Buehler Anna Maria, Ascef Bruna de Oliveira, Oliveira Júnior Haliton Alves de, Ferri Cleusa Pinheiro, Fernandes Jefferson Gomes
Health Technology Assessment Unit, Hospital Alemão Oswaldo Cruz - São Paulo - SP - Brasil.
Rev Assoc Med Bras (1992). 2019 Mar;65(3):452-459. doi: 10.1590/1806-9282.65.3.452. Epub 2019 Apr 11.
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.
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.
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.
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.
协助临床医生对评估诊断试验的研究中的科学证据作出充分解读，以便在临床实践中合理使用这些证据。
这是一篇叙述性综述，重点关注主要概念、研究设计、诊断准确性数据的充分解读，以及推断诊断试验在临床实践中的影响。
大多数评估诊断试验性能的文献采用横断面设计。比较诊断策略的随机临床试验很少。横断面研究测量的诊断准确性结果被认为是间接的，不足以确定对患者的实际益处。在准确性结果中，阳性似然比和阴性似然比在临床管理中最有用。讨论了研究横断面设计中的变异（可能给结果增加偏倚）以及其他导致研究结果可靠性降低的因素，还讨论了如何将此类准确性结果外推至对患者而言重要的影响和后果。决策时最好考虑成本、获得结果的时间、患者的偏好和价值观等方面。
了解诊断准确性研究的方法对于合理使用诊断试验至关重要，但并不充分。需要权衡试验结果对患者的有利和不利后果，以便在临床实践中就推荐哪些试验形成合理的决策方法。
