Home About us Contact
|
Home About us Contact | ||
|
|
||
Prospective Multicenter Study (prospective + multicenter_study)
Selected AbstractsProspective Multicenter Study of Bronchiolitis: Predictors of an Unscheduled Visit After Discharge From the Emergency DepartmentACADEMIC EMERGENCY MEDICINE, Issue 4 2010Agatha Norwood MD Abstract Objectives:, There is little evidence about which children with bronchiolitis will have worsened disease after discharge from the emergency department (ED). The objective of this study was to determine predictors of post-ED unscheduled visits. Methods:, The authors conducted a prospective cohort study of patients discharged from 2004 to 2006 at 30 EDs in 15 U.S. states. Inclusion criteria were diagnosis of bronchiolitis, age <2 years, and discharge home; the exclusion criterion was previous enrollment. Unscheduled visits were defined as urgent visits to an ED/clinic for worsened bronchiolitis within 2 weeks. Results:, Of 722 patients eligible for the current analysis, 717 (99%) had unscheduled visit data, of whom 121 (17%; 95% confidence interval [CI] = 14% to 20%) had unscheduled visits. Unscheduled visits were more likely for children age <2 months (11% vs. 6%; p = 0.04), males (70% vs. 57%; p = 0.007), and those with history of hospitalization (27% vs. 18%; p = 0.01). The two groups were similar in other demographic and clinical factors (all p > 0.10). Using multivariable logistic regression, independent predictors of unscheduled visits were age <2 months, male, and history of hospitalization. Conclusions:, In this study of children age younger than 2 years with bronchiolitis, one of six children had unscheduled visits within 2 weeks of ED discharge. The three predictors of unscheduled visits were age under 2 months, male sex, and previous hospitalization. ACADEMIC EMERGENCY MEDICINE 2010; 17:376,382 © 2010 by the Society for Academic Emergency Medicine [source] Prospective Multicenter Study of the Viral Etiology of Bronchiolitis in the Emergency DepartmentACADEMIC EMERGENCY MEDICINE, Issue 2 2008Jonathan M. Mansbach MD Abstract Objectives:, To determine the viral etiology of bronchiolitis and clinical characteristics of children age < 2 years presenting to the emergency department (ED) with bronchiolitis. Methods:, The authors conducted a 14-center prospective cohort study during 2005,2006 of ED patients age < 2 years with bronchiolitis. The study was conducted in 10 states as part of the Emergency Medicine Network. Researchers collected nasopharyngeal aspirates and conducted structured interviews, medical record reviews, and 2-week follow-up telephone calls. Samples were tested using reverse transcription polymerase chain reaction for respiratory syncytial virus (RSV), rhinovirus (RV), human metapneumovirus (hMPV), and influenza viruses (Flu). Results:, Testing of 277 samples revealed 176 (64%) positive for RSV, 44 (16%) for RV, 26 (9%) for hMPV, 17 (6%) for Flu A, and none for Flu B. When children were categorized as RSV only, RV only, RV and RSV, and all others (hMPV, Flu, no identified virus), children with RV only were more likely to be African American (19, 62, 14, and 40%, respectively; p < 0.001) and have a history of wheezing (23, 52, 21, and 15%, respectively; p = 0.01). In multivariate models, children with RV were more likely to receive corticosteroids (odds ratio [OR] 3.5; 95% confidence interval [CI] = 1.5 to 8.15). The duration of illness may be shorter for children with RV (Days 8, 3, 6, and 8; p = 0.07). Conclusions:, In this multicenter study, RSV was the most frequent cause of bronchiolitis (64%). RV was present in 16%, and these children have a distinct profile in terms of demographics, medical history, and ED treatment. [source] Minimally Invasive Flapless Implant Surgery: A Prospective Multicenter StudyCLINICAL IMPLANT DENTISTRY AND RELATED RESEARCH, Issue 2005ODhc, William Becker DDS ABSTRACT Background: Placement of implants with a minimally invasive flapless approach has the potential to minimize crestal bone loss, soft tissue inflammation, and probing depth adjacent to implants and to minimize surgical time. Purpose: The aim of this multicenter study was to evaluate implant placement using a minimally invasive one-stage flapless technique up to 2 