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  1. Article ; Online: Treatment characteristics among patients with binge-eating disorder: an electronic health records analysis.

    Spalding, William M / Bertoia, Monica L / Bulik, Cynthia M / Seeger, John D

    Postgraduate medicine

    2022  Volume 135, Issue 3, Page(s) 254–264

    Abstract: Objectives: Treatment for adults diagnosed with binge-eating disorder (BED) includes psychotherapy and/or pharmacotherapy and aims to reduce the frequency of binge-eating episodes and disordered eating, improve metabolic-related issues and reduce weight, ...

    Abstract Objectives: Treatment for adults diagnosed with binge-eating disorder (BED) includes psychotherapy and/or pharmacotherapy and aims to reduce the frequency of binge-eating episodes and disordered eating, improve metabolic-related issues and reduce weight, and address mood symptoms. Data describing real-world treatment patterns are lacking; therefore, this study aims to characterize real-world treatment patterns among patients with BED.
    Methods: This retrospective study identified adult patients with BED using natural language processing of clinical notes from the Optum electronic health record database from 2009 to 2015. Treatment patterns were examined during the 12 months preceding the BED recognition date and during a follow-up period after BED recognition (1-3 years for most patients).
    Results: Among 1042 patients, 384 were categorized as the BED cohort and 658, who met less stringent criteria, were categorized as probable BED. In the BED cohort, mean ± SD age was 45.2 ± 13.4 years and 81.8% were women (probable BED, 45.9 ± 12.8 years, 80.2%). A greater percentage of patients in the BED cohort were prescribed pharmacotherapy (70.6% [probable BED, 66.9%]) than received/discussed psychotherapy (53.1% [probable BED, 39.2%]) at baseline. In the BED cohort, 54.4% of patients were prescribed antidepressants (probable BED, 52.4%), 25.3% stimulants (probable BED, 20.1%), and 34.4% nonspecific psychotherapy (probable BED, 24.6%) at baseline, with no substantive differences observed during follow-up. Low percentages of patients in the BED cohort received/discussed cognitive behavioral therapy at baseline (12.5% [probable BED, 9.0%) or during follow-up (13.0% [probable BED, 8.8%). Among patients with ≥1 psychotherapy visit, the mean ± SD number of visits in the BED cohort was 1.2 ± 5.9 at baseline (probable BED, 1.7 ± 7.3) and 2.2 ± 7.7 during follow-up (probable BED, 2.6 ± 7.7).
    Conclusion: This cohort of patients with BED was treated more frequently with pharmacotherapy than psychotherapy. These data may help inform strategies for reducing differences between real-world treatment patterns and evidence-based recommendations.
    MeSH term(s) Adult ; Humans ; Female ; Middle Aged ; Male ; Binge-Eating Disorder/therapy ; Binge-Eating Disorder/diagnosis ; Binge-Eating Disorder/psychology ; Obesity/therapy ; Retrospective Studies ; Electronic Health Records ; Weight Loss ; Treatment Outcome
    Language English
    Publishing date 2022-01-17
    Publishing country England
    Document type Journal Article
    ZDB-ID 410138-8
    ISSN 1941-9260 ; 0032-5481
    ISSN (online) 1941-9260
    ISSN 0032-5481
    DOI 10.1080/00325481.2021.2018255
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  2. Article ; Online: Future Proofing Adverse Event Monitoring.

    Seeger, John D

    Drug safety

    2015  Volume 38, Issue 10, Page(s) 847–848

    MeSH term(s) Delivery of Health Care/methods ; Drug-Related Side Effects and Adverse Reactions/epidemiology ; Female ; Humans ; Male
    Language English
    Publishing date 2015-10
    Publishing country New Zealand
    Document type Comment ; Journal Article
    ZDB-ID 1018059-x
    ISSN 1179-1942 ; 0114-5916
    ISSN (online) 1179-1942
    ISSN 0114-5916
    DOI 10.1007/s40264-015-0342-4
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  3. Article ; Online: Incident autoimmune conditions among males receiving quadrivalent human papillomavirus vaccine in the United States

    Seeger, John D. / Amend, Kandace L. / Turnbull, Bruce R. / Zhou, Li / Marks, Morgan A. / Velicer, Christine / Saddier, Patricia

    Vaccine. 2023 Mar., v. 41, no. 11 p.1826-1833

    2023  

    Abstract: The potential for vaccines to induce autoimmunity has been the subject of considerable investigation and autoimmune induction remains a common focus for vaccine safety research. This study assessed the risk of new onset autoimmune conditions among males ... ...

