bluuebunny/crossref_metadata_2025 huggingface dataset:
Simultaneous Transurethral Resection of Bladder Tumour and Prostate: Is It Safe?
Authors: Kouriefs Chryssanthos , Loizides Sofronis , Mufti Gulzar
Published: September 2008

Objectives: This study aims to review and assess the safety of carrying out transurethral resection of prostate (TURP) and transurethral resection of bladder tumour (TURBT) simultaneously, in men who require TURP for bladder outflow obstruction and are incidentally found to have a transitional cell carcinoma of the bladder. Methods: A detailed Medline search between 1966 and 2005 identified only five published papers in the English literature addressing this subject. These were retrospective studies of small numbers and were analysed together in order to quantify the risk of bladder cancer recurrence that could be attributed to TURP. The anatomical area of interest for tumour recurrence was hence the bladder neck and prostatic urethra. Results: 424 patients had simultaneous TURBT and TURP, whereas 350 had TURBT alone. The rate of recurrence of bladder tumour in these two groups of patients was 58 and 63%, respectively. The recurrence rate at the bladder neck and prostatic urethra was equally comparable. Tumour grade and multiplicity do not appear to influence the tumour recurrence rate when TURP is carried out at the same time as TURBT. Conclusions: There is paucity of clinical evidence to support the theoretical risk of tumour cell implantation at the bladder neck and prostatic urethra when TURP is carried out at the time of TURBT.
Comparative Analysis of the Reproducibility and Applicability of the Condom Catheter Method for Noninvasive Urodynamics in Two Dutch Centers
Authors: Huang Foen Chung J.W.N.C. , Spigt M.G. , Knottnerus J.A. , van Mastrigt R.
Published: September 2008

Objectives: We compared the applicability and reproducibility of the condom catheter method for noninvasive urodynamics in two Dutch studies. Materials and Methods: A longitudinal study of changes in bladder contractility secondary to benign prostatic enlargement is taking place at the Erasmus MC in Rotterdam. Volunteers aged 38–77 years will be studied three times in 5 years. The first series of measurements has been completed in 1,020 men. A randomized controlled trial to test the effect of additional water intake on bladder function has been completed at the University of Maastricht. 184 subjects aged 55–77 years with International Prostate Symptom Scores of 8–19 were investigated twice in 6 months. Bladder contractility was measured noninvasively with the condom method. Two consecutive measurements were attempted in each subject. Reproducibility was tested according to Bland and Altman and compared by calculating the normalized standard deviation of the differences by dividing by the difference. Results: The success rate for single measurements was 95% in both studies. The success rates for double measurements varied from 87 to 90%. The normalized standard deviation of the differences between the double measurements was 0.15 for the longitudinal noninvasive study and randomized controlled trial at baseline, and 0.13 for the randomized controlled trial at 6 months. Conclusion: Both studies showed good reproducibility of the noninvasive method comparable to invasive urodynamics.
Clinical Significance of Urodynamic Analysis in Patients with Benign Prostatic Enlargement Complicated with Diabetes Mellitus
Authors: Zhang Keqin , Xu Zhishun , Zhang Jing , Wang Haixin , Zhang Dongqing , Shi Benkang
Published: September 2008

Aim: To compare the bladder dysfunction associated with benign prostatic enlargement (BPE) in patients with and without diabetes mellitus (DM) by urodynamic study. Materials and Methods: The records of 166 first-visit BPE patients were reviewed. Patients were divided into two groups: concomitant group (CG) – 74 patients with BPE complicated with DM, and single group (SG) – 92 isolated BPE patients. Urodynamic findings of the two groups were analyzed. Results: In the clinical data, increased postvoiding residual urine volume (PVR) appeared more often in CG (p < 0.05). In the urodynamic findings, significantly higher maximum cystometric capacity (MCC), incidence of impaired bladder sensation, bladder compliance and detrusor overactivity existed in CG (p < 0.05). In addition, the maximum detrusor pressure during voiding (Pdetmax) and the incidence of bladder outlet obstruction (BOO) were significantly higher in SG (p < 0.05). Conclusions: Impaired bladder function is more severe in patients with BPE complicated with DM than those isolated BPE patients. Urodynamic study can provide objective data on diagnosis of voiding dysfunction in BPE patients with and without DM, and it is helpful for doctors to choose better clinical intervention.
Sensitivity and Specificity of One-Hour Pad Test as a Predictive Value for Female Urinary Incontinence
Authors: Costantini Elisabetta , Lazzeri Massimo , Bini Vittorio , Giannantoni Antonella , Mearini Luigi , Porena Massimo
Published: September 2008

Aim: To analyze the sensitivity and specificity of the 1-hour pad test, as suggested by the International Continence Society, in the diagnosis of female urinary incontinence. Methods: 158 female patients, with or without urinary incontinence, underwent a 1-hour pad test. The pad test was assessed as positive or negative and pad weight was recorded. Uni- and multivariate analysis investigated correlation with age, body mass index (BMI), symptoms, prolapse grade, urinary incontinence grade and type, number of pads daily, urodynamic variables and Urogenital Distress Inventory and Incontinence Impact Quality of Life questionnaires. Results: A positive 1-hour pad test was significantly associated with urinary incontinence grade, with a positive stress test, with detrusor overactivity (DO), urine leakage and a positive Valsalva leak point pressure at urodynamics. The association between presence/absence of incontinence and DO, stress test, urine leakage and pad weight had 83% sensitivity and 89% specificity in predicting urinary incontinence. When the 1-hour pad test result was added to stress test and urine leakage versus presence/absence of incontinence, the sensitivity was 90%, and specificity 65%. Conclusions: Our data seem to confirm the 1-hour pad test has poor predictive value in the diagnosis of female urinary incontinence when associated to stress test and urine leakage.
Extracorporeal Magnetic Innervation for the Treatment of Stress Urinary Incontinence: Results of Two-Year Follow-Up
Authors: Hoşcan M.B. , Dilmen C. , Perk H. , Soyupek S. , Armağan A. , Tükel O. , Ekinci M.
Published: September 2008

