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Advancing the Science in Gastric Pre-Neoplasia: Study Design Considerations.
Davitkov P, Altayar O, Shah SC, Gawron AJ, Mustafa RA, Sultan S, Morgan DR
(2020) Gastroenterology 158: 751-759
MeSH Terms: Biomedical Research, Biopsy, Endoscopy, Gastrointestinal, Gastric Mucosa, Humans, Incidence, Metaplasia, Population Surveillance, Precancerous Conditions, Prevalence, Research Design, Risk Factors, Stomach Neoplasms
Added March 3, 2020
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13 MeSH Terms
Unmet need in rheumatology: reports from the Targeted Therapies meeting 2019.
Winthrop KL, Weinblatt ME, Bathon J, Burmester GR, Mease PJ, Crofford L, Bykerk V, Dougados M, Rosenbaum JT, Mariette X, Sieper J, Melchers F, Cronstein BN, Breedveld FC, Kalden J, Smolen JS, Furst D
(2020) Ann Rheum Dis 79: 88-93
MeSH Terms: Arthritis, Psoriatic, Arthritis, Rheumatoid, Biomedical Research, Central Nervous System Sensitization, Clinical Trials as Topic, Congresses as Topic, Humans, Lupus Erythematosus, Systemic, Molecular Targeted Therapy, Needs Assessment, Research, Research Design, Rheumatic Diseases, Rheumatology, Spondylitis, Ankylosing
Show Abstract · Added March 25, 2020
OBJECTIVES - To detail the greatest areas of unmet scientific and clinical needs in rheumatology.
METHODS - The 21st annual international Advances in Targeted Therapies meeting brought together more than 100 leading basic scientists and clinical researchers in rheumatology, immunology, epidemiology, molecular biology and other specialties. During the meeting, breakout sessions were convened, consisting of 5 disease-specific groups with 20-30 experts assigned to each group based on expertise. Specific groups included: rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, systemic lupus erythematosus and other systemic autoimmune rheumatic diseases. In each group, experts were asked to identify unmet clinical and translational research needs in general and then to prioritise and detail the most important specific needs within each disease area.
RESULTS - Overarching themes across all disease states included the need to innovate clinical trial design with emphasis on studying patients with refractory disease, the development of trials that take into account disease endotypes and patients with overlapping inflammatory diseases, the need to better understand the prevalence and incidence of inflammatory diseases in developing regions of the world and ultimately to develop therapies that can cure inflammatory autoimmune diseases.
CONCLUSIONS - Unmet needs for new therapies and trial designs, particularly for those with treatment refractory disease, remain a top priority in rheumatology.
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
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15 MeSH Terms
Assessing cardiac safety in oncology drug development.
Seltzer JH, Gintant G, Amiri-Kordestani L, Singer J, Koplowitz LP, Moslehi JJ, Barac A, Yu AF
(2019) Am Heart J 214: 125-133
MeSH Terms: Antineoplastic Agents, Antineoplastic Agents, Immunological, Biomarkers, Cardiologists, Cardiovascular Diseases, Cell Line, Tumor, Clinical Trials as Topic, Data Collection, Drug Development, Drug Screening Assays, Antitumor, Heart, Humans, Immunotherapy, Medical Oncology, Research Design, Trastuzumab
Added November 12, 2019
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16 MeSH Terms
A Coordinated Attack: Rett Syndrome Therapeutic Development.
Gogliotti RG, Niswender CM
(2019) Trends Pharmacol Sci 40: 233-236
MeSH Terms: Animals, Drug Discovery, Drug Evaluation, Preclinical, Drug Repositioning, Female, Humans, Methyl-CpG-Binding Protein 2, Mutation, Research Design, Rett Syndrome
Show Abstract · Added March 3, 2020
Rett syndrome (RTT) is a neurodevelopmental disorder caused by mutations in the Methyl CpG binding protein 2 (MeCP2) gene. This Science & Society article focuses on pharmacological strategies that attack RTT treatment from multiple angles, including drug repurposing and de novo discovery efforts, and discusses the impacts of preclinical study design and translationally relevant outcome measures.
Copyright © 2019 Elsevier Ltd. All rights reserved.
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MeSH Terms
A Hierarchical Taxonomy of Psychopathology Can Transform Mental Health Research.
