Self- induction of abortion among women accessing second- trimester abortion services in the public sector, Western Cape Province, South Africa : An exploratory study

KMBackground: Despite South Africa's liberal abortion law permitting abortion on request in the first trimester and under restricted conditions for second-trimester pregnancies, the practice of unsafe self-induced abortion persists. However, the prevalence of this practice, the methods used and the reasons behind it are relatively under-researched. As part of a larger study seeking to improve abortion services in the Western Cape Province, we explored reports of prior attempts to self-induce abortion among women undergoing legal second-trimester abortion. Objectives: To describe the prevalence and methods of and factors related to unsuccessful attempts at self-induction of abortion by women presenting without complications and seeking second-trimester abortion at public health facilities in the Western Cape. Methods: In a cross-sectional study from April to August 2010, 194 consenting women undergoing second-trimester abortion were interviewed by trained fieldworkers using structured questionnaires at four public sector facilities near Cape Town. Results: Thirty-four women (17.5%; 95% confidence interval 12.7 - 23.4) reported an unsuccessful attempt to self-induce abortion during the current pregnancy before going to a facility for second-trimester abortion. No factors were significantly associated with self-induction, but a relatively high proportion of this small sample were unemployed and spoke an indigenous African language at home. A readily available herbal product called Stametta was most commonly used; other methods included taking tablets bought from unlicensed providers and using other herbal remedies. No use of physical methods was reported. Conclusions: The prevalence of unsafe self-induction of abortion is relatively high in the Western Cape. Efforts to inform women in the community about the availability of free services in the public sector and to educate them about the dangers of self-induction and unsafe providers should be strengthened to help address this public health issue

Access to and safety of COVID-19 convalescent plasma in the United States Expanded Access Program: A national registry study

BACKGROUND: The United States (US) Expanded Access Program (EAP) to coronavirus disease 2019 (COVID-19) convalescent plasma was initiated in response to the rapid spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19. While randomized clinical trials were in various stages of development and enrollment, there was an urgent need for widespread access to potential therapeutic agents. The objective of this study is to report on the demographic, geographical, and chronological characteristics of patients in the EAP, and key safety metrics following transfusion of COVID-19 convalescent plasma. METHODS AND FINDINGS: Mayo Clinic served as the central institutional review board for all participating facilities, and any US physician could participate as a local physician-principal investigator. Eligible patients were hospitalized, were aged 18 years or older, and had-or were at risk of progression to-severe or life-threatening COVID-19; eligible patients were enrolled through the EAP central website. Blood collection facilities rapidly implemented programs to collect convalescent plasma for hospitalized patients with COVID-19. Demographic and clinical characteristics of all enrolled patients in the EAP were summarized. Temporal patterns in access to COVID-19 convalescent plasma were investigated by comparing daily and weekly changes in EAP enrollment in response to changes in infection rate at the state level. Geographical analyses on access to convalescent plasma included assessing EAP enrollment in all national hospital referral regions, as well as assessing enrollment in metropolitan areas and less populated areas that did not have access to COVID-19 clinical trials. From April 3 to August 23, 2020, 105,717 hospitalized patients with severe or life-threatening COVID-19 were enrolled in the EAP. The majority of patients were 60 years of age or older (57.8%), were male (58.4%), and had overweight or obesity (83.8%). There was substantial inclusion of minorities and underserved populations: 46.4% of patients were of a race other than white, and 37.2% of patients were of Hispanic ethnicity. Chronologically and geographically, increases in the number of both enrollments and transfusions in the EAP closely followed confirmed infections across all 50 states. Nearly all national hospital referral regions enrolled and transfused patients in the EAP, including both in metropolitan and in less populated areas. The incidence of serious adverse events was objectively low (\u3c1%), and the overall crude 30-day mortality rate was 25.2% (95% CI, 25.0% to 25.5%). This registry study was limited by the observational and pragmatic study design that did not include a control or comparator group; thus, the data should not be used to infer definitive treatment effects. CONCLUSIONS: These results suggest that the EAP provided widespread access to COVID-19 convalescent plasma in all 50 states, including for underserved racial and ethnic minority populations. The study design of the EAP may serve as a model for future efforts when broad access to a treatment is needed in response to an emerging infectious disease. TRIAL REGISTRATION: ClinicalTrials.gov NCT#: NCT04338360

Donor chimerism and immune reconstitution following haploidentical transplantation in sickle cell disease

