Administrative Healthcare Databases Research Articles

Prognosis and Survival in Idiopathic Pulmonary Fibrosis in the Era of Antifibrotic Therapy in Italy: Evidence from a Longitudinal Population Study Based on Healthcare Utilization Databases.

The aim was to evaluate the determinants of acute exacerbation (AE) and death in new cases of idiopathic pulmonary fibrosis (IPF) using administrative databases in the Marche Region. Adults at their first prescription of antifibrotics or hospitalization with a diagnosis of IPF occurring in 2014-2019 were considered as new cases. Multiple Cox regression was used to estimate the risk of AE and of all-cause mortality adjusted by demographic and clinical characteristics, stratifying patients according to antifibrotic treatment. Overall, 676 new cases of IPF were identified and 276 deaths and 248 AE events occurred. In never-treated patients, the risk of AE was higher in patients with poor health conditions at diagnosis; the risk of death was higher in males, in patients aged ≥75 and in those with poor health conditions at baseline. The increasing number of AEs increased the risk of death in treated and never-treated patients. Within the limits of an observational study based on secondary data, the combined use of healthcare administrative databases allows the accurate analysis of progression and survival of IPF from the beginning of the antifibrotic therapy era, suggesting that timely and early diagnosis is critical to prescribing the most suitable treatment to increase survival and maintain a healthy life expectancy.

Association of topical glaucoma medications with lacrimal drainage obstruction and eyelid malposition.

Adverse effects of topical glaucoma medications (TGMs) may include development of ocular adnexal disorders. We undertook a study to determine the effect of TGMs on the risk of developing lacrimal drainage obstruction (LDO) and eyelid malposition. All patients 66 years of age and older in Ontario, Canada initiating TGM and all patients diagnosed with glaucoma/suspected glaucoma but not receiving TGM from 2002 to 2018 were eligible for inclusion in this retrospective cohort study. Using validated healthcare administrative databases, cohorts were identified with TGM and no TGM patients matched 1:2 on sex and birth year. The effect of TGM treatment on risk of surgery for LDO and lid malpositions was estimated using Kaplan-Meier and Cox proportional hazards models. Cohorts included 122,582 patients in the TGM cohort and 232,336 patients in the no TGM cohort. Among the TGM cohort there was decreased event-free survival for entropion (log-rank P < 0.001), trichiasis (P < 0.001), and LDO (P = 0.006), and increased ectropion-free survival (P = 0.007). No difference in ptosis-free survival was detected (P = 0.78). For the TGM cohort there were increased hazards for entropion (hazard ratio [HR] 1.24, 95% confidence interval [CI] 1.12-1.37; P < 0.001), trichiasis (HR 1.74, 95% CI 1.57-1.94; P < 0.001), and LDO (at 15 years: HR 2.39, 95% CI 1.49-3.85; P = 0.004), and a decreased hazard for ectropion (HR 0.89, 95% CI 0.81-0.97; P = 0.008). No association between TGM treatment and ptosis hazard was detected (HR 0.99, 95% CI 0.89-1.09; P = 0.78). TGMs are associated with an increased risk of undergoing surgery for LDO, entropion, and trichiasis.

Impact of rheumatoid arthritis and methotrexate on pregnancy outcomes: retrospective cohort study of the Italian Society for Rheumatology

ObjectiveTo evaluate the impact of rheumatoid arthritis (RA) and methotrexate (MTX) on the probability of becoming pregnant, pregnancy losses, elective termination of pregnancy (TOP) and congenital malformations.MethodsA retrospective cohort study...

Long-term persistence of second-line biologics in psoriatic arthritis patients with prior TNF inhibitor exposure: a nationwide cohort study from the French health insurance database (SNDS)

IntroductionTumour necrosis factor inhibitor (TNFi) agents are most often the first-choice biological treatment for patients with psoriatic arthritis (PsA). When their discontinuation is needed, a switch to another TNFi or...

Wykorzystanie baz danych Narodowego Funduszu Zdrowia przy ocenie dowodów naukowych z praktyki klinicznej

The use of the National Health Fund databases as a source of real-world evidence Patient medical records and administrative healthcare databases are possible sources of real-world evidence (RWE), i.e., evidence on the potential benefits and risks of a medical product. RWE can complement the evidence from randomized clinical trials. The wide range of information collected by the National Health Fund (NFZ) and the Ministry of Health in Poland ensures the versatility of the data that cover almost all patients treated in Poland. In addition to administrative data (without detailed information about patients and their disease), electronic medical records of some patient groups can be obtained from special programs (e.g., KOS-Zawał) or the System of Monitoring Drug Programs (SMPT). Low usage (only 37 studies) but high usability of NFZ databases as a source of RWE were identified. Joint analysis of data from administrative databases and SMPT can increase the credibility of the study, but limits the study to only patients treated within the Drug Programs.

