Psychosocial health and quality of life in ICSI and naturally conceived adolescents: a cross-sectional comparison.

PURPOSE: Psychosocial health (PH) and quality of life (QoL) are important health outcomes. We compared PH and QoL of adolescents conceived with intrazytoplasmatic sperm injection (ICSI) and of naturally conceived controls. The impact of disclosure of ICSI-conception on QoL and PH was quantified. METHODS: The cross-sectional sample consisted of 545 ICSI-conceived adolescents and 427 unmatched singleton controls aged 14-18 years. Adolescents reported PH with the 'Strengths and Difficulties Questionnaire' (low values indicating high PH), and QoL with the KINDL questionnaire (high values indicating high QoL). Because of clustering of multiples within families, adjusted linear regressions with generalized estimating equations were used to compare ICSI- and naturally conceived adolescents. Missing values were treated by multiple imputation. Minimal importance was defined as half a standard deviation. RESULTS: Both ICSI and control adolescents had high PH (low mean 'total difficulties' score: 9 of 40) and high QoL (mean 'total KINDL' score: 75 of 100). Differences were generally in favour of the ICSI group. Significant differences occurred for 'impact of behavioural problems' (p = 0.033), the 'total KINDL' score (p = 0.021) and the dimensions 'physical wellbeing' (p = 0.031) and 'school' (p = 0.005), but all differences were far below minimal importance. About 80% of ICSI adolescents were informed about their mode of conception. PH and QoL were slightly higher in informed adolescents; behavioural difficulties ('total behavioural problems' and 'conduct problems') were significantly lower (p = 0.013 and p = 0.003), behavioural strengths ('prosocial behaviour') and 'physical QoL' significantly higher (p = 0.004 and p = 0.018), but differences remained clearly below minimal importance. CONCLUSIONS: Our results are reassuring for parents using ICSI and their children. Speaking openly about an ICSI conception in the family may be beneficial.

Pubertal development and reproductive hormone levels of singleton ICSI offspring in adolescence: results of a prospective controlled study.

STUDY QUESTION: Are there any differences in the pubertal development and reproductive hormone status during adolescence between singletons following ICSI therapy or spontaneous conception (SC)? SUMMARY ANSWER: Pubertal development and reproductive hormone levels are largely similar between ICSI and SC adolescents, except for a tendency towards lower inhibin B levels as well as significantly higher estradiol levels and a lower testosterone-to-estradiol-ratio in male adolescents. WHAT IS KNOWN ALREADY: Previous data are scarce and partly inconclusive regarding pubertal development in female ICSI adolescents as well as demonstrating a tendency towards lower inhibin B serum levels in male ICSI offspring. STUDY DESIGN, SIZE, DURATION: Prospective controlled study including 274 singleton ICSI-conceived adolescents (141 girls, 133 boys) followed up for the third time, and 273 SC controls (142 girls, 131 boys) from seven German registration offices (Aachen, Eichstätt, Erfurt, Lübeck, Hamburg, Heidelberg and Schwerin). PARTICIPANTS/MATERIALS, SETTING, METHODS: Pubertal development assessed by Tanner staging (breast, genital and pubic hair development), age at menarche and reproductive hormone levels were analyzed in ICSI and SC adolescents at the mean age of 16.5 years. Differences were analyzed by multinomial regression (Tanner stages) or t test and linear regression for hormonal assessments. MAIN RESULTS AND THE ROLE OF CHANCE: Both female and male ICSI and SC adolescents showed adequate pubertal maturation according to their age, and the mean age at menarche (at 12.7 versus 12.8 years) was similar. Tanner stages as well did not display any relevant or significant differences between the groups. Reproductive hormone levels in female adolescents not using hormonal contraception were largely similar before and after adjustment for several factors such as preterm birth, Tanner stages, BMI or physical activity. In male ICSI adolescents, a tendency towards lower inhibin B (-14.8 pg/ml, 95% CI: -34.2 to 4.6 pg/ml), significantly higher estradiol (2.6 ng/l, 95% CI: 0.0 to 5.2 ng/l) and a significantly lower testosterone-to estradiol ratio (-0.047, 95% CI: -0.089 to -0.004) was found. LIMITATIONS, REASONS FOR CAUTION: The all-over response rate and the willingness to participate in the blood test and medical examination were very low in the control group. Participating control families may have greater health awareness, and selection bias cannot be ruled out. Hormonal data in the females were measured irrespective of the cycle day and restricted to those not using hormonal contraception. Some parameters from the questionnaire data such as usage of hormonal contraception might suffer from reporting bias. As this is an observational study, we can draw only limited causal conclusions from the findings. WIDER IMPLICATIONS OF THE FINDINGS: Differences in male reproductive hormones may indicate altered testicular function. However, at this time possible consequences for later reproductive success are unknown. STUDY FUNDING/COMPETING INTEREST(S): DFG research grant KA 1643/4-1. The authors declare no conflict of interest.

