Background
Methods
Data sources and searches
Inclusion and exclusion criteria
Screening process and data extraction
Development of the conceptual model of systemic lupus erythematosus
Review of the patient-reported outcome measures for systemic lupus erythematosus
Results
Findings from the literature search
Conceptual model of systemic lupus erythematosus
Review of patient-reported outcomes measures
Instrument | Number of items | Recall period | Response format | Reference or rationale for inclusion of PRO if not cited in the literature search |
---|---|---|---|---|
Systemic Lupus Activity Questionnaire (SLAQ) [47] | 28 | Last 3 months | First 27 items have 4-point scale, ranging from ‘none’ to ‘severe’. Last item has a 1–10 numerical rating scale (NRS) | |
LupusQoL [50] | 34 | Last 4 weeks | 5-point scale ranging from ‘never’ to ‘all of the time’ | |
LupusPRO [52] | 43 | Last 4 weeks | 5-point scale ranging from ‘never’ to ‘all of the time’ | |
L-QoL [40] | 25 | At the moment | Dichotomous ‘true’/’not true’ scale | |
SLEQOL [55] | 40 | Last week | All 7 point Likert scales, although scales have different labels (i.e. ‘not difficult at all’ to ‘very difficult’; ‘not at all’ to ‘extremely troubled’; ‘not at all’ to ‘extremely often’) | |
Short Form 36 version 2 (SF-36v2) [56] | 36 | Standard 4-week recall or Acute 1-week recall version. | Varies dependent on scale [Yes/No and 3, 5 and 6-point Likert scales]. | |
6 | Recall of ‘today’ for both 3L and 5 L version. | 3-point scale on 3L and 5-point scale on 5 L version, ranging from absence to inability to perform activity or extreme severity of symptom | Previously used in patients with SLE, and normative data exist for comparison. EQ-5D is a measure used to derive utilities | |
Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) [66] | 13 | Past 7 days | 5-point scale ranging from ‘not at all’ to ‘very much’. | [54] |
Multidimensional Fatigue Inventory (MFI) [67] | 20 | Lately | 5-level agreement scale from ‘Yes, that is true’ to ‘No, that is not true’. | [35] |
Multidimensional Assessment of Fatigue (MAF) [68] | 16 | Past week | 1-10 numerical rating scale (‘not at all’ – ‘a great deal) for items 1–14. Multiple-choice response for items 15 and 16. | [35] |
McGill Pain Questionnaire (MPQ) [69] | 20 | Present pain | Mixed, ranging from 2-point to 6-point scales | [70] |
Brief Pain Inventory – Short Form (BPI-SF) [71] | 15 | Last 24 hours | Most items have an 11 point numerical rating scale, ranging from 0 = no pain and 10 = pain. One item has a binary yes/no response and another ask patients to shade a diagram to show where they have pain. One item has a 0%-100% scale increasing in 10% increments. | Pain is a key symptom of SLE and the BPI-SF has previously been used in a SLE population |
Beck Depression Inventory (BDI) [72] | 21 | Not specified | 4-point scale with detailed wording provided for each response. | Depression is a key concept in SLE. The BDI has been used previously with patients with SLE, and normative data exist for comparison |
Hospital Anxiety and Depression Scale (HADS) [73] | 14 | Past week | 4-point scale | Depression is a key concept in SLE. The HADS has been used previously with patients with SLE and normative data exist for comparison |
Work Productivity and Activity Impairment Questionnaire: Lupus (WPAI:Lupus) [74] | 6 | Past 7 days | Yes/No & NRS | Absenteeism and presenteeism is a major burden for patients with SLE. The WPAI:Lupus has been used previously in patients with SLE and normative data exist for comparison. |
Content validity – conceptual coverage
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
|
Face validity
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 | ✓ | ✓ |
Psychometric properties
Instrument | Psychometrically validated in a SLE population | Reliability | Validity | Ability to detect change | |||
---|---|---|---|---|---|---|---|
Internal consistency (Cronbach’s α) | Test-retest (ICC) | Construct validity | Known groups validity | Concurrent validity | |||
SLAQ | ✓ (0.87) [47] | - | - | ✓ [78] | ✓ [47] | ||
LupusQoL | ✓ [50] | ✓ (>0.70) [50] | ✓ (0.72-0.93) [50] | ✓ [50] | ✓ [50] | ✓ [50] | - |
LupusPRO | ✓ (0.72-0.94) [52] | ✓ (>0.70, except for 3 domains) [52] | ✗ (High floor effects) [52] - | ✓ [52] | - | ||
L-QoL | ✓ [40] | ✓ (0.92) [40] | ✓ (0.92) [40] | - | ✓ [40] | ✓ [40] | - |
SLEQOL | ✓ [55] | ✓ (0.95) [55] | ✓ (0.83) [55] | ✗ (High floor effects) [55] | - | Partial [55] | Partial [55] |
SF-36v2 | ✗ | ||||||
EQ-5D | ✓ [75] | - | ✗ [82] | ✓ [76] | ✓ [76] | ✓ [76] | |
FACIT-Fatigue | ✓ [77] | ✓ (>0.95) [77] | Partial (0.95) [83] | - | ✓ [77] | ✓ [77] | ✓ [77] |
MFI | ✗ | Partial (0-68-0.89) [84] | - | Partial[84] | Partial[87] | ||
MAF | ✗ | Partial (0.93) [68] | Partial (0.87) [88] | Partial[89] | Partial[90] | Partial[68] | Partial[91] |
MPQ | ✗ | Partial (α not provided) [69] | - | - | Partial[93] | Partial[94] | |
BPI-SF | ✗ | Partial (0.80-0.92) [95] | Partial (0.83-0.88) [96] | Partial[99] | |||
BDI | ✗ | Partial (0.81) [102] | Partial (0.93) [102] | Partial[102] | - | ||
HADS | ✗ | Partial (0.83, Anxiety sub-scale; 0.82, Depression sub-scale) [104] | Partial (0.84-0.85 for both sub-scales) [105] | Partial[105] | Partial[105] | ||
WPAI:Lupus | ✗ | - | Partial (Pearson’s: 0.71-0.75) [74] | - | Partial[107] | Partial[108] | Partial[107] |