S Afr Med J
· 2025 Jun · PMID 41378569
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BACKGROUND: South Africa's ongoing efforts to realise universal health coverage (UHC) have produced three discernible policy trajectories: UHC0, the de facto configuration of public and private health systems; UHC1, the...BACKGROUND: South Africa's ongoing efforts to realise universal health coverage (UHC) have produced three discernible policy trajectories: UHC0, the de facto configuration of public and private health systems; UHC1, the incremental reform framework initiated post 1994 and recently revisited by the Universal Healthcare Access Coalition; and UHC2, the centralised National Health Insurance approach formalised in a 2017 White Paper. OBJECTIVE: To offer a comparative analysis between the three alternative policy trajectories, to determine which offers the most productive pathway to deepen UHC. METHODS: This analysis uses the organising principle of subsidiarity, which argues that decision-making authority should be handled at the most local level possible, with higher levels stepping in only when needed. A qualitative comparative policy analysis methodology is applied to assess the institutional design, financial sustainability, governance integrity, implementation feasibility and equity outcomes of these approaches. RESULTS: Drawing from primary policy documents, the study finds that UHC1 provides the most feasible and constitutionally aligned pathway for realising UHC. UHC2, by way of contrast, is least likely to be implemented, with design features that deviate substantially from the principle of subsidiarity. UHC0, the status quo option, also incorporates severe deviations from the principle of subsidiarity and is likely to perpetuate systemic inequity and poor outcomes. Importantly, continued attempts to implement UHC2 effectively converge on UHC0, with the result that UHC0 is likely to continue indefinitely unless revised toward UHC1. CONCLUSION: Of the three options, UHC1, as envisaged in the 1990s, remains the most viable approach to deepen UHC, with UHC2 unlikely to achieve any key UHC goals owing to design weaknesses that deviate from the principle of subsidiarity and financial constraints. Attempts to implement UHC2, thereby obstructing the implementation of key aspects of UHC1, defaults the health system to the residual UHC0 approach - which lacks any strategic vision for deepening UHC.
Mlotshwa NW, Ngutshane NB, Taunyane IC
… +2 more, Mogaladi SM, Nweke EE
S Afr Med J
· 2025 Jun · PMID 41378568
BACKGROUND: Extracorporeal membrane oxygenation (ECMO) is a means of supporting an inefficient cardiorespiratory system, refractory to medical treatment, with a mechanical device. Low cardiac output syndrome (LCOS) is a...BACKGROUND: Extracorporeal membrane oxygenation (ECMO) is a means of supporting an inefficient cardiorespiratory system, refractory to medical treatment, with a mechanical device. Low cardiac output syndrome (LCOS) is a frequent problem after cardiopulmonary bypass. Globally, centres have investigated outcomes of ECMO and have documented associated preoperative, intraoperative and postoperative predictive factors. Our centre has used ECMO since the mid-1990s, but there has been no study investigating the outcomes. OBJECTIVES: To evaluate 30-day survival and associated predictive factors among patients with LCOS in whom ECMO was used during or after open-heart surgery. METHODS: The study was a retrospective review of clinical records of adult patients in whom ECMO was used during or within 72 hours after open-heart surgery from November 2016 until the end of December 2022. Data were collected using the RedCap (Research Electronic Data Capture) online database manager at the University of the Witwatersrand and entered into a Microsoft Excel spreadsheet. For descriptive analysis, continuous data were analysed using a one-way analysis of variance. The association between patient factors and outcomes was analysed using Fisher's exact test. Statistical analysis was conducted using Stata. RESULTS: ECMO was used in 4.6% (n=60) of 1 311 patients who underwent heart surgery during the study period, of whom 38 met the study selection criteria; of these, 6 (15.8%) survived to discharge. Of the patients who survived, 5 were black females in the working age group. All the patients who died (n=32/38; 84.2%) did so within 30 days. All the patients experienced morbidity while on ECMO. All the surviving patients survived for >30 days and were discharged from hospital. CONCLUSION: Our ECMO survival rate following open heart surgery (~16%) is low compared with other better-established centres. Various factors were associated with the poor outcomes.
