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Biomedical subjects

S Michael Marcy

Publications and source records attributed to S Michael Marcy.

15 recordsLinked to original sources
PubMed2006

Safety of trivalent inactivated influenza vaccine in children 6 to 23 months old.

CONTEXT: Beginning with the winter season of 2004-2005, influenza vaccination has been recommended for all children 6 to 23 months old in the United States. However, its safety in young children has not been adequately studied in large populations. OBJECTIVE: To screen for medically attended events in the clinic, emergency department, or hospital after administration of trivalent inactivated influenza vaccine in children 6 to 23 months old. DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort using self-control analysis, with chart review of significant medically attended events at 8 managed care organizations in the United States that comprise the Vaccine Safety Datalink. Participants were all children in the Vaccine Safety Datalink cohort 6 to 23 months old who received trivalent inactivated influenza vaccine between January 1, 1991, and May 31, 2003 (45,356 children with 69,359 vaccinations). MAIN OUTCOME MEASURE: Any medically attended event significantly associated with trivalent inactivated influenza vaccine in risk windows 0 to 3 days, 1 to 14 days (primary analysis), 1 to 42 days, or 15 to 42 days after vaccination, compared with 2 control periods, one before vaccination and the second after the risk window. All individual ICD-9 codes as well as predefined aggregate codes were examined. RESULTS: Before chart review, only 1 diagnosis, gastritis/duodenitis, was more likely to occur in the 14 days after trivalent inactivated influenza vaccine (matched odds ratio [OR], 5.50; 95% confidence interval [CI], 1.22-24.81 for control period 1, and matched OR, 4.33; 95% CI, 1.23-15.21 for control period 2). Thirteen medically attended events were less likely to occur after trivalent inactivated influenza vaccine, including acute upper respiratory tract infection, asthma, bronchiolitis, and otitis media. After chart review, gastritis/duodenitis was not significantly associated with trivalent inactivated influenza vaccine (matched OR, 4.00; 95% CI, 0.85-18.84 for control period 1; matched OR, 3.34; 95% CI, 0.92-12.11 for control period 2). CONCLUSIONS: In the largest population-based study to date of the safety of trivalent inactivated influenza vaccine in young children, there were very few medically attended events, none of which were serious, significantly associated with the vaccine. This study provides additional evidence supporting the safety of universally immunizing all children 6 to 23 months old with influenza vaccine.

Cohort Studies↗
PubMed2006

Clinical practice guideline: acute otitis externa.

OBJECTIVE: This guideline provides evidence-based recommendations to manage diffuse acute otitis externa (AOE), defined as generalized inflammation of the external ear canal, which may also involve the pinna or tympanic membrane. The primary purpose is to promote appropriate use of oral and topical antimicrobials and to highlight the need for adequate pain relief. STUDY DESIGN: In creating this guideline, the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) selected a development group representing the fields of otolaryngology-head and neck surgery, pediatrics, family medicine, infectious disease, internal medicine, emergency medicine, and medical informatics. The guideline was created with the use of an explicit, a priori, evidence-based protocol. RESULTS: The group made a strong recommendation that management of AOE should include an assessment of pain, and the clinician should recommend analgesic treatment based on the severity of pain. The group made recommendations that clinicians should: 1) distinguish diffuse AOE from other causes of otalgia, otorrhea, and inflammation of the ear canal; 2) assess the patient with diffuse AOE for factors that modify management (nonintact tympanic membrane, tympanostomy tube, diabetes, immunocompromised state, prior radiotherapy); and 3) use topical preparations for initial therapy of diffuse, uncomplicated AOE; systemic antimicrobial therapy should not be used unless there is extension outside of the ear canal or the presence of specific host factors that would indicate a need for systemic therapy. The group made additional recommendations that: 4) the choice of topical antimicrobial therapy of diffuse AOE should be based on efficacy, low incidence of adverse events, likelihood of adherence to therapy, and cost; 5) clinicians should inform patients how to administer topical drops, and when the ear canal is obstructed, delivery of topical preparations should be enhanced by aural toilet, placing a wick, or both; 6) when the patient has a tympanostomy tube or known perforation of the tympanic membrane, the clinician should prescribe a nonototoxic topical preparation; and 7) if the patient fails to respond to the initial therapeutic option within 48 to 72 hours, the clinician should reassess the patient to confirm the diagnosis of diffuse AOE and to exclude other causes of illness. And finally, the panel compiled a list of research needs based on limitations of the evidence reviewed. CONCLUSION: This clinical practice guideline is not intended as a sole source of guidance in evaluating patients with AOE. Rather, it is designed to assist clinicians by providing an evidence-based framework for decision-making strategies. It is not intended to replace clinical judgment or establish a protocol for all individuals with this condition and may not provide the only appropriate approach to the diagnosis and management of this problem. SIGNIFICANCE: This is the first, explicit, evidence-based clinical practice guideline on acute otitis externa, and the first clinical practice guideline produced independently by the AAO-HNSF.

