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  1. Article ; Online: Handling missing disease information due to death in diseases that need two visits to diagnose.

    Thao, Le Thi Phuong / Wolfe, Rory / Heritier, Stephane / Geskus, Ronald

    Statistics in medicine

    2024  Volume 43, Issue 9, Page(s) 1708–1725

    Abstract: In studies that assess disease status periodically, time of disease onset is interval censored between visits. Participants who die between two visits may have unknown disease status after their last visit. In this work, we consider an additional ... ...

    Abstract In studies that assess disease status periodically, time of disease onset is interval censored between visits. Participants who die between two visits may have unknown disease status after their last visit. In this work, we consider an additional scenario where diagnosis requires two consecutive positive tests, such that disease status can also be unknown at the last visit preceding death. We show that this impacts the choice of censoring time for those who die without an observed disease diagnosis. We investigate two classes of models that quantify the effect of risk factors on disease outcome: a Cox proportional hazards model with death as a competing risk and an illness death model that treats disease as a possible intermediate state. We also consider four censoring strategies: participants without observed disease are censored at death (Cox model only), the last visit, the last visit with a negative test, or the second last visit. We evaluate the performance of model and censoring strategy combinations on simulated data with a binary risk factor and illustrate with a real data application. We find that the illness death model with censoring at the second last visit shows the best performance in all simulation settings. Other combinations show bias that varies in magnitude and direction depending on the differential mortality between diseased and disease-free subjects, the gap between visits, and the choice of the censoring time.
    MeSH term(s) Humans ; Proportional Hazards Models ; Computer Simulation ; Risk Factors
    Language English
    Publishing date 2024-02-21
    Publishing country England
    Document type Journal Article
    ZDB-ID 843037-8
    ISSN 1097-0258 ; 0277-6715
    ISSN (online) 1097-0258
    ISSN 0277-6715
    DOI 10.1002/sim.10038
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: A comparison of model selection methods for prediction in the presence of multiply imputed data.

    Thao, Le Thi Phuong / Geskus, Ronald

    Biometrical journal. Biometrische Zeitschrift

    2018  Volume 61, Issue 2, Page(s) 343–356

    Abstract: Many approaches for variable selection with multiply imputed data in the development of a prognostic model have been proposed. However, no method prevails as uniformly best. We conducted a simulation study with a binary outcome and a logistic regression ... ...

    Abstract Many approaches for variable selection with multiply imputed data in the development of a prognostic model have been proposed. However, no method prevails as uniformly best. We conducted a simulation study with a binary outcome and a logistic regression model to compare two classes of variable selection methods in the presence of MI data: (I) Model selection on bootstrap data, using backward elimination based on AIC or lasso, and fit the final model based on the most frequently (e.g.
    MeSH term(s) Adult ; Biostatistics/methods ; Humans ; Models, Statistical ; Multivariate Analysis ; Regression Analysis ; Tuberculosis, Meningeal/mortality
    Language English
    Publishing date 2018-10-23
    Publishing country Germany
    Document type Comparative Study ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 131640-0
    ISSN 1521-4036 ; 0323-3847 ; 0006-3452
    ISSN (online) 1521-4036
    ISSN 0323-3847 ; 0006-3452
    DOI 10.1002/bimj.201700232
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Advancing randomized controlled trial methodologies: The place of innovative trial design in eating disorders research.

    Ryan, Elizabeth G / Gao, Caroline X / Grantham, Kelsey L / Thao, Le Thi Phuong / Charles-Nelson, Anaïs / Bowden, Rhys / Herschtal, Alan / Lee, Katherine J / Forbes, Andrew B / Heritier, Stephane / Phillipou, Andrea / Wolfe, Rory

    The International journal of eating disorders

    2024  

    Abstract: Randomized controlled trials can be used to generate evidence on the efficacy and safety of new treatments in eating disorders research. Many of the trials previously conducted in this area have been deemed to be of low quality, in part due to a number ... ...

