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Open Access
A 52-Week Placebo-Controlled Trial of Evolocumab in Hyperlipidemia
(2014) Blom, Dirk J; Hala, Tomas; Bolognese, Michael; Lillestol, Michael J; Toth, Phillip D; Burgess, Lesley; Ceska, Richard; Roth, Eli; Koren, Michael J; Ballantyne, Christie M; Monsalvo, Maria Laura; Tsirtsonis, Kate; Kim, Jae B; Scott, Rob; Wasserman, Scott M; Stein, Evan A
BACKGROUND Evolocumab, a monoclonal antibody that inhibits proprotein convertase subtilisin/ kexin type 9 (PCSK9), significantly reduced low-density lipoprotein (LDL) cholesterol levels in phase 2 studies. We conducted a phase 3 trial to evaluate the safety and efficacy of 52 weeks of treatment with evolocumab. METHODS We stratified patients with hyperlipidemia according to the risk categories outlined by the Adult Treatment Panel III of the National Cholesterol Education Program. On the basis of this classification, patients were started on background lipid-lowering therapy with diet alone or diet plus atorvastatin at a dose of 10 mg daily, atorvastatin at a dose of 80 mg daily, or atorvastatin at a dose of 80 mg daily plus ezetimibe at a dose of 10 mg daily, for a run-in period of 4 to 12 weeks. Patients with an LDL cholesterol level of 75 mg per deciliter (1.9 mmol per liter) or higher were then randomly assigned in a 2:1 ratio to receive either evolocumab (420 mg) or placebo every 4 weeks. The primary end point was the percent change from baseline in LDL cholesterol, as measured by means of ultracentrifugation, at week 52. RESULTS Among the 901 patients included in the primary analysis, the overall least-squares mean (±SE) reduction in LDL cholesterol from baseline in the evolocumab group, taking into account the change in the placebo group, was 57.0±2.1% (P<0.001). The mean reduction was 55.7±4.2% among patients who underwent background therapy with diet alone, 61.6±2.6% among those who received 10 mg of atorvastatin, 56.8±5.3% among those who received 80 mg of atorvastatin, and 48.5±5.2% among those who received a combination of 80 mg of atorvastatin and 10 mg of ezetimibe (P<0.001 for all comparisons). Evolocumab treatment also significantly reduced levels of apolipoprotein B, non-high-density lipoprotein cholesterol, lipoprotein(a), and triglycerides. The most common adverse events were nasopharyngitis, upper respiratory tract infection, influenza, and back pain. CONCLUSIONS At 52 weeks, evolocumab added to diet alone, to low-dose atorvastatin, or to high-dose atorvastatin with or without ezetimibe significantly reduced LDL cholesterol levels in patients with a range of cardiovascular risks.
Open Access
Anemia in type 2 diabetic patients and correlation with kidney function in a tertiary care sub-Saharan African hospital: a cross-sectional study
(2016) Feteh, Vitalis F; Choukem, Simeon-Pierre; Kengne, André Pascal; Nebongo, Daniel N; Ngowe-Ngowe, Marcelin
BackgroundAnemia is common in diabetic patients and increases morbidity and mortality, but its burden has been less well characterized in sub-Saharan Africans. We determined the prevalence of anemia and investigated the related factors, with a particular focus on the role of declining renal function, in type 2 diabetic patients attending a tertiary health care institution in Cameroon.MethodsHemoglobin (Hb) levels were measured in a consecutive sample of patients with type 2 diabetes, who reported for annual review at the outpatient section of the Douala General Hospital in 2013. Patients were classified as anemic according to the World Health Organisation criteria (Hb < 12g/dl for females and Hb < 13g/dl for males). Estimated glomerular filtration rate (eGFR) was calculated using the abbreviated Modification of Diet in Renal Disease Study Group formula. Determinants of Hb concentration and anemia were investigated using multivariable logistic regressions.ResultsA total of 636 patients were examined including 263 (prevalence rate 41.4%) who had anemia. The prevalence of anemia increased significantly with deteriorating kidney function, although up to 31.9% of patients with normal kidney function had anemia. Compared with their non-anemic counterparts, anemic diabetic patients were older, had longer duration of diabetes, lower eGFR, higher prevalence of proteinuria and diabetic retinopathy (all p < 0.05). In multivariable logistic regressions, eGFR (p = 0.001) and presence of retinopathy (p = 0.023) were the independent determinants of prevalent anemia.ConclusionsThe prevalence of anemia is high in type 2 diabetic patients attending referral institutions in Cameroon, including among those without chronic kidney disease. Routine screening for anemia in all diabetic patients may aid early identification and correction as appropriate.
