Bortezomib administration is a risk factor associated with the development of tumor lysis syndrome in male patients with multiple myeloma: A retrospective study

Abstract Background Novel agents such as proteasome inhibitors have been developed for several years to treat multiple myeloma. Although multiple myeloma is a low-risk disease for developing tumor lysis syndrome (TLS), treatment with these novel therapies might increase TLS risk. Previous studies, mostly case reports or case series, have reported bortezomib-induced TLS in patients with multiple myeloma. This study aimed to investigate risk factors associated with TLS development in multiple myeloma patients. Methods We retrospectively investigated incidences of laboratory and clinical TLS (LTLS and CTLS, respectively) in patients who received primary therapy for treatment-naive, symptomatic multiple myeloma between May 2007 and January 2018. We used multivariate logistic regression analyses to evaluate the associations between TLS and several parameters previously reported to be associated with increased risk. Results This study included 210 patients with multiple myeloma, of which ten (4.8%) had LTLS and seven (3.3%) had CTLS. The characteristics of the administered anticancer or prophylactic antihyperuricemic agents were similar between patients with and without TLS. Multivariate analyses revealed that TLS was most strongly associated with bortezomib-containing therapy (odds ratio = 3.40, P = 0.069), followed by male sex (odds ratio = 2.29, P = 0.153). In a subgroup analysis focused on men, treatment with bortezomib-containing therapy was significantly associated with increased risk of TLS (odds ratio = 8.51, P = 0.046). Conclusion In the present study, we investigated the risk factors associated with TLS development in 210 multiple myeloma patients, which, to the best of our knowledge, is the largest number of patients reported to date. Furthermore, this study is the first to evaluate TLS risk factors in MM by adjusting for the effects of potential confounding factors in patients’ backgrounds. Consequently, we found that bortezomib-containing therapy increases the risk of TLS in male patients with multiple myeloma. TLS risk should be evaluated further in low-risk diseases such as multiple myeloma, since a significant number of novel therapies can achieve high antitumor responses.

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Bortezomib administration is a risk factor associated with the development of tumor lysis syndrome in male patients with multiple myeloma: A retrospective study

10.21203/rs.3.rs-22557/v3 ◽

2020 ◽

Author(s):

Masahiro Kondo ◽

Yuji Hotta ◽

Karen Yamauchi ◽

Akimasa Sanagawa ◽

Hirokazu Komatsu ◽

...

Keyword(s):

Risk Factors ◽

Multiple Myeloma ◽

Odds Ratio ◽

Tumor Lysis Syndrome ◽

Low Risk ◽

Novel Therapies ◽

Tumor Lysis ◽

Factors Associated ◽

Increased Risk ◽

Male Patients

Abstract Background: Novel agents such as proteasome inhibitors have been developed for several years to treat multiple myeloma. Although multiple myeloma is a low-risk disease for developing tumor lysis syndrome (TLS), treatment with these novel therapies might increase TLS risk. Previous studies, mostly case reports or case series, have reported bortezomib-induced TLS in patients with multiple myeloma. This study aimed to investigate risk factors associated with TLS development in multiple myeloma patients.Methods: We retrospectively investigated incidences of laboratory and clinical TLS (LTLS and CTLS, respectively) in patients who received primary therapy for treatment-naive, symptomatic multiple myeloma between May 2007 and January 2018. We used multivariate logistic regression analyses to evaluate the associations between TLS and several parameters previously reported to be associated with increased risk.Results: This study included 210 patients with multiple myeloma, of which ten (4.8%) had LTLS and seven (3.3%) had CTLS. The characteristics of the administered anticancer or prophylactic antihyperuricemic agents were similar between patients with and without TLS. Multivariate analyses revealed that TLS was most strongly associated with bortezomib-containing therapy (odds ratio = 3.40, P = 0.069), followed by male sex (odds ratio = 2.29, P = 0.153). In a subgroup analysis focused on men, treatment with bortezomib-containing therapy was significantly associated with increased risk of TLS (odds ratio = 8.51, P = 0.046).Conclusion: In the present study, we investigated the risk factors associated with TLS development in 210 multiple myeloma patients, which, to the best of our knowledge, is the largest number of patients reported to date. Furthermore, this study is the first to evaluate TLS risk factors in MM by adjusting for the effects of potential confounding factors in patients’ backgrounds. Consequently, we found that bortezomib-containing therapy increases the risk of TLS in male patients with multiple myeloma. TLS risk should be evaluated further in low-risk diseases such as multiple myeloma, since a significant number of novel therapies can achieve high antitumor responses.

