South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde最新文献

{"title":"Point-of-care CD4+ technology implementation in Free State, South Africa, was associated with improved patient health outcomes.","authors":"L Van Turha,&nbsp;K Maharaj,&nbsp;A Rose,&nbsp;C Boeke,&nbsp;T F Peter,&nbsp;L Vojnov,&nbsp;J Quevedo,&nbsp;Y Tsibolane","doi":"10.7196/SAMJ.2020.v110i2.13823","DOIUrl":"https://doi.org/10.7196/SAMJ.2020.v110i2.13823","url":null,"abstract":"BACKGROUND Point-of-care (POC) CD4+ technologies have the potential to increase patient access to treatment and care through rapid testing and result delivery at or close to where patients seek care. South African (SA) guidelines suggest the use of CD4+ testing to prioritise patients most in need of antiretroviral therapy (ART) and to support identification of patients with advanced HIV disease and opportunistic management of patients on ART. Understanding the patient impact of implementing POC CD4+ testing in the intended setting and operated by lower cadres of healthcare worker or non-professional healthcare facility staff will provide valuable insight into the appropriate use and placement of POC CD4+ technologies throughout SA. OBJECTIVES To determine the patient impact (turnaround time of tests, loss to follow-up, and proportions of eligible patients proceeding to the next steps in the testing and treatment cascade) of implementing POC CD4+ testing technologies compared with conventional laboratory-based CD4+ testing. METHODS This retrospective cohort study included all HIV-positive adults from 30 healthcare facilities in Free State Province, SA. Healthcare facilities were placed into two groups (POC and laboratory referral) using a stratified randomisation technique based on the presence of a POC CD4+ technology and minimal ART volumes. Patients who received a CD4+ test prior to ART initiation between September 2012 and September 2014 were included. Data were collected from patient charts and the POC devices. RESULTS For new patients, the average time from HIV diagnosis and CD4+ testing was reduced from 7.6 days in the laboratory referral group to 4.5 days in the POC group, a decrease of almost 60%. Additionally, 59.6% of patients in the POC group received their HIV diagnosis and CD4+ test result on the same day, compared with 37.5% in the laboratory referral group (risk ratio (RR) 1.49; 95% confidence interval (CI) 1.01 - 2.18). Fewer patients were lost between HIV diagnosis and CD4+ testing (2.7% v. 8.6%) (RR 0.02; 95% CI 0.05 - 0.78) in the POC group. The average test error rate across the study time period was 8.4%; however, the error rate remained <5% for the final 5 months of the study. CONCLUSIONS Introduction of the Alere Pima POC CD4+ technology in the Free State, operated by nurses and lay counsellors, was associated with positive patient outcomes across all parameters analysed. While this study highlighted an effective conventional laboratory network, a full costing and affordability analysis coupled with patient impact and access data from this study will provide further insight into the potential deployment strategies of POC CD4+ technologies in SA.","PeriodicalId":520778,"journal":{"name":"South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde","volume":" ","pages":"126-131"},"PeriodicalIF":2.2,"publicationDate":"2020-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.7196/SAMJ.2020.v110i2.13823","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38153210","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An analysis of recent stroke cases in South Africa: Trend, seasonality and predictors.","authors":"E Ranganai,&nbsp;L Matizirofa","doi":"10.7196/SAMJ.2020.v110i2.013891","DOIUrl":"https://doi.org/10.7196/SAMJ.2020.v110i2.013891","url":null,"abstract":"<p><strong>Background: </strong>South Africa (SA) is experiencing an epidemiological transition as a result of sociodemographic and lifestyle changes. This process is leading to an increase in non-communicable diseases, which in turn may result in an upswing of stroke cases. Stroke is among the top 10 leading causes of disability in SA, and accounts for ~25 000 deaths annually and 95 000 years lived with disability (YLD). This huge burden of stroke hampers socioeconomic development as a result of YLD.</p><p><strong>Objectives: </strong>To investigate the seasonality and trend of stroke cases in SA, and determine the risk factors associated with stroke.