Open Access
APOL1 genetic variants, chronic kidney diseases and hypertension in mixed ancestry South Africans
(2015) Matsha, Tandi E; Pheiffer, Carmen; Masconi, Katya L; Yako, Yandiswa Y; Erasmus, Rajiv T
BackgroundThe frequencies of apolipoprotein L1 (APOL1) variants and their associations with chronic kidney disease (CKD) vary substantially in populations from Africa. Moreover, available studies have used very small sample sizes to provide reliable estimates of the frequencies of these variants in the general population. We determined the frequency of the two APOL1 risk alleles (G1 and G2) and investigated their association with renal traits in a relatively large sample of mixed-ancestry South Africans. APOL1 risk variants (G1: rs60910145 and rs73885319; G2: rs71785313) were genotyped in 859 African mixed ancestry individuals using allele-specific TaqMan technology. Glomerular filtration rate (eGFR) was estimated using the Modification of Diet in Renal Disease (MDRD) and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations.ResultsThe frequencies of rs73885319, rs60910145 and rs71785313 risk alleles were respectively, 3.6%, 3.4%, and 5.8%, resulting in a 1.01% frequency of the APOL1 two-risk allele (G1:G1 or G1:G2 or G2:G2). The presence of the two-risk allele increased serum creatinine with a corresponding reduction in eGFR (either MDRD or CKD-EPI based). In dominant and log-additive genetic models, significant associations were found between rs71785313 and systolic blood pressure (both p ≤ 0.025), with a significant statistical interaction by diabetes status, p = 0.022, reflecting a negative non-significant effect in nondiabetics and a positive effect in diabetics.ConclusionsAlthough the APOL1 variants are not common in the mixed ancestry population of South Africa, the study does provide an indication that APOL1 variants may play a role in conferring an increased risk for renal and cardiovascular risk in this population.
Open Access
Association between perceived built environmental attributes and physical activity among adults in South Africa
(2017) Malambo, Pasmore; Pheiffer, Carmen; Lambert, Estelle V; De Villers, Anniza; Puoane, Thandi
Abstract Background To investigate the association between perceived environmental attributes and leisure-time and transport-related physical activity. Methods This was a cross-sectional survey involving 671 South Africans aged ≥35 years from urban and rural settings. International Physical Activity Questionnaire and Neighbourhood Walkability Scale were used to collect data. Multivariable logistic regressions were used to investigate the associations. Results Significant urban vs. rural differences were apparent in the distribution of most attributes of neighborhood environment. After adjusting for gender, age, setting and relevant interaction terms, proximity to local stores was significantly associated with leisure-time physical activity (OR: 4.26; 95% CI, 1.00–18.08); while proximity to transit stops (2.44; 1.48–4.02), pleasant scenery (1.93; 1.07–3.46), sidewalks (2.36; 1.25–4.44), shade from trees (2.14; 1.19–3.85), traffic (2.17; 91.21–3.91) and well-lit streets (2.01; 1.04–3.89) were significantly associated with walking for leisure. Four-way intersections (4.54; 1.54–13.43), pleasant scenery (3.84; 1.35–10.99), traffic (0.28; 0.09–0.89), sidewalks (3.75; 1.06-13.27) and crosswalks were associated with transport related physical activity. Proximity to transit stops (2.12; 1.17–3.84) and well maintained sidewalks (2.69; 2.20–10.02) were significantly associated with total physical activity. Significant interactions by setting were apparent in some of the associations. Conclusion Some, but not all attributes of a neighborhood environment were significantly associated in expected directions with the three physical activity domains in this mixed urban and rural population. This study highlights the need for policy strategies aimed at improving or maintaining these perceived environmental attributes to promote physical activity.
