Browsing by Subject "Feasibility Studies"
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Item Unknown A Randomized Controlled Trial Investigating the Feasibility and Adherence to an Aerobic Training Program in Healthy Individuals.(Journal of sport rehabilitation, 2019-09) Teel, Elizabeth F; Marshall, Stephen W; Appelbaum, L Gregory; Battaglini, Claudio L; Carneiro, Kevin A; Guskiewicz, Kevin M; Register-Mihalik, Johna K; Mihalik, Jason PCONTEXT:Concussion management is moving from passive rest strategies to active interventions, including aerobic exercise therapy. Little information is available regarding the feasibility and adherence of these programs. OBJECTIVES:To determine whether an aerobic exercise training program intended for rehabilitation in people with concussion is feasible. Healthy, nonconcussed subjects were studied in this phase 1 trial. DESIGN:Phase 1 parallel-group, randomized controlled trial in a sample of healthy (nonconcussed), recreationally active university students. SETTING:Laboratory. PATIENTS:40 healthy university students. METHODS:Participants were equally randomized to acute concussion therapy intervention (ACTIVE) training or nontraining groups. All participants completed maximal cardiopulmonary exercise tests on a stationary cycle ergometer at 2 test sessions approximately 14 days apart. During this 2-week study period, ACTIVE training participants completed six 30-minute cycling sessions, progressing from 60% to 80% of the participant's individualized maximal oxygen consumption. A subset of participants (NACTIVE = 12, Nnontraining = 11) wore physical activity monitors throughout the 2-week study period. MAIN OUTCOMES MEASURES:Study protocol and randomization effectiveness, exercise safety and adherence, and progressive intensity of the ACTIVE training procedures. RESULTS:No adverse events occurred during any exercise sessions. Twelve ACTIVE training participants (60%) completed all training sessions, and every participant completed at least 4 sessions. Heart rate increased throughout the training period (P < .001), but symptom changes and training adherence remained stable despite the progressively increasing workload. ACTIVE training participants completed approximately 30 additional minutes of physical activity on training sessions days, although that was not statistically significant (P = .20). CONCLUSIONS:University-aged students were adherent to the ACTIVE training protocol. Future research should investigate the safety and feasibility of aerobic training programs in acutely concussed individuals to determine their appropriateness as a clinical rehabilitation strategy.Item Unknown A unifying framework for interpreting and predicting mutualistic systems.(Nature communications, 2019-01) Wu, Feilun; Lopatkin, Allison J; Needs, Daniel A; Lee, Charlotte T; Mukherjee, Sayan; You, LingchongCoarse-grained rules are widely used in chemistry, physics and engineering. In biology, however, such rules are less common and under-appreciated. This gap can be attributed to the difficulty in establishing general rules to encompass the immense diversity and complexity of biological systems. Furthermore, even when a rule is established, it is often challenging to map it to mechanistic details and to quantify these details. Here we report a framework that addresses these challenges for mutualistic systems. We first deduce a general rule that predicts the various outcomes of mutualistic systems, including coexistence and productivity. We further develop a standardized machine-learning-based calibration procedure to use the rule without the need to fully elucidate or characterize their mechanistic underpinnings. Our approach consistently provides explanatory and predictive power with various simulated and experimental mutualistic systems. Our strategy can pave the way for establishing and implementing other simple rules for biological systems.Item Unknown Addressing Diabetes and Poorly Controlled Hypertension: Pragmatic mHealth Self-Management Intervention.(Journal of medical Internet research, 2019-04) Lewinski, Allison A; Patel, Uptal D; Diamantidis, Clarissa J; Oakes, Megan; Baloch, Khaula; Crowley, Matthew J; Wilson, Jonathan; Pendergast, Jane; Biola, Holly; Boulware, L Ebony; Bosworth, Hayden BBackground
Patients with diabetes and poorly controlled hypertension are at increased risk for adverse renal and cardiovascular outcomes. Identifying these patients early and addressing modifiable risk factors is central to delaying renal complications such as diabetic kidney disease. Mobile health (mHealth), a relatively inexpensive and easily scalable technology, can facilitate patient-centered care and promote engagement in self-management, particularly for patients of lower socioeconomic status. Thus, mHealth may be a cost-effective way to deliver self-management education and support.Objective
