Skip to main content

Jesse David Troy

Associate Professor of Biostatistics & Bioinformatics
Biostatistics & Bioinformatics, Division of Biostatistics
Box 2721, Durham, NC 27710
2424 Erwin Rd., Box 2721, Durham, NC 27710

Selected Publications


Moving beyond "Better Late than Never": High Symptom Burden and Diminished Functional Status at First Palliative Care Visit for Patients with Gynecological Cancers.

Journal Article J Palliat Med · August 7, 2024 Background: Despite physical and emotional distress in patients with gynecologic malignancies, palliative care (PC) is underutilized. Objectives: We characterize referral practices, symptom burden and functional status at the time of initial PC encounter f ... Full text Link to item Cite

Design and Rationale of the Outcomes Database to Prospectively Assess the Changing Therapy Landscape in Renal Cell Carcinoma Registry: A Multi-institutional, Prospective Study of Patients with Metastatic Renal Cell Carcinoma.

Journal Article Eur Urol Open Sci · August 2024 INTRODUCTION AND HYPOTHESES: The Outcomes Database to prospectivelY aSSEss the changing TherapY landscape in Renal Cell Carcinoma (ODYSSEY RCC) Registry is a large, nationally representative prospective registry of patients with metastatic renal cell carci ... Full text Link to item Cite

Timing of Palliative Care Consultation Impacts End of Life Care Outcomes in Metastatic Non-Small Cell Lung Cancer.

Journal Article J Pain Symptom Manage · July 23, 2024 CONTEXT: Early specialist palliative care (PC) involvement in metastatic non-small cell lung cancer (mNSCLC) is associated with improved quality of life, less aggressive end of life (EoL) care, and longer survival. As treatment paradigms for NSCLC have evo ... Full text Link to item Cite

Clinical outcomes in patients with piperacillin/tazobactam-non-susceptible but ceftriaxone-susceptible E. coli or K. pneumoniae bloodstream infection.

Journal Article J Antimicrob Chemother · June 3, 2024 BACKGROUND: A small proportion of Escherichia coli and Klebsiella pneumoniae demonstrate in vitro non-susceptibility to piperacillin/tazobactam but retain susceptibility to ceftriaxone. Uncertainty remains regarding how best to treat these isolates. OBJECT ... Full text Link to item Cite

Methods for building a staff workforce of quantitative scientists in academic health care.

Journal Article Stat (Int Stat Inst) · June 2024 Collaborative quantitative scientists, including biostatisticians, epidemiologists, bio-informaticists, and data-related professionals, play vital roles in research, from study design to data analysis and dissemination. It is imperative that academic healt ... Full text Link to item Cite

Accelerating resident research within quantitative collaboration units in academic healthcare

Journal Article Stat · June 1, 2024 With increased access to biomedical and electronic health records data and the complexity of research questions, individuals in residency programmes who aim to conduct research require specialized educational programmes and biostatistics support. Biostatis ... Full text Cite

Biomedical Researchers Should be Taught Statistics Differently than Biostatisticians in Training: Illustration of a Module within a Clinical Research Seminar Course

Journal Article Journal of Curriculum and Teaching · May 1, 2024 The predominant model for biomedical research is team science. Two critical members of the team are the clinical investigator and the biostatistician. Typically, the biostatistician performs statistical analyses and the clinical investigator interprets the ... Full text Cite

A Randomized, Placebo-Controlled, Phase II Trial of Intravenous Allogeneic Non-HLA Matched, Unrelated Donor, Cord Blood Infusion for Ischemic Stroke.

Journal Article Stem Cells Transl Med · February 14, 2024 Stroke remains a leading cause of death and disability in the US, and time-limited reperfusion strategies remain the only approved treatment options. To address this unmet clinical need, we conducted a phase II randomized clinical trial to determine whethe ... Full text Open Access Link to item Cite

Knowledge of Palliative Care and Barriers to Access Among Outpatients with Cancer.

Journal Article J Pain Symptom Manage · February 2024 CONTEXT: Palliative Care (PC) is poorly understood by laypersons. However, little is known about what ambulatory patients with cancer understand about PC or what barriers to access exist. METHODS: Outpatients undergoing cancer treatment completed a survey ... Full text Link to item Cite

A Curriculum Review of Programming Courses in a Master of Biostatistics Program

Journal Article Journal of Curriculum and Teaching · February 1, 2024 Computing is a core competency for collaborative biostatisticians, who work on interdisciplinary scientific teams in medicine and publich health. However, computing is a broad field that encompases many underlying pedagogical constructs and subspeciality t ... Full text Cite

Treatment Effect Estimates From Pilot Trials Are Unreliable.

Journal Article J Pain Symptom Manage · December 2023 CONTEXT: The CONSORT guideline defines a pilot trial as a small-scale version of a desired future efficacy trial that is intended to answer the key questions of whether and how a larger study should be done. For example, a pilot trial might evaluate differ ... Full text Link to item Cite

Impact of Publicly Reported Center Specific Analysis on Patient Selection Practices for Hematopoietic Stem Cell Transplantation

Conference Blood · November 2, 2023 IntroductionPublic reporting of outcomes drives healthcare improvement in many fields, including hematopoietic cell transplantation (HCT), although with possible unintended consequences. ... Full text Cite

Automated movement tracking of young autistic children during free play is correlated with clinical features associated with autism.

Journal Article Autism · November 2023 Play-based observations allow researchers to observe autistic children across a wide range of ages and skills. We recorded autistic children playing with toys in the center of a room and at a corner table while a caregiver remained seated off to the side a ... Full text Link to item Cite

Automated Video Tracking of Autistic Children's Movement During Caregiver-Child Interaction: An Exploratory Study.

