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

From: 'In situ simulation' versus 'off site simulation' in obstetric emergencies and their effect on knowledge, safety attitudes, team performance, stress, and motivation: study protocol for a randomized controlled trial

Variable/outcome on individual level (N = 100) Research hypothesis: experimental group versus control group Outcome measure Type of variable Methods of statistical analysis
Primary outcome     
Multiple choice questions Improvement occurs in the experimental group Percentage correct in 40 multiple choice questions Will be analyzed as interval data, a Gaussian distribution is expected Parametric techniques
  ANOVA
Exploratory outcome     
Safety Attitudes Questionnaire Increased score in the experimental group 33 items on a 5-point scale. Divided into 6 dimensions Will be analyzed as interval data, a Gaussian distribution is expected Parametric techniques
ANOVA
Data are converted to the 100-point scale   Chi-square tests
Stress-Trait Anxiety Inventory Baseline Increased peak score in the experimental group Inventory 20 item (interval 20 to 80). Will be analyzed as interval data, a Gaussian distribution is expected Parametric techniques
ANOVA
Stress-Trait Anxiety Inventory 1
Stress-Trait Anxiety Inventory 2
Cognitive appraisal A Baseline Increased peak score in the experimental group Likert scale 1 (10 point)/Likert scale 2 (10 point) (interval 1/10 to 10) Ordinal data Non-parametric techniques
Cognitive appraisal 1 Mann Whitney U test
Cognitive appraisal 2
Test for salivary cortisol Baseline Increased salivary cortisol level from baseline to peak in the experimental group Cortisol level in nmol/l Interval data Parametric techniques
Test for salivary cortisol 1 ANOVA
Test for salivary cortisol 2
Test for salivary cortisol 3
Evaluation questionnaire Increased positive evaluation in the experimental group 20 questions on a 5-point Likert scale Ordinal data Non-parametric techniques
Treated as ordinal data at the item level
Intrinsic Motivation Inventory Increased score in the experimental group Task evaluation inventory 22 items on a 7-point scale. Divided into 4 dimensions Ordinal data Non-parametric techniques
Mann Whitney U test
Variables on team-level     
(N = 10 teams)
Team Emergency Assessment Measure Improved outcome in the experimental group Video assessment on a 5-point scale (0 to 5) of 11 questions (0 to 44) 10 points scale for global rating of the team Ordinal data Non-parametric techniques
  Mann Whitney U test
Selected clinical measures Improved outcome in the experimental group Minutes before decision making about operation, minutes before operation initiated. Medication given yes/no Interval data Parametric techniques
  1. The table is inspired by SPIRIT 2013: Explanation and elaboration: guidance for protocols of clinical trials [44]. ANOVA, analysis of variance.
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