Consensus Guidelines in Image-guided Tumor Ablation: Toward Evidence-based Interventional Oncology
2021; Radiological Society of North America; Volume: 301; Issue: 3 Linguagem: Inglês
10.1148/radiol.2021210577
ISSN1527-1315
Autores Tópico(s)Advanced Radiotherapy Techniques
ResumoHomeRadiologyVol. 301, No. 3 PreviousNext Reviews and CommentaryFree AccessEditorialConsensus Guidelines in Image-guided Tumor Ablation: Toward Evidence-based Interventional OncologyRobert P. Liddell Robert P. Liddell Author AffiliationsFrom the Department of Radiology and Radiological Sciences, Johns Hopkins School of Medicine, 1800 Orleans St, Sheik Zayed Tower, Suite 7203, Baltimore, MD 21287.Address correspondence to the author (e-mail: [email protected]).Robert P. Liddell Published Online:Sep 28 2021https://doi.org/10.1148/radiol.2021210577MoreSectionsPDF ToolsImage ViewerAdd to favoritesCiteTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinked In See also the article by Puijk et al in this issue.Dr Liddell is an assistant professor in the division of vascular and interventional radiology in the Russell H. Morgan Department of Radiology and Radiological Science at the Johns Hopkins University School of Medicine. He also holds appointments in the departments of surgery and oncology at Johns Hopkins. Dr Liddell’s clinical and research interests focus on interventional oncology, interventional training, simulation, new devices, and procedures.Download as PowerPointOpen in Image Viewer Image-guided tumor ablation refers to a group of treatment modalities that have evolved over the past 2 decades as important minimally invasive tools in the treatment of a wide range of tumors throughout the body (1). Although most widely used in the treatment of hepatic and renal tumors, the role of image-guided tumor ablation has expanded to include lesions of the lung, bone, breast, prostate, and other organs and its clinical applications continue to increase. As more studies are published describing these techniques, an ever-increasing number of outcome measures have been used as surrogates for overall survival. These end points are generally composite “time-to-event” end points, such as progression-free survival or disease-free survival. Although these end points are commonly used in the interventional oncology literature, they are generally poorly defined and are often specific to the particular trial in which they are being used (2). The lack of standardized definitions within the interventional oncology literature limits the use of these end points as outcomes measures, directly impacting trial results by affecting the estimated treatment effects and trials’ statistical power, and, importantly, limiting comparison between studies and techniques.In response to the lack of standardization, the International Working Group on Image-Guided Tumor Ablation published a document that proposed terminology and reporting criteria related to image-guided tumor ablation (3). Their efforts were intended to facilitate effective communication for reporting the various aspects of image-guided tumor ablation, including classification of techniques, procedure terms, descriptors of imaging guidance, and terminology of imaging and pathologic findings. Also addressed were methods for standardizing reporting of technique, follow-up timing, complications, and clinical results. The guidelines proposed provided a framework with which to facilitate comparisons of studies and techniques in interventional oncology. However, clear definitions and recommendations on how to use and interpret outcome measures were not proposed.In this issue of Radiology, Puijk and colleagues (4) attempt to advance the field of interventional oncology toward a more evidence-based clinical specialty by presenting the first consensus guidelines for collecting, analyzing, and reporting time-to-event outcomes related to image-guided tumor ablation. The method by which the authors achieved consensus on these definitions and recommendations is not new to health care consensus guideline development. It is, however, new to interventional oncology and therefore worthy of further discussion.Consensus guidelines have increasingly become an integral part of evidence-based health care not only in individual and institutional clinical practices, but also with governments and payers (5). Consensus guidelines in health care are recommendations that are provided by a body of experts who conduct a systemic review of the data on how to treat or diagnose disease, with the aim of better patient outcomes. These guidelines provide evidence that is meant to (a) serve as a framework for informed clinical decisions intended to improve patient outcomes; (b) help incorporate best available evidence into clinical medicine—a tool to close the gap between the current standard of care and what evidence supports; (c) reduce variation, prevent errors, and increase clinicians’ accountability in patient care; (d) reduce per capita health care costs and improve resource utilization; (e) focus on quality control; and (f) help researchers identify gaps in the evidence and what key research questions have yet to be answered.It is important to be clear what consensus guideline development is and is not. It is a process for making guidelines, not a scientific method for creating new knowledge. At its best, consensus development makes the best use of available information, be that scientific data or the collective wisdom of the participants. It is only since the 1950s that formal consensus development methods have been used in the health care sector (6). The case for using formal methods is based on a number of assumptions about decision-making in groups, as follows: (a) Several people are less likely than a single individual to arrive at a wrong decision; (b) a selected group of individuals is more likely to lend some authority to the decision produced; (c) decisions are improved by a reasoned argument in which assumptions are challenged and members are forced to justify their views; (d) by providing a structured process, formal methods can eliminate negative aspects of group decision-making; and (e) formal consensus methods meet requirements of scientific methods.Puijk et al used a modified Delphi method of consensus building to define outcomes measures for image-guided tumor ablation (4). The Delphi method was initially developed by the RAND Corporation in the 1950s to synthesize expert opinion, mainly in evaluating emerging technologies (6). Since then, the Delphi method has been used in health care as a reliable means of determining consensus for many clinical issues (7). This method is an iterative process that uses a systemic progression of repeated rounds