Acute Disease↗
PubMed2006

Compliance with the recommendations for 2 doses of trivalent inactivated influenza vaccine in children less than 9 years of age receiving influenza vaccine for the first time: a Vaccine Safety Datalink study.

OBJECTIVES: Children <9 years of age do not respond optimally to a first dose of trivalent inactivated influenza vaccine, and so 2 doses of trivalent inactivated influenza vaccine are recommended for children <9 years of age who are being vaccinated for the first time. We conducted a population-based retrospective cohort study to evaluate compliance with the 2-dose trivalent inactivated influenza vaccine recommendations. POPULATION AND SETTING: We evaluated 125,928 children 6 months through 8 years of age who were enrolled in health maintenance organizations in the United States participating in the Vaccine Safety Datalink project and who received their first dose of trivalent inactivated influenza vaccine in the 2001-2002, 2002-2003, or 2003-2004 influenza seasons. RESULTS: Compliance with the 2 dose recommendations varied by age group and influenza season. Among children 6 to 23 months of age, the proportion of first-vaccinated children who received a second vaccination was 44% in 2001-2002, 54% in 2002-2003, and 29% in 2003-2004. Among children 2 to 8 years of age, the corresponding proportions were 15%, 24%, and 12%, respectively. In all seasons, compliance with the second vaccination was highest in children first vaccinated by mid-November. CONCLUSIONS: The majority of children who received their first dose of trivalent inactivated influenza vaccine did not complete the 2-dose series. The recently expanded recommendation for universal vaccination of children 6 to 59 months of age and their household contacts will substantially increase the number of children targeted for a first influenza vaccination. Noncompliance with the 2-dose trivalent inactivated influenza vaccine series may be associated with suboptimal protection against infection, which may impact the magnitude of the direct and indirect benefits achieved by the vaccination program.

Child↗
PubMed2005

Compliance with national immunization guidelines for children younger than 2 years, 1996-1999.

OBJECTIVES: To evaluate compliance with national immunization guidelines among a large cohort of children cared for at health maintenance organizations (HMOs) and to examine effects on immunization status. METHODS: A cohort study of 176134 children born between January 1, 1994, and December 31, 1997, and monitored from birth to the second birthday was performed. Subjects belonged to the Vaccine Safety Datalink Project, a study of children enrolled in 1 of 4 HMOs. Children were continuously enrolled in a HMO for the first 2 years of life. Prevailing recommendations regarding optimal ages of immunization and intervals between doses were applied to define appropriate immunization timing and immunization status. Noncompliance was defined as having a missing or late immunization or an immunization error. Immunization errors included invalid immunizations (too early to be acceptable), extra immunizations (superfluous immunizations or make-up immunizations for invalid immunizations), and missed opportunities resulting in late or missing immunizations. RESULTS: Although 75.4% of children in these HMOs were up to date for all immunizations at 2 years, only 35.6% of children were fully compliant with recommended immunization practices. Less than 8% of children received all immunizations in accordance with strict interpretation of recommended guidelines. Fifty-one percent of children had at least 1 immunization error by age 2 years; 29.7% had a missed opportunity with subsequent late or missing immunization, 20.4% had an invalid immunization, and 11.6% had an extra immunization. Common reasons for noncompliance included missed opportunities for the fourth Haemophilus influenzae type b vaccine (14.6%), invalid fourth diphtheria-tetanus-pertussis/acellular pertussis immunizations (11.0%), and superfluous polio immunizations (9.8%). CONCLUSIONS: Approximately 35.6% of children were compliant with prevailing childhood immunization recommendations from 1996 to 1999. Efforts to improve compliance with guidelines are recommended, to optimize childhood infectious disease prevention.

Cohort Studies↗
PubMed2004

Fever after immunization: current concepts and improved future scientific understanding.

Fever is a common clinical complaint in adults and children with a variety of infectious illnesses, as well as a frequently reported adverse event following immunization. Although the level of measured temperature indicative of a "fever" was first defined in 1868, it remains unclear what role fever has as a physiologic reaction to invading substances, how best to measure body temperature and compare measurements from different body sites, and, consequently, how to interpret fever data derived from vaccine safety trials or immunization safety surveillance. However, even with many aspects of the societal, medical, economic, and epidemiologic meanings of fever as an adverse event following immunization (AEFI) still elusive, it is a generally benign--albeit common--clinical sign. By standardizing the definition and means of assessment of fever in vaccine safety studies, thereby permitting comparability of data, we hope to arrive at an improved understanding of its importance as an AEFI.

