Population-based Retrospective Study Research Articles

Impact of vaccination against severe COVID-19 in the French population aged 50 years and above: a retrospective population-based study

BackgroundGiven the widespread implementation of COVID-19 vaccination to mitigate the pandemic from the end of 2020, it is important to retrospectively evaluate its impact, in particular by quantifying the number of severe outcomes prevented through vaccination.MethodsWe estimated the number of hospitalizations, intensive care unit (ICU) admissions and deaths directly averted by vaccination in France, in people aged ≥ 50 years, from December 2020 to March 2022, based on (1) the number of observed events, (2) vaccination coverage, and (3) vaccine effectiveness. We accounted for the effect of primary vaccination and the first booster dose, the circulating variants, the age groups, and the waning of vaccine-induced protection over time.ResultsAn estimated 480,150 (95% CI: 260,072–582,516) hospitalizations, 132,156 (50,409–157,767) ICU admissions and 125,376 (53,792–152,037) deaths were directly averted by vaccination in people aged ≥ 50 years, which corresponds to a reduction of 63.2% (48.2–67.6), 68.7% (45.6–72.4) and 62.7% (41.9–67.1) respectively, compared to what would have been expected without vaccination over the study period. An estimated 5852 (2285–6853) deaths were directly averted among the 50–59 years old, 16,837 (6568–19,473) among the 60–69 years old, 32,136 (13,651–36,758) among the 70–79 years old and 70,551 (31,288–88,953) among the ≥ 80 years old.ConclusionsThe vaccination campaign in France considerably reduced COVID-19 morbidity and mortality, as well as stress on the healthcare system.

Abstract 13023: Trends and Disparities in Cardiovascular Deaths in Non-Hodgkin Lymphoma: A Population-Based Retrospective Study in the United States From 1999 to 2020

Background: Non-Hodgkin lymphoma (NHL) survivors are at increased risks of cardiovascular disease related death (CVD) compared to the general population. Objective: This study sought to determine the longitudinal trends in mortality attributed to CVD with comorbid NHL by race, sex, and geographic location. Methods: We queried the Centers for Disease Control and Prevention's Wide-Ranging Online Data for Epidemiologic Research database among patients aged 18 and above from 1999 to 2020. Patients were identified when the primary causes of death were ischemic heart diseases (ICD 10 I20-I25), cerebrovascular diseases (I60-I69), or hypertensive disease (I10-I15), and NHL (C82-C85) was a contributing cause of death. We calculated age-adjusted mortality rates (AAMRs) per 1,000,000 individuals and determined the trends over time by estimating the annual percent change using the Joinpoint regression program. Results: In the 22-year study period, a total of 22,778 CVD with comorbid NHL were identified. Overall, there was a significant decrease in annual trends for the AAMRs of CVD from 6.91 per 1,000,000 individuals in 1999 to 4.12 per 1,000,000 individuals in 2020 (p<0.05), with an annual percent decrease of 3.3. Overall, men recorded a higher AAMRs compared to women (6.76 vs 3.45, p<0.05). When stratified by race, White individuals had the highest AAMRs (5.07), while the AAMRs for American African, Asian, American Indian individuals were 3.01, 2.77, and 2.48 per 1,000,000 individuals respectively. The AAMRs were higher in the rural region than in the urban region (4.97 vs 4.78, p<0.05). Among all consensus regions, South region had the highest AAMRs. Conclusion: In conclusion, our study revealed a significant decrease in cardiovascular disease related deaths with comorbid NHL over the past two decades. It provides valuable insights into the effectiveness of management of comorbid CVD or CVD risk factors in patients with NHL.

Abstract 12985: Trends and Disparities in Cardiovascular Death in Sarcoidosis: A Population-Based Retrospective Study in the United States From 1999 to 2020

Background: Sarcoidosis is a multisystem inflammatory disease that could result in debilitating cardiac manifestations. Despites, data on the cardiovascular deaths (CVDs) among patients with sarcoidosis are limited. Objective: This study sought to determine the longitudinal trends in mortality attributed to CVDs with comorbid sarcoidosis by age, sex, and race in the United States. Methods: We queried the Centers for Disease Control and Prevention's Wide-Ranging Online Data for Epidemiologic Research database and performed serial cross-sectional analyses of national death certificate data for CVDs with comorbid sarcoidosis among patients aged 25 and above. Diseases of the circulatory system (ICD-10 I00-I99) were listed as the underlying cause of death, and sarcoidosis (ICD-10 D86) as contributing cause of death. We calculated age-adjusted mortality rates (AAMRs) per 1,000,000 individuals and determined the trends over time by estimating the annual percent change using the Joinpoint Regression Program. Results: In the 22-year study period, 5,630 CVDs with comorbid sarcoidosis in the United States were identified between 1999 and 2020. The AAMRs from CVDs with comorbid sarcoidosis increased from 1.03 (95% CI, 0.88-1.17) in 1999 to 1.38 (95% CI, 1.24-1.52) in 2020. Overall, women recorded a higher AAMRs compared to men (1.25 [95% CI, 1.21-1.30] vs. 1.10 [95% CI, 1.06-1.15]). Black individuals had higher AAMRs than White individuals (5.17 [95% CI, 4.97-5.37] vs. 0.68 [95% CI, 0.66-0.71]). A higher percentage of CVDs with comorbid sarcoidosis was seen in the age groups of 55-64 in men (24.68%) and 65-74 in women (22.62%). Conclusion: The CVDs in sarcoidosis have increased over the last two decades, with disparities seen in women and Black individuals. Most CVDs with comorbid sarcoidosis occurred at a younger age compared to general population. This highlights the importance of early screening for cardiovascular diseases in sarcoidosis individuals.

