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术后居家天数:一种用于临床试验和质量保证的综合高效结局指标。

Days at Home after Surgery: An Integrated and Efficient Outcome Measure for Clinical Trials and Quality Assurance.

作者信息

Bell Max, Eriksson Lars I, Svensson Tobias, Hallqvist Linn, Granath Fredrik, Reilly Jennifer, Myles Paul S

机构信息

Section for Anaesthesiology and Intensive Care Medicine, Department of Physiology and Pharmacology, Karolinska Institute, Stockholm, Sweden.

Function Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden.

出版信息

EClinicalMedicine. 2019 Apr 27;11:18-26. doi: 10.1016/j.eclinm.2019.04.011. eCollection 2019 May-Jun.

Abstract

BACKGROUND

Surgical audit, sometimes including public reporting, is an important foundation of high quality health care. We aimed to assess the validity of a novel outcome metric, , as a surgical outcome measure in clinical trials and quality assurance.

METHODS

This was a multicentre, registry-based cohort study. We used prospectively collected hospital and national healthcare registry data obtained from patients aged 18 years or older undergoing a broad range of surgeries in Sweden over a 10-year period. The association between days at home up to 30 days after surgery and patient (older age, poorer physical status, comorbidity) and surgical (elective or non-elective, complexity, duration) risk factors, process of care outcomes (re-admissions, discharge destination), clinical outcomes (major complications, 30-day mortality) and death up to 1 year after surgery were measured.

FINDINGS

From January, 2005, to December, 2014, we obtained demographic and perioperative data on 636,885 patients from 21 Swedish hospitals. Mortality at 30 days and one year was 1.8% and 7.3%, respectively. The median (IQR) days at home up to 30 days after surgery was 27 (23-29), being significantly lower among high-risk patients, those recovering from more complex surgical procedures, and suffering serious postoperative complications (all p < 0.0001). Patients with 8 days or less at home up to 30 days after surgery had a nearly 7-fold higher risk of death up to 1 year postoperatively when compared with those with 29 or 30 days at home (adjusted HR 6.78 [95% CI: 6.44-7.13]).

INTERPRETATION

Days at home up to 30 days after surgery is a valid, easy to measure patient-centred outcome metric. It is highly sensitive to changes in surgical risk and impact of complications, and has prognostic importance; it is therefore a valuable endpoint for perioperative clinical trials and quality assurance.

FUNDING

Swedish National Research Council Medicine and Stockholm County Council ALF-project grant (LE), and the Australian National Health and Medical Research Council (PM).

摘要

背景

手术审计,有时包括公开报告,是高质量医疗保健的重要基础。我们旨在评估一种新的结果指标,作为临床试验和质量保证中的手术结果测量指标的有效性。

方法

这是一项基于登记处的多中心队列研究。我们使用了前瞻性收集的医院和国家医疗保健登记数据,这些数据来自于瑞典10年间18岁及以上接受各种手术的患者。测量了术后30天内在家天数与患者(年龄较大、身体状况较差、合并症)和手术(择期或非择期、复杂性、持续时间)风险因素、护理过程结果(再次入院、出院目的地)、临床结果(主要并发症、30天死亡率)以及术后1年内死亡之间的关联。

结果

从2005年1月至2014年12月,我们从瑞典21家医院获得了636,885例患者的人口统计学和围手术期数据。30天和1年时的死亡率分别为1.8%和7.3%。术后30天内在家的中位(四分位间距)天数为27天(23 - 29天),在高危患者、从更复杂手术中恢复的患者以及患有严重术后并发症的患者中显著更低(所有p < 0.0001)。术后30天内在家天数为8天或更少的患者与在家天数为29天或30天的患者相比,术后1年内死亡风险高出近7倍(调整后风险比6.78 [95%置信区间:6.44 - 7.13])。

解读

术后30天内在家天数是一个有效、易于测量的以患者为中心的结果指标。它对手术风险变化和并发症影响高度敏感,并且具有预后重要性;因此,它是围手术期临床试验和质量保证的一个有价值的终点指标。

资金来源

瑞典国家研究委员会医学部和斯德哥尔摩郡议会ALF项目资助(LE),以及澳大利亚国家卫生与医学研究委员会(PM)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0251/6610780/5703047ff259/gr1.jpg

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