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Zuñiga, Eliana Angarita Gonzalez, Sebastián Camilo Tabares Rodríguez, María Paula Carrillo Ayerbe, Iván Santiago Acuña Cortes, Ruddy Paola Montoya Rumpf, Luis Oswaldo Martínez Arias, Jhon Edisson Parra, Juan José Diaztagle Fernández" "autores" => array:10 [ 0 => array:4 [ "nombre" => "John Jaime" "apellidos" => "Sprockel Díaz" "email" => array:1 [ 0 => "jjsprockel@fucsalud.edu.co" ] "referencia" => array:4 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] 2 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0015" ] 3 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] 1 => array:3 [ "nombre" => "Victoria Eugenia" "apellidos" => "Coral Zuñiga" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] ] 2 => array:3 [ "nombre" => "Eliana" "apellidos" => "Angarita Gonzalez" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] ] 3 => array:3 [ "nombre" => "Sebastián Camilo" "apellidos" => "Tabares Rodríguez" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] ] 4 => array:3 [ "nombre" => "María Paula" "apellidos" => "Carrillo Ayerbe" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] ] 5 => array:3 [ "nombre" => "Iván Santiago" "apellidos" => "Acuña Cortes" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] ] 6 => array:3 [ "nombre" => "Ruddy Paola" "apellidos" => "Montoya Rumpf" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] ] 7 => array:3 [ "nombre" => "Luis Oswaldo" "apellidos" => "Martínez Arias" "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] ] 8 => array:3 [ "nombre" => "Jhon Edisson" "apellidos" => "Parra" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0015" ] ] ] 9 => array:3 [ "nombre" => "Juan José" "apellidos" => "Diaztagle Fernández" "referencia" => array:3 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] 2 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">d</span>" "identificador" => "aff0020" ] ] ] ] "afiliaciones" => array:4 [ 0 => array:3 [ "entidad" => "Internal Medicine Department, Hospital San Jose (San Jose Hospital), Bogota, Colombia" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Fundacion Universitaria De Ciencias De La Salud (University Foundation of Health Sciences), Bogota, Colombia" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Intensive Care Unit of El Tunal Hospital — Comprehensive Health Services Southern Sub-network (Unidad de Cuidados Intensivos del Hospital El Tunal – Subred Integrada de Servicios de Salud del Sur), Bogota, Colombia" "etiqueta" => "c" "identificador" => "aff0015" ] 3 => array:3 [ "entidad" => "Department of Physiological Sciences, School of Medicine, National University of Colombia – Bogota, Bogota, Colombia" "etiqueta" => "d" "identificador" => "aff0020" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Obesidad y paradoja de la obesidad en pacientes con COVID-19 severo: Resultados de dos cohortes prospectivas" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:8 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1433 "Ancho" => 3341 "Tamanyo" => 245623 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0005" "detalle" => "Figure " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Kaplan Meier survival curves from the association between the presence or absence of obesity and: a) inpatient admission to intensive care, b) mortality of patients hospitalized in the intensive care unit.</p>" ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">The existence of a phenomenon known as the obesity paradox has been recognized for several years. According to this paradox, the presence of overweight and obesity favors the development of certain clinical conditions, but at the same time decreases the risk of adverse outcomes due to that condition. This paradox has been described for diabetes,<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> heart failure,<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> coronary artery disease,<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> peripheral arterial disease,<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> group I pulmonary hypertension,<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> and chronic occlusive pulmonary disease.<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">The first mention of this paradox was in 1989 in patients with pneumonia when LaCroix et al. found a negative correlation between body mass index (BMI) and pneumonia mortality.<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> Perhaps the best evidence for the existence of an obesity paradox in pneumonia comes from a large meta-analysis including thirteen studies that evaluated 2,912,105 patients, overweight and obesity were associated with an increased risk of deterioration (RR = 1.33), and decreased mortality (RR = 0.83).