The pacifier debate.
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Guidelines as Topic↗
Biomedical subjects
Diana Petitti
Publications and source records attributed to Diana Petitti.
Commentary: hormone replacement therapy and coronary heart disease: four lessons.
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Attitude↗
Use of inhaled steroids by pregnant asthmatic women does not reduce intrauterine growth.
BACKGROUND: Inhaled steroids are recommended for the treatment of persistent asthma during pregnancy, but their potential effects on intrauterine growth have been inadequately evaluated. OBJECTIVE: The purpose of this study was to evaluate the association between maternal use of specific inhaled steroids and inhaled steroid dose during pregnancy and the incidence of infants who are small for gestational age (SGA) and mean birth weight. METHODS: Pregnant asthmatic women being treated with inhaled steroids were enrolled in the study before delivery by their managing allergists. Information regarding the specific inhaled steroid and daily dose used, requirement for oral steroids, occurrence of acute asthmatic episodes, maternal race, birth weight, gestational age, and congenital malformations was obtained for each patient. SGA was defined through use of a published normative sample of American births. RESULTS: A total of 474 women were enrolled in the study; of the 451 enrolled participants whose pregnancy ended in a singleton live birth, 396 (88%) completed the study. The incidence of infants with low birth weight, preterm births, and congenital malformations in this cohort was not greater than expected in the general population. The incidence of SGA was 7.1% (95% CI, 5.0% to 10.1%). No significant relationships between specific inhaled steroid or dose of inhaled steroid used and either SGA or mean birth weight were observed. CONCLUSION: These data suggest that the use of inhaled steroids by pregnant asthmatic women does not reduce intrauterine growth and supports the recommendation that inhaled steroids should be used in the management of persistent asthma during pregnancy.
Administration, Inhalation↗
Asthma population management: development and validation of a practical 3-level risk stratification scheme.
OBJECTIVE: To define and validate a practical risk stratification scheme based on administrative data for use in identifying patients at high, medium, and low risk of requiring emergency hospital care for asthma. STUDY DESIGN: Retrospective cohort. PATIENTS AND METHODS: Predictors in 1999 were evaluated in relation to 2000 asthma emergency hospital care (any asthma hospitalization or emergency department visit) in a training set (n = 8789, 2000 emergency hospital care = 5.5%) and a testing set (n = 6104, 2000 emergency hospital care = 7.9%). Logistic regression was used to assign risk points in the training set, and positive and negative predictive values, sensitivities, and specificities were calculated in the training and testing sets. RESULTS: High risk was defined as asthma emergency hospital care in the previous year or use of >14 beta-agonist canisters and oral corticosteroid use; medium risk was defined as no emergency hospital care but use of either >14 beta-agonist canisters or oral corticosteroids; and low risk was defined as none of the above. For the high-risk groups in the training and testing sets, positive predictive values were 12.9% and 22.0%, sensitivities were 24.8% and 25.4%, specificities were 90.3% and 92.0%, and negative predictive values were 95.4% and 93.2%, respectively. The medium-risk groups identified another 32.6% of patients in the training set and 28.3% in the testing set requiring subsequent asthma emergency hospital care. CONCLUSION: This simple risk stratification scheme is useful for identifying patients from administrative data who are at increased risk of experiencing emergency hospital care for asthma.
Adolescent↗
Inhaled corticosteroids and allergy specialty care reduce emergency hospital use for asthma.
BACKGROUND: The interrelationships between optimal inhaled corticosteroid (IC) therapy, allergy specialist care, and reduced emergency hospital care for asthma have not been well defined. OBJECTIVE: We sought to evaluate the independent effectiveness of various levels of IC dispensing and allergy specialist care in reducing subsequent emergency asthma hospital use. METHODS: Asthmatic patients (n = 9608) aged 3 to 64 years were identified from an electronic database of a large health maintenance organization. The outcome was any year 2000 asthma hospitalization or emergency department visit. The main predictors were at least one allergy department visit and the number of IC canisters dispensed in 1999. Analyses were adjusted for age, sex, insurance type, and asthma severity (1999 emergency asthma hospital use, beta-agonist use, and oral corticosteroid use). RESULTS: Dispensing of 7 or more canisters of ICs (odds ratio [OR], 0.64; 95% CI, 0.43-0.94) and allergy care (OR, 0.73; 95% CI, 0.55-0.97) were associated with reduced subsequent emergency asthma hospital use. More patients with allergy specialist care than those without such care received 7 or more dispensations of ICs (24.7% vs 8.3%, P <.001). When 7 or more dispensations of ICs and allergy specialist care were simultaneously included in an adjusted model, both ICs (OR, 0.68; 95% CI, 0.46-1.00) and allergy care (OR, 0.77; 95% CI, 0.58-1.02) were independently associated with a lower risk of year 2000 emergency asthma hospital care, although significance was borderline. CONCLUSION: Allergy care reduces emergency hospital use for asthma by increasing use of ICs but probably also has an independent effect.
