Roselie A. Bright

Incidence and short-term outcomes of primary and revision hip replacement in the United States.

BACKGROUND The purpose of this study was to use 2003 nationwide United States data to determine the incidences of primary total hip replacement, partial hip replacement, and revision hip replacement and to assess the short-term patient outcomes and factors associated with the outcomes. METHODS We screened more than eight million hospital discharge abstracts from the 2003 Healthcare Cost and Utilization Project Nationwide Inpatient Sample and approximately nine million discharge abstracts from five state inpatient databases. Patients who had undergone total, partial, or revision hip replacement were identified with use of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) procedure codes. In-hospital mortality, perioperative complications, readmissions, and the association between these outcomes and certain patient and hospital variables were analyzed. RESULTS Approximately 200,000 total hip replacements, 100,000 partial hip replacements, and 36,000 revision hip replacements were performed in the United States in 2003. Approximately 60% of the patients were sixty-five years of age or older and at least 75% had one or more comorbid diseases. The in-hospital mortality rates associated with these three procedures were 0.33%, 3.04%, and 0.84%, respectively. The perioperative complication rates associated with the three procedures were 0.68%, 1.36%, and 1.08%, respectively, for deep vein thrombosis or pulmonary embolism; 0.28%, 1.88%, and 1.27% for decubitus ulcer; and 0.05%, 0.06%, and 0.25% for postoperative infection. The rates of readmission, for any cause, within thirty days were 4.91%, 12.15%, and 8.48%, respectively, and the rates of readmissions, within thirty days, that resulted in a surgical procedure on the affected hip were 0.79%, 0.91%, and 1.53%. The rates of readmission, for any cause, within ninety days were 8.94%, 21.14%, and 15.72%, and the rates of readmissions, within ninety days, that resulted in a surgical procedure on the affected hip were 2.15%, 1.61%, and 3.99%. Advanced age and comorbid diseases were associated with worse outcomes, while private insurance coverage and planned admissions were associated with better outcomes. No consistent association between outcomes and hospital characteristics, such as hip procedure volume, was identified. CONCLUSIONS Total hip replacement, partial hip replacement, and revision hip replacement are associated with different rates of postoperative complications and readmissions. Advanced age, comorbidities, and nonelective admissions are associated with inferior outcomes.

Breast Pump Adverse Events: Reports to the Food and Drug Administration

Breast pumps are medical devices used to express milk and maintain the milk supply. The purpose of this study was to characterize adverse events reported to the United States Food and Drug Administration (FDA) on breast pumps. Thirty-seven adverse event reports on breast pumps were identified from the Manufacturer and User Facility Device Experience database between 1992 and 2003. Four additional reports were found in the Device Experience Network database from 1992 to 1996. The most commonly reported adverse events for electric breast pumps were pain, soreness, or discomfort; the need for medical intervention; and breast tissue damage. Most frequently reported problems for manual breast pumps were breast tissue damage and infection. Contamination of breast milk during pumping was also reported. Breast pump adverse events are likely underreported to the FDA. Reporting adverse events is important for improving the design and manufacture of breast pumps and subsequently decreasing adverse events. Journal of Human Lactation. 21(2):169-174.

The Relation of Household Income to Mammography Utilization in a Prepaid Health Care System

Managed care organizations should be expected to provide equivalent access to preventive and screening services to all members. We studied mammography in 1,667 women members of one HMO who had an overall utilization rate of 84.9%. Significant correlates of mammography utilization included age, estimated household income, and division of the managed care organization in which the member was enrolled. Each

Racial Differences in the Prevalence of Intraocular Lens Implants in the United States

10,000 increment of income increased mammography rates by 2.5 percentage points (95% confidence interval [CI], 1.4% to 3.6%), independent of age and division. Our findings suggest that coverage for mammography services is not sufficient to ensure equivalent use of screening across income groups.

Medical device epidemiology and surveillance: patient safety is the bottom line

We generated population-based estimates of the prevalence of intraocular lens implants by using the 1988 Medical Device Implant Supplement to the National Health Interview Survey. This national survey of a probability sample of the civilian noninstitutionalized United States population comprised 47,485 households and 122,310 persons. To produce national projections, we used survey respondent-reported data based on 1,941 reported intraocular lenses in 1,337 persons. Projected to the United States population, an estimated 2.6 million people had a total of 3.8 million lens implants. The predominant reason for the implant was cataract. The intraocular lens replacement rate was 0.9%. The use of intraocular lens implants was statistically significantly different from the general population in persons with the following socioeconomic characteristics: age (65 years or older), race (white), gender (female), annual family income (less than

Databases for Studying the Epidemiology of Implanted Medical Devices

20,000, although more commonly at or above the poverty threshold), and education (less than high school). The prevalence rates per 1,000 persons according to age were as follows: 0.3 for persons 44 years old or younger, 9.9 for persons 45 to 64 years old, 33.3 for persons aged 65 to 69 years, 63.5 for persons aged 70 to 74 years, and 113.5 for persons 75 years old or older.(ABSTRACT TRUNCATED AT 250 WORDS)

Automated support for pharmacovigilance: a proposed system.

(2004). Medical device epidemiology and surveillance: patient safety is the bottom line. Expert Review of Medical Devices: Vol. 1, No. 1, pp. 1-2.

How Frequently Are Home Pregnancy Tests Used? Results from the 1988 National Maternal and Infant Health Survey

The worldwide market for implanted medical devices continues to accelerate from

Medical device epidemiology and surveillance

41.7 billion in 1993 to

Medical Device Epidemiology

56.7 billion in 1995 (1). Unlike epidemiological research for pharmaceuticals, which builds knowledge on clinical trials that are typically completed in several months, clinical trials for implanted medical devices require longer follow-up to determine safety and efficacy. Follow-up for the purpose of regulatory approval is usually complete in 1 or 2 years, but practitioners and patients are interested in the safety and efficacy of implants for the entire life span of patients. This was highlighted in the development of a National Institutes of Health (NIH) Technology Assessment Panel Consensus Statement on Implant Registries (2). The panel noted that 20 to 25 million US patients have had a medical device implanted. Device epidemiology provides a scientific method to contribute to this area of inquiry.