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At least 163 records · Page 9Linked to original sources
PubMed2006

Development of a commercial cigarette "market map" comparison methodology for evaluating new or non-conventional cigarettes.

A "market map" comparison methodology for cigarette smoke chemistry yields is presented. Federal Trade Commission machine-method smoke chemistry was determined for a range of filtered cigarettes from the US marketplace. These data were used to develop illustrative market maps for each smoke constituent as analytical tools for comparing new or non-conventional cigarettes to a sampling of the broader range of marketplace cigarettes. Each market map contained best-estimate "market-means," showing the relationship between commercial cigarette constituent and tar yields, and yield "market ranges" defined by prediction intervals. These market map means and ranges are the basis for comparing new cigarette smoke yields to those of conventional cigarettes. The potential utility of market maps for evaluating differences in smoke chemistry was demonstrated with 1R4F and 2R4F Kentucky reference cigarettes, an Accord cigarette, and an Advance cigarette. Conventional cigarette tobacco nicotine, nitrate, soluble ammonia, and tobacco specific nitrosamine levels are reported. Differences among conventional cigarette constituent yields at similar tar levels were explained in part by the chemical composition range of those cigarette tobaccos. The study also included a comparison of smoke constituent yields and in vitro smoke cytotoxicity and mutagenicity assay results for the 1R4F Kentucky reference cigarette and its replacement 2R4F. Significant smoke yield differences were noted for lead, NNK, and NNN. The majority of their smoke constituent yields were within the market range developed from the sampled conventional cigarettes. Within the sensitivity and specificity of the in vitro bioassays used, smoke toxic activity differences for the two reference cigarettes were not statistically significant. These results add to the limited information available for the 2R4F reference cigarette.

Animals↗
PubMed1990

Evaluation of methodology for assessing release characteristics of thermosoftening vehicles.

Methodology has been devised for the testing and evaluation of the mechanistic release of drug or markers from thermosoftening materials, as represented by the Gelucire class of excipients, which could be predictive. Release of a drug (anhydrous theophylline) and a marker (D&C yellow No. 10) was determined using a calibrated stationary disc/rotating fluid system. Of the fourteen commercially available Gelucire excipients, six were investigated in detail (G46/07, G48/09, G50/02, G50/13, G53/10, G62/05) and found to have biphasic release profiles. Lipid soluble materials demonstrated predominantly diffusion-controlled release, while water-dispersible materials absorbed water and showed signs of swelling which led to erosion as an additional component of the release characteristics.

Biopharmaceutics↗
PubMed2006

[Evaluation on methodological problems in reports concerning quantitative analysis of syndrome differentiation of diabetes mellitus].

OBJECTIVE: To evaluate the quality of reports published in recent 10 years in China about quantitative analysis of syndrome differentiation for diabetes mellitus (DM) in order to explore the methodological problems in these reports and find possible solutions. METHODS: The main medical literature databases in China were searched. Thirty-one articles were included and evaluated by the principles of clinical epidemiology. RESULTS: There were many mistakes and deficiencies in these articles, such as clinical trial designs, diagnosis criteria for DM, standards of syndrome differentiation of DM, case inclusive and exclusive criteria, sample size and estimation, data comparability and statistical methods. CONCLUSION: It is necessary and important to improve the quality of reports concerning quantitative analysis of syndrome differentiation of DM in light of the principles of clinical epidemiology.

Bibliometrics↗
PubMedDate not supplied

[Methodology for evaluation of disinfectants on the basis of system analysis].

The paper proposes a methodology based on the operation study theory, which can compare disinfectants by a combination of all their properties, which is integrated in the cost of tackling a disinfectological task rather than by the presence or magnitude of these or those useful properties.

Costs and Cost Analysis↗
PubMed2003

Using receiver operating characteristic methodology to evaluate the diagnostic quality of radiography on paper prints versus film.

OBJECTIVE: The aim of this study was to compare the diagnostic quality of paper prints with film copies in a sample of observers who were trying to detect small coin lesions on radiographs of a phantom. MATERIALS AND METHODS: The phantom consisted of 60 high-contrast and 60 low-contrast test objects, half of which had holes in them. Diameter and depth of the holes varied from 0.5 mm to 2 mm. Fifteen radiographs were obtained from different areas of the test objects. Film copies and paper prints were made using high-quality printers. Five observers independently evaluated 1,800 high-contrast and 1,800 low-contrast images. Data were evaluated using the well-established receiver operating characteristic methodology. RESULTS: The mean area under the curve rated 0.863 for paper prints (0.859 for high contrast and 0.860 for low contrast) and 0.926 for laser films (0.937 for high contrast and 0.913 for low contrast). The difference between the two imaging techniques was statistically significant for both high- and low-contrast lesions (p < 0.05). CONCLUSION: Detection of small coin lesions on radiographs of a phantom was significantly less sensitive on paper prints than on film. We found paper prints less acceptable for the diagnosis of small-sized lesions.

