Entry Criteria (entry + criterion)

Distribution by Scientific Domains
Distribution within Medical Sciences


Selected Abstracts


Silicone Gel Sheeting for the Management and Prevention of Onychocryptosis

DERMATOLOGIC SURGERY, Issue 3 2003
A. Burhan Aksakal MD
BACKGROUND Onychocryptosis, commonly referred to as ingrown nails, has many therapeutic alternatives for its management. Although mild cases can be treated conservatively, in severe cases, surgical treatment is preferred. Silicone gel sheeting is found to be effective in the treatment of hypertrophic scars and keloids. OBJECTIVE To document the effectiveness of silicone gel sheeting in the management of patients with onychocryptosis and in the prevention of the recurrences by breaking the devil's circle, which usually took place after the surgical procedures used in the treatment of the onychocryptosis. METHODS Fourteen patients were enrolled in the study. Entry criteria required the presence of slight (2 patients), moderate (2 patients), or severe (10 patients) onychocryptosis. The simple technique used in the study was the excision of the one-quarter part of the lesional side of the nail plate without excising the granulation tissue. After 24 hours, the silicone was placed on the granulation tissue and the exposed nail bed. Silicone gel sheet was bandaged loosely without applying any pressure. Patients entering the study were given detailed instructions in applying and using the gel for 12 hours during the daytime. The study lasted for 14 months and was composed of a treatment period of 4 months and a follow-up period of 10 months. The patients were evaluated every 2 weeks in the first month and then monthly. The change in thickness of granulation tissue was evaluated by comparing them with the baseline photographs and those taken at each visit. RESULTS The management and prevention of onychocryptosis were achieved in 12 of 14 patients (85.71%). The silicone gel sheeting treatment was well tolerated except for an occasional transient exudation, which was resolved when the treatment was withdrawn. CONCLUSION The results show that the new method that we used for the treatment of onychocryptosis is successful in reducing the thickness of the hypertrophic nail fold and prevents the recurrence of the condition during the regrowth of the nail plate by breaking the devil's circle. The advantage of this method is that it is not destructive to the nail matrix and the adjacent tissue. [source]


Geographic Pathology of Helicobacter pylori Gastritis

HELICOBACTER, Issue 2 2005
Yi Liu
ABSTRACT Background and aim.,Helicobacter pylori is etiologically associated with gastritis and gastric cancer. There are significant geographical differences between the clinical manifestation of H. pylori infections. The aim of this study was to compare gastric mucosal histology in relation to age among H. pylori -infected patients from different geographical areas using the same grading system. The prevalence of atrophy and intestinal metaplasia were also compared with the respective gastric cancer incidence in the different countries. Methods., A total of 1906 patients infected with H. pylori from seven countries were evaluated. Entry criteria included H. pylori positive cases with antral and corpus biopsies between the ages of 18 and 75 years. The minimum number of cases required from a country was 100. Hematoxylin-eosin stained biopsies from antrum and corpus were scored semiquantitatively using the parameters suggested by the Sydney Classification System. Statistical evaluation was performed using Krusakal-Wallis test and Spearman's rank correlation test. Results., The severity of gastric atrophy varied among the different groups with the highest scores being present in Japan. The lowest scores were found in four European countries and in Thailand. The scores for intestinal metaplasia were low in general except for Xi-an, Japan, and Shanghai. For all the countries, the presence of atrophy in the antrum correlated well (r = 0.891) with the incidence of gastric cancer. Conclusion., Using a standardized grading system in a large study of H. pylori -related geographic pathology, we found major differences in the overall prevalence and severity of H. pylori gastritis in relation to age. These differences mirrored the respective incidences of gastric cancer in those geographical areas. [source]


Atrioventricular Nodal Reentrant Tachycardia in Children: Effect of Slow Pathway Ablation on Fast Pathway Function

JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 3 2002
GEORGE F. VAN HARE M.D.
AV Nodal Reentry in Children.Introduction: Prior studies in adults have shown significant shortening of the fast pathway effective refractory period after successful slow pathway ablation. As differences between adults and children exist in other characteristics of AV nodal reentrant tachycardia (AVNRT), we sought to characterize the effect of slow pathway ablation or modification in a multicenter study of pediatric patients. Methods and Results: Data from procedures in pediatric patients were gathered retrospectively from five institutions. Entry criteria were age < 21 years, typical AVNRT inducible with/without isoproterenol infusion, and attempted slow pathway ablation or modification. Dual AV nodal pathways were defined as those with > 50 msec jump in A2-H2 with a 10-msec decrease in A1-A2. Successful ablation was defined as elimination of AVNRT inducibility. A total of 159 patients (age 4.4 to 21 years, mean 13.1) were studied and had attempted slow pathway ablation. AVNRT was inducible in the baseline state in 74 (47%) of 159 patients and with isoproterenol in the remainder. Dual AV nodal pathways were noted in 98 (62%) of 159 patients in the baseline state. Ablation was successful in 154 (97%) of 159 patients. In patients with dual AV nodal pathways and successful slow pathway ablation, the mean fast pathway effective refractory period was 343 ± 68 msec before ablation and 263 ± 64 msec after ablation. Mean decrease in the fast pathway effective refractory period was 81 ± 82 msec (P < 0.0001) and was not explained by changes in autonomic tone, as measured by changes in sinus cycle length during the ablation procedure. Electrophysiologic measurements were correlated with age. Fast pathway effective refractory period was related to age both before (P = 0.0044) and after ablation (P < 0.0001). AV block cycle length was related to age both before (P = 0.0005) and after ablation (P < 0.0001). However, in dual AV nodal pathway patients, the magnitude of change in the fast pathway effective refractory period after ablation was not related to age. Conclusion: Lack of clear dual AV node physiology is common in pediatric patients with inducible AVNRT (38%). Fast pathway effective refractory period shortens substantially in response to slow pathway ablation. The magnitude of change is large compared with adult reports and is not completely explained by changes in autonomic tone. Prospective studies in children using autonomic blockade are needed. [source]


The addition of rosiglitazone to insulin in adolescents with type 1 diabetes and poor glycaemic control: a randomized-controlled trial

PEDIATRIC DIABETES, Issue 4pt1 2008
Monique L Stone
Objective:, To evaluate the effect of rosiglitazone, an insulin sensitizer, on glycaemic control and insulin resistance in adolescents with type 1 diabetes mellitus (T1DM) Research design and methods:, Randomized, double-blind, placebo-controlled crossover trial of rosiglitazone (4 mg twice daily) vs. placebo (24 wk each, with a 4 wk washout period). Entry criteria were diabetes duration >1 yr, age 10,18 yr, puberty (,Tanner breast stage 2 or testicular volume >4 mL), insulin dose ,1.1 units/kg/day, and haemoglobin A1c (HbA1c) >8%. Responses to rosiglitazone were compared with placebo using paired t -tests. Results:, Of 36 adolescents recruited (17 males), 28 completed the trial. At baseline, age was 13.6 ± 1.8 yr, HbA1c 8.9 ± 0.96%, body mass index standard deviation scores (BMI-SDS) 0.94 ± 0.74 and insulin dose 1.5 ± 0.3 units/kg/day. Compared with placebo, rosiglitazone resulted in decreased insulin dose (5.8% decrease vs. 9.4% increase, p = 0.02), increased serum adiponectin (84.8% increase vs. 26.0% decrease, p < 0.01), increased cholesterol (+0.5 mmol/L vs. no change, p = 0.02), but no significant change in HbA1c (,0.3 vs. ,0.1, p = 0.57) or BMI-SDS (0.08 vs. 0.04, p = 0.31). Insulin sensitivity was highly variable in the seven subjects who consented to euglycaemic hyperinsulinaemic clamps. There were no major adverse effects attributable to rosiglitazone. Conclusion:, The addition of rosiglitazone to insulin did not improve HbA1c in this group of normal weight adolescents with T1DM. [source]


High-dose cyclophosphamide versus monthly intravenous cyclophosphamide for systemic lupus erythematosus: A prospective randomized trial,

ARTHRITIS & RHEUMATISM, Issue 5 2010
Michelle 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]


Noninvasive Ventilation Outcomes in 2,430 Acute Decompensated Heart Failure Patients: An ADHERE Registry Analysis

