Jennifer M Polinski

Brigham and Women's Hospital, Boston, Massachusetts, United States

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Publications (52)240.9 Total impact

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    ABSTRACT: Generic drugs are approved on the basis of pharmaceutical equivalence and bioequivalence. Some drug products have unique structural or functional attributes, necessitating modified approaches to bioequivalence determinations. The aim of this systematic review was to identify studies that evaluated laboratory or clinical outcomes of six drugs approved via modified bioequivalence approaches. We conducted a systematic review of articles published through February 2014 in MEDLINE, EMBASE, and International Pharmaceutical Abstracts related to six recent drugs subject to modified regulatory approaches: venlafaxine extended release tablet (Effexor XR), acarbose (Precose), enoxaparin (Lovenox), vancomycin capsules (Vancocin), sodium ferric gluconate (Ferrlecit), and calcitonin salmon nasal spray (Miacalcin NS). We included all empirical evaluations (whether in vivo or in vitro) and excluded case studies, qualitative analyses, and pharmacoeconomic evaluations. Studies were summarized and evaluated on their methodological quality and assessed for bias using the Cochrane Risk of Bias Assessment Tool. Articles were divided into studies of US FDA-approved generics and non-FDA-approved generics available in non-US locations. We extracted drug(s) studied, study design, setting, sample size, population characteristics, study endpoints and results, and source of funding. After retrieving 1408 articles and searching through the full text of 106 articles, we found 26 articles that met our inclusion criteria-8 examining FDA-approved versions and 18 examining non-FDA-approved versions. Among FDA-approved generics, five studies of enoxaparin showed minor variations in biologic activities of unclear clinical importance, and no publications involved acarbose, venlafaxine ER, or vancomycin capsules. Among non-FDA-approved generics, nine studies of enoxaparin supported generic bioequivalence, despite three showing minor variations in drug activity. Four of six studies of venlafaxine ER supported generic bioequivalence, while two found a lack of bioequivalence with a Canadian generic version of the drug. Most studies were either highly susceptible to bias (12/26) or were not able to be assessed for bias (13/26), in part because eight studies were abstracts/posters without full reports. Pharmaceutical manufacturers sometimes raise scientific concerns related to potential generic versions of their drugs; however, in the six cases we reviewed, these companies did not follow up the pre-approval concerns they raised with any methodologically rigorous post-approval testing using clinical endpoints. Despite their pre-approval controversy, experience with these generic drugs provides reassurance of their clinical interchangeability. Systematized post-approval study of certain generic drug bioequivalence determinations is needed.
    Drugs 03/2015; DOI:10.1007/s40265-015-0382-1 · 4.13 Impact Factor
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    ABSTRACT: With proliferating treatment options for anticoagulant therapy, physicians and patients must choose among them based on their benefits and risks. Using a Discrete Choice Experiment, we elicited patients' relative preferences for specific benefits and risks of anticoagulant therapy.