Journal Article J Autism Dev Disord · August 29, 2023 Objective, quantitative measures of caregiver-child interaction during play are needed to complement caregiver or examiner ratings for clinical assessment and tracking intervention responses. In this exploratory study, we examined the feasibility of using ... Full text Link to item Cite

Impact of Public Reporting of Center-Specific Survival Analysis Scores on Patient Volumes at Hematopoietic Cell Transplant Centers.

Journal Article Transplant Cell Ther · August 2023 The Center for International Blood and Marrow Transplant Research reports the outcomes of allogeneic hematopoietic cell transplantation (alloHCT) at United States transplantation centers (TC) annually through its Center-Specific Survival Analysis (CSA). Th ... Full text Link to item Cite

Institutional approaches to preventing questionable research practices.

Journal Article Account Res · May 2023 Questionable research practices (QRP) are actions taken by researchers that span a range of concern related to violation of research best practices, and ultimately expose institutions and research participants to risk. Numerous studies have shown that QRP ... Full text Link to item Cite

Feasibility Study of Cord Tissue Derived Mesenchymal Stromal Cells in COVID-19-Related Acute Respiratory Distress Syndrome.

Journal Article Stem Cells Transl Med · April 17, 2023 BACKGROUND: Treatment options for patients with COVID-19-related acute respiratory distress syndrome (ARDS) are desperately needed. Allogeneic human umbilical cord derived mesenchymal stromal cells (hCT-MSCs) have potential therapeutic benefits in these cr ... Full text Link to item Cite

Unrelated Donor Cord Blood Transplantation in Children: Lessons Learned Over 3 Decades.

Journal Article Stem Cells Transl Med · January 30, 2023 Four decades ago, Broxmeyer et al. demonstrated that umbilical cord blood (CB) contained hematopoietic stem cells (HSC) and hypothesized that CB could be used as a source of donor HSC for rescue of myeloablated bone marrow. In 1988, Gluckman et al. reporte ... Full text Link to item Cite

Comparing ability and norm-referenced scores as clinical trial outcomes for neurodevelopmental disabilities: a simulation study.

Journal Article J Neurodev Disord · January 17, 2023 BACKGROUND: For genetic conditions associated with neurodevelopmental disorder (GCAND), developmental domains such as motor ability, thinking and learning, social abilities, and communication are potential intervention targets. Performance on measures of d ... Full text Link to item Cite

A Visual Tool to Help Develop a Statistical Analysis Plan for Randomized Trials in Palliative Care.

Journal Article J Pain Symptom Manage · January 2023 Collaboration with a statistician about the design of a statistical analysis plan can be enhanced by illustrating how statisticians conceptualize their task. This conceptualization can be represented by a directed acyclic graph (DAG), which illustrates the ... Full text Link to item Cite

Moving beyond "Better Late than Never": High Symptom Burden and Diminished Functional Status at First Palliative Care Visit for Patients with Gynecological Cancers.

Journal Article J Palliat Med · August 7, 2024 Background: Despite physical and emotional distress in patients with gynecologic malignancies, palliative care (PC) is underutilized. Objectives: We characterize referral practices, symptom burden and functional status at the time of initial PC encounter f ... Full text Link to item Cite

Design and Rationale of the Outcomes Database to Prospectively Assess the Changing Therapy Landscape in Renal Cell Carcinoma Registry: A Multi-institutional, Prospective Study of Patients with Metastatic Renal Cell Carcinoma.

Journal Article Eur Urol Open Sci · August 2024 INTRODUCTION AND HYPOTHESES: The Outcomes Database to prospectivelY aSSEss the changing TherapY landscape in Renal Cell Carcinoma (ODYSSEY RCC) Registry is a large, nationally representative prospective registry of patients with metastatic renal cell carci ... Full text Link to item Cite

Timing of Palliative Care Consultation Impacts End of Life Care Outcomes in Metastatic Non-Small Cell Lung Cancer.

Journal Article J Pain Symptom Manage · July 23, 2024 CONTEXT: Early specialist palliative care (PC) involvement in metastatic non-small cell lung cancer (mNSCLC) is associated with improved quality of life, less aggressive end of life (EoL) care, and longer survival. As treatment paradigms for NSCLC have evo ... Full text Link to item Cite

Clinical outcomes in patients with piperacillin/tazobactam-non-susceptible but ceftriaxone-susceptible E. coli or K. pneumoniae bloodstream infection.

Journal Article J Antimicrob Chemother · June 3, 2024 BACKGROUND: A small proportion of Escherichia coli and Klebsiella pneumoniae demonstrate in vitro non-susceptibility to piperacillin/tazobactam but retain susceptibility to ceftriaxone. Uncertainty remains regarding how best to treat these isolates. OBJECT ... Full text Link to item Cite

Methods for building a staff workforce of quantitative scientists in academic health care.

