Search

The process recommendations of the Ethics Section of the German Interdisciplinary Association for Intensive Care and Emergency Medicine (DIVI) for ethically based decision-making in intensive care medicine are intended to create the framework for a structured procedure for seriously ill patients in intensive care. The processes require appropriate structures, e.g., for effective communication within the treatment team, with patients and relatives, legal representatives, as well as the availability of palliative medical expertise, ethical advisory committees and integrated psychosocial and spiritual care services. If the necessary competences and structures are not available in a facility, they can be consulted externally or by telemedicine if necessary. The present recommendations are based on an expert consensus and are not the result of a systematic review or a meta-analysis., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (Thieme. All rights reserved.)

Background: Long-term survival of high-risk neuroblastoma patients is still below 50% despite intensive multimodal treatment. This trial aimed to address whether the addition of two topotecan-containing chemotherapy courses compared to standard induction therapy improves event-free survival (EFS) of these patients., Patients and Methods: An open-label, multicenter, prospective randomized controlled trial was carried out at 58 hospitals in Germany and Switzerland. Patients aged 1-21 years with stage 4 neuroblastoma and patients aged 6 months to 21 years with MYCN-amplified tumors were eligible. The primary endpoint was EFS. Patients were randomly assigned to standard induction therapy with six chemotherapy courses or to experimental induction chemotherapy starting with two additional courses of topotecan, cyclophosphamide, and etoposide followed by standard induction chemotherapy (eight courses in total). After induction chemotherapy, all patients received high-dose chemotherapy with autologous hematopoietic stem cell rescue and isotretinoin for consolidation. Radiotherapy was applied to patients with active tumors at the end of induction chemotherapy., Results: Of 536 patients enrolled in the trial, 422 were randomly assigned to the control arm (n = 211) and the experimental arm (n = 211); the median follow-up time was 3.32 years (interquartile range 1.65-5.92). At data lock, the 3-year EFS of experimental and control patients was 34% and 32% [95% confidence Interval (CI) 28% to 40% and 26% to 38%; P = 0.258], respectively. Similarly, the 3-year overall survival of the patients did not differ [54% and 48% (95% CI 46% to 62% and 40% to 56%), respectively; P = 0.558]. The response to induction chemotherapy was not different between the arms. The median number of non-fatal toxicities per patient was higher in the experimental group while the median number of toxicities per chemotherapy course was not different., Conclusion: While the burden for the patients was increased by prolonging the induction chemotherapy and the toxicity, the addition of two topotecan-containing chemotherapy courses did not improve the EFS of high-risk neuroblastoma patients and thus cannot be recommended. CLINICAL TRIALS., Gov Number: NCT number 03042429., Competing Interests: Disclosure The authors have declared no conflicts of interests., (Copyright © 2019 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Background: Overdrainage in shunted patients is a known predisposing factor for the formation of hygromas, but little is known about risk factors in endoscopic third ventriculocisternostomy (ETV)., Materials and Methods: We retrospectively analysed data of 34 patients younger than 1 year with obstructive hydrocephalus, undergoing ETV, with respect to incidence, management, outcome and possible risk factors for the formation of hygromas. Hygromas were arbitrarily defined as a collection of cerebrospinal fluid of more than 10 mm in diameter over the paramedian hemispheric convexities, diagnosed by ultrasonography., Results: They occurred in 9 of 34 (26%) patients 3 to 28 days after ETV. They were on the operated side in four and bi-lateral in five cases. There was no relevant age difference between patients with hygromas (median 127 days) and those without hygromas (median 166 days). Etiology of obstructive hydrocephalus had no impact on the frequency of hygromas. Hygromas occurred somewhat less frequently when a paediatric endoscope with an outer diameter of 3 mm was used for ETV instead of an endoscope with a diameter of 6 mm. Hygromas were asymptomatic and conservatively managed in five cases; 4 of 34 (12%) patients underwent surgery because of clinical symptoms of increasing intracranial pressure or increasing hygroma diameter. Two patients were treated with a temporary external drainage only and another two patients with an external drainage first and eventually a subduro-peritoneal shunt. There were no neurological long-term sequelae., Conclusion: Clear predisposing factors for the formation of hygromas could not be identified, but the outer diameter of the endoscope may play a role.

The highest standard, humanity in the care of patients, efficiency and budgetary responsibility are what is expected of the public health service. Outside pressure makes internal coordination more efficient and effective. Restructuring of personnel and non-personnel budgets within the limits of precision budgeting must be possible. In the interest of the overall goal, professional and individual interests must be put aside and subordinated. Coordinated routines within the occupational group and extended operational times of X-ray apparatus, the laboratory and so on must be possible. We should never forget that the patient must be the centre of attention in research, training and medical care.