Background
Methods
Search strategy
Selection of literature
PROM characteristics
Assessment of methodological quality
Measurement propertya | Definition | Deviations from COSMIN checklist | Threshold for positive rating |
---|---|---|---|
Score reliability (single administration) | Classical test theory based estimate of overall proportion of true score variance, calculated from the interitem covariance matrix. | Following Sijtsma et al. 2009, the term “internal consistency” was replaced by single administration reliability. Single administration reliability coefficients were considered to provide information about score reliability. | Reliability coefficient ≥ 0.70. |
Score reliability (test-retest) | Classical test theory based estimate of overall proportion of true score variance, obtained from the correlation between repeated measures with same instrument in stable patients. | None, but single administration and test-retest reliability categories were merged in the measurement properties appraisal. | ICC ≥ 0.70. |
Construct Validity | The degree to which PRO scores are related to scores of other validated measures in a way that is consistent with theories about how the constructs the measures presume to assess, are related. | None. | At least 75% of the results are in accordance with the hypotheses. |
Floor and Ceiling effects | The number of respondents who achieved the lowest or highest possible score. | None. | ≤15% of the respondents achieved the highest or lowest possible score. |
Responsiveness | The extent to which a PROM can detect changes in the construct being measured over time. | Following the ISOQOL recommendations and Revicky et al. 2008, favorable rating for responsiveness required empirical evidence of changes in scores consistent with a priori expectations of researchers; Either evidenced by score improvement following intervention with known efficacy, or score changes in accordance with expectations derived from external anchors of change (e.g. patient-reported changed overall health status). | Standardized change scores of at least moderate magnitude (e.g., ES / SRM ≥ 0.30 in the expected direction if changes were expected). |
Assessment of measurement properties
Content evaluation and assessment of content validity
Item response theory (IRT)
Results
Instrument characteristics
OMERACT core outcome domains | Feasibility | |||||
---|---|---|---|---|---|---|
Instrument | Target population | Subscale (number of items) | Acute gouta | Chronic goutb | Readabilityc | Availability |
Multidimensional scales
| ||||||
Generic | Physical functioning (10), role-physical (4), bodily pain (2), general health (5), vitality (4), social functioning (2), role-emotional (3), mental health (5) | P, PGA, AL | HRQOL, P, PGA, AL | 5.6 | License fee may apply | |
MOS-20 [33] | Generic | Physical function (6), role functional (2), social functioning (1), mental health (5), current perception of health (5), pain (1) | P, PGA, AL | HRQOL, P, PGA, AL | 6.5 | Freely available |
AIMS [33] | Arthritis | Mobility (4), physical activity (5), dexterity (5), household activity (7), social activities (4), activities of daily living (4), pain (4), depression (6), anxiety (6) | P, AL | HRQOL, P, AL | 5.6 | Freely available |
Gout | GIS (24), consists of 5 subscales: gout concern overall (4), gout medication side effects (2), unmet gout treatment need (3), well-being during attack (11), gout concern during attack (4) | PGA | AGA, HRQOL, P, PGA | 7.2d | Freely available | |
Unidimensional scales
| ||||||
Generic | (43)e | AL | AL | 4.6 | Freely available | |
Rheumatic conditions | (10) | AL | AL | 4.0 | Freely available | |
TIQ-20 [42] | Tophaceous gout | (20) | – | TB | 5.6 | Freely available |
RA-WIS [36] | RA | (23) | – | – | 3.7 | License fee may apply |
Single-item PROMs
| ||||||
Multiple | (1) | P | P | 3.3g | Freely available | |
Likert painh [15] | Multiple | (1) | P | P | n/a | Freely available |
NRS paini [15] | Multiple | (1) | P | P | n/a | Freely available |
Multiple | (1) | PGA | PGA | 11.9k | Freely available | |
Physical function NRSl [15] | Gout | (1) | AL | AL | 12.7m | Freely available |
Content description & validity
Truth | Discrimination | ||||
---|---|---|---|---|---|
Instrument | Content Validity | Construct validity | Reliability | Responsiveness | Floor and ceiling effects |
Physical function
| + | + | + | + | + |
Role physical
| – | ? | 0 | + | – |
Bodily pain
| + | + | 0 | + | + |
General health
| n/a | ? | 0 | + | + |
Vitality
| + | ? | 0 | + | + |
Social functioning
| + | ? | 0 | + | – |
Role emotional
| + | ? | 0 | – | – |
Mental health
| + | ? | 0 | – | + |
SF-36 PCS
| n/a | ? | 0 | + | + |
SF-36 MCS
| n/a | ? | 0 | – | + |
MOS-20 [33] | |||||
Physical function
| + | ? | ? | ? | 0 |
Role functioning
| – | ? | ? | ? | 0 |
Social functioning
| + | ? | ? | ? | 0 |
Mental health
| + | ? | ? | ? | 0 |
Health perception
| n/a | ? | ? | ? | 0 |
Pain
| + | ? | ? | ? | 0 |
AIMS [33] | |||||
Mobility
| + | ? | ? | ? | 0 |
Physical activity
| + | ? | ? | ? | 0 |
Dexterity
| + | ? | ? | ? | 0 |
Household activities
| – | ? | ? | ? | 0 |
Social activities
| – | ? | ? | ? | 0 |
Activities of daily living
| – | ? | ? | ? | 0 |
Pain
| + | ? | ? | ? | 0 |
Depression
| + | ? | ? | ? | 0 |
Anxiety
| + | ? | ? | ? | 0 |
Concern overall
| + | ? | +/− | + | + |
Medication side effects
| + | ? | – | – | + |
Unmet treatment need
| + | ? | – | – | + |
Wellbeing during attack
| + | ? | + | + | + |
Concern during attack
| + | ? | + | – | + |
Total GIS
| n/a | ? | + | + | 0 |
+ | +/− | + | + | +/− | |
+ | + | + | ? | – | |
TIQ-20 [42] | + | + | ? | 0 | + |
RA-WIS [36] | + | + | + | 0 | – |
+ | + | ? | + | + | |
Likert pain [15] | n/d | ? | ? | + | + |
NRS pain [15] | n/d | ? | 0 | + | + |
n/a | + | 0 | + | + | |
WPAI Physical function NRS [15] | – | ? | 0 | + | + |