Eva Pagano, Luca Pellegrino, Manuela Robella, Anna Castiglione, Francesco Brunetti, Lisa Giacometti, Monica Rolfo, Alessio Rizzo, Sarah Palmisano, Maurizio Meineri, Ilaria Bachini, Mario Morino, Marco Ettore Allaix, Alfredo Mellano, Paolo Massucco, Paola Bellomo, Roberto Polastri, Giovannino Ciccone, Felice Borghi
{"title":"在审计和反馈支持下，在地区医院网络中实施结直肠癌术后强化恢复方案：阶梯式楔形群随机试验。","authors":"Eva Pagano, Luca Pellegrino, Manuela Robella, Anna Castiglione, Francesco Brunetti, Lisa Giacometti, Monica Rolfo, Alessio Rizzo, Sarah Palmisano, Maurizio Meineri, Ilaria Bachini, Mario Morino, Marco Ettore Allaix, Alfredo Mellano, Paolo Massucco, Paola Bellomo, Roberto Polastri, Giovannino Ciccone, Felice Borghi","doi":"10.1136/bmjqs-2023-016594","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Enhanced recovery after surgery (ERAS) protocols are known to potentially improve the management and outcomes of patients undergoing colorectal surgery, with limited evidence of their implementation in hospital networks and in a large population. We aimed to assess the impact of the implementation of an ERAS protocol in colorectal cancer surgery in the entire region of Piemonte, Italy, supported by an audit and feedback (A&F) intervention.</p><p><strong>Methods: </strong>A large, stepped wedge, cluster randomised trial enrolled patients scheduled for elective surgery at 29 general surgery units (clusters). At baseline (first 3 months), standard care was continued in all units. Thereafter, four groups of clusters began to adopt the ERAS protocol successively. By the end of the study, each cluster had a period in which standard care was maintained (control) and a period in which the protocol was applied (experimental). ERAS implementation was supported by initial training and A&F initiatives. The primary endpoint was length of stay (LOS) without outliers (>94th percentile), and the secondary endpoints were outliers for LOS, postoperative medical and surgical complications, quality of recovery and compliance with ERAS items.</p><p><strong>Results: </strong>Of 2626 randomised patients, 2397 were included in the LOS analysis (1060 in the control period and 1337 in the experimental period). The mean LOS without outliers was 8.5 days during the control period (SD 3.9) and 7.5 (SD 3.5) during the experimental one. The adjusted difference between the two periods was a reduction of -0.58 days (95% CI -1.07, -0.09; p=0.021). The compliance with ERAS items increased from 52.4% to 67.3% (estimated absolute difference +13%; 95% CI 11.4%, 14.7%). No difference in the occurrence of complications was evidenced (OR 1.22; 95% CI 0.89, 1.68).</p><p><strong>Conclusion: </strong>Implementation of the ERAS protocol for colorectal cancer, supported by A&F approach, led to a substantial improvement in compliance and a reduction in LOS, without meaningful effects on complications. <b>Trial registration number</b> NCT04037787.</p>","PeriodicalId":9077,"journal":{"name":"BMJ Quality & Safety","volume":null,"pages":null},"PeriodicalIF":5.6000,"publicationDate":"2024-05-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11103294/pdf/","citationCount":"0","resultStr":"{\"title\":\"Implementation of an enhanced recovery after surgery protocol for colorectal cancer in a regional hospital network supported by audit and feedback: a stepped wedge, cluster randomised trial.\",\"authors\":\"Eva Pagano, Luca Pellegrino, Manuela Robella, Anna Castiglione, Francesco Brunetti, Lisa Giacometti, Monica Rolfo, Alessio Rizzo, Sarah Palmisano, Maurizio Meineri, Ilaria Bachini, Mario Morino, Marco Ettore Allaix, Alfredo Mellano, Paolo Massucco, Paola Bellomo, Roberto Polastri, Giovannino Ciccone, Felice Borghi\",\"doi\":\"10.1136/bmjqs-2023-016594\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Enhanced recovery after surgery (ERAS) protocols are known to potentially improve the management and outcomes of patients undergoing colorectal surgery, with limited evidence of their implementation in hospital networks and in a large population. We aimed to assess the impact of the implementation of an ERAS protocol in colorectal cancer surgery in the entire region of Piemonte, Italy, supported by an audit and feedback (A&F) intervention.</p><p><strong>Methods: </strong>A large, stepped wedge, cluster randomised trial enrolled patients scheduled for elective surgery at 29 general surgery units (clusters). At baseline (first 3 months), standard care was continued in all units. Thereafter, four groups of clusters began to adopt the ERAS protocol successively. By the end of the study, each cluster had a period in which standard care was maintained (control) and a period in which the protocol was applied (experimental). ERAS implementation was supported by initial training and A&F initiatives. The primary endpoint was length of stay (LOS) without outliers (>94th percentile), and the secondary endpoints were outliers for LOS, postoperative medical and surgical complications, quality of recovery and compliance with ERAS items.