</p><p><strong>Methods: </strong>Using recent hospital-based data (January 2014 - December 2017 inclusive) from SA private and public hospitals (33% private and 67% public), a sample of 14 645 suspected stroke cases was drawn. Associations between suspected stroke cases and potential predictors were assessed using χ2 tests and bivariate analysis. Time series analysis tools for trend and seasonality components included both time domain and frequency domain techniques. A Poisson generalised linear model was used, as there was no over-dispersion inherent in the data. Multiple logistic regression analysis was used to assess the effect of several predictors on stroke cases.</p><p><strong>Results: </strong>Of the 14 645 suspected cases of stroke, 51.5% were confirmed. Seasonality analysis gave an approximate seasonal change of 120  cases, the highest seasonal peak occurring in mid-winter and the lowest dip in mid-summer. Both upward trend and seasonality parameters were found to be statistically significant. Predictors significantly associated with an increased likelihood of stroke were heart problems (odds ratio (OR) 8.86; 95% confidence interval (CI) 8.23 - 9.55; p&lt;0.0001), diabetes (OR 14.53; 95% CI 13.36 - 15.79; p&lt;0.0001), female sex (OR 18.23; 95% CI 16.75 - 19.85; p&lt;0.0001), age 59 - 77 years (OR 1.37; 95% CI 1.24 - 1.50; p&lt;0.0001) and 78 - 98 years (OR 1.25; 95% CI 1.16 - 1.35; p&lt;0.0001) and white ethnic group (OR 2.00; 95% CI 1.86 - 2.15; p&lt;0.0001), compared with the respective reference groups. The prevalence ratios of stroke cases as measured by Poisson regression were in agreement with logistic regression results.</p><p><strong>Conclusions: </strong>The increasing trend of stroke in SA should be arrested urgently, taking into account both the associated risk factors and seasonality.</p>","PeriodicalId":520778,"journal":{"name":"South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde","volume":" ","pages":"92-99"},"PeriodicalIF":2.2,"publicationDate":"2020-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.7196/SAMJ.2020.v110i2.013891","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38152744","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Maternal and neonatal outcomes following the introduction of oral hypoglycaemic agents for gestational diabetes mellitus were comparable to insulin monotherapy in two historical cohorts.","authors":"V Nicolaou,&nbsp;L Soepnel,&nbsp;K R Huddle,&nbsp;N Levitt,&nbsp;K Klipstein-Grobusch,&nbsp;S A Norris","doi":"10.7196/SAMJ.2020.v110i2.14024","DOIUrl":"https://doi.org/10.7196/SAMJ.2020.v110i2.14024","url":null,"abstract":"<p><strong>Background: </strong>Gestational diabetes mellitus (GDM), a disorder of glucose intolerance first encountered during pregnancy, has far-reaching implications for both mother and child. Insulin therapy remains the 'gold standard' of care, with oral hypoglycaemic agents (OHAs) increasingly being viewed as potential alternatives.</p><p><strong>Objectives: </strong>To compare maternal and neonatal outcomes in two cohorts of women with GDM exposed to either insulin monotherapy or OHAs.</p><p><strong>Methods: </strong>A retrospective medical record review at Chris Hani Baragwanath Academic Hospital in South Africa was conducted for women with GDM diagnosed using the 100 g oral glucose tolerance test and/or random capillary blood glucose &gt;11.1 mmol/L in 2010 - 2014. The findings were compared with a previous audit at the same clinic for the period 1992 - 2002. Variables of interest included maternal demographics, maternal comorbidities, glycaemic indices, treatments used during pregnancy, and obstetric and neonatal outcomes.</p><p><strong>Results: </strong>A total of 192 women with GDM were identified for 2010 - 2014, and there were 348 women in the previous audit (1992 - 2002). Baseline characteristics and outcomes of women in the two cohorts were similar apart from earlier presentation (mean (standard deviation) gestational age (GA) 27 (7.5) weeks v. 28.3 (6.4) weeks; p=0.04), lower GA at delivery (36.3 (3.6) weeks v. 37 (1.6) weeks); p=0.008) and lower macrosomia rates (12.5% v. 4.9%; p=0.011) in the later cohort. When comparing the individual OHAs against insulin in the later cohort, both agents were comparable to insulin in terms of maternal and neonatal outcomes.</p><p><strong>Conclusions: </strong>This study contributes to the paucity of data on the safety of OHAs in GDM pregnancy in terms of maternal and neonatal outcomes. OHAs were shown to be an effective alternative to insulin for women with GDM in whom lifestyle measures fail, particularly in a resource-poor setting.