Journal articles on the topic 'Outcome imprecision'
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Westgard, J. O., J. J. Seehafer, and P. L. Barry. "Allowable imprecision for laboratory tests based on clinical and analytical test outcome criteria." Clinical Chemistry 40, no. 10 (October 1, 1994): 1909–14. http://dx.doi.org/10.1093/clinchem/40.10.1909.
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Abstract The allowable imprecision for laboratory tests has been estimated from criteria based on clinical and analytical test outcome. The analytical outcome criteria studied are the Clinical Laboratory Improvement Amendments (CLIA) criteria for proficiency testing. The clinical outcome criteria are estimates of medically significant changes in test results taken from a study in the literature. The estimates of allowable imprecision were obtained from quality-planning models that relate test outcome criteria to the allowable amount of imprecision and inaccuracy and to the quality control that is necessary to assure achievement of the desired outcome criteria in routine operation. These operating specifications for imprecision are consistently more demanding (require lower CVs) than the medically useful CVs originally recommended in the literature because the latter do not properly consider within-subject biological variation. In comparing estimates of allowable imprecision, the CLIA outcome criteria are more demanding than the clinical outcome criteria for aspartate aminotransferase (asymptomatic patients), cholesterol, creatinine (asymptomatic patients), glucose, thyroxine, total protein, urea nitrogen, hematocrit, and prothrombin time. The clinical outcome criteria are more demanding for bilirubin (acute illness), iron, potassium, urea nitrogen (acute illness), and leukocyte count. The estimates of allowable imprecision from analytical and clinical outcome criteria overlap for aspartate aminotransferase (acute illness), bilirubin (asymptomatic patients), calcium, creatinine (acute illness), sodium, triglyceride, and hemoglobin.
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Schreiber, William E., David B. Endres, Geraldine A. McDowell, Glenn E. Palomaki, Ronald J. Elin, George G. Klee, and Edward Wang. "Comparison of Fresh Frozen Serum to Proficiency Testing Material in College of American Pathologists Surveys: α-Fetoprotein, Carcinoembryonic Antigen, Human Chorionic Gonadotropin, and Prostate-Specific Antigen." Archives of Pathology & Laboratory Medicine 129, no. 3 (March 1, 2005): 331–37. http://dx.doi.org/10.5858/2005-129-331-coffst.
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Abstract Context.—Most proficiency testing materials (PTM) contain an artificial matrix that may cause immunoassays to perform differently with this material than with clinical samples. We hypothesized that matrix effects would be reduced by using fresh frozen serum (FFS). Objective.—To compare the performance of an FFS pool to standard PTM for measurement of α-fetoprotein, carcinoembryonic antigen, human chorionic gonadotropin (hCG), and prostate-specific antigen (PSA). Design.—One FFS specimen and 4 different admixtures of PTM were distributed in the 2003 College of American Pathologists K/KN-A (for α-fetoprotein, carcinoembryonic antigen, hCG, and total and free PSA) and C-C (hCG only) Surveys. Participants.—The number of laboratories that participated in the surveys varied from a low of 288 (free PSA, K/KN-A Survey) to a high of 2659 (hCG, C-C Survey). Main Outcome Measures.—Method imprecision and method bias were compared between the FFS specimen and the standard PTM specimen with the closest value. Method imprecision was determined by calculating the coefficients of variation for each method and for all methods combined. Bias was defined as the proportional difference between peer-group mean and the median of all method means. Results.—The FFS specimen gave significantly higher imprecision than PTM for the analytes α-fetoprotein, carcinoembryonic antigen, total PSA, and free PSA. For hCG, no substantial imprecision differences were observed in both surveys. Bias was significantly greater for the α-fetoprotein, carcinoembryonic antigen, and total PSA assays and significantly lower for the hCG and free PSA assays when comparing the FFS with the PTM. Conclusions.—Fresh frozen serum did not provide consistently lower imprecision or bias than standard PTM in a survey of commonly ordered tumor markers.
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Dijkstra, J. A., A. J. Voerman, B. Greijdanus, D. J. Touw, and J. W. C. Alffenaar. "Immunoassay Analysis of Kanamycin in Serum Using the Tobramycin Kit." Antimicrobial Agents and Chemotherapy 60, no. 8 (May 16, 2016): 4646–51. http://dx.doi.org/10.1128/aac.03025-15.
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ABSTRACTKanamycin is one of the aminoglycosides used in the treatment of multidrug-resistant tuberculosis. Blood concentrations of kanamycin are predictive for the treatment efficacy and the occurrence of side effects, and dose adjustments can be needed to optimize therapy. However, an immunoassay method for the quantification of kanamycin is not commercially available. We modified the existing tobramycin immunoassay to analyze kanamycin. This modified method was tested in a concentration range of 0.3 to 80.0 mg/liter for inaccuracy and imprecision. In addition, the analytical results of the immunoassay method were compared to those obtained by a liquid chromatography-tandem mass spectrometry (LC-MS/MS) analytical method using Passing and Bablok regression. Within-day imprecision varied from 2.3 to 13.3%, and between-day imprecision ranged from 0.0 to 11.3%. The inaccuracy ranged from −5.2 to 7.6%. No significant cross-reactivity with other antimicrobials and antiviral agents was observed. The results of the modified immunoassay method were comparable with the LC-MS/MS analytical outcome. This new immunoassay method enables laboratories to perform therapeutic drug monitoring of kanamycin without the need for complex and expensive LC-MS/MS equipment.
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Martins, Luciana Dorochenko, Márcia Rezende, Ana Cláudia Chibinski, Alessandro Dourado Loguercio, Marcelo Carlos Bortoluzzi, Jadson Araújo, and Alessandra Reis. "Does Ketorolac reduce the intensity of postoperative pain after impacted third molars surgery in adults compared to the use of tramadol? A systematic review and meta-analysis." Research, Society and Development 10, no. 3 (March 12, 2021): e19410313137. http://dx.doi.org/10.33448/rsd-v10i3.13137.
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This systematic review and meta-analysis evaluated if ketorolac reduces the intensity of postoperative pain after impacted third molars surgery in adults compared to the use of tramadol. A comprehensive search was performed in the MEDLINE/PubMed, Scopus, Web of Science, LILACS, BBO, EMBASE, Cochrane Library, SIGLE and grey literature, in accordance with the PRISMA guidelines. The quality of the evidence was evaluated using the GRADE approach. Meta-analysis was performed on studies considered at low risk of bias. After duplicates removal, 4526 articles were identified, but only nine studies were included for qualitative analysis. After updating in 2021, four studies were added, totaling 13 studies included for qualitative analysis. Only two studies, classified at “low” risk of bias, were included in the meta-analysis of the primary outcome. The difference in means for pain intensity (moderate quality of evidence due to imprecision) was – 0.27 (95% CI = – 0.82 to 0.28; p = 0.34). Data from adverse effects (low quality of evidence due to very serious issues in imprecision) was just reported in one study at “low” risk of bias. Data was not heterogeneous (Chi2 test p = 0.14; I2 = 55%). It was not possible to evaluate any secondary outcomes (time to first rescue analgesic drug in h, total amount of analgesics consumed and adverse effects) due to low number of studies included. There is a lack of strong evidence to assure the superiority of ketorolac or tramadol in reducing the postoperative pain after extraction of impacted third molars.
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Smith, Alison F., Bethany Shinkins, Peter S. Hall, Claire T. Hulme, and Mike P. Messenger. "Toward a Framework for Outcome-Based Analytical Performance Specifications: A Methodology Review of Indirect Methods for Evaluating the Impact of Measurement Uncertainty on Clinical Outcomes." Clinical Chemistry 65, no. 11 (November 1, 2019): 1363–74. http://dx.doi.org/10.1373/clinchem.2018.300954.
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Abstract BACKGROUND For medical tests that have a central role in clinical decision-making, current guidelines advocate outcome-based analytical performance specifications. Given that empirical (clinical trial-style) analyses are often impractical or unfeasible in this context, the ability to set such specifications is expected to rely on indirect studies to calculate the impact of test measurement uncertainty on downstream clinical, operational, and economic outcomes. Currently, however, a lack of awareness and guidance concerning available alternative indirect methods is limiting the production of outcome-based specifications. Therefore, our aim was to review available indirect methods and present an analytical framework to inform future outcome-based performance goals. CONTENT A methodology review consisting of database searches and extensive citation tracking was conducted to identify studies using indirect methods to incorporate or evaluate the impact of test measurement uncertainty on downstream outcomes (including clinical accuracy, clinical utility, and/or costs). Eighty-two studies were identified, most of which evaluated the impact of imprecision and/or bias on clinical accuracy. A common analytical framework underpinning the various methods was identified, consisting of 3 key steps: (a) calculation of “true” test values; (b) calculation of measured test values (incorporating uncertainty); and (c) calculation of the impact of discrepancies between (a) and (b) on specified outcomes. A summary of the methods adopted is provided, and key considerations are discussed. CONCLUSIONS Various approaches are available for conducting indirect assessments to inform outcome-based performance specifications. This study provides an overview of methods and key considerations to inform future studies and research in this area.
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Steele, Bernard W., Edward Wang, Darryl E. Palmer-Toy, Anthony A. Killeen, Ronald J. Elin, and George G. Klee. "Total Long-term Within-Laboratory Precision of Cortisol, Ferritin, Thyroxine, Free Thyroxine, and Thyroid-Stimulating Hormone Assays Based on a College of American Pathologists Fresh Frozen Serum Study: Do Available Methods Meet Medical Needs for Precision?" Archives of Pathology & Laboratory Medicine 129, no. 3 (March 1, 2005): 318–22. http://dx.doi.org/10.5858/2005-129-318-tlwpoc.
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AbstractContext.—It is important that the total long-term precision of laboratory methods meet the medical needs of the patients being served.Objectives.—To determine the long-term within- and between-laboratory variation of cortisol, ferritin, thyroxine, free thyroxine, and thyroid-stimulating hormone measurements using commonly available methods and to determine if these variations are within accepted medical needs.Design.—Two vials of pooled frozen serum were mailed 6 months apart to laboratories participating in 2 separate College of American Pathologists surveys. The data from those laboratories that analyzed an analyte in both surveys were used to determine for each method the total variance and the within- and between-laboratory components.Setting.—The study included the A mailing of the 2003 College of American Pathologists Ligand Survey and the C mailing of the Chemistry Survey.Main Outcome Measures.—For each analyte, total variance was partitioned into within- and between-laboratory components for each analytic method. The within-laboratory variations were then compared with imprecision criteria based on biological variation.Participants.—The laboratories that reported results on the same analyte using the same method in both surveys.Results.—For each analyte, the median of the long-term within-laboratory variances of each peer group was 78% to 95% of its total-survey variance, and the median long-term within-laboratory coefficients of variation varied from 5.1% to 7.6%. The number of methods that met within-laboratory imprecision goals based on biological criteria were 5 of 5 for cortisol; 5 of 7 for ferritin; 0 of 7 for thyroxine and free thyroxine; and 8 of 8 for thyroid-stimulating hormone.Conclusions.—For all analytes tested, the total within-laboratory component of variance was the major source of variability in this study. In addition, there are several methods, especially for thyroxine and free thyroxine, that may not meet analytic goals in terms of their imprecision.
