No votes yet
Online Exclusive Article

Development of a Postsurgical Patient-Reported Outcome Instrument for Women With Vulvar Neoplasia

Beate Senn
Michael D. Mueller
Annette Hasenburg
Thomas Blankenstein
Beatrice Kammermann
Anke Hartmann
Heidi Donovan
Manuela Eicher
Rebecca Spirig
Sandra Engberg
ONF 2012, 39(6), E489-E498 DOI: 10.1188/12.ONF.E489-E498

Purpose/Objectives: To (a) develop the Women With Vulvar Neoplasia—Patient-Reported Outcome (WOMAN-PRO) instrument as a measure of women's post-vulvar surgery symptom experience and informational needs, (b) examine its content validity, (c) describe modifications based on pilot testing, and (d) examine the content validity of the revised instrument.

Design: Mixed-methods research project.

Setting: One Swiss and two German university hospitals.

Sample: 10 patients and 6 clinicians participated in the pilot test.

Methods: The instrument was developed based on literature searches, clinician feedback, and patient interviews. Thirty-seven items were first pilot tested by patients and clinicians. The revised 36 items were pilot tested by patients. The content validity index (CVI) for each item and the entire instrument was calculated.

Main Research Variables: Symptom experience and informational needs of patients with vulvar neoplasia.

Findings: The initial pilot test showed excellent scale CVI based on feedback from patients (CVI = 0.98) and clinicians (CVI = 0.92). After revising six items based on low individual CVIs and participant comments, the revised WOMAN-PRO showed excellent item and scale content validity (CVI = 1).

Conclusions: The newly developed WOMAN-PRO instrument can guide patients and clinicians in assessing symptoms, informational needs, and related distress.

Implications for Nursing: Use of the WOMAN-PRO instrument in clinical practice can offer patients guidance in self-assessment and early recognition of symptoms. The instrument also can provide clinicians with systematic information about key symptoms from a patient perspective, as well as women's unmet informational needs. If the results of additional psychometric testing are promising, the WOMAN-PRO tool may provide an outcome measure for clinical trials.


Basch, E., Artz, D., Dulko, D., Scher, K., Sabbatini, P., Hensley, M., … Schrag, D. (2005). Patient online self-reporting of toxicity symptoms during chemotherapy. <i>Journal of Clinical Oncology, 23</i>, 3552-3561. doi:10.1200/JCO.2005.04.275

Basen-Engquist, K., Bodurka-Bevers, D., Fitzgerald, M. A., Webster, K., Cella, D., Hu, S., & Gershenson, D. M. (2001). Reliability and validity of the Functional Assessment of Cancer Therapy-Ovarian. <i>Journal of Clinical Oncology, 19</i>, 1809-1817.

Beesley, V., Janda, M., Eakin, E., Obermair, A., & Battistutta, D. (2007). Lymphedema after gynecological cancer treatment: Prevalence, correlates, and supportive care needs. <i>Cancer, 109</i>, 2607-2614.

Brod, M., Hammer, M., Kragh, N., Lessard, S., & Bushnell, D. M. (2010). Development and validation of the Treatment Related Impact Measure of Weight (TRIM-Weight). <i>Health and Quality of Life Outcomes, 8</i>, 19. doi:10.1186/1477-7525-8-19

Burke, L., Stifano, T., & Dawisha, S. (2006). Guidance for industry: Patient-reported outcome measures: Use in medical product development to support labeling claims: Draft guidance. <i>Health and Quality of Life Outcomes, 4</i>, 79.