</p>","PeriodicalId":520778,"journal":{"name":"South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde","volume":" ","pages":"154-158"},"PeriodicalIF":2.2,"publicationDate":"2020-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.7196/SAMJ.2020.v110i2.14024","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38153180","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A decade of hepatitis C at the University of Cape Town/Groote Schuur Hospital Liver Clinic, South Africa, in the pre-direct-acting antivirals era.","authors":"R Nordien,&nbsp;M W Sonderup,&nbsp;C W Spearman","doi":"10.7196/SAMJ.2020.v110i2.14208","DOIUrl":"https://doi.org/10.7196/SAMJ.2020.v110i2.14208","url":null,"abstract":"<p><strong>Background: </strong>Hepatitis C virus (HCV) in South Africa (SA) is incompletely characterised and understood. Epidemiological and clinical data will better inform our understanding and assist national policy decision-making. Against the background of more than two decades of clinical challenges in HCV management, the advent of direct-acting antivirals (DAAs) now makes HCV elimination plausible.</p><p><strong>Objectives: </strong>To better understand the base from which we come, we elected to review and characterise our HCV experience at Groote Schuur Hospital (GSH), Cape Town, SA, in the pegylated interferon (Peg-IFN) and ribavirin (RBV) management era.</p><p><strong>Methods: </strong>Patients with chronic HCV infection attending the GSH Liver Clinic from 2002 to 2014 were included in the analysis. Relevant data were extracted from a registry and existing clinical records were accessed. Two brands of Peg-IFN were available, and patients treated with the first-generation add-on protease inhibitor telaprevir were included.</p><p><strong>Results: </strong>A total of 238 patients were included in the analysis (median (interquartile range) 47 (37 - 58) years, 60.5% males). Males were significantly younger than females (43.5 (35 - 52) years v. 55 (42 - 64) years, respectively) (p&lt;0.0001). The majority were white (55.9%) or of mixed ancestry (21.8%), 16.4% were HIV co-infected, 3.7% were hepatitis B virus (HBV) co-infected, and 1 patient (0.4%) was triple-infected with HCV, HBV and HIV. The most likely mode of HCV acquisition was blood or blood product exposure prior to 1992 (32.8%) and injecting drug use (17.6%), while 30.3% of patients had no clear risk factor identifiable. Genotypes (GTs) 1 - 5 were observed, with GT-1 (34.9%) predominating. Of patients who were biopsied (n=90), 30.0% had ≥F3 fibrosis, with 15.6% cirrhotic. With IL28B polymorphisms, the heterozygous CT (23.9%) and CC (15.5%) genotypes were most frequent. Of the patients, 32.6% accessed Peg-IFN/RBV-based therapy, 6.5% (n=5) with add-on telaprevir. GT-1 (35.1%) was most prevalent in the treatment group, followed by GT-3 (26.0%) and GT-5 (18.2%); 10.0% were HIV co-infected. The overall sustained virological response (SVR) rate was 75.3%, with 37.0% of GT-1 patients not achieving SVR. Of the patients treated, 49.4% experienced adverse events, including cytopenias (32.5%) and depression (15.6%), and 23.4% required cell support in the form of erythropoietin and/or granulocyte-macrophage colony-stimulating factor.</p><p><strong>Conclusions: </strong>HCV patients in the Peg-IFN/RBV management era typified the epidemiology of HCV. GT distribution was pangenotypic, and treatment outcomes were encouraging despite treatment challenges. Patient selection, IL28B and sensible support of cytopenias probably accounted for these favourable outcomes. However, numbers treated were limited, and the DAA era of therapy allows for rapid expansion of therapy with now growing numbers of patien","PeriodicalId":520778,"journal":{"name":"South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde","volume":" ","pages":"106-111"},"PeriodicalIF":2.2,"publicationDate":"2020-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.7196/SAMJ.2020.v110i2.14208","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38152747","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"HIV and breast cancer - a mammographic analysis: An observational study to identify the mammographic pattern of breast cancer in HIV-positive patients.","authors":"A Vanmali,&nbsp;I Buccimazza","doi":"10.7196/SAMJ.2020.v110i2.14149","DOIUrl":"https://doi.org/10.7196/SAMJ.2020.v110i2.14149","url":null,"abstract":"<p><strong>Background: </strong>Data on the association between HIV and breast cancer mammographic patterns and histological subtypes are limited.