Automated symptom and treatment side effect monitoring for improved quality of life among adults with diabetic peripheral neuropathy in primary care: a pragmatic, cluster, randomized, controlled trial.

AIMS: To evaluate the effectiveness of automated symptom and side effect monitoring on quality of life among individuals with symptomatic diabetic peripheral neuropathy. METHODS: We conducted a pragmatic, cluster randomized controlled trial (July 2014 to July 2016) within a large healthcare system. We randomized 1834 primary care physicians and prospectively recruited from their lists 1270 individuals with neuropathy who were newly prescribed medications for their symptoms. Intervention participants received automated telephone-based symptom and side effect monitoring with physician feedback over 6 months. The control group received usual care plus three non-interactive diabetes educational calls. Our primary outcomes were quality of life (EQ-5D) and select symptoms (e.g. pain) measured 4-8 weeks after starting medication and again 8 months after baseline. Process outcomes included receiving a clinically effective dose and communication between individuals with neuropathy and their primary care provider over 12 months. Interviewers collecting outcome data were blinded to intervention assignment. RESULTS: Some 1252 participants completed the baseline measures [mean age (sd): 67 (11.7), 53% female, 57% white, 8% Asian, 13% black, 20% Hispanic]. In total, 1179 participants (93%) completed follow-up (619 control, 560 intervention). Quality of life scores (intervention: 0.658 ± 0.094; control: 0.653 ± 0.092) and symptom severity were similar at baseline. The intervention had no effect on primary [EQ-5D: -0.002 (95% CI -0.01, 0.01), P = 0.623; pain: 0.295 (-0.75, 1.34), P = 0.579; sleep disruption: 0.342 (-0.18, 0.86), P = 0.196; lower extremity functioning: -0.079 (-1.27, 1.11), P = 0.896; depression: -0.462 (-1.24, 0.32); P = 0.247] or process outcomes. CONCLUSIONS: Automated telephone monitoring and feedback alone were not effective at improving quality of life or symptoms for people with symptomatic diabetic peripheral neuropathy. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02056431).

The effect of stent graft oversizing on radial forces considering nitinol wire behavior and vessel characteristics.

Stent graft fixation in the vessel affects the success of endovascular aneurysm repair. Thereby the radial forces of the stent, which are dependent on several factors, play a significant role. In the presented work, a finite element sensitivity study was performed. The radial forces are 29% lower when using the hyperelastic approach for the vessel compared with linear elastic assumptions. Without the linear elastic modeled plaque, the difference increases to 35%. Modeling plaque with linear elastic material approach results in 8% higher forces than with a hyperelastic characteristic. The significant differences resulting from the investigated simplifications of the material lead to the conclusion that it is important to apply an anisotropic nonlinear approach for the vessel. The oversizing study shows that radial forces increase by 64% (0.54 N) when raising the oversize from 10 to 22%, and no further increase in force can be observed beyond these values (vessel diameter D=12 mm). Starting from an oversize of 24%, the radial force steadily decreases. The findings of the investigation show that besides the oversizing the material properties, the ring design and the vessel characteristics have an influence on radial forces.

Racial/ethnic differences in hip and diaphyseal femur fractures.

