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