</p><p><strong>Objectives: </strong>To determine whether specific mammographic findings, histological features and patient profiles were unique to a cohort of HIV-positive patients who developed breast cancer, by comparing them with a HIV-negative cohort.</p><p><strong>Methods: </strong>This was a descriptive study in which we conducted a retrospective chart review and mammographic and pathology analysis of newly diagnosed breast cancer patients referred to the Addington Hospital breast clinic between August 2008 and June 2012 and entered into a prospective database.</p><p><strong>Results: </strong>Thirty-eight HIV-positive and 38 HIV-negative patients were included in the study. HIV-positive patients were more likely to have multifocal breast cancer (p=0.007), but not multicentric disease (p=0.05). The presence of grouped and fine pleomorphic microcalcifications and positive HIV status demonstrated statistical significance (p=0.000). A statistically significant relationship between grouped and fine pleomorphic microcalcifications with biopsies confirming high-grade ductal carcinoma in situ (HGDCIS) and HIV status was demonstrated (p=0.001). The mean age of the HIV-positive patients was 42.5 years (p=0.000).</p><p><strong>Conclusions: </strong>We demonstrated a statistically significant relationship between HIV status, the presence of multifocal breast cancer, and mammographically detected grouped and fine pleomorphic microcalcifications. A statistically significant relationship between HGDCIS and HIV status, and the presence of grouped and fine pleomorphic microcalcifications in HIV-positive patients with biopsies confirming HGDCIS, was demonstrated. Our study also showed that there is a relationship between age of presentation and HIV status.</p>","PeriodicalId":520778,"journal":{"name":"South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde","volume":" ","pages":"118-122"},"PeriodicalIF":2.2,"publicationDate":"2020-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.7196/SAMJ.2020.v110i2.14149","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38152749","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Renal denervation in South Africa.","authors":"M J Heradien,&nbsp;P Van der Bijl,&nbsp;P A Brink","doi":"10.7196/SAMJ.2020.v110i2.14521","DOIUrl":"https://doi.org/10.7196/SAMJ.2020.v110i2.14521","url":null,"abstract":"","PeriodicalId":520778,"journal":{"name":"South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde","volume":" ","pages":"12841"},"PeriodicalIF":2.2,"publicationDate":"2020-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.7196/SAMJ.2020.v110i2.14521","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38147282","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Competition Commission Health Market Inquiry Report: An overview and key imperatives.","authors":"G C Solanki,&nbsp;J E Cornell,&nbsp;D Besada,&nbsp;R L Morar,&nbsp;T Wilkinson","doi":"10.7196/SAMJ.2020.v110i2.14455","DOIUrl":"https://doi.org/10.7196/SAMJ.2020.v110i2.14455","url":null,"abstract":"<p><p>The Competition Commission's Health Market Inquiry (HMI) is the most systematic and comprehensive investigation carried out into the South African private health sector. The recommendations as set out in the HMI Final Report merit extensive discussion and debate, as they could - if implemented - have far-reaching consequences for the future of the healthcare system. The objective of this article is to contribute to this discussion by providing an overview of the key findings and recommendations of the HMI and highlighting the resultant key imperatives at this critical juncture of policy development.</p>","PeriodicalId":520778,"journal":{"name":"South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde","volume":" ","pages":"88-91"},"PeriodicalIF":2.2,"publicationDate":"2020-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.7196/SAMJ.2020.v110i2.14455","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38147283","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A 10-year analysis of organ donor referrals to a South African tertiary public sector hospital.","authors":"T Du Toit,&nbsp;K Manning,&nbsp;D Thomson,&nbsp;F McCurdie,&nbsp;E Muller","doi":"10.7196/SAMJ.2020.v110i2.14125","DOIUrl":"https://doi.org/10.7196/SAMJ.2020.v110i2.14125","url":null,"abstract":"<p><strong>Background: </strong>South Africa (SA) has one of the lowest deceased organ donor rates in the world (1.4 donors per million population), with thousands of patients awaiting solid-organ transplantation. In order to improve access to transplantation we have to clearly define the reasons for the low deceased donation rate, specific to the population we serve.