Association of Concomitant Gestational Hypertensive Disorders and Gestational Diabetes With Cardiovascular Disease

Accruing evidence suggests that gestational hypertensive disorders (GHTD) and gestational diabetes (GD) are each associated with an increased risk of cardiovascular disease (CVD). However, the extent to which the co-occurrence of GHTD and GD is associated with the risk of CVD remains largely unknown. To estimate the individual and joint associations of GHTD and GD with incident CVD. This population-based cohort study used the Ministry of Health and Long-Term Care of Ontario (Canada) health care administrative databases. All women in Ontario with a GHTD and/or GD diagnosis, and a live-birth singleton delivery between July 1, 2007, and March 31, 2018, were considered for inclusion. Women with pregravid diabetes, hypertension, or cardiovascular disease were excluded. Statistical analysis was performed from November 2021 to September 2022. GD and/or GHTD, defined using diagnosis coding. Individual and joint associations of GHTD and GD with incident CVD (including a composite of myocardial infarction, acute coronary syndrome, stroke, coronary artery bypass grafting, percutaneous coronary intervention, or carotid endarterectomy), estimated using Cox regression models, adjusting for relevant cardiometabolic risk factors. The follow-up extended from the index pregnancy until March 31, 2020. Among 886 295 eligible women (mean [SD] age, 30 [5.6] years; 43 861 [4.9%] with isolated GHTD, 54 061 [6.1%] with isolated GD, and 4975 [0.6%] with GHTD and GD), there were 1999 CVD events over 12 years of follow-up. In the early postpartum phase (first 5 years post partum), there was no association of co-occurrence of GTHD and GD (adjusted hazard ratio [aHR], 1.42, 95% CI, 0.78-2.58) or GD alone (aHR, 0.80; 95% CI, 0.60-1.06) with CVD; there was an association between isolated GTHD and incident CVD compared with no GTHD and no GD (aHR, 1.90; 95% CI, 1.51-2.35). In the late postpartum period (after the initial 5 years post partum), compared with no GD and no GHTD, isolated GHTD (aHR, 1.41, 95% CI, 1.12-1.76) and co-occurrence of GHTD and GD (aHR, 2.43, 95% CI, 1.60-3.67) were each associated with a higher risk of incident CVD. There was no association between isolated GD and incident CVD. In this cohort study, GHTD was associated with a high risk of CVD post partum, and the co-occurrence of GD and GHTD was associated with a much greater postpartum CVD risk. These findings suggest that CVD preventive care is particularly needed in the aftermath of combined GD and GHTD.

Effectiveness of community hospital post-acute care on mortality, re-admission, institutionalization, and activation of a home care programme in Emilia-Romagna region, Italy.

In Italy, there is scant evidence on the impact of Community Hospitals (CHs) on clinical outcomes. To assess the effectiveness of CHs versus long-term care hospital or inpatient rehabilitation facilities on mortality, re-admission, institutionalization, and activation of a home care programme in the Emilia-Romagna Region (ERR-Italy) after acute hospitalisation. We implemented a cohort study drawing upon the ERR Administrative Healthcare Database System and including hospital episodes of ERR residents subject ≥ 65years, discharged from a public or private hospital with a medical diagnosis to a CH or to usual care between 2017 and 2019. To control for confounding, we applied a propensity score matching. Patients transferred to CHs had a significantly lower risk of dying but an increased risk of being readmitted to community or acute hospital within 30/90days from discharge. The hazard of institutionalisation within 30/90days was significantly lower in the whole population of the CH exposed group but not among patients with cardiac or respiratory chronic diseases or diabetes. The activation of a home care program within 90days was slightly higher for those who were transferred to a CH. The findings of our study show mixed effects on outcomes of patients transferred to CHs compared to those who followed the post-acute usual care and should be taken with cautious as could be affected by the so-called 'confounding by indication'. The study contributes to the intermediate care available evidence from a region with a well-established care provision through CHs.

