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PubMed1996

Economic evaluation of vaccination.

With increasing expenditures in healthcare, in absolute terms as well as in relative terms, interest in the efficiency of certain interventions in healthcare has also increased. Faced with the limitations of the healthcare budget, budget holders try to find the optimal way of dividing their funds over different healthcare provisions, without discarding human and medical considerations. In economic terms, this process could be called the 'optimal allocation of scarce resources over the inputs of a function of production'. The means of production would then be 'the provision of healthcare', whereas the output would be 'improvement of health'. Clearly choices have to be made with regard to spending the healthcare budget. One of the instruments that can help in making such choices is the economic evaluation. In economic evaluations of vaccinations, different vaccination strategies are defined. The consequences in terms of costs and effects of each strategy are being calculated and compared with a reference strategy, which is often the nonintervention strategy, i.e. 'no vaccination'. According to the way in which the benefit or the output of vaccination-'improvement of health'-is measured, a distinction is made between various methods of economic evaluation: in a cost-effectiveness analysis, health gains are measured in natural units (e.g. prevented infections, prevented illness days, life-years gained, etc.); in a cost-utility analysis, the quality of the health gains is taken into account (e.g. quality-adjusted life-year); and in a cost-benefit analysis, health gains are converted into monetary units. Costs can be divided into direct and indirect costs. Direct costs are directly related to medical treatments (medication, laboratory tests, consultations, etc.) or to vaccination (e.g. purchasing price of the vaccine, costs for administering the vaccine, treatment of side effects, etc.). Costs indirectly related to treatments and vaccination are mainly costs of lost productivity due to disease morbidity or mortality, and opportunity costs. In comparison with other vaccine-preventable infections, influenza vaccination for the elderly seems acceptable from an economic point of view (about $US650 per life-year gained, in 1981). Cost-effectiveness ratios of other vaccinations range from about $US720 per life-year gained for universal hepatitis B vaccination to about $US190,000 per life-year gained for universal Haemophilus influenzae type by vaccination. Because of differences in methods, the representation of results, and country-specific parameters, different economic evaluations of the same vaccination strategy may show divergent results. Therefore, until sufficient standardisation of economic evaluations exists, comparisons of the sort we are making here should be interpreted with prudence.

Cost-Benefit Analysis↗
PubMedDate not supplied

Multifocal neurological impairment caused by infection-induced rise in blood lithium and amitriptyline.

We present the case of a thirty-eight-year-old woman who developed a febrile illness which was associated with a rise of blood lithium and amitriptyline, and subsequently suffered permanent neurological impairment, implicating CNS dysfunction at several levels. Medical, laboratory, radiological and neuropsychological findings are described, and the attribution of the syndrome is discussed. It is crucial to emphasize that the authors are not challenging the frequently useful combination of lithium and antidepressants. Rather, we urge psychiatrists to be vigilant when such patients develop febrile illnesses.

Adult↗
PubMed1995

Clinical MR spectroscopy: fundamentals, current applications, and future potential.

In 1959, Dr. Erik Odeblad, a physician, wrote about nuclear magnetic resonance (NMR): "NMR really seems to possess extensive possibilities to help study, in a non-invasive way, many problems in biology and medicine ... When instruments for NMR become more common and available at medical laboratories, we may expect direct routine clinical diagnosis with this new technique" [1]. This 1959 prediction has become a reality in 1995, when examinations using MR spectroscopy and MR imaging are allowing physicians direct routine clinical diagnoses that were previously unobtainable by other radiologic or clinical tests. Many questions are commonly asked about MR spectroscopy, its use, and its applications. The purpose of this article is to answer some of these questions, provide an introduction to MR spectroscopy, review some current clinical applications, and speculate on the future potential of this technique.

Humans↗
PubMed2003

Complications in young adults with early-onset type 2 diabetes: losing the relative protection of youth.