UNLABELLED: Contemporary femur fracture rates were examined in northern California women and compared by race/ethnicity. During 2006-2012, hip fracture rates declined, but diaphyseal fracture rates increased, especially in Asians. Women with diaphyseal fracture were younger and more likely to be bisphosphonate-treated. These disparities in femur fracture should be further examined. INTRODUCTION: The epidemiology of diaphyseal femur fracture differs from proximal femur (hip) fracture, although few studies have examined demographic variations in the current era. This study examines contemporary differences in low-energy femur fracture by race/ethnicity in a large, diverse integrated health-care delivery system. METHODS: The incidence of hip and diaphyseal fracture in northern California women aged ≥50 years old during 2006-2012 was examined. Hip (femoral neck and pertrochanteric) fractures were classified by hospital diagnosis codes, while diaphyseal (subtrochanteric and femoral shaft) fractures were further adjudicated based on radiologic findings. Demographic and clinical data were obtained from health plan databases. Fracture incidence was examined over time and by race/ethnicity. RESULTS: There were 10,648 (97.3 %) hip and 300 (2.7 %) diaphyseal fractures among 10,493 women. The age-adjusted incidence of hip fracture fell from 281 to 240 per 100,000 women and was highest for white women. However, diaphyseal fracture rates increased over time, with a significant upward trend in Asians (9 to 27 per 100,000) who also had the highest rate of diaphyseal fracture. Women with diaphyseal fracture were younger than women with hip fracture, more likely to be of Asian race and to have received bisphosphonate drugs. Women with longer bisphosphonate treatment duration were also more likely to have a diaphyseal fracture, especially younger Asian women. CONCLUSION: During 2006 to 2012, hip fracture rates declined, but diaphyseal fracture rates increased, particularly among Asian women. The association of diaphyseal fracture and bisphosphonate therapy should be further investigated with examination of fracture pattern.

Experimental modal analysis on fresh-frozen human hemipelvic bones employing a 3D laser vibrometer for the purpose of modal parameter identification.

To provide a close-to-reality simulation model, such as for improved surgery planning, this model has to be experimentally verified. The present article describes the use of a 3D laser vibrometer for determining modal parameters of human pelvic bones that can be used for verifying a finite elements model. Compared to previously used sensors, such as acceleration sensors or strain gauges, the laser vibrometric procedure used here is a non-contact and non-interacting measuring method that allows a high density of measuring points and measurement in a global coordinate system. Relevant modal parameters were extracted from the measured data and provided for verifying the model. The use of the 3D laser vibrometer allowed the establishment of a process chain for experimental examination of the pelvic bones that was optimized with respect to time and effort involved. The transfer functions determined feature good signal quality. Furthermore, a comparison of the results obtained from pairs of pelvic bones showed that repeatable measurements can be obtained with the method used.

[Emergency open surgical treatment of extravasations of cytostatic agents in the upper extremity]. / Sofortige offene chirurgische Behandlung von Zytostatika-Paravasaten der oberen Extremität.

Extravasations of cytostatic agents can create necrosis of soft tissues in the hand and forearm. The early emergency subcutaneous "wash-out" with liposuction is the treatment of choice to avoid the development of soft-tissue defects. The objective of this study was to evaluate the open surgical debridement as a possible alternative method since the liposuction device is not commonly available in every hospital. In our study 10 patients were treated for extravasations of cytostatic drugs with a high potential for necrosis by emergency open debridement. All patients were evaluated prospectively by photography and clinical examination. 9 patients out of ten had a primary wound healing, one displayed a wound dehiscence with pre-existing MRSA infection. Another patient developed a seroma postoperatively which was treated by puncture. The mean functional outcome was good. The Eemergency open surgical treatment is a simple, in every hospital suitable therapy to prevent soft-tissue necrosis after extravasation of cytostatic drugs.

[The pelvic subcutaneous cross-over internal fixator]. / Der subkutane ventrale Fixateur interne (SVFI) am Becken.

The pelvic subcutaneous cross-over internal fixator is a minimally invasive technique for the fixation of instable anterior pelvic ring fractures. A USS-II-VAS screw is anchored bilaterally in the supra-acetabular region of the os ileum by a mini-incision approach. An angled fixation rod is inserted subcutaneously and after successful closed reduction attached to the screws forming a locking internal fixation. In a retrospective study of the clinical and radiological outcomes of 19 patients after an average follow-up of 2.54 years, results were excellent and good in 31.6%, moderate in 63.2% and poor in 5.3%. Complications were one wound infection, one loosening of the VAS screw and seven temporary lesions of the lateral femoral cutaneous nerve. The main benefits are a simple surgical technique preventing damage to soft tissue, a low risk of neurovascular lesions and the avoidance of pin infections. Moreover patients with multiple trauma profit from a shorter time of surgery and greater comfort allowing a prone position. The new procedure combines the advantages of internal osteosynthesis and a minimally invasive technique, providing early mobilization under full-weight bearing for instable pelvic fractures.

