Quality of life, walking ability and change of living situation after trochanteric femur fracture in geriatric patients-Comparison between sliding hip screw and cephalomedullary nails from the registry for geriatric trauma.

BACKGROUND: There is no well-established gold standard for treating trochanteric femur fractures in the elderly. The two common treatment options are cephalomedullary nails (CMN) and sliding hip screws (SHS). In this study, treatment using CMN and SHS were compared for a cohort of patients older than 70 years of age: The main outcomes were quality of life and main residence after surgery. METHODS: In this retrospective study we analyzed 24,919 patients from 100 hospitals, treated between 2016 and 2019 and documented in the Registry for Geriatric Trauma. The impact of CMN vs. SHS on the walking ability, quality of life (QoL), living situation, mortality, and revision rate were analyzed. To analyze the change of the living situation, the main residence 120 days after surgery for patients, who lived in their own home before fracture, was described for both groups. FINDINGS: A total of 10,995 patients could be included of which 10,436 patients were treated with CMN and 369 patients with SHS. 120 days postoperative the QoL differed significantly (p = 0.020) in favor of treatment using CMN. 26% of the SHS group who lived at home prior to surgery had to reside in a nursing home after surgery, whereas the rate was only 18% in the CMN group (p < 0.001). No significant difference in the mortality rate nor a difference in the walking ability 120 days postoperative were found. CMN were implanted more promptly (median: 13.9 vs. 18.4 hours; p < 0,001). No differences were found concerning the revision rate between the two groups, neither during inpatient treatment (p = 0.723) nor during the 120 day follow-up period (p = 0.524). INTERPRETATION: There might be a benefit for geriatric patients with trochanteric femur fractures to be treated with a proximal femur nail in regard to a higher QoL and a reduced institutionalization rate. Mortality or revision rate was not affected by the chosen implant.

Extended induction chemotherapy does not improve the outcome for high-risk neuroblastoma patients: results of the randomized open-label GPOH trial NB2004-HR.

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.

[Data content of the TraumaRegister DGU® : Results of a random sample control]. / Datengüte des TraumaRegister DGU® : Ergebnisse einer Stichprobenkontrolle.

BACKGROUND: Registries are becoming increasingly more important in clinical research. The TraumaRegister DGU® of the German Society for Trauma Surgery plays an excellent role with respect to the care of severely injured patients. AIM: Within the framework of this investigation the quality of data provided by this registry was to be verified. MATERIAL AND METHODS: Certified hospitals participating in the TraumaNetzwerk DGU® of the German Society for Trauma Surgery are obliged to submit data of treated severely injured patients to the TraumaRegister DGU®. Participating hospitals have to undergo a re-certification process every 3 years. Within the framework of this re-audit, data from 5 out of 8 randomly chosen patient cases included in the registry are controlled and compared to the patient files of the certified hospital. In the present investigation discrepancies concerning data provided were documented and the pattern of deviation was analyzed. RESULTS: The results of 1075 re-certification processes carried out in 631 hospitals including the documentation of 5409 checked patient cases from 2012-2017 were analyzed. The highest number of discrepancies detected concerned the documented time until initial CT (15.8%) and the lowest concerned the discharge site (3.2%). The majority of data sheets with discrepancies showed deviations in only one out of seven checked parameters. Interestingly, large trauma centers with a high throughput of severely injured patients showed the most deviations. CONCLUSION: The present investigation underlines the importance of standardized checks concerning data provided for registries in order to be able to guarantee an improvement in entering data.

Extrarenal Manifestations in Shigatoxin-associated Haemolytic Uremic Syndrome.

BACKGROUND: Shigatoxin-associated haemolytic uremic syndrome (STEC-HUS) is the most frequent cause of acute kidney injury in children worldwide. Extrarenal manifestations are the main determinants for both, short- and long-term prognosis of patients with STEC-HUS. PATIENTS: 46 patients treated over the last 10 years for STEC-HUS in a single center. METHODS: This retrospective study analysed the incidence and outcome of extrarenal manifestations in our cohort of children with STEC-HUS. Risk factors for extrarenal involvement and adverse outcome were assessed by detailed chart review. RESULTS: Eleven extrarenal manifestations occurred in 9/46 patients comprising 8 neurological, 2 gastro-intestinal, and 1 cardiovascular complication. One patient died from cerebral bleeding. Liver transplantation was required in a girl 18 months after HUS due to secondary sclerosing cholangitis. PATIENTS with extrarenal manifestations were significantly younger and presented with higher leucocyte counts and higher alanine aminotransferase levels at admission. Renal replacement therapy was necessary for a longer period than in patients without extrarenal complications. CONCLUSION: Extrarenal manifestations occurred in about 20% of our patients with STEC-HUS. The identification of risk-factors will help to provide a better management of these patients which might also include novel treatment strategies like complement inhibition.

