Does South Africa need a national clinical trials support unit?

ArticleThe original publication is available at http://www.samj.org.zaBackground. No national South African institution provides a coherent suite of support, available skills and training for clinicians wishing to conduct randomised controlled trials (RCTs) in the public sector. We report on a study to assess the need for establishing a national South African Clinical Trials Support Unit. Objectives. To determine the need for additional training and support for conduct of RCTs within South African institutions; identify challenges facing institutions conducting RCTs; and provide recommendations for enhancing trial conduct within South African public institutions. Design. Key informant interviews of senior decision-makers at institutions with a stake in the South African public sector clinical trials research environment. Results. Trial conduct in South Africa faces many challenges, including lack of dedicated funding, the burden on clinical load, and lengthy approval processes. Strengths include the high burden of disease and the prevalence of treatmentnaïve patients. Participants expressed a significant need for a national initiative to support and enhance the conduct of public sector RCTs. Research methods training and statistical support were viewed as key. There was a broad range of views regarding the structure and focus of such an initiative, but there was agreement that the national government should provide specific funding for this purpose. Conclusions. Stakeholders generally support the establishment of a national clinical trials support initiative. Consideration must be given to the sustainability of such an initiative, in terms of funding, staffing, expected research outputs and permanence of location.Publishers' versio

Is it time for South Africa to end the routine high-dose vitamin A supplementation programme?

In accordance with World Health Organization guidelines, South Africa (SA) introduced routine periodic high-dose vitamin A supplementation (VAS) in 2002. These guidelines were developed after research in the 1980s and 1990s showed the efficacy of VAS in reducing childhood mortality. However, two recent studies in low- to middle-income countries (2013 and 2014) have shown no effect of high-dose VAS on mortality. Additionally, there is no clear research evidence that 6-monthly doses of vitamin A result in a sustained shift in serum retinol levels or reduce subclinical vitamin A deficiency. These two points should encourage SA to re-examine the validity of these guidelines. A long-term view of what is in the best interests of the majority of the people is needed. The short-term intervention of administering vitamin A capsules not only fails to improve serum retinol levels but may create dependence on a ‘technical fix’ to address the fundamental problem of poor nutrition, which is ultimately underpinned by poverty. It may also cause harm. Although there are those, some with vested interests, who will argue for continuation of the routine high-dose VAS programmes, SA policymakers and scientists need to evaluate the facts and be prepared to rethink this policy. There is cause for optimism: SA’s health policymakers have previously taken bold stands on the basis of evidence. The examples of regulation of tobacco products and taxation of sugar-sweetened beverages, ending the free distribution of formula milk for HIV-positive mothers and legislating against the marketing of breastmilk substitutes provide precedents. Here is a time yet again for decision-makers to make bold choices in the interests of the people of SA. While the cleanest choice would be national discontinuation of the routine VAS programme, there may be other possibilities, such as first stopping the programme in Northern Cape Province (where there is clear evidence of hypervitaminosis A), followed by the other provinces in time

Factors that affected the efficacy of nonsurgical periodontal treatment carried out by postgraduate periodontology students

The training of postgraduate students in periodontology has a significant clinical impact. The overall assessment of the efficacy of non-surgical treatment of periodontitis, has value to inform training protocols as well as assess the quality of clinical service delivery. Furthermore, obstacles to successful treatment can be identified. The aim of the study was to determine the effectiveness of non-surgical periodontal treatment, as well as the factors that may determine treatment outcome at the postgraduate clinic in the Periodontology Department at the University of the Western Cape, Tygerberg Dental Hospital, between 2016 and 2018. A cross-sectional record-based study of 100 patients was conducted. Demographic, social, clinical, treatment data were obtained from the hospital files. Periodontal parameters including bleeding index (BI), Pocket Probing depth (PPD), Plaque index (PI), and clinical attachment level (CAL), were recorded at the initial visit (Pre-treatment) and follow-up visits (Post-treatment), and the final treatment outcomes were calculated based on the differences of these parameters’ values between the initial visit and the last follow-up visit. Data were presented as mean and range for continuous variables and as a frequency for categorical variables. Statistical analyses were performed to determine if there was a relationship between the varied factors and treatment outcome with p < 0.05 as statistically significant. The results showed that all 100 patients demonstrated a marked reduction in PPD, PI, BI, and loss of CAL. The overall mean PPD reduction was 0.32 (0.5), the mean reduction in PI and BI were 37.2 (24.08) and 34.61 (22.78), respectively, and the mean clinical attachment gain was 0.42 (0.97) mm. Treatment outcome showed no differencein PPD, PI, BI, and CAL between females, smokers, and patients with systemic conditions compared to males, non smokers, and patients without systemic conditions. On the other hand, patients who underwent more maintenance treatment visits over a period longer than 2 months duration had significantly better outcomes compared to patients who had less than two months of duration of treatment. This study proved the effectiveness of the non-surgical surgical periodontal treatment at the postgraduate periodontal clinic. Treatment duration and frequency of recall visits were the most influential factor impacting the treatment outcome

The targeting of nutritionally at-risk children attending a primary health care facility in the Western Cape Province of South Africa