[A comparative study of unstable per- and intertrochanteric femoral fractures treated with dynamic hip screw (DHS) and trochanteric butt-press plate vs. proximal femoral nail (PFN)]. / Eine vergleichende Untersuchung der Versorgung instabiler per- und intertrochantärer Femurfrakturen mittels DHS-Osteosynthese unter Verwendung der Trochanterabstützplatte und dem Proximalen Femurnagel (PFN).

The aim of the present paper is to compare the results obtained using two osteosynthesis systems developed for the surgical treatment of unstable fractures of the trochanteric region of the femur: the proximal femoral nail (PFN) and the dynamic hip screw (DHS) with trochanteric butt-press plate (TBPP). From December 1997 to November 2000, 173 patients with instable trochanteric fractures (type 31 A-2 and A-3 according to the AO-classification) had osteosynthesis by PFN (n = 122) or DHS/TBPP (n = 51). The average patient age was 74 years (range 27 to 98). No significant differences between the two study groups were observed with regard to age, sex, and rate of fracture types. At an average follow-up of 17 months the radiological and clinical outcome according to the score of "Merle d'Aubigné" was analysed in 61 % of all patients. All fractures were healed with no difference in functional outcome between the two groups. In the case of PFN 17.2 % revisions were necessary and in the case of DHS with TBPP 21.6 %. A shorter operation time (43 vs. 61 min) and a considerable shorter in-patient stay (20 vs. 24 days) were common with PFN. Full-weight-bearing immediately after the osteosynthesis was possible for 98 % of the PFN patients and 81 % of the DHS/TBPP patients. The DHS/TBPP osteosynthesis in instable trochanteric fractures is associated with a higher incidence of complications. Therefore we recommend to treat instable fractures of the trochanteric region with the PFN.

Synaptic targeting of N-methyl-D-aspartate receptor splice variants is regulated differentially by receptor activity.

The formation of postsynaptic clusters of various ligand-gated ion channels is regulated by receptor activity. Here we describe the developmental- and activity-dependent modification of N-methyl-D-aspartate (NMDA) receptor clustering in spinal cord neurons in vitro detected by immunofluorescence analysis using subunit and splice variant specific antibodies. NMDA receptors form synaptic and extrasynaptic clusters with sequential changes in subunit composition during in vitro development. During the first week of in vitro culture, a NR1 splice variant containing the C2-carboxy terminus and lacking the N1-cassette and the NR2B subunit are the prevailing components of receptor clusters at synaptic and extrasynaptic sites. After 3 weeks in culture (days in vitro [DIV] 22), the numbers of postsynaptic receptor clusters with N1-containing NR1 splice variants and NR2A subunits are upregulated. At DIV22, C2-specific clusters are abundant and are predominantly localized at postsynaptic sites, whereas the total number of C2'-clusters in dendrites is much lower and these clusters are localized mostly extrasynaptically. However, upon chronic inhibition of NMDA receptor activity in DIV8 and DIV22 cultures with MK801, the number of postsynaptic NR1-C2' subunit clusters is strongly upregulated. In contrast, numbers of NR1-C2 clusters are only modestly increased in DIV8 and not changed in DIV22 cultures upon MK801 treatment, suggesting a specific role of NR1 carboxy-terminal sequences in the activity-dependent synaptic targeting of NMDA receptor clusters of spinal cord neurons.

[Therapy of unstable sacrum fractures in pelvic ring fractures with dorsal sacrum distraction osteosynthesis]. / Die Therapie instabiler Sakrumfrakturen bei Beckenringbrüchen mit dorsaler Sakrumdistanzosteosynthese.