    Abstract The potential for vaccines to induce autoimmunity has been the subject of considerable investigation and autoimmune induction remains a common focus for vaccine safety research. This study assessed the risk of new onset autoimmune conditions among males receiving the 4-valent human papillomavirus (HPV) vaccine (4vHPV). Within a US health insurance claims database, we formed a cohort of male 4vHPV vaccine recipients between 2009 and 2016, along with a propensity score matched cohort of males who did not receive the 4vHPV vaccine. The study outcome was new onset autoimmune conditions (20 separate conditions) within four categories (rheumatologic/hematologic, gastroenterologic, endocrinologic and neurologic/ophthalmalogic). Outcomes identified using diagnosis codes were adjudicated through medical record review. Incidence rates (per 1,000 person-years) were estimated for the vaccinated and unvaccinated groups along with rate ratios (RRs). There were 65,606 males receiving at least one dose of 4vHPV vaccine, and 55,670 were matched to a comparator. The matched 4vHPV vaccine cohort provided 35 confirmed cases among 39,735 person-years, for an incidence rate of 0.88 (95% CI: 0.61-1.23), while the comparator cohort provided 47 confirmed cases among 58,215 person-years, an incidence rate of 0.81 (0.59-1.07), a RR of 1.09 (0.70-1.69). The RR within categories was 0.49 (0.10-2.42) for rheumatologic/hematologic, 1.26 (0.58-2.71) for gastroenterologic, 1.11 (0.61-2.02) for endocrinologic and 1.46 (0.21-10.40) for neurologic. The incidence of autoimmune conditions among males receiving the 4vHPV vaccine was similar to that among unvaccinated males. These results are consistent with other studies that have assessed autoimmunity with the 4vHPV vaccine.
    Keywords Papillomaviridae ; autoimmunity ; databases ; health insurance ; humans ; males ; medical records ; vaccines ; Autoimmune conditions ; Human papillomavirus ; Human papillomavirus vaccine ; Vaccine safety
    Language English
    Dates of publication 2023-03
    Size p. 1826-1833.
    Publishing place Elsevier Ltd
    Document type Article ; Online
    Note Use and reproduction
    ZDB-ID 605674-x
    ISSN 1873-2518 ; 0264-410X
    ISSN (online) 1873-2518
    ISSN 0264-410X
    DOI 10.1016/j.vaccine.2022.10.050
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  4. Article ; Online: Using RWE research to extend clinical trials in diabetes: An example with implications for the future.

    Seeger, John D / Nunes, Anthony / Loughlin, Anita M

    Diabetes, obesity & metabolism

    2020  Volume 22 Suppl 3, Page(s) 35–44

    Abstract: Background: Although randomized, controlled trials (RCTs) are seen as the gold standard for evidence in clinical medicine, a number of considerations are increasing the use of real-world data (RWD) to generate evidence. A series of methodological ... ...

    Abstract Background: Although randomized, controlled trials (RCTs) are seen as the gold standard for evidence in clinical medicine, a number of considerations are increasing the use of real-world data (RWD) to generate evidence. A series of methodological challenges must be overcome in order for such real-world evidence (RWE) to gain acceptance. In diabetes, RWE faces some particular issues that have limited its development. As the natural history of diabetes progresses, patients' disease changes over time and treatments will be modified as a result. This evolving disease and treatment pattern requires application of methods that account for such changes over time. Research developing RWE in diabetes and other conditions has sometimes been subject to important biases, and researchers should be aware of, and take steps to mitigate potential for bias in order to enhance the evidence produced.
    Results: We review a RWE study that replicated and extended evidence provided by a RCT regarding the effects of weekly exenatide relative to basal insulin (glargine or detemir) to illustrate a potential application of RWE. This study observed a 0.7% decrease in HbA1C for weekly exenatide relative to a 0.5% decrease in HbA1C for the comparator along with a 2 kg weight loss for weekly exenatide relative to a 0.25 kg weight gain, effects that were close to those from the RCT. Further, the RWE study was able to extend results to patient populations that were not well represented in the RCT.
    Conclusion: Despite numerous challenges, RWE can be used to complement evidence from RCTs.
    MeSH term(s) Diabetes Mellitus/drug therapy ; Diabetes Mellitus/epidemiology ; Exenatide ; Humans ; Insulin Glargine
    Chemical Substances Insulin Glargine (2ZM8CX04RZ) ; Exenatide (9P1872D4OL)
    Language English
    Publishing date 2020-04-06
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 1454944-x
    ISSN 1463-1326 ; 1462-8902
    ISSN (online) 1463-1326
    ISSN 1462-8902
    DOI 10.1111/dom.14021
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  5. Article: Vaccine initiation and 3-dose series completion of 4vHPV vaccine among US insured males 2012–2016

