Real-world Population-based Study Research Articles

A real-world observational study assessing relationships between excessive daytime sleepiness and patient satisfaction in obstructive sleep apnea

Objectives/BackgroundTo estimate prevalence and severity of excessive daytime sleepiness among patients with obstructive sleep apnea (OSA) who were prescribed treatment; assess perception and satisfaction of OSA-related care; describe relationships between excessive daytime sleepiness, treatment adherence, and patient satisfaction. Patients/methodsA national population-based cross-sectional sample of US adults with clinician-diagnosed OSA was surveyed in January 2021 via Evidation Health's Achievement App. Patients completed the Epworth Sleepiness Scale, rated satisfaction with healthcare provider and overall OSA care, and reported treatment adherence. Covariates affecting excessive daytime sleepiness (average weekly sleep duration, treatment adherence, sleepiness-inducing medications, age, sex, body mass index, nasal congestion, smoking status, and comorbidities) were adjusted in multivariate regression models. ResultsIn 2289 participants (50.3 % women; 44.8 ± 11.1 years), EDS was highly prevalent (42 %), and was experienced by 36 % of patients with high positive airway pressure (PAP) therapy adherence. Each additional hour of nightly PAP use was associated with improved sleepiness (a 0.28-point lower Epworth score; p < 0.001). Excessive daytime sleepiness was associated with lower patient satisfaction with healthcare providers and overall care (OR [95 % CI] 0.62 [0.48–0.80] and 0.50 [0.39–0.64], respectively; p < 0.0001), whereas PAP adherence was associated with higher patient satisfaction (OR [95 % CI] 2.37 [1.64–3.43] and 2.91 [2.03–4.17]; p < 0.0001), after adjusting for confounders. ConclusionsIn a real-world population-based study of patients with OSA, excessive daytime sleepiness was highly prevalent and associated with poor patient satisfaction ratings. Better patient-centered care among patients with OSA may require interventions aimed at addressing excessive daytime sleepiness and treatment adherence.

Comparison of GLP-1 Receptor Agonists and Other Glucose-Lowering Agents on Cardiovascular Outcomes in Individuals with Type 2 Diabetes and Obesity: A Spanish Real-World Population-Based Study

AimsAssess the impact of glucagon-like peptide receptor agonists (GLP-1RA) compared to other glucose-lowering agents on cardiovascular outcomes in individuals with type 2 diabetes and obesity in a Spanish metropolitan area MethodsA retrospective population-based type 2 diabetes cohort was identified from the Valencia Clinic-Malvarrosa Department electronic databases (2014-2019). Study groups included GLP-1RA, sodium-glucose co-transporter-2 inhibitors (SGLT2i), Insulin, and Miscellany (other glucose-lowering agents). 1:1:1:1 propensity score matching was conducted. The primary outcome was a composite of major adverse cardiovascular events (4-point MACE) comprising myocardial infarction, stroke, all-cause mortality, and heart failure. Secondary outcomes included individual 4-point MACE components. Hazard ratios were estimated using Cox regression analyses against the Miscellany group. ResultsFrom 26,944 subjects, 1,848 adults were selected per group. GLP-1RA did not show a significant reduction in 4-point MACE risk (HR 1.05 [95%CI 0.82-1.34]). SGLT2i significantly reduced the risk of heart failure (HR 0.16 [95%CI 0.05-0.54]) and atrial fibrillation (HR 0.58, [95%CI 0.35-0.95]). The Insulin group exhibited a higher risk for 4-point MACE and most individual outcomes compared to GLP-1RA and SGLT2i. ConclusionsOur findings do not provide evidence of a reduced cardiovascular risk, as assessed by 4-point MACE, with GLP-1RA. In contrast, SGLT2i demonstrated protective effects against heart failure and atrial fibrillation.

THU338 Risks Of Stroke, Its Subtypes And Atrial Fibrillation Associated With Glucagon-like Peptide 1 Receptor Agonists Versus Sodium-glucose Cotransporter 2 Inhibitors: A Real-world Population-based Study In Hong Kong

