TY - JOUR
T1 - Consensus guidelines for the definition of time-to-event end points in image-guided tumor ablation
T2 - Results of the sio and datecan initiative
AU - SIO and DATECAN Initiative
AU - Puijk, Robbert S
AU - Ahmed, Muneeb
AU - Adam, Andreas
AU - Arai, Yasuaki
AU - Arellano, Ronald
AU - de Baère, Thierry
AU - Bale, Reto
AU - Bellera, Carine
AU - Binkert, Christoph A
AU - Brace, Christopher L
AU - Breen, David J
AU - Brountzos, Elias
AU - Callstrom, Matthew R
AU - Carrafiello, Gianpaolo
AU - Chapiro, Julius
AU - de Cobelli, Francesco
AU - Coupé, Veerle M H
AU - Crocetti, Laura
AU - Denys, Alban
AU - Dupuy, Damian E
AU - Erinjeri, Joseph P
AU - Filippiadis, Dimitris
AU - Gangi, Afshin
AU - Gervais, Debra A
AU - Gillams, Alice R
AU - Greene, Tissy
AU - Guiu, Boris
AU - Helmberger, Thomas
AU - Iezzi, Roberto
AU - Kang, Tae Wook
AU - Kelekis, Alexis
AU - Kim, Hyun S
AU - Kröncke, Thomas
AU - Kwan, Sharon
AU - Lee, Min Woo
AU - Lee, Fred T
AU - Lee, Edward W
AU - Liang, Ping
AU - Lissenberg-Witte, Birgit I
AU - Lu, David S
AU - Madoff, David C
AU - Mauri, Giovanni
AU - Meloni, Maria Franca
AU - Morgan, Robert
AU - Nadolski, Gregory
AU - Narayanan, Govindarajan
AU - Newton, Isabel
AU - Nikolic, Boris
AU - Scheffer, Hester J
AU - Meijerink, Martijn R
AU - Goldberg, S. Nahum
N1 - Publisher Copyright: © 2021 Radiological Society of North America Inc.. All rights reserved.
PY - 2021/12/1
Y1 - 2021/12/1
N2 - 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.
AB - 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.
KW - Ablation Techniques/methods
KW - Consensus
KW - Humans
KW - Neoplasms/surgery
KW - Reproducibility of Results
KW - Societies, Medical
UR - http://www.scopus.com/inward/record.url?scp=85120079289&partnerID=8YFLogxK
U2 - https://doi.org/10.1148/radiol.2021203715
DO - https://doi.org/10.1148/radiol.2021203715
M3 - Review article
C2 - 34581627
SN - 0033-8419
VL - 301
SP - 533
EP - 540
JO - Radiology
JF - Radiology
IS - 3
ER -