The implementation of a national paediatric oncology protocol for neuroblastoma in South Africa

Purpose
The aim of the World Health Organization-International Paediatric Oncology Society is to improve childhood cancer survival in low- and middle-income countries to 60% by 2030. This can be achieved using standardised evidence-based national treatment protocols for common childhood cancers. The aim of the study was to describe the development and implementation of the SACCSG NB-2017 neuroblastoma (NB) treatment protocol as part of the treatment harmonisation process of the South African Children’s Cancer Study Group.

Methods
The Consolidated Framework for Implementation Research was used to identify factors that could influence the implementation of the national NB protocol as a health care intervention. The evaluation was done according to five interactive domains for implementation: intervention characteristics, inner setting, outer setting, individual or team characteristics and the implementation process.

Results
The protocol was developed over 26 months by 26 physicians involved in childhood cancer management. The process included an organisational phase, a resource identification phase, a development phase and a research ethics approval phase. Challenges included nationalised inertia, variable research ethical approval procedures with delays and uncoordinated clinical trial implementation.

Conclusion
The implementation of the national NB protocol demonstrated the complexity of the implementation of a national childhood cancer treatment protocol. However, standardised paediatric cancer treatment protocols based on local expertise and resources in limited settings are feasib

District hospital surgical capacity in Western Cape Province, South Africa: A cross-sectional survey

Background. The role of the district hospital (DH) in surgical care has been undervalued. However, decentralised surgical services at DHs have been identified as a key component of universal health coverage. Surgical capacity at DHs in Western Cape (WC) Province, South Africa, has not been described.

Objectives. To describe DH surgical capacity in WC and identify barriers to scaling up surgical capacity at these facilities.

Methods. This was a cross-sectional survey of 33 DHs using the World Health Organization surgical situational analysis tool administered to hospital staff from June to December 2019. The survey addressed the following domains: general services and financing; service delivery and surgical volume; surgical workforce; hospital and operating theatre (OT) infrastructure, equipment and medication; and barriers to scaling up surgical care.

Results. Seven of 33 DHs (21%) did not have a functional OT. Of the 28 World Bank DH procedures, small WC DHs performed up to 22 (79%) and medium/large DHs up to 26 (93%). Only medium/large DHs performed all three bellwether procedures. Five DHs (15%) had a full-time surgeon, anaesthetist or obstetrician (SAO). Of DHs without any SAO specialists, 14 (50%) had family physicians (FPs). These DHs performed more operative procedures than those without FPs (p=0.005). Lack of finances dedicated for surgical care and lack of surgical providers were the most reported barriers to providing and expanding surgical services.

Conclusions. WC DH surgical capacity varied by hospital size. However, FPs could play an essential role in surgery at DHs with appropriate training, oversight and support from SAO specialists. Strategies to scale up surgical capacity include dedicated financial and human resources.

Inequity in paediatric oncology in South Africa – The neuroblastoma case study

Background: The South African Constitution affords everyone the right to access healthcare services, but in children the care must ensure survival.

Aim: This study aimed to determine whether there was access to equitable paediatric oncology services for the management of neuroblastoma in South Africa.

Setting: Paediatric oncology services in South Africa between 2000 to 2014.

Methods: A literature review was carried out, focussing on access to healthcare in South Africa for children with neuroblastoma. Services were classified in accordance with the International Society of Paediatric Oncology resource settings for neuroblastoma diagnosis. Supplementary data from a retrospective study of the management of neuroblastoma in South Africa were evaluated.

Results: The neuroblastoma care services in South Africa were not uniformly resourced and accessible across the provinces. Two provinces (2/9 provinces) had excellent healthcare services that included access to transplant facilities, whilst three (3/9 provinces) had no services. Traveling distances to healthcare services pose major challenges, whilst number of medical staff providing oncology care were unequally distributed. The Constitution did not define basic healthcare for children, nor did the National Cancer Control plan acknowledge childhood cancer as a defined entity without provision until 2022.