Economic evaluation of maintenance treatment with tacrolimus 0.1% ointment in adults with moderate to severe atopic dermatitis.

BACKGROUND: Rational health care decision-making based on outcomes and economic evidence is essential to provide the best possible care for individual patients with atopic dermatitis (AD). OBJECTIVES: To describe treatment outcomes and to evaluate resource utilization and associated cost of maintenance use of tacrolimus ointment (MU) vs. standard use of tacrolimus ointment (SU) in adults with AD. METHODS: A pan-European, phase III multicentre randomized clinical trial was conducted. Patients with mild to severe AD were randomized to tacrolimus 0.1% ointment (MU) or vehicle (SU) twice per week for 12 months. Disease exacerbations were treated by using open-label tacrolimus 0.1% ointment twice daily. Resource utilization data were collected prospectively alongside the clinical trial. Costs of pooled resource data were determined using German unit cost data. Direct and indirect costs were considered from third party payer, patient and societal perspectives. RESULTS: All patients with moderate and severe AD were included in a subanalysis, 75 patients in the MU arm (57% moderately affected) and 59 patients in the SU arm (59% moderately affected). In patients with moderate AD, the number of disease exacerbations in the MU arm was 2.4 vs. 5.5 in the SU arm (P<0.001); in patients with severe AD corresponding figures were 2.3 vs. 7.4 (P<0.001), respectively. Mean+/-SD total annual cost per patient was euro1525+/-1081 (MU) vs. euro1729+/-1209 (SU) in patients with moderate AD and euro2045+/-2013 (MU) vs. euro2904+/-1510 (SU) in patients with severe AD. CONCLUSIONS: Maintenance treatment with 0.1% tacrolimus ointment is more effective and leads to cost savings and improved health-related quality of life in comparison with standard use of 0.1% tacrolimus ointment, especially in patients with severe AD.

Assessing health-related quality of life in patients with Parkinson's disease in a prospective longitudinal study.

OBJECTIVE: To prospectively assess the health-related quality of life (HrQoL) in Parkinson's disease (PD) during 12 months. METHODS: HrQoL was assessed in 145 PD patients using the PD-specific PDQ-39, PDQL and the generic EQ-5D. In addition, clinical rating-scales were used. RESULTS: All scales showed a pronounced effect of PD. In comparison to an age-matched population the EQ-5D was considerably affected. In comparison to baseline, however, there was no significant change in the generic scale but a significant change in the sum-score of disease-specific HrQoL-scales. CONCLUSIONS: Only disease-specific scales were sensitive to change. Further studies are necessary to evaluate the time-dependent change in HrQoL.

Brush-like branched biodegradable polyesters, part III. Protein release from microspheres of poly(vinyl alcohol)-graft-poly(D,L-lactic-co-glycolic acid).

Brush-like branched polyesters, obtained by grafting poly(lactic-co-glycolic acid), PLGA, onto water-soluble poly(vinyl alcohol) (PVAL) backbones, were investigated regarding their utility for the microencapsulation of proteins. Poly(vinyl alcohol)-graft-poly(lactic-co-glycolic acid), PVAL-g-PLGA, offers additional degrees of freedom to manipulate properties such as e.g. molecular weight, glass transition temperature and hydrophilicity. PLGA chain length was varied at a constant molecular weight (M(w)) of the PVAL backbone and secondly M(w) of the PVAL backbone was varied keeping the PLGA chain lengths constant. The most striking feature of these polymers is their high M(w). Microencapsulation of hydrophilic macromolecules, such as bovine serum albumin, ovalbumin, cytochrome c and FITC-dextran using a w/o/w double emulsion technique was investigated. Surface morphology, particle size, encapsulation efficiencies and protein release profiles were characterized as well. Microencapsulation of model compounds was feasible at temperatures of 0-4 degrees C with yields typically in the range of 60-85% and encapsulation efficiencies of 70-90%. Both, encapsulation efficiency and initial protein release (drug burst) were strongly affected by the glass transition temperature, T(g), of the polymer in contact with water, whereas the in vitro protein release profile depended on the PVAL-g-PLGA structure and composition. In contrast to PLGA, protein release patterns were mostly continuous with lower initial drug bursts. Shorter PLGA chains increased drug release in the erosion phase, whereas initial pore diffusion was affected by the M(w) of PVAL backbone. Release profiles from 2 to 12 weeks could be attained by modification of composition and molecular weight of PVAL-g-PLGA and merit further investigations under in vivo conditions. The in vitro cytotoxicity of PVAL-g-PLGA is comparable to PLGA and therefore, this new class of biodegradable polyesters has considerable potential for parenteral drug delivery systems.

