Plain English summary
What is the key problem/issue/question this manuscript addresses?
Why is this study needed?
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Provide a brief overview of your results and what they mean
Introduction
Methods
Patients
Outcome variables
Generic HRQoL
Disease-specific HRQoL
Criterion measures of change
Patient characteristics
Sociodemographic and clinical variables
Psychosocial variables
Procedure
Statistical analysis
Step 1: establishing a measurement model
Step 2: overall test of response shift
Step 3: detection of specific response shift effects
Step 4: impact of response shift on the assessment of change in HRQoL
Step 5: criterion validity
Step 6: associations of patient characteristics with detected response shift
Results
Patients
Background variables | N |
---|---|
Total number of patients | 191 |
Male patients (%) | 139 (73) |
Age (in years) | |
Mean (SD) | 68.42 (8.67) |
Median | 69 |
Range | 46–86 |
Number of comorbidities | |
1 (%) | 75 (39) |
2 or more (%) | 116 (61) |
Type of Intervention | |
PCI (%) | 145 (76) |
CABG (%) | 46 (24) |
Generic HRQoL
Baseline | Follow-up | |||||
---|---|---|---|---|---|---|
Scales/items | Mean (SD) | Skewness | Kurtosis | Mean (SD) | Skewness | Kurtosis |
SF-36 | ||||||
PCS | 36.02 (9.96) | 0.13 | − 0.70 | 41.66 (10.17) | − 0.35 | − 0.57 |
PF | 51.03 (25.28) | − 0.05 | − 0.93 | 64.81 (25.84) | − 0.63 | − 0.58 |
RP | 28.85 (39.32) | 0.90 | − 0.88 | 54.32 (42.99) | − 0.16 | − 1.72 |
RE | 55.65 (43.74) | − 0.15 | − 1.73 | 70.20 (40.70) | − 0.75 | − 1.18 |
VT | 51.40 (20.46) | − 0.17 | − 0.47 | 59.81 (20.99) | − 0.28 | − 0.53 |
MCS | 47.65 (11.22) | − 0.12 | − 0.92 | 51.09 (10.96) | − 0.90 | 0.06 |
MH | 68.54 (19.34) | − 0.31 | − 0.62 | 75.02 (20.28) | − 0.87 | 0.14 |
SF | 67.80 (25.47) | − 0.52 | − 0.39 | 77.73 (22.33) | − 0.81 | − 0.16 |
BP | 63.30 (23.51) | − 0.06 | − 0.85 | 71.47 (24.07) | − 0.37 | − 0.99 |
GH | 48.06 (18.31) | 0.21 | − 0.65 | 55.92 (20.12) | 0.07 | − 0.52 |
SAQ7 | ||||||
PF | 60.31 (36.23) | − 0.25 | − 1.13 | 74.15 (31.45) | − 0.93 | 0.06 |
PF 1 | 82.73 (23.66) | − 1.34 | 1.01 | 89.44 (20.97) | − 2.41 | 6.37 |
PF 2 | 55.18 (33.89) | − 0.23 | − 1.30 | 71.24 (30.32) | − 0.96 | − 0.03 |
PF 3 | 39.78 (35.71) | 0.36 | − 1.27 | 56.34 (34.91) | − 0.32 | − 1.23 |
AF | 79.59 (27.64) | − 0.94 | 0.17 | 93.32 (17.41) | − 2.57 | 8.09 |
AF 1 | 68.94 (30.36) | − 0.67 | − 0.70 | 88.13 (21.75) | − 2.27 | 5.13 |
AF 2 | 89.21 (20.68) | − 1.97 | 3.01 | 97.07 (11.54) | − 5.62 | 36.42 |
QL | 47.82 (31.24) | 0.07 | − 0.92 | 74.93 (25.32) | − 0.82 | − 0.32 |
QL 1 | 57.98 (30.00 | − 0.32 | − 0.93 | 79.39 (24.29) | − 1.11 | 0.69 |
QL 2 | 38.19 (28.33) | 0.40 | − 0.74 | 69.25 (26.84) | − 0.83 | 0.07 |
SSQ | ||||||
Overall QoL | 5.15 (1.36) | − 0.55 | − 0.45 | |||
Fatigue | 4.80 (1.40) | − 0.39 | − 0.36 | |||
Physical Condition | 4.78 (1.43) | − 0.38 | − 0.58 | |||
Pain | 5.49 (1.47) | − 0.61 | − 0.78 | |||
Social Activities | 4.72 (1.43) | 0.16 | − 0.72 | |||
Emotional Sate | 4.56 (1.31) | 0.31 | − 0.84 | |||
Change NYHA class | 0.55 (0.89) | 0.25 | 0.53 |
The occurrence of response shift (steps 1–3)
Step 1
Steps | χ2 (df) | CFI | RMSEA [90% CI] | SRMR |
---|---|---|---|---|
Step 1: Measurement model | ||||
Initial measurement model | 283.082 (90) | 0.893 | 0.109 [0.095–0.123] | 0.061 |
+ Residual covariance RP-RE | 244.305 (86) | 0.912 | 0.101 [0.086–0.116] | 0.059 |
