Comparison of normal distribution-based and nonparametric decision limits on the GH-2000 score for detecting growth hormone misuse (doping) in sport.

This paper is motivated by the GH-2000 biomarker test, though the discussion is applicable to other diagnostic tests. The GH-2000 biomarker test has been developed as a powerful technique to detect growth hormone misuse by athletes, based on the GH-2000 score. Decision limits on the GH-2000 score have been developed and incorporated into the guidelines of the World Anti-Doping Agency (WADA). These decision limits are constructed, however, under the assumption that the GH-2000 score follows a normal distribution. As it is difficult to affirm the normality of a distribution based on a finite sample, nonparametric decision limits, readily available in the statistical literature, are viable alternatives. In this paper, we compare the normal distribution-based and nonparametric decision limits. We show that the decision limit based on the normal distribution may deviate significantly from the nominal confidence level 1-α or nominal FPR γ when the distribution of the GH-2000 score departs only slightly from the normal distribution. While a nonparametric decision limit does not assume any specific distribution of the GH-2000 score and always guarantees the nominal confidence level and FPR, it requires a much larger sample size than the normal distribution-based decision limit. Due to the stringent FPR of the GH-2000 biomarker test used by WADA, the sample sizes currently available are much too small, and it will take many years of testing to have the minimum sample size required, in order to use the nonparametric decision limits. Large sample theory about the normal distribution-based and nonparametric decision limits is also developed in this paper to help understanding their behaviours when the sample size is large.

Comparability of pulse oximeters used in sleep medicine for the screening of OSA.

Obstructive sleep apnea syndrome (OSA) is a frequent clinical picture. It is characterized by repetitive respiratory arrest with a consecutive decrease in arterial oxygen saturation (SaO(2)). In clinical practice, the number of desaturations per hour, oxygen desaturation index (ODI), is used as an important diagnostic criterion. Medical literature, however, mentions different threshold values that are defined as pathological. By means of systematic comparative measurements, the study presented here will examine to what extent the diagnosis and the quantification of OSA severity are affected by the device-specific measurement technique, thus impacting the predictive value of nighttime pulse oximetry in outpatient OSA screening. Different pulse oximeters commonly used in clinical practice were analyzed comparatively regarding technical parameters, temporal dynamics and the reproducibility of measuring results. The measurements were executed simultaneously and time synchronized in a reference group of five test subjects (four males, one female, average age 33.0 +/- 9.4 years), in a group of five patients (all males, average age 51.8 +/- 18.4 years) and using a simulator (pulse oximeter simulator index 2). All devices underestimate the simulator's predetermined oxygen desaturation of 10%. The dispersion of values is high. The device-specific characteristics have a significant influence on the collected data. The fundamental weakness of the systems lies in the reproducibility of measuring results (this only seems adequate at a signal resolution in steps of 0.1%) as well as the differing temporal dynamics. In the synchronous use of different systems on patients for the purpose of a direct comparison of devices, the dispersion of values is serious, reaching a fluctuation range of up to factor 1.42. In measuring dynamic events (apneas), different pulse oximeters do not record identical values. This is due to the different internal signal processing of the devices. Without prior knowledge of the pulse oximeter used and the chosen device settings, meaningful interpretation of the measured desaturations is, therefore, ambiguous. Accordingly, different devices require different threshold values in determining the ODI. Standardized technical parameters and the standardization of signal processing are imperative for outpatient screening of sleep-related breathing disorders (SRBD) via pulse oximetry.

Fenoterol hydrobromide delivered via HFA-MDI or CFC-MDI in patients with asthma: a safety and efficacy comparison.

The main objective of the study was to compare the long-term safety and tolerability of fenoterol hydrobromide delivered using a metered-dose inhaler formulated with the alternative propellant, hydrofluoroalkane 134a (HFA-MDI), with delivery using the currently available chlorofluorocarbon MDI (CFC-MDI; Berotec 100). A further objective was to compare the efficacy of fenoterol HFA-MDI with fenoterol CFC-MDI, using the pulmonary function parameters of forced expiratory volume in 1 sec (FEV1), forced vital capacity (FVC) and peak expiratory flow (PEF). Following a 2-week run-in phase, a 12-week, double-blind parallel group comparison was undertaken in 290 patients randomized on a 2:1 basis to two puffs of 100 microg fenoterol four times a day (HFA-MDI=197 patients; CFC-MDI=93 patients). A total of 236 patients in this multi-centre study completed the trial as planned. The overall incidence of adverse events (AEs) was similar in both groups (29.9% of HFA-MDI patients and 28% of CFC-MDI patients). Reports of respiratory disorder AEs were also comparable (21.8% HFA-MDI; 22.6% CFCMDI). End of study laboratory tests, ECG, pulse, blood pressure and physical examination showed no significant differences from pre-study baselines in either group and both treatments appeared to be well tolerated. Pre-dose FEV1 measurements taken at the three clinic visits were constant and increase in FEV1 at 5 and 30 min post-dose demonstrated equivalent efficacy for the two formulations. No difference between the two groups was observed in PEF or in the use of rescue medication. We conclude from these findings that the long-term safety and efficacy profile of fenoterol HFA-MDI is comparable to that of the fenoterol CFC-MDI.

