Validation of Clinical Tools for Vaginal and Vulvar Symptom Assessment in Cancer Patients and Survivors

Abstract

Introduction Healthcare professionals can play a pivotal role in promoting vulvovaginal health through assessment and appropriate intervention. Aim The development and validation of brief clinical measures to facilitate the identification of vulvovaginal symptoms in cancer patients/survivors is warranted. Methods 175 female cancer survivors attending a Female Sexual Medicine and Women’s Health Program from 9/26/2012–10/31/2014 completed the Vaginal Assessment Scale (VAS) and Vulvar Assessment Scale (VuAS)—a modified version of the VAS that targets vulvar symptoms. Pelvic exam results were recorded using a clinical exam checklist. Internal consistency of both scales was assessed using Cronbach’s alpha, and correlation between scales and other outcomes was reported. Results The internal consistency measures of the VAS and VuAS at first visit were 0.70 and 0.68, which decreased to 0.53 and 0.66 at last visit. The VAS composite and VuAS composite scores were moderately correlated with one another (0.42 and 0.45 at first and last visit, respectively). Strong correlation was observed between VAS pain with intercourse and Female Sexual Function Index (FSFI) pain with intercourse (−0.63 and −0.71 at first and last visit, respectively). Worse pain with exam, worse functioning on the FSFI pain, lubrication and total scales, and worse vulvar irritation were correlated with more severe symptoms on the VAS and VuAS. Conclusions The VAS and VuAS are simple tools that can be used by clinicians to assess health concerns in women diagnosed with and treated for cancer. Future validation across diverse settings and groups of women are needed.

The Female Sexual Function Index (FSFI)—A Systematic Review of Measurement Properties

“…49 studies reported on convergent validity of the FSFI-19 (Supplementary Table 3). The FSFI-19 was compared to measures measuring sexual function and satisfaction, 15,17,18,21,23e25,28,29,31,33,37,46,53,55,57,58,60,62,64,67e69,71, 72,74,78,79,92,93 quality of life, 19,92 mental health measures, 20,39 physical functional problems, 20,30,32,34,49,54,66,74,77,81,83,87 relationship quality, 20,39,52 and body image. 35,42,43,56,60 A full list of comparison measures can be found in Supplementary Table 3.…”

“…28 studies of "adequate" rating, 15,19,23,24,28e31,35,37,46,49,54e57,60, 66e69,71,72,74,77,78,81,87,93 2 studies of "doubtful" rating, 33,64 and 1 study of "inadequate" quality, 53 provided correlations rated as sufficient. 14 studies of "adequate" rating, 17,20,21,25,32,34,39,42,43,52,60,62,79,83 and 2 studies of "doubtful" rating, 58,92 provided correlations rated as insufficient. 1 study was rated as indeterminate, because not enough information was given for a reliable interpretation.…”

“…ContinuedReferencePopulation Sample size Main aim of study Eaton et al32 Female cancer survivors 175 To develop and validate brief clinical measurements to facilitate the identification of vulvovaginal symptoms in patients with and survivors of cancer Fakhri et al33 Iranian gynecological outpatients 448 To translate, validate, and enhance cross-cultural comparability of the FSFI-IV…”

Quality of Life with Vulvar Carcinoma Treated with Palliative Electrochemotherapy: The ELECHTRA (ELEctroCHemoTherapy vulvaR cAncer) Study

“…The clinical response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 60 days after the procedure, as previously reported [ 15 ]. To assess the QoL before and after ECT, the following questionnaires were administered: (i) visual analog pain scale (VAS) [ 20 ]; (ii) EuroQol 5-Dimension 5-Level (EQ-5D-L5) [ 21 , 22 ]; (iii) Functional Assessment Of Cancer Therapy—Vulva cancer (FACT—V) [ 23 ]. FACT—V is a specific instrument used to assess the QoL during VC therapy.…”

“…The questionnaire is composed of 15 specific items providing information on the QoL of patients treated for VC. Among the 15 items of FACT—V, for the purposes of the present analysis, we considered only the following four items as they appeared significantly modified in a previous study [ 17 , 18 , 19 , 20 , 21 , 22 , 23 ]: (i) I am bothered by discharge or bleeding from my vulva (“bleeding”); (ii) I am bothered by itching/burning in my vulva area (“burning”); (iii) I have discomfort when I urinate (“urination”); (iv) I have discomfort when I am sitting (“sitting”).…”