Publication Trends of Clinical Trials Performed in South Africa

BACKGROUND:Investigators and sponsors of clinical trials have an ethical obligation to disseminate clinical trial results; whether positive or negative; in a timely manner.OBJECTIVES:To determine the publication rate and average time to reporting for clinical trials carried out in South Africa (SA) and to explore factors indicating whether a study is published or not.METHODS:A registry-based quantitative retrospective analysis of 79 SA clinical trials for new medicines registered between January 2008 and December 2010 was performed. The relevant trial identification number in the register was used to track all peer-reviewed publications subsequent to registration. Tracking of clinical trials was done through a systematic literature search of the electronic journal databases of the South African Medical Journal (SAMJ); the Cochrane Library; Public Library of Science Medical Journal (PLoS Medicine) and BioMed Central; all of which are indexed on MEDLINE via PubMed. In addition; a manual search of the Open Access Journal of Clinical Trials databases and reference lists on articles related to the trial medicine was performed. RESULTS:Of the 79 clinical trials surveyed; 72 were concluded by December 2014. Only 35 (48.6%) of them had the results published in a peer-reviewed journal; the current benchmark for dissemination of trial results. The majority (82.9%) of those published had a positive outcome. Of the 35 trials that were published; 77.1% were published within 2 years. The average time from completion to initial reporting was 22 months. Fewer than half (40.5%) of the clinical trials surveyed were placebo controlled.CONCLUSION:The absence of complete outcomes data from SA clinical trials warrants utmost attention. The study puts forward a case to the regulatory body and research ethics committees to compel all data from clinical trials to be made accessible to clinicians and the public in general by being published in an easily accessible form and in a timely manner

High prevalence of cisplatin-induced ototoxicity in Cape Town, South Africa.

BACKGROUND: Cisplatin is administered as the first-line treatment of soft-tissue cancers. It has a reported cure rate of up to 85%, but is associated with a high incidence of ototoxicity, characterised by irreversible bilateral hearing loss and affecting 23 - 50% of adults who receive the drug. OBJECTIVES: To determine the incidence of cisplatin-induced ototoxicity at Groote Schuur Hospital (GSH), Cape Town, South Africa. METHODS: retrospective cross-sectional study of cisplatin-receiving cancer patients attending GSH between January 2006 and August 2011. RESULTS: A total of 377 patients were recorded as receiving cisplatin therapy during the study period. A 300% increase in new cisplatin-receiving patients receiving audiological monitoring was observed between 2006 and 2010. However, only patients with all clinical data as well as baseline and follow-up audiometric analyses were investigated. One hundred and seven such patients were identified, 55.1% of whom developed cisplatin-induced ototoxicity while receiving high-dose (> or = 60 mg/m2) cisplatin treatment. Higher cumulative cisplatin dosages were associated with development of significant hearing loss (p = 0.027). The odds of developing cisplatin-induced hearing loss were elevated for patients with head and neck tumours and lymphoma (p = 0.0465 and p = 0.0563, respectively) and were significantly lower for those with reproductive cancers (p = 0.0371). CONCLUSION: Comprehensive audiological monitoring should be available for every patient during cisplatin treatment to minimise the development of disabling hearing loss.

Prolonged breastfeeding in Bangladesh: indicators of inadequate feeding practices or mothers' response to children's poor health?

The association between breastfeeding and diarrhoeal morbidity was examined in a prevalence study of 5502 children aged 6-71 months from rural and urban Bangladesh. Breastfeeding was found to be associated with reduced prevalence of diarrhoea. This association was most pronounced at the age of six months and declined linearly to zero at approximately 30 months of age; thereafter, breastfeeding was increasingly associated with diarrhoeal illness. The linear association was found only among those children who have no access to modern health services and information, when controlling for urban and rural differences. The literature provides two opposing explanations for the positive association of prolonged breastfeeding with diarrhoeal illness. The first explanation suggests that breastfeeding can be seen as mothers' response to children's poor health. The second explanation incriminates sub-optimal child feeding practices, characterised by prolonged breastfeeding and inadequate quality and quantity of complementary foods, as the cause of malnutrition and diarrhoea. Further studies are needed to identify which explanation is correct, given the public health implications in terms of children's survival, growth and development.

