Projects
Completed Projects
Last Projects Update 08.03.07
| Project Name | Project Description | Partners |
|---|---|---|
| Web-based education about drug interactions, especially in women. | Reduced drug interactions and adverse reactions to medications | |
| National medication errors survey of third-year medical students, internal medicine clerkship, and residency programs. | What are the educational needs of medical education programs to address content specific to medication errors and can web based educational modules address the educational needs. | Food and Drug Administration |
| Advance PCS data mining for drug interactions. | To determine the frequency with which drugs that have the ability to prolong the QT are co-prescribed. | AdvancePCS |
| Curriculum for therapeutics in women's health. | To guide the integration of women's health and sex differences into pharmacy curricula. | American Association of Colleges of Pharmacy American College of Clinical Pharmacy American Pharmaceutical Association Foundation Health Resources and Services Administration University of Illinois at Chicago Public Health Service U.S. Department of Health and Human Services/Office on Womens Health National Institutes of Health/Office of Research on Womens Health Food and Drug Administration |
| Role of heart rate correction in QT analysis of drug action. | Are the formulas most commonly reported by the FDA in drug safety premarketing studies providing an accurate assessment of risk. | |
| Fourth-year medical school course on therapeutics. | A curriculum has been developed for a fourth year course in therapeutics | Food and Drug Administration |
| Effects of herbal remedies in diabetic Hispanic women in the Southwestern US. | Assess herbal use by Hispanic Women with diabetes | |
| Community pharmacy factors associated with drug interactions | Determine pharmacy characteristics that are associated with higher rates of dispensed potential DDIs | Georgetown University Society for Womens Health Research Medco Health Solutions |
| Evaluation of computerized physician order entry with Veterans Affairs Medical Centers. | The purpose of this study was to examine reasons provided for overriding drug-drug interactions, examine prescriber and pharmacist satisfaction with the current alerting system, and to examine rates of clinically significant DDIs in the VA setting | Department of Veterans Affairs |
| Health information seeking needs for women at the UA National Center of Excellence in Women's Health (CoE). | To identify gaps in and barriers to patients' access of information and to evaluate patients' preferred means of accessing health information. | University of Arizona National Center of Excellence in Womens Health University of Arizona Department of Communiction |
| Project Name | Project Description | Partners |
|---|---|---|
| Project Name | Project Description | Partners |
|---|---|---|
| Retrospective evaluation of aspirin use in patients with coronary artery disease | Determine prevalence of aspirin use, predictors of aspirin use, and consequences of aspirin use from the Duke Databank for Cardiovascular Disease | |
| Evaluation of reasons reported for aspirin non-use in patients with coronary artery disease | Through patient survey, determine the proportion of patients with known coronary artery disease who are taking aspirin, their aspirin dose, reasons for aspirin discontinuation, and patient reported side effects from aspirin. | |
| Evaluation of beta-blocker use and non-use in patients with heart failure | Through patient survey, assess beta-blocker use in patients with heart failure and determine potential reasons for non-use. | |
| Prospective demonstration project to improve use of beta-blockers in patients with heart failure | Develop and implement a multi-faceted intervention to increase beta-blocker use in appropriate heart failure patients in an ambulatory setting. | AstraZeneca Conceptis Technologies GlaxoSmithKline Duke Heart Center |
| Evaluation of the national market uptake of dofetilide | Evaluate prescribing trends of all antiarrhythmic agents from the time dofetilide was marketed through 2001. | Food and Drug Administration IMS Health |
| Evaluation of the dofetilide risk management program at Duke University Medical Center: practitioner perceptions | Determine practitioner perceptions of the dofetilide risk management program and agreement with dosing and monitoring recommendations | |
| Evaluation of physicians' understanding of the QT interval and medications that may alter it | Evaluate physicians' knowledge of the QT interval and the medications, diseases, and drug combinations that may alter the QT interval. | |
| Evaluation of the dofetilide risk management program at Duke University Medical Center: adherence to guidelines | To compare adherence to dosing and monitoring recommendations for dofetilide and sotalol at Duke University Medical Center. | |
| Educational module on QT prolonging medications | Develop an Internet-based educational module for health care providers on the QT interval to help minimize risk associated with use of QT-prolonging medications. | American Heart Association |
| Determine critical postmarket surveillance questions and explore novel solutions for cardiovascular devices | To bring together a multidisciplinary conference of regulators, manufacturers, and clinicians to address postapproval surveillance (PAS) issues for selected cardiovascular (CV) devices and to develop generalizable concepts for future improvements to the system of PAS of CV devices. The devices discussed in detail were left ventricular assist devices, implantable cardioverter defibrillators, intracoronary brachytherapy, and vascular embolic protection devices. | Food and Drug Administration Advanced Medical Technology Association American College of Cardiology Society of Thoracic Surgeons |