Conclusion: Children diagnosed with neuroblastoma do not have equitable access to healthcare as stated in the South African Constitution. The case of neuroblastoma highlights the inequitable access to childhood care as a whole in South Africa. As the health of children is a national priority, it is therefore necessary to sensitise policymakers to the needs of children with cancer.

Clavien–Dindo classification of post-operative complications in a South African setting

Background: Clavien-Dindo (CD) classification is used to standardize the reporting of post-operative complications. The aim of the study was to report our initial experience following the adoption of the use of CD classification for reporting of post-operative complications across surgical specialities. Methods: An audit of prospectively collected data, from records of patients aged 18 years and older who had surgery, was conducted. Data collected included patients’ demographics, acuity of operations, types of surgery, recorded post-operative complications and assigned CD class. Categorical variables were summarized using frequency and percentages. The mean with standard deviation (SD) was used for the aggregation of continuous data. χ2-test or Fisher’s exact test was used to compare categorical findings. The strength of associations was measured using Cramer’s V and the φ coeficient. Data analysis was carried out using the SAS version 9.4 for Windows. The level of significance was set at a P value below 0.05. Results: A total of 3399 surgical procedures were performed, of which 1700 (50.0%) were emergencies. The mean (± SD) age of operated patients was 44.3 (±16.7) years. eThre were 11.2% post-operative complications of which 65.8% were directly related to surgical procedures. Approximately 48.1% of the complications were infections. The CD classicfiation was applied to the complications, of which 31.6% were categorized as Grade I and 26.3% as Grade IIIb. There was a significant but weak association between reported complication types and surgical specialty (P < 0.0001; Cramer's V = 0.25), and between the reported grade of complications and surgical specialty (P < 0.0001; Cramer's V = 0.21). Overall mortality was 7.7%. Conclusions: The CD classification was adopted by all specialties studied. The rate of post-operative complications was 11%, the majority of which were infections. Reported grades of complications were influenced by surgical specialty. A high number of Grade IIIb complications were recorded than have been previously reported.

Long-term mortality after lower extremity amputation: A retrospective study at a second-level government hospital in Cape Town, South Africa

Background:
Long-term mortality after lower extremity amputation (LEA) is not well reported in low- and middle-income countries. The primary aim of this study was to report 30-day and one-year mortality after LEA in South Africa. The secondary objective was to report risk factors for one-year mortality.
Methods:
This was a retrospective study of patients undergoing LEA at New Somerset Hospital, a second-level government facility in Cape Town, South Africa from October 1, 2015 to October 31, 2016. A medical record review was undertaken to identify co-morbidities, operation details, and perioperative mortality rate. Outcome status was defined as alive, dead, or lost to follow-up. Outcomes at 30 days and one-year were reported.
Results:
There were 152 patients; 90 (59%) males and the median age was 60 years. Co-morbidities were available for 137 (90%). One hundred and eight (79%) had peripheral vascular disease and 91 (66%) had diabetes mellitus. Fifty-three (35%) had more than one LEA on the same or contralateral limb. There were 183 LEAs in 152 patients. The most common LEA was above knee amputation (n=104, 57%) followed by below-knee amputation (n=36, 20%). At 30 days, 102 (67%) of 152 were traced and 12 (12%) were dead. At one year, 86 (57%) were traced and 37 (43%) were dead.
Conclusions:
At this second-level South African hospital, 43% of patients undergoing LEA were dead after one year. In resource-constrained settings, mortality data are necessary when considering resource allocation for LEA and essential surgical care packages.

Quality of Histopathological Reporting in Breast Cancer: Results From Four South African Breast Units

PURPOSE
High-quality histopathology reporting forms the basis for treatment decisions. The quality indicator for pathology reports from the European Society of Breast Cancer Specialists was applied to a cohort from four South African breast units.