ACADEMIC EMERGENCY MEDICINE, Issue 4 2008
Thomas A. Tallman DO
Abstract Objectives:, Continuous or bilevel positive airway pressure ventilation, called noninvasive ventilation (NIV), is a controversial therapy for acute decompensated heart failure (ADHF). While NIV is considered safe and effective in patients with chronic obstructive pulmonary disease (COPD), clinical trial data that have addressed safety in ADHF patients are limited, with some suggestion of increased mortality. The objective of this study was to assess mortality outcomes associated with NIV and to determine if a failed trial of NIV followed by endotracheal intubation (ETI) (NIV failure) is associated with worse outcomes, compared to immediate ETI. Methods:, This was a retrospective analysis of the Acute Decompensated Heart Failure National Registry (ADHERE), which enrolls patients with treatment for, or with a primary discharge diagnosis of, ADHF. The authors compared characteristics and outcomes in four groups: no ventilation, NIV success, NIV failure, and ETI. One-way analysis of variance or Wilcoxon testing was performed for continuous data, and chi-square tests were used for categorical data. In addition, multivariable logistic regression was used to adjust mortality comparisons for risk factors. Results:, Entry criteria were met by 37,372 patients, of which 2,430 had ventilation assistance. Of the ventilation group, 1,688 (69.5%) were deemed NIV success, 72 (3.0%) were NIV failures, and 670 (27.6%) required ETI. The NIV failure group had the lowest O2 saturation (SaO2) (84 ± 16%), compared to either NIV success (89.6 ± 10%) or ETI (88 ± 13%; p = 0.017). ETI patients were more likely to receive vasoactive medications (p < 0.001) than the NIV success cohort. When comparing NIV failures to ETI, there were no differences in treatment during hospitalization (p > 0.05); other than that the NIV failure group more often received vasodilators (68.1% vs. 54.3%; p = 0.026). In-hospital mortality was 7.9% with NIV, 13.9% with NIV failure, and 15.4% with ETI. After risk adjustment, the mortality odds ratio for NIV failure versus ETI increased to 1.43, although this endpoint was not statistically significant. Conclusions:, In this analysis of ADHF patients receiving NIV to date, patients placed on NIV for ADHF fared better than patients requiring immediate ETI. Patients who failed NIV and required ETI still experienced lower mortality than those initially placed on ETI. Thus, while the ETI group may be more severely ill, starting therapy with NIV instead of immediate ETI will likely not harm the patient. When ETI is required, mortality and length of stay may be adversely affected. Since a successful trial of NIV is associated with improved outcomes in patients with ADHF, application of this therapy may be a reasonable treatment option. [source]


Retrospective Review: The Incidence of Non-ST Segment Elevation MI in Emergency Department Patients Presenting With Decompensated Heart Failure

CONGESTIVE HEART FAILURE, Issue 6 2003
W. Frank Peacock MD
The authors performed a 6-month review of heart failure patients presenting to a teaching hospital emergency department to determine the rate of positive serum myocardial infarction markers. All patients with an emergency department discharge diagnosis of heart failure were included; those with a creatinine level >2.0 mg/dL were excluded. There were 151 patients who met the entry criteria, with a mean age of 68.6±13.6 years, and 84 (56%) were men. The mean ejection fraction was 32%, and the mean Framingham score was 3.8±1.6. Twenty (14%) had positive markers. Troponin T was positive in 17 (11%), and creatine kinase was positive in nine (6%). Both markers were positive in six (4%). Chest pain was absent in 70% of the positive marker group. The authors conclude that elevated cardiac markers are not rare in decompensated heart failure. These pilot data suggest these tests should be routinely obtained on heart failure patients. [source]


Issues with recruitment to randomised controlled trials in the drug and alcohol field: a literature review and Australian case study

DRUG AND ALCOHOL REVIEW, Issue 2 2008
CLARE L. THOMSON
Abstract Issues. The randomised control trial (RCT) is a widely used tool for measuring the effectiveness of health treatments and services. However, subject recruitment is an ongoing challenge for those conducting RCTs and may have a serious impact on the success of the study and the reliability of the outcomes. Approach. In this review we present an examination of the problems and strategies associated with recruitment to RCTs, with particular reference to studies conducted in the drug and alcohol field. A case study of recruitment to an RCT for the treatment of alcohol dependence is presented, supplemented by PubMed, Current Contents and Medline searches to identify relevant publications. Key Findings. The literature suggests that the most common barriers to patient participation involve fears of assignment to placebo treatment, insufficient compensation and poor attendance at initial appointments. Moreover, subject referrals from staff may be a greater problem than reluctance of patients. Referrals are inhibited by complicated entry criteria, time constraints due to busy work schedules or a limited research culture. Implications. Subject recruitment may be promoted by financial reimbursement, close partnerships between research and referral staff; increasing the treatment group ratio in multi-drug trials to minimise randomisation to placebo; addressing negative staff attitudes; and simplifying the referral process. Conclusion. The need for multi-centre sites in Australian drug and alcohol treatment studies is highlighted. [source]


Binge eating disorder pharmacotherapy clinical trails,who is left out?

EUROPEAN EATING DISORDERS REVIEW, Issue 2 2009
Anna I. Guerdjikova
Abstract Objective This report examined the characteristics of subjects interested in binge eating disorder (BED) pharmacotherapy trails who were ineligible for participation. Methods Data on 2685 potential subjects interested in participating in five different placebo-controlled monotherapy trails of BED were analysed. Results Of the 2685 potential subjects, 1230 (45.8%) were ineligible because they did not meet entry criteria, 586 (21.8%) were eligible for participation, 531 (19.8%) were not interested in the study and 338 (12.6%) were not contacted. Among the 1230 ineligible candidates, 525 (42.7%) were taking exclusionary psychotropic medication, 305 (24.8%) did not meet specified BED criteria, 157 (12.7%) were out of the required age (n,=,83) or weight (n,=,74) range, 212 (17.2%) had prohibited medical (n,=,78) or psychiatric (n,=,134) disorders and 31 (2.5%) were participating in weight loss programmes. Discussion Given the complexity of BED, future pharmacotherapy studies should examine a broader range of subjects, including subjects with subthreshold forms of BED, those with comorbid disorders and elderly subjects. Copyright © 2008 John Wiley & Sons, Ltd and Eating Disorders Association. [source]


