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1.
Health Res Policy Syst ; 19(1): 148, 2021 Dec 20.
Article in English | MEDLINE | ID: covidwho-1577207

ABSTRACT

BACKGROUND: The launch in 2017 of the Irish 10-year reform programme Sláintecare represents a key commitment in the future of the health system. An important component of the programme was the development of a health system performance assessment (HSPA) framework. In 2019, the Department of Health of Ireland (DoH) and Health Service Executive (HSE) commissioned the technical support of researchers to develop an outcome-oriented HSPA framework which should reflect the shared priorities of multiple stakeholders, including citizens. This study describes the method applied in the Irish context and reflects on the added value of using a citizen panel in the development of an HSPA framework. METHODS: A panel of 15 citizens was convened, recruited by a third-party company using a sampling strategy to achieve a balanced mix representing the Irish society. Panellists received lay-language preparatory materials before the meeting. Panellists used a three-colour scheme to signal the importance of performance measures. An exit questionnaire was administered to understand how participants experienced being part of the panel. The citizen panel was the first in a series of three panels towards the development of the HSPA framework, followed by panels including representatives of the DoH and HSE, and representatives from professional associations and special interest groups. RESULTS: The citizen panel generated 249 health performance measures ranging across 13 domains. Top-ranking domains to the citizen panel (people-centredness, coordination of care, and coverage) were less prioritized by the other panels; domains less prioritized by the citizen panel, such as accessibility, responsiveness, efficiency, and effectiveness, were of higher priority in the other panels. Citizen panellists shared a similar understanding of what a citizen panel involves and described their experience at the panel as enjoyable, interesting, and informative. CONCLUSIONS: The priorities of the citizen panel were accounted for during all phases of developing the HSPA framework. This was possible by adopting an inclusive development process and by engaging citizens early on. Citizen engagement in HSPA development is essential for realizing citizen-driven healthcare system performance and generating trust and ownership in performance intelligence. Future research could expand the use of citizen panels to assess, monitor, and report on the performance of healthcare systems.


Subject(s)
Government Programs , Humans , Ireland
2.
J Health Organ Manag ; ahead-of-print(ahead-of-print)2021 May 07.
Article in English | MEDLINE | ID: covidwho-1561834

ABSTRACT

PURPOSE: Workplace silence impedes productivity, job satisfaction and retention, key issues for the hospital workforce worldwide. It can have a negative effect on patient outcomes and safety and human resources in healthcare organisations. This study aims to examine factors that influence workplace silence among hospital doctors in Ireland. DESIGN/METHODOLOGY/APPROACH: A national, cross-sectional, online survey of hospital doctors in Ireland was conducted in October-November 2019; 1,070 hospital doctors responded. This paper focuses on responses to the question "If you had concerns about your working conditions, would you raise them?". In total, 227 hospital doctor respondents (25%) stated that they would not raise concerns about their working conditions. Qualitative thematic analysis was carried out on free-text responses to explore why these doctors choose to opt for silence regarding their working conditions. FINDINGS: Reputational risk, lack of energy and time, a perceived inability to effect change and cultural norms all discourage doctors from raising concerns about working conditions. Apathy arose as change to working conditions was perceived as highly unlikely. In turn, this had scope to lead to neglect and exit. Voice was seen as risky for some respondents, who feared that complaining could damage their career prospects and workplace relationships. ORIGINALITY/VALUE: This study highlights the systemic, cultural and practical issues that pressure hospital doctors in Ireland to opt for silence around working conditions. It adds to the literature on workplace silence and voice within the medical profession and provides a framework for comparative analysis of doctors' silence and voice in other settings.


Subject(s)
Physicians , Workplace , Attitude of Health Personnel , Cross-Sectional Studies , Hospitals , Humans , Ireland
5.
Crit Care ; 25(1): 399, 2021 11 17.
Article in English | MEDLINE | ID: covidwho-1523316