of questionnaires and is an effective process for determining expert group consensus where there is little or no definitive evidence and where expert opinion is important. Using this technique, Puijk et al effectively achieved consensus on 59 of 62 time-to-event definitions and recommendations (4). Included within these guidelines were when to assess outcomes per patient, per session, and per tumor; starting and ending times; survival time definitions; and time-to-event end points. The modified Delphi method consisted of two rounds of questionnaires and a final face-to-face meeting (8). The anonymous nature of the first two rounds of this method prevents participants from conforming to the opinions of others while providing a controlled feedback process. The final face-to-face round, on the other hand, is critical in consensus development, as it encourages participating experts to provide clarification and present arguments justifying their viewpoints. These characteristics are designed to offset the shortcomings of conventional means of pooling opinions obtained by group interaction (ie, influences of dominant individuals, noise, and group pressure for conformity).Despite the many strengths of the Delphi method in consensus building, there are potential shortcomings. Choosing the appropriate experts to participate has been described as the most important step in the entire process because it directly relates to the quality of the results generated (8). Regarding any standards for selecting participants, there is, in fact, no exact criterion. It is generally accepted that participants should be experts within the specialized area of knowledge related to the target issue. It is also recommended that researchers use a minimally sufficient number of experts to provide a “representative pooling of judgements” regarding the target issue, with most Delphi studies using between 15 and 20 participants (8). If the number of participants is too large, the drawbacks inherent within the Delphi method, such as potentially low response rates and the obligation of large blocks of time by the experts, can be the result. In fact, Puijk et al (4) enlisted a relatively large number of opinion leaders in interventional oncology (n = 62), perhaps explaining the modest response rates of 58%, 56%, and 54% for rounds 1, 2, and 3, respectively. Given the large number of participants, it is also not surprising it took over 9 months to achieve consensus on 59 of the 62 recommendations and definitions. Consensus was unfortunately not reached for the preferred classification system to document, analyze, and report complications and adverse events and quality-of-life and health economics issues. One can hope that these will be addressed in the near future by a group of interventional oncology opinion leaders.Ideally, clinical guidelines are based on evidence derived from rigorously conducted empirical studies. In practice, however, there are few areas of health care where sufficient research-based evidence exists or may ever exist. In such situations, the development of guidelines inevitably must be based largely on consensus opinions and experience of clinicians and others with knowledge of the subject at issue. The consensus guidelines presented by Puijk et al (4) in this issue of Radiology represent a significant step forward for evolving the field of interventional oncology toward its goal of becoming an established evidence-based clinical specialty.Disclosures of Conflicts of Interest: R.P.L. disclosed no relevant relationships.References1. Knavel EM, Brace CL. Tumor ablation: common modalities and general practices. Tech Vasc Interv Radiol 2013;16(4):192–200. Crossref, Medline, Google Scholar2. Mathoulin-Pelissier S, Gourgou-Bourgade S, Bonnetain F, Kramar A. Survival end point reporting in randomized cancer clinical trials: a review of major journals. J Clin Oncol 2008;26(22):3721–3726. Crossref, Medline, Google Scholar3. Ahmed M, Solbiati L, Brace CL, et al. Image-guided tumor ablation: standardization of terminology and reporting criteria—a 10-year update. Radiology 2014;273(1):241–260. Link, Google Scholar4. Puijk RS, Ahmed M, Goldberg SN, et al. Consensus guidelines for the definition of time-to-event end points in image-guided tumor ablation: Results of the SIO and DATECAN initiative. Radiology 2021;301(3):533–540. Link, Google Scholar5. Nair R, Aggarwal R, Khanna D. Methods of formal consensus in classification/diagnostic criteria and guideline development. Semin Arthritis Rheum 2011;41(2):95–105. Crossref, Medline, Google Scholar6. Dalkey N. Experimental study of group opinion – Delphi method. Futures 1969;1(5):408–426. Crossref, Google Scholar7. Jones J, Hunter D. Consensus methods for medical and health services research. BMJ 1995;311(7001):376–380. Crossref, Medline, Google Scholar8. Hsu CC, Sandford BA. The Delphi technique: Making sense of consensus. Pract Assess Res Eval 2007;12(10):1–8. Google ScholarArticle HistoryReceived: Mar 2 2021Revision requested: Mar 12 2021Revision received: July 7 2021Accepted: July 12 2021Published online: Sept 28 2021Published in print: Dec 2021 FiguresReferencesRelatedDetailsAccompanying This ArticleConsensus Guidelines for the Definition of Time-to-Event End Points in Image-guided Tumor Ablation: Results of the SIO and DATECAN InitiativeSep 28 2021RadiologyRecommended Articles Consensus Guidelines for the Definition of Time-to-Event End Points in Image-guided Tumor Ablation: Results of the SIO and DATECAN InitiativeRadiology2021Volume: 301Issue: 3pp. 533-540Achieving Curative Ablation Outcomes: It Is All about the ImagingRadiology2020Volume: 298Issue: 1pp. 219-220Microwave Ablation versus Surgery for Papillary Thyroid Carcinoma: More Therapeutic Options, More ControversiesRadiology2022Volume: 304Issue: 3pp. 714-715Updates and New Frontiers in Interventional Radiology The 2022 RadioGraphics Monograph IssueRadioGraphics2022Volume: 42Issue: 6pp. 1577-1578Preventing Colorectal Metastatic Tumor Growth Caused by Radiofrequency AblationRadiology2019Volume: 294Issue: 2pp. 473-474See More RSNA Education Exhibits Novel Image-Guided Micro-Invasive Percutaneous Treatments of Breast Lesions: Where Do We Stand?Digital Posters2019Engaging Medical Students in Interventional Radiology: In the Era of the New Integrated IR ResidencyDigital Posters2018Immune Effector Cell Therapy for Solid Tumors: Opportunities for Interventional RadiologyDigital Posters2019 RSNA Case Collection Intra-articular Osteoid OsteomaRSNA Case Collection2020Cerebral Air EmboliRSNA Case Collection2021Sternectomy after infected sternotomyRSNA Case Collection2021 Vol. 301, No. 3 Metrics Altmetric Score PDF download
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