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Historical Controls (historical + control)
Terms modified by Historical Controls Selected AbstractsIncidence of In-Hospital Falls in Geriatric Patients Before and After the Introduction of an Interdisciplinary Team,Based Fall-Prevention InterventionJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 12 2007Wolfgang Von Renteln-Kruse MD Falls are among the most common unwanted events in older hospital inpatients, but evidence of effective prevention is still limited compared with that in the community and in long-term care facilities. This article describes a prevention program and its effects on the incidence of falls in geriatric hospital wards. It was a prospective cohort study with historical control including all 4,272 patients (mean age 80, 69% female) before and 2,982 (mean age 81, 69% female) after introduction of the intervention. The intervention included fall-risk assessment on admission and reassessment after a fall; risk alert; additional supervision and assistance with the patients' transfer and use of the toilet; provision of an information leaflet; individual patient and caregiver counseling; encouragement of appropriate use of eyeglasses, hearing aids, footwear, and mobility devices; and staff education. Measurements included standardized fall-incidence reporting, activity of daily living and mobility status, number of falls and injurious falls, and number of patients who fell. Before the intervention was introduced, 893 falls were recorded. After the intervention was implemented, only 468 falls were recorded (incidence rate ratio (IRR)=0.82, 95% confidence interval (CI)=0.73,0.92), 240 versus 129 total injurious falls (IRR=0.84, 95% CI=0.67,1.04), 10 versus nine falls with fracture (IRR=1.40, 95% CI=0.51,3.85) and 611 versus 330 fallers. The relative risk of falling was significantly reduced (0.77, 95% CI=0.68,0.88). A structured multifactorial intervention reduced the incidence of falls, but not injurious falls, in a hospital ward setting with existing geriatric multidisciplinary care. Improvement of functional competence and mobility may be relevant to fall prevention in older hospital inpatients. [source] Drug-Eluting Stents Versus Bare Metal Stents Following Rotational Atherectomy for Heavily Calcified Coronary Lesions: Late Angiographic and Clinical Follow-Up ResultsJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 2 2007AHMED A. KHATTAB M.D. Objectives: To study the effectiveness of drug-eluting stents following rotablation of severely calcified lesions. Background: Drug-eluting stents are increasingly showing promising results in complex lesions and high-risk patients. Heavily calcified stenoses have not been adequately studied, and form a challenge both for the immediate and late outcomes. Methods: Single-center prospective study among 27 patients treated by rotablation followed by a drug-eluting stent implantation for angiographically heavily calcified lesions, compared with a historical control of 34 patients treated by rotablation followed by bare stent implantation for the same indication. The primary endpoint was the late lumen loss at 9 months; secondary endpoints were binary restenosis and major adverse cardiac events at 9 months. A 2-year follow-up directed to death and myocardial infarction was added. Results: Both groups were comparable regarding baseline and procedural characteristics. Angiographic success was 100% for both groups. At 9 months, there was a significant difference in the late lumen loss (0.11 ± 0.7 mm in the DES group and 1.11 ± 0.9 mm in the BMS group, P = 0.001). This difference was manifest in the clinical event rates at late follow-up (combined incidence of death due to any cause, MI, and TLR was 7.4% in the DES group and 38.2% in the BMS group; P = 0.004). At 2 years, there were 5 deaths in each group (P = 0.5) and 2 infarctions in the BMS group versus none in the DES group (P = 1.0). Conclusion: The combination of rotablation and drug-eluting stent implantation (Rota-DES) has a favorable effect on clinical and angiographic outcomes at 9 months when treating heavily calcified lesions compared to rotablation followed by bare metal stent implantation. No safety concerns are observed at 2 years. [source] Community-based programmes to prevent falls in children: A systematic reviewJOURNAL OF PAEDIATRICS AND CHILD HEALTH, Issue 9-10 2005Rod McClure Objective: We systematically reviewed the literature to examine the evidence for the effectiveness of community-based interventions to reduce fall-related injury in children aged 0,16 years. Methods: We performed a comprehensive search of the literature using the following study selection criteria: community-based intervention study; target population was children aged 0,16 years; outcome measure was fall-related injury rates; and either a community control or historical control was used in the study design. Quality assessment and data abstraction were guided by a standardized procedure and performed independently by two authors. Results: Only six studies fitting the inclusion criteria were identified in our search and only two of these used a trial design with a contemporary community control. Neither of the high quality evaluation studies showed an effect from the intervention and while authors of the remaining studies reported effective falls prevention programmes, the pre- and post-intervention design, uncontrolled for background secular trends, makes causal inferences from these studies difficult. Conclusion: There is a paucity of research studies from which evidence regarding the effectiveness of community-based intervention programmes for the prevention of fall-related injury in children could be based. [source] Mid-term effects of steroid therapy on childhood-onset IgA nephropathyNEPHROLOGY, Issue 2001S Watanabe Purpose: IgA nephropathy (IgAN) is considered the most common glomerular disease in the world. Although treatment of children with severe IgAN with predonisolone (PSL) has been reported, the mid-term prognosis of paediatric patients treated with PSL is unclear. In the present study we examined the mid-term effects of PSL therapy. Method: Thirty-seven paediatric patients with IgAN (18 males, 19 females), whose biopsy findings showed acute segmental lesions including cellular crescent and adhesion in more than 10% of glomeruli examined, were prospectively treated with PSL plus heparin-warfarin and dipyridamole (Tx) for 1.5 years and followed up over 1 years after Tx end. Fifteen age and histological grade-matched children with IgAN (six males, nine females), who had never been treated with PSL, were also evaluated as a historical control. The mean observation period was 5.0 ± 1.8 years (range, 2.5,8.6 years). The histological grade (acute lesion) and stage (chronic lesion) were scored semiquantitatively based on the Shigematsu's grade-stage system.1 Result: Proteinuria decreased 1.48 g/day/1.73 m2 at the start of Tx to 0.32 g/day/1.73 m2 at the end of Tx. Eighteen patients (48.6%) achieved complete remission (CR). No patient developed chronic renal failure in Tx group, while two of the controls deteriorated renal function in the last