Table 2.
Content validity of patient-reported outcome measure ~
|
Concept identified in literature review |
SLE-specific HRQoL |
Generic HRQoL |
Fatigue |
Pain |
Depression |
Work |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SLAQ | LupusQoL $ | LupusPRO $ | L-QoL | SLEQOL | SF-36v2 | EQ-5D # | FACIT-Fatigue | MFI | MAF | MPQ | BPI-SF | BDI | HADS | WPAI: Lupus | |
|
Disease-defining signs and symptoms | |||||||||||||||
| Marks on skin |
✓ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Weight gain/bloating |
✓ |
✓ |
|
|
|
|
|
|
|
|
|
|
|
|
|
| Hair loss |
✓ |
✓ |
✓ |
|
|
|
|
|
|
|
|
|
|
|
|
| Looking sick |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Reduced cognitive function |
✓ |
✓ |
✓ |
|
✓ |
|
|
|
✓ |
|
|
|
|
|
|
| Fatigue |
✓ |
✓ |
✓ |
✓ |
✓ |
✓ |
|
✓* |
✓* |
✓* |
|
|
✓ |
|
|
| Pain |
✓ |
|
✓ |
|
✓ |
✓ |
✓ |
|
|
|
✓ |
✓ |
|
|
|
| Fever |
✓ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Weakness |
|
|
|
|
|
✓ |
|
✓* |
✓* |
|
|
|
|
|
|
| Flu-like symptoms |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Impacts | |||||||||||||||
| Physical functioning |
|
✓ |
✓ |
|
✓ |
✓ |
✓ |
|
✓* |
✓* |
|
✓* |
|
|
|
| Daily activities |
|
✓ |
✓ |
✓ |
✓ |
✓ |
✓ |
✓* |
✓* |
✓* |
|
✓* |
|
|
✓ |
| Sleep problems |
|
✓ |
|
|
|
✓ |
|
✓* |
✓* (p) |
|
|
✓* |
|
|
|
| Emotional/Psychological |
✓ |
✓ |
✓ |
✓ |
✓ |
✓ |
✓ |
✓* |
|
✓* (p) |
|
✓* |
✓ |
✓ |
|
| Social functioning |
|
✓ |
|
✓ |
✓ |
✓ |
|
✓* |
✓* (p) |
✓* |
|
|
|
|
|
| Leisure activities |
|
✓ |
|
|
✓ |
✓ |
|
|
✓* |
✓* |
|
|
|
|
|
| Relationships |
|
✓ |
|
✓ |
|
✓ |
|
|
|
✓ (p) |
|
✓* |
|
|
|
|
Work & economic impacts | |||||||||||||||
| Work disability |
|
|
✓ |
|
✓ |
✓ |
|
|
|
✓* |
|
✓* |
|
|
✓ |
| Economic impact |
|
|
✓ |
|
✓ |
✓ |
|
|
|
|
|
|
|
|
|
| Total | 8/27 | 11/27 | 9/27 | 5/27 | 10/27 | 12/27 | 4/27 | 6/27 | 8/27 | 8/27 | 1/27 | 7/27 | 2/27 | 1/27 | 2/27 |
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.
~ The following symptoms were identified as important in the literature review, but are not measured by current PROs: flu-like symptoms, dry mouth, skin rash, speech problems, vision sensitivity to bright lights, sensitivity to hot/cold temperatures, reduced hand grip, haematological abnormalities, sleep related respiratory and movement problems $PRO measure has documented evidence of qualitative research with patients with SLE during item generation #Result valid for both the EQ-5D-3L and EQ-5D-5L *Concept assessed only as a fatigue related impact (p) Concept partially covered by one or more items.