years. Materials and Methods: Fifty-seven patients ranging in age from 24 to 86 years were recruited from three clinical centers (Tucson, AZ, USA; Tel Aviv, Israel; Göteborg, Sweden). Seventy-nine implants were placed. A small, sharp-tipped guiding drill was used to create a precise, minimally invasive initial penetration through the mucosa and into bone (Nobel Biocare, Yorba, Linda, CA, USA). Implants were placed according to the manufacturer's instructions, with minimal countersinking. The parameters evaluated were total surgical time, implant survival, bone quality and quantity, implant position by tooth type, depth from mucosal margin to bone crest, implant length, probing depth, inflammation, and crestal bone changes. At 2 years, for 79 implants placed in 57 patients, the cumulative success rate using a minimally invasive flapless method was 98.7%, indicating the loss of 1 implant. Changes in crestal bone for 77 baseline and follow-up measurements were insignificant (radiograph 1: mean 0.7 mm, SD 0.5 mm, range 2.8 mm, minimum 0.2 mm, maximum 3.0 mm; radiograph 2: mean 0.8 mm, SD 0.5 mm, range 3.4 mm, minimum 0.12 mm, maximum 3.5 mm). Using descriptive statistics for 78 patients (one implant lost), mean changes for probing depth and inflammation were clinically insignificant. The average time for implant placement was 28 minutes (minimum 10 minutes, maximum 60 minutes, SD 13.1 minutes). Average depth from mucosal margin to bone was 3.3 mm (SD 0.7 mm, minimum 2 mm, maximum 5 mm, range 3 mm). Thirty-two implants were placed in maxillae and 47 in mandibles. Conclusions: The results of this study demonstrate that following diagnostic treatment planning criteria, flapless surgery using a minimally invasive technique is a predictable procedure. The benefits of this procedure are lessened surgical time; minimal changes in crestal bone levels, probing depth, and inflammation; perceived minimized bleeding; and lessened postoperative discomfort. [source] ,Rescue' Therapy with Rifabutin after Multiple Helicobacter pylori Treatment FailuresHELICOBACTER, Issue 2 2003Javier P. Gisbert abstract Aim. Eradication therapy with proton pump inhibitor, clarithromycin and amoxicillin is extensively used, although it fails in a considerable number of cases. A ,rescue' therapy with a quadruple combination of omeprazole, bismuth, tetracycline and metronidazole (or ranitidine bismuth citrate with these same antibiotics) has been recommended, but it still fails in approximately 20% of cases. Our aim was to evaluate the efficacy and tolerability of a rifabutin-based regimen in patients with two consecutive H. pylori eradication failures. Patients and Methods. Design: Prospective multicenter study. Patients: Consecutive patients in whom a first eradication trial with omeprazole, clarithromycin and amoxicillin and a second trial with omeprazole, bismuth, tetracycline and metronidazole (three patients) or ranitidine bismuth citrate with these same antibiotics (11 patients) had failed were included. Intervention: A third eradication regimen with rifabutin (150 mg bid), amoxicillin (1 g bid) and omeprazole (20 mg bid) was prescribed for 14 days. All drugs were administered together after breakfast and dinner. Compliance with therapy was determined from the interrogatory and the recovery of empty envelopes of medications. Outcome: H. pylori eradication was defined as a negative 13C-urea breath test 8 weeks after completing therapy. Results. Fourteen patients have been included. Mean age ± SD was 42 ± 11 years, 41% males, peptic ulcer (57%), functional dyspepsia (43%). All patients took all the medications and completed the study protocol. Per-protocol and intention-to-treat eradication was achieved in 11/14 patients (79%; 95% confidence interval = 49,95%). Adverse effects were reported in five patients (36%), and included: abdominal pain (three patients), nausea and vomiting (one patient), and oral candidiasis (one patient); no patient abandoned the treatment due to adverse effects. Conclusion. Rifabutin-based rescue therapy constitutes an encouraging strategy after multiple previous eradication failures with key antibiotics such as amoxicillin, clarithromycin, metronidazole and tetracycline. [source] Fall Prediction in Inpatients by Bedside