Rheeder P, Botha G, Mohlala GM
… +3 more, Eales O, Van Zyl D, Ngassa Piotie P
S Afr Med J
· 2025 Jun · PMID 41378567
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BACKGROUND: In South Africa (SA), glucose control for individuals with type 2 diabetes follows a stepwise approach. According to the guidelines, insulin therapy is started after using two oral agents. However, various ch...BACKGROUND: In South Africa (SA), glucose control for individuals with type 2 diabetes follows a stepwise approach. According to the guidelines, insulin therapy is started after using two oral agents. However, various challenges may delay the initiation of insulin. OBJECTIVES: To implement a nurse-led, telehealth-assisted programme to address these challenges, aiming to transition patients to insulin safely to achieve better glycaemic control. METHODS: From 2021 to 2023, we conducted a single-arm, unblinded before-and-after study in primary care facilities in Tshwane District, Gauteng Province, SA. Participants were on insulin or two oral agents at maximum doses. Study nurses monitored glycated haemoglobin (HbA1c) results, and participants with HbA1c levels of ≥8% (≥10% during the COVID-19 pandemic) were counselled about insulin use. During an initiation visit, participants received demonstrations and education on using insulin and glucose meters. The participants then tested their glucose levels at home according to a fixed schedule. Over 14 weeks, we implemented monthly clinic visits supplemented by home visits facilitated by community healthcare worker teams. During these visits, glucose results were communicated to the clinic physician via the Vula mobile app, allowing timely adjustments to insulin therapy. RESULTS: Of the 293 participants, 65% (n=192) were women and 35% (n=101) were men. The mean (standard deviation (SD)) age was 53 (10) years, with a baseline mean (SD) HbA1c level of 12.1% (1.7%). Of those initiated, 169 (58%) were on oral agents and 124 (42%) were on insulin. Biphasic mixed human insulin was prescribed to 185 participants (63%) and intermediate human neutral protamine Hagedorn (NPH) insulin to 108 (37%). Immediately after baseline assessment and during the 14-week study period, 72 participants (23%) were lost to follow-up, and seven were hospitalised during the study period. Glucose values decreased over 14 weeks, with approximately one-third of participants having no insulin adjustments, one-third having one adjustment, and one-third having more than one adjustment. The mean (SD) HbA1c level decreased from 12.1% (1.6%) to 8.8% (1.6%) over the 14 weeks in 240 paired samples (p<0.001). Ten percent of these participants achieved HbA1c levels <7%, and 34% had levels <8%. CONCLUSION: The nurse-led, telehealth-supported intervention successfully transitioned participants onto twice-daily mixed insulin or night-time intermediate NPH insulin, resulting in a significant decrease in HbA1c from 12.1% to 8.8%. However, clinics will require additional resources to initiate or intensify insulin therapy in primary care settings.
Seimela D, Du Plessis JM, Vorster M
… +1 more, Van Niekerk AF
S Afr Med J
· 2025 Jun · PMID 41378566
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BACKGROUND: The misuse and overuse of intravenous (IV) antibiotics contribute to the spread of multidrug resistance, consequently increasing mortality. These effects can be minimised through treatment reviews that aim to...BACKGROUND: The misuse and overuse of intravenous (IV) antibiotics contribute to the spread of multidrug resistance, consequently increasing mortality. These effects can be minimised through treatment reviews that aim to optimise antibiotic therapy without compromising patient clinical outcomes. There is therefore a need to evaluate and monitor intravenous antibiotic usage in hospitals. OBJECTIVES: To describe IV antibiotic use in admitted patients at a private hospital in North West Province, South Africa. METHODS: A cross-sectional study design was followed using retrospective data from patient files and the hospital electronic healthcare software (TriMed) between 1 January and 31 December 2022. A Microsoft Excel spreadsheet was used to capture demographic information for each patient profile that met the inclusion criteria, and data on IV antibiotic use were captured for each admission episode. The data were analysed using IBM statistical software. RESULTS: Demographic data were recorded for 677 patient profiles, with males representing 53.8% (n=364). A total of 731 admissions occurred during the study period. The most prevalent indication for IV antibiotic use, according to the provisional diagnosis, was upper and lower respiratory tract disorders, which represented 25.2% of the total admissions. Staphylococcus aureus was the most commonly treated micro-organism, representing 22.8% (n=23) of the total isolated micro-organisms. IV antibiotics were initiated 885 times, and amoxicillin-clavulanic acid was the most used antibiotic (51.2%). Most antibiotics (48.2%) were used at a dose of 1 200 mg, with a dosing frequency of three times a day (72.3%). A total of 806 review actions, out of 885 intravenous antibiotic initiations, were conducted (91.1%). The prevalence of IV-to-oral switch was 49.0%, while 41.3% of IV antibiotics were stopped after review. IV antibiotic de-escalation represented 7.2% of the total reviews, while an oral antibiotic was added to 1.7% of the IV antibiotics after review. At review, the prevalence of adding IV antibiotics to another IV antibiotic was 0.7%. The average length of hospital stay was 5.8 days, while patients continuously received IV antibiotics for 3.4 days on average. CONCLUSION: There is a need to monitor IV antibiotic use and encourage IV antibiotic de-escalation to limit the rampant use of broad- spectrum antibiotics and manage the most prevalent infections effectively in the shortest possible time, consequently reducing the average duration of hospitalisation. IV antibiotic treatment review is therefore pivotal to optimise antibiotic therapy, the transition of IV to oral antibiotics, and discontinuation of IV antibiotics when they are no longer necessary.
