The research, led by Astrid Machielsen of Catharina Hospital Eindhoven and colleagues across multiple Dutch centers, was conducted between December 2021 and March 2024 and followed a rigorous three-step methodology aligned with the COMET Initiative, the international standard for core outcome set development. First, the team performed a systematic literature review of studies published between 2010 and 2021 to catalog the questionnaires already in use. That search identified 301 records, of which 46 articles met eligibility criteria, and revealed a fragmented measurement landscape: 46 different questionnaires had been deployed to assess quality of life, with the Female Sexual Function Index and the EORTC QLQ-C30 each appearing in ten studies, followed by the FACT-V, FACT-G, and SF-12. No single instrument, and no agreed set of outcomes, dominated the field.

The second step brought patients, partners, and healthcare professionals directly into the process. The researchers conducted 28 semi-structured telephone interviews with ten patients treated for vulvar cancer within the previous two years, eight partners, and ten healthcare professionals including gynecologic oncologists, radiation therapists, oncologists, plastic surgeons, and physician assistants. Interviewers, who had no prior clinical relationship with participants to reduce bias, presented established questionnaires and probed for what was missing. The conversations surfaced concepts that standard instruments had never captured: the ability to cycle or wear tight clothing, feelings of comfort looking at and touching one’s own genital area, vaginal odor, changes in genital sensation, and the impact of surgery on entering new relationships. From these interviews, the team extracted 55 patient outcomes and 23 partner outcomes to carry forward.

The third and decisive step was a two-round online Delphi study, run between March and November 2023 using DelphiManager software developed by the COMET Initiative. Seventy participants registered for the first round: 34 patients, 12 partners, and 24 healthcare professionals. Each participant rated the importance of every outcome on a ten-point Likert scale, with consensus criteria defined in advance. An outcome was deemed ‘consensus in’ if at least 70 percent of participants scored it as very important, between 7 and 10, and fewer than 15 percent scored it as not important, between 1 and 3. Outcomes failing to reach agreement in round one were re-presented in round two alongside an anonymized graphical summary of how the other groups had rated them, allowing participants to revise their own scores in light of the collective view.

The patient Delphi proved rich and revealing. Of the 55 outcomes presented in the first round, 28 achieved consensus in, five were voted out, and 22 remained contested, with disagreement concentrated in the domains of sexual functioning and delivery of care. Participants also proposed four new outcomes: removal of part of the clitoris, vaginal odor, change in genital sensation, and the impact on entering new relationships. After the second round and a final online consensus meeting attended by eight patients and five healthcare professionals, the researchers consolidated four overlapping fear-of-recurrence items into a single outcome and settled on a final patient-centered core outcome set of 45 outcomes. These span physiological functioning and physical symptoms, physical, sexual, and emotional functioning, global quality of life, and information provision.

Notably, the set includes outcomes that are rarely measured in cancer research generally: wound healing, body image, and fear of recurrence. During the consensus meeting, patients explained that lichen sclerosus, a chronic inflammatory skin condition, is intertwined with their fear that symptoms signal returning cancer, and that the inability to wear tight clothes after surgery carries a persistent sense of embarrassment, particularly when complicated by visible lymphedema. Patients also clarified that while sexuality matters deeply, detailed discussions are not always wanted at every visit; instead, the topic should be revisited periodically, because needs change over time. Communication about sexuality, they emphasized, should extend beyond partners to include healthcare professionals themselves.

The partner results were unexpectedly spare. The partner Delphi began with 23 outcomes, but after two rounds and a planned consensus meeting that was canceled due to low participation, the final partner-centered set contained just six outcomes, all related to information provision rather than partners’ own quality of life. Partners repeatedly affirmed that the patient should be the primary focus of care, and the majority of healthcare professionals agreed, with some cautioning that formally assessing partner well-being could raise expectations of treating the partner as a patient. Partners did describe real worries, including concern about their partner’s sexual pleasure and fear of hurting them during sexual activity, but they saw an additional questionnaire during aftercare as offering limited value. The researchers concluded that a full partner-centered outcome set is unnecessary, and that the six information-related outcomes can be assessed with the EORTC QLQ-INFO25.

A crucial practical contribution of the study is its mapping of the 45 patient outcomes onto existing validated instruments. The researchers recommend a combination of scales and items from the EORTC QLQ-C30, the vulvar cancer module QLQ-VU34, the sexual health module SH22, and INFO25, together with the FACT-V and the WOUND-Q, which covers wound-related outcomes. Because all EORTC questionnaires share a similar answering format, assembling them into a coherent assessment is feasible. Some outcomes still lack any dedicated measure, including cycling, wearing clothes, feeling comfortable with the genital area, intimacy, and the impact of wounds on quality of life. For these, the team identified partial solutions from the EORTC item bank, such as item Q273 for tight clothing and item Q364 or the Fear of Cancer Recurrence Inventory for lichen sclerosus-related fear, and recommended the Maudsley Marital Questionnaire where deeper exploration of the patient-partner interaction is needed.

The authors are candid about the limitations. Vulvar cancer’s low incidence constrained the sample size, and the Delphi process, though iterative and inclusive, suffered attrition of roughly 20 to 25 percent between rounds, which may have narrowed the diversity of perspectives. No single comprehensive questionnaire yet exists that captures all 45 outcomes, meaning clinics must combine instruments. The EORTC QLQ-VU34, while promising, is still in phase four of development and validation and was designed for clinical trials rather than routine care. These caveats notwithstanding, the adherence to COMET guidance, the anonymity of Delphi ratings, and the mixed-methods foundation of literature review plus qualitative interviews give the findings substantial credibility and reproducibility.

The implications reach well beyond the Netherlands. By defining, from the patient’s own vantage point, what quality of life after vulvar cancer surgery actually consists of, the study gives trialists a common language for comparing interventions, reduces reporting bias, and gives clinicians a concrete checklist for aftercare conversations that too often skip sexuality, body image, and fear of recurrence. Patient-reported outcome measures have previously been linked to improved symptom management, particularly when results are discussed with patients, and this core outcome set provides the framework for doing so systematically. The next step is already underway: the outcome set will be integrated into the IMPACT-V project, a Dutch quality improvement initiative for vulvar cancer care, where it will enable ongoing evaluation of whether daily clinical practice becomes genuinely responsive to the outcomes patients themselves have declared most important.

Subject of Research: Development of a patient-centered core outcome set for health-related quality of life after vulvar cancer surgery using a Delphi consensus method

Article Title: Determining core quality of life outcomes for patients with vulvar cancer and their partners: a Delphi consensus study

Article References: Machielsen, A., Meijer, N., van Dongen, J., Boll, D., van Haren, E., Oonk, M., Aarts, J. A. W. M., Oerlemans, S., Kimman, M., van Esch, E., & Ezendam, N. (2026). Determining core quality of life outcomes for patients with vulvar cancer and their partners: a Delphi consensus study. Supportive Care in Cancer, 34(10), Article 1061. https://doi.org/10.1007/s00520-026-11270-0

Image Credits: AI Generated

DOI: 10.1007/s00520-026-11270-0

Keywords: vulvar cancer, core outcome set, quality of life, Delphi study, patient-reported outcomes, gynecologic oncology, sexual functioning, body image, fear of recurrence, EORTC questionnaires, supportive care, partners of cancer patients