METHODS
The study included 1,850 patients with invasive breast cancer and evaluated 1,850 core biopsies and 1,158 surgical specimen reports with cross-center comparisons. A core biopsy report required histologic type; tumor grade; and estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 (HER2) status, with a confirmatory test for equivocal HER2 results. Ki-67 was regarded as optional. Pathologic stage, tumor size, lymphovascular invasion, and distance to nearest invasive margin were mandatory for surgical specimens. Specimen turnaround time (TAT) was added as a locally relevant indicator.

RESULTS
Seventy-five percent of core biopsy and 74.3% of surgical specimen reports were complete but showed large variability across study sites. The most common reason for an incomplete core biopsy report was missing tumor grade (17.9%). Half of the equivocal HER2 results lacked confirmatory testing (50.6%). Ki-67 was reported in 89.3%. For surgical specimens, the closest surgical margin was reported in 78.1% and lymphovascular invasion in 84.8% of patients. Mean TAT was 11.9 days (standard deviation [SD], 10.8 days) for core biopsies and 16.1 days (SD, 11.3) for surgical specimens.

CONCLUSION
Histopathology reporting is at a high level but can be improved, especially for tumor grade, HER2, and Ki-67, as is reporting of margins and lymphovascular invasion. A South African pathology consensus will reduce variability among laboratories. Routine use of standardized data sheets with synoptic reports and ongoing audits will improve completeness of reports over time.

Clinical quality and performance measurement in the prehospital emergency medical services in the low-to-middle income country setting

BACKGROUND
Measuring quality and safety in any healthcare setting however is highly contextual, and depends on the manner in which quality is defined or viewed within that setting. It is this contextual nature that has provoked significant debate and hindered efforts at developing formal standards or criteria for measuring quality and safety in healthcare, regardless of setting. Historically, performance within the Emergency Medical Services (EMS) delivering prehospital emergency care has been assessed primarily based on response times. While easy to measure and valued by the public, overall, response time targets are a poor predictor of quality of care and clinical outcomes.
AIM
The overall aim of the research was to develop a framework for clinical quality and performance-based assessment of prehospital emergency care for use in the South African EMS.
METHOD
The research was divided amongst four studies, with each study constituting one of the overall research objectives. Study I was a sequential explanatory mixed methods study with the aim of understanding the knowledge, attitudes and practices of clinical quality and performance assessment amongst South African EMS personnel. Part 1 consisted of a webbased cross-sectional survey, and Part 2 consisted of semi-structured telephonic interviews of select participants from Part 1 to explore the results of the survey. Descriptive statistics were carried out to summarise and present all survey items, and conventional content analysis employed to analyse the interview data. Study II utilised a three round modified Delphi study to identify, refine and review a list of appropriate quality indicators for potential use in the South African EMS setting. For Study III a novel quality indicator appraisal protocol was developed consisting of two categorical-based appraisal methods, combined with the qualitative analysis of their consensus application, and tested against the outcomes of Study II. Descriptive statistics were utilised to describe and summarize the categorical based appraisal data. Inter-rater reliability was calculated using percentage agreement and Gwet’s AC1. Correlation between the individual methods and the protocol was calculated using Spearman’s rank Correlation and z-test. Conventional content analysis was utilised to analyse the group discussions. Study IV utilised a multiple exploratory case study design to evaluate the current state of quality systems in the South African EMS. A formative assessment was conducted on the quality systems of four provincial EMS and one national private EMS, following which semi-structured interviews were conducted to further explore the results obtained from the formative assessment, supported by multiple
secondary data sources. Descriptive statistics were utilised to describe and summarize the formative assessment. Conventional content analysis was utilised to analyse the interview data and document analysis utilised to sort and analyse the supporting data
RESULTS
Despite relatively poor knowledge of organisational-specific quality systems, understanding of the core components and importance of quality systems was demonstrated. The role of these systems in the Low to Middle Income Country setting (LMICs) was supported by participants, where the importance of context, system transparency, reliability and validity were essential towards achieving ongoing success and utilisation. The role of leadership and communication towards the effective facilitation of such a system was equally identified. Participating services generally scored higher for structure and planning. Measurement and improvement were found to be more dependent on utilisation and perceived mandate. There was a relatively strong focus on clinical quality assessment within the private service, whereas in the provincial systems, measures were exclusively restricted to call times with little focus on clinical care. Staff engagement and programme evaluation were generally among the lowest scores. A multitude of contextual factors were identified that affected the effectiveness of quality systems, centred around leadership, vision and mission, and quality system infrastructure and capacity, guided by the need for comprehensive yet pragmatic strategic policies and standards. A total, 104 quality indicators reached consensus agreement including, 90 clinical QIs, across 15 subcategories, and 14 non-clinical QIs across two subcategories. Amongst the clinical category, airway management (n=13 QIs; 14%); out-of-hospital cardiac arrest (n=13 QIs; 14%); and acute coronary syndromes (n=11 QIs; 12%) made up the majority. Within the non-clinical category, adverse events made up the significant majority with nine QIs (64%). There was mixed inter-rater reliability of the individual methods. There was similarly poor to moderate correlation of the results obtained between the individual methods (Spearman’s rank correlation=0.42,p<0.001). From a series of 104 QIs, 11 were identified that were shared between the individual methods. A further 19 QIs were identified and not shared by each method, highlighting the benefits of a multimethod approach.
CONCLUSION
For the purposes of this study we focused on the technical competence aspect of quality, in developing our measurement framework. Towards this, we identified a significant number of QIs assessed to be valid and feasible for the South African prehospital emergency care setting. The majority of which are centred around clinically focused processes of care, measures that are lacking in current performance assessment in EMS in South Africa. However, we also discovered the importance and influencing role of the individual practitioners and quality system in which the QIs will be implemented, a point highlighted across all the methodologies and studies. Given the potential magnitude of this influence, it is of the utmost importance that any measurement framework examining technicalquality, have equal in-depth understanding of these factors in order to be successful.