</p><p><strong>Results: </strong>Of 2626 randomised patients, 2397 were included in the LOS analysis (1060 in the control period and 1337 in the experimental period). The mean LOS without outliers was 8.5 days during the control period (SD 3.9) and 7.5 (SD 3.5) during the experimental one. The adjusted difference between the two periods was a reduction of -0.58 days (95% CI -1.07, -0.09; p=0.021). The compliance with ERAS items increased from 52.4% to 67.3% (estimated absolute difference +13%; 95% CI 11.4%, 14.7%). No difference in the occurrence of complications was evidenced (OR 1.22; 95% CI 0.89, 1.68).</p><p><strong>Conclusion: </strong>Implementation of the ERAS protocol for colorectal cancer, supported by A&F approach, led to a substantial improvement in compliance and a reduction in LOS, without meaningful effects on complications. <b>Trial registration number</b> NCT04037787.</p>\",\"PeriodicalId\":9077,\"journal\":{\"name\":\"BMJ Quality & Safety\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":5.6000,\"publicationDate\":\"2024-05-17\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11103294/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"BMJ Quality & Safety\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1136/bmjqs-2023-016594\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"HEALTH CARE SCIENCES & SERVICES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMJ Quality & Safety","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1136/bmjqs-2023-016594","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}
Implementation of an enhanced recovery after surgery protocol for colorectal cancer in a regional hospital network supported by audit and feedback: a stepped wedge, cluster randomised trial.
Background: Enhanced recovery after surgery (ERAS) protocols are known to potentially improve the management and outcomes of patients undergoing colorectal surgery, with limited evidence of their implementation in hospital networks and in a large population. We aimed to assess the impact of the implementation of an ERAS protocol in colorectal cancer surgery in the entire region of Piemonte, Italy, supported by an audit and feedback (A&F) intervention.
Methods: A large, stepped wedge, cluster randomised trial enrolled patients scheduled for elective surgery at 29 general surgery units (clusters). At baseline (first 3 months), standard care was continued in all units. Thereafter, four groups of clusters began to adopt the ERAS protocol successively. By the end of the study, each cluster had a period in which standard care was maintained (control) and a period in which the protocol was applied (experimental). ERAS implementation was supported by initial training and A&F initiatives. The primary endpoint was length of stay (LOS) without outliers (>94th percentile), and the secondary endpoints were outliers for LOS, postoperative medical and surgical complications, quality of recovery and compliance with ERAS items.
Results: Of 2626 randomised patients, 2397 were included in the LOS analysis (1060 in the control period and 1337 in the experimental period). The mean LOS without outliers was 8.5 days during the control period (SD 3.9) and 7.5 (SD 3.5) during the experimental one. The adjusted difference between the two periods was a reduction of -0.58 days (95% CI -1.07, -0.09; p=0.021). The compliance with ERAS items increased from 52.4% to 67.3% (estimated absolute difference +13%; 95% CI 11.4%, 14.7%). No difference in the occurrence of complications was evidenced (OR 1.22; 95% CI 0.89, 1.68).
Conclusion: Implementation of the ERAS protocol for colorectal cancer, supported by A&F approach, led to a substantial improvement in compliance and a reduction in LOS, without meaningful effects on complications. Trial registration number NCT04037787.
期刊介绍：
BMJ Quality & Safety (previously Quality & Safety in Health Care) is an international peer review publication providing research, opinions, debates and reviews for academics, clinicians and healthcare managers focused on the quality and safety of health care and the science of improvement.
The journal receives approximately 1000 manuscripts a year and has an acceptance rate for original research of 12%. Time from submission to first decision averages 22 days and accepted articles are typically published online within 20 days. Its current impact factor is 3.281.
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