Duke Health Research Articles

A Mobile App to Support Self-Management in Patients with Multiple Myeloma or Chronic Lymphocytic Leukemia: Pilot Randomized Controlled Trial.

Patients with blood cancer experience serious physical and emotional symptoms throughout their cancer journey. Building on previous work, we aimed to develop an app designed to help patients with multiple myeloma and chronic lymphocytic leukemia self-manage symptoms and test it for acceptability and preliminary efficacy. We developed our Blood Cancer Coach app with input from clinicians and patients. Our 2-armed randomized controlled pilot trial recruited participants from Duke Health and nationally in partnerships with the Association of Oncology Social Work, Leukemia and Lymphoma Society, and other patient groups. Participants were randomized to the attention control (Springboard Beyond Cancer website) arm or the Blood Cancer Coach app intervention arm. The fully automated Blood Cancer Coach app included symptom and distress tracking with tailored feedback, medication reminders and adherence tracking, multiple myeloma and chronic lymphocytic leukemia education resources, and mindfulness activities. Patient-reported data were collected at baseline, 4 weeks, and 8 weeks for both arms through the Blood Cancer Coach app. Outcomes of interest were global health (Patient Reported Outcomes Measurement Information System Global Health), posttraumatic stress (Posttraumatic Stress Disorder Checklist for DSM-5), and cancer symptoms (Edmonton Symptom Assessment System Revised). Among participants in the intervention arm, satisfaction surveys and usage data were used to evaluate acceptability. Among 180 patients who downloaded the app, 49% (89) of them consented to participate and 40% (72) of them completed baseline surveys. Of those who completed baseline surveys, 53% (38) of them completed week 4 surveys (16 intervention and 22 control) and 39% (28) of them completed week 8 surveys (13 intervention and 15 control). Most participants found the app at least moderately effective at helping manage symptoms (87%), feeling more comfortable seeking help (87%), increasing awareness of resources (73%), and reported being satisfied with the app overall (73%). Participants completed an average of 248.5 app tasks over the 8-week study period. The most used functions within the app were medication log, distress tracking, guided meditations, and symptom tracking. There were no significant differences between the control and intervention arms at week 4 or 8 on any outcomes. We also saw no significant improvement over time within the intervention arm. The results of our feasibility pilot were promising in which most participants found the app to be helpful in managing their symptoms, reported satisfaction with the app, and that it was helpful in several important areas. We did not, however, find significantly reduced symptoms or improved global mental and physical health over 2 months. Recruitment and retention were challenging for this app-based study, an experience echoed by others. Limitations included a predominantly White and college educated sample. Future studies would do well to include self-efficacy outcomes, target those with more symptoms, and emphasize diversity in recruitment and retention. ClinicalTrials.gov NCT05928156; https://clinicaltrials.gov/study/NCT05928156.

A complex puzzle realized: US achieves one-millionth organ transplant: Decades of visionary scientists, skilled surgeons, and courageous patients have made this miraculous milestone a reality

A complex puzzle realized: US achieves one-millionth organ transplant: Decades of visionary scientists, skilled surgeons, and courageous patients have made this miraculous milestone a reality

LBSUN162 Cumulative Probability Of Heart Failure Hospitalization Among Non-Hispanic Black Compared To Non-Hispanic White Individuals With Type 2 Diabetes On Empagliflozin (EMPA-AA): Real-world Data

