Invasive Respiratory or Vasopressor Support and/or Death as a Proposed Composite Outcome Measure for Perioperative Care Research
Invasive Respiratory or Vasopressor Support and/or Death as a Proposed Composite Outcome Measure for Perioperative Care Research
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DOI：
10.1213/ane.0000000000003921
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发表时间：
2019-09-01
影响因子：
5.7
通讯作者：
Kai, Shinichi
中科院分区：
文献类型：
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作者：
Mizota, Toshiyuki;Dong, Li;Kai, Shinichi
背景：需要一个临床相关的和可行的结果措施，以促进围手术期护理医学的临床研究。这项大规模回顾性队列研究提出了一种新的复合结局指标，包括有创呼吸或血管加压药支持（IRVS）和死亡。我们描述了接受腹部大手术的患者中IRVS的患病率，并评估了IRVS和死亡相结合以形成复合结局指标的有效性。方法：我们回顾性收集了2776例在京都大学医院接受腹部大手术（肝、结直肠、胃、胰腺或食管切除术）的患者的围手术期数据。我们将IRVS定义为术后需要机械通气≥ 24小时、术后重新插管或术后使用血管加压药。我们评估了术后30天内IRVS的患病率，并检查了IRVS与随后临床结局之间的相关性。主要关注的结果是长期生存率。进行多变量考克斯比例回归分析，以调整基线患者和手术特征。次要结局为住院时间和住院死亡率。结果：共有85例患者（3.1%）在术后30天内接受了IRVS，其中15例患者在30天内死亡。IRVS患者的长期生存率较低（1年和3年生存概率分别为66.1%和48.5% vs 95.2%和84.0%; P <0.001，对数秩检验）。在调整基线患者和手术特征后，IRVS与较低的长期生存率显着相关（调整后的风险比，2.72; 95%置信区间，1.97-3.77; P < .001）。IRVS与更长的住院时间（中位数[四分位距]，65 [39-326] vs 15 [12-24]天;校正后P < .001）和更高的住院死亡率（24.7% vs 0.5%;校正后P < .001）相关。此外，IRVS与随后的临床结局（包括较低的长期生存率）存在不良相关性（校正风险比，1.78; 95%置信区间，1.21-2.63; P = 0.004），当分析仅限于30天生存者时。结论：IRVS患者即使在术后30天存活，也可能持续存在严重发病率和长期生存率降低的风险。我们的研究结果支持使用IRVS和/或死亡作为围手术期护理医学临床研究的复合结局指标的有效性。
BACKGROUND: There is a need for a clinically relevant and feasible outcome measure to facilitate clinical studies in perioperative care medicine. This large-scale retrospective cohort study proposed a novel composite outcome measure comprising invasive respiratory or vasopressor support (IRVS) and death. We described the prevalence of IRVS in patients undergoing major abdominal surgery and assessed the validity of combining IRVS and death to form a composite outcome measure. METHODS: We retrospectively collected perioperative data for 2776 patients undergoing major abdominal surgery (liver, colorectal, gastric, pancreatic, or esophageal resection) at Kyoto University Hospital. We defined IRVS as requirement for mechanical ventilation for >= 24 hours postoperatively, postoperative reintubation, or postoperative vasopressor administration. We evaluated the prevalence of IRVS within 30 postoperative days and examined the association between IRVS and subsequent clinical outcomes. The primary outcome of interest was long-term survival. Multivariable Cox proportional regression analysis was performed to adjust for the baseline patient and operative characteristics. The secondary outcomes were length of hospital stay and hospital mortality. RESULTS: In total, 85 patients (3.1%) received IRVS within 30 postoperative days, 15 of whom died by day 30. Patients with IRVS had a lower long-term survival rate (1- and 3-year survival probabilities, 66.1% and 48.5% vs 95.2% and 84.0%, respectively; P < .001, log-rank test) compared to those without IRVS. IRVS was significantly associated with lower long-term survival after adjustment for the baseline patient and operative characteristics (adjusted hazard ratio, 2.72; 95% confidence interval, 1.97-3.77; P < .001). IRVS was associated with a longer hospital stay (median [interquartile range], 65 [39-326] vs 15 [12-24] days; adjusted P < .001) and a higher hospital mortality (24.7% vs 0.5%; adjusted P < .001). Moreover, IRVS was adversely associated with subsequent clinical outcomes including lower long-term survival (adjusted hazard ratio, 1.78; 95% confidence interval, 1.21-2.63; P = .004) when the analyses were restricted to 30-day survivors. CONCLUSIONS: Patients with IRVS can experience ongoing risk of serious morbidity and less long-term survival even if alive at postoperative day 30. Our findings support the validity of using IRVS and/or death as a composite outcome measure for clinical studies in perioperative care medicine.