Introduction: Extracorporeal magnetic innervation (ExMI) is a relatively new technology used for pelvic muscle strengthening for the treatment of stress urinary incontinence. We aimed to evaluate the clinical efficacy of extracorporeal magnetic stimulation for the treatment of stress urinary incontinence. Materials and Methods: A total of 30 patients with demonstrable stress urinary incontinence were enrolled in this study. All were neurologically normal with normal urinalysis and none was pregnant. Evaluation before treatment included 3-day bladder diaries, a dynamic pad weight test, urodynamics, and a validated quality of life survey. Treatment sessions lasted 20 min, twice a week, for 6 weeks. After ExMI, all measures were repeated at follow-up including 3-day bladder diary, dynamic pad weight test, urodynamics and quality of life survey. The follow-up was done at 3, 12 and 24 months after ExMI therapy but urodynamics were performed only at first follow-up. Results: After ExMI therapy, 8 out of the 27 patients were cured (29.7%) and 13 patients were improved (48.1%) at 3 months. The cumulative success rate was 77.8%. Six patients did not show any improvement after treatment. Pad weight was reduced from 14.4 ± 10.7 to 6.5 ± 5.1 g. The mean score of quality of life survey at baseline was 61.6 and this increased to 75.4 at 12 weeks. The effect of ExMI approximately continued until the 1st year after therapy but gradually decreased and came close to baseline at the 2nd year after therapy. Conclusion: As a result, ExMI therapy offers a new effective modality for pelvic floor muscle stimulation. ExMI also offers a noninvasive, effective and painless treatment for women with stress urinary incontinence. Further studies are needed to address how long the therapy will continue and benefits will last and whether retreatment or continuation therapy sessions will be necessary.
Proximal Ureteral Calculi: Shock Wave or Ureterolithotripsy?
Authors: Pedro Renato N. , Netto, Jr. Nelson Rodrigues
Published: September 2008

Objective: To compare the success rates and efficiency of ureterolithotripsy (URL) and extracorporeal shock wave lithotripsy (SWL) for proximal ureteric stones. Casuistry and Methods: A prospective non-randomized study was performed between 1999 and 2004. Of a total of 235 patients, 121 underwent SWL and 114 had ureteroscopy with ultrasonic lithotripsy. There were no significant differences between the groups. The success rate, operative time, postoperative pain and complications were analyzed in each group. Patients were followed postoperatively for a minimum of 3 months (median 6 months).Results: Treatment success rate was defined as the complete removal or as the radiographic absence of calculi at a 3-month follow-up. The URL success rate was 85.6% (98/114) and 89.5% (68/95) after one SWL session and (77/85) 90.6% after a second treatment. No differences were found in the results, overall complication rates and mean procedure time. However, the fluoroscopy time was longer in the URL group and pain was more frequent. Conclusions: Semirigid URL is as efficient as SWL in the treatment for proximal ureteral stone. However, SWL requires less fluoroscopic time and fewer pain relievers.
Bilateral Single-Session Ureteroscopy with Pneumatic Lithotripsy for Bilateral Ureter Stones: Feasible and Safe
Authors: Gunlusoy Bulent , Degirmenci Tansu , Arslan Murat , Kozacıoğlu Zafer , Nergiz Nihat , Minareci Suleyman , Ayder Ali Riza
Published: September 2008

Introduction: To evaluate the feasibility and safety of bilateral single-session ureteroscopy in the treatment of bilateral stones with different localizations. Materials and Methods: Between February 2001 and October 2006, a total of 1,296 patients underwent ureteroscopy with pneumatic lithotripsy. Of these, 38 patients (2.9%) had bilateral ureter stones. The stones were located in the lower, middle and upper ureter in 44 (57.9%), 21 (27.6%) and 11 (14.5%) of the cases, respectively. Fifty-one stones (67.1%) were less than 1 cm. Results: Of the 76 stones, 67 (88.1%) were fragmented in a single procedure. The stone clearance rate was 93.1% after the second session. According to the localization of the stones, the stone clearance rate after single endoscopic session was 72.7% for upper ureteral calculi, 80.9% for midureter and 95.4% for lower ureter stones. For patients with calculi less than 1 cm and greater than 1 cm, the initial stone-free rate after ureteroscopy was 94.1% (48 of 51) and 76% (19 of 25), respectively (p < 0.05). No major complication was observed. Conclusions: Bilateral single-session pneumatic lithotripsy can be performed safely and has high success rates with minimal morbidity and short hospital stay.
To Cohen and Forget? Evaluation of Postoperative Imaging Studies after Transtrigonal Ureteric Reimplantation for Vesicoureteric Reflux in Children
Authors: Falkensammer Markus L. , Gobet Rita , Stauffer Urs G. , Weber Daniel M.
Published: September 2008