Open Access
Blood-Pressure and Cholesterol Lowering in Persons without Cardiovascular Disease
(2016) Yusuf, Salim; Lonn, Eva; Pais, Prem; Bosch, Jackie; López-Jaramillo, Patricio; Zhu, Jun; Xavier, Denis; Avezum, Álvaro; Leiter, Lawrence A; Piegas, Leopoldo S; Parkhomenko, Alexander; Keltai, Matyas; Keltai, Katalin; Sliwa, Karen; Chazova, Irina; Peters, Ron JG; Held, Claes; Yusoff, Khalid; Lewis, Basil S; Jansky, Petr; Khunti, Kamlesh; Toff, William D; Reid, Christopher M; Varigos, John; Accini, Jose L; McKelvie, Robert; Pogue, Janice; Jung, Hyejung; Liu, Lisheng; Diaz, Rafael; Dans, Antonio; Dagenais, Gilles
BACKGROUND Elevated blood pressure and elevated low-density lipoprotein (LDL) cholesterol increase the risk of cardiovascular disease. Lowering both should reduce the risk of cardiovascular events ...
Open Access
Blood-Pressure Lowering in Intermediate-Risk Persons without Cardiovascular Disease
(2016) Lonn, Eva M; Bosch, Jackie; López-Jaramillo, Patricio; Zhu, Jun; Liu, Lisheng; Pais, Prem; Diaz, Rafael; Xavier, Denis; Sliwa, Karen; Dans, Antonio; Avezum, Álvaro; Piegas, Leopoldo S; Keltai, Katalin; Keltai, Matyas; Chazova, Irina; Peters, Ron JG; Held, Claes; Yusoff, Khalid; Lewis, Basil S; Jansky, Petr; Parkhomenko, Alexander; Khunti, Kamlesh; Toff, William D; Reid, Christopher M; Varigos, John; Leiter, Lawrence A; Molina, Dora I; McKelvie, Robert; Pogue, Janice; Wilkinson, Joanne; Jung, Hyejung; Dagenais, Gilles
Antihypertensive therapy reduces the risk of cardiovascular events among high-risk persons and among those with a systolic blood pressure of 160 mm Hg or higher, but its role in persons at intermediate risk and with lower blood pressure is unclear. In one comparison from a 2-by-2 factorial trial, we randomly assigned 12,705 participants at intermediate risk who did not have cardiovascular disease to receive either candesartan at a dose of 16 mg per day plus hydrochlorothiazide at a dose of 12.5 mg per day or placebo. The first coprimary outcome was the composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke; the second coprimary outcome additionally included resuscitated cardiac arrest, heart failure, and revascularization. The median follow-up was 5.6 years. The mean blood pressure of the participants at baseline was 138.1/81.9 mm Hg; the decrease in blood pressure was 6.0/3.0 mm Hg greater in the active-treatment group than in the placebo group. The first coprimary outcome occurred in 260 participants (4.1%) in the active-treatment group and in 279 (4.4%) in the placebo group (hazard ratio, 0.93; 95% confidence interval [CI], 0.79 to 1.10; P=0.40); the second coprimary outcome occurred in 312 participants (4.9%) and 328 participants (5.2%), respectively (hazard ratio, 0.95; 95% CI, 0.81 to 1.11; P=0.51). In one of the three prespecified hypothesis-based subgroups, participants in the subgroup for the upper third of systolic blood pressure (>143.5 mm Hg) who were in the active-treatment group had significantly lower rates of the first and second coprimary outcomes than those in the placebo group; effects were neutral in the middle and lower thirds (P=0.02 and P=0.009, respectively, for trend in the two outcomes). Therapy with candesartan at a dose of 16 mg per day plus hydrochlorothiazide at a dose of 12.5 mg per day was not associated with a lower rate of major cardiovascular events than placebo among persons at intermediate risk who did not have cardiovascular disease. (Funded by the Canadian Institutes of Health Research and AstraZeneca; ClinicalTrials.gov number, NCT00468923.)
Open Access
Conference on "Multidisciplinary approaches to nutritional problems". Symposium on "Diabetes and health". Nutrition interventions for the prevention of type 2 diabetes.