Journal Article Stat (Int Stat Inst) · June 2024 Collaborative quantitative scientists, including biostatisticians, epidemiologists, bio-informaticists, and data-related professionals, play vital roles in research, from study design to data analysis and dissemination. It is imperative that academic healt ... Full text Link to item Cite

Accelerating resident research within quantitative collaboration units in academic healthcare

Journal Article Stat · June 1, 2024 With increased access to biomedical and electronic health records data and the complexity of research questions, individuals in residency programmes who aim to conduct research require specialized educational programmes and biostatistics support. Biostatis ... Full text Cite

Biomedical Researchers Should be Taught Statistics Differently than Biostatisticians in Training: Illustration of a Module within a Clinical Research Seminar Course

Journal Article Journal of Curriculum and Teaching · May 1, 2024 The predominant model for biomedical research is team science. Two critical members of the team are the clinical investigator and the biostatistician. Typically, the biostatistician performs statistical analyses and the clinical investigator interprets the ... Full text Cite

A Randomized, Placebo-Controlled, Phase II Trial of Intravenous Allogeneic Non-HLA Matched, Unrelated Donor, Cord Blood Infusion for Ischemic Stroke.

Journal Article Stem Cells Transl Med · February 14, 2024 Stroke remains a leading cause of death and disability in the US, and time-limited reperfusion strategies remain the only approved treatment options. To address this unmet clinical need, we conducted a phase II randomized clinical trial to determine whethe ... Full text Open Access Link to item Cite

Knowledge of Palliative Care and Barriers to Access Among Outpatients with Cancer.

Journal Article J Pain Symptom Manage · February 2024 CONTEXT: Palliative Care (PC) is poorly understood by laypersons. However, little is known about what ambulatory patients with cancer understand about PC or what barriers to access exist. METHODS: Outpatients undergoing cancer treatment completed a survey ... Full text Link to item Cite

A Curriculum Review of Programming Courses in a Master of Biostatistics Program

Journal Article Journal of Curriculum and Teaching · February 1, 2024 Computing is a core competency for collaborative biostatisticians, who work on interdisciplinary scientific teams in medicine and publich health. However, computing is a broad field that encompases many underlying pedagogical constructs and subspeciality t ... Full text Cite

Treatment Effect Estimates From Pilot Trials Are Unreliable.

Journal Article J Pain Symptom Manage · December 2023 CONTEXT: The CONSORT guideline defines a pilot trial as a small-scale version of a desired future efficacy trial that is intended to answer the key questions of whether and how a larger study should be done. For example, a pilot trial might evaluate differ ... Full text Link to item Cite

Impact of Publicly Reported Center Specific Analysis on Patient Selection Practices for Hematopoietic Stem Cell Transplantation

Conference Blood · November 2, 2023 IntroductionPublic reporting of outcomes drives healthcare improvement in many fields, including hematopoietic cell transplantation (HCT), although with possible unintended consequences. ... Full text Cite

Automated movement tracking of young autistic children during free play is correlated with clinical features associated with autism.

Journal Article Autism · November 2023 Play-based observations allow researchers to observe autistic children across a wide range of ages and skills. We recorded autistic children playing with toys in the center of a room and at a corner table while a caregiver remained seated off to the side a ... Full text Link to item Cite

Automated Video Tracking of Autistic Children's Movement During Caregiver-Child Interaction: An Exploratory Study.

Journal Article J Autism Dev Disord · August 29, 2023 Objective, quantitative measures of caregiver-child interaction during play are needed to complement caregiver or examiner ratings for clinical assessment and tracking intervention responses. In this exploratory study, we examined the feasibility of using ... Full text Link to item Cite

Impact of Public Reporting of Center-Specific Survival Analysis Scores on Patient Volumes at Hematopoietic Cell Transplant Centers.

Journal Article Transplant Cell Ther · August 2023 The Center for International Blood and Marrow Transplant Research reports the outcomes of allogeneic hematopoietic cell transplantation (alloHCT) at United States transplantation centers (TC) annually through its Center-Specific Survival Analysis (CSA). Th ... Full text Link to item Cite

Institutional approaches to preventing questionable research practices.

Journal Article Account Res · May 2023 Questionable research practices (QRP) are actions taken by researchers that span a range of concern related to violation of research best practices, and ultimately expose institutions and research participants to risk. Numerous studies have shown that QRP ... Full text Link to item Cite

Feasibility Study of Cord Tissue Derived Mesenchymal Stromal Cells in COVID-19-Related Acute Respiratory Distress Syndrome.

Journal Article Stem Cells Transl Med · April 17, 2023 BACKGROUND: Treatment options for patients with COVID-19-related acute respiratory distress syndrome (ARDS) are desperately needed. Allogeneic human umbilical cord derived mesenchymal stromal cells (hCT-MSCs) have potential therapeutic benefits in these cr ... Full text Link to item Cite

Unrelated Donor Cord Blood Transplantation in Children: Lessons Learned Over 3 Decades.

Journal Article Stem Cells Transl Med · January 30, 2023 Four decades ago, Broxmeyer et al. demonstrated that umbilical cord blood (CB) contained hematopoietic stem cells (HSC) and hypothesized that CB could be used as a source of donor HSC for rescue of myeloablated bone marrow. In 1988, Gluckman et al. reporte ... Full text Link to item Cite

Comparing ability and norm-referenced scores as clinical trial outcomes for neurodevelopmental disabilities: a simulation study.

Journal Article J Neurodev Disord · January 17, 2023 BACKGROUND: For genetic conditions associated with neurodevelopmental disorder (GCAND), developmental domains such as motor ability, thinking and learning, social abilities, and communication are potential intervention targets. Performance on measures of d ... Full text Link to item Cite

A Visual Tool to Help Develop a Statistical Analysis Plan for Randomized Trials in Palliative Care.

Journal Article J Pain Symptom Manage · January 2023 Collaboration with a statistician about the design of a statistical analysis plan can be enhanced by illustrating how statisticians conceptualize their task. This conceptualization can be represented by a directed acyclic graph (DAG), which illustrates the ... Full text Link to item Cite

Patient-Reported Distress and Clinical Outcomes with Immuno-Oncology Agents in Metastatic Non-Small Cell Lung Cancer (mNSCLC): A Real-World Retrospective Cohort Study.