Objectives: To determine the clinical significance of routine postoperative voiding cystourethrography (VCUG) and renal functional studies in the postoperative management of children after a transtrigonal ureteric reimplantation. Methods: A retrospective record review of 126 consecutive patients undergoing transtrigonal ureteric reimplantation. Inclusion criteria included primary reflux and >5 years of follow-up. Follow-up imaging studies consisted of serial renal ultrasounds (US) and one VCUG and intravenous urogram (IVU) each. Results: Of 126 patients, 2 required a reoperation for contralateral reflux and pyelonephritis. In all other patients the results of the VCUG did not alter management. Dilatation seen in IVU was always visible in the renal US as well and always resolved spontaneously. No new dilatation was observed after 1 year of follow-up. Conclusions: Routine postoperative VCUG and renal functional studies are not warranted in asymptomatic patients after transtrigonal reimplantation. Only in patients with postoperative pyelonephritis did the imaging studies alter the treatment. In the majority of patients, follow-up with an early and 1-year renal US may suffice. Elimination of routine VCUG and functional studies will decrease morbidity and cost after ureteric reimplantation.
Activation of TAFI on the Surface of Streptococcus pyogenes Evokes Inflammatory Reactions by Modulating the Kallikrein/Kinin System
Authors: Bengtson Sara H. , Sandén Caroline , Mörgelin Matthias , Marx Pauline F. , Olin Anders I. , Leeb-Lundberg L.M. Fredrik , Meijers Joost C.M. , Herwald Heiko
Published: September 2008

Bacteria-controlled regulation of host responses to infection is an important virulence mechanism that has been demonstrated to contribute to disease progression. Here we report that the human pathogen Streptococcus pyogenes employs the procarboxypeptidase TAFI (thrombin-activatable fibrinolysis inhibitor) to modulate the kallikrein/kinin system. To this end, bacteria initiate a chain of events starting with the recruitment and activation of TAFI. This is followed by the assembly and induction of the contact system at the streptococcal surface, eventually triggering the release of bradykinin (BK). BK is then carboxyterminally truncated by activated TAFI, which converts the peptide from a kinin B2 receptor ligand to a kinin B1 receptor (B1R) agonist. Finally, we show that streptococcal supernatants indirectly amplify the B1R response as they act on peripheral blood mononuclear cells to secrete inflammatory cytokines that in turn stimulate upregulation of the B1R on human fibroblasts. Taken together our findings implicate a critical and novel role for streptococci-bound TAFI, as it processes BK to a B1R agonist at the bacterial surface and thereby may redirect inflammation from a transient to a chronic state.
Cellular Protein TIA-1 Regulates the Expression of HBV Surface Antigen by Binding the HBV Posttranscriptional Regulatory Element
Authors: Tang Hua , Huang Ying , Chen Jing , Yu Chao , Huang Ai-long
Published: September 2008

Objective: To identify T-cell intracellular antigen 1 (TIA-1) interacting with the posttranscriptional regulatory element (PRE) of hepatitis B virus (HBV), and reveal TIA-1 function on HBV gene expression. Methods: In order to demonstrate TIA-1 binding to PRE, electrophoretic mobility shift and RNA and protein pull-down assays were used. The pDM138-PRE reporter system, HepG2.2.15 cell line and HBs-PRE transient expression cells were adopted to identify TIA-1 function in the HBV life cycle. Results: TIA-1 could directly bind to PRE RNA. The functional binding region of TIA-1 was identified. Functional analysis indicated that TIA-1 could dose-dependently inhibit PRE function in pDM138-PRE system. Down-expression of HBs antigen induced by TIA-1 was detected both in the HepG2.2.15 cell line and in HBs-PRE transient expression cells. Conclusion: These data demonstrated that TIA-1 inhibits HBs expression by interacting with PRE.
Clinical Features Associated with Early Hospital Arrival after Acute Intracerebral Hemorrhage: Challenges for New Trials
Authors: Valiente Raul Alberto , Araújo de Miranda-Alves Maramélia , Sampaio Silva Gisele , Laranja Gomes Daniela , Dozzi Brucki Sonia Maria , Guimarães Rocha Maria Sheila , Massaro Ayrton Roberto
Published: September 2008

Background: Early hospital admission followed by correct diagnosis with minimum delay is a prerequisite for successful new interventions in acute intracerebral hemorrhage (ICH). The aim of this study was to evaluate clinical features associated with early hospital arrival in ICH patients and their influence on the outcome. Methods: Data from all patients arriving within 24 h of the ICH onset were prospectively collected at 2 stroke centers in São Paulo, Brazil. The cutoff of 3 h was chosen to select 2 groups: 0–3 h (early) and >3–24 h (late). Results: We identified 91 ICH patients (mean age 57.9 years, 62% men, 63% white) admitted within the first 24 h of symptom onset between March 2004 and April 2005. Systolic blood pressure, mean arterial pressure and pulse pressure were significantly higher in patients arriving within 3 h. Patients that arrived early also had a higher NIHSS score (p = 0.003), a lower Glasgow Coma Score (p = 0.001) and presence of intraventricular hemorrhage (p = 0.02). Lower ICH scores were more frequent in those that arrived late. Fourteen patients showed hematoma enlargement and the majority of them (n = 13) were admitted within the first 3 h from symptom onset (p = 0.01). Patients who arrived within the 3-hour window had a higher 30-day mortality (p = 0.0008) and a worse Rankin score after 6 months (p = 0.001). Conclusions: Treatment decisions in acute ICH may need to establish new combined approaches to maximize the number of eligible patients for early therapy considering the interactions between independent outcome predictors presented at early onset.
P27 and P53 Gene Polymorphisms and Restenosis following Coronary Implantation of Drug-Eluting Stents
Authors: Tiroch K. , Koch W. , Mehilli J. , Böttiger C. , Schömig A. , Kastrati A.
Published: September 2008

