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1.
Br J Surg ; 108(7): 740-741, 2021 07 23.
Article in English | MEDLINE | ID: covidwho-2188274
2.
Australas J Dermatol ; 63(3): 344-351, 2022 Aug.
Article in English | MEDLINE | ID: covidwho-2192241

ABSTRACT

BACKGROUND: Clinical quality registries aim to identify significant variations in care and provide anonymised feedback to institutions to improve patient outcomes. Thirty-six Australian organisations with an interest in melanoma, raised funds through three consecutive Melanoma Marches, organised by Melanoma Institute Australia, to create a national Melanoma Clinical Outcomes Registry (MelCOR). This study aimed to formally develop valid clinical quality indicators for the diagnosis and early management of cutaneous melanoma as an important step in creating the registry. METHODS: Potential clinical quality indicators were identified by examining the literature, including Australian and international melanoma guidelines, and by consulting with key melanoma and registry opinion leaders. A modified two-round Delphi survey method was used, with participants invited from relevant health professions routinely managing melanoma as well as relevant consumer organisations. RESULTS: Nineteen participants completed at least one round of the Delphi process. 12 of 13 proposed clinical quality indictors met the validity criteria. The clinical quality indicators included acceptable biopsy method, appropriate excision margins, standardised pathology reporting, indications for sentinel lymph node biopsy, and involvement of multidisciplinary care and referrals. CONCLUSION: This study provides a multi-stakeholder consensus for important clinical quality indicators that define optimal practice that will now be used in the Australian Melanoma Clinical Outcomes Registry (MelCOR).


Subject(s)
Melanoma , Skin Neoplasms , Australia , Delphi Technique , Humans , Melanoma/pathology , Quality Indicators, Health Care , Registries , Skin Neoplasms/pathology
4.
Lancet Child Adolesc Health ; 6(7): 446-447, 2022 07.
Article in English | MEDLINE | ID: covidwho-2150885
5.
Surg Endosc ; 36(12): 9123-9128, 2022 Dec.
Article in English | MEDLINE | ID: covidwho-2128651

ABSTRACT

BACKGROUND: The introduction of new technologies in endoscopy has been met with uncertainty, skepticism, and lack of standardization or training parameters, particularly when disruptive devices or techniques are involved. The widespread availability of a novel endoscopic suturing device (OverStitch™) for tissue apposition has enabled the development of applications of endoscopic suturing. METHODS: The American Gastroenterological Association partnered with Apollo Endosurgery to develop a registry to capture in a pragmatic non-randomized study the safety, effectiveness, and durability of endoscopic suturing in approximating tissue in the setting of bariatric revision and fixation of endoprosthetic devices. RESULTS: We highlight the challenges of the adoption of novel techniques by examining the process of developing and executing this multicenter registry to assess real-world use of this endoscopic suturing device. We also present our preliminary data on the safety and effectiveness of the novel device as it is applied in the treatment of obesity. CONCLUSIONS: The Prospective Registry for Trans-Orifice Endoscopic Suturing Applications (ES Registry) was an effective Phase 4, postmarketing registry aimed at capturing pragmatic, real-world use of a novel device. These findings serve to solidify the role of endoscopic suturing in clinical practice.


Subject(s)
Suture Techniques , Sutures , Humans , Endoscopy, Gastrointestinal/methods , Obesity , Registries
6.
Int J Environ Res Public Health ; 19(21)2022 Nov 04.
Article in English | MEDLINE | ID: covidwho-2143044

ABSTRACT

BACKGROUND: Cardiovascular diseases ranked first in terms of the number of deaths in Serbia in 2019, with 52,663 deaths. One fifth of those were from ischemic heart disease (IHD), and half of IHD deaths were from acute coronary syndrome (ACS). We present the ACS mortality time trend in Serbia during a 15-year period using the latest available data, excluding the COVID-19 pandemic. METHODS: The data on patients who died of ACS in the period from 2005 to 2019 were obtained from the National Statistics Office and processed at the Department of Prevention and Control of Non-communicable Diseases of the Institute of Public Health of Serbia. Number of deaths, crude mortality rates (CR) and age-standardized mortality rates (ASR-E) for the European population were analyzed. Using joinpoint analysis, the time trend in terms of annual percentage change (APC) was analyzed for the female and male population aged 0 to 85+. Age-period-cohort modeling was used to estimate age, cohort and period effects in ACS mortality between 2005 and 2019 for age groups in the range 20 to 90. RESULTS: From 2005 to 2019 there were 90,572 deaths from ACS: 54,202 in men (59.8%), 36,370 in women (40.2%). Over the last 15 years, the number of deaths significantly declined: 46.7% in men, 49.5% in women. The annual percentage change was significant: -4.4% in men, -5.8% in women. Expressed in terms of APC, for the full period, the highest significant decrease in deaths was seen in women aged 65-69, -8.5%, followed by -7.6% for women aged 50-54 and 70-74. In men, the highest decreases were recorded in the age group 50-54, -6.7%, and the age group 55-59, -5.7%. In all districts there was significant decline in deaths in terms of APC for the full period in both genders, except in Zlatibor, Kolubara and Morava, where increases were recorded. In addition, in Bor and Toplica almost no change was observed over the full period for both genders. CONCLUSIONS: In the last 15 years, mortality from ACS in Serbia declined in both genders. The reasons are found in better diagnostic and treatment through an organized network for management of ACS patients. However, there are districts where this decline was small and insignificant or was offset in recent years by an increase in deaths. In addition, there is space for improvement in the still-high mortality rates through primary prevention, which at the moment is not organized.