Unstable pelvic ring injuries AO type C ("vertical shear") with a fractured sacrum are treated operatively in less than 50% of the cases (DGU pelvis study group). Furthermore, only 12% of these ORIF involve the sacrum bone itself. No specific technique has gained wide acceptance in treating transsacral instability. In accordance with earlier publications (Käch, Josten) suggesting an internal fixator, we developed the dorsal sacrum fracture distantly anchored ORIF (DSDO). This procedure closes the dorsal pelvic ring by joining the two dorsal iliac crests (fixed-angle screws inserted in the posterior superior iliac spine) and additionally anchors in a lumbar pedicle. Thus, a three-dimensional reduction and stable fixation device with optional local nerve decompression and even plating possibility is achieved. Between January 1996 and July 2001, 35 unstable sacrum disruptions were treated with DSDO in 180 patients operated for pelvic trauma. This allowed immediate mobilization in all cases. The radiologic follow-up examination ( n=20) revealed a solid union in all patients. Complications focused on management of the soft tissue degloving injury (Morel-Lavalleé lesion), which needs special attention.

Anxiety disorders following miscarriage.

BACKGROUND: Several previous studies have established that miscarriage is a risk factor for depressive symptoms and disorder. By contrast, research on miscarriage as a possible risk factor for anxiety symptoms is inconclusive, and for anxiety disorders, sparse and uninformative. The current study examines the incidence of and relative risk for 3 DSM-III anxiety disorders (obsessive-compulsive disorder [OCD], panic disorder, and phobic disorders) within the 6 months following miscarriage. Adequate diagnostic data on other anxiety disorders were not available. METHOD: Using a cohort design, we tested whether women who miscarry are at increased risk for a first or recurrent episode of an anxiety disorder in the 6 months following loss. The miscarriage cohort consisted of women attending a medical center for spontaneous abortion (N = 229); the comparison group was a population-based cohort of women drawn from the community (N = 230). RESULTS: Among miscarrying women, 3.5% experienced a recurrent episode of OCD, compared with 0.4% of community women (relative risk [RR] = 8.0; 95% confidence interval [CI] = 1.0 to 63.7). The relative risk for noncomorbid panic disorder was substantial (RR = 3.6), albeit not statistically significant (95% CI = 0.8 to 17.2). There was no strong evidence for increased risk for phobic disorders or agoraphobia, combined or considered separately, in the 6 months following loss. Relative risk for all 3 disorders combined was 1.5 (95% CI = 0.9 to 2.3). CONCLUSION: In this first miscarriage cohort study using a concurrent frequency-matched comparison group, miscarriage was a substantial risk factor for an initial or recurrent episode of OCD. Given statistical power limitations of this investigation, the current findings do not preclude a possible contribution of miscarriage to risk for other anxiety disorders.

Monocyclic zwitterionic lambda(5)Si-silicates with an SiO(2)FC(2) framework: syntheses and structural characterization in the solid state and in solution.

Treatment of the acyclic zwitterionic pentacoordinate silicate F(3)MeSiCH(2)NMe(2)H with 1 molar equiv of Me(3)SiOC(6)H(4)OSiMe(3), Me(3)SiOCH(2)C(O)OSiMe(3), Me(3)SiOC(Ph)=NOSiMe(3), or Me(3)SiOC(O)C(O)OSiMe(3) (solvent CH(3)CN, room temperature) yielded the respective monocyclic zwitterionic pentacoordinate silicates (11a), (12a), (13a), and (14a), along with 2 molar equiv of Me(3)SiF. The derivatives 11b-14b with a 2,2,6,6-tetramethylpiperidinio substituent instead of the dimethylammonio group were prepared analogously, starting from F(3)MeSiCH(2)NR(2)H (NR(2)H = 2,2,6,6-tetramethylpiperidinio). Single-crystal X-ray diffraction studies showed that the Si-coordination polyhedra of 11a.1.5CH(3)CN, 12a-14a, and 11b-14b are distorted trigonal bipyramids, the axial positions being occupied by the fluorine atom and one of the two oxygen atoms (12a/12b, carboxylate oxygen atom; 13a/13b, carbon-linked oxygen atom). These results are in agreement with the NMR data ((1)H, (13)C, (19)F, (29)Si) obtained for these compounds in solution. The chiral (C(1) symmetry) zwitterions 11a-14a and 11b-14b exist as pairs of (A)- and (C)-enantiomers in solution. VT (1)H NMR studies with 11b-14b in CH(3)CN in the temperature range 25-85 degrees C gave no indications for an enantiomerization process [(A)/(C)-enantiomerization] at the silicon atom.