    Abstract Randomized controlled trials can be used to generate evidence on the efficacy and safety of new treatments in eating disorders research. Many of the trials previously conducted in this area have been deemed to be of low quality, in part due to a number of practical constraints. This article provides an overview of established and more innovative clinical trial designs, accompanied by pertinent examples, to highlight how design choices can enhance flexibility and improve efficiency of both resource allocation and participant involvement. Trial designs include individually randomized, cluster randomized, and designs with randomizations at multiple time points and/or addressing several research questions (master protocol studies). Design features include the use of adaptations and considerations for pragmatic or registry-based trials. The appropriate choice of trial design, together with rigorous trial conduct, reporting and analysis, can establish high-quality evidence to advance knowledge in the field. It is anticipated that this article will provide a broad and contemporary introduction to trial designs and will help researchers make informed trial design choices for improved testing of new interventions in eating disorders. PUBLIC SIGNIFICANCE: There is a paucity of high quality randomized controlled trials that have been conducted in eating disorders, highlighting the need to identify where efficiency gains in trial design may be possible to advance the eating disorder research field. We provide an overview of some key trial designs and features which may offer solutions to practical constraints and increase trial efficiency.
    Language English
    Publishing date 2024-03-12
    Publishing country United States
    Document type Journal Article
    ZDB-ID 603170-5
    ISSN 1098-108X ; 0276-3478
    ISSN (online) 1098-108X
    ISSN 0276-3478
    DOI 10.1002/eat.24187
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  4. Article ; Online: Reply to Dian et al.

    Thao, Le Thi Phuong / Geskus, Ronald / Thwaites, Guy

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

    2018  Volume 67, Issue 12, Page(s) 1955

    MeSH term(s) Humans ; Prognosis ; Tuberculosis, Meningeal
    Language English
    Publishing date 2018-05-31
    Publishing country United States
    Document type Letter ; Comment
    ZDB-ID 1099781-7
    ISSN 1537-6591 ; 1058-4838
    ISSN (online) 1537-6591
    ISSN 1058-4838
    DOI 10.1093/cid/ciy447
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  5. Article: Plant-Associated Representatives of the

    Vater, Joachim / Tam, Le Thi Thanh / Jähne, Jennifer / Herfort, Stefanie / Blumenscheit, Christian / Schneider, Andy / Luong, Pham Thi / Thao, Le Thi Phuong / Blom, Jochen / Klee, Silke R / Schweder, Thomas / Lasch, Peter / Borriss, Rainer

    Microorganisms

    2023  Volume 11, Issue 11

    Abstract: Seventeen bacterial strains able to suppress plant pathogens have been isolated from healthy Vietnamese crop plants and taxonomically assigned as members of ... ...

    Abstract Seventeen bacterial strains able to suppress plant pathogens have been isolated from healthy Vietnamese crop plants and taxonomically assigned as members of the
    Language English
    Publishing date 2023-10-31
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2720891-6
    ISSN 2076-2607
    ISSN 2076-2607
    DOI 10.3390/microorganisms11112677
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  6. Article: Transfusion practices in intensive care units: An Australian and New Zealand point prevalence study.

    Flint, Andrew W J / Brady, Karina / Wood, Erica M / Thao, Le Thi Phuong / Hammond, Naomi / Knowles, Serena / Nangla, Conrad / Reade, Michael C / McQuilten, Zoe K

    Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine

    2023  Volume 25, Issue 4, Page(s) 193–200

    Abstract: Objective: To describe current transfusion practices in intensive care units (ICUs) in Australia and New Zealand, compare them against national guidelines, and describe how viscoelastic haemostatic assays (VHAs) are used in guiding transfusion decisions. ...

    Abstract Objective: To describe current transfusion practices in intensive care units (ICUs) in Australia and New Zealand, compare them against national guidelines, and describe how viscoelastic haemostatic assays (VHAs) are used in guiding transfusion decisions.
    Design setting and participants: Prospective, multicentre, binational point-prevalence study. All adult patients admitted to participating ICUs on a single day in 2021.
    Main outcome measures: Transfusion types, amounts, clinical reasons, and triggers; use of anti-platelet medications, anti-coagulation, and VHA.
    Results: Of 712 adult patients in 51 ICUs, 71 (10%) patients received a transfusion during the 24hr period of observation. Compared to patients not transfused, these patients had higher Acute Physiology and Chronic Health Evaluation II scores (19 versus 17,
    Conclusions: Non-RBC transfusion decisions are often not aligned with guidelines and VHA is commonly available but rarely used to guide transfusions. Better evidence to guide transfusions in ICUs is needed.
    Language English
    Publishing date 2023-12-14
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 2401976-8
    ISSN 1441-2772
    ISSN 1441-2772
    DOI 10.1016/j.ccrj.2023.10.006
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  7. Article ; Online: CKD Biomarkers, Cognitive Impairment, and Incident Dementia in an Older Healthy Cohort.