Subject(s)
Acute Coronary Syndrome , COVID-19 , Myocardial Ischemia , Humans , Female , Male , Serbia/epidemiology , Acute Coronary Syndrome/epidemiology , Pandemics , Cohort Studies , Registries , Myocardial Ischemia/epidemiology
7.
Am J Epidemiol ; 191(11): 1975-1980, 2022 Oct 20.
Article in English | MEDLINE | ID: covidwho-2134828

ABSTRACT

The coronavirus disease 2019 (COVID-19) pandemic has underscored the importance of observational studies of real-world vaccine effectiveness (VE) to help answer urgent public health questions. One approach to rapidly answering questions about real-world VE relies on linking data from a population-based registry of vaccinations with a population-based registry of health outcomes. Here we consider some potential sources of bias in linked registry studies, including incomplete reporting to the registries, errors in linking individuals between registries, and errors in the assumed population size of the catchment area of the registries. We show that the direction of the bias resulting from one source of error by itself is predictable. However, if multiple sources of error are present, the direction of the bias can be either upward or downward. The biases can be so strong as to make harmful vaccines appear effective. We provide explicit formulas with which to quantify and adjust for multiple biases in estimates of VE which could be used in sensitivity analyses. While this work was motivated by COVID-19 vaccine questions, the results are generally applicable to studies that link population-based exposure registries with population-based case registries to estimate relative risks of exposures.


Subject(s)
COVID-19 Vaccines , COVID-19 , Humans , Vaccine Efficacy , Bias , Registries
8.
Twin Res Hum Genet ; 25(3): 156-164, 2022 06.
Article in English | MEDLINE | ID: covidwho-2133125

ABSTRACT

Nature and nurture have always been a prerogative of evolutionary biologists. The environment's role in shaping an organism's phenotype has always intrigued us. Since the inception of humankind, twinning has existed with an unsettled parley on the contribution of nature (i.e. genetics) versus nurture (i.e. environment), which can influence the phenotypes. The study of twins measures the genetic contribution and that of the environmental influence for a particular trait, acting as a catalyst, fine-tuning the phenotypic trajectories. This is further evident because a number of human diseases show a spectrum of clinical manifestations with the same underlying molecular aberration. As of now, there is no definite way to conclude just from the genomic data the severity of a disease or even to predict who will get affected. This greatly justifies initiating a twin registry for a country as diverse and populated as India. There is an unmet need to set up a nationwide database to carefully curate the information on twins, serving as a valuable biorepository to study their overall susceptibility to disease. Establishing a twin registry is of paramount importance to harness the wealth of human information related to the biomedical, anthropological, cultural, social and economic significance.


Subject(s)
Diseases in Twins , Twins , Diseases in Twins/epidemiology , Diseases in Twins/genetics , Humans , India/epidemiology , Registries , Twins/genetics , Workforce
9.
Br Dent J ; 233(9): 787-793, 2022 11.
Article in English | MEDLINE | ID: covidwho-2118335

ABSTRACT

Introduction People who present with more advanced stage head and neck cancer (HNC) are associated with poorer outcomes and survival. The burden and trends of advanced stage HNC are not fully known at the population level. The UK national cancer registries routinely collect data on HNC diagnoses.Aims To describe trends in stage of diagnosis of HNCs across the UK before the COVID-19 pandemic.Methods Aggregated HNC incidence data were requested from the national cancer registries of the four UK countries for the ten most recent years of available data by subsite and American Joint Commission on Cancer stage at diagnosis classification. Additionally, data for Scotland were available by age group, sex and area-based socioeconomic deprivation category.Results Across the UK, rates of advanced stage HNC had increased, with 59% of patients having advanced disease at diagnosis from 2016-2018. England had a lower proportion of advanced disease (58%) than Scotland, Wales or Northern Ireland (65-69%) where stage data were available. The completeness of stage data had improved over recent years (87% by 2018).Conclusion Prior to the COVID-19 pandemic, diagnoses of HNC at an advanced stage comprised the majority of HNCs in the UK, representing the major challenge for the cancer healthcare system.


