(Circulation. 2001;103:e9038.)
© 2001 American Heart Association, Inc.
Cardiovascular News
New Food and Drug Administration Office and Director Named to Oversee Human Research Studies
A new office created by officials at the US Food and Drug Administration (FDA) will concentrate the agency’s activities in the area of human research subject protection under the direction of David Lepay, MD, PhD, who was appointed April 23, 2001, to head the Office for Human Research Trials.
Dr Lepay, who was previously a senior advisor of clinical science at the FDA, will coordinate the monitoring program for human clinical trials and oversee its good clinical practice policy. His office will also participate in such activities on an international level and coordinate with the Office of Human Research Protections in the US Department of Health and Human Services.
The move is only the latest in a series at the federal level to tighten the monitoring of medical research involving human beings.
Link Found Between Nurse Staffing and Patient Outcomes
The number of nurses in a hospital and the mix of their capabilities made a difference in the quality of care that patients receive, according to a study released April 20, 2001, by the US Department of Health and Human Services (HHS) Health Research and Services Administration (HRSA).
The study was based on data from records of 5 million hospital discharges from 799 hospitals in 11 states in 1997. The analysis of the data showed that there was a "strong and consistent relationship" between nurse staffing and 5 outcomes in patients: urinary tract infection, pneumonia, shock, upper gastrointestinal bleeding, and length of stay. In the study, more registered nurses in clinical positions at the hospital was associated with 3% to 12% reductions in the rates of these adverse outcomes. A higher staffing level for all kinds of nurses was associated with a 2% to 25% decrease in adverse outcomes.
The costs of adverse outcomes can be substantial, according to the government study. "Hospitals can use these findings to improve quality and performance measures across the board to ensure better nursing care for all patients," said Sam Shekar, MD, MPH, HRSA associate administrator for health professions, in a released statement. "We need to know more not only about how nurse staffing affects quality, but also about the working conditions in which nurses provide care," said John Eisenberg, MD, director of the Agency for Healthcare Research and Quality.
A study by the Federation of Nurses and Health Professionals, a division of the AFL-CIO’s American Federation of Teachers, demonstrated that 1 in 5 nurses plans to leave the profession in the next 5 years because of poor working conditions. The survey, which was based on interviews with 700 practicing nurses and 207 who are no longer in practice, found that half of nurses have thought about leaving the profession.
In the study, the nurses said their jobs were too stressful and physically demanding, with irregular hours. Most nurses rated morale at their institutions as fair or poor. Seventy-four percent of those at hospitals reported only fair or poor morale.
The number one problem, according to 66% of nurses, was staffing, the nurses say their institutions have too few nurses and that they cannot spend enough time taking care of patients. The Bush Administration has proposed increased funding for nurse training programs, according to a statement released by HHS Secretary Tommy G. Thompson.
Double-Counting Causes Overestimate of Numbers of US Patients Hospitalized for Heart Attack
Double-counting patients with myocardial infarction could be as high as 15%, according to researchers reporting in the May issue of the journal Medical Care (2001;39:459–468). John M. Westfall, MD, MPH, and Joe McGloin, MS, of the University of Colorado Health Sciences Center and the High Plains Research Network in Denver, found that many estimates of the numbers of heart attack patients depended on hospital discharge data, which can result in double counts of patients who are transferred from rural hospitals to urban centers.
They analyzed hospital discharge data from Kansas, Colorado, Nebraska, Arizona, New Jersey, Michigan, Pennsylvania, and Illinois for the years 1995 to 1997 using an algorithm to link hospitalizations and a sensitivity analysis of the algorithm using data from a state that provided an encrypted patient identifier. They also validated their algorithm with an in-depth chart review of patients treated for heart attack in hospitals of the High Plains Research Network.
Of the 1 442 696 hospital discharges for ischemic heart disease in the 8 states, 385 028 were for acute myocardial infarction, 155 190 were for unstable angina, and 277 537 were for unspecified chest pain. A total of 183 447 of the patients (12.7%) were double counted, including 51 032 of those with acute myocardial infarction (13.3%), 3059 of those with unstable angina (2%), 127 of those with stable angina (0.3%), 43 278 of those with other chronic ischemic heart disease (7.4%), and 4409 of those with unspecified chest pain (1.6%). The remaining 82 542 patients who were double-counted had different diagnoses at the 2 hospitals.
The researchers also found that the rate of double counts increased with time. For example, data from Colorado and Illinois went from 4.5% double counts in 1988 to nearly 11% in 1997. In counties with small cities, the double-count rate averaged 14% to 15%. The highest double-count rates (16% to 18%) were in counties where the largest town had between 10 000 and 25 000 people.
They concluded that "double counting of single episodes of acute myocardial infarction because of hospital transfers has a significant impact on the reported incidence rates of acute myocardial infarction. The common practice of using ‘hospital discharges’ or ‘hospitalizations’ for estimating the number of acute myocardial infarctions has become increasingly inaccurate over the past 10 to 15 years. We estimate that the actual incidence rate for myocardial infarction is 10% to 15% less than previously reported and 15% to 30% less in rural regions."
The researchers also believe that a reported decline in case fatality from myocardial infarction may be the result of this double counting. "If true, nationwide, there may actually be 100 000 to 200 000 fewer acute myocardial infarctions per year than previously reported."
National Heart, Lung, and Blood Institute Expands Community-Based Heart-Health Education Program for Latinos
Salud para su Corazon, a program designed to bring heart-health information to Latinos in the United States, is expanding geographically from its starting point in Washington, DC, to underserved communities in Texas, Illinois, New Mexico, and California, according to the National Heart, Lung, and Blood Institute (NHLBI), which created it. The program uses Latino lay educators called promotores to teach individuals and families in the community to prevent and control heart disease.
"Heart disease is the leading cause of death among Latinos, as it is for all Americans. But Latinos are generally unaware that the risk factors for heart disease, including high blood pressure, high blood cholesterol, diabetes, overweight, physical inactivity, and cigarette smoking can be controlled and prevented," said NHLBI Director Dr Claude Lenfant.
The program uses cooking demonstrations, "weigh-ins," and participation in physical activity to help promotores bring life-saving heart-health information to their neighbors and families. The printed materials are available in both English and Spanish. Latinos constitute 13% of the US population and are the largest minority group in the country.
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