Conway CC, Forbes MK, Forbush KT, Fried EI, Hallquist MN, Kotov R, Mullins-Sweatt SN, Shackman AJ, Skodol AE, South SC, Sunderland M, Waszczuk MA, Zald DH, Afzali MH, Bornovalova MA, Carragher N, Docherty AR, Jonas KG, Krueger RF, Patalay P, Pincus AL, Tackett JL, Reininghaus U, Waldman ID, Wright AGC, Zimmermann J, Bach B, Bagby RM, Chmielewski M, Cicero DC, Clark LA, Dalgleish T, DeYoung CG, Hopwood CJ, Ivanova MY, Latzman RD, Patrick CJ, Ruggero CJ, Samuel DB, Watson D, Eaton NR
(2019) Perspect Psychol Sci 14: 419-436
MeSH Terms: Heuristics, Humans, Mental Disorders, Models, Theoretical, Research Design, Terminology as Topic
Show Abstract · Added April 15, 2019
For more than a century, research on psychopathology has focused on categorical diagnoses. Although this work has produced major discoveries, growing evidence points to the superiority of a dimensional approach to the science of mental illness. Here we outline one such dimensional system-the Hierarchical Taxonomy of Psychopathology (HiTOP)-that is based on empirical patterns of co-occurrence among psychological symptoms. We highlight key ways in which this framework can advance mental-health research, and we provide some heuristics for using HiTOP to test theories of psychopathology. We then review emerging evidence that supports the value of a hierarchical, dimensional model of mental illness across diverse research areas in psychological science. These new data suggest that the HiTOP system has the potential to accelerate and improve research on mental-health problems as well as efforts to more effectively assess, prevent, and treat mental illness.
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6 MeSH Terms
Minimal clinically important differences for measures of treatment efficacy in Stevens-Johnson syndrome and toxic epidermal necrolysis.
Kim WB, Worley B, Holmes J, Phillips EJ, Beecker J
(2018) J Am Acad Dermatol 79: 1150-1152
MeSH Terms: Clinical Trials as Topic, Dermatologists, Disease Progression, Humans, Length of Stay, Minimal Clinically Important Difference, Professional Practice, Re-Epithelialization, Research Design, Stevens-Johnson Syndrome, Surgeons, Surveys and Questionnaires, Survival Rate, Treatment Outcome
Added March 30, 2020
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Treatment options in idiopathic subglottic stenosis: protocol for a prospective international multicentre pragmatic trial.
Gelbard A, Shyr Y, Berry L, Hillel AT, Ekbom DC, Edell ES, Kasperbauer JL, Lott DG, Donovan DT, Garrett CG, Sandhu G, Daniero JJ, Netterville JL, Schindler JS, Smith ME, Bryson PC, Lorenz RR, Francis DO
(2018) BMJ Open 8: e022243
MeSH Terms: Adolescent, Adult, Constriction, Pathologic, Female, Humans, Laryngostenosis, Larynx, Multicenter Studies as Topic, Pragmatic Clinical Trials as Topic, Prospective Studies, Quality of Life, Research Design, Treatment Outcome
Show Abstract · Added July 30, 2020
INTRODUCTION - Idiopathic subglottic stenosis (iSGS) is an unexplained progressive obstruction of the upper airway that occurs almost exclusively in adult, Caucasian women. The disease is characterised by mucosal inflammation and localised fibrosis resulting in life-threatening blockage of the upper airway. Because of high recurrence rates, patients with iSGS will frequently require multiple procedures following their initial diagnosis. Both the disease and its therapies profoundly affect patients' ability to breathe, communicate and swallow. A variety of treatments have been advanced to manage this condition. However, comparative data on effectiveness and side effects of the unique approaches have never been systematically evaluated. This study will create an international, multi-institutional prospective cohort of patients with iSGS. It will compare three surgical approaches to determine how well the most commonly used treatments in iSGS 'work' and what quality of life (QOL) trade-offs are associated with each approach.
METHODS AND ANALYSIS - A prospective pragmatic trial comparing the 'Standard of Care' for iSGS at multiple international institutions. Patients with a diagnosis of iSGS without clinical or laboratory evidence of vasculitis or a history of endotracheal intubation 2 years prior to symptom onset will be included in the study. Prospective evaluation of disease recurrence requiring operative intervention, validated patient-reported outcome (PRO) measures as well as patient-generated health data (mobile peak flow recordings and daily steps taken) will be longitudinally tracked for 36 months. The primary endpoint is treatment effectiveness defined as time to recurrent operative procedure. Secondary endpoints relate to treatment side effects and include PRO measures in voice, swallowing, breathing and global QOL as well as patient-generated health data.
