South African Renal Registry Annual Report 2017

The sixth annual report of the South African Renal Registry summarises the 2017 data on renal replacement therapy (RRT) for patients with end-stage renal disease (ESRD) in South Africa. In December 2017, the number of patients with ESRD who were treated with chronic dialysis or transplantation stood at 10 744, a prevalence of 190 per million population (pmp). The growing prevalence observed since the registry was established is due mainly to the increasing numbers of patients accessing haemodialysis in the private sector, where the prevalence was 855 pmp. In the public sector, which serves 84% of the South African population, the prevalence of RRT (66 pmp) remained below the level reported for 1994, so that the disparity in access continued to increase. The disparities between provinces remained, with Limpopo and Mpumalanga the most under-served, as did the disparities between ethnic groups, with Blacks being the most under-served group. The Western Cape was the province with the highest public sector treatment rates and was also where most of the country’s public sector kidney transplants were performed

A review of adherence and predictors of adherence to the CONSORT Statement in the reporting of tuberculosis vaccine trials

CITATION: Ngah, V. D. et al. 2020. A review of adherence and predictors of adherence to the CONSORT Statement in the reporting of tuberculosis vaccine trials. Vaccines, 8(4):770, doi:10.3390/vaccines8040770.The original publication is available at https://www.mdpi.comThe statement on Consolidated Standards of Reporting Trials (CONSORT) ensures transparency in the reporting of randomized trials. However, it is unclear if the statement has led to improvement in the quality of reporting of tuberculosis (TB) vaccine trials. We explored the quality of reporting of TB vaccine trials according to the latest version of the CONSORT statement, released in 2010. We searched PubMed and the Cochrane Central Register of Controlled Trials in August 2019. We conducted screening, study selection, and data extraction in duplicate; and resolved differences through discussion. We assessed reporting to be adequate if trials reported at least 75% of the CONSORT 2010 items. We conducted a trend analysis to assess if there was improvement in reporting over time. We also used logistic regression to assess factors associated with adequate reporting. We included 124 trials in the analyses. The mean proportion of adherence was 67.3% (95% confidence interval 64.4% to 70.1%), with only 46 (37%) trials having adequate reporting. There was a significant improvement in the quality of reporting over time (p < 0.0001). Trials published in journals with impact factors between 10 and 20 were more likely to have adequate reporting (odds ratio 9.4; 95% confidence interval 1.30 to 67.8), compared to lower-impact-factor journals. Despite advances over time, the reporting of TB vaccine trials is still inadequate and requires improvement.https://www.mdpi.com/2076-393X/8/4/770Publisher's versio

Quality of pilot trial abstracts in heart failure is suboptimal: a systematic survey

Background: Pilot trials are miniature researches carried out with the sole aim of acting as the precursor for larger more definitive studies. Abstracts are used to summarize and introduce the findings to the reading audience. There is substantive empirical evidence showing that abstracts, despite their important roles, are not informative enough, lacking the necessary details. This systematic survey was designed to assess the quality of reporting of heart failure pilot trial abstracts. The quality of reporting was defined as the completeness of reporting based on adherence to the CONSORT extension for reporting of pilot trial abstracts. We also identified factors associated with reporting quality. Methods: We searched MEDLINE (PubMed), Cochrane Controlled Trials Register, Scopus, and African-wide information databases for abstracts from heart failure pilot trials in humans published from 1 January 1990 to 30 November 2016. These were assessed to determine the extent of adherence to CONSORT extension checklist for reporting of abstracts of pilot trials. We screened identified studies for inclusion based on title and abstract. Data were independently extracted by two reviewers using the checklist. We used regression analysis to assess the association between completeness of reporting (measured as the number of items in the CONSORT extension checklist for reporting of abstracts in pilot trials contained in each abstract) and factors influencing the quality of the reports. Results: Two hundred and twenty-eight (228) articles were retrieved, of which 92 met the inclusion criteria. The mean CONSORT extension score was 8.3/16 (standard deviation 1.7); the least reported items were the source of funding (1% [1/92]), trial registration (13% [12/92]), randomization sequence (13% [12/92]), number randomized to each arm (16% [15/92]), and number analyzed in each arm (16% [15/92]). Multivariable regression analysis showed that pharmacological intervention pilot trials [incidence rate ratio (IRR) = 0.88; 95% confidence interval (CI), 0.81–0.97] were significantly associated with better reporting. Other factors such as structured abstract (IRR = 1.10; 95% CI, 0.99–1.23) and CONSORT endorsement (IRR = 1.10; 95% CI, 0.99–1.23) only showed minimal relationship with better reporting quality. Conclusion: The quality of reporting of abstracts of heart failure pilot trials was suboptimal. Pharmacological intervention was significantly associated with better reporting. These findings are consistent with previous research on reporting of trials

