10,399 research outputs found
ORCHESTRA Delphi consensus: diagnostic and therapeutic management of Post-COVID-19 condition in vulnerable populations
No full textBackground: Post-COVID condition (PCC) remains poorly understood, especially in clinically vulnerable groups. Within the ORCHESTRA Project, we applied the Delphi approach to drive recommendations for the diagnosis, management, and prevention of PCC in people living with HIV (PWH) and patients affected by rheumatological diseases (RD) and haematological malignancies (HM). Methods: Based on literature review, three areas of interest in PCC in PWH, HM, and RD were identified: 1) features and risk factors; 2) diagnosis and management; and 3) prevention. A three-round Delphi anonymous survey consisting of 15 questions was conducted including 69 experts. Consensus was measured by the 6-point Likert scale categorised into four tiers: strong disagreement, moderate disagreement, moderate agreement, and strong agreement. Statements were generated on questions achieving consensus. Results: Eleven statements were generated: six on features and risk factors of PCC in clinically vulnerable populations, two on diagnosis and management, and three on prevention. Chronic fatigue was identified as the most frequent presentation of PCC in PWH and RD populations. A different case definition of PCC is required for RD population, as symptoms of PCC and autoimmune disorders may overlap. Risk factors for PCC include age>65, severity of COVID-19, and female sex; this latter is also associated with increased smell/taste impairment. A clinical assessment or a routine laboratory test performed three months after acute infection is not suggested to diagnose PCC in PWH. PWH and RD should be screened to exclude additional autoimmune disorders in case of chronic fatigue/arthralgia of new onset. Full-course vaccination and early treatment for COVID-19 should be promoted to prevent PCC, while corticosteroids during acute infection are not recommended. Conclusion: Diagnosis, management and prevention of PCC are still under discussion. This Delphi offers valuable insights on PCC in selected clinically vulnerable populations and suggests a tailored approach in vulnerable populations
SARS-CoV-2 Reinfections in Health-Care Workers, 1 March 2020–31 January 2023
No full textObjective: To study SARS-CoV-2 reinfections in health-care workers (HCWs) of the University Health Agency Giuliano-Isontina (ASUGI), covering the provinces of Trieste and Gorizia (northeastern Italy) routinely screened for SARS-CoV-2 via nasopharyngeal swab. Design: Cohort study of HCWs (N = 8205) followed since the start of the pandemic (1 March 2020) through 31 January 2023. The risk of reinfection during the Omicron transmission period (after 30 November 2021) among HCWs previously infected by SARS-CoV-2 was estimated based on days since last dose of COVID-19 vaccine received, adjusting for age, sex, job task, workplace, number of doses of COVID-19 vaccines and number of swab tests performed. In the crude as well as adjusted incidence rate analysis, reinfections ocurring 15+ days after a first dose of COVID-19 vaccine or 8+ days following a second or more dose were counted. Results: In a highly vaccinated population, during the entire study period (1 March 2020–31 January 2023) 5253 HCWs incurred at least one SARS-CoV-2 infection, 4262 HCWs were infected only once, and 1091 were reinfected. Reinfections almost entirely (99.1% = 1071/1091) occurred after 30 November 2021, peaking in July 2022 (N = 161). Six hundred eighty-three reinfections followed a pre-Omicron primary event against 408 reinfections following an Omicron event. Reinfections during the Omicron transmission period occurred a mean of 400 ± 220 days after primary SARS-CoV-2 infection; 512 ± 205 days following a pre-Omicron primary event, as opposed to 218 ± 74 days after an Omicron primary infection. Thirty-four hospitalizations were observed, all before the Omicron wave, following 18 (0.4%) primary SARS-CoV-2 infections and 16 (1.5%) reinfections. By excluding events occurring <15 days after a first dose or <8 days after a further dose of COVID-19 vaccine, 605 reinfections followed a pre-Omicron primary event (raw incidence = 1.4 × 1000) against 404 after a primary Omicron infection (raw incidence = 0.3 × 1000). Apart from nurse aids (slightly enhanced biological risk) and academic HCWs (remarkably lower risk with pre-Omicron primary events), the effect of occupation in terms of job task and workplace was marginal. Furthermore, whilst the risk of reinfection was lower in males and HCWs < 60 years old following a pre-Omicron primary infection, HCWs aged 30–50 were more likely to be infected after an Omicron primary event. Regardless of timeline of primary SARS-CoV-2 event, the risk of reinfection decreased with higher number of doses of COVID-19 vaccines, being lowest after the second booster. In particular, VE was 16% for one dose, 51% for two doses, 76% for the booster and 92% for the second booster with a pre-Omicron primary SARS-CoV-2 event. The latter figures increased to 72%, 59%, 74% and 93%, respectively, with Omicron primary infections. Conclusions: SARS-CoV-2 reinfections were frequent during the Omicron transmission period, though featured by mild or no symptoms. Whilst the impact of occupation on biological risk was relatively marginal, COVID-19 vaccination had the strongest protective effect against reinfection, with a 93% VE by second booster following an Omicron primary infection