This feasibility study aimed to build a population management program by identifying patients with diabetes and poorly controlled hypertension who were at risk for adverse renal outcomes and evaluate a multifactorial intervention to address medication self-management. We recruited patients from a federally qualified health center (FQHC) in an underserved, diverse county in the southeastern United States.Methods
Patients were identified via electronic health record. Inclusion criteria were age between 18 and 75 years, diagnosis of type 2 diabetes, poorly controlled hypertension over the last 12 months (mean clinic systolic blood pressure [SBP] ≥140 mm Hg and/or diastolic blood pressure [DBP] ≥90 mm Hg), access to a mobile phone, and ability to receive text messages and emails. The intervention consisted of monthly telephone calls for 6 months by a case manager and weekly, one-way informational text messages. Engagement was defined as the number of phone calls completed during the intervention; individuals who completed 4 or more calls were considered engaged. The primary outcome was change in SBP at the conclusion of the intervention.Results
Of the 141 patients enrolled, 84.0% (118/141) of patients completed 1 or more phone calls and had follow-up SBP measurements for analysis. These patients were on average 56.9 years of age, predominately female (73/118, 61.9%), and nonwhite by self-report (103/118, 87.3%). The proportion of participants with poor baseline SBP control (50/118, 42.4%) did not change significantly at study completion (53/118, 44.9%) (P=.64). Participants who completed 4 or more phone calls (98/118, 83.1%) did not experience a statistically significant decrease in SBP when compared to those who completed fewer calls.Conclusion
We did not reduce uncontrolled hypertension even among the more highly engaged. However, 83% of a predominately minority and low-income population completed at least 67% of the multimodal mHealth intervention. Findings suggest that combining an automated electronic health record system to identify at-risk patients with a tailored mHealth protocol can provide education to this population. While this intervention was insufficient to effect behavioral change resulting in better hypertension control, it does suggest that this FQHC population will engage in low-cost population health applications with a potentially promising impact.Trial registration
ClinicalTrials.gov NCT02418091; https://clinicaltrials.gov/ct2/show/NCT02418091 (Archived by WebCite at http://www.webcitation.org/76RBvacVU).Item Unknown Assessment of the Feasibility of Using Noninvasive Wearable Biometric Monitoring Sensors to Detect Influenza and the Common Cold Before Symptom Onset.(JAMA network open, 2021-09) Grzesiak, Emilia; Bent, Brinnae; McClain, Micah T; Woods, Christopher W; Tsalik, Ephraim L; Nicholson, Bradly P; Veldman, Timothy; Burke, Thomas W; Gardener, Zoe; Bergstrom, Emma; Turner, Ronald B; Chiu, Christopher; Doraiswamy, P Murali; Hero, Alfred; Henao, Ricardo; Ginsburg, Geoffrey S; Dunn, JessilynImportance
Currently, there are no presymptomatic screening methods to identify individuals infected with a respiratory virus to prevent disease spread and to predict their trajectory for resource allocation.Objective
To evaluate the feasibility of using noninvasive, wrist-worn wearable biometric monitoring sensors to detect presymptomatic viral infection after exposure and predict infection severity in patients exposed to H1N1 influenza or human rhinovirus.Design, setting, and participants
The cohort H1N1 viral challenge study was conducted during 2018; data were collected from September 11, 2017, to May 4, 2018. The cohort rhinovirus challenge study was conducted during 2015; data were collected from September 14 to 21, 2015. A total of 39 adult participants were recruited for the H1N1 challenge study, and 24 adult participants were recruited for the rhinovirus challenge study. Exclusion criteria for both challenges included chronic respiratory illness and high levels of serum antibodies. Participants in the H1N1 challenge study were isolated in a clinic for a minimum of 8 days after inoculation. The rhinovirus challenge took place on a college campus, and participants were not isolated.Exposures
Participants in the H1N1 challenge study were inoculated via intranasal drops of diluted influenza A/California/03/09 (H1N1) virus with a mean count of 106 using the median tissue culture infectious dose (TCID50) assay. Participants in the rhinovirus challenge study were inoculated via intranasal drops of diluted human rhinovirus strain type 16 with a count of 100 using the TCID50 assay.Main outcomes and measures
The primary outcome measures included cross-validated performance metrics of random forest models to screen for presymptomatic infection and predict infection severity, including accuracy, precision, sensitivity, specificity, F1 score, and area under the receiver operating characteristic curve (AUC).Results
