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一种用于评估髋部骨折手术后 30 天死亡率和并发症风险的工具:对于某些目的足够准确,但并非所有目的都准确?来自 ACS-NSQIP 数据库的研究。

A Tool to Estimate Risk of 30-day Mortality and Complications After Hip Fracture Surgery: Accurate Enough for Some but Not All Purposes? A Study From the ACS-NSQIP Database.

机构信息

Center for Innovation to Implementation, VA Palo Alto Healthcare System, Palo Alto, CA, USA.

Stanford-Surgery Policy Improvement Research and Education Center (S-SPIRE), Stanford, CA, USA.

出版信息

Clin Orthop Relat Res. 2022 Dec 1;480(12):2335-2346. doi: 10.1097/CORR.0000000000002294. Epub 2022 Jun 27.

Abstract

BACKGROUND

Surgical repair of hip fracture carries substantial short-term risks of mortality and complications. The risk-reward calculus for most patients with hip fractures favors surgical repair. However, some patients have low prefracture functioning, frailty, and/or very high risk of postoperative mortality, making the choice between surgical and nonsurgical management more difficult. The importance of high-quality informed consent and shared decision-making for frail patients with hip fracture has recently been demonstrated. A tool to accurately estimate patient-specific risks of surgery could improve these processes.

QUESTIONS/PURPOSES: With this study, we sought (1) to develop, validate, and estimate the overall accuracy (C-index) of risk prediction models for 30-day mortality and complications after hip fracture surgery; (2) to evaluate the accuracy (sensitivity, specificity, and false discovery rates) of risk prediction thresholds for identifying very high-risk patients; and (3) to implement the models in an accessible web calculator.

METHODS

In this comparative study, preoperative demographics, comorbidities, and preoperatively known operative variables were extracted for all 82,168 patients aged 18 years and older undergoing surgery for hip fracture in the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) between 2011 and 2017. Eighty-two percent (66,994 of 82,168 ) of patients were at least 70 years old, 21% (17,007 of 82,168 ) were at least 90 years old, 70% (57,260 of 82,168 ) were female, and 79% (65,301 of 82,168 ) were White. A total of 5% (4260 of 82,168) of patients died within 30 days of surgery, and 8% (6786 of 82,168) experienced a major complication. The ACS-NSQIP database was chosen for its clinically abstracted and reliable data from more than 600 hospitals on important surgical outcomes, as well as rich characterization of preoperative demographic and clinical predictors for demographically diverse patients. Using all the preoperative variables in the ACS-NSQIP dataset, least absolute shrinkage and selection operator (LASSO) logistic regression, a type of machine learning that selects variables to optimize accuracy and parsimony, was used to develop and validate models to predict two primary outcomes: 30-day postoperative mortality and any 30-day major complications. Major complications were defined by the occurrence of ACS-NSQIP complications including: on a ventilator longer than 48 hours, intraoperative or postoperative unplanned intubation, septic shock, deep incisional surgical site infection (SSI), organ/space SSI, wound disruption, sepsis, intraoperative or postoperative myocardial infarction, intraoperative or postoperative cardiac arrest requiring cardiopulmonary resuscitation, acute renal failure needing dialysis, pulmonary embolism, stroke/cerebral vascular accident, and return to the operating room. Secondary outcomes were six clusters of complications recently developed and increasingly used for the development of surgical risk models, namely: (1) pulmonary complications, (2) infectious complications, (3) cardiac events, (4) renal complications, (5) venous thromboembolic events, and (6) neurological events. Tenfold cross-validation was used to assess overall model accuracy with C-indexes, a measure of how well models discriminate patients who experience an outcome from those who do not. Using the models, the predicted risk of outcomes for each patient were used to estimate the accuracy (sensitivity, specificity, and false discovery rates) of a wide range of predicted risk thresholds. We then implemented the prediction models into a web-accessible risk calculator.

RESULTS

The 30-day mortality and major complication models had good to fair discrimination (C-indexes of 0.76 and 0.64, respectively) and good calibration throughout the range of predicted risk. Thresholds of predicted risk to identify patients at very high risk of 30-day mortality had high specificity but also high false discovery rates. For example, a 30-day mortality predicted risk threshold of 15% resulted in 97% specificity, meaning 97% of patients who lived longer than 30 days were below that risk threshold. However, this threshold had a false discovery rate of 78%, meaning 78% of patients above that threshold survived longer than 30 days and might have benefitted from surgery. The tool is available here: https://s-spire-clintools.shinyapps.io/hip_deploy/ .