Abstract 14874: Trends and Disparities in Cardiovascular Death in Colorectal Cancer: A Population-Based Retrospective Study in the United States From 1999 to 2020

Background: Overlap between cardiovascular diseases and colorectal cancer(CRC) has become more prominent with enhanced life expectancy. The data on cardiovascular deaths (CVDs) among those patients is not well-established. Objective: This study sought to determine the longitudinal trends in mortality attributed to CVDs with comorbid CRC by race, sex, and region. Methods: We queried the Centers for Disease Control and Prevention's Wide-Ranging Online Data for Epidemiologic Research database and performed serial cross-sectional analyses of national death certificate data for CVDs with comorbid CRC among patients aged 18 and above. Diseases of the circulatory system were listed as the underlying cause of death, and colorectal cancer as contributing cause of death. We calculated age-adjusted mortality rates (AAMR) per 1,000,000 individuals and determined the trends by using the Joinpoint Regression Program. Results: In the 22-year study period, 77,094 CVDs with comorbid CRC were identified between 1999 and 2020. The AAMR from CVDs with comorbid CRC decreased significantly from 29.73 per 1,000,000 individuals in 1999 to 9.65 per 1,000,000 individuals in 2020 (p<0.05). The most common CVDs reported were ischemic heart disease (56%) and cerebrovascular disease (14%). Males had a higher AAMR compared to females (21.51 vs 12.53 per 1,000,000 individuals, p<0.05). African Americans had the highest AAMR (18.12 per 1,000,000 individuals), while the AAMRs for White populations, American Indian, and Asian populations were 16.28, 9.09, and 9.06 respectively. Rural areas had a higher AAMR than urban areas (18.25 vs 15.76 per 1,000,000 individuals, p<0.05). Conclusion: The CVDs in patients with CRC have decreased significantly over the past two decades, with disparities seen in African Americans and rural regions. This highlights the importance of early screening among high-risk populations, and the importance of improving healthcare access in underserved populations.

Abstract 13020: Trend and Disparities in Cardiovascular Death in Amyloidosis: A Population-Based Retrospective Study in the United States From 1999 to 2020

Background: Despite advancements in the management of cardiac amyloidosis, the contemporary estimates of the cardiovascular deaths (CVDs) in amyloidosis are not well-established. Objective: This study sought to assess the longitudinal trends of CVDs with comorbid amyloidosis and analyze the disparities in mortality in terms of race, gender, and geographical location. Methods: We queried the Centers for Disease Control and Prevention's Wide-Ranging Online Data for Epidemiologic Research database and performed serial cross-sectional analyses of national death certificate data for cardiovascular mortality with comorbid amyloidosis among patients aged 25 and above. Diseases of the circulatory system (ICD-10 I00-I99) were listed as the underlying cause of death, and amyloidosis (ICD-10 E85) as contributing cause of death. We calculated age-adjusted mortality rates (AAMRs) per 1,000,000 individuals and determined the trends over time by estimating the annual percent change using the Joinpoint Regression Program. Results: In the 22-year study period, 4,145 CVDs with comorbid amyloidosis in the United States were identified between 1999 and 2020. The AAMRs increased significantly from 0.69 per 1,000,000 individuals in 1999 to 2.13 per 1,000,000 individuals in 2020 (p< 0.05), with an annual percent increase of +3.92. The AAMRs for the span of 22 years were higher in males than females (1.66 vs. 0.75, p<0.05). When stratified by race, African American populations had the highest cumulative AAMR (2.34) compared to other racial groups. In terms of urbanization, the AAMR was significantly higher in the urban regions compared to the rural areas (1.15 vs. 0.91, p<0.05). Conclusion: The AAMRs from CVDs with comorbid amyloidosis have increased significantly over the past two decades, with significant disparities in male and African American individuals. This emphasises the need of further research in the development of effective treatments for amyloid heart disease.

Syncope While Driving and the Risk of a Subsequent Motor Vehicle Crash

Syncope that occurs while driving can result in a motor vehicle crash. Whether individuals with a prior syncope-related crash exhibit an exceptional risk of subsequent crash remains uncertain. We performed a population-based retrospective observational study of patients diagnosed with 'syncope and collapse' at any of 6 emergency departments in British Columbia, Canada (2010 to 2015). Data were obtained from chart abstraction, administrative health records, insurance claims and police crash reports. We compared crash-free survival among individuals with crash-associated syncope (a crash and an emergency visit for syncope on the same date) to that among controls with syncope alone (no crash on date of emergency visit for syncope). In the year following their index emergency visit, 13 of 63 drivers with crash-associated syncope and 852 of 9,160 controls with syncope alone experienced a subsequent crash as a driver (crash risk 21% versus 9%). After accounting for censoring and potential confounders, crash-associated syncope was not associated with a significant increase in the risk of subsequent crash (adjusted hazard ratio [aHR] 1.38, 95% confidence interval [CI] 0.78 to 2.47). Individuals with crash-associated syncope were 31-fold more likely to have physician driving advice documented during their index visit (prevalence ratio 31.0, 95% CI, 21.3 to 45.1). In the subgroup without documented driving advice, crash-associated syncope was associated with a significant increase in subsequent crash risk (aHR 1.88, 95% CI 1.06 to 3.36). Crash risk after crash-associated syncope appears similar to crash risk after syncope alone.

