Can Clinical Assessment of Postural Control Explain Locomotive Body Function, Mobility, Self-Care and Participation in Children with Cerebral Palsy?

Trunk control may influence self-care, mobility, and participation, as well as how children living with cerebral palsy (CP) move around. Mobility and Gross Motor performance are described over environmental factors, while locomotion can be understood as the intrinsic ontogenetic automatic postural function of the central nervous system, and could be the underlying element explaining the relationship between these factors. Our goal is to study the correlation among Trunk Control Measurement Scale (TCMS) and Pediatric Evaluation of Disability Inventory (PEDI) domains, as well as Locomotor Stages (LS). METHODS: A feasibility observational analysis was designed including 25 children with CP who were assessed with these scales. RESULTS: The strong correlation confirms higher levels of trunk control in children with better self-care, mobility and participation capacities. Strong correlations indicate also that higher LS show better levels of PEDI and TCMS domains. CONCLUSIONS: Our results suggest that more mature LS require higher levels of trunk control, benefitting self-care, mobility and social functions.

Femoral vessel complications after transfemoral TAVR-A contemporary sonography-based assessment of 480 patients with third-generation transcatheter valves.

BACKGROUND: Postinterventional sonographic assessment of the femoral artery after transfemoral transcatheter aortic valve replacement (TF-TAVR) has the potential to identify several pathologies. We investigated the incidence and risk factors of femoral vessel complications in a modern TAVR collective using postinterventional sonography. METHODS: Between September 2017 and March 2022, 480 patients underwent TF-TAVR with postinterventional femoral sonography at a single center. Clinical outcomes and adverse events were analyzed after the Valve Academic Research Consortium 3 (VARC-3) criteria. RESULTS: In this cohort (51.2% male; age 80 ± 7.5 years, median EuroSCORE II 3.7) 74.8% (n = 359) were implanted with a self-expandable and 25.2% (n = 121) with a balloon-expandable valve. The main access (valve-delivery) was located right in 91.4% (n = 438), and the primary closure system was Proglide in 95% (n = 456). Vascular complications (VC) were observed in 29.16% (n = 140) of patients; 23.3% (n = 112) presented with minor- and 5.8% (n = 28) with major VC. Postinterventional femoral artery stenosis on the main access was observed in 9.8% (n = 47). Multivariable logistic regression analysis revealed female sex (p = .03, odds ratio [OR] 2.32, 95% confidence interval [CI] 1.09-4.89) and the number of used endovascular closure devices (p = .014, OR 0.11, 95%CI 0.02-0.64) as predictive factors for femoral artery stenosis. CONCLUSIONS: The incidence of postinterventional femoral artery stenosis following TF-TAVR was higher than expected with a number of used closure devices and female sex being independent risk factors. Considering the continuous advance of TAVR in low-risk patients with preserved physical activity, emphasis should be directed at the correct diagnosis and follow-up of these complications.

Improved Clinical and Financial Outcomes in Proximal Gastric Bypass Surgery Following the Transition from a Conventional Circular Stapling to an Augmented Linear Stapling Protocol.

Bariatric techniques for bypass surgery evolve constantly. Switching from one well-established protocol to another in a running surgical teaching program is challenging. We analyzed clinical and financial outcomes at a single bariatric center transitioning from circular to an augmented linear bypass protocol. MATERIALS AND METHODS: Between 2011 and 2018, 454 patients were included in this retrospective study. The circular bypass protocol (CIRC; n = 177) was used between 2011 and 2012. Between 2013 and 2015 the transition occurred. Thereafter, the augmented linear protocol (aLIN; n = 277) was primarily utilized. RESULTS: Overall, the mean preoperative BMI dropped from 42.2 to 29.6 kg/m2 after 5 years with no difference between groups. Operation times were significantly shorter in the aLIN vs. CIRC group at 108 (± 32) vs. 120 (± 34) min (P < 0.001), respectively. The reoperation rate was significantly higher in the CIRC vs. aLIN group at n = 65 (36%) vs. n = 35 (13%; P < 0.001), respectively. Specifically, revision due to internal hernia occurred much more frequently in the CIRC-group, n = 36 (20%) vs. n = 12 (4%; P < 0.001). Moreover, reoperation rates for gastrojejunostomy leakage and endoscopic dilatations for anastomotic stenosis were higher in the CIRC vs. aLIN group (P < 0.001). Adjusted overall mean cost per case was lower in aLIN-patients at 15,403 (± 7848) vs. CIRC-patients at 18,525 (± 7850) Swiss francs (P < 0.001). Overall profit was 2555 ± 4768 vs. 1455 ± 5638 Swiss francs in the aLIN vs. CIRC-group, respectively (P = 0.026). CONCLUSION: This study shows improved clinical and financial outcomes after a gradual transition from a circular stapling protocol to an augmented linear stapling protocol in proximal gastric bypass surgery.