<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a> Moreover, a meta-analysis involving five trials with 6268 patients hospitalized in intensive care for ARDS documented that obesity was more likely to result in lower mortality (OR = 0.68).<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> Meanwhile, another meta-analysis of six studies with 7115 patients hospitalized in intensive care for sepsis and septic shock documented that obesity reduced the adjusted risk of mortality (OR = 0.82).<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">With respect to the current coronavirus disease (COVID)-19 pandemic, the way in which obesity becomes a risk factor for severe complications of COVID-19 has been documented.<a class="elsevierStyleCrossRefs" href="#bib0055"><span class="elsevierStyleSup">11,12</span></a> The most plausible explanation is assumed to be that the direct SARS-CoV-2 virus-influenced damage to tissues depends on the widespread expression of the Angiotensin Converting Enzyme 2 (ACE2) receptor in adipose tissue.<a class="elsevierStyleCrossRefs" href="#bib0065"><span class="elsevierStyleSup">13,14</span></a> Added to this are mechanisms such as the fact that it is a recognized risk factor for cardiovascular disease that in itself is a predictor of poor results in COVID-19, and that it can affect the immune response to viral infections, the abnormal secretion of adipokines and cytokines that determine low-grade systemic inflammation, etc.<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">15</span></a> Obesity also changes respiratory physiology by aggravating hypoxia and hypercapnia in COVID-19 pneumonia, fosters venous thrombosis and pulmonary embolism, and is associated with decreased vaccine effectiveness.<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">16</span></a> It could also be the result of obesity-related comorbidities such as hypertension and diabetes, that are associated with worse outcomes compared to simple obesity without comorbidities.<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">17</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">In view of the above, the present study explores obesity as a factor associated with the development of complications in and death of patients hospitalized in general and intensive care wards due to COVID-19.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Methodology</span><p id="par0025" class="elsevierStylePara elsevierViewall">An observational study was done using data from two prospective cohorts, one of patients hospitalized in the general ward and the other of patients admitted to the Intensive Care Unit (ICU). The first database included individuals over 18 years of age hospitalized for COVID-19 confirmed by Real-Time Polymerase Chain Reaction (RT-PCR) testing between April 15 and November 30, 2020 at three fourth-level care hospitals in Bogota, Colombia. Patients admitted directly to intensive care, those referred after 72 h in another institution, pregnant women, and those with a condition that seriously affected their survival were excluded. The second database consisted of patients hospitalized in the ICU of another fourth-level care hospital in Bogota for COVID-19 confirmed by RT-PCR for SARS-CoV-2 during the months of May to October 2020. Patients who decided to discontinue treatment due to pre-existing conditions and pregnant women were excluded.</p><p id="par0030" class="elsevierStylePara elsevierViewall">The clinical data from each of the institutions were completed in the respective virtual formats that were constructed based on the variables recommended by the International Severe Acute Respiratory and Emerging Infections Consortium (ISARIC) of the World Health Organization (which can be accessed through the link): <a href="https://media.tghn.org/medialibrary/2020/05/ISARIC_WHO_COVID-19_CORE_CRF_V1.3_24Feb2020_ES.pdf">https://media.tghn.org/medialibrary/2020/05/ISARIC_WHO_COVID-19_CORE_CRF_V1.3_24Feb2020_ES.pdf</a>).</p><p id="par0035" class="elsevierStylePara elsevierViewall">The outcomes evaluated were transfer of patients hospitalized in the general ward to intensive care and in-hospital death of intensive care patients. Obesity was defined as a BMI >30 kg/m<span class="elsevierStyleSup">2</span> according to World Health Organization criteria under which weight is categorized as follows: a low weight BMI <18.5 kg/m<span class="elsevierStyleSup">2</span>, b) normal weight: BMI 18.5–24.9 kg/m<span class="elsevierStyleSup">2</span>, c) overweight: BMI 25.0–29.9 kg/m<span class="elsevierStyleSup">2</span>, d) grade I obesity: BMI 30.0–34.9 kg/m<span class="elsevierStyleSup">2</span>, e) grade II obesity BMI 35.0–39.9 kg/m<span class="elsevierStyleSup">2</span>, and f) grade III obesity: BMI >40.0 kg/m<span class="elsevierStyleSup">2</span>.