Phase-Specific Costs of Care in Hematological Malignancies in Ontario, Canada

Background: Hematological malignancies contribute a significant economic burden to health care systems. Therefore, to improve health care system planning, this Canadian study analyzed real-world data to estimate phase-specific costs and health care resource utilization for patients with hematological malignancies. Methods: A cohort of adult patients diagnosed with hematological malignancies (diffuse large B-cell lymphoma [DLBCL], Hodgkin lymphoma [HL], follicular lymphoma [FL], chronic lymphocytic leukemia [CLL], multiple myeloma [MM], acute myeloid leukemia [AML], acute lymphocytic leukemia [ALL], and others) were identified between 2003-2014 from the Ontario Cancer Registry (OCR) and linked to treatment data from Cancer Care Ontario and other provincial administrative health care databases. Health system costs and resource utilization were determined for four defined phases of care in which index date was defined as the diagnosis date, including: pre-diagnosis (90 days prior to index date), initial treatment (index date to 6 months), follow-up (end of treatment phase to beginning of end-of-life or completion of cohort follow-up) and end-of-life (last 6 months of life for patients who died). Costs (Canadian dollars in 2014) and resource utilization were normalized to 30-days. Results: There were 35,556 individuals (45% females and 55% males) diagnosed with hematological malignancies. The median age of diagnosis was 64 (IQR: 53-74) years. The median follow-up was 1,874 (IQR: 1,232-2,814) days. At follow-up completion, 26,092 (73.4%) individuals were alive. The median survival time among those who died was 1,005 (568-1,682) days. The phase-specific costs were highest overall in AML and ALL for the initial treatment and end-of-life phases; the costs were $1,169 (±3,230) and $733 (±1,787) for pre-diagnosis, $12,424 (±8,181) and $10,565 (±9,823) for initial treatment, $4,051 (±6,152) and $3,033 (±5,991) for follow-up, as well as $11,815 (±13,973) and $13,484 (±12,039) for end-of-life for AML and ALL, respectively. The phase-specific costs of care for DLBCL and HL were $1,175 (±2,267) and $813 (±1,541) in the pre-diagnosis phase, $9,166 (±5,581) and $5,474 (±3,485) in the initial treatment phase, $1,462 (±2,757) and $895 (±1,619) in the follow-up phase, and $7,966 (±7,104) and $8,679 (±9,087) in the end-of-life phase. For MM, the costs were $1,537 (±3,011) in pre-diagnosis, $7,254 (±6,870) in initial treatment, $4,100 (±4,217) in follow-up, and $9,820 (±8,294) in end-of-life. In comparison, the costs of care for FL and CLL were less in the initial treatment phase but remained elevated in the end-of-life phase; the costs were $775 (±1,798) and $674 (±1,902) in pre-diagnosis, $3,884 (±3,997) and $1,610 (±3,345) in initial treatment, $1,253 (±1,744) and $1,010 (±1,827) in follow-up, and $7,310 (±6,852) and $6,189 (±6,413) in end-of-life phases. Across the phases, the key cost driver was inpatient care. In particular, the increased costs due to inpatient care for the initial treatment and end-of-life phases, respectively, were: $3,864 (±5,013) and $5,045 (±5,908) for DLBCL; $2,384 (±3,712) and $6,441 (±8,129) for HL; $2,131 (±3,502) and $5,146 (±5,612) for FL; $2,435 (±3,860) and $4,498 (±5,582) for CLL; $3,798 (±4,847) and $5,026 (±6,788) for MM; $9,330 (±6,985) and $7,941 (±9,063) for AML; and $8,133 (±8,178) and $10,144 (±10,780) for ALL. The second largest contributor to the cost of care, particularly in the initial treatment phase, was the cost of cancer treatment medication; $3,115 (±1,236) for DLBLC, $1,132 (±766) for HL, $2,851 (±1,755) for FL, $1,069 (±1,549) for CLL, $1,602 (±1,877) for MM, $843 (±1,429) for AML, and $494 (±756) for ALL. Of note, the cost of cancer treatment medication remains elevated for MM across the phases after diagnosis; $1,602 (±1,877) in initial treatment, $1,622 (±2,160) in follow-up, and $2,078 (±2,697) in end-of-life. Conclusions: In general, the mean total costs were highest in the initial treatment and end-of-life phases, and lowest in the pre-diagnosis and follow-up phases of care for all hematological malignancies, following a U-shaped pattern. Inpatient care was the cost driver across all phases. These findings can help allocate appropriate resources throughout the different phases of cancer care for hematological malignancies, with particular focus on improving access to palliative-care at end-of-life. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

The Impact of Drug Interactions on Outcomes in Ibrutinib-Treated Patients with Chronic Lymphocytic Leukemia in Routine Clinical Care: A Population-Based Cohort Study

