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Biomedical subjects

T R Einarson

Publications and source records attributed to T R Einarson.

99 records · Page 6Linked to original sources
PubMedDate not supplied

Moderate alcohol consumption during pregnancy and the incidence of fetal malformations: a meta-analysis.

To determine whether there is an association between moderate alcohol consumption in the first trimester of pregnancy and increased risk of fetal malformations, we conducted a literature search using Medline (1966-present), PsycLit (1974-1995), and EMBASE (1988-1995). The following inclusion criteria were used to select the studies to be evaluated: 1) pregnant women; 2) moderate alcohol consumption (> 2 drinks/week to 2 drinks/day); 3) case-control or cohort studies; 4) presence of an abstainer group (0 to 2 drinks/wk); 5) outcome measures include major or minor malformations; 6) papers published in the English language. The exclusion criteria were: 1) studies in which moderate alcohol consumption could not be confirmed; 2) case reports, and editorials. The Methods section of each study was examined independently by two blinded investigators with a third investigator settling any disagreement. The number of malformations in the abstainer and moderate alcohol consuming groups in two by two tables. Out of 24 studies which met the inclusion criteria, only seven had extractable data. The included studies evaluated 130,810 pregnancy outcomes, with 24,007 in the moderate alcohol group and 106,803 in the control group. An overall Mantel-Haenszel odds ratio showed that the relative risk for fetal malformations was 1.01 with 95% confidence limits of 0.94 to 1.08 and a chi-square for homogeneity of 8.26 (p = 0.220). Quality of the studies did not correlate with their showing negative or positive association. Moderate alcohol consumption during the first trimester of pregnancy is not associated with increased risk of fetal malformations.

Abnormalities, Drug-Induced↗
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Cost-effectiveness of treprostinil versus epoprostenol in patients with pulmonary arterial hypertension: a Canadian analysis.

BACKGROUND: Pulmonary arterial hypertension (PAH) is associated with substantial morbidity and mortality, exerting a tremendous health and economic impact on patients. In the present study, an economic evaluation of patients with PAH treated with either treprostinil or epoprostenol was performed. METHODS: A cost-minimization analysis (a cost-effectiveness subtype) was performed under the assumption that treprostinil and epoprostenol were clinically equivalent. Two cohorts of 60 patients, treated with treprostinil or epoprostenol, were evaluated over three years by using a dynamic spreadsheet model. The evaluation included both the provincial ministries of health and societal perspectives. Resource valuation data for drugs, medical supplies, consultations, and surgical and diagnostic procedures were obtained from standard lists. Costs of hospitalizations and adverse events were derived from published sources. Additional outpatient costs were considered equivalent and, therefore, were excluded from the analysis. Costs are presented in 2003 Canadian dollars discounted at 3%. Sensitivity analyses were performed testing all uncertainties in the model. RESULTS: In the base-case analysis (over three years), treatment with treprostinil resulted in an expected savings of 2,610,642 US dollars and 2,781,438 US dollars from the ministries of health and societal perspectives, respectively. On a per-patient level, treatment with treprostinil resulted in an average annual savings of 14,504 US dollars and 15,452 US dollars, respectively. The greatest savings with treprostinil came from reduced hospitalizations. Multivariate sensitivity analyses estimated cost savings in greater than 99% of scenarios. CONCLUSIONS: By initiating and continuing treprostinil treatment over a three-year period, the economic burden associated with PAH may be reduced compared with epoprostenol treatment.

Administration, Oral↗
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Rank-order stability analysis (ROSA): testing pharmacoeconomic data.

In a pharmacoeconomic analysis, the validity of findings is critical because product ranking may influence formulary decision making. The authors present an approach for examining uncertainty in a pharmacoeconomic analysis that parallels the confidence-interval approach to statistical analysis. This method, rank-order stability analysis (ROSA), is a clear and comprehensive method for validating results of a pharmacoeconomic analysis, as it identifies and evaluates all inputs and values. It is a break-even analysis that identifies the specific point of insensitivity for all parameters analyzed in the pharmacoeconomic model. ROSA is proposed as the preferred method for judging the validity of results derived from estimated parameters in pharmacoeconomic analyses.

Confidence Intervals↗
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Chymopapain.

Chymopapain is a proteolytic enzyme injected intradiscally for the treatment of herniated lumbar discs. The average success rate is 73 percent for elimination of backache and sciatica. Side effects occur in three percent of patients, the most serious being anaphylaxis in about one percent. A majority of patients experience severe back pain or spasms during the first 24-48 hours after treatment. This treatment modality consumes fewer hospital days and produces a quicker return to work than does surgery. It does not affect subsequent surgical procedures adversely. Chymopapain chemonucleolysis is safe and effective when administered by experienced physicians and when adequate precautions are taken. It can be considered the last step before surgery in the conservative management of herniated lumbar discs.

Chymopapain↗
PubMedDate not supplied

Drug-related hospital admissions.