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Lyon, Andrew W., Peter A. Kavsak, Oliver A. S. Lyon, Andrew Worster, and Martha E. Lyon. "Simulation Models of Misclassification Error for Single Thresholds of High-Sensitivity Cardiac Troponin I Due to Assay Bias and Imprecision." Clinical Chemistry 63, no. 2 (February 1, 2017): 585–92. http://dx.doi.org/10.1373/clinchem.2016.265058.
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Abstract BACKGROUND Clinical outcome studies for cardiac troponins (cTn) are expensive and difficult to design owing to variation in patients, in the assays, and in the incidence of different types of myocardial infarction (MI). To overcome these difficulties, simulation models were used to estimate the rate of misclassification error for MI and risk prediction resulting from assay bias and imprecision. METHODS Finite mixture analysis of Abbott high-sensitivity cTnI (hs-cTnI) results at time 0 h in patients presenting early with acute coronary syndrome (ACS) symptoms to the emergency department (ED) [n = 145, Reducing the Time Interval for Identifying New Guideline (RING) study] allowed derivation of a simulation data set (n = 10000). hs-cTnI concentrations were modified by addition of bias or imprecision error. The percentage of all 10000 modified hs-cTnI results that were misclassified for MI at thresholds of 2, 5, 26.2, and 52 ng/L was determined by Monte Carlo simulation. Analyses were replicated with an all-comer emergency department (ED) population (n = 1137) ROMI (Optimum Troponin Cutoffs for ACS in the ED) study. RESULTS In the RING study, simulation at 26.2-ng/L (99th percentile) and 52-ng/L thresholds were affected by both bias ±2 ng/L and imprecision (10%–20%) and had misclassification rates of 0.4% to 0.6%. Simulations at the 2-ng/L and 5-ng/L thresholds were only affected by bias. Misclassification rates at bias of ±1 ng/L were 10% for the 2-ng/L threshold, and 5% for the 5-ng/L threshold. CONCLUSIONS Simulation models predicted that hs-cTnI results are seldom misclassified (<1% of patients) when interpretative thresholds are near or exceed the overall 99th percentile. However, simulation models also predicted that low hs-cTnI results, as recommended in guidelines, are prone to misclassification of 5%–10% of patients.
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Palmer-Toy, Darryl Erik, Edward Wang, William E. Winter, Steven J. Soldin, George G. Klee, Joan H. Howanitz, and Ronald J. Elin. "Comparison of Pooled Fresh Frozen Serum to Proficiency Testing Material in College of American Pathologists Surveys: Cortisol and Immunoglobulin E." Archives of Pathology & Laboratory Medicine 129, no. 3 (March 1, 2005): 305–9. http://dx.doi.org/10.5858/2005-129-305-copffs.
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Abstract Context.—The College of American Pathologists (CAP) provides proficiency testing (PT) surveys to laboratories around the world. Objectives.—To compare diagnostic assay methods for serum/plasma cortisol and immunoglobulin (Ig) E in terms of their bias and precision, to determine how well CAP PT specimens simulate human serum, and to reassess proficiency test grading criteria in light of these findings. Design.—A participant-blinded, prospective trial. One vial of pooled fresh frozen serum (FFS) and 4 different admixtures of PT material (PTM) were sent to laboratories participating in PT surveys. Participants.—Laboratories providing cortisol (>1000) or IgE (>230) results among the subscribers to the CAP surveys, Ligand (General) 2003, set K/KN-A and Chemistry 2003, set C-C. Main Outcome Measures.—The main outcome measures were (1) bias among laboratories using the same method (peer groups), defined relative to the median of method means (MedMM); (2) imprecision as measured by the SD and coefficient of variation (CV) about each method mean; and (3) total error across laboratories for the FFS cortisol results, defined as |Bias Relative to Reference Method| + 2 SD. Results.—Cortisol method biases, relative to MedMM, ranged from −22% to 9% for the FFS challenge and from −24% to 36% for comparable PTM challenges. The method biases, relative to the reference method, ranged from −3% to 19% for the FFS challenge. The cortisol method CVs ranged from 4.2% to 13.6% for the FFS challenge and from 4.7% to 12.7% for comparable PTM challenges. Total error across laboratories ranged from 1.4 to 6.9 μg/dL (39 to 190 nmol/L) for the FFS challenge. Immunoglobulin E method biases, relative to MedMM, ranged from −8% to 9% for the FFS challenge and from −7% to 5% for comparable PTM challenges. The IgE method CVs ranged from 3.6% to 6.7% for the FFS challenge and from 3.4% to 9.8% for comparable PTM challenges. Conclusions.—The bias for cortisol results was less with FFS than with PTM, but imprecision was comparable. The FFS MedMM was 8.5% higher than the reference value. Fresh frozen serum and PTM bias and imprecision for IgE methods were each less than 10%. Because some of the methods demonstrated greater bias when analyzing PTM than FFS, peer group grading of both these analytes is appropriate.
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DEBNATH, Animesh, Abhirup BANDYOPADHYAY, Jagannath ROY, and Samarjit KAR. "GAME THEORY BASED MULTI CRITERIA DECISION MAKING PROBLEM UNDER UNCERTAINTY: A CASE STUDY ON INDIAN TEA INDUSTRY." Journal of Business Economics and Management 19, no. 1 (May 4, 2018): 154–75. http://dx.doi.org/10.3846/16111699.2017.1401553.
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The long-term evolution of multi agent multi criteria decision making (MCDM) and to obtain sustainable decision a novel methodology is proposed based on evolutionary game theory. In this paper multi agent MCDM is represented as an evolutionary game and the evolutionary strategies are defined as sustainable decisions. Here we consider the problem of decision making in Indian Tea Industry. The agents in this game are essentially Indian Tea Estate owner and Indian Tea board. The replicator dynamics of the evolutionary game are studied to obtain evolutionary strategies which could be defined as sustainable strategies. The multi agent MCDM in Indian Tea Industry is considered under different socio-political and Corporate Social Responsibility scenario and groups of Indian Tea Industry. Again, the impacts of imprecision and market volatility on the outcome of some strategies (decisions) are studied. In this paper the imprecision on the impact of the strategies are modelled as fuzzy numbers whereas the market volatility is taken into account as white noise. Hence the MCDM problem for Indian Tea Industry is modelled as a hybrid evolutionary game. The probabilities of strategies are obtained by solving hybrid evolutionary game and could be represented as a Dempster-Shafer belief structure. The simulation results facilitate the Decision Makers to choose the strategies (decisions) under different type of uncertainty.
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Stubbs, Carl, Sean Mc Auliffe, Adrian Mallows, Kieran O’sullivan, Terence Haines, and Peter Malliaras. "The strength of association between psychological factors and clinical outcome in tendinopathy: A systematic review." PLOS ONE 15, no. 11 (November 30, 2020): e0242568. http://dx.doi.org/10.1371/journal.pone.0242568.
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Objective Tendinopathy is often a disabling, and persistent musculoskeletal disorder. Psychological factors appear to play a role in the perpetuation of symptoms and influence recovery in musculoskeletal pain. To date, the impact of psychological factors on clinical outcome in tendinopathy remains unclear. Therefore, the purpose of this systematic review was to investigate the strength of association between psychological factors and clinical outcome in tendinopathy. Methods A systematic review of the literature and qualitative synthesis of published trials was conducted. Electronic searches of ovid MEDLINE, ovid EMBASE, PsychINFO, CINAHL and Cochrane Library was undertaken from their inception to June 2020. Eligibility criteria included RCT’s and studies of observational design incorporating measurements of psychological factors and pain, disability and physical functional outcomes in people with tendinopathy. Risk of Bias was assessed by two authors using a modified version of the Newcastle Ottawa Scale. High or low certainty evidence was examined using the GRADE criteria. Results Ten studies of observational design (6-cross sectional and 4 prospective studies), involving a sample of 719 participants with tendinopathy were included. Risk of bias for the included studies ranged from 12/21 to 21/21. Cross-sectional studies of low to very low level of certainty evidence revealed significant weak to moderate strength of association (r = 0.24 to 0.53) between psychological factors and clinical outcomes. Prospective baseline data of very low certainty evidence showed weak strength of association between psychological factors and clinical outcome. However, prospective studies were inconsistent in showing a predictive relationship between baseline psychological factors on long-term outcome. Cross sectional studies report similar strengths of association between psychological factors and clinical outcomes in tendinopathy to those found in other musculoskeletal conditions. Conclusion The overall body of the evidence after applying the GRADE criteria was low to very low certainty evidence, due to risk of bias, imprecision and indirectness found across included studies. Future, high quality longitudinal cohort studies are required to investigate the predictive value of baseline psychological factors on long-term clinical outcome.
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Steele, Bernard W., Edward Wang, Steven J. Soldin, George Klee, Ronald J. Elin, and David L. Witte. "A Longitudinal Replicate Study of Immunosuppressive Drugs." Archives of Pathology & Laboratory Medicine 127, no. 3 (March 1, 2003): 283–88. http://dx.doi.org/10.5858/2003-127-0283-alrsoi.
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Abstract Objective.—To identify the sources of analytical variation for cyclosporine and tacrolimus in a 3-year longitudinal study. Design.—Two pools of whole blood were spiked with cyclosporine and tacrolimus, respectively. One aliquot of cyclosporine and 2 of the tacrolimus pool were distributed in the first and last mailing for years 1999 to 2001. For both drugs, the total variance for each method was partitioned into within- and between-laboratory components. Setting.—The A and C mailings of the 1999, 2000, and 2001 AACC/CAP [American Association for Clinical Chemistry/College of American Pathologists] Immunosuppressive Drugs (CS) Monitoring Survey. Main Outcome Measures.—For each drug, total variance was partitioned into specimen, mailing, year, and interlaboratory effects for each analytical method. Participants.—The 292 laboratories for cyclosporine and 177 laboratories for tacrolimus enrolled in the survey from 1999 to 2001. Results.—For both cyclosporine and tacrolimus, the major source of imprecision came from within-laboratory factors, which accounted for nearly 85% (range, 77% to 90%) of the total variance. For cyclosporine, the major component of within-laboratory variance was between-mailing, within-year effect, whereas for tacrolimus it was the between-year, within-laboratory variation. Conclusion.—The major source of long-term survey imprecision for cyclosporine and tacrolimus is within-laboratory factors. The finding that 85% of the total variance was due to within-laboratory variation is similar to other therapeutic drugs.
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Sarici, Serdar Umit, Esad Köklü, and Oguzhan Babacan. "Comparison of Two Transcutaneous Bilirubinometers in Term and Near-Term Neonates." Neonatal Network 33, no. 3 (2014): 138–42. http://dx.doi.org/10.1891/0730-0832.33.3.138.
