Scholars@Duke
Hwanhee Hong

Hwanhee Hong

Associate Professor of Biostatistics & Bioinformatics
Biostatistics & Bioinformatics, Division of Biostatistics
hwanhee.hong@duke.edu
Duke Box 2721, Durham, NC 27705
2424 Erwin Road, Suite 1105, Durham, NC 27705

Selected Publications

Obstetric Racial Disparities in the Era of the ARRIVE (A Randomized Trial of Induction Versus Expectant Management) Trial and the Coronavirus Disease 2019 (COVID-19) Pandemic.

Journal Article Obstet Gynecol · May 1, 2024 OBJECTIVE: To evaluate the influence of the ARRIVE (A Randomized Trial of Induction Versus Expectant Management) trial and the coronavirus disease 2019 (COVID-19) pandemic on racial and ethnic differences in labor induction, pregnancy-associated hypertensi ... Full text Link to item Cite

Comparison of methods that combine multiple randomized trials to estimate heterogeneous treatment effects.

Journal Article Stat Med · March 30, 2024 Individualized treatment decisions can improve health outcomes, but using data to make these decisions in a reliable, precise, and generalizable way is challenging with a single dataset. Leveraging multiple randomized controlled trials allows for the combi ... Full text Open Access Link to item Cite

Optimizing warfarin dosing for patients with atrial fibrillation using machine learning.

Journal Article Sci Rep · February 24, 2024 While novel oral anticoagulants are increasingly used to reduce risk of stroke in patients with atrial fibrillation, vitamin K antagonists such as warfarin continue to be used extensively for stroke prevention across the world. While effective in reducing ... Full text Link to item Cite

Harms were detected but not reported in six clinical trials of gabapentin.

Journal Article J Clin Epidemiol · December 2023 OBJECTIVES: We sought to assess and report harms that were observed but not disclosed previously in clinical trials of gabapentin. STUDY DESIGN AND SETTING: We reanalyzed individual participant data from six randomized parallel trials of gabapentin for neu ... Full text Link to item Cite

Methods for Integrating Trials and Non-experimental Data to Examine Treatment Effect Heterogeneity.

Journal Article Stat Sci · November 2023 Estimating treatment effects conditional on observed covariates can improve the ability to tailor treatments to particular individuals. Doing so effectively requires dealing with potential confounding, and also enough data to adequately estimate effect mod ... Full text Open Access Link to item Cite

Methodology of a Natural History Study of a Rare Neurodevelopmental Disorder: Alternating Hemiplegia of Childhood as a Prototype Disease.

Journal Article J Child Neurol · October 2023 Here, we describe the process of development of the methodology for an international multicenter natural history study of alternating hemiplegia of childhood as a prototype disease for rare neurodevelopmental disorders. We describe a systematic multistep a ... Full text Link to item Cite

Cardiovascular Effects of GnRH Antagonists Compared With Agonists in Prostate Cancer: A Systematic Review.

Journal Article JACC CardioOncol · October 2023 BACKGROUND: Androgen deprivation therapy is the cornerstone of treatment for patients with advanced prostate cancer. Meta-analysis of small, oncology-focused trials suggest gonadotropin-releasing hormone (GnRH) antagonists may be associated with fewer adve ... Full text Link to item Cite

External Control Arms in Idiopathic Pulmonary Fibrosis Using Clinical Trial and Real-World Data Sources.

Journal Article Am J Respir Crit Care Med · September 1, 2023 Rationale: Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease for which novel therapies are needed. External controls (ECs) could enhance IPF trial efficiency, but the direct comparability of ECs versus concurrent controls is unknown. Object ... Full text Link to item Cite

Calibrated meta-analysis to estimate the efficacy of mental health treatments in target populations: an application to paliperidone trials for treatment of schizophrenia.

Journal Article BMC Med Res Methodol · June 26, 2023 BACKGROUNDS: Meta-analyses can be a powerful tool but need to calibrate potential unrepresentativeness of the included trials to a target population. Estimating target population average treatment effects (TATE) in meta-analyses is important to understand ... Full text Link to item Cite

Safety and efficacy of hydroxychloroquine as prophylactic against COVID-19 in healthcare workers: a meta-analysis of randomised clinical trials.