Effect of an interprofessional care concept on the hospitalization of nursing home residents: study protocol for a cluster-randomized controlled trial.

BACKGROUND: The rising number of nursing home (NH) residents and their increasingly complex treatment needs pose a challenge to the German health care system. In Germany, there is no specialized geriatric medical care for NH residents. Nursing staff and general practitioners (GPs) in particular have to compensate for the additional demand, which is compounded by organizational and structural hurdles. As a result, avoidable emergency calls and hospital admissions occur. In the SaarPHIR project (Saarländische PflegeHeimversorgung Integriert Regelhaft), a complex intervention focusing on a medical care concept was developed in a participatory practice-based approach involving NH representatives and GPs. The complex intervention addresses the collaboration between nurses and GPs and aims to help restructure and optimize the existing daily care routine. It is expected to improve the medical care of geriatric patients in NHs and reduce stressful, costly hospital admissions. The intervention was pilot-tested during the first 12 months of the project. In the present study, its effectiveness, cost-effectiveness, and safety will be evaluated. METHODS: The study is a cluster-randomized controlled trial, comparing an intervention group with a control group. The intervention includes a concept of interprofessional collaboration, in which GPs group into regional cooperating teams. Teams are encouraged to cooperate more closely with NH staff and to provide on-call schedules, pre-weekend visits, joint team meetings, joint documentation, and improved medication safety. At least 32 NHs in Saarland, Germany (with at least 50 residents each) will be included and monitored for 12 months. The primary endpoint is hospitalization. Secondary endpoints are quality of life, quality of care, and medication safety. The control group receives treatment as usual. Process evaluation and health economic evaluation accompany the study. The data set contains claims data from German statutory health insurance companies as well as primary data. Analysis will be conducted using a generalized linear mixed model. CONCLUSION: A reduction in hospital admissions of NH residents and relevant changes in secondary endpoints are expected. In turn, these will have a positive impact on the economic assessment. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00017129. Registered on 23 April 2019. https://www.drks.de/drks_web/setLocale_EN.do.

Assessment of brain delivery of a model ABCB1/ABCG2 substrate in patients with non-contrast-enhancing brain tumors with positron emission tomography.

BACKGROUND: P-glycoprotein (ABCB1) and breast cancer resistance protein (ABCG2) are two efflux transporters expressed at the blood-brain barrier which effectively restrict the brain distribution of the majority of currently known anticancer drugs. High-grade brain tumors often possess a disrupted blood-brain tumor barrier (BBTB) leading to enhanced accumulation of magnetic resonance imaging contrast agents, and possibly anticancer drugs, as compared to normal brain. In contrast to high-grade brain tumors, considerably less information is available with respect to BBTB integrity in lower grade brain tumors. MATERIALS AND METHODS: We performed positron emission tomography imaging with the radiolabeled ABCB1 inhibitor [11C]tariquidar, a prototypical ABCB1/ABCG2 substrate, in seven patients with non-contrast -enhancing brain tumors (WHO grades I-III). In addition, ABCB1 and ABCG2 levels were determined in surgically resected tumor tissue of four patients using quantitative targeted absolute proteomics. RESULTS: Brain distribution of [11C]tariquidar was found to be very low across the whole brain and not significantly different between tumor and tumor-free brain tissue. Only one patient showed a small area of enhanced [11C]tariquidar uptake within the brain tumor. ABCG2/ABCB1 ratios in surgically resected tumor tissue (1.4 ± 0.2) were comparable to previously reported ABCG2/ABCB1 ratios in isolated human micro-vessels (1.3), which suggested that no overexpression of ABCB1 or ABCG2 occurred in the investigated tumors. CONCLUSIONS: Our data suggest that the investigated brain tumors had an intact BBTB, which is impermeable to anticancer drugs, which are dual ABCB1/ABCG2 substrates. Therefore, effective drugs for antitumor treatment should have high passive permeability and lack ABCB1/ABCG2 substrate affinity. TRIAL REGISTRATION: European Union Drug Regulating Authorities Clinical Trials Database (EUDRACT), 2011-004189-13. Registered on 23 February 2012, https://www.clinicaltrialsregister.eu/ctr-search/search?query=2011-004189-13.

