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PubMed2002

Effects of various test media on the activities of 21 antimicrobial agents against Haemophilus influenzae.

As considerable variation in the antimicrobial susceptibility of Haemophilus influenzae has been reported, the effects of various test media on the susceptibility of H. influenzae were studied. MICs were determined by three laboratories for 21 antimicrobial agents against a panel of 100 selected isolates. Testing was performed using a reference NCCLS frozen broth microdilution method with Haemophilus test medium (HTM) broth and dried commercial MIC trays rehydrated with the following media: in-house and commercially prepared HTM broth, Mueller-Hinton broth with 2% lysed horse blood and NAD, IsoSensitest broth with 2% lysed horse blood and NAD, and IsoSensitest broth-based HTM. Overall, all results were very reproducible, with the MIC at which 50% of the isolates tested are inhibited (MIC(50)), MIC(90), and geometric mean MIC being within one doubling dilution by all six methods and at all three testing centers for 15 of the 21 agents tested. Interlaboratory differences were more marked than intralaboratory differences or differences among media. Cefprozil, cefaclor, and trimethoprim-sulfamethoxazole results differed the most, while results for ampicillin, amoxicillin-clavulanic acid, cefdinir, cefixime, ceftriaxone, and clarithromycin were the most reproducible. However, these variations in results caused considerable differences in susceptibility rates for agents for which NCCLS susceptible breakpoints were close to the geometric mean MIC, particularly for cefaclor and cefprozil. This was much less of a problem when pharmacokinetic-pharmacodynamic breakpoints were used. Reproducible susceptibility results were obtained for a wide range of agents against H. influenzae in three laboratories using a variety of media that support the growth of this fastidious species.

Anti-Bacterial Agents↗

PubMed2005

The EPAGE internet guideline as a decision support tool for determining the appropriateness of colonoscopy.

BACKGROUND: Few studies have examined how physicians perceive guidelines, much less their perceptions of an Internet presentation of such guidelines. This study assessed physicians' acceptance ofan Internet-based guideline on the appropriateness of colonoscopy. METHODS: Gastroenterologists participating in an international observational study consulted an Internet-based guideline for consecutive patients referred for colonoscopy. The guideline was produced by the European Panel on the Appropriateness of Gastrointestinal Endoscopy (EPAGE), using a validated method (RAND). Through the use of questionnaires, physicians were asked their opinions and perspectives of the guideline and website. RESULTS: There were 289 patients included in the study. The mean time for consulting the website was 1.8 min, and it was considered easy to use by 86% of physicians. The recommendations were easily located for 82% of patients and physicians agreed with the appropriateness in 86% of cases. According to the EPAGE criteria, colonoscopy was appropriate, uncertain, and inappropriate in 59, 28, and 13% of patients, respectively. CONCLUSIONS: The EPAGE guideline was considered acceptable and user-friendly and the use, usefulness and relevance of the website were considered acceptable. However, its actual use will depend on the removal of certain organizational and cultural obstacles.

Adolescent↗

PubMed1989

Evaluating interns' performance using simulated patients in a casualty department.

An observational study examined the care that was provided by 61 interns for three simulated (standardized) patients in a casualty department within a large teaching hospital. The consultations were recorded on videotape and were scored by reference to explicit criteria that were set by an expert panel. The criteria described standards of clinical competence, communication skills and preventive care for each of the three cases. An additional list of the general opportunities for preventive advice that were suggested by the patients' case histories also was compared with the interns' actual behaviour. Clinical competence was not demonstrated uniformly across the three cases. The problem of urinary-tract infection was managed best; 19% of the interns complied with all criteria, and 93% of the interns complied with 75% of the criteria. For tension headache, only 3% of the interns complied with all the criteria but 67% of interns complied with 75% of the criteria. In the case of bronchitis, only 3% of interns complied with all the criteria but 58% of interns met 75% of the criteria. The quality of preventive care also varied from case to case, being best for the patient with bronchitis and worst for the patient with tension headache. Over all, only three of the 13 criteria were met by more than half the interns. The communication-skills criteria identified three behaviours which the interns were most likely to omit: the interns summarized the patients' problems in only 73 of the 173 consultations; they explained the aetiology of the problems in only 127 of the 173 consultations; and they ensured that the patients understood their plan of management in only 21 of the 173 consultations.

