scholarly journals Estimating the Risk of Myocardial Infarction in Persons with Hemophilia A Using a Machine-Learning Approach with US Claims Data

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 1133-1133 ◽  
Author(s):  
Imi Faghmous ◽  
Carlos Flores ◽  
Kati Sarouei ◽  
Tiffany Y. Chang ◽  
Anisha M. Patel ◽  
...  
Keyword(s):  
Machine Learning ◽  
Incidence Rate ◽  
Drug Utilization ◽  
Claims Data ◽  
Hemophilia A ◽  
Pharmacy Claim ◽  
Inclusion Criteria ◽  
Crude Incidence ◽  
Cohort Identification ◽  
Equity Ownership

Introduction Epidemiological studies in the literature provide conflicting conclusions regarding the risk of myocardial infarction (MI) in people diagnosed with congenital hemophilia A (HA). As a result, the question of protection from MI conferred by HA remains debated. Using insurance claims data, we conducted a study to explore this potential relationship. Methods Initially, a traditional pharmaco-epidemiological approach was conducted using the Truven MarketScan Commercial Database and/or Medicare Supplemental Database. A cohort of persons with HA (PwHA) was identified based on the following criteria: having had a confirmed diagnosis of congenital HA between Jan 1, 2000 and Sept 30, 2017; at least three claims for HA within 365 consecutive days; and continuous enrollment with insurance coverage for the 6 months after first diagnosis of HA. In addition, all individuals were required to be aged ≥18 years, male, and with no evidence of a diagnosis of von Willebrand disease (VWD), hemophilia B, acquired HA, or MI prior to their first HA diagnosis. Based on the results of the first analysis, a second, novel approach was undertaken, using a 2-step method incorporating machine learning and drug utilization for cohort identification. For this approach, the inclusion criteria for the study were further refined to include persons with at least one medical or pharmacy claim for factor VIII (FVIII) therapy, activated prothrombin complex concentrate, or activated factor VIIa therapy; or at least one medical or pharmacy claim for FVIII/VWD therapy; or at least one medical or pharmacy claim for desmopressin and at least one medically-attended visit with a diagnosis of HA in the same claim line; or at least one medically-attended visit with a HA diagnosis. The earliest date for fulfilling any of these inclusion criteria was deemed the individual's index date. Participants also had to have 183 days of continuous insurance enrollment prior to study entry in order to participate. Secondly, a HA classification algorithm, first developed and validated by Lyons et al (Value in Health 2018), was adapted and applied to the above refined cohort. A cohort of individuals with no evidence of HA in the study period was then randomly selected from the MarketScan database and frequency matched to the HA cohort by age, sex, insurance type, region, enrollment length, diabetes status, and hypertensive status at a 1:3 ratio, yielding a control cohort of 18,817 individuals. A Poisson regression model was then fitted to estimate the adjusted incidence rate ratio (IRR). The model was adjusted for all baseline covariates as well as HIV and hepatitis C status, with age as a time-varying covariate. Results Based on the chosen criteria, an initial cohort of 2148 PwHA was identified. The crude incidence rate of MI in this cohort was estimated to be 1.75 (95% confidence interval [CI] 1.43-2.11) per 100 person-years. Relative to the matched cohort of individuals with no evidence of HA (N=10,661), this yielded an IRR of 1.68. Such a high relative risk was investigated further by examining concomitant medications. This revealed evidence of misclassification bias with 16% of participants having been prescribed anticoagulants and a low frequency of hemophilia drug utilization. These results prompted the revision of methods underlying cohort identification to the machine learning/drug utilization approach. The revised cohort yielded a 98.5% specificity and 77.8% sensitivity for selection of PwHA, identifying 3154 individuals with a ≥90% probability of being true PwHA. Ten were excluded as they had a previous history of MI, leaving a final cohort of 3144 PwHA. The crude incidence rate of MI in this HA cohort was calculated to be 0.25 (95% CI 0.15-0.34) per 100 person-years and 0.22 (95% CI 0.18-0.27) in the non-HA population, yielding an unadjusted IRR of 1.13. The adjusted IRR was estimated to be 1.31 (95% CI 0.85-2.00, p=0.22), indicating no statistically significant difference in the risk of MI in the HA population versus a matched non-HA control. Conclusions No evidence of a different risk of MI in PwHA relative to non-HA counterparts was observed in this analysis. To our knowledge, this represents the largest real-world data study investigating MI in the HA population. While every effort was taken to mitigate for the effects of confounders and bias, the results should be interpreted in the context of the limitations of a secondary data use study. Disclosures Faghmous: F. Hoffmann-La Roche Ltd: Employment. Sarouei:Genentech, Inc.: Employment. Chang:Genentech, Inc.: Employment; Genentech/Roche: Equity Ownership. Patel:Genentech: Employment; Roche/Genentech: Equity Ownership. Sima:Roche/Genentech: Employment; Roche: Equity Ownership. Kuebler:Genentech, Inc.: Employment, Equity Ownership.

