The CRASH Trial (Corticosteroid Randomisation After Significant Head injury), which started in April 1999 hopes to answer the question of whether or not there is any benefit to giving high dose corticosteroids after significant head injuries. To do this patients are randomised to receive either the standard care for head injuries, as defined by the receiving hospital, or standard care plus a 48 hour infusion of corticosteroids. This is to be started within eight hours of injury, preferably as soon as possible. As all eligible patients will have a reduced level of consciousness informed consent has been deemed unnecessary. In this review the issue of consent in human experimentation is presented with a special emphasis on the problems faced in emergency medicine research, and the way these have been tackled.

https://emj.bmj.com/content/emermed/18/3/198.full.pdf

The problem of informed consent in emergency medicine research.

Should the BMJ reject all studies that do not include informed consent? That's a simple question, and surely the answer should be equally simple–“Yes.” Unfortunately, ethical questions rarely allow simple answers, and we want help with answering this one. This issue includes a cluster of material that relates to the question. We publish the material–including two studies in which informed consent was not sought–to encourage debate and to arrive at a deeper understanding if not a simple answer.

Medical journals must consider the ethical aspects of all the material they publish, and medical editors are presented with ethical issues just as often as doctors–that is, every day. Almost everything that doctors and editors do has an ethical aspect. However, a paper published last month in JAMA shows that many journals do not give their authors clear ethical guidance.1 A survey of the published instructions to authors of the 102 major English language biomedical journals showed that a quarter did not give authors any guidance on human research ethics, and only half required approval by an ethics committee or institutional review board before publication.

An accompanying editorial looked at 53 consecutive research papers published in Annals of Internal Medicine , BMJ , Lancet , JAMA , and New England Journal of Medicine .2 The authors found that 47% did not record informed consent and 58% did not record approval by an ethics committee or institutional review board. Importantly, they found six papers in which they judged there was a compelling need for informed consent or approval by an ethics committee or institutional review board and yet where there was no mention of either. These data are supported by a study that found that, of 586 interventional studies published in four geriatrics journals, only 54% included informed consent and 40% …

/pdf/informed-consent-the-intricacies-4x5sa9eali.pdf

Informed consent: the intricacies.

Impact toughness at ambient and cryogenic temperatures was investigated with systematic fracture analyses for CuFeMn and Al15(CuFeMn)85 (at%) immiscible medium-entropy alloys. These two types of alloys exhibited different impact toughness behavior at different temperatures, while exhibiting higher impact toughness values than those of dual-phase steels with a similar strength level. 

Charpy impact toughness of Cu–Fe–Mn-based immiscible medium-entropy alloys

The high-temperature deformation behaviour of Al0.7CoCrFeNi alloy was studied at 800–1100 °C and 0.01–10 s−1. The alloy exhibited extensive softening via recrystallization and recovery with the examined temperature and strain rate domains. The recrystallization mechanism in the FCC phase was geometric dynamic recrystallization, and that in the BCC/B2 phase was continuous dynamic recrystallization. Further, the BCC/B2 lamellae underwent fragmentation via boundary splitting and termination migration. The amount of softening and subgrain morphology were dependent on the crystallographic orientation of the grains prior to deformation. Apart from lamellar fragmentation, dynamic globularization of BCC/B2 phase was found in certain grain colonies. Compared to heat treatment, hot deformation improved the globularization kinetics. Further, BCC/B2 precipitation occurred along the grain boundaries and at the triple points of the recrystallized FCC phase. However, the overall BCC/B2 phase fraction remained constant. Post-deformed alloy was also characterized by preferential cracking along the allotriomorphic FCC phase boundaries. The difference in strength between the idiomorphic and allotriomorphic regions was attributed to this grain boundary cracking. The activation energy for deformation showed a direct dependency on temperature and strain rate but an inverse relationship with strain. 

Effect of temperature and strain rate on the deformation behaviour and microstructure of Al0.7CoCrFeNi high entropy alloy

The development of high-entropy alloys (HEAs) for high-temperature applications has been driven by the limitation of nickel-based superalloys in achieving optimal efficiency at higher temperatures for higher efficiency in power generation engines. The alloys must have high oxidation resistance and microstructural stability at high temperatures. Relatively equimolar multi elements involved in HEAs produce microstructure containing a single solid solution or multiphase that improves the mechanical properties and oxidation resistance resulting from sluggish diffusion and core effects. In this study, the oxidation behavior and microstructural changes of Al0.75CoCrFeNi HEA at 900, 1000, and 1100 °C in air atmosphere were investigated. Based on the XRD and SEM-EDS analysis, the mechanism of oxide scale formation and microstructural changes of the substrate are proposed. The results show that the oxidation behavior of the alloy follows a logarithmic rate law. Different oxide compounds of CoO, NiO, Cr2O3, and CrO3, θ-Al2O3, α-Al2O3, and Ni(Cr,Al)2O4 with semicontinuous oxides of Al2O3 with Cr2O3 subscale and an oxide mixture consisting of spinel of Ni(Cr,Al)2O4 and Co(Cr,Al)2O4 were found. During oxidation, Widmanstätten of FCC-A1 and BCC-B2/A2 phases in the substrate have changed. Spheroidization of B2 and a reduction in volume fraction decrease the hardness of the substrates. 