[Procalcitonin in comparison to C-reactive protein as markers of the course of sepsis in severely immunocompromised children after bone marrow transplantation]. / Procalcitonin im Vergleich zum C-reaktiven Protein als Marker für septische Krankheitsverläufe bei schwer immunsupprimierten Kindern nach Knochenmarktransplantation.

BACKGROUND: PCT has recently drawn attention as a quite specific marker for bacterial, fungal, and parasitic origin of severe sepsis-syndrome. These specific properties could make PCT to an important tool for sepsis monitoring in severely immunocompromised children. The clinical value of PCT in comparison to CrP was investigated in children after bone marrow transplantation (BMT). METHODS: PCT was measured in the serum of 48 children (median age 12.4 years) after BMT in a prospective study. Results were correlated with the clinical findings and compared to the C-reactive protein (CrP). RESULTS: PCT showed a sensitivity for diagnosing a sepsis-syndrome of 56%, a specificity of 87%, a positive predictive value of 69%, and a negative predictive value of 80%. Regarding CrP they were 100%, 41%, 46% and 100% respectively. The relative risk to die due to sepsis-syndrome was 26.4 for PCT levels over 10 ng/ml and 4.0 for CrP levels over 200 mg/l. It could be shown furthermore that there can be a significant liberation of PCT even during hematological aplasia. CONCLUSION: (1) Measuring PCT levels in the sera of children undergoing BMT improves the possibility of diagnosing severe infection and gives an important prognostic tool. (2) Measuring PCT can be recommended if severe sepsis-syndrome is suspected and there is an additional need for differential diagnosis and prognostic evaluation.

The economic impact of Parkinson's disease. An estimation based on a 3-month prospective analysis.

OBJECTIVE: This study prospectively assesses the medical costs of Parkinson's disease (PD). DESIGN: Over a period of 3 months (from July to September 1995), patients with PD documented all items of healthcare provision. These data were then used to calculate medical costs for an individual patient as well as the costs of PD. PATIENTS AND SETTING: We included 20 outpatients with idiopathic PD from the neurological outpatient clinic, Klinikum Grosshadern, Munich, and 20 patients from two office-based neurologists in South-West Germany. MAIN RESULTS: The mean 3-month medical cost of PD in 1995 deutschmarks (DM) was 5210 ($US3390, 2240 Pounds) consisting of DM1410 ($US920, 610 Pounds) for care and nursing, DM1580 ($US1030, 680 Pounds) for drug therapy, DM1320 ($US860, 570 Pounds) for inpatient hospital care, DM40 ($US26, 17 Pounds) for outpatient care and DM860 for other expenses ($US560, 370 Pounds). The expenditure was related to the disease evolution. Patients complaining of one-sided symptoms [Hoehn and Yahr stage I; (HY I)] were less expensive to treat (DM1930, $US1250, 830 Pounds) than patients who were severely incapacitated (HY V) [DM9740, $US6330, 4200 Pounds; HY V]. After 3 to 5 years of levodopa treatment approximately 50% of patients start to experience fluctuations in motor ability and dyskinesias [Unified Parkinson's disease rating scale, part IV (UPDRS IV)]. This onset of motor complications parallels an increase in costs. For patients who experienced motor fluctuations, annual costs were DM6550 ($US4260, 2820 Pounds) compared with DM3030 ($US1960, 1300 Pounds) for patients lacking this problem. Indirect non-medical costs were not calculated due to the limited number of patients. The impact of the disease on work, however, is clearly apparent from the patients' history: 19 out of 34 patients who had already stopped working attributed this to the disease, and only 6 patients were still working at the time of the survey. CONCLUSION: PD poses a major financial impact to society which is expected to increase in future years as the age distribution shifts to older age groups. On the basis of a prevalence of PD of 183 per 100,000, we calculated an annual expenditure of DM3.0 billion for the direct medical costs of PD in Germany.