(2009) Steyn, Nelia P; Lambert, Estelle V; Tabana, Hanani
Diabetes mellitus is escalating globally and it is predicted that 200 million individuals worldwide will have diabetes by 2010 and 300 million by 2025. However, there is compelling evidence from many studies that for subjects with impaired fasting glucose or impaired glucose tolerance the presentation of type 2 diabetes can be delayed by lifestyle modification. The aim of the present review is to present a summary of lifestyle modification interventions that have included a dietary component in their overall diabetes prevention programme. Medline, allied health literature and diabetes journals were searched for peer-reviewed literature using the terms 'diet*' and 'diabetes' and 'intervention'. Inclusion criteria were: peer-reviewed studies from 1975 to 2008; a sample of at least fifty subjects; a healthy eating and/or physical activity component; prevention of diabetes as a primary goal. Generally, the participants were in a high-risk category for the development of diabetes. Outcomes were evaluated at two points in time (pre- and post-intervention) in terms of knowledge, behaviour change and clinical improvement, which included weight, blood pressure, BMI, body fat, waist circumference, waist:hip ratio and physiological and/or biochemical measures. Findings indicate that the most successful interventions combine individual dietary counselling with an activity component. Further factors predicting success are weight loss achieved, duration and intensity of the intervention and dietary compliance.
Open Access
Development and validation of a short questionnaire to assess sodium intake
(2008) Charlton, Karen E; Steyn, Krisela; Levitt, Naomi S; Jonathan, Deborah; Zulu, Jabulisiwe V; Nel, Johanna H
OBJECTIVES: To develop and validate a short food-frequency questionnaire to assess habitual dietary salt intake in South Africans and to allow classification of individuals according to intakes above or below the maximum recommended intake of 6 g salt day-1. DESIGN: Cross-sectional validation study in 324 conveniently sampled men and women. METHODS: Repeated 24-hour urinary Na values and 24-hour dietary recalls were obtained on three occasions. Food items consumed by >5% of the sample and which contributed > or =50 mg Na serving-1 were included in the questionnaire in 42 categories. A scoring system was devised, based on Na content of one index food per category and frequency of consumption. RESULTS: Positive correlations were found between Na content of 35 of the 42 food categories in the questionnaire and total Na intake, calculated from 24-hour recall data. Total Na content of the questionnaire was associated with Na estimations from 24-hour recall data (r = 0.750; P < 0.0001; n = 328) and urinary Na (r = 0.152; P = 0.0105; n = 284). Urinary Na was higher for subjects in tertile 3 than tertile 1 of questionnaire Na content (P < 0.05). Questionnaire Na content of <2400 and > or =2400 mg day-1 equated to a reference cut-off score of 48 and corresponded to mean (standard deviation) urinary Na values of 145 (68) and 176 (99) mmol day-1, respectively (P < 0.05). Sensitivity and specificity against urinary Na > or =100 and <100 mmol day-1 was 12.4% and 93.9%, respectively. CONCLUSION: A 42-item food-frequency questionnaire has been shown to have content-, construct- and criterion-related validity, as well as internal consistency, with regard to categorising individuals according to their habitual salt intake; however, the devised scoring system needs to show improved sensitivity.
Open Access
Does sentinel lymph node biopsy have a role in node-positive head and neck squamous carcinoma?
(2013) Edkins, O; Hofmeyr, C; Fagan, J
OBJECTIVES/HYPOTHESIS: The objective of the study was to determine whether sentinel lymph node biopsy (SLNB) can be used to reduce clinical overstaging of cervical nodes in head and neck squamous cell carcinoma (SCC) in a developing world setting. STUDY DESIGN: Sentinel and echelon lymph nodes were identified by means of a combination of lymphoscintigraphy, gamma probe and blue dye identification. They were analysed histologically and their pathological status was compared with the rest of the neck dissection specimen to determine diagnostic accuracy in patients with T1-4 N0-3 SCC of the oral cavity or oropharynx undergoing primary surgical resection and neck dissection. RESULTS: Thirty-three patients were included in the study, 13 in the node-negative (N0) and 20 in the node-positive (N+) group. In the clinically N0 group the sensitivity of SLNB was 100% and the negative predictive value (NPV) 100%. In the clinically N+ group the sensitivity was 71% and the NPV 60% for staging the nodal status of the neck. CONCLUSIONS; The accuracy of SLNB in the clinically N+ neck is too low for SLNB to be a means of avoiding comprehensive neck dissection. LEVEL OF EVIDENCE: 2B.