Administration, Inhalation↗
Risk factors for asthma hospitalizations in a managed care organization: development of a clinical prediction rule.
OBJECTIVE: To use a computerized administrative database to develop and validate a clinical prediction rule for the occurrence of asthma hospitalizations. STUDY DESIGN: Retrospective cohort. METHODS: Subjects included asthmatic patients ages 3 to 64 who were continuously enrolled in the Southern California Kaiser Permanente managed care organization in both 1998 and 1999. Data were based on linkage of a hospital discharge database, diagnosis and procedures database, membership database, and prescription database. The outcome was any 1999 hospitalization with a primary diagnosis of asthma. The outcome was evaluated and modeled separately for children (ages 3-17) and adults (ages 18-64). RESULTS: Univariate analyses showed that hospitalized children were younger than nonhospitalized children. Adults and children hospitalized in 1999 had lower mean household incomes, were more likely to have required an emergency department visit or hospitalization in 1998, used more beta-agonists and oral corticosteroids in 1998, and had more 1998 prescribers than nonhospitalized patients. In multivariable analysis, independent predictors of 1999 hospitalization in children included age and 1998 hospitalizations, beta-agonist dispensings, total anti-inflammatory dispensings, and number of prescribers. Among adults, 1998 hospitalizations and oral steroid dispensings as well as income were independent predictors of hospitalization in 1999. The prediction rules developed in this study identified the 11% to 13% of adults or children with an approximately 6-fold higher likelihood for being hospitalized in the following year. CONCLUSION: These models can be used to identify high-risk asthmatic patients in whom targeted intervention might reduce asthma morbidity and cost of care.
Adolescent↗
Hormone replacement therapy and coronary heart disease: results of randomized trials.
A number of lines of evidence have suggested that postmenopausal hormone replacement therapy might be useful in the primary and secondary prevention of coronary heart disease (CHD). Data from recent randomized trials are consistent in showing no overall benefit of hormone replacement therapy as a continuous combined regimen of estrogen and a progestin (PERT) in preventing the development of CHD or preventing recurrent events or progression of atherosclerosis. The randomized trials also raise questions about hormone replacement therapy in the form of estrogen alone (ERT) for prevention of CHD and CHD recurrence. Other interventions to prevent CHD and decrease morbidity and mortality in women with established disease have a strong evidence base. Hormone replacement therapy should not be recommended to prevent CHD or CHD recurrence until and unless data from randomized trials establish this as a benefit.
Age Factors↗
Good research practices for cost-effectiveness analysis alongside clinical trials: the ISPOR RCT-CEA Task Force report.
OBJECTIVES: A growing number of prospective clinical trials include economic end points. Recognizing the variation in methodology and reporting of these studies, the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) chartered the Task Force on Good Research Practices: Randomized Clinical Trials-Cost-Effectiveness Analysis. Its goal was to develop a guidance document for designing, conducting, and reporting cost-effectiveness analyses conducted as a part of clinical trials. METHODS: Task force cochairs were selected by the ISPOR Board of Directors. Cochairs invited panel members to participate. Panel members included representatives from academia, the pharmaceutical industry, and health insurance plans. An outline and a draft report developed by the panel were presented at the 2004 International and European ISPOR meetings, respectively. The manuscript was then submitted to a reference group for review and comment. RESULTS: The report addresses issues related to trial design, selecting data elements, database design and management, analysis, and reporting of results. Task force members agreed that trials should be designed to evaluate effectiveness (rather than efficacy), should include clinical outcome measures, and should obtain health resource use and health state utilities directly from study subjects. Collection of economic data should be fully integrated into the study. Analyses should be guided by an analysis plan and hypotheses. An incremental analysis should be conducted with an intention-to-treat approach. Uncertainty should be characterized. Manuscripts should adhere to established standards for reporting results of cost-effectiveness analyses. CONCLUSIONS: Trial-based cost-effectiveness studies have appeal because of their high internal validity and timeliness. Improving the quality and uniformity of these studies will increase their value to decision makers who consider evidence of economic value along with clinical efficacy when making resource allocation decisions.
Advisory Committees↗