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PubMed1991

Exposure assessment of consumer products: human body weights and total body surface areas to use, and sources of data for specific products.

A thorough understanding of the routes and magnitudes of chemical exposures that consumers experience during the use of a household product is needed as part of a well-founded risk assessment for that product and its components. This review describes some sources of generic consumer data (eg, relevant body weight or total body surface area for a given human age), and exposure-related data (eg, task frequency and duration) for specific product types needed for exposure assessments. The review also contains a discussion of the importance of statistical characterization of the consumer data (eg, does its range follow a normal, log-normal, or other type of distribution?). The importance of examining these data for correlative interactions is emphasized.

Body Surface Area↗
PubMedDate not supplied

Health care for children and youth in the United States: 2001 annual report on access, utilization, quality, and expenditures.

OBJECTIVES: To provide an update on insurance coverage, use of health care services, and health expenditures for children and youth in the United States and new information on parents' perceived quality of care for their children and to provide information on variation in hospitalizations for children from a 24-state hospital discharge data source. METHODS: The data on insurance coverage, utilization, expenditures, and perceived quality of care come from the Medical Expenditure Panel Survey. The data on hospitalizations come from the Nationwide Inpatient Sample, which is part of the Healthcare Cost and Utilization Project. Both data sets are maintained by the Agency for Healthcare Research and Quality. RESULTS: In 2000, 64.5% of children were privately insured, 21.6% were insured through public sources, and 13.9% were uninsured. Children aged 15-17 years were more likely to be uninsured than children 1-4 years old. Children without health insurance coverage were less likely to use health care services, and when they did, their rates of utilization and expenditures were lower than insured children. Publicly insured children were the most likely to use hospital inpatient and emergency department (ED) care. Being black or Hispanic and living in families with incomes below 200% of the poverty line were associated with lower utilization and expenditures. A small proportion of children account for the bulk of health care expenditures: approximately 80% of all children's health care expenditures are attributable to 20% of children who used medical services. Although most parents report that their experiences with health care for their children are good, there are significant variations by type of insurance coverage. There are substantial differences in average length of hospitalization across the United States, ranging from 2.9-4.1 days, and rates of hospital admission through the ED, which vary across states from 10%-25%. Injuries are a major reason for hospitalization, accounting for 1 in 6 hospital stays among 10- to 14-year-olds. In the 10- to 17-year age group, more than 1 in 7 hospital stays are due to mental disorders. Among 15- to 17-year-olds, more than one third of all hospital stays are related to childbirth and pregnancy. The top 10 most common conditions treated in the hospital account for 40%-60% of all hospital stays. CONCLUSION: Children's use of health care services varies considerably by the type of health insurance coverage, race/ethnicity, and family income. Quality of care, as measured by parents' experiences of care, also varies by type of coverage. There is substantial variation in use of hospital services across states.

Adolescent↗
PubMedDate not supplied

Annual report on access to and utilization of health care for children and youth in the United States--2000.

OBJECTIVE: This report provides an update on insurance coverage, use of health care services, and health expenditures for children and youth in the United States. In addition, the report provides information on variation in hospitalizations for children from a new 22-state hospital discharge data source. METHODS: The data on insurance coverage, utilization, and expenditures come from the Medical Expenditure Panel Survey. The data on hospitalizations come from the Database for Pediatric Studies, which is part of the Healthcare Cost and Utilization Project. Both data sets have been prepared by the Agency for Healthcare Research and Quality. RESULTS: Few changes in insurance coverage occurred between 1996 and 1998. About two thirds of American children are covered by private insurance and 19% by public sources; the remaining 15% are uninsured. Of the 71.5% of children who have at least 1 doctor's office visit, the average number of visits was 3.9, but this ranged from 2.7 among the uninsured to 4.2 for those with private insurance. Slightly more than half of children had a prescription, and these averaged 5.4 prescriptions. The majority of children (85%) incur medical expenditures, averaging $1019 for children with any expenditure. Private health insurance was by far the largest payer of medical care expenses for children, even more so than among the general population. However, nearly 21% of expenditures for children's health care were paid out of pocket by children's families. The data also show substantial differences in average length of hospitalization across states, ranging from 2.7 to 4.0 days, and rates of hospital admission through the emergency department, which vary across states from 9% to 23%. Injuries are a major reason for hospitalization, accounting for 1 in 6 hospital stays among 10- to 14-year-olds. In the 10-17 age group, 1 in 7 hospital stays are due to mental disorders. Among 15- to 17-year-olds, more than one third of all hospital stays are related to childbirth and pregnancy. CONCLUSION: Children's use of health care services varies considerably by what type of health insurance coverage they have. Expenditures for children entail a substantial out-of-pocket component, which may be quite large for children with major health problems and which may represent a significant burden on lower-income families. Substantial variation in hospitalization exits across states.