Abstract 17556: Predictors of Mortality and Burden of Arrhythmias in the Hospitalized Population With End-Stage Heart Failure; a Five-Year Retrospective Population-Based Study

Introduction: Heart failure (HF) is a significant cause of morbidity and mortality in the United States, contributing to approximately 1 in 8 deaths. Individuals with end-stage HF (eHF) experience debilitating symptoms leading to poor quality of life (QoL). We aimed to identify arrhythmias contributing to poor QoL and mortality in the inpatient setting. Hypothesis: The burden of arrhythmias in eHF may be overwhelming and a significant predictor of mortality. Understanding this may help proffer clinical management and improve outcomes. Methods: We used the ICD-10 code for eHF (I5084) from the National Inpatient Sample (NIS) (2016-2020) to identify all patients with eHF. We used a multivariate logistic regression model to adjust for confounders and estimate the mortality probability in each arrhythmia cohort. Our primary outcome was in-hospital mortality risk in each group. A p-value of 0.05 was deemed significant. Results: There were 22703 hospitalizations with eHF (mean age 67 years ±16), 66.5% (15091) were men, 59% (13018) were Caucasians, 27.2% (6017) were Blacks, 8.7% (1924) were Hispanics and 2.9% (505) Asians. Of these, 50.4% (11434) had atrial fibrillation (AFIB), 5.3% (1201) supraventricular tachycardia (SVT), 2.6% (586) ventricular fibrillation (VFIB), 1.6% (372) complete heart block (AVB3), and 0.4% (85) type 2 degree block (AVB2). All subgroups had independent associations with mortality, and VFIB was the highest predictor; adjusted odds ratio (aOR) 5.8 (4.6-7.1, p<0.0001), AFIB 4.3 (3.9-4.5, p<0.0001), SVT 1.9 (1.6-2.4, p<0.0001), AVB3 1.8 (1.3-2.4, p<0.0001), and AVB2 1.3 (0.6-3.0, p=0.5). Conclusion: Our analysis revealed that a high percentage of the in-hospital population with end-stage heart failure is burdened with atrial fibrillation. Ventricular fibrillation, atrial fibrillation, supraventricular tachycardia, and complete heart block all carried independent mortality risk, with ventricular fibrillation having the highest risk. Proactive management of arrhythmias in this population is warranted.

Abstract 16523: Trends and Outcomes of Preeclampsia Hospitalizations According to the Nationwide Inpatient Sample 2016-2020; An Updated Retrospective Population-Based Study

Introduction: Preeclampsia occurs in about 5-8% of pregnancies and is a leading cause of maternal morbidity and mortality. We aimed to study the inpatient population with preeclampsia. Hypothesis: The disparity gap remains apparent in maternal health, and minority populations would have poorer outcomes Methods: We conducted a retrospective analysis using the 2016 to 2020 Nationwide Inpatient Sample (NIS) database. Using ICD-10 codes, we identified all hospitalizations with a primary diagnosis of preeclampsia. We adjusted for confounders and used a multivariate logistic regression model to estimate the odds ratio (adjusted odds ratios (aOR)) of our outcomes of interest. Results: There were 126,255 primary preeclampsia hospitalizations (PRE) during the study period, of which 2.2% (2,736) had eclampsia (ECL). There was an increase in the number of PRE hospitalizations from 24459 (24.5 per 1000 deliveries) in 2016 to 28448 (28.4 per 1000 pregnancies) in 2020 (p <0.0001). Contrary to PRE admissions, there was a considerable decrease in hospitalizations or diagnoses for ECL from 958 (1 per 1000 deliveries) in 2016 to 417 (0.4 per 1000 deliveries) in 2020 (p<0.0001). The mean age was 29 years (SD=6.3), and the mean length of hospitalization was 4 days (SD=3.6). Compared to their Caucasian counterparts, the risk of eclampsia was higher in the minority populations, with aOR of 2.4 (CI 2.1-2.6, p<0.0001) in the Black, 1.3 (CI 1.1-1.4, p<0.0001) in the Hispanic, 1.01 (CI 0.8-1.3, p=0.7) in the Asian, and 1.7 (CI 1.1-2.4, p<0.0001) in the Native-American populations. Furthermore, the PRE group had a higher likelihood of postpartum acute kidney injury, 9.6 (CI 7.8-11.6, p<0.0001), and postpartum cardiomyopathy 3.3 (2.9-3.9, p<0.0001). Conclusions: Our five-year inpatient analysis revealed that while preeclampsia hospitalizations increased, eclampsia decreased. It also highlighted a higher likelihood of eclampsia in Black, Hispanic, and Native-American women and a subsequent increased risk for postpartum cardiomyopathy and acute kidney injury. Tailoring individualized maternal cardiovascular care based on risk stratification is crucial in these populations.

Abstract 18446: Rates and Risk Factors of Pregnancy-Related Ischemic Stroke During Labor Admissions

Background: Pregnancy-related stroke is a relatively uncommon yet devastating complication. However, the rates and associated risk factors of stroke in this context remain poorly described. Hypothesis: We aim to evaluate rates and associated risk factors for stroke. Methods: We conducted a population-based retrospective study using national inpatient data from 2016 to 2020 to assess ischemic stroke rates and identify associated risk factors during labor admissions. Regression analysis was performed, adjusting for multiple patient characteristics, to determine significant factors related to stroke occurrence. Results: We examined a total of 19,089,780 labor admissions. The incidence of ischemic stroke during labor admissions was recorded at a rate of 445 per 100,000 cases. Several factors showed significant associations with ischemic stroke in this context. Atrial fibrillation exhibited a strong correlation (odds ratio [OR] 5.98, 95% confidence interval [CI] [1.16-30.92], p=0.033), as did dyslipidemia (OR 9.54, 95% CI [4.38-20.80], p<0.001), heart failure (OR 3.95, 95% CI [1.09-14.34], p=0.037), chronic kidney disease (OR 6.27, 95% CI [1.92-20.47], p=0.002), cesarean section (OR 2.23, 95% CI [1.60-3.13], p<0.001), chronic hypertension (OR 1.67, 95% CI [1.12-2.47], p=0.011), and hypertensive disorders of pregnancy (OR 7.00, 95% CI [4.94-9.44], p<0.001). However, factors such as advanced maternal age, race/ethnicity, income quartile, gestational and non-gestational diabetes mellitus, coronary artery disease, tobacco use, polycystic ovarian syndrome, and peripartum cardiomyopathy did not exhibit significant associations with stroke. Conclusion: Our study highlights an incidence rate of 445 per 100,000 cases for pregnancy-related ischemic stroke during labor admissions and identified certain associated risk factors. These findings provide valuable guidance to healthcare professionals in identifying high-risk individuals.

