Dr. Isabel White Clinical Research Fellow in Psychosexual Practice Assessment of Sexual Difficulties Associated with Multi-modal Treatment for Cervical or Endometrial Cancer: a systematic review of measurement instruments Dr. Isabel White Clinical Research Fellow in Psychosexual Practice Change Presentation title and date in Footer dd.mm.yyyy

Background & Aim of Review 30-63% of women with cervical cancer experience sexual difficulties after pelvic radiotherapy (Sadovsky et al 2010, Jensen & Froeding 2015) Discussion of sexual consequences took place in only 25% of routine pelvic radiotherapy FUP clinic consultations (White et al 2011;2013) Practitioners & researchers need outcome measures that accurately identify the range of common treatment-induced sexual difficulties experienced by women after cervical or endometrial cancer Systematic Review critically appraised measurement properties & clinical utility of instruments validated for measurement of female sexual dysfunction (FSD) in this clinical population

Methods: Bibliographic database search Change Presentation title and date in Footer dd.mm.yyyy Methods: Bibliographic database search Instrument development or validation papers published 1995-2015 Identifiable cervical / endometrial patient sample Female sexual dysfunction = sole concept measured OR as one domain within wider QOL Instrument Exclusion Criteria Papers focused on sexual history taking, communication about sexual impact of illness / treatment, or body image Case reports, literature reviews Sexual dysfunction in disease types or treatment effects unrelated to cervical or endometrial cancer

Measurement Properties Methods: COSMIN Methodological quality & measurement properties of studies rated using: Consensus-based Standards for the selection of health Measurement Instrument (COSMIN) checklist Measurement Properties Internal Consistency Content Validity Reliability Structural Validity Hypothesis testing Cross-cultural Validity Measurement Error Criterion Validity Responsiveness 4-point Likert scale: poor, fair, good excellent

Results: Search Outcomes 1

Search Results Database Search Records n= 1242 N = 31 Excluded n = 650 Embase – 484 Medline – 381 Psychinfo – 216 CINAHL – 157 BNI – 4 AMED – 0 n= 1242 Records screened after duplicates removed n = 738   Excluded n = 650 Did not meet stated inclusion criteria Papers subjected to data extraction & COSMIN guidelines n = 6 Additional records identified from other sources N = 31 Full text papers assessed for eligibility n = 13 Full text papers excluded n=7 not validated in a cancer sample n = 2 not instrument development or validation paper n = 2 cervical / endometrial sample not identifiable n = 2 repeat validation in surgical sample n = 1 Papers selected based on title and abstract n = 88 Excluded n = 75 not validated in a cancer sample n = 56 not validated in endometrial or cervical cancer sample n= 7 repeat validation in non-English speaking sample n= 5 not sexual dysfunction n= 1 not instrument development or validation paper n= 6

Search Results 4 female sexual dysfunction & 2 QOL instruments validated in this clinical population: Female Sexual Function Index : FSFI (Baser et al 2012) Sexual Adjustment and Body Image Scale - Gynecologic Cancer: SABIS-G (Ferguson et al 2012) Sexual function-Vaginal changes Questionnaire: SVQ (Jensen et al 2004) Gynaecologic Leiden Questionnaire: GLQ (Pieterse et al 2008 ) European Organisation for Research & Treatment of Cancer Quality of Life Questionnaire - Cervical Cancer Module: EORTC QLQ CX-24 (Greimel et al 2008) European Organisation for Research & Treatment of Cancer Quality of Life Questionnaire - Endometrial Cancer Module: EORTC QLQ EN-24 (Greimel et al 2011)

Results: Instrument Measurement Properties

Measurement Properties of Instruments 4/6 [FSFI, EORTC CX-24, EN-24, SVQ ]instruments achieved an “excellent” rating for content validity BUT ONLY FSFI measured all dimensions of female sexual function No paper reported measurement error Responsiveness only reported for SVQ & GLQ 3/6 papers [FSFI, SVQ, GLQ) failed to report on criterion validity Test-retest reliability reporting was inconsistent: tendency to omit details of time lapse & stability of participant health status between measurement points Cross-cultural validity for 2 x EORTC instruments achieved poor rating due to inadequate sample size for country sub-groups or failure to report results for individual country samples

Measurement Properties of Instruments Although instruments measured global sexual satisfaction, or satisfaction with specific aspects of sexual response, distress or bother associated with sexual difficulty was explicitly measured by SVQ alone: one of DSM V diagnostic criteria for sexual disorders Scoring inconsistencies / lower scoring validity occurs when instrument cannot distinguish between low scoring women sexually inactive as a direct consequence of treatment / disease induced sexual difficulties Vs. women sexually inactive for unrelated reasons Standard recall period of 4 weeks may be too short especially for older women / couples who are sexually active at intervals in excess of 4 weeks

Results: Instrument Clinical Utility 11 Results: Instrument Clinical Utility 2

Clinical Utility of Instruments Only SVQ & SABIS-G included pre-treatment sexual function comparisons (clinically recognised that pre-treatment sexual function or well-being often affected by presenting disease symptoms) 4 / 6 [CX & EN-24, SVQ, GLQ] instruments included commonly encountered mediating treatment or illness effects e.g. vaginal changes, menopause, altered body image / femininity No instrument included items regarding the effect of therapeutic aids (cannot measure impact of intervention use / compliance) Sexual morbidity PROMS terminology continues to privilege heterosexual penile-vaginal intercourse as the dominant sexual activity & not validated in non-heterosexual sample

Clinical Utility of Instruments Ideal clinical instrument should be brief, easy to complete & score to minimise burden for patient & HCP, while still generating meaningful data No instrument exceeded 24 items BUT only CX-24 & EN-24 reported completion times (<15 mins) & participant feedback on ease of use Only FSFI had a simple scoring template & clinical cut-off score (FSD diagnostic threshold) 5/6 were complex or time-consuming for self or clinical interpretation thus limiting diagnostic / clinical management utility All instruments have some application for remote monitoring systems or as a vehicle for structured clinical discussion given low levels of routine assessment in clinical practice even in high risk patient groups (White et al 2011;2013)

FSFI remains the most robust female sexual morbidity PROM, for research or clinical use, in sexually active women treated for cervical or endometrial cancer White ID, Sangha A, Lucas G, Wiseman T (in press) Assessment of Sexual Difficulties Associated with Multi-modal Treatment for Cervical or Endometrial Cancer: a systematic review of measurement instruments. Gynecologic Oncology.