</p><p><strong>Objectives: </strong>Review of actual donor statistics highlights our successes, yet is not able to contextualise the factors responsible for the unsuccessful conversion of referred organ donors to actual organ donors. In an attempt to identify key factors preventing referred donors from becoming actual donors, we analysed the donor referral patterns at our institution over a 10-year period.</p><p><strong>Methods: </strong>This was a retrospective descriptive study of consecutive deceased donor referrals at Groote Schuur Hospital, Cape Town, SA (from January 2007 to December 2016), utilising a regional donor referral registry. Qualitative and quantitative data were collected and presented as descriptive statistics and temporal trends.</p><p><strong>Results: </strong>Over the 10-year study period, 861 possible organ donors were referred, with a steady increase in the number of referrals over time. Of the referrals, 514 (59.7%) were eligible for donation of at least one solid organ. Of the 508 families that were approached for consent to donation, 342 declined consent for a variety of reasons, resulting in a consent rate of 32.7%. Ultimately, at least one solid organ was obtained from 159 of the 166 consented donors. Despite the increasing number of possible and eligible donors, a statistically significant decline in consent rate was observed over time (ptrend=0.023). Furthermore, increasing trends in medical (as opposed to trauma) (ptrend&lt;0.001) and extended criteria (as opposed to standard criteria) donor referrals (ptrend&lt;0.001) were observed over the 10-year study period.</p><p><strong>Conclusions: </strong>Donor referral patterns have changed over time, with a notable increase in medical and extended criteria donors. Despite the increase in possible and eligible donors, the consent rate has declined. Further qualitative and quantitative research studies are required to understand and address this trend.</p>","PeriodicalId":520778,"journal":{"name":"South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde","volume":" ","pages":"132-134"},"PeriodicalIF":2.2,"publicationDate":"2020-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.7196/SAMJ.2020.v110i2.14125","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38153211","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and validation of an instrument for procedure-related death notification.","authors":"F K Orr,&nbsp;C Keyes,&nbsp;A Alli","doi":"10.7196/SAMJ.2020.v110i2.14083","DOIUrl":"https://doi.org/10.7196/SAMJ.2020.v110i2.14083","url":null,"abstract":"<p><strong>Background: </strong>Anaesthesia-related mortality is an important, potentially avoidable cause of perioperative mortality. A procedure-related death notification (PRDN) instrument is completed by relevant medical practitioners after a procedure-related death and is used to audit practice and identify areas of care that require improvement. It is also used in medicolegal investigations when establishing cause of death, and in the case of litigation. The current South African (SA) PRDN instrument, designated the GW7/24 form, contains both surgical and anaesthetic sections and is considered to be outdated, inadequate and in need of revision.</p><p><strong>Objectives: </strong>To develop and validate a revised anaesthetic section of the SA PRDN instrument that can be used for procedure-related deaths in future and be used to update the GW7/24 form for epidemiological, forensic or academic use.</p><p><strong>Methods: </strong>Lynn's two-stage model was utilised. After an extensive literature review, a provisional PRDN instrument was developed. This provisional instrument was debated and reviewed at a peer group discussion in which 6 local experts took part. These experts were anaesthetic and forensic pathology specialists who specifically have expert knowledge on procedure-related deaths. A revised PRDN instrument was developed, which was then rated by 8 national experts using a Likert scale. The content validity index (CVI) for each item and for the instrument as a whole was then established. Items with a CVI &lt;0.88 were removed to formulate the final PRDN instrument.</p><p><strong>Results: </strong>The provisional PRDN instrument consisted of 14 domains and 66 items. The revised PRDN instrument consisted of 13 domains and 65 items, of which 3 items with a CVI &lt;0.88 were removed. The final PRDN instrument, after minor revisions based on suggestions from the 8 national experts, consisted of 18 domains and 79 items. Every item on the form was declared relevant and important by the national experts, with the final instrument scoring an overall CVI of 1.