Issak A, Mngomezulu P, Ntlansana V
… +2 more, Tomita A, Paruk S
S Afr Med J
· 2025 Jun · PMID 41378565
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BACKGROUND: There is a silent epidemic of workplace bullying among medical doctors, with junior doctors being the most vulnerable. Little research has been conducted to establish the nature and extent of bullying of medi...BACKGROUND: There is a silent epidemic of workplace bullying among medical doctors, with junior doctors being the most vulnerable. Little research has been conducted to establish the nature and extent of bullying of medical interns in KwaZulu-Natal (KZN) Province, South Africa. OBJECTIVES: To describe the prevalence and types of workplace bullying, identify alleged perpetrators, and explore the association between bullying and the mental health and quality of life of medical interns in KZN. METHODS: A cross-sectional online survey was conducted across all state hospitals in KZN designated for training first- and second-year medical interns, from 1 June to 31 August 2023, using snowball sampling. Participants completed a newly designed sociodemographic, clinical and bullying questionnaire, the Negative Acts Questionnaire (NAQ), the Patient Health Questionnaire-9 (PHQ-9), the Generalized Anxiety Disorder-7 (GAD-7) scale, and the World Health Organization Quality of Life scale. RESULTS: Of the 270 medical interns employed in KZN, 182 responded, and 135 were included in the study. All interns were classified as having experienced bullying according to the NAQ, and 61.8% screened positive for symptoms of anxiety and/or depression on the PHQ-9 and GAD-7. The most commonly reported somatic symptoms and work-related behaviours caused by workplace bullying were recurrent headaches (42.5%), chronic lethargy (79.3%), gastrointestinal illnesses (42.7%), sleep disturbances (67.8%), loss of interest in work (81.0%) and absenteeism from work (43.5%). Most participants (61.2%) did not report the bullying to senior staff, and most of those who did report were dissatisfied with the outcome of the investigation (91.2%). CONCLUSION: Medical interns in KZN have a high prevalence of anxiety and depressive symptoms, with a negative impact on their quality of life. Bullying by senior medical and nursing staff is pervasive. However, it was not possible to explore the associations between bullying and mental health, as all participants had high bullying scores on the NAQ.
Claassens M, Steenkamp P, Gavioli R
… +1 more, Woldetsadik T
S Afr Med J
· 2025 Jun · PMID 41378564
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BACKGROUND: In Namibia, community-based directly observed tuberculosis (TB) treatment (C-DOT) has been effective for individuals living in settled villages, but it is problematic for mobile indigenous people who survive...BACKGROUND: In Namibia, community-based directly observed tuberculosis (TB) treatment (C-DOT) has been effective for individuals living in settled villages, but it is problematic for mobile indigenous people who survive through hunting and gathering and have among the highest TB and multidrug-resistant TB rates and lowest adherence to TB treatment globally. OBJECTIVES: The 99DOTS (directly observed treatment, short course) programme was piloted in the Tsumkwe Healthcare Centre and the 25 villages in the catchment area from quarter 2, 2019 to quarter 1, 2020. Programme staff facilitated and monitored TB treatment adherence. METHODS: Twenty patients and two healthcare workers who managed the patients were interviewed on treatment completion using a semi- structured interview process. RESULTS: Respondents were of low socioeconomic status; many were not schooled and not employed, and few had a monthly household income >NAD100 (USD5.50). According to the programme server reports, only six of the respondents did not miss any doses of their TB treatment, although few doses were missed proportionally. Most respondents reported a supportive family structure and health system, with treatment support given by families and regular follow-up by health workers. Positive feedback was received about use of the 99DOTS application; respondents found the application easy to use and did not mind using it in front of other people, in and out of their homes. CONCLUSION: 99DOTS was a feasible, innovative and accessible treatment adherence component integrated directly into the existing C-DOT approach. National TB programmes in similar high-burden settings could consider this approach to improve adherence.