Introduction: Ibrutinib is extensively metabolized by cytochrome P450 CYP3A and drug interactions pose a considerable challenge with its use in B-cell malignancies. Patients with chronic lymphocytic leukemia (CLL) are often older with multiple comorbidities and complex medication histories. In this study, we aimed to evaluate the impact of drug interactions, in particular CYP3A inducers and inhibitors, on survival in patients with CLL treated with ibrutinib in routine clinical care. Methods: We conducted a population-based cohort study using linked administrative healthcare databases from Ontario, Canada. All Ontario residents aged ≥66 years with CLL started on ibrutinib between January 2007 and March 2019 were identified and followed from the date of first ibrutinib prescription (index date) until March 1, 2020. The observation window was terminated in the event of death, no ibrutinib prescription for 120 days, or at the time of allogenic stem cell transplant, whichever occurred first. Cumulative medication exposure (30-day increments) to concomitant CYP3A inducers and/or CYP3A inhibitors were examined from 90 days prior to index date to the end of the observation window as a time-varying covariate. A comprehensive list of CYP3A inducers and inhibitors were obtained from the FDA (2020) and Flockhart Table of Cytochrome P450 Drug Interactions (Flockhart et al., 2021). The primary outcome was overall survival (OS). Cox regression, controlling for comorbid disease burden (aggregated diagnosis groups; ADG), ibrutinib dose (full vs. reduced) and sociodemographic factors (age, sex) examined the relationship between medication exposure and OS. Results: We identified 642 patients with CLL treated with ibrutinib in Ontario between January 1, 2007 and March 1, 2019. The median age was 74 years (interquartile range (IQR), 69 - 80), 34.4% were female with a median weighted ADG score of 17 (IQR, 8 - 25), indicating a high burden of comorbidities in our cohort. At baseline, 563 (87.7%) patients received full-dose ibrutinib and 372 patients (57.9%) were on ibrutinib as first-line therapy. The median follow-up time from ibrutinib initiation was 2 years (IQR, 1.3 - 3.0) with 162 deaths (25.2%) and the median OS was not reached. During the study period, 131 patients (20.4%) received a concomitant CYP3A inducer, and 179 patients (27.9%) received a concomitant CYP3A inhibitor. On univariate analysis, we identified an association of increased risk of all-cause death with increased age (hazard ratio [HR] 1.06, 95% confidence interval [CI] 1.04 - 1.08, p <0.0001), exposure to a concomitant CYP3A inducer (HR 1.04, 95% CI 1.01 - 1.07, p = 0.009), and greater comorbid disease burden (HR 1.02, 95% CI 1.00 - 1.03, p = 0.01). Exposure to concomitant CYP3A inhibitors was not significantly associated with all-cause death (HR 1.00, 95% CI 0.98 - 1.02, p = 0.84). Multivariable analysis adjusting for age, sex, comorbid disease burden and ibrutinib dose (full vs. reduced) demonstrated an increased risk of death for patients on a concomitant CYP3A inducer (HR 1.04 for each 30-day increase in exposure, 95% CI 1.01 - 1.07, P = 0.016; see table) whereas CYP3A inhibitors had no significant effect on all-cause death (HR 0.99, 95% CI 0.97 - 1.01, P = 0.43). The most common cause of death for patients on a concomitant CYP3A inducer, where known, was CLL (54.9%). Conclusions: Despite known drug interactions, CLL patients on ibrutinib and concomitant CYP3A inducers/inhibitors is common in routine clinical care. We demonstrate an association between CYP3A inducer exposure and an increased risk of death, which may be in part due to decreased ibrutinib levels. Our study highlights the importance of pharmacovigilance. Further analyses are underway to better understand the impact of drug interactions on ibrutinib treatment complications Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Utilization Trends of Novel Hormonal Agents in Metastatic Castration-Resistant Prostate Cancer in Quebec.

The introduction of novel hormonal agents (NHAs) such as abiraterone acetate (ABI) and enzalutamide (ENZ) for metastatic castration-resistant prostate cancer (mCRPC) was an important milestone given their survival benefits, tolerability, and ease of administration relative to taxane chemotherapies. This descriptive study sought to describe the utilization trends of ABI and ENZ in patients with mCRPC in the early years after their approval in the province of Quebec in Canada. A retrospective population-based cohort was extracted from Quebec public healthcare administrative databases. The cohort included first-time users of NHAs (ABI or ENZ) from 2011 to 2016. The primary analyses aimed to describe the overall temporal trends (2011-2016) of NHA initiators by chemotherapy status (chemotherapy-naïve versus post-chemotherapy), and prescribing specialty (medical oncology versus urology versus others). The cohort comprised 2183 patients, with 1562 (72%) in the chemotherapy-naïve group and 621 (28%) in the post-chemotherapy group. While the majority of patients were post-chemotherapy NHA initiators in 2012, this proportion decreased over time and accounted for only 13% of NHA initiators by the end of 2016. Medical oncologists were the most frequent prescribers of NHAs (upwards of 60%) throughout 2012 but fell to 45% by the end of 2016. Conversely, the proportion of prescriptions by urologists increased from 22% in 2012 to 42% in 2016. Over time, there was an increasing proportion of (1) patients who initiated NHAs without prior chemotherapy treatment, (2) NHA prescribing by urologists, and (3) ENZ users. Taken together, this implies that the introduction of NHAs has altered the management of mCRPC and urologists quickly adopted NHAs into their practice.

