Samuel Oxley, Amanda Dibden, Tia Whenham, Xia Wei, Lea Mansour, Ashwin Kalra, Subhasheenee Ganesan, Jacqueline Sia, Michail Sideris, Caitlin Fierheller, Margarida Kurzer, Rachel Perfect-Lake, Jyotsna Pundir, D Gareth Evans, Lesa Dawson, Kevin Monahan, Tracy Smith, Adam Brentnall, Rosa Legood, Ranjit Manchanda, PRESCORES study team
This randomised study provides HRUS following premenopausal RRH with and without BSO at two postoperative time-points, with adjustment against the age-and sex-matched general reference-population. These values are of relevance for informing counselling of women at increased endometrial cancer-risk regarding RRH and for health-economic evaluations.
BACKGROUND: Risk-reducing hysterectomy (RRH) is the most effective endometrial cancer preventive strategy. Understanding health-related quality-of-life using health-related utility-scores (HRUS) is essential for counselling, shared decision-making, and informing health-economic evaluations of endometrial cancer prevention. This study aimed to determine HRUS for premenopausal RRH, with and without bilateral salpingo-oophorectomy (BSO).
METHODS: Preventing Endometrial-Cancers: Comparing Risk-Reducing Strategies (PRESCORES) (ISRCTN17432105) part-2 is a UK-based randomised vignette study. Following a robust development process, vignettes described four postoperative health-states for a 40-year-old otherwise-healthy woman: "RRH at 1-month", "RRH at 1-year", "RRH-BSO at 1-month", "RRH-BSO at 1-year". These were valued using EQ-5D by participants recruited from the UK general-population and HRUS calculated. Utilities were subsequently adjusted by age-and sex-matched general-population reference values. Association of variables was explored with ordinary-least-squares regression with non-parametric bootstrapping.
FINDINGS: Overall, 1001 women were included and randomised to 1-of-4 groups. The mean-age(±SD) was 53.6 (±11.4) years. Mean(±SD) HRUS were 0.942 (±0.072) for "RRH at 1-year", 0.841 (±0.137) for "RRH-BSO at 1-year", 0.670 (±0.149) for "RRH at 1-month", and 0.733 (±0.190) for "RRH-BSO at 1-month", with significant difference between each group (p < 0.001). Adjusting for age-sex-matched population reference utilities, HRUS were 1.000(95% CI:1.00-1.00), 0.994(95% CI:0.97-1.00), 0.866(95% CI:0.84-0.90) and 0.791(95% CI:0.77-0.81), respectively. Participant factors associated with vignette valuations included age, obesity, heavy menstrual-bleeding, higher income and mixed/other ethnicity.
CONCLUSION: This randomised study provides HRUS following premenopausal RRH with and without BSO at two postoperative time-points, with adjustment against the age-and sex-matched general reference-population. These values are of relevance for informing counselling of women at increased endometrial cancer-risk regarding RRH and for health-economic evaluations.