Adult↗

PubMedDate not supplied

Device tracking: user facility responsibilities.

The purpose of FDA's device tracking regulations is to ensure that tracked devices can be traced from the device manufacturing facility to the person who receives the benefit of the device, that is, the patient. Although the manufacturer has the responsibility for establishing and monitoring the tracking program for their devices, the user facility has a key responsibility in assuring its success. The FDA initially identified 21 devices that require tracking and recently added two more to the list. This paper discusses the tracking system and the responsibilities of the manufacturer and the user facility. Information on each of the initial 21 devices to be tracked is presented, including device nomenclature, description, potential health risks, panel classification and regulation number, risk class, ECRI number, and references.

Consumer Product Safety↗

PubMed2000

Macular translocation. American Academy of Ophthalmology.

OBJECTIVE: This document describes macular translocation surgery and examines the evidence to answer four key questions about whether the surgery is effective in treating visual loss from age-related macular degeneration, the technique that is most effective, the complications that result from the procedure, and the relationship of the volume of surgery to the number of complications. METHODS: A literature search that was conducted in September 1999 retrieved 21 relevant citations, and the reference lists of these articles were consulted for additional citations. Panel members reviewed this information, and a methodologist reviewed and rated all articles as good, fair, or poor in quality. RESULTS: The published literature contains only information from case series, which lack a control group and randomization. They describe a number of approaches, all of which are evolving. Follow-up is limited and visual outcomes vary widely. Serious intraoperative and postoperative complications are frequent, with accompanying risk of visual loss. Surgical morbidity is also an important factor. CONCLUSIONS: To date no strong evidence exists with which to answer questions about the effectiveness of macular translocation surgery in treating visual loss from age-related macular degeneration or about the most effective technique. Published case series have reported a significant rate of complications. There is no evidence to date to indicate that the complication rate is related to the volume of surgery done. Randomized clinical trials are needed to determine whether macular translocation is a safe and effective treatment for visual loss from age-related macular degeneration.

Academies and Institutes↗

PubMed2000

Photodynamic therapy with verteporfin for age-related macular degeneration. American Academy of Ophthalmology.

OBJECTIVE: This document describes photodynamic therapy (PDT) with verteporfin for age-related macular degeneration (AMD) and examines the evidence to answer the key question about whether the treatment is safe and effective in reducing visual loss from AMD. METHODS: A literature search that was conducted in April 2000 retrieved eight relevant citations, and the reference lists of these articles were consulted for additional citations. Panel members reviewed this information, and a methodologist reviewed and rated all articles according to the strength of evidence. RESULTS: The published literature contains a report of the combined results from two identically designed, double-masked randomized controlled trials. Ninety-four percent of participants completed the one-year follow-up. Patients treated with verteporfin had a decreased risk of at least moderate visual loss over this one-year period, but the beneficial effect on visual acuity was greatest among eyes in which the area of classic choroidal neovascularization (CNV) occupied 50% or more of the entire lesion area. There was no statistically significant difference in visual acuity outcomes at one year for yees in which the classic CNv was more than 0% but less than 50% of the area of the entire lesion. Serious systemic complications were rare. Severe vision decrease (equivalent to four lines or more of vision) within 7 days of treatment with verteporfin has been reported in 1% to 4% of patients. Partial recovery of vision was observed in many of these patients. CONCLUSIONS: To date, evidence suggests that PDT using verteporfin can reduce the risk of visual loss in patients with predominantly classic subfoveal CNV from AMD at one year. The rate of ocular and systemic complications is low. Additional clinical research is needed to determine the long-term effectiveness of treatment and the comparitive effectiveness with existing and new treatment modalities under investigation.

