Objectives: The assessment of electronic fetal monitoring (EFM) carried out by the authors in the late 1970s provides an early case of a systematic review of evidence in health technology assessment. This paper identifies lessons pertinent for the present day in this field. Methods: We reviewed our own files for the description of our assessment and reactions to it. We also reviewed recent literature to evaluate our observations in relation to recent evidence. Results: Our findings of insufficient evidence of efficacy and concerns about safety have been confirmed by subsequent research. Still, despite findings and recommendations of prominent professional and governmental bodies, EFM continues in widespread use in the United States and Europe and is spreading into developing countries around the world. Aggressive attacks on our assessment as well as our skills and integrity have been mirrored in recent years by criticism of other researchers in health technology assessment. Conclusions: The case of EFM points to the limitations of assessment without other actions to assure the implementation of results. Health technologies that are accepted by the majority of clinicians in a particular field may require extraordinary efforts to assure appropriate use of technology assessments.
The Epidemic Intelligence Service (EIS) was established in 1951 at the Centers for Disease Control and Prevention (CDC), Atlanta, Georgia, as a combined training and service program in the practice of applied epidemiology. Since then, nearly 2,500 professionals have served in this 2-year program of the US Public Health Service. The experience of an EIS Officer has been modified because of the increased need for more sophisticated analytical methods and the use of microcomputers, as well as CDC's expanded mission into chronic diseases, environmental health, occupational health, and injury control. Officers who have entered the EIS in the past 20 years are more likely than their predecessors to stay in public health either at the federal level or in state and local health departments. The EIS Program continues to be a critical source for health professionals trained to respond to the demand for epidemiologic services both domestically and internationally.
To determine the relative merits of two quantitative methods used to estimate the summary effects of observational studies, the authors compared two methods of meta-analysis. Each quantified the relation between oral contraceptive use and the risk for ovarian cancer. One analysis consisted of a meta-analysis using summary data from 11 published studies from the literature (MAL) in which the study was the unit of analysis, and the second consisted of a meta-analysis using individual patient data (MAP) in which the patient was the unit of analysis. The authors found excellent quantitative agreement between the summary effect estimates from the MAL and the MAP. The MAP permits analysis 1) among outcomes, exposures, and confounders not investigated in the original studies, 2) when the original effect measures differ among studies and cannot be converted to a common measure (e.g., slopes vs. correlation coefficients), and 3) when there is a paucity of studies. The MAL permits analysis 1) when resources are limited, 2) when time is limited, and 3) when original study data are not available or are available only from a biased sample of studies. In public health epidemiology, data from original studies are often accessible only to limited numbers of research groups and for only a few types of studies that have high public health priority. Consequently, few opportunities for pooled analysis exist. However, from a policy view, MAL will provide answers to many questions and will help in identifying questions for future investigation.
Objective: To compare the efficacy and safety of routine electronic fetal monitoring (EFM) of labor with intermittent auscultation, using the results of published randomized controlled trials (RCTs).Data Sources: We identified RCTs by searching the MED-LINE data base for the period 1966-1994, contacting experts, and reviewing published references.Methods of Study Selection: Our search identified 12 published RCTs addressing the efficacy and safety of EFM; no unpublished studies were found. The studies included 58,855 pregnant women and their 59,324 infants in both high- and low-risk pregnancies from ten clinical centers in the United States, Europe, Australia, and Africa.Data Extraction ann Synthesis: Data were abstracted, and their accuracy was confirmed independently. A single reviewer assessed study quality based on criteria developed by others for RCTs. Data reported from similar studies were used to calculate a combined risk estimate for each of nine outcomes. Overall, a statistically significant decrease was associated with routine EFM for a 1-minute Apgar score less than 4 (relative risk [RR] 0.82, 95% confidence interval [CI] 0.65-0.98) and neonatal seizures (RR 0.5, 95% CI 0.30-0.82). The protective effect of EFM for a 1-minute Apgar score less than 4 was apparent only in the non-United States studies and the protective effect for neonatal seizures was evident only in studies with high-quality scores. No significant differences were observed in 1-minute Apgar scores less than 7, rate of admissions to neonatal intensive care units, and perinatal death. An increase associated with the use of EFM was observed in the rate of cesarean delivery (RR 1.33, 95% CI 1.08-1.59) and total operative delivery (RR 1.23, 95% CI 1.15-1.31). Risk of cesarean delivery was greatest in low-risk pregnancies.Conclusion: The only clinically significant benefit from the use of routine EFM was in the reduction of neonatal seizures. Because of the increase in cesarean and operative vaginal deliveries, the long-term benefit of this reduction must be evaluated in the decision reached jointly by the pregnant woman and her clinician to use EFM or intermittent auscultation during labor.
