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Sleep Duration and Diet Quality Among Women Within 5 Years of Childbirth in the United States: A Cross-Sectional Study

Wed, 06/08/2016 - 2:59pm

Objective: Only 9 % of women with young children consume a high quality diet. The association between sleep duration and health may be U-shaped. We examined diet quality in relation to sleep duration among US women within 5 years of childbirth.

Methods: Data were from non-pregnant women aged 20-44 years within 5 years of childbirth who completed two 24-h dietary recalls (N = 896) in the National Health and Nutrition Examination Survey 2005-2012. Self-reported weekday/workday sleep duration was categorized as short ( < /=6 h), adequate (7-8 h), or long ( > /=9 h). The Healthy Eating Index (HEI-2010, range 0-100) estimated overall and components of diet quality. Multivariable-adjusted linear regression models estimated the association between sleep duration and diet quality, adjusting for age, race/ethnicity, and education.

Results: Thirty-four percent of women reported short, 57.1 % adequate, and 8.6 % long sleep duration. The average diet quality total score was 47.4 out of 100. Short sleep duration was not associated with diet quality. Long sleep duration was associated with lower quality diet (beta = -4.3; 95 % CI -8.1 to -0.4), lower consumption of total fruit (beta = -0.7; 95 % CI -1.3 to -0.1), whole fruit (beta = -0.9; 95 % CI -1.6 to -0.2), and total protein (beta = -0.7; 95 % CI -1.3 to -0.03), and higher consumption of empty calories (beta = 2.2; 95 % CI -4.3 to -0.1).

Conclusions: for practice Future studies should examine the longitudinal association between sleep duration and diet quality among women following childbirth and whether interventions to improve sleep can enhance diet quality.

The presence of physician champions improved Kangaroo mother care in rural western India

Wed, 06/08/2016 - 2:58pm

AIM: This study determined the effect of physician champions on the two main components of Kangaroo mother care (KMC): skin-to-skin care and breastfeeding.

METHODS: KMC practices among a retrospective cohort of 648 infants admitted to a rural Indian neonatal intensive care unit (NICU) between 5 January 2011 and 7 October 2014 were studied. KMC champions were identified based on their performance evaluation. We examined the effect of withdrawing physician champions on overall use, time to initiation and intensity of skin-to-skin care and breastfeeding, using separate models.

RESULTS: In comparison to when KMC champions were present, their absence was associated with a 45% decrease in the odds of receiving skin-to-skin care, with a 95% Confidence Interval (CI) of 64% to 17%, a 38% decrease in the rate of initiation skin-to-skin care (95% CI 53% to 82%) and an average of 1.47 less hours of skin-to-skin care (95% CI -2.07 to -0.86). Breastfeeding practices were similar across the different champion environments.

CONCLUSION: Withdrawing physician champions from the NICU setting was associated with a decline in skin-to-skin care, but not breastfeeding. Training healthcare workers and community stakeholders to become champions could help to scale up and maintain KMC practices.

eScience Symposium Reflections from Christopher Erdmann: Redefining the Librarian’s Role in eScience

Wed, 06/08/2016 - 2:18pm

Christopher Erdmann, Head Librarian, Wolbach Library, Harvard Smithsonian Center for Astrophysics, shares his multiple experiences at the University of Massachusetts and New England Area Librarian eScience Symposium, as well as current challenges he sees for data science librarians. Christopher presented on a panel at the Eighth Annual eScience Symposium discussing the “future of data science” from a librarian’s perspective. See the video of this panel presentation on the 2016 eScience Symposium website.

A transcript of this interview is available for download via the Download button above.

eScience Symposium Reflections from Jian Qin: Finding Inspiration for Librarians in Data Science

Wed, 06/08/2016 - 2:18pm

Jian Qin, Professor, School of Information Studies, Syracuse University shares her multiple experiences at the University of Massachusetts and New England Area Librarian eScience Symposium, as well as her current efforts in library science and data science education. Jian presented on a panel at the Eighth Annual eScience Symposium discussing the “future of data science” from an educator’s perspective. See the video of this panel presentation on the 2016 eScience Symposium website.

A transcript of this interview is available for download via the Download button above.