The relation between selenium, zinc and copper concentration and the trace element dependent antioxidative status.

An imbalance in the antioxidative system was connected with the development of a number of pathological processes. In order to receive values of a healthy group and to evaluate pathological changes of the trace element dependent antioxidative status in future, we investigated 99 healthy volunteers (45 male and 54 female, mean age 37.4 +/- 11.7 years). We determined the concentrations of Se, Cu and Zn, the concentrations of malondialdehyde (MDA) and the activities of the Se dependent glutathione peroxidase (GSH-Px) and the Zn/Cu dependent superoxide dismutase (SOD). The plasma concentrations (mean +/- SD) for Se, Cu and Zn were 0.84 +/- 0.10 micromol/l, 15.6 +/- 2.78 micromol/l and 12.6 +/- 1.80 micromol/l, resp., and for non protein-bound and protein bound MDA 0.27 +/- 0.07 micromol/l and 1.11 +/- 0.25 micromol/l, resp. The activity of GSH-Px in plasma and erythrocytes was 130 +/- 20.8 U/l and 19.8 +/- 4.18 U/mg Hb, resp. and of SOD in erythrocytes 3,159 +/- 847.2 U/g Hb. In plasma positive correlations have been found between Se concentrations and GSH-Px activities (p < 0.002, r = 0.31) and between GSH-Px activities and concentrations of non protein-bound MDA (p = 0.004, r = 0.28). A negative correlation has been observed between GSH-Px activities in plasma and in erythrocytes. The higher the concentrations of Cu in erythrocytes, the higher were the activities of SOD (p = 0.03, r = 0.22) and GSH-Px in erythrocytes (r = 0.26, p = 0.01), while an increasing activity of GSH-Px in these cells correlated with a decreasing concentration of non protein-bound MDA (r = -0,31, p = 0.002). An increase in BMI was connected with an increase in protein-bound MDA and a decrease in GSH-Px activities in pLasma (p = 0.002 and r = 0.23). As the results demonstrate, Se and Cu concentrations in erythrocytes can improve the trace element dependent antioxidative status.

[Special considerations in therapy of injuries of the cervical spine in ankylosing spondylitis (Bechterew disease)]. / Besonderheiten der Therapie von Verletzungen der Halswirbelsäule bei Spondylitis ankylosans (M. Bechterew).

Cervical spine changed by Bechterew's disease is severely endangered with any increased load. Even decent trauma is enough to produce a fracture with affection of spinal cord. Because of little knowledge in these special items, late diagnosis of overlooked injury is not rare, especially in two-level injuries. Neurolesions following secondary fracture dislocations may occur ("fatal pause"). From january 1990 to february 2000 12 patients underwent surgery (dorsoventral stabilisation, ventral stabilisation, laminectomy). Diagnostic procedures, levels of injury, pre- and postoperative neurostatus (following Frankel's score), operative technique, typical complications and follow-up (Ø 17.8 months) were analyzed and compared with the literature. 11 patients showed preoperative neurodeficits. They were better in five cases and disappeared at all in another five cases after surgery (83% positive neurological outcome). There was no increase of neurology failure. Two patients died (ARDS and cerebral ischemia with destruction of vertebral arteries). One patient had to be reoperated because of implant dislocation. MRI is obvious in diagnostic for these lesions. There is also an absolute need for total (both clinical and radiological) examination of the whole spinal column, because there is often injury of more than one level (three times in our study). Therapy should be operative (dorsoventral stabilisation, in certain cases only anterior procedure or laminectomy). Late diagnosis and therapy with secondary worsening after fracture dislocation is not rare because of "overlooked injury". There were four patients, that would not have suffered cervical spine fracture (minimal injury force) without Bechterew's changes. There is often pulmonary failure through limitation of thoracic movement and cerebral ischemia following rupture of vertebral arteries as typical complications. Mortality (2 cases; 16%) in our collective is less than literature's medium rates (35-57%).

Minor depressive disorder in the context of miscarriage.