Bacteraemia caused by non-faecalis and non-faecium Enterococcus species—a retrospective study of incidence, focus of infection, and prognosis

Background/aimEnterococcus faecalis and Enterococcus faecium cause human infections including bacteraemia and infective endocarditis (IE). Only few studies describing non-faecalis and non-faecium Enterococcus (NFE) infections have been conducted. We aimed to describe the incidence, prognosis, and focus of infection of bacteraemia with NFE.MethodsThis retrospective population-based study included all episodes of patients having a blood culture with growth of NFE between 2012 and 2019 in Region Skåne, Sweden. Information was collected from medical records. Episodes of bacteraemia caused by NFE were compared to episodes of bacteraemia caused by E. faecalis and E. faecium.ResultsDuring the study period, 136 episodes with NFE bacteraemia were identified corresponding to an incidence of NFE bacteraemia of 16 cases per 1,000,000 person-years among adults. Enterococcus casseliflavus (n=45), Enterococcus gallinarum (n=34), and Enterococcus avium (n=29) were the most common species. The most common foci of infection were biliary tract infections (n=17) followed by gastrointestinal infections (n=7). Urinary tract infections were not commonly caused by NFE (n=1), and no episodes of IE were caused by NFE. Polymicrobial bacteraemia was more common with NFE (73%) than with E. faecalis (35%) and E. faecium (42%). Community acquired infections were more common in bacteraemia with NFE compared to E. faecium. 30- and 90-day survival rates were 76% and 68%, respectively, and recurrent NFE bacteraemia was seen after 3% of the episodes.ConclusionBacteraemia caused by NFE is rare and is often polymicrobial. Biliary tract focus is common in NFE bacteraemia whereas IE and urinary tract focus are uncommon.

Impact of Human Papillomavirus-Negative Dominance in Oropharyngeal Cancer on Overall Survival: A Population-Based Analysis in Germany from 2018 to 2020.

The impact of the relation of human papillomavirus (HPV) and smoking status of oropharyngeal squamous cell carcinoma (OPSCC) on overall survival (OS) was investigated in a retrospective population-based study in Thuringia, Germany. A total of 498 patients with OPSCC (76.9% men; mean age 62.5 years) from 2018 to 2020 were included. OPSCC cases were 37.3% HPV-positive (+) (31.2% smokers; mean incidence: 2.91/100,000 population) and 57.8% HPV-negative (63.5% smokers; mean incidence: 4.50/100,000 population). Median follow-up was 20 months. HPV+ patients had significantly better OS than HPV-negative (-) patients (HPV+: 2-year OS: 90.9%; HPV-: 2-year OS: 73.6%; p < 0.001). In multivariable analysis, HPV- patients (hazard ratio (HR) = 4.5; 95% confidence interval (CI): 2.4-8.6), patients with higher N classification (N2: HR = 3.3; 95% CI: 1.71-6.20; N3: HR = 3.6; 95% CI: 1.75-7.31) and with a higher cancer staging (III: HR = 5.7; 95% CI: 1.8-17.6; IV: HR = 19.3; 95% CI: 6.3-57.3) had an increased hazard of death. HPV- smokers formed the majority in Thuringia. Nicotine and alcohol habits had no impact on OS. Optimizing OPSCC therapeutic strategies due to the dominance of HPV- is more important than discussing de-escalation strategies for HPV+ patients.

Mortality Trends and Causes of Death in Individuals with Thalassemia: A Population-Based Retrospective Study in the United States from 1999 to 2020

