Safety and tolerability of cold-adapted influenza virus vaccine in children and adolescents with asthma.

BACKGROUND: Influenza infections can cause severe respiratory disease in high risk persons such as those with asthma, but immunization rates for high risk groups remain suboptimal. An investigational influenza virus vaccine, trivalent, types A and B, live, cold-adapted (CAIV-T) administered by intranasal spray was shown previously to be effective in healthy adults and healthy children. PURPOSE: To assess the safety and tolerability of CAIV-T in subjects 9 years of age and older with moderate to severe asthma. METHODS: In this randomized, double blind, placebo-controlled study, spirometry was performed twice before vaccination to establish a baseline forced expiratory volume at 1 s (FEV1) and once 2 to 5 days thereafter. The primary outcome index was the percent change in percent predicted FEV1 before and after vaccination. Peak flows, clinical asthma symptom scores and nighttime awakening scores were measured daily from 7 days pre- to 28 days postvaccination. RESULTS: The primary outcome index (percentage change in percent predicted FEV1) was not different between the two groups (0.2% vs. 0.4% for the treatment and placebo groups, respectively; P = 0.78). Secondary outcomes did not differ between the two groups; these included the number of subjects with a decrease in FEV1 > or =15% from baseline, reductions in peak flows > or =15%, > or =30% or > or =2 sd below baseline, use of beta-adrenergic rescue medications, asthma exacerbations and clinical asthma symptom scores before and after vaccination. The same proportion of subjects in each group experienced postvaccination symptoms within 10 days (92% and 91%, respectively; P = 1.0). No serious adverse event occurred. CONCLUSION: CAIV-T was generally safe and well-tolerated in children and adolescents with moderate to severe asthma.

When the safety net is unsafe: real-time assessment of the overcrowded emergency department.

Although much work has been done evaluating causes for increased demand for emergency department (ED) services, few ways are available to help determine that an individual ED is overcrowded. Four calculations are proposed using real-time data for accurately diagnosing an ED with potential for failing both as a safety net and as a source for quality health care. The bed ratio (BR) accounts for the number of patients in relation to the available treatment spaces. The BR is obtained by adding the current number of ED patients to the predicted arrivals minus the predicted departures and dividing the result by the total number of treatment spaces. The acuity ratio (AR) measures the relative burden of illness in the ED. The AR is the average triage category of all patients in the ED. The provider ratio (PR) determines the volume of patients that can be evaluated and treated by the physician providers. The PR is found by dividing the arrivals per hour by the sum of the average patients per hour usually disposed for each provider on duty. From these ratios, the demand value (DV) is calculated, which gives an overall measure of current demand. The DV is found by taking the sum of the BR and PR and multiplying by the AR. A DV of more than 7 should initiate a specific assessment of the individual ratios in order to accurately diagnose the problem and institute action. Based on the values, predetermined processes can be instituted to help remedy the overcrowded situation. Trended over time, the ratios can provide the data needed for better resource assessment, planning, and allocation.

Emergency Medical Services Outcomes Project (EMSOP) II: developing the foundation and conceptual models for out-of-hospital outcomes research.

Development of methodologically acceptable outcomes models for emergency medical services (EMS) is long overdue. In this article, the Emergency Medical Services Outcomes Project proposes a conceptual framework that will provide a foundation for future EMS outcomes research. The "Episode of Care Model" and the "Out-of-Hospital Unit of Service Model" are presented. The Episode of Care Model is useful in conditions in which interventions and outcomes, especially survival and major physiologic dysfunction, are linked in a time-dependent manner. Conditions such as severe trauma, anaphylaxis, airway obstruction, respiratory arrest, and nontraumatic cardiac arrest are amenable to this methodology. The Out-of-Hospital Unit of Service Model is essentially a subunit of the Episode of Care Model. It is valuable for evaluating conditions that have minimal-to-moderate therapeutic time dependency. This model should be used when studying outcomes limited to the out-of-hospital interval. An example of this is pain management for injuries sustained in motor vehicle crashes. These models can be applied to a wide spectrum of conditions and interventions. With the scrutiny of health care expenditures ever increasing, the identification of clinical interventions that objectively improve patient outcome takes on growing importance. Therefore, the development, dissemination, and use of meaningful methodologies for EMS outcomes research is key to the future of EMS system development and maintenance.

