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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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