</p><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Statistical analysis</span><p id="par0040" class="elsevierStylePara elsevierViewall">For a general description, absolute frequencies and percentages were reported for qualitative variables and measures of central tendency and dispersion based on the distribution of the variables were reported for quantitative variables. Chi-square test for categorical variables and Student’s t-test for continuous variables were used to demonstrate possible differences between obese and non-obese populations.</p><p id="par0045" class="elsevierStylePara elsevierViewall">Two bivariate analysis was conducted, one for the association of obesity with the need to transfer hospitalized patients to the ICU in the first cohort and the other for the association with the death of intensive care patients in the second cohort; to this end, a Cox proportional-hazards regression model was used. In both cases, if a p-value of less than 0.10 was obtained, a multivariate logistic regression was carried out. A Kaplan Meier curve for transfer to ICU and for survival based on the presence of obesity was built by calculating the p value using the Log Rank test. Hazard Ratios (HR) with their respective 95% confidence intervals were reported. Analyses were done in the R statistical software version 4.0.2 (R Foundation, Vienna, Austria) using the “pROC”, “ROCit”, “survival” and “survminer” packages.</p><p id="par0050" class="elsevierStylePara elsevierViewall">The work was approved by the ethics and research committees of each of the institutions (by act number 138 of the Southern Integrated Health Services Subnetwork of El Tunal Hospital, 0498-2020 of San Jose Hospital and SDM-026-20 of University Children’s Hospital of San Jose) and informed consent was not required. Funding was obtained from the University Foundation of Health Sciences through Fostering Research call for research projects number DI-I-0631-20 for the cohort of patients hospitalized in general wards while the cohort of intensive care patients did not receive funding.</p></span></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0120">Results</span><p id="par0055" class="elsevierStylePara elsevierViewall">During the collection period, information was obtained on a total of 793 patients: 162 from El Tunal Hospital, 262 from San José Hospital, and 369 from the University Children’s Hospital of San Jose. Of these, 89 patients were excluded due to lack of objective weight data. This left 704 patients for the analysis and of these, 402 constituted the cohort of patients in general hospitalization, and 302 in the ICU cohort. Among the total number of patients, 274 (38.9%) patients were female, the average age was 59.1 years (SD 15.5) and the duration of symptoms prior to admission was 8.2 days (SD 6.1) The most frequent comorbidities were: hypertension in 273 (38.8%), diabetes in 147 (20.9%) and chronic pulmonary disease in 129 (18.3%). Obesity was present in 273 (38.8%) patients. Clinical worsening requiring transfer to the ICU occurred in 121 (17.2%) of the patients hospitalized, and in-hospital mortality in the ICU cohort was 211 (30.0%). Supplementary Table 1 shows the distribution between the inpatient and ICU groups for the total variables evaluated.</p><p id="par0060" class="elsevierStylePara elsevierViewall"><a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a> shows the differentiated characteristics between the presence or absence of obesity in the groups of patients hospitalized in wards or in the ICU. Among those hospitalized in the ICU there was a higher frequency of female sex (50.0 vs. 26.5%, p < 0.001) and lower average age (55.8 vs. 62.5 years, p < 0.001) among obese patients compared to non-obese patients. In the general ward, there was a higher percentage of diabetics among the obese 32.3% compared to the non-obese 13.4% (p < 0.001). There was evidence of earlier admission to the ICU for obese patients compared to non-obese patients with 7.8 days (SD 3.8) vs. 9.1 days (SD 4.4) respectively, p = 0.007. Within the paraclinics of severity in the ICU population, lymphocytes <1200 cells/μL were seen in 80 (49.4%) patients among the non-obese vs 104 (74.3%) in obese (p = 0.038). In the general hospitalized population, the C-Reactive Protein (CRP) was higher in obese vs. non-obese patients, 66.5 mg/L (SD 206.5) vs. 21.3 (SD 40.3) respectively (p = 0.026).