Background Thalassemia is a hereditary hemoglobinopathy that results in ineffective erythropoiesis. Patients with thalassemia have varying degrees of severity ranging from mild anemia to severe complications due to iron overload. Despite its clinical significance, the study on the mortality rate among patients with thalassemia in the United States (US) remains scarce. Objective This study aimed to analyze the trends in thalassemia-related mortality rate and the underlying causes of death among individuals with thalassemia. Methods We queried the Centers for Disease Control and Prevention's Wide-Ranging Online Data for Epidemiologic Research (CDC WONDER) database and performed serial cross-sectional analyses of national death certificate data for thalassemia-related mortality among patients of all ages. Thalassemia (International Classification of Diseases, Tenth Revision [ICD-10] D56) was listed as the contributing cause of death. We calculated age-adjusted mortality rates (AAMRs) per 1,000,000 individuals and examined the trends over time by estimating the average annual percent change (AAPC) using the Joinpoint Regression Program. Subgroup analyses were performed by sex, age, race, census region, and urbanization level. Results From 1999 to 2020, there were 2,797 deaths related to thalassemia. Among these deaths, beta thalassemia accounted for 24.87%, alpha thalassemia accounted for 6.00%, thalassemia trait accounted for 2.52%, dominant thalassemia, hemoglobin C thalassemia, mixed thalassemia, or thalassemia with other hemoglobinopathies accounted for 1.92%, and unspecified thalassemia accounted for 64.37%. The baseline demographics of patients who met the inclusion criteria are shown in Table 1. Thalassemia-related mortality rate showed an overall decline in trend from 0.50 (95% CI, 0.41 - 0.58) per 1,000,000 individuals in 1999 to 0.34 (95% CI, 0.28 - 0.40) per 1,000,000 individuals in 2019, but increased to 0.48 (95% CI, 0.41 - 0.55) per 1,000,000 individuals in 2020 (Figure 1). The highest AAMR was observed among Asians (1.34 [95% CI, 1.20 - 1.47] per 1,000,000 individuals), followed by non-Hispanic Blacks (0.65 [95% CI, 0.59 - 0.71] per 1,000,000 individuals), non-Hispanic Whites (0.32 [95% CI, 0.30 - 0.33] per 1,000,000 individuals), and Hispanics (0.11 [95% CI, 0.08 - 0.14] per 1,000,000 individuals). The most common underlying causes of death among individuals with thalassemia were cardiovascular causes (26.0%), followed by hematological causes (20.7%), malignancy (17.8%), endocrine disorders (6.3%), respiratory causes (6.2%), disorders of the nervous system (5.0%), gastrointestinal diseases (4.9%), psychiatric disorders (3.3%), infection (3.0%), and other causes (6.7%). Among the cardiovascular causes, ischemic heart disease (11.0%) was the most common cause, followed by hypertensive disease (3.0%), cerebrovascular disease (1.7%), aortic valve disease (1.1%), cardiomyopathy (0.79%), and atrial fibrillation and flutter (0.79%). The urban population had a higher AAMR compared to the rural population (0.43 [95% CI, 0.41 - 0.45] per 1,000,000 individuals vs. 0.29 [95% CI, 0.26 - 0.32] per 1,000,000 individuals). Nevertheless, the rural areas exhibited an increasing trend in the AAMR (+6.90%) while the urban areas exhibited a decreasing trend in the AAMR (-11.36%) during the study period. Conclusion While there has been an overall decline in the thalassemia-related mortality rate, variations exist among different races, geographic regions, and urbanization levels. Our study emphasizes the need for targeted interventions to address these disparities.

Assessing the Impact of Marginalization on Survival for Patients Undergoing Allogeneic Stem Cell Transplant in Ontario, Canada

Background Allogeneic hematopoietic stem cell transplants (allo-SCT) are potentially life-saving interventions used to treat hematologic disorders. Recent studies have shown that living in rural areas may predict worse outcomes after allo-SCT. Marginalization, a term that encompasses social and health-related factors affecting individuals, is predictive of adverse health outcomes. The Ontario Marginalization Index (ON-Marg), an administrative index using variables obtained from census data, was used to identify marginalization status (quintile 1-least marginalized; quintile 5-most marginalized) encompassing four domains: residential instability (area-level concentrations of people who experience high rates of family or housing instability), material deprivation (area-level concentrations of inability for individuals and communities to access and attain basic material needs), dependency (area-level concentrations of people who do not have income from employment), and ethnic concentration (area-level concentrations of people who are recent immigrants and/or a visible minority). In a publicly-funded healthcare context, it is important to know how marginalization impacts survival for patients undergoing allo-SCT. Methods We performed a retrospective population-based study using administrative healthcare databases from Ontario, Canada. Patients were included if they were 18 years or older at the time of allo-SCT, and had undergone allo-SCT for acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) or acute lymphoblastic leukemia (ALL) between 2010 and 2022. Patients were excluded if they were a non-Ontario resident at the time of allo-SCT and as a result lacked ON-Marg data. Patients who received allo-SCT for a different indication were excluded. The primary outcome of this study was 2-year overall survival (OS) from time of transplant to death or end of the study period, based on ON-Marg quintiles. Multivariable Cox regression analysis was used to identify baseline characteristics associated with OS, with ON-Marg as the main exposure. Results A total of 1961 patients underwent allo-SCT for AML/MDS/ALL. The median age of patients undergoing allo-SCT was 55 years (IQR 43-63), and 55% of patients were male. 40% of patients had high aggregated diagnosis group (ADG) comorbidity burden, and a majority of patients (64%) lived within 50 kilometers (km) from the transplant center, with a mean distance of 33 km in the entire study population. The distribution of patients across each quintile of marginalization was not always uniform. For ethnic concentration, 24% of patients were in quintile 5, with 17% of patients in quintile 1. For dependency, 19% of patients were in quintile 5, and 25% of patients were in quintile 1. During the follow-up period, 43% of patients (n = 842) died. 2-year OS was not significantly different across all quintiles of the ethnic concentration domain of marginalization ( Figure 1A). 2-year OS was worse (HR 1.27, 95% CI 1.02-1.57) for patients in quintile 4 compared to quintile 1 of the dependency domain of marginalization ( Figure 1B). This effect persisted in multivariable logistic regression analyses accounting for other demographic variables ( Table 1). Increased age and a higher comorbidity index were significantly associated with worse survival across all domains. Patients with ALL had worse outcomes compared to patients with AML/MDS across all domains of marginalization. There was also a trend toward patients living &amp;gt;200 km from the transplant center having an increased risk of death compared to patients living less than 50 km from the center (HR 1.24, 95% CI 1.00-1.54). Conclusion This study shows that 2-year OS after allo-SCT for AML/MDS/ALL was not affected by marginalization quintile of ethnic concentration. This is in keeping with other published data suggesting that outcomes after allo-SCT are not impacted by socioeconomic factors such as race. Patients in quintile 4 of dependency had worse outcomes than patients in quintile 1, suggesting that employment and income support are crucial to successful patient outcomes. A majority of patients who underwent allo-SCT lived in close proximity to the transplant center. Transplant outcomes in general do not appear to vary based on marginalization status, and it is therefore crucial that all patients who may benefit receive allo-SCT regardless of demographics or distance to treatment centers.

