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[Establishment of working reference materials in laboratory medicine].

It is recognized that the establishment of reference materials is the most important factor for standardization in laboratory medicine. In particular, working reference materials for routine measurement procedures are effective tools to maintain the commutability of measured values. Working reference materials are dealt with in a traceability chain system issued by ISO 17511 (in vitro diagnostic medical devices--measurement of quantities in biological samples--metrology traceability of values assigned to calibrators and control materials). The JCCLS is strongly promoting standardization in laboratory medicine by using working reference materials. Working groups for standardization are organized by the JCCLS in cooperation with the NMIJ (National Metrology Institute of Japan) with a grant from the NEDO (New Energy and Industrial Technology Development Organization). The objective is the establishment of working reference materials for routine use. Standardization criteria using the reference materials are being established. Research and development and investigation studies of matrix reference materials have been started. In investigation studies, the production protocol of reference materials are being prepared. After being established, reference materials will be presented to the JCTLM (Joint Committee on Traceability in Laboratory Medicine). These activities will enhance standardization in laboratory medicine. As a results, they will contribute to maintaining the reliability of measured values in routine laboratory procedures.

Clinical Laboratory Techniques↗

Methods to identify and address the ethical issues associated with managed care.

There are many benefits of managed care, such as its focus on disease prevention and health promotion, its integration of healthcare services to minimize inefficiencies, and its ability to restrict healthcare costs; however, there are also some ethical concerns that arise from managing care. In the context of managed care, ethics is a method for examining conflicts of values and obligations where there are competing interests, each of which presents a reasonably justified position. The principles of procedural, commutative, and general justice are particularly applicable to the ethical issues associated with managed care. Through a review of relevant literature, this paper will examine different methods and principles of justice to consider in establishing an ethical managed care organization and it will offer some examples of plans that have established policies to meet their ethical goals. By setting common goals, plans and enrollees can minimize ethical conflicts and collaborate to ensure that plans consistently use just procedures to ensure that quality care is available.

Community Participation↗

Work-related bystander deaths in New Zealand: a significant hidden problem.

OBJECTIVES: To estimate the extent of bystander work-related traffic fatal injury for New Zealand as well as the contribution of all bystander events to the total burden of work-related fatal traffic injury and work-related fatal injury in general. METHODS: Potential cases were identified from national administrative databases. The circumstances of the deaths in each incident were reviewed directly from coronial files to determine work-relatedness. RESULTS: For 1985-1998 we identified 1447 people whose death was associated with another person's work activity on a public road and who were not working at the time. This compares with 241 "working" and 192 "commuting" deaths on a public road for the same period. Bystanders thus represented approximately 75% of the work-related fatal traffic crash injury problem. We estimate that (on average) approximately 115 bystanders were killed each year and this represents approximately 52% of the total work-related fatality problem. CONCLUSIONS: Work-related bystander deaths are a major contributor to work-related injury in New Zealand, the majority occurring in the context of road traffic crashes. These deaths deserve more attention than they have received to date.

Accidents, Traffic↗

Averaging time modeling of exposure simulation with application to the El Camino Real vehicle data.

When profiles of activity patterns are used to generate time series of simulated exposure, one typically samples from exposure distributions which are microenvironment-specific to each activity. If the simulation time step is short, then independent sampling at each time step, ignoring autocorrelation, will result in aggregates with too little variability from one simulation to another. Autocorrelation can often be modeled with one or two extra parameters and then used in the simulation. Furthermore, one may substantially reduce computation by generating a single averaged exposure for each activity segment whose distribution depends in a simple way on the activity duration and the modeled autocorrelation. The process is illustrated using the El Camino Real commuting exposure study data of Ott, Switzer, and Willits.

Carbon Monoxide↗

Electrohydraulic ventricular assist device development.

A 64 ml (effective stroke volume) in vitro electrohydraulic ventricular assist device (VAD) prototype has been built. The energy converter is an axial flow pump driven by a brushless direct current (DC) motor. Systole begins as silicone oil is pumped from the volume displacement chamber (VDC) into the ventricle, displacing the flexing diaphragm separating the oil and the blood. In diastole, the motor reverses, providing active filling by pumping oil from the ventricle into the VDC. The surface mount electronic internal controller provides motor commutator, energy management, telemetry, and physiologic control functions. Energy is supplied externally by either a 12 V DC power supply or a 12 V DC rechargeable battery and is transmitted through the skin by a transcutaneous energy transformer (TET). Energy can also be supplied by a 12 V DC rechargeable internal battery. Bidirectional infrared telemetry is used to transmit information between the internal and external controllers.

Blood Pressure↗

Applying the theory of reasoned action to AIDS risk behavior: condom use among black women.

