Gary G. Koch
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View article: Some Further Remarks concerning "A General Approach to the Estimation of Variance Components"
Some Further Remarks concerning "A General Approach to the Estimation of Variance Components" Open
The estimates of Koch [1967a] have the undesirable property that they may change in value if the same constant is added to each of the observations. In this paper, an alternative procedure based on the same general principles is developed …
View article: Hypotheses of 'No Interaction' in Multidimensional Contingency Tables
Hypotheses of 'No Interaction' in Multidimensional Contingency Tables Open
The statistical analysis of multi-dimensional contingency tables is discussed from the point of view of the associated underlying model. Different formulations of hypotheses of 'no interaction' are considered. The corresponding test statis…
View article: A Procedure to Estimate the Population Mean in Random Effects Models
A Procedure to Estimate the Population Mean in Random Effects Models Open
A general procedure for estimating the population mean in random effects models of the nested and/of classification type is considered. The suggested estimator is unbiased and consistent (with respect to the structure of the experimental d…
View article: A General Approach to the Estimation of Variance Components
A General Approach to the Estimation of Variance Components Open
A general method of estimation of variance components in random-effects models of the nested and/or classification type is considered. If a given parameter is estimable with respect to some particular experimental design (i. e., an unbiase…
View article: Randomization-based covariance adjustment of win ratios and win odds for randomized multi-visit studies with ordinal outcomes
Randomization-based covariance adjustment of win ratios and win odds for randomized multi-visit studies with ordinal outcomes Open
In many randomized multi-visit studies, some response variables have an ordinal scale for outcomes. The win odds (accounts for ties) and the win ratio (ignores ties) are useful for treatment comparisons for ordinal outcomes. This paper dis…
View article: Efficacy and safety of dapagliflozin in patients hospitalized with COVID-19 with and without type 2 diabetes: a prespecified analysis of the DARE-19 randomized trial
Efficacy and safety of dapagliflozin in patients hospitalized with COVID-19 with and without type 2 diabetes: a prespecified analysis of the DARE-19 randomized trial Open
The trial was registered on ClinicalTrials.gov (NCT04350593).
View article: Power and sample size calculation for the win odds test: application to an ordinal endpoint in COVID-19 trials
Power and sample size calculation for the win odds test: application to an ordinal endpoint in COVID-19 trials Open
The win odds is a distribution-free method of comparing locations of distributions of two independent random variables. Introduced as a method for analyzing hierarchical composite endpoints, it is well suited to be used in the analysis of …
View article: On kernel machine learning for propensity score estimation under complex confounding structures
On kernel machine learning for propensity score estimation under complex confounding structures Open
Post marketing data offer rich information and cost-effective resources for physicians and policy-makers to address some critical scientific questions in clinical practice. However, the complex confounding structures (e.g., nonlinear and n…
View article: Effects of dapagliflozin on prevention of major clinical events and recovery in patients with respiratory failure because of COVID‐19: Design and rationale for the DARE‐19 study
Effects of dapagliflozin on prevention of major clinical events and recovery in patients with respiratory failure because of COVID‐19: Design and rationale for the DARE‐19 study Open
AIMS: Coronavirus disease 2019 (COVID-19) is caused by a novel severe acute respiratory syndrome coronavirus 2. It can lead to multiorgan failure, including respiratory and cardiovascular decompensation, and kidney injury, with significant…
View article: 1125 Non-Dipping Blood Pressure Is Associated with Sleep Timing in Hypertensive Adults with Insomnia Disorder
1125 Non-Dipping Blood Pressure Is Associated with Sleep Timing in Hypertensive Adults with Insomnia Disorder Open
Introduction Blood pressure (BP) dipping during nocturnal sleep is characteristic of a normal circadian BP pattern. A blunted BP dipping pattern (< 10% dip in BP), however, is a cardiovascular disease (CVD) risk factor and is associated…
View article: Dapagliflozin and Kidney Outcomes in Hospitalized Patients with COVID-19 Infection
Dapagliflozin and Kidney Outcomes in Hospitalized Patients with COVID-19 Infection Open
BACKGROUND AND OBJECTIVES: Patients who were hospitalized with coronavirus disease 2019 (COVID-19) infection are at high risk of AKI and KRT, especially in the presence of CKD. The Dapagliflozin in Respiratory Failure in Patients with COVI…
View article: Preservation of Type I Error for Partially‐Unblinded Sample Size Re‐Estimation
Preservation of Type I Error for Partially‐Unblinded Sample Size Re‐Estimation Open
Sample size re‐estimation (SSR) at an interim analysis allows for adjustments based on accrued data. Existing strategies rely on either blinded or unblinded methods to inform such adjustments and, ideally, perform these adjustments in a wa…
View article: Sodium–glucose co-transporter-2 inhibitors for hospitalised patients with COVID-19: a prospective meta-analysis of randomised trials
Sodium–glucose co-transporter-2 inhibitors for hospitalised patients with COVID-19: a prospective meta-analysis of randomised trials Open
None.
