An International Expert Delphi Consensus on Defining Textbook Outcome in Liver Surgery (TOLS),Annals of Surgery

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An International Expert Delphi Consensus on Defining Textbook Outcome in Liver Surgery (TOLS)
Annals of Surgery ( IF 7.5 ) Pub Date : 2023-05-01 , DOI: 10.1097/sla.0000000000005668
Burak Görgec _{1,

2,

3,

4} , Andrea Benedetti Cacciaguerra _{1,

4,

5} , Timothy M Pawlik ₆ , Luca A Aldrighetti ₇ , Adnan A Alseidi ₈ , Umberto Cillo ₉ , Norihiro Kokudo ₁₀ , David A Geller ₁₁ , Go Wakabayashi ₁₂ , Horacio J Asbun ₁₃ , Marc G Besselink _{2,

3} , Daniel Cherqui ₁₄ , Tan To Cheung ₁₅ , Pierre-Alain Clavien ₁₆ , Claudius Conrad ₁₇ , Mathieu D'Hondt ₁₈ , Ibrahim Dagher ₁₉ , Christos Dervenis ₂₀ , John Devar _{21,

22} , Elijah Dixon ₂₃ , Bjørn Edwin _{24,

25} , Mikhail Efanov ₂₆ , Giuseppe M Ettore ₂₇ , Alessandro Ferrero ₂₈ , Constantino Fondevilla ₂₉ , David Fuks ₃₀ , Felice Giuliante ₃₁ , Ho-Seong Han ₃₂ , Goro Honda ₃₃ , Oscar Imventarza _{34,

35} , David A Kooby ₃₆ , Peter Lodge ₃₇ , Santiago Lopez-Ben ₃₈ , Marcel A Machado ₃₉ , Hugo P Marques ₄₀ , Nick O'Rourke ₄₁ , Juan Pekolj ₄₂ , Antonio D Pinna ₄₃ , Nazario Portolani ₄₄ , John Primrose ₄ , Fernando Rotellar ₄₅ , Andrea Ruzzenente ₄₆ , Erik Schadde _{47,

48,

49} , Ajith K Siriwardena ₅₀ , Sameer Smadi ₅₁ , Olivier Soubrane ₅₂ , Kenneth K Tanabe ₅₃ , Catherine S C Teh ₅₄ , Guido Torzilli ₅₅ , Thomas M Van Gulik _{2,

3} , Marco Vivarelli ₅ , Stephen J Wigmore ₅₆ , Mohammad Abu Hilal _{1,

4}

Affiliation

Department of Surgery, Poliambulanza Foundation Hospital, Brescia, Italy.
Department of Surgery, AmsterdamUMC, University of Amsterdam, Amsterdam, the Netherlands.
Cancer Center Amsterdam, Amsterdam, the Netherlands.
Department of Surgery, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
Hepatobiliary and Abdominal Transplantation Surgery, Department of Experimental and Clinical Medicine, Riuniti Hospital, Polytechnic University of Marche, Ancona, Italy.
Division of Surgical Oncology, Department of Surgery, The Ohio State University Wexner Medical Center and James Comprehensive Cancer Center, Columbus, OH.
Hepatobiliary Surgery Division, IRCCS San Raffaele Hospital, Milan, Italy.
Department of Surgery, University of California San Francisco, San Francisco, CA.
Department of Surgery, Oncology and Gastroenterology, Hepatobiliary Surgery and Liver Transplantation Unit, Padova University Hospital, Padova, Italy.
Department of Surgery, Hepatobiliary Pancreatic Surgery Division, National Center for Global Health and Medicine, Tokyo, Japan.
Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA.
Center for Advanced Treatment of Hepatobiliary and Pancreatic Diseases, Ageo Central General Hospital, Saitama, Japan.
Hepato-Biliary and Pancreas Surgery, Miami Cancer Institute, Miami, FL.
Department of Hepatobiliary Surgery, Paul Brousse University Hospital, Villejuif, France.
Department of Surgery, The University of Hong Kong, Hong Kong, China.
Department of surgery and transplantation, University Hospital Zurich, Switzerland.
Department of Surgery, St. Elizabeth's Medical Center, Tufts University School of Medicine, Boston, MA.
Department of Digestive and Hepatobiliary/Pancreatic Surgery, Groeninge Hospital, Kortrijk, Belgium.
Department of Minimally Invasive Digestive Surgery, Antoine Béclère Hospital, Clamart, France.
Department of Surgery, Konstantopouleio General Hospital, Nea Ionia, Athens, Greece.
Department of Surgery, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Hepato-Pancreatico-Biliary Unit, Department of General Surgery, Chris Hani Baragwanath Academic Hospital, Johannesburg, South Africa.
Department of Surgery, University of Calgary, Calgary, AB, Canada.
Department of Hepato-Pancreato-Biliary Surgery and The Intervention Center, Oslo University Hospital Oslo, Oslo, Norway.
Institute of Clinical Medicine, Medical Faculty, University of Oslo, Oslo, Norway.
Department of Hepato-Pancreato-Biliary Surgery, Moscow Clinical Research Centre, Moscow, Russia.
General Surgery and Transplantation Unit, San Camillo Hospital, Rome, Italy.
Department of General and Oncological Surgery, Umberto I Mauriziano Hospital, Turin, Italy.
General & Digestive Surgery, Hospital Universitario La Paz, IdiPAZ, Madrid, Spain.
Department of Digestive, Oncologic and Metabolic Surgery, Institut Mutualiste Montsouris, Université Paris Descartes, Paris, France.
Chirurgia Epatobiliare, Università Cattolica del Sacro Cuore-IRCCS, Rome, Italy.
Department of Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam-si, Gyeonggi-do, Republic of Korea.
Department of Surgery, Institute of Gastroenterology, Tokyo Women's Medical University, Tokyo, Japan.
Department of surgery, Hospital Argerich, Buenos Aires, Argentina.
Department of surgery, Hospital Garrahan, Buenos Aires, Argentina.
Department of Surgery, Emory University School of Medicine, Winship Cancer Institute, Atlanta, GA.
HPB and Transplant Unit, St James's University Hospital, Leeds, UK.
Department of General and Digestive Surgery, HPB Unit, Hospital Universitari de Girona Dr. Josep Trueta, Girona, Spain.
Department of Surgery, University of São Paulo, São Paulo, Brazil.
Department of Surgery, Curry Cabral Hospital, Lisbon, Portugal.
Department of HPB Surgery, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.
Division of HPB Surgery and Liver Transplant Unit, Department of General Surgery, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
Abdominal Transplant and HPB Center, Cleveland Clinic Florida, Weston, Florida.
Department of Clinical and Experimental Sciences, Surgical Clinic, University of Brescia, Italy.
Department of General and Digestive Surgery, Clinica Universidad de Navarra, Pamplona, Spain.
Department of Surgery, University of Verona, Verona, Italy.
Institute of Physiology, University of Zurich, Zurich, Switzerland.
Department of Surgery, Cantonal Hospital Winterthur, Zurich, Switzerland.
Division of Transplant Surgery, Department of Surgery, Rush University Medical Center, Chicago, IL.
Hepatobiliary and Pancreatic Surgery Unit, Manchester University NHS FT, Manchester, UK.
Department of Surgery, King Hussein Medical Center, Amman, Jordan.
Department of Hepatobiliopancreatic Surgery, APHP, Beaujon Hospital, Clichy, France.
Division of Surgical Oncology, Department of Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, MA.
Section of Hepatobiliary Pancreatic Surgery, Surgical Oncology, and Minimally Invasive Surgery, St Luke's Medical Center, Quezon City, Philippines.
Division of Hepatobiliary and General Surgery, Department of Surgery, Humanitas Clinical and Research Center, IRCCS, Humanitas University, Rozzano, Italy.
Department of Hepato-Pancreato-Biliary (HPB)/Transplant Surgery, The University of Edinburgh Clinical Surgery, Edinburgh, UK.