| Postmarket surveillance of transmyocardial revascularization | Through a collaboration of the FDA with the Duke CERTs and the Society for Thoracic Surgeons(STS), monitor the use and outcomes of TMR under conditions of general use. | Food and Drug Administration Society of Thoracic Surgeons |
| Effect of beta-blockers in heart failure patients: a meta-analysis | Conduct a meta-analysis of previously published trials evaluating the effect of beta-blockers in patients with heart failure to determine if differences between black and white patients exist. | |
| Metoclopramide and tardive dyskinesia: a review of the FDA adverse event reporting system | Not available at this time | |
| Economic implications of changes in treatment strategies for patients with cardiovascular disease | Examine the cost effectiveness of treating heart failure patients with beta-blockers from different perspectives: society, hospital, Medicare, patient, and physician. Determine whether cost effectiveness of beta-blockers is sensitive to variations in key clinical and economic variables. | |
| Evaluation of antiarrhythmic drug use patterns from 1995 to 2000 | To determine national prescribing patterns and trends for antiarrhythmic agents from 1995 through 2000. | Food and Drug Administration IMS Health |
| Evaluation of the prescribing of concomitant QT prolonging medications | Using a pharmacy benefits manager database, evaluate various combinations of different QT prolonging medications and QT prolonging medications with other medications that interact with the QT prolonging medication. | AdvancePCS University of Arizona Health Sciences Center |
| CERTs Prescribing Safety Program: Safety of use of QT prolonging drugs | Using claims data, identify patients receiving multiple QT prolonging medications or a QT prolonging medication with an interacting medication and determine how many of these patients are at even greater risk of an adverse event due to the presence of additional risk factors. | HMO Research Network |
| Duke Heart Center cardiovascular dosing guide card | Update a dosing guide for cardiovascular medications that is used by health care practitioners | Merck Pfizer AstraZeneca Duke Heart Center GlaxoSmithKline Wyeth-Ayerst Laboratories |
| Evaluation of the Duke CERTs QT educational module | Evaluate the ability of an Internet-based educational program on the QT interval to provide a test population of health care practitioners with usable, easy to understand, and clinically relevant guidance on measuring and monitoring the QT interval to reduce risk of torsades de pointes. | Duke Educational Media Services |
| Consultation with the Council for Affordable Quality Healthcare (CAQH) on their Cardiovascular Quality Initiative | To study long-term adherence to beta-blocker therapy over the first year after heart attack in patients with commercial health insurance and prescription drug benefits. | Council for Affordable Quality Healthcare |
| Evaluation of the use of life-saving cardiovascular therapies in the Duke databank for cardiovascular disease: treatments for coronary artery disease | Evaluate the prevalence of use, predictors of use, and consequences of use of all evidence-based therapies individually and in combination in patients with coronary artery disease within the Duke Databank for Cardiovascular Disease. | |
| Incremental Cost-Effectiveness of long-Term Clopidogrel Therapy following PCI | Explore the incremental cost-effectiveness of extending the use of clopidogrel from one month to 12 months following percutaneous coronary interventions as compared to use for just one month. | |
| Observational study of outcomes associated with coronary stents: Duke Databank for Cardiovascular Disease - Preliminary study | In a retrospective analysis of matched patients (with similar likelihood of receiving coronary stents based on clinical, angiographic and demographic characteristics), compare long term outcomes (death, heart attack, or target vessel revascularization) of balloon angioplasty alone vs. angioplasty with placement of a bare metal stent(s). | |
| Economic impact of drug-eluting stents on hospital systems | Create a computer model to evaluate the clinical and economic consequences to hospitals of drug eluting stents over a five-year period | |
| Evaluation of the receipt of medication guides and mandatory patient package inserts and patient comprehension of key educational messages in these materials | In a real world setting, evaluate the distribution of medication guides and mandatory patient package inserts and evaluate patients' understanding of key educational messages. | Food and Drug Administration Medco Health Solutions |
| Evaluation of patient comprehension of key educational messages in medication guides and mandatory patient package inserts: laboratory assessment | Conduct cognitive experiments to determine how well patients understand and remember key information contained within mandated patient education materials for selected medications. | Food and Drug Administration Duke University Department of Psychology |
| Post-approval cost of safety for pharmaceuticals | To estimate the resources (both human and financial) spent on current methods of assessing safety of pharmaceuticals after FDA approval | Pharmaceutical Research and Manufacturers of America |
| Focus groups for the study of physicians: perceptions and preferences of clinical practice guidelines | To gather data that will help inform the development of a larger quantitative study on physicians' perceptions and preferences with regard to clinical practice guidelines. | American College of Cardiology |
| Relationship between use of tumor necrosis factor antagonist therapy and development of heart failure | Not available at this time | Food and Drug Administration |
| OPTIMIZE Registry Organized Program to Initiate life-saving treatment in hospitalized patients | To be used for new Duke CERTs projects | |
