Home About us Contact | |||
Standardized Forms (standardized + form)
Selected AbstractsHAEdb: A novel interactive, locus-specific mutation database for the C1 inhibitor gene,HUMAN MUTATION, Issue 1 2005Lajos Kalmár Abstract Hereditary angioneurotic edema (HAE) is an autosomal dominant disorder characterized by episodic local subcutaneous and submucosal edema and is caused by the deficiency of the activated C1 esterase inhibitor protein (C1-INH or C1INH; approved gene symbol SERPING1). Published C1-INH mutations are represented in large universal databases (e.g., OMIM, HGMD), but these databases update their data rather infrequently, they are not interactive, and they do not allow searches according to different criteria. The HAEdb, a C1-INH gene mutation database (http://hae.biomembrane.hu) was created to contribute to the following expectations: 1) help the comprehensive collection of information on genetic alterations of the C1-INH gene; 2) create a database in which data can be searched and compared according to several flexible criteria; and 3) provide additional help in new mutation identification. The website uses MySQL, an open-source, multithreaded, relational database management system. The user-friendly graphical interface was written in the PHP web programming language. The website consists of two main parts, the freely browsable search function, and the password-protected data deposition function. Mutations of the C1-INH gene are divided in two parts: gross mutations involving DNA fragments >1 kb, and micro mutations encompassing all non-gross mutations. Several attributes (e.g., affected exon, molecular consequence, family history) are collected for each mutation in a standardized form. This database may facilitate future comprehensive analyses of C1-INH mutations and also provide regular help for molecular diagnostic testing of HAE patients in different centers. Hum Mutat 25:1,5, 2005. © 2004 Wiley-Liss, Inc. [source] Qualitative Analysis of Medicare Claims in the Last 3 Years of Life: A Pilot StudyJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 1 2005Amber E. Barnato MD Objectives: To study end-of-life care of a representative sample of older people using qualitative interpretation of administrative claims by clinicians and to explore whether this method yields insights into patient care, including continuity, errors, and cause of death. Design: Random, stratified sampling of decedents and all their Medicare-covered healthcare claims in the 3 years before death from a 5% sample of elderly fee-for-service beneficiaries, condensation of all claims into a chronological clinical summary, and abstraction by two independent clinicians using a standardized form. Setting: United States. Participants: One hundred Medicare fee-for-service older people without disability or end-stage renal disease entitlement who died in 1996 to 1999 and had at least 36 months of continuous Part A and Part B enrollment before death. Measurements: Qualitative narrative of the patient's medical course; clinician assessment of care continuity and apparent medical errors; cause, trajectory, and place of death. Results: The qualitative narratives developed by the independent abstracters were highly concordant. Clinicians felt that 75% of cases lacked continuity of care that could have improved the quality of life and the way the person died, and 13% of cases had a medical error identified by both abstracters. Abstracters disagreed about assignment of a single cause of death in 28% of cases, and abstracters and the computer algorithm disagreed in 43% of cases. Conclusion: Qualitative claims analysis illuminated many problems in the care of chronically ill older people at the end of life and suggested that traditional vital statistics assignation of a single cause of death may distort policy priorities. This novel approach to claims review is feasible and deserves further study. [source] Analysis of clinical features of acute pancreatitis in Shandong Province, ChinaJOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, Issue 3 2007Yan Jing Gao Abstract Aim:, To investigate and obtain a more comprehensive view of the etiology and clinical features of acute pancreatitis in China. Method:, The study comprised 1471 patients in 10 cites of China who were admitted to hospitals for acute pancreatitis from January 1992 to December 2002. Data for each patient were collected on a standardized form. Results:, Of the 1471 patients (854 men, 617 women; mean age 43.3 years; range 13,82 years), 1280 had mild pancreatitis and 191 had the severe form. Cholelithiasis (20.2%), alcohol (17.3%) and diet-induced (12.4%) were the most frequent etiological factors, followed by biliary tract infections (5.6%), hyperlipidemia (2.3%) and other factors (5.1%). However, in about 36.1% of cases, the etiology of acute pancreatitis still remained unexplained. In coastal regions, cholelithiasis was the most frequent factor but alcohol ranked first in interior regions. In males, a small predominance of alcohol over cholelithiasis was seen (27.4%vs 14.3%) and there was a clear