Table 3.
Mean PROMIS® Change Scores, by Change in Responsiveness Indicator (Anchor)
| PROMIS Measure and Responsiveness Indicator (Anchor)1 | Mean PROMIS Change2 from Pre-Implant to 3 Months Post-Implant | Mean PROMIS Change2 from 3 to 6 Months Post-Implant | ||||||
|---|---|---|---|---|---|---|---|---|
| Better | Same | Worse | p-value3 | Better | Same | Worse | p-value3 | |
| PROMIS Fatigue | ||||||||
| EQ-5D-3L Usual Activities | −13.7 (1.6) | −5.3 (1.5) | −3.5 (3.1) | <0.001 | −3.4 (2.1) | −1.9 (1.4) | 2.8 (2.3) | 0.132 |
| 6-Minute Walk Test | −10.2 (1.8) | −1.4 (3.9) | 1.2 (4.0) | 0.017 | −7.5 (2.1) | 1.1 (2.0) | −2.1 (2.4) | 0.015 |
| PROMIS Physical Function | ||||||||
| KCCQ-12 Physical Limitations | 8.5 (1.2) | 4.6 (2.3) | 2.7 (1.3) | 0.005 | 2.1 (.9) | −1.6 (1.9) | −.2 (1.4) | 0.139 |
| EQ-5D-3L Mobility | 10.9 (1.3) | 3.7 (1.1) | .1 (2.2) | <0.001 | 5.1 (1.6) | 8 (.8) | −2.8 (1.8) | 0.005 |
| Global Rating of Change | 7.3 (.8) | 5.4 (2.4) | −.7 (2.1) | 0.003 | --- | --- | --- | --- |
| 6-Minute Walk Test | 7.5 (1.2) | −.4 (2.6) | −4.9 (3.1) | <0.001 | 2.1 (1.5) | −.9 (1.4) | 1.1 (1.7) | 0.307 |
| PROMIS Sleep Disturbance | ||||||||
| PROMIS Quality of Life | −6.5 (1.1) | −5.6 (2.1) | 1.3 (2.6) | 0.024 | −1.6 (1.8) | 1.4 (1.3) | −2.2 (1.8) | 0.189 |
| Global Rating of Change | −8.1 (1.2) | −5.3 (1.7) | −.8 (1.9) | 0.006 | --- | --- | --- | --- |
| PROMIS Sleep-related Impairment | ||||||||
| PROMIS Quality of Life | −11.0 (1.2) | −4.5 (2.4) | 6.1 (3.0) | <0.001 | −3.6 (2.0) | .2 (1.4) | 4.2 (2.0) | 0.024 |
| PROMIS Depression | ||||||||
| EQ-5D-3L Anxiety/Depression | −5.2 (1.6) | −2.1 (1.0) | 5.8 (2.7) | 0.002 | −5.5 (2.7) | .6 (1.1) | 1.3 (2.6) | 0.104 |
| PROMIS Emotional Problems | −7.1 (1.1) | −1.9 (1.1) | 4.6 (1.5) | <0.001 | −6.3 (1.3) | 1.0 (1.0) | 6.4 (1.9) | <0.001 |
| Global Rating of Change | −3.8 (1.0) | −2.4 (1.4) | 4.7 (2.2) | 0.003 | --- | --- | --- | --- |
| PROMIS Anxiety | ||||||||
| EQ-5D-3L Anxiety/Depression | −10.9 (2.2) | −5.0 (1.4) | .7 (3.5) | 0.013 | −6.1 (3.2) | 8 (1.3) | 3.8 (3.0) | 0.072 |
| PROMIS Emotional Problems | −14.2 (1.4) | −5.1 (1.4) | 4.0 (1.9) | <0.001 | −5.3 (1.6) | .9 (1.2) | 6.3 (2.4) | <0.001 |
| Global Rating of Change | −9.5 (1.3) | −7.3 (2.1) | 2.2 (2.4) | <0.001 | --- | --- | --- | --- |
| PROMIS Cognitive Function | ||||||||
| PROMIS Mental Health | 6.8 (1.3) | .4 (1.4) | −.7 (1.7) | <0.001 | 2.2 (1.9) | .3 (1.2) | −2.5 (1.6) | 0.144 |
| PROMIS Ability to Participate in Social Roles and Activities | ||||||||
| KCCQ-12 Social Limitation | 6.6 (1.2) | 2.2 (3.3) | .8 (2.8) | 0.107 | 2.7 (1.3) | −2.3 (2.4) | −3.0 (1.7) | 0.020 |
| EQ-5D-3L Usual Activities | 9.2 (1.6) | 3.1 (1.5) | −1.3 (3.2) | 0.003 | 1.2 (2.0) | −.5 (1.3) | −1.5 (2.2) | 0.644 |
| PROMIS Social Activities | 8.9 (1.3) | 3.4 (1.7) | −1.5 (2.0) | <0.001 | 4.5 (1.3) | .9 (1.3) | −5.5 (1.5) | <0.001 |
| Global Rating of Change | 9.2 (1.1) | 2.7 (1.8) | −2.5 (1.9) | <0.001 | --- | --- | --- | --- |
| PROMIS Satisfaction with Social Roles and Activities | ||||||||
| PROMIS Social Activities | 9.5 (1.4) | 2.4 (1.9) | −4.5 (2.2) | <.001 | 4.3 (1.2) | .5 (1.1) | −4.4 (1.3) | <.001 |
1
Better, Same and Worse categories were defined by changes in the anchor (responsiveness indicator); see Methods
2
Mean Change: Least-squares mean (standard error)
3
p-value for overall comparison of three categories (Better, Same, Worse)
---: Global Rating of Change was not measured at 6 months