A total of 31 participants with H1N1 (24 men [77.4%]; mean [SD] age, 34.7 [12.3] years) and 18 participants with rhinovirus (11 men [61.1%]; mean [SD] age, 21.7 [3.1] years) were included in the analysis after data preprocessing. Separate H1N1 and rhinovirus detection models, using only data on wearble devices as input, were able to distinguish between infection and noninfection with accuracies of up to 92% for H1N1 (90% precision, 90% sensitivity, 93% specificity, and 90% F1 score, 0.85 [95% CI, 0.70-1.00] AUC) and 88% for rhinovirus (100% precision, 78% sensitivity, 100% specificity, 88% F1 score, and 0.96 [95% CI, 0.85-1.00] AUC). The infection severity prediction model was able to distinguish between mild and moderate infection 24 hours prior to symptom onset with an accuracy of 90% for H1N1 (88% precision, 88% sensitivity, 92% specificity, 88% F1 score, and 0.88 [95% CI, 0.72-1.00] AUC) and 89% for rhinovirus (100% precision, 75% sensitivity, 100% specificity, 86% F1 score, and 0.95 [95% CI, 0.79-1.00] AUC).Conclusions and relevance
This cohort study suggests that the use of a noninvasive, wrist-worn wearable device to predict an individual's response to viral exposure prior to symptoms is feasible. Harnessing this technology would support early interventions to limit presymptomatic spread of viral respiratory infections, which is timely in the era of COVID-19.Item Unknown Changing CHANGE: adaptations of an evidence-based telehealth cardiovascular disease risk reduction intervention.(Translational behavioral medicine, 2018-03) Zullig, Leah L; McCant, Felicia; Silberberg, Mina; Johnson, Fred; Granger, Bradi B; Bosworth, Hayden BRelatively few successful medication adherence interventions are translated into real-world clinical settings. The Prevention of Cardiovascular Outcomes in African Americans with Diabetes (CHANGE) intervention was originally conceived as a randomized controlled trial to improve cardiovascular disease-related medication adherence and health outcomes. The purpose of the study was to describe the translation of the CHANGE trial into two community-based clinical programs. CHANGE 2 was available to Medicaid patients with diabetes and hypertension whose primary care homes were part of a care management network in the Northern Piedmont region of North Carolina. CHANGE 3 was available to low-income patients receiving care in three geographical areas with multiple chronic conditions at low or moderate risk for developing cardiovascular disease. Adaptations were made to ensure fit with available organizational resources and the patient population's health needs. Data available for evaluation are presented. For CHANGE 2, we evaluated improvement in A1c control using paired t test. For both studies, we describe feasibility measured by percentage of patients who completed the curriculum. CHANGE 2 involved 125 participants. CHANGE 3 had 127 participants. In CHANGE 2, 69 participants had A1c measurements at baseline and 12-month follow-up; A1c improved from 8.4 to 7.8 (p = .008). In CHANGE 3, interventionists completed 47% (n = 45) of calls to enroll participants at the 4-month encounter, and among those eligible for a 12-month call (n = 52), 21% of 12-month calls were completed with participants. In CHANGE 2, 40% of participants (n = 50) completed all 12 encounters. Thoughtful adaptation is critical to translate clinical trials into community-based clinic settings. Successful implementation of adapted evidence-based interventions may be feasible and can positively affect patients' disease control.Item Unknown Development and Preliminary Feasibility of iByte4Health: A Mobile Health (mHealth) Pediatric Obesity Prevention Intervention to Engage Parents with Low-Income of Children 2-9 Years.(Nutrients, 2021-11-25) Tripicchio, Gina L; Kay, Melissa; Herring, Sharon; Cos, Travis; Bresnahan, Carolyn; Gartner, Danielle; Sosinsky, Laura Stout; Bass, Sarah BThis research describes the development and preliminary feasibility of iByte4Health, a mobile health (mHealth) obesity prevention intervention designed for parents with a low-income of children 2-9 years of age. Study 1 (n = 36) presents findings from formative work used to develop the program. Study 2 (n = 23) presents a 2-week proof-of-concept feasibility testing of iByte4Health, including participant acceptability, utilization, and engagement. Based on Study 1, iByte4Health was designed as a text-messaging program, targeting barriers and challenges identified by parents of young children for six key obesity prevention behaviors: (1) snacking; (2) physical activity; (3) sleep; (4) sugary drinks; (5) fruit and vegetable intake; and (6) healthy cooking at home. In Study 2, participants demonstrated high program retention (95.7% at follow-up) and acceptability (90.9% reported liking or loving the program). Users were engaged with the program; 87.0% responded to at least one self-monitoring text message; 90.9% found the videos and linked content to be helpful or extremely helpful; 86.4% found text messages helpful or extremely helpful. iByte4Health is a community-informed, evidenced-based program that holds promise for obesity prevention efforts, especially for those families at the increased risk of obesity and related disparities. Future work is warranted to test the efficacy of the program.Item Unknown EEG biomarker informed prescription of antidepressants in MDD: a feasibility trial.