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OBJECTIVE To demonstrate trends in cardiovascular risk factors in the population of former East Germany. PATIENTS AND METHODS As part of the international World Health Organisation's MONICA project ("MONItoring of Trends and Determinants of CArdiovascular Disease"), cross-sectional studies of independent random samples were undertaken, during three periods between 1982 and 1994, among the 24-64 year age groups in the population of East Germany. Those examined were 8470 (1982-1984), 9533 (1987-1989) and 2330 (1991-1994) men and women aged 25-64 years living in 17 regions (until 1989) and three regions (since 1991), respectively. Each person had standardized blood pressure measurements, His/her weight and height were measured, a blood sample was taken, and each was given a standardized interview by trained personnel. RESULTS The prevalence of hypertension, ca. 30% overall, was relatively high. There was, however, a tendency over time towards a reduced prevalence among the women, from 29% to 25% (P 6.7 mmol/l), but it was statistically significant only for women. The proportion of markedly overweight persons (body mass index > or = 30) was not significantly reduced. The frequency of regular smokers decreased among men from 41% to 35% (P < 0.05), while among women (especially those in the younger age groups) there was a slight increase. CONCLUSIONS Despite the known importance of risk factors, their prevalence was not significantly changed in East Germany over a period about 10 years. More effort and population-related primary prevention of coronary heart disease will thus be required, particularly in view of the risk factors cigarette smoking and hypertension.

Background: Previous epidemiological studies have inconsistently shown an increased or decreased risk of breast cancer in users of - mainly high estrogen dose - oral contraceptives (OCs). A reduced risk of benign breast tumours was associated to OC use in most of earlier studies. Little is known about the effects of exclusive use of low estrogen dose 0Cs. Methods: The German Cohort Study on Womens Health is an ongoing study analysing the lifedme risk of tumours going back in time in a cohort of volunteers. Self-reported data were collected from women who responded to a call for participation circulated in all German states. The data include information on exposure and time type and dose of exposure as well as time of occurrence of any outcome. Initial cohort data until 2000 were analysed using logistic regression to determine the association between lifetime OC use and the occurrence of tumours of the breast Results: The cohort currently covers 610328 women years of observation since birth on 15374 participants. 308 cases of breast cancer and 1309 cases of benign breast tumours were observed. The adjusted relative risk (RR) for the occurrence of breast cancer comparing users and never-users of OCs was 0.6 (95 % confidence interval (95% CI): 0.5 to 0.8). The comparison only of ever-users of low estrogen 0Cs versus never-users shows an adjusted RR of 0.8 (95%0 0.5 to 1.2). This was lower in women < 50 years of age (RR 0.2(95% 0 0.1-0.4). Similar risk reductions were found for benign breast tumours in OC users especially pronounced in younger women. Duration of OC use seems to playa role in benign breast tumours but not for breast cancer. Time since last OC use was not an effect modifier in breast cancer but plays a role for benign tumours in women over 50. Conclusion: Ever-use of OCs is associated with a markedly decreased risk of developing malignant or benign breast tumours particular in women under 50. In these younger women the reduced risk associated with lifelong exclusive use of low estrogen OCs may be more pronounced. (authors)

Unlike in women, where instruments are available to measure the severity of symptoms, cross-culturally validated instruments are lacking for aging males. This study set out to conduct a translation and cultural validation of the 'Aging Males' Symptoms' (AMS) scale, originally developed in German, into English for use in North America and the UK. Following international methodological recommendations, the AMS scale was translated in a standardized way consisting of forward translation, quality control, backward translation and a pretest. Five experienced bilingual translators and reviewers were involved. Many difficulties of compatibility between the cultural backgrounds of Germany, the UK and North America were identified and resolved by consensus. This resulted in one version for British and American English. A pretest in volunteers demonstrated clarity and understandability across social classes, but also suggested minor changes in the instrument. A preliminary test-retest comparison of the final scale ...

