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1.
EuropePMC; 2022.
Preprint in English | EuropePMC | ID: ppcovidwho-333040

ABSTRACT

Rationale: The COVID-19 pandemic disrupted non-COVID critical care trials globally as intensive care units (ICUs) prioritized patient care and COVID-specific research. The international randomized controlled trial CYCLE (Critical Care Cycling to Improve Lower Extremity Strength) was forced to halt recruitment at all sites in March 2020, creating immediate challenges. We applied the CONSERVE (CONSORT and SPIRIT Extension for RCTs Revised in Extenuating Circumstance) guidance to report the impact of the pandemic on CYCLE and describe our mitigation approaches. Methods On March 23, 2020, the CYCLE Methods Centre distributed a standardized email to determine the number of patients still in-hospital and those requiring imminent 90-day endpoint assessments. We assessed protocol fidelity by documenting attempts to provide the in-hospital randomized intervention (cycling or routine physiotherapy), collect the primary outcome (physical function 3-days post-ICU discharge), and 90-day outcomes. We advised sites to prioritize data for the study’s primary outcome. We sought feedback on pandemic barriers related to trial procedures. Results As of March 17, 2020, 197 patients (of 360 planned) had been randomized;26 (13.2%) remained in hospital or were pending 90-day assessments. From 15 active sites (12 Canada, 2 US, 1 Australia), we identified 5 patients still receiving the study intervention in ICUs, 6 requiring primary outcomes, and 17 requiring 90-day assessments. All ICU interventions (5/5, 100%), 5/6 (83%) of primary outcomes, and all (17/17, 100%) 90-day assessments were attempted. Out of the 6 primary outcomes, one site was unable to attempt due to a temporary institutional ban on direct patient contact for non-COVID research, 2 were attempted but not completed due to reasons unrelated to the pandemic, and 3 were completed. Our main mitigation strategies included identifying patients at risk for protocol deviations, communicating early and frequently with sites, monitoring patient progress, data entry, and validation, and providing guidance for conducting some research activities remotely. Conclusions We retained all enrolled patients with minimal missing data using several time-sensitive strategies. Although CONSERVE recommends reporting only major modifications incurred by extenuating circumstances, we suggest that there are other benefits to reporting mitigation strategies with the goal of improving research transparency and trial management. Trial Registration: NCT03471247

2.
EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-329435

ABSTRACT

Background Patient characteristics, clinical care, resource use, and outcomes associated with hospitalization for coronavirus disease (COVID-19) in Canada are not well described. Methods We described all adult discharges from inpatient medical services and medical-surgical intensive care units (ICU) between November 1, 2019 and June 30, 2020 at 7 hospitals in Toronto and Mississauga, Ontario. We compared patients hospitalized with COVID-19, influenza and all other conditions using multivariable regression models controlling for patient age, sex, comorbidity, and residence in long-term-care. Results There were 43,462 discharges in the study period, including 1,027 (3.0%) with COVID-19 and 783 (2.3%) with influenza. Patients with COVID-19 had similar age to patients with influenza and other conditions (median age 65 years vs. 68 years and 68 years, respectively, SD<0.1). Patients with COVID-19 were more likely to be male (59.1%) and 11.7% were long-term care residents. Patients younger than 50 years accounted for 21.2% of all admissions for COVID-19 and 24.0% of ICU admissions. Compared to influenza, patients with COVID-19 had significantly greater mortality (unadjusted 19.9% vs 6.1%, aRR: 3.47, 95%CI: 2.57, 4.67), ICU use (unadjusted 26.4% vs 18.0%, aRR 1.52, 95%CI: 1.27, 1.83) and hospital length-of-stay (unadjusted median 8.7 days vs 4.8 days, aRR: 1.40, 95%CI: 1.20, 1.64), and not significantly different 30-day readmission (unadjusted 8.6% vs 8.2%, aRR: 1.01, 95%CI: 0.72, 1.42). Interpretation Adults hospitalized with COVID-19 during the first wave of the pandemic used substantial hospital resources and suffered high mortality. COVID-19 was associated with significantly greater mortality, ICU use, and hospital length-of-stay than influenza.