Journal Article Lung Cancer · January 2023 OBJECTIVES: There are limited real-world data about patient-reported outcomes with immunotherapies (IO) in metastatic non-small cell lung cancer (mNSCLC). We describe patient-reported distress and clinical outcomes with IO-based treatments or cytotoxic che ... Full text Link to item Cite

The potential cost-effectiveness of novel cord blood therapies in children with autism spectrum disorder.

Journal Article PLoS One · 2023 OBJECTIVE: To model the long-term clinical and economic outcomes of potential cord blood therapy in autism spectrum disorder (ASD). STUDY DESIGN: Markov microsimulation of ASD over the lifespan was used to compare two strategies: 1) standard of care (SOC), ... Full text Link to item Cite

Are Simulated Coding Interviews a Fair and Practical Examination Format for Non-professional Programmers Enrolled in a Master's Degree Program in Biostatistics?

Journal Article Journal of Curriculum and Teaching · January 1, 2023 This report describes an innovative and evidence-based approach to implementing coding interviews as an examination format for non-professional programmers: namely, students in a Master of Biostatistics program taking a course in the language of SAS. In ad ... Full text Cite

Essential team science skills for biostatisticians on collaborative research teams.

Journal Article J Clin Transl Sci · 2023 INTRODUCTION: Despite the critical role that quantitative scientists play in biomedical research, graduate programs in quantitative fields often focus on technical and methodological skills, not on collaborative and leadership skills. In this study, we eva ... Full text Link to item Cite

Motor function and safety after allogeneic cord blood and cord tissue-derived mesenchymal stromal cells in cerebral palsy: An open-label, randomized trial.

Journal Article Dev Med Child Neurol · December 2022 AIM: To evaluate safety and motor function after treatment with allogeneic umbilical cord blood (AlloCB) or umbilical cord tissue-derived mesenchymal stromal cells (hCT-MSC) in children with cerebral palsy (CP). METHOD: Ninety-one children (52 males, 39 fe ... Full text Open Access Link to item Cite

Experiential Learning Methods for Biostatistics Students: A Model for Embedding Student Interns in Academic Health Centers.

Journal Article Stat · December 2022 This manuscript describes an experiential learning program for future collaborative biostatisticians (CBs) developed within an academic medical center. The program is a collaborative effort between the Biostatistics, Epidemiology, and Research Design (BERD ... Full text Link to item Cite

Gram-negative bacteremia in solid organ transplant recipients: Clinical characteristics and outcomes as compared to immunocompetent non-transplant recipients.

Journal Article Transpl Infect Dis · December 2022 BACKGROUND: Outcomes from Gram-negative bacteremia (GNB) in solid organ transplant (SOT) recipients are poorly understood. METHODS: This is a single center prospective cohort study comparing the clinical characteristics and outcomes of SOT recipients with ... Full text Link to item Cite

A single-site pilot feasibility randomized trial of a supportive care mobile application intervention for patients with advanced cancer and caregivers.

Journal Article Support Care Cancer · October 2022 PURPOSE: Mobile health interventions can improve patient care. We developed the Digital Supportive Care Awareness and Navigation (D-SCAN) application (app) to facilitate symptom monitoring and use/awareness of cancer supportive care resources. This study t ... Full text Link to item Cite

Abstract 12 Phase I Study of Cord Tissue Derived Mesenchymal Stromal Cells in COVID-19–Related Acute Respiratory Distress Syndrome

Conference Stem Cells Translational Medicine · September 6, 2022 AbstractIntroductionSARS-CoV-2 infection results in the COVID-19 disease that caused a global pandemic. In severe cases, COVID-19 lead ... Full text Cite

Abstract 13 A Randomized, Placebo-Controlled, Phase II Trial of Intravenous Allogeneic Umbilical Cord Blood Infusion for Adults with Ischemic Stroke

Conference Stem Cells Translational Medicine · September 6, 2022 AbstractIntroductionStroke is the fifth leading cause of death in the United States. Tissue plasminogen activator and mechanical throm ... Full text Cite

An Exploratory Analysis of Biomarkers of Perihematomal Edema in the CN-105 in Participants with Acute Supratentorial Intracerebral Hemorrhage (CATCH) Trial.

Journal Article J Stroke Cerebrovasc Dis · August 2022 OBJECTIVE: To identify biomarkers with potential to indicate severity of perihematomal edema and secondary tissue injury after intracerebral hemorrhage (ICH), and which could be used as surrogate markers in future clinical trials for novel ICH therapeutics ... Full text Link to item Cite

Tumor marker response to SARS-CoV-2 infection among patients with cancer.

Journal Article Cancer Med · July 2022 BACKGROUND: Inflammatory responses from benign conditions can cause non-cancer-related elevations in tumor markers. The severe acute respiratory coronavirus 2 (SARS-CoV-2) induces a distinct viral inflammatory response, resulting in coronavirus disease 201 ... Full text Link to item Cite

Patient-reported distress as an early warning sign of unmet palliative care needs and increased healthcare utilization in patients with advanced cancer.

Journal Article Support Care Cancer · April 2022 INTRODUCTION: Cancer patients' sources of distress are often unaddressed, and patient-reported distress data could be utilized to identify those with unmet and impending care needs. We explored the association between moderate/severe distress and healthcar ... Full text Link to item Cite

CN-105 in Participants with Acute Supratentorial Intracerebral Hemorrhage (CATCH) Trial.

