Article Text
Abstract
Introduction Sentinel lymph node dissection is widely used in the staging of endometrial cancer. Variation in surgical techniques potentially impacts diagnostic accuracy and oncologic outcomes, and poses barriers to the comparison of outcomes across institutions or clinical trial sites. Standardization of surgical technique and surgical quality assessment tools are critical to the conduct of clinical trials. By identifying mandatory and prohibited steps of sentinel lymph node (SLN) dissection in endometrial cancer, the purpose of this study was to develop and validate a competency assessment tool for use in surgical quality assurance.
Methods A Delphi methodology was applied, included 35 expert gynecological oncology surgeons from 16 countries. Interviews identified key steps and tasks which were rated mandatory, optional, or prohibited using questionnaires. Using the surgical steps for which consensus was achieved, a competency assessment tool was developed and subjected to assessments of validity and reliability.
Results Seventy percent consensus agreement standardized the specific mandatory, optional, and prohibited steps of SLN dissection for endometrial cancer and informed the development of a competency assessment tool. Consensus agreement identified 21 mandatory and three prohibited steps to complete a SLN dissection. The competency assessment tool was used to rate surgical quality in three preselected videos, demonstrating clear separation in the rating of the skill level displayed with mean skills summary scores differing significantly between the three videos (F score=89.4; P<0.001). Internal consistency of the items was high (Cronbach α=0.88).
Conclusion Specific mandatory and prohibited steps of SLN dissection in endometrial cancer have been identified and validated based on consensus among a large number of international experts. A competency assessment tool is now available and can be used for surgeon selection in clinical trials and for ongoing, prospective quality assurance in routine clinical care.
- sentinel lymph node
- surgical oncology
- surgical procedures
- operative
- uterine cancer
- endometrial neoplasms
Data availability statement
Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information. The authors confirm that the data supporting the findings of this study are available within the article and its supplementary materials.
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Data availability statement
Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information. The authors confirm that the data supporting the findings of this study are available within the article and its supplementary materials.
Footnotes
GH and AO are joint senior authors.
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Contributors KM, AO, MJ, and GH contributed to the design of the trial. KM, AO, and MJ contributed to manuscript writing. All authors contributed to data acquisition, interpretation of data, revising the draft for intellectual content, final approval of the version to be published, and agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy and integrity of any part of the work were appropriately investigated and resolved.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial, or not-for-profit sectors.
Competing interests AO reports grants and personal fees from Surgical Performance PTY LTD, grants from Medtronic, outside the submitted work; NRA-R reports grants from Stryker/Novadaq, outside the submitted work; MF reports grants from Astra Zeneca, grants from Tesaro/GSK, grants and personal fees from Stryker, grants from Biom’Up, outside the submitted work; ML reports Ad hoc consulting from Intuitive Surgical, serves on advisory board for Ethicon, partial grant support from NIH/NCI Memorial Sloan Kettering Cancer Center Support, outside the submitted work; TEI reports personal fees from Medtronic, personal fees from Intuitive Surgical, outside the submitted work; RK reports personal fees from Intuitive Surgical Inc., personal fees from Medtronic, personal fees from Medicaroid, outside the submitted work, and President of SERGS and Council Member of IGCS; HF reports personal fees from Intuitive Surgical Inc, outside the submitted work; JP reports personal fees from Intuitive Surgical Inc., outside the submitted work; AA reports grants and a site PI, speaker fees and serves on advisory board for Astrazeneca, serves on the advisory board for GSK, grants and grats and site Co-PI and speaker fees from Merck, speaker fees from Sanofi, grants from Pfizer, grants from Clovis, grants from CancerCare Manitoba Foundation, grants from Canadian Clinical Trials group, outside the submitted work.
Provenance and peer review Not commissioned; externally peer reviewed.
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