Development of a surgical competency assessment tool for sentinel lymph node dissection by minimally invasive surgery for endometrial cancer
Jazyk angličtina Země Anglie, Velká Británie Médium print-electronic
Typ dokumentu časopisecké články, multicentrická studie
Grantová podpora
P30 CA008748
NCI NIH HHS - United States
PubMed
33664126
PubMed Central
PMC9465805
DOI
10.1136/ijgc-2020-002315
PII: ijgc-2020-002315
Knihovny.cz E-zdroje
- Klíčová slova
- endometrial neoplasms, operative, sentinel lymph node, surgical oncology, surgical procedures, uterine cancer,
- MeSH
- biopsie sentinelové lymfatické uzliny metody normy MeSH
- delfská metoda MeSH
- dospělí MeSH
- gynekologie metody MeSH
- klinické kompetence MeSH
- konsensus MeSH
- lidé středního věku MeSH
- lidé MeSH
- miniinvazivní chirurgické výkony metody MeSH
- nádory endometria chirurgie MeSH
- průzkumy a dotazníky MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
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.
Clinical Sciences Obstetrics and Gynaecology Lund University Faculty of Medicine Lund Sweden
Division of Gynecologic Oncology Italy Ospedale Michele e Pietro Ferrero Verduno Italy
Faculty of Medicine The University of Queensland St Lucia Queensland Australia
Gynaecologic Oncology Fondazione IRCCS Istituto Nazionale dei Tumori Milan Italy
Gynaecologic Oncology John Hunter Hospital New Lambton Heights New South Wales Australia
Gynaecologic Oncology Mater Health Services Brisbane South Brisbane Queensland Australia
Gynaecologic Oncology National University Health System Singapore
Gynaecologic Oncology Royal Brisbane and Women's Hospital Herston Queensland Australia
Gynaecological Oncology Mercy Hospital for Women Heidelberg Victoria Australia
Gynaecological Oncology Royal Brisbane and Women's Hospital Herston Queensland Australia
Gynaecological Oncology Royal Marsden NHS Foundation Trust London UK
Gynaecology Oncology Mater Misericordiae University Hospital Dublin Ireland
Gynaecology St George's University of London London UK
Gynecologic Oncology CancerCare Manitoba Winnipeg Manitoba Canada
Gynecologic Oncology Clínica De Oncología Astorga Medellín Colombia
Gynecologic Oncology Instituto Nacional de Cancerologia Bogota Colombia
Gynecologic Oncology University Health Network Toronto Ontario Canada
Gynecologic Oncology University of Manitoba Winnipeg Manitoba Canada
Gynecology and Obstetrics Charles University 1st Faculty of Medicine Praha Praha Czech Republic
Gynecology and Obstetrics General University Hospital Prague Praha Czech Republic
Gynecology and Obstetrics University of Essen Essen Germany
Gynecology Leiden University Medical Center Leiden Zuid Holland The Netherlands
Gynecology Oncology Hospital Clinico San Borja Arriaran Santiago Chile
Gynecology Oncology Hospital General San Juan de Dios Guatemala Guatemala
Gynecology Oncology Universidad de Chile Santiago de Chile Chile
Obstetrics and Gynaecology National University of Singapore Singapore
Obstetrics and Gynaecology Royal Women's Hospital Parkville Victoria Australia
Obstetrics and Gynaecology Skanes Universitetssjukhus Lund Lund Skåne Sweden
Obstetrics and Gynaecology University of Toronto Toronto Ontario Canada
School of Medicine University College Dublin Dublin Ireland
Surgery and Cancer Imperial College London London UK
Surgical Oncology Institute Curie Paris France
Victorian Comprehensive Cancer Centre University of Melbourne Parkville Victoria Australia
Women's and Children's Health Karolinska Institute Stockholm Sweden
Women's and Children's Health Karolinska University Hospital Stockholm Sweden
Zobrazit více v PubMed
Cook JA. The challenges faced in the design, conduct and analysis of surgical randomised controlled trials. Trials 2009;10:1–9. PubMed PMC
Ergina PL, Cook JA, Blazeby JM, et al. Challenges in evaluating surgical innovation. Lancet 2009;374:1097–104. PubMed PMC
Simon C, Caballero C, Gregoire V, et al. Surgical quality assurance in head and neck cancer trials: an EORTC Head and Neck Cancer Group position paper based on the EORTC 1420 ‘Best of’ and 24954 ‘larynx preservation’ study. Eur J Cancer 2018;103:69–77. PubMed
Tsai AY-C, Mavroveli S, Miskovic D, et al. Surgical quality assurance in COLOR III: standardization and competency assessment in a randomized controlled trial. Ann Surg 2019;270:768–74. PubMed
Claassen YHM, de Steur WO, Hartgrink HH, et al. Surgicopathological quality control and protocol adherence to lymphadenectomy in the CRITICS Gastric Cancer Trial. Ann Surg 2018;268:1008–13. PubMed
Harris A, Butterworth J, Boshier PR, et al. Development of a reliable surgical quality assurance system for 2-stage esophagectomy in randomized controlled trials. Ann Surg 2020. doi:10.1097/SLA.0000000000003850. [Epub ahead of print: 27 Mar 2020]. PubMed DOI
Markar SR, Wiggins T, Ni M, et al. Assessment of the quality of surgery within randomised controlled trials for the treatment of gastro-oesophageal cancer: a systematic review. Lancet Oncol 2015;16:e23–31. PubMed
Amant F, Mirza MR, Koskas M, et al. Cancer of the corpus uteri. Int J Gynaecol Obstet 2015;131 Suppl 2:S96–104. PubMed
de Boer SM, Powell ME, Mileshkin L, et al. Adjuvant chemoradiotherapy versus radiotherapy alone in women with highrisk endometrial cancer (PORTEC-3): patterns of recurrence and post-hoc survival analysis of a randomised phase 3 trial. Lancet Oncol 2019;20:1273–85. PubMed PMC
Boronow RC, Morrow CP, Creasman WT, et al. Surgical staging in endometrial cancer: clinical-pathologic findings of a prospective study. Obstet Gynecol 1984;63:825–32. PubMed
Creasman WT, Morrow CP, Bundy BN, et al. Surgical pathologic spread patterns of endometrial cancer. A Gynecologic Oncology Group study. Cancer 1987;60:2035–41. PubMed
Mikuta JJ. International Federation of Gynecology and Obstetrics staging of endometrial cancer 1988: FIGO staging of endometrial cancer. Cancer 1993;71:1460–3. PubMed
Benedetti Panici P, Basile S, Maneschi F, et al. Systematic pelvic lymphadenectomy vs. no lymphadenectomy in early-stage endometrial carcinoma: randomized clinical trial. J Natl Cancer Inst 2008;100:1707–16. PubMed
Kitchener H, Swart AMC, group Astudy, et al., ASTEC Swart group. Efficacy of systematic pelvic lymphadenectomy in endometrial cancer (MRC ASTEC trial): a randomised study. Lancet 2009;373:125–36. PubMed PMC
National comprehensive cancer network practice guidelines in oncology: uterine neoplasms 2020.