    Amend, Kandace L. / Turnbull, Bruce / Zhou, Li / Marks, Morgan A. / Velicer, Christine / Saddier, Patricia / Seeger, John D.

    Vaccine. 2022 Jan. 28, v. 40, no. 4

    2022  

    Abstract: The quadrivalent human papillomavirus vaccine (4vHPV, GARDASIL®⁾, was approved in the US in 2009 for use in males aged 9 to 26 for the prevention of HPV-related genital warts, and in 2010 for the prevention of certain HPV-related anogenital diseases. A ... ...

    Abstract The quadrivalent human papillomavirus vaccine (4vHPV, GARDASIL®⁾, was approved in the US in 2009 for use in males aged 9 to 26 for the prevention of HPV-related genital warts, and in 2010 for the prevention of certain HPV-related anogenital diseases. A regimen was approved in 2016 for those who initiate the vaccine series between the ages of 9 to 14 years. We describe patterns of 4vHPV administration among US males before this modification.The study used a US health insurance claims database, and included males, age 9 to 26 years, who initiated 4vHPV between 2012 and 2016. Time from first dose to subsequent doses was estimated. Logistic regression identified factors associated with regimen completion.Among 100,786 males who initiated 4vHPV (corresponding to ∼ 13% of male birth cohorts), 50,573 (50.2%) and 25,763 (25.6%) received a second and third dose, respectively. Annual administration was common, with 47% of males receiving 3 doses over 3 years (1 dose per year) as compared to 12% receiving the 3-dose series in the recommended 6-month timeframe. Receipt of 4vHPV was 2.2 (range 1.5 to 2.9) times as likely to occur in summer months compared to other times of the year. Individuals aged 18 to 21 years and those living in Western states or rural regions were less likely to complete the 3-dose regimen.The real-world patterns of 4vHPV vaccination observed, particularly the low uptake and regimen completion, suggest that better strategies are needed for males to improve 4vHPV vaccine use in males.
    Keywords databases ; health insurance ; humans ; males ; regression analysis ; summer ; vaccination ; vaccines
    Language English
    Dates of publication 2022-0128
    Size p. 682-688.
    Publishing place Elsevier Ltd
    Document type Article
    ZDB-ID 605674-x
    ISSN 1873-2518 ; 0264-410X
    ISSN (online) 1873-2518
    ISSN 0264-410X
    DOI 10.1016/j.vaccine.2021.10.070
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  6. Article ; Online: Cardiovascular Outcome Risks in Patients With Erectile Dysfunction Co-Prescribed a Phosphodiesterase Type 5 Inhibitor (PDE5i) and a Nitrate: A Retrospective Observational Study Using Electronic Health Record Data in the United States.

    Nunes, Anthony P / Seeger, John D / Stewart, Andrew / Gupta, Alankar / McGraw, Thomas

    The journal of sexual medicine

    2021  Volume 18, Issue 9, Page(s) 1511–1523

    Abstract: Background: Phosphodiesterase type 5 inhibitors (PDE5i) are first-line therapy for erectile dysfunction (ED). Approximately 1-4% of PDE5i recipients co-possess nitrates, despite this combination potentially producing clinically significant hypotension. ... ...