Costs of treating dystonias and hemifacial spasm with botulinum toxin A.

Botulinum toxin (BTX) has become a safe and effective therapeutic tool in the treatment of a variety of neurological disorders, especially dystonias. One major disadvantage, however, is the high cost of a single injection of BTX. In this study of 835 patients, we calculated the cost of treatment with BTX serotype A (BTX-A) for different dystonias and hemifacial spasm. The annual expenditure per patient for BTX-A injections in this cohort totalled (mean +/- standard deviation) 1030 Deutschmarks (DM) [1996 values] +/- DM610 [$US570 +/- $US340; 230 +/- 130 pounds sterling (Pound)] for blepharospasm (n = 158), DM1450 +/- DM1520 ($US800 +/- $US830; 310 Pounds +/- 280 Pounds) for craniocervical dystonia (n = 148), and DM1480 +/- DM780 ($US810 +/- $US430; 330 Pounds +/- 180 Pounds) for oromandibular dystonia (n = 16), while the treatment of cervical dystonia consumed DM4590 +/- DM2060 ($US2520 +/- $US1130; 960 Pounds +/- 420 Pounds) [n = 362] per patient. In order to alleviate symptoms in patients with hemifacial spasm (n = 151), DM510 +/- DM270 ($US280 +/- $US150; 110 Pounds +/- 60 Pounds) had to be spent annually. The expenses for surgical therapy for cervical dystonia were DM10,120 +/- DM1900 (n = 54). No major differences concerning expenditure could be found in this study between the 2 available preparations of BTX. However, there appeared to be a lower rate of adverse effects with the Botox formulation, compared with the Dysport formulation, of BTX-A (this difference was statistically significant, i.e. p < 0.001). Although the cost of an individual injection is high, other cost factors also substantially contribute to the societal costs of adult-onset dystonias. Some of these costs may be attenuated with the use of BTX. The subjective and objective relief of these socially devastating and sometimes painful conditions rewards the expenditure associated with the use of BTX-A.

[Cost of illness in Parkinson disease. A retrospective 3-month analysis of direct costs]. / Krankheitskosten der Parkinson-Erkrankung. Eine retrospektive dreimonatige Analyse der direkten Kosten.

Parkinson's disease (PD) causes significant expense for the national health care system due to its chronic progressive course, the duration of the disease, the high prevalence and the devastating prognosis. In Germany more than DM 320 million are spent for drugs to alleviate parkinsonian symptoms. The aim of this study was to calculate the economic burden of PD by assessing direct medical costs. Forty patients suffering from idiopathic PD were interviewed at an office of neurological specialists and at an outpatient movement disorder clinic about their use of health care resources 3 months prior to the study. The total annual costs reported were DM 14,500, consisting of DM 6500 for drug therapy and DM 8000 for other medical services, including hospital inpatient care (DM 5600), outpatient care (DM 700), medical sundries (DM 1100) and physiotherapy (DM 600). The costs were positively correlated to the extent of the disease (Hoehn and Yahr stage; HY) and the occurrence of motor fluctuations/dyskinesias. We found that both drug-therapy expenses and total medical costs doubled from HYI to HYIV. The rarely employed s.c. therapy with apomorphine additionally increased the costs of drug therapy in HYV. The occurrence of fluctuations/ dyskinesias also increased medical expenses by approximately a factor of two. Indirect burden due to increased days off of work, unemployment and earlier retirement are also significant in Parkinson's disease. This study includes that a treatment which could prevent or retard disease progression as well as a treatment that delays or reduces motor complications would not only ameliorate the situation of patients suffering from PD, but would also lead to significant reductions in cost for the national health care system.

[Costs of drug treatment of neurologic diseases: Parkinson disease, dystonia, epilepsy]. / Kosten der medikamentösen Behandlung neurologischer Erkrankungen: Morbus Parkinson, Dystonie, Epilepsie.