S Afr Med J
· 2025 Jun · PMID 41378563
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South Africa's public healthcare sector faces a severe shortage of medical practitioners, exacerbated by the failure to place newly qualified graduates in internship and community service positions. Despite the country's...South Africa's public healthcare sector faces a severe shortage of medical practitioners, exacerbated by the failure to place newly qualified graduates in internship and community service positions. Despite the country's urgent need for doctors, many graduates remain unplaced each year, preventing them from practising independently. This article proposes a legislative reform to address these challenges. Currently, the Health Professions Act 56 of 1974 mandates a compulsory year of community service for medical graduates before full professional registration. However, systemic placement failures result in many graduates being left in limbo, unable to work in either the public or the private sector. The article advocates a legally recognised exemption from community service for medical graduates who remain unplaced for more than 3 months after completing their internship. The proposed amendment to the Health Professions Act would enable these individuals to enter private practice or pursue further specialisation, ensuring that trained professionals are not lost to bureaucratic inefficiencies that infringe on their labour rights.
S Afr Med J
· 2025 Sep · PMID 41378558
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BACKGROUND: Since 2011, the Health Professions Council of South Africa (HPCSA) requires completion of a Master of Medicine (MMed) research component by registrars, before specialist registration. OBJECTIVE: To determine...BACKGROUND: Since 2011, the Health Professions Council of South Africa (HPCSA) requires completion of a Master of Medicine (MMed) research component by registrars, before specialist registration. OBJECTIVE: To determine the impact of the research requirement on training and specialist registration. METHODS: A closed, de-identified cross-sectional e-survey was distributed to College of Medicine of South Africa (CMSA) Fellows passing their specialist examination between 2018 and 2022. The primary outcome was the proportion of registrars completing their MMed and clinical training within the stipulated time. Secondary outcomes were: (i) proportion unlikely to complete the MMed during training; (ii) factors contributing to MMed completion; (iii) publication rates; and (iv) whether a structured learning programme was preferred for research methodology. A Likert scale identified factors influencing completion, including administrative aspects (supervision, statistical support, ethics approval process, time allocated for research, funding, and marking timelines), and the influence of the requirement for the performance of research on mental wellness. RESULTS: The survey invitation was emailed to 3 646 participants; 564 (15.5%) responded, across 26 specialist CMSA disciplines. Overall, 273/564 (51.6%) specialists completed their MMed research component and CMSA examinations within the stipulated registrar training completion time. For secondary outcomes, 230/563 (40.8%) respondents required extension of the stipulated training time. In 291/564 (48.4%), the MMed was not completed during the stipulated training time, with 61/291 (21.0%) respondents not receiving an extension for completion. For 183/563 (32.5%) respondents, MMed submission was required by the university before specialist examination. Of these, 121/183 (66.1%) wrote their examination within the training time; 44/183 (24%) within 6 months of completion; and 18/183 (9.8%) >6 months after completion. Likert scale responses showed that >50% of respondents considered all the factors being assessed to be a barrier to the conduction of their research, with the exception of good supervision (304/563, 54%). The strongest associations with successful completion of the MMed research were good supervision (54%), access to statistical support (40%), and an uncomplicated and efficient ethics approval process (39.6%). Overall, 229/564 (40.62%) MMed research components were published. A structured research learning programme was preferred by 413/564 (73.2%) respondents. A total of 335/564 (59.4%) indicated that the MMed did not add value to training. CONCLUSION: Nearly half of registrars could not register as specialists when their training was complete, due to non-completion of their MMed research component. All the factors examined were considered to be contributing to non-completion of the MMed by the majority of participants, with the exception of access to good supervision. A structured integrated learning programme, including research methodology, statistics, appraisal of the literature, and scientific writing, should be introduced as an alternative to the requirement for original research, which should no longer be compulsory. Registrars wishing to do original research should be strongly supported.
