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1.
Journal of the Pakistan Medical Association ; 72(6):1142-1147, 2022.
Article in English | EMBASE | ID: covidwho-1885007

ABSTRACT

Objective: To assess the views of health service providers towards coronavirus disease 2019 vaccination with Cansino, Sinovac and Sinopharm vaccines. Method: The analytical cross-sectional study was conducted at the Sindh Institute of Urology and Transplantation, Karachi, in May and June 2021, and comprised doctors, nurses, technical staff, and medical social officers. Data was collected using a questionnaire, in Urdu and English languages, assessing determinants of hesitancy. Data was analysed using SPSS 19. Results: Of the 331 subjects, 156(47%) were males and 175(53%) were females. Overall, 183(55%) subjects were aged <30 years, and 7(2%) were aged >60 years. Among the responders, 274(83%) were vaccinated, 49(15%) wanted to delay, and 8(2.4%) were outright refusers. Among the hesitant, 43(80%) were women, and 56(98%) were aged <40 years. Age, gender, occupational group and personal experience with the disease had significant correlations with vaccination status (p<0.05). Personal safety 202(74%) followed by the perception of official requirement 162(59%) were the prime reasons for getting vaccinated. No respondent cited religious inhibitions or social media as the reason behind vaccine refusal. Conclusion: A lack of trust in the safety and efficacy data of the available Chinese vaccines appeared as a factor inducing hesitancy. The resistance of younger respondents, especially trainee physicians, was a finding of concern since they form the backbone of the health system in the country.

2.
Indian Journal of Pharmaceutical Education and Research ; 56(2):S356-S364, 2022.
Article in English | EMBASE | ID: covidwho-1884618

ABSTRACT

Introduction: The meteoric spread of COVID-19 had facilitated the researchers to develop vaccines. One among the most recommended, Covishield requires further investigations for lighting up the society towards the immunization program. The study has determined the severity and frequency of adverse event following immunization concerning the first and booster dose of the Covishield vaccine. Also, we investigated the relationship between the participant’s demographic characteristics with the adverse events encountered due to the two doses. Materials and Methods: An observational cross-sectional study was conducted over 6 months among the individuals who were administered with Covishield vaccine registered via Indian government website, COWIN. Results: The study constituted of 2470 participants among them the frequency of females who received the vaccine (55.18%;62.36%) was more significant than the males, so as the adverse events (Female, first dose: 51.41%, Second dose: 64.92%). We observed participants with chronic diseases (39,5%) and had long term medications (15.57%). Those with age greater than 45 years (61.15%) were discerned by the unfavorable episodes of the vaccine compared to the youngsters. First dose predominantly spawn pain at the injection site (40.15%) whereas, fever (34.72%) was the major concern in the second. The causality assessment scale put forward by World Health Organization stated all the reported adverse events following immunization in the first (62.90%) and the second dose (30.28%) was allied to the same category, consistent causal association to immunization. Conclusion: The safety surveillance study helped in the investigation wherein the adverse event profile of Covishield vaccine was causal or coincidental. We intend the generated data would reduce the fear and augment the acceptance rate of COVID-19 vaccine among the mass population.

3.
BJPsych Open ; 7(5), 2021.
Article in English | EMBASE | ID: covidwho-1883558

ABSTRACT

Background Cognitive-behavioural therapy (CBT) is recommended for all patients with psychosis, but is offered to only a minority. This is attributable, in part, to the resource-intensive nature of CBT for psychosis. Responses have included the development of CBT for psychosis in brief and targeted formats, and its delivery by briefly trained therapists. This study explored a combination of these responses by investigating a brief, CBT-informed intervention targeted at distressing voices (the GiVE intervention) administered by a briefly trained workforce of assistant psychologists. Aims To explore the feasibility of conducting a randomised controlled trial to evaluate the clinical and cost-effectiveness of the GiVE intervention when delivered by assistant psychologists to patients with psychosis. Method This was a three-arm, feasibility, randomised controlled trial comparing the GiVE intervention, a supportive counselling intervention and treatment as usual, recruiting across two sites, with 1:1:1 allocation and blind post-treatment and follow-up assessments. Results Feasibility outcomes were favourable with regard to the recruitment and retention of participants and the adherence of assistant psychologists to therapy and supervision protocols. For the candidate primary outcomes, estimated effects were in favour of GiVE compared with supportive counselling and treatment as usual at post-treatment. At follow-up, estimated effects were in favour of supportive counselling compared with GiVE and treatment as usual, and GiVE compared with treatment as usual. Conclusions A definitive trial of the GiVE intervention, delivered by assistant psychologists, is feasible. Adaptations to the GiVE intervention and the design of any future trials may be necessary.

