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Trial Comparing (trial + comparing)
Kinds of Trial Comparing Terms modified by Trial Comparing Selected AbstractsA Randomized, Double-blind, Sham-controlled Trial Comparing Two Screening Devices for Radiation ContaminationACADEMIC EMERGENCY MEDICINE, Issue 9 2010Philip Salen MD Abstract Objectives:, This exploratory study compared the screening ability of a newly introduced radiation detection portal with a traditional Geiger counter for detection of radiation contamination in the setting of a mass casualty training exercise. Methods:, Following a pretrial evaluation of interobserver reliability for Geiger counter use, 30 volunteers were randomly assigned to don gowns containing three disks, each of which was either a sham resembling the radioactive samples or an actual cesium-137 sample; each subject participated a minimum of four times with different gowns each time. Each subject underwent standard radioactivity screening with the Geiger counter and the portal. Results:, Interobserver reliability was excellent between the two Geiger counter screeners in the pretrial exercise, correctly identifying 101 of 102 sham and radioactive samples (, = 0.98; 95% confidence interval [CI] = 0.94 to 1.00). For radioactively labeled subjects across all bodily locations, the portal (43/61, or 70.5%; 95% CI = 58.1% to 80.5%) was less sensitive than the Geiger counter screening (61/61, or 100%; 95% CI = 92.9% to 100%), which resulted in a portal false-negative rate of 29.5%. For radiation detection in the posterior thorax, the portal radiation screening (4/19, or 21.1%; 95% CI = 8% to 43.9%) was less accurate than the Geiger counter (19/19, or 100%; 95% CI 80.2% to 100%). In contrast, there were no major differences between the portal and the Geiger counter for radiation detection at the left shoulder, right shoulder, or sham (nonradiation) detection. There were no false-positive detections of the sham-labeled subjects for either device, yielding a specificity of 100% for both screening modalities. Conclusions:, Geiger counter screening was more sensitive than, and equally specific to, radiation detection portal screening in detecting radioactively labeled subjects during a radiation mass casualty drill. ACADEMIC EMERGENCY MEDICINE 2010; 17:1020,1023 © 2010 by the Society for Academic Emergency Medicine [source] A double-blind study of the efficacy of venlafaxine extended-release, paroxetine, and placebo in the treatment of panic disorderDEPRESSION AND ANXIETY, Issue 1 2007Mark H. Pollack M.D. Abstract To date, no large-scale, controlled trial comparing a serotonin,norepinephrine reuptake inhibitor and selective serotonin reuptake inhibitor with placebo for the treatment of panic disorder has been reported. This double-blind study compares the efficacy of venlafaxine extended-release (ER) and paroxetine with placebo. A total of 664 nondepressed adult outpatients who met DSM-IV criteria for panic disorder (with or without agoraphobia) were randomly assigned to 12 weeks of treatment with placebo or fixed-dose venlafaxine ER (75,mg/day or 150,mg/day), or paroxetine 40,mg/day. The primary measure was the percentage of patients free from full-symptom panic attacks, assessed with the Panic and Anticipatory Anxiety Scale (PAAS). Secondary measures included the Panic Disorder Severity Scale, Clinical Global Impressions,Severity (CGI-S) and ,Improvement (CGI-I) scales; response (CGI-I rating of very much improved or much improved), remission (CGI-S rating of not at all ill or borderline ill and no PAAS full-symptom panic attacks); and measures of depression, anxiety, phobic fear and avoidance, anticipatory anxiety, functioning, and quality of life. Intent-to-treat, last observation carried forward analysis showed that mean improvement on most measures was greater with venlafaxine ER or paroxetine than with placebo. No significant differences were observed between active treatment groups. Panic-free rates at end point with active treatment ranged from 54% to 61%, compared with 35% for placebo. Approximately 75% of patients given active treatment were responders, and nearly 45% achieved remission. The placebo response rate was slightly above 55%, with remission near 25%. Adverse events were mild or moderate and similar between active treatment groups. Venlafaxine ER and paroxetine were effective and well tolerated in the treatment of panic disorder. Depression and Anxiety 24:1,14, 2007. © 2006 Wiley-Liss, Inc. [source] The association of physical activity and depression in Type 2 diabetesDIABETIC MEDICINE, Issue 10 2008Z. Lysy Abstract Aims Physical inactivity and depressed mood are both associated with a higher likelihood of diabetes-related complications; the association between physical activity and depressed mood in Type 2 diabetes has not been reviewed previously. We have reviewed (i) the strength of this association and (ii) the impact of depression-specific management and physical activity interventions on mood and activity levels in overweight adults with Type 2 diabetes. Methods Studies published between January 1996 and September 2007 were identified (Ovid - medline, Psych- Info and embase) using pertinent search terms (keyword/title). Results Of the 12 studies included (10 cross-sectional, two trials), most employed a standardized questionnaire for depressed mood but only one item for physical activity. In adults with Type 2 diabetes, the inactive are 1.72 to 1.75 times more likely to be depressed than the more active; the depressed are 1.22 to 1.9 times more likely to be physically inactive than the non-depressed. Two randomized trials demonstrated that a depression management programme improved mood, but only one demonstrated increased physical activity. Conclusions Studies to date suggest an association between depressed mood and physical inactivity in adults with Type 2 diabetes, although objective measures of physical activity have not been employed. Depression-specific management may improve mood and possibly activity. A trial comparing the impact of depression-specific management compared with exercise intervention on depressed mood and activity in Type 2 diabetes is justified. [source] Randomized controlled trial comparing the effectiveness and safety of intranasal and intramuscular naloxone for the treatment of suspected heroin overdoseADDICTION, Issue 12 2009Debra Kerr ABSTRACT Aims Traditionally, the opiate antagonist naloxone has been administered parenterally; however, intranasal (i.n.) administration has the potential to reduce the risk of needlestick injury. This is important when working with populations known to have a high prevalence of blood-borne viruses. Preliminary research suggests that i.n. administration might be effective, but suboptimal naloxone solutions were used. This study compared the effectiveness of concentrated (2 mg/ml) i.n. naloxone to intramuscular (i.m.) naloxone for suspected opiate overdose. Methods This randomized controlled trial included patients treated for suspected opiate overdose in the pre-hospital setting. Patients received 2 mg of either i.n. or i.m. naloxone. The primary outcome was the proportion of patients who responded within 10 minutes of naloxone treatment. Secondary outcomes included time to adequate response and requirement for supplementary naloxone. Data were analysed using multivariate statistical techniques. Results A total of 172 patients were