The management of tuberculous pericardial effusion : experience in 233 consecutive patients

The original publication is available at http://www.cvja.co.za/Aim: We report on the 30-day and one-year outcome of consecutive effusive pericarditis patients, including those with tuberculous pericarditis, over a six-year-period. Methods and Results: Patients with large pericardial effusions requiring pericardiocentesis were included in the study after having given written informed consent. Clinical and radiological evaluations were followed by echo-guided pericardiocentesis, and extended daily intermittent drainage via an indwelling pigtail catheter. A standard short-course anti-tuberculous regimen was initiated. A total of 233 patients was included. One hundred and sixty-two patients had pericardial tuberculosis (TB), including 118 (73%) with microbiological and/ or histological evidence of TB and 44 (27%) diagnosed on clinical and supportive laboratory data. Over the six-year period, two patients developed fibrous constrictive pericarditis after receiving adjuvant corticosteroid therapy. The 30-day mortality (8.0%) was statistically higher for HIV-positive patients (corresponding mortality 9.9%) than for HIV-negative patients (6.2%; p=0.04). The oneyear all-cause mortality was 17.3%. It was also higher for HIV-positive (22.2%) than for HIV-negative patients (12.3%; p=0.03). Cardiac mortality was equal for HIVpositive and -negative patients. Conclusion: Tuberculous pericardial effusions responded well to closed pericardiocentesis and a six-month treatment of antituberculous chemotherapy. The former was effective and safe irrespective of HIV status.Publishers' versio

Diagnostic accuracy of the Xpert MTB/Rif Ultra for tuberculosis adenitis

Abstract Background The WHO recently recommended the new Xpert MTB/RIF Ultra assay (Ultra) instead of the Xpert MTB/RIF assay because Ultra has improved sensitivity. We report the diagnostic accuracy of Ultra for tuberculous adenitis in a tuberculosis and HIV endemic setting. Methods We obtained fine-needle aspirates (FNA) and lymph node tissue by core-needle biopsy in adult patients with peripheral lymphadenopathy of >20 mm. Ultra and mycobacterial culture were performed on FNA and tissue specimens, with histological examination of tissue specimens. We assessed the diagnostic accuracy of Ultra against a composite reference standard of ‘definite tuberculosis’ (microbiological criteria) or ‘probable tuberculosis’ (histological and clinical criteria). Results We prospectively evaluated 99 participants of whom 50 were HIV positive: 21 had ‘definite tuberculosis’, 15 ‘probable tuberculosis’ and 63 did not have tuberculosis (of whom 38% had lymphoma and 19% disseminated malignancy). Using the composite reference standard the Ultra sensitivity on FNA was 70% (95% CI 51–85; 21 of 30), and on tissue was 67% (45–84; 16/24) these were far superior to the detection of acid-fast bacilli on an FNA (26%; 7/27); AFB on tissue (33%; 8/24); or tissue culture (39%; 9/23). The detection of granulomas on histology had high senstivity (83%) but the lowest specficity. When compared with culture the Ultra on FNA had a sensitvity of 78% (40-97; 7/9) and tissue 90% (55-100; 9/10). Conclusions Ultra performed on FNA or tissue of a lymph node had good sensitivity and high specificity. Ultra had a higher yield than culture and has the advantage of being a rapid test. Ultra on FNA would be an appropriate initial investigation for lymphadenopathy in tuberculosis endemic areas followed by a core biopsy for histopathology with a repeat Ultra on tissue if granulomas are present