Abstract 11522: Impact of Chronic Glucagon-Like Peptide-1 Receptor Agonist and Sodium Glucose Cotransporter-2 Inhibitor Therapy on In-Hospital Outcomes of Patients Hospitalized With Acute Myocardial Infarction

Introduction: Glucagon-like peptide-1 receptor agonists (GLP-1 RA) and sodium glucose cotransporter-2 inhibitors (SGLT-2i) demonstrated cardiovascular and renal protection in addition to their glucose-lowering effect. Whether their benefits occur also in patients with diabetes mellitus (DM) during hospitalization with acute myocardial infarction (AMI) has not been investigated yet. Methods: We evaluated in-hospital outcomes of patients hospitalized with AMI according to their chronic use (before hospitalization) of GLP-1 RA and SGLT-2i therapy. Using administrative healthcare databases, we analyzed patients hospitalized with a primary diagnosis of AMI from 2010 to 2019 in the Lombardy region, Italy. Patients were stratified according to their DM status, then divided into three cohorts: Group 1 (non-DM patients); Group 2 (DM patients taking GLP-1 RA or SGLT-2i); and Group 3 (DM patients not taking GLP-1 RA and/or SGLT-2i). Patients were matched in a 1:1:1 ratio using a propensity score including all available variables. The primary endpoint of the study was the composite of in-hospital mortality, acute heart failure, and acute kidney injury requiring renal replacement therapy. Results: We identified 146,800 patients hospitalized with AMI (26% of them with DM). After propensity score matching, 1,030 patients were included in each group. The primary endpoint rate in the overall population was 16% (n=502) and it significantly increased going from Group 1 to Group 3 (13%, 16%, and 20% respectively; p for trend &amp;lt0.0001). The risk of the composite endpoint significantly increased from Group 1 to Group 3 (P for trend &amp;lt0.0001). In comparison with Group 2, Group 3 had a significant higher risk of the composite endpoint (OR 1.40 [95% CI 1.11-1.77]). Conclusions: Our study shows that DM patients hospitalized with AMI and on chronic GLP-1 RA and/or SGLT-2i therapy have a better in-hospital clinical outcome than DM patients without them.

Riluzole use in presence of contraindications in adults affected by amyotrophic lateral sclerosis and its off-label use in other motor neuron diseases: Findings from an Italian multicentre study (the CAESAR project)

Background: This analysis describes the use of riluzole in amyotrophic lateral sclerosis (ALS) individuals with contraindications and off-label use for subjects with other motor neuron diseases (o-MND) in the Italian regions of Latium, Tuscany and Umbria.Methods: A cohort of adults with ALS prescribed with riluzole during the years 2016–2019 was enrolled from administrative healthcare databases, excluding subjects with o-MND in the preceding 5 years. Being affected by ALS for more than 5 years, presence of tracheostomy, renal or hepatic failure were considered as contraindications to the use of riluzole. A cohort of adults with o-MND was enrolled in 2016–2019 for whom off-label use of riluzole was retrieved up to 4 years, analysing over the time differences related to sex.Results: Among 206 ALS individuals prescribed with riluzole in Latium, 336 in Tuscany and 60 in Umbria, less than 1% were diagnosed with ALS for more than 5 years. Less than 2% were tracheotomised or affected by hepatic failure. Renal failure was documented for 1.9%, 2.7%, and 5.0% of ALS individuals in Latium, Tuscany and Umbria. The o-MND cohort comprised 264 subjects in Latium, 222 in Tuscany, and 66 in Umbria. Non-negligible off-label riluzole use was observed: 8.5%, 33.0%, and 4.2% in females, and 19.9%, 26.5% and 2.4% in males in Latium, Tuscany and Umbria.Discussion: Riluzole use in ALS individuals in the presence of contraindications is rare, with slightly higher numbers in presence of renal failure. Off-label use in o-MND was found to be non-negligible, with variations between sexes.

State and Government Administrative Databases: Medicare, National Inpatient Sample (NIS), and State Inpatient Databases (SID) Programs.