AIM: The aim of this study was to determine the practices of primary health care (PHC) nurses in targeting nutritionally at-risk infants and children for intervention at a PHC facility in a peri-urban area of the Western Cape Province of South Africa. METHODOLOGY: Nutritional risk status of infants and children <6 years of age was based on criteria specified in standardised nutrition case management guidelines developed for PHC facilities in the province. Children were identified as being nutritionally at-risk if their weight was below the 3rd centile, their birth weight was less than 2500 g, and their growth curve showed flattening or dropping off for at least two consecutive monthly visits. The study assessed the practices of nurses in identifying children who were nutritionally at-risk and the entry of these children into the food supplementation programme (formerly the Protein-Energy Malnutrition Scheme) of the health facility. Structured interviews were conducted with nurses to determine their knowledge of the case management guidelines; interviews were also conducted with caregivers to determine their sociodemographic status. RESULTS: One hundred and thirty-four children were enrolled in the study. The mean age of their caregivers was 29.5 (standard deviation 7.5) years and only 47 (38%) were married. Of the caregivers, 77% were unemployed, 46% had poor household food security and 40% were financially dependent on non-family members. Significantly more children were nutritionally at-risk if the caregiver was unemployed (54%) compared with employed (32%) (P=0.04) and when there was household food insecurity (63%) compared with household food security (37%) (P<0.004). Significantly more children were found not to be nutritionally at-risk if the caregiver was financially self-supporting or supported by their partners (61%) compared with those who were financially dependent on non-family members (35%) (P=0.003). The weight results of the nurses and the researcher differed significantly (P<0.001), which was largely due to the different scales used and weighing methods. The researcher's weight measurements were consistently higher than the nurses' (P<0.00). The researcher identified 67 (50%) infants and children as being nutritionally at-risk compared with 14 (10%) by the nurses. The nurses' poor detection and targeting of nutritionally at-risk children were largely a result of failure to plot weights on the weight-for-age chart (55%) and poor utilisation of the Road to Health Chart. CONCLUSIONS: Problems identified in the practices of PHC nurses must be addressed in targeting children at nutritional risk so that appropriate intervention and support can be provided. More attention must be given to socio-economic criteria in identifying children who are nutritionally at-risk to ensure their access to adequate social security networks

An evaluation for harnessing low-enthalpy geothermal energy in the Limpopo Province, South Africa

South Africa generates most of its energy requirements from coal, and is now the leading carbon emitter in Africa, and has one of the highest rates of emissions of all nations in the world. In an attempt to decrease its CO2 emissions, South Africa continues to research and develop alternative forms of energy, expand on the development of nuclear and has began to explore potentially vast shale gas reserves. In this mix, geothermal has not been considered to date as an alternative energy source. This omission appears to stem largely from the popular belief that South Africa is tectonically too stable. In this study, we investigated low-enthalpy geothermal energy from one of a number of anomalously elevated heat flow regions in South Africa. Here, we consider a 75-MW enhanced geothermal systems plant in the Limpopo Province, sustainable over a 30-year period. All parameters were inculcated within a levelised cost of electricity model that calculates the single unit cost of electricity and tests its viability and potential impact toward South Africa's future energy security and CO2 reduction. The cost of electricity produced is estimated at 14 USc/KWh, almost double that of coal-generated energy. However, a USD25/MWh renewable energy tax incentive has the potential of making enhanced geothermal systems comparable with other renewable energy sources. It also has the potential of CO2 mitigation by up to 1.5 gCO2/KWh. Considering the aggressive nature of the global climate change combat and South Africa's need for a larger renewable energy base, low-enthalpy geothermal energy could potentially form another energy option in South Africa's alternative energy basket

Primary health care facility infrastructure and services and the nutritional status of children 0 to 71 months old and their caregivers attending these facilities in four rural districts in the Eastern Cape and KwaZulu-Natal provinces, South Africa

Objective: To assess primary health care (PHC) facility infrastructure and services, and the nutritional status of 0 to 71-month-old children and their caregivers attending PHC facilities in the Eastern Cape (EC) and KwaZulu-Natal (KZN) provinces in South Africa. Design: Cross-sectional survey. Setting: Rural districts in the EC (OR Tambo and Alfred Nzo) and KZN (Umkhanyakude and Zululand). Subjects: PHC facilities and nurses (EC: n = 20; KZN: n = 20), and 0 to 71-month-old children and their caregivers (EC: n = 994; KZN: n = 992). Methods: Structured interviewer-administered questionnaires and anthropometric survey. Results: Of the 40 PHC facilities, 14 had been built or renovated after 1994. The PHC facilities had access to the following: safe drinking water (EC: 20%; KZN: 25%); electricity (EC: 45%; KZN: 85%); flush toilets (EC: 40%; KZN: 75%); and operational telephones (EC: 20%; KZN: 5%). According to more than 80% of the nurses, problems with basic resources and existing cultural practices influenced the quality of services. Home births were common (EC: 41%; KZN: 25%). Social grants were reported as a main source of income (EC: 33%; KZN: 28%). Few households reported that they had enough food at all times (EC: 15%; KZN: 7%). The reported prevalence of diarrhoea was high (EC: 34%; KZN: 38%). Undernutrition in 0 to younger than 6 month-olds was low; thereafter, however, stunting in children aged 6 to 59 months (EC: 22%; KZN: 24%) and 60 to 71 months (EC: 26%; KZN: 31%) was medium to high. Overweight and obese adults (EC: 49%; KZN: 42%) coexisted. Conclusion: Problems regarding infrastructure, basic resources and services adversely affected PHC service delivery and the well-being of rural people, and therefore need urgent attention.Keywords: primary health care facilities; nutritional status; children; caregivers’ rural; South Afric

The effect of parenteral nnutrition with lipovenous or intralipid on the fatty acid composition of plasma and erythrocyte membrane lipids in very-low-birthweight infants

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