Choroidal Neovascularization↗

PubMed1990

World Health Organization quality assessment programme on HIV testing.

A serum panel comprising 19 samples of known (five positives and 14 negatives) but undisclosed HIV-1-antibody content was distributed to 30 national reference laboratories for HIV serology. In order to simulate normal circumstances of referral, participants were asked to test the panel for HIV-1-antibody status using their normal procedures. Results of testing were returned by 28 participants. There were great variations in the number and combinations of tests used. The number used ranged from one to five assays per laboratory and none of the 24 laboratories using two or more tests employed the same combination. A high average success rate of 99% was seen with the positive samples. More errors occurred with the negative samples, with an average of 87% correct negative reports. Only four of the 14 negative specimens were reported as negative by all participants.

Acquired Immunodeficiency Syndrome↗

PubMed2006

Armored RNA as virus surrogate in a real-time reverse transcriptase PCR assay proficiency panel.

In recent years testing responsibilities for high-consequence pathogens have been expanded from national reference laboratories into networks of local and regional laboratories in order to support enhanced disease surveillance and to test for surge capacity. This movement of testing of select agents and high-consequence pathogens beyond reference laboratories introduces a critical need for standardized, noninfectious surrogates of disease agents for use as training and proficiency test samples. In this study, reverse transcription-PCR assay RNA targets were developed and packaged as armored RNA for use as a noninfectious, quantifiable synthetic substitute for four high-consequence animal pathogens: classical swine fever virus; foot-and-mouth disease virus; vesicular stomatitis virus, New Jersey serogroup; and vesicular stomatitis virus, Indiana serogroup. Armored RNA spiked into oral swab fluid specimens mimicked virus-positive clinical material through all stages of the reverse transcription-PCR testing process, including RNA recovery by four different commercial extraction procedures, reverse transcription, PCR amplification, and real-time detection at target concentrations consistent with the dynamic ranges of the existing real-time PCR assays. The armored RNA concentrations spiked into the oral swab fluid specimens were stable under storage conditions selected to approximate the extremes of time and temperature expected for shipping and handling of proficiency panel samples, including 24 h at 37 degrees C and 2 weeks at temperatures ranging from ambient room temperature to -70 degrees C. The analytic test performance, including the reproducibility over the dynamic range of the assays, indicates that armored RNA can provide a noninfectious, quantifiable, and stable virus surrogate for specific assay training and proficiency test purposes.

Laboratories↗

PubMed2003

Referred to high secure care: determinants of a bed offer/admission and placement after one year.

BACKGROUND: The admission process to high secure care ought to ensure that those admitted (a) receive mental health care that meets their needs and (b) that this is provided at an appropriate level of security. AIMS: A study was undertaken to test the effectiveness of the gate keeping process according to these two criteria. METHOD All referrals for admission to Rampton high security hospital over one year were examined and, in addition, all women, all Anglo-Caribbeans and a random 50% sample of the Caucasian male majority were selected for interview. Each case was followed up for 12 months following the panel decision to determine his/her placement at that time. RESULTS: Of 138 referred, 56 (41%) were initially offered a bed although nearly half (66) had been subsequently admitted by the end of the study period. Seriousness of mental disorder and offence were independently associated with admission. After one year, one third of those admitted were no longer in high secure care. CONCLUSIONS: The variables predictive of admission (i.e. seriousness of both mental disorder and offence) suggest that the decision-making process was valid. Placement at 12 months tended to endorse the decision not to offer a bed, but it is more difficult to interpret the reverse as short admissions to high security for those who left within 12 months may have been appropriate. There was no apparent advantage in having a panel reviewing the decision of the assessing clinician.

Admitting Department, Hospital↗

PubMed2002

Rapid confirmation of HIV infection.

