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F DeStefano

Publications and source records attributed to F DeStefano.

At least 19 recordsLinked to original sources
PubMed2001

Safety and immunogenicity of varying dosages of trivalent inactivated influenza vaccine administered by needle-free jet injectors.

To evaluate the perceived pain, other adverse events, and immunogenicity of influenza virus vaccine administered by needle-free jet injector (JI) compared with that of vaccine administered by needle and syringe (N&S), we randomly assigned 304 healthy young adults to receive one of three dosages (0.5, 0.3, or 0.2 ml) of the 1998-1999 season vaccine administered by either of two JI devices or by N&S. In multivariate analysis, female gender and JI administration were associated with higher levels of pain reported at the time of vaccination as well as with the occurrence of local injection site reactions following vaccination. Immune response did not vary significantly by dosage but administration by one JI device was associated with higher post-vaccination H1N1 antibody titers.

Adult↗
PubMed2001

The risk of seizures after receipt of whole-cell pertussis or measles, mumps, and rubella vaccine.

BACKGROUND: The administration of the diphtheria and tetanus toxoids and whole-cell pertussis (DTP) vaccine and measles, mumps, and rubella (MMR) vaccine has been associated with adverse neurologic events, including seizures. We studied the relation between these vaccinations and the risk of a first seizure, subsequent seizures, and neurodevelopmental disability in children. METHODS: This cohort study was conducted at four large health maintenance organizations and included reviews of the medical records of children with seizures. We calculated the relative risks of febrile and nonfebrile seizures among 679,942 children after 340,386 vaccinations with DTP vaccine, 137,457 vaccinations with MMR vaccine, or no recent vaccination. Children who had febrile seizures after vaccination were followed to identify the risk of subsequent seizures and other neurologic disabilities. RESULTS: Receipt of DTP vaccine was associated with an increased risk of febrile seizures only on the day of vaccination (adjusted relative risk, 5.70; 95 percent confidence interval, 1.98 to 16.42). Receipt of MMR vaccine was associated with an increased risk of febrile seizures 8 to 14 days after vaccination (relative risk, 2.83; 95 percent confidence interval, 1.44 to 5.55). Neither vaccination was associated with an increased risk of nonfebrile seizures. Analyses of automated data alone gave results similar to the analyses of the data from medical-record reviews. The number of febrile seizures attributable to the administration of DTP and MMR vaccines was estimated to be 6 to 9 and 25 to 34 per 100,000 children, respectively. As compared with other children with febrile seizures that were not associated with vaccination, the children who had febrile seizures after vaccination were not found to be at higher risk for subsequent seizures or neurodevelopmental disabilities. CONCLUSIONS: There are significantly elevated risks of febrile seizures on the day of receipt of DTP vaccine and 8 to 14 days after the receipt of MMR vaccine, but these risks do not appear to be associated with any long-term, adverse consequences.

Child↗
PubMed2001

Multiple sclerosis.

Explore the source record for details and available documents.

Hepatitis B Vaccines↗
PubMed2001

Ability to trace migrant farmworkers ten years after initial identification in a Northern State (Wisconsin).

BACKGROUND: Migrant farmworkers have rarely been included in epidemiologic studies. To assess the feasibility of following farmworkers over extended periods, a critical feature of many study designs, we attempted to trace a sample of Mexican-American farmworkers identified in a clinic in Wisconsin. METHODS: We randomly chose 100 farmworkers from a migrant health center registration list for 1984-85. In 1995, we searched recent clinic records, made telephone calls, and visited migrant camps to find these farmworkers in Wisconsin during the growing season. We also attempted to find 46 farmworkers at their homes in southwest Texas over a two-week period in 1996 using the address listed in the clinic records, local phone books, and conversations with next-door neighbors. RESULTS: Although 25 farmworkers had reregistered at the clinic in recent years, we found only 6 of them in Wisconsin in 1995. In southwest Texas, we either located or ascertained information about the vital status of 25 of the 46 farmworkers (54%). CONCLUSIONS: Tracing efforts must include extensive contacts in farmworkers' home states and must incorporate a variety of information sources. Tracing farmworkers in epidemiologic studies appears to be feasible but requires more intensive methods over longer periods of time than those used in this study.

Adolescent↗
PubMed2001

Challenges and controversies in immunization safety.

No vaccine is perfectly safe or effective. As diseases such as diphtheria and polio fade, vaccine safety concerns, especially alleged links between vaccinations and several chronic illnesses, have become increasingly prominent in the media and to the public. This article reviews the current scientific evidence on several recent vaccine safety controversies. It also provides information on how various safety research is conducted, some of the concurrent challenges, and finally, some guidance on communicating with patients on vaccine risks.

Autistic Disorder↗
PubMed2001

Childhood vaccinations, vaccination timing, and risk of type 1 diabetes mellitus.

