Impact of COVID-19 Outbreak on Non-COVID-19 Patients

Study Overview
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Brief Summary
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The Geneva Canton organized the health crisis of the COVID-19 epidemic around the care of COVID patients at the University Hospital (HUG), by moving the care of non-COVID patients to private hospitals of the canton. The COVID epidemic appears to have been associated with a decrease in consultations and care for non-COVID patients. An excess of morbidity and mortality (non-COVID) would be possible during or after the epidemic in connection with this under-medicalization of non-COVID patients. The aim of this study is to measure and analyze the impact on the morbidity and mortality of inpatients during and after the COVID-19 epidemic in the adult inpatient wards of HUG and township hospitals / clinics.

Detailed Description
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The analysis of the various results will be carried out on all HUGs and on the various hospitals / clinics in the canton. A survival analysis for the outcome of death or rehospitalization will be performed, with a comparison according to each period. After epidemy evolution, finally, the outcomes will be compared between periods pre-COVID (from 01 march 2019 to 28 february 2020) versus per-COVID (01 march 2020 to 28 february 2022), and versus post-COVID (01 march 2022 to 28 february 2023). And comparaison would be performed between periods during the wave (per-wave) versus periods inter-wave. A description will be made in number (%) for numerical data and in median (IQR) for quantitative data. Univariate comparisons between the different periods will be carried out by statistical tests, parametric or not, adapted according to the data (Chi2 or Fisher's test for qualitative data, Student's test or Mann-Whitney-Wilcoxon for quantitative data). Statistical significance will be retained in the event of p <0.05. Multivariate analysis will be performed by logistic regression for the main outcome and by cox model for survival analysis. Different variables will be included in the models, including data on gender, age and comorbidity, as well as any variable having a difference with p <0.2 in univariate analysis. Secondary analyzes will be carried out by pathology (as the main diagnosis) according to the specific results defined for each situation. In retrospective analysis, these specific data will be relatively limited on the HUG area of full analysis brings together around total of 240,000 hospital stays. The main outcome data will be complete with no missing data. On the other hand, since this is retrospective data, it is possible that some important variables are missing. In this case, other patient data with missing data will not be included in the multivariate analyzes. In the event of missing data greater than 10%, a second sensitivity analysis may be performed after replacing the missing data with a multiple imputation method.

Official Title
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Impact of the COVID-19 Pandemic on the Morbidity and Mortality of Non-COVID-19 Patients Hospitalized Around the Epidemic Peak in the Geneva Area (Switzerland) (No COVID Impact)

