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In Silico Pharmacoepidemiologic Evaluation of Drug-Induced Cardiovascular Complications Using Combined Classifiers.
Cai C, Fang J, Guo P, Wang Q, Hong H, Moslehi J, Cheng F
(2018) J Chem Inf Model 58: 943-956
MeSH Terms: Antineoplastic Agents, Cardiovascular System, Computational Biology, Computer Simulation, Drug Discovery, Drug-Related Side Effects and Adverse Reactions, Humans, Molecular Targeted Therapy, Myocytes, Cardiac, Pluripotent Stem Cells, Product Surveillance, Postmarketing, Safety
Show Abstract · Added October 1, 2018
Drug-induced cardiovascular complications are the most common adverse drug events and account for the withdrawal or severe restrictions on the use of multitudinous postmarketed drugs. In this study, we developed new in silico models for systematic identification of drug-induced cardiovascular complications in drug discovery and postmarketing surveillance. Specifically, we collected drug-induced cardiovascular complications covering the five most common types of cardiovascular outcomes (hypertension, heart block, arrhythmia, cardiac failure, and myocardial infarction) from four publicly available data resources: Comparative Toxicogenomics Database, SIDER, Offsides, and MetaADEDB. Using these databases, we developed a combined classifier framework through integration of five machine-learning algorithms: logistic regression, random forest, k-nearest neighbors, support vector machine, and neural network. The totality of models included 180 single classifiers with area under receiver operating characteristic curves (AUC) ranging from 0.647 to 0.809 on 5-fold cross-validations. To develop the combined classifiers, we then utilized a neural network algorithm to integrate the best four single classifiers for each cardiovascular outcome. The combined classifiers had higher performance with an AUC range from 0.784 to 0.842 compared to single classifiers. Furthermore, we validated our predicted cardiovascular complications for 63 anticancer agents using experimental data from clinical studies, human pluripotent stem cell-derived cardiomyocyte assays, and literature. The success rate of our combined classifiers reached 87%. In conclusion, this study presents powerful in silico tools for systematic risk assessment of drug-induced cardiovascular complications. This tool is relevant not only in early stages of drug discovery but also throughout the life of a drug including clinical trials and postmarketing surveillance.
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12 MeSH Terms
Updated procedure for the safety evaluation of natural flavor complexes used as ingredients in food.
Cohen SM, Eisenbrand G, Fukushima S, Gooderham NJ, Guengerich FP, Hecht SS, Rietjens IMCM, Davidsen JM, Harman CL, Taylor SV
(2018) Food Chem Toxicol 113: 171-178
MeSH Terms: Flavoring Agents, Food Industry, Food Safety, Humans, Toxicity Tests, United States
Show Abstract · Added March 14, 2018
An effective and thorough approach for the safety evaluation of natural flavor complexes (NFCs) was published in 2005 by the Expert Panel of the Flavor and Extract Manufacturers Association (FEMA). An updated procedure is provided here, which maintains the essential concepts of the use of the congeneric group approach and the reliance on the threshold of toxicological concern (TTC) concept. The updated procedure emphasizes more rigorous considerations of unidentified constituents and the genotoxic potential of constituents. The update of the previously established procedure is the first step in a multi-year project to conduct safety re-evaluations for more than 250 NFCs that have uses that are currently considered Generally Recognized as Safe (GRAS) by the FEMA Expert Panel. In addition, this procedure can be more generally employed in the safety evaluation of NFCs.
Copyright © 2018 The Author(s). Published by Elsevier Ltd.. All rights reserved.
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6 MeSH Terms
Speaking up about traditional and professionalism-related patient safety threats: a national survey of interns and residents.
Martinez W, Lehmann LS, Thomas EJ, Etchegaray JM, Shelburne JT, Hickson GB, Brady DW, Schleyer AM, Best JA, May NB, Bell SK
(2017) BMJ Qual Saf 26: 869-880
MeSH Terms: Academic Medical Centers, Attitude of Health Personnel, Communication, Courage, Cross-Sectional Studies, Female, Humans, Internship and Residency, Male, Patient Safety, Professional Misconduct, Professionalism, Safety Management, United States
Show Abstract · Added May 26, 2017
BACKGROUND - Open communication between healthcare professionals about care concerns, also known as 'speaking up', is essential to patient safety.
OBJECTIVE - Compare interns' and residents' experiences, attitudes and factors associated with speaking up about traditional versus professionalism-related safety threats.