Diagnostic Errors↗
PubMedDate not supplied

Phase I 1/2 evaluation and methodology of RO 20-2230 in postoperative patients.

This report presents the rationale and methodology of our "phase 1 1/2" model for drug evaluation and reports the results of a typical study. We found that Ro 20-2230, and investigational agonist-antagonist analgesic, was well tolerated in therapeutic doses, with 15 mg intramuscular Ro 20-2230 approximately equivalent to 10 mg intramuscular morphine sulfate.

Adult↗
PubMed1999

Methodologies for evaluating long-term stability of dental relationships after orthodontic treatment.

A comprehensive review of literature which considers methodologies for studying long-term occlusal stability is presented. This article focuses on the evaluation of plaster study models because occlusal changes are best reflected in longitudinal casts. Of particular interest is the assessment of crowding in the dentition and the various physical and mathematical procedures used to evaluate the measurement of space available. Indices used to assess the overall occlusal results of treatment are also presented.

Dental Arch↗
PubMed2001

Questionnaires for a randomized controlled trial methodology to evaluate the teaching utility of diabetes simulation programs.

AIDA is an interactive educational diabetes simulator which has been made available without charge on the Internet. Since its launch on the World Wide Web in 1996 over 87,000 people have visited the AIDA Website--http://www.2aida.org--and over 22,000 copies of the program have been downloaded from there free-of-charge. The AIDA software is believed to be of use in recreating clinically realistic diabetes situations for interactive simulation. However, despite its widespread application, its actual utility for supporting the education of patients with type 1 diabetes mellitus remains to be objectively demonstrated in a clinical randomised controlled trial (RCT) setting. The current "Diabetes Information Technology & WebWatch" column overviews a prospective RCT methodology for formally evaluating the educational utility of an interactive diabetes simulator, like AIDA. The protocol makes use of two study arms--each receiving different educational interventions. During lessons, arm A of the study will be exposed to the AIDA simulator (the active intervention), while arm B (the control group) will benefit from conventional educational methods using standard presentations with slides and transparencies. Six lessons will be held for each study arm (one per week). At the beginning and end of the study self-monitoring blood glucose (SMBG) data will be collected, details of any hypoglycemic episodes recorded, and assessments made of glycosylated hemoglobin (HbA1c) levels. Participants will also be required to complete a detailed questionnaire to assess their self-confidence, quality of life and metabolic control, attitudes towards SMBG, and knowledge about insulin dosage calculation. Comparisons will be made between arm A and arm B using unpaired statistical analyses. A partial cross-over study design is also proposed whereby subsequently the control group will be exposed to the AIDA simulator during a further 6-week course of lessons. This will ensure that the maximum number of subjects will eventually receive the active intervention, and will also allow further within group paired analyses to be applied (with greater statistical power). This current "Diabetes Information Technology & WebWatch" column documents two of the questionnaires which are intended to be used for this RCT approach.

Computer Simulation↗
PubMed2001

A randomised-controlled clinical trial methodology for evaluating the teaching utility of interactive educational diabetes simulators.

AIDA is an interactive educational diabetes simulator which has been made available without charge on the Internet. Since its launch on the World Wide Web in 1996 over 58,000 people have visited the AIDA Web site (http://www.2aida.org) and over 17,500 copies of the program have been downloaded from there free-of-charge. The AIDA software is believed to be of use in recreating clinical (diabetes) situations for interactive simulation. However, despite its widespread usage, its actual utility for supporting the education of patients with Type 1 diabetes mellitus remains to be objectively demonstrated in a randomised-controlled clinical trial setting. This paper describes a prospective, randomised-controlled trial (RCT) methodology for formally evaluating the educational utility of an interactive diabetes simulator, like AIDA. The protocol makes use of two study arms, each receiving different educational interventions. During lessons, Arm A of the study will be exposed to the AIDA simulator (the active intervention), while Arm B (the control group) will benefit from conventional educational methods using standard presentations with slides and transparencies. Six lessons will be held for each study arm (one per week). At the beginning and end of the study self-monitoring blood glucose (SMBG) data will be collected, details of any hypoglycaemic episodes recorded, and assessments made of HbA1c. Participants will also be required to complete a detailed questionnaire to assess their self-confidence, quality of life and metabolic control, attitudes towards SMBG, and knowledge about insulin dosage calculation. Comparisons will be made between Arm A and Arm B using unpaired statistical analyses. A partial cross-over study design is also proposed whereby subsequently the control group will be exposed to the AIDA simulator during a further 6-week course of lessons. This will ensure that the maximum number of subjects will eventually receive the active intervention, and will also allow further within group paired analyses to be applied (with greater statistical power). An initial evaluation study using this RCT approach has just recently commenced in the Ospedale di Marino in Marino (Rome), Italy.