Primary SARS-CoV-2 Infections, Re-infections and Vaccine Effectiveness during the Omicron Transmission Period in Healthcare Workers of Trieste and Gorizia (Northeast Italy), 1 December 2021–31 May 2022
No full textObjective: To evaluate the incidence of primary and recurrent COVID-19 infections in healthcare workers (HCWs) routinely screened for SARS-CoV-2 by nasopharyngeal swabs during the Omicron wave. Design: Dynamic Cohort study of HCWs (N = 7723) of the University Health Agency Giuliano Isontina (ASUGI), covering health services of the provinces of Trieste and Gorizia (Northeast Italy). Cox proportional hazard model was employed to estimate the risk of primary as well as recurrent SARS-CoV-2 infection from 1 December 2021 through 31 May 2022, adjusting for a number of confounding factors. Results: By 1 December 2021, 46.8% HCWs of ASUGI had received the booster, 37.2% were immunized only with two doses of COVID-19 vaccines, 6.0% only with one dose and 10.0% were unvaccinated. During 1 March 2020–31 May 2022, 3571 primary against 406 SARS-CoV-2 recurrent infections were counted among HCWs of ASUGI, 59.7% (=2130/3571) versus 95.1% (=386/406) of which occurring from 1 December 2021 through 31 May 2022, respectively. All HCWs infected by SARS-CoV-2 during 1 December 2021 through 31 May 2022 presented mild flu-like disease. Compared to staff working in administrative services, the risk of primary as well as recurrent SARS-CoV-2 infection increased in HCWs with patient-facing clinical tasks (especially nurses and other categories of HCWs) and in all clinical wards but COVID-19 units and community health services. Regardless of the number of swab tests performed during the study period, primary infections were less likely in HCWs immunized with one dose of COVID-19 vaccine. By contrast, the risk of SARS-CoV-2 re-infection was significantly lower in HCWs immunized with three doses (aHR = 0.58; 95%CI: 0.41; 0.80). During the study period, vaccine effectiveness (VE = 1-aHR) of the booster dose declined to 42% against re-infections, vanishing against primary SARS-CoV-2 infections. Conclusions: Though generally mild, SARS-CoV-2 infections and re-infections surged during the Omicron transmission period. Compared to unvaccinated colleagues, the risk of primary SARS-CoV-2 infection was significantly lower in HCWs immunized just with one dose of COVID-19 vaccines. By Italian law, HCWs immunized only with one dose were either suspended or re-assigned to job tasks not entailing patient facing contact; hence, while sharing the same biological risk of unvaccinated colleagues, they arguably had a higher level of protection against COVID-19 infection. By contrast, SARS-CoV-2 re-infections were less likely in HCWs vaccinated with three doses, suggesting that hybrid humoral immunity by vaccination combined with natural infection provided a higher level of protection than vaccination only. In this stage of the pandemic, where SARS-CoV-2 is more infectious yet much less pathogenic, health protection measures in healthcare premises at higher biological risk seem the rational approach to control the transmission of the virus
Clinical Impact of Monoclonal Antibodies in the Treatment of High-Risk Patients with SARS-CoV-2 Breakthrough Infections:The ORCHESTRA Prospective Cohort Study
No full textThe clinical impact of anti-spike monoclonal antibodies (mAb) in Coronavirus Disease 2019 (COVID-19) breakthrough infections is unclear. We present the results of an observational prospective cohort study assessing and comparing COVID-19 progression in high-risk outpatients receiving mAb according to primary or breakthrough infection. Clinical, serological and virological predictors associated with 28-day COVID-19-related hospitalization were identified using multivariate logistic regression and summarized with odds ratio (aOR) and 95% confidence interval (CI). A total of 847 COVID-19 outpatients were included: 414 with primary and 433 with breakthrough infection. Hospitalization was observed in 42/414 (10.1%) patients with primary and 8/433 (1.8%) patients with breakthrough infection (p < 0.001). aOR for hospitalization was significantly lower for breakthrough infection (aOR 0.12, 95%CI: 0.05–0.27, p < 0.001) and higher for immunocompromised status (aOR:2.35, 95%CI:1.08–5.08, p = 0.003), advanced age (aOR:1.06, 95%CI: 1.03–1.08, p < 0.001), and male gender (aOR:1.97, 95%CI: 1.04–3.73, p = 0.037). Among the breakthrough infection group, the median SARS-CoV-2 anti-spike IgGs was lower (p < 0.001) in immunocompromised and elderly patients >75 years compared with that in the immunocompetent patients. Our findings suggest that, among mAb patients, those with breakthrough infection have significantly lower hospitalization risk compared with patients with primary infection. Prognostic algorithms combining clinical and immune-virological characteristics are needed to ensure appropriate and up-to-date clinical protocols targeting high-risk categories.</p
Magnetic resonance imaging of pelvic floor dysfunction - joint recommendations of the ESUR and ESGAR Pelvic Floor Working Group
