Stakeholder perspectives on informed consent and ethics review of research involving human specimen resource repositories (biobanks) in South Africa: a quantitative study.

Master of Health Research Ethics. University of KwaZulu-Natal, Pietermaritzburg 2017.On-going research has made the use of human biological materials and genetic material/data for biomedical research an area of high interest to researchers, bioethicists, philosophers, lawyers and various regulatory bodies. In this era of globalization, there are profound ethical, legal and social implications for the evolving nature of biobank research; these have to be considered during the ethics review process. The main objective of this study was to explore stakeholders’ perspectives of informed consent and ethics review of biobank research in South Africa, with the aim of obtaining information that could contribute to the harmonization of ethical guidelines of the consent process and biobank governance. This was a descriptive cross-sectional study that employed a positivist approach involving qualitative data collection methods. The study was conducted at Stellenbosch University, the University of KwaZulu-Natal, and seven research ethics committees in the KwaZulu-Natal and Western Cape provinces in South Africa. A purposive sampling technique was used to recruit significant stakeholders in biobank research in South Africa. Data was collected using self-administered online survey instruments. Completion of the survey implied consent. Quantitative data were summarized using descriptive summary statistics. Conventional content analysis was used for data collected from open ended questions. The response rate was low; 19 research ethics committee members and 62 researchers and other stakeholders participated in the study. All stakeholders agreed that there is need for functional regulatory frameworks to govern biobank research, particularly the strengthening of research ethics committees, to ensure comprehensive ethics review of biobank-based research. There were several areas of agreement and divergence in respondents’ perspectives on the collection, storage and future use of human biological materials. There was no consensus on the issue of re-consent and the likelihood of donor identification and harm during the use of human biological materials for secondary research. Stakeholders also identified a number of challenges in the ethics review process and the sharing of human biological materials. Generally, the attitude of research ethics committee members, researchers and other stakeholders on informed consent, ethics review of biobank research, and the export and sharing of de-identified HBM is positive and ethically informed. Stakeholders believe that there is need for robust regulatory frameworks to govern the collection, storage, sharing and future use of HBM both within South Africa and across borders. Several recommendations are proposed that could contribute to the harmonization of ethical guidelines on the relevant consent process and biobank governance

Musculoskeletal disorders among nursing staff: a comparison of five hospitals in Uganda

Abstract Introduction: Low and middle income countries have severe nursing staff shortages which is associated with risk of poor quality of patient car

Developing digital contact tracing tailored to haulage in East Africa to support COVID-19 surveillance: a protocol

International audienceIntroduction At the peak of Uganda’s first wave of SARS-CoV-2 in May 2020, one in three COVID-19 cases was linked to the haulage sector. This triggered a mandatory requirement for a negative PCR test result at all ports of entry and exit, resulting in significant delays as haulage drivers had to wait for 24–48 hours for results, which severely crippled the regional supply chain. To support public health and economic recovery, we aim to develop and test a mobile phone-based digital contact tracing (DCT) tool that both augments conventional contact tracing and also increases its speed and efficiency. Methods and analysis To test the DCT tool, we will use a stratified sample of haulage driver journeys, stratified by route type (regional and local journeys). We will include at least 65% of the haulage driver journeys ~83 200 on the network through Uganda. This allows us to capture variations in user demographics and socioeconomic characteristics that could influence the use and adoption of the DCT tool. The developed DCT tool will include a mobile application and web interface to collate and intelligently process data, whose output will support decision-making, resource allocation and feed mathematical models that predict epidemic waves. The main expected result will be an open source-tested DCT tool tailored to haulage use in developing countries. This study will inform the safe deployment of DCT technologies needed for combatting pandemics in low-income countries. Ethics and dissemination This work has received ethics approval from the School of Public Health Higher Degrees, Research and Ethics Committee at Makerere University and The Uganda National Council for Science and Technology. This work will be disseminated through peer-reviewed publications, our websites https://project-thea.org/ and Github for the open source code https://github.com/project-thea/

Mycotic aneurysm of the femoral artery resulting from mismanagement of a pathological femur fracture due to chronic osteomyelitis: a case report

Abstract Introduction Mycotic aneurysms are rarely listed among the possible complications of osteomyelitis of the long bones. To the best of our knowledge this is the first case of chronic osteomyelitis associated with a pathological fracture of the femur and a mycotic aneurysm of the femoral artery. Case presentation We present the case of a 13-year-old Ugandan boy who was referred to our hospital with chronic osteomyelitis associated with a pathological fracture of the right femur and a mycotic aneurysm of the femoral artery. He underwent a successful above-knee amputation and is currently undergoing rehabilitation. Conclusions Aneurysms associated with chronic osteomyelitis of the long bones are very rare. However, in Africa, where people often still believe in crude traditional remedies, they should be considered among the possible diagnoses especially where acute injuries of the limbs are massaged and manipulated.</p

Students’ perspectives of undergraduate research methods education at three public medical schools in Uganda

Introduction: in this study we used a model of adult learning to explore undergraduate students’ views on how to improve the teaching of research methods and biostatistics. Methods: this was a secondary analysis of survey data of 600 undergraduate students from three medical schools in Uganda. The analysis looked at student’s responses to an open ended section of a questionnaire on their views on undergraduate teaching of research methods and biostatistics. Qualitative phenomenological data analysis was done with a bias towards principles of adult learning. Results: students appreciated the importance of learning research methods and biostatistics as a way of understanding research problems; appropriately interpreting statistical concepts during their training and post-qualification practice; and translating the knowledge acquired. Stressful teaching environment and inadequate educational resource materials were identified as impediments to effective learning. Suggestions for improved learning included: early and continuous exposure to the course; more active and practical approach to teaching; and a need for mentorship. Conclusion: the current methods of teaching research methods and biostatistics leave most of the students in the dissonance phase of learning resulting in none or poor student engagement that results in a failure to comprehend and/or appreciate the principles governing the use of different research methods. The Pan African Medical Journal 2016;2