</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0065" class="elsevierStylePara elsevierViewall">The results of the comparisons between the different weight categories for both outcomes are presented in <a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>. It seems to indicate a gradual increase in the percentage of patients transferred to the ICU as the degree of obesity increases, but only in class II obesity this difference was significant from normal weight. In the case of mortality in ICU patients, class I obesity had a lower percentage of events than normal weight. Supplementary Table 2 shows the complications of hospitalized intensive care patients and their relationship with the presence of obesity.</p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><p id="par0070" class="elsevierStylePara elsevierViewall"><a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a> shows the Kaplan Meier curves with the cumulative survival over time for groups of patients with and without the presence of obesity for both outcomes. A p value of 0.097 was obtained by LogRank test for transfer to ICU and 0.185 for death.</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0075" class="elsevierStylePara elsevierViewall">The bivariate Cox analysis for the association between obesity and the need to transfer to the ICU in the cohort of patients hospitalized in general ward yielded an HR = 1.484 (95% CI 0.945–2.330; p = 0.087). When the multivariate Cox proportional hazards model was run, an HR of 1.472 (95%CI 0.865–2.506; p = 0.154) was obtained with 8 variables. The variables that was significant were: the lymphocyte count, the PaO<span class="elsevierStyleInf">2</span>/FiO<span class="elsevierStyleInf">2</span> ratio and Creatinine with HR of 0.999, 0.996 and 1.216 respectively (<a class="elsevierStyleCrossRef" href="#tbl0015">Table 3</a>). In intensive care patients, a HR = 0.803 (95% CI 0.580–1.112; p = 0.187) was found for the association between the presence of obesity and mortality. Since no significant difference was detected, the multivariate model was not run.</p><elsevierMultimedia ident="tbl0015"></elsevierMultimedia></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0125">Discussion</span><p id="par0080" class="elsevierStylePara elsevierViewall">In the first reports describing COVID-19, obesity was not included among the risk factors that were evaluated.<a class="elsevierStyleCrossRefs" href="#bib0090"><span class="elsevierStyleSup">18–20</span></a> Perhaps one of the studies where this association was first revealed was in a cohort of 5279 patients from New York in which BMI is one of the factors most strongly associated with hospital admission and critical illness with BMI >40 kg/m<span class="elsevierStyleSup">2</span> having an OR of 2.5 and 1.5 respectively.<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">21</span></a> The present study could not demonstrate an association of obesity with admission to the ICU in contrast with other cohort studies of hospitalized patients in which this association has been documented. Among 3615 outpatients and inpatients with COVID-19 in New York, obesity class I resulted in an OR = 1.8 for ICU admission.<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">22</span></a> A small French cohort showed its association with the need for invasive ventilatory support (OR = 7.36).<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">23</span></a> A study of 10,861 patients from New York (US) documented a “dose effect” for the requirement of mechanical ventilation; overweight OR = 1.27, obesity class I OR = 1.48, obesity class II OR = 1.89 and obesity class III OR = 2.31.<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">24</span></a> The Obesity-T2DM Covid19 Study Group in 3065 patients from Italy and Spain found that obesity was an independent predictor of ICU admission in a gradual manner although with overlapping CIs.<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">25</span></a></p><p id="par0085" class="elsevierStylePara elsevierViewall">A meta-analysis that included six studies with 2770 patients with data for ICU admission and five studies with 509 patients found an OR of 1.21 for ICU admission and an OR of 2.05 for invasive mechanical ventilation.<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">26</span></a> A brief report that added 9 articles to the previous work showed that for each 5-unit increase in BMI, the summary OR rose 1.43 for invasive mechanical ventilation and 1.22 for critical COVID-19.<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">27</span></a> The systematic review with the largest number of studies reported so far (41 with 219,543 cases) reported that subjects with obesity were more likely to have a positive SARS-CoV-2 test result (OR = 1.50), hospitalizations (OR = 1.54), admission to intensive care (OR = 1.48), need for invasive mechanical ventilation (OR = 1.47) and in-hospital mortality (OR = 1.14).