Planned secondary wound closure at the circular stapler insertion site after laparoscopic gastric bypass reduces postoperative morbidity, costs, and hospital stay.

PURPOSE: The aims of the present study were to assess whether planned secondary wound closure at the insertion site of the circular stapler reduces wound infection rate and postoperative morbidity after laparoscopic Roux-en-Y gastric bypass (RYGB) and to identify independent predictive factors increasing the risk for wound infections after RYGB. METHODS: This paper is a retrospective single-center analysis of a prospectively collected database of 1400 patients undergoing RYGB surgery in circular technique between June 2000 and June 2016. Planned secondary wound closure at the circular stapler introduction site was performed at postoperative day 3 in 291 (20.8%) consecutive patients and compared to a historical control of 1109 (79.2%) consecutive patients with primary wound closure. Independent predictive factors for wound infection were assessed by multivariable analysis. RESULTS: Secondary wound closure significantly decreased wound infection rate from 9.3% (103/1109) to 1% (3/291) (p < 0.001) leading to a shorter hospital stay (mean 9 (SD8) vs. 7 days (SD2), p < 0.001), lower costs (p = 0.039), and reduced postoperative morbidity (mean 90-day Comprehensive Complication Index (CCI) 7.4 (SD14.0) vs. 5.1 (SD11.1) p = 0.008) when compared to primary wound closure. Primary wound closure, dyslipidemia, and preoperative gastritis were independent predictive risk factors for developing wound infections both in the univariate (p < 0.001; p = 0.048; p = 0.003) and multivariable analysis (p < 0.001; p = 0.040; p = 0.012). Further, on multivariable analysis, the female gender was a predictive factor (p = 0.034) for wound infection development. CONCLUSIONS: Secondary wound closure at the circular stapler introduction site in laparoscopic RYGB significantly reduces the overall wound infection rate as well as postoperative morbidity, costs, and hospital stay when compared to primary wound closure.

[HERA-QUEST: HTA evaluation of generic pharmaceutical products to improve quality, economic efficiency, patient safety and transparency in drug product changes in hospitals]. / HERA-QUEST: HTA-Evaluation generischer Arzneimittel zur Verbesserung von Qualität, Oekonomie, Patientensicherheit und Transparenz bei Produktumstellungen in Kliniken.

In view of the rising cost pressure and an increasing number of drug shortages, switches between generic drug preparations have become a daily routine in hospitals. To ensure consistently high treatment quality and best possible patient safety, the equivalence of the new and the previous drug preparation must be ensured before any change in the purchase of pharmaceutical products takes place. So far, no easily usable, transparent and standardized instrument for this kind of comparison between generic drug products has been available. A group of pharmaceutical experts has developed the drug HTA (health technology assessment) model "HERA" (HTA Evaluation of geneRic phArmaceutical products) through a multi-step process. The instrument is designed to perform both a qualitative and economic comparison of equivalent drug preparations ("aut idem" substitution) before switching products. The economic evaluation does not only consider unit prices and consumption quantity, but also the processing costs associated with a product change process. The qualitative comparison is based on the evaluation of 34 quality criteria belonging to six evaluation fields (e.g., approval status, practical handling, packaging design). The objective evaluation of the quality criteria is complemented by an assessment of special features of the individual hospital for complex drug switches, including the feedback of the physicians utilizing the drug preparation. Thus potentially problematic switches of pharmaceutical products can be avoided at the best possible rate, contributing to the improvement of patient safety. The novel drug HTA model HERA is a tool used in clinical practice that can add to an increase in quality, therapeutic safety and transparency of drug use while simultaneously contributing to the economic optimization of drug procurement in hospitals. Combining these two is essential for hospitals facing the tension between rising cost pressure and at the same time increasing demands on quality and transparency, triggered by, amongst others, current legislation (Hospital Structures Act, anti-corruption legislation).