Abstract Disclosure: D. Lui: None. E. Tang: None. T. Wu: None. I. Au: None. C. Lee: None. Y. Woo: None. K.C. Tan: None. C. Wong: None. Objectives: There are limited data on head-to-head comparative risk of stroke between sodium-glucose cotransporter 2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1RA). Such a comparison may provide further insights in the selection of appropriate anti-diabetic agents. We compared risk of stroke with its subtypes and incident atrial fibrillation (AF) between them in a population-based cohort. Methods: A population-based cohort of adult patients (aged 18 years or above) with type 2 diabetes between 2008 and 2020 were identified from the electronic health records of Hong Kong Hospital Authority. Patients who received SGLT2i or GLP-1RA were matched pairwise by propensity score. The index date of each patient was set at the date of SGLT2i or GLP-1RA initiation. Patients with end-stage kidney disease or co-initiation of SGLT2i and GLP-1RA at the index date were excluded. The primary outcome was all events of stroke, consisting of hemorrhagic and ischemic stroke. Secondary outcomes included hemorrhagic stroke, ischemic stroke, incident AF, and cardioembolic stroke. Each patient was observed from the index date until the occurrence of events, death, treatment cross-over, or end-of-study (31 December 2020), whichever was earlier. Risks of stroke and AF were evaluated by hazard ratios (HRs) from the Cox proportional hazard regression models. Results: A total of 5,840 patients (2,920 SGLT2i users; 2,920 GLP-1RA users) were included (mean age 55.5 years, 56.1% men, mean HbA1c 8.9% and duration of diabetes 13.7 years). Upon median follow-up of 17 months (IQR: 8-34), there were 111 events of stroke. SGLT2i users had comparable risk of all stroke as GLP-1RA users (HR=1.46, 95%CI 0.99-2.17, p=0.058). SGLT2i users had higher risk of ischemic stroke (HR=1.53, 95%CI 1.01-2.33, p=0.044) but similar risk of hemorrhagic stroke (HR=1.29, 95%CI: 0.53-3.14, p=0.582) compared to GLP-1RA users. Although SGLT2i was associated with lower risk of incident AF (HR=0.43, 95%CI 0.23-0.79, p=0.006), risk of cardioembolic stroke was similar (HR=1.40, 95%CI: 0.62-3.17, p=0.414). Subgroup analyses showed no significant interaction between subgroups by age, sex, glycemic control and history of AF. However, patients with history of stroke appeared to benefit more from GLP-1RA use (p for interaction=0.043) than those without history of stroke. Patients with shorter duration of diabetes (&amp;lt;10 years) also appeared to benefit more from GLP-1RA use than those with longer duration of diabetes (p for interaction=0.017). Conclusions: Our real-world study demonstrated that GLP-1RA use was associated with lower risk of ischemic stroke, despite the association between SGLT2i use and lower risk of incident AF. There was no significant difference in hemorrhagic stroke risk. GLP-1RA may be the preferred agent for patients with type 2 diabetes at risk of ischemic stroke. Presentation: Thursday, June 15, 2023

Epidemiological Trends of Haematological Malignancies in Belgium 2004-2018: Older Patients Show the Greatest Improvement in Survival.

(1) Background: Haematological malignancies (HMs) represent a heterogeneous group of mostly rare cancers that differ in pathophysiology, incidence, and outcome. (2) Methods: Our study aims to understand the epidemiological situation and trends of 24 main types of HMs in Belgium over a 15-year period, with a focus on the impact of age. Age-standardised incidence, average annual percentage change (AAPC), 5- and 10-year relative survival (RS) and RS trends were estimated for all HMs (N = 94,415) diagnosed between 2004 and 2018. (3) Results: Incidence rates of HM increased, mainly in the 70+ age group (AAPC: 3%). RS varied by age and HM type. For each HM type, outcome decreased with age. The greatest decrease with age in 5-year RS is observed for aggressive HM, acute myeloid leukaemia (AML), acute lymphoblastic leukaemia, and Burkitt lymphoma, from 67%, 90%, and 97% below 20 years, to 2%, 12%, and 16% above 80 years of age, respectively. The moderate improvement in 5-year RS over the 2004-2018 period for all HMs, of +5 percentage point (pp), masks highly heterogenous outcomes by HM type and age group. The most impressive improvements are observed in the 80+ group: +45, +33, +28, and +16 pp for Hodgkin lymphoma, immunoproliferative disorders, follicular lymphoma, and chronic myeloid leukaemia, respectively. (4) Conclusions: The increasing incidence and survival over the 2004-2018 period are likely explained by diagnostic and therapeutic innovations, which have spread to populations not targeted by clinical trials, especially older adults. This real-world population-based study highlights entities that need significant improvement, such as AML.

Rapid Reduction of HbA1c and Early Worsening of Diabetic Retinopathy: A Real-world Population-Based Study in Subjects With Type 2 Diabetes.