| Analysis of the utilization of the QT Module | To evaluate extent of use of the QT module following its public launch and review submitted evaluations to determine if additional changes to the module are necessary. | |
| CMS E-Prescribing identification and evaluation | Not available at this time | |
| The Duke Heart Center Dosing Guide 2005 | Update a dosing guide for cardiovascular medications that is used by health care practitioners | Duke Heart Center Eli Lilly and Company Reliant Pharmaceuticals, Inc. |
| Observational study of outcomes associated with coronary stents: Duke Databank for Cardiovascular Disease | Evaluate real-world use of stents and their associated long term outcomes. If adequate numbers of drug eluting stents are placed, a comparison of outcomes with bare metal and drug eluting stents will be conducted | |
| Preliminary Studies for PILOT-EBM | Gather information to complete plans for the randomized controlled trial of Patient Focused Intervention to Improve Long Term Adherence to Evidence Based Medications (PILOT-EBM) through patient interviews, pharmacist focus groups, and physician focus groups. | |
| Use and perceptions of clinical practice guidelines by internal medicine practitioners: Internet Survey | To explore use and perceptions of clinical practice guidelines among internal medicine practitioners through an Internet survey | American College of Cardiology |
| Project Name | Project Description | Partners |
|---|---|---|
| Antibiotic use in children. | Trend rates of pediatric antimicrobial use from and indications for therapy over time and across nine geographic regions | Brigham and Womens Hospital Group Health Cooperative of Puget Sound Harvard School of Medicine HealthPartners Kaiser Permanente Colorado Kaiser Permanente Northern California Kaiser Permanente Northwest Kaiser Permanente Georgia Henry Ford Health System Harvard School of Public Health Harvard Pilgrim Health Care Fallon Community Health Plan |
| Asthma drug use. | Retrospective cohort study using automated record linkage to assess patterns of use of asthma drug therapy over time and across nine geographic regions. | Brigham and Womens Hospital Kaiser Permanente Northwest Kaiser Permanente Northern California Kaiser Permanente Georgia Kaiser Permanente Colorado Henry Ford Health System HealthPartners Harvard School of Public Health Harvard School of Medicine Harvard Pilgrim Health Care Group Health Cooperative of Puget Sound Fallon Community Health Plan |
| Development of algorithms for identification of patients with Churg-Strauss syndrome. | Determine feasibility of developing an algorithm for efficient identification of Churg-Strauss syndrome in large, unselected populations | Brigham and Womens Hospital Kaiser Permanente Northwest Kaiser Permanente Northern California Kaiser Permanente Georgia Kaiser Permanente Colorado Henry Ford Health System HealthPartners Harvard School of Public Health Harvard School of Medicine Harvard Pilgrim Health Care Group Health Cooperative of Puget Sound Fallon Community Health Plan |
| Systematic review of drug interventions in managed care. | This will be the first comprehensive review of the effectiveness of drug-related interventions in managed care organizations. | |
| Web-based resource summarizing effective drug-related interventions in managed care. | Not available at this time | Americas Health Insurance Plans |
| Impact of changing co-payment requirements on use of anti-diabetic therapy. | Based on a health-plan co-payment structure that requires a member to pay more of the cost of certain drugs, this study will provide an estimate of its impact on use of anti-diabetic therapy and provide a basis for determining resulting health outcomes. | Brigham and Womens Hospital Kaiser Permanente Northwest Kaiser Permanente Northern California Kaiser Permanente Georgia Kaiser Permanente Colorado Henry Ford Health System HealthPartners Harvard School of Public Health Harvard School of Medicine Harvard Pilgrim Health Care Group Health Cooperative of Puget Sound Fallon Community Health Plan |
| CERTs Prescribing Safety Program: Overall Safety of Current Drug Use. | Assess the overall frequency of prescribing at variance with FDA 'black box' warnings or commonly accepted clinical guidelines. | University of Pennsylvania School of Medicine |
| CERTs Prescribing Safety Program: Errors in Laboratory Monitoring Associated with Drug Use. | Improved understanding of the frequency of medication prescribing errors in the ambulatory setting. The information will be used to develop interventions to reduce the frequency of inappropriate drug prescribing. | |
| CERTs Prescribing Safety Program: Assessing Patient Preferences for Notification of Prescribing Error. | The findings will allow development of better methods for informing patients and their families about errors. | |
| Prescribing Safely During Pregnancy. | Assess drug use before and during pregnancy in a large population of women in eight different health systems and geographic regions. A principal goal is to assess the frequency of prenatal exposure to drugs that may injure the fetus. | |
| Survival of COPD Patients Exposed to Inhaled Steroids and/or a Long-Acting Beta Agonist. | The project examined the relationship between survival and exposure to inhaled corticosteroids (ICS) and/or long-acting beta agonists (LABA) in patients with chronic obstructive pulmonary disease in a retrospective observational study in two managed care populations. | |
| Under treatment of osteoporosis among postmenopausal women following a fracture. | A retrospective study was conducted using the automated databases of seven health maintenance organizations to evaluate the use of drugs recommended for secondary prevention of osteoporotic fracture. | |