Journal Article BMJ Open · June 16, 2023 OBJECTIVE: We studied the safety and efficacy of hydroxychloroquine (HCQ) as pre-exposure prophylaxis for COVID-19 in healthcare workers (HCWs), using a meta-analysis of randomised controlled trials (RCTs). DATA SOURCES: PubMed and EMBASE databases were se ... Full text Link to item Cite

Direct Oral Anticoagulants Versus Warfarin Across the Spectrum of Kidney Function: Patient-Level Network Meta-Analyses From COMBINE AF.

Journal Article Circulation · June 6, 2023 BACKGROUND: There is uncertainty surrounding the use of direct oral anticoagulants (DOACs) in patients with kidney dysfunction. METHODS: Using the COMBINE AF (A Collaboration Between Multiple Institutions to Better Investigate Non-Vitamin K Antagonist Oral ... Full text Link to item Cite

Racial Inequities in Sepsis Mortality Among Children in the United States.

Journal Article Pediatr Infect Dis J · May 1, 2023 BACKGROUND: Racial inequities influence health outcomes in the United States, but their impact on sepsis outcomes among children is understudied. We aimed to evaluate for racial inequities in sepsis mortality using a nationally representative sample of ped ... Full text Link to item Cite

The normality assumption on between-study random effects was questionable in a considerable number of Cochrane meta-analyses.

Journal Article BMC Med · March 29, 2023 BACKGROUND: Studies included in a meta-analysis are often heterogeneous. The traditional random-effects models assume their true effects to follow a normal distribution, while it is unclear if this critical assumption is practical. Violations of this betwe ... Full text Link to item Cite

Comparative efficacy of tezepelumab to mepolizumab, benralizumab, and dupilumab in eosinophilic asthma: A Bayesian network meta-analysis.

Journal Article J Allergy Clin Immunol · March 2023 BACKGROUND: It is unclear how the efficacy of tezepelumab, approved for the treatment of type 2 high and low asthma, compares to the efficacy of other biologics for type 2-high asthma. OBJECTIVES: We sought to conduct an indirect comparison of tezepelumab ... Full text Link to item Cite

Systematic Review and Meta-analysis for Surgery Versus Stereotactic Radiosurgery for Jugular Paragangliomas.

Journal Article Otol Neurotol · March 1, 2023 OBJECTIVE: Comprehensively analyze tumor control and treatment complications for jugular paraganglioma patients undergoing surgery versus stereotactic radiosurgery (SRS). DATABASES REVIEWED: EMBASE, Medline, and Scopus. METHODS: The databases were searched ... Full text Link to item Cite

A note on semiparametric efficient generalization of causal effects from randomized trials to target populations.

Journal Article Commun Stat Theory Methods · 2023 When effect modifiers influence the decision to participate in randomized trials, generalizing causal effect estimates to an external target population requires the knowledge of two scores - the propensity score for receiving treatment and the sampling sco ... Full text Link to item Cite

Comparing the Value of Data Visualization Methods for Communicating Harms in Clinical Trials.

Journal Article Epidemiol Rev · December 21, 2022 In clinical trials, harms (i.e., adverse events) are often reported by simply counting the number of people who experienced each event. Reporting only frequencies ignores other dimensions of the data that are important for stakeholders, including severity, ... Full text Link to item Cite

Comparative efficacy of mepolizumab, benralizumab, and dupilumab in eosinophilic asthma: A Bayesian network meta-analysis.

Journal Article J Allergy Clin Immunol · November 2022 BACKGROUND: The comparative safety and efficacy of the biologics currently approved for asthma are unclear. OBJECTIVE: We compared the safety and efficacy of mepolizumab, benralizumab, and dupilumab in individuals with severe eosinophilic asthma. METHODS: ... Full text Link to item Cite

Landscape of coronavirus disease 2019 clinical trials: New frontiers and challenges.