[Can Psychometric Tests Predict Success in the Selection Interview for Medical School? A Cross-Sectional Study at One German Medical School]. / Können psychometrische Tests den Erfolg im Auswahlgespräch zum Medizinstudium vorhersagen? Eine Querschnittsstudie an einer deutschen Hochschule.

Background The final exam grade is the main selection criterion for medical school application in Germany. For academic success, it seems to be a reliable predictor. Its use as the only selection criterion is, however, criticised. At some universities, personal interviews are part of the selection process. However, these are very time consuming and are of doubtful validity. The (additional) use of appropriate psychometric instruments could reduce the cost and increase the validity. This study investigates the extent to which psychometric instruments can predict the outcome of a personal selection interview. Methods This is a cross-sectional study on the correlation of the results of psychometric instruments with those of the personal selection interview as part of the application process. As the outcome, the score of the selection interview was used. The NEO - Five Factor Inventory, the Hospital Anxiety and Depression Scale (HADS) and the questionnaire to identify work-related behaviour and experience patterns (AVEM) were used as psychometric interviews. Results There was a statistically significant correlation with the results of the personal selection interview for the sum score of the depression scale from the HADS and the sum score for the dimension of life satisfaction of the AVEM. In addition, those participants who did not previously complete an application training achieved a better result in the selection interview. Conclusion The instruments used measure different aspects than the interviews and cannot replace them. It remains to be seen whether the selected parameters are able to predict academic success.

Interval cancers after skin cancer screening: incidence, tumour characteristics and risk factors for cutaneous melanoma.

BACKGROUND: The rate of interval cancers is an established indicator for the performance of a cancer-screening programme. METHODS: We examined the incidence, tumour characteristics and risk factors of melanoma interval cancers that occurred in participants of the SCREEN project, which was carried out 2003/2004 in Schleswig-Holstein, Germany. Data from 350 306 SCREEN participants, who had been screened negative for melanoma, were linked to data of the state cancer registry. Melanoma interval cancers were defined as melanomas diagnosed within 4-24 months after SCREEN examination. Results were compared with melanomas of the pre-SCREEN era (1999-2002), extracted from the cancer registry. RESULTS: The overall relative incidence of melanoma interval cancers in terms of observed/expected ratio was 0.93 (95% CI: 0.82-1.05; in situ: 1.61 (1.32-1.95), invasive: 0.71 (0.60-0.84)). Compared with melanomas of the pre-SCREEN era, the interval melanomas were thinner and had a slightly greater proportion of lentigo maligna melanomas whereas nodular melanomas were less frequent. INTERPRETATION: The results indicate a moderate performance of the SCREEN intervention with an excess of in situ melanomas. In part, the findings might be due to specifics of the SCREEN project, in particular a short-term follow-up of patients at high risk for melanoma.

[Put to Test: Medical Inpatient Rehabilitation of Inflammatory Bowel Diseases]. / Auf dem Prüfstand: stationäre medizinische Rehabilitation bei chronisch entzündlichen Darmerkrankungen.

BACKGROUND: Many CED-patients struggle with complex problem profiles and may be offered and profit from multidisciplinary multimodal rehabilitation. It is still unclear by whom and with what effects this option is used. METHODS: We compared the results of an observational cohort study of 199 CED-inpatients of a single rehab clinic with those of 310 gastroenterological outpatients using propensity score matching. RESULTS: Rehabilitands show more complex problem profiles than CED-outpatients. After 6 months of follow up direct and indirect change measures show generally small positive changes - however comparable in quality and size with that of matched outpatients. CONCLUSION: Complex rehab is mainly used by CED-patients with several bio-psycho-social problems. Our preliminary data do not suggest a marked additional benefit of inpatient rehab compared to specialised outpatient care. Stricter controlled trials are urgently needed.

