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Forrow S.,Harvard University | Campion D.M.,Outcome science Inc. | Herrinton L.J.,Kaiser Permanente | Nair V.P.,Humana | And 3 more authors.
Pharmacoepidemiology and Drug Safety | Year: 2012

The US Food and Drug Administration's Mini-Sentinel pilot program is developing an organizational structure as well as principles and policies to govern its operations. These will inform the structure and function of the eventual Sentinel System. Mini-Sentinel is a collaboration that includes 25 participating institutions. We describe the program's current organizational structure and its major principles and policies. The organization includes a coordinating center with program leadership provided by a principal investigator; a planning board and subcommittees; an operations center; and data, methods, and protocol cores. Ad hoc workgroups are created as needed. A privacy panel advises about protection of individual health information. Principles and policies are intended to ensure that Mini-Sentinel conforms to the principles of fair information practices, protects the privacy of individual health information, maintains the security and integrity of data, assures the confidentiality of proprietary information, provides accurate and timely communications, prevents or manages conflicts of interest, and preserves respect for intellectual property rights. © 2012 John Wiley & Sons, Ltd.


Fonarow G.C.,University of California at Los Angeles | Albert N.M.,Cleveland Clinic | Curtis A.B.,University of South Florida | Gattis Stough W.,Duke University | And 9 more authors.
Circulation | Year: 2010

Background: A treatment gap exists between heart failure (HF) guidelines and the clinical care of patients. The Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE HF) prospectively tested a multidimensional practice-specific performance improvement intervention on the use of guideline-recommended therapies for HF in outpatient cardiology practices. Methods and Results: Performance data were collected in a random sample of HF patients from 167 US outpatient cardiology practices at baseline, longitudinally after intervention at 12 and 24 months, and in single-point-in-time patient cohorts at 6 and 18 months. Participants included 34 810 patients with reduced left ventricular ejection fraction (≤35%) and chronic HF or previous myocardial infarction. To quantify guideline adherence, 7 quality measures were assessed. Interventions included clinical decision support tools, structured improvement strategies, and chart audits with feedback. The performance improvement intervention resulted in significant improvements in 5 of 7 quality measures at the 24-month assessment compared with baseline: β-blocker (92.2% versus 86.0%, +6.2%), aldosterone antagonist (60.3% versus 34.5%, +25.1%), cardiac resynchronization therapy (66.3% versus 37.2%, +29.9%), implantable cardioverter-defibrillator (77.5% versus 50.1%, +27.4%), and HF education (72.1% versus 59.5%, +12.6%) (each P<0.001). There were no statistically significant improvements in angiotensin-converting enzyme inhibitor/angiotensin receptor blocker use or anticoagulation for atrial fibrillation. Sensitivity analyses at the patient level and limited to patients with both baseline and 24-month quality measure data yielded similar results. Improvements in the single-point-in-time cohorts were smaller, and there were no concurrent control practices. Conclusions: The Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting, a defined and scalable practice-specific performance improvement intervention, was associated with substantial improvements in the use of guideline-recommended therapies in eligible patients with HF in outpatient cardiology practices. © 2010 American Heart Association, Inc.


Albert N.M.,Cleveland Clinic | Fonarow G.C.,University of California at Los Angeles | Yancy C.W.,Baylor University | Curtis A.B.,University of South Florida | And 9 more authors.
American Heart Journal | Year: 2010

Background: National guidelines recommend heart failure (HF) disease management programs to facilitate adherence to evidence-based practices. This study examined the influence of dedicated HF clinics on delivery of guideline-recommended therapies for cardiology practice outpatients with HF and reduced left ventricular ejection fraction. Methods: IMPROVE HF, a prospective cohort study, enrolled 167 cardiology practices to characterize outpatient management of 15,381 patients with chronic systolic HF. Adherence to guideline-recommended HF therapies was recorded, and the presence of a dedicated HF clinic was assessed by survey. Multivariate models identified contributions to delivery of guideline-recommended HF therapies. Results: Of practices, 41.3% had a dedicated HF clinic. Practices with a dedicated HF clinic had greater adherence to 3 of 7 guideline-recommended HF therapy measures: angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (P = .02), β-blocker (P = .025), and HF education (P = .009). After adjustment, use of a dedicated HF clinic was associated with greater conformity in 2 of 7 measures: cardiac resynchronization therapy (P = .036) and HF education (P = .005) but not angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, β-blocker, aldosterone antagonist, implantable cardioverter-defibrillator therapy, and anticoagulation for atrial fibrillation. Conclusions: Use of dedicated HF clinics varied in cardiology outpatient practices and was associated with greater use of cardiac resynchronization therapy and HF education but not other guideline-recommended therapies. © 2010 Mosby, Inc. All rights reserved.


