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Table 2 Variables, research hypothesis, outcome measures and methods of statistical analysis

From: Randomized controlled trial of multidisciplinary team stress and performance in immersive simulation for management of infant in shock: study protocol

Measures Research hypothesis Variables and outcome measures Population Statistical test
Descriptive analysis Homogeneity of groups Quantitative variables Scores (/100), SC (μg/dl), HR (/mn), BP (mmHg), PNN50 (%), HF/LF Total population mean, standard deviation and / or median and interquartile range
Qualitative variables age, sex, status, years of experience Total population Number and percentage
Evaluation of the effect of stress on performance Impact of stress on performance with capabilities(stress adapted) or decreased (unsuitable stress) Markers of biological stress (SC) Total population Pearson correlation coefficient (or Spearman correlation coefficient, if necessary)
Markers of electrophysiological stress (HR, BP, PNN50, HF/LF) Groups 1 and 2
Markers of psychological stress (STAI, PCLS, IES-R) Research of heterogeneity related to status
Performance: overall performance scores, IO access score and scales assessing teamwork
Evaluation of changes in performance scores over time Performance scores improved over time Overall team performance, IO access performance score and scales assessing teamwork Groups 1 et 2 ANOVA for repeated measures (or a non-parametric test like Kruskal-Wallis if necessary). Scheffe tests to test the difference by pair in case of significance with the ANOVA test
For the whole population, linear models with mixed effects may be considered in order to take into account in the same analysis all data collected in the simulation sessions, including the development of stress management strategies in parallel to stress and repeated simulations.
Evaluation of repeated simulations on performance Improvement of performance during repeated simulations with higher scores in group 1 Score of overall performance, IO access score and score of scales assessing teamwork: Comparison between group 1 and 2 Student t-test and research of status and group effect by ANVOA
Relative variation of the different scores = (final score—T0 score)/T0 score
Evaluation of repeated simulations on stress level Repetitive simulation-based training-related improvement in performance is not associated with a blunting of stress response in MDT members Markers of biological stress (SC) Comparison between group 1 and group 2 Student t-test or non-parametric test U of Mann-Whitney if necessary
Markers of electrophysiological stress (HR, BP, PNN50, HF/LF)
Markers of psychological stress (STAI, PCLS, IES-R)
Inter-observer reproducibility Very good reproducibility due to the use of validated scales Scales of assessment: Observers Intra-class coefficient correlation
Overall performance, IO access, BAT, CTS
  1. Legend: BAT Behavioral Assessment Tool, BP blood pressure, CTS Clinical Teamwork Scale, EIS-R Impact of Event Scale-Revised, HF high frequency, HR heart rate, IO intra-osseous, LF low frequency, PCLS Post-traumatic Check-List Scale, PNN50 proportion of successive NN that differ by more than 50 ms divided by total number of NN, SOM Stress-O-Meter, SC salivary cortisol, STAI State Trait Anxiety Inventory