Early worsening of diabetic retinopathy (EWDR) due to the rapid decrease of blood glucose levels is a concern in diabetes treatment. The aim of the current study is to evaluate whether this is an important issue in subjects with type 2 diabetes with mild or moderate nonproliferative DR (NPDR), who represent the vast majority of subjects with DR attended in primary care. This is a retrospective nested case-control study of subjects with type 2 diabetes and previous mild or moderate NPDR. Using the SIDIAP ("Sistema d'informació pel Desenvolupament de la Recerca a Atenció Primària") database, we selected 1,150 individuals with EWDR and 1,150 matched control subjects (DR without EWDR). The main variable analyzed was the magnitude of the reduction of HbA1c in the previous 12 months. The reduction of HbA1c was categorized as rapid (>1.5% reduction in <12 months) or very rapid (>2% in <6 months). We did not find any significant difference in HbA1c reduction between case and control subjects (0.13 ± 1.21 vs. 0.21 ± 1.18; P = 0.12). HbA1c reduction did not show significant association with worsening of DR, neither in the unadjusted analyses nor in adjusted statistical models that included the main confounding variables: duration of diabetes, baseline HbA1c, presence of hypertension, and antidiabetic drugs. In addition, when stratification by baseline HbA1c was performed, we did not find that those patients with higher levels of HbA1c presented a higher risk to EWDR. Our results suggest that the rapid reduction of HbA1c is not associated with progression of mild or moderate NPDR.

Repeat operations in patients with anal fistula, a retrospective study across England and Wales.

This article reports the frequency of repeat operations including waiting times within the National Health Service (NHS) of England and Wales. Retrospective study on repeat operations for anal fistula (AF) performed between 1st January 2010 and 31st December 2016. Data were extracted from the national registry of data entered into Hospital Episode Statistics (HES). Patient factors (age, sex, self-declared ethnicity) and geographical location were tested for association with repeat operations and time to the second operation. We analysed 36,223 patients that had an operation for AF within 148 NHS trusts. The median follow-up time was 28months. The majority of patients (67.4%) had only one operation. Eighty-five per cent of them remained under the care of a single consultant. Six per cent of the repeat surgeries occurred in at least three different treatment sites. Young age and female sex were associated with higher rates of repeat operations. Non-declared and Black or Black British ethnicity were associated with fewer operations. The median waiting time between the first and second operations was 27.4weeks (IQR: 14.7-55.3); between the second and third 28.0weeks (IQR: 14.7-57.0); between the third and fourth 29.0weeks. This large real world population-based study shows that the majority of patients with AF undergo only one operation. Patients requiring multiple procedures tend to stay under the care of a small number of consultants but waiting times between operations are long. There is a geographical variation in the number of operations and the time between them.

Aspirin for the Prevention of Early and Severe Pre-Eclampsia Recurrence: A Real-World Population-Based Study.

Many clinical trials have reported that low-dose aspirin decreases the risk of pre-eclampsia in women with prior pre-eclampsia. However, its impact in a real-world population has not been fully assessed. To assess the rates of low-dose aspirin initiation during pregnancy in women with a history of pre-eclampsia, and to evaluate the impact of low-dose aspirin in prevention of pre-eclampsia recurrence in a real-world population. CONCEPTION is a French nationwide cohort study which uses data from the country's National Health Data System database. We included all women in France who gave birth at least twice between 2010-2018, and who had pre-eclampsia during their first pregnancy. Every dispensing of low-dose aspirin (75-300 mg) between the beginning of their second pregnancy and 36 weeks of gestation (WG) was identified. We used Poisson regression models to estimate the adjusted incidence rate ratios (aIRRs) of receiving aspirin at least once during their second pregnancy. In women who had early and/or severe pre-eclampsia during their first pregnancy, we estimated the IRRs of pre-eclampsia recurrence during their second pregnancy according to the aspirin therapy. In 28,467 women who were included in the study, the aspirin initiation rate during the second pregnancy ranged from 27.8% for women in whose first pregnancy the pre-eclampsia was mild and late, to 79.9% for those women whose pre-eclampsia was severe and early. Just over half (54.3%) of those treated with aspirin-initiated treatment before 16 WG and adhered to treatment. Compared with women with mild and late pre-eclampsia, the aIRRs (95% CI) for receiving aspirin at least once during the second pregnancy were 1.94 (1.86-2.03) for women with severe and late pre-eclampsia, 2.34 (2.17-2.52) for those with early and mild pre-eclampsia, and 2.87 [2.74-3.01] for those with early and severe pre-eclampsia E. Social deprivation was associated with a lower initiation of aspirin (IRR = 0.74 [0.70-0.78]). Aspirin was not associated with a lower risk of mild and late pre-eclampsia, severe and late pre-eclampsia, or mild and early pre-eclampsia during the second pregnancy. The aIRRs for severe and early pre-eclampsia during the second pregnancy were 0.77 (0.62-0.95) for women who received prescribed aspirin at least once, 0.71 (0.5-0.89) for those who initiated aspirin therapy before 16 WG, and 0.60 (0.47-0.77) for those who adhered to aspirin treatment throughout their second pregnancy. The risk of severe and early pre-eclampsia was lower only when the prescribed mean daily dose was ≥ 100 mg/day. In women with a history of pre-eclampsia, aspirin initiation during a second pregnancy and adherence to the prescribed dosage were largely insufficient, especially for women experiencing social deprivation. Aspirin initiated before 16 WG at a dose ≥ 100 mg/day was associated with a lower risk of severe and early pre-eclampsia.