Carlson, J. W., Kauderer, J., Walker, J. L., Gold, M. A., O'Malley, D., Tuller, E., & Clarke-Pearson, D. L. (2008). A randomized phase III trial of VH fibrin sealant to reduce lymphedema after inguinal lymph node dissection: A Gynecologic Oncology Group study. <i>Gynecologic Oncology, 110</i>, 76-82. doi:10.1016/j.ygyno.2008.03.005

Chang, V. T., Hwang, S. S., Feuerman, M., Kasimis, B. S., & Thaler, H. T. (2000). The memorial symptom assessment scale short form (MSAS-SF). <i>Cancer, 89</i>, 1162-1171. doi:10.1002/1097-0142(20000901)89:5<1162::AID-CNCR26>3.0.CO;2-Y

Collier, F. (2008). Vulvar intraepithelial neoplasias (VINs): Patients' experience [in French]. <i>Gynécologie, Obstétrique & Fertilité, 36</i>, 306-310. doi:10.1016/j.gyobfe.2007.12.014

Deutsche Gesellschaft für Gynäkologie und Geburtshilfe. (2009). <i>Interdisciplinary S2K guideline for diagnostic and therapy of vulvar carcinoma and vulvar intraepithelial neoplasia</i> [in German]. Retrieved from <a target="_blank" href='http://www.krebsgesellschaft.de/download/leitlinie_vulva_2010.pdf'>http:...

Dittmer, C., Katalinic, A., Mundhenke, C., Thill, M., & Fischer, D. (2011). Epidemiology of vulvar and vaginal cancer in Germany. <i>Archives of Gynecology and Obstetrics, 284</i>, 169-174. doi:10.1007/s00404-011-1850-9

Dodd, M., Janson, S., Facione, N., Faucett, J., Froelicher, E. S., Humphreys, J., … Taylor, D. (2001). Advancing the science of symptom management. <i>Journal of Advanced Nursing, 33</i>, 668-676. doi:10.1046/j.1365-2648.2001.01697.x

Gaarenstroom, K. N., Kenter, G. G., Trimbos, J. B., Agous, I., Amant, F., Peters, A. A., & Vergote, I. (2003). Postoperative complications after vulvectomy and inguinofemoral lymphadenectomy using separate groin incisions. <i>International Journal of Gynecological Cancer, 13</i>, 522-527. doi:10.1046/j.1525-1438.2003.13304

Gray, H. J. (2010). Advances in vulvar and vaginal cancer treatment. <i>Gynecologic Oncology, 118</i>, 3-5. doi:10.1016/j.ygyno.2010.04.011

Green, M. S., Naumann, R. W., Elliot, M., Hall, J. B., Higgins, R. V., & Grigsby, J. H. (2000). Sexual dysfunction following vulvectomy. <i>Gynecologic Oncology, 77</i>, 73-77. doi:10.1006/gyno.2000.5745

Greimel, E., Bottomley, A., Cull, A., Waldenstrom, A. C., Arraras, J., Chauvenet, L… . D'Haese, S. (2003). An international field study of the reliability and validity of a disease-specific questionnaire module (the QLQ-OV28) in assessing the quality of life of patients with ovarian cancer. <i>European Journal of Cancer, 39</i>, 1402-1408. doi:10.1016/S0959-8049(03)00307-1

Greimel, E. R., Kuljanic Vlasic, K., Waldenstrom, A. C., Duric, V. M., Jensen, P. T., Singer, S., … Wydra, D. (2006). The European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Cervical Cancer Module: EORTC QLQ-CX24. <i>Cancer, 107</i>, 1812-1822. doi:10.1002/cncr.22217

Janda, M., Obermair, A., Cella, D., Crandon, A. J., & Trimmel, M. (2004). Vulvar cancer patients' quality of life: A qualitative assessment. <i>International Journal of Gynecological Cancer, 14</i>, 875-881. doi:10.1111/j.1048-891X.2004.14524.x

Janda, M., Obermair, A., Cella, D., Perrin, L. C., Nicklin, J. L., Ward, B. G., … Trimmel, M. (2005). The functional assessment of cancer-vulvar: Reliability and validity. <i>Gynecologic Oncology, 97</i>, 568-575. doi:10.1016/j.ygyno.2005.01.047

Jones, P. S., Lee, J. W., Phillips, L. R., Zhang, X. E., & Jaceldo, K. B. (2001). An adaptation of Brislin's translation model for cross-cultural research. <i>Nursing Research, 50</i>, 300-304. doi:10.1097/00006199-200109000-00008

