Podcasts about results patients

N Engl J Med 2010;362:1663-74.Background: The RAVEL and TAXUS-IV trials compared the sirolimus- and paclitaxel-eluting 2nd generation stents to 1st generation bare metal stents. Both trials reported improvements in surrogate endpoints - “in-stent luminal loss” was the primary endpoint of RAVEL and “ischemia-driven target-vessel revascularization” was the primary endpoint of TAXUS-IV. Neither trial showed differences in hard endpoints like death or MI but were not powered for such events.The observation that restenosis still occurred with 2nd generation stents drove interest in developing newer stent technology with improved bioavailability and drug delivery. The 3rd generation everolimus-eluting stent was felt to represent such a development but like its predecessors had only been tested in experiments using surrogate endpoints that were not driven by clinical symptoms. Thus, the SPIRIT IV trial sought to test the hypothesis that 3rd generation everolimus-eluting stents would reduce patient-driven clinical outcomes compared 2nd generation paclitaxel-eluting stents. Furthermore, it was designed to be large enough to provide data on important subgroups, especially patients with diabetes.Patients: Limited details are provided about inclusion and exclusion criteria in the main manuscript and readers are directed to a previous publication and supplemental appendix. Lesion characteristics had to be less than 28 mm in length with a reference-vessel diameter between 2.5 to 3.75 mm. Patients were excluded if they had features making them complex from either a clinical or angiographic standpoint. *Note to learners: Be especially skeptical of trials that do not include at least an abridged version of important inclusion and exclusion criteria in the main publication manuscript. This often indicates that the criteria are complex and that patients are highly selected, which limits the generalizability of the findings to routine practice. Baseline characteristics: The average age of patients was 63 years and 68% were men. Approximately 32% of patients had diabetes with about one quarter being insulin-dependent. Over 20%of patients smoked and a similar percentage had a previous heart attack.Three quarters of patients had 1 target lesion, 22% had 2 target lesions and 3% had 3 and 11% of patients had 1 or more complex lesions. The average lesion length was 15 mm, reference-vessel diameter was 2.75 mm, minimal luminal diameter was 0.75 mm, and average % stenosis was 72%.Procedures: Patients were randomized in a 2:1 ratio to receive an everolimus- or paclitaxel-eluting stent. They were stratified based on having diabetes or not, whether they had a single or complex lesion, and study site. Operators were not blind to the stent being used. At least 300 mg of aspirin was administered before catheterization and at least 300 mg of clopidogrel was recommended before the procedure and was required within 1 hour after stent implantation. Patients took at least 80 mg of aspirin daily for an indefinite period and 75 mg of clopidogrel for at least 12 months. Clinical follow-up visits were scheduled at 30, 180, 270, and 365 days and yearly through 5 years.Endpoints: The primary end point was ischemia-driven target lesion failure at 1 year defined by the composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization. As was the case in the TAXUS-IV trial, “ischemia-driven” did not necessarily mean “symptom-driven”. Two major secondary endpoints were also prespecified which included ischemia-driven target-lesion revascularization and the composite of death or target-vessel MI.The trial was powered for sequential testing of noninferiority and superiority for both the primary and 2 major secondary endpoints. The criteria for noninferiority would be met if the upper limit of the 97.5% confidence interval was not more than 3.1%. This was based on an assumed 1 year target-lesion failure rate of 8.2% for both groups. The trial had 90% power to show non-inferiority. Superiority testing was prespecified if the criterion for noninferiority was met. It was estimated that 3690 patients would have 90% power to detect a 2.9% absolute reduction in the primary end point, at a two-sided alpha of 0.05. The trial also had 90% power to test noninferiority for ischemia-driven target-lesion revascularization and the composite of cardiac death or target-vessel MI at a 2.1% margin. It had 90% and 91% power to test for superiority of these endpoints if noninferiority was met.