Abstract The results from the SGLT-2 inhibitors cardiovascular outcome trials were generalized to all, despite that non-Hispanic Black (hereafter, "Black") participants were underrepresented. Our goal was to evaluate, among patients with type 2 diabetes, the risk of heart failure hospitalizations among black vs non-Hispanic White (hereafter "White") patients initially prescribed empagliflozin. | We performed a multicenter retrospective study using clinical data derived from Electronic Medical Records (EMR's) from adults with type 2 diabetes cared for at 4 healthcare systems (UNC Health, Duke Health, MUSC, and ECU Health) who were prescribed empagliflozin between August 2014 and December 2019. Our primary outcome was time to first heart failure hospitalization. We wanted to understand if the outcomes were different in Black vs White patients with previous hospitalizations for heart failure that occurred prior to an empagliflozin prescription. Cumulative probability of heart failure hospitalization by race was estimated using the cumulative incidence function. The association of race with risk of heart failure hospitalization was evaluated using multivariable Cox hazards models. Hazard ratio (HR) and 95% confidence interval (CI) are provided as measures of strength of association and precision, respectively. | A total of 704 patients with previous heart failure hospitalizations were eligible. Mean age by race category (Black/White) was 60.2 vs 64.3 years (p < 0. 0001); 42.8% vs 61. 0% were males (p < 0. 0001) and 81.2% vs 73.2% had a history of hypertension respectively. Black patients were significantly younger and predominantly female. Cumulative probability of heart failure hospitalization at 2-years post-initiation of empagliflozin was 71.7% (95% CI = 61.6%, 79.6%) vs. 70.9% (95% CI = 64. 0%, 76.7%) for Black vs White, respectively. When adjusting for age, gender, and baseline comorbidities, there was no statistically significant difference in the risk of hospitalizations for heart failure between Black vs White patients (HR = 1. 03; 95% CI = 0.85, 1.25, p = 0.79). | In patients with type 2 diabetes with a documented previous hospitalization for heart failure prior to a prescription for empagliflozin, we found no significant difference in the cumulative probability of heart failure hospitalization in Black vs White patients. Presentation: Sunday, June 12, 2022 12:30 p.m. - 2:30 p.m.

Younger Age and Longer Case Times Associated With Emergency Department Visits After Cataract Surgery

To characterize the frequency, reasons, hospital costs, and risk factors for emergency department (ED) visits within 30 days of cataract surgery. Retrospective cohort study. A retrospective review of all cataract surgeries at Duke Health between 2013 and 2021 was conducted. Demographics, case characteristics (length, complexity by billing codes, anesthesia type), ED visit findings, and hospital costs were collected. Logistic regression models were used to determine the odds of ED visits based on several risk factors. Of 34246 patients (57656 eyes) undergoing cataract surgery at Duke Health from 2013 to 2021, a total of 607 patients (1.77%) had 680 ED visits within 30 days of surgery. The most common ED diagnosis was cardiovascular (24.4%), whereas ocular complaints constituted 15.4% of visits. The most common ocular diagnoses were high intraocular pressure, rebound iritis, and posterior vitreous detachment. Hospital costs were lowest for ocular diagnoses (mean $467.72) and highest for trauma diagnoses (mean $4660.55). Risk factors for ED visits included case lengths greater than 30 minutes (OR 2.1, 95% CI 1.56-2.83, P < .001), the combination of Monitored Anesthesia Care (MAC) and retrobulbar anesthesia or general anesthesia (OR 2.98, 95% CI 1.73-5.12, P < .001), and age less than 70 years (OR 1.39, 95% CI 1.16-1.65, P < .001). ED visits within 30 days of cataract surgery are uncommon. Longer case lengths, anesthesia other than MAC alone, and younger age are associated with higher odds of ED visits.

Equipoise in Clinical Trials: Enough Uncertainty in Whose Opinion?

Equipoise in Clinical Trials: Enough Uncertainty in Whose Opinion?

Natural Language Processing to Identify Advance Care Planning Documentation in a Multisite Pragmatic Clinical Trial

ContextLarge multisite clinical trials studying decision-making when facing serious illness require an efficient method for abstraction of advance care planning (ACP) documentation from clinical text documents. However, the current gold standard method of manual chart review is time-consuming and unreliable. ObjectivesTo evaluate the ability to use natural language processing (NLP) to identify ACP documention in clinical notes from patients participating in a multisite trial. MethodsPatients with advanced cancer followed in three disease-focused oncology clinics at Duke Health, Mayo Clinic, and Northwell Health were identified using administrative data. All outpatient and inpatient notes from patients meeting inclusion criteria were extracted from electronic health records (EHRs) between March 2018 and March 2019. NLP text identification software with semi-automated chart review was applied to identify documentation of four ACP domains: (1) conversations about goals of care, (2) limitation of life-sustaining treatment, (3) involvement of palliative care, and (4) discussion of hospice. The performance of NLP was compared to gold standard manual chart review. Results435 unique patients with 79,797 notes were included in the study. In our validation data set, NLP achieved F1 scores ranging from 0.84 to 0.97 across domains compared to gold standard manual chart review. NLP identified ACP documentation in a fraction of the time required by manual chart review of EHRs (1-5 minutes per patient for NLP, vs. 30-120 minutes for manual abstraction). ConclusionNLP is more efficient and as accurate as manual chart review for identifying ACP documentation in studies with large patient cohorts.