Archery, Romance and Elite Culture in England and Wales, c.1780,1840

HISTORY, Issue 294 2004
Martin Johnes
During the sixteenth and seventeenth centuries, the longbow was rendered redundant as a weapon of war by technological developments such as the musket. Yet at the end of the eighteenth century, archery was revived as a fashionable pastime amongst the English aristocracy thanks to a nostalgic taste for the gothic and medieval. Archery societies were set up across the country, each with its own strict entry criteria, outlandish costumes and extravagant dinners. In a period that saw the making of the modern British upper class, as landowners became more powerful, more unified and more status-conscious, archery societies were havens of exclusivity and a way of reinforcing and reassuring one's own position in society. Furthermore, women could not only compete in the contests but retain and display their ,feminine forms' whilst doing so, and thus the clubs also acted as a forum for introductions, flirtation and romance. This article explores the meaning of archery for upper-class men and women and demonstrates how wider social needs and interests shaped play, recreation and fashion. [source]


Effect of rapid influenza testing on the clinical management of paediatric influenza

INFLUENZA AND OTHER RESPIRATORY VIRUSES, Issue 3 2009
Lance C. Jennings
Background, Rapid tests are now widely available to assist the diagnosis of influenza; implementation may optimise the use of antiviral and antibiotic agents in the clinical management of influenza. Objective, To explore the clinical management of children with influenza-like illness (ILI) when rapid influenza tests were and were not performed. Methods, Between 15 January 2007 and 30 April 2007, a standardised questionnaire was used to record the clinical features of children aged 1,12 years who presented to office-based paediatricians in Germany with febrile ILI during periods of local influenza activity. For each paediatric contact, a clinical diagnosis of either ,influenza positive', ,influenza negative' or ,suspected ILI' was made. Where performed, the outcome of a Clearview Exact Influenza A + B rapid test was recorded. Prescriptions for antiviral agents and antibiotic medications were also recorded. Results, A total of 16 907 questionnaires were evaluated. After fever (an entry criteria for all children), cough (84·6%), fatigue/decreased activity (83·0%), rhinorrhoea (73·7%) and headache (67·1%) were the most common symptoms. Influenza was clinically diagnosed in 56·8% (9596/16 907) of cases. The antiviral oseltamivir was prescribed for 24·6% (178/725) of children who were influenza positive by symptom assessment alone and 60·1% (4618/7685) of children who were influenza positive by rapid test. Antibiotics were less commonly prescribed for children who were influenza positive by rapid test [3·5% (271/7685) versus 17·2% (125/725) for symptom assessment alone]. Conclusions, In children with ILI, a positive rapid test result for influenza promotes the rational use of antiviral agents and reduces the inappropriate use of antibiotic medications. [source]


A prospective clinical study of Mineral Trioxide Aggregate and IRM when used as root-end filling materials in endodontic surgery

INTERNATIONAL ENDODONTIC JOURNAL, Issue 8 2003
B. S. Chong
Abstract Aim, To assess the success rate of the root-end filling material, Mineral Trioxide Aggregate (MTA). Methodology, Referred adult patients were recruited using strict entry criteria and randomly allocated to receive MTA or IRM. A standardized surgical technique was employed: the root end was resected perpendicularly and a root-end cavity was prepared ultrasonically and filled. A radiograph taken immediately after surgery was compared with those taken at 12 and 24 months. Customised film holders and the paralleling technique were used; radiographs were assessed by two trained observers using agreed criteria. The results from 122 patients (58 in IRM group, 64 in MTA group) after 12 months and 108 patients (47 in IRM group, 61 in MTA group) for the 24-month review period were analysed using the ,2 test. Results, The highest number of teeth with complete healing at both times was observed when MTA was used. When the numbers of teeth with complete and incomplete (scar) healing, and those with uncertain and unsatisfactory healing were combined, the success rate for MTA was higher (84% after 12 months, 92% after 24 months) compared with IRM (76% after 12 months, 87% after 24 months). However, statistical analysis showed no significant difference in success between materials (P > 0.05) at both 12 and 24 months. Conclusions, In this study, the use of MTA as a root-end filling material resulted in a high success rate that was not significantly better than that obtained using IRM. [source]