enrolled into the study. Median age was 29 years and 74% were male. Rates of response within 10 minutes were similar: i.n. naloxone (60/83, 72.3%) compared with i.m. naloxone (69/89, 77.5%) [difference: ,5.2%, 95% confidence interval (CI) ,18.2 to 7.7]. No difference was observed in mean response time (i.n.: 8.0, i.m.: 7.9 minutes; difference 0.1, 95% CI ,1.3 to 1.5). Supplementary naloxone was administered to fewer patients who received i.m. naloxone (i.n.: 18.1%; i.m.: 4.5%) (difference: 13.6%, 95% CI 4.2,22.9). Conclusions Concentrated intranasal naloxone reversed heroin overdose successfully in 82% of patients. Time to adequate response was the same for both routes, suggesting that the i.n. route of administration is of similar effectiveness to the i.m. route as a first-line treatment for heroin overdose. [source] A randomized controlled trial of a smoking cessation intervention based in community pharmaciesADDICTION, Issue 2 2001T. A. Maguire Aims. To evaluate whether a structured community pharmacy-based smoking cessation programme (the PAS model) would give rise to a higher smoking cessation rate compared with ad hoc advice from pharmacists. Design. A randomized controlled trial comparing a structured intervention with usual care. Setting. One hundred pharmacists working in community pharmacies in N. Ireland and 24 in London took part in the study and were each asked to enroll 12 smokers; 44% of pharmacists who were trained managed to recruit one or more smokers during the recruitment period of approximately 1 year. Participants. A total of 484 smokers were enrolled by the pharmacists and individually randomized into the PAS intervention group ( N = 265) or the control group ( N = 219). Intervention. The PAS intervention involved a structured counselling programme, an information leaflet and a follow-up weekly for the first 4 weeks then monthly as needed. Measurements. The primary outcome measure of this study was self-reported smoking cessation for 12 months with cotinine validation at the 12-month follow-up. Findings. Of smokers in the PAS group, 14.3% (38) were abstinent up to 12 months compared with 2.7% (6) in the control group ( p < 0.001 for the difference). Conclusion. The community pharmacy-based PAS smoking cessation service can be an effective method of helping people stop smoking when delivered by pharmacists willing to adopt this approach. [source] Computer-mediated instructional video: a randomised controlled trial comparing a sequential and a segmented instructional video in surgical hand washEUROPEAN JOURNAL OF DENTAL EDUCATION, Issue 2 2005M. Schittek Janda Background:, Video-based instructions for clinical procedures have been used frequently during the preceding decades. Aim:, To investigate in a randomised controlled trial the learning effectiveness of fragmented videos vs. the complete sequential video and to analyse the attitudes of the user towards video as a learning aid. Materials and methods:, An instructional video on surgical hand wash was produced. The video was available in two different forms in two separate web pages: one as a sequential video and one fragmented into eight short clips. Twenty-eight dental students in the second semester were randomised into an experimental (n = 15) and a control group (n = 13). The experimental group used the fragmented form of the video and the control group watched the complete one. The use of the videos was logged and the students were video taped whilst undertaking a test hand wash. The videos were analysed systematically and blindly by two independent clinicians. The students also performed a written test concerning learning outcome from the videos as well as they answered an attitude questionnaire. Results:, The students in the experimental group watched the video significantly longer than the control group. There were no significant differences between the groups with regard to the ratings and scores when performing the hand wash. The experimental group had significantly better results in the written test compared with those of the control group. There was no significant difference between the groups with regard to attitudes towards the use of video for learning, as measured by the Visual Analogue Scales. Most students in both groups expressed satisfaction with the use of video for learning. Conclusion:, The students demonstrated positive attitudes and acceptable learning outcome from viewing CAL videos as a part of their pre-clinical training. Videos that are part of computer-based learning settings would ideally be presented to the students both as a segmented and as a whole video to give the students the option to choose the form of video which suits the individual student's learning style. [source] Neurocognition and its influencing factors in the treatment of schizophrenia,effects of aripiprazole, olanzapine, quetiapine and risperidoneHUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 2 2010M. Riedel Abstract Background To examine influencing variables of neurocognition in patients with schizophrenia and to predict cognition during antipsychotic treatment. Methods Data were obtained from patients with an acute episode of schizophrenia participating in two double-blind and one open label trial comparing the effects of different atypical antipsychotics on cognition. In total, 129 patients were enrolled in this analysis. Cognitive function was assessed at admission, week 4 and 8. Efficacy and tolerability were assessed weekly using the Positive and Negative Syndrome Scale (PANSS) and the Simpson Angus Sale (SAS). Patients were treated with aripirazole, olanzapine, quetiapine and risperidone. Regression analysis including mixed effect models was performed. Results A significant improvement in all cognitive domains was observed from baseline to week 8. Regarding the antipsychotic treatment applied quetiapine seemed to achieve the most favourable cognitive improvement. Negative and depressive symptoms, the patient's age and the concomitant and antipsychotic treatment applied were observed to significantly influence and predict neurocognition. Conclusion The results may indicate that schizophrenia is a static disorder with trait and state dependent cognitive components especially in the memory domains. The influence of negative and depressive symptoms should be considered in daily clinical routine. Copyright © 2010 John Wiley & Sons, Ltd. [source] Efficacy of infliximab in pediatric Crohn's disease: A randomized multicenter open-label trial comparing scheduled to on demand maintenance therapyINFLAMMATORY BOWEL DISEASES, Issue 3 2009Frank M. Ruemmele MD Abstract Background: Infliximab (IFX) is efficacious in inducing remission in severe forms of pediatric Crohn's disease (CD). Adult studies indicate that IFX is also safe and well tolerated as maintenance therapy. The present study aimed to evaluate in a prospective manner the efficacy and safety of IFX as maintenance therapy of severe pediatric CD comparing scheduled and "on demand" treatment strategies. Methods: Forty children with CD (nonpenetrating, nonstricturing as well as penetrating forms, mean age: 13.9 ± 2.2 years) with a severe flare-up (Harvey,Bradshaw Index [HBI] ,5, erythrocyte sedimentation rate [ESR] >20 mm/h) despite well-conducted immunomodulator therapy (n = 36 azathioprine, n = 1 mercaptopurine, n = 3 methotrexate) combined with steroids were included in this randomized, multicenter, open-label