3.
BMC Med ; 20(1): 50, 2022 02 04.
Article in English | MEDLINE | ID: covidwho-1690914

ABSTRACT

BACKGROUND: A substantial portion of people with COVID-19 subsequently experience lasting symptoms including fatigue, shortness of breath, and neurological complaints such as cognitive dysfunction many months after acute infection. Emerging evidence suggests that this condition, commonly referred to as long COVID but also known as post-acute sequelae of SARS-CoV-2 infection (PASC) or post-COVID-19 condition, could become a significant global health burden. MAIN TEXT: While the number of studies investigating the post-COVID-19 condition is increasing, there is no agreement on how this new disease should be defined and diagnosed in clinical practice and what relevant outcomes to measure. There is an urgent need to optimise and standardise outcome measures for this important patient group both for clinical services and for research and to allow comparing and pooling of data. CONCLUSIONS: A Core Outcome Set for post-COVID-19 condition should be developed in the shortest time frame possible, for improvement in data quality, harmonisation, and comparability between different geographical locations. We call for a global initiative, involving all relevant partners, including, but not limited to, healthcare professionals, researchers, methodologists, patients, and caregivers. We urge coordinated actions aiming to develop a Core Outcome Set (COS) for post-COVID-19 condition in both the adult and paediatric populations.


Subject(s)
COVID-19 , Adult , COVID-19/complications , Child , Disease Progression , Humans , Outcome Assessment, Health Care , SARS-CoV-2
4.
CMAJ ; 194(4): E112-E121, 2022 01 31.
Article in English | MEDLINE | ID: covidwho-1686133

ABSTRACT

BACKGROUND: Disability-related considerations have largely been absent from the COVID-19 response, despite evidence that people with disabilities are at elevated risk for acquiring COVID-19. We evaluated clinical outcomes in patients who were admitted to hospital with COVID-19 with a disability compared with patients without a disability. METHODS: We conducted a retrospective cohort study that included adults with COVID-19 who were admitted to hospital and discharged between Jan. 1, 2020, and Nov. 30, 2020, at 7 hospitals in Ontario, Canada. We compared in-hospital death, admission to the intensive care unit (ICU), hospital length of stay and unplanned 30-day readmission among patients with and without a physical disability, hearing or vision impairment, traumatic brain injury, or intellectual or developmental disability, overall and stratified by age (≤ 64 and ≥ 65 yr) using multivariable regression, controlling for sex, residence in a long-term care facility and comorbidity. RESULTS: Among 1279 admissions to hospital for COVID-19, 22.3% had a disability. We found that patients with a disability were more likely to die than those without a disability (28.1% v. 17.6%), had longer hospital stays (median 13.9 v. 7.8 d) and more readmissions (17.6% v. 7.9%), but had lower ICU admission rates (22.5% v. 28.3%). After adjustment, there were no statistically significant differences between those with and without disabilities for in-hospital death or admission to ICU. After adjustment, patients with a disability had longer hospital stays (rate ratio 1.36, 95% confidence interval [CI] 1.19-1.56) and greater risk of readmission (relative risk 1.77, 95% CI 1.14-2.75). In age-stratified analyses, we observed longer hospital stays among patients with a disability than in those without, in both younger and older subgroups; readmission risk was driven by younger patients with a disability. INTERPRETATION: Patients with a disability who were admitted to hospital with COVID-19 had longer stays and elevated readmission risk than those without disabilities. Disability-related needs should be addressed to support these patients in hospital and after discharge.


Subject(s)
COVID-19/epidemiology , Disabled Persons/statistics & numerical data , Hospitalization/statistics & numerical data , Aged , Aged, 80 and over , Brain Injuries, Traumatic/epidemiology , COVID-19/mortality , Cohort Studies , Developmental Disabilities/epidemiology , Female , Hearing Loss/epidemiology , Hospital Mortality , Hospitals/statistics & numerical data , Humans , Intensive Care Units/statistics & numerical data , Length of Stay/statistics & numerical data , Male , Middle Aged , Ontario/epidemiology , Patient Readmission/statistics & numerical data , Retrospective Studies , SARS-CoV-2 , Vision Disorders/epidemiology
5.
Canadian journal of anaesthesia = Journal canadien d'anesthesie ; : 1-14, 2022.
Article in English | EuropePMC | ID: covidwho-1668496