    Abstract Background: Phosphodiesterase type 5 inhibitors (PDE5i) are first-line therapy for erectile dysfunction (ED). Approximately 1-4% of PDE5i recipients co-possess nitrates, despite this combination potentially producing clinically significant hypotension. Real-world data in these patients and insights into prescriber rationales for co-prescription are limited.
    Aim: This study investigated whether PDE5i and nitrate co-possession is associated with increased rates of cardiovascular (CV) outcomes.
    Methods: Adult males with ED and PDE5i prescription and males with nitrate prescription were identified from a U.S. electronic health record database (2012-2016). Quantitative comparisons were made between patients with ED and co-possession (ED + PDE5i + nitrate), only nitrate possession (ED + nitrate and nitrate only [without ED]), and only PDE5i possession (ED + PDE5i).
    Outcomes: We quantified incidence of CV outcomes in co-possession and comparator periods, calculating incidence rate ratios after propensity score matching. Prescriber rationales were derived by reviewing virtual patient records.
    Results: Over 168,000 patients had ≥1 PDE5i prescription (∼241,000 possession periods); >480,000 patients had ≥1 nitrate prescription (∼486,000 possession periods); and 3,167 patients had 3,668 co-possession periods. Non-significantly different or lower rates of CV outcomes were observed for co-possession periods vs ED + nitrate and nitrate only periods. Most CV outcome rates were non-significantly different between co-possession and ED + PDE5i periods (myocardial infarction, hospitalized unstable angina and fainting were higher with co-possession). From qualitative assessment of patient records with co-possession, 131 of 252 (52%) documented discussion with a physician regarding co-possession; 69 of 131 (53%) warned or instructed on safely managing these contraindicated medications.
    Clinical implications: Findings from this real-world study indicate that co-possession of nitrate and PDE5i prescriptions is not associated with increased rates of CV outcomes, relative to possession of nitrates alone. Physicians should and often do discuss the risks of using both medications together with their patients.
    Strengths & limitations: Strengths of this study are the large size of the U.S. real-world patient cohort with data available for analysis, and our ability to utilize natural language processing to explore co-prescription rationales and patient-physician interactions. Limitations are the retrospective nature of the analysis and inability to establish whether recorded prescriptions were filled or the medication was consumed.
    Conclusion: Co-exposure of PDE5i and nitrates should continue to be avoided; however, co-possession of PDE5i and nitrate prescriptions is not necessarily associated with increased CV risk. Co-possession can be successfully managed in suitable circumstances. Nunes AP, Seeger JD, Stewart A, et al. Cardiovascular Outcome Risks in Patients With Erectile Dysfunction Co-Prescribed a Phosphodiesterase Type 5 Inhibitor (PDE5i) and a Nitrate: A Retrospective Observational Study Using Electronic Health Record Data in the United States. J Sex Med 2021;18:1511-1523.
    MeSH term(s) Adult ; Electronic Health Records ; Erectile Dysfunction/drug therapy ; Erectile Dysfunction/epidemiology ; Humans ; Male ; Nitrates ; Phosphodiesterase 5 Inhibitors/therapeutic use ; Retrospective Studies ; United States/epidemiology
    Chemical Substances Nitrates ; Phosphodiesterase 5 Inhibitors
    Language English
    Publishing date 2021-08-11
    Publishing country Netherlands
    Document type Journal Article ; Observational Study ; Research Support, Non-U.S. Gov't
    ZDB-ID 2251959-2
    ISSN 1743-6109 ; 1743-6095
    ISSN (online) 1743-6109
    ISSN 1743-6095
    DOI 10.1016/j.jsxm.2021.06.010
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  7. Article ; Online: Retrospective Observational Real-World Outcome Study to Evaluate Safety Among Patients With Erectile Dysfunction (ED) With Co-Possession of Tadalafil and Anti-Hypertensive Medications (anti-HTN).

    Nunes, Anthony P / Seeger, John D / Stewart, Andrew / Gupta, Alankar / McGraw, Thomas

    The journal of sexual medicine

    2021  Volume 19, Issue 1, Page(s) 74–82

    Abstract: Background: Erectile dysfunction (ED) is a common condition affecting male adults and may be associated with hypertension, diabetes, hyperlipidemia, and obesity. Phosphodiesterase type 5 (PDE5) inhibitors, such as tadalafil, are the first-line drug ... ...