OBJECTIVE: To determine whether adults diagnosed with type 2 diabetes from age 18 to 44 years more aggressively develop clinical complications after diagnosis than adults diagnosed at >or=45 years of age. RESEARCH DESIGN AND METHODS: We compared outcomes among 7844 adults in a health maintenance organization who were newly diagnosed with type 2 diabetes between 1996 and 1998. We abstracted clinical data from electronic medical, laboratory, and pharmacy records. To adjust for length of follow-up and sex, we used proportional hazards models to compare incident complication rates through 2001 between onset groups (mean follow-up 3.9 years). To adjust for the increasing prevalence of macrovascular disease with advancing age, onset groups were matched by age and sex to control subjects without diabetes for macrovascular outcomes. RESULTS: Adults with early-onset type 2 diabetes were 80% more likely to begin insulin therapy than those with usual-onset type 2 diabetes (hazards ratio [HR] 1.8, 95% CI 1.5-2.0), despite a similar average time to requiring insulin ( approximately 2.2 years). Although the combined risk of microvascular complications did not differ overall, microalbuminuria was more likely in early-onset type 2 diabetes than usual-onset type 2 diabetes (HR 1.2, 95% CI 1.1-1.4). The hazard of any macrovascular complication in early-onset type 2 diabetic patients compared with control subjects was twice as high in usual-onset type 2 diabetic patients compared with control subjects (HR 7.9 vs. 3.8, respectively). Myocardial infarction (MI) was the most common macrovascular complication, and the hazard of developing an MI in early-onset type 2 diabetic patients was 14-fold higher than in control subjects (HR 14.0, 95% CI 6.2-31.4). In contrast, adults with usual-onset type 2 diabetes had less than four times the risk of developing an MI compared with control subjects (HR 3.7, P < 0.001). CONCLUSIONS: Early-onset type 2 diabetes appears to be a more aggressive disease from a cardiovascular standpoint. Although the absolute rate of cardiovascular disease (CVD) is higher in older adults, young adults with early-onset type 2 diabetes have a much higher risk of CVD relative to age-matched control subjects.

Adolescent↗
PubMed1985

The future of histopathology--a personal view.

Pathology in general and histopathology in particular has recently spent some years in the doldrums associated with loss of purpose, direction, enthusiasm and credibility. The historical reasons for this and the reasons for recent emergence from this phase are to be used as a base for identifying needs for the future. As a result of technological advances and acceptance of some philosophical concepts, particularly that functional aspects need to be added to morphological studies, the view is expressed that histopathology should now be able to maintain its regained status as a foremost science in medical laboratory disciplines. These views were shared by Vincent McGovern in private conversation and demonstrated by him in his writings and practice. This written record by a friend is, in all humility and remembrance, dedicated to him.

Cell Biology↗
PubMed1991

Performance of cell counters in primary health care.

The results are presented from two external quality control surveys of cell counters in primary health care. The precision of haemoglobin measurements in the normal range was better than that obtained by conventional haemometers. The analytical quality of leucocyte analyses was about the same as that performed by hospital instruments. The precision of cell counters with respect to thrombocytes was poorer than that obtained on hospital instruments, especially in the lower level. Celldyn and Sysmex instruments performed best among the instruments examined. Reliable cell counter results were associated with medical laboratory technicians as operators of the instruments. To improve the analytical quality of the laboratory in primary health care, it appears necessary to establish an external quality assurance programme, including a laboratory consultancy service.

Blood Cell Count↗
PubMed2002

Laboratory response to anthrax bioterrorism, New York City, 2001.

In October 2001, the greater New York City Metropolitan Area was the scene of a bioterrorism attack. The scale of the public response to this attack was not foreseen and threatened to overwhelm the Bioterrorism Response Laboratory's (BTRL) ability to process and test environmental samples. In a joint effort with the Centers for Disease Control and Prevention and the cooperation of the Department of Defense, a massive effort was launched to maintain and sustain the laboratory response and return test results in a timely fashion. This effort was largely successful. The development and expansion of the facility are described, as are the special needs of a BTRL. The establishment of a Laboratory Bioterrorism Command Center and protocols for sample intake, processing, reporting, security, testing, staffing, and and quality control are also described.

Algorithms↗
PubMed2002

First case of bioterrorism-related inhalational anthrax, Florida, 2001: North Carolina investigation.

