Core Outcome Measures in Effectiveness Trials

Systematic Review of Treatment Outcome Measures for Vulvodynia

General Information

Abstract:
OBJECTIVES OF THE STUDY: To systematically evaluate the literature regarding vulvodynia treatment outcome measures. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Authors:
Sadownik, L. A. Yong, P. J. Smith, K. B.

Publication

Journal:
J Low Genit Tract Dis
Volume:
22
Issue:
3
Pages:
251 - 259
Year:
2018
DOI:
Further Study Information

Date:
Funding source(s):

Health Area

Disease Category
Anaesthesia & pain control
Gynaecology

Disease Name
Vulvodynia

Target Population

Age Range
-

Sex
Unknown


Nature / type of Intervention
Unknown

Method(s)

Unknown

Stakeholders Involved

Unknown

Study Type

Systematic review of outcomes measured in trials

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