BACKGROUND: Although minor depressive disorder is of considerable clinical and public health importance, it has received limited research attention relative to major depressive disorder. This study examines the incidence rate and relative risk for minor depressive disorder following miscarriage. METHODS: Using a cohort design we tested whether miscarrying women are at increased risk for an episode of minor depression (diagnosed based on research criteria proposed in Appendix B of DSM-IV) in the 6 months following loss. The miscarriage cohort consisted of women attending a medical center for spontaneous abortion (n=229); the comparison group was a population-based cohort of women drawn from the community (n=230). RESULTS: Among miscarrying women, 5.2% experienced an episode of minor depression, compared with 1.0% of community women. The overall relative risk for an episode of minor depression for miscarrying women was 5.2 (95% confidence interval, 1.2-23.6). Relative risk did not vary by length of gestation at the time of loss or attitude toward the pregnancy. The majority of episodes in miscarrying women began within 1 month following loss. LIMITATIONS: Minor depression was relatively rare in both study cohorts. The resulting limits on statistical power reduced our ability to identify factors, such as sociodemographic or reproductive history variables that might moderate the effect of miscarriage on risk for minor depression. CONCLUSIONS: These results, in the context of prior work showing increased risks of major depression and depressive symptoms following miscarriage, lend some support to the conceptualization of minor depressive disorder as part of a continuum of symptom severity. Miscarrying women should be evaluated for depression at their follow-up medical visits.

Prenatal exposure to wartime famine and development of antisocial personality disorder in early adulthood.

CONTEXT: Several observational epidemiological studies report an association of pregnancy and obstetric complications with development of antisocial personality disorder (ASPD) in offspring. However, the precise nature and timing of the hypothesized biological insults are not known. OBJECTIVE: To test whether severe maternal nutritional deficiency early in gestation is associated with risk for ASPD in offspring. DESIGN AND SETTING: Retrospective cohort study. From October 1944 to May 1945, the German army blockaded food supplies to the Netherlands, subjecting the western Netherlands first to moderate (official food rations, 4200-6300 kJ/d) then to severe (<4200 kJ/d) nutritional deficiency. The north and south were subjected to moderate nutritional deficiency only. PARTICIPANTS: Dutch men born in large urban areas in 1944-1946 who were given psychiatric examinations for military induction at age 18 years (N = 100543) were classified by the degree and timing of their prenatal exposure to nutritional deficiency based on their birthdate and birthplace. MAIN OUTCOME MEASURE: Diagnosis of ASPD by psychiatric interview at time of medical examination for military induction, using the International Classification of Diseases, Sixth Revision (ICD-6). RESULTS: Men exposed prenatally to severe maternal nutritional deficiency during the first and/or second trimesters of pregnancy exhibited increased risk for ASPD (adjusted odds ratio [OR], 2.5; 95% confidence interval [CI], 1.5-4.2). Third-trimester exposure to severe nutritional deficiency and prenatal exposure to moderate nutritional deficiency were not associated with risk for ASPD. CONCLUSIONS: Our data suggest that severe nutritional insults to the developing brain in utero may be capable of increasing the risk for antisocial behaviors in offspring. The possible implications of these findings for both developed countries and developing countries, where severe nutritional deficiency is widespread and often exacerbated by war, natural disaster, and forced migration, warrant study.

Darryl, a cartoon-based measure of cardinal posttraumatic stress symptoms in school-age children.

OBJECTIVES: This report examines the reliability and validity of Darryl, a cartoon-based measure of the cardinal symptoms of posttraumatic stress disorder (PTSD). METHODS: We measured exposure to community violence through the reports of children and their parents and then administered Darryl to a sample of 110 children aged 7 to 9 residing in urban neighborhoods with high crime rates. RESULTS: Darryl's reliability is excellent overall and is acceptable for the reexperiencing, avoidance, and arousal subscales, considered separately. Child reports of exposure to community violence were significantly associated with child reports of PTSD symptoms. CONCLUSIONS: Darryl possesses acceptable psychometric properties in a sample of children with frequent exposure to community violence.