Cost-effectiveness of preoperative SPECT/CT combined with lymphoscintigraphy vs. lymphoscintigraphy for sentinel lymph node excision in patients with cutaneous malignant melanoma.

PURPOSE: Malignant melanoma has become a major growing interdisciplinary problem in public health worldwide. Sentinel lymph node excision (SLNE) in conjunction with preoperative SPECT/CT is considered the most sensitive and specific staging test for the detection of micrometastatic melanoma in regional lymph nodes. Among patients with clinically lymph node-negative melanoma, the use of SPECT/CT-aided SLNE compared with SLNE alone has been found to be associated with a higher frequency of metastatic involvement and a higher rate of disease-free survival. The aim of this study was to analyse the cost-effectiveness of SLNE with preoperative SPECT/CT for detecting sentinel lymph nodes versus that of standard SLNE with preoperative lymphoscintigraphy from a single-institution database. METHODS: Cost-effectiveness analysis of two surgical approaches for SLNE for malignant melanoma at the University Hospital Essen, Skin Cancer Center in Essen, Germany. Between March 2003 and April 2011 464 patients eligible for SLNE were identified . Of these patients, 403 with clinically negative lymph nodes who underwent SLNE with or without preoperative SPECT/CT qualified for subsequent analysis. RESULTS: Between March 2003 and October 2008, 254 patients were operated upon with the standard technique. From November 2008, 149 patients underwent the SPECT/CT technique. Cost analysis showed a mean cost saving of 710.50 when SPECT/CT was added to preoperative imaging. This was achieved by a reduction in operative time (median, Q1;Q3, 40 min, 40;50 min, vs. 45 min, 35;60 min; p = 0.002), hospital stay duration (5 days, 3;8 days, vs. 8 days, 4.5;14.5 days; p < 0.001) and more frequent use of local anaesthesia (90.6 % vs. 70.5 %; p < 0.001). The median cost of SLNE using SPECT/CT was 1,619.7 (Q1;Q3 1,317.0;2,603.4) and of SLNE without SPECT/CT was 2,330.2 ( 1,468.3;4,058.1; p < 0.001), a cost saving of 30.5 %. CONCLUSION: In patients with cutaneous melanoma, the use of preoperative SPECT/CT-aided SLNE compared with standard SLNE was associated not only with higher detection of metastatic involvement but also with a significant cost reduction.

Safety and effectiveness of a Patient Blood Management (PBM) program in surgical patients--the study design for a multi-centre prospective epidemiologic non-inferiority trial.

BACKGROUND: Preoperative and hospital-acquired anaemia is common among surgical patients. It is associated with an increased risk of morbidity and mortality and a strong risk factor for allogeneic blood transfusions with their own inherent risks. Patient Blood Management (PBM) concepts aim to increase and preserve autologous erythrocyte volume and to optimise haemotherapy. They thus have great potential to benefit patients. METHODS/DESIGN: This prospective, multi-centre clinical trial tests the hypothesis that PBM programs are safe and effective in the care of adult surgical patients. Primary outcome is a composite endpoint of adverse events and in-hospital mortality. DISCUSSION: This trial will determine whether the implementation of a PBM program is safe and effective in terms of clinical outcome compared to a pre-implementation cohort. This trial is registered at www.clinicaltrials.gov (NCT01820949).

Assessment of cerebral P-glycoprotein expression and function with PET by combined [11C]inhibitor and [11C]substrate scans in rats.

