Background
Methods
Study design
Participants
Measurements
One week before surgery T0 | One week after surgery T1 | Three weeks after surgery T2 | Five weeks after surgery T3 | |
---|---|---|---|---|
PROMIS -PF | X | X | x | x |
PROMIS-APS | X | X | x | x |
WHODAS | X | X | x | x |
SF-36 | X | x | x |
PROMIS - physical function v1.2 short form 8b (PROMIS-PF)
PROMIS ability to participate in social roles and activities v2.0 short form 8a (PROMIS-APS)
WHO disability assessment schedule 2.0 (WHODAS)
-
Cognition – understanding & communicating (WHO-CG, 6 items)
-
Mobility– moving & getting around (WHO-MO, 5 items)
-
Self-Care– hygiene, dressing, eating & staying alone (WHO-SC, 4 items)
-
Getting Along– interacting with other people (WHO-GA, 5 items)
-
Life Activities– domestic responsibilities, leisure, work & school (WHO-LA, 4 items), divided in the Household subscale (WHO-LA-H) and the Work subscale (WHO-LA-W, 4 items)
-
Participation– joining in community activities (WHO-PART, 8 items)
The short form (36) health survey (SF-36)
-
Physical Functioning (SF-PF, 10 items)
-
Emotional Role Functioning (SF-ERF, 3 items)
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Physical Role Functioning (SF-PRF, 4 items)
-
Bodily Pain (SF-BP, 2 items)
-
Mental Health (SF-MH, 5 items)
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Vitality (SF-VT, 4 items)
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Social Functioning (SF-SF, 2 items)
-
General Health (SF-GH, 5 items)
Statistical analyses
Hypotheses regarding the construct validity of the PROMIS-PF
Hypotheses regarding the construct validity of the PROMIS-APS
Hypotheses regarding the responsiveness of the PROMIS-PF
Hypotheses regarding the responsiveness of the PROMIS-APS
Results
Participants
Gender (n %) | |
- Male | 7 (23.3%) |
- Female | 23 (76.7%) |
Age (mean sd) | 45.3 (8.8) |
Level of education (n %)a | |
- Low | 6 (20.0%) |
- Medium | 12 (40.0%) |
- High | 12 (40.0%) |
Employment status (n %) | |
- Employed | 25 (83.3%) |
- Unemployed | 5 (16.7%) |
Type of surgery (all laparoscopic) (n %) | |
- Minor surgical procedures | 17 (56.7%) |
- Adnexal surgery | 7 |
- Inguinal hernia repair | 5 |
- Cholecystectomy | 5 |
- Intermediate (hysterectomy) | 13 (43.3%) |
ASA classification (mean sd) |
n = 24
|
1 | 16 (66.7%) |
2 | 7 (29.2%) |
3 | 1 (4.2%) |
BMI (mean sd) | 25.9 (4.6) |
Mean PROMIS-PF T-score (SD) before surgery (T0) | 49.4 (9.5) |
Mean PROMIS-APS T-score (SD) before surgery (T0) | 50.7 (10.1) |
Construct validity
A: Correlations of the PROMIS-PF with the WHO-MO and SF-PF | ||||
WHO-MOa | SF-PF | |||
T0 |
−0.70
|
0.92
| ||
T1 | −0.66 | Not measured | ||
T2 |
−0.84
|
0.92
| ||
T3 |
−0.76
|
0.88
| ||
B: Correlations of the PROMIS-APS with the WHO-LA-H, WHO-LA-W, WHO-PART and SF-PRF | ||||
WHO-LA-H* | WHO-LA-W* | WHO-PART* | SF-PRF | |
T0 |
−0.71
|
−0.76
|
−0.89
|
0.72
|
T1 | −0.61 | −0.55 | − 0.80 | Not measured |
T2 | −0.62 | −0.68 | − 0.65 | 0.58 |
T3 |
−0.91
|
−0.76
| − 0.69 | 0.69 |
Responsiveness