+ Factor loading VT on PCS | 207.743 (84) | 0.931 | 0.090 [0.075–0.106] | 0.061 |
+ Factor loading SF on PCS (final measurement model) | 176.174 (82) | 0.948 | 0.080 [0.063–0.096] | 0.058 |
Step 2: No response shift model | 202.068 (96) | 0.941 | 0.078 [0.063–0.093] | 0.067 |
Step 3: Response shift model | ||||
+ Reprioritization RP | 195.994 (95) | 0.944 | 0.077 [0.062–0.091] | 0.061 |
+ Recalibration VT (final response shift model) | 190.277 (94) | 0.947 | 0.075 [0.060–0.091] | 0.062 |
Step 2
Step 3
Impact of response shift on the assessment of change (steps 4 and 5)
Step 4
Observed change SE [95% CI] | Change no response shift modela SE [95% CI] | Change response shift modela SE [95% CI] | |
---|---|---|---|
PCS | 0.62 [0.32–0.91] | 0.83 [0.72–0.94] | 0.87 [0.76–0.98] |
MCS | 0.32 [0.02–0.61] | 0.45 [0.33–0.56] | 0.47 [0.35–0.59] |
Step 5
Criterion variables | Observed change | No response shift modela | Response shift modela | |||
---|---|---|---|---|---|---|
PCS | MCS | PCS | MCS | PCS | MCS | |
Change NYHA class | 0.48 | 0.17 | 0.60 | 0.38 | 0.60 | 0.38 |
SSQ | ||||||
Overall QoL | 0.39 | 0.14 | 0.61 | 0.39 | 0.61 | 0.39 |
Fatigue | 0.42 | 0.19 | 0.70 | 0.43 | 0.70 | 0.43 |
Physical Condition | 0.43 | 0.22 | 0.74 | 0.50 | 0.74 | 0.50 |
Pain | 0.32 | 0.09 | 0.45 | 0.28 | 0.45 | 0.28 |
Social Activities | 0.35 | 0.19 | 0.67 | 0.41 | 0.67 | 0.41 |
Emotional Sate | 0.26 | 0.23 | 0.54 | 0.56 | 0.56 | 0.53 |
Mean correlation | 0.38 | 0.18 | 0.60 | 0.42 | 0.62 | 0.42 |
Associations of patient characteristics with detected response shift (step 6)
Step 6
Disease-specific HRQoL
The occurrence of response shift (steps 1–3)
Step 1
Steps | χ 2 (df) | CFI | RMSEA [90% CI] | SRMR |
---|---|---|---|---|
Step 1: Measurement model | 94.239 (55) | 0.962 | 0.070 [0.045–0.093] | 0.053 |
Step 2: No response shift model | 111.374 (63) | 0.953 | 0.073[0.050–0.094] | 0.073 |
Step 3: Response shift model | ||||
+ Reconceptualization QL2 (final response shift model) | 110.487 (62) | 0.969 | 0.059[0.033–0.083] | 0.063 |
Step 2
Step 3
Impact of response shift on the assessment of change (steps 4 and 5)
Step 4
Observed change SE[95% CI] | Change no response shift modela SE[95% CI] | Change response shift modela SE[95% CI] | |
---|---|---|---|
Physical Functioning | 0.55 [0.26–0.85] | 0.63 [0.52–0.74] | 0.63 [0.52–0.74] |
Angina Frequency | 0.62 [0.32–0.91] | 0.89 [0.76–1.02] | 0.88 [0.76–1.01] |
Quality of Life | 0.95 [0.61–1.25] | 1.08 [0.94–1.22] | 0.83 [0.70–0.97] |
Step 5
Criterion variables | Observed change | No response shift modela | Response shift modela | ||||||
---|---|---|---|---|---|---|---|---|---|
PF | AF | QoL | PF | AF | QoL | PF | AF | QoL | |
Change NYHA class | 0.39 | 0.31 | 0.54 | 0.26 | 0.45 | 0.58 | 0.28 | 0.45 | 0.58 |
SSQ | |||||||||
Overall QoL | 0.17 | 0.26 | 0.30 | 0.38 | 0.68 | 0.63 | 0.38 | 0.66 | 0.58 |
Fatigue | 0.11 | 0.06 | 0.31 | 0.35 | 0.38 | 0.66 | 0.36 | 0.43 | 0.65 |
Physical Condition | 0.14 | 0.01 | 0.33 | 0.44 | 0.37 | 0.70 | 0.45 | 0.41 | 0.70 |
Pain | 0.18 | 0.24 | 0.24 | 0.36 | 0.59 | 0.41 | 0.36 | 0.53 | 0.38 |
Social Activities | 0.19 | 0.12 | 0.30 | 0.41 | 0.44 | 0.59 | 0.41 | 0.41 | 0.59 |
Emotional State | 0.04 | 0.13 | 0.23 | 0.23 | 0.40 | 0.52 | 0.23 | 0.38 | 0.52 |
Mean | 0.17 | 0.16 | 0.32 | 0.35 | 0.47 | 0.58 | 0.35 | 0.47 | 0.57 |