Deriving Analytic Insights During a Novel Pandemic.

This paper summarizes the impact health care analytics has had on the COVID-19 pandemic from the combined perspectives of three North Carolina health systems: Vidant Health in Greenville, Duke Health in Durham, and Cone Health in Greensboro. Although these systems serve a diverse set of communities

How I Do It: Transition Pain Clinic, Duke Health

How I Do It: Transition Pain Clinic, Duke Health

Machine Learning in Health Care: A Critical Appraisal of Challenges and Opportunities.

Examples of fully integrated machine learning models that drive clinical care are rare. Despite major advances in the development of methodologies that outperform clinical experts and growing prominence of machine learning in mainstream medical literature, major challenges remain. At Duke Health, we are in our fourth year developing, piloting, and implementing machine learning technologies in clinical care. To advance the translation of machine learning into clinical care, health system leaders must address barriers to progress and make strategic investments necessary to bring health care into a new digital age. Machine learning can improve clinical workflows in subtle ways that are distinct from how statistics has shaped medicine. However, most machine learning research occurs in siloes, and there are important, unresolved questions about how to retrain and validate models post-deployment. Academic medical centers that cultivate and value transdisciplinary collaboration are ideally suited to integrate machine learning in clinical care. Along with fostering collaborative environments, health system leaders must invest in developing new capabilities within the workforce and technology infrastructure beyond standard electronic health records. Now is the opportunity to break down barriers and achieve scalable growth in the number of high-impact collaborations between clinical researchers and machine learning experts to transform clinical care.

Case 3: Fever, Vomiting, and Altered Mental Status in a 17-year-old Boy

1. Jonathan Pelletier, MD* 2. Kathleen Bartlett, MD* 1. *Duke Children's Hospital and Health Center, Durham NC A 17-year-old boy with a history of restrictive eating disorder and orthostatic hypotension presents via emergency medical services from an eating disorder facility with 1 week of dizziness and confusion and 1 day of fever. He also reports months of daily first-morning, nonbloody, and nonbilious vomiting. On presentation to the emergency department he is febrile (temperature, 102.9°F [39.4°C]), tachycardic (heart rate, 112 beats/min), and hypotensive (blood pressure, 91/46 mm Hg) and requires oxygen via nasal cannula. His weight is 114.2 lb (51.8 kg) (3rd percentile), height is 64.6 in (164 cm) (5th percentile), and BMI is 19.3 (15th percentile). General physical examination findings are normal. Shortly after arrival, the patient develops a brief episode of upper extremity tonic extension, unresponsiveness, and desaturation. He recovers spontaneously without an apparent postictal period. Repeated neurologic examination reveals slowed but appropriate responses to questioning. Cranial nerves, strength, sensation, and reflexes are normal. Upper extremity coordination is normal, but he has right greater than left ataxia with heel-to-shin testing. The patient is unable to stand for gait and Romberg testing due to dizziness. Laboratory tests before fluid therapy are remarkable for a serum sodium concentration of 149 mEq/L (149 mmol/L) (reference range, 135–145 mEq/L [135–145 mmol/L]), a serum chloride concentration of 118 mEq/L (118 mmol/L) (reference range, 96–108 mEq/L [96–108 mmol/L]), leukocytosis, and normocytic anemia. Urinalysis results are normal, …