Journal Article Clin Trials · October 2022 BACKGROUND/AIM: The number of coronavirus disease 2019 deaths and cases continues to increase globally. Novel therapies are urgently needed to treat patients with coronavirus disease 2019. We sought to provide a critical review of trials designed during th ... Full text Link to item Cite

Cost-Effectiveness of Systemic Treatments for Metastatic Castration-Sensitive Prostate Cancer: An Economic Evaluation Based on Network Meta-Analysis.

Conference Value Health · May 2022 OBJECTIVES: To assess the cost-effectiveness of systemic treatments for metastatic castration-sensitive prostate cancer from the US healthcare sector perspective with a lifetime horizon. METHODS: We built a partitioned survival model based on a network met ... Full text Link to item Cite

Comparison of Treatments for Nonmetastatic Castration-Resistant Prostate Cancer: Matching-Adjusted Indirect Comparison and Network Meta-Analysis.

Journal Article J Natl Cancer Inst · February 7, 2022 BACKGROUND: For nonmetastatic castration-resistant prostate cancer (nmCRPC), 3 drugs under patent protection-apalutamide, enzalutamide, and darolutamide-were approved based on randomized, placebo-controlled trials; 1 drug with generic availability, abirate ... Full text Link to item Cite

Direct Oral Anticoagulants Versus Warfarin in Patients With Atrial Fibrillation: Patient-Level Network Meta-Analyses of Randomized Clinical Trials With Interaction Testing by Age and Sex.

Journal Article Circulation · January 25, 2022 BACKGROUND: Direct oral anticoagulants (DOACs) are preferred over warfarin for stroke prevention in atrial fibrillation. Meta-analyses using individual patient data offer substantial advantages over study-level data. METHODS: We used individual patient dat ... Full text Link to item Cite

Comparing the performance of statistical methods that generalize effect estimates from randomized controlled trials to much larger target populations.

Journal Article Commun Stat Simul Comput · 2022 Policymakers use results from randomized controlled trials to inform decisions about whether to implement treatments in target populations. Various methods - including inverse probability weighting, outcome modeling, and Targeted Maximum Likelihood Estimat ... Full text Link to item Cite

Effect of Haemophilus influenzae Type b and 13-Valent Pneumococcal Conjugate Vaccines on Childhood Pneumonia Hospitalizations and Deaths in Botswana.

Journal Article Clin Infect Dis · July 15, 2021 BACKGROUND: Globally, pneumonia is the leading cause of death among children. Few data exist regarding the effect of Haemophilus influenzae type b (Hib) vaccine and 13-valent pneumococcal conjugate vaccine (PCV-13) on the burden of childhood pneumonia in A ... Full text Link to item Cite

Restoring invisible and abandoned trials of gabapentin for neuropathic pain: a clinical and methodological investigation.

Journal Article BMJ Open · June 30, 2021 INTRODUCTION: Gabapentin (Neurontin) is prescribed widely for conditions for which it has not been approved by regulators, including certain neuropathic pain conditions. There is limited evidence that gabapentin is safe and effective for the treatment of n ... Full text Link to item Cite

Generalizability of Subgroup Effects.

Journal Article Epidemiology · May 1, 2021 Generalizability methods are increasingly used to make inferences about the effect of interventions in target populations using a study sample. Most existing methods to generalize effects from sample to population rely on the assumption that subgroup-speci ... Full text Link to item Cite

Individual Patient Data from the Pivotal Randomized Controlled Trials of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation (COMBINE AF): Design and Rationale: From the COMBINE AF (A Collaboration between Multiple institutions to Better Investigate Non-vitamin K antagonist oral anticoagulant use in Atrial Fibrillation) Investigators.

Journal Article Am Heart J · March 2021 BACKGROUND: Non-vitamin K antagonist oral anticoagulants (NOACs) are the preferred class of medications for prevention of stroke and systemic embolism in patients with atrial fibrillation unless contraindications exist. Five large, international, randomize ... Full text Link to item Cite

Comparison of Systemic Treatments for Metastatic Castration-Sensitive Prostate Cancer: A Systematic Review and Network Meta-analysis.