A survey was conducted to improve the recruitment, training, and retention of epidemiologists in the Epidemic Intelligence Service (EIS) Program of the Centers for Disease Control. The authors compared minority graduates of the program and nonminority graduates in several areas: reasons for application, degree of satisfaction, appropriateness of preparation for epidemiologic practice, and current professional activities. A closed-ended questionnaire was mailed to all 87 minority graduates from the program during the period 1970-88, and to 172 randomly selected nonminority graduates. Of 259 graduates surveyed, 234 or 90.3 percent returned the questionnaire--89.6 percent of minority graduates and 90.7 percent of nonminority graduates. Virtually all graduates were satisfied with their EIS experience (95.2 percent), have encouraged others to apply (96.1 percent), and are the most frequent sources of initial contact of prospective officers (38.2 percent). Most EIS graduates (71.2 percent) were still working in epidemiology. Compared with the nonminority graduates, the minority graduates were more likely to be women and to be single. Minority graduates were less likely than non minorities to hold academic appointments (44.2 percent versus 60.0 percent) and less likely to work in academic settings as their primary job (11.5 percent versus 18.7 percent). At the same time, minority graduates were more likely to have learned of the EIS Program from academic advisors (32.1 percent versus 19.4 percent). Graduates express high levels of satisfaction with the EIS Program and continue to practice epidemiology following graduation. Few differences between the minority and nonminority graduates were found. Because fewer minority graduates are in academic settings to serve as mentors or role models, alternative recruitment methods must be developed to sustain a high level of interest among minority groups in the EIS Program.
THE PUBLIC HEALTH IMPORTANCE OF CLUSTERS: A NOTE FROM THE CENTERS FOR DISEASE CONTROL RICHARD B. ROTHENBERG, RICHARD B. ROTHENBERG 1Assistant Director for Science, Center for Chronic Disease Prevention and Health Promotion, Centers for Disease ControlAtlanta, GA Reprint requests to Dr. Richard B. Rothenberg, Assistant Director for Science, Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control, 1600 Clifton Road, Atlanta, GA 30333 Search for other works by this author on: Oxford Academic PubMed Google Scholar KAREN K. STEINBERG, KAREN K. STEINBERG 2Center for Environmental Health and Injury Control, Division of Environmental Health Laboratory Sciences, Centers for Disease ControlAtlanta, GA Search for other works by this author on: Oxford Academic PubMed Google Scholar STEPHEN B. THACKER STEPHEN B. THACKER 3Director, Epidemiology Program Office, Centers for Disease ControlAtlanta, GA Search for other works by this author on: Oxford Academic PubMed Google Scholar American Journal of Epidemiology, Volume 132, Issue supp1, July 1990, Pages 3–5, https://doi.org/10.1093/oxfordjournals.aje.a115785 Published: 01 July 1990 Article history Received: 08 May 1989 Revision received: 06 February 1990 Published: 01 July 1990
The Epidemic Intelligence Service (EIS) was created at the Centers for Disease Control (CDC) in 1951 as a combined training and service program in the practice of applied epidemiology. Since 1951, more than 1,700 professional have served in this 2-year program of the Public Health Service. In the decade of the 1980s, EIS underwent dramatic changes in response to the increased breadth of the CDC mission and the rapid expansion of epidemiologic methods. Modifications in the experience of an EIS Officer have resulted from the increased need for more sophisticated analytic methods and the use of microcomputers, as well as CDC's expanded mission into chronic diseases, environmental health, occupational health, and injury control. Officers who have entered the EIS in the past decade tend to be older than their predecessors, tend to enter the program with more experience and training in epidemiology, and are more likely to stay in public health either at the Federal level or in State and local health departments. The EIS Program continues to be a critical source for men and women to respond to the need and demand for epidemiologic services both domestically and internationally.
