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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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1 Members
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16 MeSH Terms
Defining Early Recurrence of Hilar Cholangiocarcinoma After Curative-intent Surgery: A Multi-institutional Study from the US Extrahepatic Biliary Malignancy Consortium.
Zhang XF, Beal EW, Chakedis J, Chen Q, Lv Y, Ethun CG, Salem A, Weber SM, Tran T, Poultsides G, Son AY, Hatzaras I, Jin L, Fields RC, Buettner S, Scoggins C, Martin RCG, Isom CA, Idrees K, Mogal HD, Shen P, Maithel SK, Schmidt CR, Pawlik TM
(2018) World J Surg 42: 2919-2929
MeSH Terms: Adult, Aged, Bile Duct Neoplasms, Biliary Tract Neoplasms, Cholangiocarcinoma, Data Collection, Female, Humans, Klatskin Tumor, Lymphatic Metastasis, Male, Middle Aged, Multivariate Analysis, Neoplasm Recurrence, Local, Prognosis, Risk Factors, Time Factors, Treatment Outcome, United States
Show Abstract · Added April 10, 2018
BACKGROUND - Time to tumor recurrence may be associated with outcomes following resection of hepatobiliary cancers. The objective of the current study was to investigate risk factors and prognosis among patients with early versus late recurrence of hilar cholangiocarcinoma (HCCA) after curative-intent resection.
METHODS - A total of 225 patients who underwent curative-intent resection for HCCA were identified from 10 academic centers in the USA. Data on clinicopathologic characteristics, pre-, intra-, and postoperative details and overall survival (OS) were analyzed. The slope of the curves identified by linear regression was used to categorize recurrences as early versus late.
RESULTS - With a median follow-up of 18.0 months, 99 (44.0%) patients experienced a tumor recurrence. According to the slope of the curves identified by linear regression, the functions of the two straight lines were y = -0.465x + 16.99 and y = -0.12x + 7.16. The intercept value of the two lines was 28.5 months, and therefore, 30 months (2.5 years) was defined as the cutoff to differentiate early from late recurrence. Among 99 patients who experienced recurrence, the majority (n = 80, 80.8%) occurred within the first 2.5 years (early recurrence), while 19.2% of recurrences occurred beyond 2.5 years (late recurrence). Early recurrence was more likely present as distant disease (75.1% vs. 31.6%, p = 0.001) and was associated with a worse OS (Median OS, early 21.5 vs. late 50.4 months, p < 0.001). On multivariable analysis, poor tumor differentiation (HR 10.3, p = 0.021), microvascular invasion (HR 3.3, p = 0.037), perineural invasion (HR 3.9, p = 0.029), lymph node metastases (HR 5.0, p = 0.004), and microscopic positive margin (HR 3.5, p = 0.046) were independent risk factors associated with early recurrence.
CONCLUSIONS - Early recurrence of HCCA after curative resection was common (~35.6%). Early recurrence was strongly associated with aggressive tumor characteristics, increased risk of distant metastatic recurrence and a worse long-term survival.
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19 MeSH Terms
Validation of maternal recall of early pregnancy medication exposure using prospective diary data.
Sundermann AC, Hartmann KE, Jones SH, Torstenson ES, Velez Edwards DR
(2017) Ann Epidemiol 27: 135-139.e2
MeSH Terms: Adolescent, Adult, Anti-Inflammatory Agents, Non-Steroidal, Data Collection, Female, Humans, Interviews as Topic, Maternal Exposure, Mental Recall, Middle Aged, Nonprescription Drugs, North Carolina, Pregnancy, Pregnancy Complications, Pregnancy Trimester, First, Prescription Drugs, Prospective Studies, Sensitivity and Specificity, Tennessee, Texas, Young Adult
Show Abstract · Added February 21, 2019
PURPOSE - Data about maternal recall accuracy for classifying early pregnancy medication exposure are meager. Nonetheless, studies often rely on recall to evaluate potential impact of pharmaceuticals on the developing fetus.
METHODS - Right from the Start is a community-based pregnancy cohort that enrolled women from North Carolina, Tennessee, and Texas. A subset of 318 women participated in daily medication diaries initiated before conception (2006-2012). We examined nonsteroidal anti-inflammatory drugs (NSAIDs) as an example of a drug type that is difficult to study due to its intermittent and primarily over-the-counter use as well as its incomplete documentation in medical and pharmaceutical records. Selective serotonin reuptake inhibitors (SSRI) were assessed as a prescription medication comparator. Maternal recall of NSAID and SSRI use in early pregnancy was examined by comparing diary data (gold standard) to first-trimester interview.
RESULTS - Sensitivity and specificity for recall of NSAID exposure were 78.6% and 62.3%, respectively (kappa statistic: 0.41), with 72.3% agreement for exposure classification. Sensitivity and specificity for recall of SSRI exposure were 77.8% and 99.0%, respectively (kappa statistic: 0.79), with 97.8% agreement.