predominance of cholelithiasis over alcohol (28.4%vs 3.2%) in females. The differences in the frequency of cholelithiasis and alcohol between coastal regions and interior regions and males and females were statistically significant (P < 0.01). According to their frequency, complications of acute pancreatitis were pancreatic pseudocyst, pancreatic ascities and bacterial peritonitis, pulmonary infections, multiple organ failure, diabetes mellitus type 2 and shock. Conclusion:, Cholelithiasis, alcohol and diet-induced factors were the main etiological factors seen in China, whereas cholelithiasis alone predominated in females and alcohol ranked first in males. In about 36.1% of cases, the etiology of acute pancreatitis remained unknown. More attention should be paid to studying the etiologies of acute pancreatitis that remain unknown. [source] The adjunctive use of power Doppler imaging in the preoperative assessment of prostate cancerBJU INTERNATIONAL, Issue 9 2010Michael L. Eisenberg Study Type , Diagnostic (exploratory cohort) Level of Evidence 2b OBJECTIVE To determine if the adjunctive use of power Doppler imaging (PDI) could provide prognostic utility in the treatment of prostate cancer, as an accurate prediction of the clinical behaviour of prostate cancer is important to determine appropriate treatment. PATIENTS AND METHODS Most centres rely on a digital rectal examination or transrectal ultrasonography (TRUS) to assess the clinical stage of patients. In 2002, we began using a standardized form to evaluate TRUS findings and PDI findings. We compared preoperative clinical findings with those from pathological analysis of 620 radical prostatectomy specimens from 2002 to 2007. RESULTS The mean (sd) patient age was 58 (6.6) years with a mean prostate-specific antigen (PSA) level of 7.0 (4.5) ng/mL. Of the 620 specimens 157 (25.3%) had evidence of extracapsular extension on pathological evaluation; 443 (71.5%) men had a hypervascular lesion seen on TRUS, while 177 (28.5%) patients had none. There was no difference in preoperative PSA level, grade or stage of tumour. Furthermore, rates of biochemical recurrence or secondary treatment did not differ based on PDI findings. As a tool to help locate prostate tumours, PDI improved the specificity of TRUS but did not improve the overall accuracy or sensitivity. CONCLUSION PDI provides little prognostic utility to assess risk in prostate cancer. However, PDI might improve the specificity of TRUS in identifying prostate tumours and could have a role in image guidance for focal therapy of prostate cancer. [source] Institutional Review Boards and Multisite Studies in Health Services Research: Is There a Better Way?HEALTH SERVICES RESEARCH, Issue 1 2005Jennifer L. Gold Objective. The following paper examines the issue of whether the current system for ethics review of multisite health services research protocols is adequate, or whether there exist alternative methods that should be considered. Principal Findings. (1) Investigators at different sites in a multisite project often have very different experiences with respect to the requirements and requests of the review board. Other problems include the waste of time and resources spent on document preparation for review boards, and delays in the commencement of research activities. (2) There are several possible reasons why there is variability in ethics review. These include the absence of standardized forms, differences in the background and experiences of board members, the influence of institutional or professional culture, and regional thinking. (3) Given the limited benefits derived from the variability in recommendations of multiple boards and the numerous problems encountered in seeking ethics approval from multiple boards suggest that some sort of reform is in order. Conclusions. The increasing number of multisite, health services research studies calls for a centralized system of ethics review. The local review model is simply not conducive to multisite studies, and jeopardizes the integrity of the research process. Centralized multisite review boards, together with standardized documents and procedure, electronic access to documentation, and training for board members are all possible solutions. Changes to the current system are necessary not only to facilitate the conduct of multisite research, but also to preserve the integrity of the ethics approval process in general. [source] ORIGINAL ARTICLE: Subsegmental pulmonary embolism diagnosed by computed tomography: incidence and clinical implications.JOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 8 2010A systematic review, meta-analysis of the management outcome studies Summary.,Background:,Multiple-detectors computed tomographic pulmonary angiography (CTPA) has a higher sensitivity for pulmonary embolism (PE) within the subsegmental pulmonary arteries as compared with single-detector CTPA. Multiple-detectors CTPA might increase the rate of subsegmental PE diagnosis. The clinical significance of subsegmental PE is unknown. We sought to summarize the proportion of subsegmental