Conditions
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COVID-19

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient hospitalized in an adult department During the pre-period-COVID-19 period, the per-COVID-19 or the post-COVID-19 periods ie from the 1st march 2019 to 28 february 2023. Exclusion Criteria: Patients who have been hospitalized for COVID-19 infection Patients hospitalized in the Department of Adolescent Woman and Child, Department of Psychiatry or Intensive Care Department during the same periods.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pre-COVID-19 period<br>Patients hospitalized between 1.3.2019 and 28.02.2020 | |
| per-COVID-19 period<br>Patients hospitalized between 1.3.2020 and 28.02.2022 | |
| post-COVID-19 period<br>Patients hospitalized between 1.3.2022 and 28.02.2023 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-hospital mortality | death during hospitalization of each patient | Assessed at the discharge date, up to 3 months after admission | 
| composite outcome (worsening during hospitalization) | intra-hospital mortality and / or transfer to intensive care and / or transfer to intermediate care during hospitalization | At the discharge date of hospitalization, up to 3 months after admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathologies leading to hospitalization | Primary and secondary diagnosis during hospitalization (CIM10 codes) | At the discharge date of hospitalization, up to 3 months after admission | 
| overall mortality at 3 months (90 days) | intra or extra hospital mortality : death occuring during hospitalization or after | within the 3 months after the admission date | 
| Potentially avoidable readmission rate | Potentially avoidable readmission according to SQLape algorithm (http://www.sqlape.com/READMISSIONS.htm) | During the 30 days after the patient's discharge | 
| mortality rate by pathology at 3 months | mortality for each top 10 of pathologies (intra or extra hospital mortality for each pathology) | within the 3 months after the admission date | 
| length of stay | Hospital length of stay (Time between admission date and discharge date) | At the discharge date of hospitalization, up to 3 months after admission | 
| rate of transfer to intermediate or intensive care | Number of patients with transfer to intensive or intermediate care during hospitalization | At the discharge date, up to 3 months after admission | 
| rate of transfer to rehabilitation care | Number of patients with rehabilitation transfer during hospitalization | At the discharge date of acute care, up to 3 months after admission | 
| specific gravity outcomes for patients with pneumonia : CURB 65 scale (Confusion, Urea, Respiratory rate, Blood pressure, Age [>65]) | CURB65 scale: min-max 0 to 5 points [5 points : worse outcome] | At the acute care admission | 
| specific gravity outcomes for patients with cardiac Failure : KILLIP class | KILLIP class (class 1 to 4) [class 4 : worse outcome]. The KILLIP classification is a system used in individuals with an acute myocardial infarction (heart attack), taking into account physical examination and the development of heart failure in order to predict and stratify their risk of mortality. | At the acute care admission | 
| specific gravity outcomes for patients with cardiac Failure : Weight variation | Weight variation : variation of weight at the admission compared to the basis weight | At the acute care admission | 
| specific gravity outcomes for patients with cardiac Failure or lung disease | FIO2 (% O2 prescribed): Fraction of inspired oxygen | At the acute care admission | 
| Leukocytes serum level | Giga / litre | At the acute care admission | 
| Polynuclear neutrophils serum level | Giga / litre | At the acute care admission | 
| Lymphocytes serum level | Giga / litre | At the acute care admission | 
| Hemoglobin serum level | gram/litre | At the acute care admission | 
| Thrombocytes serum level | Giga / litre | At the acute care admission | 
| Quick serum level | in % | At the acute care admission | 
| INR (International Normalized Ratio) | No unit | At the acute care admission | 
| fibrinogen serum level | gram/litre | At the acute care admission | 
| PTT serum level (partial Thromboplastin time) | in second | At the acute care admission | 
| D-Dimers serum level | ng / ml | At the acute care admission | 
| glucose serum level | mmol / litre | At the acute care admission | 
| glycated hemoglobin serum level (HbA1C) | in % | At the acute care admission | 
| C-reactive protein serum level (CRP) | mg / litre | At the acute care admission | 
| sodium serum level | mmol / l | At the acute care admission | 
| potassium serum level | mmol / l | At the acute care admission | 
| chlorides serum level | mmol / l | At the acute care admission | 
| calculated osmolality serum level | mOsm / kg | At the acute care admission | 
| Phosphates serum level | mmol / l | At the acute care admission | 
| corrected calcium serum level | mmol / l | At the acute care admission | 
| urea serum level | mmol / l | At the acute care admission | 
| creatinine serum level | µmol / l | At the acute care admission | 
| eGFR (CKD-EPI) serum level | ml / min / 1.73m2 | At the acute care admission | 
| albumin serum level | g / l | At the acute care admission | 
| prealbumin serum level | mg / l | At the acute care admission | 
| cyanocobalamin serum level | pmol / l | At the acute care admission | 
| folate serum level | nmol / l | At the acute care admission | 
| 25-hydroxy vitamin D (D2 + D3) serum level | nmol / l | At the acute care admission | 
| proBNP (Brain Natriuretic Peptid) serum level | ng / l | At the acute care admission | 
| Ultra sensitive Troponin T serum level | ng / l | At the acute care admission | 
| ASAT (aspartate transaminase) serum level | U / l | At the acute care admission | 
| ALAT (alanine aminotransferase) serum level | U / l | At the acute care admission | 
| Alkaline phosphatases serum level | U / l | At the acute care admission | 
| Gamma glutamyl transpeptidase. serum level | U / l | At the acute care admission | 
| Total bilirubin serum level | µmol / l | At the acute care admission | 
| ferritin serum level | µg / l | At the acute care admission | 
| TSH serum level | mU / l | At the acute care admission | 
| Arterial pH | No unit | At the acute care admission | 
| Arterial pCO2 (carbon dioxide partial pressure) | kPa | At the acute care admission | 
| Arterial pO2 (oxygen partial pressure) | kPa | At the acute care admission | 
| Arterial lactate | mmol / l | At the acute care admission | 
| Arterial HCO3 (bicarbonate) | mmol / l | At the acute care admission | 
| protein serum level | g / l | At the acute care admission | 
| Arterial pressure | Arterial pression (min-max), in mmHg | At the acute care admission | 
| cardiac rates | Bat/mn | At the acute care admission | 
| respiratory rates | /mn | At the acute care admission | 
| temperature | Celsius degrees | At the acute care admission | 
| oxygen saturation | Percutaneous oxygen saturation (in %) | At the acute care admission | 
| peak flow | L/mn | At the acute care admission | 
| specific scales : VAS of pain | Visual analog Pain scale (min-max : 1 to 10 [worse outcome]) | At the acute care admission | 
| specific scales : FIM | Functional Independence Measure (min-max : 18 [worse outcome]) to 126) | At the acute care admission | 
| specific scales : SOFA score | Sequential Organ Failure Assessment Score (min-max : 0 to 24 [worse outcome]) | At the acute care admission | 
| specific scales : MNA | Mini Nutritional Assessment (min-max : 0 [worse outcome] to 14) | At the acute care admission | 
| specific scales : NRS | Nutrition Risk Screening (min-max : 0 to 12 [worse outcome]) | At the acute care admission | 
| serum or urine positive bacteriologic sample | number of positive hemoculture or urinary cultures | At the acute care admission or during hospitalization | 
| Patient questionnaire | Questionnaire asking each patient if they had difficulty seeing a doctor before their hospitalization and if they delayed their hospitalization due to the COVID-19 crisis. | At the discharge date of hospitalization, up to 3 months after admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19 Outbreak, non COVID-19