To systematically evaluate the literature regarding vulvodynia treatment outcome measures.
A systematic literature search on OVID, PubMed, and PsycINFO databases was conducted from inception until May 2016. Studies were included/excluded based on prespecified criteria. Reported outcome measures were organized into 6 core outcome domains recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT): pain; physical functioning, emotional functioning, participant ratings of global improvement and satisfaction with treatment, symptoms and adverse events, and participant disposition.
Of the 206 articles identified for full-text screening, 33 met our criteria. One study adhered to all IMMPACT recommendations. The number of outcomes measured per study ranged from 1 to greater than 20. Patient-reported pain outcomes were found in the majority (27/33; 82%) of studies. Pain severity with intercourse was reported by 24 (73%) of 33 studies—9 different scales were used to measure this outcome. Clinician-reported outcomes were present in 14 (42%) of 33 studies. Methods of measuring vestibular sensitivity by “cotton swab” test were different in 8 of 10 studies. Other domains reported included; physical function (8/33 studies; 24%), sexual function (23/33 studies; 70%), and emotional function (13/33 studies; 39%). Symptoms and adverse events were reported by 15 (45%) of 33 studies. One study formally reported participant disposition using all the information recommended by CONSORT.
Comparison of clinical trial results in vulvodynia is not possible because of a lack of standard treatment outcome measures. Vulvodynia researchers should apply the IMMPACT criteria to guide the development of a minimum core set of standard outcome measures that measure holistic health.
A core set of vulvodynia treatment outcome measures would facilitate comparison and synthesis of data and informed treatment decision making by clinicians and patients.
1BC Centre for Vulvar Health, Vancouver, British Columbia, Canada; and
2Department of Obstetrics and Gynaecology, University of British Columbia, Vancouver, British Columbia, Canada
Reprint requests to: Leslie Ann Sadownik, University of British Columbia Vancouver, British Columbia, Canada. E-mail: Leslie.email@example.com
Disclosure of Financial Support: The authors did not receive funding to conduct this systematic review.
IRB Status: IRB approval was not required for this review.
Declarations of Interest: The authors declare no conflicts of interest.