    Murray, Anne M / Thao, Le Thi Phuong / Ryan, Joanne / Wolfe, Rory / Wetmore, James B / Woods, Robyn L / Polkinghorne, Kevan R

    Kidney360

    2021  Volume 3, Issue 3, Page(s) 435–445

    Abstract: Background: CKD is a risk factor for cognitive impairment (CI), but reports of individual associations of eGFR and albuminuria with CI and incident dementia in healthier, older, longitudinal populations are lacking. Our goal was to estimate these ... ...

    Abstract Background: CKD is a risk factor for cognitive impairment (CI), but reports of individual associations of eGFR and albuminuria with CI and incident dementia in healthier, older, longitudinal populations are lacking. Our goal was to estimate these associations in a large cohort of older healthy persons.
    Methods: In a longitudinal cohort study of older persons without prior cardiovascular disease, we estimated the associations between baseline eGFR (in ml/min per 1.73 m
    Results: At baseline, among 18,131 participants, median age was 74 years, eGFR was 74 (IQR, 63-84) ml/min per 1.73 m
    Conclusion: Mild albuminuria was associated with worse baseline cognitive function, cognitive decline, and increased risk for incident CIND and dementia. Screening global cognitive tests for older persons with UACR
    MeSH term(s) Aged ; Aged, 80 and over ; Albuminuria/diagnosis ; Biomarkers ; Cognitive Dysfunction/diagnosis ; Cohort Studies ; Creatinine/urine ; Cross-Sectional Studies ; Dementia/diagnosis ; Female ; Glomerular Filtration Rate ; Humans ; Longitudinal Studies ; Male ; Renal Insufficiency, Chronic/diagnosis
    Chemical Substances Biomarkers ; Creatinine (AYI8EX34EU)
    Language English
    Publishing date 2021-12-07
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ISSN 2641-7650
    ISSN (online) 2641-7650
    DOI 10.34067/KID.0005672021
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  8. Article ; Online: Immunoglobulin replacement vs prophylactic antibiotics for hypogammaglobulinemia secondary to hematological malignancy.

    McQuilten, Zoe K / Weinkove, Robert / Thao, Le Thi Phuong / Crispin, Philip / Degelia, Amber / Dendle, Claire / Gilbertson, Michael / Johnston, Anna / Keegan, Anastazia / Pepperell, Dominic / Pullon, Humphrey / Reynolds, John / van Tonder, Tina / Trotman, Judith / Waters, Neil / Wellard, Cameron / Weston, Helen / Morrissey, C Orla / Wood, Erica M

    Blood advances

    2024  Volume 8, Issue 7, Page(s) 1787–1795

    Abstract: Abstract: Immunoglobulin replacement and prophylactic antibiotics are commonly used to prevent infections in patients with secondary hypogammaglobulinemia due to hematological malignancies but have never been directly compared. In this randomized ... ...

    Abstract Abstract: Immunoglobulin replacement and prophylactic antibiotics are commonly used to prevent infections in patients with secondary hypogammaglobulinemia due to hematological malignancies but have never been directly compared. In this randomized controlled feasibility trial conducted in 7 hospitals in Australia and New Zealand, we enrolled patients with secondary hypogammaglobulinemia with either a history of recurrent/severe infection or an immunoglobulin G level <4 g/L. Participants were randomized in a 1:2 ratio to immunoglobulin (0.4 g/kg per 4 weeks IV) or daily antibiotics (trimethoprim-sulfamethoxazole 160 mg/800 mg or, if contraindicated, 100 mg doxycycline) for 12 months. Participants allocated to antibiotics were allowed to crossover after grade ≥3 infections. The primary outcome was proportion of patients alive on the assigned treatment 12 months after randomization. Between August 2017 and April 2019, 63 patients were randomized: 42 to antibiotics and 21 to immunoglobulin. Proportion of participants alive on allocated treatment at 12 months was 76% in the immunoglobulin and 71% in the antibiotic arm (Fisher exact test P=.77; odds ratio, 0.78; 95% CI, 0.22-2.52). The lower quartile for time to first major infection (median, not reached) was 11.1 months for the immunoglobulin and 9.7 months for the antibiotic arm (log-rank test, P=.65). Three participants in the immunoglobulin and 2 in the antibiotic arm had grade ≥3 treatment-related adverse events. A similar proportion of participants remained on antibiotic prophylaxis at 12 months to those on immunoglobulin, with similar rates of major infections. Our findings support the feasibility of progressing to a phase 3 trial. Trial registration #ACTRN12616001723471.
    MeSH term(s) Humans ; Agammaglobulinemia/complications ; Agammaglobulinemia/drug therapy ; Anti-Bacterial Agents/adverse effects ; Doxycycline ; Hematologic Neoplasms/complications ; Hematologic Neoplasms/drug therapy ; Immunoglobulins ; Feasibility Studies
    Chemical Substances Anti-Bacterial Agents ; Doxycycline (N12000U13O) ; Immunoglobulins
    Language English
    Publishing date 2024-04-08
    Publishing country United States
    Document type Randomized Controlled Trial ; Journal Article
    ZDB-ID 2915908-8
    ISSN 2473-9537 ; 2473-9529
    ISSN (online) 2473-9537
    ISSN 2473-9529
    DOI 10.1182/bloodadvances.2023011231
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  9. Article ; Online: Effect of Low-Dose Aspirin Versus Placebo on Incidence of Anemia in the Elderly : A Secondary Analysis of the Aspirin in Reducing Events in the Elderly Trial.

