scholarly journals Evaluation of the Effectiveness and Safety of the BNT162b2 COVID-19 Vaccine in the Vaccination Campaign among the Health Workers of Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Author(s):  
Domenico Pascucci ◽  
Mario Cesare Nurchis ◽  
Martina Sapienza ◽  
Francesco Castrini ◽  
Flavia Beccia ◽  
...  

Health workers, especially those in patient-facing roles, had a significantly increased risk of COVID-19 infection, having serious outcomes, and risking spreading the virus to patients and staff. Vaccination campaign planning suggests allocating initial supplies of BNT162b2 vaccine to health workers given the importance of early protection to safeguard the continuity of care to patients. The aim of the study is to assess the effectiveness and safety of BNT162b2 vaccine among the health workers of Fondazione Policlinico Universitario Agostino Gemelli IRCCS (FPG). The retrospective cohort study was conducted among health staff working at the FPG. Vaccination data were collected from hospital records. The primary end points were vaccine effectiveness and safety. A total of 6649 health workers were included, of whom 5162 received injections. There were 14 cases of COVID-19 with onset at least 14 days after the second dose among vaccinated health workers and 45 cases among unvaccinated ones. BNT162b2 was 91.5% effective against COVID-19 (95% credible interval, 84.7% to 95.3%). The safety profile of BNT162b2 vaccine consisted of short-term, non-serious events. The promotion and boost of the COVID-19 vaccination campaign represents a key public health measure useful to curb the spread of the pandemic especially in vulnerable contexts, such as hospitals, where health workers carry out a paramount role for the entire community, and requires further protection with a possible booster dose in view of autumn-winter 2021.

2021 ◽  
Vol 28 ◽  
pp. 107327482110412
Author(s):  
Mei-Sheng Ku ◽  
Chen-Yu Liu ◽  
Chen-Yang Hsu ◽  
Han-Mo Chiu ◽  
Hsiu-Hsi Chen ◽  
...  

The roles of ambient fine particulate matter (PM2.5) in the prevention of colorectal cancer (CRC) have been scarcely highlighted as there is short of empirical evidence regarding the influences of PM2.5 on multistep carcinogenic processes of CRC. A retrospective cohort design with multistate outcomes was envisaged by linking monthly average PM2.5 concentrations at 22 city/county level with large-scale cohorts of cancer-screened population to study the influences of PM2.5 on short-term inflammatory process and multistep carcinogenic processes of CRC. Our study included a nationwide CRC screening cohort of 4,628,995 aged 50–69 years who attended first screen between 2004 and 2009 and continued periodical screens until 2016. We aimed to illustrate the carcinogenesis of PM2.5 related to CRC by applying both hierarchical logistical and multistate Markov regression models to estimate the effects of air pollution on fecal immunochemical test (FIT) positive (a proxy of inflammatory marker) and pre-clinical and clinical states of CRC in the nationwide cohort. We found a significant association of high PM2.5 exposure and FIT-positive by an increased risk of 11% [95% confidence interval (CI), 10–12]. PM2.5 enhanced the risk of being preclinical state by 14% (95% CI, 10–18) and that of subsequent progression from pre-clinical to clinical state by 21% (95% CI, 14–28). Furthermore, the elevated risks for CRC carcinogenesis were significantly higher for people living in high PM2.5 pollution areas in terms of yearly averages and the number days above 35 µg/m3 than those living in low PM2.5 pollution areas. We concluded that both short-term and long-term PM2.5 exposure were associated with multistep progression of CRC, which were useful to design precision primary and secondary prevention strategies of CRC for people who are exposed to high PM2.5 pollution.


Author(s):  
Karin Dahlquist ◽  
Andrea Stuart ◽  
Kärin Kallén

Objective: To study complications, within six weeks postpartum, after planned caesarean section (CS) compared with planned vaginal delivery, among women without formal indication for caesarean section. Design: Retrospective cohort study. Setting: Swedish national registries. Population: 714 326 deliveries, 2008-2017. Methods: The risks of complications were compared between planned caesarean section and planned vaginal delivery among women without formal medical indication for planned CS. Adjusted Risk Ratios (ARR) were obtained using modified Poisson-regression models adjusting for; maternal age, parity, body mass index, smoking, country of birth, and county. Main outcome measure: infections, haemorrhage and thromboembolism. Results:. In the planned CS group (n=22 855), 15% had a postpartum infection compared with 10% in the planned vaginal group (n=691 471) (ARR=1.6; 95%CI 1.5-1.6), 8.4% vs 0.6% had haemorrhage >1 litre (ARR=13.4; 95%CI 12.7-14.2), and 0.08% vs 0.05% had a postpartum pulmonary embolism (ARR=1.7; 95%CI 1.0-2.6). The obtained risk estimates correspond to a Number-Needed-to-Harm estimate of 17, 14, and 3448, respectively. When dividing the infections into subgroups, an increased risk of endometritis (ARR 1.2; 95%CI 1.1-1.3), wound infection (ARR 2.7 95%CI 2.4-3.0), urinary tract infections (ARR 1.5 95%CI 1.3-1.7), and mastitis (ARR 2.0; 1.9-2.2) was found after planned CS. Conclusion: The risks of short-term maternal complications were higher in women delivered by planned CS compared with planned vaginal delivery among women without formal medical indication for planned CS. Funding: Gorthon Foundation. Key words: caesarean section, puerperal infection, haemorrhage, thromboembolism.