Journal Article Neurocrit Care · February 2022 BACKGROUND: Endogenous apolipoprotein (apo) E mediates neuroinflammatory responses and recovery after brain injury. Exogenously administered apoE-mimetic peptides effectively penetrate the central nervous system compartment and downregulate acute inflammat ... Full text Open Access Link to item Cite

The relationship between emotional well-being and understanding of prognosis in patients with acute myeloid leukemia (AML).

Journal Article Support Care Cancer · January 2022 PURPOSE: Adults with acute myeloid leukemia (AML) face considerable distress and often have a poor prognosis. However, little is known about these patients' perceptions of prognosis and how this relates to emotional well-being (EWB). METHODS: We conducted ... Full text Link to item Cite

A Course in Biology and Communication Skills for Master of Biostatistics Students

Journal Article Journal of Curriculum and Teaching · January 1, 2022 We describe an innovative, semester-long course in biology and communication skills for master’s degree students in biostatistics. The primary goal of the course is to make the connection between biological science and statistics more explicit. The seconda ... Full text Cite

Preorientation Curriculum: An Approach for Preparing Students with Heterogenous Backgrounds for Training in a Master of Biostatistics Program

Journal Article Journal of Curriculum and Teaching · January 1, 2022 We describe an innovative preorientation curriculum (POC) for a Master of Biostatistics (MB) program. The goal of the POC is to fill critical skills gaps for students entering the MB program from heterogeneous backgrounds so they are prepared to engage in ... Full text Cite

Exploring the Educational Quality of Hospice Videos Available on YouTube

Conference JOURNAL OF PAIN AND SYMPTOM MANAGEMENT · 2022 Cite

Administrative Considerations Pertaining to the Use of Creative Methods of Student Assessment: A Theoretically Grounded Reflection from a Master of Biostatistics Program

Journal Article Journal of Curriculum and Teaching · January 1, 2022 Student evaluation is a key consideration for educational program administrators because program success depends on students' ability to demonstrate successful development of core competencies. Student evaluations must therefore be aligned with learning ob ... Full text Cite

Redesign of a First-Year Theory Course Sequence in Biostatistics

Journal Article Journal of Curriculum and Teaching · January 1, 2022 This communication describes the process and results of a curriculum review of a first-year sequence of courses in statistical inference within a Master of Biostatistics program. Our primary aim was to develop an innovative course in statistical theory tha ... Full text Cite

Review of Unrelated Donor Cord Blood Transplantation in Children over the Past 3 Decades

Conference Blood · November 5, 2021 AbstractFour decades ago, Hal Broxmeyer demonstrated that umbilical cord blood (CB) contained hematopoietic stem cells (HSC) and hypothesized that CB could be used as a source of donor HSC for rescue of myel ... Full text Cite

Mobile Application to Identify Cancer Treatment-Related Financial Assistance: Results of a Randomized Controlled Trial.

Journal Article JCO Oncol Pract · October 2021 PURPOSE: Insured patients with cancer face high treatment-related, out-of-pocket (OOP) costs and often cannot access financial assistance. We conducted a randomized, controlled trial of Bridge, a patient-facing app designed to identify eligible financial r ... Full text Link to item Cite

The patient experience of ABVD treatment in Hodgkin lymphoma: a retrospective cohort study of patient-reported distress.

Journal Article Support Care Cancer · September 2021 PURPOSE: Psychological distress is prevalent in Hodgkin lymphoma (HL). Many patients, regardless of prognosis, receive ABVD chemotherapy as first-line treatment, but few studies have specifically examined the nature of distress during this shared treatment ... Full text Link to item Cite

Sibling umbilical cord blood infusion is safe in young children with cerebral palsy.

Journal Article Stem Cells Transl Med · September 2021 Preclinical and early phase clinical studies suggest that an appropriately dosed umbilical cord blood (CB) infusion has the potential to help improve motor function in young children with cerebral palsy (CP). As many children with CP do not have their own ... Full text Open Access Link to item Cite

Parental limited English proficiency in pediatric stem cell transplantation: Clinical impact and health care utilization.

Journal Article Pediatr Blood Cancer · September 2021 BACKGROUND: Limited English proficiency (LEP) is associated with adverse clinical outcomes. The clinical impact of LEP in hematopoietic stem cell transplant (HSCT) has not been studied. The objectives of this study were to compare HSCT outcomes and health ... Full text Link to item Cite

A novel decision aid for acute myeloid leukemia: a feasibility and preliminary efficacy trial.

Journal Article Support Care Cancer · July 2021 PURPOSE: Acute myeloid leukemia (AML) is a hematologic malignancy characterized by a poor prognosis but also a paradoxical possibility of cure. This renders decision-making complex and imminent. Unfortunately, many patients with AML misestimate their progn ... Full text Link to item Cite

Expression of X-Linked Inhibitor of Apoptosis Protein (XIAP) in Breast Cancer Is Associated with Shorter Survival and Resistance to Chemotherapy.

Journal Article Cancers (Basel) · June 4, 2021 XIAP, the most potent inhibitor of cell death pathways, is linked to chemotherapy resistance and tumor aggressiveness. Currently, multiple XIAP-targeting agents are in clinical trials. However, the characterization of XIAP expression in relation to clinico ... Full text Link to item Cite

T cell-depleted cultured pediatric thymus tissue as a model for some aspects of human age-related thymus involution.