scholarly journals Characteristics of Hemophilia A Patients Treated with Emicizumab: an Early View using Claims Database Analysis

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 4928-4928
Author(s):  
Arash Mahajerin ◽  
Erru Yang ◽  
Anisha M. Patel
Keyword(s):  
Clinical Characteristics ◽  
Index Date ◽  
Claims Data ◽  
Hemophilia A ◽  
Insurance Claims ◽  
Major Bleed ◽  
Insurance Claims Data ◽  
Equity Ownership ◽  
Early View ◽  
Insurance Enrollment

Introduction Hemophilia A is a genetic bleeding disorder characterized by bleeding episodes due to deficiency of factor VIII (FVIII). Emicizumab (EMI) is a recombinant, humanized, bispecific factor IXa- and factor X-directed monoclonal antibody, indicated for routine prophylaxis in all persons with hemophilia A (PwHA) with or without FVIII inhibitors. This study aimed to provide an early view of the characteristics of PwHA who are treated with emicizumab. Methods This was a retrospective cohort study using US commercial insurance claims data from MarketScan Commercial Research Database and PharMetrics Plus Database from 11/16/17 to 12/30/18 (MarketScan data available until 9/30/18 at the time of analysis). The study cohort included PwHA with ≥1 emicizumab claim during the study period. Emicizumab claims were identified using NDC or HCPCS codes (Q9995). The index date was defined as the date of first emicizumab claim. However, this index date was adjusted to an earlier date during the study period, if an appropriate miscellaneous/unclassified drug or biologic HCPCS J-code claim was identified indicating emicizumab use prior to the specific NDC or Q-code claim. The study sample was required to have ≥12 months of continuous insurance enrollment prior to the index date i.e. prior to starting emicizumab (pre-EMI period). Demographics, all-cause health care resource utilization and clinical characteristics including major bleeds, arthropathy, and any pain diagnosis were examined in the pre-EMI period. Major bleeds were identified using a previously developed algorithm (Shrestha et al. 2017) while arthropathy and pain were identified using International Classification of Diseases, 9th Revision, Clinical Modification or ICD-9-CM/ICD-10-CM diagnosis codes. FVIII and bypassing agents (BPAs) were identified using NDC or HCPCS codes. Results We identified a total of 47 PwHA taking emicizumab with ≥12 months of prior continuous insurance enrollment. The mean age of these individuals was 20.4 years (standard deviation [SD]=16.7, range=1-61y); 19.1% (n=9) were under 5 years of age and 36.2% (n=17) ages 6-17 years. All individuals were male (100%), and the majority were in the Southern region of the US (44.7%, n=21) and covered with Preferred Provider Organization insurance plans (78.7%, n=37). In the pre-EMI period, 25.5% (n=12) of the cohort had evidence of inhibitors (i.e. claim for a BPA); 27.7% (n=13) had evidence of a major bleed, with an average of 2.8 bleeds (SD=2.3; range=1-8) among those with ≥1 major bleed-related claim; 21.3% (n=10) had diagnosis of any arthropathy; and 19.1% (n=9) had diagnosis of any pain. A total of 76.6% (n=36) and 25.5% (n=12) of PwHA had evidence of FVIII or BPA use in the pre-EMI year, with an average of 12.8 (SD=15.1) and 11.5 (SD=8.6) prescriptions/ administrations among those with ≥1 FVIII or BPA claim, respectively. Overall, 36.2% (n=17) of the cohort had ≥1 emergency room visit (mean=0.8, SD = 1.6); 17.0% (n=8) had ≥1 inpatient hospital stay (mean=0.2, SD=0.6), with a mean length of stay of 1.3 days (SD=3.3); 80.9% (n=38) had ≥1 outpatient hospital visit (mean=5.4, SD=14.2); and 83.0% (n=39) had ≥1 office visit (mean=7.3, SD=9.3) in the pre-EMI period. Conclusions This is the first study to provide an understanding of the disease and treatment characteristics of PwHA who are initiating treatment with emicizumab using insurance claims data. Based on these findings, emicizumab is being used across all age groups and in patients with different clinical characteristics. Availability of more longitudinal data following treatment initiation with emicizumab will allow for an assessment and comparison of real-world treatment outcomes in PwHA. Disclosures Mahajerin: Spark: Speakers Bureau; Alexion: Speakers Bureau; Kedrion: Membership on an entity's Board of Directors or advisory committees; Genentech: Consultancy, Speakers Bureau. Yang:Genentech: Employment, Equity Ownership. Patel:Genentech: Employment; Roche/Genentech: Equity Ownership.

