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

The premise behind the scale is deceptively simple. Anxiety about a chronic, relapsing disease does not remain a purely internal experience; it leaks into behavior. Patients with pemphigus vulgaris may inspect their skin and mouths repeatedly for the first sign of a new blister, avoid foods or physical activities that they believe could trigger lesions, or withdraw from social and occupational situations out of fear that their disease will flare. These behaviors are well documented in other anxiety-related conditions, from the body checking seen in eating disorders to the safety behaviors of social phobia and the fear-avoidance beliefs that perpetuate chronic back pain. Yet, as the authors note in their comprehensive review of the literature, no disease-specific instrument existed to measure such behaviors in pemphigus, despite guidelines recommending regular mental health screening for these patients.

To build the scale, the researchers began where good instrument development always begins: with the patients themselves. Items were generated with input from people living with pemphigus vulgaris and from specialist physicians who treat the disease, ensuring that the questions reflected the real texture of daily worry rather than a generic anxiety checklist. Face and content validity were then established through participant and expert ratings of each item, a process that confirms both that the questions make sense to the people answering them and that experts agree the items actually measure the intended construct. This collaborative approach matters, because behaviors as intimate as skin inspection or dietary avoidance can easily be misunderstood or trivialized by questionnaires designed for other populations.

The psychometric evaluation drew on a sample of 160 participants with pemphigus vulgaris, who completed the SCABS along with validated measures of depression, anxiety, and fear of disease recurrence. The team then subjected the data to a battery of standard scale-development analyses, including exploratory factor analysis, interitem reliability analyses, correlations, and analysis of variance. Exploratory factor analysis is a statistical technique that examines patterns of correlation among questionnaire items to discover whether they cluster around underlying dimensions; in this case, the analysis identified three coherent subscales, which the researchers labeled Checking and Worrying, Contact Avoidance, and Ingested and Situational Avoidance.

Each of the three subscales demonstrated strong interitem reliability, meaning that the items within each cluster consistently measured the same underlying behavior. The structure itself is clinically revealing. The Checking and Worrying subscale captures the cognitive and repetitive side of health anxiety, the compulsive surveillance of one’s own body for signs of recurrence. Contact Avoidance reflects the tendency to steer clear of physical contact or situations that might traumatize the skin, while the Ingested and Situational Avoidance subscale measures avoidance of foods, drinks, and specific circumstances that patients fear could provoke new blisters. That these three dimensions emerged independently suggests that anxiety in pemphigus expresses itself through distinct behavioral channels, each of which may require a different therapeutic approach.

Crucially, the scale did more than divide neatly into subscales; it also behaved the way a valid measure should when compared with external criteria, a property psychometricians call construct validity. Subscale and total scores were associated with remission status, depression, anxiety, fear of recurrence, and occupational impairment. In other words, patients who were not in remission, who reported more depressive and anxious symptoms, who feared their disease would return, or whose ability to work was compromised tended to score higher on checking and avoidance. These convergent relationships support the idea that the SCABS is measuring a real and consequential psychological phenomenon, not an artifact of questionnaire design.

The context for this work is a growing body of evidence that the psychological burden of pemphigus vulgaris has been chronically underestimated. Studies cited by the authors report elevated rates of depression and anxiety in pemphigus patients, including in those in clinical remission, along with post-traumatic stress symptoms, reduced quality of life, and sexual and social difficulties. A 2025 survey study by the same group documented the broad psychosocial burden of autoimmune blistering diseases, and other research has linked stressful life events to disease activity. Patients whose lesions are visible may face social appearance anxiety, and even those in complete remission can carry persistent psychological morbidity. The European S2K guidelines on pemphigus management explicitly recommend regular mental health screening, yet few disease-specific tools have been available to make such screening meaningful.

Why does a measurement tool matter so much? Because behavior is where anxiety becomes disabling. A patient who spends an hour each morning examining her skin, refuses to eat anything but soft bland foods, and has stopped hugging her children is suffering in ways that a routine dermatological exam will never detect. Avoidance, as the anxiety-treatment literature has long recognized, provides short-term relief but reinforces fear over time, narrowing a patient’s life and sometimes worsening disease outcomes through stress and delayed recognition of genuine flares. Cognitive-behavioral therapy, which has strong evidence in anxiety disorders and has shown benefit in other chronic autoimmune conditions such as lupus erythematosus and multiple sclerosis, targets exactly these checking and avoidance patterns. But clinicians cannot intervene effectively on behaviors they cannot see, and the SCABS gives them a way to see them.

The authors are careful to frame this as a preliminary validation. The scale was tested in a single sample of 160 participants, recruited with assistance from the International Pemphigus and Pemphigoid Foundation, and further work will be needed to confirm its structure in independent populations, establish test-retest reliability, and determine how scores change with treatment. The study received ethics exemption from the Yale University Institutional Review Board, and the authors declared no competing interests. Data are available from the corresponding author on reasonable request, with identifying information removed. These are the standard caveats of early instrument development, and they do not diminish the significance of filling an empty niche: until now, no validated scale existed specifically for checking and avoidance in pemphigus vulgaris.

The broader lesson extends beyond a single rare disease. Pemphigus vulgaris belongs to a family of autoimmune blistering conditions whose patients, research suggests, carry a heavy and often invisible psychological load. As immunologists develop increasingly effective biologics and immunosuppressive regimens, the frontier of care is shifting from survival to quality of life, and that frontier runs directly through mental health. Instruments like the SCABS, and its companion measure for fear of disease recurrence developed by the same group, represent a quiet revolution in dermatology: the recognition that a disease of the skin is also a disease of the mind, and that measuring worry, checking, and avoidance is as much a part of good medicine as measuring antibody titers. For the hundreds of thousands of people worldwide living with pemphigus, a short questionnaire that asks about the behaviors they have been hiding may be the first step toward treatment that addresses the whole patient, blisters and all.

Subject of Research: Development and validation of a scale measuring skin checking and avoidance behaviors in pemphigus vulgaris

Article Title: Development and preliminary validation of the skin checking and avoidance behaviors scale in pemphigus vulgaris

Article References: Development and preliminary validation of the skin checking and avoidance behaviors scale in pemphigus vulgaris. (n.d.). https://doi.org/10.1007/s00403-026-04969-x

Image Credits: AI Generated

DOI: 10.1007/s00403-026-04969-x

Keywords: pemphigus vulgaris, health anxiety, skin checking, avoidance behaviors, psychometrics, scale validation, autoimmune blistering disease, mental health screening, depression, anxiety, fear of recurrence, quality of life