<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">28</span></a></p><p id="par0090" class="elsevierStylePara elsevierViewall">With respect to mortality in patients admitted to the ICU, the present study was unable to document a protective effect of obesity. Several reports have documented increased mortality related to the presence of obesity in patients with COVID-19. A report on 300 patients hospitalized in 9 ICUs in New York (US) documented an association between BMI and death in a multivariate model with a RR = 1.02 per kg/m<span class="elsevierStyleSup">2</span>.<a class="elsevierStyleCrossRef" href="#bib0145"><span class="elsevierStyleSup">29</span></a> A multicenter cohort of 138 hospitals in France, Belgium, and Switzerland that included 4643 critically ill patients documented that grade II and III obesity correlated with increased 90-day mortality (HR = 1.50 and 2.05 respectively).<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">30</span></a> A large cohort of 13,301 critically ill patients in the Rede D’Or São Luiz from eight Brazilian states demonstrated that obesity had a borderline association with mortality (HR = 1.11).<a class="elsevierStyleCrossRef" href="#bib0155"><span class="elsevierStyleSup">31</span></a></p><p id="par0095" class="elsevierStylePara elsevierViewall">Nevertheless, one group of studies has failed to demonstrate an effect of the presence of obesity on mortality. Among 121 critically ill patients in the Netherlands, there was no significant difference in survival at 28 days on Kaplan-Meier curves (log rank p = 0.545) or in the multivariable Cox regression model for patients with obesity.<a class="elsevierStyleCrossRef" href="#bib0160"><span class="elsevierStyleSup">32</span></a> The cohort of 633 patients from 30 Spanish ICUs found that the average BMI was not significantly different between patients who survived and those who did not (p = 0.466).<a class="elsevierStyleCrossRef" href="#bib0165"><span class="elsevierStyleSup">33</span></a> This finding is similar to that of the European RISC-19-ICU registry with 639 critically ill patients (p = 0.589).<a class="elsevierStyleCrossRef" href="#bib0170"><span class="elsevierStyleSup">34</span></a> In another report, no difference in the prevalence of obesity between survivors and non-survivors was documented in 1909 patients from 63 Argentine ICUs (p = 0.148).<a class="elsevierStyleCrossRef" href="#bib0170"><span class="elsevierStyleSup">34</span></a></p><p id="par0100" class="elsevierStylePara elsevierViewall">The controversial results previously exposed have also been addressed in a systematic review of 23 systematic reviews that indicates how “it is difficult to draw a firm conclusion about Class I and Class II obesity due to conflicting outcomes of meta-analyses”.<a class="elsevierStyleCrossRefs" href="#bib0175"><span class="elsevierStyleSup">35,36</span></a> It seems that obesity acts as a risk factor for both hospitalization and clinical worsening as well as for death although it could be neutral in the latter aspect. This makes it impossible to establish a paradox for obesity in the context of COVID-19.<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">36</span></a> It is not easy to reach a conclusion as to a reason for this different behavior compared to other pneumonias. The special characteristics of clinical care during the first phase of the pandemic from which most of the information for analyzing this risk factor is derived could have implications with respect to the clinical outcomes of this population. However, a profound degree of pulmonary dysfunction predominates, and this could signal an irreversible trend towards death for those who reach this condition.<a class="elsevierStyleCrossRefs" href="#bib0185"><span class="elsevierStyleSup">37,38</span></a> Note that the indications for transfer to intensive care may have been disregarded during specific times of the pandemic (such as the first and second waves from which the patients in this study came) depending on variations in the availability of ICU beds.</p><p id="par0105" class="elsevierStylePara elsevierViewall">A possible limitation of the present study is that a sample size was not calculated a priori although the number of events presented seems to be sufficiently high for the statistical analyses carried out. Patients who died directly in general hospitalization were not included in the analysis, so a selection bias could have arisen, either determined by the time of the pandemic or individual decision for “not to transfer to the ICU”. The way in which obesity has been studied as a risk factor has included various methodologies. We consider the inclusion of several of them as well as the multicenter character of the cohort to be a strength of the present analysis. Although the intensive care cohort only included one institution, it received patients from a wide area in the city after having become a reference center for critical care, with a five-fold increase in the number of beds during the period included.