PulmCrit - Top ten problems with the new sepsis definitionby Josh Farkas翻译：北京协和医院 江伟Problem #6: qSOFA is inconsistent with a validated prognostic model (CURB65)问题#6：qSOFA与经过验证的预后模型(CURB65)并不一致Pneumonia is the most common source of septic shock. This naturally leads to a comparison of qSOFA with the CURB65 prognostic score for pneumonia. 肺炎是感染性休克最常见的病因。很自然人们会将qSOFA与肺炎的CURB65预后评分进行比较。 Comparison suggests that qSOFA over-estimates the mortality of a pneumonia patients. For example, consider a 50-year-old patient with pneumonia, respiratory rate of 24 breaths/minute, blood pressure of 95/65, BUN of 15 mg/dL, and normal mental status. According to qSOFA, this patient has sepsis and perhaps should be transferred to the ICU. However, according to the CURB65 score, this patient has a 0.6% mortality and could be sent home with oral antibiotics. 比较提示，qSOFA会高估肺炎患者的病死率。例如，一名50岁肺炎患者呼吸频率24次/分，血压95/65，BUN 15 mg/dL，意识状态正常。根据qSOFA，该患者存在全身性感染，可能需要转入ICU。而根据CURB65评分，该患者病死率为0.6%，可以回家口服抗生素治疗。
This is an example of how qSOFA may be less specific in patients with primary pulmonary disease (as discussed above). A respiratory rate >22 is not particularly unusual or alarming in a patient with pneumonia (4). Thus, many pneumonia patients will start out with one qSOFA criteria, only requiring one additional criteria to become qSOFA-positive. 这个例子说明为何qSOFA在原发肺部疾病患者中特异性偏低（如上所述）。肺炎患者呼吸频率> 22并不少见，且没有警示价值(4)。因此，许多肺炎患者据此就满足一项qSOFA标准，仅需要额外一项标准就成为qSOFA阳性。
Problem #7: Combining qSOFA and SOFA scores is not evidence-based among patients outside the ICU问题#7：对于非ICU患者联合qSOFA和SOFA评分没有证据支持A common approach to diagnosis is shown here. When a condition is suspected (e.g. pulmonary embolism), first a screening test is utilized. An ideal screening test has a high sensitivity, but is fast and easy to perform (e.g. D-dimer). Patients who have a positive screening test will need to proceed onward to a definitive test, which is often more expensive or difficult to perform, but has both high sensitivity and specificity (e.g. CT angiogram). 常见的诊断过程如上所述。怀疑某种疾病（如肺栓塞）时，首先采用筛查试验。理想的筛查试验应当具有较高的敏感性，而且快速简便（如D二聚体）。筛查试验阳性的患者需要进一步接受确证实验，通常更加昂贵或难以实施，但具有很高的敏感性和特异性（如CT血管造影）。 The sepsis diagnostic algorithm seems to be designed with qSOFA as a screening test and SOFA as a definitive test. On face value this makes sense, because qSOFA is a simple and fast, whereas the full SOFA test is labor intensive. 全身性感染诊断流程中似乎将qSOFA作为筛查试验，而将SOFA作为确证试验。从表面看貌似是有道理的，因为qSOFA简便快速，而完整的SOFA则需要耗费大量人力。 However, the specificity of SOFA is actually lower than the specificity of qSOFA, making this test sequence illogical. Thus, SOFA adds little to qSOFA among patients outside the ICU (5). 但是，SOFA的特异性实际上低于qSOFA，使得这一检查顺序并不符合逻辑。因此，对于非ICU患者，与qSOFA相比，SOFA并无额外意义(5)。
Problem #8: The combined performance of {qSOFA + SOFA} for mortality is not reported问题#8：未报告qSOFA和SOFA联合应用对病死率的价值Although evidence is provided regarding the performance of qSOFA and SOFA, there is no evidence provided about the performance of the combination of {qSOFA+SOFA}. Since qSOFA and SOFA scores are not statistically independent, it is difficult to predict how they will function in combination. To explore this, lets imagine two extreme possibilities: qSOFA and SOFA either being maximally concordant or maximally discordant: 虽然文中报告了qSOFA和SOFA预测准确性的相关证据，但未提供联合应用qSOFA和SOFA的数据。因为qSOFA和SOFA评分在统计学方面并不完全独立，所以很难预测其联合应用的价值。为此，我们可以假设两种极端的情况：qSOFA和SOFA完全一致或完全不一致： Discordance improves the specificity of the combined test sequence, because only one test needs to be negative to exclude sepsis. However, discordance impairs the sensitivity, because both tests must be positive to rule in sepsis. The tests are almost certainly more concordant than discordant. Without evidence, the only definitive conclusion is that the combined tests have a sensitivity between 23-55% and a specificity between 84-100% (2). 不一致性会提高联合检测的特异性，因为只要其中一项结果阴性就可以排除全身性感染。但是，不一致性会影响敏感性，因为只有两项检测都阳性才能诊断全身性感染。两项检查更多情况下趋于一致而非不一致。尽管没有证据证实，目前唯一的结论是联合检测的敏感性约23-55%，特异性84-100% (2)。 Problem #9: The overall sensitivity of Sepsis-III for sepsis might be <50% outside="" of="" the="">问题#9：非ICU患者全身性感染-III对全身性感染的总敏感性可能<>As discussed above the sensitivity of {qSOFA+SOFA} for mortality is likely <55%. however,="" the="" most="" important="" patients="" to="" identify="" are="" patients="" who="" receive="" critical="" care="" and="" subsequently="">survive (i.e. truly benefit from their ICU care). These ICU survivors may initially look less ill than the patients who die. Therefore, the sensitivity of {qSOFA+SOFA} for ICU survivors is likely lower than for nonsurvivors (i.e., <> 如上所述，联合应用qSOFA和SOFA对病死率的敏感性很可能<><>