    Circulation Cardiovascular Quality and Outcomes 11/2014; DOI:10.1161/CIRCOUTCOMES.114.001013 · 5.04 Impact Factor
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    ABSTRACT: Objective: Disease-modifying antirheumatic drugs (DMARDs) are recommended for all patients with rheumatoid arthritis (RA). Some estimate that approximately one-half of patients with RA do not receive DMARDs. We hypothesized that patients with RA living further from rheumatologists would be less likely to receive RA diagnoses and to receive DMARDs. Methods: U.S.-based Medicare patients aged ≥65 were study eligible. We calculated driving distance from patients' homes to the nearest rheumatologist. Using multivariable logistic regression, we assessed relationships between driving distance and RA diagnosis and between driving distance and DMARD receipt. In one set of analyses, distance was divided into quartiles: 0-2, 2.1-5, 5.1-15.9, ≥16 miles. In a second, we used pre-defined categories: 0-15, 15.1-30, 30.1-60, ≥60 miles. Results: Among 59,426 Medicare beneficiaries, 918 had diagnosed RA. Compared to the first quartile, increased distance was associated with decreased odds of RA diagnosis: second quartile, OR=0.96 (95% CI, 0.80-1.16); third=0.88 (0.72-1.07); fourth=0.72 (0.56-0.93), p for trend=0.01. Similar results were observed using pre-defined categories. Among those with RA, increased distance was associated with increased odds of DMARD receipt across quartiles: second=1.15 (1.06-1.25); third=1.41 (1.29-1.54); fourth=1.32 (1.18-1.46), p for trend=0.001. There was no relationship between pre-defined categories and DMARD receipt, p for trend=0.45. Conclusion: Increased driving distance to rheumatologists was associated with decreased odds of RA diagnosis. Among those with diagnosed RA, the odds of DMARD receipt rose as distance increased from <2-16 miles, but not beyond. Urban residents living closer to rheumatologists may have barriers to DMARD use besides from geographic access. © 2014 American College of Rheumatology.
    11/2014; 66(11). DOI:10.1002/acr.22333
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    ABSTRACT: Background: Statins are effective in preventing cardiovascular events, but patients do not fully adhere to them. Objective: To determine whether patients are more adherent to generic statins versus brand-name statins (lovastatin, pravastatin, or simvastatin) and whether greater adherence improves health outcomes. Design: Observational, propensity score-matched, new-user cohort study. Setting: Linked electronic data from medical and pharmacy claims. Participants: Medicare beneficiaries aged 65 years or older with prescription drug coverage between 2006 and 2008. Intervention: Initiation of a generic or brand-name statin. Measurements: Adherence to statin therapy (measured as the proportion of days covered [PDC] up to 1 year) and a composite outcome comprising hospitalization for an acute coronary syndrome or stroke and all-cause mortality. Hazard ratios (HRs) and absolute rate differences were estimated. Results: A total of 90 111 patients who initiated a statin during the study was identified; 83 731 (93%) initiated a generic drug, and 6380 (7%) initiated a brand-name drug. The mean age of patients was 75.6 years, and most (61%) were female. The average PDC was 77% for patients in the generic group and 71% for those in the brand-name group (P < 0.001). An 8% reduction in the rate of the clinical outcome was observed among patients in the generic group versus those in the brand-name group (HR, 0.92 [95% CI, 0.86 to 0.99]). The absolute difference was -1.53 events per 100 person-years (CI, -2.69 to -0.19 events per 100 person-years). Limitation: Results may not be generalizable to other populations with different incomes or drug benefit structures. Conclusion: Compared with those initiating brand-name statins, patients initiating generic statins were more likely to adhere and had a lower rate of a composite clinical outcome.
    Annals of internal medicine 09/2014; 161(6):400-407. DOI:10.7326/M13-2942 · 16.10 Impact Factor