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Bortezomib administration is a risk factor associated with the development of tumor lysis syndrome in male patients with multiple myeloma: A retrospective study

10.21203/rs.3.rs-22557/v2 ◽

2020 ◽

Author(s):

Masahiro Kondo ◽

Yuji Hotta ◽

Karen Yamauchi ◽

Akimasa Sanagawa ◽

Hirokazu Komatsu ◽

...

Keyword(s):

Risk Factors ◽

Multiple Myeloma ◽

Odds Ratio ◽

Tumor Lysis Syndrome ◽

Low Risk ◽

Novel Therapies ◽

Tumor Lysis ◽

Factors Associated ◽

Increased Risk ◽

Male Patients

Abstract Background: Novel agents such as proteasome inhibitors have been developed for several years to treat multiple myeloma. Although multiple myeloma is a low-risk disease for developing tumor lysis syndrome (TLS), treatment with these novel therapies might increase TLS risk. Previous studies, mostly case reports or case series, have reported bortezomib-induced TLS in patients with multiple myeloma. This study aimed to investigate risk factors associated with TLS development in multiple myeloma patients.Methods: We retrospectively investigated incidences of laboratory and clinical TLS (LTLS and CTLS, respectively) in patients who received primary therapy for treatment-naive, symptomatic multiple myeloma between May 2007 and January 2018. We used multivariate logistic regression analyses to evaluate the associations between TLS and several parameters previously reported to be associated with increased risk.Results: This study included 210 patients with multiple myeloma, of which ten (4.8%) had LTLS and seven (3.3%) had CTLS. The characteristics of the administered anticancer or prophylactic antihyperuricemic agents were similar between patients with and without TLS. Multivariate analyses revealed that TLS was most strongly associated with bortezomib-containing therapy (odds ratio = 3.40, P = 0.069), followed by male sex (odds ratio = 2.29, P = 0.153). In a subgroup analysis focused on men, treatment with bortezomib-containing therapy was significantly associated with increased risk of TLS (odds ratio = 8.51, P = 0.046).Conclusion: In the present study, we investigated the risk factors associated with TLS development in 210 multiple myeloma patients, which, to the best of our knowledge, is the largest number of patients reported to date. Furthermore, this study is the first to evaluate TLS risk factors in MM by adjusting for the effects of potential confounding factors in patients’ backgrounds. Consequently, we found that bortezomib-containing therapy increases the risk of TLS in male patients with multiple myeloma. TLS risk should be evaluated further in low-risk diseases such as multiple myeloma, since a significant number of novel therapies can achieve high antitumor responses.

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Bortezomib administration is a risk factor associated with the development of tumor lysis syndrome in male patients with multiple myeloma: A retrospective study

10.21203/rs.3.rs-22557/v1 ◽

2020 ◽

Author(s):

Masahiro Kondo ◽

Yuji Hotta ◽

Karen Yamauchi ◽

Akimasa Sanagawa ◽

Hirokazu Komatsu ◽

...

Keyword(s):

Risk Factors ◽

Multiple Myeloma ◽

Odds Ratio ◽

Tumor Lysis Syndrome ◽

Low Risk ◽

Primary Therapy ◽

Novel Therapies ◽

Tumor Lysis ◽

Number Of Patients ◽

Increased Risk

Abstract Background Many novel medicines such as proteasome inhibitors have been developed during the last decade to treat multiple myeloma. Although multiple myeloma is defined as a low-risk disease for developing tumor lysis syndrome (TLS), treatment with these novel therapies might increase TLS risk. In fact, there have been some prior reports of bortezomib-induced TLS in patients with multiple myeloma. However, almost all of them have been case reports or case series. Thus, we investigated the risk factors for TLS in multiple myeloma patients. Methods We retrospectively investigated incidences of laboratory and clinical TLS (LTLS and CTLS, respectively) in patients who received primary therapy for treatment-naive, symptomatic multiple myeloma between May 2007 and January 2018. We used multivariate logistic regression analyses to evaluate the associations between LTLS and several parameters previously reported to be associated with increased risk. Results This study included 210 patients, seventeen (8.1%) and seven (3.3%) patients with LTLS and CTLS, respectively. The characteristics of the administered anticancer or prophylactic antihyperuricemic agents were similar between the patients with and without LTLS. Multivariate analyses revealed that LTLS was most strongly associated with bortezomib-containing therapy (odds ratio = 3.40, P = 0.069), followed by male sex (odds ratio = 2.29, P = 0.153). In a subgroup analysis focused on men, treatment with bortezomib-containing therapy was significantly associated with increased risk of LTLS (odds ratio = 8.51, P = 0.046). Conclusion In the present study, we investigated the risk factors for developing TLS in 210 multiple myeloma patients, which, to the best of our knowledge, is the largest number of patients reported to date. Furthermore, this study is the first to evaluate TLS risk factors in MM by adjusting for the effects of potential confounding factors in patients’ backgrounds. Consequently, we found that bortezomib-containing therapy increases the risk of TLS in male multiple myeloma patients. TLS risk should be evaluated further in low-risk diseases such as multiple myeloma, as an increasing number of novel therapies can achieve high antitumor responses.

