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Table 4 Known groups validity: UFS-QOL scale scores by PGI-I response categories after 12 weeks of treatment in VENUS II: per protocol population (patient-reported outcome approach)

From: Psychometric validation of the 1-month recall Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire (UFS-QOL)

  PGI-I  
Improveda No changeb Worsenedc Pairwise comparison
UFS-QOL n Mean (SD) n Mean (SD) n Mean (SD) p valued
Symptom Severity 284 26.6 (21.7) 45 59.2 (22.5) 18 68.8 (23.2) 1***, 2***
Concern 285 74.7 (31.8) 44 25.2 (23.8) 18 30.6 (32.5) 1***, 2***
Activities 285 79.8 (27.2) 44 31.8 (26.5) 18 40.3 (27.7) 1***, 2***
Revised Activities 285 79.3 (27.8) 44 30.6 (27.4) 18 39.7 (29.4) 1***, 2***
Energy/Mood 285 75.2 (26.7) 44 39.4 (24.8) 18 43.2 (26.8) 1***, 2***
Control 285 79.9 (26.9) 44 47.8 (30.6) 18 42.2 (31.0) 1***, 2***
Self-Consciousness 285 68.9 (31.8) 44 31.8 (29.5) 18 42.6 (32.9) 1***, 2**
Sexual Function 285 71.3 (33.4) 44 42.6 (36.1) 18 48.6 (37.3) 1***, 2*
HRQoL Total 285 76.1 (26.1) 44 36.0 (22.7) 18 40.5 (25.7) 1***, 2***
  1. aIncludes responses of “Very much better”, “Much better”, and “A little better”
  2. bIncludes response of “No change”
  3. cIncludes responses of “A little worse”, “Much worse”, and “Very much worse”
  4. dGeneral linear model – pairwise comparisons between means were performed using Scheffe’s test adjusting for multiple comparisons: *p < 0.05; **p < 0.01; ***p < 0.001; 1, “improved” versus “no change”; 2, “improved” versus “worsened”. The comparison between “no change” versus “worsened” was not significant for each scale. HRQoL health-related quality of life, PGI-I Patient Global Impression of Improvement scale, SD standard deviation, UFS-QOL Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire
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