Objective: Drug-eluting stents (DES) have reduced restenosis rates compared with bare-metal stents. P27 and P53 play important roles in the signal transduction leading to neointimal growth inhibition and induction of apoptosis of smooth muscle cells due to rapamycin and paclitaxel. We hypothesized that genetic variants of P27 and P53 influence the development of restenosis and the clinical outcome of patients receiving DES. Methods: Polymorphisms in the genes encoding for P27 and P53 were tested for their association with restenosis and major adverse cardiac events. P27 C-79T and P53 G72C polymorphism genotypes were determined in a series of 433 consecutive patients receiving DES. Follow-up angiography after 6 months was performed in 87% of the patients. Genotyping was performed with PCR-based methods. Results: For patients with the respective P27 C-79T and P53 G72C genotypes, the angiographic restenosis rates were between 5.0 and 22.0%, and the clinical restenosis rates were between 0.0 and 16.3%, without significant differences for the studied genotypes (p > 0.19). There was no association of the studied genotypes with the 1-year incidences of death and myocardial infarction. Conclusion: This study could not demonstrate a clinically relevant role of P27 and P53 polymorphisms in the processes leading to in-stent restenosis.
Aspiration of Hypertensive Intracerebral Hematoma with Frameless and Fiducial-Free Navigation System: Technical Note and Preliminary Result
Authors: Chen Chien-hua , Lee Hsu-tung , Shen Chiung-chyi , Sun Ming-hsi
Published: September 2008

Stereotactic aspiration of hematoma is an effective method for the treatment of basal ganglia hematoma. Hematoma aspiration with a frameless navigation system using external fiducials has been published in the literature. But the literature is lacking in the use of a fiducial-free method for frameless aspiration of hematoma. We report an effective and safe method for the aspiration of intracerebral hematoma with a frameless and fiducial-free navigation system. Methods: Six patients with hypertensive basal ganglia hematoma underwent stereotactic aspiration of hematoma with a frameless and fiducial-free navigation system during January 2007 to April 2007. Patient registration to 3D data was done with surface matching. An articulated holder was used to maintain the trajectory. A catheter was inserted into the hematoma through the trajectory. Urokinase was injected into the hematoma. CT scan was performed after a few days of hematoma drainage. The pre- and postoperative hematoma volume and neurological function were compared. Results: The patients’ GCS improved from an average of 11.25 to an average of 14.83 after several days of hematoma drainage. Brain CT carried out after several days of drainage showed a 68–100% (average 79.3%) reduction of hematoma. No surgery-induced complication was noted. Conclusion: The use of a frameless and fiducial-free navigation system appears to be a time-efficient, safe, and effective method for the aspiration of hypertensive intracerebral hematoma.
Endocrine Response after Gamma Knife-Based Stereotactic Radiosurgery for Secretory Pituitary Adenoma
Authors: Tinnel Brent A. , Henderson Mark A. , Witt Thomas C. , Fakiris Achilles J. , Worth Robert M. , Des Rosiers Paul M. , Edmondson James W. , Timmerman Robert D. , Lo Simon S.
Published: September 2008

Purpose: To examine treatment outcomes of Gamma Knife-based stereotactic radiosurgery (GK-based SRS) for secretory pituitary adenomas. Materials and Methods: 25 patients were treated with GK-based SRS for secretory pituitary adenomas with ≧12 months of follow-up. Results: For prolactinomas, 2 of 4 patients (50%) showed normalization of serum prolactin at a mean time of 18 months. One of 4 had a ≧50% decrease but still abnormal prolactin levels. For adrenocorticotrophic hormone-secreting tumors, 6 of 12 patients (50%) showed normalization of their endocrine levels at a median of 10 months. An additional 2 (17%) had a ≧50% decrease. For growth hormone-secreting tumors, 4 of 9 patients (44%) showed normalization of endocrine levels at a median time of 30 months. Two patients (22%) had ≧50% lower but abnormal endocrine levels. Conclusion: GK-based SRS provides a reasonable rate of endocrine normalization of secretory pituitary adenoma. The time to endocrine response is shorter than reported for fractionated external beam radiotherapy. There is a low risk of optic neuropathy.
The Genetics of Nephrolithiasis
Authors: Sayer John A.
Published: September 2008