</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0130">Conclusions</span><p id="par0110" class="elsevierStylePara elsevierViewall">The results of the present study do not show an association between inpatients with presence of obesity and the risk of being transfered to intensive care or with death in the case of intensive care patients due to COVID-19. This is why it does not confirm the presence of an obesity paradox in this patient population.</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0135">Funding</span><p id="par0115" class="elsevierStylePara elsevierViewall">The current study received funding from the call for proposals under Research Promotion number DI-I-0631-20 of the research division of the Fundación Universitaria de Ciencias de la Salud (Health Sciences University Foundation)</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0140">Availability of data and materials</span><p id="par0120" class="elsevierStylePara elsevierViewall">All data generated and/or analyzed during this study are available from the corresponding author upon reasonable request conditioned by its review by the institutional ethics and research committee.</p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0145">Authors’ contributions</span><p id="par0125" class="elsevierStylePara elsevierViewall">All the authors participated in the planning, design, data analysis, and preparation of this article.</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0150">Ethics approval and consent to participate</span><p id="par0130" class="elsevierStylePara elsevierViewall">The work was approved by the ethics and research committees at each one of the institutions and filling out an informed consent document was not considered necessary given the retrospective nature of the study.</p></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0155">Consent for publication</span><p id="par0135" class="elsevierStylePara elsevierViewall">Not applicable.</p></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0160">Competing interests</span><p id="par0140" class="elsevierStylePara elsevierViewall">The authors declare that they have no competing interests.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:16 [ 0 => array:3 [ "identificador" => "xres2007694" "titulo" => "Abstract" "secciones" => array:8 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Objective" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Design" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Setting" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Patients" ] 4 => array:2 [ "identificador" => "abst0025" "titulo" => "Interventions" ] 5 => array:2 [ "identificador" => "abst0030" "titulo" => "Main variables of interest" ] 6 => array:2 [ "identificador" => "abst0035" "titulo" => "Result" ] 7 => array:2 [ "identificador" => "abst0040" "titulo" => "Conclusions" ] ] ] 1 => array:2 [ "identificador" => "xpalclavsec1720183" "titulo" => "Keywords" ] 2 => array:3 [ "identificador" => "xres2007693" "titulo" => "Resumen" "secciones" => array:8 [ 0 => array:2 [ "identificador" => "abst0045" "titulo" => "Objetivo" ] 1 => array:2 [ "identificador" => "abst0050" "titulo" => "Diseño" ] 2 => array:2 [ "identificador" => "abst0055" "titulo" => "Ámbito" ] 3 => array:2 [ "identificador" => "abst0060" "titulo" => "Pacientes" ] 4 => array:2 [ "identificador" => "abst0065" "titulo" => "Intervenciones" ] 5 => array:2 [ "identificador" => "abst0070" "titulo" => "Variables de interés principales" ] 6 => array:2 [ "identificador" => "abst0075" "titulo" => "Resultado" ] 7 => array:2 [ "identificador" => "abst0080" "titulo" => "Conclusiones" ] ] ] 3 => array:2 [ "identificador" => "xpalclavsec1720184" "titulo" => "Palabras clave" ] 4 => array:2 [ "identificador" => "sec0005" "titulo" => "Introduction" ] 5 => array:3 [ "identificador" => "sec0010" "titulo" => "Methodology" "secciones" => array:1 [ 0 => array:2 [ "identificador" => "sec0015" "titulo" => "Statistical analysis" ] ] ] 6 => array:2 [ "identificador" => "sec0020" "titulo" => "Results" ] 7 => array:2 [ "identificador" => "sec0025" "titulo" => "Discussion" ] 8 => array:2 [ "identificador" => "sec0030" "titulo" => "Conclusions" ] 9 => array:2 [ "identificador" => "sec0035" "titulo" => "Funding" ] 10 => array:2 [ "identificador" => "sec0040" "titulo" => "Availability of data and materials" ] 11 => array:2 [ "identificador" => "sec0045" "titulo" => "Authors’ contributions" ] 12 => array:2 [ "identificador" => "sec0050" "titulo" => "Ethics