Different interpretation of additional evidence for HTA by the commissioned HTA body and the commissioning decision maker in Germany: whenever IQWiG and Federal Joint Committee disagree.

Background: The purpose of this study was to analyse the impact of commissioned addenda by the Federal Joint Committee (FJC) to the HTA body (IQWiG) and their agreement with FJC decisions and to identify potential additional decisive factors of FJC.

Methods: All available relevant documents up to end of 2017 were screened and essential content extracted. Next to descriptive statistics, differences between IQWiG and FJC were tested and explored by agreement statistics (Cohen's kappa and Fleiss' kappa) and ordinal logistic regression.

Predictive value of venous thromboembolism (VTE)-BLEED to predict major bleeding and other adverse events in a practice-based cohort of patients with VTE: results of the XALIA study.

Venous thromboembolism (VTE)-BLEED, a decision tool for predicting major bleeding during chronic anticoagulation for VTE has not yet been validated in practice-based conditions. We calculated the prognostic indices of VTE-BLEED for major bleeding after day 30 and day 90, as well as for recurrent VTE and all-cause mortality, in 4457 patients enrolled in the international, prospective XALIA study. The median at-risk time was 190 days (interquartile range 106-360).

Methodological problems in the method used by IQWiG within early benefit assessment of new pharmaceuticals in Germany.

Background: The decision matrix applied by the Institute for Quality and Efficiency in Health Care (IQWiG) for the quantification of added benefit within the early benefit assessment of new pharmaceuticals in Germany with its nine fields is quite complex and could be simplified. Furthermore, the method used by IQWiG is subject to manifold criticism: (1) it is implicitly weighting endpoints differently in its assessments favoring overall survival and, thereby, drug interventions in fatal diseases, (2) it is assuming that two pivotal trials are available when assessing the dossiers submitted by the pharmaceutical manufacturers, leading to far-reaching implications with respect to the quantification of added benefit, and, (3) it is basing the evaluation primarily on dichotomous endpoints and consequently leading to an information loss of usable evidence.

Objective: To investigate if criticism is justified and to propose methodological adaptations.

Functional neuroimaging of emotional learning and autonomic reactions.

This article provides a selective overview of the functional neuroimaging literature with an emphasis on emotional activation processes. Emotions are fast and flexible response systems that provide basic tendencies for adaptive action. From the range of involved component functions, we first discuss selected automatic mechanisms that control basic adaptational changes.

Recruitment of the sensorimotor cortex--a developmental FMRI study.

Introduction: The growing mastery of motor tasks is one of the most visible changes in the developing child. The cortex is known to play a central role in learning, planning, and performance of motor tasks. We investigated the age dependency of motor cortex activation using functional magnetic resonance imaging (fMRI).

Activation of a residual cortical network during painful stimulation in long-term postanoxic vegetative state: a 15O-H2O PET study.

Survivors of prolonged cerebral anoxia often remain in the persistent vegetative state (PVS). In this study, long-term PVS patients were investigated by 15O-H(2)O PET to analyze their central processing of pain. The study was approved by the local Ethics Committee, the experiments were performed in accordance with the Helsinki Declaration of 2000.

Determination of hemisphere dominance for language: comparison of frontal and temporal fMRI activation with intracarotid amytal testing.

The reliability of frontal and temporal fMRI activations for the determination of hemisphere language dominance was evaluated in comparison with intracarotid amytal testing (IAT). Twenty-two patients were studied by IAT (bilateral in 13, unilateral in 9 patients) and fMRI using a paradigm requiring semantic decisions. Global and regional (frontal and temporoparietal) lateralisation indices (LI) were calculated from the number of activated (r>0.

The morphological effects of a radio frequency lesion adjacent to the dorsal root ganglion (RF-DRG)--an experimental study in the goat.

Radiofrequency (RF) lesions adjacent to the dorsal root ganglion (DRG) are increasingly used in the treatment of intractable chronic pain of spinal origin. Opinions differ on which nerve fibres are affected by these lesions. Morphological studies have been carried out to assess the effects of radiofrequency lesions on nervous tissue.

