Περίληψη:
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.
Συγγραφείς:
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.