Munzhedzi M, Guler JL, Krivacsy S
… +5 more, Shifflett P, Operario DJ, Dillingham R, McQuade ETR, Bessong PO
S Afr Med J
· 2025 Sep · PMID 41378557
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BACKGROUND: Asymptomatic Plasmodium infections in endemic areas pose a challenge to malaria prevention and control strategies. The Ha-Lambani area in Vhembe district, Limpopo Province, South Africa, experiences periodic...BACKGROUND: Asymptomatic Plasmodium infections in endemic areas pose a challenge to malaria prevention and control strategies. The Ha-Lambani area in Vhembe district, Limpopo Province, South Africa, experiences periodic malaria outbreaks, possibly influenced by asymptomatic Plasmodium infections. In addition, the identification and monitoring of the Plasmodium falciparum Kelch 13 (Pfk13) gene associated with artemisinin resistance are crucial for understanding the emergence and spread of drug-resistant malaria in endemic areas. OBJECTIVE: To determine the prevalence of asymptomatic Plasmodium infection and Pfk13 gene polymorphisms in the Ha-Lambani area in the absence of a malaria outbreak. METHODS: Finger-prick dried blood spots from 985 asymptomatic individuals were collected from November 2018 to May 2019. A P. falciparum-specific rapid diagnostic test (RDT) was used to test for Plasmodium infection. High-resolution melt (HRM) analysis was used to test for P. falciparum, P. ovale, P. vivax and P. malariae. The prevalence of Plasmodium infection was determined by the proportion of positive cases detected by at least one of the tests. The Pfk13 gene was amplified from P. falciparum-positive samples, sequenced by Sanger and Illumina next-generation sequencing (NGS) and analysed for genetic diversity and resistance mutations to artemisinin. RESULTS: A prevalence of 7.1% (70/985; 95% confidence interval (CI): 0.054 - 0.087) of Plasmodium infection was observed. The dominant species was P. ovale (57.14%; n=40), followed by P. falciparum (37.1%; n=26), P. malariae (1.43%) and P. vivax (1.43%). Mixed infections were P. falciparum/P. ovale (2.9%). Plasmodium infections differed significantly by village (p<0.01). The Pfk13 gene was amplified from 5/30 (95% CI: 0.03 - 0.29). Analysis of NGS reads revealed 57 single nucleotide polymorphisms (SNPs) across the Pfk13 gene (≥20% minority level). Up to 70.1% (39/57; 95% CI: 0.59 - 0.83) of the SNPs were non-synonymous and none was previously associated with artemisinin resistance. However, novel SNPs (H719Q, P701T, M472I, I526R and P443S) were detected in the propeller domain. CONCLUSION: A relatively high asymptomatic Plasmodium infection prevalence was observed in the study area, with P. ovale being the most prevalent species. Therefore, P. ovale infections may be missed with the Plasmodium RDT. R21 and RTS,S vaccines may not offer protection against P. ovale in the study area. Further research is needed to link asymptomatic infections in the study area and the periodic malaria outbreaks, and to determine the significance of the novel SNP in the Pfk13 gene.
Mshweshwe-Pakela N, Mabuto T, Lebyane R
… +4 more, Hamisi M, Gininza S, Chihota V, Hoffmann CJ
S Afr Med J
· 2025 Sep · PMID 41378556
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BACKGROUND: Most ongoing HIV infection is caused by individuals with undiagnosed or untreated HIV. HIV index testing services (ITS), also known as risk network recruitment, have been recommended by international and nati...BACKGROUND: Most ongoing HIV infection is caused by individuals with undiagnosed or untreated HIV. HIV index testing services (ITS), also known as risk network recruitment, have been recommended by international and national programmes to increase diagnosis of untreated people living with HIV (PLHIV) to link them to HIV treatment services. The scale of routine implementation of ITS is unclear. OBJECTIVES: To describe clinic-level adoption and implementation of ITS in South Africa (SA). METHODS: We used random sampling to select participating healthcare facilities from all nine SA provinces. A survey link was sent to a facility manager via email or WhatsApp. Summary statistics were used to describe the findings. RESULTS: From August 2022 to March 2024, we sent a survey link to 350 systematically sampled clinics; 305 (87.1%) completed the survey. Of those clinics, 260 (85.2%) reported some form of ITS implementation. More than half (n=166, 63.8%) reported using client (passive) referral. Available intimate partner violence (IPV) mitigation services provided counselling by lay HIV testing counsellors for most (n=215, 82.7%) facilities; 120 (46.1%) also had an on-site social worker to assist with IPV mitigation, and 12 (4.1%) had no IPV service available. Approximately half of the clinics offering ITS depended on a supporting non-governmental organisation to provide this service. CONCLUSION: ITS was reported to be provided by most public clinics in SA. However, the majority provided passive ITS, depending on the index client to refer their contacts to a local clinic for HIV testing. This approach had little evidence of effectiveness.