ABSTRACT

BACKGROUND: The coronavirus disease-19 (COVID-19) pandemic had a relatively minimal direct impact on critical illness in children compared to adults. However, children and paediatric intensive care units (PICUs) were affected indirectly. We analysed the impact of the pandemic on PICU admission patterns and patient characteristics in the UK and Ireland. METHODS: We performed a retrospective cohort study of all admissions to PICUs in children < 18 years during Jan-Dec 2020, using data collected from 32 PICUs via a central database (PICANet). Admission patterns, case-mix, resource use, and outcomes were compared with the four preceding years (2016-2019) based on the date of admission. RESULTS: There were 16,941 admissions in 2020 compared to an annual average of 20,643 (range 20,340-20,868) from 2016 to 2019. During 2020, there was a reduction in all PICU admissions (18%), unplanned admissions (20%), planned admissions (15%), and bed days (25%). There was a 41% reduction in respiratory admissions, and a 60% reduction in children admitted with bronchiolitis but an 84% increase in admissions for diabetic ketoacidosis during 2020 compared to the previous years. There were 420 admissions (2.4%) with either PIMS-TS or COVID-19 during 2020. Age and sex adjusted prevalence of unplanned PICU admission reduced from 79.7 (2016-2019) to 63.1 per 100,000 in 2020. Median probability of death [1.2 (0.5-3.4) vs. 1.2 (0.5-3.4) %], length of stay [2.3 (1.0-5.5) vs. 2.4 (1.0-5.7) days] and mortality rates [3.4 vs. 3.6%, (risk-adjusted OR 1.00 [0.91-1.11, p = 0.93])] were similar between 2016-2019 and 2020. There were 106 fewer in-PICU deaths in 2020 (n = 605) compared with 2016-2019 (n = 711). CONCLUSIONS: The use of a high-quality international database allowed robust comparisons between admission data prior to and during the COVID-19 pandemic. A significant reduction in prevalence of unplanned admissions, respiratory diseases, and fewer child deaths in PICU observed may be related to the targeted COVID-19 public health interventions during the pandemic. However, analysis of wider and longer-term societal impact of the pandemic and public health interventions on physical and mental health of children is required.


Subject(s)
COVID-19/epidemiology , Intensive Care Units, Pediatric/statistics & numerical data , Pandemics , Patient Admission/statistics & numerical data , Child , Humans , Ireland/epidemiology , Retrospective Studies , United Kingdom/epidemiology
6.
PLoS One ; 16(11): e0258871, 2021.
Article in English | MEDLINE | ID: covidwho-1502069

ABSTRACT

COVID-19 continues to pose a threat to global public health. Multiple safe and effective vaccines against COVID-19 are available with one-third of the global population now vaccinated. Achieving a sufficient level of vaccine coverage to suppress COVID-19 requires, in part, sufficient acceptance among the public. However, relatively high rates of hesitance and resistance to COVID-19 vaccination persists, threating public health efforts to achieve vaccine-induced population protection. In this study, we examined longitudinal changes in COVID-19 vaccine acceptance, hesitance, and resistance in two nations (the United Kingdom and the Republic of Ireland) during the first nine months of the pandemic, and identified individual and psychological factors associated with consistent non-acceptance of COVID-19 vaccination. Using nationally representative, longitudinal data from the United Kingdom (UK; N = 2025) and Ireland (N = 1041), we found that (1) COVID-19 vaccine acceptance declined in the UK and remained unchanged in Ireland following the emergence of approved vaccines; (2) multiple subgroups existed reflecting people who were consistently willing to be vaccinated ('Accepters': 68% in the UK and 61% in Ireland), consistently unwilling to be vaccinated ('Deniers': 12% in the UK and 16% in Ireland), and who fluctuated over time ('Moveable Middle': 20% in the UK and 23% in Ireland); and (3) the 'deniers' and 'moveable middle' were distinguishable from the 'accepters' on a range of individual (e.g., younger, low income, living alone) and psychological (e.g., distrust of scientists and doctors, conspiracy mindedness) factors. The use of two high-income, Western European nations limits the generalizability of these findings. Nevertheless, understanding how receptibility to COVID-19 vaccination changes as the pandemic unfolds, and the factors that distinguish and characterise those that are hesitant and resistant to vaccination is helpful for public health efforts to achieve vaccine-induced population protection against COVID-19.