OBJECTIVE: To investigate the utility of a prototype rapid confirmatory HIV assay which offers specific results in 5 min and has applications in a variety of important testing situations. METHODS: The performance of the rapid confirmatory assay was assessed with 849 blood samples, including serum, plasma, venipuncture whole blood, and peripheral blood collected via fingerstick. Included were over 700 HIV Western blot (WB)-confirmed antibody positive sera, and others which were classified as negative or indeterminate by WB. The analytic sensitivity of the rapid confirmatory assay was assessed using 13 HIV-1 seroconversion panels, and all results were compared to those of an FDA-licensed WB reference test. RESULTS: The rapid test exhibited 100% concordance with the reference test when testing HIV-1 WB-confirmed positive samples, and 92.3% concordance with samples having WB-inconclusive results. The sensitivity for confirming recent seroconversion was as good, or better than, the FDA-licensed HIV-1 WB in 10/13 panels. The rapid assay performed accurately with whole blood collected from fingerstick, and exhibited excellent precision and reproducibility. CONCLUSION: We conclude that this rapid HIV confirmatory assay, the first of its kind, demonstrates proof of principle for the accurate confirmation of HIV-1 infection and offers important advantages in public health and clinical testing venues.

AIDS Serodiagnosis↗

PubMed1989

Therapy-relevant discrepancies between diagnoses of institutional pathologists and experienced hematopathologists in the diagnosis of malignant lymphoma.

We have studied therapy-relevant discrepancies in the diagnoses of institutional pathologists and a panel of 4 experienced hematopathologists in 375 cases from patients with malignant lymphoma. Two hundred and fifty four cases (68%) were contributed by non-panel pathologists and 121 (32%) by individual panel pathologists. Overall, in 24% (91/375) of the cases, therapy-relevant discrepancies were present between institutional pathologists and panel diagnoses. Thirty-four percent (87/254) therapy-relevant discrepancies were present in cases contributed by non-panel pathologists, whereas in only 3% (4/121) discrepancies were found in cases forwarded by individual panel pathologists. The percentages erroneously diagnosed Hodgkin's disease by non-panel pathologists and individual panel pathologists were 8 and 0% respectively and faulty diagnosed Non-Hodgkin lymphomas 5 and 0%, whereas the number of consultation cases, in which the referring pathologist was not certain of his diagnosis, appeared to be 24 and 3% for non-panel and panel pathologists respectively. In addition, in 14% of panel confirmed NHL contributed by non-panel pathologists, therapy-relevant discrepancies in the degree of malignancy grading according to the Working Formulation were present, whereas no discrepancies in malignancy grading were noted between individual panel members and panel diagnoses. Apart from extensive hematopathological experience, a reason for the higher diagnostic accuracy of the panel pathologists could well be the frequency in which the diagnoses were supplemented by immunophenotyping: in 22% of the cases from non-panel pathologists and 63% of the cases from panel pathologists immunophenotyping on frozen sections was carried out.(ABSTRACT TRUNCATED AT 250 WORDS)

Diagnosis, Differential↗

PubMed1990

Accuracy of individual and panel visual interpretations of coronary arteriograms: implications for clinical decisions.

The visual interpretation of coronary arteriograms by individuals has been shown to be variable and inaccurate. To determine whether observer accuracy improves with experience or with use of the mean values obtained from a panel of observers, the visual readings of percent diameter stenosis and "normal" reference segment diameter were compared with the quantitative analyses of 13 randomly chosen coronary stenoses. Visual interpretation was also performed on cineangiograms of seven phantom stenoses ranging in severity from 17% to 83%. Repeated quantitative arteriography demonstrated good intraobserver variability for minimal stenosis diameter (r = 0.91, SD = 0.23 mm) and percent diameter stenosis (r = 0.93, SD = 6.4%). When the mean of the repeated quantitative analyses was used as the standard, visual interpretations of percent diameter stenosis were found to have considerable inaccuracy (r = 0.78, SD = 14.5%). Phantom percent diameter stenosis data were better correlated (r = 0.85), but accuracy remained poor (SD = 17.8%). Fifty percent narrowings were read over a range from 30% to 95%. Substantial inaccuracies were also found for observer assessment of normal reference segment diameter (r = 0.75, SD = 0.75 mm). Observer accuracy of percent stenosis did not correlate with prior angiographic experience but was progressively improved by taking the mean value of the interpretations of three and five experienced angiographers (r = 0.88, 0.89; SD = 11.3%, 8.3%, respectively). These findings suggest that arteriographic interpretations accurate enough for interventional decisions can only be obtained using quantitative arteriography or the mean value of data from a large panel of angiographers.