observation. The pattern of responsiveness to Tx were divided into three groups according to the levels of proteinuria: CR, rebound (> 0.5 g/day/1.73 m2) and incomplete remission (< 0.5 g/day/1.73 m2). The rebound of proteinuria is usually accompanied with PSL reduction. The grade of glomerular pathology was improved with Tx (Gg: 0.8,0.3), while the stage of tubulo-interstitial change progressed (Sint: 0.7,1.2). Conclusions: The present study shows that Tx to children with IgAN showing acute lesions for 1.5 years is effective to subside acute glomerular injury. However, because clinical courses of treated patients vary in each patient, dosage and duration of PSL administration should be modified in their clinical setting. [source] Early administration of surfactant in spontaneous breathing with nCPAP: feasibility and outcome in extremely premature infants (postmenstrual age ,27 weeks)PEDIATRIC ANESTHESIA, Issue 4 2007ANGELA KRIBS MD Summary Background:, Spontaneous breathing supported by nasal continuous positive airway pressure (nCPAP) is thought to have some advantages compared with mechanical ventilation in extremely premature infants. In addition, early or prophylactic surfactant administration has been shown to be superior to delayed use. A strategy to combine these two principles was tested in our neonatal intensive care unit (NICU). The aim of this feasibility study was to describe the procedure and compare short-term results with a historical control. Methods:, The study took place in a level III NICU. In the observational period all extremely premature infants with clinical signs of moderate to severe respiratory distress syndrome despite nCPAP received 100 mg·kg,1 of a natural surfactant preparation via an intratracheal catheter during spontaneous breathing. In the historical control period those infants were intubated and ventilated to receive surfactant. Results:, Twenty-nine of 42 infants fulfilled the criteria and were treated with the new approach. In five cases ventilation with manual bag was necessary after administration of surfactant but all infants could be retransferred to nCPAP within a few minutes. Ten infants were intubated later during the first 3 days. Mortality was 7% in the group of infants treated in this way and 12% in all infants treated during the observational period. Mortality was 35% in the historical control period. Morbidity was within ranges reported by other authors. Conclusions:, Surfactant administration during nCPAP is feasible. First results indicate that early complications are rare. This warrants a prospective randomized trial. [source] Improved pain management in pediatric postoperative liver transplant patients using parental education and non-pharmacologic interventionsPEDIATRIC TRANSPLANTATION, Issue 2 2006Paul J. Sharek Abstract:, A pain management intervention, consisting of pretransplant parental education and support, pre- and postoperative behavioral pediatrics consultation, postoperative physical and occupational therapy consultation, and implementation of non-pharmacologic pain management strategies, was introduced to all pediatrics patients receiving liver transplants at Lucile Packard Children's Hospital beginning August 2001. Children receiving transplants pre-intervention (May, 2000 to February, 2001) and post-intervention (August, 2001 to March, 2002) were compared using pain scores, parent perception of pain ratings, length of stay, ventilator days, total cost, and opioid use. A total of 27 children were evaluated (13 historical control, 14 intervention). The two populations did not differ on age at transplant (mean age 53.8 vs. 63.6 months), sex (46.1% vs. 50% male), ethnicity (53.8% vs. 57.1% white, non-Hispanic) weight at transplant (17.5 vs. 24.7 kg), percent with biliary atresia as the primary reason for transplant (42.9% vs. 69.2%), percent with status 1 transplant listing score (38.5% vs. 50.0%), or public insurance status (30.8 vs. 57.2% with Medicaid). No differences were found in mean pediatric intensive care unit (PICU) postoperative length of stay (6.7 vs. 5.3 days), total postoperative length of stay (17.5 vs. 17.5 days), total inpatient length of stay (27.0 vs. 24.4 days), time to extubation (30 vs. 24.3 h), total cost ($147 983 vs. $157 882) or opioid use through postoperative day (POD) 6 (0.24 vs. 0.25 mg/kg/day morphine equivalent). A decrease in mean pain score between POD 0 and 6 (2.82 vs. 2.12; p = 0.047), a decrease in mean parental pain perception score (3.1 vs. 2.1; p = 0.001), and an increase in number of pain assessments per 12 h shift (3.43 vs. 6.79; p < 0.005) were seen. A comprehensive non-pharmacologic postoperative pain management program in children receiving a liver transplant was associated with decreased pain scores, improved parent perception of pain, and an increased number of pain assessments per 12 h shift. No increases in lengths of stay (PICU, postoperative, total), time to extubation, or total cost were found. [source] Population pharmacokinetic modelling of carbamazepine in epileptic elderly patients: implications for dosageJOURNAL OF CLINICAL PHARMACY & THERAPEUTICS, Issue 3 2006I. B. Bondareva PhD Summary Background:, Proper use of antiepileptic drugs in the elderly involves knowledge of their pharmacokinetics to ensure a patient-specific balance between efficacy and toxicity. However, populations of epileptic patients on chronic carbamazepine (CBZ) therapy which have been studied have included data of relatively few elderly patients. Aims:, The aim of the present study was to evaluate the population pharmacokinetics of CBZ in elderly patients on chronic monotherapy. Methods:, We have used the non-parametric expectation maximization (NPEM) program in the USC*PACK collection of PC programs to estimate individual and population post-induction pharmacokinetics of CBZ in epileptic elderly patients who received chronic CBZ monotherapy. Age-related changes of CBZ population pharmacokinetics were evaluated from routine therapeutic drug monitoring (TDM) data of 37 elderly and 35 younger patients with epilepsy. As a ,historical control' we used previously published population modelling results from 99 young epileptic patients on chronic CBZ monotherapy. In that control group, TDM was performed in the same pharmacokinetic (PK) laboratory, using the same sampling strategy as in the present study, and the same PK population modelling software was used for data analysis. Results and conclusions:, A poor correlation was found between daily CBZ dose and serum concentrations in the elderly patients (r = 0·2, P = 0·25). Probably statistically significant difference in the median values of the CBZ metabolic rate constant (P < 0·001) between elderly and relatively young epileptic patients was found. Our results showed that age-related influences in CBZ pharmacokinetics in elderly patients should be considered in the optimal planning of CBZ dosage regimens. Most elderly patients with epilepsy will usually need CBZ dosages lower than those based on the median population PK parameter values obtained from younger patients. The present population model is also uniquely well suited for the new ,multiple model' design of dosage regimens