Journal Article JAMA Oncol · March 1, 2021 IMPORTANCE: Multiple systemic treatments are available for metastatic castration-sensitive prostate cancer (mCSPC), with unclear comparative effectiveness and safety and widely varied costs. OBJECTIVE: To compare the effectiveness and safety determined in ... Full text Link to item Cite

Meta-analysis of rare adverse events in randomized clinical trials: Bayesian and frequentist methods.

Journal Article Clin Trials · February 2021 BACKGROUND/AIMS: Regulatory approval of a drug or device involves an assessment of not only the benefits but also the risks of adverse events associated with the therapeutic agent. Although randomized controlled trials (RCTs) are the gold standard for eval ... Full text Link to item Cite

Aspiration thrombectomy in ST-Elevation myocardial infarction: Further insights from a network meta-analysis of randomized trials.

Journal Article Indian Heart J · 2021 BACKGROUND: The initial enthusiasm for thrombectomy during percutaneous coronary intervention (PCI) of ST-elevation myocardial infarction (STEMI) patients has given way to restraint. There has been some limited interest whether it is beneficial in a few se ... Full text Link to item Cite

Microbiology of Bloodstream Infections in Children After Hematopoietic Stem Cell Transplantation: A Single-Center Experience Over Two Decades (1997-2017).

Journal Article Open Forum Infect Dis · November 2020 BACKGROUND: Bloodstream infections (BSIs) occur frequently after hematopoietic stem cell transplantation (HSCT). We examined the microbiology of BSI in pediatric HSCT recipients over a 2-decade period at our institution to inform empirical antimicrobial pr ... Full text Link to item Cite

Optimal Antithrombotic Regimens for Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention: An Updated Network Meta-analysis.

Journal Article JAMA Cardiol · May 1, 2020 IMPORTANCE: Antithrombotic treatment in patients with atrial fibrillation (AF) and percutaneous coronary intervention (PCI) presents a balancing act with regard to bleeding and ischemic risks. OBJECTIVES: To evaluate the safety and efficacy of 4 antithromb ... Full text Link to item Cite

Opportunities for selective reporting of harms in randomized clinical trials: Selection criteria for non-systematic adverse events.

Journal Article Trials · September 5, 2019 BACKGROUND: Adverse events (AEs) in clinical trials may be reported in multiple sources. Different methods for reporting adverse events across trials or across sources for a single trial may produce inconsistent information about the adverse events associa ... Full text Link to item Cite

Harms are assessed inconsistently and reported inadequately Part 2: nonsystematic adverse events.

Journal Article J Clin Epidemiol · September 2019 OBJECTIVE: We examined nonsystematic adverse events (AEs) in Part 2 (of 2) of a study describing the assessment and reporting AEs in clinical trials. STUDY DESIGN AND SETTING: We examined 21 trials of gabapentin for neuropathic pain (52 sources) and seven ... Full text Link to item Cite

Harms are assessed inconsistently and reported inadequately part 1: systematic adverse events.

Journal Article J Clin Epidemiol · September 2019 OBJECTIVES: We examined systematic adverse events (AEs) in Part 1 (of 2) of a study describing the assessment and reporting of AEs in clinical trials. STUDY DESIGN AND SETTING: We examined 52 public and nonpublic data sources about trials of quetiapine for ... Full text Link to item Cite

Safety and Efficacy of Antithrombotic Strategies in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention: A Network Meta-analysis of Randomized Controlled Trials.

Journal Article JAMA Cardiol · August 1, 2019 IMPORTANCE: The antithrombotic treatment of patients with atrial fibrillation (AF) and coronary artery disease, in particular with acute coronary syndrome (ACS) and/or percutaneous coronary intervention (PCI), poses a significant treatment dilemma in clini ... Full text Link to item Cite

Keloid Excision and Adjuvant Treatments: A Network Meta-analysis.