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Purpose: Determination of bilirubin levels is performed for many newborns in the first days of life, and several different transcutaneous bilirubinometers are available. We aimed to determine whether transcutaneous bilirubin measurement, as performed using Jaundice Detector JH20-1C, a new device, correlates with Minolta/Hill-Rom Air-Shields Transcutaneous Jaundice Meter model JM-103.Design and Sample: The study was performed on term or near-term newborn infants who underwent transcutaneous bilirubin measurements as part of their normal care. The study group consisted of 585 newborn infants with gestational ages ranging from 35 to 42 weeks, coming from an uneventful pregnancy. In this prospective study, bilirubin concentrations were determined with two different transcutaneous bilirubinometers.Main Outcome Variable: In 585 infants, the correlation coefficient for Jaundice Detector JH20-1C versus Minolta Air-Shields Jaundice Meter model JM-103 was .965 (p < .0001). The mean (± standard deviation) difference between the Jaundice Detector JH20-1C versus Minolta Air-Shields Jaundice Meter model JM-103 was 0.26 ± 0.95 mg/dL. Results showed the Jaundice Detector JH20-1C to have an acceptable level of intradevice imprecision (r = .978, p < .0001, mean differences .0158 ± .871 mg/dL).Results: Jaundice Detector JH20-1C showed the good performances of intradevice and interdevice imprecision in comparison with Minolta/Hill-Rom Air-Shields Transcutaneous Jaundice Meter model JM-103. Jaundice Detector JH20-1C may be suitable for screening term or near-term newborn infants for jaundice in the well-baby nursery or maternity ward.
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Venge, Per, and Bertil Lindahl. "Cardiac Troponin Assay Classification by Both Clinical and Analytical Performance Characteristics: A Study on Outcome Prediction." Clinical Chemistry 59, no. 6 (June 1, 2013): 976–81. http://dx.doi.org/10.1373/clinchem.2012.194928.
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BACKGROUND Cardiac troponin assays have been classified according to whether they measure the 99th percentile concentration of a healthy reference population with imprecision (expressed as CV) of ≤10%, between 10% and 20%, or >20%. Assays in these categories have been deemed “guideline acceptable,” “clinically usable,” or “not acceptable,” respectively. We compared four widely used “clinically usable” cardiac troponin I (cTnI) assays with an assay designated “not acceptable” for accuracy in predicting the clinical outcome of death. METHODS Blood was collected from 259 men and 249 women, mean (SD) age 68.8 (17.8) and 70.2 (17.8) years, respectively, admitted to the emergency department for suspected myocardial infarction. We measured cTnI by the Access, Architect, i-Stat, Stratus CS, and VIDAS assays. Deaths in this population were recorded over a 31-month period. RESULTS We found VIDAS cTnI assay measurement CVs of 10% and 20% at concentrations of 0.04 and 0.02 μg/L, respectively. Comparing at the 10% CV cutoff concentration, VIDAS cTnI was less sensitive than the Access and Architect assays (P < 0.001) but more sensitive than i-Stat (P < 0.001) and Stratus CS (P < 0.001) in identifying patients with poor outcomes. At the 20% CV cutoff, the VIDAS assay was equivalent to the other assays in identifying patients with poor outcomes. CONCLUSIONS For outcome prediction, the VIDAS cTnI assay was clinically equivalent or superior to other cTnI assays judged to be acceptable from a pure analytical standpoint. Thus, comparison of cardiac troponin assays should consider not only analytical performance, but also clinical performance characteristics.
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Greenberg, Peter, Christopher Cox, Michelle M. LeBeau, Pierre Fenaux, Pierre Morel, Guillermo Sanz, Miguel Sanz, et al. "International Scoring System for Evaluating Prognosis in Myelodysplastic Syndromes." Blood 89, no. 6 (March 15, 1997): 2079–88. http://dx.doi.org/10.1182/blood.v89.6.2079.
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Abstract Despite multiple disparate prognostic risk analysis systems for evaluating clinical outcome for patients with myelodysplastic syndrome (MDS), imprecision persists with such analyses. To attempt to improve on these systems, an International MDS Risk Analysis Workshop combined cytogenetic, morphological, and clinical data from seven large previously reported risk-based studies that had generated prognostic systems. A global analysis was performed on these patients, and critical prognostic variables were re-evaluated to generate a consensus prognostic system, particularly using a more refined bone marrow (BM) cytogenetic classification. Univariate analysis indicated that the major variables having an impact on disease outcome for evolution to acute myeloid leukemia were cytogenetic abnormalities, percentage of BM myeloblasts, and number of cytopenias; for survival, in addition to the above, variables also included age and gender. Cytogenetic subgroups of outcome were as follows: “good” outcomes were normal, −Y alone, del(5q) alone, del(20q) alone; “poor” outcomes were complex (ie, ≥3 abnormalities) or chromosome 7 anomalies; and “intermediate” outcomes were other abnormalities. Multivariate analysis combined these cytogenetic subgroups with percentage of BM blasts and number of cytopenias to generate a prognostic model. Weighting these variables by their statistical power separated patients into distinctive subgroups of risk for 25% of patients to undergo evolution to acute myeloid leukemia, with: low (31% of patients), 9.4 years; intermediate-1 (INT-1; 39%), 3.3 years; INT-2 (22%), 1.1 years; and high (8%), 0.2 year. These features also separated patients into similar distinctive risk groups for median survival: low, 5.7 years; INT-1, 3.5 years; INT-2, 1.2 years; and high, 0.4 year. Stratification for age further improved analysis of survival. Compared with prior risk-based classifications, this International Prognostic Scoring System provides an improved method for evaluating prognosis in MDS. This classification system should prove useful for more precise design and analysis of therapeutic trials in this disease.
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Rodrigues Pereira, Ronnie, Crispin Miller, Esther Baena, and Robert G. Bristow. "Machine learning approaches to improve prostate cancer outcome." Journal of Clinical Oncology 37, no. 7_suppl (March 1, 2019): 82. http://dx.doi.org/10.1200/jco.2019.37.7_suppl.82.
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82 Background: High-risk Prostate Cancer (PCa) occurs in as much as 37% of PCa cases in England and Wales. This proportion is much higher than in other developed countries. Furthermore, there is an imprecision in the primary treatment of these patients. More specifically, in the administration of systemic therapy. Currently, surgeons prescribe radical prostatectomy and radiation, while radiation oncologists often combine radiation with androgen deprivation therapy (ADT). However, ADT has significant side effects and not all patients develop Biochemical Recurrence/Metastasis. Furthermore, clinical factors have limited ability to identify these patients. Consequently, we turn to biomarker discovery for more accurate disease management. Methods: We applied a machine learning strategy to identify discriminatory DNA Methylation patterns between patients with biochemical recurrence from those with stable disease in high-risk PCa (D’Amico Classification, T-stage ≤ 3a). Training and feature selection occurred in cross-validation (4 Folds, 10 reps) on 102 patients from the TCGA-PRAD dataset (26 BCR). Gene co-expression networks were derived from mRNA expression (|Pearson correlation| > 0.70). Network clustering maximised global modularity (Louvain algorithm) and unsupervised clustering evaluated complete linkage. Functional enrichment employed MiSigDB Hallmarks and g:ProfileR. Results: A linear support vector machine outperformed Naïve Bayes, Random Forest and Artificial Neural Networks with an AUC = 0.91 ± 0.14 (95% CI). This epigenomic test preferentially sub-stratifies high-risk patients, as it shows no improvement over the “No Information Rate” of intermediate- and low-risk patients (p-value > 0.05, t-test). We identified functional clusters from a co-expression network superimposed with the genes most correlated to the epigenomic test. The most enriched cluster reveals disturbances in MYC targets, cell cycle and RNA splicing. Conclusions: Preliminary results indicate that an epigenomic test identifies a sub-group of patients which could benefit from ADT at the stage of primary treatment, however it requires further validation.
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Dominitz, Jeff, and Charles F. Manski. "More Data or Better Data? A Statistical Decision Problem." Review of Economic Studies 84, no. 4 (February 20, 2017): 1583–605. http://dx.doi.org/10.1093/restud/rdx005.
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AbstractWhen designing data collection, crucial questions arise regarding how much data to collect and how much effort to expend to enhance the quality of the collected data. To make choice of sample design a coherent subject of study, it is desirable to specify an explicit decision problem. We use the Wald framework of statistical decision theory to study allocation of a budget between two or more sampling processes. These processes all draw random samples from a population of interest and aim to collect data that are informative about the sample realizations of an outcome. They differ in the cost of data collection and the quality of the data obtained. One may incur lower cost per sample member but yield lower data quality than another. Increasing the allocation of budget to a low-cost process yields more data, while increasing the allocation to a high-cost process yields better data. We initially view the concept of “better data” abstractly and then fix attention on two important cases. In both cases, a high-cost sampling process accurately measures the outcome of each sample member. The cases differ in the data yielded by a low-cost process. In one, the low-cost process has non-response and in the other it provides a low-resolution interval measure of each sample member’s outcome. In these settings, we study minimax-regret sample design for prediction of a real-valued outcome under square loss; that is, design which minimizes maximum mean square error. The analysis imposes no assumptions that restrict the unobserved outcomes. Hence, the decision maker must cope with both the statistical imprecision of finite samples and the partial identification of the true state of nature.
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Du, Ning, and Ray Whittington. "An experimental investigation of dimensional precision in uncertainty disclosures related to revenue recognition." Accounting Research Journal 31, no. 1 (May 8, 2018): 90–101. http://dx.doi.org/10.1108/arj-12-2016-0150.
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Purpose The purpose of this paper is to investigate how managerial disclosure of imprecise information about revenue recognition affects investors’ perceptions of corporate and management performance. Specifically, the authors focus on how outcome and probability dimensions and their respective (im) precision interact with each other and jointly affect investors’ judgments and decision-making. Design/methodology/approach The authors conducted an experiment where the dimensions are manipulated (outcome vs probability) of disclosed revenue recognition information and its related precision (a point vs a range estimate). Findings Results from this study suggest that participants are sensitive to specific dimensions of uncertainty disclosure: participants were highly aware of the (im)precision in outcome information, were more likely to invest when both dimensions were vague and expected higher revenue when dimensional precision was consistent. Practical implications The results imply that dimensional precision is an important component in uncertainty disclosure and may have a significant impact on investors’ judgments and decision making. Regulators and managers should consider dimensional imprecision when they develop and implement disclosure strategy regarding revenue recognition. Social implications The results have practical value for regulators/managers, who are in the process of developing/implementing disclosure strategy regarding revenue recognition. Originality/value This is the first study to examine the interaction of dimensions of uncertainty in revenue disclosures.
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Kubrova, Eva, Gabriel A. Martinez Alvarez, Yeng F. Her, Robert Pagan-Rosado, Wenchun Qu, and Ryan S. D’Souza. "Platelet Rich Plasma and Platelet-Related Products in the Treatment of Radiculopathy—A Systematic Review of the Literature." Biomedicines 10, no. 11 (November 4, 2022): 2813. http://dx.doi.org/10.3390/biomedicines10112813.
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Back pain with radicular symptoms is associated with detrimental physical and emotional functioning and economic burden. Conservative treatments including physical, pharmacologic and injection therapy may not provide clinically significant or long-standing relief. Regenerative medicine research including Platelet rich plasma (PRP), Platelet lysate (PL) or Plasma rich in growth factors (PRGF) continues to develop, however evidence appraisal for treatment of radicular pain remains lacking. Thus, we performed a systematic review to evaluate the effectiveness of epidural steroid injections containing PRP or related products to treat radicular pain. Embase, PubMed/MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), and Google Scholar databases were queried. Twelve studies were included in qualitative analysis, consisting of three randomized controlled trials and nine observational studies. The primary outcome was pain intensity, and secondary outcomes included functional improvement, anatomical changes on advanced imaging, and adverse events. All studies identified improved pain intensity and functional outcomes after epidural injection of PRP, PRGF and/or PL. Similar or longer lasting pain relief was noted in the PRP cohort compared to the cohort receiving epidural steroid injections with effects lasting up to 12–24 months. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) analysis revealed a very-low certainty of evidence due to risk of bias, indirectness, and imprecision.