Open Access
Door-to-needle time for administration of fibrinolytics in acute myocardial infarction in Cape Town
(2012) Maharaj, Roshen C; Geduld, Heike; Wallis, Lee A
OBJECTIVES: To determine the current door-to-needle time for the administration of fibrinolytics for acute myocardial infarction (AMI) in emergency centres (ECs) at three hospitals in Cape Town, and to compare it with the American Heart Association/American College of Cardiology (AHA/ACC) recommendation of 30 minutes as a marker of quality of care. METHODS: A retrospective review of case notes from January 2008 to July 2010 of all patients receiving thrombolytics for AMI in the ECs of three Cape Town hospitals. The total door-to-needle time was calculated and patient demographics and presentation, physician qualification, clinical symptomology and reasons for delays in thromobolytic administration were analysed. RESULTS: A total of 372 patients with acute ST elevation myocardial infarction (STEMI) were identified; 161 patients were eligible for the study. The median door-to-needle time achieved was 54 minutes (range 13 - 553 mins). A door-to-needle time of 30 minutes or less was achieved in 33 (20.5%) patients; 51.3% of the patients arrived by ambulance; 34% of patients had a pre-hospital 12-lead ECG; and 88.8% had typical symptoms of myocardial infarction. Medical officers administered thrombolytics to 44.7% of the patients. The predominant infarct location on ECG was inferior (55.9%). CONCLUSION: A significant number of patients were not thrombolysed within 30 minutes of presentation. The lack of senior doctors, difficulty interpreting ECGs, atypical presentations and EC system delays prolonged the door-to-needle time in this study.
Open Access
Efficacy and Safety of Evolocumab in Reducing Lipids and Cardiovascular Events
(2015) Sabatine, Marc S; Giugliano, Robert P; Wiviott, Stephen D; Raal, Frederick J; Blom, Dirk J; Robinson, Jennifer; Ballantyne, Christie M; Somaratne, Ransi; Legg, Jason; Wasserman, Scott M; Scott, Robert; Koren, Michael J; Stein, Evan A
BACKGROUND: Evolocumab, a monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9), significantly reduced low-density lipoprotein (LDL) cholesterol levels in short-term studies. We conducted two extension studies to obtain longer-term data. METHODS: In two open-label, randomized trials, we enrolled 4465 patients who had completed 1 of 12 phase 2 or 3 studies ("parent trials") of evolocumab. Regardless of study-group assignments in the parent trials, eligible patients were randomly assigned in a 2:1 ratio to receive either evolocumab (140 mg every 2 weeks or 420 mg monthly) plus standard therapy or standard therapy alone. Patients were followed for a median of 11.1 months with assessment of lipid levels, safety, and (as a prespecified exploratory analysis) adjudicated cardiovascular events including death, myocardial infarction, unstable angina, coronary revascularization, stroke, transient ischemic attack, and heart failure. Data from the two trials were combined. RESULTS: As compared with standard therapy alone, evolocumab reduced the level of LDL cholesterol by 61%, from a median of 120 mg per deciliter to 48 mg per deciliter (P<0.001). Most adverse events occurred with similar frequency in the two groups, although neurocognitive events were reported more frequently in the evolocumab group. The risk of adverse events, including neurocognitive events, did not vary significantly according to the achieved level of LDL cholesterol. The rate of cardiovascular events at 1 year was reduced from 2.18% in the standard-therapy group to 0.95% in the evolocumab group (hazard ratio in the evolocumab group, 0.47; 95% confidence interval, 0.28 to 0.78; P=0.003). CONCLUSIONS: During approximately 1 year of therapy, the use of evolocumab plus standard therapy, as compared with standard therapy alone, significantly reduced LDL cholesterol levels and reduced the incidence of cardiovascular events in a prespecified but exploratory analysis. (Funded by Amgen; OSLER-1 and OSLER-2 ClinicalTrials.gov numbers, NCT01439880 and NCT01854918.).
Open Access
Efficacy of budesonide/formoterol maintenance and reliever therapy compared with higher-dose budesonide as step-up from low-dose inhaled corticosteroid treatment
(2017) Jenkins, Christine R; Eriksson, Göran; Bateman, Eric D; Reddel, Helen K; Sears, Malcolm R; Lindberg, Magnus; O’Byrne, Paul M
Asthma management may involve a step up in treatment when symptoms are not well controlled. We examined whether budesonide/formoterol maintenance and reliever therapy (MRT) is as effective as higher, fixed-dose budesonide plus as-needed terbutaline in patients requiring step-up from Step 2 treatment (low-dose inhaled corticosteroids), stratified by baseline reliever use.
