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Considerations for Disease Impact and Outcome Measures in Vulvar Disease

Simpson, Rosalind C. BMedSci, BMBS, MRCP(UK)1; Murphy, Ruth BMedSci, MBChB, PhD, FRCP, MMedSci2

Journal of Lower Genital Tract Disease: October 2012 - Volume 16 - Issue 4 - p 460–463
doi: 10.1097/LGT.0b013e3182449bc1
Review Article

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.

Materials and 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.

Specific measures of health-related quality of life do not exist for vulvar disease. The authors discuss the importance of developing such measures within this area of dermatology.

1Centre of Evidence Based Dermatology, University of Nottingham; and 2Department of Dermatology, Nottingham University Hospitals, Nottingham, United Kingdom

Reprint requests to: Rosalind C. Simpson, BMedSci, BMBS, MRCP(UK), Centre of Evidence Based Dermatology, University of Nottingham, King’s Meadow Campus, Lenton Lane, Nottingham, NG7 2NR, United Kingdom. E-mail:

The authors have no disclosures for this study.

©2012The American Society for Colposcopy and Cervical Pathology