Linden Judith A, Grimmnitz Benjamin, Hagopian Laura, Breaud Alan H, Langlois Breanne K, Nelson Kerrie P, Hart Lauren L, Feldman James A, Brown Jeremy, Reid Marc, Desormeau Elise, Mitchell Patricia M
Department of Emergency Medicine, Boston University School of Medicine and Boston Medical Center, Boston, MA.
Boston Medical Center, Emergency Medicine Residency, Boston, MA.
Ann Emerg Med. 2017 Dec;70(6):825-834. doi: 10.1016/j.annemergmed.2017.07.487. Epub 2017 Sep 19.
We determine whether omitting the pelvic examination in emergency department (ED) evaluation of vaginal bleeding or lower abdominal pain in ultrasonographically confirmed early intrauterine pregnancy is equivalent to performing the examination.
We conducted a prospective, open-label, randomized, equivalence trial in pregnant patients presenting to the ED from February 2011 to November 2015. Patients were randomized to no pelvic examination versus pelvic examination. Inclusion criteria were aged 18 years or older, English speaking, vaginal bleeding or lower abdominal pain, positive β-human chorionic gonadotropin result, and less than 16-week intrauterine pregnancy by ultrasonography. Thirty-day record review and follow-up call assessed for composite morbidity endpoints (unscheduled return, subsequent admission, emergency procedure, transfusion, infection, and alternate source of symptoms). Wilcoxon rank sum tests were used to assess patient satisfaction and throughput times.
Only 202 (of a planned 720) patients were enrolled, despite extension of the study enrollment period. The composite morbidity outcome was experienced at similar rates in the intervention (no pelvic examination) and control (pelvic examination) groups (19.6% versus 22.0%; difference -2.4%; 90% confidence interval [CI] -11.8% to 7.1%). Patients in the intervention group were less likely to report feeling uncomfortable or very uncomfortable during the visit (11.2% versus 23.7%; difference -12.5; 95% CI -23.0% to -2.0%).
Although there was only a small difference between the percentage of patients experiencing the composite morbidity endpoint in the 2 study groups (2.4%), the resulting 90% CI was too wide to conclude equivalence. This may have been due to insufficient power. Patients assigned to the pelvic examination group reported feeling uncomfortable more frequently.
我们要确定在超声确诊为早期宫内妊娠的阴道出血或下腹痛的急诊科（ED）评估中，不进行盆腔检查是否等同于进行该检查。
我们对2011年2月至2015年11月到急诊科就诊的孕妇进行了一项前瞻性、开放标签、随机、等效性试验。患者被随机分为不进行盆腔检查组和进行盆腔检查组。纳入标准为年龄18岁及以上、会说英语、有阴道出血或下腹痛、β-人绒毛膜促性腺激素结果为阳性且超声检查显示宫内妊娠少于16周。通过30天的记录审查和随访电话评估复合发病终点（非计划复诊、随后入院、急诊手术、输血、感染以及症状的其他来源）。采用Wilcoxon秩和检验来评估患者满意度和就诊时间。
尽管延长了研究入组期，但仅纳入了（计划的720例中的）202例患者。干预组（不进行盆腔检查）和对照组（进行盆腔检查）的复合发病结局发生率相似（19.6%对22.0%；差异-2.4%；90%置信区间[CI]-11.8%至7.1%）。干预组患者在就诊期间报告感到不舒服或非常不舒服的可能性较小（11.2%对23.7%；差异-12.5；95%CI-23.0%至-2.0%）。
尽管两个研究组中经历复合发病终点的患者百分比之间只有微小差异（2.4%），但由此产生的90%CI太宽，无法得出等效性结论。这可能是由于检验效能不足。被分配到盆腔检查组的患者报告感到不舒服的频率更高。