Blood Glucose↗
PubMed1975

Evaluating health programs: Where do we find the data?

This paper examines the data requirements for impact evaluation in the light of recent federal efforts to improve the evaluation of health programs. Typically, new health programs are launched before there is sufficient time or administrative interest in devising appropriate evaluation methodology. Therefore, any evaluation of such a program must be designed retrospectively. We argue that the best and typically only sources of data appropriate for such evaluations are pre-existing administrative statistics and archival records. The potential and limitations of these data sources are reviewed.

American Medical Association↗
PubMed1983

Evaluation of a methodology for the use of preparations from rat small intestine in the Salmonella/microsome assay.

A methodology is evaluated for the use in the Ames assay of a microsomal metabolising system derived from villous tip cells of rat small intestine. The procedure involved high frequency vibration of everted gut segments followed by gentle lysis and homogenisation. This technique, which has previously been shown to result routinely in high levels of cytochrome P450 and linked enzymes, has now been investigated for its ability to yield preparations capable of activating several promutagens in the Salmonella/plate incorporation test. The data obtained have been compared with results observed with standard rat liver metabolising fractions. In the presence of intestinal microsomes, 2-aminoanthracene, 2-aminofluorene, 2-acetylaminofluorene, aflatoxin B1, benzo[a]pyrene and cyclophosphamide all caused dose-related increases in revertants, the maximum yields of which were lower than those detected with liver microsomes or S9 mix. These and other differences in dose-responses have been discussed in relation to the levels of microsomal protein and cytochrome P450 plated and with respect to the activities of relevant enzymes in the tissue extracts.

Animals↗
PubMed2006

A systematic review and meta-analysis of the diagnostic accuracy of rapid immunochromatographic assays for the detection of dengue virus IgM antibodies during acute infection.

A meta-analysis of rapid (</=60 min) dengue diagnostic assays was conducted to determine accuracy and identify causes of between-study heterogeneity. A systematic review identified 302 potentially suitable studies, of which 11 were selected for meta-analysis. All selected studies evaluated the immunochromatographic test (ICT) manufactured by Panbio Pty Ltd. Individual study results for sensitivity ranged from 0.45 to 1.0, specificity 0.57-1.0, diagnostic odds ratio 4.5-1287, and positive:negative likelihood ratios 2.3-59 and 0.01-0.56, respectively. Results indicated that the ICT evaluated in the selected studies can both rule in and rule out disease but is more accurate when samples are collected later in the acute phase of infection. Limitations of this meta-analysis were significant between-study heterogeneity caused by inconsistencies in evaluation methodologies, and the evaluation of only the Panbio ICT. It is recommended that additional, standardized evaluations are required for other dengue ICTs.

Antibodies, Viral↗
PubMed2003

Evaluation of extraction methodologies for corn kernel (Zea mays) DNA for detection of trace amounts of biotechnology-derived DNA.

Sensitive and accurate testing for trace amounts of biotechnology-derived DNA from plant material requires pure, high-quality genomic DNA as template for subsequent amplification using the polymerase chain reaction (PCR). Six methodologies were evaluated for extracting DNA from ground corn kernels spiked with 0.1% (m/m) CBH351 (StarLink) corn. DNA preparations were evaluated for purity and fragment size. Extraction efficiency was determined. The alcohol dehydrogenase gene (adh1) and the CBH351 (cry9C, 35S promoter) genes in the genomic DNA were detected using PCR. DNA isolated by two of the methods proved unsuitable for performing PCR amplification. All other methods produced some DNA preparations that gave false negative PCR results. We observed that cornstarch, a primary component of corn kernels, was not an inhibitor of PCR, while acidic polysaccharides were. Our data suggest that amplification of an endogenous positive control gene, as an indicator for the absence of PCR inhibitors, is not always valid. This study points out aspects of DNA isolation that need to be considered when choosing a method for a particular plant/tissue type.

Biotechnology↗
PubMed2001

Effective approaches to persuading pregnant women to quit smoking: a meta-analysis of intervention evaluation studies.

