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Health technology assessment (HTA) is a dynamic, rapidly evolving process embracing different types of assessment that inform decisions about the value (i.e., benefits, risks and costs) of new and existing technologies. The role of HTA is to support health policy decision-making and financing in health care. In this paper we describe and analyse the German approach to cost-effectiveness analysis in health care and HTA. Two institutes operate as HTA agencies, namely the German Agency of Health Technology Assessment (DAHTA) and the Institute for Quality and Efficiency in Health Care (IQWiG). The operational principles of IQWiG are somewhat different from the rules governing HTA organizations in other countries. The efficiency frontier approach, applying an indication-specific threshold and neglecting the concept of quality-adjusted life year (QALY) are the most important differences. Previously, health gains were in focus and assessment was based exclusively on such benefits, but in 2010, cost-effectiveness analysis was introduced as an integral part of the HTA process at IQWiG. A brief comparison is also made with the HTA systems in Central-Eastern-European countries, among them concentrating mainly on Hungary.

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Authors: Szilárd Czóbel, János Balogh, Orsolya Szirmai and Zoltán Tuba
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Authors: Orsolya Kutasi, Orsolya Fehér, Sára Sárdi, Nándor Balogh, Anna Nagy, Leticia Moravszki, Emese Bódai and Ottó Szenci

Abstract

West Nile virus (WNV) is a zoonotic arbovirus transmitted by mosquitoes between wild birds (natural hosts) and other vertebrates. Horses and humans are incidental, dead-end hosts, but can develop severe neurological disorders. Owing to the close contact of cerebrospinal fluid (CSF) with the extracellular fluid of the brain, the analysis of CSF composition can reflect central nervous system (CNS) impairments enabling the diagnosis and understanding of various neurodegenerative CNS disorders. Our objective was to compare the findings from the CSF samples of horses with neuroinvasive WNV infection with those of healthy controls. We compared findings from fifteen CSF samples of 13 horses with acute WNV encephalomyelitis with those of 20 healthy controls. Protein, particular enzymes and ions, glucose and lactate showed abnormal levels in a significant number of WNV cases. None of the six horses with elevated glucose concentrations survived. Rather neutrophilic than mononuclear pleocytosis was identified with WNV infection. Neutrophils probably play a role in the development of inflammatory response and brain damage. Although elevated glucose levels reliably predicted the outcome, they might be the consequence of increased plasma levels and reflect general stress rather than CNS pathophysiology. The CSF findings of WNV encephalomyelitis patients are non-specific and variable but facilitate the differential diagnosis.

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Authors: Orsolya Balogh, Hedvig Fébel, Gyula Huszenicza, Margit Kulcsár, Zsolt Abonyi-Tóth, Tamás Endrődi and György Gábor

The aim of this study was to identify relationships among seasonal differences of fertility, metabolic parameters and appearance of irregular luteal forms in high-yielding dairy cows. Holstein-Friesian cows were put on the Provsynch regimen in winter (n = 10) and in summer (n = 10). Blood sampling (starting 35 days post partum) and rectal ultrasound examinations (starting post insemination) were carried out once a week in each examination period. Metabolic [plasma nonesterified fatty acid (NEFA) and beta-hydroxybutyrate (BHB) levels, ferric reducing ability of plasma (FRAP) and serum beta-carotene] and endocrine parameters [plasma thyroxine (T4), triiodothyronine (T3), insulin-like growth factor (IGF-I) and insulin levels] were measured. In summer, two cows were excluded from the study because of metritis and none of the remaining animals became pregnant, but 6 of the 8 cows had irregular luteal forms (ILF) on their ovaries. In winter, one cow was excluded because of metritis and 6 of the 9 cows became pregnant, while 2 of the 3 open cows had irregular luteal forms. In summer the mean plasma NEFA and BHB concentrations were significantly higher, while serum carotene and plasma IGF-I concentrations were significantly lower than in winter. The high plasma NEFA concentration found in summer seemed to be in association with the lower body condition score (BCS) caused by depressed appetite. In conclusion, statistical analysis supports the hypothesis that increased plasma NEFA and BHB and decreased plasma IGF-I concentrations may result in reduced fertility in summer. These changes may be associated with the more frequent appearance of ILFs and probably have a negative effect on ovarian function and/or oocyte quality.