Subject(s)
COVID-19 Vaccines , COVID-19/prevention & control , Patient Acceptance of Health Care , Adolescent , Adult , Aged , COVID-19/psychology , Female , Humans , Ireland , Longitudinal Studies , Male , Middle Aged , Politics , Socioeconomic Factors , Time Factors , United Kingdom , Young Adult
7.
Psychosom Med ; 83(4): 338-344, 2021 05 01.
Article in English | MEDLINE | ID: covidwho-1494128

ABSTRACT

OBJECTIVE: Persistent somatic symptoms, such as pain and fatigue, have been referred to as somatization. Somatization is commonly associated with histories of trauma and posttraumatic stress disorder (PTSD). Although previous research has demonstrated that PTSD can predict somatic problems, there has been no examination of this at the level of PTSD symptom clusters and multidimensional assessment of somatic symptoms. We examined the association between the three International Classification of Disease (11th Edition) PTSD symptom clusters (reexperiencing in the here and now, avoidance, and sense of threat), measured in relation to the COVID-19 pandemic as the stressor, and somatic symptoms while statistically adjusting for confounding variables. METHODS: Participants were a nationally representative sample of 1041 adults from the general population of the Republic of Ireland. Physical health problems across the domains of pain, gastrointestinal, cardiopulmonary, and fatigue were assessed by the Patient Health Questionnaire, and PTSD symptoms were assessed using the International Trauma Questionnaire. RESULTS: Sense of threat was associated with the presence of pain (ß = 0.254), fatigue (ß = 0.332), gastrointestinal (ß = 0.234), and cardiovascular symptoms (ß = 0.239). Avoidance was associated with pain (ß = 0.347). Reexperiencing was not associated with any physical health variable. CONCLUSIONS: In the context of COVID-19, the sense of threat symptoms in PTSD is most strongly related to somatic problems. Findings suggest that interventions addressing sense of threat symptoms might provide relief from somatization.


Subject(s)
COVID-19/psychology , Fear/psychology , Medically Unexplained Symptoms , Stress Disorders, Post-Traumatic/etiology , Adolescent , Adult , Aged , COVID-19/complications , Female , Humans , Ireland/epidemiology , Male , Middle Aged , Pandemics , Stress Disorders, Post-Traumatic/epidemiology , Surveys and Questionnaires , Young Adult
8.
Vaccine ; 39(40): 5954-5962, 2021 09 24.
Article in English | MEDLINE | ID: covidwho-1372608

ABSTRACT

The influenza vaccine is free to all healthcare workers (HCWs) working in hospitals and long-term/residential health care facilities in Ireland. To evaluate influenza vaccine uptake, the Health Service Executive-Health Protection Surveillance Centre surveyed HCWs each season between 2011-2012 and 2019-2020. The national HCW uptake target was 40% for the first six seasons and was increased to 75% for the 2019-2020 season. Data on seasonal influenza vaccine uptake among HCWs employed in these healthcare settings were obtained using web-based surveys sent to occupational or management contact points. Data on numbers of staff vaccinated by Health Service Executive (HSE) professional staff grade and numbers eligible for vaccination in each grade were provided. Since the 2017-2018 season, a point prevalence survey for residents to assess influenza vaccine uptake has also been undertaken in long-term/residential care facilities (LTCFs) and aggregate data submitted, initially using a desktop spreadsheet survey tool, but later using web-based survey tools; these surveys were undertaken to investigate how uptake differed between HCWs and residents, both long-term and short-term. Participation by healthcare facilities and influenza vaccine uptake by both HCWs and LTCF-residents in these surveys increased over the nine seasons. Uptake among HCWs employed in publicly-funded hospitals increased from 18.1% (2011-2012) to 58.9% (2019-2020). Uptake in publicly-funded LTCFs increased from 17.8% (2011-2012) to 45.5% (2019-2020). Overall, uptake among hospital nursing staff was lowest among all staff categories for most seasons, but increased from 12.4% in 2011-2012 to 58.1% in 2019-2020. In all seasons since 2011-2012, medical/dental, management/administrative or health and social care professional staff reported the highest uptake values in public LTCFs. Of the three annual point prevalence surveys between 2017-2018 and 2019-2020, all showed high overall uptake among long-term residents (between 88.9% and 89.4%), and a lower and wider uptake range among respite residents (between 57.5% and 66.5%).