Cineangiography↗

PubMed1988

The application of monoclonal antibody panels to characterize pestivirus isolates from ruminants in Great Britain.

Monoclonal antibodies were prepared against bovine virus diarrhoea virus and hog cholera virus. They were used to test 101 field isolates of ruminant pestivirus in a simple binding assay using an indirect immunoperoxidase label on fixed cell cultures. The monoclonals were divided into three panels: (1) pestivirus group specific, (2) hog cholera specific, (3) selectively reactive with ruminant pestiviruses. The reaction patterns with panel 3 were analyzed by a computer spreadsheet to determine the percentage match with seven reference patterns. Field viruses could be divided into two main groups. Group A consisted of 73 (87%) of the 84 bovine isolates and three (19%) of the 16 ovine, and was reactive with 40% or more of panel 3. Group B showed only limited reactivity with panel 3 and comprised 13/16 (81%) of the ovine (border disease) isolates together with the remaining 11 (13%) bovine viruses.

Animals↗

PubMed2006

Applicability and efficacy of qualifying criteria for an appropriate use of diagnostic upper gastrointestinal endoscopy.

UNLABELLED: Appropriate indication for upper gastrointestinal endoscopy (UGE) may be facilitated by referring to qualifying criteria such as those devised by the European Panel (EPAGE) and French Experts (ANAES). This prospective study evaluates the applicability and efficacy of these criteria in clinical practice. PATIENTS AND METHODS: A total of 522 patients was included (55% inpatients, 57% male, mean age 55 years). Appropriateness of referral was evaluated using EPAGE and ANAES criteria sets by a single independent expert. RESULTS: EPAGE criteria were applicable in 71% of cases. Indications for UGE were appropriate, inappropriate and uncertain in 62%, 27% and 11% respectively; 74%, 16% and 10% of clinically significant lesions detected by UGE were disclosed in patients having appropriate, inappropriate and uncertain indications respectively. ANAES criteria were applicable in 81% of cases. Indications for UGE were appropriate in 74%, inappropriate in 26%; 76% and 24% of clinically significant lesions detected by UGE were disclosed in patients having appropriate and inappropriate indications respectively. Whatever the criteria set used, all cancers and most of the severe lesions were observed in patients with appropriate indications: those patients were more often in-patients and were significantly older than patients belonging to the inappropriate group. CONCLUSION: Reference to EPAGE and ANAES qualifying criteria facilitates patient selection for UGE. Final decision must however rely upon practitioner advice. ANAES criteria are significantly more often applicable than EPAGE ones. However EPAGE referential when applicable is more predictive of the UGE findings.

Endoscopy, Gastrointestinal↗

PubMedDate not supplied

Experiences with the French Aging Males' Symptoms (AMS) scale.

INTRODUCTION: The aim of this paper is to report on experiences gained from the application of the French version of the Aging Males' Symptoms (AMS) scale, to show correlations with other relevant scales and to provide population reference values for France. METHODS: A representative survey based on an existing, representative population panel was performed in France (963 males, aged 15 + years). Other AMS data from Europe were then used for comparison. Mean scores of the French AMS scale do not systematically differ from the data of other European studies. The population reference values obtained for France strongly suggest that the scale measures can appreciate the level of well-being whatever the patients' age; however, some variables, such as age and family income, can influence the total AMS scores. Comparisons with the generic quality-of-life scale, SF-12, and a depression scale, HAD, have shown good correlations, as have comparisons with the ADAM questionnaire. CONCLUSION: The French AMS scale is a standardized, valid and simple health-related quality of life (HRQoL) scale, with results comparable to other published European findings. The results also indicate that the AMS scale can be used to measure and compare HRQoL in those less than 40 years of age.