Jones, R. W., Rowan, D. M., & Stewart, A. W. (2005). Vulvar intraepithelial neoplasia: Aspects of the natural history and outcome in 405 women. <i>Gynecologic Oncology, 106</i>, 1319-1326. doi:10.1097/01.AOG.0000187301.76283.7f

Kaushik, S., Pepas, L., Nordin, A., Bryant, A., & Dickinson, H. O. (2011). Surgical interventions for high grade vulval intraepithelial neoplasia. <i>Cochrane Database of Systematic Reviews, 1</i>, CD007928. doi:10.1002/14651858.CD007928.pub2

Kirkova, J., Davis, M. P., Walsh, D., Tiernan, E., O'Leary, N., LeGrand, S. B., … Russell, K. M. (2006). Cancer symptom assessment instruments: A systematic review. <i>Journal of Clinical Oncology, 24</i>, 1459-1473. doi:10.1200/JCO.2005.02.8332

Klassen, A. F., Cano, S. J., Scott, A., Snell, L., & Pusic, A. L. (2010). Measuring patient-reported outcomes in facial aesthetic patients: Development of the FACE-Q. <i>Facial Plastic Surgery, 26</i>, 303-309. doi:10.1055/s-0030-1262313

Lai, K. W., & Mercurio, M. G. (2010). Medical and surgical approaches to vulvar intraepithelial neoplasia. <i>Dermatologic Therapy, 23</i>, 477-484. doi:10.1111/j.1529-8019.2010.01351.x

Lanneau, G. S., Argenta, P. A., Lanneau, M. S., Riffenburgh, R. H., Gold, M. A., McMeekin, D. S., … Judson, P. L. (2009). Vulvar cancer in young women: Demographic features and outcome evaluation. <i>American Journal of Obstetrics and Gynecology, 200</i>, 645. doi:10.1016/j.ajog.2009.01.014

Leventhal, H., Diefenbach, M., & Leventhal, E. A. (1992). Illness cognition: Using common sense to understand treatment adherence and affect cognition interactions. <i>Cognitive Therapy and Research, 16</i>, 143-163. doi:10.1007/BF01173486

Likes, W. M., Russell, C., & Tillmanns, T. (2008). Women's experiences with vulvar intraepithelial neoplasia. <i>Journal of Obstetric, Gynecologic, and Neonatal Nursing, 37</i>, 640-646. doi:10.1111/j.1552-6909.2008.00291.x

Lipscomb, J., Gotay, C. C., & Snyder, C. F. (2007). Patient-reported outcomes in cancer: A review of recent research and policy initiatives. <i>CA: A Cancer Journal for Clinicians, 57</i>, 278-300. doi:10.3322/CA.57.5.278

Maclean, A. B. (2006). Vulval cancer: Prevention and screening. <i>Best Practice and Research. Clinical Obstetrics and Gynaecology, 20</i>, 379-395. doi:10.1016/j.bpobgyn.2005.11.001

McFadden, K. M., Sharp, L., & Cruickshank, M. E. (2009). The prospective management of women with newly diagnosed vulval intraepithelial neoplasia: Clinical outcome and quality of life. <i>Journal of Obstetrics and Gynaecology, 29</i>, 749-753. doi:10.3109/01443610903191285

National Cancer Institute. (2010). Stage information for vulvar cancer. TNM category—AJCC stage groupings. Retrieved from <a target="_blank" href='http://www.cancer.gov/cancertopics/pdq/treatment/vulvar/HealthProfession...

National Cancer Institute. (2012). Vulvar cancer. Retrieved from <a target="_blank" href='http://www.cancer.gov/cancertopics/types/vulvar'>http://www.cancer.gov/c...