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Authors: Tímea Milisits-Németh, Orsolya Gabriella Balogh, István Egerszegi, László Kern, R. Garth Sasser and György Gábor

The early detection of pregnancy and the determination of fetal numbers have economic benefits in sheep production because of the seasonal breeding patterns where missing a breeding opportunity means the loss of one productive year. The purpose of this study was to evaluate the efficacy of the B6-HRP ELISA for ovine pregnancy-specific protein B (oPSPB) measurement in the detection of pregnancy and estimation of fetal numbers in different sheep breeds. BioPRYN® ELISA assay kit was used for the detection of pregnancy in the experimental animals. Ninety-three ewes of three breeds (British Milksheep – BM, Lacaune – L and Transylvanian Racka – TR), each from three farms in Hungary, were included in the study. BM and L ewes were artificially inseminated (AI). Thirty-five days after AI, all ewes were examined by transabdominal ultrasound. The TR flock was mated naturally over a six-week period. At the end of the mating period, the ewes were similarly examined by ultrasound. Blood samples were taken from all pregnant ewes twice (35 and 65 days after AI), and serum samples were assayed by the BioPRYN test. It can be concluded that the detection of serum PSPB by ELISA is a much easier, safer, less expensive and highly accurate method for the detection of ovine pregnancy. Although some breed-related differences were detectable at 35 and 65 days post breeding, no differences in oPSPB levels were found in pregnant ewes carrying different numbers of fetuses.

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Authors: Zoltán Szelényi, Orsolya Gabriella Balogh, Fernando Lopez-Gatius, Irina Garcia-Ispierto, Eszter Krikó and György Gábor

Double ovulation occurs more frequently in multiparous cows with high milk production than in primiparous cows and the rate of twin pregnancy/calving is increasing worldwide. Diagnosis of twin pregnancy is possible by ultrasound at the time of early pregnancy examination [28–34 days after artificial insemination (AI)]. Pregnancy proteins are also well-known indicators of gestation. The risk of pregnancy loss during the first trimester of gestation for cows carrying twins is three to nine times higher than for cows carrying singletons. Pregnancy-specific protein B (PSPB) is a good indicator not only of pregnancy but also of pregnancy loss. The aims of this study were (a) to collect calving data in some Hungarian Holstein-Friesian herds (n = 7,300) to compare PSPB serum concentrations (measured 29–35 days post insemination) in twin- and singleton-calving cows (Trial 1), and (b) to check the predictive value of PSPB serum concentration for twin pregnancy and pregnancy loss in high-producing Spanish Holstein-Friesian cows (n = 98; Trial 2). Our results showed almost 7% twin calving rate. Although hormonal treatments are commonly believed to be major causes of twin pregnancies, our data do not support this hypothesis. The only exception is the single PGF injection, which significantly increased twin calving. No effect of milk production on the risk of twin pregnancy was found, and twin pregnancy increased with parity. The AI bull, the bull’s sire, the bull’s grandfather and the cow’s father also affected twin calving (P ≤ 0.02). We found much higher frequency of twin calving in cows diagnosed pregnant with higher than 3 ng/ml serum PSPB concentrations at 29–35 days after insemination. In Trial 2, non-significant but well-marked differences were found in PSPB serum concentration between singleton- and twin-pregnant cow samples (2.1 and 2.9 ng/ml) at different bleeding times. Probably the small size of the study population and the effects of milk production on PSPB values may explain this lack of significance.