approval and consent to participate" ] 13 => array:2 [ "identificador" => "sec0055" "titulo" => "Consent for publication" ] 14 => array:2 [ "identificador" => "sec0060" "titulo" => "Competing interests" ] 15 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2022-12-03" "fechaAceptado" => "2023-03-01" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec1720183" "palabras" => array:4 [ 0 => "COVID-19" 1 => "Prognosis" 2 => "Death" 3 => "Intensive care" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec1720184" "palabras" => array:4 [ 0 => "COVID-19" 1 => "Pronóstico" 2 => "Muerte" 3 => "Cuidados intensivos" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:3 [ "titulo" => "Abstract" "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Objective</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">To test the presence of the obesity paradox in two cohorts of patients hospitalized for COVID-19.</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Design</span><p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Two multicenter prospective cohorts.</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Setting</span><p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">Three fourth level institutions.</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Patients</span><p id="spar0055" class="elsevierStyleSimplePara elsevierViewall">Adults hospitalized in the general ward for confirmed COVID-19 in the three institutions and those admitted to one of the 9 critical care units of one of the institutions.</p></span> <span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">Interventions</span><p id="spar0060" class="elsevierStyleSimplePara elsevierViewall">None.</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Main variables of interest</span><p id="spar0065" class="elsevierStyleSimplePara elsevierViewall">Categorized weight and its relationship with admission to the ICU in hospitalized patients and death in the ICU.</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Result</span><p id="spar0070" class="elsevierStyleSimplePara elsevierViewall">Of 402 hospitalized patients, 30.1% were obese. Of these, 36.1% were admitted to the ICU vs. 27.1% of non-obese patients. Of the 302 ICU patients, 46.4% were obese. Of these, mortality was 45.0% vs. 52.5% for non-obese. The requirement to transfer hospitalized patients to the ICU admission get a HR of 1.47 (95%CI 0.87–2.51, p = 0.154) in the multivariate analysis. In intensive care patients, an HR of 0.99 (95%CI: 0.92–1.07, p = 0.806) was obtained to the association of obesity with mortality.</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Conclusions</span><p id="spar0075" class="elsevierStyleSimplePara elsevierViewall">The present study does not demonstrate an association between obesity and risk of inpatient transfer to intensive care or death of intensive care patients due to COVID-19 therefore, the presence of an obesity paradox is not confirmed.</p></span>" "secciones" => array:8 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Objective" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Design" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Setting" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Patients" ] 4 => array:2 [ "identificador" => "abst0025" "titulo" => "Interventions" ] 5 => array:2 [ "identificador" => "abst0030" "titulo" => "Main variables of interest" ] 6 => array:2 [ "identificador" => "abst0035" "titulo" => "Result" ] 7 => array:2 [ "identificador" => "abst0040" "titulo" => "Conclusions" ] ] ] "es" => array:3 [ "titulo" => "Resumen" "resumen" => "<span id="abst0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0055">Objetivo</span><p id="spar0080" class="elsevierStyleSimplePara elsevierViewall">Comprobar la presencia la paradoja de la obesidad en dos cohortes de pacientes hospitalizados por COVID-19.</p></span> <span id="abst0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0060">Diseño</span><p id="spar0085" class="elsevierStyleSimplePara elsevierViewall">Dos cohortes prospectivas multicéntricas.</p></span> <span id="abst0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Ámbito</span><p id="spar0090" class="elsevierStyleSimplePara elsevierViewall">Tres instituciones de cuarto nivel.</p></span> <span id="abst0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Pacientes</span><p id="spar0095" class="elsevierStyleSimplePara elsevierViewall">Adultos hospitalizados en pabellón general por COVID-19 confirmado en las tres instituciones y aquellos internados en alguna de las 9 unidades de cuidado crítico de una de las instituciones.</p></span> <span id="abst0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Intervenciones</span><p id="spar0100" class="elsevierStyleSimplePara elsevierViewall">Ninguna.