OBJECTIVES: To evaluate suggested associations between childhood vaccinations, particularly against hepatitis B and Haemophilus influenzae type b, and risk of developing type 1 diabetes; and to determine whether timing of vaccination influences risk. METHODS: We conducted a case-control study within 4 health maintenance organizations (HMOs) that participate in the Vaccine Safety Datalink project of the Centers for Disease Control and Prevention. Study eligibility was restricted to children who met the following criteria: 1) born during 1988 through 1997; 2) HMO member since birth; 3) continuously enrolled for first 6 months of life; and 4) at least 12 months of HMO membership before diabetes incidence date (or index date for controls) unless incidence date was before 12 months of age. All 4 HMOs maintain registries of their members who have diabetes, and we used the registries to identify potential cases of diabetes. We conducted chart reviews to verify that potential cases met the World Health Organization epidemiologic case definition for type 1 diabetes mellitus (ie, a physician's diagnosis of diabetes plus treatment with daily insulin injections). We defined the incidence date of diabetes as the first date that the child received a diagnosis of diabetes. We attempted to match 3 controls to each case. Controls had the same eligibility criteria as cases and were matched to individual cases on HMO, sex, date of birth (within 7 days), and length of health plan enrollment (up to the incidence or index date). The index date for controls was defined as the incidence date of the case to which the control was matched. Chart abstraction was performed by trained chart abstractors using standardized forms. In addition to complete vaccination histories, the chart abstraction forms for both cases and controls included information on sociodemographic characteristics, selected medical conditions, history of breastfeeding, and family medical history. We used conditional logistic regression to estimate the odds ratio (OR) of diabetes associated with vaccination, with vaccine exposure defined as before the diabetes incidence date (or index date for controls). RESULTS: Two hundred fifty-two confirmed cases of diabetes and 768 matched controls met the study eligibility criteria. The OR (95% confidence interval) for the association with type 1 diabetes was 0.28 (0.07-1.06) for whole cell pertussis vaccine (predominantly in combination as diphtheria, tetanus toxoids and pertussis vaccine), 1.36 (0.70-2.63) for measles-mumps-rubella, 1.14 (0.51-2.57) for Haemophilus influenzae type b, 0.81 (0.52-1.27) for hepatitis B vaccine, 1.16 (0.72-1.89) for varicella vaccine, and 0.92 (0.53-1.57) for acellular pertussis-containing vaccines. Compared with children who had not received hepatitis B vaccine, the OR of diabetes was 0.51 (0.23-1.15) for children vaccinated at birth and 0.86 (0.54-1.35) for those first vaccinated against hepatitis B at 2 months of age or later. Race and ethnicity and family history of diabetes were independently associated with risk of type 1 diabetes, but adjustment for these factors did not materially alter the ORs for any of the vaccines. CONCLUSIONS: In this large, population-based, case-control study, we did not find an increased risk of type 1 diabetes associated with any of the routinely recommended childhood vaccines. Our study adds to previous research by providing data on newer vaccines, including hepatitis B, acellular pertussis, and varicella vaccines. For the older vaccines, our results are generally in agreement with previous studies in not finding any increased risks. Ours is the first epidemiologic study to evaluate the possibility that timing of vaccination is related to risk of clinical diabetes in children. Our results on hepatitis B vaccine do not support the hypothesis; risk of type 1 diabetes was not different between infants vaccinated at birth and those who received their first vaccination later in life. The results of our study and the preponderance of epidemiologic evidence do not support an association between any of the recommended childhood vaccines and an increased risk of type 1 diabetes. Suggestions that diabetes risk in humans may be altered by changes in the timing of vaccinations also are unfounded.

Adolescent↗
PubMed2001

Autism and measles-mumps-rubella vaccination: controversy laid to rest?

It has been suggested that vaccination, particularly with measles-mumps-rubella (MMR) vaccine, may be related to the development of autism. The main evidence for a possible association is that the prevalence of autism has been increasing at the same time that infant vaccination coverage has increased, and that in some cases there is an apparent temporal association in which autistic characteristics are first noted shortly after vaccination. Although the prevalence of autism and similar disorders appears to have increased recently, it is not clear if this is an actual increase or the result of increased recognition and changes in diagnostic criteria. The apparent onset of autism in close proximity to vaccination may be a coincidental temporal association. The clinical evidence in support of an association derives from a series of 12 patients with inflammatory bowel conditions and regressive developmental disorders, mostly autism. The possibility that measles vaccine may cause autism through a persistent bowel infection has generated much interest, since it provides a possible biological mechanism. Epidemiological studies, however, have not found an association between MMR vaccination and autism. The epidemiological findings are consistent with current understanding of the pathogenesis of autism, which has a strong genetic component and in which the neurological defects probably occur early in embryonic development. It seems unlikely that a vaccination that is given after birth could cause autism. A minority of cases of autism may have onset after 1 year of age (regressive autism), but the single epidemiological study that included such cases did not find an association with MMR vaccination. Currently, the weight of the available epidemiological and related evidence does not support a causal association between MMR vaccine, or any other vaccine or vaccine constituent, and autism.

