South African Medical Journal (SAMJ)
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Confronting the bane of antimicrobial resistance
Confronting the bane of antimicrobial resistanc
Physical activity in obesity management
RECOMMENDATIONS
1. Aerobic PA (30 - 60 minutes of moderate to vigorous intensity most days of the week) can be considered for adults who want to:a. achieve small amounts of body weight and fat loss (Level 2a, Grade B)b. achieve reductions in abdominal visceral fat (Level 1a, Grade A) and ectopic fat such as liver and heart fat (Level 1a, Grade A),even in the absence of weight lossc. favour weight maintenance after weight loss (Level 2a, Grade B)d. favour the maintenance of fat-free mass during weight loss (Level 2a, Grade B)e. increase cardiorespiratory fitness (Level 2a, Grade B)[9] and mobility (Level 2a, Grade B).
2. For adults living with overweight or obesity, resistance training may promote weight maintenance or modest increases in muscle mass or fat-free mass and mobility (Level 2a, Grade B)
3. Increasing exercise intensity, including high-intensity interval training (HIIT), can achieve greater increases in cardiorespiratory fitness compared with moderate-intensity aerobic activity, and reduce the amount of time required to achieve similar benefits (Level 2a, Grade B).
4. Regular PA, with and without weight loss, can improve many cardiometabolic risk factors in adults who have overweight or obesity, including:
a. hyperglycaemia and insulin sensitivity (Level 2b, Grade B)
b. high blood pressure (Level 1a, Grade B)
c. dyslipidaemia (Level 2a, Grade B).
5. Regular PA can improve health-related quality of life, mood disorders (i.e. depression, anxiety) and body image in adults with overweight or obesity (Level 2b, Grade B)
The role of mental health in obesity management
RECOMMENDATIONS
1. We recommend regular monitoring of weight, glucose and lipid profile in people with a mental health diagnosis who are taking medications associated with weight gain (Level 3, Grade C).
2. Healthcare providers can consider both efficacy and effects on body weight when choosing psychiatric medications (Level 2a, Grade B).
3. Metformin and psychological treatment, such as CBT, should be considered for prevention of weight gain in people with severe mental illness who are treated with antipsychotic medications associated with weight gain (Level 1a, Grade A)
Optimising insulin use in people living with type 2 diabetes at primary healthcare facilities: The Tshwane Insulin Project
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
Early results of starting a fracture liaison service for fragility hip fractures in a regional South African hospital
Background. Fragility hip fracture is a rising pandemic, with the burden currently shifting to developing countries. A fracture liaison service (FLS) was implemented in September 2021 in a regional South African (SA) hospital.
Objective. To describe two groups of patients with surgically treated fragility hip fractures – those before and after implementation of the FLS – in terms of early mortality, refracture and readmission rates.
Methods. Patients aged >50 years who sustained hip fractures between January 2020 and June 2022 were considered; those with high-energy injuries, pathological and periprosthetic fractures were excluded. Associations between treatment group and mortality, readmission and refracture rates within the first year after surgery were investigated. Subgroup analyses were also conducted for specific risk factors.
Results. A total of 299 patients (mean (standard deviation) age of 74.5 (11.0) years, 68.2% female) were included, of whom 32.8% (n=98) received bisphosphonates. The overall 30-day, 90-day and 1-year mortality rates were 9.4% (n=28), 17.4% (n=52) and 29.8% (n=89), respectively, while 24.1% (n=72) of patients had unplanned readmissions to hospital, and 2.7% (n=8) refractured within the first year after surgery. No statistical difference in 30-day, 90-day or 1-year mortality rate, refracture incidence or readmission incidence was observed between patient groups. Time to surgery was shorter after the implementation of the FLS (median (interquartile range (IQR)) 30.8 (22.3 - 48.9) hours v. before (median (IQR) 42.5 (23.1 - 70.8) hours, p=0.039).
