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Prospectively
Kinds of Prospectively Selected AbstractsMonitoring cytomegalovirus IE-1 and pp65-specific CD4+ and CD8+ T-cell responses after allogeneic stem cell transplantation may identify patients at risk for recurrent CMV reactivations ,CYTOMETRY, Issue 4 2008Jan W. Gratama Abstract We studied the recovery of CMV-specific CD4+ and CD8+ T-cell immunity in 52 recipients of allogeneic stem cell transplantation (SCT). The proportions of IFN-,-producing CD4+ and CD8+ T cells upon in vitro activation using peptide pools representing the CMV pp65 and IE-1 proteins were assessed at multiple time points post SCT, and correlated with the occurrence of CMV reactivation. In a retrospective analysis, recurrent CMV reactivations occurred in 9 patients and were associated with low pp65-specific CD4+ T-cell and low IE-1-specific CD8+ T-cell reactivities, whereas patients without detectable CMV reactivation (n = 30) or a single reactivation (n = 13) showed a better recovery of these immune responses. CD4+ T-cell responses to IE-1 were infrequent in most patients, whereas CD8+ T-cell responses to pp65 occurred frequently, but did not correlate with protection against (recurrent) reactivation. Prospectively, CMV-specific T-cell responses could be studied prior to 14 reactivation episodes in 8 patients. CD4+ T-cell responses to IE-1 and pp65 were positive in only 1 and 2 episodes, respectively. CD8+ T-cell responses against IE-1 were positive in 4, but against pp65 in 12 episodes, again showing that CD8+ T-cell reactivity against pp65 did not prevent CMV reactivation. Thus, monitoring of particular CMV-specific CD4+ and CD8+ T-cell responses after allogeneic SCT may identify patients at risk for recurrent CMV reactivations. © 2008 Clinical Cytometry Society [source] Prospective non-randomized study of preoperative concurrent platinum plus 5-fluorouracil-based chemoradiotherapy with or without paclitaxel in esophageal cancer patients: long-term follow-upDISEASES OF THE ESOPHAGUS, Issue 2 2010M. Zemanova SUMMARY Combined modality treatment for esophageal carcinoma seems to improve survival over surgery alone. Different combinations of cytotoxic drugs have been studied to improve antitumor efficacy and limit the toxicity of chemoradiotherapy (CRT) with inconsistent results. We present a prospective study of neoadjuvant CRT with or without paclitaxel in chemotherapy schedule. One hundred seven patients (93 males, 14 females), median age 59 years (range 44,76), with operable esophageal cancer were enrolled. They received the following neoadjuvant therapy: Carboplatin, area under curve (AUC) = 6, intravenously on days 1 and 22, 5-fluorouracil (5-FU), 200 mg/m2/day, continuous infusion on days 1 to 42, radiation therapy 45 grays/25fractions/5 weeks beginning on day 1. Forty-four patients (41%) were furthermore non-randomly assigned to paclitaxel 200 mg/m2/3 h intravenously on days 1 and 22. Nutritional support from the beginning of the treatment was offered to all patients. Surgery was done within 4,8 weeks after completion of CRT, if feasible. All patients were evaluated for grade 3 plus 4 toxicities: leukopenia (28%), neutropenia (30%), anemia (6%), thrombocytopenia (31%), febrile neutropenia (6%), esophagitis (24%), nausea and vomiting (7%), pneumotoxicity (8%). Seventy-eight patients (73%) had surgery and 63 of them were completely resected. Twenty-two patients (20%) achieved pathological complete remission, and additional 20 (19%) had node-negative and esophageal wall-positive residual disease. There were 10 surgery-related deaths, mostly due to pulmonary insufficiency. Twenty-nine patients were not resected, 15 for early progression, 14 for medical reasons or patient refusal. After a median follow-up of 52 months (range 27,80), median survival of 18.0 months and 1-, 2-, 3- and 5-year survival of 56.7, 37.5, 27.0 and 21% was observed in the whole group of 107 patients. Addition of paclitaxel to carboplatin and continual infusion of FU significantly increased hematologic and non-hematologic toxicity, but treatment results as overall survival or time to progression did not differ significantly in groups with and without paclitaxel. Patients achieving pathological complete remission or nodes negativity after neoadjuvant therapy had favorable survival prognosis, whereas long-term prognosis of node positive patients was poor. Distant metastases prevailed as a cause of the treatment failure. Factors significant for survival prognosis in multivariate analysis were postoperative node negativity, performance status, and grade of dysphagia. Addition of paclitaxel to carboplatin and continual FU significantly increased hematologic and non-hematologic toxicity without influencing efficacy of the treatment. This study confirmed improved prognosis of patients after achieving negativity of nodes. Distant metastases prevailed as cause of the treatment failure. Prospectively, it is important to look for a therapeutic combination with better systemic effect. [source] Outcomes of surgical treatment of intrathoracic stomachDISEASES OF THE ESOPHAGUS, Issue 3 2009F. Yano SUMMARY The purpose of this study is to assess the long-term outcomes after surgical repair of intrathoracic stomach. Prospectively collected data was retrospectively reviewed. Patients underwent a phone questionnaire 1 year postoperatively to assess gastroesophageal reflux disease-related symptoms and surgical satisfaction. In addition, objective evaluation for integrity of hiatal hernia repair was undertaken either by esophagram or endoscopy. Any recurrence was considered a failure. Forty-one patients underwent surgical repair of a large paraesophageal hernia with intrathoracic stomach during the study period. Thirty-four patients underwent a laparoscopic repair, and seven patients underwent a transthoracic repair. An antireflux procedure was performed on 28 patients, and 13 patients had only hernia reduction and hiatal closure. In the laparoscopic group, two patients required conversion to open laparotomy, as one was unable to tolerate the pneumoperitoneum, and the other had mediastinal bleeding. Thirty-eight (93%) were available for 1-year follow-up. There were three (7.8%) recurrences, one requiring emergency transabdominal repair, and the other two being asymptomatic 1-cm recurrences. All patients report a high degree of satisfaction with surgery. There is a high incidence of short esophagus in patients with intrathoracic stomach. The surgical repair is safe and durable, with high patient satisfaction at 1-year follow-up. [source] Helicobacter pylori, Ethnicity, and the Gastroesophageal Reflux Disease Spectrum: A Study from the