Candace Fuller

Sapovirus Outbreaks in Long-Term Care Facilities, Oregon and Minnesota, USA, 2002–2009

Sapovirus gives new meaning to the phrase “cradle to grave.” Historically, sapovirus has been associated with gastrointestinal illness in children living in group settings such as hospitals, shelters, or refugee camps. But now, sapovirus outbreaks are occurring among elderly residents of long-term care and similar facilities. These elderly residents are especially vulnerable to rapidly transmitted gastrointestinal viruses and serious complications. This virus has been making the rounds in long-term care facilities since 2002, and outbreaks started increasing in 2007. Sapovirus testing should be added to routine diagnostic workups for gastrointestinal infections, regardless of patient age group. Results can be used to develop prevention, control, and treatment guidelines, especially for vulnerable elderly populations.

Comparison of Medicare Claims Versus Physician Adjudication for Identifying Stroke Outcomes in the Women’s Health Initiative

Background and Purpose— Many studies use medical record review for ascertaining outcomes. One large, longitudinal study, the Women’s Health Initiative (WHI), ascertains strokes using participant self-report and subsequent physician review of medical records. This is resource-intensive. Herein, we assess whether Medicare data can reliably assess stroke events in the WHI. Methods— Subjects were WHI participants with fee-for-service Medicare. Four stroke definitions were created for Medicare data using discharge diagnoses in hospitalization claims: definition 1, stroke codes in any position; definition 2, primary position stroke codes; and definitions 3 and 4, hemorrhagic and ischemic stroke codes, respectively. WHI data were randomly split into training (50%) and test sets. A concordance matrix was used to examine the agreement between WHI and Medicare stroke diagnosis. A WHI stroke and a Medicare stroke were considered a match if they occurred within ±7 days of each other. Refined analyses excluded Medicare events when medical records were unavailable for comparison. Results— Training data consisted of 24 428 randomly selected participants. There were 577 WHI strokes and 557 Medicare strokes using definition 1. Of these, 478 were a match. With regard to algorithm performance, specificity was 99.7%, negative predictive value was 99.7%, sensitivity was 82.8%, positive predictive value was 85.8%, and &kgr;=0.84. Performance was similar for test data. Whereas specificity and negative predictive value exceeded 99%, sensitivity ranged from 75% to 88% and positive predictive value ranged from 80% to 90% across stroke definitions. Conclusions— Medicare data seem useful for population-based stroke research; however, performance characteristics depend on the definition selected.

Ground Beef Handling and Cooking Practices in Restaurants in Eight States

Eating in table-service restaurants has been implicated as a risk factor for Escherichia coli O157:H7 infection. To explore this association and learn about the prevalence of risky ground beef preparation practices in restaurants, the Environmental Health Specialists Network (EHS-Net) assessed ground beef handling policies and practices in restaurants in California, Colorado, Connecticut, Georgia, Minnesota, New York, Oregon, and Tennessee. Eligible restaurants prepared and served hamburgers. EHS-Net specialists interviewed a restaurant employee with authority over the kitchen (defined as the manager) using a standard questionnaire about food safety policies, hamburger preparation policies, and use of irradiated ground beef. Interviews were followed by observations of ground beef preparation. Data from 385 restaurants were analyzed: 67% of the restaurants were independently owned and 33% were chain restaurants; 75% of the restaurants were sit down, 19% were quick service or fast food, and 6% were cafeteria or buffet restaurants. Eighty-one percent of restaurants reported determining doneness of hamburgers by one or more subjective measures, and 49% reported that they never measure the final cook temperatures of hamburgers. At least two risky ground beef handling practices were observed in 53% of restaurants. Only 1% of restaurants reported purchasing irradiated ground beef, and 29% were unfamiliar with irradiated ground beef. Differences in risky ground beef handling policies and practices were noted for type of restaurant ownership (independently owned versus chain) and type of food service style (sit down versus quick service or fast food). This study revealed the pervasiveness of risky ground beef handling policies and practices in restaurants and the need for educational campaigns targeting food workers and managers. These results highlight the importance of continued efforts to reduce the prevalence of E. coli O157:H7 in ground beef.

Successful Comparison of US Food and Drug Administration Sentinel Analysis Tools to Traditional Approaches in Quantifying a Known Drug‐Adverse Event Association

The US Food and Drug Administrations Sentinel system has developed the capability to conduct active safety surveillance of marketed medical products in a large network of electronic healthcare databases. We assessed the extent to which the newly developed, semiautomated Sentinel Propensity Score Matching (PSM) tool could produce the same results as a customized protocol‐driven assessment, which found an adjusted hazard ratio (HR) of 3.04 (95% confidence interval [CI], 2.81–3.27) comparing angioedema in patients initiating angiotensin‐converting enzyme (ACE) inhibitors vs. beta‐blockers. Using data from 13 Data Partners between 1 January 2008, and 30 September 2013, the PSM tool identified 2,211,215 eligible ACE inhibitor and 1,673,682 eligible beta‐blocker initiators. The tool produced an HR of 3.14 (95% CI, 2.86–3.44). This comparison provides initial evidence that Sentinel analytic tools can produce findings similar to those produced by a highly customized protocol‐driven assessment.