PIP: The importance of breast-feeding in preventing and treating diarrheal diseases during infancy is well documented. The association between breast-feeding and diarrheal morbidity was investigated in a study of 5502 children aged 6-71 months from rural and urban Bangladesh. 88.2% of the 740 infants aged 6-11 months were breast-fed, as well as 82.6% of the 946 aged 12-23 months, 44.6% of the 980 aged 24-35 months, 13.9% of the 999 aged 36-47 months, 6.2% of the 788 aged 48-59 months, and 3.5% of the 806 aged 60-71 months. Breast-feeding was found to be associated with reduced prevalence of diarrhea, with the association most pronounced at age 6 months and declining linearly to zero at approximately age 30 months. Thereafter, breast-feeding was increasingly associated with diarrheal illness in the child. The linear association was found only among children who had no access to modern health services and information, when controlling for urban and rural differences. One explanation proposed in the literature for the positive association of prolonged breast-feeding with diarrheal illness is that breast-feeding can be seen as mothers' response to children's poor health. A second possible explanation cites sub-optimal child feeding practices, characterized by prolonged breast-feeding and inadequate quality and quantity of complementary foods, as the cause of malnutrition and diarrhea. Further study is needed to identify which explanation is correct.

Nutritional status of Haitian children, 1978-1995: deleterious consequences of political instability and international sanctions.

Results from three national surveys in Haiti suggest that the prevalence of stunting, underweight, and wasting in children fell considerably between 1978 and 1990. In the following four years, rates of stunting and underweight levelled off, while that of wasting nearly doubled. Child nutrition deteriorated dramatically during a period of intense political crisis and international sanctions that included a strictly enforced trade embargo. Human welfare should be monitored whenever international sanctions are imposed to regulate a country's behavior.

Decentralized data management in nutritional surveillance for timely warning and intervention.

In this paper we describe a theoretical approach for decentralized data management in sentinel community nutritional surveillance systems for timely warning and intervention, by using customized computer programs. By making the data available at lower levels first, the decentralized data management system builds the institutional capacity at regional level and allows rapid and appropriate action by decision-makers. In addition, it facilitates the flow of information and strengthens the involvement of field staff. Reports from field experiences should further demonstrate the feasibility, efficacy, costs and benefits of customized data management computer programs.

Antimicrobial activities of ziziphus abyssinica and berchemia discolor.

Aqueous, petroleum-ether, chloroform and dichloromethane extracts of both the barks and leaves of Ziziphus abyssinica and Berchemia discolor were tested for activity against Staphylococcus aureus, Escherichia coli and Candida albicans using the hole plate diffusion and the test tube dilution methods. The aqueous extracts showed significant activity against S. aureus and C. albicans.

A study on factors leading to non-functioning of medical equipment at Parirenyatwa Group of Hospitals

(Summary of findings and recommendations) - The Parirenyatwa Group of Hospitals has been experiencing the problem of non-functioning medical equipment. A lot of medical equipment breakdown in every department to such an extent that the Hospital staff has realised that most of the Departments complain of having equipment which are non-functioning. This problem is so severe that it affects their role in providing health care delivery services to patients. The main objective of this study was to identify factors which led to non-functioning of medical equipment at Parirenyatwa Group of Hospitals in order to make recommendations for improvements to the management; users; and the Ministry of Health. The study was carried out in fifty (50) departments of the Parirenyatwa Group of Hosptials which were identified according to their different functions and services they provide to the patients. The study was mainly descriptive with quantitative and qualitative elements. Information on functioning and non-functioning medical equipment was obtained from the users. An inventory on both functioning and non-functioning medical equipment for each department was first carried out. From; this inventory; a random sample of two (2) functioning medical equipment and three (3) non-functioning medical equipment was done for each department. A total of one hundred (100) and one hundred and fifty (150) functioning and non-functioning medical equipment respectively; was obtained. Furthermore information was obtained from five (5) Hospital Equipment Technicians and four (4) purchasers who were interviewed using structured questionnnaires