Adolescent↗
PubMed1992

Loss of seizure control associated with generic substitution of carbamazepine.

OBJECTIVE: We report two cases of lost seizure control associated with the generic substitution of carbamazepine, review pertinent literature, and discuss the impact of this substitution on patient care. DATA SOURCES: Case studies, abstracts, and research publications identified in MEDLINE and bibliographic review. DATA EXTRACTION: One author reviewed cases supplied by the other authors and abstracted information from published literature sources. DATA SYNTHESIS: The first case describes a 15-year-old boy who received valproic acid and carbamazepine for partial seizures. A change in government program policies caused him to receive generic carbamazepine. This resulted in loss of seizure control and a decrease in his serum carbamazepine concentration from 12.4 to 6.7 micrograms/mL. When his carbamazepine concentration returned to previous levels, seizure control was not reestablished. A second case involves a 21-year-old woman who substituted generic carbamazepine because of financial problems. After being seizure-free for at least five years on phenobarbital and carbamazepine, she experienced seizures related to the product change. Her carbamazepine concentration decreased from 11.8 to 8.5 micrograms/mL; she also became pregnant at that time. Seizure control was not reestablished. At least three other studies do not support these observations, but the tightly controlled conditions in these studies may not have simulated actual clinical practice. CONCLUSIONS: When generic substitution of carbamazepine is required, serum concentrations should be carefully monitored. The extra care required may negate the financial advantages of the substitution.

Adolescent↗
PubMed2003

Methodological issues in the surveillance of poisoning, illicit drug overdose, and heroin overdose deaths in new Mexico.

New Mexico leads the nation in poisoning mortality, which has increased during the 1990s in New Mexico and the United States. Most of this increase has been due to unintentional deaths from illicit drug overdoses. Medical examiner and/or vital statistics data have been used to track poisoning deaths. In this study, the authors linked medical examiner and vital statistics records on underlying cause of death, coded using the International Classification of Diseases, Ninth Revision, to assess the extent to which these data sources agreed with respect to poisoning deaths. The authors used multiple-cause files, which are files with several causes listed for each death, to further assess poisoning deaths involving more than one drug. Using vital statistics or medical examiner records, 94.7% of poisoning deaths were captured by each source alone. For unintentional illicit drug and heroin overdose deaths, each data source alone captured smaller percentages of deaths. Deaths coded as E858.8 (unintentional poisoning due to other drugs) require linkage with medical examiner or multiple-cause records, because this code identifies a significant percentage of illicit drug overdose deaths but obscures the specific drug(s) involved. Surveillance of poisoning death should include the use of medical examiner records and underlying- and multiple-cause vital statistics records.

Adult↗
PubMed1995

Maternal-fetal transfer of immunoglobulins.

OBJECTIVE: The goal of this review is to summarize the current knowledge about the transfer of immunoglobulins from the mother to the fetus. Data obtained experimentally and clinically will be discussed, and intervention trials and options will be examined. DATA SOURCE: References are limited to the English language and to human data. Sources include computerized databases and bibliographies of recent articles and books. RESULTS: Electronmicroscopic studies have unveiled the passage route of IgG through the placenta. The placental in vitro perfusion system has become a valuable experimental model, with a crucial role in the preclinical evaluation of trials to manipulate the maternal-fetal passage of immunoglobulins. CONCLUSIONS: Immunoglobulins are transferred through the placenta in an active, selective and affinity-restricted process, which is Fc-gamma receptor mediated and intracellular. Much work is still required to improve our ability to control the rate and the efficiency of this process, but the results of pioneering attempts have been encouraging.

Female↗
PubMed1995

Pathogenesis of sepsis with central venous catheter use: alternate locus-related versus central venous catheter-related sepsis.

OBJECTIVE: To review literature identifying a central venous catheter (CVC) as either a primary or a secondary source of sepsis. DATA SOURCES: Studies of CVC use in adults, children, and infants from 1968 to 1994. STUDY SELECTION: Selection of 10 studies was based on documented distinction between CVC-related and alternate infectious locus-related sepsis. DATA EXTRACTION: Abstracted from each study were either total sepsis or colonization rates, as well as the percentages of infection related to the CVC and to alternate infectious loci. DATA SYNTHESIS: Percentages of alternate-locus-related sepsis can be two to four times greater than percentages of CVC-related sepsis. CONCLUSIONS: The potential exists for the development of alternate-locus-related sepsis in patients with CVCs. Surveillance measures should reflect this potential.