study. Three IFX infusions (5 mg/kg) were administered at week (W)0/W2/W6. At W10, clinical remission (HBI <5) and steroid withdrawal were analyzed and IFX responders were randomized to maintenance therapy over 1 year: group A, scheduled every 2 months; group B, "on demand" on relapse. Results: In all, 34/40 children came into remission during IFX induction therapy (HBI: 6.7 ± 2.5 (WO) vs. 1.1 ± 1.5 (W10); P < 0.001). At the end of phase 2, 15/18 (83%) patients were in remission in group A compared to 8/13 (61%) children in group B (P < 0.01), with a mean HBI of 0.5 versus 3.2 points (group A versus B, P = 0.011). In group A, 3/13 (23.1%) children experienced a relapse compared to 11/12 (92%) children in group B. No severe adverse event occurred during this trial. Conclusions: IFX is well tolerated and safe as maintenance therapy for pediatric CD, with a clear advantage when used on a scheduled 2-month basis compared to an "on demand" basis. (Inflamm Bowel Dis 2009) [source] Cutting through the statistical fog: understanding and evaluating non-inferiority trialsINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 10 2010W. S. Weintraub Summary Every year, results from many important randomised, controlled trials are published. Knowing the elements of trial design and having the skills to critically read and incorporate results are important to medical practitioners. The goal of this article is to help physicians determine the validity of trial conclusions to improve patient care through more informed medical decision making. This article includes a review of 162 randomised, controlled non-inferiority (n = 116) and equivalence (n = 46) hypothesis studies as well as the larger Stroke Prevention using Oral Thrombin Inhibitor in atrial Fibrillation V study and the Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial. Evaluation of data from small and large trials uncovers significant flaws in design and models employed and uncertainty about calculations of statistical measures. As one example of questionable study design, discussion includes a large (n = 3922), double-blind, randomised, multicentre trial comparing the efficacy of ximelagatran with warfarin for prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and additional stroke risk factors. Investigators concluded that ximelagatran was effective compared with well-controlled warfarin for prevention of thromboembolism. However, deficiencies in design, as well as concerns about liver toxicity, resulted in the rejection of the drug by the US Food and Drug Administration. Many trials fail to follow good design principles, resulting in conclusions of questionable validity. Well-designed non-inferiority trials can provide valuable data and demonstrate efficacy for beneficial new therapies. Objectives and primary end-points must be clearly stated and rigorous standards met for sample size, establishing the margin, patient characteristics and adherence to protocol. [source] Patients with problematic opioid use can be weaned from codeine without pain escalationACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 5 2010H. K. NILSEN Background: Brief treatments for chronic non-malignant pain patients with problematic opioid use are warranted. The aims of the present study were to investigate (1) whether it is possible to withdraw codeine use in such patients with a brief cognitive-behavioural therapy (CBT), (2) whether this could be done without pain escalation and reduction in quality of life and (3) to explore the effects of codeine reduction on neurocognitive functioning. Methods: Eleven patients using codeine daily corresponding to 40,100 mg morphine were included. Two specifically trained physicians treated the patients with six CBT sessions, tapering codeine gradually within 8 weeks. Codeine use, pain intensity, quality of life and neuropsychological functioning were assessed at pre-treatment to the 3-month follow-up. Results: Codeine use was significantly reduced from mean 237 mg [standard deviation (SD) 65] pre-treatment to 45 mg (SD 66) post-treatment and to 48 mg (SD 65) at follow-up without significant pain escalation or reductions in quality of life. Moreover, neuropsychological functioning improved significantly on some tests, while others remained unchanged. Conclusion: The promising findings of codeine reduction in this weaning therapy programme for pain patients with problematic opioid use should be further evaluated in a larger randomized control trial comparing this brief CBT with both another brief treatment and attention placebo condition. [source] Sparing the larynx during gynecological laparoscopy: a randomized trial comparing the LMA SupremeÔ and the ETTACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 2 2010W. ABDI Background: We designed a prospective randomized single-blind study to compare efficiency and post-operative upper airway morbidity when the laryngeal mask airway (LMA) SupremeÔ is used as an alternative to the endotracheal tube (ETT). Methods: One hundred and thirty-eight elective pelvic laparoscopic ASA I,II female patients were assigned to receive either the LMA Supreme® or the ETT for airway management. Balanced anesthesia and ventilation techniques were standardized to control end-tidal CO2 and BIS value in the range 4.5,5 kPa and 40,50, respectively, and to maintain adequate hemodynamic stability. A single surgeon blinded to the airway management technique performed all surgical procedures. The ventilation efficiency of each airway was evaluated. Anesthesia- and surgery-related times were calculated and anesthesia details were recorded. Post-operative pain and pharyngolaryngeal morbidity were measured in a blind fashion using a numerical rating scale (NRS) (0,100). Results: Surgery duration was similar in both groups. Airway management duration was shorter with the LMA Supreme®. Post-operative pharyngolaryngeal morbidity incidence and all symptoms' intensity were significantly increased after ETT as compared with LMA Supreme® anesthesia. At the end of the PACU stage, the incidence and mean NRS of post-operative hoarseness were reduced when LMA Supreme® was used as an alternative to the ETT (16% vs. 47%; P<0.01 and 9 vs. 19, P<0.01, respectively). Conclusion: We demonstrated that choosing an LMA Supreme® was an efficient pharyngolaryngeal morbidity-sparing strategy. Moreover, we showed that the LMA Supreme® and the ETT were equally effective airways for a routine gynecological laparoscopy procedure. [source] Orthotopic Cardiac Transplantation: Comparison of Outcome Using Biatrial, Bicaval, and Total TechniquesJOURNAL OF CARDIAC SURGERY, Issue 1 2005Jeffrey A. Morgan M.D. More recently, however, bicaval and total techniques have been devised in an attempt to improve cardiac anatomy, physiology, and postoperative outcome. A bicaval approach preserves the donor atria and combines the standard left atrial anastomosis with a separate bicaval anastomosis. Total orthotopic heart transplantation involves complete excision of the recipient atria with separate bicaval end-to-end anastomoses, as well as pulmonary venous anastomoses. The aim of this study was to conduct a literature review of studies that compared the three surgical techniques (biatrial, bicaval, and total) for performing orthotopic cardiac transplantation. Numerous outcome variables were evaluated, and included post-transplant survival, atrial dimensions, atrioventricular valvular insufficiency, arrhythmias, pacing