Survival with nonmelanoma skin cancer in Germany.

BACKGROUND: Nonmelanoma skin cancer (NMSC) is the most common cancer in Germany, but detailed information on survival is lacking. OBJECTIVES: To provide survival estimates for female and male patients with basal cell carcinoma (BCC), squamous cell carcinoma (SCC), sarcoma, adenocarcinoma and Merkel cell carcinoma. Further subgroup analyses were carried out by age, tumour stage and body site. METHODS: In total 459 640 patients diagnosed with NMSC in 1997-2011 were included from population-based cancer registers, covering a population of 33 million inhabitants. Age-standardized absolute and relative 5-year and 10-year survival were calculated using period analysis. RESULTS: The absolute and relative 5-year survival were 87·1% and 102·9% for BCC, 77·6% and 93·6% for SCC, 82·1% and 96·0% for sarcoma, 71·4% and 85·7% for adenocarcinoma and 60·0% and 70·7% for Merkel cell carcinoma, respectively. Higher age, female sex and advanced stage were associated with lower survival. CONCLUSIONS: A comprehensive overview of NMSC survival in Germany is provided. The differences between the NMSC subtypes require a more differentiated consideration of patient survival. The survival advantage of patients with BCC may be related to health-promoting factors related to the BCC diagnosis, such as changes to a healthier lifestyle.

Length and weight of very low birth weight infants in Germany at 2 years of age: does it matter at what age they start complementary food?

BACKGROUND/OBJECTIVES: We analysed at what age parents start complementary food in very low birth weight infants, determined risk factors for early introduction of complementary food (post-term age) and analysed whether the age at introduction of complementary food influences height or weight at 2 years of age. SUBJECTS/METHODS: Parents of premature infants born in 2009-2011 answered questionnaires regarding introduction of complementary food in the first year of life (N=2262) and were followed up at a post-term age of 2 years (N=981). Length and weight were compared with full-term infants from the KiGGs study. Logistic and linear regression analyses were conducted to study predictors for early introduction of complementary food and the influence of age at introduction of complementary food on later height and weight. RESULTS: Average age at introduction of complementary food was 3.5 months post-term age. The lower the gestational age at birth, the earlier (post-term age) vegetables and meat were introduced. Age at introduction of complementary food was influenced by intrauterine growth restriction, gestational age at birth, maternal education and a developmental delay perceived by the parents. Length and weight at a post-term age of 2 years was not negatively influenced by early introduction of complementary food. CONCLUSIONS: VLBW infants are introduced to complementary food on average before a post-term age of 4 months. There was no negative effect of early introduction of complementary food on height and weight at 2 years of age.

[Over- and Underestimation of Success Rates]. / Über- und Unterschätzung von Erfolgsquoten.

The patient reported outcome in interventional studies is often measured with questionnaires at baseline and after the intervention. A person whose difference in outcome exceeds a critical threshold (the minimal important difference, MID) is classified as a responder, otherwise as a non-responder. The generally low reliability of differences causes misclassifications. False positives and false negatives usually do not cancel out: an MID above the average difference results in an overestimated proportion of responders, while an MID below the average difference results in an underestimated proportion of responders. Such misclassifications can be substantial. We introduce a new and simple method for estimating the true proportion of responders which is based on the assumptions of classical test theory. The consequences of the method are demonstrated with empirical data. It is recommended to report the estimates of true responders. This applies to settings with one study group as well as to settings with an additional control group.

[Incidence of melanoma and changes in stage-specific incidence after implementation of skin cancer screening in Schleswig-Holstein]. / Inzidenz des malignen Melanoms und Veränderung der stadienspezifischen Inzidenz nach Einführung eines Hautkrebsscreenings in Schleswig-Holstein.