Open Access
Glucose tolerance, MTHFR C677T and NOS3 G894T polymorphisms, and global DNA methylation in mixed ancestry African individuals
(2016) Matsha, Tandi E; Pheiffer, Carmen; Pheiffer, Carmen
The aim of this study is to quantify global DNA methylation and investigate the relationship with diabetes status and polymorphisms in MTHFR C677T and NOS3 G894T genes in mixed ancestry subjects from South Africa. Global DNA methylation was measured, and MTHFR rs1801133 and NOS3 rs1799983 polymorphisms were genotyped using high throughput real-time polymerase chain reaction and direct DNA sequencing. Of the 564 participants, 158 (28%) individuals had T2DM of which 97 (17.2%) were screen-detected cases. Another 119 (21.1%) had prediabetes, that is, impaired fasting glucose, impaired glucose tolerance, or the combination of both, and the remainder 287 (50.9%) had normal glucose tolerance. Global DNA methylation was significantly higher in prediabetes and screen-detected diabetes than in normal glucose tolerance (both ) and in screen-detected diabetes compared to known diabetes on treatment (). There was no difference in global DNA methylation between known diabetes on treatment and normal glucose tolerance (). In multivariable linear regression analysis, only NOS3 was associated with increasing global DNA methylation (; 95% CI: 0.286 to 1.560). The association of global DNA methylation with screen-detected diabetes but not treated diabetes suggests that glucose control agents to some extent may be reversing DNA methylation. The association between NOS3 rs1799983 polymorphisms and DNA methylation suggests gene-epigenetic mechanisms through which vascular diabetes complications develop despite adequate metabolic control.
Open Access
Health risks of the clean-shave chiskop haircut
(2013) Khumalo, Nonhlanhla P; Gantsho, Nomphelo; Gumedze, Freedom; Mthebe, Thami
The clean-shave haircut known locally as the chiskop is rare among females but popular with black South African men, who are also predisposed to folliculitis keloidalis nuchae (FKN) (keloids on the back of the head). During a previous study, participants described an unexpected symptom of haircut-associated bleeding. As this is not a widely recognised entity, we conducted the present study at an HIV clinic servicing the same population, with the objective of comparing the prevalences of haircut-associated bleeding and FKN in 390 HIV-positive subjects with published data for Langa (Western Cape, South Africa). The results for HIV-positive participants were similar to the population data, but in both groups the prevalence of haircut-associated bleeding (24.5% v. 32%; p =0.17) was much higher than that of FKN (10.2% v. 10.5%), suggesting that the hairstyle increases the risk of bleeding even in people with healthy scalps without folliculitis. This study does not (and was not intended to) prove a higher HIV prevalence in chiskop wearers or in FKN sufferers, but it confirms a history of haircut-associated bleeding in at least a quarter of our male study participants. The risk of transmission of blood-borne infection via haircuts is likely to be low, but requires formal quantification. Public education on adequate sterilisation of barber equipment between haircuts and promotion of individual hair-clipper ownership for chiskop clients should not be delayed. Depilatory creams formulated for African hair offer a non-mechanical means of achieving clean-shave hairstyles.