DESIGN - Anonymous, cross-sectional survey.
SETTING - Six US academic medical centres, 2013-2014.
PARTICIPANTS - 1800 medical and surgical interns and residents (47% responded).
MEASUREMENTS - Attitudes about, barriers and facilitators for, and self-reported experience with speaking up. Likelihood of speaking up and the potential for patient harm in two vignettes. Safety Attitude Questionnaire (SAQ) teamwork and safety scales; and Speaking Up Climate for Patient Safety (SUC-Safe) and Speaking Up Climate for Professionalism (SUC-Prof) scales.
RESULTS - Respondents more commonly observed unprofessional behaviour (75%, 628/837) than traditional safety threats (49%, 410/837); p<0.001, but reported speaking up about unprofessional behaviour less commonly (46%, 287/628 vs 71%, 291/410; p<0.001). Respondents more commonly reported fear of conflict as a barrier to speaking up about unprofessional behaviour compared with traditional safety threats (58%, 482/837 vs 42%, 348/837; p<0.001). Respondents were also less likely to speak up to an attending physician in the professionalism vignette than the traditional safety vignette, even when they perceived high potential patient harm (20%, 49/251 vs 71%, 179/251; p<0.001). Positive perceptions of SAQ teamwork climate and SUC-Safe were independently associated with speaking up in the traditional safety vignette (OR 1.90, 99% CI 1.36 to 2.66 and 1.46, 1.02 to 2.09, respectively), while only a positive perception of SUC-Prof was associated with speaking up in the professionalism vignette (1.76, 1.23 to 2.50).
CONCLUSIONS - Interns and residents commonly observed unprofessional behaviour yet were less likely to speak up about it compared with traditional safety threats even when they perceived high potential patient harm. Measuring SUC-Safe, and particularly SUC-Prof, may fill an existing gap in safety culture assessment.
Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
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14 MeSH Terms
A Prospective Case-Control Study Comparing LithoVue, a Single-Use, Flexible Disposable Ureteroscope, with Flexible, Reusable Fiber-Optic Ureteroscopes.
Usawachintachit M, Isaacson DS, Taguchi K, Tzou DT, Hsi RS, Sherer BA, Stoller ML, Chi T
(2017) J Endourol 31: 468-475
MeSH Terms: Adult, Aged, Case-Control Studies, Equipment Design, Female, Fiber Optic Technology, Humans, Kidney Calculi, Male, Middle Aged, Operative Time, Patient Safety, Prospective Studies, Treatment Outcome, Ureteroscopes, Ureteroscopy, Urinary Bladder Neoplasms, Urinary Calculi, Urothelium
Show Abstract · Added March 15, 2017
OBJECTIVE - LithoVue™ is a novel, single-use, digital flexible ureteroscope that was released to the US market in January 2016. There are scant data regarding its performance in humans. Procedural outcomes comparing LithoVue with reusable ureteroscopes are presented in patients undergoing ureteroscopy for upper urinary tract pathology.
PATIENTS AND METHODS - Clinical outcomes between two groups of patients undergoing flexible ureteroscopy for upper urinary tract pathology were analyzed. The first group underwent surgery utilizing LithoVue, and the second group used reusable fiber-optic flexible ureteroscopes. Differences in procedural outcomes, operative times, and time spent in hospital were analyzed using two-tailed t-tests and chi-squared and Fisher's exact tests.
RESULTS - One hundred fifteen cases utilizing LithoVue and 65 cases utilizing reusable ureteroscopes were included in this study. Demographics, surgical indications, stone size, location, total stone burden, composition, procedural outcomes, and complications were comparable between groups. For all cases, LithoVue procedures lasted 54.1 ± 25.7 minutes compared with 64.5 ± 37.0 minutes for reusable scope procedures (p < 0.05) and for stone removal cases, 57.3 ± 25.1 vs 70.3 ± 36.9 minutes, respectively (p < 0.05). Scope failure occurred in 4.4% of LithoVue cases and 7.7% of reusable cases (p = 0.27).
CONCLUSIONS - LithoVue represents a feasible alternative to reusable ureteroscopes with a low rate of scope failure comparable with reusable ureteroscopes. Its use shortens procedure duration, a finding that warrants further investigation.
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19 MeSH Terms
Pragmatic trial of an intervention to increase human papillomavirus vaccination in safety-net clinics.