The Nature of Nurture: Refining the Definition of the Exposome

Historical debates concerning human biology and behavior have frequently focused on contributions of nature, ie, the inherited characteristics with which we are born, and nurture, ie, life’s influences after birth. Indeed, the concept of nature vs nurture has guided our understanding of human biology for decades, if not centuries. A series of discoveries has greatly advanced the knowledge of our nature. Watson and Crick’s unraveling of the double helix revolutionized the understanding of our genetic makeup (Watson and Crick, 1953). The polymerase chain reaction allowed amplification and manipulation of genes (Saiki et al., 1988). Identified links between specific genes and disease (Saiki et al., 1985) led to new diagnostic tools and treatments. These advances spurred the Human Genome Project with success in sequencing the entire human genome (Lander et al., 2001; Venter et al., 2001). This epic undertaking of biomedical science and technology was completed with amazing speed and celebrated with great fanfare. But the limitation of genetics to predict disease rapidly became obvious; as noted by Dr Venter shortly after the completion of human genome sequence, “We simply do not have enough genes for this idea of biological determinism to be right (McKie 2001).” Genome-wide association studies (GWAS) have revealed genetic associations and networks that improve understanding of disease, but these still account for only a fraction of disease risk. With the majority of disease causation being nongenetic, the need for improved tools to quantify environmental contributions seems obvious. The simple distinction between genes and environment is blurred by knowledge that environmental exposures cause permanent genetic changes via mutagenesis and also have long-term impact on gene expression through epigenetic mechanisms. Importantly, epigenetic mechanisms are central to differentiation and development, impacting genome function before birth and throughout life. The epigenome is highly reliant on nurture, ie, the nature and timing of environmental exposures and external forces. Randy Jirtle, a pioneer in epigenomics stated “The nature vs. nurture argument is rapidly proving to be irrelevant, because we’re finding that the 2 forces interact in highly specific ways that alter gene behavior (Duke Health, 2006).” Although Dr Jirtle suggests the argument is becoming irrelevant, the reality is that biomedical research is overwhelmingly focused on the gene side of this debate. The tools and knowledge of our nature are far ahead of those for the environment. If we want to focus on the interaction between nature and nurture, we need better ways of cataloguing and integrating the complex exposures and forces that represent nurture. Such a framework is provided by the exposome.

Surgeons implant bioengineered vein in dialysis patient

There can be no doubt that, for the patient receiving haemodialysis, the importance of how venous access is achieved, managed and maintained is paramount. Despite progress having been made in technique and application, the mainstay of current practice continues to be centred on the formation of arteriovenous fistulae. However, this, and the use of various grafts using synthetic materials, remains beset with problems (Fluck and Kumweda, 2011). These centre on issues to do with infection, clotting (when synthetic substitutes are used) and the inherent challenges in harvesting patient’s own veins, which can be further compromised owing to the patient’s age or other associated pathology, such as diabetes mellitus. On 5 June 2013, surgeons at the Duke University Hospital successfully implanted a bioengineered vein into the arm of a patient suffering from endstage kidney disease, in what is the first stage of a US clinical trial. This may well be seen as one of the most significant steps forward in the ongoing management for this group of patients (Duke Health, 2013). Furthermore, and just as exciting, is the potential for future application in patients with blocked blood vessels (e.g. for use in bypass grafting in cardiac patients) and in the promise it holds out for bioengineering with other organs and tissues. The technology that has enabled this new initiative has been slowly developed over 15 years in collaboration between Laura Niklason and Jeffrey Lawson (Duke Health, 2013). This development can be seen as significant for a number of reasons, as Niklason explained:

Early markers of prolonged hospital stay in demented inpatients: a multicentre and prospective study.

Dementia is a serious, chronic, and costly public health problem. Prior studies have described dementia as increasing length of hospital stay, but so far no explanations have been proposed. To identify early markers for prolonged hospital stay in demented elderly inpatients, 178 community-dwelling or institutionalized subjects aged 75+, hospitalized through an emergency department in 9 teaching hospitals in France, were analyzed. Prolonged hospital stays were defined according a limit adjusted for Diagnosis Related Group. All patients underwent a comprehensive geriatric assessment at admission. Logistic regression multifactorial mixed model was performed. Center effect was considered as a random effect. Of the 178 stays, 52 were prolonged. Most concerned community-dwelling patients (86%). Multifactor analysis demonstrated that demographic variables had no influence on the length of stay, while diagnosis of delirium (OR 2.31; 95% CI 1.77 - 2.91), walking difficulties (OR 1.94; 95% CI 1.62 - 2.43) and report by the informal caregiver of moderate or severe burden (OR 1.52; 95% CI 1.19 - 1.86) or low social quality-of-life score (OR 1.25; 95% CI 1.03 - 1.40), according to the Zarit's Burden Inventory short scale (12 items) and the Duke's Health Profile respectively, were identified as early markers for prolonged hospital stays. At the time of the rising incidence of cognitive disorders, these results suggest that preventive approaches might be possible. In a hospital setting as well as in a community-dwelling population, more specific, specialized and coordinated care, using the expertise of multiple disciplines appears as a probable effective measure to limit prolonged hospital stay. Such approaches require (i) clear patient-oriented goal definition, (ii) understanding and appreciation of roles among various health care and social disciplines and, (iii) cooperation between partners in patient's management. However, the cost- and health-effectiveness of such approaches should be evaluated.

