BOX 3-1Examples of Important Findings from Medical Database Research

Herceptin and breast cancer: Data were collected from a cohort of more than 9,000 breast cancer patients whose tumor specimens were consecutively received at the University of San Antonio (1974–1992, from across the United States). Data were collected prospectively with audits for verification, and recurrences were recorded through systematic patient follow-up. This database was analyzed to identify prognostic factors, and the results showed that amplification of the HER-2 oncogene was a significant predictor of both overall survival and time to relapse in patients with breast cancer. This information subsequently led to the development of Herceptin (trastuzumab), a targeted therapy that is effective for many women with HER-2–positive breast cancer.

Folic acid and birth defects: Medical records research led to the discovery that supplementing folic acid during pregnancy can prevent neural tube birth defects (NTDs). Studies in the 1970s found that vitamin (folate) deficiency and use of anticonvulsive drugs that deplete folate were associated with higher rates of NTDs, and studies in the 1980s found that use of folate supplements was associated with decreased rates. Population-based surveillance systems showed that the number of NTDs decreased 31 percent after mandatory fortification of cereal grain products.

Effects of intrauterine DES exposure: Starting in the 1940s, diethylstilbestrol (DES) was used by millions of pregnant women to prevent miscarriages and other disorders in pregnancy. In the 1970s, retrospective studies of medical records began to show that infants exposed to DES during the first trimester of pregnancy had an increased risk as adults of breast, vaginal, and cervical cancer as well as reproductive anomalies. In November 1971, the FDA sent a FDA Drug Bulletin to all U.S. physicians advising them to stop prescribing DES to pregnant women and ordered that prevention of miscarriage be removed from Indications and pregnancy be added to Contraindications in the physician-prescribing information for DES.

Patient safety: Health services research estimated that tens of thousands of Americans die each year from medical errors in the hospital. A 1998 study led by David Bates (Brigham & Women’s Hospital) found that computerized order entry of prescriptions at Brigham & Women’s Hospital reduced medical error rates by 55 percent; rates of serious errors fell by 86 percent. In response to this groundbreaking work, hospitals around the country are installing their own computerized physician order entry systems. For example, The Leapfrog Group—a large national coalition of more than 100 public and private organizations that provide health care benefits—includes computerized physician order entry as one of the safety standards it encourages hospitals to adopt.

Mortality risks of antipsychotic drugs in the elderly: In 2005, the FDA issued a public health advisory stating that the atypical (second generation) antipsychotic medications increase mortality among elderly patients. This decision was based on the results of 17 placebo-controlled trials with such drugs that enrolled a total of 5,106 elderly patients with dementia who had behavioral disorders. Fifteen of the studies showed numerical increases in mortality in the drug-treated group compared to the placebo-treated patients (approximately 1.6-1.7–fold increase in mortality), most often due to heart-related events (e.g., heart failure, sudden death) or infections (mostly pneumonia). However, the risk of death with older, conventional agents was not known. Results from two subsequent retrospective reviews of 27,000 and 37,000 medical records of elderly patients who had been treated with either conventional or atypical antipsychotic drugs indicated that conventional antipsychotic medications are at least as likely as atypical agents to increase the risk of death among those patients. As a result, the FDA now requires that the prescribing information for all antipsychotic drugs includes the same information about this risk in a boxed warning and a warnings section.

Child safety: Using the Partners for Child Passenger Safety (PCPS)—an ongoing child-focused, real-time, crash surveillance system established with the State Farm Insurance Companies in 1997—Flaura Winston (Children’s Hospital ofPennsylvania) found that only 25 percent of children between 3 and 7 years of age were appropriately restrained in crashes; children in seat belts alone were at a 3.5-fold increased risk of serious injury. Winston’s analysis of PCPS data led to the rapid adoption of belt-positioning boosters as the appropriate form of restraint for children once they have outgrown car seats. Appropriate restraint by children in this age group has doubled, and child fatality from crashes is at its lowest level ever.

Obesity: Eric Finkelstein (RTI International) used data from the late 1990s to find that obesity is responsible for up to $92.6 billion in medical expenditures each year; approximately half of obesity-related health care costs are borne by Medicare and Medicaid. A 2002 study by Roland Sturm (RAND) found that the effects of obesity on a number of chronic conditions were larger than those of smoking or problem drinking. Since then, obesity has been escalated to the top of the list of health care priorities, and policy makers have appropriated funds for federal agencies to fund health services research that encourages people to understand the effects of diet and exercise on their health.

Rural health: Stephen Mick (Virginia Commonwealth University) and colleagues examined rural hospital performance in the late 1980s and early 1990s and found that activity typical of urban hospitals is beyond the capacity of most rural facilities and recommended that a new federal approach would be required to preserve rural acute-care services. This work helped form the intellectual basis for Medicare’s highly successful Critical Access Hospital program, which was designed to improve rural health care access and reduce closures of hospitals that provide essential community services.

Workforce and health outcomes: In 1997, Jack Needleman (University of California–Los Angeles) and Peter Buerhaus (Vanderbilt University) analyzed more than 6 million patient discharge records from 799 hospitals in 11 states. They found that patients in hospitals with fewer registered nurses stay hospitalized longer and are more likely to suffer complications, such as urinary tract infections and upper gastrointestinal bleeding. This research established a causal link between the nursing shortage and outcomes, and helped move the nursing shortage into the public’s eye and onto policy makers’ radar. In 2002, Congress passed the Nurse Reinvestment Act to increase the domestic supply of nurses.

SOURCES: Bates et al. (1998); FDA (1971, 2005, 2008); Finkelstein et al. (2003); Gill et al. (2007); Herbst et al. (1971); IOM (2000b); Mick et al. (1994); Needleman et al. (2002); Pitkin (2007); Schneeweiss et al. (2007); Slamon et al. (1987); Thorpe et al. (2004); Veurink et al. (2005); Winston et al. (2000).

From: 3, The Value, Importance, and Oversight of Health Research

Cover of Beyond the HIPAA Privacy Rule
Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research.
Institute of Medicine (US) Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule; Nass SJ, Levit LA, Gostin LO, editors.
Washington (DC): National Academies Press (US); 2009.
Copyright © 2009, National Academy of Sciences.

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