*Note to learners: The statistical analysis plan for this trial demonstrates 2 important concepts in hypothesis testing. First, trials can be powered in a prespecified manner for non-inferiority and superiority testing. Second, trials can be powered for prespecified hypothesis testing of more than just a single endpoint.Results: Patients were enrolled over a 2 year period from 66 U.S. sites. There were a total of 3,687 patients included in the final analysis with 2,458 in the everolimus-eluting stent group and 1,229 in the paclitaxel-eluting stent group. There were some significant differences for patients receiving everolimus-eluting stents that included the number of stents per lesion, total stent length per lesion, the ratio of stent length to lesion length and the maximum pressure used.At 1 year, everolimus-eluting stents met non-inferiority for the primary and major secondary endpoints and met superiority for 2 of 3. Everolimus-eluting stents reduced the primary endpoint of target-lesion failure (4.2% vs 6.8%; RR 0.62; 95% CI 0.46 to 0.82) and the major secondary endpoint of ischemia-driven target lesion revascularization (2.5 vs 4.6%; RR 0.55; 95% CI 0.38 to 0.78) but not the other major secondary endpoint of cardiac death or target-vessel MI (2.2% vs 3.2%; RR 0.69; 95% CI 0.46 to 1.04). Differences in target-lesion failure were driven by statistically significant reductions in target-lesion revascularization (2.5% vs 4.6%) as well as MI (1.9% vs 3.1%) but not all-cause (1.0% vs 1.3%) or cardiac death (0.4% vs 0.4%). Stent thrombosis was also significantly reduced but rates were very low in both groups and the trial was not powered for this endpoint.Interestingly, subgroup analysis of the primary endpoint revealed a statistically significant interaction for treatment efficacy in patients with diabetes such that diabetics did not appear to benefit from everolimus-eluting stents (6.4% vs 6.9%) compared to non-diabetics (3.3% vs 6.7%; p for interaction = 0.02).Conclusions: In patients with stable CAD who underwent generally non-complex PCI procedures, 3rd generation everolimus-eluting stents compared to 2nd generation paclitaxel-eluting stents reduced a composite endpoint of ischemia-driven target-lesion failure by 38% with a number needed to treat of approximately 40 patients. This was associated with statistically significant reductions in nonfatal MI with a NNT of approximately 100 patients and ischemia-driven target lesion revascularization with a NNT of approximately 50 patients. Everolimus-eluting stents did not reduce death.There was an interaction noted for diabetic patients who did not appear to significantly benefit from everolimus-eluting stents. Notably, diabetics exhibited more severe angiographic disease with a higher prevalence of multivessel disease, diffuse plaque burden, and a greater likelihood of left main coronary artery involvement. This subgroup finding along with the highly selected nature of the study cohort reduces our confidence that the 3rd generation everolimus-eluting stent confers significant advantages over 2nd generation stents for many patients who receive them in clinical practice.One final consideration is that the trial was single blinded and operators were aware of stent type which could have biased their performance and the study results.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support our work, consider becoming a free or paid subscriber. 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Link to bioRxiv paper: http://biorxiv.org/cgi/content/short/2023.03.28.534348v1?rss=1 Authors: Ntwatwa, Z., Lochner, C., Roos, A., Sevenoaks, T., van Honk, J., Alonso, P., Batistuzzo, M. C., Choi, S., Hoexter, M. Q., Kim, M., Kwon, J. S., Mataix-Cols, D., Menchon, J. M., Miguel, E. C., Nakamae, T., Phillips, M. L., Soriano-Mas, C., Veltman, D., Groenewold, N. A., van den Heuvel, O. A., Stein, D. J., Ipser, J. Abstract: Intro: Although it has been suggested that the hippocampus and amygdala (HA) are involved in the neurobiology of obsessive-compulsive disorder (OCD), volumetric findings have been inconsistent. Furthermore, the HA consist of heterogenous anatomic units with specific functions and cytoarchitecture, and little work has been undertaken on the volumetry of these subfields in OCD. Methods: T1-weighted images from 381 patients with OCD and 338 healthy controls (HCs) from the OCD Brain Imaging Consortium were segmented to produce twelve hippocampal subfields and nine amygdala subfields using FreeSurfer 6.0. We assessed between-group differences in subfield volume using a mixed-effects model adjusted for age, quadratic effects of age, sex, site, and whole HA volume. Given evidence of confounding effects of clinical characteristics on brain volumes in OCD, we also performed subgroup analyses to examine subfield volume in relation to comorbid anxiety and depression, medication status, and symptom severity. Results: Patients with OCD and HCs did not significantly differ in HA subfield volume. However, medicated patients with OCD had significantly smaller hippocampal dentate gyrus (pFDR=0.042, d=-0.26) and molecular layer (pFDR=0.042, d=-0.29) and larger lateral (pFDR=0.049, d=0.23) and basal (pFDR=0.049, d=0.25) amygdala subfields than HCs. Unmedicated patients had significantly smaller hippocampal CA1 (pFDR=0.016, d=-0.28) than HCs. No association was detected between any subfield volume and OCD severity. Conclusion: Differences in HA subfields between OCD and HCs are dependent on medication status, in line with previous work on other brain volumetric alterations in OCD. This emphasizes the importance of considering psychotropic medication in neuroimaging studies of OCD. Copy rights belong to original authors. Visit the link for more info Podcast created by Paper Player, LLC