Adult↗
PubMed2004

Safety of the trivalent inactivated influenza vaccine among children: a population-based study.

BACKGROUND: To our knowledge, there are no published population-based studies on the safety of the inactivated trivalent influenza vaccine among children. OBJECTIVE: To screen a large population of children for evidence of increased medical visits in the 2 weeks after influenza vaccination compared with 2 control periods. Secondary analyses included shorter risk periods and restricted age categories. DESIGN: Self-control screening analysis. Children vaccinated from January 1, 1993, through December 31, 1999, were randomly divided into 2 equal groups. In group 1, risks of outpatient, emergency department, and inpatient visits during the 14 days after vaccination were compared with the risks of visits in 2 control periods. Significant plausible medically attended events identified in group 1 were then analyzed in group 2, using the same 2 control periods. Medically attended events significant in both groups were considered potentially associated with vaccination and were assessed by medical record review. SETTING: Five managed care organizations in the United States. PARTICIPANTS: Children younger than 18 years who received an influenza vaccination in one of the managed care settings (N = 251 600). MAIN OUTCOME MEASURE: Among vaccinated children seen for a medically attended event, the odds of the visit occurring in the 2 weeks after vaccination vs during 1 of the 2 control periods. RESULTS: Study participants incurred 1165, 230, and 489 different diagnoses during the 14 days after vaccination according to the outpatient, emergency department, and inpatient data, respectively. Four diagnoses were positively associated with the vaccine in both groups 1 and 2: impetigo, dermatitis, uncomplicated diabetes mellitus, and ureteral disorder not otherwise specified. After medical record review, impetigo (9 cases) in children 6 to 23 months old remained significantly associated with vaccination. CONCLUSION: This large screening safety study did not reveal any evidence of important medically attended events associated with pediatric influenza vaccination.

Case-Control Studies↗
PubMed2004

Epidemiology of anaphylaxis among children and adolescents enrolled in a health maintenance organization.

BACKGROUND: There is little information about the incidence of anaphylaxis from all causes. OBJECTIVE: The objects of this study were (1) to estimate the incidence of anaphylaxis; (2) to explore the range of diagnoses attributed to an anaphylactic episode; and (3) to describe the clinical features of anaphylaxis. METHODS: The study population consisted of children and adolescents enrolled at a health maintenance organization. We identified potential episodes of anaphylaxis occurring between 1991 and 1997 from automated databases and reviewed the medical record to confirm the diagnosis. We reviewed all diagnoses specific for anaphylaxis (eg, ICD-9 995.0, anaphylactic shock) and sampled from among other related diagnoses (eg, ICD-9 995.3, allergy unspecified). Estimation of the incidence of provider-diagnosed anaphylaxis was based on cases confirmed from among the specific diagnosis codes. Description of the clinical features of anaphylaxis involved all confirmed cases regardless of diagnosis. RESULTS: We identified 67 episodes of anaphylaxis among children with diagnosis codes specific for anaphylaxis (10.5 episodes per 100,000 person-years). There was no increase in incidence over time. Review of samples of diagnoses not specific for anaphylaxis yielded an additional 18 episodes. Among all identified episodes (n = 85), mucocutaneous and respiratory manifestations were the most common. Seventy-one percent of episodes were treated in the emergency department. Nine episodes (11%) resulted in hospitalization. CONCLUSIONS: The incidence of anaphylaxis did not increase during these years. A majority of episodes were treated in the emergency department. Anaphylaxis in this population was frequently diagnosed as another related condition, and the basis and implications of diagnostic practices in this disorder warrant further exploration.

Adolescent↗
PubMed2004

Lack of association between hepatitis B birth immunization and neonatal death: a population-based study from the vaccine safety datalink project.

BACKGROUND: There have been no population-based studies of the potential association between neonatal death and newborn immunization with hepatitis B vaccine (HBV). METHODS: As part of the Vaccine Safety Datalink Project, we defined a birth cohort at Southern and Northern California Kaiser Permanente Health Plans of more than 350,000 live births from 1993 to 1998 and ascertained all deaths occurring under 29 days of age. We compared the proportions of deaths among birth HBV-vaccinated and unvaccinated newborns and reviewed the causes and circumstances of their deaths. We performed detailed clinical reviews of all HBV-vaccinated neonates who died and a sample of unvaccinated neonates who died and who were matched to vaccinated deaths for days of life, sex, birth year and site of care. To avoid confounding, we categorized the causes of death as either "expected" or "unexpected" and performed a stratified analysis to compare mortality with immunization status. RESULTS: There were 1363 neonatal deaths during the study period. Whereas 67% of the entire birth cohort received HBV at birth, only 72 (5%) of the neonates who died were HBV-vaccinated at birth (P < 0.01). We found no significant difference in the proportion of HBV-vaccinated (31%) and unvaccinated (35%) neonates dying of unexpected causes (P = 0.6). Further we could not identify a plausible causal or temporal relationship between HBV administration and death for the 22 vaccinated neonates who died unexpectedly. CONCLUSIONS: A relationship between HBV and neonatal death was not identified.