Thinking Like A Scientist ... And An Engineer: Training future leaders and innovators in health care systems and delivery

Tue, 06/07/2016 - 3:25pm

Health care is increasingly becoming more complex with the advancement of accountable organizations, expansion of hospital systems, and major insurance and government reforms. As leaders of care teams, physicians are often expected to have a hybrid set of skills extending beyond clinical expertise. Examples of leadership knowledge and skill sets include organizational thinking, health quality improvement, health policy, financial literacy, health innovation, and many more. The number of MD/MBA programs has risen significantly since the 1990s and more recently, leadership pipelines for both medical residents and students have also emerged. These trends support a rising demand for well-rounded physician leaders. This project sets out to answer two questions: will a health care leadership program add value to undergraduate medical training for University of Massachusetts medical students? If so, what would such a leadership program look like?

We used the Lean management framework and “A3” Plan Do Study Analyze cycle (PDSA) to identify the challenges and appropriateness of developing a leadership program, and then to highlight ideas for promoting leadership. Key components of the framework include a root cause analysis and development of counter measures. As a platform for analysis, we examined the experiences of the “Quality Improvement Health Care Elective,” a student led series of lectures on health care process, Lean management, and health care leadership. We tested our counter measures as well as other ideas in a student opinion survey that focused on level of interest in leadership, career aspirations, desired deliverables, and the option of a training certificate.

An estimated 20% of the student population at UMass Medical School completed our survey (n=125). Our study discovered strong interest in the topic of leadership, with 20% of students stating they are very likely to take an elective on leadership, and 54% somewhat likely. Students were especially interested in career aspirations that included management and administration responsibilities, general career exploration, and opportunities for mentorship. These findings can be core features of developing a health care leadership option for medical students at UMass Medical School.

A Review of "Library Analytics and Metrics"

Tue, 06/07/2016 - 8:13am

This is a review of the book, Library Analytics and Metrics, edited by Ben Showers. Published by Facet Publishing, 2015.

Albanian Immigrants' Experience and Attitude toward Health Care in Albania versus the USA

Mon, 06/06/2016 - 9:00am

Purpose: To describe the experiences and attitudes of Albanian immigrants toward health care in Albania versus the United Stated (USA).

Method: A cross-sectional descriptive survey using venue sampling was administered at the Albanian Festival in Worcester on June 5-7, 2015. The data was entered and analyzed using SPSS.

Results: There were a total of 146 subjects eligible for analysis. Most subjects were female (52.7%) and the mean subject age was 41.6 with a range of 18-77 years old. Subjects moved to the USA at a mean age of 28.8 years with a range of 1-66 years old. Subjects have lived in the USA for a mean of 12.9 years, with a range of 3 months to 28 years. Categorical response items comparing health care in Albania versus the USA were statistically significant in favor of the USA health care system regarding comfort seeking care, care worth money, receiving preventative care, and having good communication with the doctor. Subgroup analysis of males vs. females showed a significant finding only on females receiving more preventative care. Continuous response items comparing health care in Albania versus the USA were statistically significant in favor of the USA health care system regarding the patient liking care received and trusting the doctors. Content analysis of the open-ended comments showed positive and negative perceptions of both health care systems.

Conclusions: Our results show that Albanian Immigrants have an overwhelming positive experience and attitude toward the USA health care system in all categories including comfort seeking care, care being worth the money, having good communication with the doctor, trusting the doctors, receiving preventative care, and liking care received. These finding are important because they show that even though Albanian immigrants are exposed to under-funded and corrupt medical care in Albania, the majority does not allow this experience to influence the interaction with USA health care professionals. The findings from this study are applicable to the clinical setting in the USA and some recommendations can be made to USA health care providers about how to best approach Albanian immigrant patients.

Deliberate Practice of IV Medication Procedures by Student Nurses: Feasibility, Acceptability, and Preliminary Outcomes: A Dissertation

Thu, 05/26/2016 - 3:25pm

Background: Medication errors continue to be one of the most prevalent problems in healthcare related to patient safety, often resulting in injury or death, with higher incidences of error occurring with intravenous medications. The purpose of this study was to explore the use of deliberate practice (DP) with second-degree nursing students in developing and maintaining fundamental intravenous medication management practices required for safe practice.

Method: This was a feasibility study using a two-arm, single-blind, randomized controlled trial design. Vygotsky’s Zone of Proximal Development model was used to explore the use of a DP teaching intervention to achieve competency in skills associated with safe IV medication management. A convenience sample of first-year, first-semester nursing students enrolled in an accelerated graduate program (N = 32) were invited to participate; 19 enrolled, and 12 completed the study. Students (n = 12) received three 30- minute one-on-one practice sessions at 2-week intervals with an expert nurse (the intervention group focused on IV skills and the control group on skills unrelated to IVs). Pre- and post-intervention instruments tested participants’ confidence with IV management and safety skills. The primary outcome was their ability to safely administer and monitor IV medications during a 20-minute videotaped medication administration scenario.