Role of the Clinical Breast Examination in Breast Cancer Screening

JOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 7 2001
Does This Patient Have Breast Cancer?
QUESTION: The authors, in an article for the JAMA section on the rational clinical examination, consider the evidence on whether and how to use clinical breast examination as a cancer screening technique. BACKGROUND: Breast cancer is a common disease, particularly in older women. The authors note that by age 70 the annual incidence of breast cancer is one in 200 women. Breast cancer survival is strongly influenced by the stage of the disease at the time of diagnosis. As a result, it is important to consider how best to screen for this disease. In recent years there has been considerable attention in the clinical literature and in the popular media paid to the screening strategies of breast self-examination and of screening mammography, but somewhat less to the potential role of the breast examination by the healthcare provider. In actual clinical practice, the same woman may be the recipient of any, none, or all of these screening modalities. The best way to combine these screening strategies, particularly in the case of the older woman, remains a subject of some uncertainty and controversy. DATA SOURCES: Data were obtained from a MEDLINE search of the English-language literature for 1966 through 1997 and additional articles as identified by the authors. STUDY SELECTION CRITERIA: In their evaluation of the effectiveness of clinical breast examination, the authors included both controlled trials and case-controlled studies in which clinical breast examination was used as a component of the screening. Study of breast examination technique considered both clinical studies and studies using silicone breast models. DATA EXTRACTION: The combined data from the trials included information on approximately 200,000 women who received a breast cancer screening intervention (mammography and/or clinical breast examination). However, none of the studies made the direct comparison of a group receiving clinical breast examination as a sole intervention with a control group that did not receive any screening. Data on the utility of clinical breast examination were partially derived from studies where that screening modality was used in combination with mammography. MAIN RESULTS: A number of trials of cancer screening have demonstrated a reduction in mortality from the use of mammography and clinical breast examination as combined screening strategies compared with no screening, with the inference that the reduction in mortality comes from the earlier detection of breast cancer. The percentage of the detected cancers that are detected in the trials by clinical breast examination despite having been missed on mammography varies across the trials from a low of 3% of the detected cancers to a high of 45%. It is speculative whether the marginal contribution of clinical breast examination to the mortality reduction in these screening trials corresponds to the percentage of cancers detected by clinical breast examination alone. In most of the clinical trials, the technique of breast examination reportedly was not well described. It is unclear therefore how much the technique of breast examination used varied within and among the clinical trials. Data from studies using examinations of breast models made of silicone demonstrated that test performance accuracy correlated with a lengthier breast examination, better breast examination technique, and perhaps with examiner experience. The report includes data from six comparator studies and from two demonstration projects. Of the six comparator studies, four compared a screened population with an unscreened population and two compared different intensities of screening strategies. None of the eight clinical trials was directed to a geriatric population and in fact older women were excluded by upper age entry criteria from the six comparator studies. (The upper age limit for study entry in the six comparator studies varied from 49 to 64.) CONCLUSION: The authors drew on the pooled results of these eight studies to conclude that clinical breast examination has a sensitivity of 54% (95% confidence interval, 48.3,59.8) and a specificity of 94% (95% confidence interval, 90.2,96.9). The authors conclude that screening clinical breast examination should be done for women age older than 40. [source]


Predictors of Clinical Outcome Following NIR Stent Implantation for Coronary Artery Disease: Analysis of the Results of the First International New Intravascular Rigid-Flex Endovascular Stent Study (FINESS Trial)

JOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 1 2002
STEVEN FELD M.D.
Background: Patient and procedural characteristics associated with major adverse cardiac events following balloon angioplasty have been identified. Factors predictive of angiographic restenosis following coronary stent implantation have been reported, although patient variables associated with adverse clinical outcome are not well defined. Hypothesis and Methods: To identify predictors of adverse clinical outcome following NIR stent implantation, clinical and angiographic characteristics of patients enrolled in the FINESS Trial were subjected to stepwise logistic regression analysis. From December 1995 through March 1996, NIR stent implantation was attempted in 255 patients (341 lesions) enrolled prospectively in a multicenter registry with broad entry criteria. Results: On stepwise logistic regression analysis, the presence of multivessel disease, diabetes, and the total length of the stented segment were predictive of major adverse cardiac events during 6-month follow-up. For every 1 mm increase in stent length, the risk for the combined end point of death or myocardial infarction increased by 3%. Lesion length was not predictive of clinical events on multivariate analysis. Conclusions: Our data raise the possibility that an attempt to use shorter stents to cover significant stenoses, but not adjacent areas of visible narrowing, may improve outcome. [source]


Liver test patterns in patients with acute calculous cholecystitis and/or choledocholithiasis