4.
Arch Argent Pediatr ; 120(2): 111-117, 2022 04.
Article in English, Spanish | MEDLINE | ID: covidwho-1884623

ABSTRACT

INTRODUCTION: Prescription errors are the most common cause of preventable errors. Electronic prescription (EP) systems may help to reduce errors and improve the quality of care. OBJECTIVES: To assess the effect of EP on the prevalence of prescription errors and related adverse events (AE) among hospitalized pediatric patients. To assess EP adherence, acceptability, and suitability among users. METHODS: Hybrid, descriptive, and quasi-experimental, before-and-after design. Prescriptions made to hospitalized patients were included, estimating the prevalence of prescription errors and related AE in the pre- and post- EP implementation periods at a children's hospital (CH) and a general hospital (GH) used as control. Adherence was assessed based on the proportion of EP among all prescriptions registered in the post-implementation period. The acceptability and suitability of EP implementation was assessed via a user survey. RESULTS: The prevalence of prescription errors pre- and post-EP implementation at the CH was compared and a statistically significant reduction was observed in both hospitals: CH: 29.1 versus 19.9 prescription errors/100 prescriptions (OR: 1.65; 95% CI: 1.34-2.02; p < 0.01). GH: 24.9 versus 13.6 prescription errors/100 prescriptions (OR: 2.1; 95% CI: 1.5-2.8; p < 0.01). The rate of overall adherence to EP was 83%. The implementation of EP was adequately acceptable and suitable. CONCLUSION: The prevalence of prescription errors reduced 30% after the implementation of EP. The overall adherence to EP was adequate.


Introducción. Los errores en prescripción médica (EPM) son la causa más frecuente de errores prevenibles. El empleo de sistemas de prescripción informatizada (PI) contribuiría a disminuir el error y a mejorar la calidad de atención. Objetivos. Evaluar el efecto de la PI en la prevalencia de EPM y eventos adversos (EA) relacionados en pacientes pediátricos hospitalizados. Evaluar la adherencia, aceptabilidad y apropiabilidad de la herramienta por parte de los usuarios. Método. Diseño híbrido, descriptivo y cuasiexperimental tipo antes-después. Se incluyeron prescripciones médicas de pacientes hospitalizados, calculando la prevalencia de EPM y EA relacionados, en los períodos pre-y posimplementación de la PI en un hospital pediátrico (HP) y en uno general (HG) que se tomó como control. Se evaluó la adherencia mediante la proporción de las PI sobre las totales registradas en el período posimplementación. Se evaluó la aceptabilidad y apropiabilidad de la implementación por encuesta a los usuarios. Resultados. Al comparar la prevalencia de EPM pre- y posimplementación en el HP, se observó una disminución estadísticamente significativa en los dos hospitales: HP 29,1 versus 19,9 EPM/100 prescripciones (OR: 1,65; IC95 %: 1,34-2,02; p < 0,01). En el HG 24,9 versus 13,6 EPM/100 prescripciones (OR: 2,1; IC95 %: 1,5-2,8; p < 0,01). La tasa de adherencia global a la PI fue del 83 %. La implementación presentó aceptabilidad y apropiabilidad satisfactoria. Conclusión. La prevalencia de EPM se redujo un 30 % posimplementación. La adherencia global a la herramienta fue satisfactoria.


Subject(s)
Electronic Prescribing , Child , Hospitals, Pediatric , Humans , Medication Errors/prevention & control
5.
Vaccines (Basel) ; 10(6)2022 Jun 10.
Article in English | MEDLINE | ID: covidwho-1884448