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van de Griendt, Erik-Jonas, Mariska K. Tuut, Hans de Groot, and Paul L. P. Brand. "Applicability of evidence from previous systematic reviews on immunotherapy in current practice of childhood asthma treatment: a GRADE (Grading of Recommendations Assessment, Development and Evaluation) systematic review." BMJ Open 7, no. 12 (December 2017): e016326. http://dx.doi.org/10.1136/bmjopen-2017-016326.
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ObjectiveBecause most children with asthma now use inhaled corticosteroids (ICS), the added benefit of immunotherapy in asthmatic children needs to be examined. We re-assessed the effectiveness of subcutaneous (SCIT) and sublingual immunotherapy (SLIT) in childhood asthma treatment focusing on studies with patient-relevant outcome measures and children using ICS.MethodsWe used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to systematically search and appraise the evidence using predefined critical patient-relevant outcomes (asthma symptoms, asthma control and exacerbations). We searched to retrieve systematic reviews and randomised controlled trials on immunotherapy for asthma in children (1960–2017). We assessed the quality of the body of evidence with GRADE criteria.ResultsThe quality of the evidence for SCIT was very low due to a large risk of bias and indirectness (dated studies in children not using ICS). No effect of SCIT was found for asthma symptoms; no studies reported on asthma control. For asthma exacerbations, studies favoured SCIT. We have little confidence in this effect estimate, due to the very low quality of evidence. For SLIT, quality of the evidence was very low due to a large risk of bias, indirectness and imprecision. The outcome ‘asthma symptoms’ could not be calculated due to lack of standardisation and large clinical heterogeneity. Other predefined outcomes were not reported.ConclusionThe beneficial effects of immunotherapy in childhood asthma found in earlier reviews are no longer considered applicable, because of indirectness (studies performed in children not being treated according to current asthma guidelines with ICS). There was absence of evidence to properly determine the effectiveness or lack thereof of immunotherapy in asthma treatment in children with ICS.
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Wong, Min Ney, Bruce E. Murdoch, and Brooke-Mai Whelan. "Lingual Kinematics in Dysarthric and Nondysarthric Speakers with Parkinson's Disease." Parkinson's Disease 2011 (2011): 1–8. http://dx.doi.org/10.4061/2011/352838.
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Articulatory dysfunction is recognised as a major contributor to the speech disturbances seen in Parkinson's disease (PD). The present study aimed to compare lingual kinematics during consonant production within a sentence in eight dysarthric (DPD) and seven nondysarthric (NDPD) speakers with PD with those of eleven nonneurologically impaired normal participants. The tongue tip and tongue back movements of the participants during sentence production were recorded using electromagnetic articulography (EMA). Results showed that both the DPD and NDPD had deviant articulatory movement during consonant production that resulted in longer duration of consonant production. When compared with the NDPD group, the DPD group primarily exhibited increased range of lingual movement and compatible duration of production with an accompanying increase in maximum velocity, maximum acceleration, and maximum deceleration. These findings are contrary to proposed theories that suggest articulatory imprecision in dysarthric speakers with PD is the outcome of reduced range of articulatory movement.
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Steele, Bernard W., Edward Wang, Glenn E. Palomaki, George G. Klee, Ronald J. Elin, Steven J. Soldin, and David L. Witte. "An Evaluation of Analytic Goals for Assays of Drugs." Archives of Pathology & Laboratory Medicine 125, no. 6 (June 1, 2001): 729–35. http://dx.doi.org/10.5858/2001-125-0729-aeoagf.
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Abstract Objective.—To determine if the levels of imprecision of the commonly used analytic methods for drug measurements are suitable for long-term therapeutic drug monitoring. Design.—In 1996, 4 identical lyophilized samples (2 in the first mailing and 2 in the second mailing 4 months later) were sent to laboratories participating in a nationwide proficiency testing program. Similarly, in 1999, replicates from a liquid pool of spiked sera were mailed 3 times, 4 months apart, to participating laboratories. For each of 11 drugs regulated under the Clinical Laboratory Improvement Amendments of 1988 and 1 metabolite, the total variance for each method was partitioned into within- and between-laboratory components. The total within-laboratory and the total survey coefficients of variation (CVs) for each method were then compared with the “acceptable” precision criteria of Glick, Burnett, and Fraser for each drug. Setting.—The first 2 mailings of the College of American Pathologists Therapeutic Drug Monitoring surveys for 1996, sets Z and ZM, and the 3 mailings of 1999, sets ZM, Z, and Z2. Main Outcome Measures.—For each drug studied, the CV of each method was compared with the various imprecision criteria, and if greater than any of the criteria, the method was then tabulated as not meeting that specific criterion. Participants.—The approximately 5000 participants of the survey. Results.—The number of methods deemed as not having acceptable total long-term within-laboratory precision by the various criteria ranged from 35% to 88% in 1996 and from 22% to 77% in 1999. Conclusion.—The number of failures possibly indicates that many of the reagent assays being utilized are not precise enough for long-term therapeutic drug monitoring of chronically administered drugs or that the published criteria used to evaluate the data in this study are too stringent.
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Venge, Per, Nina Johnston, Bo Lagerqvist, Lars Wallentin, and Bertil Lindahl. "Clinical and Analytical Performance of the Liaison Cardiac Troponin I Assay in Unstable Coronary Artery Disease, and the Impact of Age on the Definition of Reference Limits. A FRISC-II Substudy." Clinical Chemistry 49, no. 6 (June 1, 2003): 880–86. http://dx.doi.org/10.1373/49.6.880.
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Abstract Background: Measurements of cardiac troponins are currently used as the standard for the detection of myocardial injury. None of the current assays complies with the new requirements on assay imprecision as proposed by the European Society of Cardiology/American College of Cardiology. Our aim was to evaluate the clinical and analytical performance of the Liaison cardiac troponin I (cTnI) assay. Methods:EDTA-plasma was used, and cardiac troponins were assayed with the first-generation AxSYM assay, the second-generation AccuTnI assay, the third-generation Elecsys assay, and the first-generation Liaison assay. Results: In a 6-day imprecision study, the Liaison cTnI assay had mean CV ≤10% at 0.027 μg/L and ≤20% at 0.015 μg/L. The 99th percentile of the upper reference limit (URL) of a reference population was 0.041 μg/L (age range, 41–76 years). Individuals <60 years had a significantly (P = 0.001) lower 99th percentile, 0.022 μg/L. The FRISC-II study participants with cTnI ≥0.041 μg/L had a poorer outcome relating to death/acute myocardial infarction than those with cTnI <0.041 μg/L (P <0.001). Treatment with low-molecular-weight heparin (dalteparin) or an invasive strategy reduced cardiac events only in patients with concentrations >0.041 μg/L (P = 0.002 and 0.02, respectively). Comparison with the AccuTnI assay showed that a large cohort of the patients with poor prognosis was identified by the AccuTnI assay but not by the Liaison cTnI assay. Conclusion: The Liaison cTnI assay is a sensitive assay with a CV ≤10% at the 99th percentile URL. The ability to detect age-related differences among apparently healthy individuals is unique among today’s commercial assays. The results indicate that different assays seem to identify different patient cohorts for cardiac risk in the lower range of cTnI concentrations.
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Papageorgiou, Spyridon N., Despina Koletsi, Anna Iliadi, Timo Peltomaki, and Theodore Eliades. "Treatment outcome with orthodontic aligners and fixed appliances: a systematic review with meta-analyses." European Journal of Orthodontics 42, no. 3 (November 23, 2019): 331–43. http://dx.doi.org/10.1093/ejo/cjz094.
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Summary Background The use of orthodontic aligners to treat a variety of malocclusions has seen considerable increase in the last years, yet evidence about their efficacy and adverse effects relative to conventional fixed orthodontic appliances remains unclear. Objective This systematic review assesses the efficacy of aligners and fixed appliances for comprehensive orthodontic treatment. Search methods Eight databases were searched without limitations in April 2019. Selection criteria Randomized or matched non-randomized studies. Data collection and analysis Study selection, data extraction, and risk of bias assessment was done independently in triplicate. Random-effects meta-analyses of mean differences (MDs) or relative risks (RRs) with their 95% confidence intervals (CIs) were conducted, followed by sensitivity analyses, and the GRADE analysis of the evidence quality. Results A total of 11 studies (4 randomized/7 non-randomized) were included comparing aligners with braces (887 patients; mean age 28.0 years; 33% male). Moderate quality evidence indicated that treatment with orthodontic aligners is associated with worse occlusal outcome with the American Board of Orthodontics Objective Grading System (3 studies; MD = 9.9; 95% CI = 3.6–16.2) and more patients with unacceptable results (3 studies; RR = 1.6; 95% CI = 1.2–2.0). No significant differences were seen for treatment duration. The main limitations of existing evidence pertained to risk of bias, inconsistency, and imprecision of included studies. Conclusions Orthodontic treatment with aligners is associated with worse treatment outcome compared to fixed appliances in adult patients. Current evidence does not support the clinical use of aligners as a treatment modality that is equally effective to the gold standard of braces. Registration PROSPERO (CRD42019131589).
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Rahmawati, Nur Aini Lutfi, Esti Yunitasari, Ni Ketut Alit Armini, Padoli Padoli, and Suharyono Suharyono. "A Systematic Review of Endocrine Therapy for Improved Reproductive and Metabolic Outcomes in PCOS Women." Pediomaternal Nursing Journal 7, no. 2 (August 30, 2021): 65. http://dx.doi.org/10.20473/pmnj.v7i2.27497.
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Introduction: Polycystic ovarian syndrome (PCOS) is characterized by infrequent or absent ovulation as well as elevated levels of androgens and insulin (hyperinsulinaemia). The purpose of this study was to determine the efficacy of endocrine treatment in improving reproductive and metabolic outcomes in women with PCOS.Methods: We searched the following databases from inception to Maret 2020: PubMed, Proquest, ScienceDirect, Scopus and CINAHL. We investigated at metformin, clomiphene citrate, metformin plus clomiphene citrate, D-chiro-inositol, statins, and resveratrol as treatments. We compared them to each other, as well as to a placebo or no therapy. The quality of the evidence ranged from extremely low to moderate. The risks of bias (poor reporting of technique and inadequate outcome data), imprecision, and inconsistency were the limitations.Results: Although the evidence quality was low, our latest evaluation indicated that metformin alone may be superior to placebo for live birth. Data for live birth were equivocal when metformin was compared to clomiphene citrate, and our conclusions were hampered by a paucity of evidence. Body mass index (BMI) varies in the results, emphasizing the need of stratifying data by BMI.Conclusion: Clinical pregnancy and ovulation improvements demonstrate that clomiphene citrate is still preferred to metformin for ovulation induction in obese women with PCOS.
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Kertay, Les. "Precision Matters in Behavioral Health, Too." Guides Newsletter 23, no. 1 (January 1, 2018): 9. http://dx.doi.org/10.1001/amaguidesnewsletters.2018.janfeb02.