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    ABSTRACT: PurposeType 2 diabetes mellitus has reached epidemic proportions worldwide. Many patients with type 2 diabetes mellitus will require insulin, and the evidence-based use of insulin is described in the prescription drug label. Product labels in different countries may provide inconsistent information. We evaluated the variability in drug label content for one brand of basal insulin across diverse settings.Methods We examined the drug label content pertinent to effective and safe use of insulin glargine across 17 countries: Abu Dhabi (United Arab Emirates), Argentina, Brazil, Canada, China, Germany, Israel, Italy, Japan, Mexico, Russia, Saudi Arabia, South Korea, Spain, Turkey, UK, and the USA. We compared label characteristics in settings where drug labels were governed by a local regulatory authority versus countries where labels were administered by a regional body or adopted from another locale.ResultsAll 17 labels cautioned that providers should consider age, illness, diet, and exercise when prescribing. Only two (12%) described care of the fasting patient. Caution was urged for patients with renal or hepatic impairment in 16 (94%) labels. Four (24%) did not describe responses to missed doses, and five (29%) failed to recommend patient counseling about the risk of hypoglycemia. Labels emerging from regional or adopted regulatory bodies reported fewer patients in efficacy studies than did labels from settings with their own drug regulatory agencies (365 ± 0 patients vs. 3560 ± 2938, p = 0.04).Conclusions There is substantial variation in the content of drug labels for glargine, which may lead to international inconsistency in quality of care for diabetic patients. Copyright © 2014 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 09/2014; DOI:10.1002/pds.3704 · 2.90 Impact Factor
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    ABSTRACT: Primary medication adherence occurs when a patient properly fills the first prescription for a new medication. Primary adherence only occurs about three-quarters of the time for antihypertensive medications. We assessed patients' barriers to primary adherence and attributes of patient-provider discussions that might improve primary adherence for antihypertensives. In total, 26 patients with incomplete primary adherence for an antihypertensive, identified using their retail pharmacy claims, participated in four focus groups. Following a moderators' guide developed a priori, moderators led patients in a discussion of patients' attitudes and experiences with hypertension and receiving an antihypertensive medication, barriers to primary adherence, and their preferences for shared decision making and communication with providers. Three authors analysed and organized data into salient themes, including patients' anger about and suspicion of their hypertension diagnosis, the need for medication and providers' credibility. A trusting patient-provider relationship, shared decision-making support, full disclosure of side effects and cost sensitivity were attributes that might enhance primary adherence. Developing decision support interventions that strengthen the patient-provider relationship by enhancing provider credibility and patient trust prior to prescribing may provide more effective approaches for improving primary adherence.
    Health Education Research 05/2014; 29(5). DOI:10.1093/her/cyu023 · 1.66 Impact Factor
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    ABSTRACT: Longitudinal healthcare claim databases are frequently used for studying the comparative safety and effectiveness of medications, but results from these studies may be biased due to residual confounding. It is unclear whether methods for confounding adjustment that have been shown to perform well in small, simple nonrandomized studies are applicable to the large, complex pharmacoepidemiologic studies created from secondary healthcare data. Ordinary simulation approaches for evaluating the performance of statistical methods do not capture important features of healthcare claims. A statistical framework for creating replicated simulation datasets from an empirical cohort study in electronic healthcare claims data is developed and validated. The approach relies on resampling from the observed covariate and exposure data without modification in all simulated datasets to preserve the associations among these variables. Repeated outcomes are simulated using a true treatment effect of the investigator’s choice and the baseline hazard function estimated from the empirical data. As an example, this framework is applied to a study of high versus low-intensity statin use and cardiovascular outcomes. Simulated data is based on real data drawn from Medicare Parts A and B linked with a prescription drug insurance claims database maintained by Caremark. Properties of the data simulated using this framework are compared with the empirical data on which the simulations were based. In addition, the simulated datasets are used to compare variable selection strategies for confounder adjustment via the propensity score, including high-dimensional approaches that could not be evaluated with ordinary simulation methods. The simulated datasets are found to closely resemble the observed complex data structure but have the advantage of an investigator-specified exposure effect.