    McQuilten, Zoe K / Thao, Le Thi Phuong / Pasricha, Sant-Rayn / Artz, Andrew S / Bailey, Michael / Chan, Andrew T / Cohen, Harvey Jay / Lockery, Jessica E / Murray, Anne M / Nelson, Mark R / Schneider, Hans G / Wolfe, Rory / Woods, Robyn L / Wood, Erica M / McNeil, John J

    Annals of internal medicine

    2023  Volume 176, Issue 7, Page(s) 913–921

    Abstract: Background: Daily low-dose aspirin increases major bleeding; however, few studies have investigated its effect on iron deficiency and anemia.: Objective: To investigate the effect of low-dose aspirin on incident anemia, hemoglobin, and serum ferritin ...

    Abstract Background: Daily low-dose aspirin increases major bleeding; however, few studies have investigated its effect on iron deficiency and anemia.
    Objective: To investigate the effect of low-dose aspirin on incident anemia, hemoglobin, and serum ferritin concentrations.
    Design: Post hoc analysis of the ASPREE (ASPirin in Reducing Events in the Elderly) randomized controlled trial. (ClinicalTrials.gov: NCT01038583).
    Setting: Primary/community care in Australia and the United States.
    Participants: Community-dwelling persons aged 70 years or older (≥65 years for Black persons and Hispanic persons).
    Intervention: 100 mg of aspirin daily or placebo.
    Measurements: Hemoglobin concentration was measured annually in all participants. Ferritin was measured at baseline and 3 years after random assignment in a large subset.
    Results: 19 114 persons were randomly assigned. Anemia incidence in the aspirin and placebo groups was 51.2 events and 42.9 events per 1000 person-years, respectively (hazard ratio, 1.20 [95% CI, 1.12 to 1.29]). Hemoglobin concentrations declined by 3.6 g/L per 5 years in the placebo group and the aspirin group experienced a steeper decline by 0.6 g/L per 5 years (CI, 0.3 to 1.0 g/L). In 7139 participants with ferritin measures at baseline and year 3, the aspirin group had greater prevalence than placebo of ferritin levels less than 45 µg/L at year 3 (465 [13%] vs. 350 [9.8%]) and greater overall decline in ferritin by 11.5% (CI, 9.3% to 13.7%) compared with placebo. A sensitivity analysis quantifying the effect of aspirin in the absence of major bleeding produced similar results.
    Limitations: Hemoglobin was measured annually. No data were available on causes of anemia.
    Conclusion: Low-dose aspirin increased incident anemia and decline in ferritin in otherwise healthy older adults, independent of major bleeding. Periodic monitoring of hemoglobin should be considered in older persons on aspirin.
    Primary funding source: National Institutes of Health and Australian National Health and Medical Research Council.
    MeSH term(s) Aged ; Humans ; United States/epidemiology ; Aged, 80 and over ; Aspirin/adverse effects ; Incidence ; Australia/epidemiology ; Hemorrhage/epidemiology ; Anemia/epidemiology ; Anemia/prevention & control ; Anemia/drug therapy ; Ferritins ; Hemoglobins ; Double-Blind Method
    Chemical Substances Aspirin (R16CO5Y76E) ; Ferritins (9007-73-2) ; Hemoglobins
    Language English
    Publishing date 2023-06-20
    Publishing country United States
    Document type Randomized Controlled Trial ; Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural
    ZDB-ID 336-0
    ISSN 1539-3704 ; 0003-4819
    ISSN (online) 1539-3704
    ISSN 0003-4819
    DOI 10.7326/M23-0675
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  10. Article ; Online: Low-Dose Aspirin and the Risk of Stroke and Intracerebral Bleeding in Healthy Older People: Secondary Analysis of a Randomized Clinical Trial.