Finally, the sensitivity of the 'suspected infection' criteria is unknown (but almost certainly below 100%). Taking all of these factors into account, the sensitivity of Sepsis-III criteria for sepsis could be under 50% (6). 最后，“可疑感染”标准的敏感性尚属未知（但几乎肯定低于100%）。鉴于上述各种因素，全身性感染-III标准对全身性感染诊断的敏感性可能不足50% (6)。
Problem #10: Sepsis-III is not a consensus guideline in the United States问题#10：全身性感染-III并非美国的共识指南Sepsis-III has been endorsed by the Society of Critical Care Medicine, the American Thoracic Society, and the American Association of Critical Care Nurses. However, it has not been endorsed by the American College of Chest Physicians, the Infectious Disease Society of America, any of the Emergency Medicine societies, or any of the hospital medicine societies. It is difficult to call this a consensus guideline without support from Emergency Physicians or Hospitalists, who diagnose sepsis most often. 全身性感染-III得到了由美国危重病学会(SCCM)、美国胸科学会(ATS)、美国重症护理学会(AACCN)的认可。然而，该标准并未得到美国胸科医师学院(ACCP)、美国传染病学会(IDSA)、所有急诊医学学会或任何医院医学学会的批准。如果没有最常诊断全身性感染的急诊医师或医院医师(hospitalist)的支持，该标准就很难称为共识指南。
[Update: since posting this, the American College of Chest Physicians has issued a strong statement opposing Sepsis III] 【更新：本文公开发表后，美国胸科医师学会提出了反对脓毒症III的强烈声明】 总结
Notes 备注1. Misunderstanding of qSOFA isn't technically a failure of Sepsis-III, but rather our failure to correctly apply the definition. Nonetheless, qSOFA and SOFA components are emphasized in Sepsis-III (with scant discussion of the 'suspected infection' component). Thus, this may be an easy mistake to make. 对qSOFA的误解并非全身性感染-III定义在技术上的失败，而是我们不能准确应用这一定义。无论如何，全身性感染-III定义中对qSOFA和SOFA的各组分进行了强调（关于“可疑感染”部分的讨论较少）。因此，这是个很容易犯的错误。
2. All evidence discussed here pertains to patients outside the ICU. The primary clinical utility of sepsis definitions is to determine who is sick and who needs to be admitted to the ICU. Sensitivity and specificity values are obtained from eTable 3 in the supplemental data accompanying Seymour et al. Please note that there appears to be a discrepancy between the text of the article and the table regarding the performance of the SIRS criteria, with data shown here being based on eTable 3 (The text states that for patients outside the ICU, '55% of decedents had 2 or more SIRS criteria, whereas 81% of survivors had less than 2 SIRS criteria' – this is inconsistent with the eTable 3 which shows values of 64% and 65%, respectively). 本文讨论的所有证据都来自非ICU患者。全身性感染定义最主要的临床用途即发现病情危重需要收入ICU的患者。敏感性和特异性数据来自Seymour等补充数据的表3。需要注意的是，正文和表格里关于SIRS标准的诊断准确性的描述似乎并不一致，本文数据基于表3（正文中描述非ICU患者，“55%的死亡者具备2条或以上SIRS标准，而81%的存活者具备2条以下的SIRS标准”—这与表3中所述的数据不符，分别为64%和65%）。
3. A receiver-operator curve (ROC curve) is a graph of the sensitivity vs. specificity of a test at every possible value of the test. This is a useful method to compare the overall performance of two tests, independent of any specific cutoff. A perfect test would have an area under the ROC curve of 1.0, whereas a completely worthless test would have an area of 0.5. However, once you've selected a cutoff point, the area under the ROC curve is less relevant than the sensitivity and specificity of the cutoff that has been selected. 受试者工作特征曲线（ROC曲线）是用于评价某项检查在任何可能结果时敏感性和特异性的曲线图。该曲线可用于比较两种检查方法的整体准确性，而与各自的临界值无关。一项完美的检查ROC曲线下面积为1.0，而完全无价值的检查面积为0.5。然而，一旦选定了临界值，ROC曲线下面积就与选定临界值所对应的敏感性和特异性不太相关。
4. Respiratory rate clearly has enormous prognostic value in pneumonia, but the cutoff of 22 b/m is too low in this disease process. I usually start getting substantially more worried when the respiratory rate is above 30, consistent with the CURB65 score. 呼吸频率显然对肺炎的预后具有重大意义，但临界值22次/分对于该病而言过低。我通常在呼吸频率超过30时才会更加担心，这与CURB65是一致的。
5. SOFA performs better among ICU patients. However, clinically the definition of sepsis is mostly useful outside the ICU (e.g. identifying patients who require ICU transfer). SOFA对ICU患者的价值更高些。然而，临床上全身性感染的定义在ICU以外更有用（例如发现需要转入ICU的患者）。 6. The fact that the 'definition' of sepsis may not capture most patients who require ICU care for infection management creates some strange linguistic problems. I suppose that if we accept the Sepsis-III definition then, by definition, it must have a performance of 100%? 全身性感染的“定义”有可能无法筛选出大多数需要收入ICU接受感染控制的患者，这样就会带来一些奇怪的语言问题。我认为如果我们接受全身性感染-III定义，那么，根据定义，其准确性应当达到100%？ |
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