to hit target therapeutic goals with maximum precision. [source] Open trial of nefazodone among Hispanics with major depression: Efficacy, tolerability, and adherence issuesDEPRESSION AND ANXIETY, Issue 3 2001J. Arturo Sánchez-Lacay M.D., M.P.H. Abstract The efficacy and tolerability of nefazodone in the treatment of major depression among Spanish-monolingual Hispanics was examined and compared to historical controls among English-speaking, predominantly non-Hispanic subjects. Fifty monolingual Hispanic outpatients with major depression and a HAM-D17 score ,18 were treated with nefazodone in a flexible-dose 8-week open-label protocol. Sixty-three percent of the intent-to-treat (ITT) sample with ,1 efficacy visit were considered responders according to CGI-I criteria, falling within the range of response rates (58,69%) reported in six prior nefazodone trials with non-Hispanic subjects. Significant improvement was found for the ITT and completer samples in HAM-D17, HAM-D28, and SCL-90 scores and in two measures of psychosocial functioning. Endpoint mean dose in the ITT sample was 379 mg/day (SD=170), also within the range of previous trials (321,472mg/day). Adverse effects were not elevated, with only dry mouth (8%) reported by >6% of subjects. However, 42% of the sample dropped out of treatment before study termination, usually because of side effects or due to family or work difficulties, a higher rate than previously reported for nefazodone (21,33%). This open trial finds nefazodone to be an efficacious treatment for major depression among monolingual Hispanics, with comparable efficacy to previous controlled trials among non-Hispanic subjects. Double-blind studies are required to confirm this comparable efficacy. Mean endpoint doses and adverse effect rates similar to previous trials do not support the need for reduced doses of nefazodone among Hispanics. However, an elevated rate of treatment discontinuation threatens treatment efficacy among this population. Causes for this elevated rate require explanation, given the apparently unremarkable pattern of adverse effect reports. Depression and Anxiety 13:118,124, 2001. © 2001 Wiley-Liss, Inc. [source] Combined treatment of achalasia , botulinum toxin injection followed by pneumatic dilatation: long-term resultsDISEASES OF THE ESOPHAGUS, Issue 2 2010R. Kroupa SUMMARY Injection of botulinum toxin (BT) and pneumatic dilatation are available methods in nonsurgical treatment of achalasia. Authors anticipate beneficial effect of prior BT injection on the success of pneumatic dilatation and duration of its effect. There are no long-term data available to assess efficacy of combined treatment. From 1998 to 2007, 51 consecutive patients (20 men and 31 women, age 24,83) with achalasia were included and prospectively followed up. Each patient received injection of 200 IU of BT into the lower esophageal sphincter (LES) during endoscopy and 8 days later pneumatic dilatation (PD) under X-ray control was performed. The follow-up was established every 3 months first year and then annually. The efficacy was evaluated by a questionnaire concerning patient's symptoms and manometry. Results were compared with 40 historical controls (16 men and 24 women, age 26,80) treated by PD alone using the same method and follow-up. Fifty-one patients underwent combined treatment. Four patients failed in follow-up and were not included for analysis. The mean duration of follow-up was 48 months with range 12,96 months. Thirty-four of forty-seven (72%) patients were satisfied with results with none or very rare and mild troubles at the time of the last visit. Forty-one patients were followed up more than 2 years. Effect of therapy lasted in 75% (31/41) of them. In 17 patients, more than 5 years after treatment, effect lasted in 12 (70%). Mean tonus of LES before therapy was 29 mm Hg (10,80), 3 months after therapy decreased to 14 mmHg (5,26). The cumulative 5 years remission rate (±95% CI) in combined treated patients 69% ± 8% was higher than in controls 50% ± 9%; however it, was not statistically significant (P= 0.07). In control group 1, case of perforation (2.5%) occurred. Eight patients (17%) with relapse of dysphagia were referred to laparoscopic Heller myotomy with no surgical complication. The main adverse effect was heartburn that appeared in 17 patients (36%). Initial injection of BT followed by PD seems to be effective for long-term results with fewer complications. But the combined therapy is not significantly superior to PD alone. [source] Can First Responders Be Sent to Selected 9-1-1 Emergency Medical Services Calls without an Ambulance?ACADEMIC EMERGENCY MEDICINE, Issue 4 2003Craig B. Key MD Objectives: To evaluate the feasibility and safety of initially dispatching only first responders (FRs) to selected low-risk 9-1-1 requests for emergency medical services. First responders are rapidly-responding fire crews on apparatus without transport capabilities, with firefighters trained to at least a FR level and in most cases to the basic emergency medical technician (EMT) level. Low-risk 9-1-1 requests include automatic medical alerts (ALERTs), motor vehicle incidents (MVIs) for which the caller was unable to answer any medical dispatch questions designed to prioritize the call, and 9-1-1 call disconnects (D/Cs). Methods: A before-and-after study of patient dispositions was conducted using historical controls for comparison. During the historical control phase of six months, one year prior to the study phase, basic life support ambulances (staffed with two basic EMTs) were dispatched to selected low-risk 9-1-1 incidents. During the six-month study phase, a fire FR crew equipped with automated external defibrillators (AEDs) was sent initially without an ambulance to these incidents. Results: For ALERTs (n= 290 in historical group vs. 330 in study group), there was no statistical difference in the transport rate (7% vs 10%), but there was a statistically significant increase in the follow-up use of advanced life support (ALS) (1% vs 4%, p = 0.009). No patient in the ALERTs historical group required airway management, while one patient in the study group received endotracheal intubation. No patient required defibrillation in either group. Analysis of the MVIs showed a significant decrease (p < 0.0001) in the patient transport rate from 39% of controls to 33% of study patients, but no change in the follow-up use of ALS interventions (2% for each group). For both the ALERTs and MVIs, the FR's mean response time was faster than ambulances (p < 0.0001). Among the 9-1-1 D/Cs with FRs only (n= 1,028), 15% were transported and 43 (4%) received subsequent ALS care. Four of these patients (0.4%) received intubation and two (0.2%) required defibrillation. However, no patient was judged to have had adverse outcomes as a result of the dispatch protocol change. Conclusions: Fire apparatus crews trained in the use of AEDs can safely be used to initially respond alone (without ambulances) to selected, low-risk 9-1-1 calls. This tactic improves response intervals while reducing ambulance responses to these incidents. [source] Emergency Medicine Resident Patient Care Documentation Using a Hand-held