INTRODUCTION: The adenosine triphosphate-binding cassette (ABC) transporter P-glycoprotein (Pgp) protects the brain from accumulation of lipophilic compounds by active efflux transport across the blood-brain barrier. Changes in Pgp function/expression may occur in neurological disorders, such as epilepsy, Alzheimer's or Parkinson's disease. In this work we investigated the suitability of the radiolabeled Pgp inhibitors [(11)C]elacridar and [(11)C]tariquidar to visualize Pgp density in rat brain with PET. METHODS: Rats underwent a first PET scan with [(11)C]elacridar (n = 5) or [(11)C]tariquidar (n = 6) followed by a second scan with the Pgp substrate (R)-[(11)C]verapamil after administration of unlabeled tariquidar at a dose which half-maximally inhibits cerebral Pgp (3 mg/kg). Compartmental modeling using an arterial input function and Logan graphical analysis were used to estimate rate constants and volumes of distribution (VT) of radiotracers in different brain regions. RESULTS: Brain PET signals of [(11)C]elacridar and [(11)C]tariquidar were very low (~0.5 standardized uptake value, SUV). There was a significant negative correlation between VT and K1 (i.e. influx rate constant from plasma into brain) values of [(11)C]elacridar or [(11)C]tariquidar and VT and K1 values of (R)-[(11)C]verapamil in different brain regions which was consistent with binding of [(11)C]inhibitors to Pgp and efflux of (R)-[(11)C]verapamil by Pgp. CONCLUSION: The small Pgp binding signals obtained with [(11)C]elacridar and [(11)C]tariquidar limit the applicability of these tracers to measure cerebral Pgp density. PET tracers with higher (i.e. subnanomolar) binding affinities will be needed to visualize the low density of Pgp in brain.

Assessment of perfusion in normal carpal bones with dynamic gadolinium-enhanced MRI at 3 Tesla.

PURPOSE: To investigate the normal enhancement patterns of the scaphoid, lunate, and capitate bones with dynamic contrast-enhanced magnetic resonance imaging (MRI). MATERIALS AND METHODS: The study was approved by the hospital's Ethics Committee. Nineteen volunteers (13 female, 6 male; mean age 38 years) were examined and all gave written consent. Perfusion was assessed at 3 Tesla using dynamic contrast-enhanced MRI. After two-dimensional (2D) motion correction of the data set, regions of interest were placed in the capitate, lunate, and distal and proximal pole of scaphoid bone and from the mean signal intensities (SI), the enhancement was computed. The four locations were compared for time to peak, delay time, maximum enhancement, and maximum slope using Friedman's two-way analysis of variance. RESULTS: Typical SI versus time curves revealed two components: a faster component with strong contrast enhancement and a slow component with prolonged enhancement. The mean value (standard deviation, SD) for maximum enhancement was 51 (33)% in the capitate, 54 (25)% in the lunate, 51 (34)% in the proximal pole and 51 (28)% in the distal pole of the scaphoid. The result of the Friedman test showed no significant difference (P < 0.05) in the perfusion variables between the capitate, lunate, and distal and proximal scaphoid bones. CONCLUSION: Assessment of perfusion in normal carpal bone using contrast-enhanced MRI is possible. Optimization of the method and understanding of the normal perfusion may allow evaluation of pathological conditions such as osteonecrosis.

[Blood--a special resource]. / Rationaler Einsatz von Blutprodukten - Blut - eine besondere Ressource.

Haemotherapy is an integral part of modern high-tech medicine. Without supportive care including red blood cell (RBC), platelet concentrate (PC) and fresh frozen plasma (FFP) transfusion, invasive therapies such as high-dose chemotherapy regimens for haematological and solid malignancies, haematopoietic stem cell (HSC) and solid organ transplantation as well as major surgery and modern trauma management would not be possible. In this article we describe the current state of haemotherapy, the risk of adverse effects and risk minimization measures, specifically focussing on haemolytic transfusion reactions (HTR), transfusion-related lung injury (TRALI) and transfusion-transmitted infections (TTI). Aided by the introduction of NAT technology for blood component screening, the residual risk of transfusion transmitted infections was reduced to 1:10.8 million for HCV, to 1:4.3 million for HIV-1, and to 1:360,000 for HBV for blood products of the German Red Cross Blood Service.

The impact of complications on costs of major surgical procedures: a cost analysis of 1200 patients.