Modeling global transfusion medicine education

This document provides an analysis and oversight of the necessary educational infrastructure at national level needed for successful and sustainable education programs undergraduate and post-graduate and is focused on desired outcomes needed to secure general Transfusion Medicine (TM) competence and basic skills when appointed in a professional TM position. It provides a global model framework for TM education allowing individual countries to tailor the context and contents of the institutional curriculum. Education in transfusion medicine is a complex set of intimately interrelated and interconnected components that allow student and fellow exposure to knowledge and skills, the ultimate curriculum. The extent to which knowledge and skills, professionalism and leadership principles are offered depends on the expected outcomes needed for the desired roles, tasks and functions. A model for the development and implementation of an education (teaching and training) curriculum in Transfusion Medicine aimed at medical students and doctors, nurses and midwives, and laboratory professionals should ideally include an outcomes-based component, with clear recommendations on the required roles, skills, attitudes, and knowledge of a trainee completing such a curriculum. This should correspond to the environment and scope of practice required from such a vocational or academic professional and should address deficiencies in knowledge, skills and attitudes present before the curriculum is completed, while taking into account fundamental international standards of knowledge and the needs of their working climate and environment. Therefore, it is considered more practical to provide a set of outcomes that would be useful in most contexts and settings, while equipping students, as adult learners, with the tools for advancing their educational, professional and leadership development suited to their availability and socio-economic environment. The framework or model recognizes that no one set of education or training initiatives will be appropriate in all countries or settings and should be tailored to specific settings based on the assessment of local needs and available environments

Small‐volume blood sample collection tubes in adult intensive care units: A rapid practice guideline

Background: This Intensive Care Medicine Rapid Practice Guideline (ICM‐RPG) provides an evidence‐based recommendation to address the question: in adult patients in intensive care units (ICUs), should we use small‐volume or conventional blood collection tubes? Methods: We included 23 panelists in 8 countries and assessed and managed financial and intellectual conflicts of interest. Methodological support was provided by the Guidelines in Intensive Care, Development, and Evaluation (GUIDE) group. We conducted a systematic review, including evidence from observational and randomized studies. Using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach, we evaluated the certainty of evidence and developed recommendations using the Evidence‐to‐Decision framework. Results: We identified 8 studies (1 cluster and 2 patient‐level randomized trials; 5 observational studies) comparing small‐volume to conventional tubes. We had high certainty evidence that small‐volume tubes reduce daily and cumulative blood sampling volume; and moderate certainty evidence that they reduce the risk of transfusion and mean number of red blood cell units transfused, but these estimates were limited by imprecision. We had high certainty that small‐volume tubes have a similar rate of specimens with insufficient quantity. The panel considered that the desirable effects of small‐volume tubes outweigh the undesirable effects, are less wasteful of resources, and are feasible, as demonstrated by successful implementation across multiple countries, although there are upfront implementation costs to validate small‐volume tubes on laboratory instrumentation. Conclusion: This ICM‐RPG panel made a strong recommendation for the use of small‐volume sample collection tubes in adult ICUs based on overall moderate certainty evidence

Allergic reactions to the Ad26.COV2.S vaccine in South Africa

BACKGROUND : The Janssen-Ad26.COV2.S vaccine is authorized for use in several countries, with more than 30 million doses administered. Mild and severe allergic adverse events following immunization (AEFI) have been reported. OBJECTIVE : We sought to detail allergic reactions reported during the Sisonke phase 3B study in South Africa. METHODS : A single dose of the Ad26.COV2.S vaccine was administered to 4,77,234 South African health care workers between February 17 and May 17, 2021. Monitoring of adverse events used a combination of passive reporting and active case finding. Telephonic contact was attempted for all adverse events reported as “allergy.” Anaphylaxis adjudication was performed using the Brighton Collaboration and National Institute of Allergy and Infectious Disease case definitions. RESULTS : Only 251 (0.052%) patients reported any allergic-type reaction (<1 in 2000), with 4 cases of adjudicated anaphylaxis (Brighton Collaboration level 1, n = 3) (prevalence of 8.4 per million doses). All anaphylaxis cases had a previous history of drug or vaccine-associated anaphylaxis. Cutaneous allergic reactions were the commonest nonanaphylatic reactions and included self-limiting, transient/localized rashes requiring no health care contact (n = 92) or isolated urticaria and/or angioedema (n = 70; median onset, 48 [interquartile range, 11.5-120] hours postvaccination) that necessitated health care contact (81%), antihistamine (63%), and/or systemic/topical corticosteroid (16%). All immediate (including adjudicated anaphylaxis) and most delayed AEFI (65 of 69) cases resolved completely. CONCLUSIONS : Allergic AEFI are rare following a single dose of Ad26.COV, with complete resolution in all cases of anaphylaxis. Although rare, isolated, delayed-onset urticaria and/or angioedema was the commonest allergic AEFI requiring treatment, with nearly half occurring in participants without known atopic disease.The Sinsonke Study is funded by the South African Medical Research Council. J.P.’s research is supported by a career development award and financial support from the National Institutes of Health; the European Developing Clinical Trials Partnership (EDCTP2 Program supported by the European Union; and the SA Medical Research Council and National Research Foundation.https://www.sciencedirect.com/journal/journal-of-allergy-and-clinical-immunology-globalhj2023Paediatrics and Child HealthSchool of Health Systems and Public Health (SHSPH