The index case of inhalational anthrax in October 2001 was in a man who lived and worked in Florida. However, during the 3 days before illness onset, the patient had traveled through North Carolina, raising the possibility that exposure to Bacillus anthracis spores could have occurred there. The rapid response in North Carolina included surveillance among hospital intensive-care units, microbiology laboratories, medical examiners, and veterinarians, and site investigations at locations visited by the index patient to identify the naturally occurring or bioterrorism-related source of his exposure.

Anthrax↗
PubMed1999

Evaluation of dot immunogold filtration assay for anti-HAV IgM antibody.

AIM:To detect hepatitis A virus-specific immunoglobulin M (IgM) antibody rapidly.METHODS:Colloidal gold with an average diameter of 15nm was prepared by controlled reduction of a boiling solution of 0.2g/L chloroauric acid with 10g/L sodium citrate and labeled with anti-HAVIgG as gold probe. Dot immunogold filtration assay (DIGFA) has been developed by coating anti-human &mgr; chain on nitrocellulose membrane (NCM) for capturing the anti-HAV IgM in serum, then using cultured hepatitis A antigen as a bridge , connecting anti-HAV IgM in sample and anti-HAV IgG labeled colloidal gold. If there was anti-HAV IgM in sample, gold probes would concentrate on NCM, which will appear a pink dot.RESULTS:A total of 264 serum samples were comparatively detected with both DIGFA and ELISA by blind method. Among them, 88 were positive and 146 were negative with the two methods. The sensitivity and the specificity of DIGFA were 86.27% and 90.12%, respectively. Fifteen negative serum samples and 15 positive serum samples were detected 3 times repeatedly, the results were the same.CONCLUSION:DIGFA is a simple, rapid, sensitive, specific and reliable method without expensive equipment and is not interfered with rheumatoid factor (RF) in serum. It is suitable for basic medical laboratories. The test could be applied for diagnosis and epidemiological survey of hepatitis A. It has a broad prospect in application.

Journal Article↗
PubMed2002

HER2 testing in patients with breast cancer: poor correlation between weak positivity by immunohistochemistry and gene amplification by fluorescence in situ hybridization.

OBJECTIVE: To evaluate amplification of the HER-2/neu gene by fluorescence ir situ hybridization (FISH) in tumors with weakly positive (2+) immunohistochemical staining. METHODS: A total of 1556 breast tumor biopsy specimens were referred to Mayo Medical Laboratories, Rochester, Minn, for HER2 testing between August and December 2000. Immunohistochemical (IHC) analysis was performed with use of a diagnostic test for the assessment of HER2 overexpression, the HercepTest. The IHC-stained slides were interpreted and scored on a scale ranging from 0 to 3+ according to Food and Drug Administration-approved guidelines. All specimens scored as 2+ were also routinely evaluated by FISH with use of a HER-2/neu DNA probe kit (PathVysion). Specimens were determined to be amplified if the ratio of HER-2/neu signals to chromosome 17 centromere (CEP17) signals was higher than 2.0. RESULTS: Thirty-eight percent of the specimens evaluated with the HercepTest were scored 0, 35% were 1+, 14% were 2+, and 13% were 3+. Of the 216 tumor specimens scored as 2+, 26 (12%) had a high level of HER-2/neu gene amplification, 54 (25%) demonstrated duplication of HER2, 4 (2%) deleted HER-2/neu and/or CEP17, and 123 (57%) had no apparent HER-2/neu anomaly, no apparent CEP17 anomaly, nor apparent single gain (aneusomy) of CEP17. CONCLUSION: We recommend that all specimens with a 2+ HercepTest result be evaluated by FISH for HER-2/neu gene amplification. The results of both assays should be considered before making a decision to recommend anti-HER2 therapy.

Antibodies, Monoclonal↗
PubMed1993

Etiology of hypoferremia in a recently sedentary Kalahari village.

To determine the etiology of hypoferremia in recently sedentary hunter-gatherers, a community located in the Kalahari Desert of Botswana was studied. Iron profiles of 106 Basarwa (Bushmen, San) volunteers were examined. Hematocrits were measured in the field. The remaining blood was processed for transportation to a research medical laboratory for further studies. Subnormal serum iron values were present, depending on the subpopulation, in 50-52% of the volunteers. Transferrin saturation was subnormal in 35-49% of those tested. The absence of subnormal serum ferritin levels indicates that dietary iron deficiency is not the cause of the hypoferremia. Instead, serum ferritin was greater than 50 micrograms/l (a level indicative of anemia of chronic disease/inflammation) in 92% of the hypoferremic adult Basarwa. We suggest that by depriving microbes of needed iron, the frequency of the anemia of infections and chronic disease in this population might be a response to, and defense against, a chronically high pathogen load in a community that has not yet incorporated sanitation practices appropriate for sedentary aggregations.