In studies of oral contraceptive oral contraceptive use and risk of venous thromboembolism, bias related to heightened diagnostic suspicion and preferential referral of oral contraceptive users has been an issue. The aim of our study was to determine the presence and potential impact of diagnostic suspicion and referral bias.We conducted a case/non-case study in 21 regional study centers in Germany and, in parallel, a conventional case-control study using the same cases but randomly selected population controls from the same areas. Women with symptoms compatible with venous thromboembolism were included in the study between 1994 and 1999, and classified as cases or non-cases (first reference group) according to the diagnostic work-up (case/non-case study). A second reference group consisted ofpopulation controls (conventional case-control study as an internal comparison for the case/non-case study): 606 cases, 462 non-cases and 2942 population controls aged 15-49 years. Adjusted unconditional regression analyses were performed.Adjusted odds ratios for venous thromboembolism in oral contraceptive users were systematically higher in the classical case-control study compared to the case/non-case approach (using the same cases) across all subgroup analyses (e.g. for idiopathic cases, the odds ratio was 67% higher in the case-control study: 4.33 (95% confidence interval (CI) 3.27-5.74) versus 2.60 (95% CI 1.75-3.88)). We found a significantly increasing trend of oral contraceptive use in four categories of increasingly sophisticated diagnostic tests that were applied to 1067 women with a suspicion of venous thromboembolism, irrespective of the outcome. Stratified analysis showed the diagnostic level to be a confounder.In our population-based study with the possibility of internal comparison, we found clear evidence that diagnostic suspicion and referral bias does play an important role in case-control studies of venous thromboembolism risk among oral contraceptive users. This underlines the importance of making an effort to avoid this bias when designing a new study.

Analysen zur Schlaganfallerkrankungshaufigkeit oder -sterblichkeit beruhen meist auf offiziellen Statistikdaten. Eine Reduktion der Schlaganfallsterblichkeit wurde fur sehr viele Landern gezeigt. Es ist jedoch unklar, ob das mit verminderter Morbiditat oder Letalitat (oder beidem) zusammenhangt. Dafur sind bevolkerungsbezogene Registerdaten erforderlich. Mit einheitlicher Methodik des WHO-MONICA-Projekts wurden auch in Deutschland von 1984–1993 Schlaganfalle registriert (7.435 Erst- und Wiederholungsschlaganfalle). Die Datensammlung beschrankte sich weitgehend auf Ostdeutschland. Die altersspezifische Schlaganfallerkrankungshaufigkeit von Mannern/ Frauen steigt steil von 9/11 pro 100 000 Bevolkerung in der jungsten Altersgruppe (25–34) auf 1005/799 in der altesten untersuchten Altersgruppe (65–74) an. Versucht man eine Klassifikation der Schlaganfalltypen, was in epidemiologischen Studien nicht immer moglich ist, wurde die beste Schatzung fur Mannern (Frauen) ergeben: 63(62)% thromboembolische Hirninfarkte, 25(22)% intrazerebrale Blutungen und 12(17)% subarachnoidale Blutungen. Die 28-Tage-Letalitat der 25- bis 74jahrigen Schlaganfallpatienten betrug etwa 40%. Es konnten weder hinsichtlich der Erkrankungshaufigkeit noch der Letalitat uberzeugende Trends uber die 10 Jahre gezeigt werden. Die insgesamt geringen Veranderungen uber die 10 Jahre sollten – nicht nur im Osten Deutschlands – dazu fuhren, dem Schlaganfall wesentlich mehr Aufmerksamkeit zu widmen, insbesondere seiner primaren und sekundaren Pravention. Das betrifft aber auch die Behandlung in der Akutphase, da die Sterblichkeit vor Aufnahme ins Krankenhaus und in den ersten Tagen noch auserordentlich hoch ist. Auch fehlen bevolkerungsbezogene Studien zur Langzeitprognose des Schlaganfalls in Deutschland, einschlieslich der Effektivitat verschiedener Formen der Therapie und Rehabilitation. Eine systematische Beobachtung der Entwicklung auf diesem Gebiet gehort zu den vordringlichen Aufgaben der Beurteilung von Qualitat und Effektivitat des Gesundheitssystems.