A pilot project in skin cancer screening (SCREEN) was conducted in Schleswig-Holstein from July 2003 to June 2004. Although the impact of this screening on the stage-specific incidence of melanoma is of great importance for screening evaluation, it remains unknown. In theory, an effective skin cancer screening program should result in a medium-term incidence decrease of melanomas with a prognostically unfavorable stage. This is studied on a population-based level by using cancer registry data. Based on data from the Cancer Registry of Schleswig-Holstein for 1999-2009, stage-specific (T-category of the TNM-classification system) age-standardized incidence rates were calculated. After implementation of the SCREEN project, the incidence of prognostically favorable melanomas (in situ and T1) was higher than before, while the incidence of advanced melanomas (T2, T3, and for women also T4) decreased considerably. The classification of tumor stages changed during the project period, which may have contributed to an artificial decrease of the stages with a poor prognosis. Nevertheless, the results are in agreement with the observed decrease of melanoma mortality in the screening region.

[Data quality or differences in oncological care? - standards of reporting for cancer survival analyses based on registry data]. / Datenqualität oder Unterschiede in der onkologischen Versorgung? - Berichtsstandards für Überlebenszeitanalysen mit Krebsregisterdaten.

BACKGROUND: The results of population-based cancer survival analyses are essential criteria with regard to the evaluation of oncological care. Their use and their interpretation as such require knowledge and transparency with regard to the data basis in order to avoid inadequate conclusions. METHOD: The working group 'survival analysis' of the Association of Population-Based Cancer Registries in Germany (GEKID) has identified factors within cancer registration and data evaluation which may distort population-based cancer survival analyses to a relevant degree. Recommendations in terms of standards of reporting were developed by mutual consent following empirical studies and discussions within GEKID. RESULTS: We provide a list of 17 indicators to be taken into account and to be presented within the scope of population-based survival analyses. CONCLUSIONS: Referring to the "standards of reporting concerning population-based cancer survival analyses" introduced by GEKID there is a proposal on data transparency on hand, which might contribute substantially to the assessability of outcome quality in oncological care.

Epidemiology of Malignant Cervical, Corpus Uteri and Ovarian Tumours - Current Data and Epidemiological Trends.

Cervical, uterine and ovarian cancers are the most common malignancies of the female genital tract. Using current data from population-based cancer registries in Germany, we present the recent figures for the incidence, prevalence, associated mortality and survival for these cancers. In 2009, a total of 23 800 women were newly diagnosed with one of the three gynaecological cancers (cervical cancer: 20.3 %, endometrial cancer: 48.5 %, ovarian cancer: 31.2 %). This figure equals approximately one third of the number of women newly diagnosed with breast cancer in the same year. The relative 5-year survival for carcinomas of the corpus uteri is 79 % and is higher that those for cervical cancer (68 %) and ovarian cancer (40 %). Ovarian cancer in particular is often diagnosed at a later stage and has a high risk of recurrence. Due to the favourable prognosis for endometrial tumours and the unfavourable prognosis for ovarian malignancies, the incidence of various gynaecological tumours is ranked differently compared to the 5-year prevalence of these same tumours. Currently, the 5-year prevalence in Germany for patients with cervical, endometrial or ovarian cancer is estimated to be around 80 000 women. Slightly more than half of these women were diagnosed with cancer of the corpus uteri. Around 25 % of women have ovarian and 21 % have cervical cancer.

Epidemiology of Breast Cancer - Current Figures and Trends.

The epidemiology of breast cancer has clearly changed in the past few years. On the basis of current data from population-based cancer registries characteristic numbers for incidence, prevalence, mortality and survival after breast cancer are presented. The number of incident cases has increased to around 72 000 in 2009 (+ 23 % since 2003). It is estimated that at present 250 000 women with a prevalent breast cancer (5-year prevalence) are living in Germany. The most frequent localisation is the outer upper quadrant of the breast. Poorly differentiated or undifferentiated tumour tissue is found in every third patient. Since 2003 the age-standardised mortality has declined slightly (- 9 %) whereas the relative survival has improved from 79 to 86 %. Changes in the epidemiology of breast cancer can most probably be attributed to the introduction of early detection programmes such as mammography screening as well as to improved treatment options. To what extent mammography screening will lead to a further reduction of mortality remains to be seen.

Up-to-date results on survival of patients with melanoma in Germany.

