Consensus Guidelines for the Definition of Time-to-Event End Points in Image-guided Tumor Ablation: Results of the SIO and DATECAN Initiative,Radiology

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Consensus Guidelines for the Definition of Time-to-Event End Points in Image-guided Tumor Ablation: Results of the SIO and DATECAN Initiative
Radiology ( IF 19.7 ) Pub Date : 2021-09-28 , DOI: 10.1148/radiol.2021203715
Robbert S Puijk ₁ , Muneeb Ahmed ₁ , Andreas Adam ₁ , Yasuaki Arai ₁ , Ronald Arellano ₁ , Thierry de Baère ₁ , Reto Bale ₁ , Carine Bellera ₁ , Christoph A Binkert ₁ , Christopher L Brace ₁ , David J Breen ₁ , Elias Brountzos ₁ , Matthew R Callstrom ₁ , Gianpaolo Carrafiello ₁ , Julius Chapiro ₁ , Francesco de Cobelli ₁ , Veerle M H Coupé ₁ , Laura Crocetti ₁ , Alban Denys ₁ , Damian E Dupuy ₁ , Joseph P Erinjeri ₁ , Dimitris Filippiadis ₁ , Afshin Gangi ₁ , Debra A Gervais ₁ , Alice R Gillams ₁ , Tissy Greene ₁ , Boris Guiu ₁ , Thomas Helmberger ₁ , Roberto Iezzi ₁ , Tae Wook Kang ₁ , Alexis Kelekis ₁ , Hyun S Kim ₁ , Thomas Kröncke ₁ , Sharon Kwan ₁ , Min Woo Lee ₁ , Fred T Lee ₁ , Edward W Lee ₁ , Ping Liang ₁ , Birgit I Lissenberg-Witte ₁ , David S Lu ₁ , David C Madoff ₁ , Giovanni Mauri ₁ , Maria Franca Meloni ₁ , Robert Morgan ₁ , Gregory Nadolski ₁ , Govindarajan Narayanan ₁ , Isabel Newton ₁ , Boris Nikolic ₁ , Franco Orsi ₁ , Philippe L Pereira ₁ , Uei Pua ₁ , Hyunchul Rhim ₁ , Jens Ricke ₁ , William Rilling ₁ , Riad Salem ₁ , Hester J Scheffer ₁ , Constantinos T Sofocleous ₁ , Luigi A Solbiati ₁ , Stephen B Solomon ₁ , Michael C Soulen ₁ , Daniel Sze ₁ , Raman Uberoi ₁ , Thomas J Vogl ₁ , David S Wang ₁ , Bradford J Wood ₁ , S Nahum Goldberg ₁ , Martijn R Meijerink ₁