</p></span> <span id="abst0070" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Variables de interés principales</span><p id="spar0105" class="elsevierStyleSimplePara elsevierViewall">El peso categorizado y su relación con el ingreso a UCI en hospitalizados y de muerte en UCI.</p></span> <span id="abst0075" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Resultado</span><p id="spar0110" class="elsevierStyleSimplePara elsevierViewall">Entre 402 hospitalizados 30.1% fueron obesos, de los que 36.1% ingresaron a UCI vs. 27.1% en los no obesos. De los 302 pacientes en UCI, el 46.4% fueron obesos, entre ellos la mortalidad fue de 45.0% vs. 52.5% en los no obesos. En hospitalizados el análisis multivariado obtuvo HR de 1.47 (IC95% 0.87–2.51, p = 0.154) para traslado a UCI. En UCI se obtuvo un OR de 0.99 (IC95%: 0.92–1.07, p = 0.806) para la muerte.</p></span> <span id="abst0080" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Conclusiones</span><p id="spar0115" class="elsevierStyleSimplePara elsevierViewall">El presente estudio no demuestran una asociación entre la obesidad y el riesgo de traslados a cuidados intensivos en pacientes hospitalizados ni con la muerte en pacientes en cuidados intensivos por COVID-19 por lo que no se confirma la presencia de una paradoja de la obesidad.</p></span>" "secciones" => array:8 [ 0 => array:2 [ "identificador" => "abst0045" "titulo" => "Objetivo" ] 1 => array:2 [ "identificador" => "abst0050" "titulo" => "Diseño" ] 2 => array:2 [ "identificador" => "abst0055" "titulo" => "Ámbito" ] 3 => array:2 [ "identificador" => "abst0060" "titulo" => "Pacientes" ] 4 => array:2 [ "identificador" => "abst0065" "titulo" => "Intervenciones" ] 5 => array:2 [ "identificador" => "abst0070" "titulo" => "Variables de interés principales" ] 6 => array:2 [ "identificador" => "abst0075" "titulo" => "Resultado" ] 7 => array:2 [ "identificador" => "abst0080" "titulo" => "Conclusiones" ] ] ] ] "apendice" => array:1 [ 0 => array:1 [ "seccion" => array:1 [ 0 => array:4 [ "apendice" => "<p id="par0155" class="elsevierStylePara elsevierViewall">The following is Supplementary data to this article:<elsevierMultimedia ident="upi0005"></elsevierMultimedia></p>" "etiqueta" => "Appendix A" "titulo" => "Supplementary data" "identificador" => "sec0075" ] ] ] ] "multimedia" => array:5 [ 0 => array:8 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1433 "Ancho" => 3341 "Tamanyo" => 245623 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0005" "detalle" => "Figure " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Kaplan Meier survival curves from the association between the presence or absence of obesity and: a) inpatient admission to intensive care, b) mortality of patients hospitalized in the intensive care unit.</p>" ] ] 1 => array:8 [ "identificador" => "tbl0005" "etiqueta" => "Table 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0010" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:3 [ "leyenda" => "<p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">SD: standard deviation, ND: no data, N/A: not applicable.</p>" "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col">Characteristic \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " colspan="3" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">General hospitalization (n = 402)</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " colspan="3" align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Intensive care (n = 302)</th></tr><tr title="table-row"><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black"> \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Non-obese (n = 269) \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Obese (n = 133) \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">p Value<a class="elsevierStyleCrossRef" href="#tblfn0005">*</a> \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Non-obese (n = 162) \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Obese (n = 140) \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">p Value<a class="elsevierStyleCrossRef" href="#tblfn0005">*</a> \t\t\t\t\t\t\n \t\t\t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Female, n (%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">102 (37.9%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">59 (44.4%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">0.258 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">23, (26.5%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">70 (50.0%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><0.001 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Age (years), average (SD) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">59.4 (16.4) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n