Is international economic migration spreading?

"Are the numbers of migrants growing? Proof is hard to come by--many countries' statistics do not provide reliable data for legal migration; most countries do not have good estimates for illegal migration; quite a few have no useable data at all, especially migrant-sending countries. We make use of an alternative yardstick, which over a period of time compares the number of countries that receive foreigners who are economically active or that are these persons' countries of origin.... Our yardstick includes only countries of a minimum population size fixed in terms of a comparable population base in the years 1970 and 1990."

Amoxicillin/clavulanic acid vs cefetamet pivoxil in the treatment of acute exacerbation of chronic bronchitis (AECB) in adults.

In this open comparative and prospective study 180 adults of either sex were randomised to treatment with either amoxicillin/clavulanic acid (AMC) 500/125mg tid or cefetamet pivoxil (CAT) 500mg bid for 7 days. Demographic data and assessable findings were similar in both groups. Clinical outcomes of 169 assessable patients showed high efficacy of both drugs: 92% with AMC and 96% with CAT. Bacteriological response rates were equivalent in 141 evaluable cases: 84% vs. 89%, respectively. Baseline susceptibility testing (DIN) revealed a notable number of Haemophilus species either intermediately susceptible or resistant to AMC. Gastrointestinal disorders predominated among the adverse events with diarrhea occurring nearly twice as often in the AMC group. CAT is an effective and safe alternative option in the treatment of AECB in adults. The advantage of CAT is its enhanced activity against gram-negative bacteria. It is well tolerated.

Integration and immigration pressures in western Europe.

"With xenophobia resurgent in Europe, this article addresses some of the complexities of immigration and integration in EC [European Community] and EFTA [European Free Trade Association] countries. The categories of legal and illegal immigrants (including estimates thereof) are first described, as are the necessary ingredients of an integration policy (a framework law, a secure environment, cultural tolerance, demarginalization in housing and the labour market). The author then considers what types of action would help to ease the present immigration pressure, discussing in turn quota policies, project-tied or training migration and, finally, the use of international aid."

[Anaphylactic shock after sucking on a throat lozenge]. / Anaphylaktischer Schock nach Einnahme einer Lutschtablette.

A few minutes after sucking a lozenge for a sore throat a 68-year-old man developed an anaphylactic shock. At a heart rate of 110/min there was no palpable blood pressure. A red confluent exanthem, predominantly of the trunk, was noted. After brief intensive-care treatment the patient was completely well again and diagnostic tests for allergy were performed. The prick test for the 14 individual ingredients of the throat lozenge produced massive reddening and urticaria on the test arm with carbowax, a polyethylene glycol which serves as a vehicle in the remedy and does not have to be listed. Later there were an urge to cough and urticaria all over the trunk. There was no systemic reaction. Neither specific IgE antibodies nor any complement-consuming reaction could be demonstrated. Thus the precipitating mechanism remains unexplained.

[Intranasal salmon calcitonin for the prophylaxis of bone mineral loss in steroid-treated chronic obstructive lung diseases ]. / Intranasales Lachscalcitonin zur Prophylaxe des Knochenmineralverlustes bei Steroid-bedürftigen, chronisch-obstruktiven Atemwegserkrankungen.

In the present controlled study the effect of calcitonin nasal spray (CAS 47931-85-1; Lachs-Calcitonin Nasal spray Sandoz) on the bone mineral content was investigated in 36 patients in need of corticosteroid therapy suffering from chronic, obstructive lung diseases. The treatment consisted of 200 IU intranasal daily and lasted for one year. In the control group there was a statistically significant decline of bone mineral content of 5% or 4.3% concerning the lumbar vertebrae L1-L4 and the femur, whereas in the treated group there was only a statistically not significant decrease of 0.9% and 0.8%, respectively. These findings show that calcitonin nasal spray in a dose of 200 IU daily is quite useful for the prophylaxis of steroid-induced osteoporosis.