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Tumor-Lysis Syndrome in Relapsed or Refractory Multiple Myeloma Patients Treated with Proteasome Inhibitors

Blood ◽

10.1182/blood-2018-99-114822 ◽

2018 ◽

Vol 132 (Supplement 1) ◽

pp. 5631-5631

Author(s):

Kazuhito Suzuki ◽

Kaichi Nishiwaki ◽

Tadahiro Gunji ◽

Mitsuji Katori ◽

Rika Hosoba ◽

...

Keyword(s):

Risk Factors ◽

Multiple Myeloma ◽

Prognostic Factors ◽

Odds Ratio ◽

Tumor Lysis Syndrome ◽

Proteasome Inhibitors ◽

Cytotoxic Agents ◽

Tumor Lysis ◽

Number Of Patients ◽

Significant Difference

Abstract <Introduction> Tumor-lysis syndrome (TLS) describes a group of metabolic disturbances caused by the massive and abrupt release of cellular components into the blood after the rapid lysis of malignant cells. TLS is a potentially life-threatening complication in rapidly proliferating, bulky tumor, or highly chemo-radiosensitive cancers. In contrast, TLS is the rare complication among patients with multiple myeloma (MM). TLS seems to occur more frequently in MM patients receiving bortezomib (BOR) and carfilzomib (CFZ) than in those receiving other cytotoxic agents. We retrospectively investigated the frequency, risk factors, and clinical outcome among the relapsed or refractory MM (RRMM) patients treated with proteasome inhibitors (PI), such as BOR, CFZ, and ixazomib (IXA), in our institute. <Methods> Between November 2005 and December 2017, seventy-two RRMM myeloma patients treated with BOR, CFZ, or IXA, in our institute. The number of patients treated PI was defined as below. Relapse or refractory disease and response criteria were defined according to the International Myeloma Working Group criteria. Patients with monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, and primary plasma cell leukemia were excluded. We evaluated TLS by the Cario-Bishop grading classification. After starting of PI, the following parameters were recorded and evaluated for prognosis: serum hemoglobin concentration (Hb), serum level of lactate dehydrogenase (LDH), creatinine (Cr), uric acid (UA). The cutoff levels of LDH, Cr, and UA were the upper normal limit. Anemia was defined by the CRAB criteria. Hepatosplenomegaly and plasmacytoma were evaluated using computed tomography. We analyze these two groups in terms of patient characteristics, laboratory findings, response, and survival. Fisher's exact tests were used to compare differences between the two groups. We analyzed prognostic factors for survival in significant poor predictors of laboratory parameters and well-established prognostic factors by Cox regression analysis. Overall survival (OS) and time to next treatment (TTNT) were analyzed by the Kaplan-Meier method. <Results> Median age of the patients was 71 years (range, 41-86) at the time of PI treatment. Median number of prior treatments was 2 (range, 1-8). The number of patients treated 53 of BOR, 10 of IXA, 4 of BOR + CFZ, 3 of CFZ + IXA, 1 of BOR + IXA, and 1of BOR + CFZ + IXA, respectively. TLS occurred in 13 patients (18.1%); such as 8 of BOR (13.3%), 4 of CFZ (40.0%), and 1 of IXA (6.7%). TLS occurred more frequently in the patients treated with twice weekly CFZ plus dexamethasone (CFZ 56mg/m2) than twice weekly CFZ, lenalidomide, plus dexamethasone (CFZ 27mg/m2); 50% and 25%, respectively. Median day of TLS after PI was 8 (range, 4-21). Median day of TLS in BOR, CFZ, and IXA were 7.5, 5.5, and 13 days, respectively. Two patients received rasbricase after TLS occurred. There was no patient who underwent hemodialysis for TLS. The mortality related with TLS was none. The significant factors associated TLS were anemia, high LDH level, prior treatments of 2 or more and hepatosplenomegaly according to univariate analysis. In multivariate analysis, high LDH level (Odds ratio; 12.9, P=0.027) and hepatosplenomegaly (Odds ratio; 13.4, P=0.035) was related with TLS significantly. There was no significant difference between overall response rate in the TLS group and non-TLS group (46.4% vs 64.8%, P=0.117). In median follow-up was 12.9 months, the median TTNT of the TLS group was significantly shorter than that of the non-TLS group (1.9 vs 7.0 months, P = 0.009, Figure 1a). The median OS of the TLS group was significantly shorter than that of the non-TLS group as well (5.8 vs 46.4 months, P = 0.017, Figure 1b). <Conclusion> Our analysis revealed that 18.1% of RRMM patients treated with PI developed TLS although TLS was manageable by prophylaxis.gh LDH level and hepatosplenomegaly were identified with significant risk factors for TLS. TLS was not associated with good response of treatment. The TTNT and OS in the TLS group was significantly shorter than those in the non-TLS group. We considered that TLS might be related with progressive disease without activity of treatment in RRMM patients treated with PI. Among the RRMM patients with high LDH level, TLS is one of common adverse events in first cycle of PI but tolerable. Disclosures No relevant conflicts of interest to declare.