Subject(s)
COVID-19 , Head and Neck Neoplasms , Humans , United States , COVID-19/epidemiology , Pandemics , Head and Neck Neoplasms/epidemiology , Registries , Incidence , England/epidemiology
10.
Lancet Oncol ; 23(7): 865-875, 2022 07.
Article in English | MEDLINE | ID: covidwho-2117574

ABSTRACT

BACKGROUND: The omicron (B.1.1.529) variant of SARS-CoV-2 is highly transmissible and escapes vaccine-induced immunity. We aimed to describe outcomes due to COVID-19 during the omicron outbreak compared with the prevaccination period and alpha (B.1.1.7) and delta (B.1.617.2) waves in patients with cancer in Europe. METHODS: In this retrospective analysis of the multicentre OnCovid Registry study, we recruited patients aged 18 years or older with laboratory-confirmed diagnosis of SARS-CoV-2, who had a history of solid or haematological malignancy that was either active or in remission. Patient were recruited from 37 oncology centres from UK, Italy, Spain, France, Belgium, and Germany. Participants were followed up from COVID-19 diagnosis until death or loss to follow-up, while being treated as per standard of care. For this analysis, we excluded data from centres that did not actively enter new data after March 1, 2021 (in France, Germany, and Belgium). We compared measures of COVID-19 morbidity, which were complications from COVID-19, hospitalisation due to COVID-19, and requirement of supplemental oxygen and COVID-19-specific therapies, and COVID-19 mortality across three time periods designated as the prevaccination (Feb 27 to Nov 30, 2020), alpha-delta (Dec 1, 2020, to Dec 14, 2021), and omicron (Dec 15, 2021, to Jan 31, 2022) phases. We assessed all-cause case-fatality rates at 14 days and 28 days after diagnosis of COVID-19 overall and in unvaccinated and fully vaccinated patients and in those who received a booster dose, after adjusting for country of origin, sex, age, comorbidities, tumour type, stage, and status, and receipt of systemic anti-cancer therapy. This study is registered with ClinicalTrials.gov, NCT04393974, and is ongoing. FINDINGS: As of Feb 4, 2022 (database lock), the registry included 3820 patients who had been diagnosed with COVID-19 between Feb 27, 2020, and Jan 31, 2022. 3473 patients were eligible for inclusion (1640 [47·4%] were women and 1822 [52·6%] were men, with a median age of 68 years [IQR 57-77]). 2033 (58·5%) of 3473 were diagnosed during the prevaccination phase, 1075 (31·0%) during the alpha-delta phase, and 365 (10·5%) during the omicron phase. Among patients diagnosed during the omicron phase, 113 (33·3%) of 339 were fully vaccinated and 165 (48·7%) were boosted, whereas among those diagnosed during the alpha-delta phase, 152 (16·6%) of 915 were fully vaccinated and 21 (2·3%) were boosted. Compared with patients diagnosed during the prevaccination period, those who were diagnosed during the omicron phase had lower case-fatality rates at 14 days (adjusted odds ratio [OR] 0·32 [95% CI 0·19-0·61) and 28 days (0·34 [0·16-0·79]), complications due to COVID-19 (0·26 [0·17-0·46]), and hospitalisation due to COVID-19 (0·17 [0·09-0·32]), and had less requirements for COVID-19-specific therapy (0·22 [0·15-0·34]) and oxygen therapy (0·24 [0·14-0·43]) than did those diagnosed during the alpha-delta phase. Unvaccinated patients diagnosed during the omicron phase had similar crude case-fatality rates at 14 days (ten [25%] of 40 patients vs 114 [17%] of 656) and at 28 days (11 [27%] of 40 vs 184 [28%] of 656) and similar rates of hospitalisation due to COVID-19 (18 [43%] of 42 vs 266 [41%] of 652) and complications from COVID-19 (13 [31%] of 42 vs 237 [36%] of 659) as those diagnosed during the alpha-delta phase. INTERPRETATION: Despite time-dependent improvements in outcomes reported in the omicron phase compared with the earlier phases of the pandemic, patients with cancer remain highly susceptible to SARS-CoV-2 if they are not vaccinated against SARS-CoV-2. Our findings support universal vaccination of patients with cancer as a protective measure against morbidity and mortality from COVID-19. FUNDING: National Institute for Health and Care Research Imperial Biomedical Research Centre and the Cancer Treatment and Research Trust.


Subject(s)
COVID-19 , Neoplasms , Aged , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Testing , Disease Outbreaks , Europe/epidemiology , Female , Humans , Male , Middle Aged , Neoplasms/epidemiology , Neoplasms/therapy , Oxygen , Registries , Retrospective Studies , SARS-CoV-2
11.
Environ Health Perspect ; 130(11): 117006, 2022 Nov.
Article in English | MEDLINE | ID: covidwho-2117113