Public expectations of survival following cardiopulmonary resuscitation.

UNLABELLED: Previous studies have demonstrated that the public maintains unrealistic expectations of the potential for successful recovery following administration of cardiopulmonary resuscitation (CPR). Others have attributed this phenomenon to misrepresentation of CPR outcomes on television and other sources of public information. OBJECTIVES: To determine public expectations of CPR and correlate these expectations with various sources of information regarding CPR, including age, television, personal medical training, public programs, friends/family with medical training, and personal experience with CPR. METHODS: A written survey was randomly distributed to local church congregations and completed on a voluntary basis. RESULTS: Ninety-six percent of the respondents expected CPR to be unrealistically effective. Those factors found to increase predicted CPR survival rate were as follows: 1) being under 50 years of age, 2) use of television as a source of information regarding CPR, 3) personal medical training, and 4) use of public programs about CPR. Neither exposure to friends or family with medical training nor personal experience with CPR resulted in increased CPR survival predictions. CONCLUSIONS: Regardless of the source, the public is not accurately informed about the effectiveness of CPR. This creates a situation in which people may elect CPR for themselves or for family members when survival, not to mention recovery, is unlikely. Without dissemination of realistic statistics regarding survival and recovery following CPR, the public will maintain unrealistic expectations of CPR, and be unable to make well-informed decisions concerning its use.

Study design and outcomes in out-of-hospital emergency medicine research: a ten-year analysis.

OBJECTIVE: Lack of rigorous study design and failure to follow diverse patient outcomes have been identified as critical gaps in the medical research literature. This study sought to determine whether similar gaps exist in the literature for out-of-hospital interventions. METHODS: A computerized MEDLINE search was conducted for the ten-year period 1985 through 1994 using the MeSH terms "emergency medical services," "prehospital," and "transportation of patients." Using a standard abstraction form, two investigators independently analyzed articles meeting these inclusion criteria: original research evaluating an out-of-hospital intervention and measuring a patient outcome. Study design was categorized in order of scientific rigor, moving from case series to randomized trial. Measures of outcomes were classified into the six Ds: death, disease, discomfort, disability, dissatisfaction, and debt (cost). RESULTS: Interobserver agreement was high (kappa = 0.80). For the ten-year period, 3,686 titles, 1,454 abstracts, and 373 articles were examined serially; all 285 studies meeting inclusion criteria were analyzed. Case series (44%) was the most frequently used design, while only 15% were randomized trials. The majority of the studies were retrospective (53%). A single outcome was assessed in 45% of the articles; 41% measured two outcomes, 13% three outcomes, and 1% four outcomes. Death and disease were the most common outcomes evaluated. Disability, debt, discomfort, and dissatisfaction were infrequently measured. CONCLUSION: Studies of out-of-hospital emergency medical interventions are limited in the scientific rigor of study design and the diversity of patient outcomes measured. To adequately assess the effectiveness of out-of-hospital care, efforts should be directed toward strengthening study designs and examining the full range of patient outcomes.

Injury prevention and emergency medical services for children in a managed care environment.

Each year, 1 in 5 US children receives medical care as a result of injury. Injuries are the leading cause of medical spending for children ages 5 to 21 years, accounting for more than 20% of hospital admissions and days spent in the hospital. Pediatric injuries become an important issue for managed care organizations because of concern for member safety and increasing medical costs related to treatment. Because effective prevention decreases health care consumption, injury prevention often costs less than treating injuries. Simple devices, such as bicycle helmets, smoke detectors, and child safety seats, help keep children safe and save money. Appropriate emergency care at the scene of an injury, poison control centers that dispense expert advice over the telephone, and triaged regional trauma systems improve the outcome and save money at the same time. This article continues the white paper series by the Emergency Medical Services for Children Managed Care Task Force.

