Academic Medical Centre, Amsterdam, Department of Radiology, The Netherlands.
Eur J Obstet Gynecol Reprod Biol. 2013 Jul;169(1):69-74. doi: 10.1016/j.ejogrb.2013.01.019. Epub 2013 Mar 6.
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.
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.
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.
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.
确定偏好和治疗分配对接受子宫动脉栓塞术（UAE）与子宫切除术治疗症状性子宫肌瘤的随机 EMMY 试验患者健康相关生活质量（HRQOL）的影响。
我们邀请了 349 名符合试验条件的患者，其中 177 名同意参加（“随机组”）。在随机组中，患者被分配到 UAE（n=88）或子宫切除术（n=89）。其余 172 名患者拒绝随机化并接受他们偏好的治疗（从子宫切除术到根本不治疗不等），其中 103 名患者同意填写问卷（“偏好组”）。在基线时评估患者的治疗偏好和 HRQOL，并前瞻性随访患者，以评估治疗后 12 个月的 HRQOL。
在基线时，随机组中的大多数患者更喜欢 UAE：115/177（65%）。在偏好组中，大多数患者更喜欢子宫切除术：100/172（58%）。在 12 个月时，接受首选治疗对 HRQOL 没有影响，无论是在随机组还是偏好组中。与基线相比，随机组在心理健康和身体健康方面均有显著改善。在偏好组中，与基线相比，只有心理健康得到改善，而身体健康没有显著改善。
在比较 UAE 和子宫切除术治疗症状性肌瘤的随机试验中，治疗前的偏好并不影响 HRQOL。与拒绝参与的女性相比，试验参与者在身体 HRQOL 方面的改善更好。