Walsh M.N.,The Care Group LLC | Yancy C.W.,Baylor University | Albert N.M.,Cleveland Clinic | Curtis A.B.,University of South Florida | And 9 more authors.
American Heart Journal | Year: 2010

Background: Electronic health records (EHRs) are considered an important technology to improve the quality of health care, yet few data exist regarding their effect on delivery of evidence-based care in the outpatient setting. Methods: IMPROVE HF is a prospective cohort study of 15,381 patients with HF or post myocardial infarction and left ventricular ejection fraction ≤35% cared for in 167 US outpatient cardiology practices. Baseline patient characteristics and quality data were collected by chart abstraction. To quantify care, 7 HF quality measures were assessed; practices with and without EHR were compared. Results: Among practices, 52% had EHR systems (30% EHR-only; 22% both EHR and paper) and 48% paper-only systems. Conformity with indicated care for practices with EHR systems was modestly higher for 2 of 7 quality measures compared to those without. After controlling for patient and site characteristics, use of EHR was associated with improved delivery of 3 of 7 quality measures (angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, aldosterone antagonist, and HF education), similar care for 3 measures (β-blocker, anticoagulation for atrial fibrillation, and cardiac resynchronization therapy), and worse for 1 measure (implantable cardioverter-defibrillator). Conclusions: These data are among the first to assess the potential influence of EHR on conformity with HF guidelines in the outpatient setting and suggest that EHR systems as currently deployed are associated with only modest differences in some, but not other, quality measures provided to HF patients compared with use of paper-only systems. © 2010 Elsevier Inc. All rights reserved.


Berz J.P.B.,Boston University | Singer M.R.,Boston University | Guo X.,Outcome science Inc | Daniels S.R.,University of Colorado at Denver | Moore L.L.,Boston University
Archives of Pediatrics and Adolescent Medicine | Year: 2011

Objective: To study the effects of selected dietary patterns, particularly a DASH (Dietary Approach to Stop Hypertension) eating pattern, on body mass index (BMI) throughout adolescence. Design: Prospective National Growth and Health Study. Setting: Washington, DC; Cincinnati, Ohio; and Berkeley, California. Participants: A total of 2327 girls with 10 annual visits starting at age 9 years. Main Exposures: Individual DASH-related food groups and a modified DASH adherence score. Main Outcome Measure: The BMI value from measured yearly height and weight over 10 years. Results: Longitudinal mixed modeling methods were used to assess the effects of individual DASH food groups and a DASH adherence score on BMI during 10 years of follow-up, adjusting for race, height, socioeconomic status, television viewing and video game playing hours, physical activity level, and total energy intake. Girls in the highest vs lowest quintile of the DASH score had an adjusted mean BMI of 24.4 vs 26.3 (calculated as weight in kilograms divided by height in meters squared) (P<.05). The strongest individual food group predictors of BMI were total fruit (mean BMI, 26.0 vs 23.6 for <1 vs ≥2 servings per day; P<.001) and low-fat dairy (mean BMI, 25.7 vs 23.2 for <1 vs ≥2 servings per day; P<.001). Whole grain consumption was more weakly but beneficially associated with BMI. Conclusions: Adolescent girls whose diet more closely resembled the DASH eating pattern had smaller gains in BMI over 10 years. Such an eating pattern may help prevent excess weight gain during adolescence. ©2011 American Medical Association. All rights reserved.