Die modernen oralen Kontrazeptiva der 3. Generation verwenden als neue Substanzen Gestoden und Desogestrel. Epidemologische Studien haben in den letzten 15 Monaten fur diese Stoffe ein scheinbar hoheren Risiko einer venosen Thrombose gegenuber der 2. Generation festgestellt. Diese Ergebnisse haben eine kontroverse Diskussion ausgelost, zumal eine ausreichende biologische Plausibilitat fehlt. Damit ist die Frage nach den Moglichkeiten und Grenzen epidemologischer Untersuchungen zur Beurteilung seltener Arzneimittelwirkungen aufgeworfen. Die 7 grosen Typen von Untersuchungsansatzen fur die Informationsgewinnung, deren Aussagekraft und Fehlermoglichkeiten werden ausfuhrlich besprochen. Mogliche Fehlerquellen konnen in der richtigen Auswahl der Kollektive liegen. In die Thrombosestudien wurden z. B. Patientinnen aufgenommen, die in die Klinik eingewiesen worden waren. Dies konnte Verzerrungen der Ergebnisse im Zusammenhang mit einer Exposition zu venosen Thrombosen geben. Auch die Auswahl des Kontrazeptivum durch den Arzt und die Art der Risikoaufklarung der Patientin haben einen Einflus auf die Studienergebnisse. Zu berucksichtigen ist ferner die Erfahrung aus der Praxis, das Arzneimittel in der ersten Zeit nach ihrer Einfuhrung ein hoheres Risiko aufweisen als nach jahrelanger Nutzung, was sich anhand von Beispielen belegen last. Kurzlich wurden eine Reihe von Beobachtungsstudien zu einem scheinbar leicht erhohten venosen Thromboembolierisiko (VTE) der 3. gegenuber der 2. Generation veroffentlicht, die zu konroversen Diskussionen fuhrten, die Frage nach den Grenzen der Epidemiologie ebenso stellen lies wie die nach der klinischen Relevanz. Das Design der benutzten Beobachtungsstudien ist sicher im Vergleich zu anderen methodischen Ansatzen aus Grunden der Kosten-Nutzen-Betrachtung am ehesten geeignet, seltene Arzneimittelrisiken wie VTE zu erfassen. Jedoch sind es gerade diese Studien, die ganz generell durch Bias und Confounding leicht zu beeintrachtigen sind, was in ganz speziellem Mase fur venose Thrombosen zutrifft. Hier ergeben sich Zweifel, ob die Wirklichkeit hinreichend verlaslich durch das Design der durchgefuhrten Fall-Kontrol-Studien widergespiegelt werden konnte oder das gefundene Risiko zu einem nicht quantifizierbaren Anteil einen Artefakt darstellt. Es ist nicht auszuschliesen, das die Erkennung von Fallen expositionsabhangig war und sogar unterschiedlich zwischen Nutzerinnen der 2. und 3. Pillengeneration. Daruber hinaus ist zu berucksichtigen, das sich die OC der 2. und 3. Generation in unterschiedlichen Phasen der Entwicklung ihrer „zeitabhangigen Risikofunktion“ befinden, womit Kopf-an-Kopf-Vergleiche sehr problematisch werden. Der dahinterstehende „healthy-user effect“ wurde an den Daten einer der Studien gezeigt. Es wird die Schlusfolgerung gezogen, das die beschriebene 1,5- bis 2fach erhohte Risikoschatzung fur VTE bei Nutzung von OC der 3. Generation im Vergleich zur 2. nicht belastbar ist, da die methodischen Voraussetzungen in den Studien nicht gegeben waren, viele mogliche Storgrosen wirklich ausschliesen zu konnen.

The Aging Males' Symptoms (AMS) scale was designed and standardized as self-administered scale (a) to assess symptoms of aging (independent from those which are disease-related) among groups of males under different conditions, (b) to evaluate the severity of symptoms over time, and (c) to measure changes pre- and post-androgen replacement therapy. It is a short and easy to apply instrument, it has a very simple evaluation scheme, and was internationally well accepted (translated into over 20 languages). Methodological test characteristics are: a) reliability measures: (internal consistency and test-retest stability) were found to be good across countries, b) validity: the internal structure of the AMS in healthy and androgen deficient males and across countries was sufficiently similar to conclude that the scale really measures the same phenomenon across all age groups. The comparison of the AMS with the two established screening instruments for androgen deficiency showed sufficiently good compatibility. Consequently, a screening tool for hypogonadism was developed, consisting of the AMS scale, body mass index (BMI) and age. The test characteristics of this screening tool (sensitivity and specificity) are promising. Clinicians often consider validity as utility for outcome measurement. The AMS scale showed a convincing ability to measure treatment effects on quality of life across the full range of severity of complaints before therapy. The distribution of complaints of testosterone deficient men before therapy almost returned to normal values after 12 weeks of testosterone treatment.

The interest in clinical investigations in health-related quality of life (HRQoL) of aging men has increased over recent years, particularly in the context of partial androgen deficiency. The aim of this paper is to inform the scientific community about a harmonized Italian Aging Males' Symptoms (AMS) scale.There were two slightly different Italian AMS scales, which both underwent an up-to-date linguisticcultural translation process, i.e., were both valid to be applied in clinical research. However, there are potential long-term problems associated with having two Italian language versions of the scale in the same country. Therefore, an ad hoc committee of key persons related to both versions met with the scale's developer, to create a harmonized single Italian AMS.The harmonization meeting came up with a consensus item-by-item and the new Italian reference scale was agreed upon. It was decided that this scale should be published to avoid any confusion among future users.The Italian AMS scale published in this paper should be used for future clinical and other research.