Demographic, clinical and occupational characteristics associated with early onset of delivery: Findings from the duke health and safety surveillance system, 2001–2004

This cross-sectional study explores associations between preterm delivery and demographic, clinical and occupational characteristics of women employed within a university and health system. A comprehensive surveillance system linking individual-level data from Human Resources, medical insurance claims and a job-exposure matrix was used to identify women with a single live birth between 2001 and 2004 and describe maternal characteristics during pregnancy. Preterm delivery occurred in 7.1% (n = 74) of the 1,040 women, a lower preterm delivery prevalence than observed in the general U.S. population. Nearly all (>99.5%) women utilized prenatal care services. Prevalence of preterm delivery was highest for inpatient nurses, nurses' aides and office staff. In multivariate analyses, preterm delivery was positively associated with several clinical conditions: placenta previa, diabetes and cardiovascular disorder/disease. We observed associations between preterm delivery and several previously indicated clinical conditions. Further study of the effect of job characteristics on preterm delivery is warranted.

Blood and body fluid exposure risks among health care workers: Results from the Duke Health and Safety Surveillance System

Health care workers (HCWs) are at risk of exposures to human blood and body fluids (BBF). Needlestick injuries and splashes place HCWs at risk for numerous blood-borne infections including human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV). Utilizing a new comprehensive occupational health surveillance system, the objective of this research was to better define the BBF exposure risk and risk factors among employees of a large tertiary medical center. A population of 24,425 HCWs employed in jobs with potential BBF exposures was followed for BBF exposure events from 1998 to 2002. BBF exposure rates were calculated for strata defined by age, race, gender, occupation, work location, and duration of employment. Poisson regression was used for detailed analyses of risk factors for BBF exposure. The study population reported 2,730 BBF exposures during the study period, resulting in an overall annual rate of 5.5 events/100 FTEs and a rate of 3.9 for percutaneous exposures. Higher rates were observed for males, persons employed less than 4 years, Hispanic employees, and persons less than 45 years of age. Much higher rates were observed for house staff, nurse anesthetists, inpatient nurses, phlebotomists, and surgical/operating room technicians. Poisson regression results strengthened and extended results from stratified analyses. Rates of percutaneous exposures from hollow needles were found to decrease over the study period; however, exposure rates from suture needles appear to be increasing. While continued training efforts need to be directed toward new HCWs, our data also suggest that employees who have been in their job 1-4 years continue to be at higher risk of BBF exposures. This research also points to the need for better safety devices/products and work practices to reduce suture-related injuries.

Improving glycaemic control of patients with Type 2 diabetes in a primary care setting: a French application of the Staged Diabetes Management programme

To assess the impact of a French adaptation of the Staged Diabetes Management (SDM) programme on glycaemic control of people with Type 2 diabetes in primary care. Secondary endpoints were blood pressure, blood lipids, healthcare costs and quality of life. Prospective, randomized controlled study, of 1 years' duration. General practitioners (GPs) were recruited in four separate districts of a French region. They enrolled consecutive patients with Type 2 diabetes. GPs in the intervention group were educated in the SDM programme. GPs in the control group were asked to provide usual care. Healthcare costs were collected by medical departments of the Health Insurance systems. Quality of life was assessed with the Duke Health Profile. Three hundred and forty patients enrolled by 57 GPs completed the study, 192 in the intervention group and 148 in the control group. Patients in the intervention group were managed more adequately in accordance with the guidelines (P < 0.05 for nine out of 10 items). HbA(1c) decreased by 0.31% in the intervention group and increased by 0.56% in the control group, resulting in a difference of 0.87% by the end of the study (P = 0.001). Blood pressure and blood lipids did not differ between groups. Occurrence of major complications was low and identical in both groups. Incremental costs during the study in the intervention group were 35 euros per patient per month, and this was not significantly different in comparison with the control group. Quality of life was not affected by the intervention. Educating GPs in the French adaptation of the SDM programme improves glycaemic control in a primary care setting, without significantly increasing healthcare costs.