High-Temperature Oxidation and Microstructural Changes of Al0.75CoCrFeNi High-Entropy Alloy at 900 and 1100 °C

Microstructural evolution and effect of heat treatment on the precipitation and mechanical behaviour of Al0.7CoCrFeNi alloy.

The obvious ethical problems posed by this study concern ( a ) the fact that all patients admitted to the intensive care unit over a six month period were included in the study without their knowledge or consent, and ( b ) the fact that blood samples obtained from all patients were tested for HIV infection without the consent of the patients, with the information that blood samples had been tested for the infection being given to patients only after the test had been done.

At first sight the decision to override the patients' right to full information, and to give or to refuse consent to inclusion and testing, seemed to all members of the research ethics committee to be so fundamentally at variance with the ethical principles governing research involving patients that it seemed impossible to give ethical approval for the study. However, during lengthy discussions with the investigators several considerations emerged.

Firstly, the information being sought by the investigators was clearly going to be of crucial importance to the community, not only in South Africa or in Africa as a whole but also worldwide. The importance of the study was perceived to be twofold. If it showed that a patient's HIV status significantly worsened his or her chances of a favourable outcome from intensive care–to …

Commentary: No simple and absolute ethical rule exists for every conceivable situation

Politics and ethics: Should the twain never meet?

Background Asthma medication prescription trends, including those of short-acting β2 -agonists (SABAs), are not well documented for South Africa (SA). Objectives To describe demographics, disease characteristics and asthma prescription patterns in the SA cohort of the SABA use IN Asthma (SABINA) III study. Methods An observational, cross-sectional study conducted at 12 sites across SA. Patients with asthma (aged ≥12 years) were classified by investigator-defined asthma severity, guided by the Global Initiative for Asthma (GINA) 2017 recommendations, and practice type (primary/ specialist care). Data were collected using electronic case report forms. Results Overall, 501 patients were analysed − mean (standard deviation) age, 48.4 (16.6) years; 68.3% female − of whom 70.6% and 29.4% were enrolled by primary care physicians and specialists, respectively. Most patients were classified with moderate-to-severe asthma (55.7%; GINA treatment steps 3 - 5), were overweight or obese (70.7%) and reported full healthcare reimbursement (55.5%). Asthma was partly controlled/uncontrolled in 60.3% of patients, with 46.1% experiencing ≥1 severe exacerbations in the 12 months before the study visit. Overall, 74.9% of patients were prescribed ≥3 SABA canisters in the previous 12 months (over-prescription); 56.5% were prescribed ≥10 SABA canisters. Additionally, 27.1% of patients reported purchasing SABA over-the-counter (OTC); among patients with both SABA purchase and prescriptions, 75.4% and 51.5% already received prescriptions for ≥3 and ≥10 SABA canisters, respectively, in the preceding 12 months. Conclusion SABA over-prescription and OTC purchase were common in SA, demonstrating an urgent need to align clinical practices with the latest evidence-based recommendations and regulate SABA OTC purchase to improve asthma outcomes. Study synopsis What the study adds. This study provides valuable insights into asthma medication prescription patterns, particularly SABAs, across SA. Collection of this real-world data in patients treated in primary and specialty care demonstrates that SABA over-prescription and SABA OTC purchase are common, even in patients with mild asthma. These findings will enable clinicians and policymakers to make targeted changes to optimise asthma outcomes across the country Implications of the findings. SABA over-prescription represents a major public health concern in SA. Healthcare providers and policymakers will need to work together to promote educational initiatives aimed at patients, pharmacists and physicians, align clinical practices with the latest evidence-based recommendations, improve access to affordable medications and regulate SABA purchase without prescription.

https://samajournals.co.za/index.php/ajtccm/article/download/619/328

Over-prescription of short-acting β2-agonists for asthma in South Africa: Results from the SABINA III study

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Papers

Microstructural evolution and effect of heat treatment on the precipitation and mechanical behaviour of Al0.7CoCrFeNi alloy.

Commentary: No simple and absolute ethical rule exists for every conceivable situation

Politics and ethics: Should the twain never meet?

Over-prescription of short-acting β2-agonists for asthma in South Africa: Results from the SABINA III study