EastHELICOBACTER, Issue 2 2007Shanmugarajah Rajendra Abstract Background:, Ethnic differences in gastroesophageal reflux disease (GERD) and its complications as well as racial variations in the prevalence of Helicobacter pylori infection are well documented. Nevertheless, the association between reflux disease, H. pylori, and race has not been adequately explored. Aims:, We estimated the strength of the association between H. pylori, ethnicity, and the gastroesophageal reflux disease (GERD) spectrum, including Barrett's esophagus, in Asian patients presenting for endoscopy in a tertiary referral center. Methods:, Prospectively, we studied 188 consecutive patients with GERD, short- and long-segment Barrett's esophagus, and controls. All patients underwent gastroscopy with gastric biopsies to assess H. pylori, gastritis, and atrophy. CagA status and H. pylori infection were determined by immunoblot assay. Results:, The overall prevalence of H. pylori infection was 52.1% (of which 77.6% were cagA+) and was lowest in the long-segment Barrett's esophagus group (36.7%) (p = .048). When Barrett's esophagus was present, the length of abnormality was 44.8% shorter in the presence of H. pylori (p = .015). Indians had the highest prevalence of H. pylori (75%) and Malays the lowest (19.6%) (p < .001). In Indians, increased prevalence of H. pylori and cagA -positive strains was associated with reduced severity of GERD (p < .004 and p < .001, respectively), a trend not apparent in the other races. Corpus atrophy, which was almost exclusively associated with H. pylori, was highest in Indians as compared to the other races (p = .013). Conclusions:, Presence of H. pylori was associated with a reduced severity of GERD spectrum disease in Asians, especially Indians. H. pylori infection may protect against complicated reflux disease via induction of corpus atrophy. [source] Protein profile study of breast-tissue homogenates by HPLC-LIFJOURNAL OF BIOPHOTONICS, Issue 5 2009K. Kalyan Kumar Abstract Proteomics is a promising approach for molecular understanding of neoplastic processes including response to treatment. Widely used 2D-gel electrophoresis/Liquid chromatography coupled with mass spectrometry (LC-MS) are time consuming and not cost effective. We have developed a high-sensitivity (femto/subfemtomoles of protein/20 ,l) High Performance Liquid Chromatography-Laser Induced Fluorescence HPLC-LIF instrument for studying protein profiles of biological samples. In this study, we have explored the feasibility of classifying breast tissues by multivariate analysis of chromatographic data. We have analyzed 13 normal, 17 malignant, 5 benign and 4 post-treatment breast-tissue homogenates. Data was analyzed by Principal Component Analysis PCA in both unsupervised and supervised modes on derivative and baseline-corrected chromatograms. Our findings suggest that PCA of derivative chromatograms gives better classification. Thus, the HPLC-LIF instrument is not only suitable for generation of chromatographic data using femto/subfemto moles of proteins but the data can also be used for objective diagnosis via multivariate analysis. Prospectively, identified fractions can be collected and analyzed by biochemical and/or MS methods. (© 2009 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim) [source] A comparison of SAPS II and SAPS 3 in a Norwegian intensive care unit populationACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 5 2009K. STRAND Background: Simplified Acute Physiology Score (SAPS II) is the most widely used general severity scoring system in European intensive care medicine. Because its performance has been questioned in several external validation studies, SAPS 3 was recently released. To our knowledge, there are no published validation studies of SAPS II or SAPS 3 in the Scandinavian countries. We aimed to evaluate and compare the performance of SAPS II and SAPS 3 in a Norwegian intensive care unit (ICU) population. Method: Prospectively collected data from adult patients admitted to two general ICUs at two different hospitals in Norway were used. Probability of mortality was calculated using the SAPS 3 global equation (SAPS 3 G), the SAPS 3 Northern European equation (SAPS 3 NE), and the original SAPS II equation. Performance was assessed by the standardized mortality ratio (SMR), area under receiving operating characteristic, and the Hosmer and Lemeshow goodness-of-fit , test. Results: One thousand eight hundred and sixty-two patients were included after excluding readmissions, and patients who were admitted after coronary surgery or burns. The SMRs were SAPS 3 G 0.71 (0.65, 0.78), SAPS 3 NE 0.74 (0.68, 0.81), and SAPS II 0.82 (0.75, 0.91). Discrimination was good in all systems. Only the SAPS 3 equations displayed satisfactory calibration, as measured by the Hosmer,Lemeshow test. Conclusion: The performance of SAPS 3 was satisfactory, but not markedly better than SAPS II. Both systems considerably overestimated mortality and exhibited good discrimination, but only the SAPS 3 equations showed satisfactory calibration. Customization of these equations based on a larger cohort is recommended. [source] Epidemiology of major paediatric chest traumaJOURNAL OF PAEDIATRICS AND CHILD HEALTH, Issue 11 2009Sumudu P Samarasekera Aim: Paediatric chest trauma is a marker of severe injury and a significant cause of morbidity and mortality. However, current trends in the Australian population are unknown. This study aims to outline the profile and management of major paediatric chest trauma in Victoria. Methods: Prospectively collected data of patients from the Victorian State Trauma Registry from July 2001 to June 2007 were retrospectively reviewed. Data on fatalities were obtained from the National Coroners Information System. Descriptive statistics were used to summarise the profiles of major trauma cases and coroners' cases. Results: Overall, 204 cases with serious paediatric chest injuries were reported by the Victorian State Trauma Registry (n = 158) and National Coroners Information System (n = 46) (excluding overlapping cases) in 2001,2007. Paediatric chest trauma was more common in males. The Injury Severity Score ranged from 16 to 25 in most patients. Blunt trauma was responsible for 96% of cases, of which motor vehicle collisions accounted for 75%. Median hospitalisation was 9 days, and 64% of patients were admitted to intensive care. Common injuries included lung contusion (66%), haemo/pneumothorax (32%) and rib fracture (23%). Multiple organ injury occurred in 99% of cases, with head (62%) and abdominal (50%) injury common. Management was conservative, with only 11 cases (7%) treated surgically. The highest mortality was