Affiliation

From the Department of Radiology, Center of Image-guided Tumor Ablation, Amsterdam University Medical Centers, Location VUMC, De Boelelaan 1117, 1081 HV Amsterdam, the Netherlands (R.S.P., H.J.S., M.R.M.); Department of Radiology, Onze Lieve Vrouwe Gasthuis (OLVG) Hospital, Amsterdam, the Netherlands (R.S.P.); Department of Radiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass (M.A., S.N.G.); Department of Radiology, King's College, St Thomas' Hospital, London, England (A.A.); Department of Radiology, National Cancer Center Hospital, Tokyo, Japan (Y.A.); Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, Mass (R.A., D.A.G.); Department of Radiology, Institut de Cancérologie Gustave Roussy, Villejuif, France (T.d.B.); Department of Radiology, Medical University Innsbruck, Innsbruck, Austria (R.B.); Clinical and Epidemiological Research Unit, Comprehensive Cancer Centre, Institut Bergonié, Bordeaux, France (C.B.); Department of Radiology, Kantonsspital Winterthur, Winterthur, Switzerland (C.A.B.); Department of Radiology, Biomedical Engineering, and Medical Physics, University of Wisconsin School of Medicine and Public Health, Madison, Wis (C.L.B., F.T.L.); Department of Radiology, University Hospital Southampton, Southampton, England (D.J.B.); 2nd Department of Radiology, University General Hospital "ATTIKON" Medical School, National and Kapodistrian University of Athens, Athens, Greece (E.B., D.F., A.K.); Department of Radiology, Mayo Clinic, Rochester, Minn (M.R.C.); Department of Radiology, Dipartimento di Scienze Medico-Chirurgiche, IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy (G.C.); Department of Radiology, Yale University School of Medicine, New Haven, Conn (J.C., H.S.K., D.C.M.); Department of Radiology, IRCCS Ospedale San Raffaele, Milan, Italy (F.d.C.); Department of Epidemiology and Data Science, Decision Modeling Center, Amsterdam University Medical Centers, Location VUMC, Amsterdam, the Netherlands (V.M.H.C., B.I.L.W.); Department of Radiology, University of Pisa, Pisa University Hospital, Pisa, Italy (L.C.); Department of Radiology, CHUV University of Lausanne, Lausanne, Switzerland (A.D.); and Department of Radiology, Brown Medical School, Cape Cod Hospital, Hyannis, Mass (D.E.D.); Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY (J.P.E., C.T.S., S.B.S.); Department of Radiology, University Hospital of Strasbourg, Strasbourg, France (A.G.); Department of Radiology, The London Clinic, London, England (A.R.G.); Society of Interventional Oncology, Washington, DC (T.G.); Department of Radiology, University Hospital of Dijon, Dijon, France (B.G.); Department of Radiology, University Hospitals Schlewsig-Holstein, Lübeck, Germany (T.H.); Department of Radiology, Agostino Gemelli University Policlinic, Catholic University of the Sacred Heart, Rome, Italy (R.I.); Department of Radiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea (T.W.K., M.W.L., H.R.); Department of Radiology, Universitätsklinikum Augsburg, Augsburg, Germany (T.K.); Department of Radiology, University of Washington Medical Center, Seattle, Wash (S.K.); Department of Radiology, David Geffen School of Medicine, Ronald Reagan UCLA Medical Center, Los Angeles, Calif (E.W.L., D.S.L.); Department of Radiology, Chinese PLA General Hospital, Beijing, China (P.L.); Department of Radiology, IEO Istituto Europeo di Oncologia, Gruppo Ospedaliero San Donato, Milan, Italy (G.M.); Department of Radiology, Ospedale Valduce, Como, Italy (M.F.M.); Department of Radiology, St George's University Hospitals, London, England (R.M.); Department of Radiology, Hospital of the University of Pennsylvania, Philadelphia, Pa (G. Nadolski, M.C.S.); Department of Radiology, Baptist Health of South Florida, Miami Cardiac and Vascular Institute, Miami, Fla (G. Narayanan); Department of Radiology, University of California, San Diego Health, San Diego, Calif (I.N.); Department of Radiology, Cooley Dickinson Hospital, Northampton, Mass (B.N.); Department of Radiology, European Institute of Oncology, IRCCS, Milan, Italy (F.O.); Department of Radiology, Academic Hospital Ruprecht-Karls-University Heidelberg, SLK Clinics GmbH, Heilbronn, Germany (P.L.P.); Department of Radiology, Tan Tock Seng Hospital, Singapore (U.P.); Department of Radiology, Klinikum der Universität München, Munich, Germany (J.R.); Department of Radiology, Medical College of Wisconsin, Milwaukee, Wis (W.R.); Department of Radiology, Northwestern University, Chicago, Ill (R.S.); Department of Radiology, Humanitas University, Ospedale Generale, Milan, Italy (L.A.S.); Department of Radiology, Stanford University, Stanford University Medical Center, Stanford, Calif (D.S., D.S.W.); Department of Radiology, John Radcliffe Hospital, Oxford, England (R.U.); Department of Radiology, University of Frankfurt, University Hospital Frankfurt Johann Wolfgang Goethe-University, Frankfurt, Germany (T.J.V.); and Department of Radiology and Imaging Science, National Institutes of Health, Bethesda, Md (B.J.W.); Department of Radiology, Image-guided Therapy and Interventional Oncology Unit, Hadassah Hebrew University Hospital, Jerusalem, Israel (S.N.G.); and Department of Radiology, Noordwest Ziekenhuisgroep, Alkmaar, the Netherlands (M.R.M.).