Comparative Effectiveness of FOLFIRINOX Versus Gemcitabine and Nab-paclitaxel in Initially Unresectable Locally Advanced Pancreatic Cancer: A Population-based Study to Assess Subsequent Surgical Resection and Overall Survival

AimsFirst-line FOLFIRINOX (FOLinic acid, Fluorouracil, IRINotecan, and OXaliplatin) and gemcitabine plus nab-paclitaxel (GnP) have been publicly funded for patients with unresectable locally advanced pancreatic cancer (uLAPC) in Ontario, Canada. We examined the overall survival and surgical resection rate after first-line FOLFIRINOX or GnP and determined the association between resection and overall survival in patients with uLAPC. Materials and methodsWe conducted a retrospective population-based study including patients with uLAPC who received first-line treatment FOLFIRINOX or GnP from April 2015 to March 2019. The cohort was linked to administrative databases to ascertain demographic and clinical characteristics. Propensity score methods were used to balance differences between FOLFIRINOX and GnP. The Kaplan–Meier method was used to calculate overall survival. Cox regression was used to determine the association between receipt of treatment and overall survival, adjusting for time-dependent surgical resections. ResultsWe identified 723 patients with uLAPC (mean age = 65.8, 43.5% female) who received FOLFIRINOX (55.2%) or GnP (44.8%). The median overall survival and 1-year overall survival probability were higher for FOLFIRINOX (13.7 months, 54.6%) than for GnP (8.7 months, 34.0%). Post-chemotherapy surgical resection occurred in 89 (12.3%) patients (FOLFIRINOX: 74 [18.5%] versus GnP: 15 [4.6%]), with no difference in survival since surgery between FOLFIRINOX and GnP (P = 0.29). After adjusting time-dependent post-treatment surgical resection, FOLFIRINOX (inverse probability treatment weighting hazard ratio 0.72, 95% confidence interval 0.61, 0.84) was independently associated with improved overall survival. ConclusionsIn this real-world population-based study of patients with uLAPC, FOLFIRINOX was associated with improved survival and higher resection rates. FOLFIRINOX was associated with improved survival in patients with uLAPC after accounting for the effect of post-chemotherapy surgical resection, suggesting the benefit of FOLFIRINOX was not solely due to improving resectability.

Prostatic artery embolization compared to transurethral resection of the prostate and prostatic urethral lift: a real-world population-based study.

There are growing interests for minimally invasive surgical techniques (MISTs) for the treatment of benign prostatic hyperplasia (BPH)-associated lower urinary tract symptoms (LUTS). Prostatic artery embolization (PAE) uses selective angioembolization of prostatic arteries, thereby reducing size to improve LUTS/BPH. However, real-world data comparing surgical outcomes between MISTs and tissue resective techniques are lacking. We assessed the differences in surgical outcomes between PAE, transurethral resection of the prostate (TURP), and prostatic urethral lift (PUL) in a real-world population for LUTS/BPH. We present an observational population-based study of 12,902 men with BPH in New York State who received PAE, TURP, and PUL in outpatient and ambulatory surgery settings from 2014 to 2018. For short-term outcomes, we report 30-day and 90-day risks of readmission to inpatient and emergency room (ER) with/without complications and compared them across groups using χ2 tests and mixed-effect logistic regressions. For long-term outcomes, we report surgical retreatment and stricture rates using Kaplan-Meier failure curves and compared them using Log rank tests and Cox regression models. Of 12 902 men, 335 had PAE, 11,205 had TURP, and 1362 had PUL. PAE patients had the highest 30-day (19.9%) and 90-day (35.6%) risks of readmission to inpatient or ER (p < 0.01). Non-specific abdominal pain was the main diagnosis associated with 30-day and 90-day readmissions to inpatient or ER after PAE (14.3% and 26.8%, respectively). After 2years of follow-up, PAE patients had the highest retreatment rate of 28.5% (95%CI 23.7-34.2%) compared to TURP (3.4% (95%CI 3.1-3.8%)) and PUL (8.5% (95%CI 5.6-12.9%)) (p < 0.001). In a real-world population, PAE was associated with the most frequent 30-day and 90-day readmission to inpatient or ER and the highest retreatment rate among all surgical techniques even when controlled for individual patient comorbidities and surgical volume.

Glycemic outcomes in patients with type 2 diabetes after bariatric surgery compared with routine care: a population-based, real-world cohort study in the United Kingdom.