No full textObjective: To develop recommendations that can be used as guidance for standardized approach regarding indications, patient preparation, sequences acquisition, interpretation and reporting of magnetic resonance imaging (MRI) for diagnosis and grading of pelvic floor dysfunction (PFD). Methods: The technique included critical literature between 1993 and 2013 and expert consensus about MRI protocols by the pelvic floor-imaging working group of the European Society of Urogenital Radiology (ESUR) and the European Society of Gastrointestinal and Abdominal Radiology (ESGAR) from one Egyptian and seven European institutions. Data collection and analysis were achieved in 5 consecutive steps. Eighty-two items were scored to be eligible for further analysis and scaling. Agreement of at least 80 % was defined as consensus finding. Results: Consensus was reached for 88 % of 82 items. Recommended reporting template should include two main sections for measurements and grading. The pubococcygeal line (PCL) is recommended as the reference line to measure pelvic organ prolapse. The recommended grading scheme is the “Rule of three” for Pelvic Organ Prolapse (POP), while a rectocele and ARJ descent each has its specific grading system. Conclusion: This literature review and expert consensus recommendations can be used as guidance for MR imaging and reporting of PFD. Key points: • These recommendations highlight the most important prerequisites to obtain a diagnostic PFD-MRI.• Static, dynamic and evacuation sequences should be generally performed for PFD evaluation.• The recommendations were constructed through consensus among 13 radiologists from 8 institutions. © 2016 The Author(s
ORCHESTRA Delphi consensus: diagnostic and therapeutic management of Post-COVID-19 condition in vulnerable populations
No full textInternational audienceBACKGROUND: Post-COVID condition (PCC) remains poorly understood, especially in clinically vulnerable groups. Within the ORCHESTRA Project, we applied the Delphi approach to drive recommendations for the diagnosis, management, and prevention of PCC in people living with HIV (PWH) and patients affected by rheumatological diseases (RD) and haematological malignancies (HM). METHODS: Based on literature review, three areas of interest in PCC in PWH, HM, and RD were identified: 1) features and risk factors; 2) diagnosis and management; and 3) prevention. A three-round Delphi anonymous survey consisting of 15 questions was conducted including 69 experts. Consensus was measured by the 6-point Likert scale categorised into four tiers: strong disagreement, moderate disagreement, moderate agreement, and strong agreement. Statements were generated on questions achieving consensus. RESULTS: Eleven statements were generated: six on features and risk factors of PCC in clinically vulnerable populations, two on diagnosis and management, and three on prevention. Chronic fatigue was identified as the most frequent presentation of PCC in PWH and RD populations. A different case definition of PCC is required for RD population, as symptoms of PCC and autoimmune disorders may overlap. Risk factors for PCC include age>65, severity of COVID-19, and female sex; this latter is also associated with increased smell/taste impairment. A clinical assessment or a routine laboratory test performed three months after acute infection is not suggested to diagnose PCC in PWH. PWH and RD should be screened to exclude additional autoimmune disorders in case of chronic fatigue/arthralgia of new onset. Full-course vaccination and early treatment for COVID-19 should be promoted to prevent PCC, while corticosteroids during acute infection are not recommended. CONCLUSION: Diagnosis, management and prevention of PCC are still under discussion. This Delphi offers valuable insights on PCC in selected clinically vulnerable populations and suggests a tailored approach in vulnerable populations
Incidence and determinants of symptomatic and asymptomatic SARS-CoV-2 breakthrough infections after booster dose in a large European multicentric cohort of health workers-ORCHESTRA project
No full textThe ORCHESTRA project is funded by the European Commission, Horizon 2020 Program, Grant Agreement No. 101016167.
The Verona and Oviedo cohorts were also supported by the Regional
Health Authority (Azienda Zero), Veneto Region, Italy, and by the
Health Research Institute of Asturias (ISPA), Spain, respectively. The
Northern Barcelona cohort has been funded by the regional Ministry
of Health of the Generalitat de Catalunya (Spain) (Called COVID19-
PoC SLT16_04).Porru S, Monaco MGL, Spiteri G, Carta A, Caliskan G, Violán C, Torán-Monserrat P, Vimercati L, Tafuri S, Boffetta P, Violante FS, Sala E, Sansone E, Gobba F, Casolari L, Wieser A, Janke C, Tardon A, Rodriguez-Suarez MM, Liviero F, Scapellato ML, dell'Omo M, Murgia N, Mates D, Calota VC, Strhársky J, Mrázová M, Pira E, Godono A, Magnano GC, Negro C, Verlato G; Orchestra WP5 Working Grou
Data Quality and Standards
No full textThe Data Quality and Standards Working Group determined where current administrative data quality standards exist and where additional guidance are needed. The group used a hypothetical example to illustrate how improved data quality can make administrative data research better.
Chair and Lead Author: Amy O\u27Hara (Stanford University)https://repository.upenn.edu/admindata_reports/1001/thumbnail.jp
Data Sharing Governance and Management
No full textThe Data Sharing Governance and Management Working Group focused on data intermediaries that help to expand access to administrative data for a broad range of researchers. The group interviewed 11 data intermediaries and identified 9 unique functions that they serve to facilitate the data sharing process between data providers and researchers.
Chair: Ken Poole (Center for Regional and Economic Competitiveness)Lead Author: Monica King (ADRF Network)https://repository.upenn.edu/admindata_reports/1002/thumbnail.jp
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