[Does COPD affect bone mineral content?]. / Hat COPD einen Einfluss auf den Knochenmineralgehalt?

In a retrospective study, 85 COPD patients not treated with steroids, and 78 who received steroid therapy, were compared with a control group of normal subjects (n = 126) matched for age and sex. The determination of the bone mineral content (BMC) was carried out with the aid of two-photon absorption measurement performed in the region of the lumbar spine L2-4 and of the neck of the femur. With respect to the distribution of the bone mineral content as a function of sex and pulmonary function reduction, the following results were obtained: 1. There are significant differences between men and women. The BMC is generally lower in women. 2. Significant differences are to be found between the normal subject group and the steroid-free group on the one hand, and the steroid-treated group on the other. The group receiving steroid treatment has appreciably lower BMC values. 3. There are statistically significant correlations between the severity of airway obstruction and the decrease in BMC both in steroid-treated and steroid-free patients.

[Long-term therapy with almitrine dimesilate has no effect on pulmonary hemodynamics at rest and during stress]. / Die Langzeittherapie mit Almitrindimesilat hat keinen Einfluss auf die pulmonale Hämodynamik in Ruhe und unter Belastung.

A 6-month double-blind study was conducted in 26 patients suffering from a severe obstructive disturbance of ventilation and respiratory insufficiency to find out the behaviour of blood gases and pulmonary haemodynamics under Almitrin treatment compared with placebo. The acute administration of 75 mg Almitrin resulted in a significant increase of PaO2 by 11.7 mmHg, as well as of PAPR by 4.4 mmHg. Statistical significance was seen only for the systolic pressure of the a. pulmonalis. After subsequent 6-month treatment with 3 x 25 mg Almitrin, a significantly higher PaO2 is seen at T6 than in the control group. Another additional administration of 75 mg Almitrin results in a further increase of PaO2 by 7.7 mmHg. At T6 the behaviour of pulmonary haemodynamics is identical in both groups A and P.

The protection of migrant workers and international labour standards.

PIP: International labor standards take the form of Conventions and Recommendations that embody the agreements reached by a 2/3 majority of the representatives of Governments, Employers, and Workers of International Labour Office (ILO) member states. Originally designed to guard against the danger that 1 country or other would keep down wages and working conditions to gain competitive advantage and thereby undermine advances elsewhere, international labor standards have also been inspired by humanitarian concerns--the visible plight of workers and the physical dangers of industrialization and by the notion of social justice, which embraces wellbeing and dignity, security, and equality as well as a measure of participation in economic and social matters. ILO standards apply to workers generally and therefore also to migrant workers, irrespective of the fact that the general standards are complemented by standards especially for migrant workers. The social security protection of migrant workers has been dealt with in ILO instruments primarily from the angle of equality of treatment but also from that of the maintenance of acquired rights and rights in course of acquisition, including the payment of benefits to entitled persons resident abroad. The ILO Conventions on migrant workers and the Recommendations which supplement them deal with practically all aspects of the work and life of non-nationals such as recruitment matters, information to be made available, contract conditions, medical examination and attention, customs, exemption for personal effects, assistance in settling into their new environment, vocational training, promotion at work, job security and alternative employment, liberty of movement, participation in the cultural life of the state as well as maintenance of their own culture, transfer of earnings and savings, family reunification and visits, appeal against unjustified termination of employment or expulsion, and return assistance. ILO's supervisory mechanism consists basically of a dialogue between the ILO and the Government that is responsible for a law, regulation, or practice alleged to be in contravention of principles it voluntarily accepted. The control machinery is often set in motion by workers' organizations. The UN General Assembly is currently elaborating a new instrument designed to cover both regular and irregular migrant workers and their families.^ieng

International migration in Western Europe: reflections on the past five years.

PIP: Five significant developments have occurred since 1974 with regard to the European labor force: 1) growth of return migration; 2) adoption of a new ILO Convention and Recommendation on return migration; 3) the movement towards a New International Economic Order; 4) the holding of the World Employment Conference in 1976; and 5) growing support for the idea that countries of origin should be compensated for out-migration of its citizens. About 1.5-2 million migrant workers have returned to their country of origin since the early 1970's when about 6 million workers and dependents were in Western Europe. The inequity that pervades international economic relations in general and migration in particular stems from the unequal bargaining power of the partners and the absense of corrective international social policies. The developing countries' wish for a new economic order questions the distributional aspects of the old liberal order. While raw materials and trade are covered comprehensively, labor movement is neglected. The growing realization that migration is a resource drain has led many poor countries to request compensation.^ieng