Bassett J, Schapkaitz E, Jacobson B
… +1 more, Essop R
S Afr Med J
· 2025 Sep · PMID 41378555
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BACKGROUND: Thromboprophylaxis significantly reduces the risk of venous thromboembolism (VTE) in hospitalised medical and surgical patients. Nonetheless, the implementation of thromboprophylaxis in South Africa (SA) and...BACKGROUND: Thromboprophylaxis significantly reduces the risk of venous thromboembolism (VTE) in hospitalised medical and surgical patients. Nonetheless, the implementation of thromboprophylaxis in South Africa (SA) and worldwide is low. OBJECTIVE: The TUNE-IN (The Use of venous thromboembolism prophylaxis in relatioN to patiEnt risk profilINg) Wave 3 study is an extension of TUNE-IN Wave 1 and 2. This prospective, cross-sectional study assessed the use of VTE thromboprophylaxis in hospitalised medical, surgical and orthopaedic patients. METHODS: Over a 9-month period, 451 consenting patients >18 years of age hospitalised at Charlotte Maxeke Johannesburg Academic Hospital in Gauteng, SA, were systematically included. Patients were assessed and risk stratified according to the IMPROVE (International Medical Prevention Registry on Venous Thromboembolism) bleeding risk and Caprini risk assessment tools. Data on the use of VTE thromboprophylaxis, agent and dose were collected from the hospital records. RESULTS: The study identified 180 (40%) medical, 198 (44%) surgical and 73 (16%) orthopaedic participants. VTE thromboprophylaxis was administered in 263 (58%) study participants. In accordance with the American College of Chest Physicians guidelines on VTE prevention, adequate thromboprophylaxis was administered in 233 (52%). The most common thromboprophylaxis agent was low molecular weight heparin. Subsequently, the Caprini risk assessment tool identified 337 participants (75%) with a VTE risk score >2, whereas the IMPROVE risk assessment tool identified 22 participants (5%) with a high bleeding risk score (≥7). In accordance with the risk assessment tools, recommended thromboprophylaxis was administered in 68% of medical, 59% of surgical and 79% of orthopaedic high-risk participants (p<0.012). The proportion of medical and surgical participants at high VTE risk was similar to that in the Wave 1 and/or 2 studies; however, the rates of VTE thromboprophylaxis in the present study were lower (p=0.097 for medical and p<0.001 for surgical participants). CONCLUSION: This study shows a significant gap between evidence-based thromboprophylaxis recommendations and clinical practice in a large sample of hospitalised medical, surgical and orthopaedic participants. It is recommended that an institutional VTE risk assessment tool be implemented to standardise risk evaluation and improve the administration of appropriate thromboprophylaxis for hospitalised patients.