Clinical trials have shown that bariatric surgery (BS) is associated with better glycemic control and diabetes remission in patients with type 2 diabetes (T2D) compared with routine care. We conducted a real-world population-based study examining the impact of BS on glycemic control and medications in patients with T2D. This was a retrospective, matched, controlled cohort study conducted between January 1, 1990, and January 31, 2018, using IQVIA Medical Research Data, a primary care electronic records database. Adults with body mass index (BMI) ≥30 kg/m2 and T2D who had BS (surgical) were matched for age, sex, BMI, and diabetes duration to two controls (with T2D and no BS). A total of 1126 patients in the surgical group and 2219 patients in the control group were analyzed. Mean (standard deviation) age was 50.0 (9.3) years, 67.6% were women, baseline glycocylated hemoglobin (HbA1C) was 7.8% (1.7 mmol/mol), and diabetes duration was 4.7 years (range, 2.0-8.4 years). Over a median (interquartile range) follow-up of 3.6 years (1.7-5.9 years), a higher proportion of patients in the surgical group achieved an HbA1C of ≤6.0% than the control group (65.8% versus 22.8%). The surgical group showed a decrease in mean HbA1C of 1.5% (95% confidence interval [CI]: 1.4%-1.7%), 1.4% (1.2%-1.5%), and 1.3% (1.1%-1.5%) at 1-, 2-, and 3-year follow-up, respectively, whereas HbA1C increased in the control group. The proportion of patients receiving glucose-lowering medications decreased in the surgical group (92.2% to 66.5%) but increased in the control group (85.3% to 90.2%). BS is associated with significant improvement in glycemic control, achievement ofnormal HbA1C levels, and reduced need for glucose-lowering therapy in patients with T2D.

P1727: EPIDEMIOLOGICAL TRENDS OF HAEMATOLOGICAL MALIGNANCIES IN BELGIUM 2004-2018: OLDER PATIENTS SHOWED THE GREATEST IMPROVED SURVIVAL OVER TIME

Background: Haematological malignancies (HM) are common (11% of the total cancer burden in Belgium in 2018) and, at the same time, they represent a heterogeneous group of rare malignancies, which are distinguished by specific clinico-biological characteristics, behaviour and outcome. Aims: We aim to analyse in more depth the epidemiological trends of HM in Belgium over a recent 15-year period, with a particular focus on the impact of age at diagnosis on the incidence and the survival trends by type of HM. Methods: The Belgian Cancer Registry (BCR) is a population based national cancer registry, collecting data since incidence year 2004. We studied the 23 main HM types (see Figure 1), representing 98% of all HM cases (N = 92.202), diagnosed between 2004 and 2018. Patients follow-up was available until 01/07/2020. We estimated age-standardised (WSR) incidence, incidence trends (Average Annual Percentage Change or AAPC), projections up to 2025, 5- & 10-year relative survival (RS), conditional RS and RS trends for the 23 main types of HM. Results: During the period 2004-2018, the WSR incidence rates of HM increased in Belgium (AAPC: 1.2%) and mainly in the older population (70+), while they remain stable in children. The greatest increase is observed for BCR/ABL1-negative chronic myeloid neoplasms. The 10-yr RS varies by age group and HM type. ALL shows the greatest age variation, from >90% in children under age 10 to <20% in adults 70+. For each type of HM, outcome gets progressively worse with age. The greatest decrease in 5yr-RS with age is observed for aggressive HM, such as AML, ALL/LL and BL: from 67%, 90% and 97% respectively in children and adolescents (0-19 yr) to 2%, 12% and 16% in adults 80+, respectively. The 5-yr RS of all HM has increased over the 15 years with 5 percentage point (pp) from 64% in 2004-08 to 69% in 2014-18 (Table 1). The greatest improvement is seen in ALL (+14 pp), followed by IPD and HDCN (+11 pp). No clear improvement is observed for most myeloid neoplasms except CML. Analysis by age group reveals larger increases in survival over time. The most impressive increases are seen in the older patients (80+), with +45 pp in HL (from 21% in 2004-2008 to 66% in 2014-2018), followed by IPD (+33 pp), FL (+28 pp), CML (+16 pp), PMF (+13 pp), CLL/SLL (+12pp) and MCL (+11pp). A strong improvement (+22 pp) is also observed for ALL/LL in the 60-79 age group, even if the 5y-RS remains low (37% over the 2014-18period). Young adults (20-39 yr) with BL showed great improvement (+21%) with survival progressing towards the level seen in children. PNK/TCL and MDS showed the greatest increase (+14 pp and +13pp respectively) in adults (20-59 yr), and AML (+17 pp) in children. Image:Summary/Conclusion: The increase in incidence and the improvement in survival during the period 2004-2018 can be partly explained by the diagnostic and therapeutic innovations over the 2 last decades. This real-world population-based study provides useful information on patients usually excluded from clinical trials (those with advanced age, comorbidities, other malignancies).Older patients showed the greatest improvement over time. However, this study also highlights entities that need more attention for improvement, such as AML and MDS.