</p><p><strong>Conclusions: </strong>A comprehensive, updated and validated anaesthetic section of the SA PRDN instrument was developed. This could be used as a government and anaesthesiology society-endorsed template when updating the current GW7/24 form.</p>","PeriodicalId":520778,"journal":{"name":"South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde","volume":" ","pages":"140-144"},"PeriodicalIF":2.2,"publicationDate":"2020-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.7196/SAMJ.2020.v110i2.14083","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38153179","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"CYP3A5 polymorphisms and their effects on tacrolimus exposure in an ethnically diverse South African renal transplant population.","authors":"W K Muller,&nbsp;C Dandara,&nbsp;K Manning,&nbsp;D Mhandire,&nbsp;J Ensor,&nbsp;Z Barday,&nbsp;R Freercks","doi":"10.7196/SAMJ.2020.v110i2.13969","DOIUrl":"https://doi.org/10.7196/SAMJ.2020.v110i2.13969","url":null,"abstract":"<p><strong>Background: </strong>Tacrolimus forms the cornerstone for immunosuppression in solid-organ transplantation. It has a narrow therapeutic window with wide inter- and intra-patient variability (IPV). Cytochrome P-450 3A5 (CYP3A5) is the main enzyme involved in tacrolimus metabolism, and rs776746A&gt;G is the most frequently studied polymorphism in the CYP3A5 gene. The rs776746A&gt;G (i.e. CYP3A5*3) single-nucleotide polymorphism in CYP3A5 alters tacrolimus predose trough concentration (C0) and may also affect IPV, which may lead to immune- and/or drug-mediated allograft injury. CYP3A5*3 may result in absent (*3/*3), partial (*1/*3) or normal (*1/*1) CYP3A5 expression. The effect of CYP3A5*3 on tacrolimus exposure and variability has not been examined in South African (SA) transplant recipients.</p><p><strong>Objectives: </strong>To determine the frequencies and effect of CYP3A5 and adenosine triphosphate-binding cassette subfamily B member 1 (ABCB1) polymorphisms on tacrolimus C0/dose ratios in different ethnic groups attending a tertiary renal transplant clinic in SA, and other factors that may explain inter- and IPV in tacrolimus C0.</p><p><strong>Methods: </strong>All consenting stable renal transplant recipients on tacrolimus at the Livingstone Hospital Renal Unit in Port Elizabeth, SA, were included. Tacrolimus concentrations were obtained using a microparticle enzyme immunoassay method (ARCHITECT analyser, Abbott Laboratories). Polymerase chain reaction/restriction fragment length polymorphism was used to genotype for CYP3A5*3 and *6 allelic variants.</p><p><strong>Results: </strong>There were 43 participants (35% black African, 44% mixed ancestry and 21% white), with a mean age of 44.5 years, median duration post-transplant of 47 months and median (interquartile range) creatinine and estimated glomerular filtration rate levels of 118 (92 - 140) µmol/L and 62 (49 - 76) mL/min at study inclusion. The mean tacrolimus C0 in the study was 6.7 ng/mL, with no difference across the different ethnic groups. However, the mean total daily dose of tacrolimus required was 9.1 mg (0.12 mg/kg), 7.2 mg (0.09 mg/kg) and 4.3 mg (0.06 mg/kg) in black, mixed-ancestry and white patients, respectively (p=0.017). The frequencies for CYP3A5 expressors (i.e. CYP3A5*1/*1 + CYP3A5*1/*3 genotypes) were 72%, 100%, 76% and 12% for all patients combined and black, mixed-ancestry and white patients, respectively. The frequencies for CYP3A5 non-expressors (i.e. CYP3A5*3/*3 genotypes) were 0%, 24% and 88% among the black, mixed-ancestry and white patients, respectively. None of the patients carried the CYP3A5*6 allele. CYP3A5*1/*1 and CYP3A5*1/*3 genotype carriers required a two-fold increase in dose compared with the non-expressor genotype carriers, CYP3A5*3/*3 (p&lt;0.05). CYP3A5*3/*3 carriers also demonstrated higher IPV than CYP3A5*1/*1 and *1/*3 carriers (18.1% v. 14.2%; p=0.125).</p><p><strong>Conclusions: </strong>Compared with global transplant populations,","PeriodicalId":520778,"journal":{"name":"South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde","volume":" ","pages":"159-166"},"PeriodicalIF":2.2,"publicationDate":"2020-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.7196/SAMJ.2020.v110i2.13969","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38153182","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}