{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T22:39:04Z","timestamp":1777588744064,"version":"3.51.4"},"reference-count":27,"publisher":"BMJ","issue":"6","license":[{"start":{"date-parts":[[2025,6,2]],"date-time":"2025-06-02T00:00:00Z","timestamp":1748822400000},"content-version":"unspecified","delay-in-days":1,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100015250","name":"NIHR Bristol Biomedical Research Centre","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100015250","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Royal College of Surgeons Surgical Trials Initiative"},{"DOI":"10.13039\/501100000272","name":"NIHR","doi-asserted-by":"crossref","award":["CS-2016-16-019"],"award-info":[{"award-number":["CS-2016-16-019"]}],"id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment Programme","doi-asserted-by":"publisher","award":["NIHR158400"],"award-info":[{"award-number":["NIHR158400"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,4,28]]},"published-print":{"date-parts":[[2025,6]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Patients with node-positive breast cancer having primary surgery currently undergo axillary node clearance (ANC) to reduce the risk of breast cancer recurrence. Evidence that this highly morbid procedure improves survival is lacking, but approximately 30% of patients will develop lifelong complications which significantly impact their quality of life.<\/jats:p>\n                    <jats:p>Targeted axillary dissection (TAD) may be a safe, less morbid alternative to ANC and will be evaluated in the upcoming Targeted Axillary Dissection versus axillary node clearance in patients with POsitive axillary Lymph nodes in Early breast cancer (TADPOLE) randomised controlled trial.<\/jats:p>\n                    <jats:p>TAD is not currently routine practice in patients having primary surgery, so it is vital that the procedure is performed in an agreed upon, standardised way within the trial and procedure fidelity monitored to ensure the results are generalisable and will be accepted by the surgical community. Robust surgical quality assurance (SQA) is essential. Here we describe the first phase of the TADPOLE SQA, a consensus process with the breast surgical community to agree upon how (1) surgery should be performed and standardised; (2) procedure fidelity will be monitored and (3) requirements for surgeon credentialling within the trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>The consensus process will have three phases:<\/jats:p>\n                    <jats:list list-type=\"order\">\n                      <jats:list-item>\n                        <jats:p>Generation of a long list of possible components of TAD from a scoping review and expert opinion. Identified items will be categorised and formatted into Delphi consensus questionnaire items.<\/jats:p>\n                      <\/jats:list-item>\n                      <jats:list-item>\n                        <jats:p>At least two rounds of an online Delphi survey in which at least 100 breast cancer surgeons will rate the importance of mandating\/prohibiting, standardising and\/or monitoring each component.<\/jats:p>\n                      <\/jats:list-item>\n                      <jats:list-item>\n                        <jats:p>A consensus meeting with surgeons to discuss, agree upon and ratify the approach to SQA within TADPOLE.<\/jats:p>\n                      <\/jats:list-item>\n                    <\/jats:list>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Ethical approval has been obtained from the University of Bristol Faculty of Health Sciences Ethics Committee. Educational materials including videos and webinars will be developed and shared with surgeons participating in TADPOLE. Results will be presented at national\/international meetings and published in peer-reviewed journals.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2024-095774","type":"journal-article","created":{"date-parts":[[2025,6,3]],"date-time":"2025-06-03T04:30:33Z","timestamp":1748925033000},"page":"e095774","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":2,"title":["Consensus process to agree upon surgical quality assurance processes within a pragmatic, multicentre randomised clinical trial comparing targeted axillary dissection and axillary node clearance: the TADPOLE-TOGETHER project"],"prefix":"10.1136","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6977-312X","authenticated-orcid":false,"given":"Shelley","family":"Potter","sequence":"first","affiliation":[{"name":"Translational Health Sciences, Bristol Medical School, Bristol, UK"},{"name":"Bristol Breast Care Centre, NHS North Bristol NHS Trust, Bristol, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ruth","family":"Mullan","sequence":"additional","affiliation":[{"name":"Patrick G Johnston Centre for Cancer Research, Queen\u2019s University Belfast Faculty of Medicine Health and Life Sciences, Belfast, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Henry","family":"Cain","sequence":"additional","affiliation":[{"name":"Breast