ABSTRACT

BACKGROUND: Studies have suggested links between ambient air pollution and coronavirus 2019 (COVID-19) mortality, yet confirmation by well-designed epidemiological studies with individual data is needed. OBJECTIVES: We aimed to examine whether short-term exposure to air pollution is associated with risk of mortality from COVID-19 for those infected with COVID-19. METHODS: The Cook County Medical Examiner's Office reports individual-level data for deaths from COVID-19 that occur in its jurisdiction, which includes all confirmed COVID-19 deaths in Cook County, Illinois. Case-crossover analysis was conducted to estimate the associations of estimated short-term exposures to particulate matter (PM) with aerodynamic diameter ≤2.5µm (PM2.5) and ozone (O3) on the day of death and up to 21 d before death at location of death with COVID-19. A total of 7,462 deaths from COVID-19 that occurred up to 28 February 2021 were included in the final analysis. We adjusted for potential confounders by time-stratified case-crossover design and by covariate adjustments (i.e., time-invariant factors, meteorological factors, viral transmission, seasonality, and time trend). RESULTS: Of the 7,462 case and 25,457 self-control days, almost all were days with exposure levels below the PM2.5 24-h National Ambient Air Quality Standard (NAAQS) (35 µg/m3); 98.9% had O3 levels below the maximum 8-h NAAQS (35.7 µg/m3 or 70 parts per billion). An interquartile range (IQR) increase (5.2 µg/m3) in cumulative 3-wk PM2.5 exposure was associated with a 69.6% [95% confidence interval (CI): 34.6, 113.8] increase in risk of COVID-19 mortality. An IQR increase (8.2 µg/m3) in 3-d O3 exposure was associated with a 29.0% (95% CI: 9.9, 51.5) increase in risk of COVID-19 mortality. The associations differed by demographics or race/ethnicity. There was indication of modification of the associations by some comorbid conditions. DISCUSSION: Short-term exposure to air pollution below the NAAQS may increase the mortality burden from COVID-19. https://doi.org/10.1289/EHP10836.


Subject(s)
Air Pollutants , Air Pollution , COVID-19 , Humans , Cross-Over Studies , Air Pollutants/analysis , Coroners and Medical Examiners , Environmental Exposure/analysis , Air Pollution/analysis , Particulate Matter/analysis , Registries
12.
Crit Care ; 26(1): 354, 2022 Nov 15.
Article in English | MEDLINE | ID: covidwho-2115766

ABSTRACT

BACKGROUND: The survival rate of patients with critical coronavirus disease-19 (COVID-19) over time is inconsistent in different settings. In Japan, a national database was organized to monitor and share the patient generation across the country in an immediate response to the COVID-19 pandemic. This study aimed to evaluate changes in survival over time and the prognostic factors in critical COVID-19 patients receiving mechanical ventilation with/without extracorporeal membrane oxygenation (ECMO) using the largest database in Japan. METHODS: This is a prospective observational cohort study of patients admitted to intensive care units in Japan with fatal COVID-19 pneumonia receiving mechanical ventilation and/or ECMO. We developed a prospective nationwide registry covering > 80% of intensive care units in Japan, and analyzed the association between patients' backgrounds, institutional ECMO experience, and timing of treatment initiation and prognosis between February 2020 and November 2021. Prognostic factors were evaluated by Kaplan-Meier analysis and Cox proportional hazards analysis. RESULTS: A total of 9418 patients were ventilated, of whom 1214 (13%) received ECMO. The overall survival rate for ventilated patients was 79%, 65% for those receiving ECMO. There have been five outbreaks in Japan to date. The survival rate of ventilated patients increased from 76% in the first outbreak to 84% in the fifth outbreak (p < 0.001). The survival rate of ECMO patients remained unchanged at 60-68% from the first to fifth outbreaks (p = 0.084). Age of ≥ 59 (hazard ratio [HR] 2.17; 95% confidence interval [CI] 1.76-2.68), ventilator days of ≥ 3 before starting ECMO (HR 1.91; 95% CI 1.57-2.32), and institutional ECMO experiences of ≥ 11 (HR 0.70; 95% CI 0.58-0.85) were independent prognostic factors for ECMO. CONCLUSIONS: During five COVID-19 outbreaks in Japan, the survival rate of ventilated patients tended to have gradually improved, and that of ECMO patients did not deteriorate. Older age, longer ventilator days before starting ECMO, and fewer institutional ECMO experiences may be independent prognostic factors for critical COVID-19 patients receiving ECMO.


Subject(s)
COVID-19 , Extracorporeal Membrane Oxygenation , Humans , Pandemics , COVID-19/epidemiology , COVID-19/therapy , Respiration, Artificial , Japan/epidemiology , Prospective Studies , Cohort Studies , Registries , Retrospective Studies
13.
Lancet Diabetes Endocrinol ; 10(11): 786-794, 2022 11.
Article in English | MEDLINE | ID: covidwho-2106221

