Table 4

Key properties of a methodologically robust health related quality of life (HRQOL) instrument

PropertyDefinitionMethod of assessment
Validity
 Face12 Measures what it is supposed to measureFull literature review, expert opinion, patient input (eg focus groups)
 Content12 Adequately samples most important areas of interestPre-testing with item reduction or augmentation
 Construct12 Relationship between score and a hypothesis of what is being measuredInstrument compared with another marker of illness to determine if it behaves as predicted
 Criterion12 (convergent)Relationship between new questionnaire and an accepted referenceInstrument compared to an accepted reference measure that evaluates the same or similar features
 Discriminative4 Instrument can distinguish between two groups of dissimilar patientsQOL scores for patients with different disease severity or different patterns of disease should differ significantly
Reliability
 Test-retest4 Ratio of between patient variation to total variation in score Patients who remain stable should have little change in QOL scores on repeated measures. Described by intraclass correlation coefficient (ICC) (0–1, 1 perfect agreement)
 Internal consistency4 Correlation of items within same domain or with the full questionnaire scoreCronbach's alpha coefficient (0–1, 1 excellent)
Responsiveness4 Signal to noise ratio of change with timePatients with clinically important change (improve or deteriorate) should have significant change in QOL score