目的:评估在区域医院网络中,在接受择期子宫切除术的患者中实施加速康复手术(ERAS)方案的有效性,由强化审计和反馈(A&F)方法支持。
方法:多中心,阶梯式楔形集群随机试验(ClinicalTrials.govNCT04063072)。
方法:皮埃蒙特地区的妇科单位,意大利。
方法:接受选择性子宫切除术的患者,无论是癌症还是良性疾病。
方法:二十三个单位(集群),按手术量分层,被随机分为四个序列。在基线(前3个月),所有单位均继续进行标准护理。随后,这四个序列每3个月相继实施ERAS协议,经过专门的训练。在研究结束时,每个单元都有一个维持标准护理的时期(对照)和一个方案的时期,在反馈的支持下,被应用(实验)。
方法:住院时间(LOS),没有异常值(>第98百分位数)。
结果:在2019年9月至2021年5月之间,以意向治疗方法将2086例患者纳入主要分析:对照组1104例(53%),ERAS期间982例(47%)。符合ERAS协议从控制期的60%增加到实验期的76%,调整后的绝对差异为+13.3%(95%CI11.6%至15.0%)。LOS,从3.5天移动到3.2天,没有显着减少(-0.12天;95%CI-0.30至0.07天)。在并发症发生方面没有观察到差异。
结论:在区域一级实施ERAS子宫切除术方案,在A&F方法的支持下,导致合规性的实质性改善,但对LOS和并发症没有意义的影响。这项研究证实了A&F在促进整个医院网络中重要创新方面的有效性,并建议需要更高的ERAS协议合规性,以获得有价值的临床结果改善。
OBJECTIVE: To evaluate the effectiveness of implementing the Enhanced Recovery After Surgery (ERAS) protocol in patients undergoing elective hysterectomy in a network of regional hospitals, supported by an intensive audit-and-feedback (A&F) approach.
METHODS: A multi-centre, stepped-wedge cluster randomised trial (ClinicalTrials.gov NCT04063072).
METHODS: Gynaecological units in the Piemonte region, Italy.
METHODS: Patients undergoing elective hysterectomy, either for cancer or for benign conditions.
METHODS: Twenty-three units (clusters), stratified by surgical volume, were randomised into four sequences. At baseline (first 3 months), standard care was continued in all units. Subsequently, the four sequences implemented the ERAS protocol successively every 3 months, after specific training. By the end of the study, each unit had a period in which standard care was maintained (control) and a period in which the protocol, supported by feedback, was applied (experimental).
METHODS: Length of hospital stay (LOS), without outliers (>98th percentile).
RESULTS: Between September 2019 and May 2021, 2086 patients were included in the main analysis with an intention-to-treat approach: 1104 (53%) in the control period and 982 (47%) in the ERAS period. Compliance with the ERAS protocol increased from 60% in the control period to 76% in the experimental period, with an adjusted absolute difference of +13.3% (95% CI 11.6% to 15.0%). LOS, moving from 3.5 to 3.2 days, did not show a significant reduction (-0.12 days; 95% CI -0.30 to 0.07 days). No difference was observed in the occurrence of complications.
CONCLUSIONS: Implementation of the ERAS protocol for hysterectomy at the regional level, supported by an A&F approach, resulted in a substantial improvement in compliance, but without meaningful effects on LOS and complications. This study confirms the effectiveness of A&F in promoting important innovations in an entire hospital network and suggests the need of a higher compliance with the ERAS protocol to obtain valuable improvements in clinical outcomes.