Link to bioRxiv paper: http://biorxiv.org/cgi/content/short/2020.06.12.141945v1?rss=1 Authors: von Schwanenflug, N., Krohn, S., Heine, J., Paul, F., Pruess, H., Finke, C. Abstract: Introduction: Anti-N-methyl-d-aspartate receptor encephalitis (NMDARE) is an autoimmune disorder associated with severe neuropsychiatric symptoms. While patients with NMDARE exhibit disrupted functional connectivity (FC), these findings have been limited to static connectivity analyses. This study applies time-resolved FC analysis to explore the temporal variability of large-scale brain activity in NMDARE and to assess the discriminatory power of functional brain states in a supervised classification approach. Methods: Resting-state fMRI data from 57 patients with NMDARE and 61 controls was included. To capture brain dynamics, four discrete connectivity states were extracted and state-wise group differences in FC, occurrence, dwell time and transition frequency were assessed. Furthermore, logistic regression models with embedded feature selection were trained for each state to predict group status in a leave-one-out cross validation scheme. Results: Patients showed FC alterations in three out of four states. Besides a reduction in hippocampal-frontal connectivity, we observed connectivity decreases within the default mode network and between frontal areas and subcortical as well as visual regions, which remained undetected in static FC. Furthermore, patients displayed a shift in dwell time from the weakly connected dominant state to a higher connected, but less frequent state, accompanied by increased transition frequencies. Discriminatory network features and predictive power varied dynamically over states, reaching up to 78.6% classification accuracy. Conclusion: Patients showed state-specific alterations in FC along with a shift in dwell time and increased volatility of state transitions. These measures were associated with disease severity and duration, highlighting the potential of spatiotemporal dynamics in FC as prognostic biomarkers in NMDARE. Copy rights belong to original authors. Visit the link for more info

Background: Management of community-acquired pneumonia (CAP) places a considerable burden on hospital resources. REACH was a retrospective, observational study (NCT01293435) involving adults >= 18 years old hospitalized with CAP and requiring in-hospital treatment with intravenous antibiotics conducted to collect data on current clinical management patterns and resource use for CAP in hospitals in ten European countries. Methods: Data were collected via electronic Case Report Forms detailing patient and disease characteristics, microbiological diagnosis, treatments before and during hospitalization, clinical outcomes and health resource consumption. Results: Patients with initial antibiotic treatment modification (n = 589; 28.9%) had a longer mean hospital stay than those without (16.1 [SD: 13.1; median 12.0] versus 11.1 {SD: 8.9; median: 9.0] days) and higher ICU admission rate (18.0% versus 11.9%). Septic shock (6.8% versus 3.0%), mechanical ventilation (22.2% versus 9.7%), blood pressure support (fluid resuscitation: 19.4% versus 11.4%), parenteral nutrition (6.5% versus 3.9%) and renal replacement therapy (4.2% versus 1.4%) were all more common in patients with treatment modification than in those without. Hospital stay was longer in patients with comorbidities than in those without (mean 13.3 [SD: 11.1; median: 10.0] versus 10.0 [SD: 7.5; median: 8.0] days). Conclusions: Initial antibiotic treatment modification in patients with CAP is common and is associated with considerable additional resource use. Reassessment of optimal management paradigms for patients hospitalized with CAP may be warranted.