Adult↗
PubMed2004

Multidrug-resistant Acinetobacter infections: an emerging challenge to clinicians.

OBJECTIVE: To review and evaluate clinically relevant epidemiology, microbiology, and clinical studies regarding the treatment of multidrug-resistant Acinetobacter infections. DATA SOURCES: Pertinent literature was identified by a MEDLINE search (1966-September 2003) and through secondary bibliographies of pertinent articles. STUDY SELECTION AND DATA EXTRACTION: All English-language articles identified from data sources were evaluated for clinical relevance. DATA SYNTHESIS: Acinetobacter baumannii has emerged as a worldwide problem as a nosocomial pathogen in hospitalized patients. Acinetobacter spp. can cause a multitude of infections including pneumonia, bacteremia, meningitis, urinary tract infections, and skin and soft tissue infections, and the mortality associated with these infections is high. Isolates resistant to almost all commercially available antimicrobials have been identified, thus limiting treatment options. The development of new agents and reappraisal of older compounds (ie, polymyxins, ampicillin/sulbactam) are necessary as we consider the optimal treatment of these multidrug-resistant organisms. CONCLUSIONS: There is no simple answer to the treatment of Acinetobacter infections. Eradication of Acinetobacter spp. requires adherence to good infection control practices and prudent antibiotic use, as well as effective antimicrobial therapy. Alternative therapies such as colistin, ampicillin/sulbactam, and tetracycline are potential options, but prospective, randomized, controlled trials are still lacking.

Acinetobacter Infections↗
PubMedDate not supplied

Teenage smoking: a longitudinal analysis.

This paper examines the binary recurrent outcome "teenage smoking" within a statistical modelling paradigm. The proposed statistical modelling relates smoking to a set of explanatory variables, which include subjective as well as objective measures. In order to assess the degree to which explanatory variables influence smoking, an adequate statistical model must handle the possibility that substantial variation between respondents will be due to omitted variables, multicollinearity and past behaviour. An earlier paper, using a secondary cross-sectional data source, concluded that an investigation of smoking needs to be based on longitudinal data using appropriate statistical modelling. The same data source provided observations on young adults over a period of 2 years. For comparison purposes, the same cross-sectional model was fitted to the longitudinal data. The results suggest there may be substantial heterogeneity due to omitted variables in the data and complex inter-relationships between observed explanatory variables leading to underestimation. Longitudinal data provide additional flexibility to control for omitted variables and are necessary to investigate dynamic social processes such as smoking. The results from our analysis suggest that the effects of variables reported in the literature on teenage smoking may be overestimated. For example, the role of peer pressure may not be as clear as it has been made out to be.

Adolescent↗
PubMedDate not supplied

New systems: the restructuring of cancer care delivery and economics.

PURPOSE/OBJECTIVE: To review and discuss the economic and care delivery implications of the healthcare reform currently being debated. DATA SOURCES: Projections are based on synthesis of multiple scholarly, professional, and governmental sources of information. DATA SYNTHESIS: Future projections regarding the hallmarks of healthcare reform (e.g., universal access, fewer payors, rationing of care), changes in practice settings, and novel communications technologies are discussed. CONCLUSIONS: Opportunities for nurses resulting from these changes include roles as resource allocators, cost-benefit analysis, cancer system liaisons, satellite-program builders, and quality-assessment experts. IMPLICATIONS FOR NURSING PRACTICE: Changes will challenge nurses to assume multiple responsibilities as clinicians, administrators, educators, and researchers who will need to integrate input from numerous sources to make decisions that take into account competing and contradictory factors.

Community Health Services↗
PubMed1982

A national study of student selection practices in the allied health professions.

Allied health education program directors must often deal with a selective admissions policy that results in large numbers of rejected applicants. This study reports the national outcomes of a 1978 survey of candidate selection practices in four baccalaureate level and seven associate degree level allied health disciplines. A total response rate of 53% (451 of 848 programs) was achieved. The survey evaluated the content of the selection process (types of selection variables and weighting of data sources) and the process or mechanics of applicant selection (selection committees, interviewing, data quantification, and evaluation of the process). The applicants' academic records and interview outcomes were primary data sources. Few programs conducted evaluation of their admissions activities. Physical therapy and dental hygiene programs, the most competitive curricula in terms of applicant numbers at each educational level, evidenced the greatest degree of structure in student selection. The authors propose guidelines designed to address some of the admissions weaknesses revealed by the survey.