This study tested hypotheses regarding attitudinal and normative influences on intentions to use condoms, a practice that would reduce women's risk of sexually transmitted HIV infection. Participants were 103 sexually active unmarried black women undergraduates at an inner-city commuter university, in an area with a high rate of reported AIDS cases among women. Consistent with the theory of reasoned action, multiple regression analysis on women's anonymous responses to a mailed survey revealed that those who registered more favorable attitudes toward condoms and those who perceived subjective norms more supportive of condom use reported firmer intentions to use condoms in the next three months. Key behavioral beliefs related to attitudes centered on the adverse effects of condom use on sexual enjoyment. Key normative influences were respondents' sexual partners and mothers. However, women's own attitudes were a stronger determinant of intentions to use condoms than were their perceptions of normative influences, particularly among women with above-average AIDS knowledge. The results suggest that the theory of reasoned action provides a potentially useful conceptual framework for interventions to change a key AIDS risk behavior among women.

Acquired Immunodeficiency Syndrome↗

Reference system for cholesterol measurements.

A reference system for cholesterol measurement is necessary to assure accuracy of cholesterol measurements by clinical, research, and manufacturers' laboratories. Such a reference system is based on the collaboration of laboratory and clinical professionals, research groups, professional societies, government groups, and manufacturers of diagnostic products. Essential components include a definitive method, a reference method, and commutable reference materials that are accurately labeled and have long-term stability. A mechanism by which clinical, research, and manufacturers' laboratories can establish traceability to the reference system is also needed. In the United States, the NRS/CHOL was organized as part of the National Reference System for the Clinical Laboratory. The major organizational components of the NRS/CHOL include the National Institute for Standards and Technology, the CDC, the CRMN, the CAP, the AAB, regional reference programs, and manufacturers of cholesterol diagnostic products. The NIST maintains an isotope dilution-mass spectrometer definitive method and distributes certified reference materials. The CDC maintains a modified Abell-Levy-Brodie-Kendall reference method and offers a CDC-NHLBI Lipid Standardization Program; the CRMN provides reference method analyses on specimens furnished by manufacturers and clinical or research laboratories; CAP, AAB, and regional reference programs provide either proficiency testing, quality assurance programs, or both; and manufacturers assure that results on diagnostic products are the same as those achieved when using fresh patient specimens and the NRS/CHOL reference method. The NRS/CHOL has contributed much to the success of clinical epidemiologic and research and development investigations in coronary heart disease.

Chemistry, Clinical↗

Laboratory measurement of lipid and lipoprotein risk factors.

Accuracy in measurement of serum cholesterol and the other lipid risk factors is essential for reliable patient classification within the context of newly implemented national coronary heart disease intervention programs utilizing uniform cutpoints. This requires agreement or traceability of laboratory methods to national reference systems, which provided the accuracy base for the population studies from which the cutpoints are derived. Adhering to accepted guidelines for patient preparation, blood collection and processing will minimize preanalytical variability. Standardization of the lipid/lipoprotein assays is the next essential step. The assay technology for cholesterol measurement is reasonably mature, although still not perfected; recent activities have focused primarily on achieving traceability of field methods through improving access to the accuracy base, the National Reference System for Cholesterol and developing better (commutable) reference materials. A major hindrance to standardization has been matrix interactions; alterations in reference materials from their preparation which change the measurement characteristics, necessitating the use of fresh specimens in accuracy studies. Considering the importance of LDL cholesterol which is the primary decision parameter in the new clinical guidelines; methodology for routine laboratory quantification is substantially lacking, the usual routine approach still involving estimation. Efforts to develop a reference system for LDL are just beginning. Field methods for HDL cholesterol are reasonably reliable but with some inter-method differences. Agreement on and access to a Reference Method is needed. Accuracy in triglyceride measurement is less important compared to the other risk factors. Convenient methods allowing correction for the free glycerol blank and ready access to a Reference Method are needed.

Chemistry, Clinical↗

[Observations on the current status concerning the epidemic of acute myocardial infarction].

After the mortality from acute myocardial infarction had reached its peak in 1972, a decrease started which by now, taking into account the increase and the greying of the population, already amounts to 33%. Nevertheless, in 1987 as many as 19,168 deaths were still recorded. When after World War II the mortality rose, it was found that the victims included a growing proportion of younger persons. Currently, however, the decrease of mortality in general is most pronounced among the younger age groups. Among the patients treated in hospital, mortality shows an evenly distributed decrease. The admission rates from the populations of commuter municipalities and from rural areas are relatively low, those from medium-sized municipalities with an urban character, relatively high.

Adult↗

[Retrospective demographic study in a small mountainous region of the province of Rome].