Vascular thrombosis after single dose Ad26.COV2.S vaccine in healthcare workers in South Africa : open label, single arm, phase 3B study (Sisonke study)

DATA AVAILABILITY STATEMENT : All data relevant to the study are included in the article or uploaded as supplementary information.OBJECTIVE : To assess the rates of vascular thrombotic adverse events in the first 35 days after one dose of the Ad26.COV2.S vaccine (Janssen/ Johnson & Johnson) in healthcare workers in South Africa and to compare these rates with those observed in the general population. DESIGN : Open label, single arm, phase 3B study. SETTING : Sisonke study, South Africa, 17 February to 15 June 2021. PARTICIPANTS : The Sisonke cohort of 477 234 healthcare workers, aged ≥18 years, who received one dose of the Ad26.COV2.S vaccine. MAIN OUTCOME MEASURES : Observed rates of venous arterial thromboembolism and vaccine induced immune thrombocytopenia and thrombosis in individuals who were vaccinated, compared with expected rates, based on age and sex specific background rates from the Clinical Practice Research Datalink GOLD database (database of longitudinal routinely collected electronic health records from UK primary care practices using Vision general practice patient management software). RESULTS : Most of the study participants were women (74.9%) and median age was 42 years (interquartile range 33-51). Twenty nine (30.6 per 100 000 person years, 95% confidence interval 20.5 to 44.0) vascular thrombotic events occurred at a median of 14 days (7-29) after vaccination. Of these 29 participants, 93.1% were women, median age 46 (37-55) years, and 51.7% had comorbidities. The observed to expected ratios for cerebral venous sinus thrombosis with thrombocytopenia and pulmonary embolism with thrombocytopenia were 10.6 (95% confidence interval 0.3 to 58.8) and 1.2 (0.1 to 6.5), respectively. Because of the small number of adverse events and wide confidence intervals, no conclusions were drawn between these estimates and the expected incidence rates in the population. CONCLUSIONS : Vaccine induced immune thrombocytopenia and thrombosis after one dose of the Ad26.COV2.S vaccine was found in only a few patients in this South African population of healthcare workers. These findings are reassuring if considered in terms of the beneficial effects of vaccination against covid-19 disease. These data support the continued use of this vaccine, but surveillance is recommended to identify other incidences of venous and arterial thromboembolism and to improve confidence in the data estimates. TRIAL REGISTRATION : ClinicalTrials. gov NCT04838795.The National Treasury of South Africa, National Department of Health, Solidarity Response Fund NPC, Michael and Susan Dell Foundation, Elma Vaccines and Immunisation Foundation, and Bill and Melinda Gates Foundation.https://bmjmedicine.bmj.comam2024Paediatrics and Child HealthSchool of Health Systems and Public Health (SHSPH)SDG-03:Good heatlh and well-bein