Data Collection↗
PubMed2003

Teriparatide for severe osteoporosis.

OBJECTIVE: To review the pharmacology, toxicology, pharmacokinetics, pharmacodynamics, efficacy, safety, therapeutic controversies, administration, patient counseling, and formulary recommendations for teriparatide (rDNA origin). DATA SOURCES: A MEDLINE search (1966-May 2003) of articles using the key words parathyroid hormone and osteoporosis, parathyroid hormone and fracture, and teriparatide was conducted to identify relevant literature in the English language. Additional references were obtained from bibliographies of those articles. Some clinical trial data not yet published were obtained from the manufacturer. STUDY SELECTION AND DATA EXTRACTION: All articles obtained from the data sources were reviewed; all data deemed relevant were included. DATA SYNTHESIS: Teriparatide, recombinant human parathyroid hormone (1-34) [rhPTH (1-34)], is the first anabolic agent to treat postmenopausal women with osteoporosis and men with idiopathic or hypogonadal osteoporosis who are at high risk for osteoporotic fracture. Daily subcutaneous injections of teriparatide significantly increase both spine and hip bone-mineral density (BMD) while decreasing the incidence of fractures in both women and men. Common adverse effects noted with teriparatide use were nausea, headache, dizziness, and arthralgias. An increased incidence of osteosarcoma in rats during preclinical trials with teriparatide led to a black box warning for the drug. CONCLUSIONS: Teriparatide substantially increases spine and hip BMD and may offer additional benefits to patients with severe osteoporosis. Clinical trials comparing teriparatide with other available agents to treat osteoporosis are needed to more clearly define its place in therapy. Long-term safety and efficacy are not known.

Adult↗
PubMed2004

Grassland management activity data: current sources and future needs.

Estimates of potential and actual C sequestration require areal information about various types of management activities. Forest surveys, land use data, and agricultural statistics contribute information enabling calculation of the impacts of current and historical land management on C sequestration in biomass (in forests) or in soil (in agricultural systems). Unfortunately little information exists on the distribution of various management activities that can impact soil C content in grassland systems. Limited information of this type restricts our ability to carry out bottom-up estimates of the current C balance of grasslands or to assess the potential for grasslands to act as C sinks with changes in management. Here we review currently available information about grassland management, how that information could be related to information about the impacts of management on soil C stocks, information that may be available in the future, and needs that remain to be filled before in-depth assessments may be carried out. We also evaluate constraints induced by variability in information sources within and between countries. It is readily apparent that activity data for grassland management is collected less frequently and on a coarser scale than data for forest or agricultural inventories and that grassland activity data cannot be directly translated into IPCC-type factors as is done for IPCC inventories of agricultural soils. However, those management data that are available can serve to delineate broad-scale differences in management activities within regions in which soil C is likely to change in response to changes in management. This, coupled with the distinct possibility of more intensive surveys planned in the future, may enable more accurate assessments of grassland C dynamics with higher resolution both spatially and in the number management activities.

Agriculture↗
PubMed2005

A systematic review of the role of hydrolyzed infant formulas in allergy prevention.

OBJECTIVE: To critically examine the published literature to determine whether feeding hydrolyzed infant formulas from birth has a role in allergy prevention. DATA SOURCES: We identified data through a MEDLINE search using allergy prevention and infant formulas as indexing terms. The search was restricted to 1985 through the present, English-language articles, and human subjects. STUDY SELECTION: Criteria for inclusion in the review were prospective controlled trials published in peer-reviewed journals. DATA EXTRACTION: Symptoms of allergy were defined and observed by health care providers (physicians and nurses). DATA SYNTHESIS: Nine published trials evaluated the use of extensively hydrolyzed formulas, 12 evaluated the use of partially hydrolyzed formulas in high-risk infants, and 1 evaluated the use of partially hydrolyzed formulas in an unselected infant population. The reports compared hydrolyzed formulas with breastfeeding, cow's milk formulas, soy formulas, and combinations thereof. The cohort of studies consistently showed reductions in the cumulative incidence of atopic disease from 12 to 60 months of age among high-risk infants fed extensively hydrolyzed casein formulas or partially hydrolyzed whey formulas vs cow's milk formulas. No studies showed an increase in allergy risk with any hydrolyzed formulas. CONCLUSIONS: Extensively hydrolyzed casein formulas and partially hydrolyzed whey formulas are appropriate alternatives to breast milk for allergy prevention in infants at risk. Because atopic disease in children cannot be predicted, the use of these formulas in the general population should be considered, and one must weigh cost, compliance, and long-term benefits.