Adolescent↗
PubMed1999

Insulin secretion, clearance and sensitivity in black pregnant and non-pregnant women in Harare, Zimbabwe.

OBJECTIVE: To assess whether reported gestational differences in glucose tolerance in Caucasian and Black women could be due to alterations in insulin secretion, clearance or sensitivity. DESIGN: Cross sectional survey. SETTING: Antenatal Clinic, Harare; Department of Medical Laboratory Sciences, University of Zimbabwe. SUBJECTS: 90 healthy women in all the trimesters of pregnancy and 30 healthy non-pregnant women of reproductive age. MAIN OUTCOME MEASURES: Fasting (basal) plasma insulin, C-peptide and glucose concentration. Fasting plasma C-peptide, C-peptide to insulin ratio and glucose to insulin ratio were used as indices of insulin secretion, hepatic insulin clearance and insulin sensitivity respectively. RESULTS: Not all means of the fasting plasma glucose levels amongst the four groups of women were equal (p < 0.001), with all possible comparisons being significant except for the first and second trimester groups. Among the comparisons of the means of the glucose:insulin ratio in the four groups of women, only the means of the first and second trimester women differed (mean difference = 0.23, honestly significance difference = 0.20). All groups were comparable in the means of plasma insulin, C-peptide levels and the C-peptide:insulin ratio. CONCLUSION: Since fasting plasma insulin, C-peptide and C-peptide:insulin ratio were not significantly altered in all trimesters of pregnancy, these data suggest normal basal insulin secretion and clearance during gestation in these sub-Saharan African women.

Analysis of Variance↗
PubMed2005

Time to pregnancy among Danish laboratory technicians who were a part of the National Birth Cohort.

OBJECTIVES: The Danish National Birth Cohort was used to examine whether laboratory work was associated with reduced fecundity. METHODS: Self-reported data on laboratory work and waiting time to pregnancy (0-2, 3-5, 6-12 and > 12 months) were used for 829 female laboratory technicians interviewed in 1997-2003. Altogether 6250 female teachers formed the reference group. A discrete-time survival analysis with a complementary log-log link was applied to estimate the fecundability ratio between the exposed and unexposed women, with adjustment for maternal age, gravidity, smoking, prepregnancy body mass index, and paternal job. RESULTS: No difference in time to pregnancy was found between the laboratory technicians and teachers or between the laboratory technicians with different exposures. The adjusted fecundability ratio for the laboratory technicians was 0.94 [95% confidence interval (95% CI) 0.86-1.02] for all pregnancies and 0.98 (95% CI 0.86-1.13) for first pregnancies. A healthy worker effect was found for the laboratory technicians working with the work processes under study. CONCLUSIONS: The results do not suggest that laboratory work in Denmark at present impairs female fecundity.

Adult↗
PubMed2006

Factors associated with healthcare utilization costs for statin therapy--a pilot study in Hong Kong.

BACKGROUND: Socio-economic status, comorbidities and adherence to statin therapy might affect the cost-effectiveness of statin therapy in hyperlipidemia. OBJECTIVE: To examine the effects size of demographic factors, clinical factors and adherence to statin therapy on the direct medical costs for Chinese patients at high risk of coronary heart disease (CHD). METHODS: This was a prospective, observational cohort study conducted in the outpatient departments of a public teaching hospital in Hong Kong. Patients at high risk of CHD who had been on statin monotherapy for < 12 months were recruited. Baseline demographic and clinical data were obtained. Statin adherence was monitored prospectively over 6 months using the Medication Event Monitoring System. Total direct medical costs per member per month (cPMPM), including cost for clinic visits, statin medication, laboratory tests on lipids and management of CHD events if any, were calculated from the perspective of a public healthcare organization. RESULTS: 83 patients completed the study. Median cPMPM in 80 patients (96% of 83 patients) without a new CHD event (USD 42) and for 3 (4%) patients who experienced CHD events (USD 444) were significantly different (p = 0.003). History of congestive heart failure (beta = 1,957, 95% CI = 1,006 - 2,909), male gender (beta = 584, 95% CI = 215 - 952), coronary atherosclerosis (beta = 1,436, 95% CI = 538 - 2,334) and diabetes mellitus (beta = 604, 95% CI = 136 - 1,07 1) were positive predictors for cPMPM. CONCLUSION: In this pilot study male gender, diabetes mellitus, congestive heart failure and coronary atherosclerosis appear to be significantly associated with higher costs for Chinese patients at high risk of CHD.