2021 ◽  
Vol 49 (6) ◽  
pp. 030006052110251
Author(s):  
Minqiang Huang ◽  
Ming Han ◽  
Wei Han ◽  
Lei Kuang

Objective We aimed to compare the efficacy and risks of proton pump inhibitor (PPI) versus histamine-2 receptor blocker (H2B) use for stress ulcer prophylaxis (SUP) in critically ill patients with sepsis and risk factors for gastrointestinal bleeding (GIB). Methods In this retrospective cohort study, we used the Medical Information Mart for Intensive Care III Clinical Database to identify critically ill adult patients with sepsis who had at least one risk factor for GIB and received either an H2B or PPI for ≥48 hours. Propensity score matching (PSM) was conducted to balance baseline characteristics. The primary outcome was in-hospital mortality. Results After 1:1 PSM, 1056 patients were included in the H2B and PPI groups. The PPI group had higher in-hospital mortality (23.8% vs. 17.5%), GIB (8.9% vs. 1.6%), and pneumonia (49.6% vs. 41.6%) rates than the H2B group. After adjusting for risk factors of GIB and pneumonia, PPI use was associated with a 1.28-times increased risk of in-hospital mortality, 5.89-times increased risk of GIB, and 1.32-times increased risk of pneumonia. Conclusions Among critically ill adult patients with sepsis at risk for GIB, SUP with PPIs was associated with higher in-hospital mortality and higher risk of GIB and pneumonia than H2Bs.


BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Bimandra A. Djaafara ◽  
Charles Whittaker ◽  
Oliver J. Watson ◽  
Robert Verity ◽  
Nicholas F. Brazeau ◽  
...  

Abstract Background As in many countries, quantifying COVID-19 spread in Indonesia remains challenging due to testing limitations. In Java, non-pharmaceutical interventions (NPIs) were implemented throughout 2020. However, as a vaccination campaign launches, cases and deaths are rising across the island. Methods We used modelling to explore the extent to which data on burials in Jakarta using strict COVID-19 protocols (C19P) provide additional insight into the transmissibility of the disease, epidemic trajectory, and the impact of NPIs. We assess how implementation of NPIs in early 2021 will shape the epidemic during the period of likely vaccine rollout. Results C19P burial data in Jakarta suggest a death toll approximately 3.3 times higher than reported. Transmission estimates using these data suggest earlier, larger, and more sustained impact of NPIs. Measures to reduce sub-national spread, particularly during Ramadan, substantially mitigated spread to more vulnerable rural areas. Given current trajectory, daily cases and deaths are likely to increase in most regions as the vaccine is rolled out. Transmission may peak in early 2021 in Jakarta if current levels of control are maintained. However, relaxation of control measures is likely to lead to a subsequent resurgence in the absence of an effective vaccination campaign. Conclusions Syndromic measures of mortality provide a more complete picture of COVID-19 severity upon which to base decision-making. The high potential impact of the vaccine in Java is attributable to reductions in transmission to date and dependent on these being maintained. Increases in control in the relatively short-term will likely yield large, synergistic increases in vaccine impact.


2020 ◽  
Vol 7 (1) ◽  
pp. 148-156
Author(s):  
Kari Jorunn Kværner ◽  
Linn Nathalie Støme ◽  
Jonathan Romm ◽  
Karianne Rygh ◽  
Frida Almquist ◽  
...  

ObjectiveTo describe unmet needs and values in stroke rehabilitation using the Health Value Framework and the associated coassessment tool Health Value Spider, a framework designed to identify and prioritise unmet needs based on health technology assessment (HTA).SettingThe study took place at Oslo University Hospital, Norway, from February to April 2019. Participants in three consecutive workshops were recruited from Sunnaas Rehabilitation Hospital, Oslo Municipality, Hospital Procurement Trust and Oslo University Hospital. Twenty-four hospital workers (medical and allied health staff and administrative staff) participated in workshop 1 and 29 patients, user representatives and hospital workers in workshop 2. Twenty-one patients and hospital workers participated in workshop 3.InterventionsStakeholder analysis and scenario building was performed in a coassessment setting where unmet needs were identified applying the Health Value Framework. Two of the authors are also the developers of the Health Value Framework (KJK and LNS).ResultsIn the two first workshops where health workers, patients and next of kin perspectives were elicited, three needs were identified: patient insecurity in patient journey transitions, lack of stroke rehabilitation expertise in primary care and invisible patient problems, such as fatigue and cognitive impairment. In workshop 3, 12 opportunity areas were identified. Four opportunity areas were selected by the stakeholders based on a prioritisation process: early discovery of cognitive impairment, rehabilitation continuity, empowered patients and next of kin and remote monitoring and digital touchpoints.ConclusionHealth Value Spider successfully identified and prioritised unmet needs and described associated values.