Dreyer N.A.,Outcome science Inc. | Schneeweiss S.,Harvard University | McNeil B.J.,Harvard University | Berger M.L.,Eli Lilly and Company | And 3 more authors.
American Journal of Managed Care | Year: 2010

Nonrandomized comparative effectiveness studies contribute to clinical and biologic understanding of treatments by themselves, via subsequent confirmation in a more targeted randomized clinical trial, or through advances in basic science. Although methodological challenges and a lack of accepted principles to assess the quality of nonrandomized studies of comparative effectiveness have limited the practical use of these investigations, even imperfect studies can contribute useful information if they are thoughtfully designed, well conducted, carefully analyzed, and reported in a manner that addresses concerns from skeptical readers and reviewers. The GRACE (Good Research for Comparative Effectiveness) principles have been developed to help healthcare providers, researchers, journal readers, and editors evaluate the quality inherent in observational research studies of comparative effectiveness. The GRACE principles were developed by experienced academic and private sector researchers and were vetted over several years through presentation, critique, and consensus building among outcomes researchers, pharmacoepidemiologists, and other medical scientists and via formal review by the International Society of Pharmacoepidemiology. In contrast to other documents that guide systematic review and reporting, the GRACE principles are high-level concepts about good practice for nonrandomized comparative effectiveness research. The GRACE principles comprise a series of questions to guide evaluation. No scoring system is provided or encouraged, as interpretation of these observational studies requires weighing of all available evidence, tempered by judgment regarding the applicability of the studies to routine care.


Knox S.S.,West Virginia University | Guo X.,Outcome science Inc | Zhang Y.,Boston University | Weidner G.,San Francisco State University | And 2 more authors.
PLoS ONE | Year: 2010

Background: Both anxiety and elevated heart rate (HR) have been implicated in the development of hypertension. The HyperGen cohort, consisting of siblings with severe and mild hypertension, an age-matched random sample of persons from the same base populations, and unmedicated adult offspring of the hypertensive siblings (N = 1,002 men and 987 women), was analyzed for an association of the angiotenisinogen AGTM235T genotype (TT, MT, MM) with an endophenotype, heart rate (HR) in high and low anxious groups. Methodology: The interaction of AGTM genotype with anxiety, which has been independently associated with hypertension, was investigated adjusting for age, hypertension status, smoking, alcohol consumption, beta blocker medication, body mass index, physical activity and hours of television viewing (sedentary life style). Principal Findings: Although there was no main effect of genotype on HR in men or women, high anxious men with the TT genotype had high HR, whereas high anxious men with the MM genotype had low HR. In women, HR was inversely associated with anxiety but there was no interaction with genotype. Conclusion/Significance: The results suggest that high anxiety in men with the TT genotype may increase risk for hypertension whereas the MM genotype may be protective in high anxious men. This type of gene x environment interaction may be one reason why genome wide association studies sometimes fail to replicate. The locus may be important only in combination with certain environmental factors. © 2010 Knox et al.


Li Q.,Harvard University | Glynn R.J.,Brigham and Women's Hospital | Dreyer N.A.,Outcome science Inc. | Liu J.,Brigham and Women's Hospital | And 2 more authors.
Pharmacoepidemiology and Drug Safety | Year: 2011

Purpose: Ejection fraction (EF) is crucial information when studying the use and effectiveness of therapies in patients with heart failure (HF) and myocardial infarction (MI). We aimed to assess the validity of claims data-based definitions of systolic dysfunction (SD). Methods: We identified 1072 patients with EF recorded for an HF/MI hospitalization in Medicare linked with pharmacy data and national HF/MI registries in 1999-2006. Thirteen claims-based definitions for SD were developed using a single or combination of ICD-9 diagnosis codes and cardiovascular medications use. We calculated sensitivity, specificity, and positive predictive values (PPVs) using recorded EFs as the gold standard. Results: Using an EF cutoff of 45%, the definitions based on digoxin use and no atrial fibrillation or flutter had the highest PPVs (76% to 84%) and specificity (>97%) but low sensitivity (6%-14%). As we varied the EF cutoff between 50% and 25%, the specificity decreased by 3%, but the PPVs decreased by 52%. We observed potential differences in the PPVs by patients' characteristics. In a hypothetical study assessing implantable defibrillator effectiveness, using our definition to identify patients with SD would underestimate the effectiveness by 3% to 24%. In another hypothetical study comparing two classes of angiotensin system blockers where SD was considered confounding, our definition introduced ~43% misclassification bias. Conclusions: Claims-based definitions for SD had excellent specificity and good PPV but low sensitivity. The definitions with good PPV could be used for cohort identification or confounding adjustment by restriction and would result in relatively small misclassification bias albeit limited generalizability. © 2011 John Wiley & Sons, Ltd.


