Outcome | Specific measurement | Metric | Method of aggregation | Time point for measurement | Method of analysis for difference between COs and AMOs |
---|---|---|---|---|---|
Primary outcome | |||||
 Major AEs | AEs graded according to predefined criteria (see Additional file 2, Adverse event listing). | Presence of major AEs | Five-level ordinal categorical measure of AE severity, grouped as major (IIIa–V) or minor (I and II) | During the tubal ligation procedure and through 42 days of follow-up | Chi-square test |
Secondary outcomes | |||||
 Major and minor AEs at different time points during the study | AEs graded according to predefined criteria (see Additional file 2, Adverse event listing). | Presence of major or minor AEs | Five-level ordinal categorical measure of AE severity, grouped as major (IIIa–V) or minor (I and II). | ▪ Intraoperatively ▪ Immediately postoperatively ▪ 3 days postoperatively ▪ 7 days postoperatively ▪ 42 days postoperatively | Chi-square test. |
 Performance: procedure time | Time to event in minutes | Difference between procedure end time and start time | Continuous measure reported as mean procedure time | Intraoperatively | Independent sample t test |
 Performance: difficulties performing procedures | Yes/no | Reported occurrence | Categorical measure of proportion of occurrence | Chi-square test | |
 Performance: inability to complete procedure | Yes/no | Reported occurrence | Categorical measure of proportion of occurrence | Chi-square test | |
 Performance: need for assistance to complete procedure | Yes/no | Reported occurrence | Categorical measure of proportion of occurrence | Chi-square test | |
 Performance: maximum reported pain experienced by participant during procedure | Visual analogue scale (0 = no pain, 10 = worst possible pain) | Reported level of pain | Continuous measure reported as mean pain score | Independent sample t test | |
 Participant satisfaction with tubal ligation | Rating scale | Reported level of satisfaction | Four-category ordinal value (very satisfied, somewhat satisfied, somewhat dissatisfied, or very dissatisfied) | Day 3 and day 42 follow-up visits | Ordinal logistic regression |
 Self-efficacy of providers in performing tubal ligation by minilaparotomy | Self-administered confidence scale | Reported level of confidence | Continuous measure with higher value indicating greater level of confidence | At completion of recruitment | Independent sample t test |
Self-administered comfort scale | Reported level of comfort | Continuous measure with higher value indicating greater level of comfort | Independent sample t test | ||
Self-administered self-efficacy questionnaire adapted from the General Self-Efficacy Scale | Reported level of self-efficacy | Continuous measure with higher value indicating greater level of self-efficacy | Independent sample t test |