使用控制图表监测手术结果可降低患者重大不良

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使用控制图表监测手术结果可降低患者重大不良

本期文章:《英国医学杂志》:Online/在线发表

法国克劳德·伯纳德-里昂第一大学Antoine Duclos团队研究了使用控制图表监测手术结果以减少患者重大不良事件的效果。2020年11月4日,该研究发表在《英国医学杂志》上。

为了确定通过控制图表和定期向外科团队反馈患者重大不良事件的指标,以进行前瞻性监测的效果,研究组进行了一项嵌入差异分析的全国性、平行、集群随机试验。

研究组在法国的40个外科医院招募了155362名接受消化道手术的患者,将其随机分为两组,其中20个科室采用控制图表前瞻性监测预后,并定期反馈指标(干预组),另外20个科室采用常规护理(对照组)。主要结局为术后30天内重大不良事件的综合结局,包括住院患者死亡、重症监护住院、再次手术和严重并发症。

研究组对干预医院的75047名患者(计划实施前37579名,实施后37468名)和对照医院的80315名患者(41548名和38767名)进行了分析。引入控制图表后,与对照医院相比,干预医院中发生重大不良事件的绝对风险降低了0.9%,相当于有114名患者需要接受干预治疗以预防某项重大不良事件。

与对照医院相比,干预医院的重大不良事件发生率、患者死亡率和接受重症监护率均显著降低,但再次手术和严重并发症发生率相差不大。在干预医院中,效果大小与控制图表实施的程度成正比。患者依从性高的医院重大不良事件、患者死亡、重症监护住院和再次手术的风险大大降低。

综上,实施控制图表并向外科团队提供指标反馈,可显著降低患者的重大不良事件发生率。

附:英文原文

Title: Effect of monitoring surgical outcomes using control charts to reduce major adverse events in patients: cluster randomised trial

Author: Antoine Duclos, Franois Chollet, Léa Pascal, Hector Ormando, Matthew J Carty, Stéphanie Polazzi, Jean-Christophe Lifante

Issue&Volume: 2020/11/04

Abstract:

Objective To determine the effect of introducing prospective monitoring of outcomes using control charts and regular feedback on indicators to surgical teams on major adverse events in patients.

Design National, parallel, cluster randomised trial embedding a difference-in-differences analysis.

Setting 40 surgical departments of hospitals across France.

Participants 155362 adults who underwent digestive tract surgery. 20 of the surgical departments were randomised to prospective monitoring of outcomes using control charts with regular feedback on indicators (intervention group) and 20 to usual care only (control group).

Interventions Prospective monitoring of outcomes using control charts, provided in sets quarterly, with regular feedback on indicators (intervention hospitals). To facilitate implementation of the programme, study champion partnerships were established at each site, comprising a surgeon and another member of the surgical team (surgeon, anaesthetist, or nurse), and were trained to conduct team meetings, display posters in operating rooms, maintain a logbook, and devise an improvement plan.

Main outcome measures The primary outcome was a composite of major adverse events (inpatient death, intensive care stay, reoperation, and severe complications) within 30 days after surgery. Changes in surgical outcomes were compared before and after implementation of the programme between intervention and control hospitals, with adjustment for patient mix and clustering.

Results 75047 patients were analysed in the intervention hospitals (37579 before and 37468 after programme implementation) versus 80315 in the control hospitals (41548 and 38767). After introduction of the control chart, the absolute risk of a major adverse event was reduced by 0.9% (95% confidence interval 0.4% to 1.4%) in intervention compared with control hospitals, corresponding to 114 patients (70 to 280) who needed to receive the intervention to prevent one major adverse event. A significant decrease in major adverse events (adjusted ratio of odds ratios 0.89, 95% confidence interval 0.83 to 0.96), patient death (0.84, 0.71 to 0.99), and intensive care stay (0.85, 0.76 to 0.94) was found in intervention compared with control hospitals. The same trend was observed for reoperation (0.91, 0.82 to 1.00), whereas severe complications remained unchanged (0.96, 0.87 to 1.07). Among the intervention hospitals, the effect size was proportional to the degree of control chart implementation witnessed. Highly compliant hospitals experienced a more important reduction in major adverse events (0.84, 0.77 to 0.92), patient death (0.78, 0.63 to 0.97), intensive care stay (0.76, 0.67 to 0.87), and reoperation (0.84, 0.74 to 0.96).

Conclusions The implementation of control charts with feedback on indicators to surgical teams was associated with concomitant reductions in major adverse events in patients. Understanding variations in surgical outcomes and how to provide safe surgery is imperative for improvements.

DOI: 10.1136/bmj.m3840

Source: https://www.bmj.com/content/371/bmj.m3840

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