PE diagnosed with single- and multiple-detectors CTPA and assess the safety of diagnostic strategies based on single- or multiple-detectors CTPA to exclude PE. Patients and methods:,A systematic literature search strategy was conducted using MEDLINE, EMBASE and the Cochrane Register of Controlled Trials. We selected 22 articles (20 prospective cohort studies and two randomized controlled trials) that included patients with suspected PE who underwent a CTPA and reported the rate of subsegmental PE. Two reviewers independently extracted data onto standardized forms. Results:,The rate of subsegmental PE diagnosis was 4.7% [95% confidence interval (CI): 2.5,7.6] and 9.4 (95% CI: 5.5,14.2) in patients that underwent a single- and multiple-detectors CTPA, respectively. The 3-month thromboembolic risks in patients with suspected PE and who were left untreated based on a diagnostic algorithm including a negative CTPA was 0.9% (95% CI: 0.4,1.4) and 1.1% (95% CI: 0.7,1.4) for single- and multiple-detectors CTPA, respectively. Conclusion:,Multiple-detectors CTPA seems to increase the proportion of patients diagnosed with subsegmental PE without lowering the 3-month risk of thromboembolism suggesting that subsegmental PE may not be clinically relevant. [source] Prospective Validation of the Pediatric Appendicitis Score in a Canadian Pediatric Emergency DepartmentACADEMIC EMERGENCY MEDICINE, Issue 7 2009Maala Bhatt MD Abstract Objectives:, Clinical scoring systems attempt to improve the diagnostic accuracy of pediatric appendicitis. The Pediatric Appendicitis Score (PAS) was the first score created specifically for children and showed excellent performance in the derivation study when administered by pediatric surgeons. The objective was to validate the score in a nonreferred population by emergency physicians (EPs). Methods:, A convenience sample of children, 4,18 years old presenting to a pediatric emergency department (ED) with abdominal pain of less than 3 days' duration and in whom the treating physician suspected appendicitis, was prospectively evaluated. Children who were nonverbal, had a previous appendectomy, or had chronic abdominal pathology were excluded. Score components (right lower quadrant and hop tenderness, anorexia, pyrexia, emesis, pain migration, leukocytosis, and neutrophilia) were collected on standardized forms by EPs who were blinded to the scoring system. Interobserver assessments were completed when possible. Appendicitis was defined as appendectomy with positive histology. Outcomes were ascertained by review of the pathology reports from the surgery specimens for children undergoing surgery and by telephone follow-up for children who were discharged home. Sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV) were calculated. The overall performance of the score was assessed by a receiver operator characteristic (ROC) curve. Results:, Of the enrolled children who met inclusion criteria (n = 246), 83 (34%) had pathology-proven appendicitis. Using the single cut-point suggested in the derivation study (PAS 5) resulted in an unacceptably high number of false positives (37.6%). The score's performance improved when two cut-points were used. When children with a PAS of ,4 were discharged home without further investigations, the sensitivity was 97.6% with a NPV of 97.7%. When a PAS of ,8 determined the need for appendectomy, the score's specificity was 95.1% with a PPV of 85.2%. Using this strategy, the negative appendectomy rate would have been 8.8%, the missed appendicitis rate would have been 2.4%, and 41% of imaging investigations would have been avoided. Conclusions:, The PAS is a useful tool in the evaluation of children with possible appendicitis. Scores of ,4 help rule out appendicitis, while scores of ,8 help predict appendicitis. Patients with a PAS of 5,7 may need further radiologic evaluation. [source] Doxazosin for treating lower urinary tract symptoms compatible with benign prostatic obstruction: a systematic review of efficacy and adverse effectsBJU INTERNATIONAL, Issue 9 2004Roderick MacDonald The first paper in this section is a systematic review of the efficacy and adverse effects of doxazosin for treating LUTS compatible with benign prostatic obstruction. The criteria for inclusion were met by 13 studies involving 6033 men. The authors found evidence that doxazosin was effective and well tolerated in patients with LUTS. Combined therapy was superior to doxazosin alone in reducing the risk of clinical progression and other long-term complications of this condition. Authors from the UK reviewed the long-term results they achieved with an endourethral stent for treating BPH; quite a large proportion of patients had either died from unrelated causes or had had the stent removed. They stressed the necessity for careful case selection, but showed that it was a safe treatment for BPH in poor-risk patients. OBJECTIVE To evaluate the efficacy and adverse effects of doxazosin for treating lower urinary tract symptoms (LUTS) compatible with benign prostatic obstruction (BPO). METHODS Randomized controlled trials