| A cohort study of the incidence of acute hepatic failure and lesser degrees of liver injury in patients with type 2 diabetes mellitus. | Study of liver injury after exposure to different types of hypoglycemic agents. | Parke-Davis Pharmaceutical |
| Evaluation of a program to identify and treat patients with H-pylori associated peptic ulcer disease. | Will elucidate the role of system and educational interventions in improving quality of care. | Harvard Vanguard Medical Associates TAP Pharmaceutical Products Inc. |
| Prevalence and strategies for appropriate prescription medication dosing for children. (AHRQ task order). | Retrospective cohort comparing error rates from pharmacy claims with medical records and electronic medical records. Also will compare error rates at site with electronic medical records to 2 sites without EMR. | Fallon Community Health Plan Group Health Cooperative of Puget Sound Kaiser Permanente Northwest |
| A population based HMO study of gout pharmacoepidemiology. | Develop an algorithm based on claims data to identify patients with recurrent gout attacks. | TAP Pharmaceutical Products Inc. University of Alabama at Birmingham |
| CERTs Prescribing Safety Program: Errors in prescribing of QT interval prolonging drugs. | An evaluation of the co-prescription of QT-prolonging medications, and of appropriateness of dosing of renally cleared, QT-prolonging antiarrhythmic agents. | Duke University Medical Center |
| HMO CERT NCQA collaboration on therapeutic indicators. | Participate in collaboration with NCQA to test and develop quality of care indicators. | National Committee for Quality Assurance |
| Project Name | Project Description | Partners |
|---|---|---|
| Project Name | Project Description | Partners |
|---|---|---|
| Project Name | Project Description | Partners |
|---|---|---|
| Effect of formulary changes on the resistance patterns of E. coli and klebsiella. | To identify the impact of hospital wide antibiotic formulary interventions on ESBL-EK prevalence | University of Pennsylvania Health System/Presbyterian Medical Center |
| Use of tetracycline for acne in an outpatient clinic: effects on antibiotic resistance patterns. | The goal of this study was to determine the presence of and resistence patterns of Group A Strept (GAS) found in the throat. | |
| Study the feasibility of using GPRD to study the epidemiology of drug-resistant pneumococcal pneumonia. | To identify whether discharge diagnosis codes for pneumococcal pneumonia are accurate | General Practice Research Database/EPIC Department of Veterans Affairs |
| Risk factors for infection due to fluoroquinolone-resistant escherichia coli and klebsiella pneumoniae. | To identify risk factors for FQ resistance | Infectious Diseases Society of America Roche Laboratories Inc. University of Pennsylvania Health System/Presbyterian Medical Center |
| Adherence to protease inhibitors in HIV. | To determine if poor adherence to HIV therapy results in treatment failure. | Agouron Pharmaceuticals Inc. |
| Epidemiologic investigation of fluoroquinolone resistance in infections due to extended-spectrum-beta-lactamase (ESBL) producing escherichia coli and klebsiella pneumoniae (ESBL-EK). | To identify risk factors for FQ resistance in ESBL-EK | National Institutes of Health/National Institute of Diabetes & Digestive & Kidney Diseases |
| Re-administration of antibiotics in patients with a history of beta-lactam allergy. | To assess morbidity with readministration of penicillin to patients with a defined history of a previous allergic-like event | General Practice Research Database/EPIC |
| Refill adherence with antiretroviral therapy and outcomes in human immunodeficiency virus (HIV). | To determine if pharmacy refill data was a valid measure of adherence and determine pharmacy-based risk factors for poor adherence as measured using pharmacy refill data | Agouron Pharmaceuticals Inc. GlaxoSmithKline Department of Veterans Affairs |
| Research sponsorship and the statistical power to detect adverse effects of newly approved drugs. | To determine the proportion of postmarketing studies of antiretroviral drugs that are adequately powered, and to determine whether public versus private sponsorship influences power | |
| Risk factors for drug-resistant urinary tract infections. | To identify risk factors for trimethoprim-sulfamethoxazole resistant E coli UTIs among outpatients | Department of Veterans Affairs |
| Tensions between patient and public health values in generalists use of antibiotics. | To measure the impact of public health awareness on physician decisions to prescribe antibiotics for patients with respiratory tract infections | Robert Wood Johnson Foundation |
| Risk factors for drug-resistant pneumococcal pneumonia. | To identify patient level factors that predict infection with macrolide resistant pneumococcal pneumonia | National Institutes of Health/National Institute of Allergy and Infectious Diseases |
| Vancomycin resistant enterococcal colonization in liver transplant candidates: Prevalence and risk factors. | To identify the prevalence of VRE colonization in patients awaiting liver transplant | |
| Colonization and resistance of Staphylococcus Aureus and Streptococcus pyogenes in the oropharynx of individuals without acne. | The goal of this study was to determine the presence of and resistence patterns of Group A Strept (GAS), Staph, and S. salivarius found in the throat. | |
| Knowledge and attitudes regarding antimicrobial use among emergency department (ED) physicians in Pennsylvania following bioterrorism events. | To survey ED physicians about bioterrorism | Pennsylvania Department of Public Health |
| Extended-Spectrum Β-Lactamase-(ESBL) Producing Escherichia Coli and Klebsiella species: Risk Factors for Colonization and Impact of Antimicrobial Formulary Interventions on Colonization Prevalence. | To examine factors associated with colonization with an ESBL and to evaluate the effect of formulary changes on colonization prevalence | |