BACKGROUND: Prior analyses of survival of patients with primary cutaneous malignant melanoma from Germany were based only on small populations and need to be updated. OBJECTIVES: We give a detailed overview of relative 5-year survival by sex, age group, histology, tumour stage and body site, and of time trends in a population of 33 million (40% of Germany), and compare survival in the federal states. METHODS: Conventional and model-based period analysis using the Ederer II method was applied to patients with melanoma diagnosed during 1997-2006 in Germany to assess 5-year relative survival (RS) rates and time trends. RESULTS: In total, 37,155 melanoma cases were included. Overall age-adjusted 5-year RS for the time period 2002-2006 was 91·9% for women and 87·0% for men. Survival differences by age group, histology, tumour stage and body site were found. No significant overall trend (2002-2006) was seen either in women or in men. Differences in survival between federal states were small; no clear pattern was seen. CONCLUSIONS: Based on the most recent and high-quality data from population-based cancer registries a comprehensive picture on melanoma survival in Germany was given. Survival from cutaneous malignant melanoma was high compared with other cancer sites and did not change during the analysed period 2002-2006. Patterns in melanoma survival by sex, age, tumour stage, histology and body site were in good agreement with previously published findings. No relevant differences between federal states were found.

Skin cancer screening participation and impact on melanoma incidence in Germany--an observational study on incidence trends in regions with and without population-based screening.

BACKGROUND: The SCREEN (Skin Cancer Research to provide Evidence for Effectiveness of Screening in Northern Germany) project involved population-wide skin cancer screening with whole-body examination by general physicians and dermatologists. It was conducted in the German state of Schleswig-Holstein (July 2003-June 2004), but not in the German state of Saarland. METHODS: The population-based registries of Schleswig-Holstein and Saarland provided data on melanoma incidence before, during, and after SCREEN to assess the association of skin cancer screening with incidence. RESULTS: Approximately 19% of the Schleswig-Holstein population participated in SCREEN (women: 27%, men: 10%). A total of 52% of all melanomas diagnosed during SCREEN in Schleswig-Holstein were detected as part of the project. Melanoma incidence increased during SCREEN (invasive melanoma in women: +8.9 per 100,000 (95% confidence intervals (CI): 6.1; 11.7); men: +4.0 per 100,000 (95% CI: 1.6; 6.4)) and decreased afterwards (women: -10.6 per 100,000 (95% CI: -13.3; -7.9); men: -4.1 per 100,000 (95% CI: -6.5; -1.7)). Similar changes were not observed in Saarland that had no such project. The differences between the two states were greatest among women, the group with the greater SCREEN participation. CONCLUSION: The SCREEN project had a substantial impact on melanoma incidence. This is consistent with the impact of effective screening for other cancers.

[Structure and process quality of quality-assured mamma diagnostics in Schleswig-Holstein]. / Struktur- und Prozessqualität in der qualitätsgesicherten Mammadiagnostik in Schleswig-Holstein.

PURPOSE: To demonstrate the structure and process quality of quality-assured mamma diagnostics (QuaMaDi) by means of quality indicators as defined in the European Guidelines for Quality Assurance in Breast Cancer Screening and Diagnosis and in the National Guideline on Early Detection of Cancer in Germany. Furthermore, spatial differences and changes in the chronological sequence were analyzed. MATERIALS AND METHODS: We used administrative data as documented in the time period 2006 - 2009 in QuaMaDi in Schleswig-Holstein (SH), Germany, and analyzed quality indicators as defined in the abovementioned guidelines (absolute and relative frequencies, 95 % confidence intervals). RESULTS: Each year approximately 6 % of all women age 20 or older living in SH are examined using QuaMaDi. Only minor differences regarding age and clinical data were seen between the patients in the four regions of SH. Reference values for the quality indicators are largely reached (i. e., proportion of women with breast density ACR 3 or 4 plus additional ultrasound = 96.2 %; proportion with repeated mammography = 0.2 %). Spatial differences are only minor. In the chronological sequence, quality indicators improve, if they did not reach the reference values in the beginning, or indicate a high and constant quality. CONCLUSION: With regard to those quality indicators that were computable, reference values as defined in the guidelines were reached in 9 of 12 cases. In one case the difference between the observed value and the reference values is system-immanent and in another case the difference is less than four percentage points (reference value 90 %).