Discussion questions

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  How does the study contribute to knowledge in the field?

  
  
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  What was the research question?

  
  
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  What type of study was this?

  
  
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  What statistical methods were used?

  
  
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  What data are in the tables?

  
  
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  What did the authors conclude?

  
  
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  How does this study apply to your clinical practice?

Patients with symptomatic uterine fibroids often present with heavy menstrual bleeding and pelvic pressure. Classically, only surgical treatments were available: hysterectomy or myomectomy. While hysterectomy is the definitive treatment—nearly all patients experience amenorrhea, and most report diminished pelvic pressure—it is a major surgical procedure with possible morbidity and necessary recovery time. Uterine artery embolization (UAE), first described 15 years ago, has garnered increased attention in recent years as a treatment for symptomatic uterine fibroids. Previous publications from the EMbolization versus hysterectoMY (EMMY) trial indicate that compared with hysterectomy, UAE was associated with an equal rate of major complications but a shorter hospital stay and a faster return to usual daily activities. The latest study of EMMY participants, by van der Kooji and colleagues, examined how patients who underwent UAE instead of hysterectomy were faring at the 5-year postprocedure mark. The data were discussed at this month’s meeting of the Journal Club.

Prospecting for gold

Given the prevalence of uterine leiomyomas and the substantial number of hysterectomies performed for this indication, development of less invasive treatments is an enticing prospect. However, any new procedure must be compared to hysterectomy to establish whether its efficacy and side-effect profile are favorable enough to deem it a feasible alternative. Randomized controlled trials (RCTs) are the preferred study design when weighing a new medication or device against a so-called gold standard.

Recruitment of patients into surgical/procedural RCTs can be quite challenging, though, as patients often have preconceived notions about the type of intervention they desire. This study’s 51% participation rate prior to randomization likely reflected the difficulty of enrolling patients in a study where a theoretical flip of a coin decided whether the patient would have a major surgical procedure or a less common, less familiar radiologic procedure.

Nonetheless, as long as the sample size is adequate, randomization of participants to an intervention controls for both known and unknown confounders by producing groups with similar baseline characteristics. In this study, for instance, without the randomization process, factors such as prior treatment, number and volume of fibroids, and duration of symptoms could have affected the results. If this study had been designed as a cohort study, it would be possible for patients to be preferentially assigned to a specific treatment based on factors such as uterine size, and this could have introduced additional bias into the study.