ABSTRACT

BACKGROUND: An increased prevalence of diabetic ketoacidosis at diagnosis of type 1 diabetes in children was observed in various diabetes centres worldwide during the COVID-19 pandemic. We aimed to evaluate trends in the prevalence of diabetic ketoacidosis at diagnosis of paediatric type 1 diabetes before and during the COVID-19 pandemic, and to identify potential predictors of changes in diabetic ketoacidosis prevalence during the pandemic. METHODS: For this international multicentre study, we used data from 13 national diabetes registries (Australia, Austria, Czechia, Denmark, Germany, Italy, Luxembourg, New Zealand, Norway, Slovenia, Sweden, USA [Colorado], and Wales). The study population comprised 104 290 children and adolescents aged 6 months to younger than 18 years, who were diagnosed with type 1 diabetes between Jan 1, 2006, and Dec 31, 2021. The observed diabetic ketoacidosis prevalence in 2020 and 2021 was compared to predictions based on trends over the pre-pandemic years 2006-19. Associations between changes in diabetic ketoacidosis prevalence and the severity of the COVID-19 pandemic and containment measures were examined with excess all-cause mortality in the whole population and the Stringency Index from the Oxford COVID-19 Government Response Tracker. FINDINGS: 87 228 children and adolescents were diagnosed with type 1 diabetes between 2006 and 2019, 8209 were diagnosed in 2020, and 8853 were diagnosed in 2021. From 2006 to 2019, diabetic ketoacidosis at diagnosis of type 1 diabetes was present in 23 775 (27·3%) of 87 228 individuals and the mean annual increase in the prevalence of diabetic ketoacidosis in the total cohort from 2006 to 2019 was 1·6% (95% CI 1·3 to 1·9). The adjusted observed prevalence of diabetic ketoacidosis at diagnosis of type 1 diabetes was 39·4% (95% CI 34·0 to 45·6) in 2020 and 38·9% (33·6 to 45·0) in 2021, significantly higher than the predicted prevalence of 32·5% (27·8 to 37·9) for 2020 and 33·0% (28·3 to 38·5) for 2021 (p<0·0001 for both years). The prevalence of diabetic ketoacidosis was associated with the pandemic containment measures, with an estimated risk ratio of 1·037 (95% CI 1·024 to 1·051; p<0·0001) per ten-unit increase in the Stringency Index for 2020 and 1·028 (1·009 to 1·047; p=0·0033) for 2021, but was not significantly associated with excess all-cause mortality. INTERPRETATION: During the COVID-19 pandemic, there was a marked exacerbation of the pre-existing increase in diabetic ketoacidosis prevalence at diagnosis of type 1 diabetes in children. This finding highlights the need for early and timely diagnosis of type 1 diabetes in children and adolescents. FUNDING: German Federal Ministry for Education and Research, German Robert Koch Institute, German Diabetes Association, German Diabetes Foundation, Slovenian Research Agency, Welsh Government, Central Denmark Region, and Swedish Association of Local Authorities and Regions.


Subject(s)
COVID-19 , Diabetes Mellitus, Type 1 , Diabetic Ketoacidosis , Adolescent , Child , Humans , Diabetic Ketoacidosis/diagnosis , Diabetic Ketoacidosis/epidemiology , Diabetic Ketoacidosis/complications , Diabetes Mellitus, Type 1/diagnosis , Diabetes Mellitus, Type 1/epidemiology , Diabetes Mellitus, Type 1/complications , COVID-19/diagnosis , COVID-19/epidemiology , Pandemics , Prevalence , Registries
14.
Int J Environ Res Public Health ; 19(21)2022 Nov 02.
Article in English | MEDLINE | ID: covidwho-2099512

ABSTRACT

We examined the all-cause and COVID-19-specific mortality among World Trade Center Health Registry (WTCHR) enrollees. We also examined the socioeconomic factors associated with COVID-19-specific death. Mortality data from the NYC Bureau of Vital Statistics between 2015-2020 were linked to the WTCHR. COVID-19-specific death was defined as having positive COVID-19 tests that match to a death certificate or COVID-19 mentioned on the death certificate via text searching. We conducted step change and pulse regression to assess excess deaths. Limiting to those who died in 2019 (n = 210) and 2020 (n = 286), we examined factors associated with COVID-19-specific deaths using multinomial logistic regression. Death rate among WTCHR enrollees increased during the pandemic (RR: 1.70, 95% CL: 1.25-2.32), driven by the pulse in March-April 2020 (RR: 3.38, 95% CL: 2.62-4.30). No significantly increased death rate was observed during May-December 2020. Being non-Hispanic Black and having at least one co-morbidity had a higher likelihood of COVID-19-associated mortality than being non-Hispanic White and not having any co-morbidity (AOR: 2.43, 95% CL: 1.23-4.77; AOR: 2.86, 95% CL: 1.19-6.88, respectively). The racial disparity in COVID-19-specific deaths attenuated after including neighborhood proportion of essential workers in the model (AOR:1.98, 95% CL: 0.98-4.01). Racial disparities continue to impact mortality by differential occupational exposure and structural inequality in neighborhood representation. The WTC-exposed population are no exception. Continued efforts to reduce transmission risk in communities of color is crucial for addressing health inequities.


