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  1. Article ; Online: Efficacy of COVID-19 vaccines in patients taking immunosuppressants.

    Shen, Chen / Risk, Malcolm / Schiopu, Elena / Hayek, Salim S / Xie, Tiankai / Holevinski, Lynn / Akin, Cem / Freed, Gary / Zhao, Lili

    Annals of the rheumatic diseases

    2022  Volume 81, Issue 6, Page(s) 875–880

    Abstract: Objectives: We intended to assess the effectiveness of all three US Food and Drug Administration approved COVID-19 vaccines at preventing SARS-CoV-2 infection and COVID-19 hospitalisation in a large cohort of individuals on immunosuppressants for a ... ...

    Abstract Objectives: We intended to assess the effectiveness of all three US Food and Drug Administration approved COVID-19 vaccines at preventing SARS-CoV-2 infection and COVID-19 hospitalisation in a large cohort of individuals on immunosuppressants for a diverse range of conditions.
    Methods: We studied the effectiveness of BNT162b2 (Pfizer-BioNTech), mRNA-1273 (Moderna) and Ad26.COV2.S (Johnson & Johnson-Janssen) vaccines among individuals who take immunosuppressants (including disease-modifying antirheumatic drugs and glucocorticoids) by comparing vaccinated (n=97688) and unvaccinated (n=42094) individuals in the Michigan Medicine healthcare system from 1 January to 7 December 2021, using Cox proportional hazards modelling with time-varying covariates.
    Results: Among vaccinated and unvaccinated individuals, taking immunosuppressants increased the risk of SARS-CoV-2 infection (adjusted HR (aHR)=2.17, 95% CI 1.69 to 2.79 for fully vaccinated and aHR=1.40, 95% CI 1.07 to 1.83 for unvaccinated). Among individuals taking immunosuppressants, we found: (1) vaccination reduced the risk of SARS-CoV-2 infection (aHR=0.55, 95% CI 0.39 to 0.78); (2) the BNT162b2 and mRNA-1273 vaccines were highly effective at reducing the risk of SARS-CoV-2 infection (n=2046, aHR=0.59, 95% CI 0.38 to 0.91 for BNT162b2; n=2064, aHR=0.52, 95% CI 0.33 to 0.82 for mRNA-1273); (3) with a smaller sample size (n=173), Ad26.COV2.S vaccine protection did not reach statistical significance (aHR=0.34, 95% CI 0.09 to 1.30, p=0.17); and (4) receiving a booster dose reduced the risk of SARS-CoV-2 infection (aHR=0.42, 95% CI 0.24 to 0.76).
    Conclusions: The mRNA-1273 and BNT162b2 vaccines are effective in individuals who take immunosuppressants. However, individuals who are vaccinated but on immunosuppressants are still at higher risk of SARS-CoV-2 infection and COVID-19 hospitalisation than the broader vaccinated population. Booster doses are effective and crucially important for individuals on immunosuppressants.
    MeSH term(s) Ad26COVS1 ; BNT162 Vaccine ; COVID-19/epidemiology ; COVID-19/prevention & control ; COVID-19 Vaccines ; Humans ; Immunosuppressive Agents ; SARS-CoV-2
    Chemical Substances Ad26COVS1 ; COVID-19 Vaccines ; Immunosuppressive Agents ; BNT162 Vaccine (N38TVC63NU)
    Language English
    Publishing date 2022-02-23
    Publishing country England
    Document type Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 7090-7
    ISSN 1468-2060 ; 0003-4967
    ISSN (online) 1468-2060
    ISSN 0003-4967
    DOI 10.1136/annrheumdis-2021-222045
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.MO 167: Show issues

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  2. Article ; Online: Primary Aldosteronism Screening Rates Differ with Sex, Race, and Comorbidities.

    Turcu, Adina F / Nhan, Winnie / Grigoryan, Seda / Zhang, Lei / Urban, Caitlin / Liu, Haiping / Holevinski, Lynn / Zhao, Lili

    Journal of the American Heart Association

    2022  Volume 11, Issue 14, Page(s) e025952

    Abstract: Background Primary aldosteronism (PA) is a common but under-recognized cause of secondary hypertension. Data directly comparing screening rates across single and overlapping indications are lacking. Methods and Results We conducted a retrospective review ...