A nomogram to predict the prognosis of advanced soft tissue sarcoma patients treated with anlotinib: A real-world population-based study.

e23550 Background: The ALTER0203 randomized controlled trial proved the antitumor activity of anlotinib, a multitargeted tyrosine kinase inhibitor, in 8 subtypes of advanced refractory soft tissue sarcoma (STS). Our previous studies have shown that anlotinib showed antitumor activity in more than 30 STS pathological subtypes in the real world. This study further constructed a nomogram to predict the prognosis of advanced STS patients treated with anlotinib based on real-world data. Methods: We retrospectively analyzed the data of patients with unresectable locally advanced or metastatic STS who received at least one dose of anlotinib from June 2018 to March 2021. A nomogram was developed to predict the survival probability based on the multivariate analysis. The performance of the nomogram was evaluated by concordance index, bootstrap resampling calibration curve and time-dependent ROC curve. Results: A total of 209 patients were included in this study. The median age was 48 years (range 11-85 years), and the median follow-up time was 18.7 months. Based on five independent prognostic factors including ECOG performance status, FNCLCC grade G2-3, poor nutrition, increased neutrophil count, and treatment patterns according to the multivariate analysis, we constructed a nomogram to predict the prognosis of advanced STS patients treated with anlotinib. The concordance index was 0.780. For the prediction of 1-year and 2-year overall survival probability according to the nomogram, the area under the receiver operating characteristic curve was 0.833 and 0.829, respectively. Conclusions: The nomogram based on ECOG performance status, FNCLCC grade, nutritional status, neutrophil count, and treatment patterns can accurately predict the 1-year and 2-year OS probability for advanced STS patients treated with anlotinib.

Increased Risk of Hypothyroidism in People with Asthma: Evidence from a Real-World Population-Based Study.

Background: Non-T2 asthma and hypothyroidism share several inflammatory mechanisms in common. However, large-scale, real-world studies evaluating the association between asthma and hypothyroidism are lacking. The objective of this study was to evaluate the risk for asthma patients of developing hypothyroidism. Methods: In the retrospective cohort study, people with asthma were recruited from the Longitudinal Health Insurance Database in Taiwan. After excluding ineligible patients with a previous history of hypothyroidism, 1:1 propensity matching was conducted to select a non-asthma control group. Based on the multivariate Cox regression model, the adjusted hazard ratio of asthma patients developing hypothyroidism was calculated. Results: In total, 95,321 asthma patients were selected as the asthma group and the same amount of people without asthma were selected as the control group. The incidence levels of new-onset hypothyroidism in asthma and non-asthma groups were 8.13 and 6.83 per 100,000 people per year, respectively. Compared with the non-asthma group, the adjusted hazard ratio of the asthma group developing hypothyroidism was 1.217 (95% confidence interval, 1.091–1.357). Conclusions: We found having asthma to be associated with an increased risk of hypothyroidism. Clinicians should be concerned regarding the endocrinological and inflammatory interaction between the two diseases while caring for people with asthma.

Real-World Estimation of First- and Second-Line Treatments for Diffuse Large B-Cell Lymphoma Using Health Insurance Data: A Belgian Population-Based Study.

We determined first- and second-line regimens, including hematopoietic stem cell transplantations, in all diffuse large B cell lymphoma (DLBCL) patients aged ≥20 yr (n = 1,888), registered at the Belgian Cancer Registry (2013–2015). Treatments were inferred from reimbursed drugs, and procedures registered in national health insurance databases. This real-world population-based study allows to assess patients usually excluded from clinical trials such as those with comorbidities, other malignancies (12%), and advanced age (28% are ≥80 yr old). Our data show that the majority of older patients are still started on first-line regimens with curative intent and a substantial proportion of them benefit from this approach. First-line treatments included full R-CHOP (44%), “incomplete” (R-)CHOP (18%), other anthracycline (14%), non-anthracycline (9%), only radiotherapy (3%), and no chemo-/radiotherapy (13%), with significant variation between age groups. The 5-year overall survival (OS) of all patients was 56% with a clear influence of age (78% [20–59 yr] versus 16% [≥85 yr]) and of the type of first-line treatments: full R-CHOP (72%), other anthracycline (58%), “incomplete” (R-)CHOP (47%), non-anthracycline (30%), only radiotherapy (30%), and no chemo-/radiotherapy (9%). Second-line therapy, presumed for refractory (7%) or relapsed disease (9%), was initiated in 252 patients (16%) and was predominantly (71%) platinum-based. The 5-year OS after second-line treatment without autologous stem cell transplantation (ASCT) was generally poor (11% in ≥70 yr versus 17% in <70 yr). An ASCT was performed in 5% of treated patients (n = 82). The 5-year OS after first- or second-line ASCT was similar (69% versus 66%). After adjustment, multivariable OS analyses indicated a significant hazard ratio (HR) for, among others, age (HR 1.81 to 5.95 for increasing age), performance status (PS) (HR 4.56 for PS >1 within 3 months from incidence), subsequent malignancies (HR 2.50), prior malignancies (HR 1.34), respiratory and diabetic comorbidity (HR 1.41 and 1.24), gender (HR 1.25 for males), and first-line treatment with full R-CHOP (HR 0.41) or other anthracycline-containing regimens (HR 0.72). Despite inherent limitations, patterns of care in DLBCL could be determined using an innovative approach based on Belgian health insurance data.