Patel F, Le Roux J, Sawry S
… +12 more, Kieser R, Dhar M, Gill K, Lazarus E, Nana A, Garrett N, Moore PL, Sigal A, Gray G, Rees HV, Jacobson BF, Fairlie L
S Afr Med J
· 2025 Sep · PMID 41378554
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BACKGROUND: Rapid COVID-19 vaccine development occurred during the pandemic and vaccine-related complications such as thrombosis with thrombocytopenia syndrome were discovered. Clinical trials and treating facilities inc...BACKGROUND: Rapid COVID-19 vaccine development occurred during the pandemic and vaccine-related complications such as thrombosis with thrombocytopenia syndrome were discovered. Clinical trials and treating facilities included D-dimer testing in COVID-19 vaccine trials and COVID-19 disease-severity assessments, respectively. D-dimer testing and result interpretation is complex and its use in isolation is controversial. OBJECTIVES: To evaluate D-dimer levels in healthy adult participants regardless of HIV status, prior to and 2 weeks after receipt of fractional and full-dose Ad26.COV2.S or Comirnaty booster COVID-19 vaccination, after a full dose Ad26.COV2.S prime, stratified by booster vaccination arm, age and HIV status. METHODS: BaSiS, a prospective open-label trial, enrolled 289 healthy adults. Participants with controlled comorbidities, HIV infection with no immunological or virological exclusions, and no prior thrombosis enrolled at four sites in South Africa (SA). Participants previously received a single Ad26.COV2.S prime vaccination through the Sisonke phase IIIB open-label implementation study or the COVID-19 vaccine programme in SA. Participants were randomised 1:1:1:1 to receive one of four boosters: full-dose Ad26.COV2.S, half-dose Ad26.COV2.S, full-dose Comirnaty or half-dose Comirnaty. D-dimer testing (INNOVANCE D-dimer assay), as a coagulopathy marker, was conducted before the booster (baseline) and 2 weeks after the booster. The primary objectives previously reported included safety and immunogenicity of booster vaccination and fractional dosing with Ad26.COV2.S or Comirnaty in Ad26.COV2.S-vaccinated participants. An exploratory objective evaluating clotting profiles, measured by D-dimers, is reported here. RESULTS: The median age among 285 evaluable participants included in this analysis was 42.2 (interquartile range (IQR): 35.5 - 48.7) years; 82.5% (235/285) were female and 94.4% (269/285) were black African. Of the 40.4% (115/285) of people living with HIV, 79.1% (91/115) were well controlled on antiretroviral therapy. At baseline, 39.3% (112/285) of participants had elevated D-dimer levels ‒ all asymptomatic. Females and obese participants were significantly more likely to have elevated baseline D-dimer levels (adjusted odds ratio (aOR): 3.14, 95% confidence interval (CI): 1.32 - 7.48 and aOR: 2.20, 95% CI: 1.22 - 3.96, respectively). Of 276 participants with D-dimer results available at 2 weeks after the booster, 109 (39.5%) had elevated D-dimer levels. Those with elevated levels at baseline and female participants (aOR: 14.75, 95% CI: 7.64 - 28.48 and aOR: 3.24, 95% CI: 1.14 - 9.22, respectively) were significantly more likely to have elevated D-dimer levels at 2 weeks. CONCLUSION: Elevated D-dimer levels in asymptomatic, low-risk adults were unexpectedly common and not associated with thromboembolism. This supports the rationale of including D-dimer testing in conjunction with other coagulopathy markers, only if clinically indicated in both COVID-19 vaccine clinical trials and the general population.
S Afr Med J
· 2025 Sep · PMID 41378553
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Sodium nitrite (NaNO2) ingestion results in methaemoglobinaemia, which can cause hypoxia, metabolic acidosis and death. Sodium nitrite is an inorganic salt, easily accessible and widely used as a colourant, food preserva...Sodium nitrite (NaNO2) ingestion results in methaemoglobinaemia, which can cause hypoxia, metabolic acidosis and death. Sodium nitrite is an inorganic salt, easily accessible and widely used as a colourant, food preservative and corrosion inhibitor. Although previously rarely seen in medicolegal practice, sodium nitrite poisoning cases are increasing globally. This case series examines three fatalities investigated at the Observatory Forensic Pathology Institute (formerly Salt River Mortuary) in Cape Town, Western Cape Province, South Africa, between 2020 and 2023. The three cases involve sodium nitrite, with labelled containers found at the death scene. Postmortem findings included chocolate-brown discolouration of the blood, blue-grey discolouration of the nail beds and distinctive skin lividity. Toxicological analyses included ethanol, common drugs of abuse, methaemoglobin and sodium nitrite determined in various matrices. This report highlights the importance of thorough death scene investigations and challenges in ancillary testing, and contributes to the literature on sodium nitrite-related suicides. The accessibility and rapid lethality of the chemical underscore the need for greater awareness among medical professionals and policy-makers regarding its misuse.