Articular , Follow-Up StudiesABSTRACT
BACKGROUND: Achilles tendon tenotomy is an integral part of the Ponseti method, aimed at correcting residual equinus and lack of dorsiflexion after correction of the adductus deformity in clubfoot. Percutaneous tenotomy using a number 15 scalpel blade is considered the gold standard, resulting in excellent results with minimal complications. The use of a large-bore needle to perform Achilles tendon tenotomies has been described in literature, but a large-scale randomized controlled trial is currently lacking. In this trial, we aim to show the non-inferiority of the needle tenotomy technique compared to the gold standard blade tenotomy technique. METHODS: We will randomize 244 feet into group A: needle tenotomy or group B: blade tenotomy. Randomization will be done using a block randomization with random block sizes and applying a 1:1 allocation to achieve an intervention and control group of the exact same size. Children will be evaluated at 3 weeks and 3 months post-tenotomy for primary and secondary clinical outcomes. The primary clinical outcome will be the range of dorsiflexion obtained the secondary clinical outcomes will be frequency of minor and major complications and Pirani score. The non-inferiority margin was set at 4°, and thus, the null hypothesis of inferiority of the needle technique will be rejected if the mean difference between both techniques is less than 4°. The statistical analysis will use a multi-level mixed effects linear regression model for the primary outcomes and a multi-level mixed effects logistic regression model for the secondary clinical outcomes. The physician performing the evaluations post-tenotomy will be the only one blinded to group allocation. TRIAL REGISTRATION: This trial was registered prospectively with ClinicalTrials.gov registration number: NCT04897100 on 21 May 2021.
Subject(s)
Achilles Tendon , Clubfoot , Child , Humans , Infant , Tenotomy/adverse effects , Tenotomy/methods , Clubfoot/diagnosis , Clubfoot/surgery , Achilles Tendon/surgery , Casts, Surgical , Foot , Treatment Outcome , Randomized Controlled Trials as TopicABSTRACT
Pakistan is a lower middle-income country in South Asia with a population of 225 million. No estimate for surgical care access exists for the country. We postulate the estimated access to surgical care is less than the minimum 80% to be achieved by 2030. We conducted a randomized, stratified two-stage cluster household survey. A sample of 770 households was selected using 2017 census frames from the Pakistan Bureau of Statistics. Data was collected on choice of hospital and travel time to the chosen hospital for C-section, laparotomy, open fracture repair (OFR), and specialized surgery. Analysis was conducted using Stata 14. Access to all Bellwether surgeries (C-section, laparotomy, and open fracture repair) in Pakistan is estimated to be 74.8%. However, estimated access in rural areas and the provinces of Balochistan, Khyber Pakhtunkhwa (KP) and Sindh is far less than in urban areas and in Punjab and Islamabad. Estimated access to C-sections is more compared to OFR, laparotomy, and specialized surgery. Health system strengthening efforts should focus on improving surgical care access in rural areas and in Balochistan, KP, and Sindh. More focus is required on standardizing the availability and quality of surgical services in secondary-level hospitals.
ABSTRACT
Health metrics have evolved with increasing sophistication. The disability-adjusted life-year (DALY) has emerged as a widely used metric. While DALYs vary between countries, the global disability weights (DWs) that are integral to the DALY ignore the potential impact of local factors on the burden of disease. Developmental dysplasia of the hip (DDH), a spectrum of hip pathologies, typically develops during early childhood and is a leading cause of early hip osteoarthritis. This paper explores the variability in the DW for DDH in relation to to local health environments using select health system indicators.The DW for DDH increases with decreasing income level of countries. The Human Development Index and the Gross Domestic Product per capita are both negatively correlated with (p<0.05) the DW for DDH per country. For the indicators surgical workforce, surgical procedures and hospital beds per 1000 population, there is a significant negative correlation in countries not meeting the minimum standard of that indicator (p<0.05), while for countries meeting that minimum standard, the correlation between DW for DDH and the respective indicator is not significantly different from zero.Consideration should be given to re-establishing the DWs for health entities in countries that do not meet the minimum standards of a functional health system. This would more accurately reflect the burden of disease from a functional perspective in LMICs, and perhaps allow for more informed priority setting within LMICs and for donors. The establishment of these DWs should not start from scratch; our data suggest that the variability in DWs due to context can most likely be modelled using health system and financial protection indicators already in use today.