A. PROMIS-PF | ||
Hypotheses on each time point | Explanation Group or subscale: Effect size Change score (SD) | |
Hypothesis: Intermediate surgical procedures show larger change in physical function scores on each time point than minor surgical procedures. | ||
T0-T1 |
Intermediate: 2.11
19.52 (9.25)
|
Minor: 1.23
12.26 (10.00)
|
T1-T2 |
Intermediate: 1.78
4.85 (2.73)
|
Minor: 1.27
10.22 (8.07)
|
T2-T3 |
Intermediate: 1.81
8.12 (4.48)
|
Minor: 0.26
2.61 (9.88)
|
Hypothesis: The PROMIS-PF is equally or more responsive (at most 0.05 smaller effect size) than the WHO-MO subscale of the WHODAS between the consecutive time points | ||
T0-T1 | PROMIS-PF: 1.62 15.40 (9.52) | Who-MO: 2.49 43.96 (17.62) |
T1-T2 |
PROMIS-PF: 1.11
7.90 (7.14)
|
Who-MO: 1.16
33.96 (29.37)
|
T2-T3 |
PROMIS-PF: 0.51
5.08 (10.01)
|
Who-MO: 0.56
12.50 (22.44)
|
The PROMIS-PF is equally or more responsive (at most 0.05 smaller effect size) than the SF-PF subscale of the SF-36 between the consecutive time points | ||
T2-T3 |
PROMIS-PF: 0.51
5.08 (10.01)
|
SF-PF: 0.53
11.21 (21.26)
|
Total hypotheses confirmed: 6/7 = 85.7% | ||
B. PROMIS-APS | ||
Hypotheses on each time point | Explanation Group or subscale: Effect size Change score (SD) | |
Hypothesis: Intermediate surgical procedures show larger change in participation scores between the consecutive time points than minor surgical procedures | ||
T0-T1 |
Intermediate: 1.20
11.81 (9.82)
|
Minor: 0.68
6.97 (10.12)
|
T1-T2 | Intermediate: 0.25 2.56 (10.04) | Minor: 0.42 5.06 (12.04) |
T2-T3 |
Intermediate: 1.16
8.78 (7.54)
|
Minor: 0.45
5.55 (12.36)
|
Hypothesis: The PROMIS-APS is equally or more responsive (at most 0.05 smaller effect size) than the WHO-LA-H of the WHODAS between the consecutive time points | ||
T0-T1 | PROMIS-APS: 0.90 9.07 (10.06) | Who-LA-H: 2.10 51.67 (24.37) |
T1-T2 | PROMIS-APS: 0.33 3.98 (11.95) | Who-LA-H: 1.17 34.00 (29.13) |
T2-T3 |
PROMIS-APS: 0.59
7.00 (11.91)
|
Who- LA-H: 0.32
10.00 (31.58)
|
Hypothesis: The PROMIS-APS is equally or more responsive (at most 0.05 smaller effect size) than the WHO-LA-W of the WHODAS between the consecutive time points | ||
T0-T1 | PROMIS-APS: 0.90 9.07 (10.06) | WHO-LA-W: 1.79 51.42 (28.80) |
T1-T2 | PROMIS-APS: 0.33 3.98 (11.95) | WHO-LA-W: 0.96 30.24 (31.47) |
T2-T3 |
PROMIS-APS: 0.58
7.00 (11.91)
|
WHO-LA-W: 0.30
11.08 (36.47)
|
Hypothesis: The PROMIS-APS is equally or more responsive (at most 0.05 smaller effect size) than the WHO-PART of the WHODAS between the consecutive time points | ||
T0-T1 |
PROMIS-APS: 0.90
9.07 (10.06)
|
WHO-PART: 0.74
16.11 (21.70)
|
T1-T2 | PROMIS-APS: 0.33 3.98 (11.95) | WHO-PART: 0.70 13.06 (18.61) |
T2-T3 |
PROMIS-APS: 0.58
7.00 (11.91)
|
WHO-PART: 0.49
9.78 (20.00)
|
The PROMIS-APS is equally or more responsive (at most 0.05 smaller effect size) than the SF-PRF subscale of the SF-36 between the consecutive time points (T2-T3) | ||
T2-T3 |
PROMIS-APS: 0.58
7.00 (11.91)
|
SF-PRF: 0. 23
9.48 (40.97)
|
Total hypotheses confirmed: 7/13 = 53.8% |