CRITICAL NEED FOR A NEW PATIENT-RELATED OUTCOMES (PRO) MEASURE IN CLINICAL PRACTICE AND RESEARCH FOR PATIENTS WITH VULVODYNIA
Author(s)
Joensson L1, Duttagupta S2, Nash P3, Yang M2
1Grunenthal GmbH, Aachen, Germany, 2CBPartners, New York, NY, USA, 3CBPartners, San Francisco, CA, USA
OBJECTIVES: To appraise existing PRO measures used in clinical practice and research for vulvodynia. METHODS: The study employed a literature review followed by interviews with clinicians and payers to appraise PRO measures in vulvodynia. Exhaustive review of literature, and review of trials from Clinicaltrials.gov were carried out, accompanied by structured interviews of 27 clinicians and payers from France, Germany, Spain, Great Britain, Italy, and the USA. Strengths, weaknesses, and unmet needs associated with existing PRO measures were identified in the context of evidence development as well as importance of PRO-generated data on future access to treatments for patients with vulvodynia. RESULTS: Nine PROs were identified through secondary research, five were generic measures including Numerical Rating Scale (NRS), Visual Analog Scale (VAS), Short Form-McGill Pain (SF-MPQ), Brief Pain Inventory (BPI), and SF-36. Four disease-specific measures were identified including Female Sexual Functioning Index (FSFI), Female Sexual Distress Scale (FSDS), Marinoff Dyspareunia Scale (MDS), and Vulvovaginal Symptoms Questionnaire (VSQ). Pain and sexual functioning were important attributes captured in these measures. Stakeholders were satisfied with the NRS and VAS for measuring pain, while clinicians were somewhat satisfied with the FSFI and SF-36 to capture the impact on daily life. Critical gaps identified in existing PROs included their relevance to patients’ daily lives, such as ability to wear tight pants, use tampons, or ride a bike without pain. Payers in Spain and Germany identified the need for such specificity in order to understand the impact of new treatments, and to provide broader access. CONCLUSIONS: Pain intensity and sexual quality of life were adequately captured, however, existing PROs did not capture all aspects of the patient experience with vulvodynia, as communicated by both clinicians and payers across six countries. Therefore, there is a critical need for a robust disease-specific PRO for clinical practice and research.
Conference/Value in Health Info
2017-05, ISPOR 2017, Boston, MA, USA
Value in Health, Vol. 20, No. 5 (May 2017)
Code
PIH31
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Reproductive and Sexual Health