Nurses Using the St. Thomas's Risk Assessment Tool in Falling Elderly Inpatients (STRATIFY) Instrument: A Multicenter StudyJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 5 2007Koen Milisen RN OBJECTIVES: To assess the predictive value of the St. Thomas's Risk Assessment Tool in Falling Elderly Inpatients (STRATIFY) instrument, a simple fall-risk assessment tool, when administered at a patient's hospital bedside by nurses. DESIGN: Prospective multicenter study. SETTING: Six Belgian hospitals. PARTICIPANTS: A total of 2,568 patients (mean age±standard deviation 67.2±18.4; 55.3% female) on four surgical (n=875, 34.1%), eight geriatric (n=687, 26.8%), and four general medical wards (n=1,006, 39.2%) were included in this study upon hospital admission. All patients were hospitalized for at least 48 hours. MEASUREMENTS: Nurses completed the STRATIFY within 24 hours after admission of the patient. Falls were documented on a standardized incident report form. RESULTS: The number of fallers was 136 (5.3%), accounting for 190 falls and an overall rate of 7.3 falls per 1,000 patient days for all hospitals. The STRATIFY showed good sensitivity (,84%) and high negative predictive value (,99%) for the total sample, for patients admitted to general medical and surgical wards, and for patients younger than 75, although it showed moderate (69%) to low (52%) sensitivity and high false-negative rates (31,48%) for patients admitted to geriatric wards and for patients aged 75 and older. CONCLUSION: Although the STRATIFY satisfactorily predicted the fall risk of patients admitted to general medical and surgical wards and patients younger than 75, it failed to predict the fall risk of patients admitted to geriatric wards and patients aged 75 and older (particularly those aged 75,84). [source] Extended Mechanical Circulatory Support With a Continuous-Flow Rotary Left Ventricular Assist DeviceCONGESTIVE HEART FAILURE, Issue 2 2010Scott Harris DO Background LVAD therapy is an established treatment modality for patients with advanced heart failure. Pulsatile LVADs have limitations in design precluding their use for extended support. Continuous-flow rotary LVADs represent an innovative design with potential for small size and greater reliability by simplification of the pumping mechanism. Methods In a prospective multicenter study, 281 patients urgently listed (United Network for Organ Sharing status 1A or 1B) for heart transplant underwent implant of a continuous-flow LVAD. Survival and transplant rates were assessed at 18 months. Patients were assessed for adverse events throughout the study and for quality of life, functional status, and organ function for 6 months. Results Of 281 patients, 222 (79%) underwent transplant or LVAD removal for cardiac recovery or had ongoing LVAD support at 18-month follow-up. Actuarial survival on support was 72% (95% confidence interval, 65%,79%) at 18 months. At 6 months, there were significant improvements in functional status and 6-minute walk test results (from 0% to 83% of patients in New York Heart Association functional class I or II and from 13% to 89% of patients completing a 6-minute walk test) and in quality of life (mean values improved 41% with Minnesota Living With Heart Failure and 75% with Kansas City Cardiomyopathy questionnaires). Major adverse events included bleeding, stroke, right heart failure, and percutaneous lead infection. Pump thrombosis occurred in 4 patients. Conclusions A continuous-flow LVAD provides effective hemodynamic support for at least 18 months in patients awaiting transplant, with improved functional status and quality of life. [source] Validation and Clinical Utility of a Simple In-Home Testing Tool for Sleep-Disordered Breathing and Arrhythmias in Heart Failure: Results of the Sleep Events, Arrhythmias, and Respiratory Analysis in Congestive Heart Failure (SEARCH) StudyCONGESTIVE HEART FAILURE, Issue 5 2006William T. Abraham MD Fifty patients with New York Heart Association class III systolic heart failure were enrolled in this prospective multicenter study that compared the diagnostic accuracy of a home-based cardiorespiratory testing system with standard attended polysomnography. Patients underwent at least 2 nights of evaluation and were scored by blinded