scholarly journals Epidemiology of Thyroid Carcinomas in North Macedonia (1999-2015)

2021 ◽  
Vol 12 ◽  
pp. 215013272110042
Author(s):  
Makazlieva Tanja ◽  
Vaskova Olivija ◽  
Stojanoski Sinisha ◽  
Manevska Nevena ◽  
Miladinova Daniela ◽  
...  
Keyword(s):  
Incidence Rate ◽  
Prevalence Rate ◽  
Epidemiological Data ◽  
Female Gender ◽  
The Elderly ◽  
Inclusion Criteria ◽  
Statistical State ◽  
Total Prevalence ◽  
Low Incidence ◽  
Histopathological Type

Objective: We have set as objective to analyze epidemiological data of diagnosed thyroid carcinoma (TC) cases, incidence and prevalence rate by gender, age, histopathological type, and statistical regions in R. of N. Macedonia during the period 1999 to 2015. Material and Methods: Retrospective analysis of medical data collected from the 2 state thyroid departments. Inclusion criteria included newly diagnosed cases of TC in appropriate years for the period 1999 to 2015. We have evaluated: yearly incidence rate, incidence and prevalence by gender, age, the distribution in 8 statistical state regions and histopathological types and subtypes representation. Results: A total number of 422 TC patients were detected, average incidence rate of 1.22/105, with most prevalent papillary TCs79.5%, followed by follicular 10.9%, medullar 4.1%, anaplastic 3.1%, and other rare types with 2.3%. The highest incidence rate was detected in Skopje region, while the lowest in Southeast and the Polog region. The total prevalence rate for the female gender was 32.61/104 and for male 9.27/104 (f/m ratio = 3.52:1), with lowest female/male difference found in the elderly > 65 years (f/m = 2.21/1). Conclusion: Compared with regional epidemiological data we can conclude that Republic of N. Macedonia has very low incidence and prevalence rate, while female/male ratio was similar to that described in the literature. Our low incidence and prevalence rate may be due to 2 possible reasons, 1 would be insufficient diagnosis of only small portion of the real cases in the population, or the second reason may be a real low incidence resulting of specific etiopathogenetic circumstances.

scholarly journals Factor VIII Use in the Treatment of Breakthrough Bleeds in Hemophilia A Patients without Inhibitors on Emicizumab Prophylaxis: The Phase 3 HAVEN 3 Study Experience

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2395-2395
Author(s):  
Michael Callaghan ◽  
Benjamin Trzaskoma ◽  
Richard H. Ko ◽  
Lucy Lee ◽  
Anisha M. Patel ◽  
...  
Keyword(s):  
Factor Viii ◽  
Exposure Time ◽  
Cumulative Dose ◽  
Research Funding ◽  
Hemophilia A ◽  
Phase 3 ◽  
Breakthrough Bleeding ◽  
On Demand ◽  
Equity Ownership ◽  
The Individual