Subject(s)
COVID-19 , September 11 Terrorist Attacks , Humans , New York City/epidemiology , Registries , Pandemics
15.
PLoS One ; 17(11): e0276806, 2022.
Article in English | MEDLINE | ID: covidwho-2098761

ABSTRACT

BACKGROUND: Racial and ethnic disparities in COVID-19 outcomes exist, but whether in-hospital care explains this difference is not known. We sought to determine racial and ethnic differences in demographics, comorbidities, in-hospital treatments, and in-hospital outcomes of patients hospitalized with COVID-19. METHODS AND FINDINGS: This was a cohort study using MiCOVID-19, a multi-center, retrospective, collaborative quality improvement registry, which included data on patients hospitalized with COVID-19 across 38 hospitals in the State of Michigan. 2,639 adult patients with COVID-19 hospitalized at a site participating in the MiCOVID-19 Registry were randomly selected. Outcomes included in-hospital mortality, age at death, intensive care unit admission, and need for invasive mechanical ventilation by race and ethnicity. Baseline comorbidities differed by race and ethnicity. In addition, Black patients had higher lactate dehydrogenase, erythrocyte sedimentation rate, C-reactive protein, creatine phosphokinase, and ferritin levels. Black patients were less likely to receive dexamethasone and remdesivir compared with White patients (4.2% vs 14.3% and 2.2% vs. 11.8%, p < 0.001 for each). Black (18.7%) and White (19.6%) patients experienced greater mortality compared with Asian (13.0%) and Latino (5.9%) patients (p < 0.01). The mean age at death was significantly lower by 8 years for Black patients (69.4 ± 13.3 years) compared with White (77.9 ± 12.6), Asian (77.6 ± 6.6), and Latino patients (77.4 ± 15.5) (p < 0.001). CONCLUSIONS: COVID-19 mortality appears to be driven by both pre-hospitalization clinical and social factors and potentially in-hospital care. Policies aimed at population health and equitable application of evidence-based medical therapy are needed to alleviate the burden of COVID-19.


Subject(s)
COVID-19 , Adult , Humans , Child , Ethnicity , Retrospective Studies , Cohort Studies , Whites , Hospitalization , Registries
16.
Crit Care ; 26(1): 335, 2022 10 31.
Article in English | MEDLINE | ID: covidwho-2098416

ABSTRACT

BACKGROUND: Early public-access defibrillation (PAD) effectively improves the outcomes of out-of-hospital cardiac arrests (OHCA), but several strategies implemented to prevent the spread of coronavirus disease 2019 (COVID-19) could decrease the availability of PAD and worsen outcomes after OHCA. Previous studies have reported conflicting findings, and there is a paucity of nationwide observations. This study aims to investigate the impact of COVID-19 on PAD and OHCA outcomes using a nationwide OHCA registry in Japan, where PAD is well-documented. METHODS: This secondary analysis of the All-Japan Utstein Registry, a prospective population-based nationwide registry of OHCA patients, included patients aged ≥ 18 years with bystander-witnessed OHCA and an initial shockable rhythm who were transported to medical facilities between January 1, 2005, and December 31, 2020. The analytical parameters of this study were the proportion of patients who underwent PAD and patients with one-month survival with favorable neurological outcomes, defined as a cerebral performance category score of 1 or 2. We compared the data between 2019 and 2020 using a multivariable logistic regression analysis. RESULTS: During the study period, 1,930,273 OHCA patients were registered; of these, 78,302 were eligible for the analysis. Before the COVID-19 pandemic, the proportion of OHCA patients who underwent PAD and demonstrated favorable neurological outcomes increased gradually from 2005 to 2019 (P for trend < 0.001). The proportion of patient who had PAD were 17.7% (876/4959) in 2019 and 15.1% (735/4869) in 2020, respectively. The proportion of patient who displayed favorable neurological outcomes were 25.1% (1245/4959) in 2019 and 22.8% (1109/4869) in 2020, respectively. After adjusting for potential confounders, a significant reduction in the proportion of PAD was observed compared to that in 2019 (adjusted odds ratio [AOR], 0.86; 95% confidence interval [CI], 0.76-0.97), while no significant reduction was observed in favorable neurological outcomes (AOR, 0.97; 95% CI 0.87-1.07). CONCLUSION: The proportion of PAD clearly decreased in 2020, probably due to the COVID-19 pandemic in Japan. In contrast, no significant reduction was observed in favorable neurological outcomes.


Subject(s)
COVID-19 , Cardiopulmonary Resuscitation , Emergency Medical Services , Out-of-Hospital Cardiac Arrest , Humans , Out-of-Hospital Cardiac Arrest/epidemiology , Out-of-Hospital Cardiac Arrest/therapy , Out-of-Hospital Cardiac Arrest/complications , Defibrillators , COVID-19/epidemiology , COVID-19/therapy , Prospective Studies , Pandemics , Japan/epidemiology , Electric Countershock , Registries
17.
BMC Med Res Methodol ; 22(1): 221, 2022 08 10.
Article in English | MEDLINE | ID: covidwho-2098312