requirements, vasopressor requirements, and hospital stay. Methods: We conducted a Medline (Pubmed) search using the terms "biatrial and cardiac transplantation,""bicaval and cardiac transplantation," and "total technique and cardiac transplantation," which yielded 192 entries: 39 of these were studies that compared surgical techniques and were included in the review. Results: There was overwhelming evidence that the bicaval technique provided anatomic and functional advantages, with improvements in post-transplant survival, atrial geometry, and hemodynamics, as well as decreased valvular insufficiency, arrhythmias, pacing requirements, vasopressor requirements, and hospital stay. Conclusions: The bicaval technique was superior to both biatrial and total techniques for numerous outcome variables. To further elucidate this issue, a prospective randomized trial comparing the three techniques, with long-term follow-up, is warranted. [source] Feasibility and tolerability of probiotics for prevention of antibiotic-associated diarrhoea in hospitalized US military veteransJOURNAL OF CLINICAL PHARMACY & THERAPEUTICS, Issue 6 2008N. Safdar MD MS Summary Background:, Probiotics may be efficacious for the prevention of antibiotic-associated diarrhoea. The tolerability and acceptability of probiotics in an elderly US veteran population has not been assessed. Purpose:, To undertake a randomized trial to determine the tolerability and acceptability of a probiotic, Florajen® in an elderly population with multiple comorbidities. Methods:, Pilot randomized double-blind trial comparing a probiotic, Florajen® to placebo for the prevention of antibiotic-associated diarrhoea in elderly hospitalized patients receiving antibiotics. Results:, Forty patients were enrolled and randomized. Antibiotic-associated diarrhoea occurred in 6/16 (37%) in the placebo group and 4/23 (17%) patients in the Florajen® group, (RR 1·63, 95% CI 0·73,3·65, P = 0·15). Florajen® was well tolerated in the study population with no major side effects that necessitated discontinuation. Conclusions:, In this pilot study, Florajen® was well tolerated in an elderly population, all of whom were taking several other medications. A larger study is needed to determine the effect of Florajen® on antibiotic-associated diarrhoea and Clostridium difficile infection. [source] Single-Center Experience with the HelexÔ Septal Occluder for Closure of Atrial Septal Defects in ChildrenJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 1 2003ROBERT N. VINCENT M.D. Catheter closure of atrial septal defects (ASDs) is an accepted procedure among pediatric cardiologists. We report our early experience with the newest of these devices in clinical trials in the United States. Between April and October 2001, 14 patients were enrolled in an FDA phase II multicenter trial comparing the results of ASD closure using the HELEXÔ Septal Occluder to a surgical control group. Of the 14 patients, devices were placed and left in 13, one being removed for an excessive residual leak despite placing the largest device available. Of the remaining 13 patients, all patients had successful closure of their defects. An average of 1.8 devices/patient were deployed, reflecting the learning curve for this new device and new delivery style. Six devices were replaced because of excessive residual leaks, three for premature lock release, and two for improper seating of the device. There were no procedural complications, however, one patient required device removal 4 months postimplant for possible allergic reaction to nickel. The same patient had removal of stainless steel sternal wires for the same reason. At the 6-month follow-up, 11 of 13 patients had complete closure of the ASD, the other two having small, hemodynamically insignificant left to right shunts. In one of these patients, there was complete closure at the 12-month follow-up, whereas the other patient awaits the 1-year evaluation. Early experience at our institution has demonstrated the ease of use of this device, its complete retrievability, and excellent closure of small to moderate ASDs in children. (J Interven Cardiol 2003;16:79,82) [source] Direct Coronary Stenting in Noncomplex and Noncalcified Lesions: Immediate and Mid-term Results of a Prospective RegistryJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 4 2000MARC BEDOSSA M.D. Stenting of coronary arteries is currently used in clinical practice. The aim of this prospective registry was to assess the feasibility and the safety of stent implantation without balloon predilatation in noncomplex and noncalcifed lesions. One hundred six stents were implanted in 85 patients who underwent percutaneous coronary angioplasty (PTCA) of native vessels (n = 95) or bypass grafts (n = 11). The lesions were type A (21%) or B1 (79%). The stent was a tubular or a coil stent in 71 ± and 29% of the cases, respectively. The angiographic success rate was 94%. The maximal pressure was 12.1 ± 2.1 atm. In only 7 cases, it was not possible to cross the stenosis with the stent, necessitating retrieval of it and predilation with a balloon before stent implantation. Three dissections after stent implantation were treated by a second stent implantation. The primary success rate was 98% (no acute closure or myocardial infarction). A clinical follow-up was obtained in 98% of patients with a mean delay of 6 ± 0.5 months. Eighty-one percent of patients were asymptomatic. The target lesion revascularization rate was 9.4%. Four patients underwent a new PTCA and four patients a coronary artery bypass graft surgery. This technique of stent implantation appears to be safe with good immediate and midterm results. A prospective randomized trial comparing this technique to the standard technique of stent delivery in noncomplex lesions is currently ongoing with an intravascular ultrasound substudy. [source] Attempted randomized controlled trial of pamidronate versus calcium and calcitriol supplements for management of steroid-induced osteoporosis in children and adolescentsJOURNAL OF PAEDIATRICS AND CHILD HEALTH, Issue 11 2005JJ Brown Objectives: To describe an attempted interventional trial for glucocorticoid-induced osteoporosis in children and adolescents and to discuss the reasons for trial failure to inform future interventional studies in this important group of patients. Methods: Prospective randomized controlled trial comparing the effect of bisphosphonate therapy with calcium and vitamin D supplementation on bone mineral accrual is described. For non-trial patients, retrospective analysis of the effect of calcium and vitamin D supplementation combined with bisphosphonate treatment on bone mineral accrual. Results: Only 12 patients were enrolled in the trial over 4 years. Bisphosphonate recipients (n = 5) had a mean annual percentage increase in lumbar spine bone mineral density of 8.76 ± 5.2% compared to 6.6 ± 4.0% in the calcium/vitamin-treated group (difference not significant). Mean annual change in lumbar spine areal bone mineral density in non-trial patients (n = 11) was 3.72 ± 2.5%. Conclusion: Conducting a randomized controlled trial in this group of corticosteroid users is difficult, given the unpredictable nature of the underlying disease and intermittent need for steroid treatment. The trial failed through inadequate recruitment combined with discontinued interventions. [source] A hierarchical modelling approach to analysing