OBJECTIVES: The study aimed to: (1) assess the effectiveness of prenatal smoking cessation interventions, (2) clarify whether the psychological changes targeted by interventions are related to their effectiveness, (3) identify specific intervention components associated with greater effectiveness, and (4) establish whether aspects of evaluation methodology are associated with a greater effectiveness. DESIGN: Differences in proportions of women quitting and odds ratios were calculated for the intervention and control groups. Interventions were categorized in relation to the main intervention target (i.e. cognitive preparation versus increased threat perception), use of follow-up contact, use of individual cessation counselling and other characteristics. Methodological approaches to evaluation were also categorized. METHODS: A systematic literature review generated 36 controlled evaluations, including one unpublished study. A meta-analysis was used to relate study classifications to effectiveness. This involved univariate analyses and a multivariate model of the relationship between observed univariate effects. RESULTS: A weighted mean odds ratio of 1.93 indicated a good overall effectiveness. Cognitive preparation interventions achieved higher quit rates (6.5%) compared to interventions focusing on threat perception (2.2%). However, this effect was not maintained in the multivariate analysis. CONCLUSION: Interventions should employ follow-up, but further research is required to assess the impact of one-to-one counselling. Clarification of the psychological change processes underlying the observed effectiveness of these interventions is required. Future research should seek to identify the active ingredients and cognitive mediators of successful interventions.

Journal Article↗
PubMed2005

Clinical evidence of growth hormone for patients undergoing abdominal surgery: meta-analysis of randomized controlled trials.

AIM: To assess the effectiveness and safety of perioperative growth hormone (GH) in patients undergoing abdominal surgery. METHODS: We searched the following electronic databases: MEDLINE, EMBASE, the Cochrane Controlled Trials Register, Chinese Bio-medicine Database. The search was undertaken in February 2003. No language restrictions were applied. Randomized controlled trials (RCT) comparing GH with placebo in patients undergoing abdominal surgery were extracted and evaluated. Methodological quality was evaluated using the Jadad scale. RESULTS: Eighteen trials involving 646 patients were included. The combined results showed that GH had a positive effect on improving postoperative nitrogen balance (standardized mean difference (SMD) = 3.37, 95%CI (2.46, 4.27), P<0.00001), and decreasing the length of hospital stay (weighted mean difference (WMD) = -2.07, 95%CI (-3.03, -1.11), P = 0.00002), and reducing the duration of postoperative fatigue syndrome (SMD = -1.83, 95%CI (-2.37, -1.30), P<0.00001), but it could increase blood glucose levels (WMD = 0.91, 95%CI (0.56, 1.25), P<0.00001). CONCLUSION: GH for patients undergoing abdominal surgery is effective and safe, if blood glucose can be controlled well. Further trials are required with a sufficient size to account for clinical heterogeneity and to measure other important outcomes such as infection, morbidity, mortality, fluid retention, immunomodulatory effects, and tumor recurrence.

Abdomen↗
PubMed2005

[Conception of health risks and its place in the system of sociohygienic monitoring (problems and approaches to their solution)].

The author describes the milestones of the development of health risk analysis methodology within the system of sanitary and hygienic monitoring. He gives definitions of risk of disorder of sanitary-and-epidemiological well-being of population, acceptable, target, and maximum permissible risk. The author considers methods of practical application of risk analysis methodology for quantitative evaluation of health detriment in the interests of authorities of various levels. The united role here belongs to Interdepartmental commission on risk evaluation. The author analyzes prospective directions and the main problems of further development of scientific and juridical fundamentals of risk evaluation methodology that will be topical within the nearest years.

Health Promotion↗
PubMed2004

One more time: improve your board through self-assessment.

Evaluating board effectiveness is a highly subjective, individualized, and potentially powerful undertaking if pursued with the proper motivation and with the ownership of the board. In this article, the authors describe one successful approach to board self-evaluation pursued by the Albert Lea Medical Center, Mayo Health System, Minnesota. The authors share evaluation methodology as well as process and outcomes. Recommendations directed toward organizations considering the self-evaluation process are formed around three themes. First, engage your board and have them own the process. Second, engage your board in developing the evaluation methodology. Third, ensure accountability in the board and the senior organization leadership for action on self-assessment outcomes. Finally, the authors discuss board development as a functional responsibility of the board. In that context, they present self-evaluation as one opportunity for a board to tangibly embrace its education and development responsibilities.

Governing Board↗
PubMed2005

Analysis and evaluation of methodologies to assess technical urban water systems.

The paper reports on the methodology and findings of a recent project on behalf of the Austrian Federal Ministry of Agriculture, Forestry, Environment and Water Management. The Ministry is seeking procedures for combining ecological and economic criteria to assess which technical urban water alternatives shall receive funding. To this end the current decision making process (DMP) for implementing urban water alternatives in Austria has been analyzed and compared with the situation elsewhere, e.g. in Sweden. The DMP entails specific requirements on assessment, whence the most common decision aid methodologies, ranging from LCA-based to multi-criteria methods, have been described and evaluated from an environmental, economic, legal and practical point of view, turning out recommendations to the Ministry. Their main points are: First the DMP should be kept as simple as possible in order to make it transparent. Second the aggregation of different criteria groups should and can be avoided. Therefore the stakeholders should not be allowed to make trade-offs. Finally clear objectives need to be stated.

Austria↗