2020 ◽  
Vol 10 (04) ◽  
pp. e369-e379
Author(s):  
Amanda Yeaton-Massey ◽  
Rebecca J. Baer ◽  
Larry Rand ◽  
Laura L. Jelliffe-Pawlowski ◽  
Deirdre J. Lyell

Abstract Objective The aim of this study was to evaluate rates of preterm birth (PTB) and obstetric complication with maternal serum analytes > 2.5 multiples of the median (MoM) by degree of elevation. Study Design Retrospective cohort study of singleton live-births participating in the California Prenatal Screening Program (2005–2011) examining PTB and obstetric complication for α-fetoprotein (AFP), human chorionic gonadotropin (hCG), unconjugated estriol (uE3), and inhibin A (INH) by analyte subgroup (2.5 to < 6.0, 6.0 to < 10.0, and ≥ 10.0 MoM vs. < 2.5 MoM). Results The risk of obstetric complication increased with increasing hCG, AFP, and INH MoM, and were greatest for AFP and INH of 6.0 to <10.0 MoM. The greatest risk of any adverse outcome was seen for hCG MoM ≥ 10.0, with relative risk (RR) of PTB < 34 weeks of 40.8 (95% confidence interval [CI]: 21.7–77.0) and 13.8 (95% CI: 8.2–23.1) for obstetric complication. Conclusions In euploid, structurally normal fetuses, all analyte elevations > 2.5 MoM confer an increased risk of PTB and, except for uE3, obstetric complication, and risks for each are not uniformly linear. These data can help guide patient counseling and antenatal management.


2021 ◽  
Vol 3 (1) ◽  
Author(s):  
Vivian Ntono ◽  
Daniel Eurien ◽  
Lilian Bulage ◽  
Daniel Kadobera ◽  
Julie Harris ◽  
...  

Abstract Background On 18 January 2018 a 40 year old man presented with skin lesions at Rhino Camp Health Centre. A skin lesion swab was collected on 20 January 2018 and was confirmed by PCR at Uganda Virus Research Institute on 21 January 2018. Subsequently, about 9 persons were reported to have fallen ill after reporting contact with livestock that died suddenly. On 9 February 2018, Arua District notified Uganda Ministry of Health of a confirmed anthrax outbreak among humans in Rhino Camp sub-county. We investigated to determine the scope and mode of transmission and exposures associated with identified anthrax to guide control and prevention measures. Methods We defined a suspected cutaneous anthrax case as onset of skin lesions (e.g., papule, vesicle, or eschar) in a person residing in Rhino Camp sub-county, Arua District from 25 December 2017 to 31 May 2018. A confirmed case was a suspected case with PCR-positivity for Bacillus anthracis from a clinical sample. We identified cases by reviewing medical records at Rhino Camp Health Centre. We also conducted additional case searches in the affected community with support from Community Health Workers. In a retrospective cohort study, we interviewed all members of households in which at least one person had contact with the carcasses of or meat from animals suspected to have died of anthrax. We collected and tested hides of implicated animals using an anthrax rapid diagnostic test. Results We identified 14 case-patients (1 confirmed, 13 suspected); none died. Only males were affected (affected proportion: 12/10,000). Mean age of case-persons was 33 years (SD: 22). The outbreak lasted for 5 months, from January 2018–May 2018, peaking in February. Skinning (risk ratio = 2.7, 95% CI = 1.1–6.7), dissecting (RR = 3.0, 95% CI = 1.2–7.6), and carrying dead animals (RR = 2.7, 95% CI = 1.1–6.7) were associated with increased risk of illness, as were carrying dissected parts of animals (RR = 2.9, 95% CI 1.3–6.5) and preparing and cooking the meat (RR = 2.3, 95% CI 0.9–5.9). We found evidence of animal remains on pastureland. Conclusion Multiple exposures to the hides and meat of animals that died suddenly were associated with this cutaneous anthrax outbreak in Arua District. We recommended public education about safe disposal of carcasses of livestock that die suddenly.


2020 ◽  
Vol 35 (6) ◽  
pp. 1253-1255
Author(s):  
Zeev Blumenfeld ◽  
Norbert Gleicher ◽  
Eli Y Adashi

Abstract Whereas longstanding dogma has purported that pregnancies protect women from breast cancer, a recent meta-analysis now mandates reconsideration since it reported an actual higher breast cancer risk for more than two decades after childbirth before the relative risk turns negative. Moreover, the risk of breast cancer appears higher for women having their first birth at an older age and with a family history and it is not reduced by breastfeeding. The process of obtaining informed consent for all fertility treatments, therefore, must make patients aware of the facts that every pregnancy, to a small degree, will increase the short-term breast cancer risk. This observation may be even more relevant in cases of surrogacy where women agree to conceive without deriving benefits of offspring from assuming the risk, thus creating a substantially different risk-benefit ratio. Consequently, it appears prudent for professional societies in the field to update recommendations regarding consent information for all fertility treatments but especially for treatments involving surrogacy.


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