The availability of large state and federally run administrative health-care databases provides potentially comprehensive population-wide information that can dramatically impact both medical and health-policy decision-making. Specific opportunities and important limitations exist with all administrative databases based on what information is collected and how reliably specific data elements are reported. Access to patient identifiable-level information can be critical for certain long-term outcome studies but can be difficult (although not impossible) due to patient privacy protections, while more easily available de-identified information can provide important insights that may be more than sufficient for some short-term operative or in-hospital outcome questions. The first section of this paper by Sarah K. Meier and Benjamin D. Pollock discusses Medicare and the different data files available to health-care researchers. They describe what is and is not generally available from even the most granular Medicare Standard Analytic Files, and provide an analysis of the strengths and weaknesses of Medicare administrative data as well as the resulting best and inappropriate uses of these data. In the second section, the Nationwide Inpatient Sample and complementary State Inpatient Database programs are reviewed by Steven M. Kurtz and Edmund Lau, with insights into the origins of these programs, the data elements that are recorded relating to the operative procedure and hospital stay, and examples of the types of studies that optimally utilize these data sources. They also detail the limitations of these databases and identify studies that they are not well-suited for, especially those involving linkage or longitudinal studies over time. Both sections provide useful guidance on the best uses and pitfalls related to these important large representative national administrative data sources.

A systematic review of validated case-finding definitions to identify hypertensive disorders of pregnancy in administrative healthcare databases

Abstract Background Administrative healthcare data are frequently used to study cardiovascular disease (CVD) risk in women with hypertensive disorders of pregnancy (HDP); however, little is known about the validity of case-finding definitions (CFDs, e.g., International Classification of Disease codes/algorithms) designed to identify these conditions in administrative databases. Purpose To systematically identify and summarize available evidence on the validity of administrative CFDs for HDP. Methods Four bibliographic databases and grey literature sources were searched for eligible studies. The titles/abstracts of all records were independently screened for eligibility by two reviewers, then assessed at full text. Study data (design and participant characteristics, validation statistics) were extracted by two independent reviewers and discrepancies resolved through consensus. Quality of reporting was assessed using checklists; risk of bias was assessed using a modified version of the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool, adapted for administrative validation studies. Results Twenty-five studies, published between 1998 and 2021, met the eligibility criteria. Nearly half (48%) were conducted in the United States. Ten studies validated CFDs for ≥1 HDP as a primary aim; most (60%) validated several maternal and infant morbidities, including ≥1 HDP. Preeclampsia (any, mild, moderate, serious, severe, superimposed) was the most validated HDP subtype. Only six studies reported gold standard definitions for all HDPs validated; definitions were heterogeneous with respect to blood pressure thresholds and timing of diagnosis. Seven studies (∼25%) reported all 2x2 table values (true positives/negatives, false positives/negatives) for ≥1 CFD, or they were calculable. The majority of CFDs reported in primary analyses (n=23) were highly specific (≥98%); however, sensitivity varied widely (3.2% to 100%; Figure 1). Nearly all (n=20, 87%) had a positive predictive value (PPV) of ≥70%, 13 of which had a PPV of &amp;gt;80% in combination with high specificity. Across studies, HDP prevalence ranged from 0.1% (eclampsia) to 37% (any maternal hypertensive disorder). Quality of reporting was generally poor to moderate, and all studies were judged to be at unclear or high risk of bias on ≥1 QUADAS-2 domain. Five studies were judged to be of “low concern” regarding study applicability (Figure 2). Conclusions Clinical understanding of CVD risk in women with HDP could be drastically impacted if there is low confidence that these conditions have been correctly identified from administrative data. Researchers should quantitatively explore the extent to which CVD risk estimates may be impacted by CFDs with low sensitivity and artificially inflated PPVs, influenced by greater study prevalence of HDP than would be expected in the general population. Higher quality validation studies that employ more rigorous methodology and improved reporting are needed. Funding Acknowledgement Type of funding sources: None.

Impact of chronic GLP-1 receptor agonist and SGLT-2 inhibitor therapy on in-hospital outcomes of patients with diabetes mellitus hospitalized with acute myocardial infarction

Abstract Background Glucagon-like peptide-1 receptor agonists (GLP-1 RA) and sodium glucose cotransporter-2 inhibitors (SGLT-2i) demonstrated cardiovascular and renal protection in addition to their glucose-lowering effect. Whether their benefits occur also in patients with diabetes mellitus (DM) during hospitalisation with acute myocardial infarction (AMI) has not been investigated yet. Purpose We evaluated in-hospital outcomes of patients hospitalised with AMI according to their chronic use (before hospitalisation) of GLP-1 RA and SGLT-2i therapy. Methods Using administrative healthcare databases, we analysed patients hospitalised with a primary diagnosis of AMI from 2010 to 2019 in the Lombardy region, Italy. Patients were stratified according to their DM status, then divided into three cohorts: Group 1 (non-DM patients); Group 2 (DM patients taking GLP-1 RA or SGLT-2i); and Group 3 (DM patients not taking GLP-1 RA and/or SGLT-2i). Patients were matched in a 1:1:1 ratio using a propensity score including all available variables. The primary endpoint of the study was the composite of in-hospital mortality, acute heart failure, and acute kidney injury requiring renal replacement therapy. Results We identified 146,800 patients hospitalised with AMI (26% of them with DM). After propensity score matching, 1,030 patients were included in each group. The primary endpoint rate in the overall population was 16% (n=502) and it significantly increased going from Group 1 to Group 3 (13%, 16%, and 20% respectively; p for trend &amp;lt;0.0001). The risk of the composite endpoint significantly increased from Group 1 to Group 3 (P for trend &amp;lt;0.0001). In comparison with Group 2, Group 3 had a significant higher risk of the composite endpoint (OR 1.40 [95% CI 1.11–1.77]). Conclusions Our study shows that DM patients hospitalised with AMI and on chronic GLP-1 RA and/or SGLT-2i therapy have a better in-hospital clinical outcome than DM patients without them. Funding Acknowledgement Type of funding sources: None.