in the 10,15-year age group. In 52 (79%) fatalities, injury was transport related. Conclusion: Australian paediatric chest trauma trends are similar to international patterns. Serious injury requiring surgical intervention is rare. This limited exposure may lead to difficulty in maintaining surgical expertise in this highly specialised area. [source] Detection of uveal melanoma by optometrists in the United KingdomOPHTHALMIC AND PHYSIOLOGICAL OPTICS, Issue 4 2001Bertil Damato Summary In the United Kingdom, most uveal melanomas are detected by optometrists. Prospectively collected data on patients with uveal melanoma presenting to optometrists were analysed retrospectively to determine: (a) the proportion of patients who were asymptomatic at the time of tumour detection, (b) the proportion of symptomatic patients reporting that their tumour was missed at their initial presentation and (c) the clinical features related to immediate tumour detection. The 223 patients had a mean age of 59.7 years, a mean tumour diameter of 11.3 mm and a mean tumour thickness of 4.6 mm. Symptoms were present in 122 patients (55%) and were associated with large tumour size (p<0.0001) and male gender (p=0.003), with more males tending to have a large tumour (p=0.004). Seventy-nine percent of symptomatic patients reported that their tumour was detected at their first visit. Failure of tumour detection in symptomatic patients was associated with absence of tumour extension posterior to equator (p<0.0001). [source] Data collected on maternal dietary exposures in the Danish National Birth CohortPAEDIATRIC & PERINATAL EPIDEMIOLOGY, Issue 1 2007Sjúrdur Fródi Olsen Summary Recent research suggests that the diet consumed in, or shortly before, pregnancy can potentially lead to maldevelopment and diseases in the offspring, which may become apparent at any time from the embryonic stage until old age. For example, maternal diet may affect the chance of twinning (and associated complications), malformation risk, brain development, and the offspring's fecundity and risk of contracting cardiovascular dieases and cancer in adult life. Prospectively designed longitudinal studies with sufficient size and data quality are much needed to substantiate or refute these hypotheses. At present, the Danish National Birth Cohort is likely to be the largest epidemiological database containing extensive information on maternal dietary exposures. By October 2002, 100 000 women had been recruited in early pregnancy, for long-term follow-up of themselves and their offspring. The present paper details the information available in the database on early nutritional exposures with emphasis on maternal dietary intake. We also present distributions of selected nutritional exposures. [source] Efficacy of prednisolone in children hospitalized for recurrent wheezingPEDIATRIC ALLERGY AND IMMUNOLOGY, Issue 4 2007Tuomas Jartti Data on the efficacy of corticosteroids on respiratory picornavirus-induced wheezing are limited. To determine whether prednisolone is effective in rhinovirus- or enterovirus-induced recurrent wheezing, we conducted a controlled trial comparing oral prednisolone (2 mg/kg/day in three divided doses for 3 days) with placebo in hospitalized wheezing children and studied post hoc virus-specific efficacy in early wheezing (<3 episodes, reported elsewhere) and in recurrent wheezing (,3 episodes). Virus-negative children where excluded. Our primary endpoint was the time until children were ready for discharge. Secondary endpoints included oxygen saturation and exhaled nitric oxide during hospitalization, duration of symptoms, blood eosinophil count, and impulse oscillometry 2 wk after discharge, and occurrence of relapses during the following 2 months. Virus-specific effects were analyzed with interaction analysis in a multivariate regression model. During the study period, 661 patients were hospitalized, 293 randomized, and 59 were accepted in this analysis (mean age 2.6 yr, s.d. 1.3). Prednisolone did not significantly decrease the time until ready for discharge in all patients (prednisolone vs. placebo, medians, 18 vs. 24 h, p = 0.11). However, prednisolone decreased the time until ready for discharge in children with picornavirus infection (respectively, 12 vs. 24 h, p = 0.0022) and more specifically, in children with enterovirus infection (6 vs. 35 h, p = 0.0007). In the secondary endpoints, prednisolone decreased the duration of cough and dyspnea in rhinovirus-affected children (p = 0.033 for both). Prospectively designed clinical trial is needed to test the hypothesis that prednisolone reduces symptoms in picornavirus-affected wheezing children. [source] ORIGINAL RESEARCH,EJACULATION DISORDERS: A Multinational Population Survey of Intravaginal Ejaculation Latency TimeTHE JOURNAL OF SEXUAL MEDICINE, Issue 4 2005Marcel D. Waldinger MD ABSTRACT Introduction., Intravaginal ejaculation latency time (IELT), defined as the time between the start of vaginal intromission and the start of intravaginal ejaculation, is increasingly used in clinical trials to assess the amount of selective serotonin reuptake inhibitor-induced ejaculation delay in men with premature ejaculation. Prospectively, stopwatch assessment of IELTs has superior accuracy compared with retrospective questionnaire and spontaneous reported latency. However, the IELT distribution in the general male population has not been previously assessed. Aim., To determine the stopwatch assessed-IELT distribution in large random male cohorts of different countries. Methods., A total of 500 couples were recruited from five countries: the Netherlands, United Kingdom, Spain, Turkey, and the United States. Enrolled men were aged 18 years or older, had a stable heterosexual relationship for at least 6 months, with regular sexual intercourse. The surveyed population were not included or excluded by their ejaculatory status and comorbidities. This survey was performed on a "normal" general population. Sexual events and stopwatch-timed IELTs during a 4-week period were recorded, as well as circumcision status and condom use. Main Outcome Measures., The IELT, circumcision status, and condom use. Results., The distribution of the IELT in all the five countries was positively skewed, with a median IELT of 5.4 minutes (range, 0.55,44.1 minutes). The median IELT decreased significantly with age, from 6.5 minutes in the 18,30 years group, to 4.3 minutes in the group older than 51 years (P < 0.0001). The median IELT varied between countries, with the median value for Turkey being the lowest, i.e., 3.7 minutes (0.9,30.4 minutes), which was significantly different from each of the other countries. Comparison of circumcised (N = 