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Abstract Behavioral health terminology is an area beset by imprecision that results from confusing claim determinations, unnecessary evaluations, and poor outcomes that result from inappropriate treatment. In medical evaluation reports, one notes references to depression, anxiety, and stress, which are not diagnoses but often are treated as such. Behavioral factors can affect claims in four ways: the presence of a formal clinical diagnosis that meets specific criteria, psychological symptoms, difficult life circumstances, and behavioral overlays. Only the first of these can be attributed to a workplace injury or illness, and determining a causal relationship requires, at minimum, a precise diagnosis. For example, by depression does the health provider mean major depressive disorder with specifiers, persistent depressive/dysthymic disorder, adjustment disorder with depressed mood, or some other specific condition? The behavioral layers can affect the outcome of the claims process and may or may not be appropriate targets of an evidence-informed intervention aimed at returning an injured or ill worker to a higher level of function. The point is not to argue whether or not behavioral interventions are appropriate in workers’ compensation, personal injury, and other claims; the point, rather, is that precise language is the first, necessary step in sorting out the myriad ways in which behavior affects claim incidence, duration, and cost.
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Yang, Hui-Juan, De-Yu Zhang, Ying-Ying Hao, He-Li Xu, Yi-Zi Li, Shuang Zhang, Xin-Yu Li, Ting-Ting Gong, and Qi-Jun Wu. "GRADE Use in Evidence Syntheses Published in High-Impact-Factor Gynecology and Obstetrics Journals: A Methodological Survey." Journal of Clinical Medicine 12, no. 2 (January 5, 2023): 446. http://dx.doi.org/10.3390/jcm12020446.
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Objective: To identify and describe the certainty of evidence of gynecology and obstetrics systematic reviews (SRs) using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. Method: Database searches of SRs using GRADE, published between 1 January 2016 to 31 December 2020, in the 10 “gynecology and obstetrics” journals with the highest impact factor, according to the Journal Citation Report 2019. Selected studies included those SRs using the GRADE approach, used to determine the certainty of evidence. Results: Out of 952 SRs, ninety-six SRs of randomized control trials (RCTs) and/or nonrandomized studies (NRSs) used GRADE. Sixty-seven SRs (7.04%) rated the certainty of evidence for specific outcomes. In total, we identified 946 certainty of evidence outcome ratings (n = 614 RCT ratings), ranging from very-low (42.28%) to low (28.44%), moderate (17.65%), and high (11.63%). High and very low certainty of evidence ratings accounted for 2.16% and 71.60% in the SRs of NRSs, respectively, compared with 16.78% and 26.55% in the SRs of RCTs. In the SRs of RCTs and NRSs, certainty of evidence was mainly downgraded due to imprecision and bias risks. Conclusions: More attention needs to be paid to strengthening GRADE acceptance and building knowledge of GRADE methods in gynecology and obstetrics evidence synthesis.
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Thandar, Moe Moe, Md Obaidur Rahman, Rei Haruyama, Sadatoshi Matsuoka, Sumiyo Okawa, Jun Moriyama, Yuta Yokobori, et al. "Effectiveness of Infection Control Teams in Reducing Healthcare-Associated Infections: A Systematic Review and Meta-Analysis." International Journal of Environmental Research and Public Health 19, no. 24 (December 19, 2022): 17075. http://dx.doi.org/10.3390/ijerph192417075.
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The infection control team (ICT) ensures the implementation of infection control guidelines in healthcare facilities. This systematic review aims to evaluate the effectiveness of ICT, with or without an infection control link nurse (ICLN) system, in reducing healthcare-associated infections (HCAIs). We searched four databases to identify randomised controlled trials (RCTs) in inpatient, outpatient and long-term care facilities. We judged the quality of the studies, conducted meta-analyses whenever interventions and outcome measures were comparable in at least two studies, and assessed the certainty of evidence. Nine RCTs were included; all were rated as being low quality. Overall, ICT, with or without an ICLN system, did not reduce the incidence rate of HCAIs [risk ratio (RR) = 0.65, 95% confidence interval (CI): 0.45–1.07], death due to HCAIs (RR = 0.32, 95% CI: 0.04–2.69) and length of hospital stay (42 days vs. 45 days, p = 0.52). However, ICT with an ICLN system improved nurses’ compliance with infection control practices (RR = 1.17, 95% CI: 1.00–1.38). Due to the high level of bias, inconsistency and imprecision, these findings should be considered with caution. High-quality studies using similar outcome measures are needed to demonstrate the effectiveness and cost-effectiveness of ICT.
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Mogilevski, Eugene, and Jack L. Burston. "Morphosyntactic accuracy in the written compositions of advanced university level students of French." Australian Review of Applied Linguistics 22, no. 1 (January 1, 1999): 61–80. http://dx.doi.org/10.1075/aral.22.1.03mog.
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This article investigates the morphosyntactic accuracy of second year examination compositions written by advanced level students of French. The study provides a detailed error analysis of 212 compositions done on the basis of an error classification system consisting of twenty-two linguistic categories. The findings derived from this data highlight areas where students’ linguistic competence is at its weakest, and the rate of progress made by students from one semester to another. More specifically, they present the problem of linguistic accuracy, or rather lack thereof, as widespread, deeply engrained, and worthy of serious attention. The outcome of this investigation leads to a discussion of practical and theoretical explanations for our students’ lack of morphosyntactic accuracy and to a consideration of ways of reducing orthographic and grammatical imprecision. The effectiveness of focus on form is examined, with particular reference to processing instruction linked to the classroom use of the French grammar checker Le Correcteur 101.
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Lombardo, Luca, Angela Arreghini, Luis T. Huanca Ghislanzoni, and Giuseppe Siciliani. "Does low-frequency vibration have an effect on aligner treatment? A single-centre, randomized controlled trial." European Journal of Orthodontics 41, no. 4 (November 13, 2018): 434–43. http://dx.doi.org/10.1093/ejo/cjy076.
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Summary Background Low-frequency vibrations have been proposed as a means of accelerating tooth movement and reducing orthodontic treatment times. Objective To determine any differences in the accuracy of dental movement in patients treated with a low-frequency vibration aligner protocol and/or by reducing the aligner replacement interval with respect to a conventional protocol. Design This trial was designed as a single-centre, randomized controlled clinical trial. Methods Participants: Patients (aged 27.1 ± 9.0 years) who required orthodontic treatment with aligners. Randomization: Patients were randomly allocated to three arms as determined by a computer-randomization scheme. Group A were assigned a conventional protocol (aligners replaced every 14 days); group B also used a low-frequency vibration device for 20 minutes per day; group C followed the same vibration protocol but replaced their aligners every 7 days. Blinding: The operator who performed the set-up and the one who analysed the data were blinded to the group of the patients. Outcome: Pre- and post-treatment digital models were analysed using VAM software to identify the accuracy/imprecision of dental movements. One-way analysis of variance (P < 0.05) and the Bonferroni post hoc test were used to identify any statistically significant differences between the three arms in terms of the accuracy of tooth movement versus the prescription. Results Numbers analysed: A total of 45 patients (15 for group) were analysed (i.e. 2286 dental movements). Outcome: No statistically significant differences emerged between groups A and C in the upper arch, or among groups A, B, and C in the lower. Group B displayed significantly greater accuracy with respect to group A in upper incisor rotation (P = 0.016), and to group C in vestibulolingual (P = 0.007) and mesiodistal tipping (P = 0.029) of the upper canines, and vestibulolingual tipping of the upper molars (P = 0.0001). Harms: No adverse events or side-effects were registered. Conclusions Considering all tooth and movement types of the 45 participants, the mean total imprecision was 2.1 ± 0.9 degrees, with respect to a mean prescription of 5.7 ± 2.2 degrees. There was no difference in accuracy between replacing the aligners accompanied by low-frequency vibration every 7 days and replacing them every 14 days without vibration. Moreover, low-frequency vibration seemed to improve the accuracy of a conventional protocol in terms of upper incisor rotation. Trial registration The German Clinical Trials Register (DRK00015613).
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Weir, Christopher J., Valentina Assi, Lumine Na, Stephanie C. Lewis, Gordon D. Murray, Peter Langhorne, and Marian C. Brady. "Unreported Summary Statistics in Trial Publications and Risk of Bias in Stroke Rehabilitation Systematic Reviews: An International Survey of Review Authors and Examination of Practical Solutions." Journal of Stroke Medicine 2, no. 2 (October 30, 2019): 136–42. http://dx.doi.org/10.1177/2516608519873476.
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Objective: Continuous outcome measures are essential in rehabilitation research. Incomplete reporting of their mean and standard deviation, required for meta-analysis, potentially introduces bias and imprecision if it prevents studies being included. We aimed to determine how often systematic reviewers encounter missing mean or standard deviation values and to recommend practical statistical solutions. Design: 1. Cross-sectional survey of systematic review authors. 2. Reanalysis of Cochrane review data to evaluate how accurately statistical methods for recovering missing mean or standard deviation values estimate the true meta-analysis treatment effect. Setting: Rehabilitation intervention systematic reviews. Participants: Cochrane stroke rehabilitation review authors; stroke patients. Interventions: Reanalysis of a Cochrane review of early supported discharge services. Main measures: Hospital length of stay. Results: Survey responses covered 53 of 70 Cochrane reviews. Almost all studied continuous outcome measures, 68% encountering missing summary statistics. Various solutions were attempted but 76% of meta-analyses omitted at least one study due to missing information. In the review reanalysis ( N = 1055), a method based on the minimum and maximum performed best in recovering missing standard deviations; a method based on the median, lower and upper quartiles successfully estimated a missing mean. Conclusion: Practical statistical methods help reduce risk of bias, maximise the evidence included in rehabilitation meta-analyses and offer a clear hierarchy of solutions to handling unreported mean and standard deviation values.
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Radford, S., V. Sinopoulou, M. Gordon, M. E. A. A. Eldragini, A. M. Darie, A. Akobeng, and G. W. Moran. "P469 Infliximab for induction of medically-induced remission in Crohn’s disease: a Cochrane systematic review." Journal of Crohn's and Colitis 16, Supplement_1 (January 1, 2022): i442—i443. http://dx.doi.org/10.1093/ecco-jcc/jjab232.596.
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Abstract Background Infliximab is a monoclonal antibody that binds and neutralizes tumour necrosis factor-alpha, which is present in high levels in the blood serum, mucosa and stool of patients with Crohn’s disease (CD). We sought to determine the effectiveness and safety of infliximab in inducing remission in patients with CD. Methods On 31 August 2021, we searched CENTRAL, CINAHL, ClinicalTrials.gov, Embase, MEDLINE, and WHO ICTRP with no language, date, publication status, or document type limitations. We included randomized controlled trials (RCTs) in which infliximab was compared to placebo or another active comparator in adult (18 and over) patients with active CD. The review authors independently conducted data extraction and ‘Risk of bias’ assessment of the included studies. We expressed dichotomous and continuous outcomes as risk ratios and mean differences with 95% confidence intervals. We assessed the certainty of the evidence using GRADE methodology. The primary outcome was the proportion of patients who achieved clinical remission. Results We included 9 RCTs (1130 participants). Three studies compared multiple arms with different infliximab doses (between 5mg and 20mg/kg) to placebo. Two studies each with three arms compared azathioprine and placebo, infliximab and placebo, or infliximab and azathioprine combined. One study compared infliximab with biosimilar CT-P13. One study compared infliximab and azathioprine with steroids and azathioprine and only infliximab if no response. The final study compared a single dose (5mg/kg) of infliximab to placebo. In all trials that didn’t require a purine analogue to be given to both study groups, they allowed such concomitant use in both groups. There is evidence that infliximab combined with azathioprine is superior to azathioprine combined with placebo in inducing clinical remission for CD (RR 1.97, 95% CI 1.60–2.42, moderate certainty evidence downgraded due to risk of bias, NNT = 3). Sensitivity analysis considering a fixed effects model and then removing a study where most received azathioprine in both groups instead of all, had no impact on the result, which remained significant. There is evidence that there may be no difference in withdrawals from adverse events between infliximab combined with azathioprine and azathioprine combined with placebo when inducing clinical remission for CD (RR 0.74, 95% CI 0.29–1.86, low certainty evidence downgraded due to serious imprecision). The evidence is uncertain for all other comparisons and outcomes due to imprecision from small sample sizes. Conclusion There is evidence that infliximab with azathioprine is probably better than azathioprine, however the remaining data is based on limited total patient numbers and offers limited scope for meta-analysis.
