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Journal of Patient-Reported Outcomes

Table 3 Patient-reported outcomes measured 18 months after randomization among outpatients with epilepsy

From: Patient-initiated versus fixed-interval patient-reported outcome-based follow-up in outpatients with epilepsy: a pragmatic randomized controlled trial

Secondary outcomes

Intention-to-treat population

Per-protocol population

Intervention arm (open access telePRO):

N = 202

Control arm (standard telePRO):

N = 150

Difference a at 18- mo. follow-up (95% CI)

Completed the open access intervention:

N = 195

Difference b at 18- mo. follow-up (95% CI)

Well-being (WHO-5)

 Mean (SD)

66.99 (19.45)

69.29 (18.01)

−3.21 (−6.38 to −0.05)

66.94 (19.64)

−3.26 (−6.68 to 0.16)

 Missing, n (%)

4 (2)

4 (3)

3 (2)

Social support for health (HLQ 4)

 Mean (SD)

3.24 (0.60)

3.38 (0.53)

−0.08 (−0.17 to 0.02)

3.24 (0.61)

−0.04(− 0.14 to 0.07)

 Missing, n (%)

5 (2)

4 (3)

5 (3)

Ability to actively engage with healthcare providers (HLQ 6)

 Mean (SD)

3.84 (0.82)

3.87 (0.89)

−0.05 (−0.21 to 0.10)

3.85 (0.82)

−0.04 (− 0.20 to 0.14)

 Missing, n (%)

6 (3)

4 (3)

6 (3)

Understanding health information well enough to know what to do (HLQ 9)

 Mean (SD)

4.03 (0.77)

3.97 (0.85)

0.009 (−0.13 to 0.15)

4.02 (0.78)

0.04 (−0.12 to 0.20)

 Missing, n (%)

6 (3)

4 (3)

6 (3)

Self-efficacy (GSE)

 Mean (SD)

29.78 (5.69)

29.73 (6.14)

−0.22 (−1.22 to 0.78)

29.81 (5.75)

−0.02 (−1.16 to 1.13)

 Missing, n (%)

7 (3)

4 (3)

7 (4)

General health

 Mean (SD)

2.63 (0.93)

2.60 (0.82)

0.05 (−0.10 to 0.19)

2.61 (0.94)

0.06 (−0.11 to 0.22)

 Missing, n (%)

1 (0.05)

1 (0.07)

1 (0.05)

No. of seizure last year

 Mean (SD)

2.50 (11.89)

3.20 (10.21)

−0.72 (−3.20 to 1.75)

2.52 (12.04)

−0.63 (−3.50 to 2.24)

 Missing, n (%)

36 (18)

28 (19)

33 (17)

Side effects

 Mean (SD)

1.54 (0.76)

1.56 (0.83)

−0.03 (−0.18 to 0.11)

1.53 (0.77)

0.005 (−0–15 to 0.17)

 Missing, n (%)

6 (3)

1 (0.07)

6 (3)

Patient activation c

 Mean (SD)

3.42 (0.65)

3.34 (0.77)

0.04 (−0.10 to 0.17)

3.42 (0.65)

0.001 (−0.15 to 0.15)

 Missing, n (%)

6 (3)

4 (3)

6 (3)

Patient activation d

 Mean (SD)

3.22 (0.72)

3.12 (0.75)

0.01 (−0.13 to 0.16)

3.22 (0.73)

0.02 (−0.14 to 0.17)

 Missing, n (%)

5 (2)

4 (3)

5 (2)

Confidence

 Mean (SD)

1.39 (0.65)

1.33 (0.53)

0.03 (−0.9 to 0.16)

1.39 (0.65)

0.06 (−0.07 to 0.20)

 Missing, n (%)

21 (10)

9 (6)

20 (10)

Safety

 Mean (SD)

1.41 (0.70)

1.35 (0.56)

0.02 (−0.12 to 0.16)

1.41 (0.70)

0.07 (−0.09 to 0.23)

 Missing, n (%)

37 (18)

14 (9)

36 (18)

Satisfaction

 Mean (SD)

1.63 (0.68)

1.61 (0.59)

0.01 (−0.13 to 0.15)

1.63 (0.69)

0.05 (−0.11 to 0.20)

 Missing, n (%)

35 (17)

18 (12)

34 (17)

  1. SD Standard deviation, CI Confidence interval, WHO-5 WHO-5 well-being index, HLQ Health literacy questionnaire, GSE General self-efficacy scale
  2. aThe estimated intention-to-treat differences and 95% CIs were obtained after multiple linear regression adjusted for baseline measure
  3. bThe estimated per-protocol differences and 95% CIs were obtained after multiple linear regression adjusted for baseline measure, gender, age, education, cohabitation status, epilepsy duration, and seizures last year
  4. cI am confident that I can tell when I need to get outpatient care
  5. dI am confident I can figure out solutions when new situations or problems arise with my health condition
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