Results: Low recruitment (19 of 32) and high attrition (37%) were observed. Participants completing the study (5 in the intervention group and 7 in the control group) reported that the time required to attend the sessions was not burdensome (91.7%); time allotted was adequate (100%); 100% reported positive experience; 91.7% found the DP sessions essential to learning. Change in confidence scores for IV skills were not significant (P = 0.210), but were higher in the intervention group (2.97–4.14 = 1.50 change) compared to the control group (2.71–3.77 = 1.04 change). Significant differences were found in overall medication administration skills between the control and intervention groups (t [-2.302], p = 0.044) in favor of the intervention group, particularly with medication preparation skills (p = 0.039). Overall raw scores were low in both groups; only 16–42 (26%–70%) of the total 60 steps required for safe practice were completed. Participants scored lowest in the evaluation phase, with all participants performing less than 50% of the 14 steps.

Conclusion: Even though participant satisfaction was high, significant attrition occurred. Students reported the DP sessions to be beneficial and they felt more confident in performing skills, but three 30-minute sessions (90 minutes) were not adequate to develop, maintain, or refine all the IV-management skills associated with safe medication practices. Determining the length and duration of DP sessions as well as comparing the efficacy of DP sessions between individual and group sessions with varying doses and frequencies is needed to advance our understanding of using DP within nursing education.

Quality Improvement (QI) in Evaluation: Anatomy of a Fishbone (Diagram)

Thu, 05/26/2016 - 2:38pm

Blog post to AEA365, a blog sponsored by the American Evaluation Association (AEA) dedicated to highlighting Hot Tips, Cool Tricks, Rad Resources, and Lessons Learned for evaluators. The American Evaluation Association is an international professional association of evaluators devoted to the application and exploration of program evaluation, personnel evaluation, technology, and many other forms of evaluation. Evaluation involves assessing the strengths and weaknesses of programs, policies, personnel, products, and organizations to improve their effectiveness.

Evaluating the Full Potential of Your Staff

Thu, 05/26/2016 - 2:38pm

Blog post to AEA365, a blog sponsored by the American Evaluation Association (AEA) dedicated to highlighting Hot Tips, Cool Tricks, Rad Resources, and Lessons Learned for evaluators. The American Evaluation Association is an international professional association of evaluators devoted to the application and exploration of program evaluation, personnel evaluation, technology, and many other forms of evaluation. Evaluation involves assessing the strengths and weaknesses of programs, policies, personnel, products, and organizations to improve their effectiveness.

Post-Project Debriefings as Part of Performance Improvement

Thu, 05/26/2016 - 2:37pm

Blog post to AEA365, a blog sponsored by the American Evaluation Association (AEA) dedicated to highlighting Hot Tips, Cool Tricks, Rad Resources, and Lessons Learned for evaluators. The American Evaluation Association is an international professional association of evaluators devoted to the application and exploration of program evaluation, personnel evaluation, technology, and many other forms of evaluation. Evaluation involves assessing the strengths and weaknesses of programs, policies, personnel, products, and organizations to improve their effectiveness.

Systematic dissection of roles for chromatin regulators in a yeast stress response

Mon, 05/23/2016 - 10:50am

Packaging of eukaryotic genomes into chromatin has wide-ranging effects on gene transcription. Curiously, it is commonly observed that deletion of a global chromatin regulator affects expression of only a limited subset of genes bound to or modified by the regulator in question. However, in many single-gene studies it has become clear that chromatin regulators often do not affect steady-state transcription, but instead are required for normal transcriptional reprogramming by environmental cues. We therefore have systematically investigated the effects of 83 histone mutants, and 119 gene deletion mutants, on induction/repression dynamics of 170 transcripts in response to diamide stress in yeast. Importantly, we find that chromatin regulators play far more pronounced roles during gene induction/repression than they do in steady-state expression. Furthermore, by jointly analyzing the substrates (histone mutants) and enzymes (chromatin modifier deletions) we identify specific interactions between histone modifications and their regulators. Combining these functional results with genome-wide mapping of several histone marks in the same time course, we systematically investigated the correspondence between histone modification occurrence and function. We followed up on one pathway, finding that Set1-dependent H3K4 methylation primarily acts as a gene repressor during multiple stresses, specifically at genes involved in ribosome biosynthesis. Set1-dependent repression of ribosomal genes occurs via distinct pathways for ribosomal protein genes and ribosomal biogenesis genes, which can be separated based on genetic requirements for repression and based on chromatin changes during gene repression. Together, our dynamic studies provide a rich resource for investigating chromatin regulation, and identify a significant role for the "activating" mark H3K4me3 in gene repression.

