Figure 1
Flowchart.
Table 1
Baseline characteristics of the study sample and the sample with only baseline information. M = Mean, SD = standard deviation. achi-square test for categorical variables, independent for continuous variables.
| BASELINE (T0) MEAN (SD, n) | STUDY SAMPLE AT BASELINE | NO VALID FOLLOW-UP MEASUREMENT | P-VALUEa |
|---|---|---|---|
| Number of participants (N = 966) | 457 | 612 | |
| Female/Male | 349 (76%)/108 | 446 (73%)/166 | 0.196 |
| Mean age (SD, range) | 48.98 (12.6, 18–85) | 48.92 (12.9, 20–89) | |
| Age groups | 0.480 | ||
| <45 | 160 (35%) | 225 (36.8%) | |
| 45–55 | 151 (33%) | 181 (29.6%) | |
| >55 | 146 (32%) | 206 (33.6%) | |
| Outcome variables | |||
| SPH (M, SD, n) | 2.84 (0,78, 328) | 2.71 (0.81, 328) | 0.044* |
| MANSA Scale score (M, SD, n) | 4.18 (0.93, 275) | 4.07 (1,08, 243) | 0.200 |
| UPCC-ACT Scale score (M, SD, n) | 2.42 (0.61, 320) | 2.39 (0.66, 287) | 0.646 |
| HoNOS Scale score (M, SD, n) | 11.53 (4.71, 260) | 10.69 (5.32, 358) | 0.039* |
Table 2
Paired-samples T-Test. Outcomes at baseline and after a minimum of 120 days for SPH and scale scores of MANSA, UPCC-ACT and HoNOS. D = difference, SD = standard deviation, CI = confidence interval.
| OUTCOME VARIABLES | BASELINE MEAN | >120 DAYS MEAN | D | SD | 95% CI | P- VALUE | COHEN’S d |
|---|---|---|---|---|---|---|---|
| SPH (n = 257) | 2.83 | 3.29 | 0.46 | 0.77 | [–0.55, –0.37] | <.001 | –0.60 |
| MANSA (n = 205) | 4.16 | 4.79 | 0.63 | 0.72 | [–0.73, –0.53] | <.001 | –0.87 |
| UPCC-ACT (n = 250) | 2.42 | 2.63 | 0.21 | 0.51 | [–0.27, –0.15] | <.001 | –0.41 |
| HoNOS (n = 219) | 11.65 | 7.09 | –4.56 | 4.48 | [3.96, 5.16] | <.001 | 1.02 |
Table 3
Repeated measures ANOVA of outcomes by sex.
| OUTCOME VARIABLES | SEX | BASELINE MEAN (SD) | >120 DAYS MEAN (SD) | F | P- VALUE | ηP2 |
|---|---|---|---|---|---|---|
| SPH (n = 257) | Female (n = 186) | 2.90 (0.74) | 3.33 (0.63) | 81.8 | 0.326 | 0.004 |
| Male (n = 71) | 2.65 (0.88) | 3.18 (0.78) | ||||
| MANSA (n = 205) | Female (n = 145) | 4.26 (0.91) | 4.88 (0.86) | 129.8 | 0.895 | 0.000 |
| Male (n = 60) | 3.92 (0.98) | 4.55 (1.02) | ||||
| UPCC-ACT (n = 250) | Female (n = 182) | 2.42 (0.63) | 2.59 (0.55) | 42.4 | 0.118 | 0.010 |
| Male (n = 68) | 2.44 (0.67) | 2.73 (0.58) | ||||
| HoNOS (n = 219) | Female (n = 174) | 11.13 (4.21) | 6.89 (4.19) | 182.4 | 0.037 | 0.020 |
| Male (n = 45) | 13.67 (6.13) | 7.87 (5.84) |
Table 4
Repeated measures ANOVA of outcomes by age group <45, 45–55, >55.
| OUTCOME VARIABLES | AGE GROUPS | BASELINE MEAN (SD) | >120 DAYS MEAN (SD) | F | P- VALUE | ηP2 |
|---|---|---|---|---|---|---|
| SPH (n = 257) | Age <45 (n = 93) | 2.80 (0.82) | 3.32 (0.71) | 90.6 | 0.361 | 0.008 |
| Age 45–55 (n = 84) | 2.74 (0.78) | 3.21 (0.73) | ||||
| Age >55 (n = 80) | 2.96 (0.75) | 3.32 (0.57) | ||||
| MANSA (n = 205) | Age <45 (n = 74) | 4.20 (0.86) | 4.74 (0.95) | 157.1 | 0.370 | 0.010 |
| Age 45–55 (n = 65) | 3.93 (1.01) | 4.56 (1.02) | ||||
| Age >55 (n = 66) | 4.33 (0.91) | 5.05 (0.70) | ||||
| UPCC-ACT (n = 250) | Age <45 (n = 90) | 2.37 (0.63) | 2.62 (0.59) | 41.0 | 0.309 | 0.009 |
| Age 45–55 (n = 82) | 2.43 (0.66) | 2.66 (0.53) | ||||
| Age >55 (n = 78) | 2.48 (0.63) | 2.62 (0.55) | ||||
| HoNOS (n = 219) | Age <45 (n = 76) | 11.51 (4.69) | 7.11 (4.42) | 222.9 | 0.928 | 0.001 |
| Age 45–55 (n = 81) | 12.35 (5.36) | 7.74 (5.16) | ||||
| Age >55 (n = 62) | 10.92 (3.90) | 6.23 (3.78) |
Table 5
Individual clinically relevant change based on EN-index and the SEM. CI = Confidence interval.
| CLINICALLY RELEVANT CHANGE (N, CI EN-INDEX) | EN- INDEX IMPROVEMENT | EN-INDEX STABLE | EN-INDEX DECLINE | SEM IMPROVEMENT | SEM STABLE | SEM DECLINE |
|---|---|---|---|---|---|---|
| SPH (n = 257) (1.78–3.89) | 73 (28.4%) | 184 (71.6%) | 0 (0%) | 117 (45.5%) | 122 (47.5%) | 18 (7%) |
| MANSA (n = 205) (3.53–4.84) | 92 (44.9%) | 110 (53.7%) | 3 (1.5%) | 138 (67.3%) | 47 (22.9%) | 20 (9.8%) |
| UPCC-ACT (n = 250) (2.00–2.84) | 76 (30.4%) | 154 61.6%) | 20 (7.8%) | 120 (48%) | 81 (32.4%) | 49 (19.6%) |
| HoNOS (n = 219) (15.59–7.58) | 124 (56.6%) | 90 (41.1%) | 5 (2.3%) | 146 (66.7%) | 62 (28.3%) | 11 (5%) |