observers. At diagnostic cutoff points of ,5, ,10, and ,15 events per hour for respiratory disturbance severity, polysomnography demonstrated a sleep-disordered breathing prevalence of 69%, 59%, and 49%, respectively. Compared with polysomnography, the cardiorespiratory testing system demonstrated predictive accuracies of 73%, 73%, and 75%, which improved to 87%, 87%, and 83%, respectively, when analysis of covariance suggested reanalysis omitting one site's data. The system accurately identified both suspected and unsuspected arrhythmias. The device was judged by 80% of patients to be easy or very easy to use, and 74% of patients expressed a preference for the in-home system. Therefore, this system represents a reasonable home testing device in these patients. [source] New immunochemical fecal occult blood test with two-consecutive stool sample testing is a cost-effective approach for colon cancer screening: Results of a prospective multicenter study in Chinese patientsINTERNATIONAL JOURNAL OF CANCER, Issue 12 2006Shirong Li Abstract The purpose of the study is to evaluate a new immunochemical fecal occult blood test method (Hemosure IFOBT), and compare it to the Guaiac-based chemical method (CFOBT) for colorectal cancer detection. A hypothetical sequential method (SFOBT), in which IFOBT was used only as a confirmatory test for CFOBT, was also evaluated. A total of 324 patients were recruited from 5 major hospitals in Beijing, China. For each patient, 3 consecutive stool samples were collected for simultaneous CFOBT and IFOBT tests, followed by colonoscopic examination. We compared the sensitivity and specificity of the 3 methods (CFOBT, IFOBT and SFOBT) in two settings, with the first 2 consecutive samples versus all 3 samples. Although the sensitivity for the detection of cancer and large (>20 mm) or multiple adenoma was similar for all 3 methods in the three-sample setting, in the two-sample setting IFOBT had higher sensitivity than SFOBT for detecting cancer (87.8% vs. 75.5%, respectively, p < 0.05) and large (>20 mm) or multiple adenomas (65.4% vs. 42.3%, respectively, p < 0.05). The IFOBT also had a higher specificity than the CFOBT (89.2% vs. 75.5%, respectively, p < 0.01) in "normal" individuals defined by colonoscopy in the three-sample setting. Comparing two-sample setting to the three-sample setting, both CFOBT and SFOBT showed significant loss of sensitivity for the detection of cancer as well as adenoma, whereas the sensitivity for IFOBT did not change significantly. Overall, IFOBT with two-sample testing showed compatible sensitivity and specificity to the three-sample testing, and had a lower relative cost per cancer detected than the three-sample testing. In conclusion, the new Hemosure IFOBT with two consecutive stool samples appears to be the most cost-effective approach for colon cancer screening. © 2006 Wiley-Liss, Inc. [source] Catheter Ablation of Recurrent Scar-Related Ventricular Tachycardia Using Electroanatomical Mapping and Irrigated Ablation Technology: Results of the Prospective Multicenter Euro-VT-StudyJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 1 2010HILDEGARD TANNER M.D. Catheter Ablation of Ventricular Tachycardia.,Introduction: Ventricular tachycardia (VT) late after myocardial infarction is an important contributor to morbidity and mortality. This prospective multicenter study assessed the efficacy and safety of electroanatomical mapping in combination with open-saline irrigated ablation technology for ablation of chronic recurrent mappable and unmappable VT in remote myocardial infarction. Methods and Results: In 8 European institutions, 63 patients (89% males) were enrolled in the study. All patients had remote myocardial infarction and presented with a median number of 17 (range 1,380) VTs in the preceding 6 months. Incessant VT was present in 14 patients (22%). Left ventricular ejection fraction measured 30 ± 13%. A mean of 3 VTs were targeted per patient and 22% of all patients had only unmappable VT. The mean follow-up period was 12 ± 3 months. A total of 164 VTs were targeted during catheter ablation. Ablation was acutely successful in 51 patients (81%). One patient (1.5%) experienced a major complication with degeneration of VT into ventricular fibrillation