Table 3.
Content and face validity of each patient-reported outcome measure
| PRO Instrument | Content and face validity evaluated with SLE patients using cognitive debriefing methodology | Item wording acceptable | Recall period acceptable for patient population | Response options acceptable |
|---|---|---|---|---|
|
SLE-specific HRQoL |
|
|
|
|
| SLAQ |
✗ |
✓ |
✗ |
✓ |
| LupusQoL |
✓ |
✓ |
✗ |
✓ |
| LupusPRO |
✓ |
✓ |
✗ |
✓ |
| L-QoL |
✓ |
✓ |
✓ |
✓ |
| SLEQOL |
✗ |
✗ ‘Fatigue’ not defined |
✓ |
✗ Confusing |
|
Generic HRQoL |
|
|
|
|
| SF-36v2 |
✗ |
✓ |
✗ |
✓ |
| EQ-5D# |
✗ |
✓ |
✓ |
✓ |
|
Fatigue |
|
|
|
|
| FACIT-Fatigue |
✗ |
✓ |
✓ |
✓ |
| MFI |
✗ |
✓ |
✗ ‘Lately’ too vague |
✗ Confusing |
| MAF |
✗ |
✗ ‘Fatigue’ not defined |
✓ |
✗ Confusing |
|
Pain |
|
|
|
|
| MPQ |
✗ |
✗ Complex terms used |
✓ |
✗ Complex terms used |
| BPI-SF |
✗ |
✓ |
✗ Some items don’t specify recall |
✓ |
|
Depression |
|
|
|
|
| BDI |
✗ |
✗ No question wording |
✗ None specified |
✗ Lengthily |
| HADS |
✗ |
✓ |
✓ |
✓ |
|
Work productivity |
|
|
|
|
| WPAI:Lupus | ✗ | ✗ Some complex terms used | ✓ | ✓ |
SLAQ – Systemic Lupus Activity Questionnaire, SF-36v2 – Short Form [36] Health Survey, EQ-5D – EuroQol 5-Dimensions, FACIT-Fatigue - Functional Assessment of Chronic Illness Therapy, MFI – Multidimensional Fatigue Inventory, MAF – Multidimensional Assessment of Fatigue, MGQ – McGill Pain Scale, BPI – Brief Pain Inventory, BDI – Beck Depression Inventory, HADS – Hospital Anxiety and Depression Scale, WPAI:Lupus – Work Productivity and Activity Impairment Questionnaire: Lupus. #Result valid for both the EQ-5D-3L and EQ-5D-5L.