Patient-Reported Outcomes in Women with Vulvar Neoplasia after Surgical Treatment A Mixed-Methods Project
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1 Patient-Reported Outcomes in Women with Vulvar Neoplasia after Surgical Treatment A Mixed-Methods Project Beate Senn 1, Manuela Eicher 2, Michael Mueller 3, Sandra Engberg 4 & 5, Rebecca Spirig 4 & 6 1 Institute for Applied Nursing Sciences IPW-FHS, FHS St.Gallen, University of Applied Sciences 2 University of Applied Science, School of Health Fribourg, Switzerland 3 Department of Gynecology & Obstetrics, University Hospital of Bern, Switzerland 4 Institute of Nursing Science, Faculty of Medicine, University of Basel, Switzerland 5 School of Nursing, University of Pittsburgh, US 6 Center of Clinical Nursing Science, University Hospital of Zurich, Switzerland
2 Women with Vulvar Neoplasia Vulvar intraepithelial neoplasia Vulvar cancer incidence Germany 2.5 / newly diagnosed 620 died Standard therapy 2012 WOMAN-PRO (Deutsche Gesellschaft für Gynäkologie & Geburtshilfe, 2009)
3 Background Lower extremity lymph edema 30-70% Wound complications 5-40% Psychosexual complications10-30% Jamie McCartney Artist (Kaushik et al., 2011; Senn et al., 2010; Jefferies et al., 2009) 3
4 Research Gaps Women s perspective Symptom Experience Nursing care Structured Symptom Assessment Research Evidence on Symptoms 4
5 Aims 1. To explore symptom experience of women during the first six months following surgical treatment of vulvar neoplasia in a qualitative study. 2. To develop and pilot-test the self-administered WOMAN- PRO instrument for monitoring the post-vulvar-surgery symptom experience and informational needs of women with vulvar neoplasia. 3. To examine the occurrence and distress related to postsurgery symptoms of women with vulvar neoplasia during the first week following hospital discharge following vulvar surgery in a cross-sectional study. 5
6 Mixed-Methods Project Design: Sequential exploratory (Creswell & Clark, 2007) 6
7 Study 1: To Explore Symptom Experience occurred in parallel Critical hermeneutic approach Women with vulvar neoplasia & surgery Hospitals: Berne, Freiburg, Munich Design, Sample, Setting Data collection Purposeful sample Narrative interviews 09/ /2010 Data analysis Content analysis to identify categories, themes, patterns Assisted by ATLAS.ti (Diekelmann et al., 1989) 7
8 Study 1: Sample (n=20) Variable Category Frequency, Median (ME) Percent, Inter Quartile Range (IQR) Age In years 55.5 (ME) occurred in parallel (IQR) Nationality German 9 45% Swiss 10 50% Thai 1 5% Stage of disease 0-I II-III % 25% Recurrence Yes 8 40% Surgical therapy Local excision Laser-vaporization Partial or radical vulvectomy % 45% 45% Lymph node dissection Sentinel Inguinofemoral % 20% Hospitalization Length (in days) 6.5 (ME) (IQR) (Senn et al., 2011) 8
9 Study 1: Symptom Experience Feared illness progression Delayed diagnosis Disclosed disease LACK OF INFORMATION occurred in parallel Affected interpersonal interactions Disturbed self-image STRATEGIES TO HANDLE SITUATIONS Evoked emotions Experienced woundrelated symptoms Changed vulva care DISTRESS LEVEL Figure 1: Symptom experience in women with vulvar neoplasia and surgical treatment (Senn et al., 2011) 9
10 Study 1: Symptom Experience Theme: Disturbed self-image occurred in parallel 1. Female genital 2. Sexuality 3. Attractiveness 4. Self- confidence Harriet*: When I walk through the city I have the feeling that I am surely the only woman running around here now with half a vulva I feel incomplete. (* pseudonym) 10
11 Study 2: To Develop / Pilot-Test a PRO 1. Hypothesize conceptual framework 5. Modify instrument 2. Adjust conceptual framework and draft instrument 4. Collect, analyze and interpret data 3. Assess other measurement properties PRO = Patient Reported Outcome instrument (Food and Drug Administration, 2009) 11