ABSTRACT

Purpose Critical illness is a transformative experience for both patients and their family members. For COVID-19 patients admitted to the intensive care unit (ICU), survival may be the start of a long road to recovery. Our knowledge of the post-ICU long-term sequelae of acute respiratory distress syndrome (ARDS) and severe acute respiratory syndrome (SARS) may inform our understanding and management of the long-term effects of COVID-19. Source We identified international and Canadian epidemiologic data on ICU admissions for COVID-19, COVID-19 pathophysiology, emerging ICU practice patterns, early reports of long-term outcomes, and federal support programs for survivors and their families. Centred around an illustrating case study, we applied relevant literature from ARDS and SARS to contextualize knowledge within emerging COVID-19 research and extrapolate findings to future long-term outcomes. Principal findings COVID-19 is a multisystem disease with unknown long-term morbidity and mortality. Its pathophysiology is distinct and unique from ARDS, SARS, and critical illness. Nevertheless, based on initial reports of critical care management for COVID-19 and the varied injurious supportive practices employed in the ICU, patients and families are at risk for post-intensive care syndrome. The distinct incremental risk of COVID-19 multiple organ dysfunction is unknown. The risk of mood disorders in family members may be further exacerbated by imposed isolation and stigma. Conclusion Emerging literature on COVID-19 outcomes suggests some similarities with those of ARDS/SARS and prolonged mechanical ventilation. The pathophysiology of COVID-19 is presented here in the context of early outcome data and to inform an agenda for longitudinal research for patients and families.

6.
Can J Anaesth ; 69(5): 630-643, 2022 05.
Article in English | MEDLINE | ID: covidwho-1661743

ABSTRACT

PURPOSE: Critical illness is a transformative experience for both patients and their family members. For COVID-19 patients admitted to the intensive care unit (ICU), survival may be the start of a long road to recovery. Our knowledge of the post-ICU long-term sequelae of acute respiratory distress syndrome (ARDS) and severe acute respiratory syndrome (SARS) may inform our understanding and management of the long-term effects of COVID-19. SOURCE: We identified international and Canadian epidemiologic data on ICU admissions for COVID-19, COVID-19 pathophysiology, emerging ICU practice patterns, early reports of long-term outcomes, and federal support programs for survivors and their families. Centred around an illustrating case study, we applied relevant literature from ARDS and SARS to contextualize knowledge within emerging COVID-19 research and extrapolate findings to future long-term outcomes. PRINCIPAL FINDINGS: COVID-19 is a multisystem disease with unknown long-term morbidity and mortality. Its pathophysiology is distinct and unique from ARDS, SARS, and critical illness. Nevertheless, based on initial reports of critical care management for COVID-19 and the varied injurious supportive practices employed in the ICU, patients and families are at risk for post-intensive care syndrome. The distinct incremental risk of COVID-19 multiple organ dysfunction is unknown. The risk of mood disorders in family members may be further exacerbated by imposed isolation and stigma. CONCLUSION: Emerging literature on COVID-19 outcomes suggests some similarities with those of ARDS/SARS and prolonged mechanical ventilation. The pathophysiology of COVID-19 is presented here in the context of early outcome data and to inform an agenda for longitudinal research for patients and families.


RéSUMé: OBJECTIF: Les maladies au stade critique constituent une expérience bouleversante tant pour les patients que pour leurs proches. Pour les patients atteints de la COVID-19 admis aux soins intensifs (USI), la survie peut être le début d'un long parcours vers la guérison. Notre connaissance des séquelles à long terme post-USI d'un syndrome de détresse respiratoire aiguë (SDRA) ou d'un syndrome respiratoire aigu sévère (SRAS) pourrait éclairer notre compréhension et notre prise en charge des effets à long terme de la COVID-19. SOURCES: Nous avons identifié des données épidémiologiques internationales et canadiennes sur les admissions aux soins intensifs pour la COVID-19, la physiopathologie de la COVID-19, les schémas de pratique émergents en soins intensifs, les premiers rapports sur les issues à long terme et les programmes de soutien fédéraux pour les survivants et leurs familles. En nous centrant autour d'une étude de cas pour illustrer notre propos, nous avons appliqué la littérature pertinente à propos du SDRA et du SRAS afin de contextualiser les connaissances de la recherche émergente sur la COVID-19 et extrapoler les conclusions aux futures issues à long terme. CONSTATATIONS PRINCIPALES: La COVID-19 est une maladie multisystémique dont la morbidité et la mortalité à long terme sont inconnues. Sa physiopathologie est unique et distincte du SDRA, du SRAS et des maladies graves. Néanmoins, en nous fondant sur les rapports initiaux de prise en charge aux soins intensifs de la COVID-19 et sur les diverses pratiques de support préjudiciables utilisées aux soins intensifs, les patients et les familles sont à risque de syndrome post-soins intensifs. Le risque distinct supplémentaire de dysfonctionnement multiviscéral de la COVID-19 est inconnu. Le risque de troubles de l'humeur chez les proches peut être encore exacerbé par l'isolement imposé et la stigmatisation. CONCLUSION: La littérature émergente sur les issues de la COVID-19 suggère certaines similitudes avec celles du SDRA/SRAS et de la ventilation mécanique prolongée. La physiopathologie de la COVID-19 est présentée ici dans le contexte des premières données sur les issues et pour éclairer un programme de recherche longitudinale pour les patients et leurs familles.