(European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology, 2021-03) van der Vinne, Nikita; Vollebregt, Madelon A; Rush, A John; Eebes, Michiel; van Putten, Michel JAM; Arns, MartijnUsing pre-treatment biomarkers to guide patients to the preferred antidepressant medication treatment could be a promising approach to enhance its current modest response and remission rates. This open-label prospective study assessed the feasibility of using such pre-treatment biomarkers, by using previously identified EEG features (paroxysmal activity; alpha peak frequency; frontal alpha asymmetry) to inform the clinician in selecting among three different antidepressants (ADs; escitalopram, sertraline, venlafaxine) as compared to Treatment As Usual (TAU). EEG data were obtained from 195 outpatients with major depressive disorder prior to eight weeks of AD treatment. Primary outcome measure was the percentage change between before and after treatment on the Beck Depression Inventory-II (BDI-II). We compared TAU and EEG-informed prescription through AN(C)OVAs. Recruitment started with patients receiving TAU to establish baseline effectiveness, after which we recruited patients receiving EEG-informed prescription. 108 patients received EEG-informed prescription and 87 patients received TAU. Clinicians and patients were satisfied with the protocol. Overall, 70 (65%) of the EEG-informed clinicians followed recommendations (compared to 52 (60%) following prescriptions in the TAU group), establishing feasibility. We here confirm that treatment allocation informed by EEG variables previously reported in correlational studies, was feasible.Item Unknown Experience in Transitioning From Parenteral Prostacyclins to Selexipag in Pulmonary Arterial Hypertension.(Journal of cardiovascular pharmacology, 2020-04) Parikh, Kishan S; Doerfler, Sean; Shelburne, Nicholas; Kennedy, Karla; Whitson, Jordan; Dahhan, Talal; Fortin, Terry; Rajagopal, SudarshanParenteral prostacyclin therapies remain first-line therapy for patients with pulmonary arterial hypertension (PAH) with class IV symptoms. In selected patients who have been clinically stabilized, switching to selexipag, a chemically distinct prostacyclin receptor agonist, may alleviate risks associated with long-term parenteral therapy. We report our experience with transition of patients from parenteral prostacyclin therapy to selexipag. From January 2016 to July 2017, patients with PAH at the Duke University Pulmonary Vascular Disease Center with functional class II symptoms on stable parenteral prostacyclin therapy were offered the opportunity to transition to selexipag. A standardized protocol was developed to guide titration of therapies. Patients underwent pre- and post-transition assessments of hemodynamics, echocardiography, laboratory biomarkers, and functional status. We studied 14 patients with PAH (11 women; median age 53 years) in total. Overall, 13 patients tolerated the switch to selexipag and remained on the drug at study completion, and 1 patient passed away due to progressive liver failure. Surrogate markers including NT-proBNP, 6MWD, RV function, and TAPSE, and right heart catheterization hemodynamics were similar before and after transition. The transition from parenteral prostanoid therapy to oral selexipag was overall well-tolerated in patients with stable PAH and functional class II symptoms. Finally, doses of selexipag up to 3200 μg twice daily were well-tolerated in patients who had been treated with prior parenteral prostacyclins.Item Unknown Feasibility of autologous cord blood cells for infants with hypoxic-ischemic encephalopathy.(The Journal of pediatrics, 2014-05) Cotten, C Michael; Murtha, Amy P; Goldberg, Ronald N; Grotegut, Chad A; Smith, P Brian; Goldstein, Ricki F; Fisher, Kimberley A; Gustafson, Kathryn E; Waters-Pick, Barbara; Swamy, Geeta K; Rattray, Benjamin; Tan, Siddhartha; Kurtzberg, JoanneObjective
To assess feasibility and safety of providing autologous umbilical cord blood (UCB) cells to neonates with hypoxic-ischemic encephalopathy (HIE).Study design
We enrolled infants in the intensive care nursery who were cooled for HIE and had available UCB in an open-label study of non-cyropreserved autologous volume- and red blood cell-reduced UCB cells (up to 4 doses adjusted for volume and red blood cell content, 1-5 × 10(7) cells/dose). We recorded UCB collection and cell infusion characteristics, and pre- and post-infusion vital signs. As exploratory analyses, we compared cell recipients' hospital outcomes (mortality, oral feeds at discharge) and 1-year survival with Bayley Scales of Infant and Toddler Development, 3rd edition scores ≥85 in 3 domains (cognitive, language, and motor development) with cooled infants who did not have available cells.Results