CONCLUSIONS - Our findings suggest the validity of maternal recall varies with medication type and prospective data collection should be prioritized when studying early pregnancy drug exposures.
Copyright © 2016 Elsevier Inc. All rights reserved.
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Rationale and Design of the Registry for Stones of the Kidney and Ureter (ReSKU): A Prospective Observational Registry to Study the Natural History of Urolithiasis Patients.
Chang HC, Tzou DT, Usawachintachit M, Duty BD, Hsi RS, Harper JD, Sorensen MD, Stoller ML, Sur RL, Chi T
(2016) J Endourol 30: 1332-1338
MeSH Terms: Automation, Biomedical Research, Canada, China, Data Collection, Databases, Factual, Female, Humans, International Cooperation, Japan, Kidney, Kidney Calculi, Male, Middle Aged, Outcome Assessment, Health Care, Prospective Studies, Registries, United States, Ureter, Ureteral Calculi, Ureterolithiasis, Urolithiasis
Show Abstract · Added January 16, 2018
OBJECTIVES - Registry-based clinical research in nephrolithiasis is critical to advancing quality in urinary stone disease management and ultimately reducing stone recurrence. A need exists to develop Health Insurance Portability and Accountability Act (HIPAA)-compliant registries that comprise integrated electronic health record (EHR) data using prospectively defined variables. An EHR-based standardized patient database-the Registry for Stones of the Kidney and Ureter (ReSKU™)-was developed, and herein we describe our implementation outcomes.
MATERIALS AND METHODS - Interviews with academic and community endourologists in the United States, Canada, China, and Japan identified demographic, intraoperative, and perioperative variables to populate our registry. Variables were incorporated into a HIPAA-compliant Research Electronic Data Capture database linked to text prompts and registration data within the Epic EHR platform. Specific data collection instruments supporting New patient, Surgery, Postoperative, and Follow-up clinical encounters were created within Epic to facilitate automated data extraction into ReSKU.
RESULTS - The number of variables within each instrument includes the following: New patient-60, Surgery-80, Postoperative-64, and Follow-up-64. With manual data entry, the mean times to complete each of the clinic-based instruments were (minutes) as follows: New patient-12.06 ± 2.30, Postoperative-7.18 ± 1.02, and Follow-up-8.10 ± 0.58. These times were significantly reduced with the use of ReSKU structured clinic note templates to the following: New patient-4.09 ± 1.73, Postoperative-1.41 ± 0.41, and Follow-up-0.79 ± 0.38. With automated data extraction from Epic, manual entry is obviated.
CONCLUSIONS - ReSKU is a longitudinal prospective nephrolithiasis registry that integrates EHR data, lowering the barriers to performing high quality clinical research and quality outcome assessments in urinary stone disease.
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22 MeSH Terms
Merging Electronic Health Record Data and Genomics for Cardiovascular Research: A Science Advisory From the American Heart Association.
Hall JL, Ryan JJ, Bray BE, Brown C, Lanfear D, Newby LK, Relling MV, Risch NJ, Roden DM, Shaw SY, Tcheng JE, Tenenbaum J, Wang TN, Weintraub WS, American Heart Association Professional and Public Education and Publications Committee of the Council on Functional Genomics and Translational Biology, Council on Clinical Cardiology, Council on Epidemiology and Prevention, Council on Quality of Care and Outcomes Research, and Stroke Council
(2016) Circ Cardiovasc Genet 9: 193-202
MeSH Terms: Biomedical Research, Cardiovascular Diseases, Data Collection, Electronic Health Records, Genomics, Humans, Informed Consent, Patient Care, Societies, Medical
Show Abstract · Added March 24, 2020
The process of scientific discovery is rapidly evolving. The funding climate has influenced a favorable shift in scientific discovery toward the use of existing resources such as the electronic health record. The electronic health record enables long-term outlooks on human health and disease, in conjunction with multidimensional phenotypes that include laboratory data, images, vital signs, and other clinical information. Initial work has confirmed the utility of the electronic health record for understanding mechanisms and patterns of variability in disease susceptibility, disease evolution, and drug responses. The addition of biobanks and genomic data to the information contained in the electronic health record has been demonstrated. The purpose of this statement is to discuss the current challenges in and the potential for merging electronic health record data and genomics for cardiovascular research.
© 2016 American Heart Association, Inc.
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A Scalable Framework to Detect Personal Health Mentions on Twitter.
Yin Z, Fabbri D, Rosenbloom ST, Malin B
(2015) J Med Internet Res 17: e138
MeSH Terms: Data Collection, Disclosure, Health Status, Humans, Internet, Self Disclosure, Social Media
Show Abstract · Added January 26, 2016
BACKGROUND - Biomedical research has traditionally been conducted via surveys and the analysis of medical records. However, these resources are limited in their content, such that non-traditional domains (eg, online forums and social media) have an opportunity to supplement the view of an individual's health.