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 9 2009
M. S. PADDA
Summary Background, Liver tests are utilized to determine the presence of biliary obstruction. Aim, To examine our hypothesis that liver tests aid in elucidating whether patients have simple calculous cholecystitis (ACC) or choledocholithiasis (CDL). Methods, We performed a retrospective study of patients admitted to two University of Texas Southwestern teaching hospitals with a clinical picture consistent with ,acute gallstone disease', i.e. cholecystitis ± choledocolithiasis. The presence of ACC and CDL was based on defined clinical criteria. Results, The cohort consisted of 154 patients meeting specific entry criteria, primarily with right upper quadrant pain; 62 ACC, 79 both ACC and CDL and 13 CDL alone. Approximately 30% of patients with ACC had abnormal alkaline phosphatase (ALP) and/or bilirubin level and approximately 50% had abnormal aminotransferase levels. Among patients with ACC/CDL, 77% had abnormal ALP, 60% had abnormal bilirubin and 90% had abnormal aminotransferase levels. By multivariate analysis, increasing common bile duct size and an abnormal ALP and alanine aminotransferase (ALT) were excellent predictors of having ACC with CDL. Conclusions, Liver test patterns can aid in elucidating CDL, including in ACC patients. Fundamentally, patients with CDL were more likely to have more abnormal liver tests, whether they had CDL only, or CDL and ACC. A dilated CBD, and abnormal ALP and ALT had modest sensitivity and high specificity for identification of patients with ACC and CDL. [source]


Prostate cancer patients' support and psychological care needs: Survey from a non-surgical oncology clinic

PSYCHO-ONCOLOGY, Issue 8 2003
Kathleen Lintz
While there are numerous uncertainties surrounding prostate cancer's detection and treatment, more research focusing on the psychological needs of prostate patients is required. This study investigated the support and psychological care needs of men with prostate cancer. Patients were approached during urological oncology clinics and asked to complete the: Support Care Needs Survey (SCNS), Support Care Preferences Questionnaire, EORTC QLQ-C30 (Version 3) Measure plus Prostate Module, and the Hospital Anxiety and Depression Scale (HADS). Of the 249 patients meeting study entry criteria, there was an 89% response rate resulting in a cohort of 210 patients. The data showed that significant unmet need exists across a number of domains in the areas of psychological and health system/information. The more commonly reported needs were ,fears about cancer spreading (44%),' ,concerns about the worries of those close to you (43%),' and ,changes in sexual feelings (41%).' Half of all patients reported some need in the domain of sexuality, especially men younger than 65 years. Needs were being well met in the domain of patient care and support. A significant number of patients reported having used or desiring support services, such as information about their illness, brochures about services and benefits for patients with cancer (55%), a series of talks by staff members about aspects of prostate cancer (44%), and one-on-one counselling (48%). Quality of life (QoL) was most negatively impacted in those who: were ,65 years old, had been diagnosed within one year, or had metastatic disease. Men ,65 had decreased social functioning, greater pain, increased sleep disturbance, and were more likely to be uncomfortable about being sexually intimate. Patients recently diagnosed had increased fatigue, more frequent urination, greater disturbance of sleep, and were more likely to have hot flushes. Those with advanced disease scored lower on 12 out of 15 QoL categories. PSA level had no effect on QoL or anxiety/depression scores. Men with advanced disease had greater levels of depression and those ,65 years old were more likely to be anxious. Although most men with prostate cancer seem to function quite well, a substantial minority report areas of unmet need that may be targets for improving care. Copyright © 2003 John Wiley & Sons, Ltd. [source]


Improved safety with equivalent asthma control in adults with chronic severe asthma on high-dose fluticasone propionate

RESPIROLOGY, Issue 3 2001
Norbert Berend
Objective: High-dose inhaled corticosteroids (ICS) have been associated with the same side-effects as oral corticosteroids. Beclomethasone dipropionate (BDP) and budesonide (BUD) in doses greater than 2000 ,g/day are used regularly in severe asthma, despite the fact that safety and efficacy data at such high doses are limited. Fluticasone propionate (FP) has been promoted as being twice as potent clinically as BDP or BUD at doses of 2000 ,g/day or less with a similar safety profile. The aim of this study was to compare the efficacy and safety of FP with BDP and BUD in 133 symptomatic adult asthmatics requiring at least 1750 ,g/day of BDP or BUD. Methodology: Patients fulfilling the entry criteria were randomized to receive either their regular ICS medication or FP at approximately half the microgram dose for 6 months in an open, parallel group study. The primary efficacy measure was based on morning peak expiratory flow measurements recorded by patients on daily record cards, while determination of safety was based on a number of endpoints including changes in bone turnover indices, the incidence of topical side-effects and assessments of quality of life. Results: It was shown that patients who were switched to FP, but not those continuing with BDP or BUD, had significant increases in levels of morning serum cortisol and the urine cortisol:creatinine ratio while maintaining asthma control. Serum osteocalcin and the pyridinoline:creatinine ratio, as well as the deoxypyridinoline:creatinine ratio, were also shown to increase only in the FP group. Subjective assessments such as quality of life score, the incidence and ease of bruising, and reports of hoarseness also favoured the FP group. Conclusions: It is concluded that, at the doses studied and with the delivery devices used clinically, FP is at least as effective as BDP/BUD in the management of severe asthma and may offer clinical advantages with respect to steroid-related adverse effects. [source]