Renal stone formation (nephrolithiasis) is a worldwide problem causing substantial morbidity and economic burden. The heritability of stone formation has long been recognized, and with the advent of the genomic era, we have the potential to define the underlying genetic defects. Renal stone formation is multifactorial, with environmental factors interacting with underlying genetic factors. Isolated genetic defects and single gene disorders which lead to stone formation have been valuable in defining renal pathophysiology, but these remain rare diseases. In this review, we examine the genetics of nephrolithiasis by considering the genetic components of defined metabolic risk factors. Hypercalciuria is the most important risk factor for calcium stone formation, although hyperoxaluria, cystinuria and other rarer defects are discussed. It is important to consider the complexity of this condition, and realize that the understanding of the genetic basis of nephrolithiasis is within our grasp.
1,25-Dihydroxy Vitamin D3 Is an Autocrine Regulator of Extracellular Matrix Turnover and Growth Factor Release via ERp60-Activated Matrix Vesicle Matrix Metalloproteinases
Authors: Boyan B.D. , Schwartz Z.
Published: September 2008

As growth plate chondrocytes mature and hypertrophy, they reorganize their proteoglycan-rich type II collagen extracellular matrix (ECM), involving 1,25(OH)2D3-dependent regulation of matrix metalloproteinases (MMPs). Stromelysin-1 (MMP-3) and 72-kD gelatinase (MMP-2) are found in extracellular matrix vesicles (MVs) and release and activate ECM-bound latent TGF-β1 and TGF-β2, respectively. 1,25(OH)2D3 regulates incorporation of MMP-2 and MMP-3 into MVs and release of these enzymes in the ECM. Plasma membranes (PMs) and MVs contain the 1α,25(OH)2D3 membrane receptor ERp60 (protein disulfide isomerase A3), phospholipase A2 (PLA2), PLA2-activating protein, the nuclear vitamin D receptor and caveolin-1. 1,25(OH)2D3 secreted by chondrocytes binds MV ERp60, activating PLA2. Resulting lysophospholipids destabilize MV membranes, releasing active MMPs. We examined 1,25(OH)2D3-dependent activation of latent TGF-β1 stored in cartilage ECM. Interestingly, TGF-β1 regulates 1,25(OH)2D3 production. 1α,25(OH)2D3 activates PM protein kinase C (PKC)-α via ERp60-dependent PLA2-signaling, lysophospholipid production and phospholipase C-γ. It also regulates distribution of phospholipids and PKC isoforms between MVs and PMs, enriching MVs in PKC-ζ. Direct activation of MV MMP-3 requires ERp60 based on blocking antibodies and PKC based on inhibitor studies. However, treatment of MVs with 1,25(OH)2D3 decreases MV PKC-ζ activity, suggesting more complex feedback mechanisms, potentially involving MV lipid signaling. Our observations indicate that one role of MVs is to provide MMPs at sites distant from the cells. Chondrocytes secrete 1,25(OH)2D3, which acts directly on MV-membranes via ERp60, releasing MMPs. MMP-specific ECM components are hydrolyzed, resulting in release and activation of growth factors that can act back on the cells.
Greater Clinical Benefit of More Intensive Oral Antiplatelet Therapy With Prasugrel in Patients With Diabetes Mellitus in the Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition With Prasugrel–Thrombolysis in Myocardial Infarction 38
Authors: Wiviott Stephen D. , Braunwald Eugene , Angiolillo Dominick J. , Meisel Simha , Dalby Anthony J. , Verheugt Freek W.A. , Goodman Shaun G. , Corbalan Ramon , Purdy Drew A. , Murphy Sabina A. , McCabe Carolyn H. , Antman Elliott M.
Published: September 2008

Background—

Patients with diabetes mellitus (DM) are at high risk for recurrent cardiovascular events after acute coronary syndromes, in part because of increased platelet reactivity. The Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition With Prasugrel–Thrombolysis in Myocardial Infarction 38 (TRITON-TIMI 38) showed an overall reduction in ischemic events with more intensive antiplatelet therapy with prasugrel than with clopidogrel but with more bleeding. We compared prasugrel with clopidogrel among subjects with DM in TRITON-TIMI 38.

Methods and Results—

We classified 13 608 subjects on the basis of preexisting history of DM and further according to insulin use. Prespecified analyses of the primary (cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) and key secondary end points, including net clinical benefit (death, nonfatal myocardial infarction, nonfatal stroke, and nonfatal TIMI major bleeding) were compared by use of the log-rank test. We found that 3146 subjects had a preexisting history of DM, including 776 receiving insulin. The primary end point was reduced significantly with prasugrel among subjects without DM (9.2% versus 10.6%; hazard ratio [HR], 0.86;
P
=0.02) and with DM (12.2% versus 17.0%; HR, 0.70;
P
<0.001,
P
interaction
=0.09). A benefit for prasugrel was observed among DM subjects on insulin (14.3% versus 22.2%; HR, 0.63;
P
=0.009) and those not on insulin (11.5% versus 15.3%; HR, 0.74;
P
=0.009). Myocardial infarction was reduced with prasugrel by 18% among subjects without DM (7.2% versus 8.7%; HR, 0.82;
P
=0.006) and by 40% among subjects with DM (8.2% versus 13.2%; HR, 0.60;
P
<0.001,
P
interaction
=0.02). Although TIMI major hemorrhage was increased among subjects without DM on prasugrel (1.6% versus 2.4%; HR, 1.43;
P
=0.02), the rates were similar among subjects with DM for clopidogrel and prasugrel (2.6% versus 2.5%; HR, 1.06;
P
=0.81,
P
interaction
=0.29). Net clinical benefit with prasugrel was greater for subjects with DM (14.6% versus 19.2%; HR, 0.74;
P
=0.001) than for subjects without DM (11.5% versus 12.3%; HR, 0.92;
P
=0.16,
P
interaction
=0.05).

