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      Rational use of diagnostic tests for clinical decision making

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          Abstract

          SUMMARY OBJECTIVE: To assist clinicians to make adequate interpretation of scientific evidence from studies that evaluate diagnostic tests in order to allow their rational use in clinical practice. METHODS: This is a narrative review focused on the main concepts, study designs, the adequate interpretation of the diagnostic accuracy data, and making inferences about the impact of diagnostic testing in clinical practice. RESULTS: Most of the literature that evaluates the performance of diagnostic tests uses cross-sectional design. Randomized clinical trials, in which diagnostic strategies are compared, are scarce. Cross-sectional studies measure diagnostic accuracy outcomes that are considered indirect and insufficient to define the real benefit for patients. Among the accuracy outcomes, the positive and negative likelihood ratios are the most useful for clinical management. Variations in the study's cross-sectional design, which may add bias to the results, as well as other domains that contribute to decreasing the reliability of the findings, are discussed, as well as how to extrapolate such accuracy findings on impact and consequences considered important for the patient. Aspects of costs, time to obtain results, patients’ preferences and values should preferably be considered in decision making. CONCLUSION: Knowing the methodology of diagnostic accuracy studies is fundamental, but not sufficient, for the rational use of diagnostic tests. There is a need to balance the desirable and undesirable consequences of tests results for the patients in order to favor a rational decision-making approach about which tests should be recommended in clinical practice.

          Translated abstract

          RESUMO OBJETIVO: Auxiliar os clínicos na interpretação adequada das evidências científicas de estudos que avaliam testes diagnósticos, de modo a permitir seu uso racional na prática clínica. MÉTODOS: Revisão narrativa da literatura dos principais conceitos, desenhos de estudo, interpretação adequada dos dados de acurácia diagnóstica e realização de inferências sobre o impacto do teste diagnóstico na prática clínica. RESULTADOS: A maioria da literatura que avalia o desempenho de testes diagnósticos utiliza como delineamento os estudos transversais. Ensaios clínicos randomizados, avaliando desfechos clínicos, que seriam considerados ideais, são escassos. Os estudos transversais mensuram desfechos de acurácia diagnóstica que são considerados indiretos e insuficientes para definir o real benefício para os pacientes. Dentre os desfechos, as razões de verossimilhança positiva e negativa são as mais úteis para a decisão da conduta clínica. Variações no delineamento transversal do estudo, que podem acrescentar vieses aos resultados, bem como outros domínios que contribuem para diminuir a confiabilidade dos achados, são discutidos, além de como extrapolar tais achados de acurácia em impacto e consequências consideradas importantes para o paciente. Aspectos sobre custos, tempo para a obtenção do resultado, preferências e valores dos pacientes devem, preferencialmente, participar da tomada de decisão. CONCLUSÃO: Conhecer a metodologia dos estudos de acurácia diagnóstica é fundamental, porém não suficiente, para o uso racional de testes diagnósticos. Há a necessidade de se ponderarem as consequências desejáveis e indesejáveis dos resultados dos testes para os pacientes, de modo a favorecer a tomada de decisão racional acerca de qual teste recomendar na prática clínica.

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          Most cited references14

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          Case-control and two-gate designs in diagnostic accuracy studies.

          In some diagnostic accuracy studies, the test results of a series of patients with an established diagnosis are compared with those of a control group. Such case-control designs are intuitively appealing, but they have also been criticized for leading to inflated estimates of accuracy. We discuss similarities and differences between diagnostic and etiologic case-control studies, as well as the mechanisms that can lead to variation in estimates of diagnostic accuracy in studies with separate sampling schemes ("gates") for diseased (cases) and nondiseased individuals (controls). Diagnostic accuracy studies are cross-sectional and descriptive in nature. Etiologic case-control studies aim to quantify the effect of potential causal exposures on disease occurrence, which inherently involves a time window between exposure and disease occurrence. Researchers and readers should be aware of spectrum effects in diagnostic case-control studies as a result of the restricted sampling of cases and/or controls, which can lead to changes in estimates of diagnostic accuracy. These spectrum effects may be advantageous in the early investigation of a new diagnostic test, but for an overall evaluation of the clinical performance of a test, case-control studies should closely mimic cross-sectional diagnostic studies. As the accuracy of a test is likely to vary across subgroups of patients, researchers and clinicians might carefully consider the potential for spectrum effects in all designs and analyses, particularly in diagnostic accuracy studies with differential sampling schemes for diseased (cases) and nondiseased individuals (controls).
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            The diagnostic accuracy of the natriuretic peptides in heart failure: systematic review and diagnostic meta-analysis in the acute care setting