Subject(s)
COVID-19 , Respiratory Distress Syndrome , COVID-19/therapy , Canada/epidemiology , Caregivers , Critical Illness/therapy , Humans , Intensive Care Units , Respiration, Artificial , Respiratory Distress Syndrome/epidemiology , Respiratory Distress Syndrome/therapy , SARS-CoV-2 , Survivors
9.
CMAJ ; 193(23): E859-E869, 2021 06 07.
Article in French | MEDLINE | ID: covidwho-1314450

ABSTRACT

CONTEXTE: Les caractéristiques des patients, les soins cliniques, l'utilisation des ressources et les issues cliniques des personnes atteintes de la maladie à coronavirus 2019 (COVID-19) hospitalisées au Canada ne sont pas bien connus. MÉTHODES: Nous avons recueilli des données sur tous les adultes hospitalisés atteints de la COVID-19 ou de l'influenza ayant obtenu leur congé d'unités médicales ou d'unités de soins intensifs médicaux et chirurgicaux entre le 1er novembre 2019 et le 30 juin 2020 dans 7 centres hospitaliers de Toronto et de Mississauga (Ontario). Nous avons comparé les issues cliniques des patients à l'aide de modèles de régression multivariée, en tenant compte des facteurs sociodémographiques et de l'intensité des comorbidités. Nous avons validé le degré d'exactitude de 7 scores de risque mis au point à l'externe pour déterminer leur capacité à prédire le risque de décès chez les patients atteints de la COVID-19. RÉSULTATS: Parmi les hospitalisations retenues, 1027 patients étaient atteints de la COVID-19 (âge médian de 65 ans, 59,1 % d'hommes) et 783 étaient atteints de l'influenza (âge médian de 68 ans, 50,8 % d'hommes). Les patients âgés de moins de 50 ans comptaient pour 21,2 % de toutes les hospitalisations dues à la COVID-19 et 24,0 % des séjours aux soins intensifs. Comparativement aux patients atteints de l'influenza, les patients atteints de la COVID-19 présentaient un taux de mortalité perhospitalière (mortalité non ajustée 19,9 % c. 6,1 %; risque relatif [RR] ajusté 3,46 %, intervalle de confiance [IC] à 95 % 2,56­4,68) et un taux d'utilisation des ressources des unités de soins intensifs (taux non ajusté 26,4 % c. 18,0 %; RR ajusté 1,50, IC à 95 % 1,25­1,80) significativement plus élevés, ainsi qu'une durée d'hospitalisation (durée médiane non ajustée 8,7 jours c. 4,8 jours; rapport des taux d'incidence ajusté 1,45; IC à 95 % 1,25­1,69) significativement plus longue. Le taux de réhospitalisation dans les 30 jours n'était pas significativement différent (taux non ajusté 9,3 % c. 9,6 %; RR ajusté 0,98 %, IC à 95 % 0,70­1,39). Trois scores de risque utilisant un pointage pour prédire la mortalité perhospitalière ont montré une bonne discrimination (aire sous la courbe [ASC] de la fonction d'efficacité du récepteur [ROC] 0,72­0,81) et une bonne calibration. INTERPRÉTATION: Durant la première vague de la pandémie, l'hospitalisation des patients atteints de la COVID-19 était associée à des taux de mortalité et d'utilisation des ressources des unités de soins intensifs et à une durée d'hospitalisation significativement plus importants que les hospitalisations des patients atteints de l'influenza. De simples scores de risque peuvent prédire avec une bonne exactitude le risque de mortalité perhospitalière des patients atteints de la COVID-19.