Autistic Disorder↗
PubMed2000

Short- and long-term survival after cardiopulmonary resuscitation.

BACKGROUND: The objective was to evaluate the effect of patient characteristics and other factors on cardiopulmonary resuscitation (CPR) survival, hospital discharge survival and function, and long-term survival. METHODS: All patients 18 years and older experiencing in-hospital CPR from December 1983 through November 1991 at Marshfield Medical Center (Marshfield Clinic and adjoining St Joseph's Hospital), Marshfield, Wis, were selected. We performed a retrospective medical record review and augmented these data with updated vital status information. MAIN OUTCOME MEASURES: Cardiopulmonary resuscitation survival, hospital discharge survival and function, and long-term survival. RESULTS: Of 948 admissions during which CPR was performed, 61.2% of patients survived the arrest and 32.2% survived to hospital discharge. Mechanism of arrest was the most important variable associated with hospital discharge. Patients with pulseless electrical activity had the worst chance of hospital discharge, followed by those with asystole and bradycardia. Follow-up information was available for 298 patients who survived to discharge. One year after hospital discharge, 24.5% of patients, regardless of age, had died. Survival was 18.5% at 7 years in those 70 years or older, compared with 45.4% in those aged 18 to 69 years. Heart rhythm at the time of arrest strongly influenced long-term survival. Bradyarrhythmias produced a nearly 2-fold increased mortality risk compared with normal sinus rhythm. CONCLUSIONS: Survival until hospital discharge after CPR at our institution during an 8-year period was higher than previously reported for other institutions. Long-term survival after discharge was equal to or higher than reported estimates from other institutions. Hospital admission practices and selection of patients receiving CPR may account for these findings.

Adult↗
PubMed2000

Influenza vaccination in children with asthma in health maintenance organizations. Vaccine Safety Datalink Team.

We assessed vaccination coverage and predictors of influenza vaccination in asthmatic children in four large Health Maintenance Organizations. We studied 68,839 children with asthma at four Health Maintenance Organizations (HMOs) in the 1995-1996 influenza season and 34,032 children at two HMOs in the 1996-1997 influenza season. In both seasons only 9-10% were vaccinated against influenza. Children who were hospitalized, had an emergency department visit for asthma or a prescription for a beta-agonist prior to the influenza season, were more likely to be vaccinated. Overall, 61% of the unvaccinated asthmatic children had made an outpatient clinic visit during months when influenza vaccination would have been appropriate. Vaccination coverage could be increased by taking advantage of all opportunities to vaccinate children with asthma whenever they make clinic visits in the fall and early winter.

Adolescent↗
PubMed2000

Influenza and the rates of hospitalization for respiratory disease among infants and young children.

BACKGROUND: Young children may be at increased risk for serious complications from influenzavirus infection. However, in population-based studies it has been difficult to separate the effects of influenzavirus from those of respiratory syncytial virus. Respiratory syncytial virus often circulates with influenzaviruses and is the most frequent cause of hospitalization for lower respiratory tract infections in infants and young children. We studied the rates of hospitalization for acute respiratory-disease among infants and children during periods when the circulation of influenzaviruses predominated over the circulation of respiratory syncytial virus. METHODS: For each season from October to May during the period from 1992 to 1997, we used local viral surveillance data to define periods in Washington State and northern California when the circulation of influenzaviruses predominated over that of respiratory syncytial virus. We calculated the rates of hospitalization for acute respiratory disease, excess rates attributable to influenzavirus, and incidence-rate ratios for all infants and children younger than 18 years of age who were enrolled in either the Kaiser Permanente Medical Care Program of Northern California or the Group Health Cooperative of Puget Sound. RESULTS: The rates of hospitalization for acute respiratory disease among children who did not have conditions that put them at high risk for complications of influenza (e.g., asthma, cardiovascular diseases, or premature birth) and who were younger than two years of age were 231 per 100,000 person-months at Northern California Kaiser sites (from 1993 to 1997) and 193 per 100,000 person-months at Group Health Cooperative sites (from 1992 to 1997). These rates were approximately 12 times as high as the rates among children without high-risk conditions who were 5 to 17 years of age (19 per 100,000 person-months at Northern California Kaiser sites and 16 per 100,000 person-months at Group Health Cooperative sites) and approached the rates among children with chronic health conditions who were 5 to 17 years of age (386 per 100,000 person-months and 216 per 100,000 person-months, respectively). CONCLUSIONS: Infants and young children without chronic or serious medical conditions are at increased risk for hospitalization during influenza seasons. Routine influenza vaccination should be considered in these children.