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Authors: Orsolya Balogh, Ernő Túry, Zsolt Abonyi-Tóth, John Kastelic and György Gábor

The primary objective of this study was to use macroscopic and histological features of corpora lutea with a cavity and anovulatory cystic ovarian structures, present in 90 pairs of abattoir-derived dairy cow ovaries, as the basis to clarify the nomenclature of ovarian structures. Excluding morphologically normal ovarian fol-licles (antrum < 2 cm, wall < 1 mm), there were 27 fluid-filled ovarian structures. Ovulatory structures > 16 mm in diameter were designated as Group A (cavity ≤ 10 mm and wall > 10 mm) or Group B (cavity > 10 mm and wall < 10 mm). The volume of luteal tissue was less (P < 0.05) in Group B than in Group A, whereas that of a solid corpus luteum (CL) was intermediate (least square means ± SEM: 72 ± 1.92, 11.22 ± 1.57 and 5.84 ± 1.92 cm3, respectively). There was a greater proportion (P < 0.05) of small luteal cells in Group B compared to a solid CL, whereas Group A was intermediate (58.6 ± 5.3, 37.4 ± 5.3 and 44.0 ± 4.4%, respectively). Connective tissue was thicker (P < 0.05) in Group B than in Group A (295.4 ± 46.9 vs. 153.9 ± 38.2 μm). Based on the above-mentioned characteristics and differences, Groups A and B were designated as a CL with a cavity and a cystic CL, respectively. Furthermore, there were three groups of anovulatory ovarian structures. Structures in Group C were termed persistent/anovulatory follicles (overall diameter and wall thickness ≤ 20 and 1–3 mm, respectively). Finally, Groups D and E were designated as a follicle-fibrous cyst and a follicle-luteinised cyst (based on histological structure) for anovulatory structures with an overall diameter and wall thickness of ≥ 20 and ≤ 3 mm, and ≥ 20 and ≥ 3 mm, respectively.

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Authors: János Balogh, Szilárd Czóbel, Szilvia Fóti, Zoltán Nagy, Orsolya Szirmai, Evelin Péli and Zoltán Tuba
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Authors: Frank Sandmann, Ralf Bender, Andreas Gerber-Grote, Noémi Hevér and Orsolya Balogh
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Authors: Orsolya Balogh, Márta Péntek, László Gulácsi, Katalin Farkas, Zoltán Járai, Anna Landi, Zsolt Pécsvárady and Valentin Brodszky

Bevezetés: A magas vérnyomásban szenvedők 14%-ánál fordulhat elő perifériás verőérbetegség, közülük 1–3% a krónikus kritikus végtagischaemiában szenvedők aránya. Kevés szakirodalmi adat áll rendelkezésre a Fontaine-stádiumok szerinti életminőségről. Cél: A kutatás célja a magyarországi Fontaine II–IV. stádiumba tartozó betegek életminőségének felmérése. Módszer: A szerzők négy angiológiai centrumban keresztmetszeti kérdőíves felmérést végeztek. A vizsgálatban 102 beteg (43% nő) vett részt, átlagéletkoruk 70 (SD = 10) év volt. Eredmények: A betegek életminősége az EQ-5D index alapján stádiumonként átlagosan 0,66; 0,35; 0,18, az EQ-5D értékek alacsonyabbak a korra illesztett átlaglakosság értékeinél. A fájdalom vizuális analóg skála eredménye 38, 65, 71 mm, az EQ-5D-vel szoros korrelációt mutat (R = –0,68). A Fontaine IV betegek között szignifikánsan rosszabb azok életminősége, akiknél nyugalmi fájdalom és ulcus egyaránt fennáll. Következtetések: A betegség jelentős életminőség-csökkenéssel jár, EQ-5D-vel jól mérhető, a Fontaine-stádiumok mentén rosszabbodik. A Fontaine IV. stádiumban az egészségnyereség mérésekor célszerű figyelembe venni a nyugalmi fájdalom csökkenéséből és az ulcus részleges gyógyulásából származó nyereséget. Orv. Hetil., 2013, 154, 464–470.

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