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Table 1 Definitions and statistical methods for analyzing primary and secondary outcomes

From: Safety of tubal ligation by minilaparotomy provided by clinical officers versus assistant medical officers: study protocol for a noninferiority randomized controlled trial in Tanzanian women

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
  1. AE Adverse event