Page 75 - JSOM Winter 2017
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              Selection of Participants                          approximately 50%.  With 50 subjects, each making a deter-
              We recruited  a  convenience  sample of  emergency  medicine   mination as to the presence of a foreign body of a given size,
              physician volunteers to participate in the study. The inclusion   our study had power to detect a 20% difference in sensitivity
              criteria were that participants be residents, attending physi-  across the range of foreign body sizes.
              cians, and physician assistants (PAs) with self-reported prior
              ultrasound training. The extent of prior training could vary   Investigators aggregated all hardcopy data into an Excel da-
              from a 2-day introductory course to completion of a formal   tabase (version 14; Microsoft,www.microsoft.com). We used
              ultrasound fellowship. Of note, all the emergency medicine   SPSS version 22 (IBM, www.ibm.com) for statistical analysis.
              residents and PAs recruited to participate had been previously   We calculated test characteristics for the use of ultrasound
              required to complete a dedicated 4-week ultrasound rotation   for foreign body detection including sensitivity, specificity,
              during which trainees must perform 175 proctored ultrasound   and positive and  negative likelihood ratios. We  generated
              examinations to include 25 soft-tissue and musculoskeletal   95% confidence  intervals  (CIs) for  these estimates,  using
              studies. The exclusion criterion was lack of any prior experi-  bootstrap techniques. We further stratified these calculations
              ence using ultrasound for foreign body detection.  by subject education level and foreign body size. The primary
                                                                 outcome analysis used a χ  test to compare subject sensitivity
                                                                                     2
              Study Protocol                                     in foreign body detection between foreign bodies of alterna-
              We used a previously described tissue simulator of food-grade   tive sizes.
              chicken thigh to model human tissue. 10,13,14,21  Common wooden
              toothpicks were the wooden foreign bodies and were cut to stan-  Results
              dard similar sizes. Each participant performed ultrasound exami-
              nations on 10 separate models and were blinded to the presence   Characteristics of Study Subjects
              or absence of foreign bodies. Five models were free of any foreign   Investigators enrolled 50 subjects for study participation via
              body. The remaining five models each contained one wooden   convenience sampling, all of whom were eligible and agreed
              toothpick of a different known length (1mm, 2.5mm, 5mm,   to participate. Of these participants, there were 37 residents
              7.5mm, and 10mm). Investigators inserted the toothpicks by   (74%), eight attending physicians (16%) without ultrasound
              pulling back the tissue model skin and inserting directly into the   fellowship training, three PAs (6%), one ultrasound fellow
              subcutaneous tissue at a 30° angle. Investigators then performed   (2%), and one attending physician (2%) with ultrasound fel-
              ultrasound to confirm a depth of insertion between 5mm and   lowship training. All subjects completed the study approxi-
              10mm. After insertion, investigators replaced the anatomic situa-  mately within the 30-second time limit.
              tion of the model skin so there were no marks visible to the study
              subjects to suggest the underlying placement of a foreign body.  Main Results
                                                                 The pooled sensitivity for all 250 examinations of tissue mod-
              The order in which participants examined each of the 10 tissue   els with foreign bodies was 48.4% (95% CI, 42.1%–54.8%).
              models was randomized using a random number generator to   The overall specificity for all 250 examinations of tissue
              produce tissue model sequences. Each participant examined   models without foreign bodies was 67.6% (95% CI, 61.3%–
              each tissue model once. Participants performed all ultrasound   73.3%). These values corresponded to a positive likelihood
              examinations using standard coupling gel and a 7.5mHz lin-  ratio of 1.5 (95% CI, 1.2–1.9) and negative likelihood ratio of
              ear probe with a Sonosite M-Turbo machine (https://www   0.8 (95% CI, 0.7–0.9).
              .sonosite.com). Investigators did not permit any direct contact
              between subjects’ hands and the individual tissue models. In-  There was no statistically significant difference in sensitiv-
              vestigators instructed each participant to examine each tissue   ity based on foreign body size (p = .709; Table 1). Moreover,
              model for the presence of a foreign body for no more than 30   sensitivity and specificity were broadly comparable across all
              seconds per model. The time started when the subject placed   education levels (Table 2). Similarly, sensitivity stratified by
              the ultrasound probe on the tissue model and ended by the   education level remained largely stable across all foreign body
              subject reporting their determination of the presence or ab-  sizes studied (Figure 1).
              sence of a foreign body. Subjects were not privy at any point
              in the study as to the presence or absence of a foreign body in   Table 1  Sensitivity of Ultrasound in Detecting Wooden Foreign
              each individual tissue model. Similarly, subjects were not privy   Body Stratified by Object Size (N = 50)
              to the proportion of models with or without foreign bodies.      Scans Identifying
                                                                 Object Size, mm  Object, No.  Sensitivity, %  95% CI
              Investigators verbally asked each subject about their level of   1    22          44.0    31.2–57.7
              education (i.e., resident, PA, attending physician, ultrasound   2.5  21          42.0    29.4–55.8
              fellow, or attending physician with formal ultrasound fellow-  5      25          50.0    36.6–63.4
              ship training). Investigators also asked each subject whether   7.5   26          52.0    38.5–65.2
              he or she identified a foreign body in each tissue model. Inves-  10  27          54.0    40.4–70.6
              tigators recorded all data on a hardcopy data collection form.  CI, confidence interval.

              Outcomes
              The primary outcome measure was subject determination as to   Discussion
              the presence or absence of a foreign body for each tissue model.  Overview of Findings
                                                                 This study found generally poor diagnostic accuracy for ultra-
              Analysis                                           sound  to  detect  wooden  foreign  bodies  in  a  chicken-tissue
              We based our sample size estimate on α = .05 and β = .20   model. We did not identify any association between ultra-
              with two-sided testing. We expected overall sensitivity to be   sound sensitivity and foreign body size ranging from 1mm to

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