    Computational Statistics & Data Analysis 04/2014; 72:219–226. DOI:10.1016/j.csda.2013.10.018 · 1.15 Impact Factor
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    ABSTRACT: Medication copayments can influence patient choices. We evaluated 2 copayment policies implemented by Massachusetts Medicaid incentivizing the use of selected generic medications. In 2009, Massachusetts Medicaid copayments were $1 for generics and $3 for brands. On February 1, 2009, copayments for generic antihypertensives, antihyperlipidemics, and hypoglycemics (target medications) remained at $1, whereas copayments for all nontarget generics increased to $2 (policy #1) and $3 on July 1, 2010 (policy #2). Using state-level, aggregate prescription data, we developed interrupted time-series models with controls to evaluate the impact of these policies on use of target generics, target brands, and nontarget essential medications (defined as medications required for ongoing treatment of serious medical conditions). After policy #1, target generic use increased by 0.93% (P<0.001) with a subsequent quarterly slope decrease of -0.16% (P<0.01); policy #2 led to a slope increase of 0.20% (P<0.01) for target generics; increase in target generics attributable to policy changes was 28,000 prescriptions per year. Neither policy affected target brand use. For nontarget essential generics, there was a -0.27% (P<0.001) quarterly slope decrease after policy #1 and a 0.32% (P<0.01) slope increase after policy #2 with total decrease attributable to policy changes of 127,300 prescriptions per year. For nontarget essential brands, there was a level increase of 0.91% (P<0.001) after policy #1 with increased use attributable to policy changes of 98,300 prescriptions per year. Two copayment policies designed to encourage use of selected generic medications modestly increased their use; however, there was a shift in other essential medications from generics to brands, which could increase Medicaid costs. When adjusting copayments, careful consideration must be given to unintended consequences of specific policy structures.
    Medical care 03/2014; 52(5). DOI:10.1097/MLR.0000000000000119 · 2.94 Impact Factor
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    ABSTRACT: Statin use has increased substantially in North America and Europe, with resultant reductions in cardiovascular mortality. However, little is known about statin use in lower-income countries. India is of interest because of its burden of cardiovascular disease, the unique nature of its prescription drug market, and the growing globalization of drug sales. We conducted an observational study using IMS Health data for the period February 2006-January 2010. During the period, monthly statin prescriptions increased from 45.8 to 84.1 per 1,000 patients with coronary heart disease-an increase of 0.80 prescriptions per month. The proportion of the Indian population receiving a defined daily statin dose increased from 3.35 percent to 7.78 percent. Nevertheless, only a fraction of those eligible for a statin appeared to receive the therapy, even though there were 259 distinct statin products available to Indian consumers in January 2010. Low rates of statin use in India may reflect problems with access to health care, affordability, underdiagnosis, and cultural beliefs. Because of the growing burden of cardiovascular disease in lower-income countries such as India, there is an urgent need to increase statin use and ensure access to safe products whose use is based on evidence. Policies are needed to expand insurance, increase medications' affordability, educate physicians and patients, and improve regulatory oversight.
    Health Affairs 02/2014; 33(2):273-82. DOI:10.1377/hlthaff.2013.0388 · 4.64 Impact Factor
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    ABSTRACT: Type 2 diabetes (T2DM) diagnoses are skyrocketing, making treatment of this disease an increasing focus of primary care visits. Guidelines recommend insulin intensification over time to achieve HbA1c targets. We conducted a systematic review regarding patterns and trends of insulin intensification and barriers to intensification. Providers across primary and specialty care settings often did not intensify insulin regimens despite patients' clinical status. Even among progressed patients, HbA1c values remained high. The paucity of available studies prevented a comprehensive understanding of patterns and trends in insulin intensification. Such information is needed to assess the quality of pharmacologic care for patients with T2DM.
    11/2013; DOI:10.1016/j.pcd.2013.10.008
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    ABSTRACT: Many patients with type 2 diabetes eventually require insulin, yet little is known about the patterns and quality of pharmacologic care received following insulin initiation. Guidelines from the American Diabetes Association and the European Association for the Study of Diabetes recommend that insulin secretagogues such as sulfonylureas be discontinued at the time of insulin initiation to reduce the risk of hypoglycemia, and that treatment be intensified if HbA1c levels remain above-target 3 months after insulin initiation. To describe pharmacologic treatment patterns over time among adults initiating insulin and/or intensifying insulin treatment. Observational study. A large commercially insured population of adult patients without recorded type 1 diabetes who initiated insulin. We evaluated changes in non-insulin antidiabetic medication use during the 120 days immediately following insulin initiation, rates of increase in insulin dose and/or dosing frequency during the 270 days following an insulin initiation treatment period of 90 days, and rates of insulin discontinuation. Seven thousand, nine hundred and thirty-two patients initiated insulin during 2003-2008, with the majority (61 %) initiating basal insulin only. Metformin (55 %), sulfonylureas (39 %), and thiazolidinediones (30 %) were commonly used prior to insulin initiation. Metformin was continued by 64 % of patients following mixed or mealtime insulin initiation; the continuation rate was nearly as high for sulfonylureas (58 %). Insulin dose and/or dosing frequency increased among 22.9 % of patients. Insulin was discontinued by 27 % of patients. We found evidence of substantial departures from guideline-recommended pharmacotherapy. Insulin secretagogues were frequently co-prescribed with insulin. The majority of patients had no evidence of treatment intensification following insulin initiation, although this finding is difficult to interpret without HbA1c levels. While each patient's care should be individualized, our data suggest that the quality of care following insulin initiation can be improved.