Purpose: To investigate the efficacy of prednisone for treatment of withdrawal headache in patients with medication overuse headache (MOH). Patients and methods: In this prospective double-blind, placebo-controlled, parallel designed multicentre trial, 96 consecutive patients with MOH were randomized to withdrawal treatment with either 100 mg prednisone or placebo over 5 days. Patients were enrolled if they met the International Headache Society criteria for MOH and were diagnosed with migraine or episodic tension-type headache as primary headache. Exclusion criteria comprised significant neurological or psychiatric disorders. Withdrawal symptoms, including headache severity and intake of rescue medication, were documented for 14 days after randomization. Results: Patients treated with prednisone did not experience fewer hours of moderate or severe headache than patients receiving placebo. However, patients requested less rescue medication within the first 5 days. Conclusions: During withdrawal in MOH, prednisone reduces rescue medication without decreasing the severity and duration of withdrawal headache.

Background: Feeding patients with severe abdominal infections isparticularly demanding. Method: The authors electronically searched theMEDLINE, EMBASE and Cochrane databases (using the keywords‘peritonitis’, ‘severe sepsis’, ‘nutrition’, ‘practice parameter’, and‘guideline’) and reviewed their personal databases for articles relevantto the issue which have been published between 2002 and 2012. Results:Patients suffering from abdominal sepsis are at a high risk for severehyperglycemia and insulin resistance. Due to an excessive proteincatabolism which cannot be overcome by standard nutritional therapy,these patients are malnourished and require a particularly carefulnutritional support. The latter is not guided by the actual energyexpenditure (which markedly increases during the acute phase) but by thecapacity of the organism to utilize exogenous substrates (this capacityusually decreases during the acute phase). It is of outmost importanceto supply sufficient amounts of protein or amino acids. Ideally, thepatients should be fed enterally. Even in patients with severe abdominalcomplications (anastomotic leakage), modern tube and jejunostomytechniques as well as surgical strategies allow an adequate enteralsupply of calories. However, patients suffering from a severe abdominalsepsis often exhibit a delayed gastrointestinal passage (delayed gastricemptying, small bowel paralysis, colonic pseudo-obstruction). Thesepathologies restrict enteral nutrition and should be recognized as earlyas possible by appropriate clinical surveillance. Besides a clinicalexamination of the abdomen, measurement of gastric residual volumerepresents the best control parameter when providing food into thestomach. Delayed gastrointestinal passage should be treated asaggressively as possible. Primary objective is the cure of the abdominalfocus. In addition, use of drugs with an antiperistaltic action shouldbe restricted as much as possible. Severe cases may profit frommedications with a properistaltic action combined with specific physicalmeasures. Conclusion: Feeding patients suffering from an abdominalinfection requires an individualized, patient-centered approach whichrequires a profound nutritional and special gastroenterologicalknowledge.

