Assessment of Clinical Criteria for Sepsis: For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).
Assessment of Clinical Criteria for Sepsis: For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).
复制标题
DOI：
10.1001/jama.2016.0288
复制
发表时间：
2016-02-23
期刊：
影响因子：
--
通讯作者：
Angus DC
中科院分区：
文献类型：
--
作者：
Seymour CW;Liu VX;Iwashyna TJ;Brunkhorst FM;Rea TD;Scherag A;Rubenfeld G;Kahn JM;Shankar-Hari M;Singer M;Deutschman CS;Escobar GJ;Angus DC
第三届国际共识定义工作组将败血症定义为“因宿主对感染反应失调而导致的危及生命的器官功能障碍”。这种脓毒症定义的临床标准尚不清楚。评估临床标准的有效性，以确定疑似感染的患者有败血症的风险。在2010年1月1日至2012年12月31日期间，宾夕法尼亚州西南部12家医院的130万份电子健康记录中，我们确定了疑似感染的患者，并对其进行了比较标准。在2008年1月1日至2013年12月31日期间，对165家美国和非美国医院的706399例院外和院外病例进行了4个数据集的验证性分析。顺序[败血症相关]器官衰竭评估（SOFA）评分，系统性炎症反应综合征（SIRS）标准，Logistic器官功能障碍系统（LODS）评分，以及在分裂样本中使用多变量Logistic回归得出的新模型，快速顺序[败血症相关]器官衰竭评估（qSOFA）评分（范围，0-3分，收缩期低血压[≤100 mm Hg]，呼吸急促[≥22/min]或精神状态改变各1分）。对于构念效度，两两一致性评估。对于预测效度，确定了脓毒症比无并发症感染更常见的结局（主要：院内死亡率；次要：院内死亡率或重症监护病房[ICU]住院时间≥3天）的区别。结果表示为基线死亡风险和受试者工作特征曲线（AUROC）下面积在十分位数上的结果变化倍数。在主要队列中，1448907例接触者有疑似感染（n = 74 453例衍生病例；n = 74 454例验证病例），其中6347例（4%）死亡。在ICU就诊的验证队列中（n = 7932例疑似感染患者，其中1289例[16%]死亡），SIRS （AUROC = 0.64; 95% CI, 0.62-0.66）和qSOFA （AUROC = 0.66; 95% CI, 0.64 - 0.68）对院内死亡率的预测效度低于SOFA （AUROC = 0.74; 95% CI, 0.73-0.76；两者P < 0.001）或LODS （AUROC = 0.75; 95% CI, 0.73-0.76；两者P < 0.001）。在非icu就诊的验证队列中（n = 66 522例疑似感染患者，其中1886例[3%]死亡），qSOFA的预测效度（AUROC = 0.81, 95% CI, 0.80-0.82）高于SOFA （AUROC = 0.79, 95% CI, 0.78-0.80, P < 0.001）和SIRS （AUROC = 0.76, 95% CI, 0.75-0.77, P < 0.001）。相对于qSOFA得分低于2分而言，qSOFA得分为2分或更高的患者在基线风险十分位数上的住院死亡率增加了3至14倍。外部数据集和次要结局的结果相似。在疑似感染的ICU患者中，SOFA对院内死亡率的预测效度与更复杂的LODS无显著差异，但在统计学上高于SIRS和qSOFA，支持其作为脓毒症的临床标准。在ICU外遇到疑似感染的患者中，qSOFA对院内死亡率的预测效度在统计学上高于SOFA和SIRS，支持将其作为考虑可能的败血症的提示。
The Third International Consensus Definitions Task Force defined sepsis as “life-threatening organ dysfunction due to a dysregulated host response to infection.” The performance of clinical criteria for this sepsis definition is unknown. To evaluate the validity of clinical criteria to identify patients with suspected infection who are at risk of sepsis. Among 1.3 million electronic health record encounters from January 1, 2010, to December 31, 2012, at 12 hospitals in southwestern Pennsylvania, we identified those with suspected infection in whom to compare criteria. Confirmatory analyses were performed in 4 data sets of 706 399 out-of-hospital and hospital encounters at 165 US and non-US hospitals ranging from January 1, 2008, until December 31, 2013. Sequential [Sepsis-related] Organ Failure Assessment (SOFA) score, systemic inflammatory response syndrome (SIRS) criteria, Logistic Organ Dysfunction System (LODS) score, and a new model derived using multivariable logistic regression in a split sample, the quick Sequential [Sepsis-related] Organ Failure Assessment (qSOFA) score (range, 0–3 points, with 1 point each for systolic hypotension [≤100 mm Hg], tachypnea [≥22/min], or altered mentation). For construct validity, pairwise agreement was assessed. For predictive validity, the discrimination for outcomes (primary: in-hospital mortality; secondary: in-hospital mortality or intensive care unit [ICU] length of stay ≥3 days) more common in sepsis than uncomplicated infection was determined. Results were expressed as the fold change in outcome over deciles of baseline risk of death and area under the receiver operating characteristic curve (AUROC). In the primary cohort, 148 907 encounters had suspected infection (n = 74 453 derivation; n = 74 454 validation), of whom 6347 (4%) died. Among ICU encounters in the validation cohort (n = 7932 with suspected infection, of whom 1289 [16%] died), the predictive validity for in-hospital mortality was lower for SIRS (AUROC = 0.64; 95% CI, 0.62–0.66) and qSOFA (AUROC = 0.66; 95% CI, 0.64–0.68) vs SOFA (AUROC = 0.74; 95% CI, 0.73–0.76; P < .001 for both) or LODS (AUROC = 0.75; 95% CI, 0.73–0.76; P < .001 for both). Among non-ICU encounters in the validation cohort (n = 66 522 with suspected infection, of whom 1886 [3%] died), qSOFA had predictive validity (AUROC = 0.81; 95% CI, 0.80–0.82) that was greater than SOFA (AUROC = 0.79; 95% CI, 0.78–0.80; P < .001) and SIRS (AUROC = 0.76; 95% CI, 0.75–0.77; P < .001). Relative to qSOFA scores lower than 2, encounters with qSOFA scores of 2 or higher had a 3- to 14-fold increase in hospital mortality across baseline risk deciles. Findings were similar in external data sets and for the secondary outcome. Among ICU encounters with suspected infection, the predictive validity for in-hospital mortality of SOFA was not significantly different than the more complex LODS but was statistically greater than SIRS and qSOFA, supporting its use in clinical criteria for sepsis. Among encounters with suspected infection outside of the ICU, the predictive validity for in-hospital mortality of qSOFA was statistically greater than SOFA and SIRS, supporting its use as a prompt to consider possible sepsis.