longitudinal data with drop-out and non-compliance, with application to an equivalence trial in paediatric acquired immune deficiency syndromeJOURNAL OF THE ROYAL STATISTICAL SOCIETY: SERIES C (APPLIED STATISTICS), Issue 1 2002Joseph W Hogan Longitudinal clinical trials with long follow-up periods almost invariably suffer from a loss to follow-up and non-compliance with the assigned therapy. An example is protocol 128 of the AIDS Clinical Trials Group, a 5-year equivalency trial comparing reduced dose zidovudine with the standard dose for treatment of paediatric acquired immune deficiency syndrome patients. This study compared responses to treatment by using both clinical and cognitive outcomes. The cognitive outcomes are of particular interest because the effects of human immunodeficiency virus infection of the central nervous system can be more acute in children than in adults. We formulate and apply a Bayesian hierarchical model to estimate both the intent-to-treat effect and the average causal effect of reducing the prescribed dose of zidovudine by 50%. The intent-to-treat effect quantifies the causal effect of assigning the lower dose, whereas the average causal effect represents the causal effect of actually taking the lower dose. We adopt a potential outcomes framework where, for each individual, we assume the existence of a different potential outcomes process at each level of time spent on treatment. The joint distribution of the potential outcomes and the time spent on assigned treatment is formulated using a hierarchical model: the potential outcomes distribution is given at the first level, and dependence between the outcomes and time on treatment is specified at the second level by linking the time on treatment to subject-specific effects that characterize the potential outcomes processes. Several distributional and structural assumptions are used to identify the model from observed data, and these are described in detail. A detailed analysis of AIDS Clinical Trials Group protocol 128 is given; inference about both the intent-to-treat effect and average causal effect indicate a high probability of dose equivalence with respect to cognitive functioning. [source] A Methodology for Evaluation of Dietary Feeding Stimulants for the Pacific White Shrimp, Litopenaeus vannameiJOURNAL OF THE WORLD AQUACULTURE SOCIETY, Issue 1 2005Dagoberto R. Sanchez A simple and practical method for quantification of feeding stimulation of shrimp Litopenaeus vannamei was developed using feed preference as an index of comparison. Feed preference was defined as the percentage of shrimp observed in each feeding tray. Preliminary trials were undertaken with two commercial feeds (45% protein with 5% squid meal and 40% protein without squid meal). Results indicated the following criteria were suitable for use as methodology for evaluating feeding stimulation in 5-m diameter static flow tanks: shrimp density (2.5 shrimp/m2); observational period (1 or 2 h post-addition of feed to trays), feed rate (2%), and between-trial feed rate (2%). A further investigation was undertaken to evaluate the influence of protein level and source on feed preference using a basal diet consisting of wheat flour, casein, carboxymethyl cellulose binder, and limestone, with or without krill meal as a feeding stimulant. A significant difference was shown in feeding preference for the 16% protein/4% krill meal vs. one without krill meal; however, this relationship was not shown in 45% protein feed comparisons. A second trial comparing 0, 16,30, and 45 % protein/casein-based feeds showed similar results. From these findings, it was postulated that casein, itself, also serves as a feeding stimulant at high dietary inclusion levels. A third trial comparing 16% protein/casein or wheat gluten-based feeds Indicated a delay of at least 2 h in maximum feeding preference response in feeds in which 4% krill meal was added as a feeding stimulant. It was postulated that chemical stimulants from krill meal were more slowly released in wheat gluten-based feeds. Our methodology appears suitable for evaluation of potential feeding stimulants when incorporated into low-protein casein-based or wheat-gluten-based feeds. [source] A randomized-controlled trial comparing an educational intervention alone vs education and biofeedback in the management of faecal incontinence in womenNEUROGASTROENTEROLOGY & MOTILITY, Issue 1 2005A. Ilnyckyj Abstract, Biofeedback (BF) training is an accepted therapy in the treatment of faecal incontinence (FI) despite a paucity of data demonstrating benefit. This study aims to determine whether BF has any specific effect above and beyond an educational intervention. Twenty-three women with regular and frequent idiopathic FI were randomized to education and pelvic exercise vs education and BF therapy. Complete data is available for 18 women. Overall, 61% of participants demonstrated a complete response. There was no difference in response rate between treatment arms. Women with FI demonstrate a good response to treatment with education and exercise and education plus BF thus questioning the specific effect of BF. [source] Mixed incontinence: Comparing definitions in women having stress incontinence surgery,,§¶NEUROUROLOGY AND URODYNAMICS, Issue 4 2009Linda Brubaker Abstract Objective To develop an empirically derived definition of mixed urinary incontinence (MUI) for use in incontinence outcomes research. Methods Participants in a randomized trial comparing the fascial sling and. Burch colposuspension were assessed using standardized measures including the Medical, Epidemiologic and Social Aspects of Aging (MESA), UI questionnaire, the Urogenital Distress Inventory (UDI), 3-day urinary diary and urodynamic studies (UDS). Participants were required to have stress incontinence with a MESA stress subscale score,>,MESA urge subscale score. Several definitions of MUI were considered. Logistic and linear regression analysis methods were used to predict clinical outcomes based on the different MUI definitions. Analyses were carried out using SAS (SAS Institute, Inc., Cary, NC, Version 9.1). Statistical significance was defined at P -value <0.05. Results In 655 participants, the proportion of women with MUI varied from 8.3% to 93.3% depending on the MUI definition All definitions were associated with severity as measured by the frequency of incontinence episodes at baseline; however little of the variability was explained by any single definition. No strict cut-off value for these baseline measures was identified to predict clinical outcomes. Conclusions These MUI definitions do not adequately categorize clinically relevant UI subgroups. For research reporting, MUI subcomponents of stress and urge UI should be described separately rather than as a single dimension. Neurourol. Urodynam. 