scholarly journals Sleep disorders, depression and anxiety are associated with adverse safety outcomes in healthcare workers: A prospective cohort study

2018 ◽  
Vol 27 (6) ◽  
pp. e12722 ◽  
Author(s):  
Matthew D. Weaver ◽  
Céline Vetter ◽  
Shantha M.W. Rajaratnam ◽  
Conor S. O’Brien ◽  
Salim Qadri ◽  
...  
Keyword(s):  
Cohort Study ◽  
Sleep Disorders ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Healthcare Workers ◽  
Depression And Anxiety ◽  
Safety Outcomes

scholarly journals COVID-19 vaccine impact on rates of SARS-CoV-2 cases and post vaccination strain sequences among healthcare workers at an urban academic medical center: a prospective cohort study

2021 ◽  
Author(s):  
Tara C. Bouton ◽  
Sara Lodi ◽  
Jacquelyn Turcinovic ◽  
Sarah E. Weber ◽  
Emily Quinn ◽  
...  
Keyword(s):  
Cohort Study ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Healthcare Workers ◽  
Positive Impact ◽  
Medical Center ◽  
Academic Medical Center ◽  
Post Vaccination ◽  
Unvaccinated Control ◽  
Rate Ratios

AbstractBackgroundCOVID-19 vaccine trials and post-implementation data suggest vaccination decreases SARS-CoV-2 infections. We examine COVID-19 vaccination’s impact on SARS-CoV-2 case rates and viral diversity among healthcare workers (HCW) during a high community prevalence period.MethodsA prospective cohort study from Boston Medical Center (BMC)’s HCW vaccination program, where staff received two doses of BNT162b2 or mRNA-1273. We included PCR-confirmed SARS-CoV-2 cases among HCWs from December 09, 2020 to February 23, 2021. Weekly SARS-CoV-2 rates per 100,000 person-day overall and by time from first injection (1-14 and >14 days) were compared with surrounding community rates. Viral genomes were sequenced from SARS CoV-2 positive samples.ResultsSARS-CoV-2 cases occurred in 1.4% (96/7109) of HCWs given at least a first dose and 0.3% (17/5913) of HCWs given both vaccine doses. Adjusted SARS-CoV-2 infection rate ratios were 0.73 (95% CI 0.53-1.00) 1-14 days and 0.18 (0.10-0.32) >14 days from first dose. HCW SARS-CoV-2 cases >14 days from initial dose compared to within 14 days were more often older (46 versus 38 years, p=0.007), Latinx (10% versus 8%, p=0.03), and asymptomatic (48% versus 11%, p=0.0002). SARS-CoV-2 rates among HCWs fell below those of the surrounding community, with a 18% versus 11% weekly decrease respectively (p=0.14). Comparison of 48 SARS-CoV-2 genomes sequenced from post-first dose cases did not indicate selection pressure towards known spike-antibody escape mutations.ConclusionsOur results indicate a positive impact of COVID-19 vaccines on SARS-CoV-2 case rates. Post-vaccination isolates did not show unusual genetic diversity or selection for mutations of concern.Main PointCases of SARS-CoV-2 among health care workers dropped rapidly with COVID-19 vaccination. Sequencing 48 breakthrough infections (overwhelmingly in 14 days after 1st dose) showed no clear sign of any differences in spike protein compared with time-matched, unvaccinated control sequences.

scholarly journals The SPARKLE registry: protocol for an international prospective cohort study in patients with alpha-mannosidosis

2020 ◽  
Author(s):  
Julia Hennermann ◽  
Nathalie Guffon ◽  
Federica Cattaneo ◽  
Ferdinando Ceravolo ◽  
Line Borgwardt ◽  
...  
Keyword(s):  
Cohort Study ◽  
Natural History ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Clinical Care ◽  
Clinical Manifestations ◽  
Routine Clinical Care ◽  
Safety Outcomes ◽  
History Of