Conclusions—

Subjects with DM tended to have a greater reduction in ischemic events without an observed increase in TIMI major bleeding and therefore a greater net treatment benefit with prasugrel compared with clopidogrel. These data demonstrate that the more intensive oral antiplatelet therapy provided with prasugrel is of particular benefit to patients with DM.
Managing Referrals for Children with Receptive Language Delay
Authors: Fagan Mary K. , Montgomery Thomas R.
Published: August 2008

This study investigates relations between language and cognitive scores in children with receptive language (RL) delay and suggests guidelines for referral for cognitive testing. This retrospective review of the test scores of 41 children, ages 17 to 76 months (mean = 37.7 months), focuses on examining associations between RL and cognitive scores. Results show that mean RL scores are positively correlated with mean cognitive scores and that receptive scores are significant predictors of cognitive performance. Children with RL scores of >1 standard deviation below the mean are at risk for concomitant cognitive deficits. Because children with RL delay are at considerable risk for cognitive deficits, the authors recommend considering referral for cognitive testing when RL standard scores fall below 85.
The Convergent, Discriminant, and Incremental Validity of Scores on a Self-Report Measure of Cultural Intelligence
Authors: Ward Colleen , Fischer Ronald , Zaid Lam Fara Sheyna , Hall Leonie
Published: August 2008

The article reports the results of three studies designed to extend the psychometric analyses of cultural intelligence (CQ) and to examine its utility in the prediction of cross-cultural adaptation. The first study supported the proposed four-factor (Cognitive, Meta-cognitive, Motivational, and Behavioral) structure of CQ in a large sample of international students ( N = 346). The second study ( N = 118) revealed a strong correlation (r = .82) between CQ and emotional intelligence and failed to support the incremental validity of CQ scores in the prediction of psychological, sociocultural, and academic adaptation in international students. The final study ( N = 102) established discriminant validity ( r = .04) between scores of CQ and a test of general cognitive ability (Raven's Advanced Progressive Matrices) and convergent validity across scores of the CQ and Multicultural Personality Questionnaire subscales; however, CQ scores did not demonstrate additional incremental validity in the prediction of adaptive outcomes. The results are discussed in relation to issues arising from the use of self-report measures for the assessment of cultural intelligence and the utility of the CQ measure in international and intercultural settings.
Generalizability of Scaling Gradients on Direct Behavior Ratings
Authors: Chafouleas Sandra M. , Christ Theodore J. , Riley-Tillman T. Chris
Published: August 2008

Generalizability theory is used to examine the impact of scaling gradients on a single-item Direct Behavior Rating (DBR). A DBR refers to a type of rating scale used to efficiently record target behavior(s) following an observation occasion. Variance components associated with scale gradients are estimated using a random effects design for persons (p) by raters (r) by occasions (o). Data from 106 undergraduate student participants are used in the analysis. Each participant viewed and rated video clips of six elementary-aged students who were engaged in a difficult task. Participant ratings are collected three times for each of two behaviors within three scale gradient conditions (6-, 10-, 14-point scale). Scale gradient does not substantially contribute to the magnitude of observed score variances. In contrast, the largest proportions of variance are attributed to rater and error across all scale gradient conditions. Implications, limitations, and future research considerations are discussed.
Fitting the Rasch Model to Account for Variation in Item Discrimination
Authors: Weitzman R.A.
Published: August 2008

Building on the Kelley and Gulliksen versions of classical test theory, this article shows that a logistic model having only a single item parameter can account for varying item discrimination, as well as difficulty, by using item–test correlations to adjust incorrect–correct (0–1) item responses prior to an initial model fit. The fit occurs through the application of least squares to the logits of the adjusted item responses. Iteration transforms each of the item–test correlations to an item–Θ correlation, of which the discrimination parameter a is shown to be a function. Comparing this response-adjusted model with the traditional Rasch model, a simulation study involving 10-, 20-, and 30-item tests showed that correlations of Θ estimates with their true values were uniformly higher for this model than for the Rasch model, whereas the reverse was true regarding b estimates. A hybrid of the two models proved to have the estimation advantages of both. Particularly notable in this study is that the correlation of Θ estimates with their true values was higher in the 20-item test using the response-adjusted or the hybrid model than in the 30-item test using the Rasch model for parameter estimation.
On the Use of Nonparametric Item Characteristic Curve Estimation Techniques for Checking Parametric Model Fit
Authors: Lee Young-Sun , Wollack James A. , Douglas Jeffrey
Published: August 2008

The purpose of this study was to assess the model fit of a 2PL through comparison with the nonparametric item characteristic curve (ICC) estimation procedures. Results indicate that three nonparametric procedures implemented produced ICCs that are similar to that of the 2PL for items simulated to fit the 2PL. However for misfitting items, especially nonmonotone items, the greatest difference is between the 2PL and kernel smoothing procedures. In general, the differences between ICCs from the nonparametric procedures and the 2PL are reduced as both sample size and test length increase. The false positive rate of the test for model fit is promising for nonparametric ICC estimation methods. Power to detect misfitting items simulated with 4PL is low. Power to detect nonmonotone items is generally much higher. Power is best for kernel smoothing but also good for isotonic regression in the medium to large sample sizes and longer test length conditions. Power for the smoothed isotonic regression is uniformly low.
Comparing Treatment and Control Groups on Multiple Outcomes
Authors: Lix Lisa M. , Deering Kathleen N. , Fouladi Rachel T. , Manivong Phongsack
Published: August 2008