AIM: The costs of drug treatment were evaluated for Parkinson's disease, focal dystonias and epilepsy. METHODS: Retrospective analysis over a period of 12 months of 785 patients who visited regularly a neurological out-patient department. RESULTS: Drug treatment caused a mean annual expenditure of DM 3,920.- (US-($) 2590, pounds 1690) for Parkinson's disease (n = 409), DM 3,620.- (US-($) 2390; pounds 1550) for focal dystonias (n = 140) and DM 660.- (US-($) 435, pounds 280) for hemifacial spasm (n = 35) per patient.- In Parkinson's disease costs are dependent on the extent of the disease, the type involved and the presence or absence of motor fluctuations. In Hoehn and Yahr stage I we calculated costs of DM 2,230.- (US-($) 1470; pounds 960), in contrast to DM 11,870.- (US-($) 7830; pounds 5100) in Hoehn and Yahr stage V. The occurrence of fluctuations in motor ability increased annual costs to DM 6,010.- (US-($) 3970, pounds 2580); patients' treatment without motor fluctuations was cheaper (DM 2,700.-; US-($) 1780, pounds 1160).- The annual treatment costs of focal dystonias and facial hemispasm varied due to the location of the involuntary movement and the extent of symptoms: DM 4,900.- (US-($) 3300; pounds 2100) were calculated for the treatment of cervical dystonias, DM 1,480.- (US-($) 930; pounds 600) for the treatment of blepharo-spasm (oromandibular dystonia: DM 1,710.-; US-($) 1200; pounds 800) and DM 600.- (US-($) 470; pounds 300) for the treatment of facial hemispasm.- The drug treatment of epilepsy caused mean costs of DM 1,740.- (US-($) 1160; pounds 750) per year. There were marked differences concerning the different epileptic syndromes and types of seizure. CONCLUSION: Costs of drug treatment varied considerably in the three diseases depending on the course, the type and the different forms of the respective disease.

Prophylaxis of migraine with oral magnesium: results from a prospective, multi-center, placebo-controlled and double-blind randomized study.

In order to evaluate the prophylactic effect of oral magnesium, 81 patients aged 18-65 years with migraine according to the International Headache Society (IHS) criteria (mean attack frequency 3.6 per month) were examined. After a prospective baseline period of 4 weeks they received oral 600 mg (24 mmol) magnesium (trimagnesium dicitrate) daily for 12 weeks or placebo. In weeks 9-12 the attack frequency was reduced by 41.6% in the magnesium group and by 15.8% in the placebo group compared to the baseline (p < 0.05). The number of days with migraine and the drug consumption for symptomatic treatment per patient also decreased significantly in the magnesium group. Duration and intensity of the attacks and the drug consumption per attack also tended to decrease compared to placebo but failed to be significant. Adverse events were diarrhea (18.6%) and gastric irritation (4.7%). High-dose oral magnesium appears to be effective in migraine prophylaxis.

[Blood collection from central venous catheter--valid also for blood coagulation analysis?]. / Blutentnahmen aus zentralvenösem Katheter--gültig auch für die Gerinnungsanalytik?

OBJECTIVE: Blood samples obtained from centralvenous catheters are commonly used on intensive care units. In this paper the question of valid conditions for sampling blood coagulation parameters of patients with heparinised catheters is examined and the data are compared with the literature. STUDY DESIGN: Blood samples were obtained at the same time as well via centralvenous catheters as from the periphery. The results of the examination were compared to each other. RESULTS: After the aspiration of 10 ml of blood via centralvenous catheters there were no differences between peripheral and central obtained samples as regards blood coagulation parameters.

[7-ethoxycoumarin o-deethylase and fibrosis in chronic liver diseases]. / Die 7-Ethoxycoumarin O-Deethylase und der fibrosierende Prozess bei chronischen Lebererkrankungen.

In the liver biopsy of 100 patients with chronic liver diseases, the activity of 7-ethoxycoumarin O-deethylase (ECOD) was determined as a parameter of hepatic monooxygenase system and was compared with some markers of fibrosis e.g. collagen peptidase and hydroxyproline. ECOD was significantly different in healthy liver, fatty liver, chronic active hepatitis (CAH) and cirrhosis. The importance of the fibrotic process was shown by the significant correlations between ECOD and the signs of fibrosis in the liver biopsy. A connection between ECOD and the markers of fibrosis was not found. Further research is necessary to clarify this difference.

Studies on the in-vitro biotransformation in patients with liver diseases.

The activity of 7-ethoxycoumarin O-deethylase (ECOD) was determined in the human liver bioptate of 53 patients with chronic liver diseases. Remarkable are the lower values of ECOD in the hepatoses, chronic hepatitis and cirrhosis as compared to patients with normal histology or residual hepatitis. The decline in the activity of ECOD in the patients with chronic hepatitis and cirrhosis has to be seen in connection with parenchymatous necrosis, nodular liver transformation and intracinar fibrosis. For the time being it is not possible to give a satisfactory explanation of the decrease in the ECOD activity of the hepatoses.