Evaluating a South African mobile application for healthcare professionals to improve diagnosis and notification of pesticide poisonings

Acute pesticide poisoning (APP) is a major global public health problem, particularly in low- and middle-income countries (LMICs) including South Africa. However, healthcare professionals (HCPs) worldwide have limited training in handling environmental health risks such as from pesticide exposures. Most HCPs lack basic training on APP and, this presents a challenge to HCPs when diagnosing and notifying pesticide-related poisonings. With a recent increase in mobile application technology, this gives a convenient platform to provide training support for HCPs in their clinical practice. An example is the integration of a South African pesticide notification guideline into an existing Emergency Medicine (EM) mobile application. This pesticide notification guideline (PNG) within the EM mobile application aims to provide an immediate point-of-care tool to help HCPs in diagnosis and notify pesticide poisoning cases. Despite this useful platform for training HCPs, there are limited studies that have evaluated mobile applications or technologies to promote HCPs training in LMICs. This study, therefore, aimed to evaluate the Centre for Environmental and Occupational Health Research (CEOHR)'s PGN adapted for the EM mobile application as a tool for improving HCP's ability to diagnose and report APPs. The protocol (Part A) provides information and a justification for the research study and, describes the methods used to gather and analyse the data. The extended literature review (Part B) provides an overview of studies assessing HCPs' knowledge of and training in pesticide poisonings and the role mobile health technologies play in improving HCPs' knowledge and training in clinical practice. Furthermore, the literature review illustrates the relevant theoretical frameworks and concepts that helps to understand HCPs' behaviour changes when using clinical guidelines or algorithms. The journal manuscript article (Part C) provides this study's research findings and how it could contribute to the body of knowledge. A total of 50 emergency medicine physicians and registrars participated in th

Evaluating oxalate-degrading Lactobacillus spp. for their ability to be used as probiotics in the treatment of kidney stone disease

Includes abstract.Includes bibliographical references (leaves 73-95).Although the direct cause of kidney stone formation is not known, reports have suggested it is probably a multifactorial disease. Lactobacillus strains which potentially had increased ability to degrade oxalate were previously isolated from a healthy low kidney stone risk group. The aim of this study was to identify these natural Lactobacillus strains and evaluate their potential for use as probiotics in reducing the risk of kidney stone disease. Identification was achieved by PCR amplification and sequencing of the 16S rRNA gene and the 16S-23S rRNA internal transcribed spacer (ITS) region. The strains were identified as follows; Lactobacillus gasseri 7(3), L. gasseri 17(4), Lactobacillus reuteri 17(7) and L. reuteri 16(9). Their probiotic characteristics were also evaluated

Evaluating a South African mobile application for healthcare professionals to improve diagnosis and notification of pesticide poisonings

Background: Mobile health is a fast-developing field. The use of mobile health applications by healthcare professionals (HCPs) globally has increased considerably. While several studies in high income countries have investigated the use of mobile applications by HCPs in clinical practice, few have been conducted in low- and middle-income countries. The University of Cape Town developed a pesticide notification guideline which has been adapted and embedded into a South African Essential Medical Guidance mobile application. This study evaluated the usefulness of the guideline within a mobile application for improving the ability of HCPs to diagnose and notify on acute pesticide poisonings (APPs). Methods A descriptive online questionnaire, with 15 open- and 20 closed-ended questions, was completed by 50 South African emergency medicine physicians and registrars (i.e. medical doctors training as specialists) between December 2015 to February 2016. Descriptive statistics were used to calculate response frequencies and percentages using SPSS version 23. Texts from the open-ended questions were thematically analysed. Fisher’s exact test was applied to determine associations. Results A significant association was found between participants’ knowledge that APP is a notifiable condition, and ever reporting the poisoning to the National Department of Health (p = 0.005). Thirty four percent of the participants were aware of the guideline within the Essential Medical Guidance application despite only seven participants having used it. Those who used the guideline found it provided useful information for the identification of unlabelled pesticides products and promoted reporting these cases to the National Department of Health for surveillance purposes. In addition, it appeared to facilitate the prompt diagnosis and treatment of APP cases, and most intended to continue using it for training and educational purposes. Conclusions Mobile health applications appear to support overburdened medical education programmes and promote better patient care. However, since most participants were not aware of the existence of the pesticide guideline within the studied essential medicine application, there is potential for the use of healthcare applications to play a more central role in healthcare systems and medical training. Furthermore, the field of medical informatics could support HCPs through mobile applications in improving reporting of APP