Twenty-three infants were cooled and received cells. Median collection and infusion volumes were 36 and 4.3 mL. Vital signs including oxygen saturation were similar before and after infusions in the first 48 postnatal hours. Cell recipients and concurrent cooled infants had similar hospital outcomes. Thirteen of 18 (74%) cell recipients and 19 of 46 (41%) concurrent cooled infants with known 1-year outcomes survived with scores >85.Conclusions
Collection, preparation, and infusion of fresh autologous UCB cells for use in infants with HIE is feasible. A randomized double-blind study is needed.Item Unknown Feasibility of Cancer Clinical Trial Enrollment Goals Based on Cancer Incidence.(JCO clinical cancer informatics, 2020-01) Tran, George; Harker, Matthew; Chiswell, Karen; Unger, Joseph M; Fleury, Mark E; Hirsch, Bradford; Miller, Kimberly; d'Almada, Philip; Tibbs, Sheri; Zafar, S YousufPurpose
More than 20% of US clinical trials fail to accrue sufficiently. Our purpose was to provide a benchmark for better understanding clinical trial enrollment feasibility and to assess relative levels of competition for patients by cancer diagnosis.Methods
The Database for Aggregate Analysis of ClinicalTrials.gov, up to date as of September 3, 2017, was used to identify actively recruiting, interventional oncology trials with US sites. Observational studies were excluded because not all are registered. Trials were categorized through Medical Subject Headings or free-text condition terms and sorted by cancer diagnosis. Trials that included more than one cancer diagnosis were included in the overall cohort but excluded when evaluating enrollment by cancer type. Trial enrollment slot availability was estimated between September 1, 2017, and August 31, 2018. Availability was estimated from total anticipated enrollment and duration, assuming a constant recruitment rate. Estimates for studies with both foreign and domestic sites were then prorated to calculate available enrollment in the United States alone. Ratios of the number of newly diagnosed patients in the United States available per trial slot were estimated using the American Cancer Society cancer incidence estimates for 2017.Results
A total of 4,598 interventional oncology trials were identified. Overall, the estimated ratio of newly diagnosed patients available per trial slot was 12.6. Estimated ratios of patients per trial slot for six cancer diagnoses with the highest potential of 12-month US enrollment were as follows: colorectal, 24.7; lung and bronchus, 20.1; prostate, 17.6; breast (female), 13.8; leukemia, 11.6; and brain and other nervous system, 6.0.Conclusion
For all cancers, successfully accruing trials currently open would require that more than one in every 13 recently diagnosed patients (7.9%) enroll. This ratio and relative difficulty of accrual varies among cancers examined.Item Unknown Feasibility of integrated depression care in an HIV clinic.(Psychiatr Serv, 2011-07) Adams, Julie; Pollard, R Scott; Sikkema, Kathleen JItem Unknown Feasibility of Interferential and Pulsed Transcranial Electrical Stimulation for Neuromodulation at the Human Scale.(Neuromodulation : journal of the International Neuromodulation Society, 2021-07) Howell, Bryan; McIntyre, Cameron CObjectives
Transcranial electrical stimulation (tES) is a promising tool for modulating neural activity, but tES has poor penetrability and spatiotemporal resolution compared to invasive techniques like deep brain stimulation (DBS). Interferential strategies for alternating-current stimulation (IF-tACS) and pulsed/intersectional strategies for transcranial direct-current stimulation (IS-tDCS) address some of the limitations of tES, but the comparative advantages and disadvantages of these new techniques is not well understood. This study's objective was to evaluate the suprathreshold and subthreshold membrane dynamics of neurons in response to IF-tACS and IS-tDCS.Materials and methods
We analyzed the biophysics of IF-tACS and IS-tDCS using a bioelectric field model of tES. Neural responses were quantified for suprathreshold generation of action potentials in axons and for subthreshold modulation of membrane dynamics in spiking pyramidal neurons.Results
IF-tACS and IS-tDCS could not directly activate axons at or below 10 mA, but within this current range, these fields were able to modulate, albeit indirectly, spiking activity in the neuron model. IF-tACS facilitated phase synchronization similar to tACS, and IS-tDCS enhanced and suppressed spiking activity similar to tDCS; however, in either case, the modulatory effects of these fields were less potent than their standard counterparts at a matched field intensity. Moreover, neither IF-tACS nor IS-tDCS improved the spatial selectivity of their parent strategies.Conclusions