Introduction HAVEN 3 was a phase 3 study investigating the use of emicizumab as prophylaxis in adult and adolescent (≥12 years old) persons with hemophilia A (PwHA) without factor VIII (FVIII) inhibitors (NCT02847637; Mahlangu et al. 2018). HAVEN 3 demonstrated that emicizumab prophylaxis once weekly or every two weeks was safe and highly effective in bleed prevention. The primary analysis of HAVEN 3 included an intrapatient comparison of 48 participants who received FVIII prophylaxis in a non-interventional study (NIS) prior to enrollment in HAVEN 3. Compared with emicizumab prophylaxis during the HAVEN 3 study, emicizumab prophylaxis resulted in an annualized bleed rate that was 68% lower than the rate with previous FVIII prophylaxis (1.5 vs 4.8, p<0.001). No dosing guidance was provided regarding the use of on-demand FVIII in HAVEN 3, and investigators prescribed FVIII at their own discretion. In this subsequent analysis, we characterize the dose and frequency of replacement FVIII used for the treatment of breakthrough bleeding in these 48 participants. Methods The primary comparisons in our analyses are focused on on-demand FVIII use for breakthrough bleeding while participants were on FVIII prophylaxis during the NIS versus its use while on emicizumab prophylaxis during HAVEN 3. Any use of on demand FVIII other than to manage breakthrough bleeding (e.g. prior to activity) was not included in our analyses. Given that, collectively, the total exposure time to emicizumab during HAVEN 3 was more than twice the exposure time to FVIII prophylaxis during the NIS (75.8 vs 28.6 years respectively), any treatment comparisons are drawn on an annualized basis. Annualized on-demand FVIII use was calculated by dividing by the number of days in the efficacy period and multiplying the resulting daily consumption by 365.25 days. The number of infusions and cumulative doses of on-demand FVIII use are described at the participant level as well as at the individual bleed level and are presented descriptively for both the NIS and HAVEN 3 exposure periods. No formal statistical inferences (i.e. calculation of p-values) have been conducted. All analyses were based on an October 2018 data cutoff. Results A total of 48 participants who were treated with FVIII prophylaxis during the NIS were then treated with emicizumab prophylaxis during HAVEN 3 and thus make up the total cohort for our analyses. Annualized infusion rates of on-demand FVIII per participant and cumulative doses of on-demand FVIII (in international units [IU] per kilogram) per participant were higher during the FVIII prophylaxis period when compared with the emicizumab exposure period (mean 15.3 vs 7.2; median 3.6 vs 0.6 annual infusions per participant and mean 602.4 IU/kg vs 209.0 IU/kg; median 75.5 IU/kg vs 19.1 IU/kg, respectively). At the individual bleed level, FVIII infusions and total cumulative dose suggested that participants were administered a similar amount of medication to treat bleeds during both the NIS and HAVEN 3 study periods: median number of infusions per bleed were 1.0 (interquartile range [IQR]=1.0) versus 2.0 (IQR=3.0) and median cumulative doses were 43.5 (IQR=35.1) versus 50.0 (IQR=72.7) IU/kg, respectively (Table 1). Conclusions This analysis revealed a lower annualized infusion rate and a correspondingly lower annualized cumulative dose of FVIII for treatment of breakthrough bleeds during emicizumab prophylaxis compared with FVIII prophylaxis. At the individual bleed level, the amount of on-demand FVIII used per bleeding episode was comparable between NIS and HAVEN 3 exposure periods. Thus, based on this single analysis, it appears that patients received less on-demand FVIII during emicizumab prophylaxis compared with FVIII prophylaxis, as a result of overall reduction of bleed frequency, while the treatment of individual bleeds appeared similar regardless of the prophylaxis therapy administered. Disclosures Callaghan: Octapharma: Consultancy; Novonordisk: Consultancy, Speakers Bureau; Global Blood Therapeutics: Consultancy; Sanofi: Consultancy; Takeda: Consultancy, Research Funding; Bayer: Consultancy, Speakers Bureau; Alnylum: Equity Ownership; Biomarin, Bioverativ, Grifols, Kedrion, Pfizer, Roche/Genentech, Shire, and Spark Therapeutics: Consultancy; Roche/Genentech: Speakers Bureau; Shire/Takeda: Speakers Bureau; Pfizer: Research Funding; Roche: Research Funding. Trzaskoma:Genentech: Employment, Equity Ownership. Ko:Genentech, Inc.: Employment. Lee:Genentech, Inc.: Employment. Patel:Genentech: Employment; Roche/Genentech: Equity Ownership. Tzeng:Genentech, Inc.: Employment. Shah:Genentech: Employment. Chang:Genentech, Inc.: Employment; Genentech/Roche: Equity Ownership. Niggli:F. Hoffmann-La Roche Ltd: Employment. Dhalluin:F. Hoffmann-La Roche Ltd: Employment. Mahlangu:Sanofi: Research Funding; Pfizer: Research Funding; Novartis: Research Funding; Biomarin: Research Funding; Spark: Consultancy, Honoraria, Research Funding, Speakers Bureau; Roche: Consultancy, Honoraria, Research Funding, Speakers Bureau; Novo Nordisk: Consultancy, Honoraria, Research Funding, Speakers Bureau; Catalyst Biosciences: Consultancy, Honoraria, Research Funding, Speakers Bureau; CSL Behring: Consultancy, Honoraria, Research Funding, Speakers Bureau; Baxalta: Consultancy, Honoraria, Research Funding, Speakers Bureau; Unique: Research Funding.