The role of inflammation in HPV infection of the Oesophagus

BACKGROUND: Several human cancers are known to be associated with inflammation and/or viral infections. However, the influence of tumour-related inflammation on viral uptake is largely unknown. In this study we used oesophageal squamous cell carcinoma (OSCC) as a model system since this type of cancer is associated with chronic irritation, inflammation and viral infections. Although still debated, the most important viral infection seems to be with Human Papillomavirus (HPV). The present study focused on a possible correlation between inflammation, OSCC development and the influence of HPV infection. METHODS: A total of 114 OSCC biopsies and corresponding normal tissue were collected at Groote Schuur Hospital and Tygerberg Hospital, Cape Town (South Africa), that were subjected to RNA and DNA isolation. RNA samples were analysed by quantitative Light Cycler RT-PCR for the expression of selected genes involved in inflammation and infection, while conventional PCR was performed on the DNA samples to assess the presence of integrated viral DNA. Further, an in vitro infection assay using HPV pseudovirions was established to study the influence of inflammation on viral infectivity using selected cell lines. RESULTS: HPV DNA was found in about 9% of OSCC patients, comprising predominantly the oncogenic type HPV18. The inflammatory markers IL6 and IL8 as well as the potential HPV receptor ITGA6 were significantly elevated while IL12A was downregulated in the tumour tissues. However, none of these genes were expressed in a virus-dependent manner. When inflammation was mimicked with various inflammatory stimulants such as benzo-alpha-pyrene, lipopolysaccharide and peptidoglycan in oesophageal epithelial cell lines in vitro, HPV18 pseudovirion uptake was enhanced only in the benzo-alpha-pyrene treated cells. Interestingly, HPV pseudovirion infectivity was independent of the presence of the ITGA6 receptor on the surface of the tested cells. CONCLUSION: This study showed that although the carcinogen benzo-alpha-pyrene facilitated HPV pseudovirion uptake into cells in culture, HPV infectivity was independent of inflammation and seems to play only a minor role in oesophageal cancer

Electronic consent in a COVID-19 vaccine implementation trial in South Africa: Participant perspectives.

The COVID-19 pandemic has warranted modifications to clinical research implementation to ensure adherence to public health and safety measures. Often, this modification has necessitated a deviation from the traditional face-to-face approach to an electronic or hybrid consent process. We assessed the acceptability and preference for electronic consent and explored understanding of the electronic consent information – an outcome which is vital in providing reassurance that consent is provided with full appreciation of the risks and benefits of study participation. In this descriptive study, healthcare professionals (HCPs) were invited, through a database of HCP contacts, snowball sampling and advertisement, to participate in an online survey between 14 July 2021 and 17 September 2021, to explore their experiences of providing electronic consent for enrolment into the largest implementation trial of a COVID vaccine in South Africa (SISONKE Trial). Descriptive analysis was used to characterise respondents and categorical data were expressed as frequencies. The prevalence of recurring responses to open-ended questions allowed for the identification of themes. A total of 1025 HCPs completed the online survey. Access to a COVID-19 vaccine was the strongest motivating factor for enrolment (82.3%) into the SISONKE Trial. Over a third of participants (38.6%) were not able to discuss the study with research staff. While the majority of participants (85.2%) indicated that online consent was acceptable, it was recognised that acceptability was context specific. Although 64% indicated awareness that reporting both a positive COVID test and adverse events were requirements, a significant percentage (32%) did not recall that the reporting period was 2 years. The electronic consent process was easily navigated by educated HCPs with access to electronic devices and data. Vaccine access was the most important motivation for participation, thus raising questions about how voluntary the consent process was and the role of desperation in deciding to participate.Significance:• Navigation of the electronic consent process for participation in a COVID-19 vaccine implementation trial is not a challenge for educated healthcare professionals with access to electronic devices and data. However, technical skills and access to technology may impact the integrity of the informed consent process for lay research participants.• Motivation to join research studies for access to scarce resources impacts negatively on the authenticity of the consent processes, as participation may be informed but not truly voluntary, and is an issue that ethics committees and researchers should address