Computerized DeviceACADEMIC EMERGENCY MEDICINE, Issue 12 2001Steven B. Bird MD Abstract Objective: To determine whether emergency medicine (EM) resident documentation of procedures, patient encounters, and patient follow-ups improved after implementation of a personal digital assistant (PDA) hand-held recording system. Methods: All first-year EM residents were provided a PalmV (Palm, Inc., Santa Clara, CA) PDA. A customized patient procedure and encounter program was constructed using Pendragon Forms (Pendragon Software Corporation, Libertyville, IL) and loaded into each PDA. Residents were instructed to enter information on patients who had any of 21 procedures performed or were considered to be clinically unstable. These data were downloaded to the residency coordinator's desktop computer. The mean number of procedures, encounters, and follow-ups performed per resident were then compared with those of a group of 36 historical controls from the three previous first-year resident classes who recorded the same information using a handwritten card system. Data from the historical controls were combined and the means of each group were compared by Student's t-test. Results: Mean documentation of three procedures was significantly increased in the PDA group versus the index card system: conscious sedation 5.8 vs. 0.03 (p < 0.000005), thoracentesis 2.2 vs. 0.0 (p = 0.002), ultrasound 6.3 vs. 0.0 (p = 0.002). The mean numbers of pericardiocenteses and unstable pediatric surgical patient evaluations were significantly decreased in the hand-held group [from 1.2 to 0.4 (p = 0.03) and from 9.1 to 2.2 (p = 0.02), respectively]. Patient follow-up documentations were not statistically different between the two groups. Conclusions: Use of a hand-held PDA was associated with an increase in first-year EM resident documentation in three of 20 procedures and a decrease in one procedure and the number of unstable surgical pediatric patient resuscitations. The overall time savings in constructing a resident procedure database, as well as the other uses of the PDAs, may make transition to a hand-held computer-based procedure log an attractive option for EM residencies. [source] An investigation of the association of the prothrombin G20210A gene mutation and inflammatory bowel disease: Factor II and IBDINFLAMMATORY BOWEL DISEASES, Issue 2 2001Neil Haslam Abstract Background A thrombotic etiology for inflammatory bowel disease (IBD) has been proposed as a result of its association with thromboembolic complications, smoking, the oral contraceptive pill, and the response of ulcerative colitis (UC) patients to heparin. We have previously demonstrated an increased prevalence of the Factor V Leiden mutation in UC and wished to investigate the frequency of the recently discovered prothrombin G20210A gene mutation in IBD. The aim of the study was to investigate the hypothesis that the prothrombic state associated with the prothrombin G20210A gene mutation is involved in the etiology of IBD. Patients and Methods A prospective cohort study of patients attending the Bristol Royal Infirmary and Gloucestershire Royal Hospital's IBD clinics was performed. Thirty-nine patients with IBD (24 with Crohn's disease and 15 with UC) and 100 historical controls were screened for the presence of the prothrombin gene mutation using a heteroduplex-based polymerase chain reaction technique. None of the patients with IBD had a personal history of thromboembolism, while three of them had a family history. Results No IBD patients had the prothrombin gene mutation compared with four (4%) controls (allelic frequency 2%). Conclusion There does not appear to be an association of the prothrombin gene mutation with IBD and therefore it is unlikely to be involved in the etiology of IBD. [source] Improved aetiological diagnosis of ischaemic stroke in a Vascular Medicine Unit , the significance of transesophageal echocardiogramINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 3 2008A. Martignoni Summary Background:, The TOAST study estimates that 34% of ischaemic strokes are of undetermined aetiology. Improvements in the diagnosis of the pathogenetic mechanism of ischaemic stroke would translate into a better care, in analogy to other fields of vascular and internal medicine. Objective:, To measure the reduction of undetermined aetiology strokes performing a set of additional diagnostic tests. Design:, Consecutive case series with historical controls. Setting:, Internal Medicine Ward with a stroke area (SA) admitting most stroke patients of a large hospital in Italy. Subjects:, A total of 179 ischaemic stroke patients admitted to SA in 2004,2005 compared with 105 ischaemic stroke patients admitted to the whole department in 2001. Intervention:, To perform more diagnostic tests, including transesophageal echocardiography (TEE), in the greatest possible number of ischaemic stroke inpatients admitted in SA of the Internal Medicine Department, in the years 2004,2005. Results:, More diagnostic tests were performed during the study period than in 2001, especially TEE (56% of patients in 2004,2005 vs. 3% of patients in 2001). We observed a significant reduction of undetermined aetiology from 38% in 2001 to 16% in 2004,2005 (p < 0.0001), largely for an increased identification of cases of cardio-embolic mechanism (from 18% to 40%, p = 0.0002). In the years 2004,2005 the fraction of patients on anticoagulant treatment at discharge was 21% vs. 12% in 2001 (p = 0.041). Conclusion:, Performing more tests, particularly TEE, brought improvements in the aetiological diagnosis of stroke, increasing cardio-embolism diagnosis and anticoagulant treatment. [source] Avoiding calcineurin inhibitors in the early post-operative course in high-risk liver transplant recipients: The role of extracorporeal photopheresisJOURNAL OF CLINICAL APHERESIS, Issue 4 2007Lucio Urbani Abstract The aim of this work is to report on the results of a single-center, prospective study on the feasibility of calcineurin-inhibitor (CNI)-staggered immunosuppression by use of extracorporeal photopheresis (ECP) in liver transplant (LT) recipients at risk of renal and neurological complications.Patients were matched on a 1:1 basis with historical controls on standard CNI immunosuppression. ECP patients were treated with ECP plus antimetabolites and/or steroids, while CNIs were withheld until clinically indicated. Thirty-six patients were evaluated: 18 ECP patients and 18 controls. ECP was tolerated in 100% of cases. CNI were introduced at a median of 8 days (4,55) in 17 ECP patients, while one patient was on a fully CNI-sparing regimen 22 months after LT. Acute rejection occurred in 27.7% patients in ECP (5/18) versus 16.7% in controls (3/18) (P = ns) with a shorter time to rejection in ECP (36 ± 31.3 days vs. 83.6 ± 65.6 days; P = ns). All rejection episodes were amenable to medical treatment. Neurological and renal complications occurred in 22.2% (4/18) of patients in either group, but led to in-hospital mortality in 3 patients among controls versus 1 in ECP (P = ns). One-, 6-, and 12-month survival rates were 94.4, 88.1, and 88.1% in ECP versus 94.4, 77.7, and 72.2% among controls (P < 0.0001). ECP seems to allow