Translating Comparative TJR Outcomes for Performance Improvement to Guide Surgical Quality Improvement

Fri, 05/20/2016 - 3:30pm

Background/Purpose: With the CMS decision to publicly report hospital-specific post-operative total joint replacement (TJR) complications and readmissions, orthopedic surgeons need new sources of post-operative outcome data to monitor and improve post-hospital care. The AHRQ funded research program, Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR), developed methods to capture longitudinal patient-reported outcomes (PROs) and comprehensive post-TJR medical and surgical events, and established a web reporting system to return comparative outcome reports to participating surgeons and hospitals in order to monitor and improve quality and outcomes.

Methods: This national cohort/registry captures post-TJR measures directly from patients in their homes to assure uniform time, completion, and consistency for data comparisons across hospitals. Quarterly updated web reports deliver hospital- and surgeon-specific TJR outcomes compared with those of their peers and risk-adjusted national benchmarks on PROs as well as on post-operative event rates.

Results: Our national cohort enrolled 25,000 patients from 150 diverse orthopedists in 22 US states with varied hospital and surgeon practices. The secure, HIPAA compliant website was established that presents summary and risk-adjusted comparative statistics for primary TJR for all enrolled patients. The website provides a downloadable and printable report and an Executive Summary of key pre-operative patient risk factors, post-operative events, and post-operative PROs enabling the providers to compare their outcomes to the other participating sites. Individual patient reports are available for surgeons with real-time scores and trended outcome data to facilitate patient and surgeon shared treatment decision making.

Conclusion/Implications: A secure reporting website was established to disseminate comparative outcome reports to all participating hospitals and surgeons. Returning comparative outcome data to hospitals and surgeons encourages their active participation in this national registry and allows them to undstand their relative performance compared to peers while supporting practice-level quality monitoring and improvement efforts in patient care.

Prenylated retinal ciliopathy protein RPGR regulates ciliary localization of Joubert Syndrome-associated protein INPP5E in cooperation with PDE6

Fri, 05/20/2016 - 3:30pm

Ciliary dysfunction is an underlying cause of severe human disorders (collectively called ciliopathies), such as retinitis pigmentosa (RP), Joubert Syndrome (JBTS), and Bardet-Biedl Syndrome. Ciliary proteins form distinct functional networks for localization to cilia as well as regulation of ciliary function. However, not much is known about the mechanism of ciliary localization and function of RPGR (retinitis pigmentosa GTPase regulator), a ciliary protein frequently associated with RP worldwide. Using tandem mass spectrometry analysis, we show that RPGR interacts with two JBTS-associated proteins: PDE6Π (delta subunit of Phosphodiesterase; a prenyl-binding protein) and INPP5E (inositol polyphosphate-5-phosphatase 5E; a ciliary cargo). Whereas PDE6Π binds in a prenylation-dependent manner to the C-terminus of RPGR, INPP5E associates with the N-terminus of RPGR. Prenylation and interaction of RPGR with PDE6Π are critical for its localization to cilia. We further show that loss of RPGR results in reduced amount of INPP5E in cilia of fibroblasts and in photoreceptor outer segment, a modified sensory cilium. Overall, our results suggest that RPGR, in complex with PDE6D, regulates the trafficking of ciliary cargo INPP5E and implicate reduction in ciliary INPP5E in the pathogenesis of RPGR-ciliopathy.

A Non-Restrictive Weight Loss Diet Focused on Increasing Fiber and Lean Protein: Results of a Pilot Trial

Fri, 05/20/2016 - 3:30pm

Objective. The vast majority of diets are not only multicomponent but also restrictive. Dietary fiber or protein can reduce hunger and enhance satiety; they also exert clinical benefits. We examined feasibility and acceptability of a non-restrictive diet combining the two for weight loss.

