TY - JOUR T1 - Assessing Patient-reported Quality of Life Outcomes in Vulva Cancer Patients: A Systematic Literature Review JF - International Journal of Gynecologic Cancer JO - Int J Gynecol Cancer SP - 808 LP - 817 DO - 10.1097/IGC.0000000000001211 VL - 28 IS - 4 AU - Ligita Paskeviciute Froeding AU - Elfriede Greimel AU - Anne Lanceley AU - Anne Oberguggenberger AU - Claudia Schmalz AU - Vesna Bjelic Radisic AU - Andy Nordin AU - Razvan Galalaei AU - Karin Kuljanic AU - Ingvild Vistad AU - Tine Henrichsen Schnack AU - Pernille Tine Jensen Y1 - 2018/05/01 UR - http://ijgc.bmj.com/content/28/4/808.abstract N2 - Objectives Vulva cancer (VC) treatment carries a high risk of severe late effects that may have a negative impact on quality of life (QoL). Patient-reported outcome measures (PROMs) are increasingly used when evaluating disease- and treatment-specific effects. However, the adequacy of measures used to assess sequelae and QoL in VC remains unclear. The aims of the present study were to evaluate disease- and treatment-related effects as measured by PROMs in VC patients and to identify available VC-specific PROMs.Methods/Materials A systematic literature search from 1990 to 2016 was performed. The inclusion criterion was report of disease- and treatment-related effects in VC patients using PROMs in the assessment. Methodological and reporting quality was in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. This systematic review was performed as part of phase 1 of the development of a European Organisation for Research and Treatment of Cancer QoL questionnaire for VC patients.Results The search revealed 2299 relevant hits, with 11 articles extracted including a total of 535 women with VC; no randomized controlled trials were identified. The selected studies exhibited great heterogeneity in terms of PROMs use. Twenty-one different instruments assessed QoL. Most of the questionnaires were generic. Different issues (sexuality, lymphedema, body image, urinary and bowel function, vulva-specific symptoms) were reported as potentially important, but the results were not systematically collected. Only one VC-specific questionnaire was identified but did not allow for assessment and reporting on a scale level.Conclusions Vulva cancer treatment is associated with considerable morbidity deteriorating QoL. To date, there is no validated PROM available that provides adequate coverage of VC-related issues. The study confirms the need for a VC-specific QoL instrument with sensitive scales that allows for broad cross-cultural application for use in clinical trials. ER -