Eine Skala zur Messung von Beschwerden bei degenerativen Veränderungen der Halswirbelsäule (HWS) Hilfe zur Indikationsstellung und zur Evaluation des Operationserfolgs

A scale for measuring symptoms related to degenerative diseases of the cervical spine is presented. Twenty typical symptoms are listed, e. g., neck pain, dysesthesia, and reduced mobility. Responses are assessed via a 6-point scaling ("did not have symptom" - "had symptom and suffered very strongly".) The cervical spine scale was tested in three samples: patients having undergone cervical spine surgery (n = 70), patients with other orthopedic diagnoses (n = 104), and healthy students (n = 100). The single items of the scale were aggregated into four scores: total number of symptoms, degree of overall symptom distress, functional disability, and pain/psychological distress. Statistical analyses proved the high reliability (Cronbach's alpha = 0.85 to 0.95) and validity (content, convergent, discriminant) of all scores. The scale differs clearly between cervical spine patients, other orthopedic patients and healthy individuals, and between cervical spine patients with different subjective operative outcomes. For applied clinical purposes the cervical spine scale can be included in a quality of life profile (QL-profile); this allows for a readily understandable graphic depiction of individual patients' QL-status.     

The application of quality by design in the development of the liquid chromatography method to determine empagliflozin in the presence of its organic impurities

Analysis of impurities is an important step in the quality control of pharmaceutical ingredients and final products. From drug synthesis or excipients, even in small concentrations, impurities may affect efficacy and safety. The method was developed following Quality by Design (QbD) for the analysis of the antidiabetic empagliflozin. The concept of QbD is used as a tool for the development of methods and formulations. Through predefined objectives and risk analysis, robust methodologies and reduced solvent consumption are developed. A simple HPLC method was developed and validated for the quantitative determination of empagliflozin and its organic impurities from the synthesis process. The method was carried out in a Shim-pack phenyl column with a mobile phase consisting of an acetonitrile/water mixture (72 : 28), with isocratic elution and the detector wavelength was 230 nm. The validation process, in accordance with international guidelines, shows that the method was linear, precise and accurate for empagliflozin, impurity 1 and impurity 2. Limits of detection (0.01, 0.02 and 0.01 μg mL⁻¹) and quantification (0.10, 0.10 and 0.05 μg mL⁻¹) were determined for EMPA, IMP1 and IMP2, respectively. The HPLC method for impurity determination in empagliflozin was linear, precise, accurate and robust. It can be successfully applied in the quality control of empagliflozin and the synthesis of impurities, being adequate for routine analysis.

Analysis of impurities is an important step in the quality control of pharmaceutical ingredients and final products.     

Driver contrast sensitivity and reaction times as measured through a salt-covered windshield.

BACKGROUND: The objective of this study was to use contrast sensitivity measurements to determine the effect of windshield salt film on driver vision. This effect simulates road salt spray that dries in place on a vehicle windshield during winter driving conditions. METHODS: Ten emmetropic subjects were tested to assess contrast sensitivity functions through windshields that were clear compared with the same stimuli as viewed through windshields coated with salt film. Achromatic stimuli were generated by a VisionWorks system and were presented at 4 spatial frequencies (0.5, 3, 10, and 20 cycles per degree). RESULTS: A significant reduction in contrast sensitivity through the salt film was found at all spatial frequencies. In addition, reaction time to detect the stimuli was also found to be increased significantly at 2 of the 4 spatial frequencies through the saline-covered windshield. CONCLUSION: The results of this study indicate that windshield salt film reduces the ability to detect high and low contrast objects in a simulated driving environment as well as increases the subjects' reaction times.     

Medicated versus saline nose drops in the management of upper respiratory infection

Seventy-four children from three weeks to two years of age with various upper respiratory symptoms were randomly assigned to three groups: two intervention groups (saline nose drops; medicated nose drops) and a control group (no nose drops). Forty-six children returned for check-up two days later. Subjects in all three groups improved between first and second contact. There was no significant difference between the three groups. It is concluded that medicated nose drops are not essential in the treatment of upper respiratory infection and rhinitis.     

Brain growth in man

25 male brains meeting the criteria for normativity and available in serial sections suitable for morphometric studies were selected from the Yakovlev Collection. Growth parameters were calculated based on the generalized logistic function. The ideal weight is 1,313 g (SD = 41), with a half value time of 387 (SD = 26) ontogenetic days and a growth factor of 4.0 (SD = 0.5). Comparison of growth parameters derived from a sample of 161 normative male brains collected at the Department of Neuroanatomy of the Medical School in Hannover revealed an ideal weight of 1,353 g (SD = 14), a half value time of 401 (SD = 10) ontogenetic days and a growth factor of 4.0 (SD = 0.2). The minor discrepancies in the corresponding parameters reflect the small sample size and a considerable lack of developmental data of the three first postnatal decades in the material derived from the Yakovlev Collection. It was, therefore, deemed necessary to analyze these data in combination with data derived from other sources of human material. A comparison of human with animal growth parameters derived from mice, cats and tree shrews reveals differences in brain development. Histological shrinkage of the 25 male brains of the Yakovlev Collection related to fixation, embedding, and staining was assessed. Fetal brains shrank by about 75%, and adult brains by about 50%. The degree of shrinkage was inversely proportional to the age of the brain and was also characterized by individual variations of up to 20%. Therefore, shrinkage had to be corrected on an individual basis in order to determine the true growth of brain regions as reflected by morphometric analysis of histological serial sections.     

Economies of scope and payment for physician services.

Physician payment reform will base payment largely upon physician work. Current reforms assume that services are provided independently, yet physicians may often perform two or more services at one time. There is evidence from other industries that services provided jointly may not require the same total resources as identical services provided independently. This study evaluated whether physician-reported work and time were the same for some common services when provided jointly and when provided separately. Six case vignettes were constructed consisting of two services each. Forty-four general internists rated the total work and time required for each vignette performed as a whole, and for the two services performed separately. Total work was estimated using a magnitude estimation technique similar to that used in developing the resource-based relative value scale. For five of the six vignettes, the work rating for performing the services together was significantly less than the sum of the ratings for the separate services. The work savings associated with providing services together ranged from 4% to 30% of the total work of the separate services. A similar reduction was observed for the estimated time to perform services jointly in four of the six vignettes. In no case was work or time lower when services were provided separately. Physicians report lower work and time for at least some pairs of services, compared with providing the same services separately. Reimbursement mechanisms that fail to account for these reductions may provide incentives to combine or add services.