Early Pregnancy and Gynaecological Scanning Unit, Queen Charlotte's and Chelsea Hospital, Imperial College, London, UK.
Ultrasound Obstet Gynecol. 2012 Aug;40(2):145-50. doi: 10.1002/uog.11184.
To evaluate the performance and potential impact on patient management of a pocket-sized ultrasound machine (PUM) in comparison to high-specification ultrasound machines (HSUM).
This was an observational cohort study with 204 unselected patients in three categories: 1) women with pain and bleeding in early pregnancy (101 patients); 2) women presenting for routine obstetric ultrasound assessment (53 patients); 3) women with possible gynecological pathology (50 patients). Scans were carried out transabdominally using a PUM. A second operator repeated the examination transvaginally and/or transabdominally, depending on the clinical indication, using an HSUM. The operators were blind to each other's findings.
In the early pregnancy group, there was good to very good agreement between the PUM and HSUM for identifying the presence or absence of an embryo, gestational sac, fetal heart motion, pregnancy location and final diagnostic outcome (kappa coefficients, 0.844, 0.843, 0.729, 0.785 and 0.812, respectively; P < 0.0001). In the obstetric ultrasound group there was good to very good agreement for fetal presentation, placental location and placental position (kappa coefficients, 0.924, 0.924 and 0.647, respectively; P < 0.0001). In the gynecological pathology group, there was very good agreement for final diagnosis and type of ovarian mass (low risk or complex) (kappa coefficients, 0.846 and 0.930, respectively; P < 0.0001). For the measured continuous variables, there was close agreement for crown-rump length, mean sac diameter, femur length and mean diameter of an ovarian mass, but not for endometrial thickness. Neither patient demographics (age, body mass index, ethnicity) nor operator experience and familiarity with a PUM had an impact on agreement between the two machines. If a PUM had been the only equipment available for an initial assessment, only two cases would have led to a suboptimal patient management plan.
The findings and final diagnosis in the three study groups were similar for both a PUM used transabdominally and an HSUM used transvaginally and/or transabdominally.
评估袖珍式超声机(PUM)与高规格超声机(HSUM)相比的性能及其对患者管理的潜在影响。
这是一项观察性队列研究,纳入了三个类别中的 204 名未经选择的患者:1)孕早期有疼痛和出血的女性(101 例);2)常规行产科超声评估的女性(53 例);3)可能存在妇科疾病的女性(50 例)。使用 PUM 经腹部进行扫描。根据临床指征,由第二位操作员使用 HSUM 经阴道和/或经腹部重复检查。操作员彼此之间不知道对方的发现。
在孕早期组中,PUM 和 HSUM 用于识别胚胎、孕囊、胎心运动、妊娠位置和最终诊断结果的存在或缺失方面具有良好到极好的一致性(kappa 系数分别为 0.844、0.843、0.729、0.785 和 0.812;P<0.0001)。在产科超声组中,胎儿胎位、胎盘位置和胎盘位置具有良好到极好的一致性(kappa 系数分别为 0.924、0.924 和 0.647;P<0.0001)。在妇科疾病组中,最终诊断和卵巢肿块类型(低风险或复杂)具有极好的一致性(kappa 系数分别为 0.846 和 0.930;P<0.0001)。对于测量的连续变量,头臀长、平均孕囊直径、股骨长度和卵巢肿块的平均直径之间具有密切的一致性,但子宫内膜厚度除外。患者特征(年龄、体重指数、种族)和操作员使用 PUM 的经验和熟悉程度均未对两种机器之间的一致性产生影响。如果仅使用 PUM 进行初始评估,则只有两例会导致患者管理计划不理想。
经腹部使用 PUM 和经阴道和/或经腹部使用 HSUM 在三个研究组中的检查结果和最终诊断相似。