    Journal of General Internal Medicine 10/2013; 29(2). DOI:10.1007/s11606-013-2643-6 · 3.42 Impact Factor
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    ABSTRACT: To examine the relation between the type of stress ulcer prophylaxis administered and the risk of postoperative pneumonia in patients undergoing coronary artery bypass grafting. Retrospective cohort study. Premier Research Database. 21 214 patients undergoing coronary artery bypass graft surgery between 2004 and 2010; 9830 (46.3%) started proton pump inhibitors and 11 384 (53.7%) started H2 receptor antagonists in the immediate postoperative period. Occurrence of postoperative pneumonia, assessed using appropriate diagnostic codes. Overall, 492 (5.0%) of the 9830 patients receiving a proton pump inhibitor and 487 (4.3%) of the 11 384 patients receiving an H2 receptor antagonist developed postoperative pneumonia during the index hospital admission. After propensity score adjustment, an elevated risk of pneumonia associated with treatment with proton pump inhibitors compared with H2 receptor antagonists remained (relative risk 1.19, 95% confidence interval 1.03 to 1.38). In the instrumental variable analysis, use of a proton pump inhibitor (compared with an H2 receptor antagonist) was associated with an increased risk of pneumonia of 8.2 (95% confidence interval 0.5 to 15.9) cases per 1000 patients. Patients treated with proton pump inhibitors for stress ulcer had a small increase in the risk of postoperative pneumonia compared with patients treated with H2 receptor antagonists; this risk remained after confounding was accounted for using multiple analytic approaches.
    BMJ (online) 09/2013; 347:f5416. DOI:10.1136/bmj.f5416 · 16.38 Impact Factor
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    ABSTRACT: To ascertain predictors of initiation of brand-name versus generic narrow therapeutic index (NTI) drugs. Retrospective cohort study. Data from CVS Caremark were linked to Medicare claims and to U.S. census data. Individuals aged 65 and older who initiated an NTI drug in 2006 and 2007 (N = 36,832). Demographic, health service utilization, and geographic predictors of whether participants initiated a generic or brand-name version of their NTI drug were identified using logistic regression. Overall, 30,014 (81.5%) participants started on a generic version of their NTI drug. The most commonly initiated NTI drugs were warfarin (n = 17,790; 48%), levothyroxine (n = 10,779; 29%), and digoxin (n = 6,414; 17%). Older age (odds ratio (OR) = 1.12, 95% confidence interval (CI) = 1.02-1.22 comparing aged ≥85 with 65-74), higher burden of comorbidity (OR = 1.05, 95% CI = 1.04-1.07 for each 1-point increase in comorbidity score), and prior use of any generic drug (OR = 1.55, 95% CI = 1.29-1.87) were positively associated with generic drug initiation. Independent of other predictors, residing in the census block group with the highest generic use was positively associated with greater odds of generic NTI drug initiation (OR = 1.24, 95% CI = 1.14-1.35 compared with the lowest quintile). Demographic, health service utilization, and geographic characteristics are important determinants of whether individuals initiate treatment with a brand-name or generic NTI drug. These factors may contribute to disparities in care and highlight potential targets for educational campaigns.