    Abstract Background: Erectile dysfunction (ED) is a common condition affecting male adults and may be associated with hypertension, diabetes, hyperlipidemia, and obesity. Phosphodiesterase type 5 (PDE5) inhibitors, such as tadalafil, are the first-line drug therapy for ED. Studies and the current prescribing information of these PDE5 inhibitors indicate they are mechanistic mild vasodilators and, as such, concomitant use of a PDE5 inhibitor with anti-hypertensive medication may lead to drops in blood pressure due to possible drug-drug interaction.
    Aim: Evaluate risks of hypotensive/cardiovascular outcomes in a large cohort of patients with ED that have co-possession of prescriptions for tadalafil and hypertensive medications versus either medication/s alone.
    Methods: A cohort study conducted within an electronic health record database (Optum) representing hospitals across the US. Adult male patients prescribed tadalafil and/or anti-hypertensive medications from January 2012 to December 2017 were eligible. Possession periods were defined by the time patients likely had possession of medication, with propensity score-matched groups used for comparison.
    Outcomes: Risk of hypotensive/cardiovascular outcomes were measured using diagnostic codes and NLP algorithms during possession periods of tadalafil + anti-hypertensive versus either medication/s alone.
    Results: In total there were 127,849 tadalafil + anti-hypertensive medication possession periods, 821,359 anti-hypertensive only medication possession periods, and 98,638 tadalafil only medication possession periods during the study; 126,120 were successfully matched. Adjusted-matched incidence rate ratios (IRRs) for the anti-hypertensive only possession periods compared with tadalafil + anti-hypertensive periods of diagnosed outcomes were all below 1. Two outcomes had a 95% confidence interval (CI) that did not include 1.0: ventricular arrhythmia (IRR 0.79; 95% CI 0.66, 0.94) and diagnosis of hypotension (IRR 0.79; 95% CI 0.71, 0.89).
    Clinical implications: Provides real world evidence that co-possession of tadalafil and anti-hypertensive medications does not increase risk of hypotensive/cardiovascular outcomes beyond that observed for patients in possession of anti-hypertensive medications only.
    Strengths and limitations: EHR data are valuable for the evaluation of real world outcomes, however, the data are retrospective and collected for clinical patient management rather than research. Prescription data represent the intent of the prescriber and not use by the patient. Residual bias cannot be ruled out, despite propensity score matching, due to unobserved patient characteristics and severity that are not fully reflected in the EHR database.
    Conclusion: In the studied real world patients, this study did not demonstrate an increased risk of hypotensive or cardiovascular outcomes associated with co-possession of tadalafil and anti-hypertensive medications beyond that observed for patients in possession of anti-hypertensive medications only. Nunes AP, Seeger JD, Stewart A, et al., Retrospective Observational Real-World Outcome Study to Evaluate Safety Among Patients With Erectile Dysfunction (ED) With Co-Possession of Tadalafil and Anti-Hypertensive Medications (anti-HTN). J Sex Med 2022;19:74-82.
    MeSH term(s) Adult ; Antihypertensive Agents/adverse effects ; Carbolines/adverse effects ; Cohort Studies ; Erectile Dysfunction/drug therapy ; Erectile Dysfunction/epidemiology ; Erectile Dysfunction/etiology ; Humans ; Hypertension/complications ; Hypertension/drug therapy ; Hypertension/epidemiology ; Male ; Outcome Assessment, Health Care ; Retrospective Studies ; Tadalafil/therapeutic use ; Treatment Outcome
    Chemical Substances Antihypertensive Agents ; Carbolines ; Tadalafil (742SXX0ICT)
    Language English
    Publishing date 2021-12-03
    Publishing country Netherlands
    Document type Journal Article ; Observational Study
    ZDB-ID 2251959-2
    ISSN 1743-6109 ; 1743-6095
    ISSN (online) 1743-6109
    ISSN 1743-6095
    DOI 10.1016/j.jsxm.2021.10.012
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  8. Article ; Online: Suicidality risk among adults with binge-eating disorder.

    Bulik, Cynthia M / Bertoia, Monica L / Lu, Mei / Seeger, John D / Spalding, William M

    Suicide & life-threatening behavior

    2021  Volume 51, Issue 5, Page(s) 897–906

    Abstract: Objective: To estimate relative suicidality risk associated with binge-eating disorder (BED).: Methods: Retrospective study of patients identified as having BED (N = 1042) and a matched general population cohort (N = 10,420) from the Optum electronic ...