Implementation Science Protocol for a participatory, theory-informed implementation research programme in the context of health system strengthening in sub-Saharan Africa (ASSET-ImplementER)

Background ASSET (Health System Strengthening in Sub-Saharan Africa) is a health system strengthening (HSS) programme that aims to develop and evaluate effective and sustainable solutions that support high-quality care that involve eight work packages across four sub-Saharan African countries. Here we present the protocol for the implementation science (IS) theme within ASSET that aims to (1) understand what HSS interventions work, for whom and how; and (2) how implementation science methodologies can be adapted to improve the design and evaluation of HSS interventions within resource-poor contexts.

Pre-implementation phase The IS theme, jointly with ASSET work-packages, applies IS determinant frameworks to identify factors that influence the effectiveness of delivering evidence-informed care. Determinants are used to select a set of HSS interventions for further evaluation, where work packages also theorise selective mechanisms to achieve the expected outcomes.

Piloting phase and rolling implementation phase Work-packages pilot the HSS interventions. An iterative process then begins involving evaluation, refection and adaptation. Throughout this phase, IS determinant frameworks are applied to monitor and identify barriers and enablers to implementation in a series of workshops, surveys and interviews. Selective mechanisms of action are also investigated. In a final workshop, ASSET teams come together, to reflect and explore the utility of the selected IS methods and provide suggestions for future use.

Structured templates are used to organise and analyse common and heterogeneous patterns across work-packages. Qualitative data are analysed using thematic analysis and quantitative data is analysed using means and proportions.

Conclusions We use a novel combination of implementation science methods at a programmatic level to facilitate comparisons of determinants and mechanisms that influence the effectiveness of HSS interventions in achieving implementation outcomes across different contexts. The study will also contribute conceptual development and clarification at the underdeveloped interface of implementation science, HSS and global health.