OBJECTIVE: To assess the impact of postoperative complications on full in-hospital costs per case. BACKGROUND: Rising expenses for complex medical procedures combined with constrained resources represent a major challenge. The severity of postoperative complications reflects surgical outcomes. The magnitude of the cost created by negative outcomes is unclear. PATIENTS AND METHODS: Morbidity of 1200 consecutive patients undergoing major surgery from 2005 to 2008 in a tertiary, high-volume center was assessed by a validated, complication score system. Full in-hospital costs were collected for each patient. Statistical analysis was performed using a multivariate linear regression model adjusted for potential confounders. RESULTS: This study population included 393 complex liver/bile duct surgeries, 110 major pancreas operations, 389 colon resections, and 308 Roux-en-Y gastric bypasses. The overall 30-day mortality rate was 1.8%, whereas morbidity was 53.8%. Patients with an uneventful course had mean costs per case of US$ 27,946 (SD US$ 15,106). Costs increased dramatically with the severity of postoperative complications and reached the mean costs of US$ 159,345 (SD US$ 151,191) for grade IV complications. This increase in costs, up to 5 times the cost of a similar operation without complications, was observed for all types of investigated procedures, although the magnitude of the increase varied, with the highest costs in patients undergoing pancreas surgery. CONCLUSION: This study demonstrates the dramatic impact of postoperative complications on full in-hospital costs per case and that complications are the strongest indicator of costs. Furthermore, the study highlights a relevant savings capacity for major surgical procedures, and supports all efforts to lower negative events in the postoperative course.

Utility of routine versus selective upper gastrointestinal series to detect anastomotic leaks after laparoscopic gastric bypass.

BACKGROUND: In up to 4% of laparoscopic Roux-en-Y gastric bypass (LRYGB) procedures, anastomotic leaks occur. Early detection of gastrointestinal leakage is important for successful treatment. Consequently, many centers advocate routine postoperative upper gastrointestinal (UGI) series. The aim of this study was to determine the utility of this practice after LRYGB. METHODS: Eight hundred four consecutive patients undergoing LRYGB from June 2000 to April 2010 were analyzed prospectively. The first 382 patients received routine UGI series between the third and fifth postoperative days (group A). Thereafter, the test was only performed when clinical findings (tachycardia, fever, and drainage content) were suspicious for a leak of the gastrointestinal anastomosis (group B; n = 422). RESULTS: Overall, nine of 804 (1.1%) patients suffered from leaks at the gastroenterostomy. In group A, four of 382 (1%) patients had a leak, but only two were detected by the routine UGI series. This corresponds to a sensitivity of 50%. In group B, the sensitivity was higher with 80%. Specificities were comparable with 97% and 91%, respectively. Routine UGI series cost only 1.6% of the overall costs of a non-complicated gastric bypass procedure. With this leak rate and sensitivity, US $86,800 would have to be spent on 200 routine UGI series to find one leak which is not justified. CONCLUSIONS: This study shows that routine UGI series have a low sensitivity for the detection of anastomotic leaks after LRYGB. In most cases, the diagnosis is initiated by clinical findings. Therefore, routine upper gastrointestinal series are of limited value for the diagnosis of a leak.

Dose-response assessment of tariquidar and elacridar and regional quantification of P-glycoprotein inhibition at the rat blood-brain barrier using (R)-[(11)C]verapamil PET.

PURPOSE: Overactivity of the multidrug efflux transporter P-glycoprotein (P-gp) at the blood-brain barrier (BBB) is believed to play an important role in resistance to central nervous system drug treatment. (R)-[(11)C]verapamil (VPM) PET can be used to measure the function of P-gp at the BBB, but low brain uptake of VPM hampers the mapping of regional differences in cerebral P-gp function and expression. The aim of this study was to evaluate the dose-response relationship of two potent P-gp inhibitors and to investigate if increased brain uptake of VPM mediated by P-gp inhibition can be used to assess regional differences in P-gp activity. METHODS: Two groups of Sprague-Dawley rats (n = 12) underwent single VPM PET scans at 120 min after administration of different doses of the P-gp inhibitors tariquidar and elacridar. In an additional six rats, paired VPM PET scans were performed before and after administration of 3 mg/kg tariquidar. RESULTS: Inhibitor administration resulted in an up to 11-fold increase in VPM brain distribution volumes (DV) with half-maximum effective dose (ED(50)) values of 3.0 +/- 0.2 and 1.2 +/- 0.1 mg/kg for tariquidar and elacridar, respectively. In paired PET scans, 3 mg/kg tariquidar resulted in regionally different enhancement of brain activity distribution, with lowest DV in cerebellum and highest DV in thalamus. CONCLUSION: Our data show that tariquidar and elacridar are able to increase VPM brain distribution in rat brain up to 11-fold over baseline at maximum effective doses, with elacridar being about three times more potent than tariquidar. Regional differences in tariquidar-induced modulation of VPM brain uptake point to regional differences in cerebral P-gp function and expression in rat brain.