Subject(s)
Influenza Vaccines , Influenza, Human , Health Personnel , Humans , Influenza, Human/epidemiology , Influenza, Human/prevention & control , Ireland/epidemiology , Public Health , Seasons
9.
Int J Environ Res Public Health ; 18(19)2021 09 24.
Article in English | MEDLINE | ID: covidwho-1438607

ABSTRACT

COVID-19 profoundly affected Irish citizens. The effects have been especially pronounced for nurses in front-line, clinical and management roles. This article discusses the national and employer policy context relevant to nurses in Ireland. There have been staff and bed shortages in public hospitals since austerity policies were introduced following the global financial crisis. Government measures responding to the pandemic include initial 'cocooning' of older citizens, travel restrictions, changed working conditions and restricted availability of childcare. This article draws on interviews with 25 older nurses in 2021, sixteen women and nine men, aged 49 or over in Ireland. It explores older nurses' experiences of COVID-19 and asks what are the implications for their working conditions and retirement timing intentions. A gendered political economy of ageing approach and thematic analysis reveals that while some nurses responded positively to the pandemic, some experienced adverse health impacts, stress and exhaustion; some reported a fear of contracting COVID-19 and of infecting their families; several women nurses decided to retire earlier due to COVID-19. The implications of the findings for employer and government policy and for research are discussed.


Subject(s)
COVID-19 , Nurses , Female , Humans , Ireland , Male , Pandemics , Retirement , SARS-CoV-2
10.
Emerg Infect Dis ; 27(9): 2499-2501, 2021 Sep.
Article in English | MEDLINE | ID: covidwho-1435937

ABSTRACT

We examined virus genomic evolution in an immunocompromised patient with prolonged severe acute respiratory syndrome coronavirus 2 infection. Genomic sequencing revealed genetic variation during infection: 3 intrahost mutations and possible superinfection with a second strain of the virus. Prolonged infection in immunocompromised patients may lead to emergence of new virus variants.


Subject(s)
COVID-19 , SARS-CoV-2 , Evolution, Molecular , Genomics , Humans , Immunocompromised Host , Ireland
11.
BMC Infect Dis ; 21(1): 735, 2021 Aug 03.
Article in English | MEDLINE | ID: covidwho-1435226

ABSTRACT

BACKGROUND: In Ireland and across the European Union the COVID-19 epidemic waves, driven mainly by the emergence of new variants of the SARS-CoV-2 have continued their course, despite various interventions from governments. Public health interventions continue in their attempts to control the spread as they wait for the planned significant effect of vaccination. METHODS: To tackle this challenge and the observed non-stationary aspect of the epidemic we used a modified SEIR stochastic model with time-varying parameters, following Brownian process. This enabled us to reconstruct the temporal evolution of the transmission rate of COVID-19 with the non-specific hypothesis that it follows a basic stochastic process constrained by the available data. This model is coupled with Bayesian inference (particle Markov Chain Monte Carlo method) for parameter estimation and utilized mainly well-documented Irish hospital data. RESULTS: In Ireland, mitigation measures provided a 78-86% reduction in transmission during the first wave between March and May 2020. For the second wave in October 2020, our reduction estimation was around 20% while it was 70% for the third wave in January 2021. This third wave was partly due to the UK variant appearing in Ireland. In June 2020 we estimated that sero-prevalence was 2.0% (95% CI: 1.2-3.5%) in complete accordance with a sero-prevalence survey. By the end of April 2021, the sero-prevalence was greater than 17% due in part to the vaccination campaign. Finally we demonstrate that the available observed confirmed cases are not reliable for analysis owing to the fact that their reporting rate has as expected greatly evolved. CONCLUSION: We provide the first estimations of the dynamics of the COVID-19 epidemic in Ireland and its key parameters. We also quantify the effects of mitigation measures on the virus transmission during and after mitigation for the three waves. Our results demonstrate that Ireland has significantly reduced transmission by employing mitigation measures, physical distancing and lockdown. This has to date avoided the saturation of healthcare infrastructures, flattened the epidemic curve and likely reduced mortality. However, as we await for a full roll out of a vaccination programme and as new variants potentially more transmissible and/or more infectious could continue to emerge and mitigation measures change silent transmission, challenges remain.


Subject(s)
COVID-19 , Epidemics , Bayes Theorem , Communicable Disease Control , Humans , Ireland/epidemiology , SARS-CoV-2
12.
BMJ Open ; 11(9): e053423, 2021 09 22.
Article in English | MEDLINE | ID: covidwho-1435059

