{"title":"Consent for critical care research after death from COVID-19: Arguments for a waiver.","authors":"K Moodley, B W Allwood, T M Rossouw","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Pandemics challenge clinicians and scientists in many ways, especially when the virus is novel and disease expression becomes variable or unpredictable. Under such circumstances, research becomes critical to inform clinical care and protect future patients. Given that severely ill patients admitted to intensive care units are at high risk of mortality, establishing the cause of death at a histopathological level could prove invaluable in contributing to the understanding of COVID-19. Postmortem examination including autopsies would be optimal. However, in the context of high contagion and limited personal protective equipment, full autopsies are not being conducted in South Africa (SA). A compromise would require tissue biopsies and samples to be taken immediately after death to obtain diagnostic information, which could potentially guide care of future patients, or generate hypotheses for finding needed solutions. In the absence of an advance written directive (including a will or medical record) providing consent for postmortem research, proxy consent is the next best option. However, obtaining consent from distraught family members, under circumstances of legally mandated lockdown when strict infection control measures limit visitors in hospitals, is challenging. Their extreme vulnerability and emotional distress make full understanding of the rationale and consent process difficult either before or upon death of a family member. While it is morally distressing to convey a message of death telephonically, it is inhumane to request consent for urgent research in the same conversation. Careful balancing of the principles of autonomy, non-maleficence and justice becomes an ethical imperative. Under such circumstances, a waiver of consent, preferably followed by deferred proxy consent, granted by a research ethics committee in keeping with national ethics guidance and legislation, would fulfil the basic premise of care and research: first do no harm. This article examines the SA research ethics framework, guidance and legislation to justify support for a waiver of consent followed by deferred proxy consent, when possible, in urgent research after death to inform current and future care to contain the pandemic in the public interest.</p>","PeriodicalId":520778,"journal":{"name":"South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde","volume":" ","pages":"629-634"},"PeriodicalIF":2.2,"publicationDate":"2020-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38340983","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":"Freedom of speech and public interest, not allegiance, should underpin science advisement to government.","authors":"J A Singh, A Habib, J Jansen","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":520778,"journal":{"name":"South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde","volume":" ","pages":"578-580"},"PeriodicalIF":2.2,"publicationDate":"2020-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38436694","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":"Statement of support for Professor Glenda Gray and the principle of academic freedom of speech.","authors":"F Venter","doi":"10.7196/SAMJ.2020.v110i7.14964","DOIUrl":"https://doi.org/10.7196/SAMJ.2020.v110i7.14964","url":null,"abstract":"","PeriodicalId":520778,"journal":{"name":"South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde","volume":" ","pages":"555-560"},"PeriodicalIF":2.2,"publicationDate":"2020-05-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.7196/SAMJ.2020.v110i7.14964","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38340118","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":"How should health resource allocation be applied during the COVID-19 pandemic in South Africa?","authors":"A Taylor, B Taylor, J Parkes, J J Fagan","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":520778,"journal":{"name":"South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde","volume":" ","pages":"12950"},"PeriodicalIF":2.2,"publicationDate":"2020-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38340116","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 policy and decision-making framework for South African doctors during the COVID-19 pandemic.","authors":"K Jones-Bonofiglio, N Nortjé","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Faced with a pandemic, doctors around the world are forced to make difficult ethical decisions about clinical, economic and politically charged issues in medicine and healthcare, with little time or resources for support. A decision-making framework is suggested to guide policy and clinical practice to support the needs of healthcare workers, help to allocate scarce resources equitably and promote communication among stakeholders, while drawing on South African doctors' knowledge, culture and experience.</p>","PeriodicalId":520778,"journal":{"name":"South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde","volume":" ","pages":"613-616"},"PeriodicalIF":2.2,"publicationDate":"2020-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38340981","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}
L Van Bruwaene, F Mustafa, J Cloete, A Goga, R J Green
{"title":"What are we doing to the children of South Africa under the guise of COVID-19 lockdown?","authors":"L Van Bruwaene, F Mustafa, J Cloete, A Goga, R J Green","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":520778,"journal":{"name":"South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde","volume":" ","pages":"574-575"},"PeriodicalIF":2.2,"publicationDate":"2020-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38436692","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}
M J Rotheram-Borus, S Gordon, J Christodoulou, M Tomlinson