Journal Article Ann Plast Surg · August 2019 BACKGROUND: Keloid disease treatment continues to be unsatisfactory with high recurrence rates. We evaluated the literature regarding the effectiveness of keloid excision with various adjuvant treatments following surgery and assessed recurrence rates. MET ... Full text Link to item Cite

Propensity Score-Based Estimators With Multiple Error-Prone Covariates.

Journal Article Am J Epidemiol · January 1, 2019 Propensity score methods are an important tool to help reduce confounding in nonexperimental studies. Most propensity score methods assume that covariates are measured without error. However, covariates are often measured with error, which leads to biased ... Full text Link to item Cite

Comparing pharmacological treatments for cocaine dependence: Incorporation of methods for enhancing generalizability in meta-analytic studies.

Journal Article Int J Methods Psychiatr Res · December 2018 OBJECTIVES: Few head-to-head comparisons of cocaine dependence medications exist, and combining data from different randomized controlled trials (RCTs) is fraught with methodological challenges including limited generalizability of the RCT findings. This s ... Full text Link to item Cite

Caveat emptor: the combined effects of multiplicity and selective reporting.

Journal Article Trials · September 17, 2018 Clinical trials and systematic reviews of clinical trials inform healthcare decisions. There is growing concern, however, about results from clinical trials that cannot be reproduced. Reasons for nonreproducibility include that outcomes are defined in mult ... Full text Open Access Link to item Cite

Power and commensurate priors for synthesizing aggregate and individual patient level data in network meta-analysis

Journal Article Journal of the Royal Statistical Society. Series C: Applied Statistics · August 1, 2018 In network meta-analysis, it is often desirable to synthesize different types of studies, featuring aggregated data and individual patient level data. However, existing methods do not sufficiently consider the quality of studies across different types of d ... Full text Cite

Correction to: Integrating multiple data sources (MUDS) for meta-analysis to improve patient-centered outcomes research: a protocol.

Journal Article Syst Rev · March 19, 2018 The correct title of the article [1] should be "Integrating multiple data sources (MUDS) for meta-analysis to improve patient-centered outcomes research: a protocol". ... Full text Link to item Cite

Correction to: Integrating multiple data sources (MUDS) for meta-analysis to improve patient-centered outcomes research: a protocol for a systematic review.

Journal Article Alzheimers Res Ther · February 16, 2018 The correct title of the article [1] should be "Integrating multiple data sources (MUDS) for meta-analysis to improve patient-centered outcomes research: a protocol". The article is a protocol for a methodological study, not a systematic review. ... Full text Open Access Link to item Cite

Bayesian Approach for Addressing Differential Covariate Measurement Error in Propensity Score Methods.

Journal Article Psychometrika · December 2017 Propensity score methods are an important tool to help reduce confounding in non-experimental studies and produce more accurate causal effect estimates. Most propensity score methods assume that covariates are measured without error. However, covariates ar ... Full text Link to item Cite

Cherry-picking by trialists and meta-analysts can drive conclusions about intervention efficacy.

Journal Article J Clin Epidemiol · November 2017 OBJECTIVES: The objective of this study was to determine whether disagreements among multiple data sources affect systematic reviews of randomized clinical trials (RCTs). STUDY DESIGN AND SETTING: Eligible RCTs examined gabapentin for neuropathic pain and ... Full text Link to item Cite

Bayesian hierarchical models for network meta-analysis incorporating nonignorable missingness.

Journal Article Stat Methods Med Res · October 2017 Network meta-analysis expands the scope of a conventional pairwise meta-analysis to simultaneously compare multiple treatments, synthesizing both direct and indirect information and thus strengthening inference. Since most of trials only compare two treatm ... Full text Link to item Cite

Multiple outcomes and analyses in clinical trials create challenges for interpretation and research synthesis.