Intervention for alcohol use disorders at an HIV care clinic in Harare: a pilot and feasibility study.

BACKGROUND: Alcohol use in HIV infected patients is associated with risky sexual behaviour, poor adherence to Highly Active Antiretroviral Therapy, treatment failure and increased physiologic harm. The objectives of the study were to pilot the outcome assessments to be used in the trial proper, assess the feasibility of delivery of a brief MI/CBT intervention compared to an WHO mhGAP intervention for problematic alcohol use in PLWH in Zimbabwe, and pilot the effectiveness (on alcohol use, functionality and CD4 count) of these interventions at 3 months in a randomised controlled trial design. METHODS: An intervention for HIV infected patients with problematic alcohol use, developed through adaptation of existing evidence based psychological treatments, was assessed for its feasibility at a tertiary HIV care clinic in Zimbabwe. Registered general nurses, using a manualised protocol, delivered the intervention. Forty patients were recruited and randomised to receive either an MI/CBT intervention or the WHO mhGAP Intervention Guide for AUDs (n = 20 patients per group). RESULTS: Out of 40 participants enrolled, 31 were successfully followed up for 3 months with a loss to follow-up rate of 23%. There was a statistically significant decrease in AUDIT score over time in both groups (p < 0.001), however no statistically significant group difference with a mean difference of 0.80, standard error of 2.07 and p = 0.70. For the CD4 count, the median and interquartile ranges at baseline for MI/CBT and WHO mhGAP IG groups were 218 (274) and 484 (211.50), respectively. At follow-up, median and interquartile ranges for the CD4 count for MI/CBT and WHO mhGAP IG groups were 390 (280) and 567 (378), respectively, indicative of improvement in immunological parameters in both arms. CONCLUSION: The findings from this pilot study suggests that a brief MI/CBT delivered by Registered General Nurses for problematic alcohol use is feasible in this population but will require the implementation of additional measures to improve retention. However, mechanisms to improve retention need special attention. Trial registration Pan African Clinical Trial Registry, current PACTR201509001211149

A cluster randomised controlled trial protocol of an adapted intervention for alcohol use disorders in people living with HIV and AIDS: impact on alcohol use, general functional ability, quality of life and adherence to HAART.

BACKGROUND: Interventions for alcohol use disorders (AUDs) in HIV infected individuals have been primarily targeted at HIV risk reduction and improved antiretroviral treatment adherence. However, reduction in alcohol use is an important goal. Alcohol use affects other key factors that may influence treatment course and outcome. In this study the authors aim to administer an adapted intervention for AUDs to reduce alcohol use in people living with HIV/AIDS (PLWHA). METHODS: This study is a cluster randomised controlled trial at 16 HIV care clinics. A motivational interviewing and cognitive behavioural therapy based intervention for AUDs, developed through adaptation and piloted in Zimbabwe, will be administered to PLWHA with AUDs recruited at HIV clinics. The intervention will be administered over 16 sessions at 8 HIV clinics. This intervention will be compared with an equal attention control in the form of the World Health Organization Mental Health Gap Action Programme (WHO mhGAP) guide, adapted for the Zimbabwean context. General function, quality of life, and adherence to highly active antiretroviral treatment (HAART) will be secondary outcomes. Booster sessions will be administered to both groups at 3 and 6 months respectively. The primary outcome measure will be the Alcohol Use Disorder Identification Test (AUDIT) score. The World Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0), World Health Organisation Quality of Life (WHOQoL) HIV, viral load, and CD4 counts will be secondary outcome measures. Outcome assessments will be administered at baseline, 3, 6, and 12 months. Moderating factors such as perceived social support, how people cope with difficult situations and post-traumatic exposure and experience will be assessed at baseline. Trained research assistants will recruit participants. The outcome assessors who will be trained in administering the outcome and moderating tools will be blinded to the treatment arms allocated to the participants. However, the principal investigator, participants and intervention staff will be unblinded. Data will be analysed using STATA Version 14. Primary and secondary outcomes will be measured at four time points that is; at baseline, 3, 6, and 12 months respectively. All participants will be included in the analysis of primary and secondary outcome measures. The mean AUDIT scores will be compared between groups using student t-tests. Multilevel logistic regression analysis will be performed for binominal variables and multilevel linear regression for continuous variables. Descriptive statistics will be computed for baseline and follow-up assessments. DISCUSSION: The study will be the first to address problematic alcohol use in PLWHA in Zimbabwe. It seeks to use local resources in delivering a modified, brief, evidence-based, and culturally contextualised intervention. The study results will determine the effectiveness of adapting psychological interventions for AUDs in HIV infected adults using a task-sharing framework. TRIAL REGISTRATION: Pan African Clinical Trial Registry, PACTR201509001211149 . Registered 22 July 2015