necessitating cardiopulmonary resuscitation maneuvers. However, no death occurred acutely or within the first 30 days after catheter ablation. During the follow-up, 19 of the initially successful ablated patients (37%) and 31 of all ablated patients (49%) developed some type of VT recurrence. Conclusions: The results of this multicenter study demonstrate the high acute success rate and a low complication rate of irrigated tip catheter ablation of all clinical relevant VTs in remote myocardial infarction. However, during the follow-up a relevant number of recurrences occurred. (J Cardiovasc Electrophysiol, Vol. 21, pp. 47,53, January 2010) [source] Efficacy and safety of DALI LDL-apheresis at high blood flow rates: A prospective multicenter studyJOURNAL OF CLINICAL APHERESIS, Issue 4 2003T. Wendler Abstract Direct adsorption of lipids (DALI) is the first LDL-apheresis method compatible with whole blood. Usually, the blood flow rate is adjusted at 60,80 ml/min, which results in session times of about 2 hr. The present study was performed to test the safety and efficacy of low-density lipoprotein cholesterol (LDL-C) and lipoprotein (a) [Lp(a)] removal by DALI at high blood flow rates in order to reduce treatment time. Thirteen chronic DALI patients in seven centers suffering from hypercholesterolemia (LDL-C 162 ± 42 mg/dl at baseline) and coronary artery disease were treated on a weekly or biweekly basis by DALI apheresis. The blood flow rate QB was held constant for at least two sessions, respectively, and was increased from 60 to 80, 120, 160, 200, and 240 ml/min. All patients had pre-existing av-fistulas. The anticoagulation was performed by a heparin bolus plus ACD-A at a ratio of citrate: blood ranging from 1:20 to 1:90. Clinically, the sessions were well tolerated and only 26/201 sessions (12%) of the treatments were fraught with minor adverse events. Acute LDL-C reductions (derived from LDL-C levels determined by lipoprotein electrophoresis) averaged 72/66/60/53/50/48% for QB = 60/80/120/160/200/240 ml/min. Lp(a) reductions were 68/67/62/60/58/56%, whereas HDL-C losses were ,10%. Routine blood chemistries and blood cell counts remained in the normal range. Treatment times averaged 142/83/45 min at Qb = 60/120/240 ml/min. On average, DALI LDL-apheresis could be performed safely and effectively at high blood flow rates up to at least 120 ml/min in patients with good blood access, which significantly reduced treatment time from 142 to 83 min (,42%). J. Clin. Apheresis 18:157,166, 2003. © 2003 Wiley-Liss, Inc. [source] Safety and Efficacy of Intrathecal Baclofen Infusion by Implantable Pump for the Treatment of Severe Spinal Spasticity: A Spanish Multicenter StudyNEUROMODULATION, Issue 4 2000J Vidal MD Objective. To assess long-term efficacy, safety and functional benefit of intrathecal baclofen for severe spinal spasticity. Materials and Methods. This prospective multicenter study was performed in two stages: the first one consisted of an intrathecal bolus injection of baclofen, and the second of a continuous intrathecal baclofen infusion by means of an implantable pump. The sample consisted of 72 adult patients with severe spinal spasticity. Sixty-four were implanted and followed for 36 months. Muscular tone, spasms, and functional scales were evaluated before and periodically after administration of the drug, with a follow-up period of 36 months. Results. A very significant decrease in tone and spasms was observed in all cases (p < 0.001). Tolerance appeared during the first 12 months, increasing doses from a mean initial dose of 83.2 ,g (range 25,200 ,g) to a mean final dose of 270 ,g (range 25,800 ,g). Later on, efficacy remained stable, except in cases of mechanical problems of the infusion system. [source] Time to Cardiac Death After Withdrawal of Life-Sustaining Treatment in Potential Organ DonorsAMERICAN JOURNAL OF TRANSPLANTATION, Issue 9 2009C. Suntharalingam Organ donation after cardiac death (DCD) is increasing markedly, allowing more patients to benefit from transplantation. The time to cardiac death following withdrawal of life-supporting treatment varies widely and is an important determinant of whether organ donation occurs. A prospective multicenter study of potential DCD donors was