ABSTRACT

Vaccines are considered to be the most beneficial means for combating the COVID-19 pandemic. Although vaccines against SARS-CoV-2 have demonstrated excellent safety profiles in clinical trials, real-world surveillance of post-vaccination side effects is an impetus. The study investigates the short-term side effects following the administration of the Pfizer-BioNTech and Oxford-AstraZeneca vaccines in Saudi Arabia. A cross-sectional quantitative study was conducted among the general population with age ≥ 18 years, from five regions (Central, Northern, Eastern, Southern, and Western Regions) of Saudi Arabia for a period of 6 months (July to December 2021). A self-administered study instrument was used to record the side effects among the COVID-19 vaccine recipients. Of the total 398 participants (males: 59%), 56.3% received Pfizer and 43.7% were vaccinated with AstraZeneca. Only 22.6% of respondents received the second dose of the COVID-19 vaccines. The most commonly reported side effects were pain at the injection site (85.2%), fatigue (61.8%), bone or joint pain (54.0%), and fever (42.5%). The average side effects score was 3.4 ± 2.2. Females, young people, and Oxford-AstraZeneca recipients had a higher proportion of side effects. The Oxford-AstraZeneca vaccine recipients complained more about fever (p < 0.001), bone and joint pain (p < 0.001), fatigue (p < 0.001), loss of appetite (p = 0.001), headache (p = 0.008), and drowsiness (p = 0.003). The Pfizer-BioNTech vaccinees had more pain and swelling at the injection site (p = 0.001), and sexual disturbance (p = 0.019). The study participants also reported some rare symptoms (<10%) including heaviness, sleep disturbance, fainting, blurred vision, palpitations, osteomalacia, and inability to concentrate. This study revealed that both Pfizer-BioNTech and Oxford-AstraZeneca administration was associated with mild to moderate, transient, short-lived side effects. These symptoms corroborate the results of phase 3 clinical trials of these vaccines. The results could be used to inform people about the likelihood of side effects based on their demographics and the type of vaccine administered. The study reported some rare symptoms that require further validation through more pharmacovigilance or qualitative studies.

6.
Vaccines (Basel) ; 10(6)2022 Jun 02.
Article in English | MEDLINE | ID: covidwho-1884426

ABSTRACT

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 disease (COVID-19) has caused a worldwide challenging and threatening pandemic. Multinational, placebo-controlled, observer-blinded trials were conducted since the beginning of pandemic because safe and effective vaccines were needed urgently. In most trials of COVID-19 vaccines patients affected by malignancies or on treatment with immunosuppressive drugs were excluded. PATIENTS AND METHODS: A retrospective monocentric study was conducted at Medical Oncological Unit of Santa Chiara Hospital (Pisa, Italy) in this subset of population to investigate safety and tolerability of COVID-19 vaccines; 377 patients with solid tumor on treatment were enrolled. Vaccine-related adverse events were recorded using a face-to-face questionnaire including a toxicity grading scale. Most of the patients (94%) received mRNA vaccine as indicated by Italian health ministry guidelines. Mean age was 66 years (range 27-87), 62% of the patients were older than 65 years and 68% had at least one additional comorbidity. The majority (86%) of patients were in a metastatic setting and 29% received immunotherapy-based treatment. For statistical analysis, multivariate binary logistic regression models were performed and linear regression models were applied. RESULTS: Adverse events were mild and transient and ended in a few days without any sequelae. No severe or uncommon adverse events were recorded. In multivariate analysis, we found that the female sex was associated with a greater risk of more severe and longer lasting adverse events, and a higher risk of adverse events was found for patients treated with immunotherapy. CONCLUSIONS: Our results demonstrate that COVID-19 vaccines were safe and well-tolerated in this population of patients being treated for solid tumors.

7.
Curr Drug Metab ; 23(1): 21-29, 2022.
Article in English | MEDLINE | ID: covidwho-1883807

ABSTRACT

Platycodonis Radix (Jiegeng), the dried root of Platycodon grandiflorum, is a traditional herb used as both medicine and food. Its clinical application for the treatment of cough, phlegm, sore throat, pulmonary and respiratory diseases has been thousands of years in China. Platycodin D is the main active ingredient in Platycodonis Radix, which belongs to the family of pentacyclic triterpenoid saponins because it contains an oleanolane type aglycone linked with double sugar chains. Modern pharmacology has demonstrated that Platycodin D displays various biological activities, such as analgesics, expectoration and cough suppression, promoting weight loss, anti-tumor and immune regulation, suggesting that Platycodin D has the potential to be a drug candidate and an interesting target as a natural product for clinical research. In this review, the distribution and biotransformation, pharmacological effects, metabolic mechanism and safety evaluation of Platycodin D are summarized to lay the foundation for further studies.