Social and contextual factors affecting HIV-infected women’s feeding practices for their infants in normal practice settings : effects on growth and morbidity

Thesis (PhD)--Stellenbosch University, 2016.ENGLISH ABSTRACT: the significant reduction in HIV transmission through breastfeeding by antiretroviral treatment guided the current recommendations favouring breastfeeding which has to be continued until 12 months of age. Infant feeding guidelines for HIV-infected women in low-resourced settings are primarily informed by studies that spend much effort in controlling guideline adherence by investigators and participants. These studies however may not reflect the real world effects of the feeding options on important outcomes because such efforts are less enforced or rear in primary care settings. Reliable studies are lacking for predicting the real world effects of the feeding options on infant growth and morbidity to guide healthcare authorities in decision making. Social and contextual factors affecting HIV-infected women’s infant feeding practices are major barriers to uptake of infant feeding recommendations to levels that would result in a significant impact. Yet less attention is paid to these during guideline development and implementation. Methods: To address this knowledge gap we performed a longitudinal cohort study in primary healthcare settings, over a 12 months period. The objectives were to a) describe HIV-infected women’s infant feeding practices b) compare infant feeding practices of HIV-infected and HIV-uninfected breastfeeding women c) assess growth and infection-related hospitalizations among predominantly breastfed and predominantly formula-fed HIV-exposed uninfected infants. We explored infant feeding experiences of a sub-set of HIV-infected women who were followed-up for at least 6 months post-delivery in the longitudinal cohort. Results: We found that few HIV-infected women chose breastfeeding, and among those who did, many switched to formula feeding early. The proportion of women who continued predominantly breastfeeding was only slightly lower among HIV-infected compared to HIV-uninfected women (p = 0.0005). These differences were seen from about two weeks, and persisted throughout follow-up. By about four months, half of the HIV-infected women had switched to predominant formula feeding. However, the proportion of HIV-uninfected women who switched to formula feeding was also relatively high. The dual infant feeding option employed by the Western Cape PMTCT program while transitioning from formula feeding policy confused HIV-infected women who were worried that their child may contract HIV through breastmilk because of conflicting messages they received from healthcare providers, possibly explaining why some women stopped breastfeeding. Women’s interpretation of information about risks and benefits of infant feeding options, formula feeding stigma and the quality of infant feeding counselling affected women’s infant feeding practices. Mean weight velocity Z-scores (95% CI) of predominantly breastfed infants was -0.70 (-1.31 to -0.09; p = 0.024) lower than that of predominantly formula fed infants in the two to four months age interval. Protection against infections by breastfeeding was minimal and insignificant, odds ratio (OR) 0.95 (95% CI 0.33 to 2.74). In conclusion, it is important that all women, whether HIV-infected or not, be educated that breastfeeding is the feeding of choice in this setting. The potential of breastfeeding to reduce risks of infections to levels similar to those observed under highly controlled settings, involves changing women’s infant feeding practices. Strategies to promote and sustain continued breastfeeding by women, to levels that would result in a significant impact on the growth and protection against infections of their children are urgently needed. The strategies should be guided by social and contextual factors affecting women’s feeding practicesAFRIKAANSE OPSOMMING: Studies toon aan dat borsvoeding beskermend is teen aansteeklike morbiditeit en ook ‘n betekenisvolle verlaging in MIV oordrag deur borsvoeding