Validation of a menstrual pictogram and a daily bleeding diary for assessment of uterine fibroid treatment efficacy in clinical studies

Journal of Patient-Reported Outcomes

Table 2 Convergent and divergent validity analysis with MP and reference measures (monthly sum scores)

Spearman Rank Correlation Coefficient of MP monthly sum score to	RND		EOT
	N	r_s	N	r_s
UF-DBD monthly sum score	283	0.56	263	0.89
UF-DSD v3 monthly average bloating and swelling domain score	283	0.12	263	0.16
UF-DSD v3 monthly average pain domain score	283	0.06	263	0.27
UF-DSD v3 monthly average total score^a	283	0.10	263	0.21
UF-IS v3 monthly sum total score	263	0.21	247	0.35
UFS-QoL symptom domain score at visit	287	0.18	262	0.45
UFS-QoL HRQoL domain score at visit	282	−0.18	255	−0.41
UFS-QoL concerns related to soiling score at visit	282	0.20	257	0.51
SF-36 v2® physical component domain score at visit	278	−0.04	258	− 0.32
SF-36 v2® mental component domain score at visit	279	−0.12	258	−0.27
SF-36 v2® bodily pain subscale score at visit	286	−0.09	262	−0.31

Classification of Spearman rank correlation coefficient r_s: Weak correlation: 0.10 < |r_s| < 0.30, Moderate correlation: 0.30 ≤ |r_s| < 0.50, Strong correlation: 0.50 ≤ |r_s| < 1
All patients analyzed here had been enrolled in the ASTEROID 1 study with an existing date of visit
EOT End of treatment, HRQoL Health-related quality of life, MP (MP SAP-c v3) Menstrual pictogram superabsorbent polymer-containing version 3, N Number of patients, RND Randomization, r_s Spearman rank correlation coefficient, SF-36 v2® Short-Form 36 Health Survey Version 2, UF-DBD Uterine Fibroid Daily Bleeding Diary, UF-DSD v3 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
^aUF-DSD v3 total score with exclusion of item 1 (UF-DBD)