Exploring perspectives of research ethics committee members on the governance of big data in sub-Saharan Africa

Interest in the governance of big data is growing exponentially. However, finding the right balance between making large volumes of data accessible, and safeguarding privacy, preventing data misuse, determining authorship and protecting intellectual property remain challenging. In sub-Saharan Africa (SSA), research ethics committees (RECs) play an important role in reviewing data-intense research protocols. However, this regulatory role must be embedded in a context of robust governance. There is currently a paucity of published literature on how big data are regulated in SSA and if the capacity to review protocols is sufficient. The aim of this study was to provide a broad overview of REC members’ awareness and perceptions of big data governance in SSA. A descriptive cross-sectional survey was conducted from April to July 2022. We invited 300 REC members to participate in our online survey via Research Electronic Data Capture (REDCap). A total of 140 REC members, representing 34 SSA countries, completed the online survey. Awareness of data governance laws, policies and guidelines was variable across the subcontinent. A quarter of respondents (25%) indicated that national regulations on the transborder flow of research data are inadequate. Institutional policies on research data protection were also regarded as being inadequate. Most respondents (64%) believed that they lacked experience in reviewing data-intense protocols. Data governance and regulation in SSA need to be strengthened at both national and institutional levels. There is a strong need for capacity development in the review of data-intense research protocols on the subcontinent. Significance: This is the first empirical survey in SSA in which awareness and perspectives of REC members have been explored specifically relating to the review of data-intense research protocols. Big data have raised new ethics and legal challenges, and this survey provides a broad overview of these challenges in SSA. Our study confirms that knowledge and awareness of legislative frameworks and ethics guidance in SSA vary considerably where big data are concerned. The research results could be useful for a range of stakeholders, including RECs, data scientists, researchers, research and academic institutions, government decisionmakers and artificial intelligence (AI) coders

COVID‑19 underscores the important role of clinical ethics committees in Africa

CITATION: Moodley, K., et al. 2021. COVID‑19 underscores the important role of Clinical Ethics Committees in Africa. BMC Medical Ethics, 22:131, doi:10.1186/s12910-021-00696-2.The original publication is available at https://bmcmedethics.biomedcentral.comPublication of this article was funded by the Stellenbosch University Open Access FundBackground: The COVID-19 pandemic has magnified pre-existing challenges in healthcare in Africa. Long-standing health inequities, embedded in the continent over centuries, have been laid bare and have raised complex ethical dilemmas. While there are very few clinical ethics committees (CECs) in Africa, the demand for such services exists and has increased during the COVID-19 pandemic. The views of African healthcare professionals or bioethicists on the role of CECs in Africa have not been explored or documented previously. In this study, we aim to explore such perspectives, as well as the challenges preventing the establishment of CECs in Africa. Methods: Twenty healthcare professionals and bioethicists from Africa participated in this qualitative study that utilized in-depth semi-structured interviews with open-ended questions. Themes were identified through thematic analysis of interviews and open-ended responses. Results: Kenya and South Africa are the only countries on the continent with formal established CECs. The following themes emerged from this qualitative study: (1) Lack of formal CECs and resolution of ethical dilemmas; (2) Role of CECs during COVID-19; (3) Ethical dilemmas presented to CECs pre-COVID-19; (4) Lack of awareness of CECs; (5) Lack of qualified bioethicists or clinical ethicists; (6) Limited resources to establish CECs; (7) Creating interest in CECs and networking. Conclusions: This study illustrates the importance of clinical ethics education among African HCPs and bioethicists, more so now when COVID-19 has posed a host of clinical and ethical challenges to public and private healthcare systems. The challenges and barriers identified will inform the establishment of CECs or clinical ethics consultation services (CESs) in the region. The study results have triggered an idea for the creation of a network of African CECs.https://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-021-00696-2Publisher's versio

Clinical Ethics Committees in Africa : lost in the shadow of RECs/IRBs?