undertaken to evaluate the time to death and identify associated factors. One hundred and ninety-one potential adult DCD donors at nine UK centers were studied. Treatment withdrawal comprised stopping ventilator support and inotropes. Demographics and physiological variables at the time of death were recorded. Following treatment withdrawal, all potential donors died, with median time to death of 36 min (range 5 min to 3.3 days). Eighty-three potential donors (43.5%) remained alive 1 h after treatment withdrawal, and 69 (36.1%) and 54 (28.3%) at 2 and 4 h, respectively. Univariate analysis revealed that age, cause of death, ventilation mode, inotrope use, systolic blood pressure, FiO2 and arterial pH at treatment withdrawal were all associated with time to death. Multivariable analysis showed that younger age, higher FiO2 and mode of ventilation were independently associated with shorter time to death. This information may aid planning and resourcing of DCD organ recovery and help maximize DCD donor numbers. [source] Serious Bacterial Infections in Febrile Outpatient Pediatric Heart Transplant RecipientsACADEMIC EMERGENCY MEDICINE, Issue 10 2009Shan Yin MD Abstract Objectives:, The purpose of this study was to describe the incidence of serious bacterial infections (SBIs) in febrile outpatient pediatric heart transplant recipients and to assess the utility of using white blood cell (WBC) indices to identify patients at low risk for bacteremia. Methods:, A retrospective study was conducted on all heart transplant recipients followed at a single children's hospital. All outpatient visits from January 1, 1995, to June 1, 2007, in which fever was evaluated were reviewed. Patients with history of a primary immunodeficiency, receiving concurrent chemotherapy, or having had a stem cell or small bowel transplant were excluded. Demographic, historical, physical examination, laboratory, and radiographic data were then recorded. Results:, Sixty-nine patients had 238 individual episodes of fever evaluation; of these, 217 (91.2%) had blood cultures drawn with results available in their initial evaluation. There were six (2.8%) true-positive blood cultures and eight (3.7%) false-positive cultures. Chest radiography was done in 185 evaluations (77.8%), and 44 episodes of pneumonia (23.8%) were diagnosed. Of 112 urine cultures done, one (0.9%) was positive. Neither of two lumbar punctures performed were positive. In non,ill-appearing children without indwelling central lines or focal bacterial infections (pneumonia, cellulitis), the incidence of bacteremia was 1.2%. In children with a focal bacterial infection, the rate of bacteremia was 6.3%. WBC indices were not significantly different between bacteremic and nonbacteremic patients. A band-to-neutrophil ratio (BNR) of ,0.25 and a published guideline for identifying low-risk infants using WBC indices identified all bacteremic patients, each with a sensitivity of 100% (95% confidence interval [CI] = 48% to 100% and 54% to 100%, respectively). Conclusions:, The incidence of bacteremia was low in febrile, outpatient pediatric heart transplant patients, especially in those who were not ill-appearing and did not have a focus of serious infection. Two different low-risk criteria performed well in identifying the bacteremic patients, although given the low number of true-positive cultures, the CIs for the sensitivities of these tests were extremely wide, and neither test could be reliably used at present. A prospective multicenter study is required to confirm the low incidence of bacteremia and low-risk criteria in this population. [source] Health-related quality of life over time since resective epilepsy surgeryANNALS OF NEUROLOGY, Issue 4 2007Susan S. Spencer MD Objective Health-related quality of life (HRQOL) improves after resective epilepsy surgery, but data are limited to short follow-up in mostly retrospective reports, with minimal consideration of other potential factors that might influence HRQOL. Methods In a prospective multicenter study, 396 patients underwent resective epilepsy surgery. They completed the Quality of Life in Epilepsy Inventory-89 (QOLIE-89) before surgery, within 6 months, and at approximately yearly intervals after surgery. Seizure outcome was ascertained by