gynaecology l " obstetrics l " financing l " DRG l " payment l " structures l " additional charge l " certified centres

No abstract

Clinical data, demographic, diagnostic and treatment information were primarily collected from the patients' charts. Patients were seen at 3-month intervals after initial diagnosis for a 2year period, thereafter at 6-month intervals for another 2 years and then once a year to evaluate for sonographic and clinical signs of relapse. The patients' data were further reviewed for the surgical procedure performed. Radicality varying from unilateral adnexectomy, in this study referred to as fertility sparing surgery, to hysterectomy with bilateral adnexectomy, omentectomy and lymphadenectomy were recorded. Bilateral adnexectomy, hysterectomy, omentectomy, cytology, and several peritoneal biopsies were regarded as full staging. Tumor typing and staging were performed by the department of pathology according to the criteria of the International Federation of Gynaecologists and Obstetricians (FIGO) and the International Union against Cancer (IUCC).The following parameters were registered for each patient: age at primary diagnosis, menopausal stage, age at menopause, surgical procedure performed, tumor type and stage. Also, the presence of BOT cells in ascites was recorded. In follow-up, the occurrence of relapse, time to relapse, death and survival time were registered. The main outcomes assessed were disease recurrence and survival.Statistical analysis was performed using MedCalc (Version 8.1; MedCalc Software, Mariakerke, Belgium). All values are given as mean and standard deviation. To test differences between continuous variables for statistical significance, the Mann-Whitney test for unpaired variables was applied. For categorical data, the chi-square test was used. For the comparison of survival times, Kaplan-Meier curves were drawn for different patient groups. The chi-square statistic of the logrank test was calculated to test differences between survival curves for significance. p values less than 0.05 were considered as statistically significant. ResultsAltogether, 113 patients could be identified, including 19 women with fertility sparing surgery. Mean follow-up time was 9.6 AE 6.6 years (minimum 6 months, maximum 23.5 years, median 7.9 years). Mean age at primary diagnosis was 51.2 AE 16.6 years; altogether 36 women (32%, 36/113) were under the age of 40. About half of the patients were premenopausal (56/113). Histology revealed a serous tumor in 73 women (64.6%), mucinous in 39 (34.5%) and endometrioid in one case (0.9%). 63 patients (55.8%) were diagnosed at FIGO stage Ia, 13 (11.5%) at stage Ib, 18 (15.9%) at stage Ic, 7 (6.3%) at stage II and 12 (10.6%) at stage III (Table 1). Cytology was positive for tumor cells in five cases (4.4%, 5/113). Implants were found in 19 patients: 11 were invasive (57.9%) and 8 non-invasive implants (42.1%). Localization of implants was the omentum (42.1%), the peritoneum (31.6%), diaphragm (10.5%) and bladder (10.5%). The mesosalpinx, uterus, umbilicus and kidney were affected in less than 10%.An adjuvant platinum-based chemotherapy was recommended to 11 patients diagnosed wi...

Background: It is still under discussion whether antibiotics are effective in the treatment of acute sinusitis. Moreover, they are known to have considerable side-effects. In contrast, complementary approaches are reported to have little side-effects and an equivalent efficiency. Objectives: To assess the success of conventional and complementary treatments of acute sinusitis and to estimate the patient numbers needed to confirm therapeutic equivalence. Treatment success was measured by three different scores, assessed by both patients and physicians. Methods: Multicentre (2 complementary and 3 conventional ENT centres), non-randomised, controlled clinical trial with 63 patients (complementary group 30, conventional group 33 patients). To control for confounders treatment differences were estimated by propensity score techniques. Treatments: The choice of medication was entirely left to the physician. We recommended to use antibiotics, secretolytics and symptomimetics in the conventional group and a combination of the herbal remedy Sinupret^® and the homeopathic remedy Cinnabaris 3X in the complementary group. Results: Treatment differences varied substantially depending on the outcome measure, but they were always not clinically relevant. Conventional treatment was slightly better when the outcome was assessed by the physicians (1.8 score points) but slightly worse when it was assessed by patients (0.2 score points) or in terms of the HCG-5 quality of life score (0.8 score points). p values were always > 0.3. Conclusions: Both treatments appear to be equally effective (or ineffective). Results might be biased because both treatment groups differed substantially. Randomised trials including at least 400 patients are needed to produce valid results.

Background : Randomised clinical trials may in principle show a small external validity. Non-randomised clinical trials therefore are sometimes regarded as an appropriate alternative when complementary and conventional treatments are compared. Objectives : To assess the value of advanced statistical methods in the process of estimating differences between a complementary and a conventional treatment of acute sinusitis in a non-randomised clinical trial. Methods : Multicentre, non-randomised, controlled clinical trial comparing 2 complementary and 3 conventional ENT centres. Patients were free to choose the physician (and hence the therapy). Treatment differences were estimated by controlling for confounders in analyses of covariance or by propensity score techniques. Results : Most potential confounders (sex, age, life-style parameters) did not have significant effects on the choice of therapy. Disease severity and previous ENT surgery were the main confounding factors. At study onset they almost cause a defined separation of both treatment groups. As a result estimated treatment differences vary substantially depending on the chosen statistical model. Conclusions : When comparing complementary and conventional treatments, non-randomised clinical trials may be misleading. Results may be strongly biased even when advanced statistical methods are used. Trials of complex statistical designs are needed to give valid results.