CONCLUSION

The models of mortality and complications we developed may be accurate enough for some uses, especially personalizing informed consent and shared decision-making with patient-specific risk estimates. However, the high false discovery rate suggests the models should not be used to restrict access to surgery for high-risk patients. Deciding which measures of accuracy to prioritize and what is "accurate enough" depends on the clinical question and use of the predictions. Discrimination and calibration are commonly used measures of overall model accuracy but may be poorly suited to certain clinical questions and applications. Clinically, overall accuracy may not be as important as knowing how accurate and useful specific values of predicted risk are for specific purposes.Level of Evidence Level III, therapeutic study.

摘要

背景

髋部骨折手术修复具有较高的短期死亡率和并发症风险。对于大多数髋部骨折患者来说,手术修复的风险-获益比倾向于手术。然而,一些患者在骨折前功能较弱、身体虚弱,且/或术后死亡风险非常高,这使得手术和非手术治疗的选择更加困难。最近已经证明,对于髋部骨折的体弱患者,高质量的知情同意和共同决策非常重要。一个能够准确估计患者手术特定风险的工具可以改善这些过程。

问题/目的:通过这项研究,我们试图:(1)开发、验证和估计髋部骨折手术后 30 天死亡率和并发症的风险预测模型的总体准确性(C 指数);(2)评估识别极高风险患者的风险预测阈值的准确性(敏感性、特异性和假阳性率);(3)在可访问的网络计算器中实现这些模型。

方法

在这项比较研究中,从美国外科医师学会国家手术质量改进计划(ACS-NSQIP)2011 年至 2017 年期间接受髋部骨折手术的 82168 名年龄在 18 岁及以上的患者中提取了术前人口统计学、合并症和术前已知的手术变量。82168 名患者中 82%(66994 名)年龄至少为 70 岁,21%(17007 名)年龄至少为 90 岁,70%(57260 名)为女性,79%(65301 名)为白人。共有 5%(4260 名)患者在手术后 30 天内死亡,8%(6786 名)患者发生主要并发症。ACS-NSQIP 数据库因其来自 600 多家医院的关于重要手术结果的临床记录和可靠数据,以及对不同人群术前人口统计学和临床预测因子的丰富描述而被选中。使用 ACS-NSQIP 数据集中的所有术前变量,最小绝对收缩和选择算子(LASSO)逻辑回归,一种选择变量以优化准确性和简约性的机器学习类型,用于开发和验证预测两个主要结果的模型:30 天术后死亡率和任何 30 天主要并发症。主要并发症定义为 ACS-NSQIP 并发症的发生,包括:呼吸机使用时间超过 48 小时、术中或术后计划外插管、脓毒症休克、深部切口手术部位感染(SSI)、器官/空间 SSI、伤口破裂、败血症、术中或术后心肌梗死、术中或术后心脏骤停需要心肺复苏、急性肾衰竭需要透析、肺栓塞、中风/脑血管意外和返回手术室。次要结果是最近开发并越来越多地用于手术风险模型开发的六个并发症簇,即:(1)肺部并发症,(2)感染性并发症,(3)心脏事件,(4)肾脏并发症,(5)静脉血栓栓塞事件,(6)神经系统事件。十折交叉验证用于评估模型的整体准确性,采用 C 指数来衡量模型区分经历结局的患者和不经历结局的患者的能力。使用这些模型,对每个患者的预测结果风险进行评估,以估计一系列广泛的预测风险阈值的准确性(敏感性、特异性和假阳性率)。然后,我们将预测模型集成到一个可访问的网络计算器中。

结果

30 天死亡率和主要并发症模型具有良好到中等的区分能力(C 指数分别为 0.76 和 0.64),并且在预测风险范围内具有良好的校准。识别 30 天死亡率极高风险患者的预测风险阈值具有较高的特异性,但也有较高的假阳性率。例如,30 天死亡率预测风险阈值为 15%,特异性为 97%,这意味着 97%的存活时间超过 30 天的患者风险阈值低于该值。然而,该阈值的假阳性率为 78%,这意味着 78%的高于该阈值的患者存活时间超过 30 天,可能受益于手术。该工具可在此处访问:https://s-spire-clintools.shinyapps.io/hip_deploy/。

结论

我们开发的死亡率和并发症模型的准确性可能足以满足某些用途,尤其是个性化的知情同意和共同决策,以及患者特定的风险估计。然而,高假阳性率表明,这些模型不应用于限制高危患者接受手术治疗。决定哪些准确性度量优先考虑以及什么是“足够准确”取决于临床问题和预测的用途。区分度和校准度是常用的整体模型准确性度量,但可能不适合某些临床问题和应用。在临床上,整体准确性可能不如了解特定目的的预测风险值的准确性和有用性重要。证据水平为 III 级,治疗性研究。

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