Subcutaneous ventricular catheter reservoir and ventriculoperitoneal drain-related infections in preterm infants and young children.

Objective: In the period January 1990 to September 1997, 70 patients, aged under 6 years were treated for hydrocephalus with a subcutaneous ventricular catheter reservoir and/or a ventriculoperitoneal drain at the University Hospital of Maastricht.

Methods: By means of a retrospective chart analysis, the number of shunt infections and related risk factors were analyzed.

Results: Twenty-one patients (30%) developed one or more infections, with an infection rate of 15.

Surgical treatment of aspergillus spondylodiscitis.

Four cases of aspergillus spondylodiscitis were treated with operative debridement and fusion. In this rarely encountered mycotic infection of the spine in immunocompromised patients rapid destruction of the intervertebral disc and vertebral bodies can occur. In advanced cases antimycotic drug therapy is thought to be ineffective and a forcing indication for surgery exists when the destruction is progressive and spinal cord compression is imminent or manifest.

Intramedullary spinal teratoma presenting with urinary retention: case report and review of the literature.

Objective And Importance: Intramedullary tumors affect a small but significant segment of patients with spinal cord tumors. Intramedullary teratomas are rare entities that are usually located in the sacrococcygeal region. Although some reports claim that diagnostic studies can exactly predict the nature of intramedullary tumors, this case report demonstrates the lack of preoperative diagnostic specificity.

Spinal cord compression caused by unusual location and extension of ossified ligamenta flava in a Caucasian male. A case report and literature review.

Study Design: A case report of a spinal cord compression caused by ossification of the ligamenta flava is presented together with a review of the literature.

Objective: To present the diagnosis of ossification of the ligamenta flava in a Caucasian man with a proximal thoracic myelopathy.

Summary Of Background Data: This case shows that the upper parts of the thoracic spine can be involved in ossification of the ligamenta flava, which never before has been reported in Caucasian individuals.

Neurogenic claudication, a delayed complication of a retained bullet.

Study Design: A case report is presented of a 31-year-old man who visited the authors' neurosurgical department in 1993, complaining of neurogenic claudication. History revealed a gunshot incident 11 years ago, with a bullet left in situ.

Objectives: To determine whether to operate on patients who have a bullet in situ near the spinal cord without initial neurologic deficits.

Assessment of cognitive performance after progesterone administration in healthy male volunteers.

Administration of progesterone produces sleep EEG patterns that resemble those of agonistic modulators at the GABAA receptor. Previous studies evaluating the effects of an oral progesterone administration on attention performance in females pointed to putative sedative effects of progesterone at high dosages. However, no data are available whether progesterone dosages that influence sleep produce sedative hangover effects on the following morning.

Use of neonatal intensive care unit as a safe place for neonatal surgery.

Aim: To evaluate the advantages, disadvantages, and short term morbidity and mortality of major surgical interventions performed in the neonatal intensive care unit.

Methods: A retrospective case review of 45 neonates was performed from April 1991 to September 1995. The characteristics of the patients were: gestational age 29 (SD 4) weeks (range 24 to 41 weeks); birth-weight 1305 (870) g (range 540 to 4040 g); presurgical weight 1430 (895) g (range 550 to 4370 g); postconceptional age at surgery 31 (4) weeks (26 to 47 weeks).

Effectiveness of antiepileptic prophylaxis used with supratentorial craniotomies: a meta-analysis.

Thirty publications on the effectiveness of prophylactic antiepileptic drugs (AEDs) with supratentorial craniotomies were reviewed (1980-1995). After a first selection, six controlled studies remained (11 publications). These six were evaluated according to previously defined methodological criteria.

Deformation of the cervicomedullary junction and spinal cord in a surgically treated adult Chiari I hindbrain hernia associated with syringomyelia: a magnetic resonance microscopic and neuropathological study. Case report.

The lower brainstem and cervical spinal cord from an ordinarily treated case of Chiari Type I hindbrain hernia associated with syringomyelia was examined using high-resolution magnetic resonance microscopy and standard neuropathological techniques. Magnetic resonance microscopy allows total screening and visualizes the disturbed internal and external microanatomy in the three orthogonal planes with the resolution of low-power optical microscopy. An additional advantage is the in situ visualization of the shunts.