Cohort Studies↗
PubMed1994

Efficacy and safety of controlled-release niacin in dyslipoproteinemic veterans.

OBJECTIVE: To evaluate the safety and efficacy of controlled-release niacin in patients with hyperlipoproteinemia. DESIGN: A retrospective cohort study. SETTING: A Department of Veterans Affairs Medical Center. PATIENTS: A consecutive sample of 969 predominantly elderly male veterans treated for dyslipoproteinemia with controlled-release niacin between October 1988 and October 1991. MAIN OUTCOME MEASURES: Primary outcomes were lipid levels and lipoprotein cholesterol response, alternations in levels of hepatic enzymes and blood chemistry test results, and characterization of niacin-induced hepatotoxicity abstracted from the patient's medical, laboratory, and pharmacy records. RESULTS: 93% (896 of 969) of the cohort was evaluable. Patients (age, 61.7 years [9.4 years], mean [SD]) were treated for 1 to 36 months (13.0 months [9.7 months]) with an average maintenance dose of 1.67 g/d (0.8 g/d). Niacin was discontinued in 48.5% (435 of 896) of the patients primarily because of adverse effects. Poor glycemic control led to discontinuation in 40.6% (43 of 106) of the patients with diabetes mellitus. The lipoprotein response was dose-related and favorable (levels of total cholesterol, -19.1%; low-density lipoprotein cholesterol, -24.0%; high-density lipoprotein cholesterol, +5.7%; and triglycerides, -32.5%). Statistically but not clinically meaningful dose-related increases were seen in levels of liver enzymes and serum glucose (aspartate aminotransferase, +29%; alanine aminotransferase, +23%; alkaline phosphatase, +25%; and glucose, +7%; P = 0.0001). Twenty of 896 (2.2%) and 42 of 896 (4.7%) patients met biochemical criteria for probable and for possible or probable niacin-induced hepatotoxicity, respectively. Predisposing factors included high dose, alcohol use, preexisting liver disease, and concurrent oral sulfonylurea therapy. CONCLUSIONS: Controlled-release niacin is effective in treating dyslipoproteinemia in selected middle-aged and elderly veterans, but approximately one half of patients discontinued the drug because of adverse effects or other causes including noncompliance. Niacin should be avoided in patients with hepatic dysfunction or a history of liver disease, patients with diabetes mellitus, and patients who abuse alcohol. Because controlled-release niacin seems to be more potent than crystalline niacin, product substitution without dose adjustment should be avoided.

Aged↗
PubMed1999

A delivery circuit for normothermic reperfusion model.

In order to facilitate the introduction and assessment of Injectio Radix Ginseng Compositae in normothermic reperfusion model, a simplified delivery circuit is described herein. The circuit added mainly a venous reservoir collecting Injectio Radix Ginseng Compositae with cardiopulmonary bypass. Injectio Radix Ginseng Compositae was pumped into the ascending aorta of the animal after mixing with cardioplegia in the venous reservoir. The circuit was acceptable in terms of price by most inland medical laboratories. Perfusion as well as biochemical results monitored were satisfactory. Significant difference was noted between the average damage rates of the reperfused myocardial mitochondria in groups by ultrastructural analysis (70.12 +/- 2.56% vs. 25.33 +/- 17.62%, p = 0.023). No complications associated with perfusion technique occurred in either group. The circuit could offer a constant arterial perfusion, and was proved to be simple, safe and effective in cohort.

Animals↗