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Assessing Patient-reported Quality of Life Outcomes in Vulva Cancer Patients: A Systematic Literature Review
  1. Ligita Paskeviciute Froeding, MD*,
  2. Elfriede Greimel, PhD,
  3. Anne Lanceley, PhD,
  4. Anne Oberguggenberger, PhD§,
  5. Claudia Schmalz, MD, PhD,
  6. Vesna Bjelic Radisic, MD,
  7. Andy Nordin, MBBS, FRCOG#,
  8. Razvan Galalaei, MD, PhD**,††,
  9. Karin Kuljanic,,
  10. Ingvild Vistad, MD, PhD§§,
  11. Tine Henrichsen Schnack, MD, PhD* and
  12. Pernille Tine Jensen, MD, PhD¶¶
  1. * Department of Gynecology and Obstetrics, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark;
  2. Department of Obstetrics and Gynecology, Medical University of Graz, Graz, Austria;
  3. The Department of Women's Cancer, Institute for Women's Health, University College London, London, UK;
  4. § Department of Psychiatry, Psychotherapy and Psychosomatics, Medical University of Innsbruck, Innsbruck, Austria;
  5. Department of Radiotherapy, University Hospital of Schlesvig Holstein, Kiel, Germany;
  6. Department of Obstetrics and Gynecology, Medical University of Graz, Graz, Austria;
  7. # East Kent Gynecological Oncology Centre, Kent, UK;
  8. ** Christian-Albrechts-University Kiel, Medical Faculty, Kiel, Germany;
  9. †† Department of Radiotherapy, Evangelical Clinics Gelsenkirchen, Gelsenkirchen, Germany;
  10. ‡‡ Department of Obstetrics and Gynecology, University Hospital Center Rijeka, Rijeka, Croatia;
  11. §§ Department of Gynecology, The Norwegian Radium Hospital, Oslo; Department of Obstetrics and Gynaecology, Sorlandet Hospital Kristiansand, Kristiansand Norway; and
  12. ¶¶ Department of Gynecology and Obstetrics, Odense University Hospital, Odense C, Denmark.
  1. Address correspondence and reprint requests to Ligita Paskeviciute Froeding, MD, Department of Gynecology and Obstetrics, Copenhagen University Hospital Rigshospitalet, Blegdamsvej 9, 2100 København Ø, Denmark. E-mail: ligitapask{at}dadlnet.dk.

Abstract

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.

  • Vulva cancer
  • Quality of life
  • Questionnaire
  • Late effects

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Footnotes

  • The authors declare no conflicts of interest.

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