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Risk Factors for Failed Nonoperative Treatment and Rerupture in Acute Achilles Tendon Rupture

Foot & Ankle International ◽

10.1177/1071100717754042 ◽

2018 ◽

Vol 39 (6) ◽

pp. 694-703 ◽

Cited By ~ 7

Author(s):

Aleksi Reito ◽

Hanna-Liina Logren ◽

Katri Ahonen ◽

Heikki Nurmi ◽

Juha Paloneva

Keyword(s):

Risk Factors ◽

Achilles Tendon ◽

Tendon Rupture ◽

Achilles Tendon Rupture ◽

Case Series ◽

Nonoperative Treatment ◽

Activity Level ◽

Factors Associated ◽

Increased Risk ◽

Male Patients

Background: Nonoperative treatment is feasible in most patients with acute Achilles tendon rupture. Risk factors associated with failed nonoperative treatment are poorly understood. We investigated risk factors associated with rerupture after nonoperative treatment and otherwise failed nonoperative treatment of Achilles tendon rupture. Methods: All patients diagnosed with acute Achilles tendon rupture between January 2009 and June 2016 and who underwent 8 weeks of nonoperative treatment with functional rehabilitation were included in the study. Patients with rerupture or otherwise failed nonoperative treatment were identified retrospectively. Time to rerupture and association of age, sex, time from injury, diabetes, and visits to the physiotherapist for cases of reruptures and otherwise failed nonoperative treatment were investigated. A total of 210 patients were included in the study. Results: Fifteen patients sustained a rerupture. Rerupture incidence was 7.1%. Incidence of late reruptures, those occurring after return to daily activities at 12 weeks, was 1.9%. Six patients had otherwise failed nonoperative treatment. Median time to rerupture was 23 days (6 to 61) after the end of the treatment. The incidence of all-cause failure was 10.0%. Male gender was associated with reruptures ( P = .013) and failed nonoperative treatment for any reason ( P = .029). Conclusion: It is important to highlight the increased risk of rerupture in male patients during the first month after the end of the nonoperative treatment. Age alone, even in male patients, was a poor indication for operative treatment since it did not predict early failure. Further studies will hopefully clarify the influence of activity level on the risk of rerupture. Level of Evidence: Level IV, retrospective case series.

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P0568INCIDENCE AND RISK FACTORS OF ACUTE KIDNEY INJURY AND TUMOR LYSIS SYNDROME IN PATIENTS WITH MULTIPLE MYELOMA TREATED WITH BORTEZOMIB

Nephrology Dialysis Transplantation ◽

10.1093/ndt/gfaa142.p0568 ◽

2020 ◽

Vol 35 (Supplement_3) ◽

Author(s):

SEUNGMIN SONG ◽

Hyo jin Boo ◽

Hye Ryoun Jang ◽

Wooseong Huh ◽

Dae Joong Kim ◽

...