    Cloud, Geoffrey C / Williamson, Jeff D / Thao, Le Thi Phuong / Tran, Cammie / Eaton, Charles B / Wolfe, Rory / Nelson, Mark R / Reid, Christopher M / Newman, Anne B / Lockery, Jessica / Fitzgerald, Sharyn M / Murray, Anne M / Shah, Raj C / Woods, Robyn L / Donnan, Geoffrey A / McNeil, John J

    JAMA network open

    2023  Volume 6, Issue 7, Page(s) e2325803

    Abstract: Importance: Low-dose aspirin has been widely used for primary and secondary prevention of stroke. The balance between potential reduction of ischemic stroke events and increased intracranial bleeding has not been established in older individuals.: ... ...

    Abstract Importance: Low-dose aspirin has been widely used for primary and secondary prevention of stroke. The balance between potential reduction of ischemic stroke events and increased intracranial bleeding has not been established in older individuals.
    Objective: To establish the risks of ischemic stroke and intracranial bleeding among healthy older people receiving daily low-dose aspirin.
    Design, setting, and participants: This secondary analysis of the Aspirin in Reducing Events in the Elderly (ASPREE) randomized, double-blind, placebo-controlled trial of daily low-dose aspirin was conducted among community-dwelling people living in Australia or the US. Participants were older adults free of symptomatic cardiovascular disease. Recruitment took place between 2010 and 2014, and participants were followed up for a median (IQR) of 4.7 (3.6-5.7) years. This analysis was completed from August 2021 to March 2023.
    Interventions: Daily 100-mg enteric-coated aspirin or matching placebo.
    Main outcomes and measures: Stroke and stroke etiology were predetermined secondary outcomes and are presented with a focus on prevention of initial stroke or intracranial bleeding event. Outcomes were assessed by review of medical records.
    Results: Among 19 114 older adults (10 782 females [56.4%]; median [IQR] age, 74 [71.6-77.7] years), 9525 individuals received aspirin and 9589 individuals received placebo. Aspirin did not produce a statistically significant reduction in the incidence of ischemic stroke (hazard ratio [HR], 0.89; 95% CI, 0.71-1.11). However, a statistically significant increase in intracranial bleeding was observed among individuals assigned to aspirin (108 individuals [1.1%]) compared with those receiving placebo (79 individuals [0.8%]; HR, 1.38; 95% CI, 1.03-1.84). This occurred by an increase in a combination of subdural, extradural, and subarachnoid bleeding with aspirin compared with placebo (59 individuals [0.6%] vs 41 individuals [0.4%]; HR, 1.45; 95% CI, 0.98-2.16). Hemorrhagic stroke was recorded in 49 individuals (0.5%) assigned to aspirin compared with 37 individuals (0.4%) in the placebo group (HR, 1.33; 95% CI, 0.87-2.04).
    Conclusions and relevance: This study found a significant increase in intracranial bleeding with daily low-dose aspirin but no significant reduction of ischemic stroke. These findings may have particular relevance to older individuals prone to developing intracranial bleeding after head trauma.
    Trial registration: ISRCTN.org Identifier: ISRCTN83772183.
    MeSH term(s) Female ; Humans ; Aged ; Platelet Aggregation Inhibitors/adverse effects ; Aspirin/adverse effects ; Stroke/epidemiology ; Stroke/prevention & control ; Stroke/drug therapy ; Cerebral Hemorrhage/chemically induced ; Cerebral Hemorrhage/epidemiology ; Cerebral Hemorrhage/prevention & control ; Intracranial Hemorrhages/chemically induced ; Intracranial Hemorrhages/epidemiology ; Intracranial Hemorrhages/prevention & control ; Ischemic Stroke/drug therapy
    Chemical Substances Platelet Aggregation Inhibitors ; Aspirin (R16CO5Y76E)
    Language English
    Publishing date 2023-07-03
    Publishing country United States
    Document type Randomized Controlled Trial ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ISSN 2574-3805
    ISSN (online) 2574-3805
    DOI 10.1001/jamanetworkopen.2023.25803
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