    Abstract Background Primary aldosteronism (PA) is a common but under-recognized cause of secondary hypertension. Data directly comparing screening rates across single and overlapping indications are lacking. Methods and Results We conducted a retrospective review of adults with hypertension seen in outpatient clinics at a tertiary referral academic center between January 1, 2017, and June 30, 2020. We included patients with hypertension plus at least one of the following: resistant hypertension; age<35 years; obstructive sleep apnea; hypokalemia; or an adrenal mass. We excluded patients with adrenal insufficiency, severe renal disease, or heart failure, and renovascular hypertension. Of 203 535 patients with hypertension, 86044 (42.3%) met at least 1 PA screening criterion, and of these, 2898 (3.4%) were screened for PA. Screening occurred in 2.7% of patients with resistant hypertension; 4.2% of those with obstructive sleep apnea; 5.1% of those <35 years; 10.0% of those with hypokalemia; and 47.3% of patients with an adrenal mass. Screening rates were higher in patients with multiple risk factors: 16.8% for ≥3, 5.7% for 2, and 2.5% for 1 criterion. Multiple logistic regression showed that the odds of PA screening were higher in patients with hypokalemia: odds ratio (95% CI): 3.0 (2.7-3.3); women: 1.3 (1.2-1.4); Black versus White: 1.5 (1.4-1.7); those with obstructive sleep apnea, chronic renal disease, stroke, and dyslipidemia. Conclusions Consideration for PA is given in a small subset of at-risk patients, and typically after comorbidities have developed.
    MeSH term(s) Adult ; Aldosterone ; Female ; Humans ; Hyperaldosteronism/complications ; Hyperaldosteronism/diagnosis ; Hyperaldosteronism/epidemiology ; Hypertension/complications ; Hypertension/diagnosis ; Hypertension/epidemiology ; Hypokalemia/diagnosis ; Male ; Mass Screening ; Renin ; Sleep Apnea, Obstructive/complications
    Chemical Substances Aldosterone (4964P6T9RB) ; Renin (EC 3.4.23.15)
    Language English
    Publishing date 2022-07-08
    Publishing country England
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 2653953-6
    ISSN 2047-9980 ; 2047-9980
    ISSN (online) 2047-9980
    ISSN 2047-9980
    DOI 10.1161/JAHA.122.025952
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Comparative Effectiveness of Coronavirus Disease 2019 (COVID-19) Vaccines Against the Delta Variant.

    Risk, Malcolm / Shen, Chen / Hayek, Salim S / Holevinski, Lynn / Schiopu, Elena / Freed, Gary / Akin, Cem / Zhao, Lili

    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

    2022  Volume 75, Issue 1, Page(s) e623–e629

    Abstract: Background: There is a lack of data regarding how the Delta variant of coronavirus disease 2019 (COVID-19) has impacted the effectiveness of the BNT162b2 (Pfizer-BioNTech), mRNA-1273 (Moderna), and Ad26.COV2.S (Johnson & Johnson-Janssen) vaccines at ... ...

    Abstract Background: There is a lack of data regarding how the Delta variant of coronavirus disease 2019 (COVID-19) has impacted the effectiveness of the BNT162b2 (Pfizer-BioNTech), mRNA-1273 (Moderna), and Ad26.COV2.S (Johnson & Johnson-Janssen) vaccines at preventing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and COVID-19 hospitalization.
    Methods: We compared the effectiveness of the three vaccines during the pre- and post-Delta variant period (before and after 1 July 2021) in a large cohort of vaccinated and unvaccinated patients in the Michigan Medicine healthcare system. We assessed vaccine effectiveness (VE) using 2 analyses: an inverse propensity weighted (IPW) Kaplan-Meier (KM) analysis based on time from vaccination, and a Cox model based on calendar time with vaccination as a time-varying covariate.
    Results: Compared to Ad26.COV2.S recipients, the risk of hospitalization for COVID-19 in the post-Delta variant period was lower for BNT162b2 recipients (hazard ratio [HR] = 0.37; 95% confidence interval [CI]: [.14-.98]; P = .05) and mRNA-1273 recipients (HR = 0.21; 95% CI: [.07-.64]; P = .006). Recipients of the mRNA-1273 vaccine had a lower risk of SARS-CoV-2 infection than Ad26.COV2.S recipients (HR = 0.6; 95% CI: [.43-.83]; P = .003) and BNT162b2 recipients (HR = 0.64; 95% CI: [.54-.76]; P < .001). After 1 July, efficacy against SARS-CoV-2 infection declined for Ad26.COV2.S recipients (VE = 76% before; VE = 49% after; P = .02), BNT162b2 recipients (VE = 87% before; VE = 52% after; P < .001), and mRNA-1273 recipients (VE = 92% before; VE = 70% after; P < .001). Waning immunity and the Delta variant contributed independently and significantly to this decline.
    Conclusions: Although there is a substantial decline in effectiveness, the approved COVID-19 vaccines remain effective against infection and hospitalization due to the Delta variant. The mRNA-based vaccines are more effective than the Ad26.COV2.S vaccine.
    MeSH term(s) 2019-nCoV Vaccine mRNA-1273 ; Ad26COVS1 ; BNT162 Vaccine ; COVID-19/prevention & control ; COVID-19 Vaccines ; Humans ; SARS-CoV-2
    Chemical Substances Ad26COVS1 ; COVID-19 Vaccines ; 2019-nCoV Vaccine mRNA-1273 (EPK39PL4R4) ; BNT162 Vaccine (N38TVC63NU)
    Language English
    Publishing date 2022-02-08
    Publishing country United States
    Document type Comparative Study ; Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 1099781-7
    ISSN 1537-6591 ; 1058-4838
    ISSN (online) 1537-6591
    ISSN 1058-4838
    DOI 10.1093/cid/ciac106
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 1505: Show issues Location:
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    Zs.MO 480: Show issues

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  4. Article ; Online: Big data analysis of associations between patient reported outcomes, observer reported toxicities, and overall quality of life in head and neck cancer patients treated with radiation therapy.