ABSTRACT

OBJECTIVES: To explore and compare the perspectives of junior doctors in Brazil and Ireland regarding transition and professional socialisation during the COVID-19 pandemic, with the purpose of identifying better ways to support doctors as they assume their new professional role. DESIGN: 27 semistructured interviews. Transcripts were analysed using qualitative thematic analysis. Cruess' framework of professional socialisation in medicine supported the interpretation of these data. SETTING: Public health hospitals across four Brazilian states (Santa Catarina, São Paulo, Ceará, Paraíba) and County Cork in the South of Ireland. PARTICIPANTS: Twenty-seven male and female medical junior doctors who had graduated between November 2019 and April 2020. RESULTS: Fourteen Brazilian and 13 Irish junior doctors were interviewed for this study. Entry to clinical practice during the pandemic had a significant impact on factors influencing the professional socialisation of junior doctors. This impact was reflected across the following six thematic areas: lack of preparedness; disrupted trajectory of role adaptation; fewer opportunities for experiential learning; solidarity and isolation; altered interactions with patients; challenges to health and well-being. CONCLUSIONS: Transition to clinical practice is an important stage in junior doctors' professional socialisation and identity formation. The COVID-19 pandemic created the opportunity for medical graduates to enter the workforce earlier than usual. Entering the workforce during this period created a lack of confidence among junior doctors concerning the boundaries of their new role and responsibilities, while simultaneously disrupting their social integration. Priorities to mitigate the impact of COVID-19 and future pandemics on this transition are presented.


Subject(s)
COVID-19 , Pandemics , Brazil/epidemiology , Female , Humans , Ireland/epidemiology , Male , SARS-CoV-2
13.
Sci Rep ; 11(1): 18474, 2021 09 16.
Article in English | MEDLINE | ID: covidwho-1415959

ABSTRACT

Understanding patient progression from symptomatic COVID-19 infection to a severe outcome represents an important tool for improved diagnoses, surveillance, and triage. A series of models have been developed and validated to elucidate hospitalization, admission to an intensive care unit (ICU) and mortality in patients from the Republic of Ireland. This retrospective cohort study of patients with laboratory-confirmed symptomatic COVID-19 infection included data extracted from national COVID-19 surveillance forms (i.e., age, gender, underlying health conditions, occupation) and geographically-referenced potential predictors (i.e., urban/rural classification, socio-economic profile). Generalised linear models and recursive partitioning and regression trees were used to elucidate COVID-19 progression. The incidence of symptomatic infection over the study-period was 0.96% (n = 47,265), of whom 3781 (8%) required hospitalisation, 615 (1.3%) were admitted to ICU and 1326 (2.8%) died. Models demonstrated an increasingly efficacious fit for predicting hospitalization [AUC 0.816 (95% CI 0.809, 0.822)], admission to ICU [AUC 0.885 (95% CI 0.88 0.89)] and death [AUC of 0.955 (95% CI 0.951 0.959)]. Severe obesity (BMI ≥ 40) was identified as a risk factor across all prognostic models; severely obese patients were substantially more likely to receive ICU treatment [OR 19.630] or die [OR 10.802]. Rural living was associated with an increased risk of hospitalization (OR 1.200 (95% CI 1.143-1.261)]. Urban living was associated with ICU admission [OR 1.533 (95% CI 1.606-1.682)]. Models provide approaches for predicting COVID-19 prognoses, allowing for evidence-based decision-making pertaining to targeted non-pharmaceutical interventions, risk-based vaccination priorities and improved patient triage.


Subject(s)
COVID-19/epidemiology , Obesity, Morbid/epidemiology , Adult , Aged , Aged, 80 and over , COVID-19/mortality , Comorbidity , Evidence-Based Medicine , Female , Hospital Mortality , Hospitalization , Humans , Incidence , Intensive Care Units , Ireland/epidemiology , Linear Models , Male , Middle Aged , Population Surveillance , Prognosis , Retrospective Studies , Rural Population/statistics & numerical data , Socioeconomic Factors , Urban Population/statistics & numerical data
14.
Int J Environ Res Public Health ; 18(18)2021 09 10.
Article in English | MEDLINE | ID: covidwho-1409580

ABSTRACT

COVID-19 is arguably the most critical science communication challenge of a generation, yet comes in the wake of a purported populist turn against scientific expertise in western societies. This study advances understanding of science-society relations during the COVID-19 pandemic by analysing how science was represented in news and social media coverage of COVID-19 on the island of Ireland. Thematic analysis was performed on a dataset comprising 952 news articles and 603 tweets published between 1 January and 31 May 2020. Three themes characterised the range of meanings attached to science: 'Defining science: Its subjects, practice and process', 'Relating to science: Between veneration and suspicion' and 'Using science: As solution, policy and rhetoric'. The analysis suggested that the COVID-19 pandemic represented a platform to highlight the value, philosophy, process and day-to-day activity of scientific research. However, the study also identified risks the pandemic might pose to science communication, including feeding public alienation by disparaging lay understandings, reinforcing stereotypical images of scientists, and amplifying the politicisation of scientific statements.