en anti-retrovirale behandeling (ARB). Hierdie feite het daartoe aanleiding gegee tot die huidge aanbevelings van borsvoeding as voorkeur tot op 12 maande te gee. Babavoedingriglyne vir MIVgeïnfekteerde vroue in lae-inkomste omgewings word primêr gedryf deur studies wat daarin poog vir die riglynbeheer toepassing deur navorsers en deelnemers. Hierdie studies mag nie noodwendig die werklikheid van voedingsopsies ten opsigte van belangrike uitkomste lewer nie omrede verskeie pogings tot ‘n mindere mate toegepas en selfs raar is in primêre gesondheidsorgomgewings. Daar bestaan ‘n leemte in betroubare studies wat die werklikheidseffekte van voedingsopsies op babagroei en morbiditeit voorspel, en wat daarin poog om gesondheidsorg owerhede se besluitneming te kan beïnvloed. Sosiale en kontekstuele faktore wat MIV-geïnfekteerde vroue se babavoedings keuses beïnvloed, is die hoof hindernis om babavoedingaanbevelings deur te voer wat ‘n betekenisvolle impak sal maak. Minder aandag word aan hierdie aspekte tydens die riglynontwikkeling en implementering spandeer. Om die kennisgaping romdom hierdie aspek te adreseer het ons ‘n longitudinale studie in primêre gesondheidsorgeenhede oor ‘n 12 maande periode ondersoek. Die doelstellings was om a) MIV-geïnfekteerde vroue se babavoedingkeuses te beskryf b) babavoedingpraktyke van MIV-geïnfekteerde vroue en MIV-nie-geïnfekteerde borsvoedende vroue te vergelyk c) groei en infeksie-verwante hospitalisasies onder hoofsaaklik borsvoedende en formule voedende MIV-blootgestelde ongeïnfekteerde babas in primêre gesondheidsorgomgewings oor ‘n 12 maande periode te evalueer. Ons het babavoedingervarings in ‘n sub-groep MIV-geïnfekteerde vroue vir ses maande na bevalling in die longitudinale kohort ondersoek. Resultate: Ons het gevind dat min MIV-geïnfekteerde vroue borsvoeding gekies het, en onder die wat wel het, baie vroeg oorgeskakel het na formule voeding. Die aantal vroue wat hoofsaaklik by borsvoeding gehou het is betekenisvol minder onder die MIV-geïnfekteerde as die ongeïnfekteerde vroue (p = 0.0005). Hierdie verskille is sigbaar teen omtrent twee weke en is regdeur die opvolg waargeneem. Om en by vier maande het die helfte van die MIV-geïnfekteerde vroue na hoofsaaklik formule voeding oorgeskakel. Die gedeelte van die MIV-geïnfekteerde vroue wat oorgeskakel het na formule voeding was ook relatief hoog. Die dubbel babavoedingopsie, wat deur die Weskaapse PMTCT program as opsie gegee word in die oorgangsfase van formule voeding, het MIVgeïnfekteerde moeders verwar omrede hulle bekommerd was dat hulle kinders deur borsmelk MIV mag opdoen weens teenstrydige boodskappe wat hulle van gesondheidswerkers ontvang het, kan moontlik verklaar waarom sommige vroue ophou borsvoed het. Die vroue se interpretasie van die inligting oor risikos en voordele van babavoedingsopsies, formule voedingstigma en die kwaliteit van voedingsberading, het die moeders se voedingskeuses beïnvloed. Gemiddelde massa snelheid Z-tellings (95% VI) van die meerderheid borsvoedende moeders was -0.70 (-1.31 to -0.09; p=0.024) laer as die van die meerderheid formule gevoede babas in die twee tot vier maande ouderdomsinterval. Vroue wat formulevoeding gegee het, het verhoogde persepsies oor MIV oordragrisiko deur borsmelk gehad. Teen ses maande ouderdom, het hoofsaaklik borsgevoede babas gewig teen ‘n tempo van 0.08 (95% vertrouheidsinterval (VI): -0.14 tot -0.02; p = 0.01) opgetel, gewig-vir-ouderdom z-tellings per maand was laer as in die hoofsaaklik formule gevoede babas. Beskerming teen infeksies deur borsvoeding was minimaal en nie betekenisvol nie, kansverhouding (KV) 0.95 (95% VI 0.33 tot 2.74). Gevolglik, is dit belangrik dat alle vroue, ongeag of hulle met die MIV geïnfekteer is of nie, opgevoed te word dat borsvoeding die voeding van keuse is in hierdie omgewing. Strategieë om borsvoeding deur vroue te bevorder, en wat tot betekenisvolle impak op die groei en beskerming teen aansteeklike siektes van hulle kinders voort te sit, is uiters noodsaaklik. Die strategieë behoort deur sosiale en kontekstuele faktore gerig te word wat vroue se voedingskeuses beïnvloed