This retrospective study takes into consideration demographic and epidemiological data relative to the population of Arcinazzo Romano, a little village on the mountains situated at 831 m. above sea level in the province of Rome. The socio-economic structure of the village is mainly agropastoral, though, in the last decades, 50% of the ground has been left uncultivated due to emigration and commuting. ISTAT data relative to population censuses of 1951, 1961, 1971 and 1981 have been used to study the population natural movement from 1943 to 1987. The active/passive rate and the population ageing index have also been considered. Whenever possible local population data have been compared with similar data on a provincial, regional and national level. From 1943 (1697 inhabitants according to the archives of the Civil Status Office) the population of Arcinazzo R. has been increasing until 1955 (1903 inhabitants). Afterwards, there has been a slow, but constant, decrement till 1987 (1435 inhabitants). The reason for this is undoubtedly the migration movement (mainly towards Rome) due to the scarcity of job possibilities in the zone. This has resulted in a decrease in both active population and agricultural manpower. From 1943 to 1987 there has been a continuous decrease in birth-rate. Starting from 33.5 in 1943, the lowest value (4.6) is reached in 1981; in the last decade the index has settled on average values (11.22) which are slightly higher than national and regional averages (10.2 and 9.7 respectively). The general death-rate has its highest value in 1944 (19.3) and its lowest value in 1958 (4.8). From this date on, the index settles on an average of 12.0, which is slightly higher than national and regional averages (9.5 and 8.4 respectively). The infant death-rate starts from a value of 228/1000 in 1943 to decrease in following years. Keeping into account that the number of children born each year in Arcinazzo R. is very small, a comparison with national or regional averages is not felt to be appropriate. In fact, local values of this index may casually result very high: for instance, in 1981, the death of two premature twins, on a total of seven children born in the same year, brings the infant death-rate to a value of 285/1000 while in the years 1982-87 the infant death-rate is 0. The population natural growth index is obtained from the difference between general birth- and death-rates.(ABSTRACT TRUNCATED AT 400 WORDS)

Adolescent↗

Comparable laboratory performances in the analysis of lead in control samples and in fresh human blood.

The validity of quality control programs is based on the assumption that the control samples can be commuted with the real samples, so that, according to the results obtained by a given laboratory on control samples, it is possible to produce reasonable predictions about the reliability of results obtained on real samples. During the implementation of a program of biological monitoring of the general population against the risk of saturnism, a great number of data have been collected allowing the evaluation--as far as blood lead determination is concerned--of the real predictive power of the results obtained by a laboratory during a quality control program, according to its specific level of analytical reliability. The results obtained by eleven laboratories in the analysis of control samples have been compared, by regression analysis, with the results obtained on the same samples by the reference laboratory. The same procedure has been adopted for the results obtained by each laboratory and by the reference laboratory in the duplicate analysis of about 10% of the real samples collected by each center during the biological monitoring program. The comparison between the regression parameters obtained, in both cases, for each laboratory has not produced evidence of systematic differences. Furthermore, a non-parametric evaluation of the data (based on the magnitude of the differences between the results of the laboratories and the results of the reference center) shows, in most cases, similar laboratory performances in the analysis of control samples and of real samples.

Blood Chemical Analysis↗

Do the right thing for the community. Interview by Howard Larkin.

When the area surrounding Greater Southeast Community Hospital, Washington, DC, changed from a middle-class commuter neighborhood to one populated mainly by the poor and elderly in the early 1970s, hospital officials decided to stay and serve where they were needed most. The 450-bed hospital now sponsors a wide variety of health and community development programs. In recognition of its commitment to community service, Greater Southeast Community Hospital was awarded this year's Foster G. McGaw Prize by the American Hospital Association, Chicago, and the Baxter Foundation, Deerfield, IL. Thomas Chapman, president of Greater Southeast Community Hospital, recently talked about the importance of community service with Hospitals finance coordinator Howard Larkin.

Awards and Prizes↗

[Adverse effects of the work process in relation to pregnancy].

Some characteristics of the working activity of pregnant women were investigated during statistical analysis of data pertaining to 6166 naturally terminated pregnancies in the Gottwaldov district (1981-1983). The threatening element from the aspect of spontaneous abortions in the first trimester is work done during most of the shift in a standing position without movement. There also the highest incidence of small-for-age and hypotrophic foetuses was found. Work involving constant movement is a risk and may lead to premature delivery. Manipulation with loads threatens pregnancy by reproductive losses (in particular a higher incidence of haemorrhage during the first trimester) and by prematurity. Social tension at the place of work also threatens pregnancy - at conflict in work places a significantly increased risk was proved. It was also proved that it is important to respect medical recommendation to transfer pregnant women to other work. As to associated factors, commuting was investigated and its adverse effect is particularly apparent when the distance is more than 25 km.

Adult↗

Production and certification of an enzyme reference material for gamma-glutamyltransferase (CRM 319). Part 1: Preparation and characterization.

