Academic literature on the topic 'Outcome imprecision'

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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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Books on the topic "Outcome imprecision"

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Manski, Charles F. Patient Care under Uncertainty. Princeton University Press, 2019. http://dx.doi.org/10.23943/princeton/9780691194738.001.0001.

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Although uncertainty is a common element of patient care, it has largely been overlooked in research on evidence-based medicine. This book strives to correct this glaring omission. Applying the tools of economics to medical decision making, the book shows how uncertainty influences every stage, from risk analysis to treatment, and how this can be reasonably confronted. In the language of econometrics, uncertainty refers to the inadequacy of available evidence and knowledge to yield accurate information on outcomes. In the context of health care, a common example is a choice between periodic surveillance or aggressive treatment of patients at risk for a potential disease, such as women prone to breast cancer. While these choices make use of data analysis, the book demonstrates how statistical imprecision and identification problems often undermine clinical research and practice. Reviewing prevailing practices in contemporary medicine, the book discusses the controversy regarding whether clinicians should adhere to evidence-based guidelines or exercise their own judgment. It also critiques the wishful extrapolation of research findings from randomized trials to clinical practice. Exploring ways to make more sensible judgments with available data, to credibly use evidence, and to better train clinicians, the book helps practitioners and patients face uncertainties honestly. It concludes by examining patient care from a public health perspective and the management of uncertainty in drug approvals. The book explains why predictability in the field has been limited and furnishes criteria for more cogent steps forward.
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Book chapters on the topic "Outcome imprecision"

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Mankad, Kunjal, and Priti Srinivas Sajja. "Measuring Human Intelligence by Applying Soft Computing Techniques." In Diagnostic Test Approaches to Machine Learning and Commonsense Reasoning Systems, 130–55. IGI Global, 2013. http://dx.doi.org/10.4018/978-1-4666-1900-5.ch006.

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The chapter focuses on Genetic-Fuzzy Rule Based Systems of soft computing in order to deal with uncertainty and imprecision with evolving nature for different domains. It has been observed that major professional domains such as education and technology, human resources, psychology, etc, still lack intelligent decision support system with self evolving nature. The chapter proposes a novel framework implementing Theory of Multiple Intelligence of education to identify students’ technical and managerial skills. Detail methodology of proposed system architecture which includes the design of rule bases for technical and managerial skills, encoding strategy, fitness function, cross-over and mutation operations for evolving populations is presented in this chapter. The outcome and the supporting experimental results are also presented to justify the significance of the proposed framework. It concludes by discussing advantages and future scope in different domains.
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Mankad, Kunjal, and Priti Srinivas Sajja. "Measuring Human Intelligence by Applying Soft Computing Techniques." In Data Mining, 299–324. IGI Global, 2013. http://dx.doi.org/10.4018/978-1-4666-2455-9.ch015.

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The chapter focuses on Genetic-Fuzzy Rule Based Systems of soft computing in order to deal with uncertainty and imprecision with evolving nature for different domains. It has been observed that major professional domains such as education and technology, human resources, psychology, etc, still lack intelligent decision support system with self evolving nature. The chapter proposes a novel framework implementing Theory of Multiple Intelligence of education to identify students’ technical and managerial skills. Detail methodology of proposed system architecture which includes the design of rule bases for technical and managerial skills, encoding strategy, fitness function, cross-over and mutation operations for evolving populations is presented in this chapter. The outcome and the supporting experimental results are also presented to justify the significance of the proposed framework. It concludes by discussing advantages and future scope in different domains.
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Pittock, Jamie, C. Max Finlayson, and Simon Linke. "Freshwater Ecosystem Security and Climate Change." In Freshwater Ecology and Conservation, 359–77. Oxford University Press, 2018. http://dx.doi.org/10.1093/oso/9780198766384.003.0017.