Child, Preschool↗
PubMed2004

A systematic review of the comparative safety of colloids.

HYPOTHESIS: Safety differences exist among colloids widely used for fluid management in acutely ill patients, as judged according to the comparative incidence of adverse events. DATA SOURCES: Colloid safety data for human subjects were sought, without language or time period restrictions, by means of computer searches of bibliographic and clinical trial databases, hand searches of medical journals and Index Medicus, inquiries with investigators and colloid suppliers, and examination of reference lists. Search terms included "colloids", "morbidity", and "mortality". STUDY SELECTION: Controlled trials, cohort studies, pharmacovigilance studies, and prior meta-analyses were independently selected by 2 unblinded investigators. Of 189 candidate studies, 113 were included, with safety data encompassing 1.54 x 10(6) patients and 1.09 x 10(8) colloid infusions. DATA EXTRACTION: Two unblinded investigators independently extracted data. Study limitations and confounding factors were tabulated. DATA SYNTHESIS: With albumin as the reference colloid, the incidence rate ratio for anaphylactoid reactions was 4.51 (95% confidence interval, 2.06-9.89) after hydroxyethyl starch administration, 2.32 (95% confidence interval, 1.21-4.45) after dextran, and 12.4 (95% confidence interval, 6.40-24.0) after gelatin. Pruritus occurrence was significantly increased by hydroxyethyl starch exposure (odds ratio, 1.78; 95% confidence interval, 1.23-2.58). Artificial colloid administration was consistently associated with coagulopathy and clinical bleeding, most frequently in cardiac surgery patients receiving hydroxyethyl starch. On the basis of large-scale pharmacovigilance study results, albumin infusion resulted in a low rate of both total adverse events (3.1 to 8.6 per 10(5) infusions) and serious adverse events (1.29 per 10(6) infusions). CONCLUSIONS: Significant safety differences exist among colloids. Therefore, conclusions regarding the clinical usefulness of colloids as a fluid class should be formed with caution.

Albumins↗
PubMedDate not supplied

Effects of acadesine on myocardial infarction, stroke, and death following surgery. A meta-analysis of the 5 international randomized trials. The Multicenter Study of Perioperative Ischemia (McSPI) Research Group.

OBJECTIVE: To determine the effects of a purine nucleoside, acadesine, on the incidence of fatal and nonfatal cardiovascular and cerebrovascular complications following coronary artery bypass graft (CABG) surgery. DATA SOURCES: Individual patient data from 5 randomized, placebo-controlled, double-blind clinical trials, including 81 international medical centers of the United States, Canada, and Europe. STUDY SELECTION: All patients from all clinical trials were included: a total of 4043 patients undergoing CABG surgery, evaluable for efficacy, and randomized to receive either placebo (n= 2031) or acadesine (0.1 mg x kg(-1) x min(-1); n=2012) by intravenous infusion for 7 continuous hours and via the cardioplegia solution. DATA EXTRACTION: Individual patient data were collected prospectively using standardized forms and methods and double-data entry. A general parametric approach and analysis-by-patient meta-analysis were used, including both fixed effects and random effects models. Inclusion and exclusion criteria, general methodology, and outcome assessment techniques were similar for all trials. DATA SYNTHESIS: Acadesine decreased the incidence of the primary outcome, perioperative myocardial infarction (MI) by 27% (odds ratio [OR], 0.69; 95% confidence interval [CI], 0.51-0.95; P=.02), decreased the incidence of cardiac death through postoperative day 4 by 50% (OR, 0.52; 95% Cl, 0.27-0.98; P=.04), and decreased the incidence of combined outcome (MI, stroke, or cardiac death) by 26% (OR, 0.73; 95% Cl, 0.57-0.93; P=.01). The random effects models for these outcomes also yielded significant results. The incidence of cerebrovascular accident was not significantly reduced by acadesine (OR, 0.69; 95% Cl, 0.44-1.08; P=.10). A secondary analysis of cardiac death following MI through postoperative day 4 demonstrated that acadesine decreased by 89% the number of deaths from 13.3% (13 deaths/98 MIs) in the placebo group to 1.4% (1 death/71 MIs) in acadesine-treated patients (P=.003). Acadesine also reduced the use of ventricular-assistance devices for severe postoperative heart failure by approximately one third (P=.05). Finally, regarding safety, the incidence of adverse events was similar in the acadesine vs placebo groups, with the exception of a transient increase in serum uric acid in the acadesine group. CONCLUSIONS: The results of this meta-analysis indicate that in patients undergoing CABG surgery, treatment with acadesine before and during surgery can reduce early cardiac death, MI, and combined adverse cardiovascular outcomes.