Subject(s)
Saponins , Triterpenes , Biotransformation , Cough , Humans , Saponins/adverse effects , Saponins/metabolism , Triterpenes/adverse effects
8.
Journal of Occupational and Organizational Psychology ; n/a(n/a), 2022.
Article in English | Wiley | ID: covidwho-1883219

ABSTRACT

During the COVID-19 pandemic, teachers in the United States, an already at-risk occupation group, experienced new work-related stressors, safety concerns, and work-life challenges, magnifying on-going retention concerns. Integrating the crisis management literature with the unfolding model of turnover, we theorize that leader actions trigger initial employee responses but also set the stage for on-going crisis response that influence changes in teachers' turnover intentions. We apply latent growth curve modelling to test our hypotheses based on a sample of 617 K-12 teachers using nine waves of data, including a baseline survey at the start of the 2020?2021 school year and eight follow-up surveys (2-week lags) through the Fall 2020 semester. In terms of overall adaptation, teachers on average, experienced an increase in work-life balance and a decrease in turnover intentions over the course of the semester. Results also suggest that district and school leadership provide unique and complementary resources, but leader behaviours that shape initial crisis responses do not similarly affect employee responses during crisis, contrary to theory. Instead, teachers' adaptive crisis response trajectories were triggered by continued resource provision over the semester;increasing provision of valued resources (i.e., continued refinement of safety practices) and improvements in work-life balance prevented turnover intentions from spiralling throughout the crisis. Crisis management theory and research should continue to incorporate temporal dynamics and identify factors that contribute to crisis response trajectories, using designs and analyses that allow for examination as crises unfold in real time.

9.
Ieee Access ; 10:52744-52759, 2022.
Article in English | English Web of Science | ID: covidwho-1883110

ABSTRACT

Wireless Mesh Networks (WMNs) have rapid real developments during the last decade due to their simple implementation at low cost, easy network maintenance, and reliable service coverage. Despite these properties, the nodes placement of such networks imposes an important research issue for network operators and influences strongly the WMNs performance. This challenging issue is known to be an NP-hard problem, and solving it using approximate optimization algorithms (i.e. heuristic and meta-heuristic) is essential. This motivates our attempts to present an application of the Coyote Optimization Algorithm (COA) to solve the mesh routers placement problem in WMNs in this work. Experiments are conducted on several scenarios under different settings, taking into account two important metrics such as network connectivity and user coverage. Simulation results demonstrate the effectiveness and merits of COA in finding optimal mesh routers locations when compared to other optimization algorithms such as Firefly Algorithm (FA), Particle Swarm Optimization (PSO), Whale Optimization Algorithm (WOA), Genetic Algorithm (GA), Bat Algorithm (BA), African Vulture Optimization Algorithm (AVOA), Aquila Optimizer (AO), Bald Eagle Search optimization (BES), Coronavirus herd immunity optimizer (CHIO), and Salp Swarm Algorithm (SSA).

10.
Vaccine ; 2022.
Article in English | ScienceDirect | ID: covidwho-1882613

ABSTRACT

The Brighton Collaboration Benefit-Risk Assessment of VAccines by TechnolOgy (BRAVATO) Working Group has prepared standardized templates to describe the key considerations for the benefit-risk assessment of several vaccine platform technologies, including nucleic acid (RNA and DNA) vaccines. This paper uses the BRAVATO template to review the features of a vaccine employing a proprietary mRNA vaccine platform to develop Moderna COVID-19 Vaccine (mRNA-1273);a highly effective vaccine to prevent coronavirus disease 2019 (Covid-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In response to the pandemic the first in human studies began in March 2020 and the pivotal, placebo-controlled phase 3 efficacy study in over 30,000 adults began in July 2020. Based on demonstration of efficacy and safety at the time of interim analysis in November 2020 and at the time of trial unblinding in March 2021, the mRNA-1273 received Emergency Use Authorization in December 2020 and full FDA approval in January 2022.