98) and not-circumcised (N = 261) men in countries excluding Turkey resulted in median IELT values of 6.7 minutes (0.7,44.1 minutes) in circumcised compared with 6.0 minutes (0.5,37.4 minutes) in not-circumcised men (not significant). The median IELT value was not affected by condom use. Conclusion., The IELT distribution is positively skewed. The overall median value was 5.4 minutes but with differences between countries. For all five countries, median IELT values were independent of condom usage. In countries excluding Turkey, the median IELT values were independent of circumcision status. [source] Obesity and screening PSA levels among men undergoing an annual physical examTHE PROSTATE, Issue 4 2008Andrew Rundle Abstract BACKGROUND Prior reports suggest that obesity is inversely associated with screening prostate-specific antigen (PSA) levels and may reduce screening sensitivity. METHODS We evaluated data on 10,623 men screened for prostate cancer during an annual physical examination program administered by EHE International, Inc., between 1/1/2004 and 6/30/2006. Of these, 3,623 men returned for additional physical exams during this period. We used multivariate linear regression analyses to determine whether higher BMI was inversely associated with PSA, and whether BMI, or change in BMI, was associated with change in PSA levels over time. We also developed a theoretical model for the effect of obesity on PSA levels in which increased plasma volume in the obese dilutes PSA levels. RESULTS After control for age and race/ethnicity, higher BMI was associated with lower PSA levels; men with a BMI ,40 had a geometric mean PSA level 0.14 ng/ml lower than men with a BMI <25 (P,<,0.001). Prospectively, BMI at initial screening and change in BMI over 2 years were not associated with change in PSA or PSA velocity. Our theoretical model accurately predicted observed PSA levels and suggests that a screening PSA of 4.0 ng/ml in normal weight and overweight men corresponds to 3.5 ng/ml in obese men and 3.1 ng/ml in morbidly obese men. CONCLUSION Across the study population, increased BMI was significantly inversely associated with lower PSA. Based on a theoretical model in which increased plasma volume in the obese dilutes PSA levels we propose new cut-points for a positive screening test. Prostate 68: 373,380, 2008. © 2008 Wiley-Liss, Inc. [source] The Elephant in the Room: Failings of Current Clinical Endpoints in Kidney TransplantationAMERICAN JOURNAL OF TRANSPLANTATION, Issue 5 2010J. D. Schold In this opinion piece, we address the limitations of the two most common clinical endpoints in kidney transplantation trials (acute rejection and renal function) and attempt to offer a reasonable framework by which to find true and reliable early endpoints that reflect long-term outcomes. Other potential endpoints tested in recent years, including the use of genomic and proteomic markers are still in development. Until other reliable endpoints are established, it is important to understand what can be inferred from ongoing studies that utilize these endpoints and what further information we need to derive ,true' surrogate endpoints. We consider evaluation of current markers using the ,Prentice criteria', which bases assessment of endpoints as true surrogates on four primary rules. Based on our assessment, progress in understanding the safety and efficacy of new therapies and interventions in kidney transplantation will remain limited with current makers. Prospectively, we advocate: (i) significant caution in extrapolating long-term outcomes from currently utilized clinical markers, (ii) use of traditional hard endpoints whenever feasible and (iii) dedication of efforts for more data collection on specific disease entities and greater diligence in determining the onset of deleterious processes. [source] Prediction of respiratory insufficiency in Guillain-Barré syndromeANNALS OF NEUROLOGY, Issue 6 2010Christa Walgaard MD Objective Respiratory insufficiency is a frequent and serious complication of the Guillain-Barré syndrome (GBS). We aimed to develop a simple but accurate model to predict the chance of respiratory insufficiency in the acute stage of the disease based on clinical characteristics available at hospital admission. Methods Mechanical ventilation (MV) in the first week of admission was used as an indicator of acute stage respiratory insufficiency. Prospectively collected data from a derivation cohort of 397 GBS patients were used to identify predictors of MV. A multivariate logistic regression model was validated in a separate cohort of 191 GBS patients. Model performance criteria comprised discrimination (area under receiver operating curve [AUC]) and calibration (graphically). A scoring system for clinical practice was constructed from the regression coefficients of the model in the combined cohorts. Results In the derivation cohort, 22% needed MV in the first week of admission. Days between onset of weakness and admission, Medical Research Council sum score, and presence of facial and/or bulbar weakness were the main predictors of MV. The prognostic model had a good discriminative ability (AUC, 0.84). In the validation cohort, 14% needed MV in the first week of admission, and both calibration and discriminative ability of the model were good (AUC, 0.82). The scoring system ranged from 0 to 7, with corresponding chances of respiratory insufficiency from 1 to 91%. Interpretation This model accurately predicts development of respiratory insufficiency within 1 week in patients with GBS, using clinical characteristics available at admission. After further validation, the model may assist in clinical decision making, for example, on patient transfer to an intensive care unit. ANN NEUROL 2010;67:781,787 [source] The Effect of Myocardial Surgical Revascularization on Left Ventricular Late PotentialsANNALS OF NONINVASIVE ELECTROCARDIOLOGY, Issue 2 2001Levent Can M.D. Background: The presence of ventricular late potentials (LP) is an important indicator for the development of ventricular tachyarrhythmias due to ischemic heart disease. The effect of myocardial revascularization on LP has remained controversial. The purpose of this study was to determine whether complete myocardial surgical revascularization (CABG) documented by myocardial perfusion scintigraphy might alter the substrate responsible for LP. Methods: Prospectively, enrolled patients undergoing elective CABG were evaluated with thallium-201 myocardial perfusion scintigraphy and signal- averaged ECG pre- and postoperatively. SAECG recordings were obtained serially: before, 48,72 hours and 3 months after CABG. LPS were defined as positive if SAECG met at least two of