Adolescent↗

PubMed1995

Comparison of antimicrobial susceptibility methods for detection of penicillin-resistant Streptococcus pneumoniae.

We sought to determine if commercially available susceptibility tests were accurate in detecting penicillin resistance and relative resistance in Streptococcus pneumoniae. We compared the reference MIC method with oxacillin disk screening and three commercial tests, E-test (AB Biodisk), JustOne (Radiometer America), and MicroScan Pos MIC Panel Type 6 (Baxter Diagnostics), with 80 selected clinical isolates. Thirty-three additional isolates were tested by the reference method and the E-test to further validate the latter method. Oxacillin screening was effective in detecting all penicillin-resistant and relatively resistant strains of S. pneumoniae. The MicroScan method was not effective in detecting penicillin resistance or relative resistance. The JustOne system classified only 6 (35%) of 17 resistant strains correctly, with 11 resistant strains classified as relatively resistant. The E-test correctly classified 30 (83%) of 36 resistant isolates, with 6 resistant isolates interpreted as relatively resistant. For determining penicillin MICs for S. pneumoniae, the E-test was the most accurate of the commercial systems that we studied.

Humans↗

PubMed2005

Performance of serum marker panels for liver fibrosis in chronic hepatitis C.

BACKGROUND/AIMS: Chronic hepatitis C (CHC) is characterised by hepatic fibrosis, used as a proxy measure of prognosis. Liver biopsy is a flawed reference standard and serum markers of fibrosis offer an attractive alternative. METHODS: A systematic review was conducted to assess the performance of panels of serum markers of hepatic fibrosis in CHC, incorporating analyses placing markers in a clinical context. RESULTS: 14 studies were included with 10 different panels. Median AUC in validation populations was 0.77 and training populations 0.81. Likelihood ratios (LR) ranged from -LR 0.1 to 0.9, + LR 1.2 to 33.1, diagnostic odds ratios (DOR) were 9.0 (median) with a range of 5 to 27- mostly below values of robust tests. Tests perform with either high sensitivity with low specificity or vice versa. Cut-off levels that gave clinically relevant predictive values for the presence/absence of significant fibrosis were applicable to 35% of the population. CONCLUSIONS: Serum markers can rule-in or rule-out fibrosis in up to 35% of patients, but cannot differentiate stages of fibrosis reliably. Improvement of index and reference test in needed including evaluation of clinical outcomes as reference. Improved test reporting is needed to derive LR and DOR as performance indicators.

Biomarkers↗

PubMed2006

Synthesis, physicochemical characterization and preliminary pharmacological in vitro evaluation of two novel cytotoxic benzophenone-linked 3,3-dimethyltriazenes.

The synthesis, physicochemical characterization and preliminary pharmacological evaluation of the cytotoxic effects of two novel substances, 1-(4-benzoylphenyl)-3,3-dimethyltriazene and 1-(2-benzoylphenyl)-3,3-dimethyltriazene is presented. The cytotoxicity of the novel benzophenone-linked triazenes and of ten other 1-phenyl-3,3-dimethyl triazene derivatives as well as of the referent alkylating drug melphalan was assessed using the MTT-dye reduction assay. A panel of human tumor cell lines was used: the chronic lymphoid leukemia SKW-3, the acute promyelocyte leukemia HL-60 and its multi-drug-resistant subline HL-60/Dox. Both novel compounds showed strong cytotoxic activity, comparable to that of the referent alkylating agent melphalan, whereas the ten ring-substituted 1-phenyl-3,3-dimethyl triazenes proved to be far less active in vitro. DNA-fragmentation analysis indicated that after 24 h treatment the novel benzophenone-linked triazenes induced programmed cell death in HL-60 cells.

Antineoplastic Agents↗