Keyword(s):

Risk Factors ◽

Multiple Myeloma ◽

Acute Kidney Injury ◽

High Risk ◽

Multivariate Analyses ◽

Tumor Lysis Syndrome ◽

Kidney Injury ◽

Renal Amyloidosis ◽

Tumor Lysis ◽

Β2 Microglobulin

Abstract Background and Aims Nephrotoxicity of bortezomib, a proteasome inhibitor, has not yet been described frequently, while tumor lysis syndrome (TLS) associated with multiple myeloma (MM) has been increased after introduction of the drug. This study compared the incidence and risk factors of acute kidney injury (AKI) and TLS in patients with MM after bortezomib-based chemotherapy to investigate the drug-related nephrotoxicity. Method From 2006 to 2017, 276 patients who underwent first cycle of bortezomib-based chemotherapy for MM were identified in single tertiary hospital. Laboratory TLS was defined according to the Cairo-Bishop definition. Development of AKI was assessed by AKI Network (AKIN) criteria within 7 days after first chemotherapy. Results The age was 65 [56-72] years old, and 47% (n=131) of participants were female and baseline estimated glomerular filtration rate (eGFR) was 61.3 [34.1-89.1] mL/min/1.73m2. The incidences of AKI and laboratory TLS were 17% (n=47) and 13% (n=36), respectively. Ten (3.6%) subjects corresponded to the both AKI and TLS criteria. Multivariate analyses showed that lower eGFR category (30∼59, odds ratio [OR]=3.063 [1.278-7.339]; 15∼29, OR=3.417 [1.088-10.726]; <15, OR=10.080 [2.677-37.951] vs ≥ 60), lower serum albumin level (OR=0.491 [0.278-0.868], P=0.0144) and renal amyloidosis (OR=11.174 [3.974-31.420], P<0.0001) were predictors of development of AKI. MM stages and β2-microglobulin were not associated with AKI occurrence. Regarding laboratory TLS, MM stage and β2-microglobulin were higher in those with TLS. In multivariate analyses, β2-microglobulin levels (OR=1.194 [1.066-1.337], P=0.0021) and any chromosomes abnormalities at high risk (OR=0.115 [0.026-0.503], P=0.0041) were associated with higher risk of TLS. Conclusion Development of AKI was often observed without being accompanied by TLS in patients with MM after treatment of bortezomib. In addition, risk factors of AKI and TLS were widely different. These findings implicated the potential nephrotoxicity of bortezomib besides TLS in patients with decreased kidney function. The efforts to prevent bortezomib associated AKI are needed in patients at high risk.

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The Risk Factors of Blood Cadmium Elevation in Chronic Kidney Disease

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph182312337 ◽

2021 ◽

Vol 18 (23) ◽

pp. 12337

Author(s):

Kai-Fan Tsai ◽

Pai-Chin Hsu ◽

Chia-Te Kung ◽

Chien-Te Lee ◽

Huey-Ling You ◽

...

Keyword(s):

Risk Factors ◽

Chronic Kidney Disease ◽

Kidney Disease ◽

Odds Ratio ◽

Cross Sectional ◽

Factors Associated ◽

Female Sex ◽

Ckd Stage ◽

Blood Cadmium ◽

Male Patients

Low-level cadmium exposure has adverse effects on chronic kidney disease (CKD); however, the risk factors for elevated blood cadmium levels (BCLs) have not been studied in CKD. We conducted a cross-sectional investigation in 200 CKD patients and stratified them by the tertiles of BCL to compare their demographic, environmental, and biochemical data. The factors associated with BCL were identified, and their effects were examined in subgroups. In the analyses, female sex, smoking, and CKD stage 5D were associated with high BCL, and statin was inversely correlated with BCL (odds ratio [95% confidence interval, CI], 6.858 [2.381–19.746], p < 0.001, 11.719 [2.843–48.296], p = 0.001, 30.333 [2.252–408.520], p = 0.010, and 0.326 [0.122–0.873], p = 0.026; deviations of BCL [nmol/L, 95% CI], 2.66 [1.33–4.00], p < 0.001, 3.68 [1.81–5.56], p < 0.001, 3.38 [0.95–5.82], p = 0.007, and −2.07 [−3.35–−0.78], p = 0.002). These factors were also independently correlated with BCL in subgroups, including non-dialysis CKD, hypertensive patients, non-smokers, and male patients. In conclusion, female sex, smoking, and CKD stage 5D were the major risk factors for elevated BCL; additionally, statins were negatively associated with BCL in CKD.

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Use of Multiple Myeloma 70-Gene Prognostic Risk Score As a Continuous Predicitor of Patient Outcome

Blood ◽

10.1182/blood.v128.22.5614.5614 ◽

2016 ◽

Vol 128 (22) ◽

pp. 5614-5614 ◽

Cited By ~ 1

Author(s):

Ryan van Laar ◽

Richard A Bender ◽

Aga Zielinski ◽

Kenton Leigh ◽

Bart Barlogie ◽

...