ABSTRACT

BACKGROUND: In response to the COVID-19 pandemic many clinical studies have been initiated leading to the need for efficient ways to track and analyze study results. We expanded our previous project that tracked registered COVID-19 clinical studies to also track result articles generated from these studies. Our objective was to develop a data science approach to identify and analyze all publications linked to COVID-19 clinical studies and generate a prioritized list of publications for efficient understanding of the state of COVID-19 clinical research. METHODS: We conducted searches of ClinicalTrials.gov and PubMed to identify articles linked to COVID-19 studies, and developed criteria based on the trial phase, intervention, location, and record recency to develop a prioritized list of result publications. RESULTS: The performed searchers resulted in 1 022 articles linked to 565 interventional trials (17.8% of all 3 167 COVID-19 interventional trials as of 31 January 2022). 609 publications were identified via abstract-link in PubMed and 413 via registry-link in ClinicalTrials.gov, with 27 articles linked from both sources. Of the 565 trials publishing at least one article, 197 (34.9%) had multiple linked publications. An attention score was assigned to each publication to develop a prioritized list of all publications linked to COVID-19 trials and 83 publications were identified that are result articles from late phase (Phase 3) trials with at least one US site and multiple study record updates. For COVID-19 vaccine trials, 108 linked result articles for 64 trials (14.7% of 436 total COVID-19 vaccine trials) were found. CONCLUSIONS: Our method allows for the efficient identification of important COVID-19 articles that report results of registered clinical trials and are connected via a structured article-trial link. Our data science methodology also allows for consistent and as needed data updates and is generalizable to other conditions of interest.


Subject(s)
COVID-19 , Publications , COVID-19 Vaccines , Humans , Pandemics , Periodicals as Topic , PubMed , Registries
18.
RMD Open ; 8(2)2022 11.
Article in English | MEDLINE | ID: covidwho-2098011

ABSTRACT

OBJECTIVES: To assess the tolerance and efficacy of targeted therapies prescribed off-label in refractory low-prevalence autoimmune and inflammatory systemic diseases. METHODS: The TATA registry (TArgeted Therapy in Autoimmune Diseases) is a prospective, observational, national and independent cohort follow-up. The inclusion criteria in the registry are as follows: age >18 years; low-prevalence autoimmune and inflammatory systemic disease treated with off-label drugs started after 1 January 2019. RESULTS: Hundred (100) patients (79 women) were enrolled. The median age was 52.5 years (95% CI 49 to 56) and the median disease duration before enrolment was 5 years (3 to 7). The targeted therapies at enrolment were as follows: Janus kinase/signal transducers and activators of transcription inhibitors (44%), anti-interleukin (IL)-6R (22%), anti-IL-12/23, anti-IL-23 and anti-IL-17 (9%), anti-B cell activating factor of the tumour necrosis factor family (5%), abatacept (5%), other targeted treatments (9%) and combination of targeted treatments (6%). 73% of patients were receiving corticosteroid therapy at enrolment (median dose 10 mg/day). The current median follow-up time is 9 months (8 to 10).Safety: 11 serious infections (incidence rate of 14.8/100 patient-years) and 1 cancer (1.3 cancers/100 patient-years) were observed. Two patients died from severe COVID-19 (2.7 deaths/100 patient-years).Efficacy: the targeted treatment was considered effective by the clinician in 56% of patients and allowed, in responders, a median reduction of oral corticosteroids of 15 (9 to 21) mg/day, below 7.5 mg/day in 76% of patients, while 28% discontinued. CONCLUSION: These initial results of the TATA registry confirm the diversity of targeted treatments prescribed off-label in refractory autoimmune diseases and their corticosteroid-sparing effect when effective. Tolerance was acceptable in these refractory patients with a long history of treatment with immunosuppressive drugs.


Subject(s)
Autoimmune Diseases , COVID-19 , Adolescent , Female , Humans , Middle Aged , Interleukin-23 , Off-Label Use , Prospective Studies , Registries
19.
Nurs Res ; 71(6): 421-431, 2022.
Article in English | MEDLINE | ID: covidwho-2097526

ABSTRACT

BACKGROUND: Nursing professional organizations and media sources indicated early in the pandemic that the physical and psychological effects of COVID-19 might be distinct and possibly greater in nurses than in other types of healthcare workers (HCWs). OBJECTIVES: Based on survey data collected in Healthcare Worker Exposure Response and Outcomes (HERO), a national registry of U.S. HCWs, this study compared the self-reported experiences of nurses with other HCWs during the first 13 months of the pandemic. METHODS: Nurse responses were compared to responses of nonnurse HCWs in terms of viral exposure, testing and infection, access to personal protective equipment (PPE), burnout, and well-being. Logistic regression models were used to examine associations between nurse and nonnurse roles for the binary end points of viral testing and test positivity for COVID-19. We also examined differences by race/ethnicity and high-risk versus low-risk practice settings. RESULTS: Of 24,343 HCWs in the registry, one third self-identified as nurses. Nurses were more likely than other HCWs to report exposure to SARS-CoV-2, problems accessing PPE, and decreased personal well-being, including burnout, feeling tired, stress, trouble sleeping, and worry. In adjusted models, nurses were more likely than nonnurse HCWs to report viral testing and test positivity for COVID-19 infection. Nurses in high-risk settings were more likely to report viral exposure and symptoms related to well-being; nurses in low-risk settings were more likely to report viral testing and test positivity. Black or Hispanic nurses were most likely to report test positivity. DISCUSSION: Differences were identified between nurses and nonnurse HCWs in access to PPE, physical and mental well-being measures, and likelihood of reporting exposure and infection. Among nurses, testing and infection differed based on race and ethnicity, and type of work setting. Our findings suggest further research and policy are needed to elucidate and address social and occupational disparities.