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Mavrakanas, Thomas A., Yiannis S. Chatzizisis, Karim Gariani, Dean J. Kereiakes, Giuseppe Gargiulo, Gérard Helft, Martine Gilard, et al. "Duration of Dual Antiplatelet Therapy in Patients with CKD and Drug-Eluting Stents." Clinical Journal of the American Society of Nephrology 14, no. 6 (April 22, 2019): 810–22. http://dx.doi.org/10.2215/cjn.12901018.
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Background and objectivesWhether prolonged dual antiplatelet therapy (DAPT) is more protective in patients with CKD and drug-eluting stents compared with shorter DAPT is uncertain. The purpose of this meta-analysis was to examine whether shorter DAPT in patients with drug-eluting stents and CKD is associated with lower mortality or major adverse cardiovascular event rates compared with longer DAPT.Design, setting, participants, & measurementsA Medline literature research was conducted to identify randomized trials in patients with drug-eluting stents comparing different DAPT duration strategies. Inclusion of patients with CKD was also required. The primary outcome was a composite of all-cause mortality, myocardial infarction, stroke, or stent thrombosis (definite or probable). Major bleeding was the secondary outcome. The risk ratio (RR) was estimated using a random-effects model.ResultsFive randomized trials were included (1902 patients with CKD). Short DAPT (≤6 months) was associated with a similar incidence of the primary outcome, compared with 12-month DAPT among patients with CKD (48 versus 50 events; RR, 0.93; 95% confidence interval [95% CI], 0.64 to 1.36; P=0.72). Twelve-month DAPT was also associated with a similar incidence of the primary outcome compared with extended DAPT (≥30 months) in the CKD subgroup (35 versus 35 events; RR, 1.04; 95% CI, 0.67 to 1.62; P=0.87). Numerically lower major bleeding event rates were detected with shorter versus 12-month DAPT (9 versus 13 events; RR, 0.69; 95% CI, 0.30 to 1.60; P=0.39) and 12-month versus extended DAPT (9 versus 12 events; RR, 0.83; 95% CI, 0.35 to 1.93; P=0.66) in patients with CKD.ConclusionsShort DAPT does not appear to be inferior to longer DAPT in patients with CKD and drug-eluting stents. Because of imprecision in estimates (few events and wide confidence intervals), no definite conclusions can be drawn with respect to stent thrombosis.
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Hazem, Ahmad, Mohamed B. Elamin, German Malaga, Irina Bancos, Yolanda Prevost, Claudia Zeballos-Palacios, Edgar R. Velasquez, et al. "The accuracy of diagnostic tests for GH deficiency in adults: a systematic review and meta-analysis." European Journal of Endocrinology 165, no. 6 (December 2011): 841–49. http://dx.doi.org/10.1530/eje-11-0476.
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ContextThe diagnostic accuracy of tests used to diagnose GH deficiency (GHD) in adults is unclear.ObjectiveWe conducted a systematic review and meta-analysis of studies that provided data on the available diagnostic tests.Data sourcesWe searched electronic databases (MEDLINE, EMBASE, Cochrane CENTRAL, Web of Sciences, and Scopus) through April 2011.Study selectionReview of reference lists and contact with experts identified additional candidate studies. Reviewers, working independently and in duplicate, determined study eligibility.Data extractionReviewers, working independently and in duplicate, determined the methodological quality of studies and collected descriptive, quality, and outcome data.Data synthesisTwenty-three studies provided diagnostic accuracy data; none provided patient outcome data. Studies had fair methodological quality, used several reference standards, and included over 1100 patients. Several tests based on direct or indirect stimulation of GH release were associated with good diagnostic accuracy, although most were assessed in one or two studies decreasing the strength of inference due to small sample size. Serum levels of GH or IGF1 had low diagnostic accuracy. Pooled sensitivity and specificity of the two most commonly used stimulation tests were found to be 95 and 89% for the insulin tolerance test and 73 and 81% for the GHRH+arginine test respectively. Meta-analytic estimates for accuracy were associated with substantial heterogeneity.ConclusionSeveral tests with reasonable diagnostic accuracy are available for the diagnosis of GHD in adults. The supporting evidence, however, is at high risk of bias (due to heterogeneity, methodological limitations, and imprecision).
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Kisbu-Sakarya, Yasemin, Thomas D. Cook, Yang Tang, and M. H. Clark. "Comparative Regression Discontinuity: A Stress Test With Small Samples." Evaluation Review 42, no. 1 (February 2018): 111–43. http://dx.doi.org/10.1177/0193841x18776881.
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Compared to the randomized experiment (RE), the regression discontinuity design (RDD) has three main limitations: (1) In expectation, its results are unbiased only at the treatment cutoff and not for the entire study population; (2) it is less efficient than the RE and so requires more cases for the same statistical power; and (3) it requires correctly specifying the functional form that relates the assignment and outcome variables. One way to overcome these limitations might be to add a no-treatment functional form to the basic RDD and including it in the outcome analysis as a comparison function rather than as a covariate to increase power. Doing this creates a comparative regression discontinuity design (CRD). It has three untreated regression lines. Two are in the untreated segment of the RDD—the usual RDD one and the added untreated comparison function—while the third is in the treated RDD segment. Also observed is the treated regression line in the treated segment. Recent studies comparing RE, RDD, and CRD causal estimates have found that CRD reduces imprecision compared to RDD and also produces valid causal estimates at the treatment cutoff and also along all the rest of the assignment variable. The present study seeks to replicate these results, but with considerably smaller sample sizes. The power difference between RDD and CRD is replicated, but not the bias results either at the treatment cutoff or away from it. We conclude that CRD without large samples can be dangerous.
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Oketch, Godrick, and Filiz Karaman. "Maximum likelihood function for fuzzy count data models (using heaped data as fuzzy)." Journal of Intelligent & Fuzzy Systems 39, no. 5 (November 19, 2020): 6891–901. http://dx.doi.org/10.3233/jifs-192094.
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Count data models are based on definite counts of events as dependent variables. But there are practical situations in which these counts may fail to be specific and are seen as imprecise. In this paper, an assumption that heaped data points are fuzzy is used as a way of identifying counts that are not definite since heaping can result from imprecisely reported counts. Because it is practically unlikely to report all counts in an entire dataset as imprecise, this paper proposes a likelihood function that not only considers both precise and imprecisely reported counts but also incorporates α - cuts of fuzzy numbers with the aim of varying impreciseness of fuzzy reported counts. The proposed model is then illustrated through a smoking cessation study data that attempts to identify factors associated with the number of cigarettes smoked in a month. Through the real data illustration and a simulation study, it is shown that the proposed model performs better in predicting the outcome counts especially when the imprecision of the fuzzy points in a dataset are increased. The results also show that inclusion of α - cuts makes it possible to identify better models, a feature that was not previously possible.
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Duan, Sophia Xiaoxia, Santoso Wibowo, and Josephine Chong. "A Multicriteria Analysis Approach for Evaluating the Performance of Agriculture Decision Support Systems for Sustainable Agribusiness." Mathematics 9, no. 8 (April 16, 2021): 884. http://dx.doi.org/10.3390/math9080884.
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Agriculture decision support systems (DSSs) play an important role in facilitating evidence-based agricultural decision-making for improving agribusiness productivity. Evaluating and selecting the most appropriate agriculture DSS for sustainable agribusiness is, however, challenging due to the existence of production and marketing alternatives, a variety of objective functions from economic to lifestyle to long-term sustainability, and the subjectiveness and imprecision involved in the evaluation process. To help decision makers effectively deal with these issues, this paper presents a multicriteria analysis approach for evaluating and selecting the most appropriate agriculture DSS for sustainable agribusiness. The subjective assessments of decision makers in the evaluation process are formulated using linguistic variables approximated by fuzzy numbers. The concept based on the positive and the negative ideal solutions is applied for producing a performance index value for every agriculture DSS alternative across all evaluation criteria based on which the most appropriate agriculture DSS is. An empirical study is presented for demonstrating the step-wise process for evaluating and selecting the most appropriate agriculture DSS for sustainable agribusiness. The outcome from the performance evaluation process allows agribusinesses to effectively adopt appropriate agriculture DSSs for achieving competitive advantages.
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Biniaz, Susan. "Comma but Differentiated Responsibilities: Punctuation and 30 Other Ways Negotiators Have Resolved Issues in the International Climate Change Regime." Michigan Journal of Environmental & Administrative Law, no. 6.1 (2016): 37. http://dx.doi.org/10.36640/mjeal.6.1.comma.
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International climate change negotiations have a long history of being contentious, and much has been written about the grand trade-offs that have allowed countries to reach agreement. Issues have often involved, for example, the level of ambition, differentiated treatment of Parties, and various forms of financial assistance to developing countries. Lesser known are the smaller, largely language-based tools negotiators have used to resolve differences, sometimes finding a solution as subtle as a shift in the placement of a comma. These tools have operated in different ways. Some, such as deliberate imprecision or postponement, have “resolved” an issue by sidestepping it and allowing Parties to preserve their positions. Other tools have enabled resolution by “splitting the difference” between opposing views. Still others have involved optical fixes, flexibility, or non-prejudice that helped one or more Parties go along with a particular outcome. This compendium of textual examples, presented in rough chronological order, is drawn from my personal involvement in international climate negotiations and is by no means exhaustive. The examples may be of interest to those who follow climate change in particular, as well as of potential use to those who work in other international fields.
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Cadena, Paola Carolina Bueno, and José Manuel Vassallo Magro. "SETTING THE WEIGHTS OF SUSTAINABILITY CRITERIA FOR THE APPRAISAL OF TRANSPORT PROJECTS." TRANSPORT 30, no. 3 (October 2, 2015): 298–306. http://dx.doi.org/10.3846/16484142.2015.1086890.
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Although the Multi-Criteria Decision Analysis (MCDA) has made progress towards appraising and measuring the performance of smart and sustainable transport projects, it still has important issues that need to be addressed such as the problem associated with incomparable quantities, the inherent subjective qualitative assessment, the complexity of identifying impacts to be included and its measurement method, and the corresponding weights. The issue of trading-off different sustainability criteria is the main unresolved matter. This problem may lead to lack of accuracy in the decision making process. This paper presents a new methodology to set the weights of the sustainability criteria used in the MCDA in order to reduce subjectivity and imprecision. We suggest eliciting criteria weights based on both expert preferences and the importance that the sustainability criteria have in the geographical and social context where the project is developed. This novel methodology is applied to a real case study to quantify sustainable practices associated with the design and construction of a new roadway in Spain. The outcome demonstrates that the approach to the weighting problem has significance and general application in a multi-criteria evaluation process.