Pleomorphic xanthoastrocytoma in the spinal cord. Case report.

The authors present the clinical, radiological, and pathological features of a patient with a recurrent pleomorphic xanthoastrocytoma located in the spinal cord. This is the first report of a pleomorphic xanthoastrocytoma at this location; until now, only cerebral supratentorial pleomorphic xanthoastrocytomas have been described. The treatment of this case is discussed.

Co-expression of glial fibrillary acidic protein- and vimentin-type intermediate filaments in human astrocytomas.

The expression of intermediate filament (IF) proteins was studied in 71 cases of malignant human astrocytoma and in 17 cases of reactive gliosis, using immunocytochemical techniques with polyclonal and monoclonal antibodies to glial fibrillary acidic protein (GFAP) and vimentin. In all cases of astrocytoma, varying in degree of malignancy from grade I to grade IV, co-expression of GFAP and vimentin was found. No change in vimentin- or GFAP-IF expression with increasing anaplasia was seen.

Primitive neuroectodermal tumors including the medulloblastoma: glial differentiation signaled by immunoreactivity for GFAP is restricted to the pure desmoplastic medulloblastoma ("arachnoidal sarcoma of the cerebellum").

Immunoreactivity of tumor cells for glial fibrillary acidic protein (GFAP) is usually regarded as sign of astrocytic histogenesis and/or differentiation. The present study aimed at a systematic evaluation of the significance of GFAP-containing cells in primitive neuroectodermal tumors (PNETs) with special reference to the controversial entity of desmoplastic medulloblastoma (so-called "circumscribed arachnoidal sarcoma of the cerebellum"). Fifty-three PNETs, including 17 pure desmoplastic medulloblastomas were investigated, using GFAP antisera and the peroxidase-antiperoxidase (PAP) technique.

Production of glial fibrillary acidic protein (GFAP) by neoplastic cells: adaptation to the microenvironment.

In 80 specimens of human glioma the production of glial fibrillary acidic protein (GFAP) by tumour cells invading meninges or connective tissue was studied immuno-cytochemically by the PAP technique. In 38 of 55 cases of astrocytoma, glioblastoma, gliosarcoma, and oligoastrocytoma, GFAP immunoreactivity was greater in the invading cells as compared with the main part of the neoplasm. Fifty-eight percent of the astroglial tumours invading the leptomeninges, all astroglial tumours invading connective tissue and all gliosarcomas showed enhanced GFAP immuno-reactivity of tumour cells getting in contact with collagenous tissue, whereas meningeal infiltrates of 25 non-astroglial tumours (oligodendroglioma, ependymoma, medulloblastoma) remained GFAP-negative like the main part of the respective tumours.

Glial fibrillary acidic protein (GFAP) in oligodendroglial tumors: gliofibrillary oligodendroglioma and transitional oligoastrocytoma as subtypes of oligodendroglioma.

Immuno-reactivity to glial fibrillary acidic protein (GFAP) is mainly regarded as a sign of astroglial histogenesis and/or differentiation. The presence of astrocytes in oligodendrogliomas is a well known phenomenon; in addition, GFAP-positive neoplastic oligodendrocytes have also been described but have not yet been studied systematically. Using an anti-GFAP serum in the peroxidase-antiperoxidase antiperoxidase (PAP) technique, 50 oligodendrogliomas and 16 mixed oligodendrocytomas were investigated; they had been diagnosed by routine histological stains.

The symptomatology of megadolicho basilar artery.

Cranial nerve dysfunction, obstruction hydrocephalus, signs of brain stem dysfunction, and signs of a space-occupying lesion in the posterior fossa are presumed to be related to a megadolicho basilar artery, if present. Since there are no large series of patients with such vascular anomaly, a bias in relating symptoms with the presence of a megadolicho basilar artery is not excluded. We therefore studied retrospectively the incidence of megadolicho and dolicho basilar artery on cranial CT-scan of 3332 patients of 50 years and older.