|
Reliability
|
Test-retest
| ✓ |
|
Internal consistency
|
Whether the items in a domain are intercorrelated, as evidenced by an internal consistency statistic (e.g., coefficient alpha)
| ✓ |
|
Inter-interviewer reproducibility (for interviewer-administered PROs only)
|
Agreement between responses when the PRO is administered by two or more different interviewers
|
NA
|
|
Validity
|
Content-related
| ✓a
|
|
Ability to measure the concept (also known as construct-related validity; can include tests for discriminant, convergent and known-groups validity)
|
Whether relationships among items, domains and concepts conform to what is predicted by the conceptual framework for the PRO instrument itself and its validation hypotheses
| ✓ |
|
Ability to predict future outcomes (also known as predictive validity)
|
Whether future events or status can be predicted by changes in the PRO scores
|
x
|
|
Ability to detect change
|
Includes calculations of effect size and standard error of measurement among others
| ✓ |
|
Interpretability
|
Smallest difference that is considered to be clinically important; this can be a specified difference (the minimum important difference) or, in some cases, any detectable difference. The minimum important difference is used as a benchmark to interpret mean score differences between treatment arms in a clinical trial
| ✓b
|
|
Responder definition – used to identify responders in clinical trials for analysing differences in the proportion of responders between treatment arms
|
Change in score that would be clear evidence that an individual patient experienced a treatment benefit. Can be based on experience with the measure using a distribution-based approach, a clinical or non-clinical anchor, an empirical rule, or a combination of approaches
|
NA
|