11.
BMC Public Health ; 22(1): 1153, 2022 Jun 09.
Article in English | MEDLINE | ID: covidwho-1883523

ABSTRACT

BACKGROUND: New vaccines that are initially approved in clinical trials are not completely free of risks. Systematic vaccine safety surveillance is required for ensuring safety of vaccines. This study aimed to provide a protocol for safety monitoring of COVID-19 vaccines, including Sputnik V, Sinopharm (BBIBP-CorV), COVIran Barekat, and AZD1222. METHODS: This is a prospective cohort study in accordance with a template provided by the World Health Organization. The target population includes citizens of seven cities in Iran who have received one of the available COVID-19 vaccines according to the national instruction on vaccination. The participants are followed for three months after they receive the second dose of the vaccine. For each type of vaccine, 30,000 people will be enrolled in the study of whom the first 1,000 participants are in the reactogenicity subgroup. The reactogenicity outcomes will be followed seven days after vaccination. Any hospitalization, COVID-19 disease, or other minor outcomes will be investigated in weekly follow-ups. The data are gathered through self-reporting of participants in a mobile application or phone calls to them. The study outcomes may be investigated for the third and fourth doses of vaccines. Other long-term outcomes may also be investigated after the expansion of the follow-up period. We have planned to complete data collection for the current objectives by the end 2022. DISCUSSION: The results of this study will be published in different articles. A live dashboard is also available for managers and policymakers. All data will be available on reasonable requests from the corresponding author.The use of the good and comprehensive guidelines provided by WHO, along with the accurate implementation of the protocol and continuous monitoring of the staff performance are the main strengths of this study which may be very useful for policymaking about COVID-19 vaccination.


Subject(s)
COVID-19 Vaccines , COVID-19 , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Humans , Iran/epidemiology , Prospective Studies , Research Design , SARS-CoV-2 , Vaccination/adverse effects
12.
BMC Public Health ; 22(1): 1148, 2022 Jun 08.
Article in English | MEDLINE | ID: covidwho-1883521

ABSTRACT

AIM: The objective of this study was to develop a cultural adopted questionnaire for evaluation of knowledge (K), attitude (A) and practice (P) of Iranian population toward food safety during Covid-19. METHODS: The study is based on an online questionnaire that filled by 712 Iranians over 16 years old. Exploratory factor analysis (EFA), confirmatory factor analysis (CFA) and reliability assessment were performed. The construct validity of A and P determined by EFA and confirmed by CFA. Difficulty index was used for K. RESULTS: The reliability score of questionnaire was satisfactory. The three items of K-A-P questionnaire were significantly associated with the total score of questionnaire. The KAP questionnaire regarding food safety in covid-19 consisted of 27 items multidimensional scale with strong psychometric features. The respondent showed a satisfactory level of KAP during covid-19 pandemics. CONCLUSION: The KAP questionnaire regarding food safety in covid-19 is a valid and reliable tool for measurement of knowledge, attitude and practice of people regarding food safety in covid-19.


Subject(s)
COVID-19 , Adolescent , COVID-19/epidemiology , Food Safety , Health Knowledge, Attitudes, Practice , Humans , Hygiene , Iran/epidemiology , Pandemics/prevention & control , Psychometrics/methods , Reproducibility of Results , Surveys and Questionnaires
13.
Vaccine ; 2022 Jun 08.
Article in English | MEDLINE | ID: covidwho-1882618

ABSTRACT

The mass inoculation of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine to induce herd immunity is one of the most effective measures to fight COVID-19. The vaccination of pregnant women cannot only avoid or reduce the probability of infectious diseases, but also offers the most effective and direct protection for neonates by means of passive immunization. However, there is no randomized clinical data to ascertain whether the inactivated vaccination of pregnant women or women of childbearing age can affect conception and the fetus. We found that human angiotensin-converting enzyme 2 (hACE2) mice that were vaccinated with two doses of CoronaVac (an inactivated SARS-CoV-2 vaccine) before and during pregnancy exhibited normal weight changes and reproductive performance indices; the physical development of their offspring was also normal. Following intranasal inoculation with SARS-CoV-2, pregnant mice in the immunization group all survived; reproductive performance indices and the physical development of offspring were all normal. In contrast, mice in the non-immunization group all died before delivery. Analyses showed that inoculation of CoronaVac was safe and did not exert any significant effects on pregnancy, lactation, or the growth of offspring in hACE2 mice. Vaccination effectively protected the pregnant mice against SARS-CoV-2 infection and had no adverse effects on the growth and development of the offspring, thus suggesting that inoculation with an inactivated SARS-CoV-2 vaccine may be an effective strategy to prevent infection in pregnant women.