A0716 - Prostatic artery embolization compared to trans-urethral resection of the prostate and prostatic urethral lift: A real-world population-based study

A0716 - Prostatic artery embolization compared to trans-urethral resection of the prostate and prostatic urethral lift: A real-world population-based study

Incidence and Predictors of Synchronous Bone Metastasis in Newly Diagnosed Differentiated Thyroid Cancer: A Real-World Population-Based Study

BackgroundClinical and sociodemographic characteristics of differentiated thyroid cancer (DTC) patients with synchronous bone metastasis (SBM) remain unclear. This real-world study aimed to elucidate the incidence and prognosis of DTC patients with SBM using population-based data.MethodsData of patients with newly diagnosed DTC from 2010 to 2016 were retrieved from the Surveillance, Epidemiology, and End Results (SEER) database. Multivariable logistic regression analysis was utilized to identify predictors of developing SBM in patients with DTC and was further evaluated by receiver operator characteristics (ROC) analysis. Multivariable Cox regression was applied to identify prognostic factors associated with overall survival (OS) and cancer-specific survival (CSS).ResultsA total of 67,176 patients with DTC were screened from the database, with 0.36% (244/67,176) developed SBM. The age-adjusted incidence of SBM in patients with DTC was relatively stable during the study period with an average annual percentage change (AAPC) of 2.52. Multivariable logistic regression analysis recognized seven factors (older age, male gender, black race, other races, follicular histology, the American Joint Committee on Cancer (AJCC) T2, T3, T4 staging, and N1 staging) as predictors of developing SBM among the entire cohort, with the value of area under the curve (AUC) of 0.931 (95% CI: 0.915–0.947). The median survival time of DTC patients with SBM was 22 months (interquartile range, 7–47 months). The multivariable Cox regression analysis indicated multiple metastatic sites, surgical procedures, and chemotherapy as predictors for the survival of patients.ConclusionsPredictors and prognostic factors of SBM in patients with DTC were identified in this study. Patients with risk factors should be given more attention in clinical practice.

DOP26 COVID-19 vaccine effectiveness in Inflammatory Bowel Disease patients on tumor-necrosis factor inhibitors: Real world data from a mass-vaccination campaign

BackgroundSome studies have shown decreased serological response to vaccination in patients on anti-tumor necrosis factor (TNF) medications. While the large majority of these patients do seroconvert after vaccination, titers have generally been lower and one study showed reduced neutralizing and inhibitory functions. One real-world population-based study compared found no increased infection rate in anti-TNF treated patients, but infection rates were low. The low event rate mandates exploration in longer-term population-based data. We used the epi-Israeli IBD Research Nucleus (IIRN) database to explore the effectiveness of COVID-19 vaccination in IBD patients in Israel.MethodsWe included all IBD patients insured in two of the four Israeli HMOs, covering 35% of the population, by validated algorithms, and selected those who received two doses of Pfizer BNT162b2 vaccine. These were matched by date of vaccination ±3 days and demographic variables to non-IBD controls. The primary outcome was incidence of positive COVID-19 PCR following vaccination between December, 2020 to June, 2021.Results12,640 IBD patients received two vaccine doses; the matched cohort included 4,946 matched pairs (total 9,892 subjects). Mean age was 50.5±16.1 years and median follow-up was 22 weeks (range 4.1–24.4). Fifteen (0.3%) vaccinated IBD patients tested positive compared with 15 (0.3%) vaccinated non-IBD controls (OR=1 [95%CI 0.49–2.05], p=1.0). Patients on anti-TNF and/or corticosteroids did not have a higher incidence of positivity – neither compared to the entire group nor to IBD patients treated with vedolizumab/ustekinumab, even after precise matching for demographics, underlying diseases and IBD severity.ConclusionIn a large population-based cohort of IBD patients in Israel, vaccine effectiveness was equivalent to non-IBD controls and was not influenced by treatment with anti-TNF or corticosteroids. Notwithstanding previous findings of impaired serological response in anti-TNF treated IBD patients, this real-world large-scale study shows that vaccine protection is robust in IBD patients, including those on immunosuppressive medications.

Evaluation of Different Breast Cancer Screening Strategies for High-Risk Women in Beijing, China: A Real-World Population-Based Study.