Subject(s)
Burnout, Professional , COVID-19 , Humans , SARS-CoV-2 , Pandemics , Personal Protective Equipment , Health Personnel/psychology , Burnout, Professional/epidemiology , Registries
20.
G Ital Cardiol (Rome) ; 23(2 Suppl 1): e3-e14, 2022 02.
Article in Italian | MEDLINE | ID: covidwho-2089544

ABSTRACT

Razionale. In Italia la pandemia COVID-19 ha determinato importanti riorganizzazioni logistiche nell'erogazione delle cure ospedaliere e di specialistica ambulatoriale. Ciò ha spinto clinici e decisori pubblico-amministrativi della Sanità ad adottare nuovi modelli organizzativi in molteplici scenari clinici. Materiali e metodi. Il registro OIBOH (Optimal Intensification therapy in a Broad Observed High risk patient population with coronary disease) è uno studio osservazionale "cross-sectional" condotto in vari centri italiani di cardiologia ambulatoriale per valutare durante la pandemia COVID-19 la capacità di identificare in breve tempo i pazienti ad altissimo rischio cardiovascolare residuo dopo un evento coronarico recente (<12 mesi). Successivamente alla valutazione clinica iniziale, venivano arruolati i pazienti ritenuti ad altissimo rischio, registrando le caratteristiche cliniche e di trattamento in una scheda di raccolta dati elettronica.Risultati. Al registro hanno partecipato 134 centri di cardiologia ambulatoriale che hanno arruolato 1428 pazienti su 3227 esaminati fra quelli che avevano avuto accesso ad una visita cardiologica durante la pandemia nel periodo ottobre 2020-marzo 2021. Il criterio di arruolamento era costituito dall'aver avuto una diagnosi di coronaropatia confermata angiograficamente negli ultimi 12 mesi, per sindrome coronarica acuta (SCA) o cronica (SCC). La SCA come evento indice era presente nel 93% dei pazienti arruolati mentre la SCC nel 7%. L'età media era 67 ± 10 anni, il 25% era di sesso femminile. Il 96.1% dei pazienti con SCA e il 67.6% dei pazienti con SCC sono stati sottoposti a rivascolarizzazione coronarica. Il 46% e 47% dei pazienti con SCA e SCC, rispettivamente, era diabetico. Oltre il 65% dei pazienti presentava una malattia coronarica multivasale. È stata osservata una importante prevalenza di arteriopatia periferica (17.5% nei pazienti con SCA e 19.6% nei pazienti con SCC). I valori di pressione arteriosa e frequenza cardiaca risultavano ben controllati (128 ± 25.2 mmHg e 65 ± 12.3 b/min nei pazienti con SCA; 127 ± 23.4 mmHg e 67 ± 13.2 b/min nei pazienti con SCC). Viceversa, è stato riportato uno scarso controllo dei livelli di colesterolemia LDL, con un valore medio di 88.8 ± 38.6 mg/dl nei pazienti con SCA e 86 ± 36.6 mg/dl nei pazienti con SCC. Solo il 16.4% dei pazienti con SCA raggiungeva i livelli raccomandati dalle attuali linee guida europee. Nonostante l'estensivo uso di statine (>90%), si è rilevato un utilizzo limitato dell'associazione statina ad alta intensità + ezetimibe (solo il 22.4% dei pazienti). Estremamente basso è stato l'utilizzo di inibitori di PCSK9 (2.5%). La duplice terapia antiaggregante piastrinica (DAPT) è risultata complessivamente ben condotta fin dalla dimissione ospedaliera. Nei pazienti in DAPT, l'inibitore P2Y12 più utilizzato è risultato il ticagrelor alla dose di 90 mg, soprattutto dopo un evento coronarico acuto (in circa l'80% dei pazienti con SCA). Nella stragrande maggioranza dei casi (>90%) i cardiologi ambulatoriali hanno posto indicazione a prosecuzione della DAPT oltre i 12 mesi con aspirina e ticagrelor 60 mg bid. Conclusioni. La gestione del paziente con coronaropatia in fase cronica stabilizzata è molto complessa. Tale complessità logistico-gestionale si è accentuata durante la pandemia COVID-19. Il registro OIBOH ha evidenziato un'ottima capacità di identificare le problematiche clinico-prognostiche delle cardiologie ambulatoriali italiane, specie nei pazienti ad altissimo rischio residuo. Rimangono importanti aree di miglioramento come uno stretto controllo della colesterolemia LDL, mentre altre raccomandazioni delle linee guida, come la prosecuzione della DAPT con ticagrelor 60 mg oltre i 12 mesi, risultano ben applicate. L'implementazione dell'assistenza con la medicina digitale e l'intelligenza artificiale potrebbe migliorare di molto la performance dei clinici.


Subject(s)
COVID-19 , Coronary Disease , Animals , Bees , Disease Outbreaks , Humans , Pandemics/prevention & control , Proprotein Convertase 9 , Registries , Secondary Prevention
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