The effect of treatment preference and treatment allocation on patients' health-related quality of life in the randomized EMMY trial

Abstract

Objectives: To determine the effect of preference and treatment allocation on health-related quality of life (HRQOL) in patients in the randomized EMMY trial of hysterectomy versus uterine artery embolization (UAE) for symptomatic uterine fibroids. Study design: We invited 349 patients eligible for trial participation, of which 177 agreed to participate (the 'randomized group'). Within the randomized group, patients were allocated to. UAE (n = 88) or hysterectomy (n = 89). The remaining 172 patients refused randomization and received the treatment of their preference (varying from hysterectomy to no treatment at all), of which 103 patients agreed to fill in questionnaires (the 'preference group'). Patients' treatment preferences and HRQOL were assessed at baseline and the patients were prospectively followed to evaluate HRQOL at 12 months after treatment. Results: At baseline, most patients in the randomized group preferred UAE: 115/177 (65%). In the preference group most patients preferred hysterectomy: 100/172 (58%). At 12 months there was no effect of having had the preferred treatment on HRQOL, neither in the randomized nor in the preference group. The randomized group improved significantly in both mental and physical health, compared to baseline. In the preference group, only mental health improved compared to baseline, while physical health did not improve significantly. Conclusions: In a randomized trial comparing UAE and hysterectomy for symptomatic fibroids, the pre-randomization preference for a specific treatment did not affect HRQOL. Trial participants improved better on physical HRQOL than women who refused to participate.