INTRODUCTION: We previously reported the initial results of a phase II multicenter transplant trial using haploidentical parental donors for children and aolescents with high-risk sickle cell disease achieving excellent survival with exceptionally low rates of graft-versus-host disease and resolution of sickle cell disease symptoms. To investigate human leukocyte antigen (HLA) sensitization, graft characteristics, donor chimerism, and immune reconstitution in these recipients. METHODS: CD34 cells were enriched using the CliniMACS RESULTS: HLA antibodies were detected in 7 of 11 (64%) evaluable patients but rarely were against donor antigens. Myeloid engraftment was rapid (100%) at a median of 9 days. At 30 days, donor chimerism was 93-99% and natural killer cell levels were restored. By 60 days, CD19 B cells were normal. CD8 and CD4 T-cells levels were normal by 279 and 365 days, respectively. Activated CD4 and CD8 T-cells were elevated at 100-365 days post-transplant while naïve cells remained below baseline. Tregs were elevated at 100-270 days post-transplant, returning to baseline levels at one year. At one year, C3 and C4 levels were above baseline and CH50 levels were near baseline. At one year, cytokine levels were not significantly different from baseline. DISCUSSION: These results suggest that haploidentical transplantation with CD34-enriched cells and peripheral blood mononuclear cell addback results in rapid engraftment, sustained donor chimerism and broad-based immune reconstitution

Clinical, histological and microbiological study of hand-excavated carious dentine in extracted permanent teeth

KIMChanges in cultivable flora in dentine samples collected before and after hand excavation were examined in association with clinical status of the cavity surface, light microscopy and scanning electron microscopy (SEM). Thirty-five extracted permanent molar teeth with an occlusal caries lesion were excavated with hand instruments according to the atraumatic restorative treatment (ART) approach. Excavation pressure, dentine colour and consistency were recorded at the dentine-enamel junction (DEJ) prior to carious dentine removal and at the cavity floor after the final excavation; a microbiological sample of dentine was taken at both stages. Twelve restored teeth; six with positive and six with negative bacterial growth on the second sample, were selected for light microscopy and SEM. The hand-excavation removed tooth structure was soft, irreversibly damaged, dark and highly infected. Hand excavation reached dentine of increased hardness with a more normal colour to provide a sound structural base for restoration. Light and SEM examination of the cavity floor showed infected dentinal tubules in all 12 teeth examined. Linear logistic analysis showed a statistical association between light-yellow dentine on the cavity floor and an absence of bacterial growth (P = 0.006). This short-term in vitro study showed that caries-producing bacteria remained in dentine close to the cavity floor in 26/35 teeth despite clinical observations that indicated a suitably prepared cavity floor

Deployment of convalescent plasma for the prevention and treatment of COVID-19

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the cause of coronavirus disease 2019 (COVID-19), has spurred a global health crisis. To date, there are no proven options for prophylaxis for those who have been exposed to SARS-CoV-2, nor therapy for those who develop COVID-19. Immune (i.e., convalescent ) plasma refers to plasma that is collected from individuals following resolution of infection and development of antibodies. Passive antibody administration through transfusion of convalescent plasma may offer the only short-term strategy for conferring immediate immunity to susceptible individuals. There are numerous examples in which convalescent plasma has been used successfully as postexposure prophylaxis and/or treatment of infectious diseases, including other outbreaks of coronaviruses (e.g., SARS-1, Middle East respiratory syndrome [MERS]). Convalescent plasma has also been used in the COVID-19 pandemic; limited data from China suggest clinical benefit, including radiological resolution, reduction in viral loads, and improved survival. Globally, blood centers have robust infrastructure for undertaking collections and constructing inventories of convalescent plasma to meet the growing demand. Nonetheless, there are nuanced challenges, both regulatory and logistical, spanning donor eligibility, donor recruitment, collections, and transfusion itself. Data from rigorously controlled clinical trials of convalescent plasma are also few, underscoring the need to evaluate its use objectively for a range of indications (e.g., prevention vs. treatment) and patient populations (e.g., age, comorbid disease). We provide an overview of convalescent plasma, including evidence of benefit, regulatory considerations, logistical work flow, and proposed clinical trials, as scale-up is brought underway to mobilize this critical resource

Convalescent plasma therapy for COVID-19: A graphical mosaic of the worldwide evidence