12 Study 2: Development of PRO Items Wound Activity Psychosocial Information 1. Bleeding 2. Clear drainage 3. Cloudy drainage 4. Warmth 5. Swelling 6. Redness 7. Pain 8. Itching 9. Unusual odor 10. Burning 11. Altered sensation 12. Pressure 13. Hardness 14. Open skin or suture 15. Unusual skin color 16. Scarring 1. Urination 2. Bowel movement 3. Sitting 4. Wearing clothes 5. Daily activities 1. Insecurity 2. Anxiety 3. Sadness 4. Tiredness 5. Feel that I reached my limit 6. Feeling that my body has changed 7. Changed feeling about myself as a woman 8. Embarrassment 9. Concerns related to sexuality 10. Difficulties in my partnership 11. Changed social activities 12. Difficulties talking about the disease 1. Disease 2. Treatment 3. Everyday hygiene of the vulva 4. Taking care of the wound area 12
13 Study 2: Example Item How often do you experienced the symptom during the first seven days after discharge? Never Daily days days days If you experienced the symptom, how distressing was it? Not A little Some- Quite Very at all bit what a bit much 1 Bleeding (Senn et al., 2012) 13
14 Study 2: To Test Content Validity Cross-sectional survey Sample: patients & clinical experts Hospitals: Bern, Freiburg, Munich Design, Sample, Setting Data Collection 1. & 2. Pilot test Content validity forms, incl. open questions Content validity index: Item & scale Content analysis Data Analysis PRO = Patient Reported Outcome measures (Polit & Beck, 2009) 14
15 Study 3: To Examine Symptoms & Distress Cross-sectional survey Women with vulvar neoplasia Bern, Basel, St.Gallen, Zurich; Berlin, Dusseldorf, Freiburg, Munich Design, Sample, Setting Data Collection WOMAN-PRO instsrument Medical & socio demographic data 10/ /2011 Descriptive statistics: Symptom occurrence & distress during the first 7 days following discharge Data Analysis WOMAN-PRO Cronbach s alpha >
16 Study 3: Sample (n=65) Variable Category Frequency, Median (ME) Percent, Inter Quartile Range (IQR) Age In years 42 (ME) (IQR) Nationality German Swiss Stage of disease 0-I II-IV % 51% 80% 15% Recurrence Yes 12 19% Surgical therapy Lymph node dissection Local excision Laser-vaporization Partial vulvectomy Radical vulvectomy Sentinel Inguinofemoral % 23% 48% 12% 43% 29% Hospitalization Length (in days) 10 (ME) 4; 14 (IQR) 16
17 Study 3: Symptom Prevalence Symptoms per patient: Mean 20.2, SD 5.77, Range % 80% 86% 84% 80% 97% 86% 79% 95% 83% 77% swelling drainage 60% pain sitting 40% clothes daily activities 20% tiredness insecurity 0% symptoms changed body SD = Standard deviation (Senn et al., 2013) 17
18 Study 3: Symptoms & Distress Symptom frequency / severity Mean (SD) Sitting Wearing clothes Swelling 2.71 (0.68) 2.31 (1.13) 2.29 (1.11) Symptom distress Sitting Daily activties Open skin or suture Mean (SD) 2.00 (0.88) 1.86 (0.87) 1.91 (0.93) SD = Standard deviation (Senn et al., 2012) 18
19 Main Results 1. QUAL: Conceptual model of symptom experience Challenge: to communicate, assess and treat symptoms 2. QUAN/QUAL: A new WOMAN-PRO instrument Content validity 3. QUAN: High symptom prevalence & distress Reliability 2010 WOMAN-PRO 19
20 Limitations Limited timeframe of data collection in the survey restricted the sample size & the testing of the psychometric properties of the WOMAN-PRO One measurement time point - changed symptoms over time could not be taken into consideration Strengths Using PRO guidelines for the instrument development International, multicenter, mixed methods research project generated initial evidence in women with rare disease 20
21 Implications: Research & Practice WOMAN-PRO psychometric properties Pilot testing WOMAN- PRO beyond seven days Implementation strategies for comprehensive symptom assessment 2012 WOMAN-PRO (Senn et al., 2013) 21
22 Acknowledgements PhD committee: Rebecca Spirig, Sandra Engberg, Michael Mueller, Manuela Eicher Financial support: Foundation Cancer Research Switzerland Collaborating centers, staff, and patients Colleagues, friends and family correspondence: 22
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