Premium
Outcome measures for vulval skin conditions: a systematic review of randomized controlled trials
Author(s) -
Simpson R.C.,
Thomas K.S.,
Murphy R.
Publication year - 2013
Publication title -
british journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.304
H-Index - 179
eISSN - 1365-2133
pISSN - 0007-0963
DOI - 10.1111/bjd.12391
Subject(s) - medicine , lichen sclerosus , vulvodynia , randomized controlled trial , quality of life (healthcare) , medline , psychological intervention , patient reported outcome , vulva , vulvar diseases , physical therapy , clinical trial , dermatology , surgery , pelvic pain , psychiatry , nursing , political science , law
Summary Symptoms and signs of vulval skin disorders are common. These conditions can have a considerable impact on quality of life, restricting physical activities and causing difficulty in everyday activities and may also affect social, psychosexual and psychological well‐being. There are no standardized measures routinely used to assess the impact of vulval disease on daily life. To report outcome measures used in clinically based randomized controlled trials ( RCT s) investigating therapeutic interventions in vulval disease. The Medline, EMBASE and CENTRAL databases were searched to identify RCT s of vulval skin conditions written in E nglish. Studies with laboratory tests or survival rates as the primary outcome, or those investigating menopausal symptoms or infections were excluded. Twenty‐eight published RCT s were included. The vulval conditions represented were vulvodynia ( n = 14), lichen sclerosus ( n = 9), vulval intraepithelial neoplasia ( n = 2), vulval pruritus ( n = 2) and lichen planus ( n = 1). The 28 RCT s measured 25 different outcomes, using 49 different scales. The method of outcome assessment was lacking on nine occasions. Only 21% (six of 28) of included trials had a clearly stated primary outcome. Patient‐reported outcomes were more commonly reported than clinician‐related outcome measures. The most commonly reported patient‐rated outcome measure was a reduction in pain (measured 15 times) and an overall improvement in symptoms using a patient global assessment (measured 11 times). The most commonly reported clinician‐rated outcome was an overall assessment of the appearance of affected sites (measured 13 times). There were no agreed standard scales used for the global assessments. Only nine of the recorded outcome measure tools were designed to assess vulval disease or sexual functioning, the remainder were general measures. There is heterogeneity in the outcome measures used when reporting therapeutic interventions in vulval disease. This field of dermatology would benefit from development of a vulval‐specific outcome measure and the establishment of a core outcome measure set.