Deep and Superficial Dyspareunia Questionnaire: a patient-reported outcome measure for genito-pelvic dyspareunia

INTRODUCTION: Dyspareunia affects 8%-22% of women worldwide and an unknown number of gender-diverse people. Dyspareunia is commonly categorized into deep and superficial subtypes based on pain location and underlying etiology; however, current assessment tools inadequately differentiate between pain locations. AIM: This study aimed to develop a patient-reported outcome measure (PROM) that independently assesses deep and superficial dyspareunia and its psychosocial correlates: the Deep and Superficial Dyspareunia Questionnaire (DSDQ). METHODS: The DSDQ development stages included item construction, categorization, review/revision, focus groups, cognitive interviews, final review, and factor analysis. Items were developed by reviewing pre-existing measures related to dyspareunia. Constructs of these measures were adapted to create items for the DSDQ. Developed items were categorized according to a conceptual framework. To review items, 4 patient partners, 2 gynecologists, and 1 psychiatrist participated in a modified eDelphi process. Next, 3 patient focus groups (n = 5, n = 3, n = 4), 1 clinician focus group (n = 2), and patient cognitive interviews (n = 15) were conducted over 2 rounds. A qualitative descriptive approach guided interview analysis, which informed DSDQ modifications and generated evidence of validity. Clinician-researchers (n = 4) and patient partners (n = 2) completed the final revision. Lastly, an exploratory factor analysis (EFA) and a confirmatory factor analysis (CFA) determined the most appropriate factor structure. OUTCOMES: Generated items, validity, factor structure. RESULTS: Fifty-nine pre-existing measures were reviewed to generate an initial pool of 163 items. Items created were categorized into domains for characteristics (pain quality, timing, location, and intensity) or psychosocial correlates (impact of pain on cognitions, affect, sexuality, and behavior). The eDelphi modified 40 items, added 23, and excluded 10. After the final review, 175 items were approved for psychometric analysis. The EFA supported a 103-item, 6-factor model. The CFA supported a 45-item, 6-factor model. Factors included: (1) Vaginal Opening Pain; (2) Deep Vaginal/Pelvic/Abdominal Pain; (3) Pain Interference; (4) Affect and Cognitions Related to Provoked Pain; (5) Sexual Distress Related to Sexual Well-being; and (6) Pain Self-efficacy. CLINICAL IMPLICATIONS: The DSDQ will aid diagnosis, treatment, and assessment of dyspareunia changes over time in research and clinical settings. STRENGTHS AND LIMITATIONS: Strengths of this work include DSDQ co-development with patient partners, multidisciplinary clinicians, and researchers, as well as the rigorous mixed-methods development. Limitations include demographic and clinical homogeneity of the patient samples and sample sizes for the EFA and CFA. CONCLUSIONS: The DSDQ is a 45-item measure intended to assess deep and superficial dyspareunia. Future psychometric evaluation will further establish validity and reliability evidence.