Objective:

To reach global expert consensus on the definition of TOLS in minimally invasive and open liver resection among renowned international expert liver surgeons using a modified Delphi method.

Background:

Textbook outcome is a novel composite measure combining the most desirable postoperative outcomes into one single measure and representing the ideal postoperative course. Despite a recently developed international definition of Textbook Outcome in Liver Surgery (TOLS), a standardized and expert consensus-based definition is lacking.

Methods:

This international, consensus-based, qualitative study used a Delphi process to achieve consensus on the definition of TOLS. The survey comprised 6 surgical domains with a total of 26 questions on individual surgical outcome variables. The process included 4 rounds of online questionnaires. Consensus was achieved when a threshold of at least 80% agreement was reached. The results from the Delphi rounds were used to establish an international definition of TOLS.

Results:

In total, 44 expert liver surgeons from 22 countries and all 3 major international hepato-pancreato-biliary associations completed round 1. Forty-two (96%), 41 (98%), and 41 (98%) of the experts participated in round 2, 3, and 4, respectively. The TOLS definition derived from the consensus process included the absence of intraoperative grade ≥2 incidents, postoperative bile leakage grade B/C, postoperative liver failure grade B/C, 90-day major postoperative complications, 90-day readmission due to surgery-related major complications, 90-day/in-hospital mortality, and the presence of R0 resection margin.

Conclusions:

This is the first study providing an international expert consensus-based definition of TOLS for minimally invasive and open liver resections by the use of a formal Delphi consensus approach. TOLS may be useful in assessing patient-level hospital performance and carrying out international comparisons between centers with different clinical practices to further improve patient outcomes.

中文翻译：

关于定义肝脏手术教科书结果 (TOLS) 的国际专家德尔菲共识

客观的：

使用改良的德尔菲法，由国际知名肝外科医生专家就微创和开腹肝切除术中 TOLS 的定义达成全球专家共识。

背景：

教科书结果是一种新颖的综合衡量标准，将最理想的术后结果结合到一个单一的衡量标准中，代表了理想的术后过程。尽管最近制定了肝脏手术教科书结果（TOLS）的国际定义，但仍缺乏标准化且基于专家共识的定义。

方法：

这项基于共识的国际定性研究使用德尔菲法就 TOLS 的定义达成共识。该调查包括 6 个手术领域，总共有 26 个关于个体手术结果变量的问题。该过程包括 4 轮在线问卷。当达到至少 80% 的同意率时，就达成了共识。德尔菲轮次的结果被用来建立 TOLS 的国际定义。

结果：

总共有来自 22 个国家和所有 3 个主要国际肝胰胆协会的 44 名肝外科医生专家完成了第一轮。其中 42 名（96%）、41 名（98%）和 41 名（98%）专家参加了分别是第2轮、第3轮和第4轮。 TOLS定义源自共识过程，包括术中不存在≥2级事件、术后胆漏B/C级、术后肝衰竭B/C级、术后90天主要并发症、因手术相关而导致的90天再入院主要并发症、90 天/院内死亡率以及 R0 切除边缘的存在。