Enhancing the spatiotemporal precision and penetrability of tES with interferential and intersectional strategies is possible at the human scale. However, IF-tACS or IS-tDCS will likely require spatial multiplexing with multiple simultaneous sources to counteract their reduced potency, compared to standard techniques, to maintain stimulation currents at tolerable levels.Item Unknown Feasibility of Post-hospitalization Telemedicine Video Visits for Children With Medical Complexity.(Journal of pediatric health care : official publication of National Association of Pediatric Nurse Associates & Practitioners, 2022-03) Ming, David Y; Li, Tingxuan; Ross, Melissa H; Frush, Jennifer; He, Jingyi; Goldstein, Benjamin A; Jarrett, Valerie; Krohl, Natalie; Docherty, Sharron L; Turley, Christine B; Bosworth, Hayden BObjectives
To evaluate feasibility and acceptability of post-hospitalization telemedicine video visits (TMVV) during hospital-to-home transitions for children with medical complexity (CMC); and explore associations with hospital utilization, caregiver self-efficacy (CSE), and family self-management (FSM).Method
This non-randomized pilot study assigned CMC (n=28) to weekly TMVV for four weeks post-hospitalization; control CMC (n=20) received usual care without telemedicine. Feasibility was measured by time to connection and proportion of TMVV completed; acceptability was measured by parent-reported surveys. Pre/post-discharge changes in CSE, FSM, and hospital utilization were assessed.Results
64 TMVV were completed; 82 % of patients completed 1 TMVV; 54 % completed four TMVV. Median time to TMVV connection was 1 minute (IQR=2.5). Parents reported high acceptability of TMVV (mean 6.42; 1 -7 scale). CSE and FSM pre/post-discharge were similar for both groups; utilization declined in both groups post-discharge.Discussion
Post-hospitalization TMVV for CMC were feasible and acceptable during hospital-to-home transitions.Item Unknown Geographic information system-based screening for TB, HIV, and syphilis (GIS-THIS): a cross-sectional study.(PLoS One, 2012) Goswami, Neela D; Hecker, Emily J; Vickery, Carter; Ahearn, Marshall A; Cox, Gary M; Holland, David P; Naggie, Susanna; Piedrahita, Carla; Mosher, Ann; Torres, Yvonne; Norton, Brianna L; Suchindran, Sujit; Park, Paul H; Turner, Debbie; Stout, Jason EOBJECTIVE: To determine the feasibility and case detection rate of a geographic information systems (GIS)-based integrated community screening strategy for tuberculosis, syphilis, and human immunodeficiency virus (HIV). DESIGN: Prospective cross-sectional study of all participants presenting to geographic hot spot screenings in Wake County, North Carolina. METHODS: The residences of tuberculosis, HIV, and syphilis cases incident between 1/1/05-12/31/07 were mapped. Areas with high densities of all 3 diseases were designated "hot spots." Combined screening for tuberculosis, HIV, and syphilis were conducted at the hot spots; participants with positive tests were referred to the health department. RESULTS AND CONCLUSIONS: Participants (N = 247) reported high-risk characteristics: 67% previously incarcerated, 40% had lived in a homeless shelter, and 29% had a history of crack cocaine use. However, 34% reported never having been tested for HIV, and 41% did not recall prior tuberculin skin testing. Screening identified 3% (8/240) of participants with HIV infection, 1% (3/239) with untreated syphilis, and 15% (36/234) with latent tuberculosis infection. Of the eight persons with HIV, one was newly diagnosed and co-infected with latent tuberculosis; he was treated for latent TB and linked to an HIV provider. Two other HIV-positive persons had fallen out of care, and as a result of the study were linked back into HIV clinics. Of 27 persons with latent tuberculosis offered therapy, nine initiated and three completed treatment. GIS-based screening can effectively penetrate populations with high disease burden and poor healthcare access. Linkage to care remains challenging and will require creative interventions to impact morbidity.Item Unknown Hyperpolarized Xe MR imaging of alveolar gas uptake in humans.(PLoS One, 2010-08-16) Cleveland, Zackary I; Cofer, Gary P; Metz, Gregory; Beaver, Denise; Nouls, John; Kaushik, S Sivaram; Kraft, Monica; Wolber, Jan; Kelly, Kevin T; McAdams, H Page; Driehuys, BastiaanBACKGROUND: One of the central physiological functions of the lungs is to transfer inhaled gases from the alveoli to pulmonary capillary blood. However, current measures of alveolar gas uptake provide only global information and thus lack the sensitivity and specificity needed to account for regional variations in gas exchange. METHODS AND PRINCIPAL FINDINGS: Here we exploit the solubility, high magnetic resonance (MR) signal intensity, and large chemical shift of hyperpolarized (HP) (129)Xe to probe the regional uptake of alveolar gases by directly imaging HP (129)Xe dissolved in the gas exchange tissues and pulmonary capillary blood of human subjects. The resulting single breath-hold, three-dimensional MR images are optimized using millisecond repetition times and high flip angle radio-frequency pulses, because the dissolved HP (129)Xe magnetization is rapidly replenished by diffusive exchange with alveolar (129)Xe. The dissolved HP (129)Xe MR images display significant, directional heterogeneity, with increased signal intensity observed from the gravity-dependent portions of the lungs. CONCLUSIONS: The features observed in dissolved-phase (129)Xe MR images are consistent with gravity-dependent lung deformation, which produces increased ventilation, reduced alveolar size (i.e., higher surface-to-volume ratios), higher tissue densities, and increased perfusion in the dependent portions of the lungs. Thus, these results suggest that dissolved HP (129)Xe imaging reports on pulmonary function at a fundamental level.Item Unknown Implementing a Continuous Quality Improvement Program in a High-Volume Clinical Echocardiography Laboratory: Improving Care for Patients With Aortic Stenosis.