Comparison of the Efficacy in Clinical Trials Versus Effectiveness in the Real-World of Treatments for Multiple Myeloma: A Population-Based Cohort Study

Introduction: Improvements in outcomes of patients with multiple myeloma (MM) depend on the use of regimens approved based on results from large phase III randomized controlled trials (RCTs) demonstrating their efficacy. However, many real-world (RW) patients would not have met the stringent RCTs inclusion criteria. Therefore, the effectiveness of these drugs in the RW setting is unknown. Understanding this efficacy-effectiveness gap is important to contextualize the expected outcomes in the current RW setting. Therefore, we conducted a retrospective population-based study to compare the efficacy versus effectiveness of registration RCTs with RW patients using standard of care (SoC) MM regimens for the primary outcomes of 1) progression free survival [PFS]; 2) overall survival [OS] and 3) serious adverse events (AEs). Methods: RW data was obtained from the Institute for Clinical Evaluative Sciences, an administrative database capturing all health records in the publicly funded health care system in Ontario, Canada. Adult patients treated between Jan 2007 to Dec 2020 with SoC regimens were included. Only regimens with corresponding registrational phase III RCTs which led to the public reimbursement in Ontario were included (lenalidomide/dex [Rd] and bortezomib/Rd [VRd] for newly diagnosed transplant ineligible patients, and relapsed MM (RRMM) regimens included carfilzomib/Rd [KRd], carfilzomib/dex [Kd], daratumumab/Rd [DRd], daratumumab/bortezomib/dex [DVd], pomalidomide/dex [Pd]). In the RW cohort, PFS was defined as the time from initiation of index regimen to death, initiation of subsequent MM treatment, or last follow-up, and patients remaining on the index regimen as last follow up were censored. Kaplan-Meier curves from pivotal phase 3 RCTs were manually digitized to provide individual patient-level estimates of PFS and OS. Meta-analyses were performed to compare the gap of PFS and OS outcomes of RW versus RCT patients, and effect estimates were summarized using hazard ratios (HR). The frequency of serious AE data was abstracted from published RCTs. Given that serious AEs in RCTs would have resulted in hospitalization, hospital admission during treatment with the index regimen was used as a surrogate for serious AEs in the RW cohort. Differences in RW and RCT safety outcomes were reported descriptively. Results &amp; Discussion: A total of 3951 RW MM patients, treated with 7 standard of care MM regimens, were included. Baseline characteristics of patients in the RW and RCT cohorts are shown in table 1. Overall, patients in the RW cohort were older than in the RCTs. For relapsed regimens, there was a longer time between MM diagnosis and start of the regimen in the real-world versus RCT. With regards to the efficacy-effectiveness gap, MM patients treated in routine practise in the RW had a worse PFS despite overestimated of RW PFS compared to highly selected RCT patients for 6 of the 7 MM regimens evaluated, with a pooled HR of 1.44 (95% CI 1.34-1.54) in the meta-analysis (Figure 1A). Similarly, RW patients had a worse OS compared to RCT patients treated with 6 of the 7 regimens, with a pooled HR of 1.75 (95% ci 1.63-1.88) in the meta-analysis (Figure 1B). RRMM patients in the RW had higher rates of prior lenalidomide exposure compared to RCT patients. The only regimen which showed a trend towards performing better in the RW as compared to RCTs was Pd. The reason for this is likely multifactorial but perhaps patients included in the MM-003 RCT may have had more refractory MM (given the higher prior immunomodulatory drug exposure and longer time from diagnosis to treatment among Pd RCT patient) compared to RW patients in this study. With regards to safety, the percentage of patients with inpatient hospitalization during treatment in the real-world cohort and reported serious AEs in RCT were comparable (VRD 57% vs not reported [NR]; Rd 64% vs NR; Kd 57% vs 59%; KRd 53% vs 60%; DVd 36% vs NR; DRd 46% vs 49%; Pd 59% vs 61%). Conclusion: This is one the largest population-level studies highlighting the significant efficacy-effectiveness gap between registrational RCTs and RW usage of these regimens, with RW patients experiencing 44% worse PFS and 75% worse OS compared to RCT patients. Our data emphasize the importance of ongoing evaluation of RW data to contextualize effectiveness and toxicity of selected regimens in the clinic, and better inform both clinicians and patients for shared treatment decision making.

Hospital admissions for physical health and psychosocial adversity among people experiencing homelessness in England: a population-based retrospective cross-sectional study

