The objective of this study was to detail the outcome measurement instruments
used in randomized control trials and observational studies investigating therapeutic interventions for provoked vulvodynia
Materials and Methods
We searched Ovid Medline, Embase, Emcare, and PyschINFO libraries from database inception through April 2017. We included randomized control trials and observational studies of provoked vulvodynia
that used instruments to measure the outcome of therapeutic interventions.
A total of 2299 articles were retrieved and 25 were eligible for inclusion in accordance with the selection criteria. The included studies measured 26 different outcomes, using 110 outcome measurement instruments
. Patient-reported outcomes were most commonly measured (144/166, 86%), followed by physician-reported outcomes (20/166, 12%). The most commonly measured outcomes were patient-reported psychological impact of disease (27/166, 16%), patient-reported improvement in dyspareunia (25/166, 15%), and patient-reported reduction in pain (24/166, 14%). The Pain Catastrophizing Scale, the Beck Depression Inventory, and the State Trait Anxiety Questionnaire were the most commonly used instruments to measure psychological impact.
The most commonly measured clinician-rated outcome was an improvement in pain (17/166, 10%), which was most frequently assessed by the cotton swab test. Only 34 (31%) outcome measurement instruments were specific to vulvodynia (26/110, 23%) or sexual functioning (8/110, 7%).
There is a wide range of outcome measurement instruments
used in provoked vulvodynia
studies, resulting in inconsistency of reporting and difficulty in comparing and combining findings for systemic review. There is a pressing need for the development of validated, reliable instruments and consensus on a core outcome set for further research purposes.