Isabel Duncan White1, Alan Tennant2, Cath Taylor3. 1. The Royal Marsden NHS Foundation Trust, Adult Psychological Support Service & Applied Health Research Group, London, UK. Electronic address: drwhite@edinburghpractice.com. 2. Leeds Institute of Rheumatic & Musculoskeletal Medicine, University of Leeds, Leeds, UK. 3. School of Health Sciences, University of Surrey, Guildford, UK.
Abstract
BACKGROUND: Clinical assessment and management of sexual difficulties after gynecological cancer remain a neglected aspect of women's rehabilitation. AIM: To develop and validate a patient-reported outcome measure of sexual well-being for women experiencing sexual consequences of cervical and endometrial cancer treatment for use in routine follow-up. METHODS: This is a sequential mixed method study comprising (i) in-depth qualitative interviews (n=21 of 118) to generate items regarding sexual consequences of cervical or endometrial cancer and treatment; (ii) questionnaire construction with 51 core items (all respondents) and 4 subsections (18-58 items), depending on the relationship status and whether or not participants were sexually active (SA/NSA); (iii) item refinement following cognitive debriefing (n=13 of 21); (iv) validation of resultant items via postal survey (n=788 women) and Rasch analysis; and (v) creation of brief (14-item) clinical screener. Women attending routine follow-up (3 months to 5 years) at 6 English cancer centers and members of 3 UK cancer patient websites, who met the study inclusion criteria, were invited to participate. OUTCOMES: The primary outcome of this study was the construction and initial psychometric testing of SWELL-CE short and long form versions. RESULTS: 21 women participated in interviews and 250 of 788 (32%) returned the postal survey (T1). 110 draft items were evaluated using cognitive testing (n=13) to refine instrument design and test face validity, comprehension, and acceptability. Exploratory factor analysis of survey data (n=250) produced an initial 6 domain structure as a guidance for the Rasch analysis. Subsequent Rasch analysis yielded a 3 domain structure: physical sexual function, sexual and relationship concerns, and sexual desire and sexual self-esteem, each satisfying Rasch model requirements within their respective SA (item pool =59) and NSA (item pool =53) categories, including the absence of local response dependency and all showing strict unidimensionality. The 3 subscales demonstrated good psychometric properties, external validity, and test-retest reliability. A valid Rasch short form of 14 items was created from the larger item pool. CLINICAL IMPLICATIONS: This PROM may assist clinicians to improve identification, discussion, and management of women who could benefit from sexual rehabilitation. STRENGTHS & LIMITATIONS: Initial evaluation supports psychometric validity and reliability in the assessment of physical sexual function, sexual interest and sexual self-esteem, and sexual and relationship concerns in this study sample. However, given this study's modest response rate (32%, n=250), findings should be interpreted with caution. This PROM identifies sexual concerns in women who are sexually active or sexually non-active due to illness or treatment-associated sexual difficulties. CONCLUSION: Sexual Well-being after Cervical or Endometrial Cancer is a novel and psychometrically valid sexual well-being measure for clinical assessment of female sexual difficulties after cervical or endometrial cancer treatment. White ID, Tennant A, Taylor C, Sexual Morbidity Assessment in Gyne-Oncology Follow-Up: Development of the Sexual Well-Being After Cervical or Endometrial Cancer (SWELL-CE) Patient-Reported Outcome Measure. J Sex Med 2020;17:2005-2015.
BACKGROUND: Clinical assessment and management of sexual difficulties after gynecological cancer remain a neglected aspect of women's rehabilitation. AIM: To develop and validate a patient-reported outcome measure of sexual well-being for women experiencing sexual consequences of cervical and endometrial cancer treatment for use in routine follow-up. METHODS: This is a sequential mixed method study comprising (i) in-depth qualitative interviews (n=21 of 118) to generate items regarding sexual consequences of cervical or endometrial cancer and treatment; (ii) questionnaire construction with 51 core items (all respondents) and 4 subsections (18-58 items), depending on the relationship status and whether or not participants were sexually active (SA/NSA); (iii) item refinement following cognitive debriefing (n=13 of 21); (iv) validation of resultant items via postal survey (n=788 women) and Rasch analysis; and (v) creation of brief (14-item) clinical screener. Women attending routine follow-up (3 months to 5 years) at 6 English cancer centers and members of 3 UK cancer patient websites, who met the study inclusion criteria, were invited to participate. OUTCOMES: The primary outcome of this study was the construction and initial psychometric testing of SWELL-CE short and long form versions. RESULTS: 21 women participated in interviews and 250 of 788 (32%) returned the postal survey (T1). 110 draft items were evaluated using cognitive testing (n=13) to refine instrument design and test face validity, comprehension, and acceptability. Exploratory factor analysis of survey data (n=250) produced an initial 6 domain structure as a guidance for the Rasch analysis. Subsequent Rasch analysis yielded a 3 domain structure: physical sexual function, sexual and relationship concerns, and sexual desire and sexual self-esteem, each satisfying Rasch model requirements within their respective SA (item pool =59) and NSA (item pool =53) categories, including the absence of local response dependency and all showing strict unidimensionality. The 3 subscales demonstrated good psychometric properties, external validity, and test-retest reliability. A valid Rasch short form of 14 items was created from the larger item pool. CLINICAL IMPLICATIONS: This PROM may assist clinicians to improve identification, discussion, and management of women who could benefit from sexual rehabilitation. STRENGTHS & LIMITATIONS: Initial evaluation supports psychometric validity and reliability in the assessment of physical sexual function, sexual interest and sexual self-esteem, and sexual and relationship concerns in this study sample. However, given this study's modest response rate (32%, n=250), findings should be interpreted with caution. This PROM identifies sexual concerns in women who are sexually active or sexually non-active due to illness or treatment-associated sexual difficulties. CONCLUSION: Sexual Well-being after Cervical or Endometrial Cancer is a novel and psychometrically valid sexual well-being measure for clinical assessment of female sexual difficulties after cervical or endometrial cancer treatment. White ID, Tennant A, Taylor C, Sexual Morbidity Assessment in Gyne-Oncology Follow-Up: Development of the Sexual Well-Being After Cervical or Endometrial Cancer (SWELL-CE) Patient-Reported Outcome Measure. J Sex Med 2020;17:2005-2015.