BackgroundHomeless health care is often characterised by physical health, mental health, and substance use problems, resulting in high use of emergency care, poor outcomes, and extreme social inequities. We assessed health needs as prevention opportunities for hospitalised people experiencing homelessness (PEH) in England. MethodsThis population-based retrospective cross-sectional study used anonymised national Hospital Episodes Statistics Admitted Patient Care data. PEH were identified as having at least one homeless code (“no fixed abode”, “registered with a homeless-exclusive GP practice”, “clinical diagnosis of homelessness”) from April 1, 2017, to March 31, 2018. We analysed admissions for PEH and for housed people. We estimated the prevalence of demographic and admission characteristics and diagnoses by 10th International Classification of Disease (ICD-10) chapter. We developed novel diagnostic phenotypes for physical health (internal disease processes) and psychosocial adversity (mental health, substance use, violence, and social factors). We compared admissions between PEH and housed people using sex-stratified logistic regression adjusted for age and ethnicity. FindingsThere were 15 566 010 admissions (51 643 PEH and 15 514 367 housed people). Compared with housed people, proportionately more PEH were younger (PEH aged 26–45 years, n=24 224 [46·9%], housed people n=3 323 951 [21·4%]), male (PEH n=37 662 [72·9%], housed people n=6 819 157 [44·0%]), and not White British (PEH n=14 605 [28·3%], housed people n=3 447 183 [22·2%]). Emergency admissions were more common among PEH (PEH male n=30 958 [82·2%], housed people male n=5 321 428 [34·3%], adjusted odds ratio [aOR] 8·76, 95% CI 8·53–9·00). The most common primary diagnoses by ICD-10 chapter for PEH were mental and behavioural conditions (PEH male n=7118 admissions [18·9%], housed people male n=155 144 [1·0%], 12·97, 12·61–13·34). Admissions for the psychosocial adversity phenotype were higher in PEH, particularly for women (PEH female n=3922 [28·1%], housed people female n=155 644 [1·79%], 18·18, 17·50–18·88). Physical health phenotype admissions were less common in PEH (PEH male n=7510 [19·9%], housed people male n=1 821 397 [26·7%], 0·91, 0·89–0·94), but specific infections, cancers, respiratory, and cardiovascular diseases were more common among PEH for both men and women. InterpretationThese results support targeting of preventative interventions for PEH before, during and after admission to hospital, highlighting psychosocial needs. Future research should aim to produce reliable estimates of the size of the national homeless population to enable calculation of admission rates for psychosocial and physical health diagnoses. FundingNational Institute for Health and Care Research (NIHR).

Rates of surgery and adjuvant chemotherapy use in patients with stage IB to IIIA non-small cell lung cancer: A provincial population-based study.

134 Background: The current standard of treatment for early-stage (IB to IIIA) non-small cell lung cancer (NSCLC) include surgery and adjuvant chemotherapy. The objective of this study is to identify rates of adherence to guideline recommended surgery and adjuvant chemotherapy treatment for early-stage NSCLC for patients living in Ontario, the most populous province of Canada. Methods: A retrospective population-based study using linked administrative data through ICES was completed that included all adult patients with a diagnosis of stage IB to IIIA NSCLC made from 2010 to 2020 in Ontario. Rates of surgery and chemotherapy completion were calculated using available OHIP (Ontario Health Insurance Plan) billing codes. Logistic multivariate regressions were completed to assess for any predictors for completion of surgery and chemotherapy. Results: A total of 24,237 eligible patients were included. By cancer staging, there were 6,495 (26.8%) stage IB, 7,156 (29.5%) stage II, and 10,586 (43.7%) stage IIIA NSCLC patients. Within 180 days of diagnosis, surgery was completed for 9,929 (41.0%) of patients, by cancer staging were 4090/6495 (63.0%), 3719/7156 (52.0%), and 2120/10586 (20.0%) for IB, II, and IIIA respectively. The median time from diagnosis to surgery was 49 days (IQR 23-77 days). Amongst patients who completed surgery, 3344/9929 (33.7%) underwent at least 1 cycle of adjuvant chemotherapy within 180 days. Having advanced age (p&lt;0.001), high Charlson comorbidity score (p&lt;0.001), and low income (p&lt;0.001) are predictors for poor uptake for both chemotherapy and surgery. Being male also reduces the likelihood of undergoing surgery (p&lt;0.001). Conclusions: In our population-based study, less than half of the patients with early-stage (IB-IIIA) NSCLC underwent surgical resection and chemotherapy. These low treatment rates are concerning and may be contributing to suboptimal outcomes. Our findings indicate that elderly individuals with multiple comorbidities and those with low incomes are at the highest risk of not receiving appropriate chemotherapy and surgery. Our data highlight the need for quality improvement strategies aimed at identifying and enhancing treatment uptake within this patient population.

Correction to “Continuity of physician care over the last year of life for different cause-of-death categories: a retrospective population-based study”

Correction to “Continuity of physician care over the last year of life for different cause-of-death categories: a retrospective population-based study”

Indolent lymphoma care delivery and outcomes during the COVID-19 pandemic in Ontario, Canada.

The treatment pattern and outcomes in patients with indolent B-cell lymphoma treated during the coronavirus disease 2019 (COVID-19) pandemic period compared to the prepandemic period are unclear. This was a retrospective population-based study using administrative databases in Ontario, Canada (follow-up to 31 March 2022). The primary outcome was treatment pattern; secondary outcomes were death, toxicities, healthcare utilization (emergency department [ED] visit, hospitalization) and SARS-CoV-2 outcomes. Adjusted hazard ratios (aHR) from Cox proportional hazards models were used to estimate associations. We identified 4143 patients (1079 pandemic, 3064 prepandemic), with a median age of 69 years. In both time periods, bendamustine (B) + rituximab (BR) was the most frequently prescribed regimen. During the pandemic, fewer patients received R maintenance or completed the full 2-year course (aHR 0.81, 95% CI 0.71-0.92, p = 0.001). Patients treated during the pandemic had less healthcare utilization (ED visit aHR 0.77, 95% CI 0.68, 0.88, p < 0.0001; hospitalization aHR 0.81, 95% CI 0.70-0.94, p = 0.0067) and complications (infection aHR 0.69, 95% CI 0.57-0.82, p < 0.0001; febrile neutropenia aHR 0.66, 95% CI 0.47-0.94, p = 0.020), with no difference in death. Independent of vaccination, active rituximab use was associated with a higher risk of COVID-19 complications. Despite similar front-line regimen use, healthcare utilization and admissions for infection were less in the pandemic cohort.