| Changes in Prevalence of Vancomycin-Resistant Enterococci (VRE) following Antimicrobial Formulary Interventions: Impact of Sequential Progressive Restrictions on Use of Vancomycin and 3rd-Generation Cephalosporins. | To identify the impact of hospital wide antibiotic formulary interventions on VRE prevalence | |
| The CERTs Prescribing Safety Research and Demonstration Project. [partners AHRQ and Harvard University] | Not available at this time | |
| Impact of a hospital-based antimicrobial management program on clinical and economic outcomes. | To determine if pharmacists trained in antimicrobial prescribing can perform as well as ID fellows in recommending antimicrobials in the inpatient setting. | University of Pennsylvania Health System/Hospital of the University of Pennsylvania |
| Health effects of schizophrenia and anti-psychotic medications. | To study the relationship between specific antipsychotic drugs and the risk of sudden death / ventricular arrhythmia and all-cause death. | Pfizer |
| Chloramphenicol resistance in Vancomycin-resistant enterococcal (VRE) infections. | To identify risk factors for chloramphenicol resistance in VRE. | |
| Antimicrobial utilization in the emergency departments of academic medical centers: investigation of inappropriate use of fluoroquinolone (FQ) antibiotics. | To identify patterns of FQ use in emergency departments (EDs) | |
| Risk factors for post-craniotomy surgical site infection following Gliadel® wafer replacement. | Not available at this time | |
| A patient intervention to reduce antibiotic overuse. | Design a computerized educational intervention to reduce antibiotic expectation and overuse | Pennsylvania Department of Public Health |
| Transplant surgeons' perceived risks of intraoperative virus transmission and use of prophylactic interventions | To identify the proportion of U.S. transplant surgeons who are adequately vaccinated against HBV, identify characteristics associated with inadequate vaccination, and assess the proportion who had been evaluated for immunization following potential HBV exposures | |
| Risk factors for multi-drug resistant Enterobacteriaceae in a neonatal intensive care unit. | To determine risk factors for infection or colonization with ESBL producing enterobacteriaceae in the neonatal intensive care unit setting | |
| Effectiveness of retrospective drug utilization review in Medicaid. | To study the effectiveness of DUR programs. | National Institutes of Health/National Institute on Aging Agency for Healthcare Research and Quality ProVantage Health Services Inc. |
| Institute of Medicine Committee on Smallpox Vaccination Program Implementation ('smallpox committee') | Dr. Strom chairs a multidisciplinary committee for the IOM, which in turn is funded by CDC, to provide CDC with advice regarding its implementation of the President's smallpox vaccine program. | |
| Willingness to be vaccinated against smallpox: an assessment of hospital-based adult and pediatric emergency first responders. | The goal of this study is to assess the current acceptability of vaccination against smallpox among emergency personnel at the largest adult and pediatric hospitals in the largest urban regions. | |
| HIV treatment interruption and immune function. | To determine if interrupting treatment as a form of autovaccination is a viable strategy for controlling HIV. | |
| Institute of Medicine Committee to review the safety and efficacy of the anthrax vaccine | Dr. Strom chaired a multidisciplinary committee funded by DOD and charged with evaluating the safety and efficacy of this controversial vaccine. | Institute of Medicine Centers for Disease Control and Prevention |
| Institute of Medicine Committee to review the CDC anthrax vaccine safety and efficacy research program. | Dr. Strom chaired a multidisciplinary committee funded by CDC and charged with evaluating the CDC's planned research program for this controversial vaccine. | |
| Educational contributions related to use of antibiotics. | To publish a textbook which addresses these issues | |
| Predicting vaccine status and ED use in Medicaid newborns. | Not available at this time | |
| Virologic effectiveness of antiretroviral therapy (ART) in Botswana's National Program. | To define the virologic response rate of ART in Botswana and to evaluate the predictive ability of CD4 count increase after ART for virologic response. | Penn Center for AIDS Research |
| Association between antibiotic use and relapse of inflammatory bowel disease. | To determine whether among patients with inflammatory bowel disease, if use of antibiotics for other reasons influences the likelihood of relapse of the disease. | |
| Gout Epidemiology | Project no. 150006, Kenneth Saag, Principle Investigator | |
| Failure of oral antibiotics to prevent early bacteremia after hematopoietic stem cell transplantation. | To determine the incidence of bacteremia and antimicrobial resistance post-HSCT in pediatric patients receiving GD, and to identify risk factors associated with infection. | |
| Test characteristics of peri-rectal and rectal swab compared to stool sample for detection of Fluoroquinolone-resistant Escherichia coli in the gastrointestinal tract | To identify the test characteristics of perirectal swab | Centers for Disease Control and Prevention |
| Occult HBV infection in HIV/HCV-Coinfected Patients | To determine the prevalence, risk factor, and clinical significance of occult HBV among HBsAg-?/anti-HBc+ HIV-infected subjects in the Penn CFAR Adult/Adolescent Database | Bristol-Myers Squibb Company |
| Time Updated Adherence and Virological Breakthrough in HOMER Cohort | To determine if adherence is associated with maintained suppression of HIV over time using a time-updated pharmacy-based refill measure of adherence. | |