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Grant, Anthony M. "Rethinking Psychological Mindedness: Metacognition, Self-reflection, and Insight." Behaviour Change 18, no. 1 (April 1, 2001): 8–17. http://dx.doi.org/10.1375/bech.18.1.8.
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AbstractPsychological mindedness (PM) has long been considered to be an important mediator of therapy outcome. However, to date, definitions of PM have been typified by linguistic imprecision and lack of conceptual clarity. Further, most definitions and measures of PM have approached the task from a psychodynamic perspective, thus limiting the use of this construct by clinicians and researchers from other theoretical perspectives. In this paper, previous definitions and self-report measures are reviewed and a new definition proposed. It is argued that PM is best conceptualised as a form of metacognition: a predisposition to engage in metacognitive acts of inquiry into how and why people behave, think, and feel in the way that they do. A new model, based on this definition, suggests that PM may be assessed by measuring individuals' metacognitive processes of self-reflection and insight, circumventing many of the problems associated with previous self-report measures of PM. Research into individual differences in propensity for PM, self-reflection, and insight may well provide the clinician with additional tools with which to facilitate purposeful, directed change in both clinical and nonclinical populations.
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Kalatharan, Vinusha, Blayne Welk, Danielle M. Nash, Eric McArthur, Justin Slater, Sisira Sarma, York Pei, and Amit X. Garg. "Complications in Patients With Autosomal Dominant Polycystic Kidney Disease Undergoing Ureteroscopy: A Cohort Study." Canadian Journal of Kidney Health and Disease 7 (January 2020): 205435812097283. http://dx.doi.org/10.1177/2054358120972830.
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Background: Ureteroscopy is a minimally invasive treatment option for upper tract stones. The distorted kidney anatomy in patients with autosomal dominant polycystic kidney disease (ADPKD) may place them at higher risk for ureteroscopic complications. Objective: To compare the 30-day risk of ureteroscopic complications between patients with and without ADPKD. Design: Retrospective cohort study. Setting: Ontario, Canada Patients: Seventy three patients with ADPKD and 81 445 patients without ADPKD who underwent ureteroscopy for upper urinary tract stones between April 1, 2002, and March 1, 2018. Measurements: A 30-day risk of (1) hospital presentation with ureteroscopic complications (which was a composite outcome of either emergency department visit or hospital admission with acute kidney injury, urinary tract infection, or sepsis); (2) all-cause hospital presentation; (3) all-cause hospital admission; and (4) all-cause emergency department visit. Methods: We regressed outcomes on demographic variables, health care use in the prior 1-year, various procedures and comorbidities related to the outcome in the prior 5 years, and prescribed medications filled in the past 120 days using modified Poisson regression to compare the risk ratio (RR) of each outcome between patients with and without ADPKD. Results: The median (interquartile, IQR) age was 44 (38-60 years) in the ADPKD group and 53 (42-64) in the control group. About 40% were women in both groups. The risk of ureteroscopic complications was not significantly different in patients with versus without ADPKD (8.2% vs 4.3%; adjusted RR = 1.5, 95% confidence interval [CI] = 0.7-3.2). Patients with versus without ADPKD were more likely to present to hospital after their procedure (35.6% vs. 20.0%; adjusted RR = 1.6, 95% CI = 1.2-2.2), which included a statistically significant increase in the risk of presenting to the emergency department (32.9% vs. 19.0%; adjusted RR = 1.6, 95% CI = 1.1-2.2) but not hospital admissions (10.9% vs. 5.0%; adjusted RR = 1.8, 95% CI = 0.9-3.4). Limitations: The low numbers of events led to imprecision around the estimates. Conclusion: Patients with ADPKD have a higher risk of return to the hospital within 30 days of ureteroscopy for stone disease. Trial registration: We did not register this study.
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Venge, Per, Stefan James, Leif Jansson, and Bertil Lindahl. "Clinical Performance of Two Highly Sensitive Cardiac Troponin I Assays." Clinical Chemistry 55, no. 1 (January 1, 2009): 109–16. http://dx.doi.org/10.1373/clinchem.2008.106500.
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Abstract Background: The aim of this study was to compare the clinical performance of 2 sensitive cTnI assays with 10% CV imprecision below the 99th percentile upper reference limit. Methods: We measured cardiac troponin and N-terminal pro-brain natriuretic peptide (NT-proBNP) concentrations in a random sample of the Global Use of Strategies To Open Occluded Coronary Arteries (GUSTO) IV cohort (n = 1251). Outcome data of 1-year mortality and the composite endpoint DMI [death and/or myocardial infarction (MI) within 30 days] were available in all patients. The 99th percentile of a healthy population was estimated from the Sweden Women and Men and Ischemic Heart Disease (SWISCH) cohort (n = 442). We measured cardiac troponin I (cTnI) using the Access AccuTnI (Beckman Coulter) and Centaur TnI Ultra (Siemens Healthcare Diagnostics) and NT-proBNP using the Elecsys 2010 (Roche Diagnostics). Results: Applying the 10% CV cutoff, the sensitivity of the Access AccuTnI assay in identifying DMI and death was higher than that of the Centaur TnI Ultra (P = 0.02 and P < 0.001), and the AccuTnI assay also identified more patients at risk (P < 0.001) and with poor outcome. Applying the 99th percentile cutoffs, AccuTnI identified more patients at risk than the Centaur TnI (P < 0.001) and with significant differences in outcome. Significantly more patients with cardiac troponins below the cutoffs as measured by Centaur TnI had increased NT-proBNP concentrations (P < 0.001) compared with AccuTnI. Conclusions: The AccuTnI assay identified more patients at risk than the Centaur cTnI Ultra assay. Our results demonstrate the clinical potential of high-sensitivity cardiac troponin assays for the identification of patients at risk of dying from cardiovascular disease.
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Petráš, Marek, Ivana Králová Lesná, Jana Dáňová, and Alexander M. Čelko. "Can Vaccination Trigger Autoimmune Disorders? A Meta-Analysis." Vaccines 9, no. 8 (July 25, 2021): 821. http://dx.doi.org/10.3390/vaccines9080821.
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Vaccination as an important tool in the fight against infections has been suggested as a possible trigger of autoimmunity over the last decades. To confirm or refute this assumption, a Meta-analysis of Autoimmune Disorders Association With Immunization (MADAWI) was conducted. Included in the meta-analysis were a total of 144 studies published in 1968–2019 that were available in six databases and identified by an extensive literature search conducted on 30 November 2019. The risk of bias classification of the studies was performed using the Newcastle–Ottawa Quality Assessment Scale. The strength of evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation. While our primary analysis was conducted in terms of measures of association employed in studies with a low risk of bias, the robustness of the MADAWI outcome was tested using measures independent of each study risk of bias. Additionally, subgroup analyses were performed to determine the stability of the outcome. The pooled association of 0.99 (95% confidence interval, 0.97–1.02), based on a total of 364 published estimates, confirmed an equivalent occurrence of autoimmune disorders in vaccinated and unvaccinated persons. The same level of association reported by studies independently of the risk of bias was supported by a sufficient number of studies, and no serious limitation, inconsistency, indirectness, imprecision, and publication bias. A sensitivity analysis did not reveal any discrepancy in the primary result. Current common vaccination is not the cause of any of the examined autoimmune disorders in the medium and long terms.
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MacRae, Andrew R., H. Allen Gardner, Lynn C. Allen, Sonya Tokmakejian, and Nathalie Lepage. "Outcome Validation of the Beckman Coulter Access Analyzer in a Second-Trimester Down Syndrome Serum Screening Application." Clinical Chemistry 49, no. 1 (January 1, 2003): 69–76. http://dx.doi.org/10.1373/49.1.69.
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Abstract Background: Mid-trimester maternal serum α-fetoprotein (AFP) and unconjugated estriol (uE3) are 30% lower and human chorionic gonadotropin (hCG) is twofold higher in Down syndrome pregnancies compared with unaffected pregnancies. In maternal serum screening, patient-specific risks are calculated using published gaussian frequency distribution parameters for these three markers obtained with previously available immunoassays. New immunoassays must generate similar distribution parameters if the accuracy of assigned risks and overall performance of prenatal screening are to be maintained. Methods: Agreement between the Beckman Coulter Access and the Bayer Immuno 1 assays for AFP and hCG and the Amersham Amerlex-M RIA for uE3 was assessed in 558 fresh sera. Precision was measured over 6 weeks. Median concentrations were calculated by regression of 568 Caucasian singleton pregnancy samples against gestational age in days. Frozen mid-trimester sera from 44 confirmed Down syndrome singleton pregnancies (cases) were selected without conscious bias for reanalysis, and each case was matched with five control specimens from unaffected pregnancies. Serum markers were expressed as the multiple of the median (MoM) concentration derived from the control samples, cor-rected for maternal weight and converted to their log-equivalent values. Normality was assessed using probability plots and the Shapiro–Wilk W-test. Gaussian distribution parameters were compared with established values, and Down syndrome risk calculations were assessed with a commonly used risk algorithm. Results: The Access AFP and hCG assays had consistent proportional agreement with the established assays, whereas agreement between the uE3 methods was less consistent. Analytical imprecision was 3–6% at mid-trimester concentrations. Normal distributions were obtained for the log MoM values of all three markers in both the Down syndrome and unaffected populations, and their gaussian distribution parameters compared well with established values. The performance of the Access assays in an established trivariate risk algorithm for Down syndrome was equal to the performance exhibited by traditional methods. Conclusion: The Beckman Coulter Access analyzer provides valid mid-trimester serum AFP, uE3, and hCG results and risk assessments when applied in a prenatal Down syndrome screening service.
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Jenny, R. W., and K. Y. Jackson. "Proficiency test performance as a predictor of accuracy of routine patient testing for theophylline." Clinical Chemistry 39, no. 1 (January 1, 1993): 76–81. http://dx.doi.org/10.1093/clinchem/39.1.76.
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Abstract Proficiency testing (PT) is pivotal in assessing laboratory qualifications for certification and licensure. PT is expected to typify routine assay performance and determine whether the laboratory is producing clinically useful test results. Conventional schemes use mail-distributed test specimens and are often criticized as measuring the best possible laboratory performance, principally because of special practices associated with processing PT specimens. We used on-site proficiency tests and split samples to evaluate the ability of conventional PT schemes to accurately characterize routine laboratory performance. Using 412 assays of theophylline, performed routinely by 200 laboratories and subsequently in a reference laboratory, we found that the predictive value of PT performance in assessing quality of routine testing was high (100% for predicting substandard reliability of routine patient testing and 94% for excluding substandard reliability of patient testing). The imprecision of interlaboratory PT results was equivalent whether testing was observed (hand-carried specimens) or unobserved (mail-distributed specimens). Many methods used for determining theophylline concentration in serum were highly automated, closed, and precise analytical systems. The performance characteristics of these analytical systems are not easily manipulated by the analyst for purposes of improving PT outcome, and PT by use of mail-distributed test specimens is effective for assessing intralaboratory performance.