            Objectives To determine and compare the diagnostic accuracy of serum natriuretic peptide levels (B type natriuretic peptide, N terminal probrain natriuretic peptide (NTproBNP), and mid-regional proatrial natriuretic peptide (MRproANP)) in people presenting with acute heart failure to acute care settings using thresholds recommended in the 2012 European Society of Cardiology guidelines for heart failure. Design Systematic review and diagnostic meta-analysis. Data sources Medline, Embase, Cochrane central register of controlled trials, Cochrane database of systematic reviews, database of abstracts of reviews of effects, NHS economic evaluation database, and Health Technology Assessment up to 28 January 2014, using combinations of subject headings and terms relating to heart failure and natriuretic peptides. Eligibility criteria for selecting studies Eligible studies evaluated one or more natriuretic peptides (B type natriuretic peptide, NTproBNP, or MRproANP) in the diagnosis of acute heart failure against an acceptable reference standard in consecutive or randomly selected adults in an acute care setting. Studies were excluded if they did not present sufficient data to extract or calculate true positives, false positives, false negatives, and true negatives, or report age independent natriuretic peptide thresholds. Studies not available in English were also excluded. Results 37 unique study cohorts described in 42 study reports were included, with a total of 48 test evaluations reporting 15 263 test results. At the lower recommended thresholds of 100 ng/L for B type natriuretic peptide and 300 ng/L for NTproBNP, the natriuretic peptides have sensitivities of 0.95 (95% confidence interval 0.93 to 0.96) and 0.99 (0.97 to 1.00) and negative predictive values of 0.94 (0.90 to 0.96) and 0.98 (0.89 to 1.0), respectively, for a diagnosis of acute heart failure. At the lower recommended threshold of 120 pmol/L, MRproANP has a sensitivity ranging from 0.95 (range 0.90-0.98) to 0.97 (0.95-0.98) and a negative predictive value ranging from 0.90 (0.80-0.96) to 0.97 (0.96-0.98). At higher thresholds the sensitivity declined progressively and specificity remained variable across the range of values. There was no statistically significant difference in diagnostic accuracy between plasma B type natriuretic peptide and NTproBNP. Conclusions At the rule-out thresholds recommended in the 2012 European Society of Cardiology guidelines for heart failure, plasma B type natriuretic peptide, NTproBNP, and MRproANP have excellent ability to exclude acute heart failure. Specificity is variable, and so imaging to confirm a diagnosis of heart failure is required. There is no statistical difference between the diagnostic accuracy of plasma B type natriuretic peptide and NTproBNP. Introduction of natriuretic peptide measurement in the investigation of patients with suspected acute heart failure has the potential to allow rapid and accurate exclusion of the diagnosis.
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              Assessing the value of diagnostic tests: a framework for designing and evaluating trials

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                Author and article information

                Contributors
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Journal
                ramb
                Revista da Associação Médica Brasileira
                Rev. Assoc. Med. Bras.
                Associação Médica Brasileira (São Paulo, SP, Brazil )
                0104-4230
                1806-9282
                April 2019
                : 65
                : 3
                : 452-459
                Affiliations
                [1] São Paulo São Paulo orgnameHospital Alemão Oswaldo Cruz orgdiv1Health Technology Assessment Unit Brazil
                Article
                S0104-42302019000300452
                10.1590/1806-9282.65.3.452
                cf53b804-2dd4-42d0-b614-befbbf9be006

                This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

                History
                : 15 May 2018
                : 26 May 2018
                Page count
                Figures: 0, Tables: 0, Equations: 0, References: 22, Pages: 8
                Product

                SciELO Brazil

                Categories
                Review Articles

                Clinical Decision-Making,Diagnostic Tests, Routine,Evidence-Based Practice,Sensitivity and specificity,Predictive value of tests,Diagnostic equipment,Tomada de decisão clínica,Testes diagnósticos de rotina,Prática clínica baseada em evidências,Sensibilidade e especificidade,Valor preditivo dos testes,Equipamentos para diagnóstico

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