    Wilkie, Joel R / Mierzwa, Michelle L / Yao, John / Eisbruch, Avraham / Feng, Mary / Weyburne, Grant / Chen, Xiaoping / Holevinski, Lynn / Mayo, Charles S

    Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology

    2019  Volume 137, Page(s) 167–174

    Abstract: Purpose: To assess associations between a variety of patient-reported outcomes (PROs), observer reported toxicities (ORTs), and patient-reported overall quality of life (QOL) for head and neck cancer patients treated with radiotherapy, in order to ... ...

    Abstract Purpose: To assess associations between a variety of patient-reported outcomes (PROs), observer reported toxicities (ORTs), and patient-reported overall quality of life (QOL) for head and neck cancer patients treated with radiotherapy, in order to identify important items for inclusion in prospective patient reporting in the clinic.
    Methods: 612 patients completed 27 PRO items from three questionnaires at 1273 follow-up visits, and clinicians provided ORTs according to CTCAE criteria. Using a big data approach, we measured associations among all PROs, between all PROs and ORTs, and between PROs/ORTs and QOL with Pearson (ρ) and Kendall (τ) correlation coefficients, and a novel analysis method based on receiver operating characteristic (ROC) curves used to detect thresholds in response levels demonstrating strong interactions.
    Results: PROs most strongly associated with QOL were recreation/entertainment, activity, and fatigue, with ρ = 0.51-0.60. Several PROs assessing a common functional outcome (eg. xerostomia) were highly associated with each other (PRO-PRO), with maximum ρ = 0.84. Maximum ORT-PRO correlations were ρ = 0.61 (dysgeusia versus taste), and ρ = 0.5 for ORT-QOL (dry mouth - day). The ROC method identified response thresholds with high area under the curve (AUC) scores for many ORT-PRO associations with maximum AUC
    Conclusions: PRO associations identified activity, lifestyle and fatigue as items for strong consideration for inclusion in questionnaires in the clinic, and suggest that outcome information can be captured in fewer items than the 27 in this study. The ability of clinicians to assess patient toxicities is highest with more severe toxicities, underscoring the need for PRO collection in patient visits to understand and address patient symptoms.
    MeSH term(s) Big Data ; Data Interpretation, Statistical ; Fatigue/epidemiology ; Fatigue/etiology ; Female ; Head and Neck Neoplasms/epidemiology ; Head and Neck Neoplasms/radiotherapy ; Humans ; Male ; Middle Aged ; Patient Reported Outcome Measures ; Prospective Studies ; Quality of Life ; Radiation Injuries/epidemiology ; Radiotherapy/adverse effects ; Radiotherapy/statistics & numerical data ; Surveys and Questionnaires ; Xerostomia/epidemiology ; Xerostomia/etiology
    Language English
    Publishing date 2019-05-22
    Publishing country Ireland
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 605646-5
    ISSN 1879-0887 ; 0167-8140
    ISSN (online) 1879-0887
    ISSN 0167-8140
    DOI 10.1016/j.radonc.2019.04.030
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    Zs.A 1926: Show issues Location:
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  5. Article: The big data effort in radiation oncology: Data mining or data farming?

    Mayo, Charles S / Kessler, Marc L / Eisbruch, Avraham / Weyburne, Grant / Feng, Mary / Hayman, James A / Jolly, Shruti / El Naqa, Issam / Moran, Jean M / Matuszak, Martha M / Anderson, Carlos J / Holevinski, Lynn P / McShan, Daniel L / Merkel, Sue M / Machnak, Sherry L / Lawrence, Theodore S / Ten Haken, Randall K

    Advances in radiation oncology

    2016  Volume 1, Issue 4, Page(s) 260–271

    Abstract: Although large volumes of information are entered into our electronic health care records, radiation oncology information systems and treatment planning systems on a daily basis, the goal of extracting and using this big data has been slow to emerge. ... ...

    Abstract Although large volumes of information are entered into our electronic health care records, radiation oncology information systems and treatment planning systems on a daily basis, the goal of extracting and using this big data has been slow to emerge. Development of strategies to meet this goal is aided by examining issues with a data farming instead of a data mining conceptualization. Using this model, a vision of key data elements, clinical process changes, technology issues and solutions, and role for professional societies is presented. With a better view of technology, process and standardization factors, definition and prioritization of efforts can be more effectively directed.
    Language English
    Publishing date 2016-10-13
    Publishing country United States
    Document type Journal Article ; Review
    ISSN 2452-1094
    ISSN 2452-1094
    DOI 10.1016/j.adro.2016.10.001
    Database MEDical Literature Analysis and Retrieval System OnLINE

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