    Journal of the American Geriatrics Society 09/2013; DOI:10.1111/jgs.12399 · 4.22 Impact Factor
  • Journal of the American Geriatrics Society 05/2013; 61(5):848-849. DOI:10.1111/jgs.12243 · 4.22 Impact Factor
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    ABSTRACT: OBJECTIVE: The incidence of hospital-acquired Clostridium difficile infection (CDI) has increased rapidly over the past decade; patients undergoing major surgery, including coronary artery bypass grafting (CABG), are at particular risk. Intravenous vancomycin exposure has been identified as an independent risk factor for CDI, but this is controversial. It is not known whether vancomycin administered for surgical site infection prophylaxis increases the risk of CDI. METHODS: Using data from the Premier Perspective Comparative Database, we assembled a cohort of 69,807 patients undergoing CABG surgery between 2004 and 2010 who received either a cephalosporin alone (65.1%) or a cephalosporin plus vancomycin (34.9%) on the day of surgery. Patients were observed for CDI until discharge from the index hospitalization. In these groups, we evaluated the comparative rate of postoperative CDI with Cox models; confounding was addressed using propensity scores. RESULTS: In all, 77 (0.32%) of the 24,393 patients receiving a cephalosporin plus vancomycin and 179 (0.39%) of the 45,414 patients receiving a cephalosporin alone had postoperative CDI (unadjusted hazard ratio [HR], 0.73; 95% confidence interval [CI], 0.56-0.95). After adjusting for confounding variables with either propensity score matching or stratification, there was no meaningful association between adjuvant vancomycin exposure and postoperative CDI (HR, 0.85; 95% CI, 0.61-1.19; and HR, 0.85; 95% CI, 0.63-1.15, respectively). Results of multiple sensitivity analyses were similar to the main findings. CONCLUSIONS: After adjustment for patient and surgical characteristics, a short course of prophylactic vancomycin was not associated with an increased risk of CDI among patients undergoing CABG surgery.
    The Journal of thoracic and cardiovascular surgery 03/2013; 146(2). DOI:10.1016/j.jtcvs.2013.02.075 · 3.41 Impact Factor
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    ABSTRACT: PurposeTreatment guidelines recommend insulin progression (switching from basal to a premixed insulin regimen, adding bolus doses, and/or increasing dosing frequency) to achieve A1C targets as type 2 diabetes progresses, but fewer patients are being progressed than would be indicated based on their disease status. This systematic review proposes 2 questions regarding insulin progression among patients with type 2 diabetes: (1) What are the patient, provider, and health system barriers to insulin progression? (2) Do insulin progression barriers differ between insulin-naive and insulin-experienced patients?Methods We conducted a systematic review in the MEDLINE, EMBASE, Science Citation Index, PsycINFO, CINAHL, and Cochrane Library databases through July 2011.ResultsOf 745 potentially relevant articles, 10 met inclusion criteria: 7 evaluated patient and 2 evaluated provider barriers, and 1 was an intervention to reduce barriers among physicians. Patients with prior insulin experience had fewer barriers arising from injection-related concerns and worries about the burden of insulin progression than did insulin-naive patients. Physician barriers included concerns about patients' ability to follow more complicated regimens as well as physicians' own inexperience with insulin and progression algorithms. The cross- sectional nature, narrow scope, and failure of all studies to examine patient, provider, and health systems barriers concurrently limited both barrier identification and an assessment of their impact on progression.Conclusions Patient and physician experience with insulin and diabetes/insulin education were associated with fewer perceived barriers to insulin progression. Future studies should use multilevel longitudinal designs to quantify the relative impact of potential patient, provider, and health system factors on progression and health outcomes.