phone calls every 3 months, and dates of postoperative seizures were chronicled. Overall HRQOL as measured by the QOLIE-89 was evaluated with respect to seizure outcome using logistic regression. Results QOLIE-89 scores increased significantly at the first postoperative measurement (within 6 months after surgery) in the cohort overall; subsequent changes over time were sensitive to seizure-free and aura-free status. After adjusting for baseline scores, the corresponding postsurgical QOLIE-89 overall, and four dimension scores, increased as a function of square root of time seizure-free, and independently as a function of square root of time aura free, leveling by 2 years of stable seizure (aura) status. HRQOL was not independently related to duration of epilepsy, duration of intractable epilepsy, or continuation of medications. Interpretation HRQOL improves early after surgery, regardless of seizure outcome. Subsequent changes parallel length of time seizure free or aura free, stabilize after 2 years, and are unrelated to duration of epilepsy, duration of intractable epilepsy, or continued medication use. Ann Neurol 2007 [source] Premature atherosclerosis in pediatric systemic lupus erythematosus: Risk factors for increased carotid intima-media thickness in the atherosclerosis prevention in pediatric lupus erythematosus cohort,ARTHRITIS & RHEUMATISM, Issue 5 2009Laura E. Schanberg Objective To evaluate risk factors for subclinical atherosclerosis in a population of patients with pediatric systemic lupus erythematosus (SLE). Methods In a prospective multicenter study, a cohort of 221 patients underwent baseline measurements of carotid intima-media thickness (CIMT) as part of the Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE) trial. SLE disease measures, medications, and traditional risk factors for atherosclerosis were assessed. A standardized protocol was used to assess the thickness of the bilateral common carotid arteries and the mean maximal IMT of 12 segments. Univariable analysis identified potential associations with CIMT, which were examined in multivariable linear regression modeling. Results Based on the mean-mean common or the mean-max CIMT as the dependent variable, univariable analysis showed significant associations of the following variables with increased CIMT: increasing age, longer SLE duration, minority status, higher body mass index (BMI), male sex, increased creatinine clearance, higher lipoprotein(a) level, proteinuria, azathioprine treatment, and prednisone dose. In multivariable modeling, both azathioprine use (P = 0.005 for the mean-mean model and P = 0.102 for the mean-max model) and male sex (P < 0.001) were associated with increases in the mean-max CIMT. A moderate dosage of prednisone (0.15,0.4 mg/kg/day) was associated with decreases in the mean-max CIMT (P = 0.024), while high-dose and low-dose prednisone were associated with increases in the mean-mean common CIMT (P = 0.021) and the mean-max CIMT (P = 0.064), respectively. BMI (P < 0.001) and creatinine clearance (P = 0.031) remained associated with increased mean-mean common CIMT, while increasing age (P < 0.001) and increasing lipoprotein(a) level (P = 0.005) were associated with increased mean-max CIMT. Conclusion Traditional as well as nontraditional risk factors were associated with increased CIMT in this cohort of patients in the APPLE trial. Azathioprine treatment was associated with increased CIMT. The relationship between CIMT and prednisone dose may not be linear. [source] Factors associated with surgical options for breast carcinoma,CANCER, Issue 7 2006Anees B. Chagpar M.D., M.Sc. Abstract BACKGROUND Breast conservation surgery (BCS) and mastectomy have equivalent survival outcomes for women with breast carcinoma, but treatment decisions are affected by many factors. The current study evaluated the impact of patient and physician factors on surgical decision-making. METHODS Statistical analyses were performed on a prospective multicenter study of patients with invasive breast carcinoma. Patient, physician, and geographic factors were considered. RESULTS Of 4086 patients, BCS was performed in 2762 (67.6%) and mastectomy was performed in 1324 (32.4%). The median tumor size was 1.5 cm (range, < 0.1,9.0 cm) in