Gomes criteria. Scintigraphies were performed pre-and 3 months postoperatively for determination of the success of revascularization. Changes observed in SAECG recordings after CABG were compared between those with and without successful revascularization. Results: CABG resulted in successful revascularization in 23 patients and was unsuccessful in 17 (no change or deterioration of the perfusion defects). Preoperative SAECG values were not different between groups except for RMS values. The incidence of LP decreased significantly postoperatively in patients with improved myocardial perfusion, whereas there were no changes in patients who did not have postoperative perfusion improvement (McNemar test, P < 0.05). Conclusions: LPs disappear following the elimination of myocardial ischemia by complete surgical revascularization. Persistence of ischemia following CABG usually results in the persistence of late potentials. The incidence of ventricular arrhythmias is expected to be unchanged in these patients and they should be reevaluated for reinterventions. A.N.E. 2001;6(2):84,91 [source] Demographic variables routinely collected at colposcopic examination do not predict who will default from conservative management of cervical intraepithelial neoplasia IAUSTRALIAN AND NEW ZEALAND JOURNAL OF OBSTETRICS AND GYNAECOLOGY, Issue 1 2005Julie A. QUINLIVAN Abstract Objective:, As a result of the low incidence of progression from low grade epithelial abnormalities to cervical intraepithelial neoplasia (CIN) 3 or cervical cancer, a conservative approach to management is supported, especially in young women. Loss to follow-up is a recognised problem with a conservative approach however, with women defaulting known to experience higher rates of cancer. Aim:, To determine if any routinely collected demographic variables could predict which Australian women would subsequently default from care having initially elected to have conservative management of CIN 1 lesions. Methods:, Prospectively collected data was audited on 279 women with a colposcopically directed biopsy diagnosis of CIN 1, confirmed on external review, who were enroled by their own choice into a conservative management program and monitored until a definitive lesion outcome was determined. Women who defaulted from follow-up and were lost to care providers despite follow-up appointments and reminder letters were compared to women who completed follow-up with either lesion resolution or progression requiring treatment, to establish if there were any demographic variables to predict default from care. Results:, Fifty-two (18.5%) women subsequently defaulted from follow-up. There were no significant differences in age, parity, proportion of women who were pregnant at diagnosis, smoking status, immunosuppressed or had a ,human papillomavirus (HPV) effect' reported on Pap-smear or colposcopic examination. Conclusion:, We cannot easily identify a subgroup of women who are more likely to default from follow-up of CIN 1 using routinely collected demographic data. Default from follow-up is a major risk with conservative approaches and further research to reduce default rates are required. [source] Three-year registry data on biological treatment for psoriasis: the influence of patient characteristics on treatment outcomeBRITISH JOURNAL OF DERMATOLOGY, Issue 3 2009R.J.B. Driessen Summary Background, The course of biological treatment in clinical practice may be highly different from treatment schedules in clinical trials. Treatment modifications and patient characteristics may influence treatment safety and efficacy. So far, long-term results from the use of biological treatment in clinical practice are lacking. Objectives, To report short- and long-term efficacy and safety data on biologics, especially etanercept, used in daily clinical practice. Special attention has been paid to patient characteristics that may have influenced the response to therapy. Methods, Prospectively collected registry data of all patients with psoriasis treated with biologics in the Radboud University Nijmegen Medical Centre outpatient clinic were used for analysis. Patient and treatment characteristics were surveyed. Efficacy and safety of etanercept for up to 3 years were analysed. Moreover, the influence of patient characteristics on etanercept treatment response was studied. Results, The analysed cohort, consisting of 118 patients, went through 142 treatment episodes in total. Patients treated with biologics had an extensive medical history. Optimization of biological treatment was established in various ways, including treatment switches and introduction of concomitant therapies. Short-term etanercept efficacy analysis showed a mean Psoriasis Area and Severity Index (PASI) improvement at week 24 of 59·7%. No significant influence of gender, age, baseline PASI, body mass index, number of previous systemic therapies or duration of psoriasis was found on week 24 efficacy results, although trends were discernible. The efficacy of etanercept remained stable for up to 156 weeks. Long-term daily practice treatment with etanercept was only occasionally accompanied by major safety concerns. Conclusions, The current study demonstrates that etanercept is able to improve psoriasis symptoms for a considerable time, and that serious side-effects are infrequent. The influence of patient characteristics on treatment response is limited. [source] Rituximab in the adjuvant treatment of pemphigus vulgaris: a prospective open-label pilot study in five patientsBRITISH JOURNAL OF DERMATOLOGY, Issue 5 2007M.S.Y. Goh Summary Background, Rituximab is a monoclonal antibody directed against the CD20 antigen expressed on B lymphocytes. There are reports of its efficacy in the treatment of autoimmune diseases, including pemphigus. Objectives, Prospectively to evaluate the efficacy of rituximab as adjuvant treatment for pemphigus vulgaris (PV). Methods, Patients with PV were treated with intravenous rituximab (375 mg m,2) weekly for 4 weeks in this prospective open-label pilot study. Other concurrent immunosuppression was continued. Results, Of five patients, one achieved complete remission and was able to cease all medication, while two achieved clearance of clinical lesions but continued on systemic therapy. Two patients had progressive disease. Time to response was 2,8 months, with a 13- to 18-month response duration. Response was associated with reduction in serum antiepithelial antibodies. Two patients had significant infectious complications (one developed community-acquired pneumonia associated with delayed-onset neutropenia and the other developed cytomegalovirus infection). Conclusions, Rituximab has shown efficacy