| Institute of Medicine Committee to review the safety and efficacy of the anthrax vaccine | Dr. Strom chaired a multidisciplinary committee funded by DOD and charged with evaluating the safety and efficacy of this controversial vaccine. |
| Project Name | Project Description | Partners |
|---|---|---|
| Project Name | Project Description | Partners |
|---|---|---|
| Preferences for fractures and other glucocorticoid-associated adverse effects among rheumatoid arthritis patients. | Determine rheumatoid arthritis (RA) patients preferences for validated health state scenarios depicting glucocorticoid adverse events, predictors of these preferences, and psychometric properties of different preference techniques in this population | National Institutes of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases |
| Practice pattern variation in glucocorticoid-induced osteoporosis (GIOP). | To characterize glucocorticoid use and patterns of osteoporosis prevention therapies among a large US national cohort | Aetna Inc. U.S. Quality Algorithms Inc. Medco Health Solutions |
| Racial variations in osteoporosis management. | To examine differences and determinants of osteoporosis preventive interventions among white and black women in a large regional health maintenance organization | Medco Health Solutions UnitedHealthcare of Alabama |
| Long-term safety and toxicity monitoring of non-steroidal anti-inflammatory drugs. | To examine the associations of physician specialty and patient characteristics with NSAID safety practices, using administrative data and medical record review from a regional managed care organization | National Institutes of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases UnitedHealthcare of Alabama |
| Arthritis quality indicators development. | To develop a comprehensive set of explicit process measures to assess the quality of health care for osteoarthritis, rheumatoid arthritis, and analgesics use. | Arthritis Foundation UCLA/RAND Center for Adolescent Health Promotion |
| Medical errors in the management of gout. | To examine the epidemiology of gout and gout treatment in the United Kingdom using a large national practice based population. | General Practice Research Database/EPIC University of Pennsylvania School of Medicine Agency for Healthcare Research and Quality |
| High risk arthritis survey. | To examine the association of race/ethnicity with the utilization of arthritis health care among community-dwelling older adults. | Arthritis Foundation-Alabama Chapter Alabama Department of Public Health |
| Outcomes of elderly onset rheumatoid arthritis. | To determine whether rheumatoid arthritis (RA) is associated with excess mortality among older women. | American College of Rheumatology Arthritis Foundation Iowa Womens Health Study |
| Glucocorticoid cost modeling. | To estimate the costs of glucocorticoid associated adverse events (GAEs) in patients with rheumatoid arthritis (RA). | Agency for Healthcare Research and Quality |
| Metabolic bone disease among HIV patients with fat redistribution and metabolic changes attributed to highly active anti-retroviral therapy (HAART) | Establish a prospective cohort of HIV positive patients and determine the associated clinical and epidemiological risk factors of bone loss and osteonecrosis | National Institutes of Health/National Institute of Nursing Research |
| Hydroxychloroquine lowers damage in systemic lupus erythematosis | To examine whether hydroxychloroquine (HCQ) usage is associated with a reduced risk of \ndamage accrual in patients with systemic lupus erythematosus (SLE). |
| Project Name | Project Description | Partners |
|---|---|---|
| NC Asthma Improvement Project | To determine the effectiveness of practice-based education using systems improvement methods to improve preventive care for children. | AccessCare Inc. North Carolina State Childrens Health Insurance Program GlaxoSmithKline North Carolina Medicaid |
| Tailored implementation strategy for pediatric therapeutic guidelines. | 1. Is there a pattern of pediatrician perceptions of therapeutic CPGs that suggests a common paradoxical taxonomy that can be used to mass customize dissemination efforts? 2.How can the identified taxonomy tool be applied in disseminating and implementing CPGs to maximize their use? | |
| Efficacy, safety, and pharmacokinetics of drugs in pediatric HIV. | Develop high performance liquid chromatographic (HPLC) for the simultaneous determination of indinavir, ritonavir, saquinavir and nelfinavir in plasma and was used to quantify PI concentrations in HIV patients. | Cincinnati Children's Hospital Medical Center Columbus Children's Hospital |
| Prevalence of Type II diabetes in childhood. | 1. Determine the prevalence of glucose intolerance and Type 2 diabetes in a large population of school-age children. 2. examined changes in predictors over time using data collected on this population during childhood. | |
| Prescribing patterns of psychotropic drugs for adolescents. | To provide a comprehensive, cross-sectional description of the ambulatory utilization of psychotropic medications (for the treatment of attention-deficit/hyperactivity disorder [ADHD] and depression) by youths in employer-insured health plans and by those covered by Medicaid. | Center for Health Care Policy and Evaluation/UnitedHealth Group |
| CERTs Summer Institute: Using the Evidence on Therapeutics to Enhance Quality of Care. | To reach pediatric practitioners for short courses on issues relating to evidence-based practice, with specific attention to use of therapeutics. This aim broaden to include family practitioners, pediatric pharmacists, and pediatric nurses and nurse practitioners. | National Initiative for Childrens Healthcare Quality |
