[Patient consent for the TraumaRegistry DGU based on the GDPR-A challenge for the hospitals: status quo and solution strategies]. / Patienteneinwilligungen für das TraumaRegister DGU® aufgrund der EU-Datenschutz-Grundverordnung (EU-DSGVO) ­ Eine Herausforderung für die Kliniken: Status quo und Lösungsstrategien.

According to the General Data Protection Regulation (GDPR 05/2018), anonymized data sets with a sufficiently high data density are classified as traceable and require a declaration of consent if they are evaluated centrally for research or quality control purposes. Quality assurance and further increases in the quality of care are, however, only possible with a nearly complete survey of seriously injured persons in the sense of health services research. The more than 600 German clinics that take part in the TraumaRegistry DGU® try to obtain the declarations of consent from this special patient population. The study clinic evaluated the rate of consent and the reasons for rejection or failure to obtain consent over a 12-month period. While using a resource-intensive workflow especially for patient education and obtaining the consent, a patient consent rate of 64.5% and an error rate of 35.5% were recorded. Of the 276 potential TraumaRegistry DGU® data records 98 could not be entered and were therefore neither available for quality control nor for multiple trauma research. In order to guarantee the quality control and the further improvement of the quality of care, an approximate total recording of the patient population is necessary; however, this cannot be achieved by requiring a declaration of consent. We therefore advocate creating the possibility of collecting the TraumaRegistry data set without consent, as this ultimately represents a standard data set, comparable to the Hospital Remuneration Act (§21-KHEntgG) data set but pseudonymised.

DNA cytophotometry and prognosis in ovarian tumors of borderline malignancy. A clinicomorphologic study of 80 cases.

Surgical specimens of 80 ovarian tumors of borderline malignancy (OTBM) were investigated by scanning DNA cytophotometry. Diploid or euploid DNA histograms were found for 21 tumors, whereas 59 OTBM showed noneuploid or aneuploid DNA patterns. All patients were followed-up after surgery for at least 3 years (mean observation period, 6.7 years). Follow-up showed 11 cases of recurrent disease and 6 deaths. DNA findings and several other morphologic and clinical details (including patient age, histologic type and stage of disease, and extent of therapy) were correlated to the postoperative course. Statistical analyses disclosed that, of these parameters, only DNA content significantly affected prognosis. Recurrences and deaths resulting from tumor exclusively were observed among patients with noneuploid or aneuploid OTBM, whereas none of the diploid or euploid tumors recurred (P less than 0.05). DNA cytophotometry thus might be regarded as an effective complementary means to assess the prognosis of individual OTBM cases.

[Signet ring carcinoma in the urinary tract. Primary tumor or metastases of an occult neoplasm?]. / Das Siegelringzellkarzinom im Harntrakt. Primärtumor oder Metastase eines okkulten Neoplasmas?

Between 26/2/88 and 23/6/88 we treated four patients with signet ring cell carcinoma of the urinary tract. There was no conformity in clinical development, results of laboratory investigations, histomorphology or symptoms. For the first time, DNA cytophotometry was used to examine histological preparations of urinary signet ring cell carcinoma. This method provides information about the prognosis of the malignant disease, as it reveals the DNA distribution in the tumor cells. In three cases there was a clearly pathologic so-called an-euploid DNA distribution, indicating the high malignant potency of this tumor entity.