in the treatment of PV. Patients on multiple immunosuppressives should be closely monitored for infectious complications. [source] Epidemiology and prognosis of ovarian metastases in colorectal cancer,BRITISH JOURNAL OF SURGERY (NOW INCLUDES EUROPEAN JOURNAL OF SURGERY), Issue 11 2010J. Segelman Background: National guidelines for prophylactic oophorectomy in women with colorectal cancer are lacking. The aim of this population-based cohort study was to report on the prevalence, incidence and prognosis of ovarian metastases from colorectal cancer, providing information relevant to the discussion of prophylactic oophorectomy. Methods: All 4566 women with colorectal cancer in Stockholm County during 1995,2006 were included and followed until 2008. Prospectively collected data regarding clinical characteristics, treatment and outcome were obtained from the Regional Quality Registry. Results: The prevalence of ovarian metastases at the time of diagnosis of colorectal cancer was 1·1 per cent (34 of 3172) among women with colonic cancer and 0·6 per cent (8 of 1394) among those with rectal cancer (P = 0·105). After radical resection of stage I,III colorectal cancer, metachronous ovarian metastases were found during follow-up in 1·1 per cent (22 of 1971) with colonic cancer and 0·1 per cent (1 of 881) with rectal cancer (P = 0·006). Survival in patients with ovarian metastases was poor. Conclusion: Ovarian metastases from colorectal cancer are uncommon. Copyright © 2010 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. [source] Rising incidence of post-transplant lymphoproliferative disease in kidney transplant recipientsBRITISH JOURNAL OF SURGERY (NOW INCLUDES EUROPEAN JOURNAL OF SURGERY), Issue 10 2001Mr G. Libertiny Background: The purpose of this study was to determine whether the incidence of post-transplant lymphoproliferative disease (PTLD) has been increasing in renal transplant recipients in this centre. Methods: Prospectively gathered data were analysed to establish trends in the epidemiology of PTLD in 1537 patients. Results: Overall, PTLD occurred in 2·3 per cent of renal transplant recipients. An increase in its incidence coincided with the introduction of cyclosporin in the 1980s. However, there was a further increase in the incidence of PTLD in the 1990s when the only change in immunosuppressive policy was the abandonment of pretransplantation blood transfusion. The latter increase was particularly pronounced in patients with early-onset PTLD in whom it presented within 600 days after transplantation. Conclusion: The incidence of PTLD has been increasing in renal transplant recipients. The recent increase appears to be independent of cyclosporin and may reflect the reduction in pretransplant blood transfusion. Changes in the incidence of PTLD may also mirror changes in the epidemiology of non-Hodgkin lymphoma in the general population. © 2001 British Journal of Surgery Society Ltd [source] Phase 1/2 trial of BMS-275291 in patients with human immunodeficiency virus-related Kaposi sarcoma,,CANCER, Issue 5 2008A multicenter trial of the AIDS Malignancy Consortium Abstract BACKGROUND. Matrix metalloproteinases (MMPs) are overexpressed in Kaposi sarcoma (KS). The safety and efficacy of a novel, orally bioavailable MMP inhibitor, BMS-275291, was evaluated in patients with human immunodeficiency virus-associated KS and the correlation between changes in the percentage of apoptotic cells in tumor biopsies and response was explored. METHODS. Cohorts of 6 patients were to be treated with BMS-275291. The initial cohort received 1200 mg once a day; subsequent doses were to be escalated to 600 mg twice daily and 1200 mg twice daily, or decreased to 600 mg/day. Tumor biopsies for apoptosis assays were collected pretreatment and on Day 29. Prospectively defined dose level adjustments were to be based on dose-limiting toxicity (DLT), tolerability, changes in the percentage of apoptotic cells, and treatment response. RESULTS. Sixteen patients were enrolled; 15 received the study drug and could be evaluated. The median duration of treatment was 20 weeks (range, 3,54 weeks). A dose of 1200 mg once a day was well tolerated but induced only 1 response. A DLT occurred in 3 patients treated with 600 mg twice daily, and included grade 3 fatigue, grade 3 allergic reaction, and grade 3 arthralgias; 2 responses were noted at this dose level (toxicity was graded according to the National Cancer Institute Common Toxicity Criteria [version 2.0]). Based on predetermined endpoints, the trial was closed after accrual of 15 treated patients. Assessment of biologic response for dose escalation/de-escalation decisions utilizing the apoptosis assay was not feasible. CONCLUSIONS. BMS-275291 given at a dose of 600 mg twice daily induced unacceptable toxicity. The better-tolerated schedule of 1200 mg once a day demonstrated inadequate efficacy in patients with human immunodeficiency virus-associated KS. The apoptosis assay was not helpful in predicting response. Cancer 2008. © 2008 American Cancer Society. [source] Screening mammography performance and cancer detection among black women and white women in community practiceCANCER, Issue 1 2004Karminder S. Gill M.S.P.H. Abstract BACKGROUND Despite improvement in mammography screening attendance, black women continue to have poorer prognosis at diagnosis than white woman. Data from the Carolina Mammography Registry were used to evaluate whether there may be differences in mammography performance or detected cancers when comparing black women with white women who are screened by mammography. METHODS Prospectively collected data from community-based mammography facilities on 468,484 screening mammograms (79,397 in black women and 389,087 in white women) were included for study. Mammograms were linked to a pathology data base for identification of cancers. Sensitivity, specificity, positive predictive value, and cancer detection rates were compared between black women and white women. Logistic regression methods were used to control for covariates associated with performance characteristics. Differences in cancer characteristics were compared between black women and white women using chi-square statistics. RESULTS Screening mammography performance results for black women compared with white women were as follows: sensitivity, odds ratio (OR) = 1.07 (95% confidence interval [95% CI], 0.83,1.39); specificity, OR = 1.02 (95% CI, 0.98,1.06); and positive predictive value, OR = 1.07 (95% CI, 0.94,1.23). Among women with no previous screening, black women had a larger proportion of invasive tumors that measured , 2 cm (38% vs. 26%; P = 0.04). The cancer detection rate was highest among black women who