OBJECTIVE: To review and summarize studies reporting rates of drug-related hospital admissions. DATA SOURCES: Manual and computerized literature searches using MEDLINE, Index Medicus, and International Pharmaceutical Abstracts as databases (key words: drug, drug-related, or iatrogenic; admission, hospital admission, or hospitalization; and ADR or adverse drug reaction). References from retrieved articles were searched to locate further studies. STUDY SELECTION: Included were English-language studies of humans admitted to the hospital because of medications. Problems investigated were admissions prompted by adverse drug reactions (ADRs) when drugs were used by the patient and admissions resulting from a patient's noncompliant or unintentionally inappropriate drug use. Excluded were cases involving drug abuse, alcoholism, suicide attempts, intoxication, or inadequate prescribing. DATA SYNTHESIS: Between 1966 and 1989, ADR rates from 49 hospitals or groups of hospitals in a variety of international settings were published in 36 articles. Samples sizes ranged from 41 to 11,891 patients, with a median of 714 (interquartile range [IQR] 275-1245) and a mean of 1412 (SD 2233). The prevalence of reported admissions resulting from ADRs ranged from 0.2 to 21.7 percent; the median was 4.9 percent (IQR 2.9-6.7 percent) and the mean was 5.5 percent (SD 4.1 percent). The weighted meta-analytic estimate was 5.1 percent (95 percent confidence interval 4.4-5.8). Of those ADR admissions, 71.5 percent were side effects, 16.8 percent excessive effects, 11.3 percent hypersensitivity reactions, and 0.4 percent idiosyncratic; 3.7 percent of patients admitted for ADRs died. Eleven reports indicated that 22.7 percent of ADR hospitalizations were induced by noncompliance. CONCLUSIONS: Drug-induced hospitalizations account for approximately five percent of all admissions. Results apply only to people from highly developed industrialized countries. Economic analyses have not been performed. Future research should include the Third World and nonindustrialized nations as well as specific cultural groups.

Drug-Related Side Effects and Adverse Reactions↗
PubMedDate not supplied

Quality assessment of economic evaluations in selected pharmacy, medical, and health economics journals.

OBJECTIVE: To assess and compare the quality of economic studies in selected pharmacy, medical, and health economics journals. DATA SOURCES: DICP The Annals of Pharmacotherapy, American Journal of Hospital Pharmacy, Hospital Pharmacy, New England Journal of Medicine, Medical Care, Journal of the American Medical Association, PharmacoEconomics, International Journal of Technology Assessment in Health Care, and Journal of Health Economics using MEDLINE, EMBASE, and International Pharmaceutical Abstracts. Search terms included "economic," "cost," and "cost analysis." STUDY SELECTION: Reviewers appraised abstracts to identify original research published during 1989-1993 comparing costs and outcomes between drugs, treatments, and/or services. Initially, 123 articles met criteria; 16 were inappropriate, 17 were randomized out, and 90 (73%) were used (30/group). DATA EXTRACTION: Quality was assessed using a 13-item checklist. Interrater reliability was 0.91 (p < 0.05) for 9 raters, test-retest reliability was 0.94 (p < 0.001). DATA SYNTHESIS: A 2-way ANOVA, with overall quality scores as a dependent variable with journal type and year as independent variables, was significant (F = 2.79, p = 0.002, r2 = 0.34), with no significant interaction (F = 0.71, p = 0.68) or time effect (F = 0.70, p = 0.60). Journal types differed; pharmacy journals scored significantly lower (chi 2 = 53.89, df = 2, p < 0.001). Items rated adequate (i.e., correct or acceptable) increased over time (chi 2 = 21.18, df = 4, p < 0.001). Ethical issues and study perspective most needed improvement. CONCLUSIONS: Article quality for all journal types increased over time nonsignificantly; health economics journals scored highest, then medical journals, with pharmacy journals significantly lower (and having the highest standard deviation). We recommend that authors and reviewers pay closer attention to study perspective and ethical implications.

Economics, Pharmaceutical↗
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The effects of age and chemotherapy on gentamicin pharmacokinetics and dosing in pediatric oncology patients.

We attempted to determine the effects of prior antineoplastic chemotherapy and age on gentamicin pharmacokinetics in children (age 1-18 yrs) with cancer and in controls, and to establish a protocol for gentamicin dosing and monitoring to ensure rapid attainment of therapeutic serum concentrations in these patients. In a prospective controlled study, patients with fever who were receiving empiric gentamicin for confirmed or suspected infections were separated into three groups: 29 with cancer who were receiving a continuing chemotherapy protocol with nonnephrotoxic antineoplastic agents; 23 with cancer who were receiving a continuing chemotherapy protocol with nephrotoxic antineoplastic agents; and 25 control patients who did not have cancer. Three blood samples (one predose, two postdose concentrations), collected between the third and sixth gentamicin doses from each patient, were analyzed by the Emit assay. Pharmacokinetic parameters were calculated and gentamicin dosages recommended based on the Sawchuk-Zaske method of serum level interpretation. When normalized by body weight, there was no significant difference in clearance, volume of distribution, and half-life between the control group and either group of patients with cancer. However, when normalized by body surface area, patients receiving prior nephrotoxic chemotherapy appeared to have a lower mean clearance (98.2 ml/min/1.73 m2) than those exposed to nonnephrotoxic chemotherapy (117.4 ml/min/1.73 m2) and controls (113.3 ml/min/1.73 m2; ANCOVA p = 0.033). When kinetic parameters were normalized by body weight, the effect of advancing age yielded a decrease in both clearance (p < 0.001) and volume of distribution (p = 0.02), and an increase in gentamicin half-life (p < 0.001). When normalized by body surface area, age had no significant effect on clearance (p = 0.579). There was no significant difference in gentamicin daily dose requirements (mg/kg) between the chemotherapy groups, which may be due to the lack of significant effects of chemotherapy on gentamicin's volume of distribution and clearance normalized by body weight. The final maintenance doses (mg/kg/day, mean +/- SD) for patients with cancer were 10.8 +/- 1.8 for those age 1-5 years, 8.9 +/- 1.1 for those age 6-12 years, and 7.9 +/- 1.9 for those age 13-18 years. However, when normalized by body surface area, the age-dependent doses became remarkably similar for children in all three age groups (ANOVA p = 0.932), approximately 250 mg/m2/day. We recommend that pediatric patients with cancer who require treatment for fever and neutropenia be given higher than standard gentamicin dosages to achieve therapeutic serum concentrations promptly. In particular, initial empiric doses of 10 mg/kg/day are appropriate for those age 1-5 years.

Adolescent↗