Acute Disease↗
PubMed2000

Does influenza vaccination exacerbate asthma? Analysis of a large cohort of children with asthma. Vaccine Safety Datalink Team.

CONTEXT: Although influenza vaccination is recommended for children with asthma, only a minority are vaccinated. One reason for low influenza vaccine coverage among children with asthma may be concern that influenza vaccination may induce an exacerbation of asthma. OBJECTIVE: To evaluate the safety of influenza vaccination in children with asthma, we studied the incidence of hospitalizations and emergency department visits for asthma following influenza vaccination. DESIGN: Retrospective cohort study-analysis of population-based computerized medical and vaccination records. SETTING: : Four large health maintenance organizations on the West Coast of the United States. SUBJECTS: Children with asthma 1 through 6 years of age, identified by search of computerized databases of medical encounters and pharmacy prescriptions. MAIN OUTCOME MEASURES: Exacerbations of asthma. RESULTS: In unadjusted analyses vaccination was associated with high rates of asthma exacerbations. However, after adjusting for asthma severity using a self-control method, the incidence rate ratios of asthma exacerbations after vaccination were 0.58 (95% confidence interval, 0.36-0.95), 0.74 (95% confidence interval, 0.47-1.17), and 0.98 (95% confidence interval, 0.76-1.27) during the 3 influenza seasons. CONCLUSIONS: After controlling for asthma severity, we found that influenza vaccination does not result in acute asthma exacerbations in children. Concern about possible exacerbation of asthma is not a valid reason to not vaccinate children with asthma against influenza.

Asthma↗
PubMed2000

The Vaccine Safety Datalink: immunization research in health maintenance organizations in the USA.

The Vaccine Safety Datalink is a collaborative project involving the National Immunization Program of the Centers for Disease Control and Prevention and several large health maintenance organizations in the USA. The project began in 1990 with the primary purpose of rigorously evaluating concerns about the safety of vaccines. Computerized data on vaccination, medical outcome (e.g. outpatient visits, emergency room visits, hospitalizations, and deaths) and covariates (e.g. birth certificates, census data) are prospectively collected and linked under joint protocol at multiple health maintenance organizations for analysis. Approximately 6 million persons (2% of the population of the USA) are now members of health maintenance organizations participating in the Vaccine Safety Datalink, which has proved to be a valuable resource providing important information on a number of vaccine safety issues. The databases and infrastructure created for the Vaccine Safety Datalink have also provided opportunities to address vaccination coverage, cost-effectiveness and other matters connected with immunization as well as matters outside this field.

Centers for Disease Control and Prevention, U.S.↗
PubMed1999

Immunization levels among premature and low-birth-weight infants and risk factors for delayed up-to-date immunization status. Centers for Disease Control and Prevention Vaccine Safety Datalink Group.

CONTEXT: Studies have noted that health care professionals may not conform to proper immunization schedules for premature and low-birth-weight infants in the United States. Little is known about the success of current efforts to immunize these high-risk infants. OBJECTIVE: To describe current immunization practices for premature and low-birth-weight infants and ascertain risk factors for poor immunization status, using large population-based data sources. DESIGN AND SETTING: Cohort and case-control analyses of immunization data tracked from March 1991 through March 1997 for 3 large health maintenance organizations (HMOs) participating in the Centers for Disease Control and Prevention's Vaccine Safety Datalink project. PARTICIPANTS: A total of 11580 low-birth-weight and premature infants were enrolled from birth to age 2 months; 6832 of these were continuously enrolled from birth to age 24 months. At age 2 months, there were 173373 full-term, normal-birth-weight infants enrolled as controls; at age 24 months, there were 103 324. MAIN OUTCOME MEASURES: Age-specific immunization status by prematurity and birth weight (<1500 g, 1500-2500 g, born at <38 weeks' gestation with birth weight of >2500 g, or full-term with normal birth weight) and patient characteristics associated with up-to-date status. RESULTS: At each age, infants weighing less than 1500 g at birth had lower up-to-date immunization levels than other infants. At age 6 months, 52% to 65% of infants weighing less than 1500 g were up-to-date at each of the 3 HMOs compared with 69% to 73% of those weighing 1500 to 2500 g, 66% to 80% of premature infants weighing more than 2500 g, and 65% to 76% of full-term, normal-birth-weight infants. By age 24 months, 78% to 86% of infants weighing less than 1500 g were up-to-date, significantly less than heavier infants, who had levels of 84% to 89%. Well-child preventive care strongly predicted immunization status, while concomitant pulmonary disease did not. CONCLUSIONS: Our data suggest that infants born prematurely are vaccinated at levels approaching that of the general population, but levels of vaccination for very low-birth-weight infants lag slightly behind.

Health Maintenance Organizations↗