28:268,273, 2009. © 2009 Wiley-Liss, Inc. [source] Latest news and product developmentsPRESCRIBER, Issue 21 2008Article first published online: 2 DEC 200 Osteoporosis guideline A new guideline on the management of osteoporosis in men over 50 and post-menopausal women has been published by the National Osteoporosis Guideline Group (www.shef.ac.uk/NOGG), a group of organisations representing health professionals and patients, with funding from several pharmaceutical companies. The guideline recommends using the FRAX tool (www.shef.ac.uk/FRAX) to assess the 10-year fracture risk in individuals with risk factors to facilitate targeting DXA scans to measure bone mineral density. Patients who have already sustained a fragility fracture should be treated without risk assessment. Treatment recommendations are similar to those published in draft NICE guidance on primary and secondary prevention, selecting alendronate as the drug of first choice for most patients. Efalizumab efficacy A multicentred postapproval trial has demonstrated long-term efficacy and a favourable safety profile for efalizumab (Raptiva) in moderate to severe chronic plaque psoriasis. The CONTROL II study, presented in September at the 17th EADV congress in Paris, was conducted at 170 sites in 18 European countries and involved 1255 patients who had failed to respond to traditional systemic therapies. In this non-blinded study, 68 per cent of participants achieved the primary efficacy end-point and showed improvement within the first 12 weeks; control was maintained in responding patients who continued treatment. Adverse effects were graded as mild or moderate and similar to those reported in earlier studies. There was no evidence of an increase in malignancies or infections. New oral anticoagulant Rivaroxaban (Xarelto), an oral factor Xa inhibitor, has been introduced for the prevention of venous thrombo-embolism in patients undergoing elective hip or knee replacement surgery. Compared with the low molecular weight heparin enoxaparin (Clexane), rivaroxaban has been shown to reduce the risk of venous thrombosis by 70 per cent after hip replacement and by 49 per cent after knee replacement; the risk of bleeding was similar. At the recommended dose of 10mg once daily, prophylaxis after hip surgery lasts five weeks and costs £157; prophylaxis after knee surgery lasts two weeks and costs £63. New products UCB Pharma has introduced lacosamide (Vimpat) as adjunctive treatment of partial-onset epilepsy with or without secondary generalisation in patients aged 16 and over. A month's treatment at the recommended maintenance dose of 100-200mg twice daily costs approximately £73-£140. A new non-nucleoside reverse transcriptase inhibitor (NNRI) is available for the treatment of HIV-1 infection in combination with a boosted protease inhibitor (PI) and other antiretrovirals in treatment-experienced adults. Etravirine (Intelence) costs approximately £320 for one month's treatment at the recommended dose of 200mg twice daily. Voltarol Pain-Eze (diclofenac) 12.5mg tablets are now available without prescription; a pack of 18 tablets costs £5.99. Atypicals and EPS risk Atypical antipsychotics are not associated with a significantly lower risk of extra-pyramidal symptoms than first-generation agents such as perphenazine (Fentazin), a new analysis of the CATIE study has shown (Br J Psychiatry 2008;193:279,88). CATIE was a large trial comparing the efficacy and safety of antipsychotics in the treatment of schizophrenia in which perphenazine was a representative first-generation agent (Am J Psychiatry 2006;163:611,22). This analysis found no differences in the risk of parkinsonism, dystonia, akathisia or tardive dyskinesia between perphenazine and the newer antipsychotics; use of antiparkinsonian medication was higher with risperidone and lower with quetiapine (Seroquel). Mental health website A new website offering information about mental illnesses and drug treatment has been launched by the United Kingdom Psychiatric Pharmacy Group (UKPPG), the College of Mental Health Pharmacists (CMHP), the Pharmaceutical Schizo-phrenia Initiative (PSI) and the National Institute for Mental Health in England (NIMHE). www.choiceandmedication.org.uk includes information about 17 mental illnesses and a large number of drug treatments. It offers links to other sites offering information and downloadable leaflets, help to identify the local mental health trust and downloadable charts comparing treatments for each indication. [source] A prospective, randomised, cross-over trial comparing the EndoFlex® and standard tracheal tubes in patients with predicted easy intubationANAESTHESIA, Issue 11 2009W. H. L. Teoh Summary We aimed to determine if using the EndoFlex® tracheal tube on the first intubation attempt provided improved placement times and intubation success compared with a standard-type tracheal tube in 50 patients undergoing gynaecological surgery in a prospective, randomised, cross-over trial. We found that using the EndoFlex resulted in shorter intubation times (mean (SD) 14.8 (9.7) vs 30.1 (30.5) s), easier intubation (VAS, median (range) 10 (0,70) vs 20 (0,100)), and an increased rate of successful insertion at the first attempt; all p < 0.001. Flexing the distal tip of the EndoFlex was used in 18 patients. There were reductions in the use of external laryngeal pressure, advancement of laryngoscope blade and increased lifting force when intubating with the EndoFlex. Furthermore, patients with a grade 2 (19/50) or 3 (6/50) laryngoscopic view had shorter intubation times, easier intubation and reduced insertion attempts with the EndoFlex. The EndoFlex is a satisfactory alternative to a standard-type tracheal tube, even with an anterior larynx. [source] A randomised crossover trial comparing the i-gel supraglottic airway and classic laryngeal mask airway,ANAESTHESIA, Issue 6 2009C. Janakiraman Summary In a randomised cross-over study, we compared the performance of the single use i-gel supraglottic airway and reusable classic laryngeal mask airway (cLMATM) in 50 healthy anaesthetised patients who were breathing spontaneously. Primary outcome was successful insertion at first attempt. Secondary outcomes included overall insertion success rate, ease of insertion, leak pressure and fibreoptic position. Success rate for insertion at the first attempt was significantly different (54% with i-gel vs 86% with cLMA; p = 0.001). Overall success after two attempts (when the anaesthetist was allowed to change the size of the device) improved to 84% with i-gel vs 92% with cLMA; p = 0.22. In 14 patients, the i-gel when used first needed to be replaced with a larger size. Leak pressure was higher for the i-gel (median [IQR] 20 [14,24] cm H2O than the cLMA 17 [12,22] cm H2O; p = 0.023). The fibreoptic view through the device was significantly better with the i-gel than the cLMA, which was statistically significant (p = 0.03). We conclude that, with its current sizing recommendations, the i-gel is not an acceptable alternative to cLMA. However because of the significantly improved success rate after a larger sized i-gel was used, we recommend the manufacturer to review the sizing guidelines to improve the success rate. [source] Initiating levodopa/carbidopa therapy with and without entacapone in early Parkinson disease: The STRIDE-PD studyANNALS OF NEUROLOGY, Issue 1 2010Fabrizio Stocchi MD Objective L-dopa is the most widely used and most effective therapy for Parkinson disease (PD), but chronic treatment is associated with motor complications in the majority of patients. It has been hypothesized that providing more continuous delivery of L-dopa to the brain would reduce the risk of motor complications, and that this might be accomplished by combining L-dopa with entacapone, an inhibitor of catechol-O-methyltransferase, to extend its elimination half-life. Methods We performed a prospective 134-week double-blind trial comparing the risk of developing dyskinesia in 747 PD patients randomized to initiate L-dopa therapy with L-dopa/carbidopa (LC) or L-dopa/carbidopa/entacapone (LCE), administered 4× daily at 3.5-hour intervals. The primary endpoint was time to onset of dyskinesia. Results In comparison to LC, patients receiving LCE had a shorter time to onset of dyskinesia (hazard ratio, 1.29; p = 0.04) and increased frequency at week 134 (42% vs 32%; p = 0.02). These effects were more pronounced in patients receiving dopamine agonists at baseline. Time to wearing off and motor scores were not significantly different, but trended in favor of LCE treatment. Patients in the LCE group received greater L-dopa dose equivalents than LC-treated patients (p < 0.001). Interpretation Initiating L-dopa therapy with LCE failed to delay the time of onset or reduce the frequency of dyskinesia compared to LC. In fact, LCE was associated with a shorter time to onset and increased frequency of dyskinesia compared to LC. These results may reflect that the treatment protocol employed did not provide continuous L-dopa availability and the higher L-dopa dose equivalents in the LCE group. ANN NEUROL 2010;68:18,27 [source] High-dose cyclophosphamide versus monthly intravenous cyclophosphamide for systemic lupus erythematosus: A prospective randomized trial,ARTHRITIS & RHEUMATISM, Issue 5 2010Michelle Petri Objective Monthly intravenous (IV) cyclophosphamide for 6 months has been the standard induction regimen for lupus nephritis, followed by a maintenance regimen of quarterly infusions for 2 years. We undertook this study to compare the efficacy and safety of the standard regimen versus a high-dose IV cyclophosphamide regimen. Methods We performed a prospective randomized trial comparing monthly IV cyclophosphamide at 750 mg/m2 body surface area for 6 months followed by quarterly IV cyclophosphamide for 2 years (traditional treatment) against high-dose IV cyclophosphamide (50 mg/kg daily for 4 days) (high-dose treatment). Entry criteria included renal lupus, neurologic lupus, or other organ system involvement with moderate-to-severe activity. Results Fifty-one patients were randomized; 3 withdrew before treatment and 1 committed suicide after 2 months of high-dose treatment. Twenty-two had renal lupus, 14 had neurologic lupus, and 11 had other organ involvement. The outcome measure was the Responder Index for Lupus Erythematosus (complete response, partial response, no change, or worsening). At 6 months (the end of induction), 11 of 21 patients (52%) in the high-dose treatment group had a complete response compared with 9 of 26 patients (35%) in the traditional treatment group (P = 0.13). At the final visit (30 months), 10 of 21 patients (48%) in the high-dose treatment group had a complete response compared with 13 of 20 patients (65%) who continued with traditional treatment (P = 0.13). Six patients crossed over from traditional treatment to high-dose treatment because of lack of response, and 3 of those patients became complete responders. Conclusion There was not strong evidence that monthly IV cyclophosphamide and high-dose IV cyclophosphamide differed in complete or in any (complete or partial) response to induction or maintenance therapy. However, nonresponders to monthly IV cyclophosphamide can sometimes be rescued with high-dose IV cyclophosphamide. [source] Incremental Benefit of 80-Lead Electrocardiogram Body Surface Mapping Over the 12-Lead Electrocardiogram in the Detection of Acute Coronary Syndromes in Patients Without ST-elevation Myocardial Infarction: Results from the Optimal Cardiovascular Diagnostic Evaluation Enabling Faster Treatment of Myocardial Infarction (OCCULT MI) TrialACADEMIC EMERGENCY MEDICINE, Issue 9 2010Brian J. O'Neil MD ACADEMIC EMERGENCY MEDICINE 2010; 17:932,939 © 2010 by the Society for Academic Emergency Medicine Abstract Background:, The initial 12-lead (12L) electrocardiogram (ECG) has low sensitivity to detect myocardial infarction (MI) and acute coronary syndromes (ACS) in the emergency department (ED). Yet, early therapies in these patients have been shown to improve outcomes. Objectives:, The Optimal Cardiovascular Diagnostic Evaluation Enabling Faster Treatment of Myocardial Infarction (OCCULT-MI) trial was a multicenter trial comparing a novel 80-lead mapping system (80L) to standard 12L ECG in patients with chest pain and presumed ACS. This secondary analysis analyzed the incremental value of the 80L over the 12L in the detection of high-risk ECG abnormalities (ST-segment elevation or ST depression) in patients with MI and ACS, after eliminating all patients diagnosed with ST-elevation MI (STEMI) by 12L ECG. Methods:, Chest pain patients presenting to one of 12 academic EDs were diagnosed and treated according to the standard care of that site and its clinicians; the clinicians were blinded to 80L results. MI was defined by discharge diagnosis of non,ST-elevation MI (NSTEMI) or unstable angina (UA) with an elevated troponin. ACS was defined as discharge diagnosis of NSTEMI or UA with at least one positive test result (troponin, stress test, angiogram) or revascularization procedure. Results:, Of the 1,830 patients enrolled in the trial, 91 patients with physician-diagnosed STEMI and 225 patients with missing 80L or 12L data were eliminated from the analysis; no discharge diagnosis was available for one additional patient. Of the remaining 1,513 patients, 408 had ACS, 206 had MI, and one had missing status. The sensitivity of the 80L was significantly higher than that of the 12L for detecting MI (19.4% vs. 10.4%, p = 0.0014) and ACS (12.3% vs. 7.1%, p = 0.0025). Specificities remained high for both tests, but were somewhat lower for 80L than for 12L for detecting both MI and ACS. Negative and positive likelihood ratios (LR) were not statistically different between groups. In patients with severe disease (defined by stenosis > 70% at catheterization, percutaneous coronary intervention, coronary artery bypass graft, or death from any cause), the 80L had significantly higher sensitivity for detecting MI (with equivalent specificity), but not ACS. Conclusions: Among patients without ST elevation on the 12L ECG, the 80L body surface mapping technology detects more patients with MI or ACS than the 12L, while maintaining a high degree of specificity. [source] A Geometric Approach to Comparing Treatments for Rapidly Fatal DiseasesBIOMETRICS, Issue 1 2006Peter F. Thall Summary In therapy of rapidly fatal diseases, early treatment efficacy often is characterized by an event, "response," which is observed relatively quickly. Since the risk of death decreases at the time of response, it is desirable not only to achieve a response, but to do so as rapidly as possible. We propose a Bayesian method for comparing treatments in this setting based on a competing risks model for response and death without response. Treatment effect is characterized by a two-dimensional parameter consisting of the probability of response within a specified time and the mean time to response. Several target parameter pairs are elicited from the physician so that, for a reference covariate vector, all elicited pairs embody the same improvement in treatment efficacy compared to a fixed standard. A curve is fit to the elicited pairs and used to determine a two-dimensional parameter set in which a new treatment is considered superior to the standard. Posterior probabilities of this set are used to construct rules for the treatment comparison and safety monitoring. The method is illustrated by a