| MedMARx monitoring and surveillance project. | Program will continue to collect data in order to establish approaches to prevent and reduce medication errors in the pediatric population. The MedMARx database will continue to provide in-depth information about medication errors involving children from birth to adolescence. | United States Pharmacopeial Convention Inc. |
| Attention deficit-hyperactivity disorder (ADHD) project. | To design and test clinical tools and effective strategies for the diagnosis and management of Attention Deficit Hyperactivity Disorder (ADHD) | National Initiative for Childrens Healthcare Quality |
| Pediatric adverse drug event and reaction reporting program. | (1) To develop an adverse drug event reporting program; and (2) To assess data generated from the reporting program in order to minimize pediatric patients' risk, improve patients' quality of care, and determine and implement 'best practice' care programs. | |
| Skeletal effects of oral replacement of vitamin D and calcium in adolescents with cystic fibrosis. | Determine short-term effects of alternate form of vitamin D supplementation, calcitriol, on fractional calcium absorption and other calcitropic markers in CF patients compared to healthy controls. | |
| Prevalence of vitamin D-deficient rickets in minority infants. | To analyze the characteristics of infants and children diagnosed with nutritional rickets at two medical centers in North Carolina in the 1990s. | Bowman Gray School of Medicine Wake Forest Baptist Medical Center |
| Optimizing prescribing and treatment for otitis media. | This study sought to 1. determine the impact of antibiotic prescribing at initial visit on the probability and frequency of AOM-related return visits among North Carolina Medicaid patients. 2. evaluate the effect of a 1-time, mailed intervention on subsequent prescribing of antibiotics for initial episodes of AOM. alter prescribing behavior in the direction of optimal treatment guidelines. | |
| Learning from Errors in Ambulatory Pediatric Settings (LEAP): A CERTs Supplemental Project. | 1. Develop a web-based tool for documenting and reporting errors in pediatric ambulatory settings. 2. Create a secure method of reporting errors in the ambulatory environment via the internet. 3. Identify the types of errors that are occurring in children's healthcare | American Academy of Pediatrics Pediatric Research in Office Settings |
| Model pediatric therapeutic drug monitoring service to improve patient outcomes. | Create an internet tool for therapeutic drug monitoring (TDM) data collection and test of the basic hypothesis that, properly run, model pediatric (TDM) services can provide a cost-effective way to improve pediatric care. | Cincinnati Children's Hospital Medical Center |
| MedMARx: Improving care through analysis of pediatric medication error data. | Collect standardized information about pediatric medication errors; analyze and describe the data; recommend best practices to prevent future pediatric medication errors; and disseminate the results of best practices to UNC CERTs for additional evaluation, recommendations, and dissemination. | United States Pharmacopeial Convention Inc. |
| Safety and efficacy of continuous subcutaneous blood glucose monitoring systems in the management of type 1 diabetes mellitus in children. | To test whether use of continuous glucose monitoring in children with type 1 diabetes mellitus improves long-term diabetes control. More specifically, we aimed (1) to improve glycemic control determined by improvement in hemoglobin A1c values, and (2) to reduce both the frequency and severity of hypoglycemic episodes in children with type 1 diabetes mellitus. | Medtronic MiniMed Inc. |
| Postmarketing surveillance of drugs in emergency department pediatric patients. | Determine how useful ED databases can be for ADE/OD identification in pediatric patients and provide recommendations for improving ED data collection procedures to enhance use of ED data for estimating population-based rates of ADE/ODs in pediatric patients. | Food and Drug Administration South Carolina Office of Research and Statistics Carolina Medical Review |
| Evaluation of Synagis treatment for the prevention of RSV infection in children using Medicaid data. | To compare the direct costs of palivizumab prophylaxis and RSV treatment in infants born at 32 to 35 weeks EGA who received and did not receive palivizumab. | AccessCare Inc. North Carolina Medicaid |
| Protection of human research subjects, with particular reference to pediatric studies. | 1. Provide documented human subjects research training for CERTs and non-CERTs researchers; 2. Create a special training session focusing on the unique challenges of doing ethical, effective research on pediatric human subjects. |
| Project Name | Project Description | Partners |
|---|---|---|
| Antipsychotics and sudden death. | Because this association has not been confirmed in controlled studies, we conducted a retrospective cohort study in Tennessee Medicaid enrollees, which included many antipsychotic users; there were also computer files describing medication use and comorbidity. | Janssen Pharmaceutica |
| NSAIDs, Coxibs & CHD: TennCare. | To measure the effects of NANSAIDs, including naproxen, on risk of serious coronary heart disease. | Food and Drug Administration |
| Prenatal erythromycin and pyloric stenosis. | To assess the association between prenatal antibiotics, including erythromycin, and infantile hypertrophic stenosis in a large cohort of infants. | Food and Drug Administration |
| NANSAIDs and cardio protection. | Assess whether NANSAIDs have a cardioprotective effect. | |
| Thioridazine and sudden death. | Provide comment on the relationship between thioridazine and sudden death. | |
| Early erythromycin and pyloric stenosis. | To assess the link between very early erythromycin exposure and pyloric stenosis in young infants. | Food and Drug Administration |
| Benzodiazepine misclassification and falls. | We used data from a historical cohort study to demonstrate the extent of misclassification potentially induced by this practice. | |