10.
Ann Intensive Care ; 11(1): 91, 2021 Jun 04.
Article in English | MEDLINE | ID: covidwho-1255967

ABSTRACT

BACKGROUND: Survivors of severe COVID-19 are at risk of impaired health-related quality of life (HRQoL) and persistent physical and psychological disability after ICU and hospital discharge. The subsequent social burden is a major concern. We aimed to assess the short-term HRQoL, physical function and prevalence of post-traumatic stress symptoms of invasively mechanically ventilated COVID-19 patients treated in our ICU. METHODS: Prospective, observational cohort study in a follow-up clinic. Patients completed a 6-min walking test (6MWT) to assess their cardio-pulmonary function around 2 months (early follow-up) from hospital discharge, the EQ-5D-5L questionnaire for quality of life assessment around 2 months and at 6 months from hospital discharge and an anonymous web-based Impact of Event Scale-Revised (IES-R) questionnaire for Post-Traumatic Stress symptoms at 2 months. RESULTS: 47 patients attended our follow-up program, mean age 59 ± 10 years, median pre-morbid Clinical Frailty Scale (CFS) 2 [2-3]. The median distance walked in 6 min was 470 [406-516] m, 83 [67-99]% of the predicted value. Overall 1 out 3 patients and 4/18 (22%) among those with a good functional baseline prior to COVID-19 (CFS of 1 or 2) had lower (84%) than predicted 6MWT. EQ-5D-5L quality of life VAS was 80 [70-90] out of 100 at early follow-up with a slight improvement to 85 [77.5-90] at 6 months. Mobility, self-care and usual activities improved between the two timepoints, while pain/discomfort and depression/anxiety did not improve or got worse. The IES-R total score was greater than the threshold for concern of 1.6 in 27/41(66%) respondents. CONCLUSIONS: Patients recovering from severe COVID-19 requiring invasive mechanical ventilation surviving hospital discharge present with early mild to moderate functional impairment, mildly reduced quality of life from hospital discharge with an overall improvement of mobility, self-care and the ability of performing usual activities, while a worsening of pain and depression/anxiety symptoms at 6 months and a large proportion of symptoms of post-traumatic distress soon after hospital discharge.

11.
CMAJ ; 193(12): E410-E418, 2021 03 22.
Article in English | MEDLINE | ID: covidwho-1160947

ABSTRACT

BACKGROUND: Patient characteristics, clinical care, resource use and outcomes associated with admission to hospital for coronavirus disease 2019 (COVID-19) in Canada are not well described. METHODS: We described all adults with COVID-19 or influenza discharged from inpatient medical services and medical-surgical intensive care units (ICUs) between Nov. 1, 2019, and June 30, 2020, at 7 hospitals in Toronto and Mississauga, Ontario. We compared patient outcomes using multivariable regression models, controlling for patient sociodemographic factors and comorbidity level. We validated the accuracy of 7 externally developed risk scores to predict mortality among patients with COVID-19. RESULTS: There were 1027 hospital admissions with COVID-19 (median age 65 yr, 59.1% male) and 783 with influenza (median age 68 yr, 50.8% male). Patients younger than 50 years accounted for 21.2% of all admissions for COVID-19 and 24.0% of ICU admissions. Compared with influenza, patients with COVID-19 had significantly greater in-hospital mortality (unadjusted 19.9% v. 6.1%, adjusted relative risk [RR] 3.46, 95% confidence interval [CI] 2.56-4.68), ICU use (unadjusted 26.4% v. 18.0%, adjusted RR 1.50, 95% CI 1.25-1.80) and hospital length of stay (unadjusted median 8.7 d v. 4.8 d, adjusted rate ratio 1.45, 95% CI 1.25-1.69). Thirty-day readmission was not significantly different (unadjusted 9.3% v. 9.6%, adjusted RR 0.98, 95% CI 0.70-1.39). Three points-based risk scores for predicting in-hospital mortality showed good discrimination (area under the receiver operating characteristic curve [AUC] ranging from 0.72 to 0.81) and calibration. INTERPRETATION: During the first wave of the pandemic, admission to hospital for COVID-19 was associated with significantly greater mortality, ICU use and hospital length of stay than influenza. Simple risk scores can predict in-hospital mortality in patients with COVID-19 with good accuracy.