Aminoimidazole Carboxamide↗
PubMed2004

Efficacy and bleeding complications among patients randomized to enoxaparin or unfractionated heparin for antithrombin therapy in non-ST-Segment elevation acute coronary syndromes: a systematic overview.

CONTEXT: Antithrombin therapy has become a guidelines-recommended standard of care in the treatment of acute coronary syndromes (ACS), but recent trials comparing use of enoxaparin and unfractionated heparin in ACS have yielded less robust efficacy and safety results than have earlier trials of these antithrombin therapies. OBJECTIVE: To systematically evaluate the end points of all-cause death and nonfatal myocardial infarction (MI), transfusion, and major bleeding observed in the 6 randomized controlled trials comparing enoxaparin and unfractionated heparin in treatment of ACS. DATA SOURCES: The primary data sets for ESSENCE, A to Z, and SYNERGY were available at the Duke Clinical Research Institute. Baseline characteristics and event frequencies for TIMI 11B, ACUTE II, and INTERACT were provided by the principal investigator of each study. STUDY SELECTION: All 6 randomized controlled trials comparing enoxaparin and unfractionated heparin in non-ST-segment elevation ACS were selected for analysis. DATA EXTRACTION: Efficacy and safety end points were extracted from the overall trial populations and the subpopulation receiving no antithrombin therapy prior to randomization. DATA SYNTHESIS: Systematic evaluation of the outcomes for 21 946 patients was performed using a random-effects empirical Bayes model. No significant difference was found in death at 30 days for enoxaparin vs unfractionated heparin (3.0% vs 3.0%; odds ratio [OR], 1.00; 95% confidence interval [CI], 0.85-1.17). A statistically significant reduction in the combined end point of death or nonfatal MI at 30 days was observed for enoxaparin vs unfractionated heparin in the overall trial populations (10.1% vs 11.0%; OR, 0.91; 95% CI, 0.83-0.99; number needed to treat, 107). A statistically significant reduction in the combined end point of death or MI at 30 days was also observed for enoxaparin in the populations receiving no prerandomization antithrombin therapy (8.0% vs 9.4%; OR, 0.81; 95% CI, 0.70-0.94; number needed to treat, 72). No significant difference was found in blood transfusion (OR, 1.01; 95% CI, 0.89-1.14) or major bleeding (OR, 1.04; 95% CI, 0.83-1.30) at 7 days after randomization in the overall safety population or in the population of patients receiving no prerandomization antithrombin therapy. CONCLUSION: In a systematic overview of approximately 22 000 patients across the spectrum of ACS, enoxaparin is more effective than unfractionated heparin in preventing the combined end point of death or MI.

Angina Pectoris↗
PubMedDate not supplied

A claims data approach to defining an episode of care.

OBJECTIVE: To utilize health services research techniques in developing an episode of care using an administrative data set. This method is demonstrated for an episodic clinical condition, migraine. DATA SOURCES: Medicaid administrative data set of 3,372 patients with a diagnosis of migraine (ICD-9-CM 346.0, 346.1) in the state of Pennsylvania between May 1990 and March 1992. STUDY DESIGN: The duration of a migraine episode was measured by assessing the magnitude of resource utilization and the proportion of patients with charges in the period after the index migraine as compared to the period before the index migraine. A confidence interval (CI) was developed around each measure using bootstrap techniques. DATA COLLECTION METHODS: All charge data were extracted daily for a 113-day observation period surrounding each index migraine in order to observe the duration of impact of a migraine diagnosis on resource utilization. PRINCIPAL FINDINGS: The lower limits of both the 95% and 99% CIs for the difference in charges are greater than 0 for three weeks. The lower limits of both CIs for the difference in the proportion of patients with charges are above 0 for six weeks. CONCLUSIONS: Our analysis demonstrates that a health services research framework can be used to define an episode of care for a chronic disease category such as migraine. This method can be used to evaluate episodes of care for clinical studies of limited or episodic conditions and to complement clinical expertise in developing time horizons for clinical trials.

Adult↗