Rossi EC. Current state of sentinel lymph nodes for women with endometrial cancer. Int J Gynecol Cancer 2019;29:613–21. PubMed
Abu-Rustum NR, Khoury-Collado F, Pandit-Taskar N, et al. Sentinel lymph node mapping for grade 1 endometrial cancer: is it the answer to the surgical staging dilemma? Gynecol Oncol 2009;113:163–9. PubMed PMC
Rossi EC, Kowalski LD, Scalici J, et al. A comparison of sentinel lymph node biopsy to lymphadenectomy for endometrial cancer staging (FIRES trial): a multicentre, prospective, cohort study. Lancet Oncol 2017;18:384–92. PubMed
Casarin J, Multinu F, Abu-Rustum N, et al. Factors influencing the adoption of the sentinel lymph node technique for endometrial cancer staging: an international survey of gynecologic oncologists. Int J Gynecol Cancer 2019;29:60–7. PubMed PMC
Holloway RW, Abu-Rustum NR, Backes FJ, et al. Sentinel lymph node mapping and staging in endometrial cancer: a Society of Gynecologic Oncology literature review with consensus recommendations. Gynecol Oncol 2017;146:405–15. PubMed PMC
Obermair A, Abu-Rustum NR. Sentinel lymph node mapping in endometrial cancer – areas where further research is needed. Int J Gynecol Cancer 2020;30:283–4. PubMed
Diamond IR, Grant RC, Feldman BM, et al. Defining consensus: a systematic review recommends methodologic criteria for reporting of Delphi studies. J Clin Epidemiol 2014;67:401–9. PubMed
Harris PA, Taylor R, Minor BL, et al. The REDCap Consortium: building an international community of software platform partners. J Biomed Inform 2019;95:103208:1–9. PubMed PMC
Harris PA, Taylor R, Thielke R, et al. Research electronic data capture (REDCap) – a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009;42:377–81. PubMed PMC
Foster JD, Mackenzie H, Nelson H, et al. Methods of quality assurance in multicenter trials in laparoscopic colorectal surgery: a systematic review. Ann Surg 2014;260:220–9. PubMed
Sprangers MA, Cull A, Bjordal K, et al. The European Organization for Research and Treatment of Cancer. approach to quality of life assessment: guidelines for developing questionnaire modules. EORTC Study Group on quality of life. Qual Life Res 1993;2:287–95. PubMed
Miskovic D, Ni M, Wyles SM, et al. Is competency assessment at the specialist level achievable? A study for the National Training Programme in laparoscopic colorectal surgery in England. Ann Surg 2013;257:476–82. PubMed
Curtis NJ, Foster JD, Miskovic D, et al. Association of surgical skill assessment with clinical outcomes in cancer surgery. JAMA Surg 2020;155:590–7. PubMed PMC
Cook JA, McCulloch P, Blazeby JM, et al. IDEAL framework for surgical innovation 3: randomised controlled trials in the assessment stage and evaluations in the long term study stage. BMJ 2013;346:f2820. PubMed PMC
Harold JA, Uyar D, Rader JS, et al. Adipose-only sentinel lymph nodes: a finding during the adaptation of a sentinel lymph node mapping algorithm with indocyanine green in women with endometrial cancer. Int J Gynecol Cancer 2019;29:53–9. PubMed
Janda M, Gebski V, Davies LC, et al. Effect of total laparoscopic hysterectomy vs total abdominal hysterectomy on diseasefree survival among women with stage I endometrial cancer: a randomized clinical trial. JAMA 2017;317:1224–33. PubMed
Ramirez PT, Frumovitz M, Pareja R, et al. Minimally invasive versus abdominal radical hysterectomy for cervical cancer. N Engl J Med 2018;379:1895–904. PubMed
Frumovitz M, Plante M, Lee PS, et al. Near-Infrared fluorescence for detection of sentinel lymph nodes in women with cervical and uterine cancers (FILM): a randomised, phase 3, multicentre, noninferiority trial. Lancet Oncol 2018;19:1394–403. PubMed PMC
Cusimano MC, Walker R, Bernardini MQ, et al. Implementing a cervical sentinel lymph node biopsy program: quality improvement in gynaecologic oncology. J Obstet Gynaecol Can 2017;39:659–67. PubMed
Consensus on surgical technique for sentinel lymph node dissection in cervical cancer