for management of high-risk LT recipients in the early post-transplant course and reduction of CNI-related mortality. Continued data validation is favored to assess the impact of ECP on long-term graft and patient survival. J Clin Apheresis 2007. © 2007 Wiley-Liss, Inc. [source] An analysis of the evidence-practice continuum: is surgery for obstructive sleep apnoea contraindicated?JOURNAL OF EVALUATION IN CLINICAL PRACTICE, Issue 1 2007Adam G. Elshaug BA BSc(Hons) MPH Abstract Rationale, aims and objectives, Currently there are multiple surgical interventions utilized in the treatment of adult obstructive sleep apnoea (OSA). The role of these operations remains controversial, with perspectives on treatment efficacy varying considerably. Despite this, their use is proliferating. Objectives, In this paper, we present the degree of variability that occurs in the application of these procedures, and examine the effectiveness of surgical intervention as a treatment for OSA. Method, A multi-centre retrospective clinical audit of consecutive, unselected surgical cases presenting at the sleep disorder clinics of two teaching hospitals in a major Australian city. Patients acted as their own historical controls, undergoing polysomnography pre and post surgery to gauge effectiveness. Results, On variability demonstrate 94 individuals in this cohort received 220 individual upper airway surgical procedures, 184 occurred in their first operation (mean 2.5 per person; range 1,7) and 36 occurred in a second operation (n = 18; cumulative mean of 4 per person; range 3,7). These 94 individuals received 41 varying combinations of surgery. Results on effectiveness demonstrate an overall physiological success rate of 13% (87% fail). One operation reduced OSA severity by 20% (patients still had severe OSA), and two operations by 35% (still moderate OSA). In contrast, conventional Continuous Positive Airway Pressure therapy controlled OSA (n = 64). Conclusions, This case study demonstrates substantial procedural variability and limited effectiveness. This raises questions as to the quality of care, the treatment-derived health outcomes of this population and of efficient resource allocation. This issue requires greater policy attention. [source] Living without aprotinin: the results of a 5-year blood saving program in cardiac surgeryACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 5 2009M. RANUCCI Background: After 20 years of regular use in cardiac surgery patients, aprotinin has recently been withdrawn from the market due to many concerns about its safety. For a number of reasons aprotinin has not been available in Italy since 1998. The present study presents an aprotinin-free treatment protocol applied at our institution during the last 5 years, and aims to verify the results of this protocol in terms of allogeneic blood product transfusions, postoperative blood loss and surgical re-exploration rate. Methods: Retrospective study on 7988 consecutive patients who underwent cardiac surgery during the years 2003,2007. All the patients received specific hemostasis/coagulation management based on (a) routine use of tranexamic acid, (b) heparin dose,response monitoring, thromboelastography, platelet (PLT) function analysis in a select population of patients, and (c) use of fresh frozen plasma (FFP), PLTs, and desmopressin according to the hemostasis/coagulation profile. Data retrieved from the institutional database were quantity of packed red cells (PRCs), FFP, PLT transfusion rate, blood loss in the first 12 postoperative hours, and surgical re-exploration rate. Results: PRCs were transfused in 40.4% of patients (with higher rates for selected high-risk subpopulations), FFP in 12.9% and PLTs in 2.6%. Surgical re-exploration rate was 3.7%. With respect to historical controls, a significant reduction of PRCs and FFP transfusions was obtained using closed circuits, point of care coagulation tests, and combination of the two. Conclusion: This aprotinin-free blood saving program is an effective strategy for allogeneic blood products transfusion containment. [source] Consensus statement on the loco-regional treatment of appendiceal mucinous neoplasms with peritoneal dissemination (pseudomyxoma peritonei),JOURNAL OF SURGICAL ONCOLOGY, Issue 4 2008Brendan Moran MD Abstract Pseudomyxoma peritonei (PMP) is a rare condition mostly originating from low malignant potential mucinous tumours of the appendix. Although this disease process is minimally invasive and rarely causes haematogenous or lymphatic metastases, expectation of long-term survival are limited with no prospect of cure. Recently, the combined approach of cytoreductive surgery (CRS) and perioperative loco-regional chemotherapy (PLC) has been proposed as the standard of treatment for the disease. The present paper summarizes the available literature data and the main features of the comprehensive loco-regional treatment of PMP. The controversial issues concerning the indications and technical methodology in PMP management were discussed through a web-based voting system by internationally known experts. Results were presented for further evaluation during a dedicated session of "The Fifth International Workshop on Peritoneal Surface Malignancy (Milan, Italy, December 4,6, 2006)". The experts agreed that multiple prospective trials support a benefit of the procedure in terms of improved survival, as compared with historical controls. Concerning the main controversial methodological questions, there was an high grade of consistency among the experts and agreement with the findings of the literature. J. Surg. Oncol. 2008;98:277,282. © 2008 Wiley-Liss, Inc. [source] Towards valid measures of self-directed clinical learningMEDICAL EDUCATION, Issue 11 2003Tim Dornan Aim, To compare the validity of different measures of self-directed clinical learning. Methods, We used a quasi-experimental study design. The measures were: (1) a 23-item quantitative instrument measuring satisfaction with the learning process and environment; (2) free text responses to 2 open questions about the quality of students' learning experiences; (3) a quantitative, self-report measure of real patient learning, and (4) objective structured clinical examination (OSCE) and progress test results. Thirty-three students attached to a single firm during 1 curriculum year in Phase 2 of a problem-based medical curriculum formed an experimental group. Thirty-one students attached to the same firm in the previous year served as historical controls and 33 students attached to other firms within the same module served as contemporary controls. After the historical control period, experimental group students were exposed to a complex curriculum intervention that set out to maximise appropriate real patient learning through increased use of the outpatient setting, briefing and supported, reflective debriefing. Results, The quantitative satisfaction instrument was insensitive to the intervention. In contrast, the qualitative measure recorded a significantly increased number of positive statements about the appropriateness of real patient learning. Moreover, the quantitative self-report measure of real patient learning found