Sanderson M, Canedo JR, Khabele D, Fadden MK, Harris C, Beard K, Burress M, Pinkerton H, Jackson C, Mayo-Gamble T, Hargreaves MK, Hull PC
(2017) BMC Public Health 17: 158
MeSH Terms: Adolescent, African Americans, Child, Cluster Analysis, Female, Follow-Up Studies, Hispanic Americans, Humans, Intention, Male, Motivation, Papillomavirus Infections, Papillomavirus Vaccines, Patient Education as Topic, Retrospective Studies, Safety-net Providers, Tennessee
Show Abstract · Added February 6, 2017
BACKGROUND - Human papillomavirus (HPV) infection has been causally linked to six cancers, and many disproportionately affect minorties. This study reports on the development and effectiveness of an intervention aimed at increasing HPV vaccine uptake among African American and Hispanic pediatric patients in safety-net clinics.
METHODS - Formative research, community engagement, and theory guided development of the intervention. A clustered, non-randomized controlled pragmatic trial was conducted in four clinics providing healthcare for the underserved in Tennessee, U.S., with two intervention sites and two usual care sites. Patients aged 9-18 years (N = 408) and their mothers (N = 305) enrolled, with children clustered within families. The intervention consisted of two provider/staff training sessions and provision of patient education materials, consisting of a video/flyer promoting HPV vaccine. Medical records were reviewed before/after the initial visit and after 12 months.
RESULTS - At the initial visit, provision of patient education materials and provider recommendation were higher at intervention sites versus usual care sites, and receipt of HPV vaccine was higher at intervention sites (45.4% versus 32.9%) but not significantly after adjusting for patient's age and mother's education. Provider recommendation, but not education materials, increased the likelihood of vaccine receipt at the initial visit, although over one-third of intervention mothers cited the flyer/video as motivating vaccination. Completion of the 3-dose series at follow-up was lower in the intervention arm.
CONCLUSIONS - Future interventions should combine patient education, intensive provider/staff education, and patient reminders. Research should compare patient education focusing on HPV vaccine only versus all adolescent vaccines.
TRIAL REGISTRATION - Retrospectively registered with ClinicalTrials.gov NCT02808832 , 9/12/16.
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17 MeSH Terms
Safety evaluation of substituted thiophenes used as flavoring ingredients.
Cohen SM, Fukushima S, Gooderham NJ, Guengerich FP, Hecht SS, Rietjens IM, Smith RL, Bastaki M, Harman CL, McGowen MM, Valerio LG, Taylor SV
(2017) Food Chem Toxicol 99: 40-59
MeSH Terms: Consumer Product Safety, Flavoring Agents, Humans, No-Observed-Adverse-Effect Level, Thiophenes, Toxicity Tests, United States, United States Food and Drug Administration
Show Abstract · Added March 14, 2018
This publication is the second in a series by the Expert Panel of the Flavor and Extract Manufacturers Association summarizing the conclusions of its third systematic re-evaluation of the safety of flavorings previously considered to be generally recognized as safe (GRAS) under conditions of intended use. Re-evaluation of GRAS status for flavorings is based on updated considerations of exposure, structural analogy, metabolism, pharmacokinetics and toxicology and includes a comprehensive review of the scientific information on the flavorings and structurally related substances. Of the 12 substituted thiophenes reviewed here, 11 were reaffirmed as GRAS based on their rapid absorption, metabolism and excretion in humans and animals; the low estimated dietary exposure from flavor use; the wide margins of safety between the conservative estimates of intake and the no-observed-adverse effect levels; and the lack of significant genotoxic and mutagenic potential. For one of the substituted thiophenes, 3-acetyl-2,5-dimethylthiophene, it was concluded that more detailed exposure information, comparative metabolism studies and comprehensive toxicity data, including an in-depth evaluation of the mechanism of action for any adverse effects observed, are required for continuation of its FEMA GRAS™ status. In the absence of these data, the compound was removed from the FEMA GRAS list.
Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.
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8 MeSH Terms
Patients and families as teachers: a mixed methods assessment of a collaborative learning model for medical error disclosure and prevention.
Langer T, Martinez W, Browning DM, Varrin P, Sarnoff Lee B, Bell SK
(2016) BMJ Qual Saf 25: 615-25
MeSH Terms: Adult, Education, Family, Female, Humans, Interdisciplinary Placement, Male, Medical Errors, Middle Aged, Models, Educational, Patient Safety, Patients, Truth Disclosure
Show Abstract · Added May 26, 2017
BACKGROUND - Despite growing interest in engaging patients and families (P/F) in patient safety education, little is known about how P/F can best contribute. We assessed the feasibility and acceptability of a patient-teacher medical error disclosure and prevention training model.