Population and Methods. Fifteen patients were enrolled in the trial (2 men, 13 women, mean age=48 y and mean BMI = 36 kg/m2) to attend 6 bi-weekly individual counselling sessions for the diet during the 12-week study period. The goals of the intervention were to attain a daily goal of higher fiber (>35g)/ and lean protein (120g). 24-hour diet recalls and body weight were collected at baseline, 6- and 12-week assessments.

Results. All participants completed 6-week assessment, one participant dropped from the study before 12-week assessment. At 12 weeks, 93% of participants liked the diet much/very much, 92% were very/extremely confident in adhering to the diet and 85% did not feel hungry on the diet. Mean fiber intake increased by 9.4 g/day (95% CI: 5.9, 12.8) at 6 weeks, and by 6.9 g/day (CI: 3.3, 10.5) at 12 weeks. Protein intake increased by a mean of 13.7 g/day (CI: 4.8, 22.6) at 6 weeks, and by 6.0 g/day (CI: -3.3, 15.3) at 12 weeks. % of calories from saturated fat decreased by 2.0% (CI: 0.5, 3.4) at 6 weeks and by 2.7% (CI: 0.5, 3.4) at 12 weeks. Alternative Healthy Eating Index score increased by 9.7 (CI: 5.3, 14.0) at 6 weeks and by 6.1 (CI: 1.5, 10.7) at 12 weeks. Mean weight loss was -2.7 lbs (CI: -4.9, 0.6) at 6 weeks and -4.7 lbs (CI: -8.0, -1.4) at 12 weeks.

Conclusion. Participants liked the diet prescribed, and significantly increased their fiber and lean protein intake, resulting in significant weight loss with improvement to dietary quality.

Optimization of the Design of an Amphiphilic Biodegradable Polymer for Tissue-engineering Application

Fri, 05/20/2016 - 3:30pm

Biodegradable polymers have been widely utilized as drug delivery vehicles and tissue engineering scaffolds. We previously designed amphiphilic triblock copolymer poly(lactic acid)-b-poly(ethylene glycol)-b-poly(lactic acid) (PELA) and its hydroxyapatite (HA) composites for bone tissue engineering applications. The hydrophilic electrospun PELA-HA composite exhibited aqueous stability and elastic handling characteristics, and was able to template the proliferation and osteogenesis of bone marrow stromal cells (BMSCs) in vitro and in vivo when spiral-wrapped into cylinders and press-fit into critical size femoral segmental defects in rats. However, the slow degradation of PELA has prevented timely disappearance of the scaffold and impeded more effective restoration of biomechanical integrity of the defect. To accelerate degradation, in this work we designed poly(lactic/glycolic acid)-b-poly(ethylene glycol)-b-poly(lactic/glycolic acid) (PELGA) with varying ratios of glycolide and lactide and confirmed their more accelerated degradations as compared to PELA. Processing conditions (e.g. solvent-casting vs. electrospinning, with or without hydration) significantly impacted the structural characteristics of PELGA and their HA composites. The PEG crystallization in PELGA was not as strong as in PEG homopolymers, giving rise to a lower Tm. HA could be well dispersed in PELGA and electrospun to give a uniform composite where the crystallization of PEG was promoted by water resulting in enhanced mechanical strength upon hydration. These HA-contained electrospun meshes exhibited excellent cytocompatibility and efficacy in templating osteogenesis of rat BMSCs in vitro.

Structural Activity Relationship Study on Dual PLK1 /BRD4 Inhibitor, BI- 2536

Fri, 05/20/2016 - 3:30pm

Polo-like kinase 1 (PLK1) and BRD4 are two different therapeutic targets in cancer drug discovery. Recently it has been reported that PLK1 inhibitor, BI-2536, is also a potent inhibitor of BRD4. The simultaneous inhibition of PLK1 and BRD4 by a single drug molecule is interesting because this could lead to the development of effective therapeutic strategy for different types of disease conditions in which PLK1 and BRD4 are implicated. Structural activity relationship studies has been carried out on BI-2536 to generate analogs with enhanced dual inhibitory activity against BRD4 and PLK1 as well as to render the molecule selective to one target over the other. UMB101 and 160 have been found to exhibit enhanced dual inhibitory activity with selectivity fold of less than 30, UMB160 being the most potent dual-kinase bromodomain inhibitor (BRD4 IC50 = 28 nM, PLK1 IC50 = 40 nM). UMB131 was found to be the most selective PLK1 inhibitor over BRD4.

