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Table 5 Improvement in patient-reported outcomes through 12months

From: The FAST-EU trial: 12-month clinical outcomes of women after intrauterine sonography-guided transcervical radiofrequency ablation of uterine fibroids

 

Baseline

3months

Change from baseline

% Change from baseline

P valuea

6months

Change from baseline

% Change from baseline

P valuea

12 months

Change from baseline

% Change from baseline

P value*

MP

50

423 ± 253

361 (119–1582)

49

202 ± 202

170 (0–1011)

49

221 ± 290

191 (−700, 1265)

49

45.2 ± 57.9%

56.9% (−225–100%)

<.001

48

181 ± 209

107 (0–1011)

48

244 ± 302

191 (−700, 1307)

48

51.9 ± 59.8%

68.6% (−225–100%)

<.001

48

173 ± 200

85 (0–786)

48

243 ± 296

217 (−343, 1543)

48

53.8 ± 50.5%

72.3% (−103–100%)

<.001

SSS

50

61.7 ± 16.9

60.9% (28.1–100%)

50

31.7 ± 20.1

31.3% (0.0–93.8%)

50

30.0 ± 22.2

31.3 (−18.8, 84.4)

50

46.7% ± 32.8%

52.5% (−33.3–100%)

<.001

49

25.1 ± 19.3

18.8 (0.0–78.1)

49

36.7 ± 22.6

37.5 (−6.3, 75.0)

49

57.6 ± 31.4%

66.7% (−22.2–100%)

<.001

49

26.6 ± 24.0

21.9 (0.0–78.1)

49

35.3 ± 26.9

37.5 (−18.8, 93.8)

49

55.1 ± 41.0%

62.5% (−66.7–100%)

<.001

HRQOL

49

34.3 ± 19.0

30.2 (0.0–73.3)

49

76.4 ± 22.2

83.6 (5.2–100)

49

42.1 ± 25.6

40.5 (−7.8, 95.7)

49

336 ± 846%

123% (−11.1–5550%)

<.001

48

79.5 ± 22.7

85.3 (0.9–100)

48

44.5 ± 26.7

45.3 (−5.2, 96.6)

48

266 ± 475%

118% (−28.6–2800%)

<.001

48

80.7 ± 24.7

91.4 (0.9–100)

48

45.7 ± 30.5

45.7 (−33.6, 96.6)

48

277 ± 483%

127% (−54.2–2800%)

<.001

  1. Data are number of subjects; mean ± standard deviation; median (range)
  2. MP Menstrual Pictogram, SSS Symptom Severity Score, HRQOL Health-Related Quality of Life
  3. aWilcoxon Signed-Rank Test, null hypothesis of no change