ETHICS AND DISSEMINATION - This protocol was approved by the local IRB Committee of the Vanderbilt University Medical Center in July 2015. The findings of the trial will be disseminated through peer-reviewed journals, national and international conference presentations and directly to patient with iSGS via social media-based support groups.
TRIAL REGISTRATION NUMBER - NCT02481817.
© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
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Randomised controlled pragmatic clinical trial evaluating the effectiveness of a discharge follow-up phone call on 30-day hospital readmissions: balancing pragmatic and explanatory design considerations.
Yiadom MYAB, Domenico H, Byrne D, Hasselblad MM, Gatto CL, Kripalani S, Choma N, Tucker S, Wang L, Bhatia MC, Morrison J, Harrell FE, Hartert T, Bernard G
(2018) BMJ Open 8: e019600
MeSH Terms: Adult, Aftercare, Communication, Emergency Service, Hospital, Female, Hospitalization, Humans, Male, Mortality, Patient Discharge, Patient Readmission, Patient Satisfaction, Research Design, Telemedicine, Telephone, Transitional Care
Show Abstract · Added March 14, 2018
INTRODUCTION - Hospital readmissions within 30 days are a healthcare quality problem associated with increased costs and poor health outcomes. Identifying interventions to improve patients' successful transition from inpatient to outpatient care is a continued challenge.
METHODS AND ANALYSIS - This is a single-centre pragmatic randomised and controlled clinical trial examining the effectiveness of a discharge follow-up phone call to reduce 30-day inpatient readmissions. Our primary endpoint is inpatient readmission within 30 days of hospital discharge censored for death analysed with an intention-to-treat approach. Secondary endpoints included observation status readmission within 30 days, time to readmission, all-cause emergency department revisits within 30 days, patient satisfaction (measured as mean Hospital Consumer Assessment of Healthcare Providers and Systems scores) and 30-day mortality. Exploratory endpoints include the need for assistance with discharge plan implementation among those randomised to the intervention arm and reached by the study nurse, and the number of call attempts to achieve successful intervention delivery. Consistent with the Learning Healthcare System model for clinical research, timeliness is a critical quality for studies to most effectively inform hospital clinical practice. We are challenged to apply pragmatic design elements in order to maintain a high-quality practicable study providing timely results. This type of prospective pragmatic trial empowers the advancement of hospital-wide evidence-based practice directly affecting patients.
ETHICS AND DISSEMINATION - Study results will inform the structure, objective and function of future iterations of the hospital's discharge follow-up phone call programme and be submitted for publication in the literature.
TRIAL REGISTRATION NUMBER - NCT03050918; Pre-results.
© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
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16 MeSH Terms
Memory decline from hippocampal electrodes? Let's not forget statistics and study design.
Englot DJ, Rolston JD
(2018) Epilepsia 59: 502-503
MeSH Terms: Electrodes, Hippocampus, Memory, Research Design, Temporal Lobe
Added September 25, 2018
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5 MeSH Terms
Mind the Hype: A Critical Evaluation and Prescriptive Agenda for Research on Mindfulness and Meditation.
Van Dam NT, van Vugt MK, Vago DR, Schmalzl L, Saron CD, Olendzki A, Meissner T, Lazar SW, Kerr CE, Gorchov J, Fox KCR, Field BA, Britton WB, Brefczynski-Lewis JA, Meyer DE
(2018) Perspect Psychol Sci 13: 36-61
MeSH Terms: Brain, Humans, Meditation, Mindfulness, Research Design, Semantics
Show Abstract · Added January 4, 2020
During the past two decades, mindfulness meditation has gone from being a fringe topic of scientific investigation to being an occasional replacement for psychotherapy, tool of corporate well-being, widely implemented educational practice, and "key to building more resilient soldiers." Yet the mindfulness movement and empirical evidence supporting it have not gone without criticism. Misinformation and poor methodology associated with past studies of mindfulness may lead public consumers to be harmed, misled, and disappointed. Addressing such concerns, the present article discusses the difficulties of defining mindfulness, delineates the proper scope of research into mindfulness practices, and explicates crucial methodological issues for interpreting results from investigations of mindfulness. For doing so, the authors draw on their diverse areas of expertise to review the present state of mindfulness research, comprehensively summarizing what we do and do not know, while providing a prescriptive agenda for contemplative science, with a particular focus on assessment, mindfulness training, possible adverse effects, and intersection with brain imaging. Our goals are to inform interested scientists, the news media, and the public, to minimize harm, curb poor research practices, and staunch the flow of misinformation about the benefits, costs, and future prospects of mindfulness meditation.
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