randomized trial comparing two cord blood transplantation methods. [source] On Estimating Medical Cost and Incremental Cost-Effectiveness Ratios with Censored DataBIOMETRICS, Issue 4 2001Hongwei Zhao Summary. Medical cost estimation is very important to health care organizations and health policy makers. We consider cost-effectiveness analysis for competing treatments in a staggered-entry, survival-analysis-based clinical trial. We propose a method for estimating mean medical cost over patients in such settings. The proposed estimator is shown to be consistent and asymptotically normal, and its asymptotic variance can be obtained. In addition, we propose a method for estimating the incremental cost-effectiveness ratio and for obtaining a confidence interval for it. Simulation experiments are conducted to evaluate our proposed methods. Finally, we apply our methods to a clinical trial comparing the cost effectiveness of implanted cardiac defibrillators with conventional therapy for individuals at high risk for ventricular arrhythmias. [source] Randomised controlled trial comparing the efficacy of same-day administration of mifepristone and misoprostol for termination of pregnancy with the standard 36 to 48 hour protocolBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 2 2007J Guest Objective, To determine the efficacy of oral mifepristone followed by vaginal misoprostol 6 hours later compared with the standard 36- to 48-hour regimen for medical termination of pregnancy. Design, Single centre, two arm, parallel, open randomised controlled trial. Setting, Medical termination service at a teaching hospital. Sample, Four hundred and fifty women undergoing medical termination of pregnancy at up to 63 days of gestation. Methods, Eligible women were randomised to receive mifepristone 200 mg orally followed by vaginal misoprostol 800 micrograms either 6 hours (n= 225) or 36,48 hours (n= 225) later. All participants were invited to attend for a follow-up pelvic ultrasound scan within 7 days following the misoprostol administration. For those women in whom products of conception remained at the follow-up ultrasound scan, expectant management ensued with weekly follow-up ultrasound scans until the termination was complete. They could elect to undergo an evacuation of uterus at any stage following the scan. Those women with a nonviable gestation sac at the follow-up scan were offered a further dose of vaginal misoprostol 800 micrograms or suction termination of pregnancy. Women with a continuing pregnancy were managed with surgical termination. Main outcome measure, Successful medical abortion defined as no requirement for medical or surgical intervention beyond the initial dose of misoprostol. Results, One hundred and sixty-five women (79%) in the 6-hour group and 197 women (92%) in the 36- to 48-hour group had a successful termination at first follow-up ultrasound or presumed on the basis of other considerations (those not seen for ultrasound but deemed successful by negative pregnancy test, products passed on ward or long-term assessment of notes). Twenty-two women (10%) in the 6-hour regimen required up to three further ultrasound scans after 7 days following the mifepristone administration in order to ensure that the termination process was complete. None of these women required a suction evacuation of uterus. In the 36- to 48-hour regimen, ten (5%) women had up to two further ultrasound scans to confirm a complete termination without the need for a surgical evacuation of uterus. Therefore, the overall successful termination rate in the 6-hour regimen was 89% (187/210) compared with 96% (207/215) in the 36- to 48-hour regimen (relative risk = 0.92, 95% CI 0.84,0.98). Repeat administration of misoprostol or surgical treatment was required in 23 women (11%) in the 6-hour group and 8 women (4%) in the 36- to 48-hour group. A viable pregnancy was found in five women (2%) in the 6-hour group and in three women (1%) in the 36- to 48-hour group. Conclusions, Oral mifepristone 200 mg followed by vaginal misoprostol 800 micrograms after 6 hours is not as effective at achieving a complete abortion compared with the 36- to 48-hour protocol. [source] The ATAC adjuvant breast cancer trial in postmenopausal women: baseline endometrial subprotocol dataBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 12 2003S. Duffy Objective The ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial is a randomised, double-blind trial comparing ,Arimidex' (anastrozole), alone or in combination with tamoxifen, relative to tamoxifen alone as a five year adjuvant treatment for postmenopausal women with early breast cancer. Because tamoxifen is associated with endometrial pathology, the ATAC endometrial subprotocol was initiated to establish the background prevalence of pathology, and to assess prospectively the incidence and nature of intrauterine changes before and following endocrine therapy. Setting International. Population and Study Design Two hundred and eighty-five women entered the subprotocol: the mean age was 60 years (range 44,80 years); 113 women (40%) had taken hormone replacement therapy prior to randomisation, and 238 women were parous (84%). The age at onset of the menopause was 32,58 years, with the majority becoming menopausal between 46 and 55 years of age. Two hundred and seventy-two women had a hysteroscopy before they commenced trial medication. Hysteroscopy was performed successfully in 265 women. In six women, failure of hysteroscopy at baseline led to withdrawal from the study. Three of the women who withdrew had a pipelle biopsy taken. Therefore, the total number of endometrial biopsies at baseline was 268. Main outcome measures To assess the demographic characteristics of women entering the endometrial subprotocol and their hysteroscopic and histological findings before commencing trial medication. Results At hysteroscopy, there was a diagnosis of endometrial polyps in 34 women (13%), fibroids in 16 women (6%) and one case of suspicious endometrium, which was confirmed as a polyp on histology. Only 21 of the 34 polyps seen hysteroscopically were proven histologically (62% accuracy of hysteroscopy). Final histology found the prevalence of endometrial diagnostic categories as follows: 123 inactive endometrium (46%), 20 benign polyps (7%), 17 secretory endometrium (6%), 7 proliferative endometrium (3%), 3 atypical hyperplasia (2 in a polyp), 1 simple hyperplasia (in a polyp) and 1 fibroid. The remaining women had pipelle samples with insufficient tissue obtained, indicating a normal endometrial cavity. Conclusion This is the first study of such size in gynaecologically asymptomatic breast cancer patients. This paper describes the findings in individual patients before any trial treatment was given. In this baseline group, 82% (219/268) of women had a normal endometrial cavity; 18% (49/268) had endometrial activity (proliferative or secretory endometrium in 9%) or an intracavity abnormality (hyperplasia, polyps and a fibroid in 9%). In total, 36% of biopsies had insufficient tissue for diagnosis, which in combination with a normal hysteroscopy was classed as normal. The appearance of a polyp hysteroscopically in this group was not proven histologically in approximately 40% of cases. The development of uterine pathology over time in the ATAC study will subsequently be assessed against the findings of this baseline paper. [source] | ||||||||||||||||||||||||||||