Validation of a Patient-Reported Outcome Measure for Moist Desquamation among Breast Radiotherapy Patients

Abstract

There has been an increasing interest in patient-reported outcome (PRO) measures in both the clinical and research settings to improve the quality of life among patients and to identify when clinical intervention may be needed. The primary purpose of this prospective study was to validate an acute breast skin toxicity PRO measure across a broad sample of patient body types undergoing radiation therapy. Between August 2018 and September 2019, 134 women undergoing adjuvant breast radiotherapy (RT) consented to completing serial PRO measures both during and post-RT treatment and to having their skin assessed by trained trial radiation therapists. There was high patient compliance, with 124 patients (92.5%) returning to the clinic post-RT for at least one staff skin assessment. Rates of moist desquamation (MD) in the infra-mammary fold (IMF) by PRO were compared with skin assessments completed by trial radiation therapists. There was high sensitivity (86.5%) and good specificity (79.4%) between PRO and staff-reported presence of MD in the IMF, and there was a moderate correlation between the peak severity of the MD reported by PRO and assessed by staff (rho = 0.61, p < 0.001). This prospective study validates a new PRO measure to monitor the presence of MD in the IMF among women receiving breast RT.

Keratin-based topical cream for radiation dermatitis during head and neck radiotherapy: a randomised, open-label pilot study

“…In previous studies, clinicianrated and patient-reported measures of moist desquamation are associated with reasonably high levels of agreement, indicating this dichotomous endpoint could be assessed either by objective clinician examination or patient report. 51,52 Since the development of moist desquamation is such a clinically meaningful event for patients, outcome measures focused on the cumulative incidence of moist desquamation rather than CTCAE grade 2 þ RD (which includes patchy moist desquamation, moderate/brisk erythema or moderate oedema) may more reliably identify topical agents with clinical benefit. 27 This study was not powered to detect a difference in the cumulative incidence of RD between groups, so the findings regarding RD should be interpreted with caution.…”

Toward a Skin Dose-Area Metric Predictive of Moist Desquamation Using In Vivo Skin Dosimetry and Skin Assessments

“…A previously validated patient-reported outcome (PRO) questionnaire was completed by patients at similar timepoints as the staff skin assessments. 20 Patients were asked to report on whether they developed open skin in the fold under the breast. This included the inferior surface of the breast, the breast crease, and the chest wall below the breast when an inframammary breast fold was present.…”