Subject(s)
COVID-19/epidemiology , Critical Care/statistics & numerical data , Hospitalization/statistics & numerical data , Influenza, Human/epidemiology , Age Factors , Aged , Aged, 80 and over , COVID-19/diagnosis , COVID-19/therapy , Female , Humans , Influenza, Human/diagnosis , Influenza, Human/therapy , Male , Middle Aged , Ontario , Outcome Assessment, Health Care , Retrospective Studies , Risk Factors , Socioeconomic Factors , Survival Rate
12.
Intensive Care Med ; 47(2): 222-224, 2021 02.
Article in English | MEDLINE | ID: covidwho-1086555
14.
Int J Mol Sci ; 21(21)2020 Oct 22.
Article in English | MEDLINE | ID: covidwho-916452

ABSTRACT

Intensive care unit-acquired weakness (ICUAW) occurs in critically ill patients stemming from the critical illness itself, and results in sustained disability long after the ICU stay. Weakness can be attributed to muscle wasting, impaired contractility, neuropathy, and major pathways associated with muscle protein degradation such as the ubiquitin proteasome system and dysregulated autophagy. Furthermore, it is characterized by the preferential loss of myosin, a distinct feature of the condition. While many risk factors for ICUAW have been identified, effective interventions to offset these changes remain elusive. In addition, our understanding of the mechanisms underlying the long-term, sustained weakness observed in a subset of patients after discharge is minimal. Herein, we discuss the various proposed pathways involved in the pathophysiology of ICUAW, with a focus on the mechanisms underpinning skeletal muscle wasting and impaired contractility, and the animal models used to study them. Furthermore, we will explore the contributions of inflammation, steroid use, and paralysis to the development of ICUAW and how it pertains to those with the corona virus disease of 2019 (COVID-19). We then elaborate on interventions tested as a means to offset these decrements in muscle function that occur as a result of critical illness, and we propose new strategies to explore the molecular mechanisms of ICUAW, including serum-related biomarkers and 3D human skeletal muscle culture models.


Subject(s)
Coronavirus Infections/complications , Critical Care , Muscle Weakness/etiology , Muscular Atrophy/etiology , Pneumonia, Viral/complications , Animals , COVID-19 , Coronavirus Infections/therapy , Humans , Iatrogenic Disease , Muscle Weakness/physiopathology , Muscle Weakness/prevention & control , Muscular Atrophy/physiopathology , Muscular Atrophy/prevention & control , Pandemics , Pneumonia, Viral/therapy
15.
International Journal of Molecular Sciences ; 21(21):7840, 2020.
Article in English | MDPI | ID: covidwho-884337

ABSTRACT

Intensive care unit-acquired weakness (ICUAW) occurs in critically ill patients stemming from the critical illness itself, and results in sustained disability long after the ICU stay. Weakness can be attributed to muscle wasting, impaired contractility, neuropathy, and major pathways associated with muscle protein degradation such as the ubiquitin proteasome system and dysregulated autophagy. Furthermore, it is characterized by the preferential loss of myosin, a distinct feature of the condition. While many risk factors for ICUAW have been identified, effective interventions to offset these changes remain elusive. In addition, our understanding of the mechanisms underlying the long-term, sustained weakness observed in a subset of patients after discharge is minimal. Herein, we discuss the various proposed pathways involved in the pathophysiology of ICUAW, with a focus on the mechanisms underpinning skeletal muscle wasting and impaired contractility, and the animal models used to study them. Furthermore, we will explore the contributions of inflammation, steroid use, and paralysis to the development of ICUAW and how it pertains to those with the corona virus disease of 2019 (COVID-19). We then elaborate on interventions tested as a means to offset these decrements in muscle function that occur as a result of critical illness, and we propose new strategies to explore the molecular mechanisms of ICUAW, including serum-related biomarkers and 3D human skeletal muscle culture models.

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