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In this chapter we review techniques that managers may use to respond to climate change. First, modelling the impacts of climate change on freshwater ecosystems is discussed. While hydro-climatic projections can be used their imprecision requires the selection of robust adaptation options that provide benefits under a range of possible climate outcomes. Second, contested concepts for managing freshwater ecosystems and resources are summarised, and we conclude that they may be used to develop and implement cross-sectoral policies that sustain freshwater ecosystems. Third, options for climate change adaptation for freshwater ecosystems recommends application of six principles, emphasising: accommodation of change; application of ecological and socio-economic targets across multiple scales; maintaining connectivity, conservation of refugia, and representative habitats; initial implementation of no- and low-regret adaptation interventions; agreeing on thresholds for ecological change that trigger new management interventions; and scientific monitoring and evaluation. We conclude by considering how to manage the negative impacts and seize positive synergies in climate change responses: conservation advocates must engage with agriculture, energy, and water resources sectors if freshwater ecosystems are to be incorporated in their decisions.
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Reports on the topic "Outcome imprecision"

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Chou, Roger, Rongwei Fu, Tracy Dana, Miranda Pappas, Erica Hart, and Kimberly M. Mauer. Interventional Treatments for Acute and Chronic Pain: Systematic Review. Agency for Healthcare Research and Quality (AHRQ), September 2021. http://dx.doi.org/10.23970/ahrqepccer247.

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Objective. To evaluate the benefits and harms of selected interventional procedures for acute and chronic pain that are not currently covered by the Centers for Medicare & Medicaid Services (CMS) but are relevant for and have potential utility for use in the Medicare population, or that are covered by CMS but for which there is important uncertainty or controversy regarding use. Data sources. Electronic databases (Ovid® MEDLINE®, PsycINFO®, the Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews) to April 12, 2021, reference lists, and submissions in response to a Federal Register notice. Review methods. Using predefined criteria and dual review, we selected randomized controlled trials (RCTs) for 10 interventional procedures and conditions that evaluated pain, function, health status, quality of life, medication use, and harms. Random effects meta-analysis was conducted for vertebral compression fracture; otherwise, outcomes were synthesized qualitatively. Effects were classified as small, moderate, or large using previously defined criteria. Results. Thirty-seven randomized trials (in 48 publications) were included. Vertebroplasty (13 trials) is probably more effective at reducing pain and improving function in older (>65 years of age) patients, but benefits are small (less than 1 point on a 10-point pain scale). Benefits appear smaller (but still present) in sham-controlled (5 trials) compared with usual care controlled trials (8 trials) and larger in trials of patients with more acute symptoms; however, testing for subgroup effects was limited by imprecision. Vertebroplasty is probably not associated with increased risk of incident vertebral fracture (10 trials). Kyphoplasty (2 trials) is probably more effective than usual care for pain and function in older patients with vertebral compression fracture at up to 1 month (moderate to large benefits) and may be more effective at >1 month to ≥1 year (small to moderate benefits) but has not been compared against sham therapy. Evidence on kyphoplasty and risk of incident fracture was conflicting. In younger (below age for Medicare eligibility) populations, cooled radiofrequency denervation for sacroiliac pain (2 trials) is probably more effective for pain and function versus sham at 1 and 3 months (moderate to large benefits). Cooled radiofrequency for presumed facet joint pain may be similarly effective versus conventional radiofrequency, and piriformis injection with corticosteroid for piriformis syndrome may be more effective than sham injection for pain. For the other interventional procedures and conditions addressed, evidence was too limited to determine benefits and harms. Conclusions. Vertebroplasty is probably effective at reducing pain and improving function in older patients with vertebral compression fractures; benefits are small but similar to other therapies recommended for pain. Evidence was too limited to separate effects of control type and symptom acuity on effectiveness of vertebroplasty. Kyphoplasty has not been compared against sham but is probably more effective than usual care for vertebral compression fractures in older patients. In younger populations, cooled radiofrequency denervation is probably more effective than sham for sacroiliac pain. Research is needed to determine the benefits and harms of the other interventional procedures and conditions addressed in this review.
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