Subject(s)
Disability-Adjusted Life Years , Musculoskeletal Diseases , Child, Preschool , Humans , Musculoskeletal Diseases/epidemiology , Developing Countries , Gross Domestic ProductABSTRACT
Clubfoot is a congenital anomaly affecting 1/1,000 live births. Ponseti casting is an effective and affordable treatment. About 75% of affected children have access to Ponseti treatment in Bangladesh, but 20% are at risk of drop-out. We aimed to identify the areas in Bangladesh where patients are at high or low risk for drop-out. This study used a cross-sectional design based on publicly available data. The nationwide clubfoot program: 'Walk for Life' identified five risk factors for drop-out from the Ponseti treatment, specific to the Bangladeshi setting: household poverty, household size, population working in agriculture, educational attainment and travel time to the clinic. We explored the spatial distribution and clustering of these five risk factors. The spatial distribution of children <5 years with clubfoot and the population density differ widely across the different sub-districts of Bangladesh. Analysis of risk factor distribution and cluster analysis showed areas at high risk for dropout in the Northeast and the Southwest, with poverty, educational attainment and working in agriculture as the most prevalent driving risk factor. Across the entire country, twenty-one multivariate high-risk clusters were identified. As the risk factors for drop-out from clubfoot care are not equally distributed across Bangladesh, there is a need in regional prioritization and diversification of treatment and enrolment policies. Local stakeholders and policy makers can identify high-risk areas and allocate resources effectively.
Subject(s)
Clubfoot , Cluster Analysis , Risk Factors , Child , Humans , Infant , Bangladesh/epidemiology , Clubfoot/epidemiology , Clubfoot/therapy , Cross-Sectional Studies , Treatment OutcomeABSTRACT
Within healthcare, several measures are used to quantify and compare the severity of health conditions. Two common measures are disability weight (DW), a context-independent value representing severity of a health state, and utility weight (UW), a context-dependent measure of health-related quality of life. Neither of these measures have previously been determined for developmental dysplasia of the hip (DDH). The aim of this study is to determine the DW and country-specific UWs for DDH. A survey was created using three different methods to estimate the DW: a preference ranking exercise, time trade-off exercise, and visual analogue scale (VAS). Participants were fully licensed orthopaedic surgeons who were contacted through national and international orthopaedic organizations. A global DW was calculated using a random effects model through an inverse-variance approach. A UW was calculated for each country as one minus the country-specific DW composed of the time trade-off exercise and VAS. Over a four-month period, 181 surgeons participated in the survey, with 116 surgeons included in the final analysis. The global DW calculated to be 0.18 (0.11 to 0.24), and the country-specific UWs ranged from 0.26 to 0.89. This is the first time that a global disability weight and country-specific utility weights have been estimated for DDH, which should assist in economic evaluations and the development of health policy. The methodology may be applied to other orthopaedic conditions.
ABSTRACT
Ponseti treatment has been well-established as the gold standard for the treatment of idiopathic clubfoot in high-income countries and middle- and low-income countries (LMICs). The tenotomy is usually performed in the clinic using a scalpel blade under local anesthesia. However, we believe that by adapting the technique from Minkowitz et al. to a low-resource setting, we can help address some of the known barriers to Ponseti care. Using a needle instead of a blade makes the procedure less cumbersome easier to learn and easier to understand for the provider, family and the patient. We were able show that the needle tenotomy technique can be implemented in a low-resource setting like Pakistan, and can be performed using only one assistant and materials that are locally and readily available for the same cost This paper and its attached educational videos can help spread the technique among providers in low-resource settings.