14.
Vaccine ; 2022 Jun 07.
Article in English | MEDLINE | ID: covidwho-1882615

ABSTRACT

INTRODUCTION: We investigated the potential association of COVID-19 vaccination with three acute neurological events: Guillain-Barré syndrome (GBS), transverse myelitis and Bell's palsy. METHODS: With the approval of NHS England we analysed primary care data from >17 million patients in England linked to emergency care, hospital admission and mortality records in the OpenSAFELY platform. Separately for each vaccine brand, we used a self-controlled case series design to estimate the incidence rate ratio for each outcome in the period following vaccination (4-42 days for GBS, 4-28 days for transverse myelitis and Bell's palsy) compared to a within-person baseline, using conditional Poisson regression. RESULTS: Among 7,783,441 ChAdOx1 vaccinees, there was an increased rate of GBS (N = 517; incidence rate ratio 2·85; 95% CI2·33-3·47) and Bell's palsy (N = 5,350; 1·39; 1·27-1·53) following a first dose of ChAdOx1 vaccine, corresponding to 11.0 additional cases of GBS and 17.9 cases of Bell's palsy per 1 million vaccinees if causal. For GBS this applied to the first, but not the second, dose. There was no clear evidence of an association of ChAdOx1 vaccination with transverse myelitis (N = 199; 1·51; 0·96-2·37). Among 5,729,152 BNT162b2 vaccinees, there was no evidence of any association with GBS (N = 283; 1·09; 0·75-1·57), transverse myelitis (N = 109; 1·62; 0·86-3·03) or Bell's palsy (N = 3,609; 0·89; 0·76-1·03). Among 255,446 mRNA-1273 vaccine recipients there was no evidence of an association with Bell's palsy (N = 78; 0·88, 0·32-2·42). CONCLUSIONS: COVID-19 vaccines save lives, but it is important to understand rare adverse events. We observed a short-term increased rate of Guillain-Barré syndrome and Bell's palsy after first dose of ChAdOx1 vaccine. The absolute risk, assuming a causal effect attributable to vaccination, was low.

15.
European Journal of Surgical Oncology ; 48(5):e200, 2022.
Article in English | EMBASE | ID: covidwho-1881969

ABSTRACT

Aim: Virtual consultations (VC) in breast surgery have been successfully utilised during the COVID pandemic and have potential to reduce the costs of outpatient clinics as well as increase patient satisfaction. We aimed to assess the utility and safety of VC in new patient clinics in women under 30, which is considered a low-risk subgroup. Methods: Data was prospectively collected on 118 women aged under 30 who were referred from primary care to the breast clinic between December 2020 and April 2021. Clinicopathological data was collected on referrals, imaging and follow up. Results: Median age was 24 years (range 17-30). The commonest presenting symptoms were a lump (69%), breast pain (16%) and nipple symptoms (14%). The VC was performed via video in 63 (53%) patients and via telephone alone in 55 (47%). Nineteen patients (16%) were reassured and discharged directly from VC. Ninety-four patients (80%) underwent an outpatient ultrasound with a sonographer trained in clinical palpation. Twenty-six (27%) ultrasounds showed benign pathology with the remainder being normal. Six biopsies were performed, all of which were benign. Seventeen (14%) patients required a face-to-face appointment with a breast surgeon after ultrasound or biopsy. Ninety-four (79%) patients were discharged after VC + ultrasound alone. No patients required surgery. Conclusion: Utilising VC, the majority of new referrals in women under 30 did not require face-to-face appointments. VC have potential to reduce burden on new patient clinics whilst improving patient convenience. Early data suggest a low risk of compromising safety in this subgroup.

