Page 52 - Journal of Special Operations Medicine - Spring 2017
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Categorical data (i.e., hemorrhage control, casualty sta-  composite being satisfactory; 44 tests had a bad out-
          tus, and damage in 2x2 contingency tables) were com-  come in that one or more components of the composite
          pared by exposure status (unexposed–exposed) with use   result were unsatisfactory. From the analysis of continu-
          of a Fisher exact test. Then a Cochran–Mantel–Haenszel   ous variables, these 44 test results were removed from
          test was used to see if such exposure effects were differ-  the subset to be analyzed, but none was removed from
          ent among the three tourniquet models. Likelihood ratio   overall analysis and from categorical data analysis.
          p values were reported. Descriptive statistics were used
          to portray results.                                Effectiveness Results by Tourniquet Model
                                                             The C-A-T’s effectiveness percentage was 91% (91 of
          Continuous data (e.g., time to stop bleed, pressure,   100 tests); unexposed C-A-T devices had 100% effec-
          blood loss) were summarized by mean ± standard error   tiveness (50 of 50 tests), whereas exposed devices had
          of the mean values and analyzed by using a mixed-model   82% effectiveness (41 of 50 tests; p = .003). The RMT’s
          analysis of variance (ANOVA). Components within the   effectiveness percentage was 98% (98 of 100 tests); un-
          statistical model, including the user as a random effect,   exposed RMT devices had 100% effectiveness (50 of 50
          were presented as a percentage for each continuous pa-  tests), whereas exposed devices had 96% effectiveness
          rameter to estimate their restricted maximal likelihood   (48 of 50 tests; all p = .495). The SOFTT-W tourniquet’s
          variance. Fixed-effect tests were made by exposure   effectiveness percentage was 94% (94 of 100 tests); un-
          group, model of tourniquet, and groupxmodel interac-  exposed SOFTT-W devices had 98% effectiveness (49 of
          tion. Group means were compared by using a Tukey ad-  50 tests); whereas exposed devices had 90% effectiveness
          justment within the mixed model.                   (45 of 50; all p = .204). The Cochran–Mantel–Haenszel
                                                             tests showed the C-A-T was significantly more suscep-
          Additionally, if the tests of tourniquet failed to stop bleed-  tible to exposure than the RMT or SOFTT-W (p ≤ .001).
          ing, the skewing of continuous data was known to be
          severe; for example, bleeding would only end upon the   Casualty Survival Results:
          death of the casualty at 2,500mL, compared with 150mL   Overall and by Tourniquet Model
          routinely measured with success in bleeding control. Fur-  For the overall study, survival rate (alive–dead) was 95%
          ther skewing from nontreatment effects, such as the ef-  (284 of 300); survival of casualties was 100% (150 of
          fect of the user, has been known by the investigators from   150) when unexposed devices were used and 89% when
          their previous studies when users have different caregiv-  the exposed devices were tested (134 of 150 tests; p <
          ing strategies, skill levels, or experience levels. Given this,   .001). The Cochran–Mantel–Haenszel tests showed the
          a contingency was planned to analyze the subset of data   C-A-T was significantly more susceptible to exposure
          that were reliable. The plan was as follows: if a test of   than the RMT or SOFTT-W (p ≤ 0.001).
          tourniquet had a bad composition (i.e., the second com-
          posite outcome was a bad result), we then removed all   Major Damage Results:
          such tests in which bleeding was not stopped (i.e., the   Overall and by Tourniquet Model
          subset analyzed had its tests with a result of composite   For the overall study, major damage (yes–no) occurred
          = good) and a two-way mixed-model ANOVA was per-   in 1% of tests (4 of 300). Unexposed devices had 0%
          formed, with the user as a random effect in the statistical   major damage, whereas exposed models had signifi-
          model to compare the continuous variables by exposure   cantly more, at 3% (4 of 150 tests; p = .018). The Co-
          status (yes–no) by model of tourniquet.            chran–Mantel–Haenszel tests showed the C-A-T to be
                                                             marginally, although significantly, more susceptible to
          For pairwise comparison of categorical data of tourni-  exposure (p =.044).
          quet models, a nonparametric Wilcoxon method was
          used. For pairwise comparison of means of tourniquet   Time to Stop Bleeding Results:
          models, Student’s t test was used to stratify results. Sig-  Overall and by Tourniquet Model
          nificance for results was established when values were   For the overall study, 14% of the variance of the time to
          p < .05. All statistical analysis was conducted by using   stop bleeding results could be attributed to the user. Over-
          SAS software (SAS Institute; http://www.sas.com) and   all, the mean time to stop bleeding results for all three
          MS Excel 2003 (Microsoft; www.microsoft.com).      models of tourniquet was 47 seconds. However, these re-
                                                             sults included all 44 tourniquet tests that had a bad com-
                                                             posite score. Excluding those 44 tests, the mean time to
          Results                                            stop bleeding was 27 seconds; for unexposed devices, the
                                                             mean was 26 seconds; and for exposed models, 29 sec-
          Overall Results                                    onds (p = .01). Results of mean time to stop bleeding by
          Of the 300 tourniquet tests, 256 had a good outcome   user were two tiered: user 1 (scientist) was slow (30 sec-
          in that the composite result had every component of the   onds) and user 2 (cadet) was fast (25 seconds; p < .001).



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