Statistical Analysis for Hospital Length-of-Stay and Readmission Rate Study

Fri, 05/20/2016 - 3:30pm

Hospital readmission rate has become a major indicator of quality of care, with penalties given to hospitals that have high rates of readmission. At the same time, insurers are applying increasing pressure to improve efficiency and reduce costs, including decreasing hospital lengths of stay. We analyze these trends to determine if reducing lengths of stay (LOS) may actually worsen readmission rates. All records of patients admitted to the neurosurgical service at one hospital from October 2007 through June 2014 were aggregated and analyzed for several variables, including initial length of stay, readmission occurrence, and length of stay, admitting diagnosis, admission priority and discharge disposition. Any trends over time were also noted. 925 out of 9,409 patient encounters are readmissions. Readmission rate and average length of stay were found significantly negative correlated. Besides linear regression which directly connecting average length of stay and readmission rate, survival analysis methods with Cox proportional hazard ratio model were employed to determine which factors were associated with a higher risk of readmission. There was a clear increase in readmissions over the study period, but LOS remained relatively constant, suggesting that increasing medical complexity confounded efforts to decrease LOS and was responsible for increased readmission rates. This study can help providers avoid readmissions by focusing on effective management of comorbidities.

Airway smooth muscle pathology in Pompe Disease

Fri, 05/20/2016 - 3:30pm

Pompe disease is a rare autosomal recessive disease which results from a deficiency of acid α-glucosidase (GAA) - an enzyme that degrades lysosomal glycogen. Patients with Pompe disease develop intra-lysosomal accumulation of glycogen in multiple tissues including skeletal muscle, CNS and smooth muscle.

Pulmonary dysfunction is a hallmark of Pompe disease and has classically been attributed to muscle weakness and CNS neuropathology. However, the potential role of respiratory smooth muscles in the respiratory pathology is unknown. Therefore we postulated that GAA deficiency results in airway smooth muscle glycogen accumulation that leads to airway smooth muscle dysfunction.

Using the Pompe mouse model, the Gaa-/- mouse, we examined the airway smooth muscle structure and function. We used in vivo forced oscillometry measurements (N=7WT, N=7 Gaa-/-) to examine pulmonary physiology and administered methacholine challenges to assess in vivo airway resistance. Also, we used ex-vivo contraction testing (N=6WT, N=5 Gaa-/-) to determine bronchi contractility. In response to the highest dose methacholine challenge (100mg/ml), there was a significant decrease in conducting airway resistance in Gaa-/- versus WT mice (p=0.007). Also, ex vivo bronchi contraction testing demonstrated a significantly weaker response to potassium chloride (p=0.008) and methacholine (2-way ANOVA p=0.005) in Pompe mice compared to WT mice, suggesting impaired smooth muscle contraction. Furtherly, we performed PAS staining on fresh-frozen tissue to examine the degree of glycogen accumulation as a result of GAA deficiency. PAS staining revealed robust glycogen accumulation in the trachea and bronchi of Pompe mice and a disruption of the airway smooth muscle architecture.

In conclusion, GAA deficiency results in glycogen accumulation and a disruption of the architecture in the airway smooth muscles of Gaa-/- mice. Furthermore, both in vivo and ex vivo tests reveal that Gaa-/- murine airways have impaired function as evidenced by decreased contractility and a decreased response to methacholine.

Text Mining From Drug Surveillance Report Narratives

Fri, 05/20/2016 - 3:30pm

Analysis of postmarket drug surveillance reports is imperative to ensure drug safety and effectiveness. FAERS (FDA Adverse Event Reporting System) is a surveillance system that monitors Adverse Events (AEs) from drugs and biologic products. The AEs are reported through MedWatch voluntary reports (initiated from patients and healthcare providers) and mandatory reports (initiated from manufacturers). Much of the information in the voluntary AE reports is narratives or unstructured text. The increasing volume of individual reports, estimated at more than one million per year, poses a challenge for the staff to review large volume of narratives for drug clinical review. We are developing a computational approach using Natural Language Processing and UMLS MetaMap biomedical software to parse the narratives, recognize named-entities in the text and extract consumer/patient and related drug indications and adverse drug reaction information. The goal is to develop a text mining tool that automatically extracts relevant information from the report narratives which can be stored in pre-defined data fields in the FAERS database for efficient searching and querying during clinical review process.