Journal Article Geroscience · June 2021 Human age-related thymus involution is characterized by loss of developing thymocytes and the thymic epithelial network that supports them, with replacement by adipose tissue. The mechanisms that drive these changes are difficult to study in vivo due to co ... Full text Open Access Link to item Cite

Differences between patients with cardiovascular disease and cancer referred for palliative care.

Journal Article Am Heart J · March 2021 Our analysis from a national registry shows that compared to cancer, cardiovascular disease patients referred to palliative care are a decade older, have worse functional status and clinician-estimated prognosis. Both groups have very high symptom burden, ... Full text Link to item Cite

Characteristics of Advance Care Planning in Patients With Cancer Referred to Palliative Care.

Journal Article JCO Oncol Pract · February 2021 PURPOSE: Advance care planning (ACP) is a process in which patients share their values, goals, and preferences regarding future medical care. ACP can improve care quality, yet may be challenging to address for patients with cancer. We sought to characteriz ... Full text Link to item Cite

The biomedical research pyramid: A model for the practice of biostatistics

Journal Article Journal of Curriculum and Teaching · February 1, 2021 Biostatisticians apply statistical methods to solve problems in the biological sciences. Successful practioners of biostatistics have advanced technical knowledge, are skilled communicators, and can seamlesslessly integrate with interdisciplinary scientifi ... Full text Cite

Data and Code from: T Cell-Depleted Cultured Pediatric Thymus Tissue as a Model for Some Aspects of Human Age-Related Thymus Involution

Dataset · January 4, 2021 Human age-related thymus involution is characterized by loss of developing thymocytes and the thymic epithelial network that supports them, with replacement by adipose tissue. The mechanisms that drive these changes are difficult to study in vivo due to co ... Full text Cite

Associations of Patient Characteristics and Care Setting with Complexity of Specialty Palliative Care Visits.

Journal Article J Palliat Med · January 2021 Background: Information routinely collected during a palliative care consultation request may help predict the level of complexity of that patient encounter. Objectives: We examined whether patient and consultation characteristics, as captured in consultat ... Full text Link to item Cite

Statistical properties of Continuous Composite Outcomes: Implications for clinical trial design.

Journal Article Contemp Clin Trials Commun · December 2020 Statistical efficiency can be gained in clinical trials by using composites of time-to-event outcomes when the individual component outcomes have low event rates. However, the utility of continuous composite outcome measures is not as clear. Efficiency can ... Full text Link to item Cite

An analysis of missing items in real-world electronic patient reported outcomes data: implications for clinical care.

Journal Article Support Care Cancer · November 2020 PURPOSE: Utilization of electronic patient-reported outcomes (ePROs) in the clinic can improve quality of life and prolong survival in cancer care. However, there remain unanswered questions regarding trends in missing data and the potential effect on real ... Full text Link to item Cite

A tutorial on the use of exploratory efficacy outcomes in uncontrolled phase I cell therapy trials.

Journal Article Stem Cells Transl Med · November 2020 Phase I cell therapy clinical trials evaluate the safety of novel biologic treatments and are often uncontrolled. Many of these studies also include exploratory efficacy outcome measures, which are frequently continuous measures of disease state or severit ... Full text Link to item Cite

Infusion of human umbilical cord tissue mesenchymal stromal cells in children with autism spectrum disorder.

Journal Article Stem Cells Transl Med · October 2020 Ongoing neuroinflammation may contribute to symptoms of autism spectrum disorder (ASD) in at least a portion of affected individuals. Mesenchymal stromal cells (MSCs) have demonstrated the capacity to modulate neuroinflammation, but safety and feasibility ... Full text Open Access Link to item Cite

A Phase II Randomized Clinical Trial of the Safety and Efficacy of Intravenous Umbilical Cord Blood Infusion for Treatment of Children with Autism Spectrum Disorder.

Journal Article J Pediatr · July 2020 OBJECTIVE: To evaluate whether umbilical cord blood (CB) infusion is safe and associated with improved social and communication abilities in children with autism spectrum disorder (ASD). STUDY DESIGN: This prospective, randomized, placebo-controlled, doubl ... Full text Open Access Link to item Cite

Acute respiratory failure and the kinetics of neutrophil recovery in pediatric hematopoietic cell transplantation: a multicenter study.

Journal Article Bone Marrow Transplant · February 2020 In this multicenter study, we investigated the kinetics of neutrophil recovery in relation to acuity and survival among 125 children undergoing allogeneic hematopoietic cell transplantation (allo-HCT) who required invasive mechanical ventilation (IMV). Rec ... Full text Link to item Cite

Correction to: Acute respiratory failure and the kinetics of neutrophil recovery in pediatric hematopoietic cell transplantation: a multicenter study.

Journal Article Bone Marrow Transplant · February 2020 An amendment to this paper has been published and can be accessed via a link at the top of the paper. ... Full text Link to item Cite

The National MDS Natural History Study: design of an integrated data and sample biorepository to promote research studies in myelodysplastic syndromes.

Journal Article Leuk Lymphoma · December 2019 Myelodysplastic syndromes (MDS), a spectrum of heterogeneous hematopoietic stem cell diseases, vary in clinical severity, response to therapy, and propensity toward progression to acute myeloid leukemia. These are acquired clonal disorders resulting from s ... Full text Link to item Cite

Real-world experience with electronic patient reported outcomes and missing items: "Don't ask me irrelevant questions".

Conference Journal of Clinical Oncology · November 1, 2019 99 Background: Electronic patient-reported outcomes (ePROs) can improve quality of life and prolong survival in patients with cancer by enhancing the detection and tracking of unmet supportive care needs. However, there remain un ... Full text Cite

Digital Supportive Care Awareness and Navigation (D-SCAN): Results of a pilot randomized trial.