METHODS - We developed an educational intervention bringing together interprofessional clinicians with P/F from hospital advisory councils to discuss error disclosure and prevention. Patient focus groups and orientation sessions informed curriculum and assessment design. A pre-post survey with qualitative and quantitative questions was used to assess P/F and clinician experiences and attitudes about collaborative safety education including participant hopes, fears, perceived value of learning experience and challenges. Responses to open-ended questions were coded according to principles of content analysis.
RESULTS - P/F and clinicians hoped to learn about each other's perspectives, communication skills and patient empowerment strategies. Before the intervention, both groups worried about power dynamics dampening effective interaction. Clinicians worried that P/F would learn about their fallibility, while P/F were concerned about clinicians' jargon and defensive posturing. Following workshops, clinicians valued patients' direct feedback, communication strategies for error disclosure and a 'real' learning experience. P/F appreciated clinicians' accountability, and insights into how medical errors affect clinicians. Half of participants found nothing challenging, the remainder clinicians cited emotions and enormity of 'culture change', while P/F commented on medical jargon and desire for more time. Patients and clinicians found the experience valuable. Recommendations about how to develop a patient-teacher programme in patient safety are provided.
CONCLUSIONS - An educational paradigm that includes patients as teachers and collaborative learners with clinicians in patient safety is feasible, valued by clinicians and P/F and promising for P/F-centred medical error disclosure and prevention training.
Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
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13 MeSH Terms
Using Coworker Observations to Promote Accountability for Disrespectful and Unsafe Behaviors by Physicians and Advanced Practice Professionals.
Webb LE, Dmochowski RR, Moore IN, Pichert JW, Catron TF, Troyer M, Martinez W, Cooper WO, Hickson GB
(2016) Jt Comm J Qual Patient Saf 42: 149-64
MeSH Terms: Clinical Competence, Communication, Documentation, Humans, Inservice Training, Leadership, Medical Staff, Patient Care Team, Patient Safety, Personnel, Hospital
Show Abstract · Added May 13, 2016
BACKGROUND - Health care team members are well positioned to observe disrespectful and unsafe conduct-behaviors known to undermine team function. Based on experience in sharing patient complaints with physicians who subsequently achieved decreased complaints and malpractice risk, Vanderbilt University Medical Center developed and assessed the feasibility of the Co-Worker Observation Reporting System(SM) (CORS (SM)) for addressing coworkers' reported concerns.
METHODS - VUMC leaders used a "Project Bundle" readiness assessment, which entailed identification and development of key people, organizational supports, and systems. Methods involved gaining leadership buy-in, recruiting and training key individuals, aligning the project with organizational values and policies, promoting reporting, monitoring reports, and employing a tiered intervention process to address reported coworker concerns.
RESULTS - Peer messengers shared coworker reports with the physicians and advanced practice professionals associated with at least one report 84% of the time. Since CORS inception, 3% of the medical staff was associated with a pattern of CORS reports, and 71% of recipients of pattern-related interventions were not named in any subsequent reports in a one-year follow-up period.
CONCLUSIONS - Systematic monitoring of documented co-worker observations about unprofessional conduct and sharing that information with involved professionals are feasible. Feasibility requires organizationwide implementation; co-workers willing and able to share respectful, nonjudgmental, timely feedback designed initially to encourage self-reflection; and leadership committed to be more directive if needed. Follow-up surveillance indicates that the majority of professionals "self-regulate" after receiving CORS data.
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10 MeSH Terms
Safety and Efficacy of 68Ga-DOTATATE PET/CT for Diagnosis, Staging, and Treatment Management of Neuroendocrine Tumors.
Deppen SA, Liu E, Blume JD, Clanton J, Shi C, Jones-Jackson LB, Lakhani V, Baum RP, Berlin J, Smith GT, Graham M, Sandler MP, Delbeke D, Walker RC
(2016) J Nucl Med 57: 708-14
MeSH Terms: Female, Humans, Indium Radioisotopes, Intestinal Neoplasms, Lung Neoplasms, Male, Middle Aged, Neoplasm Staging, Neuroendocrine Tumors, Observer Variation, Organometallic Compounds, Pancreatic Neoplasms, Positron Emission Tomography Computed Tomography, Safety, Somatostatin, Stomach Neoplasms
Show Abstract · Added May 7, 2016
UNLABELLED - Our purpose was to evaluate the safety and efficacy of (68)Ga-DOTATATE PET/CT compared with (111)In-pentetreotide imaging for diagnosis, staging, and restaging of pulmonary and gastroenteropancreatic neuroendocrine tumors.