Background: The current pilot study compares the impact of an intravenous infusion of Ringer's lactate to an acetate-based solution with regard to acid-base balance. The study design included the variables of the Stewart approach and focused on the effective strong ion difference. Because adverse hemodynamic effects have been reported when using acetate buffered solutions in hemodialysis, hemodynamics were also evaluated. Methods: Twenty-four women who had undergone abdominal gynecologic surgery and who had received either Ringer's lactate (Strong Ion Difference 28 mmol/L; n = 12) or an acetate-based solution (Strong Ion Difference 36.8 mmol/L; n = 12) according to an established clinical protocol and its precursor were included in the investigation. After induction of general anesthesia, a set of acid-base variables, hemodynamic values and serum electrolytes was measured three times during the next 120 minutes. Results: Patients received a mean dose of 4,054 +/- 450 ml of either one or the other of the solutions. In terms of mean arterial blood pressure and norepinephrine requirements there were no differences to observe between the study groups. pH and serum HCO3- concentration decreased slightly but significantly only with Ringer's lactate. In addition, the acetate-based solution kept the plasma effective strong ion difference more stable than Ringer's lactate. Conclusions: Both of the solutions provided hemodynamic stability. Concerning consistency of acid base parameters none of the solutions seemed to be inferior, either. Whether the slight advantages observed for the acetate-buffered solution in terms of stability of pH and plasma HCO3- are clinically relevant, needs to be investigated in a larger randomized controlled trial.

Background: Components of carotid atherosclerotic plaques can reliably be identified and quantified using high resolution in vivo 3-Tesla CMR. It is suspected that lipid apheresis therapy in addition to lowering serum lipid levels also has an influence on development and progression of atherosclerotic plaques. The purpose of this study was to evaluate the influence of chronic lipid apheresis (LA) on the composition of atherosclerotic carotid plaques. Methods: 32 arteries of 16 patients during chronic LA-therapy with carotid plaques and stenosis of 1-80% were matched according to degree of stenosis with 32 patients, who had recently suffered an ischemic stroke. Of these patients only the asymptomatic carotid artery was analyzed. All patients underwent black-blood 3 T CMR of the carotids using parallel imaging and dedicated surface coils. Cardiovascular risk factors were recorded. Morphology and composition of carotid plaques were evaluated. For statistical evaluation Fisher's Exact and unpaired t-test were used. A p-value

Purpose: This study investigated the impact of specific mutations in codon 12 of the Kirsten-ras (KRAS) gene on treatment efficacy in patients with metastatic colorectal cancer (mCRC). Patients: Overall, 119 patients bearing a KRAS mutation in codon 12 were evaluated. All patients received cetuximab-based first-line chemotherapy within the Central European Cooperative Oncology Group (CECOG), AIO KRK-0104 or AIO KRK-0306 trials. Results: Patients with KRAS codon 12 mutant mCRC showed a broad range of outcome when treated with cetuximab-based first-line regimens. Patients with tumors bearing a KRAS p.G12D mutation showed a strong trend to a more favorable outcome compared to other mutations (overall survival 23.3 vs. 14-18 months; hazard ratio 0.66, range 0.43-1.03). An interaction model illustrated that KRAS p.G12C was associated with unfavorable outcome when treated with oxaliplatin plus cetuximab. Conclusion: The present analysis suggests that KRAS codon 12 mutation may not represent a homogeneous entity in mCRC when treated with cetuximab-based first-line therapy. Copyright (C) 2012 S. Karger AG, Basel

Background: As cell-free circulating DNA exists predominantly as mono-and oligonucleosomes, the focus of the current study was to examine the interplay of circulating nucleosomes, DNA, proteases and caspases in blood of patients with benign and malignant breast diseases. Methods: The concentrations of cell-free DNA and nucleosomes as well as the protease and caspase activities were measured in serum of patients with benign breast disease (n = 20), primary breast cancer (M0, n = 31), metastatic breast cancer (M1, n = 32), and healthy individuals (n = 28) by PicoGreen, Cell Death Detection ELISA, Protease Fluorescent Detection Kit and Caspase-Glo (R) 3/7 Assay, respectively. Results: Patients with benign and malignant tumors had significantly higher levels of circulating nucleic acids in their blood than healthy individuals (p = 0.001, p = 0.0001), whereas these levels could not discriminate between benign and malignant lesions. Our analyses of all serum samples revealed significant correlations of circulating nucleosome with DNA concentrations (p = 0.001), nucleosome concentrations with caspase activities (p = 0.008), and caspase with protease activities (p = 0.0001). High serum levels of protease and caspase activities associated with advanced tumor stages (p = 0.009). Patients with lymph node-positive breast cancer had significantly higher nucleosome levels in their blood than node-negative patients (p = 0.004). The presence of distant metastases associated with a significant increase in serum nucleosome (p = 0.01) and DNA levels (p = 0.04), and protease activities (p = 0.008). Conclusion: Our findings demonstrate that high circulating nucleic acid concentrations in blood are no indicators of a malignant breast tumor. However, the observed changes in apoptosis-related deregulation of proteolytic activities along with the elevated serum levels of nucleosomes and DNA in blood are linked to breast cancer progression.