Evidence supports adjuvant radiotherapy in selected patients with rectal cancer

ANZ JOURNAL OF SURGERY, Issue 3 2004
Peter Gibbs
Background: Much recent data have been published on the risk of local recurrence (LR) following curative surgery for rectal cancer and the impact of adjuvant radiation therapy (RT). With improvements in surgical technique apparently reducing the risk of LR, the relevance of older data upon which the current recommendations for adjuvant RT are based has been questioned. Methods: A focused review was undertaken of the published literature on the risk of LR following surgery for rectal cancer and the impact of adjuvant radiation. In particular the authors attempt to define how accurately the risk for an individual patient can be predicted, trends in reported LR rates over the time period of randomized trials, and the relevance of changing surgical and RT techniques. Results: Many of the perceived differences in published results can be explained by variations in study entry criteria, length of follow up and data recording. Comparisons between studies are most accurate when defined subsets of patients, such as those with stage III disease, followed for the same period of time, are considered. In parallel with improvements in surgical technique, which may have reduced the risk of LR, modifications to RT delivery have resulted in recent series not reporting an increased mortality in those patients treated with modern RT techniques. Conclusion: All of the available evidence supports the use of adjuvant RT in selected patients with rectal cancer. Ongoing studies will better define individual patient risk and the risk,benefit ratio of adjuvant RT. [source]


Preoperative prediction of long-term outcome following laparoscopic fundoplication

ANZ JOURNAL OF SURGERY, Issue 7 2002
Colm J. O'Boyle
Background: Although long-term outcomes following laparoscopic fundoplication for gastro-oesophageal disease have now been reported as very satisfactory, a small, but important, minority of patients are unhappy with the outcome, often due to recurrent reflux symptoms or new-onset dysphagia. In this study, we sought to establish whether various parameters that can be determined before surgery, can predict the long-term outcome of surgery. Methods: Data collected prospectively were evaluated to determine factors that were associated with outcome at 5 years following laparoscopic fundoplication. Inclusion criteria were complete preoperative assessment data and 5-year follow-up data. Data examined included information on preoperative age, sex, weight, home address, health insurance status, duration of reflux symptoms, previous surgery, operating surgeon, endoscopy and 24-h pH monitoring. In addition, lower oesophageal sphincter resting and residual relaxation pressures were evaluated before and after surgery. The postoperative symptoms of heartburn and dysphagia, as well as overall satisfaction 5 years following surgery was determined using a 0,10 visual analogue scale. The association of the pre- and perioperative factors and outcome at 5 years was determined by univariate and linear regression analysis. Results: Two hundred and sixty-two patients from an overall experience of over 1000 laparoscopic anti-reflux procedures met the entry criteria. There was no association between patient address, age, weight, duration of symptoms, the presence of endoscopically proven oesophagitis, operating surgeon, the necessity for conversion to an open procedure, change in lower oesophageal sphincter residual relaxation pressure and the outcome parameters. Using univariate analysis, a higher heartburn score was associated with previous abdominal surgery, female sex, no private health insurance, and a normal preoperative 24-h pH study. A higher dysphagia score was associated with a normal preoperative pH study, a postoperative increase in lower oesophageal sphincter resting pressure of more than 6 mmHg, and previous abdominal surgery. Overall satisfaction with the outcome at 5 years was higher among male patients, private patients, patients who had a hiatus hernia, and patients who had an abnormal preoperative pH study. Linear regression analysis confirmed that private insurance, male sex, and the absence of previous abdominal surgery, were the strongest predictors of an improved heartburn score, whereas male sex and private health insurance were the strongest predictors of greater satisfaction with the overall outcome. Conclusions: There are parameters that can be assessed before or during laparoscopic Nissen fundoplication that correlate with late outcome parameters. In particular, male patients and those from higher socioeconomic groups appear to have a better long-term outcome. [source]