CITATION: Moodley, K., et al. 2020. Clinical Ethics Committees in Africa : lost in the shadow of RECs/IRBs?. BMC Medical Ethics, 21:115, doi:10.1186/s12910-020-00559-2.The original publication is available at https://bmcmedethics.biomedcentral.comPublication of this article was funded by the Stellenbosch University Open Access FundBackground: Clinical Ethics Committees (CECs) are well established at healthcare institutions in resource-rich countries. However, there is limited information on established CECs in resource poor countries, especially in Africa. This study aimed to establish baseline data regarding existing formal CECs in Africa to raise awareness of and to encourage the establishment of CECs or Clinical Ethics Consultation Services (CESs) on the continent. Methods: A descriptive study was undertaken using an online questionnaire via SunSurveys to survey healthcare professionals and bioethicists in Africa. Data were subjected to descriptive analysis and Fischer’s exact test was applied to determine associations. Texts from the open-ended questions were thematically analysed. Results: In total 109 participants from 37 African countries completed the survey in December 2019. A significant association was found between participants’ bioethics qualification or training and involvement in clinical ethics (p = 0.005). All participants were familiar with Research Ethics Committees (RECs), and initially conflated RECs with CECs. When CECs were explained in detail, approximately 85.3% reported that they had no formal CECs in their institutions. The constraints to developing CECs included lack of training, limited resources, and lack of awareness of CECs. However, the majority of participants (81.7%) were interested in establishing CECs. Participants listed assistance required in establishing CECs including funding, resources, capacity building and collaboration with other known CECs. The results do not reflect CECs established since the onset of COVID-19 in Africa. Conclusions: This study provides a first look into CECs in Africa and found very few formal CECs on the continent indicating an urgent need for the establishment of CECs or CESs in Africa. While the majority of healthcare professionals and bioethicists are aware of ethical dilemmas in healthcare, the concept of formal CECs is foreign. This study served to raise awareness of CECs. Research ethics and RECs overshadow CECs in Africa because international funders from the global north support capacity development in research ethics and establish RECs to approve the research they fund in Africa. Raising awareness via educational opportunities, research and conferences about CECs and their role in improving the quality of health care in Africa is sorely needed. Keywords: Clinical ethics committees, Clinical ethics consultation service, Africa, Developing countries, Ethics, Clinical ethics, Dilemmahttps://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-020-00559-2Publisher's versio

Electronic consent in a COVID-19 vaccine implementation trial in South Africa: Participant perspectives

The COVID-19 pandemic has warranted modifications to clinical research implementation to ensure adherence to public health and safety measures. Often, this modification has necessitated a deviation from the traditional face-to-face approach to an electronic or hybrid consent process. We assessed the acceptability and preference for electronic consent and explored understanding of the electronic consent information – an outcome which is vital in providing reassurance that consent is provided with full appreciation of the risks and benefits of study participation. In this descriptive study, healthcare professionals (HCPs) were invited, through a database of HCP contacts, snowball sampling and advertisement, to participate in an online survey between 14 July 2021 and 17 September 2021, to explore their experiences of providing electronic consent for enrolment into the largest implementation trial of a COVID vaccine in South Africa (SISONKE Trial). Descriptive analysis was used to characterise respondents and categorical data were expressed as frequencies. The prevalence of recurring responses to open-ended questions allowed for the identification of themes. A total of 1025 HCPs completed the online survey. Access to a COVID-19 vaccine was the strongest motivating factor for enrolment (82.3%) into the SISONKE Trial. Over a third of participants (38.6%) were not able to discuss the study with research staff. While the majority of participants (85.2%) indicated that online consent was acceptable, it was recognised that acceptability was context specific. Although 64% indicated awareness that reporting both a positive COVID test and adverse events were requirements, a significant percentage (32%) did not recall that the reporting period was 2 years. The electronic consent process was easily navigated by educated HCPs with access to electronic devices and data. Vaccine access was the most important motivation for participation, thus raising questions about how voluntary the consent process was and the role of desperation in deciding to participate. Significance: Navigation of the electronic consent process for participation in a COVID-19 vaccine implementation trial is not a challenge for educated healthcare professionals with access to electronic devices and data. However, technical skills and access to technology may impact the integrity of the informed consent process for lay research participants. Motivation to join research studies for access to scarce resources impacts negatively on the authenticity of the consent processes, as participation may be informed but not truly voluntary, and is an issue that ethics committees and researchers should address