high levels of appropriate learning activity. Regarding outpatient learning, the qualitative and quantitative real patient learning instruments were again concordant and changed in the expected direction, whereas the satisfaction measure did not. An incidental finding was that, despite all attempts to achieve horizontal integration through simultaneously providing community attachments and opening up the hospital for self-directed clinical learning, real patient learning was strongly bounded by the specialty interest of the hospital firm to which students were attached. Assessment results did not correlate with real patient learning. Conclusions, Both free text responses and students' quantitative self-reports of real patient learning were more valid than a satisfaction instrument. One explanation is that students had no benchmark against which to rate their satisfaction and curriculum change altered their tacit benchmarks. Perhaps the stronger emphasis on self-directed learning demanded more of students and dissatisfied those who were less self-directed. Results of objective, standardised assessments were not sensitive to the level of self-directed, real patient learning. Despite an integrated curriculum design that set out to override disciplinary boundaries, students' learning remained strongly influenced by the specialty of their hospital firm. [source] Idiotype-pulsed antigen presenting cells following autologous transplantation for multiple myeloma may be associated with prolonged survival,AMERICAN JOURNAL OF HEMATOLOGY, Issue 12 2009Martha Q. Lacy Vaccines are attractive as consolidation therapy after autologous stem cell transplantation (ASCT) for multiple myeloma (MM). We report the results of a phase II trial of the immunotherapeutic, APC8020 (MylovengeÔ), given after ASCT for MM. We compared the results with that of other patients with MM who underwent ASCT at Mayo Clinic during the same time period. Twenty-seven patients were enrolled on the trial between July, 1998 and June, 2001, and the outcomes were compared to that of 124 consecutive patients transplanted during the same period, but not enrolled on the trial. The median (range) follow-up for patients still alive from the vaccine trial is 6.5 (2.9,8 years), and 7.1 (6,8 years) in the control group. The median age was 57.4 range (36.1,71.3) in the DB group and 56.4 (range, 30,69) in the trial group. Known prognostic factors including PCLI, B2M, and CRP were comparable between the groups. The median overall survival for the trial patients was 5.3 years (95% CI: 4.0 years,N/A) compared to 3.4 years (95% CI: 2.7,4.6 years) for the DB group (P = 0.02). The median time to progression and progression-free survival for the trial group was similar to the DB group. Although not a controlled trial, the vaccines given after ASCT appear to be associated with improved overall survival compared to historical controls. This approach warrants further investigation to confirm this and define the role of vaccine therapy in myeloma. Am. J. Hematol. 2009. © 2009 Wiley-Liss, Inc. [source] First-line therapy for chronic myeloid leukemia: Past, present, and future,AMERICAN JOURNAL OF HEMATOLOGY, Issue 5 2009Carolina Pavlovsky The development of Bcr-Abl tyrosine kinase inhibitors has dramatically changed the prognosis of patients with newly diagnosed chronic myeloid leukemia (CML). Standard-dose imatinib (400 mg/day in chronic phase, 600 mg/day in advanced CML) now dominates the management of this disease, producing considerably higher hematologic, cytogenetic, and molecular response rates than seen with previous drug therapies. However, although many patients respond well to standard-dose imatinib initially, some patients do not achieve adequate levels of response or discontinue therapy because of resistance. One approach to improving treatment response with first-line imatinib may be to increase the imatinib dose (800 mg/day), although recent trial data indicate that overall increases in response rates may be modest. Newer Bcr-Abl tyrosine kinase inhibitors can induce responses in patients with all phases of imatinib-resistant CML, even those with imatinib-resistant mutations in the BCR-ABL gene. Furthermore, in initial studies, first-line dasatinib or nilotinib treatment has produced response rates that compare favorably with historical controls treated with imatinib, although confirmation is required from head-to-head clinical trials. Future clinical approaches may include drug combinations, which may allow quiescent leukemia stem cells to be eradicated. Further improvements in drug treatment for first-line CML are expected during the next few years. Am. J. Hematol. 2009. © 2009 Wiley-Liss, Inc. [source] Early pulmonary infection, inflammation, and clinical outcomes in infants with cystic fibrosis,PEDIATRIC PULMONOLOGY, Issue 5 2001Margaret Rosenfeld MD Abstract A thorough understanding of the early natural history of cystic fibrosis (CF) lung disease is critical for the development of effective interventions in the youngest patients. We assessed the evolution of pulmonary infection, inflammation, and clinical course among 40 infants over a 2-year period through annual bronchoalveolar lavage (BAL) for culture and measurements of pro- and anti-inflammatory cytokines, semiannual infant pulmonary function testing, and quarterly clinical evaluations. Both the prevalence of CF pathogens and their density in BAL fluid increased with age. Infants had neutrophilic lower airway inflammation and elevated IL-8 concentrations independent of whether CF pathogens were recovered. Total leukocyte and neutrophil densities and IL-8 concentrations increased with density of CF pathogens in BAL fluid, whether the isolated organism was P. aeruginosa or another pathogen. IL-10 concentrations were similar in CF subjects and non-CF historical controls. Infants generally had suboptimal growth (low weight and height percentiles) and obstructive lung disease (decreased expiratory flows and air trapping). Subjects from whom CF pathogens were isolated at >,105 cfu/mL had the worst air trapping and lowest Brasfield chest X-ray scores. Our findings provide a foundation for future studies of early intervention in CF lung disease, including antimicrobial and anti-inflammatory therapy. Pediatr Pulmonol. 