    Abstract Objective: To estimate relative suicidality risk associated with binge-eating disorder (BED).
    Methods: Retrospective study of patients identified as having BED (N = 1042) and a matched general population cohort (N = 10,420) from the Optum electronic health record database between January 2009 and September 2015. Patients had ≥1 outpatient encounter with a provider who recognized BED during the 12-month baseline preceding entry date. Incidence and relative risk of suicidality were assessed.
    Results: Incidence per 1000 person-years (95% CI) of suicidal ideation and suicide attempts, respectively, was 31.1 (23.1, 41.0) and 12.7 (7.9, 19.4) in the BED cohort and 5.8 (4.7, 7.1) and 1.4 (0.9, 2.2) in the comparator cohort. Risk of suicidal ideation and suicide attempts was greater in the BED cohort (HR [95% CIs], 6.43 [4.42, 9.37]) than in the comparator cohort (HR [95% CI], 9.47 [4.99, 17.98]) during follow-up. After adjusting for psychiatric comorbidities, associations of suicidal ideation and suicide attempts with BED remained elevated in patients with BED having histories of suicidality.
    Conclusions: Findings suggest that history of suicidality may result in an increased risk of suicidal ideation and suicide attempts in patients with BED relative to the general population. Psychiatric comorbidity burden may explain the elevated risk of these conditions in BED.
    MeSH term(s) Adult ; Binge-Eating Disorder/epidemiology ; Humans ; Retrospective Studies ; Risk Factors ; Suicidal Ideation ; Suicide ; Suicide, Attempted
    Language English
    Publishing date 2021-06-03
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 750058-0
    ISSN 1943-278X ; 0047-4592 ; 0363-0234
    ISSN (online) 1943-278X
    ISSN 0047-4592 ; 0363-0234
    DOI 10.1111/sltb.12768
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  9. Article: Patterns of Utilization and Expenditure Across Multiple Sclerosis Disease-Modifying Therapies: A Retrospective Cohort Study Using Claims Data from a Commercially Insured Population in the United States, 2010-2019.

    Zhu, Wen / Tang, Xiaoyu / Heyman, Rock A / Cai, Tianxi / Suh, Kangho / Seeger, John D / Xia, Zongqi

    Neurology and therapy

    2022  Volume 11, Issue 3, Page(s) 1147–1165

    Abstract: Introduction: Comparisons of healthcare utilization and expenditure among multiple sclerosis (MS) disease-modifying therapies (DMTs) are limited.: Methods: In this retrospective cohort study using commercial insurance claims data of a US population ( ... ...

    Abstract Introduction: Comparisons of healthcare utilization and expenditure among multiple sclerosis (MS) disease-modifying therapies (DMTs) are limited.
    Methods: In this retrospective cohort study using commercial insurance claims data of a US population (2010-2019), we compared healthcare utilization and costs in MS across different DMTs. We assigned patients to different treatment arms: no DMT (ND), high-efficacy (HE) DMT (alemtuzumab, B cell depletion, cladribine, and natalizumab), and standard-efficacy (SE) DMT (dimethyl fumarate, glatiramer acetate, interferon beta, sphingosine-1-phosphate receptor modulator, and teriflunomide). We obtained healthcare costs and occurrences of healthcare services: outpatient visits, emergency room visits, hospitalizations, MS-related magnetic resonance imaging (MRI). We quantified relapses (based on MS-related hospitalizations, as well as outpatient visits with prescription of high-dose steroids) and medical complexity (based on unique drug classes of prescriptions). We calculated covariate-adjusted incidence rate ratio of healthcare services using negative binomial regression with ND as reference and covariate-adjusted mean cumulative healthcare costs using a generalized linear model with log-link function and gamma distribution.
    Results: Among the 25,932 patients with MS (mean age 52.8 years, 75.2% women), both HE (mean age 54.0 years, 76.2% women) and SE (mean age 43.9 years, 75.6% women) groups had more non-pharmacy healthcare utilization than ND (mean age 57.6 years, 75.4% women), including overall outpatient doctor visits, neurology visits, and MS-related MRIs as well as relapses and medical complexities. Relative to ND, both HE and SE groups had higher pharmacy costs and overall healthcare costs 12 months after treatment initiation, despite having lower or equivalent non-pharmacy medical costs. In patients on DMT, pharmacy costs accounted for up to 65% of overall healthcare costs with over 85% of pharmacy costs attributable to DMT costs.
    Conclusion: DMT cost is a key driver of the overall healthcare expenditure in MS. Future comparative and cost-effectiveness studies integrating claims and electronic health records data with better balancing of patient characteristics are warranted.
    Language English
    Publishing date 2022-05-22
    Publishing country New Zealand
    Document type Journal Article
    ISSN 2193-8253
    ISSN 2193-8253
    DOI 10.1007/s40120-022-00358-4
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Safety of 4-valent human papillomavirus vaccine in males: a large observational post-marketing study.