| Cyclic antidepressants and sudden cardiac death | We thus sought to quantify the risk of sudden cardiac death among TCA users, according to dose, as well as among users of selective serotonin reuptake inhibitors (SSRIs). We conducted a retrospective cohort study in Tennessee Medicaid, from Jan 1, 1988, through Dec 31, 1993, which included large numbers of antidepressant users and computer files describing medication use and comorbidity. The cohort included 1,282,091 person-years of follow-up for persons aged 15 to 84 years who were not in a nursing home and were free of life-threatening noncardiac illness. This included 58,956 person-years | Janssen Pharmaceutica |
| Anti-lipid drugs and hip fracture. | To compare the risk of hip fracture among users of statins and other lipid-lowering agents, which is less susceptible to bias than the comparisons performed in the previous studies. | |
| Medical vs. surgical treatment GERD. | We sought to conduct a matched cohort study of patients with a diagnosis of GERD receiving surgical therapy or medical therapy. | |
| Contraindicated use of cisapride. | To evaluate the impact of the FDA's 1998 regulatory action regarding contraindicated use of cisapride. Analysis of data for the 1-year periods before (July 1997-June 1998) and after (July 1998- June 1999) the regulatory action from the population-based, pharmacoepidemiology research databases of 2 managed care organizations (sites A and B) and a state Medicaid program (site C). | Food and Drug Administration UnitedHealthcare HMO Research Network |
| Medication errors in home health. | To determine the frequency of possible medication errors in a population of older home healthcare patients according to expert panel objective criteria. | John A. Hartford Foundation |
| Corticosteroids in childhood. | To describe the use of oral corticosteroids among children enrolled in TennCare, Tennessee's managed care program for Medicaid enrollees and uninsured individuals. | Food and Drug Administration |
| Cytoprotection in NANSAID users. | To determine the frequency of use of recommended gastroprotective strategies in a cohort of patients receiving recurrent treatment with nonsteroidal anti-inflammatory drugs (NSAIDs). | |
| Beta-blocker therapy in AMI. | This study was designed to determine adherence to outpatients beta-blocker therapy following acute myocardial infarction (AMI). | |
| Reducing NSAIDs: community. | Randomized controlled trial among community-dwelling Tennessee Medicaid enrollees. | Agency for Healthcare Research and Quality |
| Reducing NSAIDs: nursing home. | Randomized controlled study. Ten pairs of Tennessee nursing homes with ?8% of residents receiving NSAIDs were randomized to intervention or control. | Agency for Healthcare Research and Quality |
| Medications home health: policy evaluation. | To test the efficacy of a medication use improvement program developed specifically for home health agencies. | John A. Hartford Foundation |
| Effect 'carve-out' on medication adherence schizophrenics | We studied the effect of this transition on the continuity of antipsychotic therapy among patients with severe mental illness who had previously adhered to treatment. | National Institutes of Health/National Institute of Mental Health |
| Gaps TennCare enrollment and asthma exacerbations | We sought to quantify the effect of gaps in enrollment on emergency department visits and hospitalizations for children with asthma in TennCare, Tennessee's managed care program for Medicaid-eligible and uninsured children. | Agency for Healthcare Research and Quality |
| Erythromycin and drugs metabolized by CYP3A | We studied the association between the use of erythromycin and the risk of sudden death from cardiac causes and whether this risk we increased with the concurrent use of strong inhibitors of CYP3A. | Bureau of TennCare Tennessee Department of Health Janssen Pharmaceutica Food and Drug Administration |
| ACEI compliance in chronic heart failure | This study was designed to assess outpatient angiotensin-converting enzyme inhibitor (ACEI) use after heart failure (HF) hospitalization. | |
| Trend increasing antipsychotic use in children: TennCare | To identify population-based new use of antipsychotics among patients aged 2-18 years. | |
| ACEI teratogenicity | We conducted a study to assess the association between exposure to ACE inhibitors during the first trimester of pregnancy only and the risk of congenital malformations. | |
| Adherence to guidelines for reducing NSAID gastropathy | Our objective was to assess adherence to evidence-based guidelines by providers of the Department of Veterans Affairs nationwide. | |
| Cardiotoxicity of valdecoxib (letter) | Letter to the editor commenting on the public health risk of valdecoxib exposure. | |
| Contraindicated statins and protease inhibitors | We performed a retrospective cohort study using the TennCare program to determine prescribing rates of contraindicated combinations of Pies and statins in HIV-infected persons in Tennessee and to assess changes in prescribing after publication of treatment guidelines. Computerized files identified adult patients with antiretroviral prescriptions and overlapping prescriptions for PIs and statins from January 1, 1996 through June 30, 2002. A subset of these combinations was defined as contraindicated based on published guidelines. Changes in patterns of prescribing after publication of prelimin | |
| Drug regulatory reform | Commentary on the limitations of the current regulatory system and proposal for a reformed regulatory process. | |
| Drugs and all-cause mortality | Commentary on observational studies of drugs and mortality. | |
| Population-based studies of adverse drug effects | Commentary on population-based studies of adverse drug effects. |