The Incidence of Symptomatic Urolithiasis in Royal Naval Submariners

1988 ◽  
Vol 74 (2) ◽  
pp. 86-94
Author(s):  
P. I. Raffaelli
Keyword(s):  
At Risk ◽  
Relative Risk ◽  
Comparative Study ◽  
Incidence Rate ◽  
Incidence Rates ◽  
Crude Incidence ◽  
Behavioural Factors ◽  
Respective Rate

AbstractSubmariners are exposed to a number of environmental, dietary and behavioural factors thought to be associated with urolithiasis. A comparative study of the incidence rate in submariners and non-submariners over a seven year period was carried out.A total of 267 cases of uroli thias is resulting in illness of 48 hours or greater duration were recorded during the years 1979 to 1985 of which 251 were available for study. Thirty four were identified as submariners and 217 as non-submariners (94% successfully identified). The total person years at risk for the two groups were 45, 171 and 311, 619 respectively. The crude incidence rates, indirectly standardised incidence ratio, the indirectly standardised incidence rates and the relative risk were calculated. Although each respective rate was greater for submariners than that for non-submariners the differences were not statistically significant. It is concluded that this study has failed to identify an increased relative risk for submariners to develop symptomatic urolithiasis.

P287Use of machine learning to determine stroke severity of patients diagnosed with stroke in claims data

2018 ◽  
Vol 39 (suppl_1) ◽  
Author(s):  
E Kogan ◽  
K Twyman ◽  
J Heap ◽  
D Milentijevic ◽  
J H Lin ◽  
...  
Keyword(s):  
Machine Learning ◽  
Claims Data ◽  
Stroke Severity

scholarly journals Nationwide incidence of central retinal artery occlusion in Japan: an exploratory descriptive study using the National Database of Health Insurance Claims (2011–2015)

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e041104
Author(s):  
Ai Kido ◽  
Hiroshi Tamura ◽  
Hanako Ohashi Ikeda ◽  
Masahiro Miyake ◽  
Shusuke Hiragi ◽  
...  
Keyword(s):  
Health Insurance ◽  
Incidence Rate ◽  
Central Retinal Artery Occlusion ◽  
Retinal Artery Occlusion ◽  
Artery Occlusion ◽  
Incidence Rates ◽  
National Database ◽  
Insurance Claims ◽  
Crude Incidence ◽  
Health Insurance Claims