We have produced a batch of lyophilized gamma-glutamyltransferase as enzyme reference material. The "light" enzyme form was purified from pig kidney to a relatively high specific activity (120 kU/g) and was essentially free of contaminating enzymes. The partly purified gamma-glutamyltransferase, lyophilized in a matrix containing bovine serum albumin (Fraction V, 60 g/L), yielded a batch of 4000 ampules and was stored at -20 degrees C. The vial-to-vial variability with respect to the catalytic concentration of the final product (CV 0.6%) and its stability (predicted loss of activity at -20 degrees C was less than 0.01% per year) were considered sufficient to allow the use of this preparation for a certification procedure. The behavior of the reference material in comparison with human serum samples was evaluated three ways: (a) by kinetic characteristics, (b) by the ratio of activities for duplicate determinations by different methods, and (c) by use of the reference material to convert values obtained by various methodologies to those by the IFCC proposed method. The material appeared to be commutable for the two methods studied. The difference in the ratios obtained for patients' samples and reference material was less than +/- 5%, and the recalculated values for patients' samples as determined with the reference material differed from values determined by the IFCC method by no more than 4.8%.

Animals↗

Treating those found incompetent for execution: ethical chaos with only one solution.

In early 1988 the population on America's death rows climbed above the 2,000 mark for the first time in history. In 1986 the United States Supreme Court firmly stated that the Constitution will have been violated if any of these prisoners is put to death while mentally incompetent for execution. In this article we discuss the case of Gary Alvord, the only inmate to be formally found incompetent for execution in modern times. Interviews with psychiatrists and mental health professionals at the Florida psychiatric hospital where Alvord was treated between 1984 and 1987 reveal much ambivalence and anger about the case. We conclude that, out of respect for the rights of these mental health professionals and the ethical codes of their professions, any prisoner found incompetent for execution should have his or her death sentence commuted to long-term imprisonment before treatment is requested or given.

Adult↗

An epidemiologic study on the correlation between salt threshold, academic test marks, biochemical data, number of complaints, and personality in women college students.

One hundred nine 19-year-old female students were surveyed as to academic test marks; salt detection and recognition thresholds; serum cholesterol, serum uric acid, serum cortisol, and other biochemical indices in serum; urinary sodium/creatinine and potassium/creatinine, as well as number of complaints based on the Cornell Medical Index (CMI) and personality based on the Yatabe-Guilford (Y-G) test. The salt recognition threshold showed a high negative correlation with serum uric acid concentration and a slight correlation with CMI complaint number, academic test marks, blood pressure, obesity, and serum cholesterol. The subjects with high salt thresholds had relatively passive personalities. Cholesterol, uric acid, hemoglobin, ferritin, and glucose levels in the serum were higher in the group with higher academic marks. These students also had fewer complaints and more of them were type B individuals based on the Y-G test. They also seemed to be under greater stress. In regression analysis, the partial regression coefficient between academic test marks and serum cholesterol was 60 percent higher than that between academic test marks and serum uric acid. Students who lived on campus had 24.8 milligrams per deciliter (15.7 percent) more serum cholesterol and 3.8 micrograms per deciliter (37.7 percent) more serum cortisol than those who commuted from home.

Achievement↗

Applied aspects of chronoergohygiene.

Chronoergohygiene defines a field of study set on optimizing the work timing compared to the desiderata of human physiology in order to improve the working conditions. Production systems follow their own laws with a timing resulting from economic, technological and natural factors; this timing could contrast with che chronological variables of the person 'involved'. Important aspects to be considered in this regard concern: a energy expense and nutrition, in relation to the mechanization and automation of the working tasks, sociocultural models, individual behaviors in eating habits; b. work performance, with particular reference to the modifications during the life-span and the rhythmic variations in the circadian period; c. toxicologic risks, considering problems of chronokinetics of the toxic agent and of 'chronoesthesia' of the body functions and apparatuses; d. work and social organization, with special reference to shift work, work pace and commuting. The research for a dynamic evaluation of the human-machine interaction in time and into forms of chronological compatibility between man and work organization should optimize industrial hygiene.

Accidents, Occupational↗

[Computer-assisted system for interstitial hyperthermia].

The combination of interstitial radiotherapy and interstitial hyperthermia is more promising in the treatment of tumors than one of these methods alone. The unit developed by us uses the afterloading needles for heating up the tumor tissue with ohm current and for controlling the distribution of temperature in the target volume. Up to twelve needles are provided by one commutator with the R.F. current controlled by the computer. The temperature is measured by three thermistors per needle which are arranged at an axial distance of 2 cm each. The linearization of the thermistor characteristics and the control of cummutator and R.F. generator is performed by the computer over an interface constructed by us. In order to achieve a homogeneous distribution of temperature in the target volume and to avoid hot spots, we have examined several needle configurations by measuring in an homogeneous phantom.

Analog-Digital Conversion↗