The Disabilities Prevention Program builds on traditional Centers for Disease Control (CDC) strengths in public health surveillance, epidemiology, and technology transfer to State and local governments in translating the findings of research into prevention programs. The objectives of the CDC program are to provide a national focus for the prevention of primary and secondary disabilities, build capacity at the State and community levels to maintain programs to prevent disabilities, and increase the knowledge base necessary for developing and evaluating effective preventive interventions. During 1989, CDC, in consultation with the National Council on Disabilities and members of the disability community, has elected to focus its effort in three areas: developmental disabilities, injuries to the head and spinal cord, and secondary complications among persons with physical disabilities.
For the period of 1961 through 1975, 10 geographic and sociologic variables in each of the 159 counties of Georgia were analyzed to determine how they were correlated with the occurrence of Rocky Mountain spotted fever (RMSF). Combinations of variables were transformed into a smaller number of factors using principal-component analysis. Based upon the relative values of these factors, geographic areas of similarity were delineated by cluster analysis. It was found by use of these analyses that the counties of the State formed four similarity clusters, which we called south, central, lower north and upper north. When the incidence of RMSF was subsequently calculated for each of these regions of similarity, the regions had differing RMSF incidence; low in the south and upper north, moderate in the central, and high in the lower north. The four similarity clusters agreed closely with the incidence of RMSF when both were plotted on a map. Thus, when analyzed simultaneously, the 10 variables selected could be used to predict the occurrence of RMSF. The most important variables were those of climate and geography. Of secondary, but still major importance, were the changes over the 15-year period in variables associated with humans and their environmental alterations. Detailed examination of these factors has permitted quantitative evaluation of the simultaneous impacts of the geographic and sociologic variables on the occurrence of RMSF in Georgia. These analyses could be updated to reflect changes in the relevant variables and tested as a means of identifying new high risk areas for RMSF in the State. More generally, this method might be adapted to clarify our understanding of the relative importance of individual variables in the ecology of other diseases or environmental health problems.
Randomized controlled trials are increasingly used to assess clinical practices in obstetrics and gynaecology. The strength of these studies is that they usually address the issue of selection bias satisfactorily. Yet, as with any form of scientific investigation, the randomized controlled trial has inherent limitations and is subject to flaws in its conduct. Using basic methodological criteria, this report assesses the quality of the four published controlled trials in which a policy of routine imaging ultrasonography in pregnancy was compared with a more restrictive policy. In addition, a pooled analysis using data from all four trials was conducted to illustrate how increasing the sample size may reveal differences between the two policies which remain undetected in trials using small samples. The researchers in these studies reached different conclusions as to the effectiveness of routine ultrasound screening. Taken together, these four trials provide valuable information about routine ultrasound screening but fail to demonstrate adequately the usefulness of imaging ultrasound as a screening procedure for all pregnant women. The assessment criteria presented here could be used by investigators, editors, referees and other readers as a guideline for assessing the quality of therapeutic studies upon which clinical practice should be based.
Surveillance is the collection, collation, and analysis of data and the dissemination to those who need to know so that an action can result. This article describes the clinician's critical role in disease reporting and outlines the benefits of surveillance to clinical practice. Four commonly used systems of disease surveillance are notifiable disease reporting, laboratory-based surveillance, hospital-based surveillance, and population-based surveillance. We analyze the relative strengths and limitations of each of these systems and present current efforts to evaluate and improve surveillance activities. (JAMA1983;249:1181-1185)
During a severe drought Port-au-Prince, Haiti, lost hydroelectric power for 10 weeks. This led to water shortages in areas of the city dependent on water supplied from electrically driven pumps. In a study of the impact of water restriction on disease, 400 families were randomly selected from two urban areas differentially affected by the water shortage. Disease in children was found to be related to quantity of water used, socioeconomic status, employment of head of household, and family size. The methods used in this study are recommended for the investigation of the relationship between water quantity and health.
Electronic fetal monitoring (EFM) is an example of a medical technology that has been widely accepted since its introduction in the mid-1960s. However, review of the literature does not provide convincing evidence of EFM efficacy, and four recent, controlled, clinical trails show little if any benefit in terms of preventing death or long-term disability of the baby. Public and private policies have largely acted to encourage use of EFM, and none have acted to slow or prevent its spread. This need for mechanisms to assure the timely evaluation of new medical technologies before they are accepted as a medical practice has led to a new medical devices program in the Food and Drug Administration, consensus development groups at the National Institutes of Health, and congressional legislation to establish a new National Center for Health Care Technology.