How many and who are patients with heart failure eligible to SGLT2 inhibitors? Responses from the combination of administrative healthcare and primary care databases

BackgroundRecent successful findings (i.e. DAPA-HF trial) in patients with heart failure (HF) with/without diabetes treated with sodium-glucose co-transporter inhibitors (SGLT2-I) have fostered real-world data analyses. Fondazione Ricerca e Salute's (ReSD) administrative and Health Search's (HSD) primary healthcare databases were combined in the ReS-HS DB Consortium, to identify and characterize HF-patients eligible to SGLT2-I, and assess their costs charged to the Italian National Health Service (INHS). Methods and resultsEligibility to SGLT2-I was HF diagnosis, age ≥ 18 years, reduced (≤40%) ejection fraction (HFrEF) and glomerular filtration rate (GFR) ≥30 ml/min. The HSD, including 13,313 HF-patients (1.5% of the total HSD population) was used to develop and test the algorithms for imputing HFrEF and GFR ≥ 30 ml/min, based on a set of covariates, to the ReSD, including 67,369 (1.5% of the total ReSD population). Subjects eligible to SGLT2-I were 2187 in HSD (61.1% of HFrEF); after the imputation, 15,145 in ReSD (58.8% of HFrEF). Prevalence of eligibility to SGLT2-I was higher in males then in females and increased with age; diabetic patients were 44.3% and 33.4% of HSD and ReSD populations eligible to SGLT2-I, respectively. Estimated from ReSD, the mean annual cost charged to the INHS per patient with HF eligible to SGLT2-I was €7122 (68% due to hospitalizations). ConclusionsApproximately 20% of patients with HF was eligible to SGLT2-I. Real-world data can identify, quantify and characterize patients eligible to SGLT2-Is and assess related costs for the health care system, thus providing useful information to Regulatory Decision makers.

Trends in quality indicators of end-of-life care for women with gynecologic malignancies in Ontario, Canada

ObjectiveA large body of research has validated several quality indicators of end-of-life (EOL) cancer care, but few have examined these in gynecologic cancer at a population-level. We examined patterns of EOL care quality in patients with gynecologic cancers across 13 years in Ontario, Canada. MethodsWe conducted a population-based, retrospective cohort study of gynecologic cancer decedents in Ontario from 2006 to 2018 using linked administrative health care databases. Proportions of quality indices were calculated, including: emergency department (ED) use, hospital or intensive care unit (ICU) admission, chemotherapy ≤14 days of death, cancer-related surgery, tube or intravenous feeds, palliative home visits, and hospital death. We used multivariable logistic regression to examine factors associated with receipt of aggressive and supportive care. ResultsThere were 16,237 included decedents over the study period; hospital death rates decreased from 47% to 37%, supportive care use rose from 65% to 74%, and aggressive care remained stable (16%). Within 30 days of death, 50% were hospitalized, 5% admitted to ICU, and 67% accessed palliative homecare. Within 14 days of death, 31% visited the ED and 4% received chemotherapy. Patients with vulvovaginal cancers received the lowest rates of aggressive and supportive care. Using multivariable analyses, factors associated with increased aggressive EOL care use included younger age, shorter disease duration, lower income quintiles, and rural residence. ConclusionsOver time, less women dying with gynecologic cancers in Ontario experienced death in hospital, and more accessed supportive care. However, the majority were still hospitalized and a significant proportion received aggressive care in the final 30 days of life.