There is no doubt, oral contraceptives are a safe, reversible and commonly used method of contraception. Ever use is about 80 % in developed countries and current use of OCs about 40 %. Almost all information about prevalence of OC use came from cross-sectional studies and did not distinguish between high- and low-dose OCs. This paper deals with the prevalence of OC use as it was observed during lifetime of a large cohort of German women by calendar year and estrogen content.The prevalence of OC use between 1980 to 1999 was analysed on occasion of an interim analysis of the German cohort study on women's health. This analysis is based on more than 10 000 women with about 390 000 women-years of observation.The proportion of women under the age of 50, that ever used OCs, increased steeply from 1980, i. e. from 62 % (1980) to about 90 % from 1996 onward. The proportion of current users in a given calendar year rose from 44 % (1980) to 49 % (1991-95) and dropped after the "pill crisis 1995". The percentage of current users who used high-estrogen-dose OCs dropped from 32 % (1980) to 5 % (1999). In contrast, the percentage of users of low-dose OCs of the 2nd generation steeply increased as was the percentage of users of the 3rd generation pills, however the latter dropped after 1995.The high acceptance of oral contraceptives despite many "pill crises" underlines the continuously high appreciation of their efficacy on the one hand, but underscores also the high responsibility of physicians and industry concerning surveillance or reduction of discussed side effects.

The association of occupational variables and hepatocellular cancer (HCC) is discussed with particular reference to women, as little research has been undertaken on their behalf. This paper reports the results of an international case-control study concerning women and involves 317 cases of HCC and 1789 controls. Working in the chemical industry was shown to have only a marginally significant risk associated with HCC: adjusted odds ratio (OR) and 95% confidence interval 2.37 (1.04-5.41). Other non-significantly elevated ORs were observed in the pharmaceutical, plastics, PVC-producing, farming and butchery industries. Little consistency was found among the risk estimates for HCC, based on three different analytical approaches. None of the analyses showed a linear trend of risk with increasing duration of exposure. However, the numbers of exposed cases and controls were small for many of the occupations and therefore the study power and precision were low. We failed to find important and consistent evidence for a relationship between HCC in women and occupational variables. However, even weak evidence of occupational risk warrants careful consideration in future studies.

The risk of cardiovascular disease associated with progestogen-only pills has rarely been studied so far.In the Transnational case-control study we were looking for a potential cardiovascular disease risk with oral progestogen-only pills in women aged 16-44 years. A total of 1058 cases of myocardial infarction, thromboembolic cerebrovascular accident or venous thromboembolism, and 3808 controls unaffected by these diseases, were enrolled. The group of women who had either used oral progestogen-only pills or no oral contraceptives included 394 cardiovascular disease cases (123 cases of myocardial infarction, 90 cases of thromboembolic cerebrovascular accident and 181 cases of venous thromboembolism) and 2366 controls.The adjusted (matched) odds ratio (OR) for all cardiovascular diseases combined for women using progestogen-only pills compared with non-users of oral contraceptives was 0.84 (95% confidence interval (CI), 0.45-1.58). The adjusted ORs for myocardial infarction, thromboembolic cerebrovascular accidents and venous thromboembolism for users of progestogen-only pills were 0.94 (95% CI, 0.31-2.91), 1.60 (95% CI, 0.24-0.72) and 0.68 (95% CI, 0.28-1.66), respectively. Hence, there was no significant increase in cardiovascular disease risk associated with progestogen-only pill use. The association between cardiovascular disease and established risk factors (smoking and hypertension) was confirmed.Although limited by the small number of exposed cases, our data suggest that there is no convincing evidence for an increased risk of cardiovascular disease associated with progestogen-only pill use.

To analyze the association between oral contraceptive use and the risk of benign liver tumors.Two parallel case-control studies on hepatocellular adenoma and focal nodular hyperplasia. Collaborative study of 15 German liver centers. Cases defined by histology and compared with population controls.Fifty-one hepatocellular adenoma and 143 focal nodular hyperplasia cases (women) were recruited between 1990 and 1997, and compared to 240 population controls with a recent abdominal imaging test. The frequency age-matched odds ratio was 1.25 (95% confidence interval (CI), 0.37-4.22) and 1.96 (95% CI, 0.85-4.57) for hepatocellular adenoma and focal nodular hyperplasia, respectively. For hepatocellular adenoma, there was neither a significantly increased risk with longer duration of oral contraceptive use, nor an association with time since first or last use. For focal nodular hyperplasia, however, a slightly increased odds ratio was found with longer duration of use and more recent last use.There is little evidence for an increased risk for hepatocellular adenoma in women using modern oral contraceptives. If there is a risk not detected by the limited study size, hepatocellular adenoma is an extremely rare, and focal nodular hyperplasia a rare, adverse effect potentially associated with long-term oral contraceptive use and likely to be without public health importance.