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.
Highlights
The coordinating committee drafted a list of 62 key opinion leaders in the field of interventional oncology
The panelists had an average of 20.9 years of experience in the field of interventional radiology, 11.1 years of experience in clinical trials serving as principal investigator, and 17.7 years of experience in clinical trials serving as collaborator
The continuing emergence of novel treatment options and growing demand for minimally invasive imageguided tumor ablation techniques have raised the need for evidence-based interventional oncology, and with that comes the need for clear documentation of oncologic outcome parameters
Summary
The initial methodology was developed and previously applied in four disease-specific projects, including pancreatic cancer [10], sarcoma and gastrointestinal stromal tumor [11], breast cancer [12], and renal cell cancer [13] initiatives. Institutional review board approval was not required as this study does not involve human participants. Coordinating Committee The coordinating committee (Table E1 [online]) was composed of Society of Interventional Oncology research committee members Nadolski, I.N.), one representative from the Definition for the Assessment of Time-to-Event End Points in Cancer Trials Initiative (C.B.), one health economist (V.M.H.C.), two epidemiologists (V.M.H.C., B.I.L.W.), one study coordinator (R.S.P.), and one operations manager (T.G.). The coordinating committee was responsible for the methodologic protocol and conduct I.N., C.B.), survey and questionnaires (all coordinating committee members), data collection and analysis (M.R.M., R.S.P., S.N.G., M.A., C.B., V.M.H.C., B.I.L.W.), and guideline and manuscript preparation (all coordinating committee members)
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