Patient Self-Management of oral Anticoagulation after mechanical heart valve replacement – Long term experience of the Department of Heart Surgery Ludwig-Maximilians-University Munich. Objectives: Lifelong oral anticoagulation treatment (OAT) is necessary after mechanical heart valve replacement. This study was conducted to find out differences in bleeding and thromboembolic complications between Patient Self-Management (PSM) of OAT with portable coagulometers and Conventional Patient Management (CPM) by the home physician. We also wanted to find out in which group more anticoagulation-values were within the therapeutic range and in which group quality of life is better. Methods: 444 Patients were included in this retrospective study (PSM-group n=160, CPM-group n=260, 24 patients were lost to follow up). Follow-up time was 95,0 (+/-23,5) months in PSM-group and 104,9 (+/- 28,5) months in CPM-group. Patients underwent mechanical heart valve replacement in our centre between 1982 and 1998. PSM-education began 1992. Follow-up time was 95,0 (+/-23,5) months in PSM-group and 104,9 (+/- 28,5) months in CPM-group. In PSM-group age was 61,2 (+/- 10,2) years, in CPM-group 66,4 (+/- 8,1) years at follow-up. Patients in PSM-group were trained using portable coagulometers and dose adjusting their coumarin-derivate (mostly Marcumar). Results: Patients in PSM-group measured their coagulation values 3,74 (+/-3,41) times per month, in CPM-group 1,53 (+/- 1,07) times per month. In the PSM-group, 73% of coagulation values measured were within the therapeutic range. In the CPM-group 57% of the values were within the therapeutic range. Grade 2 or 3 bleeding complications were 2,2% per patient year in PSM-group and 2,7% in CPM-group. Grade 2 or 3 thromboembolic complications were 0,58% per patient year in PSM-group and 1,7% in CPM-group. Quality-of-life aspects were significantly better in PSM-group than in CPM-group. Conclusions: PSM improves long-time OAT after mechanical heart valve replacement. More anticoagulation values were within the therapeutic range and fewer thromboembolic complications appeared in PSM-group. Quality of life was better in PSM-group. For that reason we offer and recommend PSM to all suitable patients after mechanical heart valve replacement.

Background: Deep brain stimulation (DBS) of the globus pallidus internus (GPi) offers a very promising therapy for medically intractable dystonia. However, little is known about the long-term benefit and safety of this procedure. We therefore performed a retrospective long-term analysis of 18 patients (age 12-78 years) suffering from primary generalized (9), segmental (6) or focal (3) dystonia (minimum follow-up: 36 months). Methods: Outcome was assessed using the Burke-Fahn-Marsden (BFM) scores (generalized dystonia) and the Tsui score (focal/segmental dystonia). Follow-up ranged between 37 and 90 months (mean 60 months). Results: Patients with generalized dystonia showed a mean improvement in the BFM movement score of 39.4% (range 0 68.8%), 42.5% (range -16.0 to 81.3%) and 46.8% (range-2.7 to 83.1%) at the 3- and 12-month, and long-term follow-up, respectively. In focal/ segmental dystonia, the mean reduction in the Tsui score was 36.8% (range 0-100%), 65.1% (range 16.7-100%) and 59.8% (range 16.7-100%) at the 3- and 12-month, and long-term follow-up, respectively. Local infections were noted in 2 patients and hardware problems (electrode dislocation and breakage of the extension cable) in 1 patient. Conclusion: Our data showed Gpi-DBS to offer a very effective and safe therapy for different kinds of primary dystonia, with a significant long-term benefit in the majority of cases. Copyright (c) 2008 S. Karger AG, Basel