Journal Article J Clin Epidemiol · June 2017 OBJECTIVE: To identify variations in outcomes and results across reports of randomized clinical trials (RCTs). STUDY DESIGN AND SETTING: Eligible RCTs examined gabapentin for neuropathic pain and quetiapine for bipolar depression, reported in public (e.g., ... Full text Link to item Cite

Bayesian network meta-analysis for multiple endpoints

Chapter · January 1, 2017 Network meta-analysis (NMA) is a statistical technique to assess various treatment effects and compare their benefits or harms simultaneously in a systematic review. In comparative effectiveness research, NMA offers useful information to help patients and ... Full text Cite

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Journal Article Ophthalmology · November 2016 Full text Link to item Cite

A Bayesian missing data framework for generalized multiple outcome mixed treatment comparisons.

Journal Article Res Synth Methods · March 2016 Bayesian statistical approaches to mixed treatment comparisons (MTCs) are becoming more popular because of their flexibility and interpretability. Many randomized clinical trials report multiple outcomes with possible inherent correlations. Moreover, MTC d ... Full text Link to item Cite

Comparative Effectiveness of First-Line Medications for Primary Open-Angle Glaucoma: A Systematic Review and Network Meta-analysis.

Journal Article Ophthalmology · January 2016 TOPIC: Primary open-angle glaucoma (POAG) is a highly prevalent condition worldwide and the most common cause of irreversible sight loss. The objective is to assess the comparative effectiveness of first-line medical treatments in patients with POAG or ocu ... Full text Link to item Cite

Integrating multiple data sources (MUDS) for meta-analysis to improve patient-centered outcomes research: a protocol.

Journal Article Syst Rev · November 2, 2015 BACKGROUND: Systematic reviews should provide trustworthy guidance to decision-makers, but their credibility is challenged by the selective reporting of trial results and outcomes. Some trials are not published, and even among clinical trials that are publ ... Full text Link to item Cite

Incorporation of individual-patient data in network meta-analysis for multiple continuous endpoints, with application to diabetes treatment.

Journal Article Stat Med · September 10, 2015 Availability of individual patient-level data (IPD) broadens the scope of network meta-analysis (NMA) and enables us to incorporate patient-level information. Although IPD is a potential gold mine in biomedical areas, methodological development has been sl ... Full text Link to item Cite

Longitudinal Changes in Nursing Home Resident-Reported Quality of Life: The Role of Facility Characteristics.

Journal Article Res Aging · August 2015 Improving quality of nursing homes (NHs) is a major social priority, yet few studies examine the role of facility characteristics for residents' quality of life (QOL). This study goes beyond cross-sectional analyses by examining the predictors of NH reside ... Full text Link to item Cite

Guidance on the implementation and reporting of a drug safety Bayesian network meta-analysis.

Journal Article Pharm Stat · 2014 The Drug Information Association Bayesian Scientific Working Group (BSWG) was formed in 2011 with a vision to ensure that Bayesian methods are well understood and broadly utilized for design and analysis and throughout the medical product development proce ... Full text Link to item Cite

Bayesian network meta-analysis for safety evaluation

Chapter · January 1, 2014 Meta-analysis is a statistical technique that compares the effectiveness or safety of two treatments by incorporating the findings from several independent studies (DerSimonian and Laird, 1986). Network meta-analysis (NMA), also sometimes referred to as mu ... Full text Cite

Comparing Bayesian and frequentist approaches for multiple outcome mixed treatment comparisons.

Journal Article Med Decis Making · July 2013 OBJECTIVES: Bayesian statistical methods are increasingly popular as a tool for meta-analysis of clinical trial data involving both direct and indirect treatment comparisons. However, appropriate selection of prior distributions for unknown model parameter ... Full text Link to item Cite

Non-AIDS-defining events among HIV-1-infected adults receiving combination antiretroviral therapy in resource-replete versus resource-limited urban setting.

Journal Article AIDS · July 31, 2011 OBJECTIVE: To compare incidence and distribution of non-AIDS-defining events (NADEs) among HIV-1-infected adults receiving combination antiretroviral therapy (cART) in urban sub-Saharan African versus United States settings. DESIGN: Retrospective cohort an ... Full text Link to item Cite