Abstract Background: Alpha-mannosidosis is a lysosomal storage disorder caused by reduced enzymatic activity of alpha-mannosidase. SPARKLE is an alpha-mannosidosis registry intended to obtain long-term safety and effectiveness data on the use of velmanase alfa during routine clinical care in patients with alpha-mannosidosis. It is a post-approval commitment to European marketing authorization for Velmanase alfa (Lamzede®), the first enzyme replacement therapy for the treatment of non-neurologic manifestations in patients with mild to moderate alpha-mannosidosis. In addition, SPARKLE will expand the current understanding of alpha-mannosidosis by collecting data on the clinical manifestations, progression, and natural history of the disease in treated and untreated patients, respectively.Results: The SPARKLE registry is designed as a multicenter, multinational, noninterventional, prospective cohort study of patients with alpha-mannosidosis, starting patient enrollment in 2020. Patients will be followed for up to 15 years. Safety and effectiveness as post-authorization outcomes under routine clinical care in patients with treatment will be evaluated. The primary safety outcomes are the rate of adverse events (anti-velmanase alfa-immunoglobulin G antibody development, infusion-related reactions, and hypersensitivity). Secondary safety outcomes include the evaluation of medical events, change in vital signs, laboratory tests, physical examination, and electrocardiogram results. The primary effectiveness outcome is a global treatment response rate, evaluated as the individual aggregate of single endpoints from pharmacodynamic, functional, and quality of life effectiveness outcomes; secondary effectiveness outcomes are to characterize the population of patients with alpha-mannosidosis with regard to clinical manifestation, progression, and natural history of the disease. Any patient in the European Union with a diagnosis of alpha-mannosidosis who is willing to participate will likely be eligible for inclusion in the registry. Publications to disseminate scientific insights from the registry are planned. Conclusion: This study will provide real-world data on the long-term safety and effectiveness of velmanase alfa in patients with alpha-mannosidosis during routine clinical care and increase the understanding of the natural course, clinical manifestations, and progression of this ultra-rare disease.

scholarly journals The SPARKLE registry: protocol for an international prospective cohort study in patients with alpha-mannosidosis

2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Julia B. Hennermann ◽  
Nathalie Guffon ◽  
Federica Cattaneo ◽  
Ferdinando Ceravolo ◽  
Line Borgwardt ◽  
...  
Keyword(s):  
Cohort Study ◽  
Natural History ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Clinical Care ◽  
Clinical Manifestations ◽  
Routine Clinical Care ◽  
Safety Outcomes ◽  
History Of

Abstract Background Alpha-mannosidosis is a lysosomal storage disorder caused by reduced enzymatic activity of alpha-mannosidase. SPARKLE is an alpha-mannosidosis registry intended to obtain long-term safety and effectiveness data on the use of velmanase alfa during routine clinical care in patients with alpha-mannosidosis. It is a post-approval commitment to European marketing authorization for Velmanase alfa (Lamzede®), the first enzyme replacement therapy for the treatment of non-neurologic manifestations in patients with mild to moderate alpha-mannosidosis. In addition, SPARKLE will expand the current understanding of alpha-mannosidosis by collecting data on the clinical manifestations, progression, and natural history of the disease in treated and untreated patients, respectively. Results The SPARKLE registry is designed as a multicenter, multinational, noninterventional, prospective cohort study of patients with alpha-mannosidosis, starting patient enrollment in 2020. Patients will be followed for up to 15 years. Safety and effectiveness as post-authorization outcomes under routine clinical care in patients with treatment will be evaluated. The primary safety outcomes are the rate of adverse events (anti-velmanase alfa-immunoglobulin G antibody development, infusion-related reactions, and hypersensitivity). Secondary safety outcomes include the evaluation of medical events, change in vital signs, laboratory tests, physical examination, and electrocardiogram results. The primary effectiveness outcome is a global treatment response rate, evaluated as the individual aggregate of single endpoints from pharmacodynamic, functional, and quality-of-life effectiveness outcomes; secondary effectiveness outcomes are to characterize the population of patients with alpha-mannosidosis with regard to clinical manifestation, progression, and natural history of the disease. Any patient in the European Union with a diagnosis of alpha-mannosidosis who is willing to participate will likely be eligible for inclusion in the registry. Publications to disseminate scientific insights from the registry are planned. Conclusion This study will provide real-world data on the long-term safety and effectiveness of velmanase alfa in patients with alpha-mannosidosis during routine clinical care and increase the understanding of the natural course, clinical manifestations, and progression of this ultra-rare disease.