were included in the meta-analysis if: the study duration was ,,1 month; the study involved men with symptomatic BPO; and doxazosin was compared with placebo or active controls. Study and patient characteristics and outcome data were extracted in duplicate onto standardized forms using a prospectively developed protocol. RESULTS Thirteen studies involving 6033 men with (mean age 64 years) met the inclusion criteria; 10 were placebo-controlled, including two with combined doxazosin/finasteride therapy and finasteride monotherapy arms. Three trials were a comparison with other ,-blockers. The study duration was 1,54 months. The mean baseline symptom scores and peak urinary flow (PUF) rates were indicative of moderate BPO. Doxazosin gave significant improvements in LUTS, assessed by symptom scores, vs placebo and finasteride in the short- to long-term. Two long-term studies (1 and 4 years) reported mean changes from baseline for the International Prostate Symptom Score of ,,8.3 and ,,6.6 points (,49% and ,,39%) for doxazosin and ,,5.7 and ,,4.9 points (,33% and ,,29%) for placebo, respectively. Doxazosin significantly increased PUF rates vs placebo. In pooled results from three studies, the weighted mean difference in the mean change from baseline vs placebo was 1.6 mL/s (95% confidence interval 1.2,2.1). Efficacy was comparable with other ,1,blockers. In the long-term (>4 years) doxazosin was no better then finasteride in improving PUF. Combined doxazosin and finasteride significantly reduced the risk of overall clinical progression of BPO vs each drug separately in men followed for >4 years. Absolute risk reductions vs placebo were 11.3%, 6.9% and 6.4% for combined therapy, doxazosin and finasteride, respectively (P < 0.001). Improvements in symptom scores and PUF were also significantly greater with combined than monotherapy, and the former reduced the need for invasive treatment for BPO and the risk of long-term urinary retention, although the absolute reductions in risk vs placebo were small (<4%). Dizziness and fatigue were significantly more common with doxazosin than placebo (11% vs 7%, and 6% vs 3%, respectively). Adverse events reported for combined therapy were similar to those with each monotherapy. CONCLUSION The evidence indicates that doxazosin is effective and generally well tolerated for improving LUTS and PUF in men with symptomatic BPO. Combined therapy was better than doxazosin alone in reducing the risk of clinical progression of BPO and other long-term complications related to BPO. [source] Terazosin for treating symptomatic benign prostatic obstruction: a systematic review of efficacy and adverse effectsBJU INTERNATIONAL, Issue 3 2002T.J. Wilt Objective To systematically review and evaluate the effectiveness and adverse effects of the ,-antagonist, terazosin, for treating urinary symptoms associated with benign prostatic obstruction (BPO). Methods Studies were sought and included in the review if they were randomized trials of at least 1 month duration, involved men with symptomatic BPO and compared terazosin with placebo or active controls. The study, patient characteristics and outcome data were extracted in duplicate onto standardized forms using a prospectively developed protocol. Results Seventeen studies involving 5151 men met the inclusion criteria, i.e. placebo-controlled (10), ,-blockers (seven), finasteride alone or combined with terazosin and placebo (one), and microwave therapy (one). The study duration was 4,52 weeks; the mean age of the men was 65 years and 82% were white. Baseline urological symptom scale scores and flow rates showed that men had moderate BPO. Efficacy outcomes were rarely reported in a way that allowed for data pooling, but indicated that terazosin improved symptom scores and flow rates more than did placebo or finasteride, and similarly to other ,-antagonists. The pooled mean percentage improvement for the Boyarsky symptom score was 37% for terazosin and 15% for placebo (four studies). The mean percentage improvement for the American Urological Association symptom score was 38%, compared with 17% and 20% for placebo and finasteride, respectively (two studies). The pooled mean improvement in the International Prostate Symptom Score of 40% was similar to that with tamsulosin (43%). Peak urinary flow rates improved more with terazosin (22%) than with placebo (11%) and finasteride (15%), but did not differ significantly from the other ,-antagonists. The percentage of men discontinuing terazosin was comparable with those receiving placebo and finasteride, but greater than with other ,-antagonists. Adverse effects were greater than with placebo and included dizziness, asthenia, headache and postural hypotension. Conclusions The available evidence indicates that terazosin improves the symptoms and flow rates associated with BPO; it was more effective than placebo or finasteride and similar to other ,-antagonists. Adverse effects were generally mild but more frequent than with other ,-antagonists and associated with a two- to four-fold increase in treatment discontinuation. [source] |