Subject(s)
COVID-19 , Social Media , Humans , Ireland/epidemiology , Pandemics , SARS-CoV-2
15.
Acta Psychol (Amst) ; 220: 103416, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1401129

ABSTRACT

The COVID-19 Psychological Research Consortium (C19PRC) study was established to determine the impact of the COVID-19 pandemic on the population of multiple countries. Here, we provide a methodological overview, cohort profile, data access, and summary of key findings from the Republic of Ireland arm of the C19PRC study. A longitudinal internet panel survey was designed to collect data from a nationally representative sample of Irish adults (N = 1041) who were tracked from March/April 2020 to March/April 2021. Quota sampling methods were used to produce a sample that was representative of the population with respect to sex, age, and regional distribution. Data were collected in five waves, and new participants were recruited at follow-up waves to cover sample attrition and produce nationally representative samples at various points during the first year of the pandemic. A comprehensive battery of measures was used throughout the project to assess an array of sociodemographic, political, social, psychological, physical health, COVID-19, and mental health variables. Analyses were conducted to compare sample characteristic to known population parameters from available census data. These analyses showed that the sample was representative of the general adult population of Ireland on the three quota variables and was reasonable representative of the population across a diverse range of sociodemographic variables. These data representative the first and only nationally representative, longitudinal survey of the mental health of the Irish population. These data are made freely available to interested users (https://osf.io/2huzd/files/) and the findings of this study provide a methodological basis for the future use of these data.


Subject(s)
COVID-19 , Pandemics , Adult , Humans , Ireland/epidemiology , Longitudinal Studies , SARS-CoV-2
16.
Br J Surg ; 108(11): 1351-1359, 2021 11 11.
Article in English | MEDLINE | ID: covidwho-1393168

ABSTRACT

BACKGROUND: Uncomplicated acute appendicitis can be managed with non-operative (antibiotic) treatment, but laparoscopic appendicectomy remains the first-line management in the UK. During the COVID-19 pandemic the practice altered, with more patients offered antibiotics as treatment. A large-scale observational study was designed comparing operative and non-operative management of appendicitis. The aim of this study was to evaluate 90-day follow-up. METHODS: A prospective, cohort study at 97 sites in the UK and Republic of Ireland included adult patients with a clinical or radiological diagnosis of appendicitis that either had surgery or non-operative management. Propensity score matching was conducted using age, sex, BMI, frailty, co-morbidity, Adult Appendicitis Score and C-reactive protein. Outcomes were 90-day treatment failure in the non-operative group, and in the matched groups 30-day complications, length of hospital stay (LOS) and total healthcare costs associated with each treatment. RESULTS: A total of 3420 patients were recorded: 1402 (41 per cent) had initial antibiotic management and 2018 (59 per cent) had appendicectomy. At 90-day follow-up, antibiotics were successful in 80 per cent (1116) of cases. After propensity score matching (2444 patients), fewer overall complications (OR 0.36 (95 per cent c.i. 0.26 to 0.50)) and a shorter median LOS (2.5 versus 3 days, P < 0.001) were noted in the antibiotic management group. Accounting for interval appendicectomy rates, the mean total cost was €1034 lower per patient managed without surgery. CONCLUSION: This study found that antibiotics is an alternative first-line treatment for adult acute appendicitis and can lead to cost reductions.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Appendicitis/therapy , Adult , Appendectomy/statistics & numerical data , Appendicitis/economics , Cohort Studies , Female , Follow-Up Studies , Humans , Ireland , Length of Stay/statistics & numerical data , Male , Matched-Pair Analysis , Middle Aged , United Kingdom
17.
Trials ; 22(1): 288, 2021 Apr 19.
Article in English | MEDLINE | ID: covidwho-1388815