OBJECTIVE - The objective of this study was to develop a scalable framework to detect personal health status mentions on Twitter and assess the extent to which such information is disclosed.
METHODS - We collected more than 250 million tweets via the Twitter streaming API over a 2-month period in 2014. The corpus was filtered down to approximately 250,000 tweets, stratified across 34 high-impact health issues, based on guidance from the Medical Expenditure Panel Survey. We created a labeled corpus of several thousand tweets via a survey, administered over Amazon Mechanical Turk, that documents when terms correspond to mentions of personal health issues or an alternative (eg, a metaphor). We engineered a scalable classifier for personal health mentions via feature selection and assessed its potential over the health issues. We further investigated the utility of the tweets by determining the extent to which Twitter users disclose personal health status.
RESULTS - Our investigation yielded several notable findings. First, we find that tweets from a small subset of the health issues can train a scalable classifier to detect health mentions. Specifically, training on 2000 tweets from four health issues (cancer, depression, hypertension, and leukemia) yielded a classifier with precision of 0.77 on all 34 health issues. Second, Twitter users disclosed personal health status for all health issues. Notably, personal health status was disclosed over 50% of the time for 11 out of 34 (33%) investigated health issues. Third, the disclosure rate was dependent on the health issue in a statistically significant manner (P<.001). For instance, more than 80% of the tweets about migraines (83/100) and allergies (85/100) communicated personal health status, while only around 10% of the tweets about obesity (13/100) and heart attack (12/100) did so. Fourth, the likelihood that people disclose their own versus other people's health status was dependent on health issue in a statistically significant manner as well (P<.001). For example, 69% (69/100) of the insomnia tweets disclosed the author's status, while only 1% (1/100) disclosed another person's status. By contrast, 1% (1/100) of the Down syndrome tweets disclosed the author's status, while 21% (21/100) disclosed another person's status.
CONCLUSIONS - It is possible to automatically detect personal health status mentions on Twitter in a scalable manner. These mentions correspond to the health issues of the Twitter users themselves, but also other individuals. Though this study did not investigate the veracity of such statements, we anticipate such information may be useful in supplementing traditional health-related sources for research purposes.
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7 MeSH Terms
Assessing data intrusion threats.
Barth-Jones D, El Emam K, Bambauer J, Cavoukian A, Malin B
(2015) Science 348: 194-5
MeSH Terms: Commerce, Data Collection, Female, Humans, Information Dissemination, Male, Privacy
Added April 10, 2018
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MeSH Terms
Anonymising and sharing individual patient data.
El Emam K, Rodgers S, Malin B
(2015) BMJ 350: h1139
MeSH Terms: Biomedical Research, Canada, Confidentiality, Data Collection, European Union, Humans, Information Dissemination, Medical Records, United States
Added April 10, 2018
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MeSH Terms
Prevalence and characteristics of medication sharing behavior in a pediatric Medicaid population with asthma.
Valet RS, Gebretsadik T, Minton PA, Woodward KB, Wu AC, Hartert TV, Larkin EK
(2015) Ann Allergy Asthma Immunol 114: 151-3
MeSH Terms: Anti-Asthmatic Agents, Asthma, Child, Child, Preschool, Data Collection, Female, Humans, Male, Medicaid, Prescription Drug Misuse, Prevalence, United States
Added January 20, 2015
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12 MeSH Terms
Sources of health information among rural women in Western Kentucky.
Simmons LA, Wu Q, Yang N, Bush HM, Crofford LJ
(2015) Public Health Nurs 32: 3-14
MeSH Terms: Adult, Aged, Confidentiality, Consumer Health Information, Data Collection, Depression, Female, Humans, Information Seeking Behavior, Internet, Kentucky, Middle Aged, Professional-Patient Relations, Public Health Nursing, Rural Population, Stereotyping
Show Abstract · Added January 21, 2015
OBJECTIVE - To identify sources of general and mental health information for rural women to inform the development of public health nursing interventions that consider preferences for obtaining information.
DESIGN AND SAMPLE - One thousand women (mean age = 57 years; 96.9% White) living in primarily nonmetropolitan areas of Western Kentucky participated via a random-digit-dial survey.
MEASURES - Data were collected on demographics, sources of health information, depression, and stigma.
RESULTS - Most participants preferred anonymous versus interpersonal sources for both general (68.1%) and mental health (69.4%) information. All participants reported at least one source of general health information, but 20.8% indicated not seeking or not knowing where to seek mental health information. The Internet was the most preferred anonymous source. Few women cited health professionals as the primary information source for general (11.4%) or mental (9.9%) health. Public stigma was associated with preferring anonymous sources and not seeking information.
CONCLUSIONS - Public health nurses should understand the high utilization of anonymous sources, particularly for mental health information, and focus efforts on helping individuals to navigate resources to ensure they obtain accurate information about symptoms, effective treatments, and obtaining care. Reducing stigma should remain a central focus of prevention and education in rural areas.
© 2014 Wiley Periodicals, Inc.
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16 MeSH Terms