No major differences in perinatal and maternal outcomes between uninterrupted embryo culture in time-lapse system and conventional embryo culture.

Is embryo culture in a closed time-lapse system associated with any differences in perinatal and maternal outcomes in comparison to conventional culture and spontaneous conception? There were no significant differences between time-lapse and conventional embryo culture in preterm birth (PTB, <37 weeks), low birth weight (LBW, >2500 g) and hypertensive disorders of pregnancy for singleton deliveries, the primary outcomes of this study. Evidence from prospective trials evaluating the safety of time-lapse incubation for clinical use show similar embryo development rates, implantation rates, and ongoing pregnancy and live birth rates when compared to conventional incubation. Few studies have investigated if uninterrupted culture can alter risks of adverse perinatal outcomes presently associated with IVF when compared to conventional culture and spontaneous conceptions. This study is a Swedish population-based retrospective registry study, including 7379 singleton deliveries after fresh embryo transfer between 2013 and 2018 from selected IVF clinics. Perinatal outcomes of singletons born from time-lapse-cultured embryos were compared to singletons from embryos cultured in conventional incubators and 71 300 singletons from spontaneous conceptions. Main perinatal outcomes included PTB and LBW. Main maternal outcomes included hypertensive disorders of pregnancy (pregnancy hypertension and preeclampsia). From nine IVF clinics, 2683 singletons born after fresh embryo transfer in a time-lapse system were compared to 4696 singletons born after culture in a conventional incubator and 71 300 singletons born after spontaneous conception matched for year of birth, parity, and maternal age. Patient and treatment characteristics from IVF deliveries were cross-linked with the Swedish Medical Birth Register, Register of Birth Defects, National Patient Register and Statistics Sweden. Children born after sperm and oocyte donation cycles and after Preimplantation Genetic testing cycles were excluded. Odds ratio (OR) and adjusted OR were calculated, adjusting for relevant confounders. In the adjusted analyses, no significant differences were found for risk of PTB (adjusted OR 1.11, 95% CI 0.87-1.41) and LBW (adjusted OR 0.86, 95% CI 0.66-1.14) or hypertensive disorders of pregnancy; preeclampsia and hypertension (adjusted OR 0.99, 95% CI 0.67-1.45 and adjusted OR 0.98, 95% CI 0.62-1.53, respectively) between time-lapse and conventional incubation systems. A significantly increased risk of PTB (adjusted OR 1.31, 95% CI 1.08-1.60) and LBW (adjusted OR 1.36, 95% CI 1.08-1.72) was found for singletons born after time-lapse incubation compared to singletons born after spontaneous conceptions. In addition, a lower risk for pregnancy hypertension (adjusted OR 0.72 95% CI 0.53-0.99) but no significant difference for preeclampsia (adjusted OR 0.87, 95% CI 0.68-1.12) was found compared to spontaneous conceptions. Subgroup analyses showed that some risks were related to the day of embryo transfer, with more adverse outcomes after blastocyst transfer in comparison to cleavage stage transfer. This study is retrospective in design and different clinical strategies may have been used to select specific patient groups for time-lapse versus conventional incubation. The number of patients is limited and larger datasets are required to obtain more precise estimates and adjust for possible effect of additional embryo culture variables. Embryo culture in time-lapse systems is not associated with major differences in perinatal and maternal outcomes, compared to conventional embryo culture, suggesting that this technology is an acceptable alternative for embryo incubation. The study was financed by a research grant from Gedeon Richter. There are no conflicts of interest for all authors to declare. N/A.

Fusion's Location and Quality within the Fixated Segment Following Transforaminal Interbody Fusion (TLIF).

Transforaminal interbody fusion (TLIF) has gained increased popularity over recent decades and is being employed as an established surgical treatment for several lumbar spine pathologies, including degenerative spondylosis, spondylolisthesis, infection, tumor and some cases of recurrent disc herniation. Despite the seemingly acceptable fusion rates after TLIF (up to 94%), the literature is still limited regarding the specific location and quality of fusion inside the fixated segment. In this single-institution, retrospective population-based study, we evaluated all post-operative computed tomography (CT) of patients who underwent TLIF surgery at a medium-sized medical center between 2010 and 2020. All CT studies were performed at a minimum of 1 year following the surgery, with a median of 2 years. Each CT study was evaluated for post-operative fusion, specifically in the posterolateral and intervertebral body areas. The fusion's quality was determined and classified in each area according to Lee's criteria, as follows: (1) definitive fusion: definitive bony trabecular bridging across the graft host interface; (2) probable fusion: no definitive bony trabecular crossing but with no gap at the graft host interface; (3) possible arthrosis: no bony trabecular crossing with identifiable gap at the graft host interface; (4) definite pseudarthrosis: no traversing trabecular bone with definitive gap. A total of 48 patients were included in this study. The median age was 55.6 years (SD ± 15.4). The median time from surgery to post-operative CT was 2 years (range: 1-10). Full definitive fusion in both posterolateral and intervertebral areas was observed in 48% of patients, and 92% showed definitive fusion in at least one area (either posterolateral or intervertebral body area). When comparing the posterolateral and the intervertebral area fusion rates, a significantly higher definitive fusion rate was observed in the posterolateral area as compared to the intervertebral body area in the long term follow-up (92% vs. 52%, p < 0.001). In the multivariable analysis, accounting for several confounding factors, including the number of fixated segments and cage size, the results remained statistically significant (p = 0.048). In conclusion, a significantly higher definitive fusion rate at the posterolateral area compared to the intervertebral body area following TLIF surgery was found. Surgeons are encouraged to employ bone augmentation material in the posterolateral area (as the primary site of fusion) when performing TLIF surgery.