This study considers the problem of testing the difference between treatment and control groups on m ≥ 2 measures when it is assumed a priori that the treatment group will perform better than the control group on all measures. Two procedures are investigated that do not rest on the assumptions of covariance homogeneity or multivariate normality: a likelihood ratio test based on a bootstrap critical value and a composite step-down procedure based on trimmed means. Type I error rates of both procedures are insensitive to assumption violations. Procedures that test a directional alternative hypothesis can be substantially more powerful than a procedure that tests a nondirectional hypothesis for certain configurations of the population mean vectors. The differences in average power of the investigated procedures are a function of the configuration of the population means, the magnitude of correlation among the outcome measures, and the shape of the population distribution.
Radiographic Investigation of the Effects of Ply Modification on Damage Development in Laminates Containing Circular Holes
Authors: Johnson W. Steven , Treasurer Paul
Published: September 2008

The goal of this research was to evaluate possible damage suppression in multi-directional notched laminates through the use of slightly off-axis longitudinal plies. These `non-traditional' laminates were compared to laminates with 0° longitudinal plies for quasi-isotropic and hard lay-ups, for open hole tension, filled hole tension, and single-shear bearing loadings. In-situ radiographic inspections were performed to evaluate damage initiation, progression, and suppression. In notched tension, the non-traditional laminates were less strong and stiff than their traditional counterparts, but X-ray images clearly showed the suppression of longitudinal splitting and delamination. Under single-shear bearing loads, the non-traditional laminates demonstrated increased bearing resistance compared to traditional laminates, and the non-traditional laminates were less prone to damage in the longitudinal plies.
Characterization of Oil Palm Empty Fruit Bunch (OPEFB) Fiber Reinforced PVC/ENR Blend
Authors: Chantara Thevy Ratnam  , Raju Gunasunderi , Nor Azowa Ibrahim  , Mohammad Zaki Ab Rahman  , Wan Md Zin WanYunus
Published: September 2008

Previous studies on the blends of poly(vinyl chloride), PVC and epoxidized natural rubber, ENR revealed that the two polymers are miscible at all compositional ranges. In this work, the effect of oil palm empty fruit bunch (OPEFB) fiber and poly(methyl acrylate) grafted OPEFB on the thermal and structural properties of PVC/ENR blends were investigated. The composites were prepared by mixing the fiber and the PVC/ENR blend using HAAKE Rheomixer at the rotor speed of 50 rpm, mixing temperature 150°C and mixing period of 20 min. Studies on dynamic mechanical analysis (DMA) indicate that the Tg of the PVC/ENR composites shifts to higher temperature with the addition of the OPEFB fiber. Thermogravimetric analysis (TGA) does not show any significant changes in the thermal stability of the composites. However, Fourier Transform Infra Red (FTIR) spectrometry did not reveal the exact nature of interaction involved in the composites.
Effect of Single and Repeated Doses of Ketoconazole on the Pharmacokinetics of Roflumilast and Roflumilast N‐Oxide
Authors: Lahu Gezim , Huennemeyer Andreas , von Richter Oliver , Hermann Robert , Herzog Rolf , McCracken Nigel , Zech Karl
Published: August 2008

Effects of single and multiple doses of oral ketoconazole on roflumilast and its active metabolite, roflumilast N‐oxide, were investigated in healthy subjects. In study 1, subjects (n = 26) received oral roflumilast 500 μg once daily for 11 days and a concomitant 200‐mg single dose of ketoconazole on day 11. In study 2, subjects (n = 16) received oral roflumilast 500 μg on days 1 and 11 and a repeated dose of ketoconazole 200 mg twice daily from days 8 to 20. Coadministration of single‐dose ketoconazole with steady‐state roflumilast increased the AUC of roflumilast by 34%; Cmaxwas unchanged. For roflumilast N‐oxide, AUC and Cmaxdecreased by 12% and 20%, respectively. Repeated doses of ketoconazole increased the AUC and Cmaxof roflumilast by 99% and 23%, respectively; for roflumilast N‐oxide, AUC was unchanged, and Cmaxdecreased by 38%. No clinically relevant adverse events were observed. Coadministration of ketoconazole and roflumilast does not require dose adjustment of roflumilast.
Near‐Thorough QT Study as Part of a First‐In‐Man Study
Authors: Malik Marek , Hnatkova Katerina , Ford John , Madge David
Published: August 2008

Detailed electrocardiographic (ECG) support was provided to a first‐in‐man, single‐ascending‐dose study that included 6 cohorts of 8 male volunteers each. In each cohort, 6 and 2 subjects received active compound and placebo, respectively. Long‐term 12‐lead ECGs were obtained on baseline day −1, dosing day 1, and day 2. Automatic QT‐interval measurements were made at 63 time points (28 at baseline and 35 on treatment). Based on QT/RR distribution, 20% of measurements were visually verified. Baseline‐corrected time‐matched ΔQTc values were obtained at 35 postdose time points. Placebo subjects of all cohorts were pooled. When 2 cohorts of the lowest, middle, and highest doses were pooled (12 subjects per active treatment group), the spreads of placebo‐corrected ΔΔQTc values were within the regulatory requirements (single‐sided 95% confidence interval <1 0 milliseconds) at all time points. Thus, this ECG support of the first‐in‐man study provided data of regulatory acceptable accuracy at a small fraction of the cost of a full thorough QT study.
Gender Has a Small but Statistically Significant Effect on Clearance of CYP3A Substrate Drugs
Authors: Greenblatt David J. , von Moltke Lisa L.
Published: August 2008

