Table 1.

Methods used to investigate psychometric and other properties of the MP and UF-DBD

Statistical analysis	PRO scores	Time points	Reference measures	Population	Interpretation
Item performance/variability – extent to which potential available response option for each item is selected by patients
Descriptive statistics	• MP • UF-DBD item levela • Monthly and bleeding episode sum scores	• RND • EOT	NA	All patients, by study	• Distributional properties • Floor and ceiling effects
Reliability/Test-retest reliability – ability to give reproducible, consistent scores over a short time period in stable patients
1. Descriptive statistics, Wilcox signed rank test  2. Intraclass correlation coefficient	• MP • UF-DBD • Monthly and bleeding episode sum scores	• SCR2, RND • T2, EOT	• AHb • PGI-S	Stable patients by study:  • AH method: MP and UF-DBD in ASTEROID 1c  • PGI-S scores: UF-DBD and MP in ASTEROID 1 and 2	UF-DBD  • ICC ≥0.50: moderate MP  • ICC < 0.40: poor  • 0.40 to 0.59: moderate  • 0.60 to 0.74: good  • 0.75+: excellent
Construct validity – extent to which a scale measures the intended construct
Known-groups validity – ability of measure to discriminate between patient groups differing in levels of condition severity
1. Jonckheere-Terpstra test   2. Kruskal-Wallis test	• MP • UF-DBD • Monthly and bleeding episode sum scores	• RND • EOT	• AHb • PGI-S	All patients, by studyc	Significance of ordered difference between known groups
Convergent and divergent validity – extent of association between a measure and other measures or variables based on an expected relationship
1. Spearman rank correlation   2. Scatterplots	• MP • UF-DBD • Monthly and bleeding episode sum scores	• RND • EOT • pooled RND and EOT	• MP • UF-DBD • UF-DSD v3 • UF-IS v3 • UFS-QoL • SF-36 v2®	All patients, by study	Strength of correlations  • 0.10 to 0.29: weak  • 0.30 to 0.49: moderate  • 0.50 to 1.0: strong
Criterion validity – extent of relation between PRO instrument scores and a known gold standard measure of the same concept
1. Spearman rank correlation  2. Scatterplots	• MP • UF-DBD • Monthly and bleeding episode sum scores	• RND • EOT	• AHb	All patients with AH measurements	Strength of correlations  • 0.10 to 0.29: weak  • 0.30 to 0.49: moderate  • 0.50 to 1.0: strong
Responsiveness – ability to detect change when a change in the measured concept has occurred
1. Spearman rank correlation, Scatterplots  2. Kruskal-Wallis test, Jonckheere-Terpstra test	• MP • UF-DBD • Monthly and bleeding episode sum scores	• RND • EOT	Correlation analysis  • MP  • UF-DBD  • UF-DSD v3d  • UF-IS v3d  • UFS-QoLd  • AHb  • PGI-S Definition of change  • AHb  • PGI-S	All patients, by studyc	Strength of correlations  • 0.10 to 0.29: weak  • 0.30 to 0.49: moderate  • 0.50 to 1.0: strong Significant or significant ordered difference across the groups
Missing data
Descriptive statistics; frequencies and percentages of missing data (daily scores over time)	• MP • UF-DBD	• RND • EOT	AH	ASTEROID 1, patients with AH measurements: all patients except for Japanese centerse and only US patients
Comparability of methods (AH, MP, UF-DBD)
1. Cross-tabulation of benchmark scores (HMB eligibility, responder status and amenorrhea, calculation of sensitivity, specificity, PPV and NPV)  2. Kaplan–Meier curves; descriptive statistics, histograms of difference	• MP • UF-DBD	• RND • EOT	AH	ASTEROID 1, patients with AH measurements

AH Alkaline hematin method, EOT End of treatment, ICC Intraclass correlation coefficient, MP (MP SAP-cv3) Menstrual pictogram superabsorbent polymer-containing version 3, NA Not applicable/available, NPV Negative predictive value, PPV Positive predictive value, PGI-S Patient Global Impression of Severity, PRO Patient-reported outcomes, RND Randomization, SF-36 v2® Short-Form 36 Health Survey Version 2, SCR Screening, T Treatment, UF-DBD Uterine Fibroid Daily Bleeding Diary, UF-DSD v3b Uterine Fibroid Daily Symptom Diary version 3, UF-IS v3 Uterine Fibroid Impact Scale version 3, UFS-QoL Uterine Fibroid Symptom and Quality of Life Questionnaire

^aMonthly sum scores were based on the 28 days prior to and including the visit date; bleeding episode sum scores were collected on or closest to the visit date within 27 days prior

^bASTEROID 1 only

^cFor analyses including the AH method, only data from patients with AH measurements in ASTEROID 1 were used

^dUse of total instrument scores only

^eAH measurements were not performed in patients from Japanese centers; therefore, these patients were excluded from analysis