Surgery, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Edward St","family":"John","sequence":"additional","affiliation":[{"name":"Breast Surgery, Portsmouth Hospitals University NHS Trust, Portsmouth, UK"},{"name":"Research Group in Breast Health, University of Portsmouth, Portsmouth, Hampshire, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Barry","sequence":"additional","affiliation":[{"name":"Breast Surgery, Royal Marsden Hospital NHS Trust, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5895-5059","authenticated-orcid":false,"given":"Yazan","family":"Masannat","sequence":"additional","affiliation":[{"name":"Mid and South Essex NHS Foundation Trust, Basildon, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James R","family":"Harvey","sequence":"additional","affiliation":[{"name":"Nightingale Centre, Wythenshawe Hospital, Manchester, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Katherine","family":"Fairhurst","sequence":"additional","affiliation":[{"name":"Translational Health Sciences, University of Bristol Medical School, Bristol, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adrienne","family":"Morgan","sequence":"additional","affiliation":[{"name":"ICPV, Independent Cancer Patients\u2019 Voice, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Margaret","family":"Perkins","sequence":"additional","affiliation":[{"name":"ICPV, Independent Cancer Patients\u2019 Voice, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"G Bruce","family":"Mann","sequence":"additional","affiliation":[{"name":"Breast Surgery, The Royal Melbourne Hospital, Parkville, Victoria, Australia"},{"name":"The Royal Women\u2019s Hospital, Parkville, Victoria, Australia"},{"name":"ANZ Breast Cancer Trials Group Ltd, Hunter Region Mail Centre, New South Wales, Australia"},{"name":"Department of Surgery, University of Melbourne VCCC, Parkville, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jocelyn","family":"Lippey","sequence":"additional","affiliation":[{"name":"Department of Surgery, University of Melbourne VCCC, Parkville, Victoria, Australia"},{"name":"St Vincent\u2019s BreastScreen, St Vincent\u2019s Hospital (Melbourne) Limited, Fitzroy, Victoria, Australia"},{"name":"Department of Surgery, St Vincent\u2019s Hospital (Melbourne) Limited, Fitzroy, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6111-2175","authenticated-orcid":false,"given":"Natalie S","family":"Blencowe","sequence":"additional","affiliation":[{"name":"Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4123-9611","authenticated-orcid":false,"given":"Stuart A","family":"McIntosh","sequence":"additional","affiliation":[{"name":"Patrick G Johnston Centre for Cancer Research, Queen\u2019s University Belfast Faculty of Medicine Health and Life Sciences, Belfast, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2025,6,3]]},"reference":[{"key":"2025121409463390000_15.6.e095774.1","unstructured":"NICE . Early and locally advanced breast cancer: diagnosis and management NICE guideline [NG101]. 2018. Available: https:\/\/www.nice.org.uk\/guidance\/ng101"},{"key":"2025121409463390000_15.6.e095774.2","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(18)30380-2"},{"key":"2025121409463390000_15.6.e095774.3","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(13)70035-4"},{"key":"2025121409463390000_15.6.e095774.4","doi-asserted-by":"publisher","DOI":"10.1097\/SLA.0b013e3181f08f32"},{"key":"2025121409463390000_15.6.e095774.5","doi-asserted-by":"publisher","DOI":"10.1097\/SLA.0000000000001863"},{"key":"2025121409463390000_15.6.e095774.6","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2011.90"},{"key":"2025121409463390000_15.6.e095774.7","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2017.11470"},{"key":"2025121409463390000_15.6.e095774.8","doi-asserted-by":"crossref","first-page":"920","DOI":"10.1245\/s10434-020-08923-7","article-title":"Axillary Management in Women with Early Breast Cancer and Limited Sentinel Node Metastasis: A Systematic Review and Metaanalysis of Real-World Evidence in the Post-ACOSOG Z0011 Era","volume":"28","author":"Huang","year":"2021","journal-title":"Ann Surg Oncol"},{"key":"2025121409463390000_15.6.e095774.9","doi-asserted-by":"crossref","first-page":"2561","DOI":"10.31557\/APJCP.2022.23.8.2561","article-title":"Comparing Early-Stage Breast Cancer Patients with Sentinel Lymph Node Metastasis with and without Completion Axillary Lymph Node Dissection: A Systematic Review and Meta-Analysis","volume":"23","author":"Heiranizadeh","year":"2022","journal-title":"Asian Pac J Cancer Prev"},{"key":"2025121409463390000_15.6.e095774.10","doi-asserted-by":"crossref","unstructured":"Mannu G , Beake G , Berry R , et al . GS02-05: overview of axillary treatment in early breast cancer: patient-level meta-analysis of long-term outcomes among 20,273 women in 29 randomised trials. 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Neoadjuvant chemotherapy: multidisciplinary guidance. 2023. 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