There is currently no consensus regarding preferred clinical outcome measures following image-guided tumor ablation or clear definitions of oncologic end points. This consensus document proposes standardized definitions for a broad range of oncologic outcome measures with recommendations on how to uniformly document, analyze, and report outcomes. The initiative was coordinated by the Society of Interventional Oncology in collaboration with the Definition for the Assessment of Time-to-Event End Points in Cancer Trials, or DATECAN, group. According to predefined criteria, based on experience with clinical trials, an international panel of 62 experts convened. Recommendations were developed using the validated three-step modified Delphi consensus method. Consensus was reached on when to assess outcomes per patient, per session, or per tumor; on starting and ending time and survival time definitions; and on time-to-event end points. Although no consensus was reached on the preferred classification system to report complications, quality of life, and health economics issues, the panel did agree on using the most recent version of a validated patient-reported outcome questionnaire. This article provides a framework of key opinion leader recommendations with the intent to facilitate a clear interpretation of results and standardize worldwide communication. Widespread adoption will improve reproducibility, allow for accurate comparisons, and avoid misinterpretations in the field of interventional oncology research.

Published under a CC BY 4.0 license.

Online supplemental material is available for this article.

See also the editorial by Liddell in this issue.

中文翻译：

在图像引导的肿瘤消融中定义时间到事件终点的共识指南：SIO 和 DATECAN 计划的结果

目前对于图像引导肿瘤消融后的首选临床结果测量或肿瘤学终点的明确定义尚无共识。该共识文件为广泛的肿瘤学结局指标提出了标准化定义，并就如何统一记录、分析和报告结局提出了建议。该倡议由介入肿瘤学会与癌症试验中事件终点评估定义或 DATECAN 小组合作协调。根据预先确定的标准，根据临床试验的经验，召集了一个由 62 位专家组成的国际小组。建议是使用经过验证的三步修改德尔福共识方法制定的。就何时评估每个患者、每个疗程或每个肿瘤的结果达成了共识；关于开始和结束时间以及生存时间的定义；以及事件发生时间终点。尽管没有就报告并发症、生活质量和健康经济学问题的首选分类系统达成共识，但专家组确实同意使用最新版本的经验证的患者报告结果问卷。本文提供了一个关键意见领袖建议的框架，旨在促进对结果的清晰解释和标准化全球交流。广泛采用将提高可重复性，允许准确比较，并避免介入肿瘤学研究领域的误解。尽管没有就报告并发症、生活质量和健康经济学问题的首选分类系统达成共识，但专家组确实同意使用最新版本的经验证的患者报告结果问卷。本文提供了一个关键意见领袖建议的框架，旨在促进对结果的清晰解释和标准化全球交流。广泛采用将提高可重复性，允许准确比较，并避免介入肿瘤学研究领域的误解。尽管没有就报告并发症、生活质量和健康经济学问题的首选分类系统达成共识，但专家组确实同意使用最新版本的经验证的患者报告结果问卷。本文提供了一个关键意见领袖建议的框架，旨在促进对结果的清晰解释和标准化全球交流。广泛采用将提高可重复性，允许准确比较，并避免介入肿瘤学研究领域的误解。本文提供了一个关键意见领袖建议的框架，旨在促进对结果的清晰解释和标准化全球交流。广泛采用将提高可重复性，允许准确比较，并避免介入肿瘤学研究领域的误解。本文提供了一个关键意见领袖建议的框架，旨在促进对结果的清晰解释和标准化全球交流。广泛采用将提高可重复性，允许准确比较，并避免介入肿瘤学研究领域的误解。

在 CC BY 4.0 许可下发布。

本文提供了在线补充材料。

另请参阅本期 Liddell 的社论。

更新日期：2021-11-23

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