(Circ Cardiovasc Imaging, 2016-03) Samad, Zainab; Minter, Stephanie; Armour, Alicia; Tinnemore, Amanda; Sivak, Joseph A; Sedberry, Brenda; Strub, Karen; Horan, Seanna M; Harrison, J Kevin; Kisslo, Joseph; Douglas, Pamela S; Velazquez, Eric JBACKGROUND: The management of aortic stenosis rests on accurate echocardiographic diagnosis. Hence, it was chosen as a test case to examine the utility of continuous quality improvement (CQI) approaches to increase echocardiographic data accuracy and reliability. A novel, multistep CQI program was designed and prospectively used to investigate whether it could minimize the difference in aortic valve mean gradients reported by echocardiography when compared with cardiac catheterization. METHODS AND RESULTS: The Duke Echo Laboratory compiled a multidisciplinary CQI team including 4 senior sonographers and MD faculty to develop a mapped CQI process that incorporated Intersocietal Accreditation Commission standards. Quarterly, the CQI team reviewed all moderate- or greater-severity aortic stenosis echocardiography studies with concomitant catheterization data, and deidentified individual and group results were shared at meetings attended by cardiologists and sonographers. After review of 2011 data, the CQI team proposed specific amendments implemented over 2012: the use of nontraditional imaging and Doppler windows as well as evaluation of aortic gradients by a second sonographer. The primary outcome measure was agreement between catheterization- and echocardiography-derived mean gradients calculated by using the coverage probability index with a prespecified acceptable echocardiography-catheterization difference of <10 mm Hg in mean gradient. Between January 2011 and January 2014, 2093 echocardiograms reported moderate or greater aortic stenosis. Among cases with available catheterization data pre- and post-CQI, the coverage probability index increased from 54% to 70% (P=0.03; 98 cases, year 2011; 70 cases, year 2013). The proportion of patients referred for invasive valve hemodynamics decreased from 47% pre-CQI to 19% post-CQI (P<0.001). CONCLUSIONS: A laboratory practice pattern that was amenable to reform was identified, and a multistep modification was designed and implemented that produced clinically valuable performance improvements. The new protocol improved aortic stenosis mean gradient agreement between echocardiography and catheterization and was associated with a measurable decrease in referrals of patients for invasive studies.Item Unknown In vivo inhibition of elevated myocardial beta-adrenergic receptor kinase activity in hybrid transgenic mice restores normal beta-adrenergic signaling and function.(Circulation, 1999-08-10) Akhter, SA; Eckhart, AD; Rockman, HA; Shotwell, K; Lefkowitz, RJ; Koch, WJBACKGROUND: The clinical syndrome of heart failure (HF) is characterized by an impaired cardiac beta-adrenergic receptor (betaAR) system, which is critical in the regulation of myocardial function. Expression of the betaAR kinase (betaARK1), which phosphorylates and uncouples betaARs, is elevated in human HF; this likely contributes to the abnormal betaAR responsiveness that occurs with beta-agonist administration. We previously showed that transgenic mice with increased myocardial betaARK1 expression had impaired cardiac function in vivo and that inhibiting endogenous betaARK1 activity in the heart led to enhanced myocardial function. METHODS AND RESULTS: We created hybrid transgenic mice with cardiac-specific concomitant overexpression of both betaARK1 and an inhibitor of betaARK1 activity to study the feasibility and functional consequences of the inhibition of elevated betaARK1 activity similar to that present in human HF. Transgenic mice with myocardial overexpression of betaARK1 (3 to 5-fold) have a blunted in vivo contractile response to isoproterenol when compared with non-transgenic control mice. In the hybrid transgenic mice, although myocardial betaARK1 levels remained elevated due to transgene expression, in vitro betaARK1 activity returned to control levels and the percentage of betaARs in the high-affinity state increased to normal wild-type levels. Furthermore, the in vivo left ventricular contractile response to betaAR stimulation was restored to normal in the hybrid double-transgenic mice. CONCLUSIONS: Novel hybrid transgenic mice can be created with concomitant cardiac-specific overexpression of 2 independent transgenes with opposing actions. Elevated myocardial betaARK1 in transgenic mouse hearts (to levels seen in human HF) can be inhibited in vivo by a peptide that can prevent agonist-stimulated desensitization of cardiac betaARs. This may represent a novel strategy to improve myocardial function in the setting of compromised heart function.Item Unknown Medication coaching program for patients with minor stroke or TIA: a pilot study.