    The Diabetes Educator 11/2012; 39(1). DOI:10.1177/0145721712467696 · 1.92 Impact Factor
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    ABSTRACT: Background Although consensus guidelines recommend insulin progression among patients with type 2 diabetes (T2DM) who fail to meet glycemic targets over time, many fewer patients are progressed than may benefit. We describe the rationale and design of the MOSAIc (Multinational Observational Study Assessing Insulin use) study, a multinational observational cohort study to identify patient-, physician, and health care environment-based factors associated with insulin progression for patients with T2DM in real-world practice. Methods/design We will enroll 4,500 patients with T2DM taking initial insulin therapy for ≥3 months across 175 physician practice sites in 18 countries. Extensive demographic, clinical, and psychosocial data at the patient and physician level and practice site characteristics will be collected at baseline and regular intervals during a 24-month follow-up period. We will use a multivariable logistic regression model to identify predictors of insulin progression and highlight potential opportunities for health behavior intervention to improve insulin progression rates. Secondary outcomes include evaluating factors associated with glycemic control, hypoglycemia, and treatment adherence among patients who do and do not progress beyond their initial insulin therapy and exploring geographic heterogeneity in treatment. Discussion Practice site and patient recruitment began in 2011 and baseline data will be available in late 2012. The MOSAIC study’s longitudinal observational design as well as the breadth and depth of data will be used to explore and quantify predictors of insulin progression and to identify potential opportunities for health behavior intervention in order to improve T2DM treatment and clinical outcomes.
    BMC Endocrine Disorders 09/2012; 12(1). DOI:10.1186/1472-6823-12-20 · 1.67 Impact Factor
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    ABSTRACT: To determine whether Part D coverage gap entry is associated with risk of death or hospitalization for cardiovascular outcomes. Prospective cohort study. Beneficiaries entered the study upon reaching the coverage gap spending threshold and were observed until an outcome reaching the threshold for catastrophic coverage occurred or year's end. Nine thousand four hundred thirty-six exposed individuals (those who were responsible for drug costs in the gap) were compared with 9,436 unexposed individuals (those who received financial assistance) based on propensity score (PS) or high-dimensional propensity score (hdPS). Medicare Part D drug insurance. Three hundred three thousand nine hundred seventy-eight Medicare beneficiaries aged 65 and older in 2006 and 2007 with linked prescription and medical claims who enrolled in stand-alone Part D or retiree drug plans and reached the gap spending threshold. Rates of death and hospitalization for any of five cardiovascular outcomes, including acute coronary syndrome with revascularization (ACS), after reaching the coverage gap spending threshold were compared using Cox proportional hazards models. In PS-matched analyses, exposed beneficiaries had higher, albeit not significantly so, hazard of death (hazard ratio (HR) = 1.25, 95% confidence interval (CI) = 0.98-1.59) and ACS (HR = 1.16, 95% CI = 0.83-1.62) than unexposed beneficiaries. hdPS-matched analyses minimized residual confounding and confirmed results (death: HR = 0.99, 95% CI = 0.78-1.24; ACS: HR = 1.07, 95% CI = 0.81-1.41). Exposed beneficiaries were no more or less likely to experience other outcomes than were those who were unexposed. During the short-term coverage gap period, having no financial assistance to pay for drugs was not associated with greater risk of death or hospitalization for cardiovascular causes, although long-term health consequences remain unclear.