BackgroundMammography-based breast cancer screening has been widely implemented in many developed countries. Evidence was needed on participation and diagnostic performance of population-based breast cancer screening using ultrasound in China.MethodsWe used data from the Cancer Screening Program in Urban China in Beijing from 2014 to 2019 and was followed up until July 2020 by matching with the Beijing Cancer Registry database. Eligible women between the ages of 45 and 69 years were recruited from six districts and assessed their risk of breast cancer through an established risk scoring system. Women evaluated to be at high risk of breast cancer were invited to undergo both ultrasound and mammography. Participation rates were calculated, and their associated factors were explored. In addition, the performance of five different breast cancer screening modalities was evaluated in this study.ResultsA total of 49,161 eligible women were recruited in this study. Among them, 15,550 women were assessed as high risk for breast cancer, and 7,500 women underwent ultrasound and/or mammography as recommended, with a participation rate of 48.2%. The sensitivity of mammography alone, ultrasound alone, combined of ultrasound and mammography, ultrasound for primary screening followed by mammography for triage, and mammography for preliminary screening followed by ultrasound for triage were19.2%, 38.5%, 50.0%, 46.2%, and 19.2%, and the specificity were 96.1%, 98.6%, 94.7%, 97.6%, 95.7%, respectively. The sensitivity of combined ultrasound and mammography, ultrasound for primary screening followed by mammography for triage, was significantly higher than mammography alone (p=0.008 and p=0.039). Additionally, ultrasound alone (48,323 RMB ($7,550)) and ultrasound for primary screening followed by mammography for triage (55,927 RMB ($8,739)) were the most cost-effective methods for breast cancer screening than other modalities.ConclusionsUltrasound alone and ultrasound for primary screening and mammography are superior to mammography for breast cancer screening in high-risk Chinese women.

Outcomes of non-metastatic poorly differentiated gastroenteropancreatic neuroendocrine neoplasms treated with surgery: a real-world population-based study.

To assess the outcomes of non-metastatic poorly differentiated gastroenteropancreatic neuroendocrine neoplasms (GEP-NENs) treated with radical surgery. Surveillance, Epidemiology, and End Results (SEER) database (1998-2015) was accessed, and patients with non-metastatic poorly differentiated/undifferentiated GEP-NENs were reviewed. Multivariable Cox regression analysis was used to evaluate factors affecting overall survival (OS) and cancer-specific survival (CSS). Patients treated with radical surgery were matched to those who did not undergo surgery through propensity score matching and Kaplan-Meier survival estimates were used to evaluate the impact of surgery in the post-propensity cohort. A total of 1517 patients were included. Within multivariable Cox regression models and compared to no surgery, radical surgery was associated with improved OS (HR: 0.41; 95% CI: 0.34-0.50) and CSS (HR: 0.37; 95% CI: 0.29-0.47). A total of 233 patients who underwent no surgery were then matched to 233 patients who underwent radical surgery. Within the post-propensity cohort, radical surgery was associated with improved OS (P < 0.001). Radical surgery is associated with improved survival outcomes in patients with non-metastatic poorly differentiated GEP-NENs. Further studies are required to better identify the best timing of radical surgery within the context of multimodal management.

In-home Compared With In-Clinic Warfarin Therapy Monitoring in Mechanical Heart Valves: A Population-Based Study.

ObjectiveTo evaluate differences in time in therapeutic range (TTR), major bleeding, thromboembolism, and survival comparing in-home and in-clinic international normalized ratio monitoring for patients with mechanical heart valves receiving warfarin anticoagulation.Patients and MethodsAn observational population-based study of 383 patients (mean ± SD age, 61.5±14.1 years; 38.6% female) with mechanical heart valves (aortic, 77.8%; mitral, 31.1%; tricuspid, 1%; pulmonic 0.2%; and multiple, 9.7%) was performed from January 1, 2012, through December 31, 2017. The target international normalized ratio was 2.5 for 199 patients (52.0%) and 3.0 for 184 (48.0). Of these patients, 37.9% (n=145) were managed by in-home monitoring (cases) and 62.1% (n=238) were monitored in the clinic (controls).ResultsDuring median follow-up of 3.1 years, mean ± SD TTR was similar between in-home (66.6%±19.2%) and in-clinic (67.2%±19.8%) monitoring (P=.76). There were no differences between the in-home and in-clinic groups regarding survival to major bleeding (5.7% per person-year vs 6.7% per person-year; P=.66) or thrombotic complications (2.3% vs 1.8%; P=.56). In-home monitoring was associated with reduced all-cause mortality (hazard ratio, 0.40; 95% CI, 0.19 to 0.83; P=.01) on univariate analysis; however, this was no longer apparent when controlling for age and baseline left ventricular ejection fraction.ConclusionIn this real-world population-based study of patients with mechanical heart valves, in-home monitoring was equivalent to in-clinic monitoring regarding TTR and important clinical outcomes.