Pregnancy and safety outcomes in women vaccinated with an AS03-adjuvanted split virion H1N1 (2009) pandemic influenza vaccine during pregnancy: A prospective cohort study

Vaccine ◽  
2011 ◽  
Vol 29 (37) ◽  
pp. 6358-6365 ◽  
Author(s):  
Fernanda Tavares ◽  
Irwin Nazareth ◽  
Javier Sawchik Monegal ◽  
Ida Kolte ◽  
Thomas Verstraeten ◽  
...  
Keyword(s):  
Cohort Study ◽  
Influenza Vaccine ◽  
Prospective Cohort Study ◽  
Pandemic Influenza ◽  
Prospective Cohort ◽  
Safety Outcomes

scholarly journals Hydroxychloroquine as pre-exposure prophylaxis against COVID-19 infection among healthcare workers: a prospective cohort study

2021 ◽  
Author(s):  
Akshay Rao ◽  
Sundar Kumar Veluswamy ◽  
Banashankari Gunjiganur Shankarappa ◽  
Rithika Manjunatha Reddy ◽  
Nethravathi Umesh ◽  
...  
Keyword(s):  
Cohort Study ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Healthcare Workers ◽  
Exposure Prophylaxis

Incidence of Asymptomatic and Symptomatic Influenza Among Healthcare Workers: A Multicenter Prospective Cohort Study

2020 ◽  
Author(s):  
Thomas Bénet ◽  
Sélilah Amour ◽  
Martine Valette ◽  
Mitra Saadatian-Elahi ◽  
Ludwig Serge Aho-Glélé ◽  
...  
Keyword(s):  
Cohort Study ◽  
Prospective Cohort Study ◽  
Cumulative Incidence ◽  
Prospective Cohort ◽  
Healthcare Workers ◽  
Control Measures ◽  
T1 And T2 ◽  
Multicenter Prospective Cohort Study ◽  
Multicenter Prospective Cohort

Abstract Background Influenza is an important cause of viral hospital-acquired infection involving patients, healthcare workers (HCW), and visitors. The frequency of asymptomatic influenza among HCW with possible subsequent transmission is poorly described. The objective is to determine the cumulative incidence of asymptomatic, paucisymptomatic, and symptomatic influenza among HCW. Method A multicenter prospective cohort study was done in 5 French university hospitals, including 289 HCW during the 2016–2017 influenza season. HCW had 3 physical examinations (time [T] 0, before epidemic onset; T.1, before epidemic peak; T.2, T.3, after epidemic peak). A blood sample was taken each time for influenza serology and a nasal swab was collected at T1 and T2 for influenza detection by polymerase chain reaction (PCR). Positive influenza was defined as either a positive influenza PCR, and/or virus-specific seroconversion against influenza A, the only circulating virus, with no vaccination record during follow-up. Symptoms were self-reported daily between T1 and T2. Cumulative incidence of influenza was stratified by clinical presentation per 100 HCW. Results Of the 289 HCW included, 278 (96%) completed the entire follow-up. Overall, 62 HCW had evidence of influenza of whom 46.8% were asymptomatic, 41.9% were paucisymptomatic, and 11.3% were symptomatic. Cumulative influenza incidence was 22.3% (95% confidence interval [CI]: 17.4%–27.2%). Cumulative incidence of asymptomatic influenza was 5.8% (95% CI: 3.3%–9.2%), 13.7% (95% CI: 9.9%–18.2%) for paucisymptomatic influenza, and 2.9% (95% CI: 1.3%–5.5%) for symptomatic influenza. Conclusions Asymptomatic and paucisymptomatic influenza were frequent among HCW, representing 47% and 42% of the influenza burden, respectively. These findings highlight the importance of systematic implementation of infection control measures among HCW regardless of respiratory symptoms from preventing nosocomial transmission of influenza. Clinical Trials Registration NCT02868658.

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