AimsThe latest evidence in the incidence of central retinal artery occlusion (CRAO) is needed to support the development of novel treatments as orphan drugs. However, up-to-date information on the incidence of CRAO in the ageing or aged population is limited. We aimed to investigate the nationwide epidemiological and clinical characteristics of CRAO in Japan, using nationwide health insurance claims data.MethodsWe analysed a total of 16 069 762 claims data in the sampling dataset of the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB), which is the nationwide health insurance claims database of 127 million whole Japanese individuals. CRAO was identified using the International Classification of Diseases 10th edition diagnostic code H34.1. The crude incidence rates and age-standardised incidence rates of CRAO, according to the standard age-structure population of the WHO, were calculated.ResultsThe crude incidence rate of CRAO in Japan was 5.84 (95% CI, 5.71 to 5.97) per 100 000 person-years. With respect to the sex-related incidence, the rate was higher 1.40 times in men than in women (6.85 (95% CI, 6.65 to 7.06) vs 4.88 (95% CI, 4.71 to 5.05), p<0.001). The age-standardised incidence rate was 2.53 (95% CI, 2.29 to 2.76) per 100 000 person-years.ConclusionsThe crude incidence rate of CRAO was higher in Japan than in other countries, as reported previously, reflecting the Japanese population structure as a super-aged society. These findings can be helpful for the development of appropriate healthcare policies to address the increasing incidence of CRAO with the ageing population.

Crude Incidence Rate of Malignancy after Kidney Transplantation

2010 ◽  
Vol 24 (3) ◽  
pp. 182 ◽  
Author(s):  
Hyo Sun Kim ◽  
Young Min Seo ◽  
Ui Jun Park ◽  
Hyoung Tae Kim ◽  
Won Hyun Cho ◽  
...  
Keyword(s):  
Kidney Transplantation ◽  
Incidence Rate ◽  
Crude Incidence Rate ◽  
Crude Incidence

Lymphoma risks in patients with rheumatoid arthritis treated with biological drugs—a Swedish cohort study of risks by time, drug and lymphoma subtype

Rheumatology ◽  
2020 ◽  
Author(s):  
Karin Hellgren ◽  
Daniela Di Giuseppe ◽  
Karin E Smedby ◽  
Christer Sundström ◽  
Johan Askling ◽  
...  
Keyword(s):  
General Population ◽  
Incidence Rate ◽  
Cox Regression ◽  
Tnf Inhibitor ◽  
Crude Incidence Rate ◽  
Biological Drugs ◽  
Crude Incidence ◽  
Hazard Ratios ◽  
Lymphoma Subtype ◽  
Lymphoma Risk

Abstract Objectives To estimate the association between biological DMARDs (bDMARDs; overall and by drug) as used in RA and the risk of malignant lymphomas including subtypes. Methods By linking nationwide Swedish registers we identified cohorts of patients with RA initiating treatment with a bDMARD (n = 16 392), bDMARD-naïve (n = 55 253), an age- and sex-matched general population comparator cohort (n = 229 047), and all incident lymphomas 2001–16. We used Cox regression to calculate hazard ratios (HRs) of lymphoma taking calendar period and other factors into account. Results There were 82 lymphomas among the bDMARD-treated patients with RA, crude incidence rate 76/100 000 person-years, and 310 lymphomas among the bDMARD-naïve patients with RA, crude incidence rate 90/100 000 person-years. This resulted in an adjusted HR (aHR) associated with bDMARD treatment (vs not) of 1.08 (95% CI: 0.83, 1.41). The corresponding aHR for bDMARD-treated and bDMARD-naïve vs the general population was 1.65 (95% CI: 1.31, 2.08) and 1.56 (95% CI: 1.37, 1.78) respectively. Restricting follow-up period to after 2006, the aHR of lymphoma for patients with RA starting a first bDMARD vs bDMARD-naïve was 0.69 (95% CI: 0.47, 1.00), and for bDMARD treated vs patients with RA switching from one conventional synthetic DMARDs to another, aHR was 0.46 (95% CI: 0.28, 0.73). There were no signals of different risks with any particular TNF inhibitor (TNFi) agent. We found no different lymphoma subtype pattern following bDMARD therapy. Conclusion Treatment with bDMARDs, including both TNFi and non-TNFi bDMARDs, does not further increase the lymphoma risk in RA; instead, bDMARD treatment may actually reduce the excess lymphoma risk in RA.

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