reported symptoms at screening (13.9 per 1000 black women vs. 7.9 per 1000 white women). Invasive cancers in black women were poorer grade (P = 0.001), and more often had negative estrogen receptor status and progesterone receptor status (P < 0.001). CONCLUSIONS Overall, screening mammography performed equally well in black women and white women controlling for age, breast density, and time since previous mammogram. Black women who reported symptoms had larger and higher grade tumors compared with white women. Educational efforts need to be strengthened to encourage black women to react sooner to symptoms, so that the tumors detected will be smaller and black women will have a better prognosis when they appear for mammography. Cancer 2004;100:139,48. © 2003 American Cancer Society. [source] Bhutani-based nomograms for the prediction of significant hyperbilirubinaemia using transcutaneous measurements of bilirubinACTA PAEDIATRICA, Issue 12 2009YA Bental Abstract Aim:, Prospectively establish the relationship between transcutaneous bilirubin (TcB) and total serum bilirubin (TSB), and develop nomograms similar to Bhutani's nomograms, based on our TcB data. Methods:, Our study sample was from a total population of 1069 infants, near term and term healthy newborns, admitted during 2.5 month period of the study. TSB was performed on all infants who were felt to be clinically jaundiced. Before obtaining the TSB, a TcB was performed (Jaundice Meter Minolta/Draeger JM-103). Measurements were performed on two sites: forehead and mid-sternum, and the mean of both measurements was calculated. Results:, A total of 1091 paired measurements were obtained from 628 infants. Linear regression showed a significant relation between TSB and TcB (R2 of 0.846). In multiple regression analysis, all independent variables studied, i.e. gestational age (or birthweight), age at sampling and ethnicity had a negligible influence on the relationship. We subsequently developed our local-nomograms of hour-specific mean TcB with 40, 75 and 95 percentile lines. Conclusions:, In our local settings and population, we found a reliable correlation between laboratory measurements of TSB and TcB. We were able to develop our local-Bhutani-based TcB nomograms for screening babies during hospital stay and pre-discharge for assessing the risk of hyperbilirubinaemia. [source] Etiologic spectrum and pattern of antimicrobial drug susceptibility in bacterial meningitis in Sokoto, NigeriaACTA PAEDIATRICA, Issue 8 2000FE EmeleArticle first published online: 2 JAN 200 Etiologic agents of meningitis were prospectively investigated among patients admitted to Usman Danfodio University Teaching Hospital, Sokoto. Of 1097 cerebrospinal fluid (CSF) samples submitted to the microbiology laboratory from various wards of the hospital, 289 (26%) were microscopically, culturally and/or serologically proven to be bacterial meningitis. The etiologic spectrum was as follows: Neisseria meningitidis (61%), Streptococcus pneumoniae (18%), Haemophilus influenzae (10%), Staphylococcus aureus (6%), Coliform bacilli (3%), Escherichia coli (0.7%), Mycobacterium tuberculosis (0.7%), Listeria monocytogenes (0.4%), Flavobacterium meningosepticum (0.4%) and Pseudomonas putrifasciens (0.4%). Bacterial meningitis was most prevalent (195 or 68%) among children aged 1-9 y, while adults and neonates were least affected. Coliform bacilli caused five of eight neonatal cases. Males were more frequently affected than females (x2=12.50;p < 0.05). Culture and microscopy were comparatively less efficient than the search for bacterial antigens, especially in the diagnosis of Haemophilus meningitis. Antimicrobial susceptibility of N. meningitidis to ampicillin and benzyl penicillin reduced progressively over the years (F = 406.98;p < 0.001). Nineteen (11%) of the isolates (5 Meningococci, 7 Staph. aureus, 1 Haem. influenza and 6 others) showed simultaneous resistance to chloramphenicol, ampicillin and benzyl penicillin. [source] The Atrial Fibrillation Paradox of Heart FailureCONGESTIVE HEART FAILURE, Issue 1 2010Rhidian J. Shelton MRCP Congest Heart Fail. 2010;16:3,9. ©2009 Wiley Periodicals, Inc. The prevalence of atrial fibrillation (AF) in patients with heart failure (HF) is high, but longitudinal studies suggest that the incidence of AF is relatively low. The authors investigated this paradox prospectively in an epidemiologically representative population of patients with HF and persistent AF. In all, 891 consecutive patients with HF [mean age, 70±10 years; 70% male; left ventricular ejection fraction, 32%±9%] were enrolled. The prevalence of persistent AF at baseline was 22%. The incidence of persistent AF at 1 year was 26 per 1000 person-years, ranging from 15 in New York Heart Association class I/II to 44 in class III/IV. AF occurred either at the same time or prior to HF in 76% of patients and following HF in 24%. A risk score was developed to predict the occurrence of persistent AF. The annual risk of persistent AF developing was 0.5% (0%,1.3%) for those in the low-risk group compared with 15% (3.4%,26.6%) in the high-risk group. Despite a high prevalence of persistent AF in patients with HF, the incidence of persistent AF is relatively low. This is predominantly due to AF coinciding with or preceding the development of HF. The annual risk of persistent AF developing can be estimated from clinical variables. [source] Effect of Bisoprolol on Right Ventricular Function and Brain Natriuretic Peptide in Patients With Heart FailureCONGESTIVE HEART FAILURE, Issue 3 2004Luís Beck-da-Silva MD Beta-blocker use improves left ventricular ejection fraction (LVEF) in patients with heart failure. A similar effect of , blockers on right ventricular function has been proposed, although the effect of bisoprolol, a highly selective ,-1 blocker, on right ventricular function has not been assessed. This study investigated the short-term effect of bisoprolol on right ventricular function in chronic heart failure patients. A cohort of 30 heart failure patients who were not taking , blockers at baseline was studied prospectively. Right ventricular ejection fraction (RVEF) and LVEF were measured at both baseline and 4 months by radionuclide angiography. Bisoprolol was up-titrated during four monthly visits by a preestablished protocol to a target dose of 10 mg/d. The dose of vasodilators was not changed. Quality of life and brain natriuretic peptide level were assessed. Mean age was 62.7±14.3 years. Baseline RVEF was 30.7%±6.3% and baseline LVEF was 21.7%±9.4%. Mean bisoprolol dose reached was 5.3±3.9 mg daily. At 4 months, RVEF significantly increased by 7.1 % (95% confidence interval, 3.9,10.2; p=0.0001) and LVEF also