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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.