Conference Journal of Clinical Oncology · November 1, 2019 101 Background: Cancer patients face many supportive care needs. In crowded clinics with rising care complexity, clinicians struggle to assess and manage these needs. Duke Cancer Patient Support Program (DCPSP) services aim to br ... Full text Cite

Patient-reported distress in Hodgkin lymphoma across the survivorship continuum.

Journal Article Support Care Cancer · July 2019 PURPOSE: Hodgkin lymphoma (HL) survivors face long-term, elevated risk of treatment-related sequelae, including psychosocial distress associated with poor health outcomes. The magnitude and sources of distress are not well described in the routine care of ... Full text Link to item Cite

Policy Changes Key To Promoting Sustainability And Growth Of The Specialty Palliative Care Workforce.

Journal Article Health Aff (Millwood) · June 2019 Specialized palliative care teams improve outcomes for the steadily growing population of people living with serious illness. However, few studies have examined whether the specialty palliative care workforce can meet the growing demand for its services. W ... Full text Link to item Cite

Automated thawing increases recovery of colony-forming units from banked cord blood unit grafts.

Conference Transfusion · December 2018 BACKGROUND: The cell dose infused for cord blood transplantation strongly correlates with outcomes following transplantation. Post thaw recoveries can be improved by washing cord blood units (CBUs) in dextran/albumin. Early methods used a labor-intensive m ... Full text Link to item Cite

Long-Term Functional Outcomes after Hematopoietic Stem Cell Transplant for Early Infantile Krabbe Disease.

Journal Article Biol Blood Marrow Transplant · November 2018 Allogeneic hematopoietic stem cell transplantation (HSCT) can retard the progression of early infantile Krabbe disease (EIKD). Superior outcomes are achieved if HSCT is performed before the onset of symptoms; however, little information is available about ... Full text Open Access Link to item Cite

Allogeneic Umbilical Cord Blood Infusion for Adults with Ischemic Stroke: Clinical Outcomes from a Phase I Safety Study.

Journal Article Stem Cells Transl Med · July 2018 Stroke is a major cause of death and long-term disability, affecting one in six people worldwide. The only currently available approved pharmacological treatment for ischemic stroke is tissue plasminogen activator; however, relatively few patients are elig ... Full text Open Access Link to item Cite

Associations between expression levels of nucleotide excision repair proteins in lymphoblastoid cells and risk of squamous cell carcinoma of the head and neck.

Journal Article Mol Carcinog · June 2018 Squamous cell carcinoma of head and neck (SCCHN) is one of the most common malignancies worldwide, and nucleotide excision repair (NER) is involved in SCCHN susceptibility. In this analysis of 349 newly diagnosed SCCHN patients and 295 cancer-free controls ... Full text Open Access Link to item Cite

Psychological distress in myelodysplastic syndromes.

Conference Journal of Clinical Oncology · May 20, 2018 Full text Cite

Patient-Reported Distress in Myelodysplastic Syndromes and Its Association With Clinical Outcomes: A Retrospective Cohort Study.

Journal Article J Natl Compr Canc Netw · March 2018 Background: NCCN defines distress as a multifactorial, unpleasant emotional experience of a psychological nature that may interfere with patients' ability to cope with cancer symptoms and treatment. Patients with myelodysplastic syndromes (MDS) are at risk ... Full text Link to item Cite

Effect of Autologous Cord Blood Infusion on Motor Function and Brain Connectivity in Young Children with Cerebral Palsy: A Randomized, Placebo-Controlled Trial.

Journal Article Stem Cells Transl Med · December 2017 Cerebral palsy (CP) is a condition affecting young children that causes lifelong disabilities. Umbilical cord blood cells improve motor function in experimental systems via paracrine signaling. After demonstrating safety, we conducted a phase II trial of a ... Full text Open Access Link to item Cite

Durable Chimerism and Long-Term Survival after Unrelated Umbilical Cord Blood Transplantation for Pediatric Hemophagocytic Lymphohistiocytosis: A Single-Center Experience.

Journal Article Biol Blood Marrow Transplant · October 2017 Hemophagocytic lymphohistiocytosis (HLH) is a life-threatening disorder of immune dysregulation characterized by fever, hepatosplenomegaly, cytopenias, central nervous system disease, increased inflammatory markers, and hemophagocytosis. Currently, allogen ... Full text Open Access Link to item Cite

4.13 Validity of Automated Methods for Assessing Child Communication Abilities (LENA) in an Autism Clinical Trial

Conference Journal of the American Academy of Child & Adolescent Psychiatry · October 2017 Full text Cite

Factors Associated with Long-Term Risk of Relapse after Unrelated Cord Blood Transplantation in Children with Acute Lymphoblastic Leukemia in Remission.

Journal Article Biol Blood Marrow Transplant · August 2017 For pediatric patients with acute lymphoblastic leukemia (ALL), relapse is an important cause of treatment failure after unrelated cord blood transplant (UCBT). Compared with other donor sources, relapse is similar or even reduced after UCBT despite less g ... Full text Open Access Link to item Cite

Patient-reported distress in myelodysplastic syndromes and its relationship with clinical outcomes.

Conference Journal of Clinical Oncology · May 20, 2017 e21564 Background: The National Comprehensive Cancer Network (NCCN) defines distress as an unpleasant emotional experience associated with the psychosocial complications of cancer. Patients with myelodysplastic syndromes (MDS) ar ... Full text Cite

Autologous Cord Blood Infusions Are Safe and Feasible in Young Children with Autism Spectrum Disorder: Results of a Single-Center Phase I Open-Label Trial.