View article: Randomization-based covariance adjustment of win ratios and win odds for randomized multi-visit studies with ordinal outcomes
Randomization-based covariance adjustment of win ratios and win odds for randomized multi-visit studies with ordinal outcomes Open
In many randomized multi-visit studies, some response variables have an ordinal scale for outcomes. The win odds (accounts for ties) and the win ratio (ignores ties) are useful for treatment comparisons for ordinal outcomes. This paper dis…
View article: Depressive symptoms are associated with clinical outcomes in heart failure with reduced ejection fraction
Depressive symptoms are associated with clinical outcomes in heart failure with reduced ejection fraction Open
Aims The objective of this study was to examine associations between elevated depressive symptoms and increased risk of adverse clinical events patients with heart failure and reduced ejection fraction (HFrEF), as well as the potential con…
View article: Angiogenic Gene Therapy for Refractory Angina: Results of the EXACT Phase 2 Trial
Angiogenic Gene Therapy for Refractory Angina: Results of the EXACT Phase 2 Trial Open
BACKGROUND: XC001 is a novel adenoviral-5 vector designed to express multiple isoforms of VEGF (vascular endothelial growth factor) and more safely and potently induce angiogenesis. The EXACT trial (Epicardial Delivery of XC001 Gene Therap…
View article: LB-2 | VEGF Gene Therapy Improves Exercise Time, Ischemia, and Symptoms in Patients with Refractory Angina: Results of the Phase II EXACT Trial
LB-2 | VEGF Gene Therapy Improves Exercise Time, Ischemia, and Symptoms in Patients with Refractory Angina: Results of the Phase II EXACT Trial Open
XC001 is a novel adenoviral-5 vector designed to express multiple isoforms of vascular endothelial growth factor to more safely and potently induce angiogenesis. The EXACT trial (NCT04125732) assessed the safety and preliminary efficacy of…
View article: Risk of extended major adverse cardiovascular event endpoints with tofacitinib versus TNF inhibitors in patients with rheumatoid arthritis: a post hoc analysis of a phase 3b/4 randomised safety study
Risk of extended major adverse cardiovascular event endpoints with tofacitinib versus TNF inhibitors in patients with rheumatoid arthritis: a post hoc analysis of a phase 3b/4 randomised safety study Open
Objectives Compare the risk of extended major adverse cardiovascular (CV) event (MACE) composite outcomes and component events in patients with rheumatoid arthritis (RA) treated with tofacitinib versus tumour necrosis factor inhibitors (TN…
View article: Cognitive behavior therapy for insomnia for untreated hypertension with comorbid insomnia disorder: The SLEEPRIGHT clinical trial
Cognitive behavior therapy for insomnia for untreated hypertension with comorbid insomnia disorder: The SLEEPRIGHT clinical trial Open
Insomnia and poor sleep are associated with an increased risk of developing cardiovascular disease (CVD) and its precursors, including hypertension. In 2022, the American Heart Association (AHA) added inadequate sleep to its list of health…
View article: Association of Depression Symptoms and Biomarkers of Risk on Clinical Outcomes in HFrEF
Association of Depression Symptoms and Biomarkers of Risk on Clinical Outcomes in HFrEF Open
BACKGROUND Prior studies have demonstrated an association of depression with adverse clinical outcomes in patients with HFrEF, but the possible mechanisms responsible for the association are not unserstood. METHODS 142 men and women with H…
View article: (311) Socioeconomic Risk-Adjustment with Area Deprivation Index (ADI) Predicts Delays to Urethroplasty for Patients with Urethral Stricture Disease
(311) Socioeconomic Risk-Adjustment with Area Deprivation Index (ADI) Predicts Delays to Urethroplasty for Patients with Urethral Stricture Disease Open
Introduction Treatment of urethral stricture disease with multiple repeated endoscopic procedures has been shown to be both ineffective and costly. While a number of patient and provider factors are known to be associated with likelihood o…
View article: Impact of cardiovascular risk enrichment on incidence of major adverse cardiovascular events in the tofacitinib rheumatoid arthritis clinical programme
Impact of cardiovascular risk enrichment on incidence of major adverse cardiovascular events in the tofacitinib rheumatoid arthritis clinical programme Open
A recent report from the Belimumab Pregnancy Registry (NCT01532310) analysed available data on the consequences of belimumab (BEL) use in pregnant women with systemic lupus erythematosus (SLE). 1 Although limited by multiple confounders an…
View article: Risk of major adverse cardiovascular events with tofacitinib versus tumour necrosis factor inhibitors in patients with rheumatoid arthritis with or without a history of atherosclerotic cardiovascular disease: a post hoc analysis from ORAL Surveillance
Risk of major adverse cardiovascular events with tofacitinib versus tumour necrosis factor inhibitors in patients with rheumatoid arthritis with or without a history of atherosclerotic cardiovascular disease: a post hoc analysis from ORAL Surveillance Open
NCT02092467.
View article: Exploratory analyses of clinical trial data used for health technology assessments: a retrospective evaluation
Exploratory analyses of clinical trial data used for health technology assessments: a retrospective evaluation Open
Objectives To examine the validity and statistical limitations of exploratory analyses of clinical trial data commonly requested by agencies responsible for determining which medical products may be financed or reimbursed by a healthcare s…