    Amend, Kandace L / Turnbull, Bruce / Zhou, Li / Marks, Morgan A / Velicer, Christine / Saddier, Patricia / Seeger, John D

    Human vaccines & immunotherapeutics

    2022  Volume 18, Issue 5, Page(s) 2073750

    Abstract: The 4-valent human papillomavirus (HPV) vaccine (4vHPV vaccine), Gardasil®, is indicated for the prevention of several HPV-related diseases. The objective was to assess the safety of 4vHPV vaccine administered to males as part of routine care. The study ... ...

    Abstract The 4-valent human papillomavirus (HPV) vaccine (4vHPV vaccine), Gardasil®, is indicated for the prevention of several HPV-related diseases. The objective was to assess the safety of 4vHPV vaccine administered to males as part of routine care. The study used a US health insurance claims database, and included males, age 9 to 26 years, who initiated 4vHPV between October 2009 and December 2016. General safety outcomes were identified using ICD diagnosis codes associated with emergency room visits and hospitalizations in the claims database in risk periods (Days 1-60 and Days 1-14 following vaccine administration) and self-comparison periods (Days 91-150 and 91-104 for the Days 1-60 and Days 1-14 analysis, respectively). Incidence rates (IRs) and relative rates (RRs) with 95% confidence intervals (CIs) were calculated comparing the risk and self-comparison periods. In this study, 114,035 males initiated 4vHPV vaccine and received 202,737 doses. Using the 60-day time window, 5 outcomes had significantly elevated RRs after accounting for multiple comparisons: ear conditions (RR 1.28, 95% CI 1.03-1.59); otitis media and related conditions (RR 1.65, 95% CI 1.09-2.54); cellulitis and abscess of arm (RR 2.17, 95% CI 1.06-4.72); intracranial injury (RR 1.23, 95% CI 1.01-1.50); and concussion (RR 1.29, 95% CI 1.05-1.59). A higher rate of allergic reactions was noted on the day of 4vHPV vaccine receipt compared to other vaccines (21.07 events per 10,000 doses, 95% CI 18.89-23.44 versus 11.44 per 10,000 doses, 95% CI 9.84-13.22). A higher incidence rate of VTE was observed following vaccination but this association was not significant (RR 2.17, 95% CI 0.35-22.74). The 4vHPV vaccine was associated with same-day allergic reactions as well as ear infections, intracranial injury, cellulitis, and concussion within 2 months after vaccination. While allergic reaction and cellulitis are consistent with the known safety profile of 4vHPV vaccine, the association of the other outcomes were determined by an independent Safety Review Committee to be most likely a result of activities common in adolescent males that coincide with the timing of vaccination and not directly related to vaccination itself.
    MeSH term(s) Adolescent ; Adult ; Cellulitis ; Child ; Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 ; Humans ; Male ; Marketing ; Papillomaviridae ; Papillomavirus Infections/epidemiology ; Papillomavirus Infections/prevention & control ; Papillomavirus Vaccines/adverse effects ; Vaccination/adverse effects ; Young Adult
    Chemical Substances Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 ; Papillomavirus Vaccines
    Language English
    Publishing date 2022-06-17
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2664176-8
    ISSN 2164-554X ; 2164-5515
    ISSN (online) 2164-554X
    ISSN 2164-5515
    DOI 10.1080/21645515.2022.2073750
    Database MEDical Literature Analysis and Retrieval System OnLINE

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