Considerations for disease impact and outcome measures in vulvar disease.
OBJECTIVE
Reliable and valid outcome measures are essential both in clinical practice and in clinical trials to be able to monitor response to treatments. In this review, we consider existing outcome measures currently used in clinical practice and discuss the need for vulvar specific measures.


METHODS
We have reviewed the existing literature describing outcome measure and disease impact scales for dermatologic and vulvar conditions.


RESULTS
A combination of measures including clinician-determined severity and patient-related quality-of-life indices are often used to assess different aspects of a disease. Health-related quality-of-life measures as scored by the patient are being increasingly recognized as the main driver in therapeutic decision making and are also important in developing service provision. Numerous disease-specific severity scores exist within dermatology, as do quality-of-life indices. However, none has been specifically designed to cover all aspects of vulvar disease.


CONCLUSIONS
It is timely to consider the assessment of vulvar disease both in terms of impact on the patient and disease severity as assessed by the clinician to design well-constructed clinical trials for the management of vulvar disease. Owing to the sensitive nature of the problem, patients' needs and expectations are often different from general dermatology patients. We suggest that scales to monitor outcomes in the vulvar population should be devised by adapting and combining existing scales so they are relevant to our patients' needs.
Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, United Kingdom. Rosalind.simpson@nottingham.ac.uk
Rosalind C
RC
Simpson
Ruth
R
Murphy
D015510:Clinical Medicine / Q000379:methods; D005260:Female; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000379:methods*; D011788:Quality of Life / Q000523:psychology; D014845:Vulvar Diseases / Q000628:therapy*