The scope of operative general paediatric surgical diseases in South Africa—the Chris Hani Baragwanath experience

Background
Infectious diseases have always been the lime light of global health with very little focus on childhood surgical conditions despite the fact that children constitute about half of the population in LMICs. A significant proportion of the burden of global disease can be reduced by surgical intervention. South Africa is one of the pioneers of the practice of paediatric surgery in Africa with a great burden of paediatric surgical conditions.

Few studies, if any, have investigated the burden of operative paediatric surgical procedures in South Africa. Therefore, this retrospective study aimed to look at the scope of operative paediatric surgical procedures at the Chris Hani Baragwanath Academic Hospital (CHBAH) based in Johannesburg, South Africa, and reports on the numbers of elective and emergency procedures over a 12-month study period.

Results
There were 1699 operative general paediatric surgical procedures of which 61.7% were electives and 38.3% were emergencies. The scope of general paediatric surgical conditions operated on fell under the categories of congenital anomalies, infections and tumours. Of these, surgeries for congenital anomalies were performed in almost all the subspecialties.

Conclusion
There is a high operative paediatric surgical burden at the CHBAH. The role of paediatric surgical care as an essential component of global health cannot be underrated.

Diagnostic assistance to improve acute burn referral and triage : assessment of routine clinical tools at specialised burn centres and potential for digital health development at point of care

Background: Inappropriate referral of patients for specialised care leads to overburdened health systems and improper treatment of patients who are denied transfer due to a scarcity of resources. Burn injuries are a global health problem where specialised care is particularly important for severe cases while minor burns can be treated at point of care. Whether several solutions, existing or in development, could be used to improve the diagnosis, referral and triage of acute burns at admission to specialised burn centres remains to be evaluated.

Aim: The overarching aim of this thesis is to determine the potential of diagnostic support tools for referral and triage of acute burns injuries. More specifically, sub-aims include the assessment of routine and digital health tools utilised in South Africa and Sweden: referral criteria, mortality prediction scores, image-based remote consultation and automated diagnosis.

Methods: Studies I and II were two retrospective studies of patients admitted to the paediatric (I) and the adult (II) specialised burn centres of the Western Cape province in South Africa. Study I examined adherence to referral criteria at admission of 1165 patients. Logistic regression was performed to assess the associations between adherence to the referral criteria and patient management at the centre. Study II assessed mortality prediction at admission of 372 patients. Logistic regression was performed to evaluate associations between patient, injury and admission-related characteristics with mortality. The performance of an existing mortality prediction model (the ABSI score) was measured. Study III and IV were related to two image-based digital-health tools for remote diagnosis. In Study III, 26 burns experts provided a diagnosis in terms of burn size and depth for 51 images of acute burn cases using their smartphone or tablet. Diagnostic accuracy was measured with intraclass correlation coefficient. In Study IV, two deep-learning algorithms were developed using 1105 annotated acute burn images of cases collected in South Africa and Sweden. The first algorithm identifies a burn area from healthy skin, and the second classifies burn depth. Differences in performances by patient Fitzpatrick skin types were also measured.

Results: Study I revealed a 93.4% adherence to the referral criteria at admission. Children older than two years (not fulfilling the age criterion) as well as those fulfilling the severity criterion were more likely to undergo surgery or stay longer than seven days at the centre. At the adult burn centre (Study II), mortality affected one in five patients and was associated with gender, burn size, and referral status after adjustments for all other variables. The ABSI score was a good estimate of mortality prediction. In Study III experts were able to accurately diagnose burn size, and to a lesser extent depth, using handheld devices. A wound identifier and a depth classifier algorithm could be developed with assessments of relatively high accuracy (Study IV). Differences were observed in performances by skin types of the patients.

Conclusions: Altogether the findings inform on the use in clinical practice of four different tools that could improve the accuracy of the diagnosis, referral and triage of patients with acute burns. This would reduce inequities in access to care by improving access for both paediatric and adult patient populations in settings that are resource scarce, geographically distant or under high clinical pressure.