Combination antiretroviral treatment use in prevention of mother-to-child transmission programmes : 6-week HIV prevalence and relationship to time of antiretroviral treatment initiation and mixed feeding

CITATION: Ndarukwa, V. & Zunza, M. 2019. Combination antiretroviral treatment use in prevention of mother-to-child transmission programmes : 6-week HIV prevalence and relationship to time of antiretroviral treatment initiation and mixed feeding. Southern African Journal of Infectious Diseases, 34(1):a117, doi:10.4102/sajid.v34i1.117.The original publication is available at https://sajid.co.zaBackground: In Zimbabwe, 16% of pregnant women aged 15–49 years are infected with HIV. More than 90% of HIV infection in children is through mother-to-child transmission (MTCT). We investigated the effectiveness of the Option B+ in reducing HIV infection and factors associated with HIV transmission among infants born to mothers enrolled in the prevention of mother-to-child transmission (PMTCT) programme. Methods: We randomly selected 1204 early infant HIV diagnosis test results for HIV-exposed infants and linked these results to maternal clinical records at primary healthcare clinics in Harare to estimate the prevalence of MTCT and to determine the clinical factors associated with MTCT of HIV at 6 weeks. Results: Of the 1204 infants in the study, 2.5% (95% confidence interval [CI], 1.7–3.5) were infected with HIV at 6 weeks post-delivery. Antiretroviral adherence reduced the odds of HIV infection by about 99% (odds ratio [OR] 0.01 [95% CI, 0.00–0.06]). Both mixed feeding (OR 3.89 [95% CI, 0.92–16.50]) and late initiation of antiretroviral treatment (ART) (after delivery) (OR 3.18 [95% CI, 0.42–23.94]) increased the odds of HIV infection. Conclusion: Early initiation of combination ART reduces 6-week MTCT of HIV in PMTCT programmes to levels similar to those found in controlled trial settings. Exclusive breastfeeding remains important even in the presence of ART.https://sajid.co.za/index.php/sajid/article/view/117Publisher's versio

A cross-sectional descriptive study of breastfeeding behaviour and galactogogue use among private-sector patients in Cape Town, South Africa