California↗
PubMed2003

Polio extraimmunization in children younger than 2 years after changes in immunization recommendations.

OBJECTIVE: To investigate trends over time in polio extraimmunization among children in 4 large health maintenance organizations and to study the association with recent changes in polio immunization policy. METHODS: Using 176 169 children who were born after 1994 and enrolled for their first 2 years of life, we assessed rates and trends of polio extraimmunization in the Vaccine Safety Datalink project. We used logistic regression to test the association of extraimmunization with different polio immunization schedules and with sociodemographic characteristics and used Poisson regression to test changes in rates over time. RESULTS: Overall, 10.5% were extraimmunized for poliovirus; children on the all inactivated polio virus or sequential schedule were one half as likely as those on the all oral polio virus schedule to be extraimmunized by 2 years of age. There was a significant decrease in extraimmunization over time, with <5% of children born at the end of 1997 being extraimmunized, compared with >15% at the beginning of 1994. CONCLUSIONS: Poliovirus extraimmunization rates have fallen dramatically in association with the change-over to the all inactivated polio virus schedule.

Administration, Oral↗
PubMed2003

Pediatric combination vaccines: their impact on patients, providers, managed care organizations, and manufacturers.

OBJECTIVES: To review the potential benefits of pediatric combination vaccines to children, parents, providers, managed care organizations, and manufacturers and to discuss the scientific, social, and economic issues that need to be addressed to provide optimum uptake of these vaccines. RESULTS: Combination vaccines provide multiple advantages for children, parents, and providers; however, their development involves considerable research and expense to ensure efficacy and safety. As the complexity of these vaccines increases, more extensive laboratory and clinical trials will be needed to ensure antigen compatibility, immunogenicity, and acceptable reactogenicity. To accommodate the large numbers of subjects necessary to establish vaccine efficacy and the absence of rare severe adverse events, revision of future licensure requirements may be necessary. Cost-benefit studies will be helpful in guiding pricing levels for manufacturers, efficient purchase plans for providers, and appropriate reimbursement policies for managed care organizations. CONCLUSIONS: The continued development and introduction of new combination vaccines offers significant potential benefits. Optimal uptake will require careful review of their many advantages and attention to potential problems perceived by those who will be affected by their use: manufacturers, children, parents, providers, and payers.

Attitude of Health Personnel↗
PubMed2002

Childhood vaccinations and risk of asthma.

BACKGROUND: A few previous studies have suggested that childhood vaccines, particularly whole cell pertussis vaccine, may increase the risk of asthma. We evaluated the suggested association between childhood vaccinations and risk of asthma. METHODS: Cohort study involving 167,240 children who were enrolled in 4 large health maintenance organizations during 1991 to 1997, with follow-up from birth until at least 18 months to a maximum of 6 years of age. Vaccinations were ascertained through computerized immunization tracking systems, and onset of asthma was identified through computerized data on medical care encounters and medication dispensings. RESULTS: In the study 18,407 children (11.0%) developed asthma, with a median age at onset of 11 months. The relative risks (95% confidence intervals) of asthma were: 0.92 (0.83 to 1.02) for diphtheria, tetanus and whole cell pertussis vaccine; 1.09 (0.9 to 1.23) for oral polio vaccine; 0.97 (0.91 to 1.04) for measles, mumps and rubella (MMR) vaccine; 1.18 (1.02 to 1.36) for Haemophilus influenzae type b (Hib); and 1.20 (1.13 to 1.27) for hepatitis B vaccine. The Hib result was not consistent across health maintenance organizations. In a subanalysis restricted to children who had at least 2 medical care encounters during their first year, the relative risks decreased to 1.07 (0.71 to 1.60) for Hib and 1.09 (0.88 to 1.34) for hepatitis B vaccine. CONCLUSION: There is no association between diphtheria, tetanus and whole cell pertussis vaccine, oral polio vaccine or measles, mumps and rubella vaccine and the risk of asthma. The weak associations for Hib and hepatitis B vaccines seem to be at least partially accounted for by health care utilization or information bias.

Asthma↗