Effectiveness and Safety of Direct Oral Anticoagulants Among Octogenarians with Venous Thromboembolism: An International Multidatabase Cohort Study

BackgroundThe effects of direct oral anticoagulants (DOACs) among octogenarian patients with venous thromboembolism remains poorly understood. To address this knowledge gap, our study aimed to assess the effectiveness and safety of DOACs compared to vitamin K antagonists (VKAs) among octogenarians with venous thromboembolism. MethodsWe conducted an international cohort study using administrative health care databases from Québec, Canada, and Germany. We assembled 2 population-based cohorts of octogenarians with incident venous thromboembolism initiating treatment with DOACs or VKAs. The study period spanned from January 2012 to the most recent date of data availability (Québec: December 2016; Germany: December 2019). Using an as-treated exposure definition, we compared use of DOACs to use of VKAs, applying inverse probability of treatment weighting based on high-dimensional propensity scores to balance exposure groups. Cox proportional hazards models estimated site-specific hazard ratios (HRs) and 95% confidence intervals (CIs) of recurrent venous thromboembolism, major bleeding, and all-cause mortality. The results were meta-analyzed using random-effects models. ResultsOverall, our study included 6737 octogenarians with venous thromboembolism (Québec: n = 2556; Germany: n = 4181) who initiated use of DOACs (n = 3778) or VKAs (n = 2959). When compared to VKAs, DOACs were associated with similar risks of recurrent venous thromboembolism (weighted HR, 0.80; 95% CI, 0.43-1.46; I2 = 0.00), major bleeding (weighted HR, 0.96; 95% CI, 0.57-1.63; I2 = 0.59), and all-cause mortality (weighted HR, 1.04; 95% CI, 0.81-1.34; I2 = 0.00). ConclusionsAmong octogenarians with venous thromboembolism, DOACs showed a comparable effectiveness and safety compared to VKAs. Our results support the use of DOACs in this high-risk group.

Inpatient care cost, duration, and acute complications associated with BMI in children and adults hospitalized for COVID-19.

ObjectiveThis study aimed to assess the association of BMI with inpatient care cost, duration, and acute complications among patients hospitalized for COVID‐19 at 273 US hospitals.MethodsChildren (aged 2–17 years) and adults (aged ≥18 years) hospitalized for COVID‐19 during March 2020–July 2021 and with measured BMI in a large electronic administrative health care database were included. Generalized linear models were used to assess the association of BMI categories with the cost and duration of inpatient care.ResultsAmong 108,986 adults and 409 children hospitalized for COVID‐19, obesity prevalence was 53.4% and 45.0%, respectively. Among adults, overweight and obesity were associated with higher cost of care, and obesity was associated with longer hospital stays. Children with severe obesity had higher cost of care but not significantly longer hospital stays, compared with those with healthy weight. Children with severe obesity were 3.7 times (95% CI: 1.4–9.5) as likely to have invasive mechanical ventilation and 62% more likely to have an acute complication (95% CI: 39%–90%), compared with children with healthy weight.ConclusionsThese findings show that patients with a high BMI experience significant health care burden during inpatient COVID‐19 care.

Prediction of Asthma Risk Using Family Health Histories identified from Population-based Electronic Healthcare Records.

ObjectivesPrediction of asthma risk can potentially be improved by including family history of asthma and related diagnoses, which reflect both genetics and shared environments. We tested the improvements in offspring asthma risk prediction using objectively-measured maternal, paternal, and offspring histories of comorbid conditions from administrative healthcare databases. ApproachA population-based cohort study was conducted using data from Manitoba, Canada. Children born from 1974 to 2000 with linkages to at least one parent using family identification numbers were included. Asthma diagnosis and comorbidities were identified from hospital and outpatient physician visit records. Lasso regression models were used to assess performance and identify important predictors. The base model included offspring demographics, diagnosed allergic conditions and respiratory infections, and diagnosed parental asthma. Subsequent models included multiple comorbid chronic health conditions for offspring and parents. ResultsThe cohort included 195,666 offspring; 51% were males, 13.6% had a parental asthma diagnosis, and 17.7% had an asthma diagnosis (median age at diagnosis: 6.0 years; interquartile range 3.0-11.0 years). The base model achieved a modest prediction performance with an area under the receiver operating characteristic curve of 0.60, sensitivity of 0.46 and a specificity of 0.67 using a threshold of 0.20. Sensitivity significantly improved when we included offspring chronic health conditions (sensitivity= 0.69; specificity = 0.66); both measures further improved when we additionally included parents’ chronic health conditions (sensitivity= 0.72; specificity = 0.70). Chronic obstructive pulmonary disease, noninfectious gastroenteritis and otitis media were among the variables that added incremental predictive value of asthma risk with odd ratios of 1.36, 1.25 and 1.18, respectively. ConclusionsIncluding offspring and parents’ chronic health conditions, identified objectively from administrative healthcare databases, improved the performance of asthma risk prediction models in children. Health histories of comorbid conditions provide important factors to improve risk prediction models of chronic health conditions, which will facilitate disease prevention and treatment strategies.