Subject(s)
Achilles Tendon , Clubfoot , Humans , Infant , Tenotomy/methods , Treatment Outcome , Clubfoot/surgery , Achilles Tendon/surgery , Ambulatory Surgical ProceduresABSTRACT
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 drop-out, 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 meta-analysis. 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. Funding: None.
ABSTRACT
In global health, a discipline with a racist and colonial history, white supremacy, white privilege and racism are still present today.1 Although many believe we are witnessing a resurgence of racism in global health, because of a recent rise of extreme right comments and racism in the community and online2, 3. In reality racism has always been an inherent aspect of global health and its predecessors: tropical health and international health by prioritizing the health issues of the colonizers over those of the native populations.4 As such, we are rather bearing witness to long standing issues that have been persistently overlooked. There is a need for a paradigm shift to enable true authentic leadership that promotes the values of our shared humanity.
Subject(s)
Global Health , Racism , Humans , Racism/prevention & controlABSTRACT
Background: Pakistan is a lower middle-income country in South Asia with a population of over 220 million. With the recent development of national health programs focusing on surgical care, two areas of high priority for research and policy are access and financial risk protection related to surgery. This is the first study in Pakistan to nationally assess geographic access and expenditures for patients undergoing surgery. Methods: This is a cross-sectional study of patients undergoing laparotomy, cesarean section, and surgical management of a fracture at public tertiary care hospitals across the country. A validated financial risk protection tool was adapted for our study to collect data on the socio-economic characteristics of patients, geographic access, and out-of-pocket expenditure. Results: A total of 526 patients were surveyed at 13 public hospitals. 73.8% of patients had 2-hour access to the facility where they underwent their respective surgical procedures. A majority (53%) of patients were poor at baseline, and 79.5% and 70.3% of patients experienced catastrophic health expenditure and impoverishing health expenditure, respectively. Discussion: A substantial number of patients face long travel times to access essential surgical care and face a high percentage of impoverishing health expenditure and catastrophic health expenditure during this process. This study provides valuable baseline data to health policymakers for reform efforts that are underway. Conclusions: Strengthening surgical infrastructure and services in the existing network of public sector first-level facilities has the potential to dramatically improve emergency and essential surgical care across the country.
Subject(s)
Cesarean Section , Financial Stress , Humans , Female , Pregnancy , Pakistan , Cross-Sectional Studies , Health ExpendituresABSTRACT
PURPOSE: Idiopathic clubfoot affects approximately 1/1000 alive-born infants, of whom 80-91% are born in low- or middle-income countries (LMICs). This retrospective study aimed to evaluate the morphological, functional, and social outcomes in patients with neglected clubfoot in rural Bangladesh, after receiving surgical treatment. METHODS: Patients received a posteromedial release (PMR) with or without an additional soft tissue intervention (group 1), a PMR with an additional bony intervention (group 2), or a triple arthrodesis (group 3) according to our surgical algorithm. Patients were followed until two year post-intervention. Evaluation was done using a modified International Clubfoot Study Group Outcome evaluation score and the Laaveg-Ponseti score. RESULTS: Twenty-two patients with 32 neglected clubfeet (ages 2-24 years) received surgical treatment. Nineteen patients with 29 clubfeet attended follow-up. At two year follow-up an excellent, good, or fair Laaveg-Ponseti score was obtained in 81% (group 1), 80% (group 2), and 0% (group 3) of the patients (p value 0.0038). Age at intervention is inversely correlated with the Laaveg-Ponseti score at two year follow-up (p < 0.0001). All patients attended school or work and were able to wear normal shoes. CONCLUSION: Our treatment algorithm is in line with other surgical algorithms used in LMICs. Our data reconfirms that excellent results can be obtained with a PMR regardless of age. Our algorithm follows a pragmatic approach that takes into account the reality on the ground in many LMICs. Good functional outcomes can be achieved with PMR for neglected clubfoot. Further research is needed to investigate the possible role of triple arthrodesis.