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Cabral, Silvia, Rita Fernandes, William Scott Selbie, Vera Moniz-Pereira, and António P. Veloso. "Reliability of a Global Gait Symmetry Index Based on Linear Joint Displacements." Applied Sciences 12, no. 24 (December 8, 2022): 12558. http://dx.doi.org/10.3390/app122412558.
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Gait symmetry is commonly used as an informal measure to assess functional gait recovery. As other outcome measures used for the evaluation of clinical change over time, gait symmetry indices must be reliable. However, studies assessing the reliability of symmetry indices are scarce and focused on discrete and local indices (i.e., peak joint angle, step length), which fail to assess overall gait symmetry. On the other hand, the repeatability of global symmetry indices (using multiple continuous waveforms) based on joint angles may be hampered by the sensitivity of these variables to marker placement imprecision. The aim of this study is to evaluate the test–retest intra-rater reliability and measurement error of an alternative global symmetry index. Two 3D gait analyses were performed on separate days (a week interval) on twenty-three healthy adults. Reliability and measurement error were assessed by calculating the intraclass correlation coefficient and the 95% limits of agreement, standard error of measurement and smallest detectable change, respectively. The new symmetry index presented acceptable results in terms of reliability (ICC = 0.71, 95% CI 0.33–0.88) and measurement error (95% LOA between −30.2% and 29.1%, SEM = 10.7% and SDC = 29.7%), thus being a more promising tool to assess overall gait symmetry.
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Cooper, George M., Matthew J. Kennedy, Bilal Jamal, and David W. Shields. "Autologous versus synthetic bone grafts for the surgical management of tibial plateau fractures: a systematic review and meta-analysis of randomized controlled trials." Bone & Joint Open 3, no. 3 (March 1, 2022): 218–28. http://dx.doi.org/10.1302/2633-1462.33.bjo-2021-0195.r1.
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Aims Our objective was to conduct a systematic review and meta-analysis, to establish whether differences arise in clinical outcomes between autologous and synthetic bone grafts in the operative management of tibial plateau fractures. Methods A structured search of MEDLINE, EMBASE, the online archives of Bone & Joint Publishing, and CENTRAL databases from inception until 28 July 2021 was performed. Randomized, controlled, clinical trials that compared autologous and synthetic bone grafts in tibial plateau fractures were included. Preclinical studies, clinical studies in paediatric patients, pathological fractures, fracture nonunion, or chondral defects were excluded. Outcome data were assessed using the Risk of Bias 2 (ROB2) framework and synthesized in random-effect meta-analysis. The Preferred Reported Items for Systematic Review and Meta-Analyses guidance was followed throughout. Results Six studies involving 353 fractures were identified from 3,078 records. Following ROB2 assessment, five studies (representing 338 fractures) were appropriate for meta-analysis. Primary outcomes showed non-significant reductions in articular depression at immediate postoperative (mean difference -0.45 mm, p = 0.25, 95%confidence interval (CI) -1.21 to 0.31, I2 = 0%) and long-term (> six months, standard mean difference -0.56, p = 0.09, 95% CI -1.20 to 0.08, I2 = 73%) follow-up in synthetic bone grafts. Secondary outcomes included mechanical alignment, limb functionality, and defect site pain at long-term follow-up, perioperative blood loss, duration of surgery, occurrence of surgical site infections, and secondary surgery. Mean blood loss was lower (90.08 ml, p < 0.001, 95% CI 41.49 to 138.67) and surgery was shorter (16.17 minutes, p = 0.04, 95% CI 0.39 to 31.94) in synthetic treatment groups. All other secondary measures were statistically comparable. Conclusion All studies reported similar methodologies and patient populations; however, imprecision may have arisen through performance variation. These findings supersede previous literature and indicate that, despite perceived biological advantages, autologous bone grafting does not demonstrate superiority to synthetic grafts. When selecting a void filler, surgeons should consider patient comorbidity, environmental and societal factors in provision, and perioperative and postoperative care provision. Cite this article: Bone Jt Open 2022;3(3):218–228.
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Contreras-Aguilar, María Dolores, Camila Peres Rubio, Luis Guillermo González-Arostegui, María Martín-Cuervo, Jose J. Cerón, Ignacio Ayala, Ida-Marie Holm Henriksen, Stine Jacobsen, and Sanni Hansen. "Changes in Oxidative Status Biomarkers in Saliva and Serum in the Equine Gastric Ulcer Syndrome and Colic of Intestinal Aetiology: A Pilot Study." Animals 12, no. 5 (March 7, 2022): 667. http://dx.doi.org/10.3390/ani12050667.
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Changes in the oxidative status of the blood of horses suffering from gastric ulcers and colic of intestinal aetiology (CIE) have been reported. However, saliva can also be a source of biomarkers of oxidative status. Therefore, this study aims to validate automated assays for the measurement of oxidative status biomarkers (ferric reducing ability of saliva/serum—FRAS/FRAP, cupric reducing antioxidant capacity—CUPRAC, the Trolox equivalent antioxidant capacity—TEAC, uric acid, and advanced oxidation protein products—AOPP) in the saliva and serum of horses, to assess their changes in the different ulcer gastric diseases (squamous—ESGD and glandular—EGGD) and CIE, and to evaluate their relationship with serum amyloid A (SAA), adenosine deaminase (ADA), and the systemic inflammatory response syndrome (SIRS) status. The assays showed a low imprecision and good linearity with enough sensitivity in both fluids. In EGGD, higher levels of FRAS, uric acid, and AOPP in saliva were observed compared to the healthy group, correlating with the salivary ADA levels. Horses with CIE showed increases in uric acid concentrations in serum associated with their SIRS status and outcome of the disease. In conclusion, analytes related to the oxidative status can be measured in the saliva and serum from horses by automated assays, and some of them can potentially be assessed as biomarkers in horses with gastric ulcers and CIE.
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Oosterhuis, Teddy, Veerle R. Smaardijk, P. Paul FM Kuijer, Miranda W. Langendam, Monique H. W. Frings-Dresen, and Jan L. Hoving. "Systematic review of prognostic factors for work participation in patients with sciatica." Occupational and Environmental Medicine 76, no. 10 (July 11, 2019): 772–79. http://dx.doi.org/10.1136/oemed-2019-105797.
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Sciatica impacts on the ability to work and may lead to a reduced return to work. This study reviewed and summarised prognostic factors of work participation in patients who received conservative or surgical treatment for clinically diagnosed sciatica. We searched MEDLINE, CINAHL, EMBASE and PsycINFO until January 2018. Cohort studies, using a measure of work participation as outcome, were included. Two independent reviewers performed study inclusion and used the Quality In Prognosis Studies tool for risk of bias assessment and GRADE to rate the quality of the evidence. Based on seven studies describing six cohorts (n=1408 patients) that assessed 21 potential prognostic factors, favourable factors for return to work (follow-up ranging from 3 months to 10 years) included younger age, better general health, less low back pain or sciatica bothersomeness, better physical function, negative straight leg raise-test, physician expecting surgery to be beneficial, better pain coping, less depression and mental stress, less fear of movement and low physical work load. Study results could not be pooled. Using GRADE, the quality of the evidence ranged from moderate to very low, with downgrading mainly for a high risk of bias and imprecision. Several prognostic factors like pain, disability and psychological factors were identified and reviewed, and these could be targeted using additional interventions to optimise return to work. PROSPERO registration number: CRD42016042497.
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Jørgensen, Mie Sedoc, Ole Jakob Storebø, Jutta M. Stoffers-Winterling, Erlend Faltinsen, Adnan Todorovac, and Erik Simonsen. "Psychological therapies for adolescents with borderline personality disorder (BPD) or BPD features—A systematic review of randomized clinical trials with meta-analysis and Trial Sequential Analysis." PLOS ONE 16, no. 1 (January 14, 2021): e0245331. http://dx.doi.org/10.1371/journal.pone.0245331.
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Objectives To review the effectiveness of psychological therapies for adolescents with borderline personality disorder (BPD) or BPD features. Methods We included randomized clinical trials on psychological therapies for adolescents with BPD and BPD features. Data were extracted and assessed for quality according to Cochrane guidelines, and summarized as mean difference (MD) with 95% confidence intervals (CI) for continuous data and as Odds ratios (OR) with 95% CI for dichotomous data. Risk of bias was assessed using Cochrane’s risk of bias tool for each domain. When possible, we pooled trials into meta-analyses, and used Trial Sequential Analysis (TSA) to control for random errors. Quality of the evidence was assessed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE). Results 10 trials on adolescents with BPD or BPD features were included. All trials were considered at high risk of bias, and the quality of the evidence was rated as “very low”. We did TSA on the primary outcome and found that the required information size was reached. The risk of random error was thus discarded. Conclusion Only 10 trials have been conducted on adolescents with BPD or BPD features. Of these only few showed superior outcomes of the experimental intervention compared to the control intervention. No adverse effects of the interventions were mentioned. Attrition rates varied from 15–75% in experimental interventions. The overall quality was very low due to high risk of bias, imprecision and inconsistency, which limits the confidence in effect estimates. Due to the high risk of bias, high attrition rates and underpowered studies in this area, it is difficult to derive any conclusions on the efficacy of psychological therapies for BPD in adolescence. There is a need for more high quality trials with larger samples to identify effective psychological therapies for this specific age group with BPD or BPD features.
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Ntaios, George, Konstantinos Vemmos, and Gregory YH Lip. "Oral anticoagulation versus antiplatelet or placebo for stroke prevention in patients with heart failure and sinus rhythm: Systematic review and meta-analysis of randomized controlled trials." International Journal of Stroke 14, no. 9 (September 16, 2019): 856–61. http://dx.doi.org/10.1177/1747493019877296.
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Background Previous meta-analyses of randomized controlled trials of oral anticoagulation in patients with heart failure and sinus rhythm reported reduced stroke risk and increased bleeding risk compared to antiplatelets or placebo. However, the effect estimates may be subject to imprecision, as all included trials were prematurely terminated; stroke was not the primary outcome and overall results were primarily driven by a single trial. Recently, new trial data became available. Aim To provide more accurate estimates of the effect of oral anticoagulation on stroke risk in heart failure patients with sinus rhythm by systematic review and meta-analysis of available randomized controlled trials including recently published evidence. Methods We searched PubMed and Scopus for full-text articles of randomized controlled trials of oral anticoagulation versus antiplatelet or placebo in heart failure patients with sinus rhythm published between inception and 28 August 2018. The outcomes assessed were any stroke, major bleeding, and death. Results In five trials (9490 patients; 21,067 patient-years), oral anticoagulation-treated patients had lower stroke risk (odds ratio (OR) 0.60, 95%CI: 0.46–0.78, absolute-risk-reduction: 1.3%, number-needed-to-treat: 77), higher major bleeding risk (OR: 1.92, 95%CI: 1.51–2.45, absolute-risk-increase: 2.0%, number-needed-to-harm: 50), and no significant difference in death rates (OR: 0.90, 95%CI: 0.73–1.11) compared to antiplatelets or placebo. Conclusions In the largest meta-analysis to date, oral anticoagulation is associated with a considerable reduction of stroke risk, which is offset by a significant increase in major bleeding risk. For every 1000 patients treated with oral anticoagulation rather than antiplatelet or no antithrombotic treatment for 2.21 years, 13 strokes are prevented but 20 additional major hemorrhages occur, without significant difference in death rates.