{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,15]],"date-time":"2026-06-15T08:55:10Z","timestamp":1781513710499,"version":"3.54.1"},"reference-count":20,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2026,6,15]],"date-time":"2026-06-15T00:00:00Z","timestamp":1781481600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,6,15]],"date-time":"2026-06-15T00:00:00Z","timestamp":1781481600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100000925","name":"National Health and Medical Research Council","doi-asserted-by":"publisher","award":["2035386"],"award-info":[{"award-number":["2035386"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100002956","name":"Cherish Women\u2019s Cancer Foundation","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100002956","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Res Involv Engagem"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Consumer involvement in clinical trials has developed to be a critical driver of feasibility and real-world translation. In gynaecological oncology, patient and clinician priorities can differ, particularly regarding acceptable risks and treatment burden. Vulvar cancer treatment typically involves a groin lymph node dissection, which carries significant morbidity, effecting the long-term health of patients. To address these harms, the Australian National Vulvar Cancer (ANVU) Phase 3 international randomised clinical trial (NCT06476639) will compare standard upfront groin lymph node dissection with serial groin ultrasound monitoring, a less invasive option, to reduce treatment burden without compromising survival. In this paper, research methodologists collaborated to bring consumer perspectives into the trial design to ensure the outcomes reflect what matters most to patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Main body<\/jats:title>\n                    <jats:p>We conducted a structured co-design workshop involving patients with lived experience of vulvar cancer as well as a multidisciplinary research team. The workshop explored priorities across three stages of care to determine the outcome measures for a clinical trial: before treatment, during treatment, and after treatment. Priority in the short-term was complete cancer removal, with acceptance of some short-term adverse effects. Medium-term priorities focused more on quality of life and functional recovery, as well as fear of recurrence. While long-term priorities identified avoiding chronic harms such as lymphoedema and maintaining a normal daily life, as important. These insights informed the trial\u2019s primary endpoint (survival following nodal metastasis at 30 months) and patient-centred secondary outcomes such as health-related quality of life, return to usual activities, and reduced chronic harms.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Patient priorities shift as they progress through the various stages of cancer treatment, highlighting the need for dynamic, patient-centred clinical trial designs. The ANVU trial aims to incorporate true co-design in complex surgical oncology research. With consumers as research partners, the team has produced a trial protocol that is scientifically robust as well as grounded in lived experience, increasing its potential for real-world impact. The current paper focuses on co-design of the outcome measures of the trial, however consumer involvement will remain ongoing throughout the ANVU trial to ensure that the research outcomes are accessible and enable women to be provided with treatment options which suit their needs.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s40900-026-00902-8","type":"journal-article","created":{"date-parts":[[2026,6,15]],"date-time":"2026-06-15T08:20:20Z","timestamp":1781511620000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Co-designing primary and secondary outcome measures for an international phase 3 trial of surgical de-escalation in vulvar cancer through a consumer workshop"],"prefix":"10.1186","volume":"12","author":[{"given":"Lauren","family":"Angel","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monika","family":"Janda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Martin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brianna","family":"Armstrong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Merran","family":"Williams","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicola Du","family":"Thaler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emma","family":"Wild","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"Obermair","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,6,15]]},"reference":[{"key":"902_CR1","doi-asserted-by":"publisher","first-page":"2022","DOI":"10.3389\/fpubh.2022.994547","volume":"10","author":"E DeBortoli","year":"2022","unstructured":"DeBortoli E, Soyer HP, Milne D, Dissanayaka N, Gartner C, Holt J, et al. Measurable outcomes of consumer engagement in health research: A scoping review. Front Public Health. 2022;10:2022.","journal-title":"Front Public Health"},{"issue":"1","key":"902_CR2","doi-asserted-by":"publisher","first-page":"110","DOI":"10.1186\/1471-2288-10-110","volume":"10","author":"LJL Forbes","year":"2010","unstructured":"Forbes LJL, Nicholls CM, Linsell L, Graham J, Tompkins C, Ramirez AJ. Involving users in the design of a randomised controlled trial of an intervention to promote early presentation in breast cancer: qualitative study. BMC Med Res Methodol. 2010;10(1):110.","journal-title":"BMC Med Res Methodol"},{"key":"902_CR3","first-page":"1","volume-title":"Handbook of Research Methods in Health Social Sciences","author":"N Manohar","year":"2018","unstructured":"Manohar N, MacMillan F, Steiner Z, Arora G. Recruitment of Research Participants. In: Liamputtong P, editor. Handbook of Research Methods in Health Social Sciences. Singapore: Springer Singapore; 2018. pp. 1\u201328."},{"issue":"7","key":"902_CR4","doi-asserted-by":"publisher","first-page":"e005234","DOI":"10.1136\/bmjopen-2014-005234","volume":"4","author":"C Gamble","year":"2014","unstructured":"Gamble C, Dudley L, Allam A, Bell P, Goodare H, Hanley B, et al. Patient and public involvement in the early stages of clinical trial development: a systematic cohort investigation. BMJ Open. 2014;4(7):e005234.","journal-title":"BMJ Open"},{"key":"902_CR5","unstructured":"Christoffersen A, Young A. Co-design in Metro North Health. Creating better healthcare together. Metro North Health, The State of Queensland.2023 Available from: https:\/\/metronorth.health.qld.gov.au\/get-involved\/co-design."},{"issue":"8","key":"902_CR6","doi-asserted-by":"publisher","first-page":"e084620","DOI":"10.1136\/bmjopen-2024-084620","volume":"14","author":"C Morley","year":"2024","unstructured":"Morley C, Jose K, Hall SE, Shaw K, McGowan D, Wyss M, et al. 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