Purpose: To evaluate the effect of intravitreal bevacizumab (Avastin) injections on visual acuity (VA) and foveal retinal thickness in patients with macular oedema secondary to branch retinal vein occlusion.Methods: A prospective, non-comparative, consecutive, interventional case series of 34 patients. Patients received repeated intravitreal injections of 1.25 mg bevacizumab. Main outcome measures were VA (Snellen charts and ETDRS) and retinal thickness (optical coherence tomography measurements) in a follow-up period of 6 months.Results: Patients presented at a mean age of 69 years (range 44--86). Mean duration of symptoms was 40 weeks (range 1--300). Mean (SD) VA at baseline was 0.79 (0.39) logMAR, improving to 0.51 (0.34) logMAR at 6 months (p = 0.009). Mean number of letters on the ETDRS chart at baseline was 45.3 (19.0), improving to 60.6 (19.9) at 6 months (p = 0.003). Mean (SD) retinal thickness at baseline was 474 (120) textgreekmm, declining to 316 (41) textgreekmm at 6 months.Conclusion: Intravitreal injection of 1.25 mg bevacizumb appears to be an effective treatment option for branch retinal vein occlusion.

Aims: The decrease in uterine resistance during normal pregnancy is known to be related to invading trophoblast cells which derive from placental tissue. Uterine and peripheral resistance is elevated in preeclampsia. The aim of the present study was to prospectively examine uterine and peripheral resistance in pregnancies complicated by preeclampsia (PE), fetal intrauterine growth restriction (IUGR) and pregnancy induced hypertension (PIH). Methods: Sixty-seven women with normal pregnancies, 17 with PE, 12 with IUGR underwent Doppler sonographic investigation of the uterine and the cubital arteries. The Pulsatility Index (PI) was calculated for each vessel. Statistical analysis was performed and a P-value < 0.05 was considered significant. Results: Patients with preeclampsia and IUGR showed a significant higher resistance at the placental (mean PI 1.267 and 1.063), nonplacental (mean PI 1.631 and 1.124) and cubital artery (mean PI 3,777 and 3.995) compared to the normal pregnancy group (mean PI 0.678; 0.859 and 2.95 respectively). Mean birth weight in the PE group was 1409 g, in the IUGR group 1649 g and 3419 g in the normal pregnancy group. Conclusions: Pregnancies with IUGR are associated with elevated peripheral resistance in the maternal arterial system as seen in pregnancies with preeclampsia. Our findings encourage to further investigate the maternal vascular system in high risk pregnancies.

Background: Nucleosomes are cell death products that are elevated in serum of patients with diseases that are associated with massive cell destruction. We investigated the kinetics of circulating nucleosomes after cerebral stroke and their correlation with the clinical status. Methods: In total, we analyzed nucleosomes by ELISA in sera of 63 patients with early stroke daily during the first week after onset. For correlation with the clinical pathology, patients were grouped into those with medium to slight functional impairment (Barthel Index BI >= 50) and those with severe functional impairment (BI < 50). Results: Patients with BI >= 50 showed a continuous increase in nucleosomes until day 5 (median: 523 arbitrary units, AU) followed by a slow decline. In contrast, patients with BI < 50 showed a steeper initial increase reaching a maximum already on day 3 (869 AU). Both, days after stroke (p < 0.001) and BI (p < 0.001), had a significant influence on nucleosome concentrations, respectively. Consistently, patients with BI < 50 had a significantly larger area under the curve (AUC/day) of nucleosome values during the first week after stroke (800 AU) than patients with BI >= 50 (497 AU; p = 0.031). Concerning the infarction volume, nucleosomes showed significant correlations for the concentrations on day 3 (r = 0.43; p = 0.001) and for the area under the curve (r = 0.34; p = 0.016). Conclusion: Even if nucleosomes are nonspecific cell death markers, their release into serum after cerebral stroke correlates with the gross functional status as well as with the infarction volume and can be considered as biochemical correlative to the severity of stroke. Copyright (c) 2006 S. Karger AG, Basel.