Chlamydiae as etiologic agents in chronic undifferentiated spondylarthritis

ARTHRITIS & RHEUMATISM, Issue 5 2009
John D. Carter
Objective The majority of patients with Chlamydia -induced reactive arthritis do not present with the classic triad of arthritis, conjunctivitis/iritis, and urethritis. Moreover, acute chlamydial infections are often asymptomatic. The aim of the present study was to assess the prevalence of synovial Chlamydia trachomatis and Chlamydia pneumoniae infections in patients with chronic undifferentiated spondylarthritis (uSpA). Methods Study patients met the European Spondylarthropathy Study Group criteria for SpA, without evidence of ankylosing spondylitis, psoriasis, inflammatory bowel disease, or preceding dysentery. Symptoms were present for ,6 months. Each patient underwent a synovial biopsy; tissue and concomitantly obtained peripheral blood mononuclear cells (PBMCs) were analyzed by polymerase chain reaction (PCR) for C trachomatis and C pneumoniae DNA. Other data collected on the day of the biopsy included standard demographic information and medical history, including any known history of C trachomatis or C pneumoniae. Physical examination (including joint count, evaluation for dactylitis and/or enthesitis, and skin examination) and HLA,B27 typing were performed. Synovial tissue (ST) samples from 167 patients with osteoarthritis (OA) were used as controls. Results Twenty-six patients met the entry criteria and underwent synovial biopsy (25 knee, 1 wrist). Sixteen of them (62%) were positive for C trachomatis and/or C pneumoniae DNA (10 for C trachomatis, 4 for C pneumoniae, and 2 for both). PCR analysis of ST revealed the presence of Chlamydia significantly more frequently in patients with uSpA than in OA controls (P < 0.0001). No specific clinical characteristics differentiated Chlamydia -positive from Chlamydia -negative patients. PBMCs from 4 of the 26 uSpA patients (15%) were positive for Chlamydia, and Chlamydia was found in ST from 2 of these 4 patients. No significant correlation between PCR positivity and HLA,B27 positivity was found. Conclusion The frequency of Chlamydia -positive ST samples, as determined by PCR, was found to be significantly higher in patients with uSpA than in patients with OA. Our results suggest that in many patients with uSpA, chlamydial infection, which is often occult, may be the cause. [source]


Real-world bare metal stenting: Identification of patients at low or very low risk of 9-month coronary revascularization

CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 2 2004
Stephen G. Ellis MD
Abstract The high cost of drug-eluting stents (DESs) has made identification of patients who are at low risk for subsequent revascularization after treatment with bare metal stents (BMSs) highly desirable. Previous reports from randomized trials suffer from biases induced by restricted entry criteria and protocol-mandated angiographic follow-up. Between 1994 and 2001, 5,239 consecutive BMS patients, excluding those with coil stents, technical failure, brachytherapy, staged procedure, or stent thrombosis within 30 days, were prospectively identified from a large single-center tertiary-referral-center prospective registry for long-term follow-up. We sought to identify characteristics of patients with very low (, 4%) or low (4,10%) likelihood of coronary revascularization 9 months after BMS. Nine-month clinical follow-up was obtained in 98.2% of patients. Coronary revascularization was required in 13.4% and did not differ significantly by stent type. On the basis of multivariate analysis identifying 11 independent correlates and previous reports, 20 potential low-risk patient and lesion groups (228 ± 356 patients/groups) were identified (e.g, patients with all of the following: native vessel, de novo, reference diameter , 3.5 mm, lesion length < 5 mm, no diabetes, not ostial in location). Actual and model-based outcomes were analyzed. No group had both predicted and observed 9-month revascularization , 4% (very low risk). Conversely, 19 of 20 groups had a predicted and observed revascularization rate of 4,10% (low risk). In the real-world setting, the need for intermediate-term revascularization after BMS may be lower than expected, but it may be very difficult to identify patients at very low risk. Conversely, if the benefits of DESs are attenuated in routine practice, many groups of patients treated with BMSs may have nearly comparable results. Catheter Cardiovasc Interv 2004;63:135,140. © 2004 Wiley-Liss, Inc. [source]


Dental fear in adults: a meta-analysis of behavioral interventions

COMMUNITY DENTISTRY AND ORAL EPIDEMIOLOGY, Issue 4 2004
Gerd Kvale
Abstract , Objectives:, The aim of this meta-analytic and systematic quantitative approach is to examine the effects of behavioral interventions for dental anxiety and dental phobia. Methods:, Eighty studies were identified where dental fear treatment with behavioral methods was evaluated. Thirty-eight of 80 met entry criteria and were included in a meta-analysis. Results:, The calculated effect sizes (ESs) for self-reported anxiety after intervention indicate positive changes in 36 of the 38 studies and no changes in two. The overall ES = 1.8 (95% CI: 1.6, 1.8). The percent of subjects with post-treatment dental visits in the first 6 months post-treatment varied between 50 and 100%. The overall ES for attendance at dental visits, weighted by sample size, is 1.4 (95% CI: 1.3, 1.6). The homogeneity analysis indicates that the studies cannot be adequately described in one ES. The reported percentage of subjects with a dental visit between 6 months and 4 years post-treatment varied from 48 to 100%. The overall weighted ES for visiting the dentist, adjusted for drop-outs in the studies, is 1.2 (95% CI: 0.99, 1.4). Conclusions:, Despite extensive heterogeneity, changes in self-reported anxiety represent medium to large ESs. Patients signing up for a behavioral intervention for dental fear can be expected to report a significant reduction in their fear, and this effect generally seems to be lasting. Mean long-term attendance (>4 years after treatment) is 77%. [source]