The role of gender on the disposition of drugs metabolized by cytochrome P4503A (CYP3A) remains controversial. Some sources suggest that CYP3A activity in women exceeds that in men, but evidence to support this position is inconsistent at best. We evaluated 38 data sets in which clearance of CYP3A substrate drugs was studied in healthy young male and young female subjects. None of these drugs was a substrate for transport by P‐glycoprotein (P‐gp). The overall mean (±SE) for the female/male ratio of weight‐normalized clearance was 1.26 (±0.07) for parenteral dosage and 1.17 (±0.07) for oral dosage. Both ratios were significantly different (P< .05) from 1.0. For oral dosage studies, the female/male clearance ratio was unrelated to the drug's absolute oral bioavailability. Thus gender has a small and statistically significant, although most likely clinically unimportant, influence on CYP3A phenotype for substrates not transported by P‐gp.
Measuring the Involvement of People with HIV in Treatment Decision Making Using the Control Preferences Scale
Authors: Kremer Heidemarie , Ironson Gail
Published: August 2008

Objectives. Since 1983, HIV patients have been advocating for participatory decision making. This study measures the involvement that HIV-positive people perceive in treatment decision making. A secondary objective is to assess the validity of the instrument used to examine decisional roles, the Control Preferences Scale (CPS). Method. The authors interviewed 79 HIV-positive people, a sub-sample of a study on long survival with HIV, diverse with respect to ethnicity, age, gender, and sexual orientation. They compared the self- and researcher-rated decisional roles of participants on the CPS. They also assessed how well the CPS corresponds with Charles's paternalistic, shared- and informed-choice models of decision making about treatment based on decisional roles and information exchange. Results. Most participants (75%) perceived collaborative/active involvement in decision making. Agreement (Kendall's tau-b ) between self- and researcher-rated decisional roles on the CPS was 0.82, whereas agreement between self-ratings on the CPS and researcher ratings on Charles's classification was 0.60. Charles's classification was difficult if participants had chosen not to take their prescribed medication without being adequately informed about the risky consequences of this decision. Conclusions. In this study, HIV-positive people perceived a high level of involvement in decision making. Reliability and convergent validity of the CPS was high. Charles's classification was problematic because decisional roles and information exchange are distinct dimensions. Some people make risky treatment decisions on their own without being adequately informed. The CPS is a useful instrument to measure decisional role perceptions of HIV-positive people but needs to be complemented by an instrument measuring treatment knowledge.
The Effect of Neuromuscular Electrical Stimulation of the Infraspinatus on Shoulder External Rotation Force Production after Rotator Cuff Repair Surgery
Authors: Reinold Michael M. , Macrina Leonard C. , Wilk Kevin E. , Dugas Jeffrey R. , Cain E. Lyle , Andrews James R.
Published: August 2008

Background

Muscle weakness, particularly of shoulder external rotation, is common after rotator cuff repair surgery. Neuromuscular electrical stimulation has been shown to be an effective adjunct in the enhancement of muscle recruitment.

Hypothesis

Shoulder external rotation peak force can be enhanced by neuromuscular electrical stimulation after rotator cuff repair surgery.

Study Design

Controlled laboratory study.

Methods

Thirty-nine patients (20 men, 19 women) who had undergone rotator cuff repair surgery were tested a mean of 10.5 days after surgery. Testing consisted of placing patients supine with the shoulder in 45° of abduction, neutral rotation, and 15° of horizontal adduction. Neuromuscular electrical stimulation was applied to the infraspinatus muscle belly and inferior to the spine of the scapula. Placement was confirmed by palpating the muscle during a resisted isometric contraction of the external rotators. Patients performed 3 isometric shoulder external rotation contractions with and without neuromuscular electrical stimulation, each with a 5-second hold against a handheld dynamometer. Neuromuscular electrical stimulation was applied at maximal intensity within comfort at 50 pulses per second, symmetrical waveform, and a 1-second ramp time. The 3 trials under each condition were recorded, and an average was taken. The order of testing was randomized for each patient tested. A paired samples t test was used to determine significant differences between conditions ( P < .05). Each group was also divided based on age, rotator cuff tear size, number of days postoperative, and neuromuscular electrical stimulation intensity. Analysis of variance Models were used to determine the influence of these variables on external rotation force production ( P < .05).

Results

Peak force production was significantly greater ( P < .001) when tested with neuromuscular electrical stimulation (3.75 kg) as opposed to without neuromuscular electrical stimulation (3.08 kg) for all groups tested. There was no significant difference based on the size of the tear, age of the patient, number of days after surgery, or level of neuromuscular electrical stimulation intensity.

Conclusion

Peak shoulder external rotation force was significantly increased by 22% when tested with neuromuscular electrical stimulation after rotator cuff repair surgery. Neuromuscular electrical stimulation significantly increased force production regardless of the age of the patient, size of the tear, intensity of the current, or the number of days postoperative.

Clinical Relevance

Neuromuscular electrical stimulation may be used concomitantly with exercises to enhance the amount of force production and potentially minimize the inhibition of the rotator cuff after repair surgery.