Assessment of regional differences in tariquidar-induced P-glycoprotein modulation at the human blood-brain barrier.

We attempted to assess regional differences in cerebral P-glycoprotein (P-gp) function by performing paired positron emission tomography (PET) scans with the P-gp substrate (R)-[(11)C]verapamil in five healthy subjects before and after i.v. infusion of tariquidar (2 mg/kg). Comparison of tariquidar-induced changes in distribution volumes (DVs) in 42 brain regions of interest (ROIs) failed to detect significant differences among brain ROIs. Statistical parametric mapping analysis of parametric DV images visualized symmetrical bilateral clusters with moderately higher DV increases in response to tariquidar administration in cerebellum, parahippocampal gyrus, olfactory gyrus, and middle temporal lobe and cortex, which might reflect moderately decreased P-gp function and expression.

Impact of clinical pathways in surgery.

BACKGROUND: One strategy to reduce the consumption of resources associated to specific procedures is to utilize clinical pathways, in which surgical care is standardized and preset by determination of perioperative in-hospital processes. The aim of this prospective study was to establish the impact of clinical pathways on costs, complication rates, and nursing activities. METHOD: Data was prospectively collected for 171 consecutive patients undergoing laparoscopic cholecystectomy (n = 50), open herniorrhaphy (n = 56), and laparoscopic Roux-en-Y gastric bypass (n = 65). RESULTS: Clinical pathways reduced the postoperative hospital stay by 28% from a mean of 6.1 to 4.4 days (p < 0.001), while the 30-day readmission rate remained unchanged (0.5% vs. 0.45%). Total mean costs per case were reduced by 25% from euro 6,390 to euro 4,800 (p < 0.001). Costs for diagnostic tests were reduced by 33% (p < 0.001). Nursing hours decreased, reducing nursing costs by 24% from euro 1,810 to euro 1,374 (p < 0.001). A trend was noted for lower postoperative complication rates in the clinical pathway group (7% vs. 14%, p = 0.07). CONCLUSIONS: This study demonstrates clinically and economically relevant benefits for the utilization of clinical pathways with a reduction in use of all resource types, without any negative impact on the rate of complications or re-hospitalization.

Resource utilisation and costs in patients with type 2 diabetes mellitus treated with insulin glargine or conventional basal insulin under real-world conditions in Germany: LIVE-SPP study.

OBJECTIVE: To assess and compare the total costs relevant to diabetes care in patients with type 2 diabetes mellitus (T2D) treated at specialised diabetes practices with either insulin glargine- or conventional basal insulin (neutral protamine Hagedorn [NPH])-based therapies from the German statutory health insurance (SHI) perspective. METHODS: The Long Acting Insulin Glargine Versus NPH Cost Evaluation in Specialised Practices (LIVE-SPP) study is an observational, retrolective, multicentre longitudinal cost comparison in adults with T2D. Costs were evaluated from the German SHI perspective based on official 2005 prices. Average total costs per patient for insulin glargine-versus NPH-based therapies were compared using multivariate general linear modelling. Sensitivity analyses were performed by varying the main cost factors by +/- 25%. RESULTS: Patients (n=1,024, 512 patients per cohort) were on average 62 years of age, with an average 8-year diabetes history at study start. The average unadjusted total annual costs per patient were euro 1,868.41 (95% CI 1,744.27-1,992.56) for insulin glargine-based vs. euro 2,063.72 (95% CI 1,922.91-2,204.54) for NPH-based therapies. Average adjusted total annual costs per patient between insulin glargine- (euro 1,241.13) and NPH-based therapies (euro 1,607.86) were statistically significantly different (p=0.0004). The economic advantage for insulin glargine-based therapies resulted mainly from fewer blood glucose measurements and other diabetes-related materials (e.g. needles). The savings remained stable in one-way sensitivity analyses. CONCLUSIONS: The LIVE-SPP study suggests that insulin glargine-based therapies may offer an economic advantage over NPH-based therapies.