Open Access
Health-related quality of life and its association with medication adherence in active pulmonary tuberculosis– a systematic review of global literature with focus on South Africa
(2016) Kastien-Hilka, Tanja; Abulfathi, Ahmed; Rosenkranz, Bernd; Bennett, Bryan; Schwenkglenks, Matthias; Sinanovic, Edina
IntroductionTuberculosis (TB) is a leading cause of morbidity and mortality in South Africa. Clinical parameters are important objective outcomes in TB; however they often are not directly correlated with subjective well-being of the patient, but can be assessed using patient-reported outcome (PRO) measures. Health-related quality of life (HRQOL) is a specific PRO generally multi-dimensional in nature and includes physical, mental and social health domains. The inclusion of HRQOL PROs in trials and clinical practice can provide additional information beyondclinical and microbiological parameters. Furthermore, HRQOL may be associated with medication adherence. This review focuses on patient-reported HRQOL and its association with medication adherence in TB patients in South Africa.MethodsA comprehensive search strategy was developed focusing on the impact of TB on patient-reported HRQOL,the existence of a conceptual framework of TB-specific HRQOL, determinants of medication adherence and the association of HRQOL with medication adherence. Data were extracted from all identified articles and additionaldata extraction was performed by two independent reviewers with special focus on longitudinal studies in order to understand changes of HRQOL and adherence over time. Research gaps were identified with regard to patient-reported HRQOL and medication adherence.ResultsA total of 66 articles met the eligibility criteria. Ten HRQOL studies and one adherence study used a longitudinal design, none of these in South Africa. A variety of different generic and disease-specific HRQOL measures were identified in the articles. In South Africa four HRQOL and five adherence studies (non-longitudinal) were published. Similar factors (socio-demographic, socio-economic, disease-related, therapy-related and psycho-social aspects) affect HRQOL and adherence. Although standard TB treatment improved all health domains, psychological well-being and social functioning remained impaired in microbiologically cured patients after treatment.ConclusionWhile evidence of TB impact on HRQOL and medication adherence and their association exists, it is verylimited for the South African situation. No valid and reliable TB-specific HRQOL measures were identified in this systematicreview. An assessment of HRQOL in TB patients in South Africa is required as this may assist with improving current disease management programmes, medication adherence and national treatment guidelines.Electronic supplementary materialThe online version of this article (doi:10.1186/s12955-016-0442-6) contains supplementary material, which is available to authorized users.
Open Access
HIV risk perception and behavior among medically and traditionally circumcised males in South Africa
(2016) Zungu, N P; Simbayi, L C; Mabaso, M; Evans, M; Zuma, K; Ncitakalo, N; Sifunda, S
Abstract Background In South Africa, voluntary medical male circumcision (VMMC) has recently been implemented as a strategy for reducing the risk of heterosexual HIV acquisition among men. However, there is some concern that VMMC may lead to low risk perception and more risky sexual behavior. This study investigated HIV risk perception and risk behaviors among men who have undergone either VMMC or traditional male circumcision (TMC) compared to those that had not been circumcised. Methods Data collected from the 2012 South African national population-based household survey for males aged 15 years and older were analyzed using bivariate and multivariate multinomial logistic regression, and relative risk ratios (RRRs) with 95 % confidence interval (CI) were used to assess factors associated with each type of circumcision relative no circumcision. Results Of the 11,086 males that indicated that they were circumcised or not, 19.5 % (95 % CI: 17.9–21.4) were medically circumcised, 27.2 % (95 % CI: 24.7–29.8) were traditionally circumcised and 53.3 % (95 % CI: 50.9–55.6) were not circumcised. In the final multivariate models, relative to uncircumcised males, males who reported VMMC were significantly more likely to have had more than two sexual partners (RRR = 1.67, p = 0.009), and males who reported TMC were significantly less likely to be low risk alcohol users (RRR = 0.72, p < 0.001). Conclusion There is a need to strengthen and improve the quality of the counselling component of VMMC with the focus on education about the real and present risk for HIV infection associated with multiple sexual partners and alcohol abuse following circumcision.
Open Access
Human resource management practices in a medical complex in the Eastern Cape, South Africa: Assessing their impact on the retention of doctors
(2014) Longmore, Bruce; Ronnie, Linda
BACKGROUND: Human resource management (HRM) practices have the potential to influence retention of doctors in the public health sector. OBJECTIVE: To explore the key human resource (HR) practices affecting doctors in a medical complex in the Eastern Cape, South Africa. METHODS: We used an open-ended questionnaire to gather data from 75 doctors in this setting. RESULTS: The most important HR practices were paying salaries on time and accurately, the management of documentation, communication, HR staff showing that they respected and valued the doctors, and reimbursement for conferences and special leave requests. All these practices were judged to be poorly administered. Essential HR characteristics were ranked in the following order: task competence of HR staff, accountability, general HR efficiency, occupation-specific dispensation adjustments and performance management and development system efficiency, and availability of HR staff. All these characteristics were judged to be poor. CONCLUSION: HRM practices in this Eastern Cape medical complex were inadequate and a source of frustration. This lack of efficiency could lead to further problems with regard to retaining doctors in public sector service.