Convalescent plasma has been used worldwide to treat patients hospitalized with coronavirus disease 2019 (COVID-19) and prevent disease progression. Despite global usage, uncertainty remains regarding plasma efficacy, as randomized controlled trials (RCTs) have provided divergent evidence regarding the survival benefit of convalescent plasma. Here, we argue that during a global health emergency, the mosaic of evidence originating from multiple levels of the epistemic hierarchy should inform contemporary policy and healthcare decisions. Indeed, worldwide matched-control studies have generally found convalescent plasma to improve COVID-19 patient survival, and RCTs have demonstrated a survival benefit when transfused early in the disease course but limited or no benefit later in the disease course when patients required greater supportive therapies. RCTs have also revealed that convalescent plasma transfusion contributes to improved symptomatology and viral clearance. To further investigate the effect of convalescent plasma on patient mortality, we performed a meta-analytical approach to pool daily survival data from all controlled studies that reported Kaplan-Meier survival plots. Qualitative inspection of all available Kaplan-Meier survival data and an aggregate Kaplan-Meier survival plot revealed a directionally consistent pattern among studies arising from multiple levels of the epistemic hierarchy, whereby convalescent plasma transfusion was generally associated with greater patient survival. Given that convalescent plasma has a similar safety profile as standard plasma, convalescent plasma should be implemented within weeks of the onset of future infectious disease outbreaks

Guidance on the use of convalescent plasma to treat immunocompromised patients with coronavirus disease 2019

Coronavirus disease 2019 (COVID-19) convalescent plasma (CCP) is a safe and effective treatment for COVID-19 in immunocompromised (IC) patients. IC patients have a higher risk of persistent infection, severe disease, and death from COVID-19. Despite the continued clinical use of CCP to treat IC patients, the optimal dose, frequency/schedule, and duration of CCP treatment has yet to be determined, and related best practices guidelines are lacking. A group of individuals with expertise spanning infectious diseases, virology and transfusion medicine was assembled to render an expert opinion statement pertaining to the use of CCP for IC patients. For optimal effect, CCP should be recently and locally collected to match circulating variant. CCP should be considered for the treatment of IC patients with acute and protracted COVID-19; dosage depends on clinical setting (acute vs protracted COVID-19). CCP containing high-titer severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies, retains activity against circulating SARS-CoV-2 variants, which have otherwise rendered monoclonal antibodies ineffective

The effect of convalescent plasma therapy on mortality among patients with COVID-19: Systematic review and meta-analysis

To determine the effect of COVID-19 convalescent plasma on mortality, we aggregated patient outcome data from 10 randomized clinical trials, 20 matched control studies, 2 dose-response studies, and 96 case reports or case series. Studies published between January 1, 2020, and January 16, 2021, were identified through a systematic search of online PubMed and MEDLINE databases. Random effects analyses of randomized clinical trials and matched control data demonstrated that patients with COVID-19 transfused with convalescent plasma exhibited a lower mortality rate compared with patients receiving standard treatments. Additional analyses showed that early transfusion (within 3 days of hospital admission) of higher titer plasma is associated with lower patient mortality. These data provide evidence favoring the efficacy of human convalescent plasma as a therapeutic agent in hospitalized patients with COVID-19

Is true caries diagnosis possible as we approach 2000?

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Accurate diagnosis of occlusal carious lesions - a stereo microscope evaluation of clinical diagnosis

KIMThis study was undertaken to validate the caries status of 214 teeth by serial sectioning and microscopy after caries diagnosis using four methods. Two hundred and fourteen extracted human teeth with varying degrees of caries were mounted in the jaws of nine training manikins. All tooth surfaces were examined and recorded for caries by four dentists using bitewing radiographs, fibre-optic transillumination (FOTI), mirror alone and a mirror and sharp probe on two separate occasions. Thereafter the teeth were serially sectioned and assessed microscopically for depth of caries lesion on a graded score of 0-7. This report assessed the diagnostic outcome of 2,183 observations for occlusal surfaces. Sound diagnoses predominated over unsound until caries was present in the inner half of dentine. Specificity was between 90% and 95% and sensitivity 26% and 50% depending on which diagnostic method was used and where the sound/unsound threshold was set. Negative and positive predictive values were similarly influenced and varied between 53% and 80% and 73% and 90%, respectively. Probit analysis showed no significant differences (P < 0.05) between examiners and diagnostic methods. Diagnosis of occlusal caries undertaken in an in vitro simulated clinical situation is inaccurate until the caries lesion extends deep into the dentine no matter which of the four methods was used