2001; 32:356,366. © 2001 Wiley-Liss, Inc. [source] Better renal function with enhanced immunosuppression and protocol biopsies after kidney transplantation in childrenPEDIATRIC TRANSPLANTATION, Issue 6 2005Paula Seikku Abstract:, Subclinical rejection may be associated with decreased graft function after renal transplantation (Tx). Detection by protocol biopsies and treatment could thus be important for the long-term prognosis. We have earlier discovered that glomerular filtration rate (GFR) declined in young children during the first 18 months. Consequently, we slightly enhanced and individualized each patient's immunosuppression. This was a retrospective study of 59 pediatric renal Tx patients between 1995 and 2001. The 35 historical controls received triple-therapy of azathioprine, methylprednisolone and cyclosporine. GFR was measured by protocol at discharge, 6 and 18 months, and a core biopsy was obtained at 18 months. The 24 study patients in addition received basiliximab, had GFR measured at 3 and 12 months, and a biopsy taken at 3 months. Based on histology and function, immunosuppression was individually adjusted. The groups were compared for GFR and histology at 18 months after Tx. There were less acute rejection episodes in the study group (0.38 vs. 1.23 per patient) and serum creatinine concentrations were lower. Subclinical rejection was detected and treated in 39% at 3 months. There were more chronic changes in the control (47%) than in the study group (29%) at 18 months. GFR was significantly higher in the study group at 18 months (87 vs. 68 mL/min/1.73 m2), most remarkably in patients ,2 yr of age (99 vs. 68 mL/min/1.73 m2). Detection of subclinical rejection and slightly enhanced and individualized immunosuppression improved GFR 18 months after renal Tx, especially in the youngest patients. [source] Sample size for post-marketing safety studies based on historical controls,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 8 2010Yu-te Wu Abstract Purpose As part of a drug's entire life cycle, post-marketing studies are an important part in the identification of rare, serious adverse events. Recently, the US Food and Drug Administration (FDA) has begun to implement new post-marketing safety mandates as a consequence of increased emphasis on safety. The purpose of this research is to provide exact sample size formula for the proposed hybrid design, based on a two-group cohort study with incorporation of historical external data. Methods Exact sample size formula based on the Poisson distribution is developed, because the detection of rare events is our outcome of interest. Performance of exact method is compared to its approximate large-sample theory counterpart. Results The proposed hybrid design requires a smaller sample size compared to the standard, two-group prospective study design. In addition, the exact method reduces the number of subjects required in the treatment group by up to 30% compared to the approximate method for the study scenarios examined. Conclusions The proposed hybrid design satisfies the advantages and rationale of the two-group design with smaller sample sizes generally required. Copyright © 2010 John Wiley & Sons, Ltd. [source] The effect of electrical and mechanical stimulation on the regenerating rodent facial nerve,THE LARYNGOSCOPE, Issue 6 2010Tessa Hadlock MD Abstract Objectives/Hypothesis: Investigators have long sought realistic methods to accelerate regeneration following nerve injury. Herein, we investigated the degree to which manual target muscle manipulation and brief electrical stimulation of the facial nerve, alone or in combination, affects recovery following rat facial nerve injury. Study Design: Prospective, randomized animal study. Methods: Sixty rats were randomized to three groups: brief electrical stimulation (BES), mechanical stimulation of the whisker pad (MEC), or both (COMBO). Animals underwent facial nerve transection and immediate microsurgical repair. In BES and COMBO groups, transection was preceded by 1-hour (3 V, 20 Hz square wave) electrical stimulation. Animals were tested weekly, with 5-minute recording sessions of whisker movement. In the MEC and COMBO groups, animals received 5 minutes of daily massage to the left whisker pad throughout the recovery period. Whisking behavior was analyzed for comparisons. Results: The BES and MEC groups demonstrated improved functional recovery in all whisking parameters compared with the COMBO group or historical controls at most time points between postoperative weeks 1 and 7. After 12 weeks, functional recovery remained superior in the BES and MEC groups compared with the COMBO and control groups, although the effect was no longer statistically significant. Conclusions: We observed an accelerative recovery effect of either electrical nerve stimulation or massage of the whisker pad on whisking behavior. The combination of both interventions had a negating effect on the acceleration of recovery. The potential clinical utility of these modalities bears consideration, and their negating interaction warrants further study. Laryngoscope, 2010 [source] Adenoidectomy With Laser or Incisional Myringotomy for Otitis Media With Effusion,THE LARYNGOSCOPE, Issue 3 2000Wasyl Szeremeta MD Abstract Objective To compare the effectiveness of CO2 laser myringotomy to incisional myringotomy at the time of adenoidectomy for refractory otitis media with effusion (OME). Study Design Controlled retrospective consecutive case series. Methods All children undergoing myringotomy and adenoidectomy for OME in the spring of 1999 had 1.7-mm-diameter perforations created in their tympanic membranes using a CO2 laser and conventional microslad. Their ears were evaluated at first postoperative visit (mean, 16.65 days after surgery) by a validated otoscopist to determine the presence or absence of perforations and middle ear effusions. These patients were compared with historical controls comprising all children undergoing incisional myringotomy and adenoidectomy in 1998. A ,2 analysis was performed to compare the results of these two myringotomy techniques. Results Twenty-three children (39 ears) underwent laser myringotomy and adenoidectomy in 1999, compared with 26 children (48 ears) who underwent incisional myringotomy and adenoidectomy in 1998. In the laser myringotomy group, 8 of the 39 ears had a persistent opening at first follow-up; 4 of the 39 ears showed evidence of effusion. In the incisional myringotomy group, all 48 ears had healed; 7 of these ears showed evidence of effusion. Conclusion Myringotomies created using the CO2 laser are more likely to be patent at first postoperative visit than those made with incisional technique (P < .01). However, this prolonged middle ear ventilation does not significantly decrease the prevalence of effusion (P > .1). [source] Prednisone-Free Maintenance Immunosuppression,A 5-Year ExperienceAMERICAN JOURNAL OF TRANSPLANTATION, Issue 10 2005Arthur J. Matas Concern persists that prednisone-free maintenance immunosuppression in kidney transplant recipients will be associated with an increase in late allograft dysfunction and graft loss. We herein report 5-year follow-up of a trial of prednisone-free maintenance immunosuppression. From October 1, 1999, through January 31, 2005, at our center, 589 kidney transplant recipients were treated with a protocol incorporating discontinuation of their prednisone on postoperative day 6. At 5 years, actuarial patient survival was 91%; graft survival, 84%; death-censored graft survival, 92%; acute rejection-free graft survival, 84% and chronic rejection-free graft survival, 87%. The mean serum creatinine level (±SD) at 1 year was 1.6 ± 0.6; at 5 years, 1.7 ± 0.8. In all, 86% of kidney recipients with functioning grafts remain prednisone-free as of April 30, 2005. As compared with historical controls, recipients on prednisone-free maintenance immunosuppression had a significantly lower rate of a number of complications, including cataracts (p < 0.001), posttransplant diabetes mellitus (p < 0.001), avascular necrosis (p = 0.001), and fractures (p = 0.004). We conclude that prednisone-related side effects can be minimized in a protocol incorporating prednisone-free maintenance immunosuppression. Five-year graft outcome remains good. [source] Role of an acute assessment and review area for general surgical patientsANZ JOURNAL OF SURGERY, Issue 6 2010Ellen Perry Abstract Background:, Increasing demand for acute surgical services is one of the major challenges facing modern health systems. The aim of this study was to assess the impact of implementing a dedicated surgical assessment and review area (SARA) on patient flow for acute general surgical patients at a major teaching hospital in New Zealand. Methods:, A specific area within inpatient surgical beds was redeveloped and staffed by a dedicated surgical team. Prospective data pertaining to patient flow and outcomes were collected (10-month period) and compared with historical controls (preceding 14 months prior to implementation). Results:, During the 24-month period 9182 acute general surgical patients were admitted (3836 [41.1%] post implementation of SARA). Subsequent to the introduction of SARA, 865 (22.5%) patients were referred directly from their general practitioner. Length of stay was reduced in all patients from 2.58 to 2.04 days (P < 0.001) and in those who did not require surgery from 2.56 to 1.96 days (P < 0.001). However, the number of days in which the department of surgery had outlying patients increased significantly from 76.7% to 86.3%, P < 0.001. Conclusions:, The introduction of a dedicated SARA significantly reduced hospital stay and improved efficiencies of the emergency department. [source] Survival in pulmonary hypertension associated with the scleroderma spectrum of diseases: Impact of interstitial lung diseaseARTHRITIS & RHEUMATISM, Issue 2 2009Stephen C. Mathai Objective Pulmonary hypertension (PH) is an important cause of mortality in systemic sclerosis (SSc), where it can be isolated (pulmonary arterial hypertension [PAH]) or associated with interstitial lung disease (ILD). This study was undertaken to characterize determinants of survival among SSc patients with either type of PH who received PAH-specific therapy. Methods Consecutive SSc patients with PAH or ILD-associated PH confirmed by right heart catheterization were included in the study. Kaplan-Meier and Cox proportional hazards models were used to compare survival between SSc patients with PAH and those with ILD-associated PH and to identify predictors of survival. Results Fifty-nine patients (39 with PAH and 20 with ILD-associated PH) were identified. The majority (15 of 20 with ILD-associated PH and 27 of 39 with PAH) received an endothelin receptor antagonist as initial therapy. Median followup time was 4.4 years (range 2.7,7.4 years). Survival was significantly worse in SSc patients with ILD-associated PH than in those with PAH (1-, 2-, and 3-year survival rates 82%, 46%, and 39% versus 87%, 79%, and 64%, respectively; P < 0.01 by log rank test). In a multivariable analysis, ILD-associated PH was associated with a 5-fold increase in risk of death compared with PAH. Pulmonary vascular resistance index was also an independent predictor of mortality in the overall cohort (hazard ratio 1.05, P < 0.01) and was a significant univariable risk factor in each group separately. Type of initial PAH therapy and the use of warfarin were not related to survival. Conclusion Survival in SSc complicated by PH remains poor despite currently available treatment options. While therapy may be associated with improved survival in PAH compared with historical controls, the prognosis for patients with ILD-associated PH is particularly grim. Early diagnosis and treatment may improve outcomes since worsening hemodynamic factors were associated with reduced survival. [source] The impact of pregnancy on breast cancer outcomes in women ,35 years,CANCER, Issue 6 2009Beth M. Beadle MD Abstract BACKGROUND: Some evidence suggests that women with pregnancy-associated breast cancers (PABC) have a worse outcome compared with historical controls. However, young age is a worse prognostic factor independently, and women with PABC tend to be young. The purpose of the current study was to compare locoregional recurrence (LRR), distant metastases (DM), and overall survival (OS) in young patients with PABC and non-PABC. METHODS: Data for 668 breast cancers in 652 patients aged ,35 years were retrospectively reviewed. One hundred four breast cancers (15.6%) were pregnancy-associated; 51 cancers developed during pregnancy and 53 within 1 year after pregnancy. RESULTS: The median follow-up for all living patients was 114 months. Patients who developed PABC had more advanced T classification, N classification, and stage group (all P < .04) compared with patients with non-PABC. Patients with PABC had no statistically significant differences in 10-year rates of LRR (23.4% vs 19.2%; P = .47), DM (45.1% vs 38.9%; P = .40), or OS (64.6% vs 64.8%; P = .60) compared with patients with non-PABC. For those patients who developed breast cancer during pregnancy, any treatment intervention during pregnancy provided a trend toward improved OS compared with delaying evaluation and treatment until after delivery (78.7% vs 44.7%; P = .068). CONCLUSIONS: Young patients with PABC had no statistically significant differences in LRR, DM, or OS compared with those with non-PABC; however, pregnancy contributed to a delay in breast cancer diagnosis, evaluation, and treatment. Primary care and reproductive physicians should be aggressive in the workup of breast symptoms in the pregnant population to expedite diagnosis and allow multidisciplinary treatment. Cancer 2009. © 2009 American Cancer Society. [source] Seroprevalence of herpes simplex virus type 2 in multiple sclerosisACTA NEUROLOGICA SCANDINAVICA, Issue 6 2006C. H. Hawkes Background,,, It has been proposed that multiple sclerosis (MS) might be a sexually transmitted disorder. There is evidence that seropositivity to herpes simplex virus type 2 (HSV-2) correlates well with the number of sexual partners. Accordingly, a raised overall HSV-2 seroprevalence in MS would lend support to this theory. Materials and methods,,, Serum from 497 UK subjects with clinically definite MS was tested for antibodies to HSV-2 and compared with matched historical controls from within and outside London, blood donors and genito-urinary medicine (GUM) clinics. Results,,, The unadjusted MS seropositivity rate was 14%. HSV-2 seroprevalence in MS patients aged 35,64 years was significantly higher overall compared with a non-London general population in an unadjusted comparison. HSV-2 seroprevalence in London MS patients compared with London blood donors was significantly greater irrespective of age, but the MS seropositive rate was lower than GUM clinic attenders. In a logistic regression analysis, increased age, female sex and MS diagnosis all independently increased the odds of seropositivity after adjustment for each other. Conclusion,,, It is concluded that there is increased likelihood of HSV-2 exposure in patients with MS and this may indicate a higher than average number of partners. 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