    Journal of the American Geriatrics Society 07/2012; 60(8):1408-17. DOI:10.1111/j.1532-5415.2012.04073.x · 4.22 Impact Factor
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    ABSTRACT: Controversy exists regarding the optimal preventative therapy for venous thromboembolism (VTE) after coronary artery bypass graft (CABG) surgery. We sought to compare the effectiveness and safety of the most commonly used regimens. We assembled a cohort of 92 699 patients who underwent CABG between 2004 and 2008, using the Premier database. Patients were categorized by method of VTE prevention initiated within 48 hours of surgery, including no preventative therapy (n=55 400), mechanical preventative therapy (n=21 162), subcutaneous unfractio--nated or low-molecular-weight heparin (n=10 718), subcutaneous fondaparinux (n=88), and concurrent mechanical-chemical therapy (n=5331). The incidence of VTE and major bleeding events within 6 weeks of CABG were compared, using multivariable and propensity score adjustment. The overall incidence of VTE for the entire cohort was 0.74%, and the incidence of major bleeding was 1.43%. VTE and bleeding events occurred with similar incidence in each of the patient categories (VTE: 0.70%, 0.79%, 0.81%, 1.14%, and 0.73%; major bleeding: 1.36%, 1.45%, 1.69%, 3.41%, 1.50%; no prevention, mechanical prevention, subcutaneous heparin, subcutaneous fondaparinux, concurrent mechanical-chemical prevention, respectively). Compared with receiving no prevention, the use of mechanical prevention or subcutaneous heparin did not significantly reduce the risk of VTE or change the risk of major bleeding (P=NS). Venous thromboembolism occurs infrequently after CABG. Compared with the use of no prevention, the administration of chemical or mechanical preventative therapies to CABG patients does not appreciably lower the risk of VTE. These data provide support for the common practice of administering no VTE preventative therapy after CABG, used for nearly 60% of patients within this cohort.
    Circulation Cardiovascular Interventions 06/2012; 5(4):590-6. DOI:10.1161/CIRCINTERVENTIONS.112.968313 · 6.54 Impact Factor
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    ABSTRACT: Under Medicare Part D, patient characteristics influence plan choice, which in turn influences Part D coverage gap entry. We compared predefined propensity score (PS) and high-dimensional propensity score (hdPS) approaches to address such "confounding by health system use" in assessing whether coverage gap entry is associated with cardiovascular events or death. We followed 243,079 Medicare patients aged 65+ years with linked prescription, medical, and plan-specific data in 2005-2007. Patients reached the coverage gap and were followed until an event or year's end. Exposed patients were responsible for drug costs in the gap; unexposed patients (patients with non-Part D drug insurance and Part D patients receiving a low-income subsidy) received financial assistance. Exposed patients were 1:1 PS-matched or hdPS-matched to unexposed patients. The PS model included 52 predefined covariates; the hdPS model added 400 empirically identified covariates. Hazard ratios for death and any of five cardiovascular outcomes were compared. In sensitivity analyses, we explored residual confounding using only low-income subsidy patients in the unexposed group. In unadjusted analyses, exposed patients had no greater hazard of death (HR = 1.00; 95%CI, 0.84-1.20) or other outcomes. PS-matched (HR = 1.29; 0.99-1.66) and hdPS-matched (HR = 1.11; 0.86-1.42) analyses showed elevated but non-significant hazards of death. In sensitivity analyses, the PS analysis showed a protective effect (HR = 0.78; 0.61-0.98), whereas the hdPS analysis (HR = 1.06; 0.82-1.37) confirmed the main hdPS findings. Although the PS-matched analysis suggested elevated but non-significant hazards of death among patients with no financial assistance during the gap, the hdPS analysis produced lower estimates that were stable across sensitivity analyses.
    Pharmacoepidemiology and Drug Safety 05/2012; 21 Suppl 2:90-8. DOI:10.1002/pds.3250 · 2.90 Impact Factor

Publication Stats

689 Citations
240.90 Total Impact Points


  • 2007–2014
    • Brigham and Women's Hospital
      • • Division of Pharmacoepidemiology and Pharmacoeconomics
      • • Department of Medicine
      Boston, Massachusetts, United States
  • 2005–2014
    • Harvard Medical School
      • Department of Medicine
      Boston, Massachusetts, United States
  • 2006–2013
    • Harvard University
      Cambridge, Massachusetts, United States
  • 2006–2009
    • Partners HealthCare
      Boston, Massachusetts, United States
  • 2008
    • Dana-Farber Cancer Institute
      Boston, Massachusetts, United States