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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).

â–ª Intraoperatively

â–ª 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