Open Access
Indices of Paraoxonase and Oxidative Status Do Not Enhance the Prediction of Subclinical Cardiovascular Disease in Mixed-Ancestry South Africans
(2014) Macharia, M; Kengne, A P; Blackhurst, D M; Erasmus, R T; Hoffmann, M; Matsha, T E
We evaluated the association of indices of paraoxonase (PON1) and oxidative status with subclinical cardiovascular disease (CVD) in mixed-ancestry South Africans. Participants were 491 adults (126 men) who were stratified by diabetes status and body mass index (BMI). Carotid intima-media thickness (CIMT) was used as a measure of subclinical CVD. Indices of PON1 and oxidative status were determined by measuring levels and activities (paraoxonase and arylesterase) of PON1, antioxidant activity (ferric reducing antioxidant power and trolox equivalent antioxidant capacity), and lipid peroxidation markers (malondialdehyde and oxidized LDL). Diabetic subjects (28.9%) displayed a significant decrease in PON1 status and antioxidant activity as well as increase in oxidized LDL and malondialdehyde. A similar profile was apparent across increasing BMI categories. CIMT was higher in diabetic than nondiabetic subjects but showed no variation across BMI categories. Overall, CIMT correlated negatively with indices of antioxidant activity and positively with measures of lipid oxidation. Sex, age, BMI, and diabetes altogether explained 29.2% of CIMT, with no further improvement from adding PON1 and/or antioxidant status indices. Though indices of PON1 and oxidative status correlate with CIMT, their measurements may not be useful for identifying subjects at high CVD risk in this population.
Open Access
Introducing a national health insurance system in South Africa: A general practitioner’s bottom-up approach to costing
(2012) Moosa, Shabir; Luiz, John M; Carmichael, Teresa
BACKGROUND: The introduction of national health insurance (NHI) is an important debate in South Africa, with affordability and institutional capacity being the key issues. NHI costing has been dominated by estimates of exorbitant cost. However, capitation is not only a different payment system but also a different service delivery model, and as a result there are opportunities for risk management and efficiencies. OBJECTIVE: This study explores how private general practitioners (GPs) may choose to embrace these service delivery concepts and deal with the cost implications to meet NHI requirements. METHODS: Data were collected from 598 solo private GPs through a self-administered online questionnaire survey across South Africa. RESULTS: In spite of poor engagement with the public sector, and some challenges in costing and organisation, GPs appear to have an affordable and pro-active response to NHI capitation costing and fee setting. On average, they would accept a minimum global fee of R4.03 million to look after a population of 10 000 people for personal healthcare services. CONCLUSION: At a total cost to the country of R16.9 billion, government could affordably use GPs to develop the primary health care part of NHI to cover the entire South African uninsured population. It is anticipated that a similar approach would be successful in other developing countries.
Open Access
Lack of paradoxical bronchoconstriction after administration of tiotropium via Respimat® Soft Mist™ Inhaler in COPD
(2011) Hodder, Rick; Lee, Angela; Bateman, Eric
Bronchoconstriction has been reported in asthma and chronic obstructive pulmonary disease (COPD) patients after administration of some aqueous inhalation solutions. We investigated the incidence of this event during long-term clinical trials of tiotropium delivered via Respimat® Soft Mist™ Inhaler (SMI). We retrospectively analyzed pooled data from two identical Phase III clinical trials, in which 1990 patients with COPD received 48 weeks’ treatment with once-daily tiotropium (5 or 10 μg) or placebo inhaled via Respimat® SMI. We recorded the incidence of bronchospasm and of a range of respiratory events that could suggest bronchoconstriction during the first 30 minutes after inhalation of study treatment on each of the eight test days. No patients reported bronchospasm. Six patients (0.3%) reported a combination of at least two events suggestive of bronchoconstriction, and 21 (1.1%) reported either rescue medication use or a respiratory adverse event. Asymptomatic falls in forced expiratory volume in one second (FEV1) of ≥15% were recorded on all test days, with no change in incidence over time, and affected 8.2% of those in the tiotropium groups and 14.5% of those on placebo. In COPD patients receiving long-term treatment with tiotropium 5 or 10 μg via Respimat® SMI, no bronchospasm was recorded, and the number of events possibly indicative of paradoxical bronchoconstriction was very low.