ABSTRACT

OBJECTIVES: The primary objective is to demonstrate that, in patients with PCR-confirmed SARS-CoV-2 resulting in Acute Respiratory Distress Syndrome (ARDS), administration of 120mg/kg of body weight of intravenous Prolastin®(plasma-purified alpha-1 antitrypsin) reduces circulating plasma levels of interleukin-6 (IL-6). Secondary objectives are to determine the effects of intravenous Prolastin® on important clinical outcomes including the incidence of adverse events (AEs) and serious adverse events (SAEs). TRIAL DESIGN: Phase 2, randomised, double-blind, placebo-controlled, pilot trial. PARTICIPANTS: The study will be conducted in Intensive Care Units in hospitals across Ireland. Patients with a laboratory-confirmed diagnosis of SARS-CoV-2-infection, moderate to severe ARDS (meeting Berlin criteria for a diagnosis of ARDS with a PaO2/FiO2 ratio <200 mmHg), >18 years of age and requiring invasive or non-invasive mechanical ventilation. All individuals meeting any of the following exclusion criteria at baseline or during screening will be excluded from study participation: more than 96 hours has elapsed from onset of ARDS; age < 18 years; known to be pregnant or breastfeeding; participation in a clinical trial of an investigational medicinal product (other than antibiotics or antivirals) within 30 days; major trauma in the prior 5 days; presence of any active malignancy (other than nonmelanoma skin cancer) which required treatment within the last year; WHO Class III or IV pulmonary hypertension; pulmonary embolism prior to hospital admission within past 3 months; currently receiving extracorporeal life support (ECLS); chronic kidney disease receiving dialysis; severe chronic liver disease with Child-Pugh score > 12; DNAR (Do Not Attempt Resuscitation) order in place; treatment withdrawal imminent within 24 hours; Prisoners; non-English speaking patients or those who do not adequately understand verbal or written information unless an interpreter is available; IgA deficiency. INTERVENTION AND COMPARATOR: Intervention: Either a once weekly intravenous infusion of Prolastin® at 120mg/kg of body weight for 4 weeks or a single dose of Prolastin® at 120mg/kg of body weight intravenously followed by once weekly intravenous infusion of an equal volume of 0.9% sodium chloride for a further 3 weeks. Comparator (placebo): An equal volume of 0.9% sodium chloride intravenously once per week for four weeks. MAIN OUTCOMES: The primary effectiveness outcome measure is the change in plasma concentration of IL-6 at 7 days as measured by ELISA. Secondary outcomes include: safety and tolerability of Prolastin® in the respective groups (as defined by the number of SAEs and AEs); PaO2/FiO2 ratio; respiratory compliance; sequential organ failure assessment (SOFA) score; mortality; time on ventilator in days; plasma concentration of alpha-1 antitrypsin (AAT) as measured by nephelometry; plasma concentrations of interleukin-1ß (IL-1ß), interleukin-8 (IL-8), interleukin-10 (IL-10), soluble TNF receptor 1 (sTNFR1, a surrogate marker for TNF-α) as measured by ELISA; development of shock; acute kidney injury; need for renal replacement therapy; clinical relapse, as defined by the need for readmission to the ICU or a marked decline in PaO2/FiO2 or development of shock or mortality following a period of sustained clinical improvement; secondary bacterial pneumonia as defined by the combination of radiographic findings and sputum/airway secretion microscopy and culture. RANDOMISATION: Following informed consent/assent patients will be randomised. The randomisation lists will be prepared by the study statistician and given to the unblinded trial personnel. However, the statistician will not be exposed to how the planned treatment will be allocated to the treatment codes. Randomisation will be conducted in a 1:1:1 ratio, stratified by site and age. BLINDING (MASKING): The investigator, treating physician, other members of the site research team and patients will be blinded to treatment allocation. The clinical trial pharmacy personnel and research nurses will be unblinded to facilitate intervention and placebo preparation. The unblinded individuals will keep the treatment information confidential. The infusion bag will be masked at the time of preparation and will be administered via a masked infusion set to maintain blinding. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total of 36 patients will be recruited and randomised in a 1:1:1 ratio to each of the trial arms. TRIAL STATUS: In March 2020, version 1.0 of the trial protocol was submitted to the local research ethics committee (REC), Health Research Consent Declaration Committee (HRCDC) and the Health Products regulatory Authority (HPRA). REC approval was granted on April 1st 2020, HPRA approval was granted on April 24th 2020 and the HRCDC provided a conditional declaration on April 17th 2020. In July 2020 a substantial amendment (version 2.0) was submitted to the REC, HRCDC and HPRA. Protocol changes in this amendment included: the addition of trial sites; extending the duration of the trial to 12 months from 3 months; removal of inclusion criteria requiring the need for vasopressors; amendment of randomisation schedule to stratify by age only and not BMI and sex; correction of grammatical error in relation to infusion duration; to allow for inclusion of subjects who may have been enrolled in a clinical trial involving either antibiotics or anti-virals in the past 30 days; to allow for inclusion of subjects who may be currently enrolled in a clinical trial involving either antibiotics or anti-virals; to remove the need for exclusion based on alpha-1 antitrypsin phenotype; removal of mandatory isoelectric focusing of plasma to confirm Pi*MM status at screening; removal of need for mandatory echocardiogram at screening; amendment on procedures around plasma analysis to reflect that this will be conducted at the central site laboratory (as trial is multi-site and no longer single site); wording amended to reflect that interim analysis of cytokine levels taken at 7 days may be conducted. HRCDC approved version 2.0 on September 14th 2020, and HPRA approved on October 22nd 2020. REC approved the substantial amendment on November 23rd. In November 2020, version 3.0 of the trial protocol was submitted to the REC and HPRA. The rationale for this amendment was to allow for patients with moderate to severe ARDS from SARS-CoV-2 with non-invasive ventilation. HPRA approved this amendment on December 1st 2020 and the REC approved the amendment on December 8th 2020. Patient recruitment commenced in April 2020 and the last patient will be recruited to the trial in April 2021. The last visit of the last patient is anticipated to occur in April 2021. At time of writing, patient recruitment is now complete, however follow-up patient visits and data collection are ongoing. TRIAL REGISTRATION: EudraCT 2020-001391-15 (Registered 31 Mar 2020). FULL PROTOCOL: The full protocol (version 3.0 23.11.2020) is attached as an additional file accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).