increased significantly by 7.9% (95% confidence interval, 4.0%,11.9%p=0.0003). Quality-of-life score improved from 42.8 to 30.8 (p=0.047). No correlation was found between brain natriuretic peptide levels and RVEF. Bisoprolol treatment for 4 months resulted in a significant improvement of RVEF, which paralleled the improvement of LVEF. [source] FS07.1 A survey of occupational hand eczema in DenmarkCONTACT DERMATITIS, Issue 3 2004Rikke Skoet Background:, The need for prevention to reduce the number of occupational hand eczema is high. Occupational hand eczema is the most frequently recognised work-related disease in Denmark. Previous findings have shown that almost half of all cases develop a chronic condition with persistent dermatitis, and the annual cost to society is immense. Aims:, The aim of this study was to survey the trends and development of occupational hand eczema in Denmark and thereby help to ensure future successful prevention of chronic disabling occupational hand eczema. Methods:, 758 patients with recognised occupational hand eczema were included prospectively in the period October 2001- November 2002. Data on diagnoses, disease duration, severity, absence from work and occupation was obtained from The Danish National Board of Industrial Injuries and an additional questionnaire was administered by mail. Results:, 621 patients answered the questionnaire (response rate 82%). Irritant contact dermatitis was the most frequent diagnosis and the female/male ratio was 2:1. High prevalence was found in particularly wet occupations. 19 per cent had sick leave more than 5 weeks per year and the mean disease duration was 4.8 years (median 2.1 years). 68.2% had chronic changes. Conclusion:, The results showed a marked gender difference in the pattern of diagnosis and occupation. The impact of occupational hand eczema is still high with prolonged absence from work and a high percentage of chronic disease. The results of the study give important suggestions for future preventive strategies for health authorities. [source] The significance of protective factors in the assessment of riskCRIMINAL BEHAVIOUR AND MENTAL HEALTH, Issue 1 2010Charlotte E. Rennie Background,Few studies have explored protective factors in the assessment of risk, despite acknowledgement that protective factors may play an important role. Aim,To examine the significance of protective factors in assessment of risk using the Structured Assessment of Violence Risk in Youth (SAVRY). Method,The SAVRY was completed on 135 male adolescents in custody in the UK. Data on previous offending and childhood psychopathology were collected. Participants were prospectively followed up at 12 months using data from the Home Office Police National Computer (HOPNC). Results,Participants with protective factors were older when first arrested, were less prolific offenders and had fewer psychopathological problems. The number of protective factors present was significantly higher for participants who did not re-offend during the follow-up. The total number of SAVRY protective factors significantly predicted desistance at follow-up and resilient personality traits constituted the only significant individual protective factor. Conclusions and implications,Protective factors might buffer the effects of risk factors and a resilient personality may be crucial. Recognition of protective factors should be an essential part of the risk management process and for interventions with high-risk adolescents to reduce re-offending. Copyright © 2010 John Wiley & Sons, Ltd. [source] Predictive, concurrent, prospective and retrospective validity of self-reported delinquencyCRIMINAL BEHAVIOUR AND MENTAL HEALTH, Issue 3 2003Darrick Jolliffe Background The self-report method is widely used to measure offending. Previous studies suggest that it is generally valid, but that its validity may be lower for blacks than for whites. Aim To assess the validity of self-reported offending in relation to court referrals, and to investigate how it varies with types of offences, sex and race. Method Annual court and self-report data were collected between ages 11 and 17 for eight offences in the Seattle Social Development Project, which is a prospective longitudinal survey of 808 youths. Results Self-reports predicted future court referrals. Predictive validity was highest for drug offences, for males and for whites, and lowest for females and Asians. The probability of youths with a court referral reporting offences and arrests was highest for drug offences, for males, for whites and for blacks. Retrospective ages of onset agreed best with prospective ages for drug offences, Asians and whites. More Asians than blacks or whites failed retrospectively to report offences that had been reported prospectively. Conclusions The validity of self-reports of offending was high, especially for drug offences, for males and for whites. Contrary to prior research, validity was high for black males. It was lowest for Asian females. Sex and race differences in validity held up after controlling for socioeconomic status. Differential validity probability did not reflect police bias. Copyright © 2003 Whurr Publishers Ltd. [source] What are adolescent antecedents to antisocial personality disorder?CRIMINAL BEHAVIOUR AND MENTAL HEALTH, Issue 1 2002Rolf Loeber PhD Background This paper fills a gap because there are very few studies that prospectively predict antisocial personality disorder (APD) from psychopathology earlier in life in clinic-referred samples of young males. Method The paper addresses the continuity between conduct disorder (CD) and other forms of psychopathology during ages 13,17 and modified APD at ages 18 and 19 (modified to remove the DSM-IV requirement of pre-existing CD by age 15) in the Developmental Trends Study. Results The results show that 82,90% of APD cases met criteria for CD at least once during ages 13,17, and very few youths who met criteria for ODD during this period progressed to APD without intermediate CD. While CD is a strong predictor of modified APD, when other factors were accounted for in regression analyses, the best predictors were callous/unemotional behaviour, depression and marijuana use. ADHD during ages 13,17 was not significant in the final model. Males with CD during adolescence who progressed to APD tended to commit more violence, as evident from their court records. Conclusions Implications are discussed for the conceptualization of developmental models leading to APD, the strengthening of relevant symptoms of CD predictive of APD, and preventive and remedial interventions. Copyright © 2002 Whurr Publishers Ltd. [source] | ||||||||||||||||||||||||||||||||||||||||