Sentinel Modular Program for Propensity Score–Matched Cohort Analyses: Application to Glyburide, Glipizide, and Serious Hypoglycemia

Sentinel is a program sponsored by the US Food and Drug Administration to monitor the safety of medical products. We conducted a cohort assessment to evaluate the ability of the Sentinel Propensity Score Matching Tool to reproduce in an expedited fashion the known association between glyburide (vs. glipizide) and serious hypoglycemia. Thirteen data partners who contribute to the Sentinel Distributed Database participated in this analysis. A pretested and customizable analytic program was run at each individual site. De-identified summary results from each data partner were returned and aggregated at the Sentinel Operations Center. We identified a total of 198,550 and 379,507 new users of glyburide and glipizide, respectively. The incidence of emergency department visits and hospital admissions for serious hypoglycemia was 19 per 1000 person-years (95% confidence interval = 17.9, 19.7) for glyburide users and 22 (21.6, 22.7) for glipizide users. In cohorts matched by propensity score based on predefined variables, the hazard ratio (HR) for glyburide was 1.36 (1.24, 1.49) versus glipizide. In cohorts matched on a high-dimensional propensity score based on empirically selected variables, for which the program ran to completion in five data partners, the HR was 1.49 (1.31, 1.70). In cohorts matched on propensity scores based on both predefined and empirically selected variables via the high-dimensional propensity score algorithm (the same five data partners), the HR was 1.51 (1.32, 1.71). These findings are consistent with the literature, and demonstrate the ability of the Sentinel Propensity Score Matching Tool to reproduce this known association in an expedited fashion. See video abstract at, http://links.lww.com/EDE/B275.

Trends in 10-Year Survival of Patients With Stroke Hospitalized Between 1980 and 2000 The Minnesota Stroke Survey

Background and Purpose— We report on trends in poststroke survival, both in the early period after stroke and over the long term. We examine these trends by stroke subtype. Methods— The Minnesota Stroke Survey is a study of all hospitalized patients with acute stroke aged 30 to 74 years in the Minneapolis–St Paul metropolis. Validated stroke events were sampled for survey years 1980, 1985, 1990, 1995, and 2000 and subtyped as ischemic or hemorrhagic by neuroimaging for survey years 1990, 1995, and 2000. Survival was obtained by linkage to vital statistics data through the year 2010. Results— There were 3773 acute stroke events. Age-adjusted 10-year survival improved from 1980 to 2000 (men 29.5% and 46.5%; P<0.0001; women 32.6% and 50.5%; P<0.0001). Ten-year ischemic stroke survival (n=1667) improved from 1990 to 2000 (men 35.3% and 50%; P=0.0001; women 38% and 55.3%; P<0.0001). Ten-year hemorrhagic stroke survival showed a trend toward improvement, but this (n=489) did not reach statistical significance, perhaps because of their smaller number (men 29.7% and 45.8%; P=0.06; women 39.2% and 49.6%; P=0.2). Markers of stroke severity including unconsciousness or major neurological deficits at admission declined from 1980 to 2000 while neuroimaging use increased. Conclusions— These poststroke survival trends are likely because of multiple factors, including more sensitive case ascertainment shifting the case mix toward less severe strokes, improved stroke care and risk factor management, and overall improvements in population health and longevity.

Impact of an Electronic Medical Record-Based Clinical Decision Support Tool for Dysphagia Screening on Care Quality

Background and Purpose— Dysphagia screening (DS) before oral intake in patients with acute stroke is a hospital-level performance measure. We report outcomes of an initiative to improve compliance to this quality measure. Methods— The design was a pre- versus postintervention comparison study. The Intervention was an electronic medical record-based clinical DS system embedded within stroke admission orders. The clinical DS was designed to facilitate DS in patients with stroke. The primary outcome was compliance to a process measure in patients with ischemic stroke: performance of a swallow screen before oral intake. Results— DS measure compliance increased from 36% to 74% (P=0.001). Chart audits found screened patients were more likely to have clinical DS-embedded admission orders initiated or stroke unit admission. Conclusion— The electronic medical record offers a ready platform for clinical DS implementation. DS is a difficult performance measure to improve. The described clinical DS has the potential for improving performance on this challenging care quality measure.

Prospective surveillance pilot of rivaroxaban safety within the US Food and Drug Administration Sentinel System

The US Food and Drug Administrations Sentinel system developed tools for sequential surveillance.

Chart validation of inpatient ICD‐9‐CM administrative diagnosis codes for acute myocardial infarction (AMI) among intravenous immune globulin (IGIV) users in the Sentinel Distributed Database

The Sentinel Distributed Database (SDD) is a large database of patient‐level administrative health care records, primarily derived from insurance claims and electronic health records, and is sponsored by the US Food and Drug Administration for medical product safety evaluations. Acute myocardial infarction (AMI) is a common study endpoint for drug safety studies that rely on health records from the SDD and other administrative databases.

Evaluation of the US Food and Drug Administration sentinel analysis tools in confirming previously observed drug-outcome associations: The case of clindamycin and Clostridium difficile infection

The Food and Drug Administrations Sentinel System developed parameterized, reusable analytic programs for evaluation of medical product safety. Research on outpatient antibiotic exposures, and Clostridium difficile infection (CDI) with non‐user reference groups led us to expect a higher rate of CDI among outpatient clindamycin users vs penicillin users. We evaluated the ability of the Cohort Identification and Descriptive Analysis and Propensity Score Matching tools to identify a higher rate of CDI among clindamycin users.