Subject(s)
COVID-19/drug therapy , Respiratory Distress Syndrome/drug therapy , alpha 1-Antitrypsin/therapeutic use , Double-Blind Method , Humans , Ireland , Pilot Projects , Plasma , Randomized Controlled Trials as Topic , Respiratory Distress Syndrome/chemically induced , Respiratory Distress Syndrome/diagnosis , alpha 1-Antitrypsin/administration & dosage
19.
Int J Environ Res Public Health ; 18(7)2021 03 31.
Article in English | MEDLINE | ID: covidwho-1378277

ABSTRACT

The development and enhancement of occupational health services (OHS) at the national level is central to ensuring the sustainable health, well-being and work engagement of the working population. However, due to differences in national health, social security and occupational safety and health systems, the content, capacity, coverage and provisions of OHS vary considerably across national contexts. Obtaining a better understanding in terms of such similarities and variations internationally is essential as such comparative information can help inform evidenced-based decision-making on OHS at both policy and practice levels. This paper therefore reviews and analyses the key policies, standards and approaches in OH systems and services, using both academic and grey literature, across 12 industrialised countries (Australia, Canada, Finland, France, Germany, Ireland, Italy, Japan, The Netherlands, Poland, United Kingdom and the United States of America). It provides a detailed overview and categorization of OHS in these selected countries in terms of the legal and policy context, organisation and financing and coverage and staffing while specifically discussing variations aimed at psychosocial risk management and the promotion of mental health and well-being at work. It draws conclusions on key development needs of OHS internationally to ensure psychosocial risk management and mental health promotion are prioritised effectively in a preventive manner.


Subject(s)
Occupational Health Services , Occupational Health , Australia , Canada , Finland , France , Germany , Humans , Ireland , Italy , Japan , Mental Health , Netherlands , Poland , Risk Management , United Kingdom , United States
20.
Euro Surveill ; 26(6)2021 02.
Article in English | MEDLINE | ID: covidwho-1376681

ABSTRACT

We report the performance of a variety of commercially available SARS-CoV-2 PCR kits, used in several different sites across Ireland to determine if Ct values across platforms are comparable. We also investigate whether a Ct value, a surrogate for calculated viral loads in the absence of viral culture of > 34 can be used to exclude SARS-CoV-2 infection and its complications. We found a variation in Ct values from different assays for the same calculated viral load; this should be taken into consideration for result interpretation.


Subject(s)
Reagent Kits, Diagnostic , Real-Time Polymerase Chain Reaction , SARS-CoV-2/isolation & purification , COVID-19/diagnosis , Humans , Ireland , Reproducibility of Results , SARS-CoV-2/genetics
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