Trademark
OUTCOME science INC. | Date: 2011-02-22

Computer software for use in collecting and reporting medical data relating to patient medical conditions in the area of patient registries, quality improvement programs and outcomes research; computer software for use in conducting patient registries, post-approval marketing studies, observational studies, electronic data capture services for patient registries, post-approval marketing studies, and quality improvement programs in the healthcare, biopharmaceutical, and medical device and diagnostic industries. Computer services, namely, providing temporary use of on-line non-downloadable computer software used for collecting, analyzing and reporting medical data relating to patient medical conditions in the area of patient registries, quality improvement programs and outcomes research; providing information regarding networks of clinicians collecting clinical data; providing temporary use of non-downloadable web-based software for use in collecting, analyzing and reporting medical data relating to patient medical conditions in the area of patient registries, quality improvement programs and outcomes research; providing temporary use of non-downloadable web-based software for use in conducting patient registries, post-approval marketing studies, observational studies, electronic data capture services for post-approval marketing studies, and quality improvement programs in the healthcare, biopharmaceutical, and medical device and diagnostic industries; providing temporary use of non-downloadable web-based electronic data capture and management systems consisting of computer software for electronic data capture, analysis and management. providing temporary use of non-downloadable web-based clinical data management systems consisting of computer software for use in collecting, analyzing and reporting medical data relating to patient medical conditions in the area of patient registries, quality improvement programs and outcomes research and for use in conducting patient registries, post-approval marketing studies, electronic data capture services for post-approval marketing studies, and quality improvement programs in the healthcare, biopharmaceutical, and medical device and diagnostic industries; providing an online interactive computer database in the field of scientific affairs used in the fields of healthcare, biopharmaceutical, and medical device and diagnostic industries. Providing an interactive database featuring healthcare information. Providing an online interactive computer database in the field of regulatory affairs used in the fields of healthcare, biopharmaceutical, and medical device and diagnostic industries.


Trademark
Outcome science Inc. | Date: 2011-10-05

Computer software for use in collecting and reporting medical data relating to patient medical conditions in the area of patient registries, quality improvement programs and research; computer software for use in conducting patient registries, post-approval marketing studies observational studies, electronic data capture services for patient registries, post-approval marketing studies, and quality improvement programs in the healthcare, biopharmaceutical, and medical device and diagnostic industries. Business consultation in the field of healthcare; business consultation in the field of healthcare, namely, providing independent consultative review of clinical trials, peri-approval studies, post-approval studies, observational studies, post-approval surveys and clinical patient registries, post-approval marketing studies, and quality improvement programs in the healthcare, biopharmaceutical, and medical device and diagnostic industries all excluding the provision of medical services and medical treatment services; healthcare technology services, namely, the design, development and management of patient registries maintaining and providing patient registries. Educational services, namely, conducting healthcare conferences on issues surrounding safety and effectiveness after drugs and devices are approved by regulatory agencies; training related to the performance and evaluation of high quality patient registries and printed instructional, educational, and teaching materials and manuals in the field of the performance and evaluation of high quality patient registries distributed therewith. Healthcare management services, namely, providing quality improvement programs and research in the field of healthcare. Providing an online interactive computer database in the field of healthcare. Providing an online interactive computer database in the field of regulatory affairs used in the fields of healthcare, biopharmaceutical, and medical device and diagnostic industries.

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