patients undergoing BCS and 1.9 cm (range, 0.1,11.0 cm) in patients undergoing mastectomy (P < 0.00001). The median age of patients undergoing BCS was 59 years (range, 27,100 yrs), whereas patients who underwent mastectomy were older (median age of 63 yrs, range, 27,96 yrs [P < 0.00001]). Physicians in academic practices performed more lumpectomies than those who were not in an academic practice (70.9% vs. 65.7%; P = 0.001). More breast conservation procedures were performed by surgeons with a higher percentage of breast practice (P = 0.012). Geographic location was found to be significant, with the Northeast having the highest rate of breast conservation (70.8%) and the Southeast having the lowest (63.2%; P = 0.002). On multivariate analysis, patient age (odds ratio [OR]: 1.455; 95% confidence interval [95% CI], 1.247,1.699 [P < 0.001]), tumor size (P < 0.001), tumor palpability (OR: 0.613; 95% CI, 0.524,0.716 [P < 0.001]), histologic subtype (P = 0.018), tumor location in the breast (P < 0.001), physician academic affiliation (OR: 1.193; 95% CI: 1.021,1.393 [P = 0.026]), and geographic location (P = 0.045) were found to be significant. CONCLUSIONS Treatment decisions were found to be related to patient clinicopathologic features, surgeon academic affiliation, and geographic location. Future studies will elucidate the communication and psychosocial factors that may influence patient decision-making. Cancer 2006. © 2006 American Cancer Society. [source] Fixed Mandibular Restorations on Three Early-Loaded Regular Platform Brånemark ImplantsCLINICAL IMPLANT DENTISTRY AND RELATED RESEARCH, Issue 4 2001Hugo De Bruyn DDS ABSTRACT Background: Originally, the Brånemark System was used as a two-stage surgical procedure. Comparable clinical results have made one-stage and early-loading concepts possible alternatives in the edentulous mandible. From the patient's point of view, the financial aspect of implant treatment is important. In an attempt to decrease financial burden, the reduction of surgical interventions and reduction of the number of implants could be considered. Purpose: This prospective multicenter study evaluated (1) the 1-and 3-year success rates of implants loaded within 1 month after one-stage surgery with a fixed 10- to 12-unit bridge on three regular platform Brånemark System implants in the mandible, (2) the outcome of the prosthetic treatment, and (3) the opinion of patients regarding the treatment procedure. Materials and Methods: Of 20 patients, 19 received five implants in the mandible, of which three were functionally loaded with the one-stage technique (group 1). The loaded implants were inserted in a tripodal position, one implant in the symphysis and two located anterior of the mental foramen in the bicuspid area. Two additional implants were inserted for safety reasons but were not intended to be included in the restoration. These two additional implants served as either an unloaded one-stage control implant (group 2) or an unloaded control implant installed with the submerged technique (group 3). Immediately after surgery, the implants were loaded with a relined denture. The patients received a 10- to 12-unit prosthetic reconstruction an average 31 days (range, 4-53 d) after surgery. Implant stability was clinically checked at 3, 12, and 36 months. Radiographs were taken at corresponding follow-up visits to calculate bone-to-implant level and marginal bone resorption. Results: Six of 60 functionally loaded implants (10%) and 3 of 20 prostheses (15%) failed within the first year. The cumulative implant failure rate in group 1, both after 1 and after 3 years, was 9.5%. No implant failure occurred in the control groups 2 and 3. The average marginal bone level measured at 1 and 3 years was 1.6 mm (SD = 0.8 mm) and 2.1 mm (SD = 0.2 mm), respectively, for group 1; 1.5 mm (SD = 1.3 mm) and 2.4 mm (SD = 0.6 mm), respectively, for group 2; 0.8 mm (SD = 1.4 mm) and 0.7 mm (SD = 0.9 mm), respectively, for group 3. Conclusions: The results of treatment using three regular platform Brånemark System implants supporting a fixed mandibular arch reconstruction were less favorable than the outcome that can be expected with a standard four- to six-implant with one-stage surgery. [source] | ||||||||||||||||||||||