A profile of the members of FASEB societies: NIH awards, degrees, and institutional affiliations, 1999.

Data from the FASEB Directory of Members and NIH were used to develop a statistical profile of the members of FASEB Societies. For the U.S.-based scientists (exclusive of retired and student members), the most frequently reported degree was a research doctorate (69. 6%). A substantial fraction, however, reported medical degrees (19. 2%) or both research and medical degrees (8.0%). The majority of members of FASEB Societies listed academic affiliations in the directory. Industrial affiliations were reported, however, in 9.7% of the entries with smaller fractions listing associations with hospitals, independent research institutes, and government agencies. Just over one-fourth of the members of FASEB Societies were principal investigators on NIH research grants. These investigators received one-half of all NIH grants and nearly 60% of the RO1 grants.

Emergency medical services outcomes project I (EMSOP I): prioritizing conditions for outcomes research.

Over the past several years, out-of-hospital EMS have come under increased scrutiny regarding the value of the range of EMS as currently provided. We used frequency data and expert opinion to rank-order EMS conditions for children and adults based on their potential value for the study of effectiveness of EMS care. Relief of discomfort was the outcome parameter EMS professionals identified as having the most potential impact for the majority of children and adults in the top quartile conditions. Future work from this project will identify appropriate severity and outcome measures that can be used to study these priority conditions. The results from the first year of this project will assist those interested in EMS outcomes research to focus their efforts. Furthermore, the results suggest that nonmortality out-come measures, such as relief of discomfort, may be important parameters in determining EMS effectiveness.

Data elements for emergency department systems, release 1.0 (DEEDS): a summary report. DEEDS Writing Committee.

Variations in the way that data are entered in ED record systems impede the use of ED records for direct patient care and deter their reuse for many other legitimate purposes. To foster more uniform ED data, the Centers for Disease Control and Prevention's (CDC) National Center for Injury Prevention and Control is coordinating a public-private partnership that has developed recommended specifications for many observations, actions, instructions, conclusions, and identifiers that are entered in ED records. The partnership's initial product. Data Elements for Emergency Department Systems, Release 1.0 (DEEDS), is intended for use by individuals and organizations responsible for ED record systems. If the recommended specifications are widely adopted, then problems--such as data incompatibility and high costs of collecting, linking, and using data--can be substantially reduced. The collaborative effort that led to DEEDS, Release 1.0 sets a precedent for future review and revision of the initial recommendations.

Development of new methods to assess the outcomes of emergency care.

This article provides information supporting the need for new outcome measures in emergency care. It also addresses the use of these measures in emergency care, the impact of emergency care, identification of at-risk groups, new approaches to measuring patient satisfaction, quality of life, and cost-effectiveness, and the related unique implications for emergency medicine.

Development of new methods to assess the outcomes of emergency care.

This article provides information supporting the need for new outcome measures in emergency care. It also addresses the use of outcome measures in emergency care, the impact of emergency care, identification of at-risk groups, new approaches to measuring patient satisfaction, quality of life and cost-effectiveness, and the unique related implications for emergency medicine.

Data elements for emergency department systems, release 1.0 (DEEDS): a summary report. DEEDS Writing Committee.

Variations in the way that data are entered in emergency department record systems impede the use of ED records for direct patient care and deter their reuse for many other legitimate purposes. To foster more uniform ED data, the Centers for Disease Control and Prevention's National Center for Injury Prevention and Control is coordinating a public-private partnership that has developed recommended specifications for many observations, actions, instructions, conclusions, and identifiers that are entered in ED records. The partnership's initial product, Data Elements for Emergency Department Systems, Release 1.0 (DEEDS), is intended for use by individuals and organizations responsible for ED record systems. If the recommended specifications are widely adopted, then problems--such as data incompatibility and high costs of collecting, linking, and using data--can be substantially reduced. The collaborative effort that led to DEEDS, Release 1.0 sets a precedent for future review and revision of the initial recommendations.