Consensus Guidelines for the Definition of Time-to-Event End Points in Image-guided Tumor Ablation: Results of the SIO and DATECAN Initiative.
Fiche publication
Date publication
septembre 2021
Journal
Radiology
Auteurs
Membres identifiés du Cancéropôle Est :
Pr GANGI Afshin
Tous les auteurs :
Puijk RS, Ahmed M, Adam A, Arai Y, Arellano R, de Baère T, Bale R, Bellera C, Binkert CA, Brace CL, Breen DJ, Brountzos E, Callstrom MR, Carrafiello G, Chapiro J, de Cobelli F, Coupé VMH, Crocetti L, Denys A, Dupuy DE, Erinjeri JP, Filippiadis D, Gangi A, Gervais DA, Gillams AR, Greene T, Guiu B, Helmberger T, Iezzi R, Kang TW, Kelekis A, Kim HS, Kröncke T, Kwan S, Lee MW, Lee FT, Lee EW, Liang P, Lissenberg-Witte BI, Lu DS, Madoff DC, Mauri G, Meloni MF, Morgan R, Nadolski G, Narayanan G, Newton I, Nikolic B, Orsi F, Pereira PL, Pua U, Rhim H, Ricke J, Rilling W, Salem R, Scheffer HJ, Sofocleous CT, Solbiati LA, Solomon SB, Soulen MC, Sze D, Uberoi R, Vogl TJ, Wang DS, Wood BJ, Goldberg SN, Meijerink MR
Lien Pubmed
Résumé
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. See also the editorial by Liddell in this issue.
Référence
Radiology. 2021 Sep 28;:203715