Background: The prognosis for patients with malignant astrocytoma or brain metastases is often fatal despite intensive therapy. Therefore we wished to elucidate whether the quality of life (QoL) is a determinant of overall survival (OAS). Patients and Methods: From 1997 to 2000 153 patients with brain tumours were screened; 39 patients (26%) refused to participate and further 47 patients were excluded (cerebral impairment 14%, amaurosis/language problems 3%, Karnofsky performance score < 50% 7%, death 8%, non-compliance 7%). Thus, 57 patients were analysed (33 with primary brain tumours, 24 with brain metastases). With the FACT-G questionnaire cancer-specific aspects of health-related QoL were assessed. Results: Patients with metastases showed a lower QoL in the physical sphere than patients with astrocytoma, but there were no significant differences in OAS. Median survival of patients with good QoL was 31.3 months versus 14.2 months in patients with bad QoL. Only the two variables `living with a spouse' and FACT-G sum score had a statistically significant influence on survival (p = 0.033 and p = 0.003) modelled by the Cox-PH regression. Patients who did not live with a spouse had shorter survival times than the other patients. Conclusion: Health-related QoL can serve to identify a patient group with higher risks of death.

Background: In Germany a considerable number of in-patient facilities offer complementary medicine in addition to conventional care. In this study we aimed to describe patient characteristics, diagnostics, therapy and outcomes of four such in-patient facilities. Methods: 2835 consecutive in-patients admitted to two private hospitals with an emphasis on complementary medical cart, one private hospital for traditional Chinese medicine, and the Department of Complementary Medicine of a public district hospital participated in a prospective observational (cohort) study with 12 months follow-up. Sociodemographic characteristics, diagnoses, duration of disease, type and frequency of therapeutic interventions, intensity of complaints, assessment of therapeutic success, and quality of life were documented. Results: Patients of the observed hospitals were mostly female (66%-80% in the four hospitals) and a high proportion was chronically ill (31%-62% with a disease history longer than 5 years). The frequency of single diagnoses varied strongly between the four hospitals, however, chronic pain syndromes were very frequent in all. Complementary care always included a large number of different therapeutic methods whose combination varied with different diagnoses and between the hospitals. At discharge, 57%-73% of patients rated the therapeutic success as good or very good, Follow-up rates were satisfactory only in two of the four hospitals. After 12 months 51%-64% of the responding patients still rated the success as good or very good. Conclusions: In the observed hospitals mainly chronically ill patients are treated with highly complex combinations of a large variety of complementary therapies. A majority of patients seems to be satisfied by the treatment. A major methodological problem in the interpretations of patient outcomes are the partly low followup rates.

Objective: Empirical investigation of the influence of patient self-selection during follow-up in a prospective observational study in 4 in-patient facilities for complementary medicine and discussion of further methodological problems. Methods: 2662 patients treated in the 4 hospitals and included in a prospective observational study had been sent follow-up questionnaires 2, 6, and 12 months after admission. Characteristics and therapeutic success at discharge were compared in patients responding and those not responding. Results: Patients not responding to the follow-up questionnaires tended to be older and to assess the benefit of the treatment less positive than patients who responded (hospital one: 56.2% of patients with a follow-up reported a good or very good response to therapy at discharge compared to 37.7% of the patients without a follow-up: hospital two: 63.7% vs. 54.6%; hospital three: 71.1% vs. 65.8%; hospital four: 78,3% vs. 70,9%). Interpretation: When interpreting the results of the observational study a certain degree of bias induced by selection during follow-up has to be taken into account. Discussion: Other methodological problems discussed narratively include spontaneous improvements, reliability of baseline measures, influence of effective cointerventions, side-effects, outcome measures, feasibility, and efficiency. Finally, recommendations for quality management programs in in-patient facilities for complementary medicine are provided.