Conclusion. An FLS was successfully implemented in a regional SA hospital. Early mortality, refractures and readmission rates were low or comparable with the existing literature, and not affected by treatment within the FLS nor by bisphosphonate initiation. Treatment within the FLS, however, resulted in a decrease in time to surgery
Clot twist – D-dimer analysis of healthy adults receiving heterologous or homologous booster COVID-19 vaccine after a single prime dose of Ad26.COV2.S in a phase II randomised open-label trial, BaSiS
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
Acute cellular rejection in adult liver transplant recipients in Johannesburg, South Africa
Background. Wits Donald Gordon Medical Centre (WDGMC) in Johannesburg, South Africa, established a liver transplant programme in 2004. Acute cellular rejection (ACR) of the transplanted liver is a serious complication because of the potential for graft loss. ACR is defined as allograft dysfunction secondary to predominantly T-cell-mediated injury to the graft, and has been reported in up to 50% of liver transplants worldwide. While the advent of tacrolimus-based immunosuppression reduces the incidence of ACR in liver transplant recipients, it remains a concern.
Objectives. To review the incidence and risk factors for ACR, as well as the impact of ACR on graft survival in adult liver transplant recipients at WDGMC.
Methods. This was a retrospective review of first-time adult liver transplants performed from 1 January 2014 to 31 December 2022. Data collected included donor and recipient sociodemographic and clinical characteristics; transplant surgical procedure details; postoperative surgical complications; overall post-transplant ACR incidence rates in the first 365 days; ACR incidence stratified as early (≤90 days) and late (>91 days - <365 days); diagnosis and treatment details of biopsy-proven ACR episodes, including steroid resistance; and graft survival.
Results. Of 326 first-time adult liver transplants performed during the review period, 295 were eligible for inclusion. The post-transplant ACR incidence rates were 10.7% (early), 8.8% (late) and 20.3% overall (first 365 days). Corticosteroid resistance occurred in 19% of adult liver transplant recipients with biopsy-proven ACR. Risk factors for early ACR were younger recipient age, black ethnicity and male-donor- to-female-recipient sex discordance. A higher pre-transplant model for end-stage liver disease (MELD) score was a risk factor in late ACR. Younger recipient age, black ethnicity, female sex, acute liver failure, lower donor risk index scores and postoperative biliary complications were associated with increased risk for ACR in the first 365 days. ACR was not significantly associated with increased graft loss in this cohort.
Conclusion. While the incidence of ACR was low in this cohort, identification of ACR risk factors and presence of steroid-resistant ACR indicate the need for personalised and context-specific immunosuppression
An initial benchmark of the quality of the diagnosis and surgical treatment of breast cancer in South Africa
Background. Monitoring quality indicators to improve breast cancer care is well established in high-income countries. This is the first evaluation of diagnostic and surgical quality indicators for initial benchmarking of breast cancer care in South Africa (SA).
Objective. To measure the adherence rates to quality indicators among women with breast cancer in SA.
Methods. Ten quality indicators were evaluated for 3 545 breast cancer patients across four SA surgical breast units using a shared electronic patient record system. Data quality and adherence rates with differences between units were determined. The effect of HIV status on adherence was assessed by multivariate Poisson regression analyses.
Results. Our electronic patient record reliably measured most quality indicators. Rates of positive margins (5.7%), overall axillary surgery (95.8%) and appropriate treatment sequencing in locally advanced breast cancer patients (98.4%) consistently reached minimum international standards. Rates of multidisciplinary team discussion (72.2%), radiotherapy (66.7%) and sentinel node biopsy (39.6%) showed wide cross-site variance. Histopathology reporting (62.0%), breast-conserving surgery (19.4%) and number of nodes excised with axillary dissection (47.3%) and sentinel node biopsy (82.7%) were consistently below minimum standards. Unit volumes were achieved consistently in Gauteng Province, but only for some years in KwaZulu-Natal Province; surgeon volumes were achieved across all units. HIV status did not affect adherence levels. Most quality indicators were well measurable, but data quality on reoperations and surgeon volumes was poor.
Conclusion. We evaluated local quality indicators for an initial benchmark, and the most emergent gaps in care are the receipt of radiotherapy and underutilisation of sentinel node biopsy