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Table 2 Patient-reported outcomes comparing telemedicine versus standard outpatient care: the DiaFOTo study, Western Norwaya

From: Effect of a telemedicine intervention for diabetes-related foot ulcers on health, well-being and quality of life: secondary outcomes from a cluster randomized controlled trial (DiaFOTo)

   Telemedicine
(n = 78)
  Standard Outpatient Care (SOC)
(n = 78)
Intervention effect
Baseline   Follow-up p-value Baseline   Follow-up p-value Effectb p-value
Generic Quality of Life measuresc n   n    n   n     
EQ-5D-5L, (0–1) 75 0.72 (0.3) 67 0.76 (0.2) 0.06 72 0.70 (0.3) 56 0.75 (0.2) 0.02 −0.01 (−0.08, 0.05) 0.66
EQ-VAS, (0–100) 74 59.0 (21.8) 68 60.4 (21.7) 0.53 73 57.7 (20.8) 57 63.5 (21.4) 0.02 −3.99 (−10.17, 2.19) 0.21
WHO-5, (0–100) 73 63.2 (21.0) 64 65.4 (19.8) 0.44 67 59.4 (21.5) 54 62.4 (20.6) 0.48 −0.67 (−6.74, 5.39) 0.83
HADS-A, (0–21) 77 4.3 (3.3) 66 4.5 (3.9) 0.89 78 4.6 (4.0) 58 4.7 (3.9) 0.43 −0.25 (−1.28, 0.78) 0.63
HADS-D, (0–21) 77 4.7 (3.3) 66 4.7 (3.9) 0.88 78 5.4 (4.1) 58 5.1 (3.5) 0.57 0.15 (−0.83, 1.1) 0.76
Disease-specific Quality of Life measuresc
 PAID-20, mean (SD) 68 21.6 (18.6) 64 25.4 (20.0) 0.04 62 21.4 (18.3) 48 22.3 (18.0) 0.76 2.56 (−1.95, 7.06) 0.27
 PAID-20 ≥ 40 (%) 68 14 (20.6) 64 11 (17.2) 0.31 62 8 (12.9) 48 7 (14.6) 0.85 −0.34 (−1.22, 0.54) 0.45
NeuroQOL weighted (1–15)
 Painful symptoms 75 4.0 (2.2) 65 4.1 (2.6) 0.97 73 4.2 (2.7) 58 4.2 (2.7) 0.89 0.06 (−0.77–0.88) 0.90
 Reduced feeling 71 4.8 (3.7) 63 4.4 (3.3) 0.19 70 5.2 (3.3) 55 4.7 (3.3) 0.26 −0.03 (−1.06–0.99) 0.95
 Diffuse sensorimotor symptoms 70 5.8 (4.2) 64 5.5 (4.3) 0.29 71 5.7 (4.0) 54 5.4 (3.7) 0.12 0.23 (−0.78–1.24) 0.66
 ADL restrictions 69 7.2 (4.2) 58 6.5 (3.7) 0.19 70 8.2 (4.4) 52 6.3 (4.0) 0.003 1.05 (−0.65–2.75) 0.23
 Interpersonal burden 70 5.5 (3.9) 59 5.1 (4.0) 0.18 71 5.3 (3.5) 50 4.7 (3.6) 0.20 0.02 (−1.18–1.22) 0.97
 Emotional distress 75 4.0 (2.2) 63 4.1 (2.6) 0.97 73 4.2 (2.7) 53 4.2 (2.7) 0.89 0.06 (−0.77–0.88) 0.90
  1. Data are shown as mean ± SD for continuous variables and n (%) percent for categorical variables
  2. aIn the current study we included all participants with at least one valid patient-reported outcome measure at baseline
  3. bRegression coefficient for interaction between time and treatment group in linear mixed effects model for continuous outcome and generalized estimation equations (GEE) for binary outcomes
  4. cHigher scores on EQ-VAS, or WHO-5 reflect better perceived health, health state or psychological well-being. Higher scores on EQ-5D, HADS-anxiety or –depression or PAID-20 reflect lower health-related quality of Life, more anxiety or depressive symptoms or more diabetes distress; Higher scores on the NeuroQOL reflect greater impact of foot ulcers on quality of life