Journal Article Stem Cells Transl Med · May 2017 Despite advances in early diagnosis and behavioral therapies, more effective treatments for children with autism spectrum disorder (ASD) are needed. We hypothesized that umbilical cord blood-derived cell therapies may have potential in alleviating ASD symp ... Full text Open Access Link to item Cite

Reduced mRNA expression of nucleotide excision repair genes in lymphocytes and risk of squamous cell carcinoma of the head and neck.

Journal Article Carcinogenesis · May 1, 2017 Nucleotide excision repair (NER) plays a critical role in the development of smoking-related cancers. We hypothesize that mRNA expression levels of NER genes are associated with risk of the squamous cell carcinoma of head and neck (SCCHN). To test this hyp ... Full text Link to item Cite

Allogeneic Umbilical Cord Blood Infusion for Adults with Ischemic Stroke (CoBIS): Clinical Outcomes from a Phase 1 Safety Study

Conference Blood · December 2, 2016 AbstractBackground: Over 750,000 patients/year in the US experience a debilitating stroke. Approximately 88% of adult strokes are ischemic in etiology, and occur when cerebral blood flow is blocked by a clot ... Full text Cite

Patient-reported distress in adults with myelodysplastic syndromes (MDS).

Conference Journal of Clinical Oncology · October 9, 2016 80 Background: MDS are hematopoietic malignancies that are incurable in most patients. The National Comprehensive Cancer Network (NCCN) defines distress as an unpleasant emotional experience associated with the psychosocial compl ... Full text Cite

A cord blood monocyte-derived cell therapy product accelerates brain remyelination.

Journal Article JCI Insight · August 18, 2016 Microglia and monocytes play important roles in regulating brain remyelination. We developed DUOC-01, a cell therapy product intended for treatment of demyelinating diseases, from banked human umbilical cord blood (CB) mononuclear cells. Immunodepletion an ... Full text Open Access Link to item Cite

Development and validation of a rapid, aldehyde dehydrogenase bright-based cord blood potency assay.

Journal Article Blood · May 12, 2016 Banked, unrelated umbilical cord blood provides access to hematopoietic stem cell transplantation for patients lacking matched bone marrow donors, yet 10% to 15% of patients experience graft failure or delayed engraftment. This may be due, at least in part ... Full text Open Access Link to item Cite

530: Preterm umbilical cord blood is enriched for progenitor cells

Conference American Journal of Obstetrics and Gynecology · January 2016 Full text Cite

Sex difference in immune response to vaccination: A participant-level meta-analysis of randomized trials of IMVAMUNE smallpox vaccine.

Journal Article Vaccine · October 5, 2015 INTRODUCTION: Previous research shows immune response to vaccination differs by sex but this has not been explored for IMVAMUNE, a replication-deficient smallpox vaccine developed in response to the potential for bioterrorism using smallpox. METHODS: We co ... Full text Link to item Cite

Myelodysplastic syndromes in the United States: an update for clinicians.

Journal Article Ann Med · August 2014 Myelodysplastic syndromes (MDS) are heterogeneous malignant bone marrow disorders diagnosed most often in elderly white persons. MDS have significant clinical consequences, including cytopenias leading to infection, bleeding, and death; and approximately o ... Full text Link to item Cite

Treatment of older patients with high-risk myelodysplastic syndromes (MDS): the emerging role of allogeneic hematopoietic stem cell transplantation (Allo HSCT).

Journal Article Curr Hematol Malig Rep · March 2014 MDS are myeloid clonal hematologic disorders that are most commonly diagnosed in the seventh decade of life. Several treatment options are currently available. However, allo HSCT remains the only curative therapy. Unfortunately, despite the higher incidenc ... Full text Link to item Cite

Expression of EGFR, VEGF, and NOTCH1 suggest differences in tumor angiogenesis in HPV-positive and HPV-negative head and neck squamous cell carcinoma.

Journal Article Head Neck Pathol · December 2013 There is current interest in anti-angiogenesis therapies for head and neck squamous cell carcinomas (HNSCC), although the utility of these therapies in human papillomavirus (HPV) positive and HPV-negative HNSCC is unclear. Therefore, we explored heterogene ... Full text Link to item Cite

Childhood passive smoke exposure is associated with adult head and neck cancer.

Journal Article Cancer Epidemiol · August 2013 INTRODUCTION: Passive smoke is carcinogenic but its association with head and neck squamous cell carcinoma (HNSCC) is uncertain. METHODS: We conducted a case-control study of childhood passive smoke exposure (CPSE) and HNSCC in 858 cases and 806 frequency- ... Full text Link to item Cite

Polymorphisms in NAT2 and GSTP1 are associated with survival in oral and oropharyngeal cancer.

Journal Article Cancer Epidemiol · August 2013 INTRODUCTION: Functional polymorphisms in drug metabolizing enzymes (DMEs) may be determinants of survival in oral and oropharyngeal squamous cell carcinoma (OOSCC). METHODS: OOSCC cases (N=159) with a history of either tobacco or alcohol use were genotype ... Full text Link to item Cite

Associations between anthropometry, cigarette smoking, alcohol consumption, and non-Hodgkin lymphoma in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial.

Journal Article Am J Epidemiol · June 15, 2010 Prospective studies of lifestyle and non-Hodgkin lymphoma (NHL) are conflicting, and some are inconsistent with case-control studies. The Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial was used to evaluate risk of NHL and its subtype ... Full text Link to item Cite