(BMC Public Health, 2012-07-25) Sides, Elizabeth G; Zimmer, Louise O; Wilson, Leslie; Pan, Wenqin; Olson, Daiwai M; Peterson, Eric D; Bushnell, CherylBACKGROUND: Patients who are hospitalized with a first or recurrent stroke often are discharged with new medications or adjustment to the doses of pre-admission medications, which can be confusing and pose safety issues if misunderstood. The purpose of this pilot study was to assess the feasibility of medication coaching via telephone after discharge in patients with stroke. METHODS: Two-arm pilot study of a medication coaching program with 30 patients (20 intervention, 10 control). Consecutive patients admitted with stroke or TIA with at least 2 medications changed between admission and discharge were included. The medication coach contacted intervention arm patients post-discharge via phone call to discuss risk factors, review medications and triage patients' questions to a stroke nurse and/or pharmacist. Intervention and control participants were contacted at 3 months for outcomes. The main outcomes were feasibility (appropriateness of script, ability to reach participants, and provide requested information) and participant evaluation of medication coaching. RESULTS: The median lengths of the coaching and follow-up calls with requested answers to these questions were 27 minutes and 12 minutes, respectively, and participant evaluations of the coaching were positive. The intervention participants were more likely to have seen their primary care provider than were control participants by 3 months post discharge. CONCLUSIONS: This medication coaching study executed early after discharge demonstrated feasibility of coaching and educating stroke patients with a trained coach. Results from our small pilot showed a possible trend towards improved appointment-keeping with primary care providers in those who received coaching.Item Unknown Mobile health devices: will patients actually use them?(Journal of the American Medical Informatics Association : JAMIA, 2016-05) Shaw, Ryan J; Steinberg, Dori M; Bonnet, Jonathan; Modarai, Farhad; George, Aaron; Cunningham, Traven; Mason, Markedia; Shahsahebi, Mohammad; Grambow, Steven C; Bennett, Gary G; Bosworth, Hayden BAlthough mobile health (mHealth) devices offer a unique opportunity to capture patient health data remotely, it is unclear whether patients will consistently use multiple devices simultaneously and/or if chronic disease affects adherence. Three healthy and three chronically ill participants were recruited to provide data on 11 health indicators via four devices and a diet app. The healthy participants averaged overall weekly use of 76%, compared to 16% for those with chronic illnesses. Device adherence declined across all participants during the study. Patients with chronic illnesses, with arguably the most to benefit from advanced (or increased) monitoring, may be less likely to adopt and use these devices compared to healthy individuals. Results suggest device fatigue may be a significant problem. Use of mobile technologies may have the potential to transform care delivery across populations and within individuals over time. However, devices may need to be tailored to meet the specific patient needs.Item Unknown Noninvasive monitoring of tissue hemoglobin using UV-VIS diffuse reflectance spectroscopy: a pilot study.(Opt Express, 2009-12-21) Bender, Janelle E; Shang, Allan B; Moretti, Eugene W; Yu, Bing; Richards, Lisa M; Ramanujam, NirmalaWe conducted a pilot study on 10 patients undergoing general surgery to test the feasibility of diffuse reflectance spectroscopy in the visible wavelength range as a noninvasive monitoring tool for blood loss during surgery. Ratios of raw diffuse reflectance at wavelength pairs were tested as a first-pass for estimating hemoglobin concentration. Ratios can be calculated easily and rapidly with limited post-processing, and so this can be considered a near real-time monitoring device. We found the best hemoglobin correlations were when ratios at isosbestic points of oxy- and deoxyhemoglobin were used, specifically 529/500 nm. Baseline subtraction improved correlations, specifically at 520/509 nm. These results demonstrate proof-of-concept for the ability of this noninvasive device to monitor hemoglobin concentration changes due to surgical blood loss. The 529/500 nm ratio also appears to account for variations in probe pressure, as determined from measurements on two volunteers.