Nugent, E. K., Brooks, R. A., Barr, C. D., Case, A. S., Mutch, D. G., & Massad, L. S. (2010). Clinical and pathologic features of vulvar intraepithelial neoplasia in premenopausal and postmenopausal women. <i>Journal of Lower Genital Tract Disease, 15</i>, 15-19. doi:10.1097/LGT.0b013e3181ee2598

Pepas, L., Kaushik, S., Bryant, A., Nordin, A., & Dickinson, H. O. (2011). Medical interventions for high grade vulval intraepithelial neoplasia. <i>Cochrane Database of Systematic Reviews, 4</i>, CD007924. doi:10.1002/14651858.CD007924.pub2

Polit, D. F., & Beck, C. T. (2006). The content validity index: Are you sure you know what's being reported? Critique and recommendations. <i>Research in Nursing and Health, 29</i>, 489-497. doi:10.1002/nur.20147

Polit, D. F., Beck, C. T., & Owen, S. V. (2007). Is the CVI an acceptable indicator of content validity? Appraisal and recommendations. <i>Research in Nursing and Health, 30</i>, 459-467. doi:10.1002/nur.20199

Portenoy, R. K., Thaler, H. T., Kornblith, A. B., Lepore, J. M., Friedlander-Klar, H., Kiyasu, E., … Scher, H. (1994). The Memorial Symptom Assessment Scale: An instrument for the evaluation of symptom prevalence, characteristics and distress. <i>European Journal of Cancer, 30A</i>, 1326-1336. doi:10.1016/0959-8049(94)90182-1

Revicki, D. A. (2007). FDA draft guidance and health-outcomes research. <i>Lancet, 369</i>, 540-542. doi:10.1016/S0140-6736(07)60250-5

Sawan, S., Mugnai, R., Lopes Ade, B., Hughes, A., & Edmondson, R. J. (2009). Lower-limb lymphedema and vulval cancer: Feasibility of prophylactic compression garments and validation of leg volume measurement. <i>International Journal of Gynecological Cancer, 19</i>, 1649-1654. doi:10.1111/IGC.0b013e3181a8446a

Senn, B., Gafner, D., Happ, M. B., Eicher, M., Mueller, M. D., Engberg, S., & Spirig, R. (2011). The unspoken disease: Symptom experience in women with vulval neoplasia and surgical treatment: A qualitative study. <i>European Journal of Cancer Care.</i> doi:10.1111/j.1365-2354.2011.01267.x

Senn, B., Mueller, M. D., Cignacco, E. L., & Eicher, M. (2010). Period prevalence and risk factors for postoperative short-term wound complications in vulvar cancer: A cross-sectional study. <i>International Journal of Gynecological Cancer, 20</i>, 646-654. doi:10.1111/IGC.0b013e3181d92723

Shylasree, T. S., Karanjgaokar, V., Tristram, A., Wilkes, A. R., MacLean, A. B., & Fiander, A. N. (2008). Contribution of demographic, psychological and disease-related factors to quality of life in women with high-grade vulval intraepithelial neoplasia. <i>Gynecologic Oncology, 110</i>, 185-189. doi:10.1016/j.ygyno.2008.04.023

Sideri, M., Jones, R. W., Wilkinson, E. J., Preti, M., Heller, D. S., Scurry, J… . Neill, S. (2005). Squamous vulvar intraepithelial neoplasia: 2004 modified terminology, ISSVD Vulvar Oncology Subcommittee. <i>Journal of Reproductive Medicine, 50</i>, 807-810.

Tishelman, C., Lovgren, M., Broberger, E., Hamberg, K., & Sprangers, M. A. (2010). Are the most distressing concerns of patients with inoperable lung cancer adequately assessed? A mixed-methods analysis. <i>Journal of Clinical Oncology, 28</i>, 1942-1949.

U. S. Food and Drug Administration. (2009). <i>Guidance for industry: Patient-reported outcome measures: Use in medical product development to support labeling claims.</i> Retrieved from <a target="_blank" href='http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati...

Van der Zee, A. G., Oonk, M. H., De Hullu, J. A., Ansink, A. C., Vergote, I., Verheijen, R. H., … Sluiter, W. J. (2008). Sentinel node dissection is safe in the treatment of early-stage vulvar cancer. <i>Journal of Clinical Oncology, 26</i>, 884-889. doi:10.1200/JCO.2007.14.0566

World Health Organization. (2002). Innovative care for chronic conditions: Building blocks for action. Retrieved from <a target="_blank" href='http://www.who.int/chp/knowledge/publications/icccreport/en'>http://www....