Periodontitis is associated with insulin resistance in adults living with diabetes mellitus in Uganda: a cross- sectional study

Abstract Introduction Evidence suggests that majority of patients with diabetes mellitus in Uganda have poor glycaemic control as well as periodontal disease. This study set out to determine the association between periodontitis and insulin resistance in adult patients with diabetes mellitus in Uganda using the triglyceride glucose index. Methods Two hundred and twenty-three adult study participants with confirmed diabetes mellitus were enrolled in a cross-sectional study. Oral examination was carried with the aid of a periodontal probe to determine the periodontal status and findings recorded using the WHO Oral Health Assessment Tool for Adults, 2013. We recorded clinical details for body mass index (BMI in kg/m2) and laboratory parameters including fasting blood sugar (mmol/L), glycated hemoglobin levels (HbA1c, %) and serum triglycerides (mmol/L) using a study questionnaire. Data were analyzed using R version 4.10. The glucose triglyceride index was used as a measure of insulin resistance. Logistic regression analysis carried out to determine the factors associated insulin resistance. Results The majority of the study participants was female (70%) with an average age of 48.5 years (SD+/- 11.1). The mean body mass index was 29.6 kg/m2 (SD+/- 5.82). The mean serum triglyceride index was 9.48 (SD+/- 0.675). Eighty-six-point 1% of the participants had periodontal disease. Bivariate analysis revealed high odds for male sex (OR = 1.31, 95% C.I = 0.44–4.84, p = 0.65) and periodontitis (OR = 3.65, 95% C.I = 0.79–26.15, p = 0.13) but low odds for a high BMI (OR = 0.45. 95% C.I = 0.07–1.67, p = 0.30). Multivariate regression revealed a significant association between insulin resistance and periodontitis. (AOR = 3.52, 95% C.I = 1.19–1.83, p = 0.03). Conclusion Insulin resistance is highly prevalent in patients with diabetes mellitus in Uganda and is associated with periodontitis and low body weight

Low bone mass in people living with HIV on long-term anti-retroviral therapy: A single center study in Uganda.

BackgroundThis study set out to determine the prevalence of low bone mass following long-term exposure to antiretroviral therapy in Ugandan people living with HIV.MethodsA cross-sectional study was conducted among 199 people living with HIV that had been on anti-retroviral therapy for at least 10 years. All participants had dual X-ray absorptiometry to determine their bone mineral density. The data collected included antiretroviral drug history and behavioral risk data Descriptive statistics were used to summarize the data. Inferential statistics were analyzed using multilevel binomial longitudinal Markov chain Monte Carlo mixed multivariate regression modelling using the rstanarm package.ResultsOne hundred ninety nine adults were enrolled with equal representation of males and females. The mean age was 39.5 (SD 8.5) years. Mean durations on anti-retroviral treatment was 12.1 (SD 1.44) years, CD4 cell count was 563.9 cells/mm3. 178 (89.5%) had viral suppression with ConclusionThese results provide additional evidence that patients on long term ART achieve bone mass stabilization. Maintaining adequate body weight is important in maintaining good bone health in people on antiretroviral therapy

Ethical, Legal, and Sociocultural Issues in the Use of Mobile Technologies and Call Detail Records Data for Public Health in the East African Region: Scoping Review

BackgroundThe exponential scale and pace of real-time data generated from mobile phones present opportunities for new insights and challenges across multiple sectors, including health care delivery and public health research. However, little attention has been given to the new ethical, social, and legal concerns related to using these mobile technologies and the data they generate in Africa. ObjectiveThe objective of this scoping review was to explore the ethical and related concerns that arise from the use of data from call detail records and mobile technology interventions for public health in the context of East Africa. MethodsWe searched the PubMed database for published studies describing ethical challenges while using mobile technologies and related data in public health research between 2000 and 2020. A predefined search strategy was used as inclusion criteria with search terms such as “East Africa,” “mHealth,” “mobile phone data,” “public health,” “ethics,” or “privacy.” We screened studies using prespecified eligibility criteria through a two-stage process by two independent reviewers. Studies were included if they were (1) related to mobile technology use and health, (2) published in English from 2000 to 2020, (3) available in full text, and (4) conducted in the East African region. We excluded articles that (1) were conference proceedings, (2) studies presenting an abstract only, (3) systematic and literature reviews, (4) research protocols, and (5) reports of mobile technology in animal subjects. We followed the five stages of a published framework for scoping reviews recommended by Arksey and O’Malley. Data extracted included title, publication year, target population, geographic region, setting, and relevance to mobile health (mHealth) and ethics. Additionally, we used the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) Extension for Scoping Reviews checklist to guide the presentation of this scoping review. The rationale for focusing on the five countries in East Africa was their geographic proximity, which lends itself to similarities in technology infrastructure development. ResultsOf the 94 studies identified from PubMed, 33 met the review inclusion criteria for the final scoping review. The 33 articles retained in the final scoping review represent studies conducted in three out of five East African countries: 14 (42%) from Uganda, 13 (39%) from Kenya, and 5 (16%) from Tanzania. Three main categories of concerns related to the use of mHealth technologies and mobile phone data can be conceptualized as (1) ethical issues (adequate informed consent, privacy and confidentiality, data security and protection), (2) sociocultural issues, and (3) regulatory/legal issues. ConclusionsThis scoping review identified major cross-cutting ethical, regulatory, and sociocultural concerns related to using data from mobile technologies in the East African region. A comprehensive framework that accounts for the critical concerns raised would be valuable for guiding the safe use of mobile technology data for public health research purposes