Keyword(s):

Multiple Myeloma ◽

Overall Survival ◽

Risk Score ◽

Odds Ratio ◽

Research Funding ◽

Low Risk ◽

Maximum Likelihood Estimates ◽

Gene Score ◽

Increased Risk ◽

Continuous Predictor

Abstract Background: The 70-gene prognostic risk score (MyPRSR) for patients with multiple myeloma is conventionally used in a binary high/low risk fashion. The ability to more precisely estimate a patients' risk of 5-year relapse or death based on their specific risk score may increase the clinical utility of the assay. Methods and Results: Logistic regression analysis of the 70-gene score in relation to event free and overall survival data from UAMS TT2/3 series was performed. 274 patients with at least 5 years' follow-up data were included in the analysis. A binary fitted line plot, which fits a model with one continuous predictor with an iterative reweighted least squares algorithm to obtain maximum likelihood estimates of the parameters, was generated for 5-year relapse-free and overall-survival. These plots correspond to the probability of a certain event occurring based on a specific 70-gene score. The deviance R-square value for the relapse free survival analysis was 12.28% and the odds ratio for the 70-gene score as a continuous predictor was 1.03 (95% CI: 1.02 to 1.05). For overall survival the deviance R-square value was 15.5% and odds ratio 1.07 (95% CI: 1.05 to 1.10). Conclusion: The 70-gene prognostic risk score is continuously associated with increased risk of 5-year relapse and death. Presentation of a patients' risk score in this format may enable superior risk-based management compared to binary high/low risk stratification. Further work is ongoing to investigate the association between GEP70 and risk of progression from precursor conditions, such as MGUS, to MM requiring treatment. Figure 1 Figure 1. Figure 2 Figure 2. Disclosures van Laar: Signal Genetics, Inc.: Employment. Bender:Signal Genetics, Inc.: Employment. Zielinski:Signal Genetics, Inc.: Employment. Leigh:Signal Genetics, Inc.: Employment. Barlogie:Mount Sinai Hospital: Employment. Morgan:Univ of AR for Medical Sciences: Employment; Bristol Meyers: Consultancy, Honoraria; Takeda: Consultancy, Honoraria; Janssen: Research Funding; Celgene: Consultancy, Honoraria, Research Funding.

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Risk factors associated with severe hospital burden of COVID-19 disease in Regione Lombardia: a cohort study

BMC Infectious Diseases ◽

10.1186/s12879-021-06750-z ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Anne M. Presanis ◽

Kevin Kunzmann ◽

Francesca M. Grosso ◽

Christopher H. Jackson ◽

Alice Corbella ◽

...

Keyword(s):

Risk Factors ◽

Cohort Study ◽

Odds Ratio ◽

Care Home ◽

Population Characteristics ◽

Factors Associated ◽

Icu Admission ◽

Lengths Of Stay ◽

Increased Risk ◽

Using Data

Abstract Background Understanding the risk factors associated with hospital burden of COVID-19 is crucial for healthcare planning for any future waves of infection. Methods An observational cohort study is performed, using data on all PCR-confirmed cases of COVID-19 in Regione Lombardia, Italy, during the first wave of infection from February-June 2020. A multi-state modelling approach is used to simultaneously estimate risks of progression through hospital to final outcomes of either death or discharge, by pathway (via critical care or not) and the times to final events (lengths of stay). Logistic and time-to-event regressions are used to quantify the association of patient and population characteristics with the risks of hospital outcomes and lengths of stay respectively. Results Risks of severe outcomes such as ICU admission and mortality have decreased with month of admission (for example, the odds ratio of ICU admission in June vs March is 0.247 [0.120–0.508]) and increased with age (odds ratio of ICU admission in 45–65 vs 65 + age group is 0.286 [0.201–0.406]). Care home residents aged 65 + are associated with increased risk of hospital mortality and decreased risk of ICU admission. Being a healthcare worker appears to have a protective association with mortality risk (odds ratio of ICU mortality is 0.254 [0.143–0.453] relative to non-healthcare workers) and length of stay. Lengths of stay decrease with month of admission for survivors, but do not appear to vary with month for non-survivors. Conclusions Improvements in clinical knowledge, treatment, patient and hospital management and public health surveillance, together with the waning of the first wave after the first lockdown, are hypothesised to have contributed to the reduced risks and lengths of stay over time.

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