16.
European Journal of Surgical Oncology ; 48(5):e189-e190, 2022.
Article in English | EMBASE | ID: covidwho-1881968

ABSTRACT

Introduction: Prepectoral breast reconstruction (PPBR) has been widely adopted due to a perceived reduction in post-operative pain and improved patient satisfaction but high-quality evidence to support these benefits is lacking. The Pre-BRA prospective multicentre cohort study aimed to explore the safety and effectiveness of PPBR prior to definitive evaluation in an RCT. Here we report the 1st analysis of the 18-month patient-reported outcome (PRO) data. Methods: Consecutive women undergoing PPBR at 40 UK centres were recruited to the Pre-BRA study between July 2019 and Dec 2020 with a 4 month pause to recruitment (March-July 2020) due to the COVID-19 pandemic. Demographic, operative, oncological, and 3-month safety data were collected. Women were asked to complete the BREAST-Q© (V2.0) at baseline, 3 and 18-months. Questionnaires were scored according to the developers' instructions and compared with the 18-month PRO results from the iBRA study which included mainly subpectoral mesh-assisted reconstruction. Results: 347 women underwent PPBR in the Pre-BRA study. Of these, 221 patients recruited pre-COVID have reached 18-month follow-up and 164 (74%) have completed the 18-month questionnaire. The median Satisfaction with Breasts score was 60 (48.5-71;0-100) [inter-quartile range;range] compared to 59 (48-71;0-100) in the UK iBRA study. Conclusions: Satisfaction with breasts at 18-months following surgery appears to be equivalent following pre and subpectoral breast reconstruction. Further analysis is needed, but this study supports the need for an RCT to definitively compare techniques and establish best practice for implant-based reconstruction.

17.
Indian Pediatrics ; 59(3):217, 2022.
Article in English | EMBASE | ID: covidwho-1881538
18.
Topics in Antiviral Medicine ; 30(1 SUPPL):174, 2022.
Article in English | EMBASE | ID: covidwho-1881008

ABSTRACT

Background: Remdesivir (RDV), a potent nucleotide inhibitor of the SARS-CoV-2 RNA-dependent RNA polymerase, effectively reduces COVID-19 related hospitalization in outpatients at high risk for progression to severe disease. However, limited data exist on the safety profile of RDV in this population. Methods: We conducted a Phase III placebo-controlled study evaluating a 3-day regimen of RDV in non-hospitalized patients who are at risk for disease progression (age>60 years or underlying comorbid condition). Patients were randomly assigned 1:1 to receive intravenous RDV (200 mg on day 1, 100 mg on days 2 to 3) or placebo (PBO). The primary safety endpoint was the proportion of patients with treatment-emergent adverse events (AEs). AEs were evaluated through day 28 and lab abnormalities were evaluated through day 14. Results: 562 patients were randomized and initiated treatment (279, RDV;283, placebo). Baseline characteristics were balanced between groups. Thirty percent were ≥60 years old and most common comorbidities were diabetes mellitus (62%), obesity (56%;median BMI, 30.7 kg/m2), and hypertension (48%). RDV was well tolerated with a similar rate of any AEs between groups (Table). Patients treated with RDV had fewer Grade ≥3 and serious AEs (SAEs) compared to PBO, but had more study-drug related AEs, with the most common one being nausea (18 [6.5%] in RDV vs. 10 [3.5%] in PBO). Grade 3 or higher ALT elevation was reported in 1 (0.4%) RDV vs. 2 (0.7%) PBO treated patients. Median change from baseline in AST, ALT, and bilirubin was similar between groups (Table). Grade 3 or higher decrease in creatinine clearance (CrCl) occurred more often in RDV vs. to PBO treated patients (5.6% vs 1.9% respectively). Most decreases in creatinine clearance occurred within the normal serum creatinine range, occurred after completion of RDV therapy, and resolved on follow-up. Median changes in CrCl from baseline were similar between groups and no renal AEs were reported (Table). Incidence of cardiac-related AEs was similar between RDV and PBO groups. All bradycardia events occurred in the PBO group. No patient experienced a serious AE or drug discontinuation due to hypersensitivity. Conclusion: Treatment with RDV was safe and well tolerated in non-hospitalized patients with risk factors for COVID-19 disease progression. Patients in the RDV group had similar type, incidence, and severity of AEs and lab abnormalities as those receiving PBO.