CITATION: Steyn, N., Zunza, M. & Decloedt, E. H. 2017. A cross-sectional descriptive study of breastfeeding behaviour and galactogogue use among private-sector patients in Cape Town, South Africa. South African Journal of Obstetrics and Gynaecology, 23(1):20-23, doi:10.7196/SAJOG.2017.v23i1.1116.The original publication is available at http://www.sajog.org.zaBackground. Failure to exclusively breastfeed is often caused by a perception of insufficient breastmilk supply. Galactogogues are frequently prescribed in these circumstances, but this is supported by sparse scientific data with safety concerns for both mother and infant. The exact extent of galactogogue use in South Africa (SA) is not well known. Objectives. To assess breastfeeding behaviour, galactogogue use and perceived galactogogue side-effects among patients attending International Board Certified Lactation Consultant (IBCLC) private practices. Methods. We administered a self-developed, expert-reviewed questionnaire in five IBCLC private practices within the Cape Town Metropole, SA. All patients attending the practices during an 8-week period were invited to participate. Results. Data from 104 participants were included in the study. An exclusive breastfeeding rate of slightly more than 50%, associated with greater parity (p=0.029), was found. Perceived lack of breastmilk predicted galactogogue use (p=0.013). There was a high prevalence of galactogogue use (54%), with 80% of these participants using non-prescription medication. Sulpiride was the most common prescription medication used. Increased milk production was reported by 41% (n=23) of galactogogue users, while 30% (n=17) reported no effect. Most reported side-effects were minor. Conclusions. Prevalence of galactogogue use exceeded other published data. Sulpiride was most frequently prescribed, despite not being recommended during breastfeeding. A large group of participants reported poor efficacy. The effect of vaginal delivery and immediate skin-to-skin contact after delivery on milk production might be smaller than previously reported in mothers who are personally motivated to breastfeed. Healthcare practitioners should acknowledge breastfeeding mothers’ concerns regarding insufficient milk supply and emphasise correct breastfeeding technique.http://www.sajog.org.za/index.php/SAJOG/article/view/1116Publisher's versio

The impact of family physician supply on district health system performance, clinical processes and clinical outcomes in the Western Cape Province, South Africa (2011–2014)

Background: A revised family physician (FP) training programme was introduced in South Africa in 2007. A baseline assessment (2011) of the impact of FP supply on district health system performance was performed within the Western Cape Province, South Africa. The impact of an increased FP supply within this province required re-evaluation. Aim: To assess the impact of FP supply on indicators of district health system performance, clinical processes and clinical outcomes in the Western Cape Province. The objectives were to determine the impact of FPs, nurses, medical officers (MOs) and other specialists. Setting: The study sample included all five rural districts and eight urban subdistricts of the Western Cape Province. Methods: A secondary analysis was performed on routinely collected data from the Western Cape Department of Health from 01 March 2011 until 30 April 2014. Results: The FP supply did not significantly impact the indicators analysed. The supply of nurses and MOs had an impact on some of the indicators analysed. Conclusion: This study did not replicate the positive associations between an increase in FP supply and improved health indicators, as described previously for high-income country settings. The impact of FP supply on clinical processes, health system performance and outcome indicators in the Western Cape Province was not statistically significant. Future re-evaluation is recommended to allow for more time and an increase in FP supply

Quality of abstracts of pilot trials in heart failure : a protocol for a systematic survey

CITATION: Isiguzo, G., et al. 2017. Quality of abstracts of pilot trials in heart failure : a protocol for a systematic survey. Contemporary Clinical Trials Communications, 8:258-263, doi:10.1016/j.conctc.2017.11.004.The original publication is available at https://www.sciencedirect.comIntroduction: Pilot trials are initial small-scale studies done to inform the design of larger trials. Their findings like other studies are usually disseminated as peer-reviewed journal articles. Abstracts are used to introduce the contents to readers, and give a general idea about the full reports and sometimes are the only source of information available to readers. Despite their importance, the contents of abstracts of trial reports are usually not informative enough and lack the essential details. Methods and analysis: This is a protocol for a planned systematic survey with a primary aim of analyzing the reporting quality measured as the completeness of the reporting of pilot trial abstracts in heart failure. The secondary aim will be to explore factors associated with better reporting quality. Abstracts of heart failure pilot trials in humans (journal and conference abstracts) published in the English language from 1 January 1990 to 30 November 2016 will be assessed to determine the reporting quality, based on the CONSORT 2010 statement extension to randomized pilot and feasibility trials. All non-pilot/feasibility trials and non-human pilot trials will be excluded. We will search Medline (PUBMED), Cochrane controlled trials register, Scopus and African wide information databases for pilot trials in heart failure. Title and abstracts of identified studies will be screened for inclusion and data extracted independently by two reviewers in duplicate without using the full text. Reported and unreported items on the abstracts will be presented as frequencies and percentages, a descriptive analysis will be used to interpret the reporting quality and regression analysis used for characteristics associated with greater statistical reporting at 95% confidence interval.https://www.sciencedirect.com/science/article/pii/S2451865417301242?via%3DihubPublisher's versio