METHODS - (68)Ga-DOTATATE PET/CT and (111)In-pentetreotide scans were obtained for 78 of 97 consecutively enrolled patients with known or suspected pulmonary or gastroenteropancreatic neuroendocrine tumors. Safety and toxicity were measured by comparing vital signs, serum chemistry values, or acquisition-related medical complications before and after (68)Ga-DOTATATE injection. Added value was determined by changes in treatment plan when (68)Ga-DOTATATE PET/CT results were added to all prior imaging, including (111)In-pentetreotide. Interobserver reproducibility of (68)Ga-DOTATATE PET/CT scan interpretation was measured between blinded and nonblinded interpreters.
RESULTS - (68)Ga-DOTATATE PET/CT and (111)In-pentetreotide scans were significantly different in impact on treatment (P < 0.001). (68)Ga-DOTATATE PET/CT combined with CT or liver MRI changed care in 28 of 78 (36%) patients. Interobserver agreement between blinded and nonblinded interpreters was high. No participant had a trial-related event requiring treatment. Mild, transient events were tachycardia in 1, alanine transaminase elevation in 1, and hyperglycemia in 2 participants. No clinically significant arrhythmias occurred. (68)Ga-DOTATATE PET/CT correctly identified 3 patients for peptide-receptor radiotherapy incorrectly classified by (111)In-pentetreotide.
CONCLUSION - (68)Ga-DOTATATE PET/CT was equivalent or superior to (111)In-pentetreotide imaging in all 78 patients. No adverse events requiring treatment were observed. (68)Ga-DOTATATE PET/CT changed treatment in 36% of participants. Given the lack of significant toxicity, lower radiation exposure, and improved accuracy compared with (111)In-pentetreotide, (68)Ga-DOTATATE imaging should be used instead of (111)In-pentetreotide imaging where available.
© 2016 by the Society of Nuclear Medicine and Molecular Imaging, Inc.
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16 MeSH Terms
'Speaking up' about patient safety concerns and unprofessional behaviour among residents: validation of two scales.
Martinez W, Etchegaray JM, Thomas EJ, Hickson GB, Lehmann LS, Schleyer AM, Best JA, Shelburne JT, May NB, Bell SK
(2015) BMJ Qual Saf 24: 671-80
MeSH Terms: Academic Medical Centers, Adult, Attitude of Health Personnel, Factor Analysis, Statistical, Female, Humans, Internship and Residency, Male, Organizational Culture, Patient Safety, Physicians, Professional Misconduct, Psychometrics, Reproducibility of Results, Surveys and Questionnaires, United States
Show Abstract · Added May 13, 2016
OBJECTIVE - To develop and test the psychometric properties of two new survey scales aiming to measure the extent to which the clinical environment supports speaking up about (a) patient safety concerns and (b) unprofessional behaviour.
METHOD - Residents from six large US academic medical centres completed an anonymous, electronic survey containing questions regarding safety culture and speaking up about safety and professionalism concerns.
RESULTS - Confirmatory factor analysis supported two separate, one-factor speaking up climates (SUCs) among residents; one focused on patient safety concerns (SUC-Safe scale) and the other focused on unprofessional behaviour (SUC-Prof scale). Both scales had good internal consistency (Cronbach's α>0.70) and were unique from validated safety and teamwork climate measures (r<0.85 for all correlations), a measure of discriminant validity. The SUC-Safe and SUC-Prof scales were associated with participants' self-reported speaking up behaviour about safety and professionalism concerns (r=0.21, p<0.001 and r=0.22, p<0.001, respectively), a measure of concurrent validity, while teamwork and safety climate scales were not.
CONCLUSIONS - We created and provided evidence for the reliability and validity of two measures (SUC-Safe and SUC-Prof scales) associated with self-reported speaking up behaviour among residents. These two scales may fill an existing gap in residency and safety culture assessments by measuring the openness of communication about safety and professionalism concerns, two important aspects of safety culture that are under-represented in existing metrics.
Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
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16 MeSH Terms