19.
Topics in Antiviral Medicine ; 30(1 SUPPL):348, 2022.
Article in English | EMBASE | ID: covidwho-1881001

ABSTRACT

Background: In attempts to rapidly immunize a greater proportion of the Ontario population against COVID, public health officials recommended extending the interval between vaccine doses and allowed "mixing of vaccine types". The impact of these decisions on the antibody response to the vaccine, particularly in the community dwelling elderly population is unknown. Methods: The STOPCoV study is designed to compare the IgG antibody response to spike protein and receptor binding domain (RBD) after COVID vaccination in those aged ≥ 70 years relative to a cohort aged 30-50 years. This prospective decentralized observational study is conducted remotely on a digital platform (www.stopcov.ca). Participants signed an e-consent, completed questionnaires and will submit dried blood spot (DBS) specimens 6-8 times over 48 weeks after the second vaccine dose. DBS samples were analyzed for IgG antibodies to spike and RBD by an in-house ELISA. We report here the ratio-normalized levels of anti-spike and anti-RBD IgG antibodies prior to and at 2 weeks after the second vaccine with comparisons between age groups. Linear regression models were used to determine the effect of age on the ratio normalized RBD antibody levels 2 weeks post second dose of vaccine after adjusting for potential confounders determined a priori. Results: 1286 persons enrolled between May 17 and July 31, 2021. 1194 participants (853 > 70 years;341 aged 30-50) completed at least one study related task. 761 (64.1%) are female. Most received an mRNA vaccine, with 863 (74%) receiving the same vaccine brand, and 196 (17%) receiving mixed brands over 2 doses. Two weeks after the second vaccine dose, the median interquartile rangeanti-spike antibody level was 0.76 [0.45, 1.16] for those ≥70 compared to 1.3 [0.98, 1.56] for those 30-50 (p<0.001). The median anti-RBD antibody levels were 0.28 [0.15, 0.53] and 0.66 [0.41, 1.08] (p<0.001) for the older and younger cohorts respectively. After adjusting for gender, cardiovascular disease, cancer, diabetes, transplant or immune suppression, body mass index, vaccine brand, and time between doses, participants ≥70 had lower levels of anti-RBD antibodies at 2 weeks after 2nd dose (β=-0.14, 95% confidence interval-0.19,-0.08, p<0.0001). Conclusion: High antibody levels against COVID-19 are attainable after 2 doses of mRNA vaccines. Levels were higher with Moderna than Pfizer. Delay of the second dose to 4 months or mixing of brands had minimal impact on the antibody level but levels are lower in the elderly.

20.
Topics in Antiviral Medicine ; 30(1 SUPPL):296, 2022.
Article in English | EMBASE | ID: covidwho-1880969

ABSTRACT

Background: There are no authorized or approved treatments in the US for COVID-19 in patients <12 years of age. SARS-CoV-2 neutralizing monoclonal antibodies bamlanivimab and etesevimab together (BAM+ETE) reduce COVID-19 related hospitalization and all-cause mortality in patients ≥12 years of age with mild to moderate COVID-19. Herein, we present the pharmacokinetic (PK), safety, and efficacy results from an open-label Phase III clinical trial addendum (BLAZE-1, NCT04427501) investigating weight-based dosing of BAM+ETE in pediatric patients at increased risk for severe COVID-19. Methods: A total of 91 pediatric patients (<18 years of age) were evaluated for PK. Pediatric patients weighing ≥40kg received 700mg BAM+1400mg ETE. Pediatric patients weighing less than 40kg received weight-based dosing to match the exposures observed in adults and adolescents (12 to <18 years of age) who received the authorized dose of 700mg BAM+1400mg ETE. Twenty additional adolescent patients (12 to <18 years of age) received BAM+ETE in controlled BLAZE-1 cohorts and were included in safety and efficacy analyses. All ambulatory patients had mild to moderate COVID-19 upon enrollment, at least one risk factor for severe COVID-19, and received treatment within 3 days of a positive SARS-CoV-2 test. The primary objective was to characterize the pharmacokinetics of weight-based dosing of BAM+ETE in pediatric patients. Results: Of the 111 pediatric patients who received BAM+ETE, the median age was 12 and age distribution was 12 to <18 (n=60), 6 to <12 (n=36), 2 to <6 (n=10), and 0 to <2 (n=5). Overall, 47.7% were female, 19.1% were Hispanic/Latino, and 62.4% were Black/African American. In patients receiving weight-based dosing, the AUC for both BAM and ETE in pediatric patients was similar (within 90% interval) to adults (Figure). For all pediatric patients, there were no reports of hospitalizations, serious adverse events, or deaths. At Day 7, pediatric patients had a change in viral load from baseline of-4.10 (normalized baseline viral load of 6.41) as compared to-3.65 (normalized baseline viral load of 6.75) in adult patients. The median time to complete symptom resolution was 5 days for all pediatric patients. Conclusion: The weight-based doses administered to pediatric patients provided similar drug exposures when compared to adult patients who received the authorized dose of 700 mg BAM+1400mg ETE. Treatment in pediatric patients was well-tolerated and resulted in favorable viral load reduction and symptom resolution.

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