{"title":"Ending HIV/AIDS: Not as close as many would have us believe.","authors":"M J Rotheram-Borus, S Gordon, J Christodoulou, M Tomlinson","doi":"10.7196/10.7196/SAMJ.2020.v110i2.14526","DOIUrl":"https://doi.org/10.7196/10.7196/SAMJ.2020.v110i2.14526","url":null,"abstract":"","PeriodicalId":520778,"journal":{"name":"South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde","volume":" ","pages":"12848"},"PeriodicalIF":2.2,"publicationDate":"2020-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.7196/10.7196/SAMJ.2020.v110i2.14526","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38147281","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":"Parents refusing blood transfusions for their children solely on religious grounds: Who must apply for the court order?","authors":"D J McQuoid-Mason","doi":"10.7196/10.7196/SAMJ.2020.v110i2.14486","DOIUrl":"https://doi.org/10.7196/10.7196/SAMJ.2020.v110i2.14486","url":null,"abstract":"<p><p>The South African Constitution provides that children have the right to healthcare, as well as all other rights. Furthermore, in all matters affecting them, their best interests must be 'of paramount importance'. It seems common practice that, when parents refuse blood transfusions for their children solely on religious grounds, doctors and health authorities apply for a court order to overturn such refusals. However, since the implementation of the Children's Act of 2005, it may be that the onus is no longer on doctors and authorities to apply to court to reverse the decision of parents and guardians. It can be argued instead that the burden has shifted to the parents to apply to court for an order to overrule the decision of doctors, by proving to the court that alternative choices are available. Guidance is given for situations, particularly in the public sector, where alternative choices are not available.</p>","PeriodicalId":520778,"journal":{"name":"South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde","volume":" ","pages":"100-101"},"PeriodicalIF":2.2,"publicationDate":"2020-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.7196/10.7196/SAMJ.2020.v110i2.14486","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38152746","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":"Understanding the basics of cannabidiol from cannabis to apply to therapeutics in epilepsy.","authors":"L Hay","doi":"10.7196/SAMJ.2020.v110i2.14410","DOIUrl":"https://doi.org/10.7196/SAMJ.2020.v110i2.14410","url":null,"abstract":"The compounds present in cannabis have been in use for both recreational and medicinal purposes for many centuries. Changes in the legislation in South Africa have led to an increase in the number of people interested in using these compounds for self-medication. Many of them may approach their general practitioner as the first source of information about possible therapeutic effects. It is important that medical professionals are able to give patients the correct information. Cannabidiol (CBD) is one of the main compounds in cannabis plants, and there is evidence that it can successfully treat certain patients with epilepsy. This review looks at the most recent evidence on the use of CBD in the treatment of epilepsy and explores the mechanisms behind these beneficial effects.","PeriodicalId":520778,"journal":{"name":"South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde","volume":" ","pages":"102-105"},"PeriodicalIF":2.2,"publicationDate":"2020-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.7196/SAMJ.2020.v110i2.14410","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38152745","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}
M W Sonderup, N Gogela, R Nordien, H Smuts, S Korsman, D Hardie, C W Spearman
{"title":"Direct-acting antiviral therapy for hepatitis C: The initial experience of the University of Cape Town/Groote Schuur Hospital Liver Clinic, South Africa.","authors":"M W Sonderup, N Gogela, R Nordien, H Smuts, S Korsman, D Hardie, C W Spearman","doi":"10.7196/SAMJ.2020.v110i2.14195","DOIUrl":"https://doi.org/10.7196/SAMJ.2020.v110i2.14195","url":null,"abstract":"BACKGROUND\u0000An estimated 600 000 South Africans are chronically infected with hepatitis C virus (HCV). To date, accurate prevalence data are lacking, but emerging data suggest a significant burden in key populations. Historically, pegylated interferon and ribavirin treatment was challenging, with access limited. The advent of all-oral, short-course direct-acting antiviral (DAA) therapy has revolutionised the management of HCV, being well tolerated and highly effective, although initial cost was a prohibitive factor.\u0000\u0000\u0000OBJECTIVES\u0000To report our initial 2-year experience with DAA therapy at the University of Cape Town/Groote Schuur Hospital Liver Clinic, South Africa (SA).\u0000\u0000\u0000METHODS\u0000Patients who were viraemic for HCV were offered access to DAA therapy. All relevant demographic, virological, serological and clinical laboratory data were captured in a registry. Liver fibrosis was assessed non-invasively with the FibroScan. DAA regimens were prescribed according to current guidance based on HCV genotype (GT), prior treatment history and degree of fibrosis. On treatment, virological response was recorded and a sustained virological response (SVR) was defined as an undetectable HCV RNA at least 12 weeks after the end of treatment.\u0000\u0000\u0000RESULTS\u0000We report on the first 210 patients treated. Their median (interquartile range (IQR)) age was 52 (42 - 61) years and 65% were male, with men significantly younger than women at 50 (42 - 59) years v. 58 (47 - 67) years, respectively (p=0.001). All GTs were observed, with 1 and 5 most prevalent at 45% and 20%, respectively, and GTs 2, 3 and 4 frequencies of 7%, 11% and 17%, respectively. Extensive subtype diversity for GTs 2 and 4 was present. The median (IQR) HCV viral load was log10 5.9 IU/mL (5.4 - 6.5). A significant proportion of patients (39%) had advanced fibrosis or cirrhosis, with 11% F3 fibrosis and 28% F4. Of those with cirrhosis, 12% were decompensated with Childs-Pugh B or C disease. Of the patients, 19% were HIV co-infected and 2% HBV co-infected. In total, 13% were treatment experienced. The majority of patients were treated with sofosbuvir and ledipasvir (38%), daclatasvir (36%) or velpatasvir (± voxilaprevir, 9%). Less frequent combinations included partitaprevir, ritonavir, ombitasvir ± dasbuvir (11%) and sofosbuvir/ribavirin (5%). The per-protocol SVR was 96% (98% if sofosbuvir/ribavirin is excluded). The majority of treatment failures occurred with GT-4, notably subtype 4r. Mild side-effects were reported in 10% of patients, with none discontinuing therapy.\u0000\u0000\u0000CONCLUSIONS\u0000DAA therapy for HCV in a pan-genotypic group of patients, many with advanced liver disease, was highly effective. Our outcomes correspond with existing trial and real-world data for similar treatment. DAA therapy and access need rapid upscaling in SA, especially targeting key populations at point of care.","PeriodicalId":520778,"journal":{"name":"South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde","volume":" ","pages":"112-117"},"PeriodicalIF":2.2,"publicationDate":"2020-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.7196/SAMJ.2020.v110i2.14195","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38152748","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}